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EXACTRAC<br />

DYNAMIC<br />

EXACTRAC DYNAMIC SURFACE<br />

Version 2.0<br />

Clinical User Guide<br />

Revision 1.0<br />

Date of issue: 2023-11-15 (ISO 8601)<br />

Copyright 2023, Brainlab AG Germany. All rights reserved.


TABLE OF CONTENTS<br />

TABLE OF CONTENTS<br />

1 GENERAL INFORMATION.............................................................................................5<br />

1.1 Contact Data ........................................................................................................................................5<br />

1.2 Legal Information ...............................................................................................................................6<br />

1.3 Symbols................................................................................................................................................9<br />

1.4 Using the System .............................................................................................................................11<br />

1.5 Compatibility with Medical Devices .............................................................................................15<br />

1.6 Cybersecurity and Software Environment..................................................................................17<br />

1.7 ExacTrac <strong>Dynamic</strong> Network Integration (IEC 80001) ................................................................23<br />

1.8 User Management.............................................................................................................................27<br />

1.9 Technical Requirements For ExacTrac <strong>Dynamic</strong> Preparation Application..........................29<br />

1.10 Training and Documentation .......................................................................................................31<br />

2 CLINICAL OVERVIEW .....................................................................................................33<br />

2.1 Using ExacTrac <strong>Dynamic</strong> in a Clinical Setting...........................................................................33<br />

2.2 ExacTrac <strong>Dynamic</strong> Integration with Specific Linacs ................................................................38<br />

2.3 Positioning with Varian or Elekta..................................................................................................41<br />

3 GETTING STARTED ..........................................................................................................42<br />

3.1 Preparing for Treatment ..................................................................................................................42<br />

3.2 Prepositioning Contour...................................................................................................................43<br />

3.3 About Patient Positioning...............................................................................................................44<br />

3.4 Room Lighting Conditions .............................................................................................................45<br />

3.5 Avoiding Collisions..........................................................................................................................46<br />

3.6 Technical Considerations ...............................................................................................................47<br />

3.7 Patient Data Prerequisites..............................................................................................................49<br />

4 SYSTEM STARTUP AND SHUTDOWN............................................................50<br />

4.1 About System Startup and Shutdown .........................................................................................50<br />

2 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


TABLE OF CONTENTS<br />

4.2 Starting the ExacTrac <strong>Dynamic</strong> Software....................................................................................53<br />

4.3 Background Services ......................................................................................................................54<br />

4.4 Restarting the System .....................................................................................................................56<br />

4.5 Shutting Down the Software ..........................................................................................................57<br />

4.6 Shutting Down the System.............................................................................................................58<br />

4.7 Overview of Available Applications..............................................................................................60<br />

5 PREPARATION .......................................................................................................................61<br />

5.1 Using the Preparation Application ...............................................................................................61<br />

5.2 Plan Selection ...................................................................................................................................63<br />

5.3 Template Selection...........................................................................................................................66<br />

5.4 Template Editor.................................................................................................................................67<br />

5.5 Treatment Plan Settings..................................................................................................................70<br />

5.6 Preparation Workflows....................................................................................................................76<br />

5.7 Isocenters Overview ........................................................................................................................77<br />

5.8 Finish Patient Preparation..............................................................................................................80<br />

6 TREATMENT.............................................................................................................................81<br />

6.1 Overview of Available Workflows .................................................................................................81<br />

6.1.1 External Positioning Workflow ..........................................................................................................82<br />

6.1.2 Breath-hold Workflow .......................................................................................................................83<br />

6.2 Loading and Confirming Plans .....................................................................................................86<br />

6.3 Patient Feedback System ...............................................................................................................89<br />

6.4 Patient Prepositioning.....................................................................................................................92<br />

6.4.2 Prepositioning .................................................................................................................................93<br />

6.4.3 External Positioning with <strong>Surface</strong> Monitoring Workflows ..................................................................96<br />

6.4.4 Prepositioning in Breath-hold Workflows ..........................................................................................98<br />

6.5 <strong>Surface</strong> Tracking Area ..................................................................................................................100<br />

6.6 Breath-hold Respiratory Point ....................................................................................................104<br />

6.7 Breath-hold Navigation .................................................................................................................106<br />

6.7.1 Breath-hold External Positioning with <strong>Surface</strong> Monitoring ..............................................................106<br />

6.8 External Imaging.............................................................................................................................123<br />

6.9 Patient Monitoring..........................................................................................................................125<br />

7 BEAM MAPPING.................................................................................................................132<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 3


TABLE OF CONTENTS<br />

7.1 About Beam Mapping ....................................................................................................................132<br />

8 SYSTEM CALIBRATION AND DAILY CHECK SURFACE ............136<br />

8.1 About Performing Calibrations ...................................................................................................136<br />

8.2 About 3D Camera Warm-Up .........................................................................................................138<br />

8.3 Calibration Workflows ...................................................................................................................140<br />

8.3.1 Performing Thermal to 3D Camera Calibration...............................................................................141<br />

8.3.2 Performing Isocenter Calibration <strong>Surface</strong> .......................................................................................144<br />

8.4 Daily Check <strong>Surface</strong>.......................................................................................................................147<br />

8.5 <strong>Surface</strong> Tracking QA......................................................................................................................150<br />

9 REVIEWING PATIENT DATA....................................................................................153<br />

9.1 Reviewing Patient Data .................................................................................................................153<br />

9.2 Repeat Export..................................................................................................................................154<br />

9.3 Archive/Delete Patients.................................................................................................................156<br />

9.4 Generating Treatment Reports ....................................................................................................158<br />

10 ALGORITHMS ....................................................................................................................159<br />

10.1 Calibration......................................................................................................................................159<br />

10.2 <strong>Surface</strong> Tracking...........................................................................................................................160<br />

11 APPENDIX..............................................................................................................................162<br />

11.1 Preparation Software Revalidation Workflow ........................................................................162<br />

11.2 Status Information........................................................................................................................163<br />

11.3 System Messages.........................................................................................................................167<br />

11.4 Abbreviations ...............................................................................................................................183<br />

INDEX ..................................................................................................................................................184<br />

4 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1 GENERAL INFORMATION<br />

1.1 Contact Data<br />

Support<br />

If you cannot find information you need in this guide, or if you have questions or problems, contact<br />

Brainlab support:<br />

Region Telephone and Fax Email<br />

United States, Canada, Central<br />

and South America<br />

Tel: +1 800 597 5911<br />

Fax: +1 708 409 1619<br />

us.support@brainlab.com<br />

Brazil Tel: 0800 892 1217 brazil.support@brainlab.com<br />

UK Tel: +44 1223 755 333<br />

Spain Tel: +34 900 649 115<br />

France and French-speaking<br />

regions<br />

Africa, Asia, Australia, Europe<br />

Japan<br />

Tel: +33 800 676 030<br />

Tel: +49 89 991568 1044<br />

Fax: +49 89 991568 5811<br />

Tel: +81 3 3769 6900<br />

Fax: +81 3 3769 6901<br />

support@brainlab.com<br />

Expected Service Life<br />

Brainlab provides ten years of service for system components. During this period of time, spare<br />

parts as well as field support are offered. If the software remains in service after the end of<br />

support, the cybersecurity risks may increase over time.<br />

Feedback<br />

Despite careful review, this user guide may contain errors. Please contact us at<br />

user.guides@brainlab.com if you have improvement suggestions.<br />

Manufacturer<br />

Brainlab AG<br />

Olof-Palme-Str. 9<br />

81829 Munich<br />

Germany<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 5


Legal Information<br />

1.2 Legal Information<br />

Copyright<br />

This guide contains proprietary information protected by copyright. No part of this guide may be<br />

reproduced or translated without express written permission of Brainlab.<br />

Brainlab Trademarks<br />

Brainlab ® , Brainlab Connected Care ® , Brainlab Elements ® , ExacTrac <strong>Dynamic</strong> and ExacTrac<br />

<strong>Dynamic</strong> <strong>Surface</strong> ® are registered trademarks of Brainlab AG or an affiliated company.<br />

NOTE: See brainlab.com/trademarks for details.<br />

Non-Brainlab Trademarks<br />

To the knowledge of Brainlab AG, the following trademark information applies:<br />

• ARIA OIS, Edge, TrueBeam, VitalBeam and PerfectPitch are registered trademarks of Varian<br />

Medical Systems, Inc.<br />

• eBUS is a registered trademark of Pleora Technologies Inc.<br />

• Elekta, iGUIDE, HexaPOD, MOSAIQ and Response are registered trademarks of Elekta AB.<br />

• Laird is a registered trademark of Laird Thermal Systems GmbH.<br />

• Bitlocker, Microsoft and Windows are registered trademarks of Microsoft Corporation.<br />

• NVIDIA is a trademark and/or registered trademark of NVIDIA Corporation in the US and/or<br />

other countries.<br />

• Varex and Varex Imaging are registered trademarks of Varex Imaging Corporation in the US<br />

and/or other countries.<br />

Patent Information<br />

This product may be covered by one or more patents or pending patent applications. For details,<br />

see: www.brainlab.com/patent.<br />

Integrated Third-Party Software<br />

This software is based in part on the following work. Full license and copyright notices can be<br />

found here: https://blguides.com/third-party-software-licenses<br />

Software Version Software Version<br />

ACE 6.5.8 LightBurst 1.6.0<br />

Chromium Embedded<br />

Framework (CEF)<br />

79.1.38+gecefb59<br />

+chromium-79.0.3945.13<br />

0<br />

Merge DICOM Toolkit 5.12.0<br />

C++ REST SDK 2.10.14 meta 0.1.0<br />

cryptopp 8.1.0 Modernizr 2.8.3<br />

d3js 3.5.17 nicescroll 3.6.0<br />

durandal 2.1.0 node.js 12.13.1<br />

eigen 3.4.0 Nvidia NVAPI release 367<br />

Filament 1.4.0 OpenCV 4.7.0<br />

FTD2XX 2.12.36 openjpeg 2.4.0<br />

6 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

Software Version Software Version<br />

FX11 4.2.0 pdf.js 1.4.20<br />

ICU 1.8.1 range-v3 0.5.0<br />

jquery 2.1.4 react.js 16.8.6<br />

jqueryui 1.11.1 RenderDocAPI 1.4.0<br />

knockout 3.5.1 requirejs 2.3.5<br />

LAPACK 3.2.1 SolvOpt 1.2<br />

libjpeg 2.1.2, 6b UltraVNC 1.3.8.1<br />

libjpeg-turbo 2.1.2 Xerces-C++ 3.2.3<br />

LibJpeg16, LibJpeg8 3.6.0, 6b yajl 2.1.0<br />

LibJpeg2k 2.4.0 zlib 1.2.12<br />

libpng 1.6.37 Xerces-C++ 3.2.3<br />

libtiff 3.6.0<br />

CE Label<br />

The CE label indicates that the Brainlab product complies with the General Safety<br />

and Performance Requirements of European Regulation 2017/745, the Medical<br />

Device Regulation ("MDR").<br />

ExacTrac <strong>Dynamic</strong> is a Class IIb product according to the rules established by<br />

the MDR.<br />

Report Incidents Related to This Product<br />

You are required to report any serious incident that may have occurred related to this product to<br />

Brainlab, and if within Europe, to your corresponding national competent authority for medical<br />

devices.<br />

Registration, Evaluation and Authorization of Chemicals (REACH)<br />

REACH is the European chemicals law that came into force to improve the protection of human<br />

health and the environment from risks that can be posed by chemicals. The identification of a<br />

substance as a substance of very high concern and its inclusion in the candidate list for REACH<br />

creates certain legal obligations for the importers, producers and suppliers of an article that<br />

contains such a substance. Brainlab requests suppliers to inform whether and to what extent<br />

substances from the list are used in their products. For further information regarding REACH<br />

processes at Brainlab, contact us here:<br />

www.brainlab.com/reach/<br />

Electronic Product Radiation Control (EPRC) Program (US Only)<br />

According to the EPRC program of the FDA, ExacTrac <strong>Dynamic</strong> is classified as a medical<br />

charged-particle radiation therapy system (Accelerator, Linear, Medical), radiation-emitting product<br />

code IYE.<br />

Based on 21 CFR (Code of Federal Regulations Title 21) of the CDRH, no performance standard<br />

is applicable and General Radiological Health requirements apply (21 CFR 1000-1005).<br />

Packaging and Packaging Disposal<br />

No special disposal of the packaging material is required.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 7


Legal Information<br />

Disposal Instructions<br />

When a medical device reaches the end of its functional life, clean the device of all biomaterial/<br />

biohazards and safely dispose of the device in accordance with applicable laws and regulations.<br />

Only dispose of electrical and electronic equipment in accordance with statutory regulations.<br />

For information regarding the WEEE (Waste Electrical and Electronic Equipment)<br />

directive or relevant substances that could be present in the medical equipment,<br />

visit:<br />

https://www.brainlab.com/sustainability/<br />

https://www.brainlab.com/about-brainlab/technology/weee/<br />

Warranty<br />

Warranties do not apply to products that have been damaged due to accidents, misuse,<br />

improper reinstallation, or inadequate packaging in the case of return shipments.<br />

Warranties do not apply to product components that have been modified or replaced<br />

without the written authorization of Brainlab.<br />

IEC Compliance<br />

In accordance with radiation protection, ExacTrac <strong>Dynamic</strong> is compliant to IEC 60601-2-68:2014.<br />

8 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.3 Symbols<br />

Warnings<br />

Warning<br />

Warnings are indicated by triangular warning symbols. They contain safety-critical<br />

information regarding possible injury, death or other serious consequences associated<br />

with device use or misuse.<br />

Cautions<br />

Cautions are indicated by circular caution symbols. They contain important information<br />

regarding potential device malfunctions, device failure, damage to device or damage to<br />

property.<br />

Notes<br />

NOTE: Notes are formatted in italic type and indicate additional useful hints.<br />

Product Symbols<br />

The below symbols may be found on the system.<br />

Symbol<br />

Explanation<br />

Unique device identifier<br />

Medical device<br />

Manufacturer's serial number<br />

Manufacturer's batch code<br />

Article number<br />

Swiss authorized representative<br />

Manufacturer<br />

Date of manufacture<br />

NOTE: The date is expressed as in ISO 8961 as YYYY-MM-DD.<br />

Consult instructions for use<br />

U.S. federal law restricts this device to sale by or on order of a physician<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 9


Symbols<br />

Symbol<br />

Explanation<br />

Temperature limit<br />

NOTE: Indicates the temperature limits to which the medical device can be safely<br />

exposed.<br />

Humidity limitation<br />

NOTE: Indicates the range of humidity to which the medical device can be safely exposed.<br />

Atmospheric pressure limitation<br />

NOTE: Indicates the range of atmospheric pressure to which the medical device can<br />

be safely exposed.<br />

Follow the instructions for use<br />

Waste Electrical and Electronic Equipment<br />

Warning; radioactive material or ionizing radiation<br />

Warning; electricity<br />

Hot surface<br />

10 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.4 Using the System<br />

Abbreviated Device Description<br />

ExacTrac <strong>Dynamic</strong> (ETD) is a patient positioning and monitoring device used in a radiotherapy<br />

environment as an add-on system to standard linear accelerators (linacs). It uses radiotherapy<br />

treatment plans and the associated computed tomography (CT) data to determine the patient's<br />

planned position and compares it via oblique X-ray images to the actual patient position. The<br />

calculated correction shift will then be transferred to the treatment machine to align the patient<br />

correctly at the machine's treatment position. During treatment, the patient is monitored with a<br />

thermal-surface camera and X-ray imaging to ensure that there is no misalignment due to patient<br />

movement. Positioning and monitoring are also possible in combination with implanted markers.<br />

By defining the marker positions, ExacTrac <strong>Dynamic</strong> can position the patient by using X-rays and<br />

thereafter monitor the position during treatment.<br />

Additionally, ExacTrac <strong>Dynamic</strong> features a breath-hold (BH) functionality to serve as a tool to<br />

assist respiratory motion management. This functionality includes special features and workflows<br />

to correctly position the patient at a BH level and thereafter monitor this position using surface<br />

tracking. Regardless of the treatment indication, a correlation between the patient’s surface and<br />

internal anatomy must be evaluated with Image-Guided Radiation Therapy. The manually<br />

acquired X-ray images support a visual inspection of organs at risk (OARs). The aim of this<br />

technique is to treat the patient only during breath hold phases where the treatment target is at a<br />

certain position to reduce respiratory-induced tumor motion and to ensure a certain planned<br />

distance to OARs such as the heart. In addition to the X-ray based positioning technique, the<br />

system can also monitor the patient after external devices such as Cone-Beam CT (CBCT has<br />

been used to position the patient).<br />

The ExacTrac <strong>Dynamic</strong> <strong>Surface</strong> (ETDS) is a camera-only platform without the X-ray system and<br />

is available as a configuration which enables surface-based patient monitoring. This system<br />

includes an identical thermal-surface camera, workstation, and interconnection hardware to the<br />

linac as the ETD system. The workflows supported by ETDS are surface based only and must be<br />

combined with an external IGRT device (e.g., CBCT).<br />

Intended Purpose<br />

The device supports radiotherapy and radiosurgery.<br />

Intended Use and Indications for Use<br />

ExacTrac <strong>Dynamic</strong> is intended to position patients at an accurately defined point within the<br />

treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures,<br />

to monitor the patient position and to provide a beam hold signal in case of a deviation in order to<br />

treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.<br />

Intended Patient Population<br />

ExacTrac <strong>Dynamic</strong> is intended for all patients undergoing Radiotherapy or Radiosurgery<br />

treatments. There are no physiological limitations or restrictions regarding age, weight, gender,<br />

etc.<br />

Intended Part of the Body or Type of Tissue Applied to or Interacted With<br />

The system consists of many components with different functions and locations. Body contact<br />

does not affect all components in the same way.<br />

Most components of the system, like X-ray generators, are out of reach for the user and patient.<br />

Other components, like covers and units mounted on the ceiling, are not reachable or not meant<br />

to be touched by users or patients during intended use.<br />

Body contact is instead expected for the following categories of components:<br />

• Phantoms, required to calibrate the system, have only user contact. They are handled by the<br />

user and no patient contact is expected nor foresee. The user picks them up from the storage<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 11


Using the System<br />

location and positions them where appropriate according to the selected calibration procedure<br />

and proceed with the calibration or daily check. Optional tools (e.g., X-ray QA support device)<br />

needed to carry out specific tests can also be included in this category.<br />

• Electronic interfaces required for the user to interact with the system. No patient contact is<br />

expected for these components.<br />

• ExacTrac <strong>Dynamic</strong> Patient Feedback System is a component of the system that is meant to<br />

help the patient follow the breathing instructions when using breath-hold functionality. The<br />

device is firstly cl<strong>amp</strong>ed to the couch-top by the user and it requires afterwards a fine<br />

adjustment to reach the desired position. This adjustment can be performed by the user or<br />

directly by the patient. The adjustment is done by means of handles located at both sides of the<br />

mirror. As an alternative to this device, the customer is provided also with the article ExacTrac<br />

<strong>Dynamic</strong> Patient Feedback Glasses. The article is worn directly by the patient during a BH<br />

treatment similarly to standard optical glasses.<br />

Intended User Profile<br />

The intended users of ExacTrac <strong>Dynamic</strong> are medical professionals, who are qualified according<br />

to country and hospital specific regulations to provide (apply) radiation therapy treatments (e.g.,<br />

Radiation Therapist, Radiation Oncologist/Physician, Medical Physicist/Physicist, Dosimetrists).<br />

ExacTrac <strong>Dynamic</strong>-specific roles:<br />

• Radiation Technologist, Technician, Radiographer (MTR)<br />

- Schedule, prepare patient for patient positioning<br />

- Patient positioning<br />

- Patient's motion monitoring during treatment<br />

- QA task, if they have extended education<br />

• Medical Physicist (MP):<br />

- Schedule, prepare patient for patient positioning<br />

- Patient positioning<br />

- Patient's motion monitoring during treatment<br />

- System calibration<br />

• Radiation Oncologist (RO):<br />

- Supervise patient's motion monitoring during treatment<br />

• Patients<br />

- Adjust and use mirror and user interface for breathing feedback<br />

Intended Use Environment<br />

For both ExacTrac <strong>Dynamic</strong> and ExacTrac <strong>Dynamic</strong> <strong>Surface</strong> shall be installed in a treatment<br />

room within a hospital radiation therapy department.<br />

ExacTrac <strong>Dynamic</strong> and ExacTrac <strong>Dynamic</strong> <strong>Surface</strong> have a surface-tracking-camera system<br />

installed in the treatment room.<br />

For ExacTrac <strong>Dynamic</strong> two flat panels are mounted to the ceiling and two X-ray tubes are<br />

embedded in the floor or placed on top of the floor (on-floor installations).<br />

For both versions the main device used to control ExacTrac <strong>Dynamic</strong> or ExacTrac <strong>Dynamic</strong><br />

<strong>Surface</strong> is a console that is located outside of the treatment room. Keyboard and monitor are also<br />

provided. A touchscreen is mounted inside the treatment room.<br />

A stable electrical and IT environment (min 1000 Base-T, Latency > 100 ms) is prerequisite for the<br />

use of ExacTrac <strong>Dynamic</strong>.<br />

Environmental conditions are as follows:<br />

Operating Conditions<br />

Storage Conditions<br />

Humidity range 30% to 70% 15% to 75%, non-condensing<br />

Ambient temperature 16 °C to 35 °C -10 °C to 50 °C<br />

Atmospheric pressure 800 hPa to 1013 hPa 700 hPa to 1013 hPa<br />

12 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

Performance Characteristics<br />

ExacTrac <strong>Dynamic</strong> shall provide a translation accuracy better than 1.0 mm and a rotational<br />

accuracy better than 1.0° for a rigid body.<br />

The surface deviation shall be better than 1.5 mm and 1° for rigid body. For the breath-hold the<br />

accuracy shall be better than 2 mm.<br />

Essential Performance Characteristics<br />

A<br />

B1<br />

B2<br />

C<br />

D<br />

E<br />

If a surface based deviation between reference and detected patient position is indicated<br />

and if an allowed tolerance for these values is defined, this deviation is calculated and<br />

shown with an accuracy of 1.5 mm and 1° for a rigid body.<br />

If an X-ray and anatomy based deviation between planned and detected patient position<br />

is indicated, this deviation is calculated and shown with an accuracy of 1 mm and 1° for a<br />

rigid body.<br />

If an X-ray and implanted marker based deviation between planned and detected patient<br />

position is indicated, this deviation is calculated and shown with an accuracy of 1 mm and<br />

1° for a rigid body.<br />

Providing shift values to a third-party patient support system as confirmed by the user.<br />

Providing a "beam hold" signal at the ExacTrac <strong>Dynamic</strong> hardware output to the thirdparty<br />

linac within 1s after a deviation between planned and actual patient position exceeding<br />

tolerance limits was detected.<br />

Indicating a deviation between actual and planned patient position during breath-hold<br />

based on surface tracking with an accuracy of 2 mm.<br />

Contraindications<br />

ExacTrac <strong>Dynamic</strong> X-ray imaging radiation, and the therapeutic treatment radiation, can<br />

potentially have detrimental interaction with active implantable medical devices such as<br />

pacemakers and active medical devices worn on the body. To prevent injury to patients wearing<br />

pacemakers or other active implants, the implant manufacturer should be contacted regarding<br />

possible hazards resulting from radiation exposure.<br />

Side Effects and Complications<br />

ExacTrac <strong>Dynamic</strong> uses ionizing radiation (kV X-ray) with its generally known potential side<br />

effects of predominantly skin irritation. There are of course known side-effects of radiotherapy.<br />

However these are associated with linear accelerator treatments in general and not with the use<br />

of ETD for patient positioning.<br />

Residual Risks<br />

There is a danger of ionizing radiation (MV) if the treatment beam is delivered to tissue outside the<br />

target volume tolerances in cranial or non-cranial mode. If the user does not recognize an<br />

incorrect fusion due to incorrect shift values (e.g., the user is unable to distinguish between similar<br />

repetitive structures, such as vertebrae and ribs, in the image fusion), healthy tissue or non-target<br />

structures could be exposed to substantial unintended radiation.<br />

Clinical Benefit<br />

• ExacTrac <strong>Dynamic</strong> assists clinicians to accurately align the patient to the radiotherapy<br />

treatment device as defined in the treatment plan.<br />

• ExacTrac <strong>Dynamic</strong> assists clinicians to monitor the treatment position of a patient during<br />

treatment.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 13


Using the System<br />

• ExacTrac <strong>Dynamic</strong> enables clinicians to keep the IGRT imaging dose delivered to the patient<br />

as low as reasonably possible.<br />

Careful Handling of Hardware<br />

System components and accessory instrumentation are comprised of precise mechanical<br />

parts. Handle them carefully.<br />

Plausibility Review<br />

Warning<br />

Before patient treatment, review the plausibility of all information input to and output from<br />

the system.<br />

14 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.5 Compatibility with Medical Devices<br />

Compatible Brainlab Medical Devices<br />

ExacTrac <strong>Dynamic</strong> is compatible with the following Brainlab medical devices.<br />

Device Name Article Number UDI-DI<br />

Cranial 4Pi CT Overlay 43420A 04056481144241<br />

Cranial 4Pi Treatment Overlay 43421A 04056481144234<br />

Cranial 4Pi Headrest Standard 43440A 04056481144227<br />

Cranial 4Pi Headrest Low-Neck 43441A 04056481144210<br />

Cranial 4Pi Headrest Inlay Standard 2pcs 43446A 04056481144203<br />

Cranial 4Pi Headrest Inlay Openface 2Pcs 43447A 04056481144197<br />

Cranial 4Pi Headrest Inlay H&N 2Pcs 43448A 04056481144180<br />

Cranial 4Pi Stereotactic Mask (5 Pcs.) 43450 04056481141936<br />

Cranial 4Pi Basic Mask (5 Pcs.) 43451 04056481141943<br />

Cranial 4Pi Open Face Mask (5 Pcs.) 43452 04056481141950<br />

SRS 4Pi CT Table Overlay 43430 04056481141363<br />

Cranial 4Pi is an assembly of the following medical device/ accessory groups:<br />

• Cranial 4Pi Overlays<br />

• Cranial 4Pi Headrests<br />

• Cranial 4Pi Headrest Inlays<br />

• Cranial 4Pi Masks<br />

The Cranial 4Pi Overlays are medical devices used for fixation of the patient in a CT- resp. linear<br />

accelerator - environment.<br />

The Cranial 4 Pi Headrests and the Cranial 4Pi Headrest Inlays are accessories to the Cranial 4Pi<br />

Overlays to allow an indication specific positioning of the patient's head and neck.<br />

The Cranial 4Pi Masks are accessories to the Cranial 4Pi Overlays used for producing individual<br />

custom-made masks for patient immobilization to the Cranial 4Pi Overlay Boards.<br />

The Cranial 4Pi Immobilization group of devices is used for fixation and repositioning of the<br />

patient’s head and neck in a CT- and linear accelerator environment. The SRS 4Pi CT Table<br />

Overlay (43430) is a medical device used for fixation and repositioning of the patient's head and<br />

neck in a CT-environment.<br />

The mask sets Cranial 4Pi Stereotactic Mask (43450) / Cranial 4Pi Basic Mask (43451) /<br />

Cranial 4Pi Open Face Mask (43452) are medical devices used for producing custom-made<br />

masks for patient fixation to the Overlay Board in a CT- and linear accelerator environment.<br />

NOTE: For further details, refer to the Cranial 4Pi Hardware User Guide and Cranial 4Pi<br />

Immobilization Hardware User Guide.<br />

NOTE: ExacTrac <strong>Dynamic</strong> is not compatible with Brainlab Robotics.<br />

Non-Brainlab Medical Devices<br />

ExacTrac <strong>Dynamic</strong> is compatible with the following non-Brainlab medical devices only. Do not<br />

use with any other devices.<br />

It is a prerequisite that the linac is calibrated correctly.<br />

For further questions about compatibility, contact Brainlab support.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 15


Compatibility with Medical Devices<br />

Device Description Interface Manufacturer<br />

Data and signal lines:<br />

TrueBeam Radiotherapy<br />

System<br />

Linear Accelerator<br />

TrueBeam Auxiliary<br />

Device Interface (ADI<br />

3.0)<br />

TrueBeam External<br />

gating interface (EXGI<br />

2.0)<br />

Varian Medical Systems,<br />

Inc.<br />

3100 Hansen Way<br />

Palo Alto, CA 94304<br />

ARIA oncology information<br />

system<br />

Record & Verify (R&V)<br />

System<br />

LAN connection, DI-<br />

COM<br />

Data and signal lines:<br />

Elekta Linear Accelerator<br />

MOSAIQ, Patient Positioning<br />

Systems Interface<br />

(PPS WebIF)<br />

Linear Accelerator<br />

Record & Verify System<br />

Elekta iGUIDE GMI<br />

Elekta Response gating<br />

interface<br />

Elekta iCOM Vx<br />

LAN connection, DI-<br />

COM<br />

Elekta Limited Cornerstone<br />

London Road Crawley<br />

West Sussex RH10<br />

9BL<br />

United Kingdom<br />

NOTE: Brainlab recommends contacting Brainlab support if any linac software or hardware needs<br />

to be changed or updated.<br />

Warning<br />

Brainlab recommends contacting Brainlab support if settings on the linac need to be<br />

changed after installation.<br />

Non-Brainlab Devices<br />

Warning<br />

Using medical device combinations that have not been authorized by Brainlab may<br />

adversely affect safety and/or effectiveness of the devices and endanger the safety of the<br />

patient, user and/or environment.<br />

DICOM Conformance<br />

DICOM conformance statements can be found on the Brainlab website at: www.brainlab.com/<br />

dicom.<br />

DICOM Functionality and Interoperability<br />

DICOM, by itself, does not guarantee interoperability. However, the conformance statement<br />

facilitates a first-level validation for interoperability between different applications supporting the<br />

same DICOM functionality. The conformance statement should be read and understood in<br />

conjunction with the DICOM standard.<br />

NOTE: ExacTrac <strong>Dynamic</strong> requires a DICOM RT data set to perform as intended.<br />

16 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.6 Cybersecurity and Software Environment<br />

Bill of Materials of Integrated Third-Party Software<br />

Software Version Software Version<br />

ACE 6.5.8 Merge DICOM Toolkit 5.12.0<br />

AltSoft XML2PDF Formatting<br />

Engine<br />

2.1.2.230 meta 0.1.0<br />

Brainlab Connected Care 1.2.2.4 Modernizr 2.8.3<br />

Chelsio viewwire 6.16.1.0 nicescroll 3.6.0<br />

Chromium Embedded<br />

Framework (CEF)<br />

79.1.38+gecefb59<br />

+chromium-79.0.3945.13<br />

0<br />

node.js 12.13.1<br />

cpprest 2.10.14 Notepad++ 8.5.4<br />

cryptopp 8.1.0 Nvidia NVAPI release 367<br />

d3js 3.5.17 Nvidia Quadro Driver 535.98<br />

durandal 2.1.0 OpenCV 4.7.0<br />

eBusSDK 3.1.0 openjpeg 1.4.0<br />

FX11 4.2.0 pdf.js 1.4.20<br />

eigen 3.4.0 range-v3 0.5.0<br />

Elekta Gmp 2.1.0 react.js 16.8.6<br />

Elekta iCOM, iCOMx86 5.14 renderdocapi 1.4.0<br />

Elekta MSQ 2.0.0 requirejs 2.3.5<br />

Elekta Responsex86 1.0.13 SolvOpt 1.2<br />

Filament 1.4.1 SpinnakerSDK 2.7.0.128<br />

Finder Toolbox NFC 3.6.1 SQLite 3.26.0<br />

FTD2XX 2.12.36 Thingworx 8.5.18<br />

ICU 1.8.1 UltraVNC 1.3.8.1<br />

Intel wired driver 27.7 Varex Viva64 Virtual CP L08 2.2<br />

jquery 2.1.4<br />

jqueryui 1.11.1<br />

kineticjs 5.1.0<br />

knockout 3.5.1<br />

LAPACK 3.2.1<br />

libjpeg<br />

2.1.2, 6b<br />

libjpeg-turbo 2.1.2<br />

LibJpeg16, LibJpeg8 3.6.0, 6b Windows 10<br />

Varex Virtual CP Software<br />

Interface<br />

Visual C++ redistributable<br />

x86 2008<br />

Visual C++ redistributable<br />

x86 2010<br />

Visual C++ redistributable<br />

x64 2010<br />

Visual C++ redistributable<br />

x64 2012<br />

Visual C++ redistributable<br />

x64 2013<br />

Visual C++ redistributable<br />

x86 & x64 2015-2019<br />

L08 2.2<br />

9.0.30729<br />

10.0.30319<br />

10.0.40219<br />

11.0.61030<br />

12.0.21005<br />

14.22.27821.0<br />

IoT Enterprise<br />

version<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 17


Cybersecurity and Software Environment<br />

Software Version Software Version<br />

LibJpeg2k 2.4.0 Xerces-C++ 3.2.3<br />

libpng 1.6.37 yajl 2.1.0<br />

libtiff 3.6.0 zlib 1.2.12<br />

LightBurst 1.6.0<br />

Cybersecurity Use Environment<br />

Cybersecurity considerations were made in accordance with the nature of the device, including<br />

the device type and the use environments of the system during its lifetime.<br />

The following common best practice security controls ("security hygiene") in the use environment<br />

are expected to be followed, independently of the status of the system (powered on / powered off):<br />

• Good physical security to prevent unauthorized physical access to the system.<br />

If the system is powered on, follow these additional security controls:<br />

• Access control measures (e.g., role based) to ensure only authenticated and authorized<br />

personnel are allowed access to network elements, stored information, services and<br />

applications.<br />

• Network access controls, such as segmentation, to limit medical device communication.<br />

• General patch management practices that ensure timely security patch updates on adjacent<br />

devices in the use environment.<br />

• Malware protection to prevent unauthorized code execution on adjacent devices in the use<br />

environment.<br />

• Ensure that prescribed maintenance is done as required, including installation of security<br />

patches.<br />

• Security awareness training of the users.<br />

Using the device outside of the intended operating environment may lead to cybersecurity<br />

incidents that may affect safety and effectiveness of the device.<br />

Hospital administration is responsible for limiting access to the system and the patient data to<br />

appropriate personnel.<br />

Be aware that screenshots created by the software contains patient-specific data. Saving the<br />

screenshot locally thereby saves patient information to the system.<br />

Warning<br />

Always follow medical network protection standards.<br />

Regional Legislation<br />

In the ExacTrac <strong>Dynamic</strong> software, patient data is identified by the patient's name and a unique<br />

ID. For this reason, it must be handled in accordance with the relevant confidentiality legislation<br />

and protected against unauthorized access. In the United States, patient data must be handled in<br />

accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).<br />

Data Access<br />

ExacTrac <strong>Dynamic</strong> receives data via DICOM Proxy from an R&V System. The externally<br />

accessible DICOM Proxy is located on the Patient Preparation Server. Data is stored within the<br />

Treatment Workstation or on the Patient Preparation Server. The two DICOM Proxys store data<br />

on the local file system. Access to this file system is controlled by the hospital via user access<br />

rights.<br />

For anonymization of patient data, use a certified third-party product.<br />

Access to Printouts<br />

As ExacTrac <strong>Dynamic</strong> treatment reports contain the patient name and ID, the printer must be<br />

located in a secure area and the printouts protected against unauthorized access.<br />

18 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

Data Backup<br />

In order to protect against patient data loss, both patient data folders need to be backed up via<br />

network or similar.<br />

Data Protection and System Disposal<br />

Because confidential patient data is stored on several hard drives or virtually, it is therefore<br />

necessary to securely erase all workstations and/or server locations where ExacTrac <strong>Dynamic</strong> or<br />

the Patient Preparation Server is running or physically destroy the hard drives before system<br />

disposal.<br />

Cybersecurity Vulnerability<br />

If you detect a cybersecurity vulnerability or weakness of the device or if a cybersecurity incident<br />

takes place involving the device, contact Brainlab support. Depending on the actual event,<br />

Brainlab support will advise which steps to take.<br />

Microsoft Security Updates for Windows and Driver Updates<br />

Brainlab allows the installation of security patches only. Do not install service packs and optional<br />

updates. Verify your settings to ensure updates are downloaded and installed correctly at a<br />

suitable time outside of clinical hours. For more information about settings and a list of Microsoft<br />

Security Updates blocked by Brainlab support, see the Brainlab website (brainlab.com/updates).<br />

Only perform Windows updates according to the Brainlab website.<br />

Do not update drivers on Brainlab platforms. Note that automatic driver updates are disabled.<br />

These shall only be performed by Brainlab support or with Brainlab approval. Neither manual<br />

steps nor Windows update functionality should be used to update drivers on Brainlab ExacTrac<br />

<strong>Dynamic</strong> Workstations.<br />

Updates<br />

Updates to the operating system or third-party software should be performed outside clinical hours<br />

and in a test environment to verify correct operation of the Brainlab system. Brainlab monitors the<br />

released Windows security updates and will know, for some updates, if problems can be<br />

expected. Contact Brainlab support if any problems to operating system security updates are<br />

encountered.<br />

Virus Scanning and Malware<br />

If the system is connected to a local area network (LAN), Brainlab recommends using malware<br />

protection software (e.g., virus scanner) and keeping the definition files up to date. Be aware that<br />

the malware protection settings can affect system performance (e.g., if each file access is<br />

monitored, patient data loading and saving might be slow). Therefore Brainlab recommends<br />

disabling real-time scans and regularly performing virus scans during non-clinical hours using an<br />

administrative account.<br />

The default Windows virus scanner, Microsoft Defender, is installed and active.<br />

Other anti-virus protection can be used if it does not block the communication between ExacTrac<br />

<strong>Dynamic</strong> and the associated hardware. The anti-virus software has to have the option to not<br />

interfere with the network communication between the 3D Camera, the Thermal Camera, Flat<br />

Panel Detectors and the treatment application (e.g., by enabling firewall exceptions).<br />

Requirements<br />

• Do not update the virus scanner software during treatment.<br />

• The virus scanner must not perform a hard disk drive scan during patient treatment.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 19


Cybersecurity and Software Environment<br />

• Do not use the virus scanner in a high security mode during treatment.<br />

• During scans of the ExacTrac <strong>Dynamic</strong> folder (D:/Brainlab and E:/Patient), do not delete<br />

any files or put any files into quarantine.<br />

Configuration<br />

Brainlab recommends:<br />

• Configure the anti-virus software so it does not modify:<br />

- D:\Brainlab<br />

- E:\Patient<br />

- D:\RVExport\<br />

- %userprofile%\AppData\Local\Brainlab<br />

• Deactivate any other anti-virus software feature such as browser/email-scanners, additional<br />

firewall, etc.<br />

Compatible Brainlab Software<br />

Only Brainlab software specified by Brainlab may be installed and used with the system. Contact<br />

Brainlab support for clarification regarding compatibility with Brainlab software.<br />

Non-Brainlab Software<br />

Only authorized Brainlab employees may install software on the Brainlab system. Do not<br />

install or remove any software applications.<br />

Information for Hospital Medical IT Network Risk Manager<br />

The following information is intended for the hospital Medical IT-Network Risk Manager.<br />

1.<br />

2.<br />

3.<br />

Item<br />

Purpose of the connection<br />

to the IT network<br />

Required IT-network characteristics<br />

Required IT-network configuration<br />

Description<br />

The Brainlab device can load and save patient data.<br />

These are transferred via DICOM Proxy from ExacTrac<br />

<strong>Dynamic</strong> to R&V, linac.<br />

The Brainlab device transfers medical imaging data and<br />

patient data between ExacTrac <strong>Dynamic</strong> and the Patient<br />

Preparation Server or between the Positioning and<br />

ExacTrac <strong>Dynamic</strong> applications via the local DICOM<br />

Proxy.<br />

The DICOM Proxy on the Patient Preparation Server also<br />

transfers medical images and data to the R&V systems<br />

or linac.<br />

The average size of a medical imaging data set transferred<br />

through the network is 100 - 500 MB.<br />

Required:<br />

• User management is achieved by joining the Brainlab<br />

device to the hospital domain and adding users to<br />

dedicated user groups with group management.<br />

• Brainlab offers remote system support which requires<br />

internet access.<br />

The Brainlab device requires firewall permissions for the<br />

services listed under point 4, below.<br />

4.<br />

Technical specifications of<br />

the network connection, including<br />

security specifications<br />

The Brainlab device includes the following network connections<br />

(4.1 - 4.8):<br />

20 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

4.1<br />

4.2<br />

4.3<br />

4.4<br />

4.5<br />

4.6<br />

Item<br />

Physical connection of the<br />

Brainlab device<br />

Logic connection between<br />

the Brainlab device and<br />

other Brainlab devices or<br />

hospital file storage<br />

Logic connection between<br />

the Brainlab device and<br />

hospital domain controller<br />

Logic connection between<br />

the Brainlab device and<br />

Brainlab support<br />

Logic connection between<br />

the Brainlab system and<br />

other linac (Varian)<br />

Logic connection between<br />

the Brainlab device and<br />

other linac (Elekta)<br />

Intended information flow<br />

between the Brainlab device<br />

and the IT network<br />

Description<br />

The system is connected to the IT-network with a<br />

100/1000 Base-T connection.<br />

• Recommended speed is 1 GBit. Minimum speed is 100<br />

MBit.<br />

• Network latency must be less than 100 ms.<br />

• The network must be fully switched on.<br />

• Protocols: CIFS<br />

• Ports: 445/TCP/in- and outbound<br />

• Protocols: Microsoft-DS, Kerberos, LDAP, DNS<br />

• Ports: 445/TCP/UDP/outbound, 88/TCP/UDP/<br />

outbound, 389/UDP/outbound, 53/TCP/UDP/outbound<br />

• Protocols: Brainlab Connected Care<br />

• Ports: 443/TCP/outbound to: support.brainlab.com,<br />

gas-aus.axeda.com, ghjap1.axeda.com, ghsj1.axeda.com,<br />

ghsom1.axeda.com, ghuk1.axeda.com<br />

• Protocol: ADI (Auxiliary Device Interface)<br />

• Port: 56050/TCP/in- and outbound<br />

• Protocol: Elekta protocol<br />

• Port: 135, 1801, 2101 /TCP/in- and outbound<br />

The Brainlab device typically consists of the following information<br />

flow:<br />

5.1 User authentication<br />

User authentication at the Brainlab device is processed<br />

with the help of local user accounts or the hospital domain<br />

controller.<br />

5.<br />

5.2<br />

Loading of medical imaging<br />

data<br />

Medical imaging data is transferred via DICOM Q/R or<br />

pushed between the R&V.<br />

5.3<br />

Storing of modified medical<br />

imaging data<br />

Modified medical imaging data is stored on the local hard<br />

drive or hospital network shared drives.<br />

5.4<br />

Patient positioning and<br />

beam approval<br />

ExacTrac <strong>Dynamic</strong> and the linac system perform internal<br />

communication for patient positioning and beam approval.<br />

5.5<br />

Remote support through<br />

Brainlab<br />

Remote support for the Brainlab device requires a connection<br />

to the Brainlab support servers.<br />

6.<br />

Hazardous situation resulting<br />

from an IT-network failure<br />

A failure of the IT Network connection can cause that the<br />

treatment cannot be continued or must be repeated. This<br />

can lead to unnecessary KV Imaging of the patient.<br />

The following documents are available upon request:<br />

7.<br />

Technical descriptions and<br />

technical manuals<br />

• Preinstallation manual<br />

• FDA and CE declarations<br />

• DICOM conformance statements: (www.brainlab.com/<br />

dicom)<br />

8.<br />

Recommended product<br />

configurations<br />

The Brainlab device will be installed and configured according<br />

to customer needs by the Brainlab service engineer.<br />

Subsequent modifications can affect the safety and<br />

effectiveness of the product.<br />

9.<br />

Known incompatibilities and<br />

restrictions<br />

The Brainlab device requires a network supporting IPv4.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 21


Cybersecurity and Software Environment<br />

10.<br />

Item<br />

Product corrective actions<br />

and recalls<br />

Description<br />

Brainlab will inform every customer in case of identified<br />

anomalies.<br />

11. Cybersecurity notices<br />

Brainlab will inform every customer in case of identified<br />

cybersecurity issues and provide software updates accordingly.<br />

12.<br />

Background according to<br />

IEC 60601-1 3rd edition,<br />

chapter 14.13 (Connection<br />

of PEMS by NETWORK/<br />

DATA COUPLING to other<br />

equipment)<br />

Connecting the Brainlab device to networks that include<br />

other equipment could result in previously unidentified<br />

risks to patients, operators or third parties. The responsible<br />

organization should identify, analyze, evaluate and<br />

control these risks. Subsequent changes to network<br />

could introduce new risks and require additional analysis.<br />

Changes to the network include:<br />

• Changes to the network configuration<br />

• Connection of additional items to the network<br />

• Disconnecting items from the network<br />

• Updating equipment connected to the network<br />

• Upgrade of equipment connected to the network<br />

Warning<br />

Do not use Brainlab Connected Care during linac Beam On.<br />

22 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.7 ExacTrac <strong>Dynamic</strong> Network Integration (IEC<br />

80001)<br />

Ensuring a Safe IT Network<br />

• Ensure a safe network connection during transferring patient data and during treatment.<br />

Minimum network specifications are defined by Brainlab.<br />

• Only install release updates from original manufacturers.<br />

• After the ExacTrac <strong>Dynamic</strong> and the linac installation, both systems must have dedicated,<br />

static IP addresses. Do not use dynamic IP addresses.<br />

• A stable, reliable and safe network environment and connection are required to guarantee a<br />

safe and effective use of the ExacTrac <strong>Dynamic</strong> system when ExacTrac <strong>Dynamic</strong> is<br />

connected to a network. Network problems during patient data transfer or patient treatment can<br />

interrupt the workflow and cause a repetition of parts of the treatment such as X-ray imaging for<br />

patient position.<br />

Standard Integration<br />

The following image shows a typical network setup for a standard ExacTrac <strong>Dynamic</strong>:<br />

1<br />

10<br />

2<br />

3<br />

11<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

Figure 1<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 23


ExacTrac <strong>Dynamic</strong> Network Integration (IEC 80001)<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

10<br />

11<br />

Description<br />

Hospital Network<br />

Varian/ADI<br />

Treatment Workstation<br />

DICOM Data<br />

Patient Preparation Server (mandatory for multiple systems, optional for single system<br />

sites)<br />

Hospital R&V<br />

Internet<br />

Remote Access<br />

Brainlab Connected Care Support<br />

Linac Network<br />

Linac<br />

NOTE: The system for the ExacTrac <strong>Dynamic</strong> Patient Preparation Server should be provided by<br />

the customer (Server or Virtual Machine) or purchased from Brainlab (Server).<br />

Elekta Integration<br />

The following image shows a typical network setup for ExacTrac <strong>Dynamic</strong> with an Elekta<br />

integration:<br />

24 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

10<br />

3<br />

11<br />

2<br />

1<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

Figure 2<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

10<br />

11<br />

Description<br />

Hospital Network<br />

Elekta Firewall<br />

Treatment Workstation<br />

DICOM Data<br />

Patient Preparation Server (mandatory for multiple systems, optional for single system<br />

sites)<br />

Hospital R&V<br />

Internet<br />

Remote Access<br />

Brainlab Connected Care Support<br />

Elekta Network<br />

Linac<br />

NOTE: The system for the ExacTrac <strong>Dynamic</strong> Patient Preparation Server should be provided by<br />

the customer (Server or Virtual Machine) or purchased from Brainlab (Server).<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 25


ExacTrac <strong>Dynamic</strong> Network Integration (IEC 80001)<br />

About Data Transferred to and From ExacTrac <strong>Dynamic</strong><br />

DICOM Proxy pushes incoming data (e.g., RT images) to ExacTrac <strong>Dynamic</strong>. ExacTrac<br />

<strong>Dynamic</strong> asks DICOM Proxy to send on outgoing data (e.g., to ARIA). ExacTrac <strong>Dynamic</strong> does<br />

not have physical limits for sending and receiving data except those set by DICOM Proxy and the<br />

hardware itself.<br />

DICOM Proxy on the Patient Preparation Server exchanges data with DICOM Proxy on the<br />

Treatment Workstation (e.g., RT images) from where ExacTrac <strong>Dynamic</strong> received its data.<br />

A backup of the system must be performed periodically.<br />

ExacTrac <strong>Dynamic</strong> can handle the following data types: DICOM and PDF (e.g., for treatment<br />

review).<br />

26 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.8 User Management<br />

Windows Users<br />

The following Windows users are implemented by default in ExacTrac <strong>Dynamic</strong>:<br />

User Group Windows OS Permissions BL User Groups<br />

Administrator<br />

Administrator rights<br />

BL Service Administrator rights BL_ET_Service<br />

EmergencyUser<br />

ExacTrac <strong>Dynamic</strong><br />

Administrator rights<br />

Power user rights<br />

BL_ET_Therapist<br />

BL_ET_TherapistRestricted<br />

Approver Power user rights BL_ET_Physician<br />

Physicist Power user rights BL_ET_Physicist<br />

• To use ExacTrac <strong>Dynamic</strong>, the user needs power user rights as a minimum.<br />

• Do not use accounts with administrator rights for treatment tasks.<br />

• Upon request, hospitals can have an emergency user/generic user account set up. It should<br />

only be used to access the system in case of an emergency. The hospital IT administrator is<br />

responsible for communicating the account information to the relevant employees.<br />

• Service tools and BL Service accounts are intended solely for Brainlab service and must not be<br />

used while treating patients.<br />

NOTE: Only members of the Windows user group Administrator can add, modify or delete user<br />

accounts. The Administrator account is preconfigured by Brainlab support and cannot be deleted.<br />

If your hospital needs to designate additional roles of user rights other than the standardized<br />

roles, Brainlab support must add the roles. For further information, contact Brainlab support.<br />

Windows Login and User Logs<br />

• The Windows login defines the user rights for the password-protected ExacTrac <strong>Dynamic</strong> user<br />

login. The hospital is responsible for administration of passwords and user logins.<br />

• Every ExacTrac <strong>Dynamic</strong> user login and ExacTrac <strong>Dynamic</strong> patient opening and closing<br />

event is logged and saved in an encrypted log. To access this information, contact Brainlab<br />

support.<br />

• In case of a technical or clinical issue with ExacTrac <strong>Dynamic</strong>, the folder "Log Files" shall be<br />

zipped and provided to Brainlab support.<br />

• Manually lock any account that has not been used for more than three months, except for<br />

Brainlab service. It is recommended to check for unused accounts at least every six months.<br />

Configuring Rights and Passwords<br />

Users must access ExacTrac <strong>Dynamic</strong> with a personal user name and password. User accounts<br />

have varying permissions, divided into roles. Upon setup, Brainlab support will create the following<br />

standardized roles:<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 27


User Management<br />

Role<br />

Task<br />

Treatment preparation<br />

Treatment<br />

Fusion approval<br />

X-ray calibration<br />

Camera calibration<br />

Template editor<br />

ET_SuperUser ✔ ✔ ✔ ✔ ✔ ✔<br />

ET_Physicist ✔ ✔ ✔ ✔ ✔<br />

ET_Physician ✔ ✔ ✔ ✔<br />

ET_Therapist ✔ ✔<br />

ET_TherapistRestricted<br />

✔<br />

ET_Service ✔ ✔ ✔ ✔ ✔ ✔<br />

When assigning rights to new users, adhere to the principle of least privilege (e.g., only assign<br />

rights that are needed).<br />

Your hospital IT administrator can configure selected users as registered users with:<br />

• Approval rights so that image fusion can be approved (e.g., physicians for billing purposes)<br />

• Calibration rights (e.g., for physicists)<br />

• Basic rights for standard users (e.g., such as therapists)<br />

NOTE: Personnel who are still in training are typically assigned ET_TherapistRestricted.<br />

Accessing Password Settings<br />

Only the hospital IT administrator can change or reset a password.<br />

28 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.9 Technical Requirements For ExacTrac <strong>Dynamic</strong><br />

Preparation Application<br />

About the Technical Requirements<br />

The ExacTrac <strong>Dynamic</strong> Preparation Application can be installed on an independent, dedicated<br />

server provided by the hospital or one purchased from Brainlab. This allows preparation of patient<br />

data for treatment with ExacTrac <strong>Dynamic</strong> independent of the Treatment Workstation used for<br />

the ExacTrac <strong>Dynamic</strong> Treatment Application for treatment.<br />

NOTE: Brainlab does not permit the installation of ExacTrac <strong>Dynamic</strong> Preparation Application<br />

on platforms with third-party medical software installed. It cannot be excluded that ExacTrac<br />

<strong>Dynamic</strong> Preparation Application influences the third-party software, and vice versa. In this<br />

context, it is the user's responsibility to provide and identify suitable platforms fulfilling the given<br />

requirements for installing the software, and to verify that ExacTrac <strong>Dynamic</strong> Preparation<br />

Application is not affected by any third-party software installations or third-party software<br />

updates.<br />

If it is necessary to revalidate the ExacTrac <strong>Dynamic</strong> Preparation Application software, use the<br />

software revalidation instructions found in this user guide. This requires access to the patient data<br />

stored by the service DICOM Proxy.<br />

Preparation Server Requirements<br />

If installed on a physical server, the following hardware and operating system minimum<br />

requirements must be fulfilled:<br />

Minimum Server<br />

CPU<br />

Memory<br />

Storage space<br />

Graphics card<br />

Network connection<br />

Operating system<br />

Screen resolution<br />

8 cores, with at least 2.2 GHz (or comparable)<br />

16 GB (or more) RAM DDR3<br />

Minimum 200 GB (1 TB recommended)<br />

N/A<br />

100 Mbit/s, 1 Gbit/s recommended<br />

Windows Server 2016<br />

Windows Server 2019<br />

Windows Server 2022<br />

English OS language<br />

1920 x 1080 (or more)<br />

NOTE: For server configurations that do not fulfill these minimum requirements, it cannot be<br />

guaranteed that ExacTrac <strong>Dynamic</strong> Preparation Application runs as intended.<br />

Server Virtual Machines<br />

Brainlab supports virtualization environments with Citrix XenServer or VMWare ESXi as<br />

recommended technologies.<br />

For access via Origin Server, the Windows Server license as well as the RD Client Access<br />

Licenses (RD CALs) and the SSL certificates must be provided by the hospital IT.<br />

3D Graphics and Algorithms Acceleration<br />

In general, the software runs without GPU support. Nevertheless, workflow steps in which graphic<br />

display and 3D rendering functions are available (DRR display, VOI restriction) have limited<br />

rendering performance and slower user interface response.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 29


Technical Requirements For ExacTrac <strong>Dynamic</strong> Preparation Application<br />

Server Requirements<br />

The minimum requirements defined above for the described hardware also apply for the minimum<br />

hardware to run ExacTrac <strong>Dynamic</strong> Preparation Application. For virtual machines, at least 8<br />

CPU cores with a minimum of 2.2 GHz and 16 GB RAM shall be available.<br />

NOTE: ExacTrac <strong>Dynamic</strong> Preparation Application and the corresponding Patient Preparation<br />

Server shall not run on the same server together with other Brainlab Elements software.<br />

Contact Brainlab support for additional questions about minimum hardware requirements for the<br />

dedicated server.<br />

Revalidating Preparation<br />

Because ExacTrac <strong>Dynamic</strong> Preparation Application indirectly affects the treatment by setting<br />

treatment parameters before actual treatment, it is recommended to test the functionality by<br />

deliberately setting a parameter using the software and performing a phantom treatment with<br />

ExacTrac <strong>Dynamic</strong> to verify that all parameters are correctly transferred.<br />

This should be done after the first installation on third-party hardware or after any change to the<br />

third-party software environment (e.g., OS hotfixes or virus scanner definition files) or to any other<br />

software that might influence software performance.<br />

If ExacTrac <strong>Dynamic</strong> Preparation Application does not start or in the unlikely event that<br />

parameters are not transferred correctly, contact Brainlab support.<br />

30 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.10 Training and Documentation<br />

ExacTrac <strong>Dynamic</strong> Installation and Preplanning Information<br />

Only trained personnel are permitted to install and service ExacTrac <strong>Dynamic</strong>. For further<br />

information, contact Brainlab support.<br />

Brainlab Training<br />

Before using the system, Brainlab recommends that all users should participate in a training<br />

program held by a Brainlab representative to ensure safe and appropriate use.<br />

Supervised Support<br />

After a sufficient number of complete procedures have been successfully simulated, and following<br />

a rigorous quality assurance review, the system can be used in selected treatments.<br />

A Brainlab representative should be present at such treatments to provide medical staff with<br />

supervision and guidance where necessary.<br />

Numerical Values Used in This User Guide<br />

In this user guide, all values and parameters describing imaging performance use standardized SI<br />

units: metric, Gy, mm and Gy*mm 2 .<br />

With the exception of angular measurements (indicated by the ° symbol), all numerical values<br />

displayed by ExacTrac <strong>Dynamic</strong> are in millimeters (mm).<br />

Responsibility<br />

Warning<br />

This system solely provides assistance to the physician and does not substitute or replace<br />

the physician's experience and/or responsibility during its use. It must always be possible<br />

for the user to proceed without the assistance of the system.<br />

Only trained medical personnel may operate system components and accessory instrumentation.<br />

Reading User Guides<br />

This guide describes complex medical software or medical devices that must be used with care.<br />

It is therefore important that all users of the system, instrument or software:<br />

• Read this guide carefully before handling the equipment<br />

• Have access to this guide at all times<br />

Available User Guides<br />

Available user guides vary depending upon your configuration. If you have questions regarding<br />

the user guides you received, please contact Brainlab support.<br />

User Guide<br />

ExacTrac <strong>Dynamic</strong> Elekta Linacs Site Planning<br />

Manual<br />

ExacTrac <strong>Dynamic</strong> Varian Truebeam Linacs<br />

Site Planning Manual<br />

Description<br />

Installation and preplanning information and requirements<br />

for use with Elekta linacs<br />

Installation and preplanning information and requirements<br />

for use with Varian Truebeam linacs<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 31


Training and Documentation<br />

User Guide<br />

ExacTrac <strong>Dynamic</strong> Clinical User Guide (all<br />

workflows)<br />

ExacTrac <strong>Dynamic</strong> Clinical User Guide (ExacTrac<br />

<strong>Dynamic</strong> <strong>Surface</strong> workflows)<br />

ExacTrac <strong>Dynamic</strong> System and Technical<br />

User Guide<br />

Description<br />

• Software setup and shutdown instructions<br />

• Detailed instructions on available workflows<br />

• Information on the clinical use<br />

• Software setup and shutdown instructions<br />

• Detailed instructions on available workflows<br />

• Information on the clinical use<br />

Detailed information on system setup, technical<br />

information on the system, specifications and<br />

compliances<br />

Additional Documentation<br />

For further information about X-ray components, see the following documents.<br />

Device Document Manufacturer<br />

Housing Data sheet "Housing B-130" Varian Medical Systems<br />

Tube<br />

Data sheet "G-892"<br />

(Varex Imaging Corporation only for the<br />

X-ray tubes)<br />

HV Cables<br />

Data sheet "CA1-type Connector"<br />

"L3-type cable"<br />

Claymount<br />

Collimator This user guide Brainlab<br />

Generator<br />

Operating instructions "EDITOR<br />

Hfe"<br />

Service manual "EDITOR Hfe"<br />

Spellman High Voltage Electronics<br />

GmbH (formerly K&S Röntgenwerk)<br />

Customer Acceptance Test<br />

The accuracy of the specific system being used is outlined in the customer acceptance test.<br />

32 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


CLINICAL OVERVIEW<br />

2 CLINICAL OVERVIEW<br />

2.1 Using ExacTrac <strong>Dynamic</strong> in a Clinical<br />

Setting<br />

About ExacTrac <strong>Dynamic</strong><br />

Figure 3<br />

ExacTrac <strong>Dynamic</strong> is a system that is used to position and monitor patients at the isocenter of a<br />

linear accelerator for radiotherapy procedures. The system consists of both hardware and<br />

software elements and can be integrated with certain Elekta and Varian linacs.<br />

Key features of ExacTrac <strong>Dynamic</strong> include:<br />

• Preparing patient plans for treatment with ExacTrac <strong>Dynamic</strong> Preparation Application.<br />

• Prepositioning the patient and monitoring patient movement throughout planned treatment with<br />

ExacTrac <strong>Dynamic</strong> Treatment Application.<br />

• <strong>Surface</strong> tracking via a single ceiling-mounted structured light projector, two high-resolution<br />

cameras and a thermal camera to ensure that no patient movement is lost.<br />

• Multiple calibration tools and a Daily Check to verify that the system is working properly.<br />

This chapter describes features of the ExacTrac <strong>Dynamic</strong> medical device. Which features are<br />

available for your system depends on your configuration, equipment and licenses. For further<br />

information, contact Brainlab support.<br />

Primary Operating Functions<br />

Schedule, prepare patient for patient positioning<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 33


Using ExacTrac <strong>Dynamic</strong> in a Clinical Setting<br />

• Treatment-specific and patient-specific data is set via templates. The templates are predefined<br />

by the hospital and not considered as primary operation function.<br />

Patient prepositioning<br />

• The user moves the treatment couch with the patient into the approximate planned isocenter<br />

until the field of view of the surface tracking unit is reached.<br />

• From there, the operator shall position the patient according to the surface tracking unit. The<br />

(pre-)positioning of the patient can be done manually or by sending the shift from ExacTrac<br />

<strong>Dynamic</strong> to the couch.<br />

Define surface tracking area<br />

• The user defines a surface tracking area for the surface and thermal cameras that is monitored<br />

during patient treatment.<br />

• For surface-only and breath-hold workflows: The surface tracking area selection is done after<br />

final treatment positioning was performed.<br />

• For breath-hold treatments, a respiratory point is defined, which is used to generate the patient<br />

breathing signal.<br />

Patient positioning to the planned isocenter<br />

• For ExacTrac <strong>Dynamic</strong>: The user acquires a stereo oblique X-ray images pair to determine<br />

actual patient position. Then the user visually verifies an automatically performed fusion<br />

between the X-rays to the reference digitally reconstructed radiograph (DRR) or the implanted<br />

marker pattern. For the verification, the user uses various verification tools.<br />

• For ExacTrac <strong>Dynamic</strong> <strong>Surface</strong> the positioning is achieved with an external IGRT device<br />

(e.g., CBCT). With ExacTrac <strong>Dynamic</strong>, monitoring these POF is not relevant.<br />

• For breath-hold treatments: For X-ray acquisition, the patient is navigated into a breath-hold<br />

state. X-rays are acquired and it is verified that X-ray acquisition timing, patient surface position<br />

and X-ray quality is correct before proceeding to the X-ray correction.<br />

Patient motion monitoring during treatment<br />

• For ExacTrac <strong>Dynamic</strong> (full system): The surface tracking unit provides surface and thermal<br />

information inside the area of interest, the software system notifies the user in case motion<br />

occurs that is outside of tolerance. If the user enables it, the system also acquires automatic X-<br />

ray images via the X-ray sequence button. Then the user must decide if repositioning is<br />

necessary before continuing treatment.<br />

• For ExacTrac <strong>Dynamic</strong> <strong>Surface</strong>: The surface tracking unit provides surface and thermal<br />

information inside the area of interest, the software system notifies the user in case motion<br />

occurs that is outside of tolerance. Then the user must decide if repositioning based on an<br />

external device is necessary before continuing treatment.<br />

• For breath-hold treatments: The treatment beam is gated based on the patient breathing signal<br />

and the area of interest position. The treatment beam is only enabled if the patient is within a<br />

defined breath-hold state and the area of interest position is within a defined tolerance. X-ray<br />

images may be acquired manually within the breath-hold state to verify correct OAR position.<br />

Calibration<br />

• The user positions the calibration phantoms exactly at the isocenter and then calibrates the<br />

system to this selected isocenter.<br />

Daily Check<br />

• The user positions the calibration phantoms on the couch near the isocenter and the software<br />

then checks if the X-ray system is still in line with the surface tracking.<br />

IEC Axis Definitions<br />

Axis<br />

Point of origin<br />

(0,0,0)<br />

Z-axis<br />

(vertical)<br />

Function<br />

The linac isocenter is defined by the intersection of the gantry rotation axis<br />

with the couch rotation axis.<br />

The vertical axis that runs through the point of origin perpendicular to the<br />

couch top plane at a tilt angle of 0°. This axis is positive above the point of<br />

origin and negative below the point of origin. This axis is also known as the<br />

vertical axis, as it describes the vertical movement of the couch.<br />

NOTE: For Varian scales, this axis is inverted.<br />

34 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


CLINICAL OVERVIEW<br />

Axis<br />

X-axis<br />

(lateral)<br />

Y-axis<br />

(longitudinal)<br />

Function<br />

The horizontal axis that runs through the point of origin perpendicular to the<br />

gantry rotation axis. When facing the linac from the foot of the couch, this axis<br />

is positive to the right of the point of origin and negative to the left. This axis is<br />

also known as the lateral axis, as it describes the lateral movement of the<br />

couch.<br />

The horizontal axis that runs through the point of origin parallel to the couch<br />

top plane at a tilt angle of 0°. When facing the linac from the foot of the couch,<br />

this axis is positive when moving towards the linac from the point of origin,<br />

and negative when moving away from the linac from the point of origin. This<br />

axis is also called the longitudinal axis, as it describes the longitudinal movement<br />

of the couch.<br />

ExacTrac <strong>Dynamic</strong> Display Coordinate System<br />

To provide the ExacTrac <strong>Dynamic</strong> patient positioning system with accurate information on the<br />

current patient position, a three-dimensional coordinate system consistent with IEC 61217 is used<br />

to describe the movement and angle of the couch and linac. Coordinates can be displayed in four<br />

different ways:<br />

• IEC 61217 CCW359<br />

• IEC 61217 CCW180<br />

• Varian Standard CW180<br />

• Varian IEC CW359<br />

The selected display of the coordinate system can be reviewed in ExacTrac <strong>Dynamic</strong>. Open the<br />

menu, go to Information and then select System.<br />

The display of the coordinate system can only be changed by Brainlab support.<br />

Variations in Displayed Coordinate System Values<br />

The position and angle indicators display patient coordinate system values in accordance with IEC<br />

61217. As soon as the table is rotated out of the default position, the values indicated by the<br />

patient coordinate system may differ from those indicated by the linac coordinate system.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 35


Using ExacTrac <strong>Dynamic</strong> in a Clinical Setting<br />

Figure 4<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

Description<br />

Couch vertical (Z)<br />

Couch longitudinal (Y) – Seen from above<br />

Couch lateral (X) – Seen from above<br />

Couch rotation (Yaw) – seen from above<br />

Couch Pitch<br />

Couch Roll<br />

36 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


CLINICAL OVERVIEW<br />

Couch Fixed Coordinates<br />

Figure 5<br />

The coordinate system rotates with the couch. This means the tolerances remain the same for<br />

rotated couch positions (i.e., lateral means patient left-right, longitudinal means patient head-feet).<br />

Rotational Angles<br />

• Rotation around the vertical axis results in a couch angle.<br />

• Rotation around the longitudinal axis results in a longitudinal tilt angle or roll angle.<br />

• Rotation around the lateral axis results in a lateral tilt angle or pitch angle.<br />

• The couch angle is displayed in ExacTrac <strong>Dynamic</strong> in accordance with the scale used by your<br />

linear accelerator. The default position may therefore be 0° or 180° and the positive rotation<br />

may be clockwise or counter-clockwise. The system is customized to match your linac during<br />

acceptance (e.g., clockwise with couch at 180° for standard position (CW180)).<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 37


ExacTrac <strong>Dynamic</strong> Integration with Specific Linacs<br />

2.2 ExacTrac <strong>Dynamic</strong> Integration with Specific<br />

Linacs<br />

ExacTrac <strong>Dynamic</strong> Integration<br />

ExacTrac <strong>Dynamic</strong> can be integrated into different linac environments. For the different linac<br />

types, specific requirements must be considered.<br />

Ensure that other third-party surface devices are inactive (e.g., no emission of light, no active<br />

interference with workflow) during treatments with ExacTrac <strong>Dynamic</strong>.<br />

Do not use two or more systems simultaneously during the same treatment fraction. Only one<br />

system may be active during one fraction and no cross-system workflows are allowed.<br />

Interfaces of Specific Linacs<br />

Depending on your system configuration, you may have one of the following interfaces.<br />

For TrueBeam linacs, ExacTrac <strong>Dynamic</strong> uses the MMI (Motion Management Interface). MMI<br />

interaction between the MMI device and TrueBeam is carried out via the underlying ADI (Auxiliary<br />

Device Interface) and EXGI (External Gating Interface) protocols.<br />

Name Purpose Description<br />

ADI<br />

EXGI<br />

XML-based TCP protocol<br />

Protocol for gating devices<br />

• Obtains all non-realtime status from TrueBeam<br />

through the ADI.<br />

• Receives patient ID, plan ID and planned/actual<br />

axis positions.<br />

• Sends couch shifts and beam authorization<br />

through the ADI.<br />

• Gating signal: The gating device requests a beam<br />

hold through the gating signal.<br />

• Interlock signal: The gating device requests a<br />

beam interlock through the interlock signal.<br />

• RS-422 interface: TrueBeam sends accumulated<br />

dose, beam state, pre-beam-on check request,<br />

plan participation, and detected gating and interlock<br />

signal states. TrueBeam receives plan participation,<br />

pre-beam-on check state, and redundant<br />

gating and interlock signal states.<br />

Do not use beam authorization by ExacTrac <strong>Dynamic</strong> via ADI as a safety feature to ensure<br />

correct patient positioning before treatment. For any treatments performed with ExacTrac<br />

<strong>Dynamic</strong>, always verify that ExacTrac <strong>Dynamic</strong> confirms the target position is in tolerance.<br />

The patient position icon must indicate that the patient isocenter is in the planned treatment<br />

position. Do not treat the patient if the patient position icon shows the patient out of tolerance.<br />

For Elekta integrations, the following interfaces may be used.<br />

Name Purpose Description<br />

iGUIDE GMI Generic measurer interface<br />

ExacTrac <strong>Dynamic</strong> can connect to the interface for<br />

automatic 6DoF positioning using iGUIDE.<br />

Response<br />

iCOM Vx<br />

MOSAIQ<br />

32bit DLL gating interface<br />

Internal communication<br />

protocol (read only)<br />

Patient positioning systems<br />

interface<br />

ExacTrac <strong>Dynamic</strong> can gate the treatment beam<br />

and enable treatment beam hold for X-ray monitoring.<br />

ExacTrac <strong>Dynamic</strong> can read linac machine parameters.<br />

ExacTrac <strong>Dynamic</strong> can connect for synchronized<br />

workflow control and automatic 3D positioning using<br />

the Elekta Precise Table.<br />

38 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


CLINICAL OVERVIEW<br />

Name Purpose Description<br />

Linac HW<br />

Signal Interface<br />

CITB board with beam inhibit,<br />

MV beam on, and other<br />

linac HW signals<br />

ExacTrac <strong>Dynamic</strong> can connect to linac signals.<br />

Varian Integrations<br />

• Hyper ARC treatments on TrueBeam are not supported with ExacTrac <strong>Dynamic</strong>.<br />

• Unplanned treatment on TrueBeam is not supported with ExacTrac <strong>Dynamic</strong>.<br />

• Triggered acquisitions of MV Port Film fields on TrueBeam is not supported with ExacTrac<br />

<strong>Dynamic</strong>.<br />

• The automatic positioning procedure is provided by the ADI positioning dialog. ExacTrac<br />

<strong>Dynamic</strong> is required to authorize every treatment on the TrueBeam linac using ADI. Ensure<br />

that ExacTrac <strong>Dynamic</strong> is always running when treating patients on linac.<br />

• Automations are not supported with TrueBeam linear accelerators as not all ADI events are<br />

transmitted for subsequent beams.<br />

NOTE: Automations is a functionality on TrueBeam that allows a one-click delivery of several<br />

treatment beams in one go.<br />

Elekta Integrations<br />

• ExacTrac <strong>Dynamic</strong> supports some consolidated field sequencing (CFS) plan modalities.<br />

• ExacTrac <strong>Dynamic</strong> supports Multi Arc CFS plans from the Monaco TPS on Elekta linacs:<br />

- Including 2-4 arcs grouped in one field/beam.<br />

- Different start-stop angle within the multi-arc beam (turning angles have to be the same).<br />

• Other CFS plan modalities such as multiple static fields in one arc are not supported.<br />

Response System Limitations<br />

Event<br />

Duty cycle restrictions<br />

VMAT delivery<br />

technique restrictions<br />

Response error<br />

handling<br />

Response with<br />

multiple clients<br />

Limitation<br />

For safety reasons, ExacTrac <strong>Dynamic</strong> prevents Beam On less than three<br />

seconds after the previous Beam On.<br />

NOTE: If you do not include this function, the PPMS can cause an incorrect<br />

dose.<br />

If radiation delivery of less than two seconds occurred, a warning message is<br />

displayed. A radiation delivery of less that two seconds can cause gantry position<br />

errors and an incorrect dose. For further information, refer to the PPMS<br />

manufacturer's instructions for use.<br />

If ExacTrac <strong>Dynamic</strong> detects a relay fault of the Response, a beam inhibit is<br />

set by ExacTrac <strong>Dynamic</strong>. For further actions, refer to the Elekta linac troubleshooting<br />

guide.<br />

Response is not a multi-client interface and needs to be manually connected<br />

via USB to the system that is used for treatment. If you want to use Exac-<br />

Trac <strong>Dynamic</strong> for positioning and monitoring, keep the Response USB cable<br />

connected.<br />

If you want to use Response with another system (and not with ExacTrac<br />

<strong>Dynamic</strong>), reconnect the USB to the other device and put ExacTrac <strong>Dynamic</strong><br />

in stand-by mode. To do this, ensure that you are in the treatment<br />

workflow and that Treatment is running. Patients that are not planned to be<br />

treated with ExacTrac <strong>Dynamic</strong> will be authorized in this state and the<br />

beam-inhibit interlock will be cleared.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 39


ExacTrac <strong>Dynamic</strong> Integration with Specific Linacs<br />

Event<br />

Limitation<br />

If a fast gating condition occurs, treatment is held and a message box is displayed<br />

by ExacTrac <strong>Dynamic</strong>.<br />

Fast gating condition<br />

For further information, see the linac manufacturer's instructions for use.<br />

NOTE: To avoid beam termination on the linac, the condition must be resolved<br />

within two minutes. The user can prevent the beam termination if they<br />

select INTERRUPT on the FKP within the two minute interval.<br />

If the fast gating condition message appears, always check the root cause of<br />

the error before acknowledging the error with OK because doing so will resume<br />

beam delivery immediately. Fast gating condition could be resolved by:<br />

• Checking the patient position<br />

• Guiding the patient into the correct breathing level (in Breath-hold X-ray<br />

Positioning with <strong>Surface</strong> Monitoring (Manual X-rays))<br />

• Modifying tolerances, if needed<br />

40 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


CLINICAL OVERVIEW<br />

2.3 Positioning with Varian or Elekta<br />

Integrations<br />

Depending on your configuration, you may need to adjust the positioning and monitoring steps as<br />

described in the upcoming pages.<br />

Using the Console or Pendant to Activate Couch Motion<br />

Once the shift has been sent to the linac, use the console or pendant to activate couch motion.<br />

NOTE: Based on the “tolerance table” configured on the linac, some motions must be enabled<br />

from within the treatment room, such as when couch rotations or large correction shifts are<br />

involved.<br />

For details regarding the console or couch pendant, as well as for general safety precautions,<br />

refer to the system documentation provided with your accelerator.<br />

Automatic Couch Motion for Elekta Linacs<br />

With Elekta linacs, ExacTrac <strong>Dynamic</strong> uses different interfaces for positioning.<br />

For prepositioning, the MOSAIQ PPS interface is used for sending 3DoF shifts to the Precise<br />

Table.<br />

Automatic Couch Motion for Varian TrueBeam Linacs<br />

With TrueBeam linacs, ExacTrac <strong>Dynamic</strong> uses the auxiliary device interface protocol (ADI) to<br />

send couch move requests to the treatment application of the Varian linac.<br />

The automatic positioning procedure is guided through the couch movement dialog.<br />

Using the iGUIDE Reference Frame<br />

The iGUIDE Reference Frame must be mounted on the table if HexaPOD will be used and 6DoF<br />

shifts should be applied.<br />

It is not recommended to do manual input in iGUIDE with the values displayed in the ExacTrac<br />

<strong>Dynamic</strong> Treatment Application Send Shift dialog. If the connection between both systems is<br />

lost, first reestablish the connection, and then resend the shifts.<br />

For further information, see the iGUIDE manufacturer's instructions for use.<br />

The iGUIDE Reference Frame should be placed in a way that it does not interfere with the<br />

ExacTrac <strong>Dynamic</strong> field of view of surface tracking. Ensure that it is possible to select a tracking<br />

area on the patient for ExacTrac <strong>Dynamic</strong> surface tracking that reflects the movement of the<br />

treated target area but that the reference frame is positioned within the tolerances given by<br />

iGUIDE.<br />

For further information regarding the placement of the iGUIDE Reference Frame, see the<br />

HexaPOD evo RT System and iGUIDE instructions for use.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 41


3 GETTING STARTED<br />

3.1 Preparing for Treatment<br />

Treatment Preparation<br />

This chapter provides general information about treatment preparation, including setting up the<br />

patient on the couch, using the iGUIDE reference frame (if required) and technical considerations<br />

for scanning patients. Which features are available for your system depends on your<br />

configuration, equipment and licenses. For further information, contact Brainlab support.<br />

42 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GETTING STARTED<br />

3.2 Prepositioning Contour<br />

About the Prepositioning Contour<br />

The Prepositioning Contour is used for the initial automatic prepositioning step of the treatment<br />

workflow. If a plan lacks a Prepositioning Contour, it does not prevent patient prepositioning<br />

and/or treatment, but it is recommended to facilitate the initial prepositioning.<br />

Prepositioning Contour Setting<br />

• The value of the Prepositioning Contour setting is determined during installation, and<br />

generally matches the contour most frequently used in the clinical setup.<br />

• You can set a list of the most used prepositioning contours.<br />

• If more than one prepositioning contour matches the contours of the plan, then none of them<br />

will be selected. Prepositioning needs to be performed manually.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 43


About Patient Positioning<br />

3.3 About Patient Positioning<br />

General Positioning Recommendations<br />

• Ensure that the patient is not positioned near any metal components in the couch top.<br />

Otherwise, these components could be included as artifacts in cone-beam CT correction and<br />

verification images.<br />

• With the patient positioned, check all intended or planned movements before leaving the<br />

treatment room. Perform a verification before starting the actual treatment to ensure that the<br />

patient is still in final treatment position.<br />

• In the breath-hold workflow, patient positioning starts in the free-breathing position.<br />

Automatic Couch Positioning<br />

When performing automatic couch positioning from the control room, observe the positioning<br />

process carefully on the video monitors and follow the positioning indicators on the screen. If<br />

couch motion is excessive (e.g., during patient prepositioning or because the couch clearly moves<br />

a substantially larger distance than the required shift), perform the positioning process from within<br />

the treatment room only.<br />

It is the hospital's responsibility that all used systems are calibrated to the linac isocenter. Within<br />

the scope of the measuring accuracy, minor inaccuracies during the different calibration<br />

procedures can occur.<br />

Warning<br />

Always ensure that patient is positioned the same during CT scanning and treatment. This<br />

includes the positioning method, patient posture and orientation as well as patient fixation.<br />

Manual Positioning<br />

If surface matching fails during prepositioning (e.g., due to a blanket or cover), preposition the<br />

patient manually.<br />

NOTE: Because accuracy is very important for the Breath-hold External Positioning with<br />

<strong>Surface</strong> Monitoring workflow, manual prepositioning is not recommended. Use the legend to aid<br />

you with prepositioning instead.<br />

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GETTING STARTED<br />

3.4 Room Lighting Conditions<br />

Adjusting Room Lighting Conditions to Prevent Tracking Loss<br />

In very rare cases, tracking can be lost due to room lighting conditions.<br />

Radiation therapy bunkers with illuminated ceiling displays may have an influence on the<br />

structured blue light of the surface camera projector (with a wavelength of 459 nm) that is used<br />

during tracking. The magnitude of potential interference depends on the color temperature<br />

(spectral composition) and intensity of the room light.<br />

To reduce potential interference between the room light and the structured blue light of the<br />

projector, consider the following lighting recommendations in case tracking issues are<br />

experienced:<br />

• Reduce light intensity.<br />

• Reduce blue light components of bunker illumination and choose a warm color temperature (if<br />

possible).<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 45


Avoiding Collisions<br />

3.5 Avoiding Collisions<br />

About Avoiding Collisions<br />

• Remote couch motion should not be used if accessories that limit the clearance between<br />

patient and gantry are used. Accessories such as conical collimators lead to a higher collision<br />

risk so that the automatic couch motion should only be enabled from inside the treatment room.<br />

• If you suspect a collision may occur, stop motion enabling immediately. Release the motion<br />

enable buttons on the console or pendant in the treatment room.<br />

• If a dry run is necessary to ensure there is no risk of collision, make sure to perform this dry run<br />

in the final treatment position (e.g., after the shift has been applied).<br />

• Tell patients to remain on the treatment couch and not move until a clinician tells them that it is<br />

safe to do so.<br />

• Ensure that there is no collision with the patient or patient fixation/tracking accessory and any<br />

part of the linac or linac accessories during patient positioning.<br />

NOTE: When the Patient Feedback System mirror is used with a breath-hold workflow, it may<br />

introduce an additional collision risk.<br />

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GETTING STARTED<br />

3.6 Technical Considerations<br />

Scan/RT Plan Requirements<br />

Requirement<br />

Description<br />

Supported number of<br />

slices (with each 512 x<br />

512 pixels)<br />

The number of slices used has an influence on software performance,<br />

especially regarding the time required for X-ray fusion. For scans with<br />

up to 900 slices (512 x 512 matrix), the software usually requires less<br />

than 5 seconds for X-ray to DRR fusion.<br />

Slice distance<br />

Gantry tilt/angulation<br />

Scan direction<br />

Treatment position<br />

Image/pixel size<br />

Table height<br />

Image representations<br />

DICOM Image Transfer<br />

Syntax<br />

Maximum 5 mm, equidistant.<br />

Not supported.<br />

• Cranial to caudal<br />

• Caudal to cranial<br />

Head first or feet first, prone or supine.<br />

Do not change during scan.<br />

Do not change during scan.<br />

Gray scale (one channel) with 1 s<strong>amp</strong>le per pixel and 16 bits allocated.<br />

See DICOM Conformance Statement for Origin Data Management.<br />

Matrix size 512 x 512 x 900<br />

Outer contour<br />

Outer contour object (patient contour) is exported with a name corresponding<br />

to the Prepositioning Contour setting list (set by Brainlab<br />

support) in the RT structure set, otherwise the user must preposition<br />

manually. This is applicable for all workflows.<br />

For breath-hold workflows, the outer contour name must correspond to<br />

the Prepositioning Contour name expected by ExacTrac <strong>Dynamic</strong>.<br />

Warning<br />

Always select the actual patient orientation and patient direction for the CT scan. Storing<br />

the wrong direction/orientation may result in an incorrect patient position.<br />

Notes<br />

Depending on the rotational correction required, a significant couch top tilt may occur during<br />

positioning. To prevent the patient slipping off the couch, ensure that they are securely positioned,<br />

and that non-secure objects, such as towels, are not placed between the patient and the couch<br />

top.<br />

Warning<br />

Brainlab strongly recommends the use of a patient fixation device to restrict patient<br />

movement.<br />

Warning<br />

Ensure that all accessories are securely mounted.<br />

Warning<br />

Tell patients to not move and remain on the treatment couch until a clinician tells them that<br />

it is safe to do so.<br />

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Technical Considerations<br />

Treatment Parameters<br />

ExacTrac <strong>Dynamic</strong> operation was tested to be fully operational with the following treatment<br />

parameters. If the treatment parameters are exceeded, it is recommended to test the parameters<br />

first before restarting Treatment, if applicable.<br />

Treatment Parameter<br />

Maximum MU/s<br />

Maximum MU/beam<br />

Maximum MU/fraction<br />

Maximum beams/<br />

patient<br />

Maximum patients in a<br />

row<br />

Maximum treatment<br />

length<br />

Maximum patient data<br />

size<br />

Maximum number of<br />

slices<br />

Maximum number of<br />

OOT events<br />

Limitation<br />

Patients can be treated with up to 100 MU/s (monitor units per second,<br />

equals 6000 MU/m)<br />

Patients can be treated with up to 10,000 MU/beam (monitor units per<br />

beam)<br />

Patients can be treated with up to 50,000 MU/fraction (monitor units per<br />

fraction)<br />

Patients can be treated with up to 50 beams per patient<br />

40 patients can be treated in a row without restart<br />

Patient sessions may last up to two hours<br />

Patients can be treated with a data set (RTPlan) of up to 495 MB<br />

Patients can be treated with a data set of up to 900 slices (with 512 x<br />

512 pixels per slice)<br />

Patients can be treated with up to 120 out-of-tolerance events<br />

NOTE: An out-of-tolerance event is defined as the point in time when a patient is within the<br />

defined limits in all translations and rotations and then moves so that at least one translation or<br />

rotation violates the defined limits.<br />

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GETTING STARTED<br />

3.7 Patient Data Prerequisites<br />

Prerequisites<br />

Warning<br />

Never manually modify any patient data. This could lead to incorrect patient treatment.<br />

Warning<br />

Do not access patient data specific to ExacTrac <strong>Dynamic</strong> with software other than<br />

ExacTrac <strong>Dynamic</strong>.<br />

Warning<br />

Ensure that the isocenter and planning data used are from the same treatment plan on the<br />

linac and on ExacTrac <strong>Dynamic</strong>. Isocenter will always be shown as DICOM coordinates.<br />

Warning<br />

To ensure subsequent positioning accuracy, verify the level of artifacts in the CT data set<br />

are as low as possible. If there are significant motion artifacts, the patient must be<br />

rescanned.<br />

Warning<br />

Artificial CT scans are not suitable for positioning or monitoring since these lead to<br />

incorrect image fusion results.<br />

Warning<br />

CT scans acquired using a contrast agent are not suitable for positioning during treatment<br />

since these lead to incorrect image fusion results.<br />

Warning<br />

Ensure that the CT scan contains appropriate anatomical information for patient<br />

positioning.<br />

Warning<br />

Using CT data sets that differ from the recommended format (in particular those that do not<br />

conform to recommended data volume), can lead to reduced performance or accuracy.<br />

NOTE: ExacTrac <strong>Dynamic</strong> cannot open patient data created with predecessor versions of<br />

ExacTrac (e.g., 5.X or 6.X). Previous versions of the Prep & Review software are also not<br />

compatible.<br />

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4 SYSTEM STARTUP AND<br />

SHUTDOWN<br />

4.1 About System Startup and Shutdown<br />

About This Chapter<br />

This chapter provides general information related to the ExacTrac <strong>Dynamic</strong> system. Which<br />

features are available for your system depends on your configuration, equipment and licenses.<br />

For further information, contact Brainlab support.<br />

About Startup<br />

This section describes how to correctly start up the system as well as the background services.<br />

How to Use the Console to Start the System<br />

By default, use the ExacTrac Console to start the system.<br />

Step<br />

1.<br />

2.<br />

Ensure that the orange standby indicator on the console is lit.<br />

Press the System ON button (I) on the console. The green indicator light should turn on<br />

and remain lit.<br />

Booting Up the Treatment Workstation<br />

The Treatment Workstation starts up automatically after the system is powered up. Booting up<br />

the Treatment Workstation separately is not required.<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

How to Power Up the System Via the Power Distribution Unit<br />

By default, use the ExacTrac Console to power up the system. System startup via the Power<br />

Distribution Unit (PDU) is for troubleshooting purposes only.<br />

Step<br />

1.<br />

2.<br />

In the PDU, set all circuit breakers to the ON position.<br />

Ensure that the red indicator of the PDU STOP button is lit (i.e., the start mode switch<br />

must be in the CIU position).<br />

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About System Startup and Shutdown<br />

Step<br />

3.<br />

To start the system, press the START button of the PDU. Ensure that the START button's<br />

green indicator and the CIU POWER blue indicator are continuously lit.<br />

Auto-Start Timer<br />

The Auto-Start Timer included in the PDU automatically turns on the system so that the camera<br />

reaches temperature equilibrium state B by a predetermined time, without the need to manually<br />

turn on the system. For further information, see the related links below.<br />

The start time must be set to at least one hour before planned clinical use. If the timer is<br />

programmed to start the system automatically, you can shut down the system every day after use<br />

(e.g., to save energy).<br />

Setting a daily system startup time helps address implications during clinical use due to 3D<br />

Camera system warm-up (e.g., failing the Daily Check).<br />

Related Links<br />

About 3D Camera Warm-Up on page 138<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

4.2 Starting the ExacTrac <strong>Dynamic</strong> Software<br />

Background<br />

Once you have booted the ExacTrac <strong>Dynamic</strong> system, and accessory components such as the<br />

camera and Treatment Workstation are running, you can start the Preparation or Treatment<br />

software.<br />

Ensure that any external devices (e.g., a USB flash drive or USB hard drive) has been removed<br />

from the Treatment Workstation prior to patient treatment.<br />

How to Start the Software<br />

Step<br />

1. To start the software, select Brainlab Elements.<br />

Content Manager opens.<br />

2. Select a workflow under ExacTrac <strong>Dynamic</strong> (e.g., Treatment).<br />

3. When starting Treatment, the following actions are performed. ExacTrac <strong>Dynamic</strong> system<br />

connects to:<br />

• Xray Service for configurations with X-ray capability<br />

• The Gating Service: Either EXGI Service for Varian linac integrations or Elekta<br />

Gating Service for Elekta linac integrations<br />

• Varian Service or Elekta Service (including iCOM Service)<br />

NOTE: The services start automatically during boot up of the ExacTrac <strong>Dynamic</strong> system.<br />

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Background Services<br />

4.3 Background Services<br />

Background Services for Software<br />

Figure 6<br />

The background services must be running before starting the ExacTrac <strong>Dynamic</strong> software.<br />

Services start automatically during boot up of the system. This can take up to a few minutes.<br />

Once the services are started properly, ExacTrac <strong>Dynamic</strong> is ready to be started.<br />

You can check the status of any service relevant to ExacTrac <strong>Dynamic</strong> by accessing the<br />

Windows Services tab of the Task Manager.<br />

Background Services for Integrations<br />

Some services that appear under the Windows Services tab of the Task Manager are relevant for<br />

ExacTrac <strong>Dynamic</strong> integrations.<br />

Varian-Relevant Services<br />

Xray Service<br />

Varian Service<br />

EXGI Service<br />

Elekta-Relevant Services<br />

Xray Service<br />

Elekta Service<br />

Elekta Gating Service<br />

iCOM Service<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

Background Services Failure<br />

Figure 7<br />

If ExacTrac <strong>Dynamic</strong> is running when a failure occurs in the background services, a warning<br />

dialog is displayed. In most cases, the corresponding service auto-recovers and the dialog<br />

disappears.<br />

If it does not, you can restart the disconnected service by selecting the button to restart it.<br />

If the problem continues, shut down and restart the system.<br />

If the issue persists, contact Brainlab support.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 55


Restarting the System<br />

4.4 Restarting the System<br />

How to Restart the System<br />

Figure 8<br />

Step<br />

1. From the menu, select Quit Treatment App.<br />

2. Shut down Windows.<br />

3. Press System Off (O) on the console to power down ExacTrac <strong>Dynamic</strong> completely.<br />

4. Restart the system by selecting either:<br />

• System On (I) on the ExacTrac Console.<br />

• START on the Power Distribution Unit (System startup via the Power Distribution<br />

Unit is for troubleshooting purposes only.).<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

4.5 Shutting Down the Software<br />

Background<br />

Once patient treatment has been completed, the software can be shut down.<br />

If the Windows user changes, the user must close the ExacTrac <strong>Dynamic</strong> application before<br />

locking Windows. Otherwise, other users will be able to log in to Elements, but will not be able to<br />

use ExacTrac <strong>Dynamic</strong>.<br />

If the system is shut down before the software is closed, data can be lost.<br />

How to Close the Patient File<br />

Step<br />

To close the current patient file, close the patient on the linac.<br />

How to Exit the ExacTrac <strong>Dynamic</strong> Software<br />

Before shutting down the system, you must exit the ExacTrac <strong>Dynamic</strong> software correctly.<br />

Step<br />

1. Open the menu.<br />

2. Select Quit Treatment App.<br />

3. An exit prompt is shown.<br />

4. Select Yes to close the software.<br />

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Shutting Down the System<br />

4.6 Shutting Down the System<br />

About Shutting Down the System<br />

By default, use the ExacTrac Console to shut down the system.<br />

For optimum system performance and reduced power consumption, Brainlab recommends<br />

shutting down the system every day after treatment ends (if the automatic start function is<br />

enabled).<br />

Emergency Stop/Off<br />

In the event of an emergency, push the emergency off switch installed in the room.<br />

How to Shut Down the System<br />

Step<br />

1. Shut down the Windows operating system by selecting Shut Down in the Start menu.<br />

2. Wait until the Treatment Workstation shuts down and the monitor goes black.<br />

3.<br />

1<br />

Turn off the system power by pressing the System Off button 1 on the ExacTrac Console<br />

for three seconds. The orange standby LED will flash during this time.<br />

• When the green POWER LED turns off, this indicates that system mains power is<br />

turned off.<br />

• As long as the system is OFF, the orange standby LED remains ON (indicating standby<br />

voltage 24 V DC).<br />

How to Power Down the System Via the Power Distribution System<br />

By default, use the ExacTrac Console to shut down the system. System shutdown via the Power<br />

Distribution Unit is for troubleshooting purposes only.<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

Step<br />

1.<br />

2.<br />

Press STOP on the Power Distribution Unit.<br />

The green and blue indicators turn off.<br />

Only the red indicator remains ON (indicates 24V DC Standby power).<br />

Additional Notes on Shutdown<br />

• The circuit breakers of the Power Distribution Unit should remain always ON. Otherwise, the<br />

daily automatic start function cannot start up the system.<br />

• If you prefer to always keep the system on, the Treatment Workstation must be restarted daily<br />

before treatment. Otherwise, its performance may be affected.<br />

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Overview of Available Applications<br />

4.7 Overview of Available Applications<br />

About the Applications<br />

• This user guide includes a description of available ExacTrac <strong>Dynamic</strong> applications. Which<br />

applications are available with your system depends on your configuration, equipment and<br />

licenses.<br />

• All of the applications are described in the ExacTrac <strong>Dynamic</strong> Clinical User Guide<br />

Preparation and Treatment Applications<br />

Option<br />

ExacTrac <strong>Dynamic</strong> Preparation<br />

Application<br />

ExacTrac <strong>Dynamic</strong> Treatment<br />

Application<br />

Description<br />

Select a plan (if one did not load automatically), review plan settings<br />

and confirm a patient plan in this application.<br />

Select a template with predefined treatment settings, which can be<br />

reviewed and adjusted to match patient-specific needs.<br />

From this point forward in this user guide, ExacTrac <strong>Dynamic</strong><br />

Preparation Application will be referred to as Preparation.<br />

Perform positioning and monitoring for multiple workflows. Adjust<br />

settings, position the patient and monitor treatment from this application.<br />

From this point forward in this user guide, ExacTrac <strong>Dynamic</strong><br />

Treatment Application will be referred to as Treatment.<br />

Quality Assurance Tools - <strong>Surface</strong><br />

ExacTrac <strong>Dynamic</strong> offers several primary and secondary quality assurance and calibration tools.<br />

Which tools are available is license dependent and based on your system configuration.<br />

Application<br />

Thermal to 3D Camera<br />

Calibration<br />

Isocenter Calibration <strong>Surface</strong><br />

Daily Check <strong>Surface</strong><br />

<strong>Surface</strong> Tracking QA<br />

Description<br />

Establishes a relative calibration between the Thermal Camera<br />

and the 3D Camera using a heated phantom.<br />

Calibrates the surface tracking system to the linac coordinate system<br />

and isocenter.<br />

Perform at least once each day to verify that:<br />

• The system setup geometry has not changed.<br />

• The phantom's position corresponds with the saved isocenter<br />

position.<br />

Quality control test to ensure optimal system performance of surface<br />

tracking system.<br />

Additional Tools - <strong>Surface</strong><br />

Application<br />

Template Editor<br />

Repeat Export<br />

Archive/Delete Patients<br />

Description<br />

Creates or adapts the templates (e.g., to use hospital-specific settings).<br />

Re-exports the patient treatment report to the R&V system.<br />

Exports or deletes local patient data.<br />

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PREPARATION<br />

5 PREPARATION<br />

5.1 Using the Preparation Application<br />

Using Preparation<br />

This user guide describes all ExacTrac <strong>Dynamic</strong> features. Which features are available for your<br />

system depends on your configuration, equipment and licenses. The following pages describe<br />

typical preparation workflows for ExacTrac <strong>Dynamic</strong> as well as information regarding the usage<br />

of specific linacs.<br />

Use Preparation for all workflow types to:<br />

• Select a patient plan<br />

• Assign a template<br />

• Review and adjust patient settings<br />

How to Prepare a Plan<br />

Step<br />

1. Select Preparation from the Content Manager.<br />

Plan Selection opens.<br />

2. Select a plan (if one did not load automatically).<br />

3. Select Load.<br />

4. Select a template from the list and select Confirm.<br />

5. Review template settings and adjust if necessary.<br />

6. Select Finish Patient Preparation to proceed.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 61


Using the Preparation Application<br />

Reviewing Plan Settings<br />

1<br />

2<br />

Figure 9<br />

No.<br />

1<br />

2<br />

Description<br />

Category of plan settings (e.g., Patient Position Preferences)<br />

Options and information about this step<br />

Once the patient plan is imported, review and adjust individual settings. Scroll down or select from<br />

the menu. Always review settings carefully before making changes.<br />

Warning<br />

The patient settings determine several parameters that directly affect patient positioning.<br />

Brainlab strongly recommends that these settings are defined by the physician and/or the<br />

physicist who created the treatment plan.<br />

Warning<br />

When using multiple ExacTrac <strong>Dynamic</strong> systems for a patient treatment, ensure that<br />

patient settings are adjusted according to the used system for each fraction.<br />

Warning<br />

Always verify that selected system settings match with the present (linac) system (e.g., the<br />

possibility to correct for pitch and roll).<br />

62 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


PREPARATION<br />

5.2 Plan Selection<br />

Selecting a Plan<br />

1<br />

Figure 10<br />

If a plan does not load automatically, the first step in the Preparation workflow is to select and<br />

load a patient plan. Select the arrow 1 to view all plans that have been pushed from the hospital's<br />

R&V system to ExacTrac <strong>Dynamic</strong>.<br />

Warning<br />

Do not load new patient when current patient is still in the treatment room.<br />

NOTE: Always prepare patient data in Preparation before beginning treatment with Treatment.<br />

How to Select a Patient Plan<br />

Step<br />

1. Start Preparation in the Content Manager.<br />

The Plan Selection page opens.<br />

Select the arrow in the upper right corner to view available plans.<br />

2. Select the appropriate option:<br />

• Not Prepared: Plans that have been imported but not prepared for treatment in Exac-<br />

Trac <strong>Dynamic</strong>.<br />

• Prepared: Imported plans that have been prepared for treatment, but not yet treated.<br />

• Treated: Patient plans that have already been treated.<br />

• All: All imported plans (except failed plans).<br />

• Import Failed: Plans that did not import successfully.<br />

3. Select the required patient plan.<br />

4. To view more information about a specific patient plan, select the arrow.<br />

5. Select Load.<br />

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Plan Selection<br />

If the Plan is Open on Another Workstation<br />

Figure 11<br />

ExacTrac <strong>Dynamic</strong> warns you if any plan of the patient you just opened is already open on<br />

another workstation.<br />

Options<br />

Close the patient plan by selecting:<br />

• Cancel & Auto-authorize (in Treatment)<br />

• Return to Patient Plan Selection (in Preparation)<br />

Open the patient plan and work on it<br />

If you open patient plan to work on it, be aware that the last changes made to the plan overwrite<br />

any previously made changes. This means either you overwrite the changes made by your<br />

colleague, or your colleague overwrites your changes.<br />

NOTE: ExacTrac <strong>Dynamic</strong> does not warn you again at the time the plan is saved.<br />

If Someone Opened the Plan you are Working on on Another Workstation<br />

Figure 12<br />

ExacTrac <strong>Dynamic</strong> warns you if you are preparing a patient plan and someone else opens any<br />

plan of the same patient on another workstation.<br />

Options<br />

Close the patient plan by selecting:<br />

• Cancel & Auto-authorize (in Treatment)<br />

• Return to Patient Plan Selection (in Preparation)<br />

Continue working on the patient plan<br />

If you continue to work on the patient plan, be aware that the last changes made to the plan<br />

overwrite any previously made changes. This means either you overwrite the changes made by<br />

your colleague, or your colleague overwrites your changes.<br />

NOTE: ExacTrac <strong>Dynamic</strong> does not warn you again at the time the plan is saved.<br />

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PREPARATION<br />

Opening the Patient Plan on the Same Workstation in Another Application<br />

Figure 13<br />

It is not possible to open the same patient plan on the same workstation in two applications<br />

simultaneously (e.g., Treatment and Preparation).<br />

You must close the patient plan in one application before you can open it in the other.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 65


Template Selection<br />

5.3 Template Selection<br />

Selecting a Template<br />

The next step is to select a template. Settings are applied to the patient plan based on your<br />

selection.<br />

Warning<br />

During patient treatment plan preparation, always verify that the template selected best<br />

suits the needs of the patient.<br />

How to Select a Template<br />

1<br />

Figure 14<br />

Step<br />

1. Select a template from the list displayed on the left side.<br />

Plan Settings Preview is displayed.<br />

2. Review the settings.<br />

3. If this is the correct template, select Confirm 1.<br />

NOTE: If you decide the template is not suitable for your planned treatment, select a different<br />

template.<br />

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PREPARATION<br />

5.4 Template Editor<br />

Using the Template Editor<br />

ExacTrac <strong>Dynamic</strong> provides a set of master templates. These are the basis when creating a<br />

custom template.<br />

After installation but before using the software for the first time, you must define at least one<br />

custom template. Otherwise there will be no template to choose from in Preparation.<br />

If you have sufficient user rights, you can modify or create custom templates (e.g., to establish<br />

hospital-specific settings) using the master templates as a starting point.<br />

Settings are applied to the patient plan based on your selection.<br />

How to Create a New Template<br />

1<br />

Figure 15<br />

Step<br />

1. From the Content Manager, open Template Editor.<br />

2. Select Add Template.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 67


Template Editor<br />

Step<br />

3.<br />

Select a master template that is similar to your requirements.<br />

Select Create new template.<br />

4.<br />

A pop-up opens.<br />

5. Enter a unique name for the new template and select Save.<br />

The number of characters are limited and you may only use lowercase and uppercase letters<br />

and the numbers 0 to 9. If you attempt to use unacceptable characters, a pop-up is<br />

displayed.<br />

6. Select OK.<br />

The new template is added to the list of templates.<br />

How to Edit an Existing Template<br />

To edit the standard settings for one of the custom templates (e.g., to use hospital-specific<br />

settings), open Template Editor.<br />

NOTE: To change template settings, you must have sufficient user rights.<br />

NOTE: When upgrading to ExacTrac <strong>Dynamic</strong> 2.0, all previously stored custom templates will be<br />

lost and new custom templates must be created based on the new master templates available in<br />

ExacTrac <strong>Dynamic</strong> 2.0. For further information, contact Brainlab support.<br />

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PREPARATION<br />

NOTE: Automatic beam control is selected by default for every master template provided by<br />

Brainlab. It is recommended to keep this feature selected when designing templates, as well as<br />

for plan preparation. In case the automatic beam control is turned off, it is not the responsibility of<br />

ExacTrac <strong>Dynamic</strong> to stop the beam if the patient moved outside the defined patient thresholds.<br />

Step<br />

1. From the Content Manager, open Template Editor.<br />

2. The Template Editor page opens. Select the template you want to edit.<br />

3.<br />

Adjust settings as required.<br />

When you are finished, you have two options:<br />

• Select Apply to save the changes under the current template name.<br />

• Select Save As to save your changes under a different template name.<br />

4.<br />

If you select Save As, a pop-up opens.<br />

Enter a unique name for the new template and select Save. The new template is added to<br />

the list of templates. The number of characters are limited and you may only use lowercase<br />

and uppercase letters and the numbers 0 to 9.<br />

You can also Cancel.<br />

5. Open the Menu and select Quit Template Editor to return to the Content Manager<br />

workflow selection.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 69


Treatment Plan Settings<br />

5.5 Treatment Plan Settings<br />

Adjusting Treatment Plan Settings<br />

Most treatment settings for patient plans can be changed in Preparation and via the menu in<br />

Treatment. The system informs you if a setting cannot be changed in the open application.<br />

The following pages are arranged in the order they appear in Preparation. They describe plan<br />

information and indicate where changes can be made, as well as for how long a change applies.<br />

Depending on where a setting is changed, a setting change may remain in effect:<br />

• For all patient sessions (e.g., the lifetime of the plan)<br />

• For the current session<br />

• For the current couch angle (PSA) of all patient sessions<br />

• For the current beam<br />

For ex<strong>amp</strong>le, any threshold set during Preparation can be changed during treatment and<br />

monitoring, but if the patient plan is closed and reopened in Preparation, the threshold will revert<br />

to what was set during plan preparation.<br />

Notes<br />

Warning<br />

The patient settings determine several parameters that directly affect patient positioning.<br />

Brainlab strongly recommends that these settings are defined by the physician and/or<br />

physicist who created the treatment plan.<br />

Warning<br />

Always review the selected thresholds and settings carefully during preparation.<br />

Warning<br />

When using multiple ExacTrac <strong>Dynamic</strong> systems for patient treatment, ensure that patient<br />

settings are adjusted according to the used system for each fraction.<br />

Warning<br />

Always verify that selected system settings match the present linac system (e.g., the<br />

possibility to correct for pitch and roll).<br />

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PREPARATION<br />

Page Overview: Preparation<br />

1<br />

2<br />

3<br />

4<br />

Figure 16<br />

Although different buttons or tools may be available based on your workflow selection or workflow<br />

step, the page layout in Preparation follows this basic design.<br />

No. Component Description<br />

1 Menu Open to quit the application or return to patient selection.<br />

2<br />

3<br />

Current workflow step indicator<br />

View area<br />

Shows the current workflow step (e.g., Plan Settings<br />

Adjustment).<br />

Information and options about the current group of settings.<br />

4 Workflow guidance Displays information about step and available options.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 71


Treatment Plan Settings<br />

General<br />

Figure 17<br />

This category of settings determines the general treatment indication, as well as the general<br />

workflow and required system positioning technique.<br />

Heading Setting Description<br />

ExacTrac <strong>Dynamic</strong> Workflow<br />

Breathing Management<br />

Positioning Device<br />

<strong>Surface</strong> Only<br />

Breath-hold<br />

External (e.g. CBCT)<br />

Only surface modality is used within<br />

the workflow.<br />

Activate to treat breath-hold workflows.<br />

ExacTrac <strong>Dynamic</strong> accepts the patient<br />

position from an external positioning<br />

device (such as CBCT).<br />

The first time you open a patient plan in Preparation, you must select from one of the treatment<br />

templates appropriate for the indication.<br />

• Your template selection will display settings that are suitable for that treatment indication.<br />

• The selected template remains valid for the lifetime of the patient plan.<br />

Select how the patient will be positioned. The option is applied to the plan for the lifetime of the<br />

plan.<br />

NOTE: With Elekta integrations using external positioning workflows, it is only possible to<br />

reposition the patient using ExacTrac <strong>Dynamic</strong> with 3DoF.<br />

Beam Hold Settings<br />

Setting<br />

Beam Hold Control<br />

Description<br />

Allows the software to hold the beam if the patient is out<br />

of tolerance. The setting in Preparation is applied to all<br />

treatment sessions and beams. Changes made via the<br />

Menu apply to the current beam only.<br />

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PREPARATION<br />

Setting<br />

<strong>Surface</strong> out of tolerance delay<br />

(slider)<br />

Description<br />

Set the time in seconds. Holds the beam if patient is out<br />

of tolerance for more than the selected time. When set in<br />

Preparation, it applies to all treatment sessions. When<br />

changed in Treatment, it applies only to the current<br />

beam of the current patient session.<br />

NOTE: Beam Hold Control is selected by default for every master template provided by Brainlab.<br />

It is recommended to keep this feature selected when designing templates, as well as for plan<br />

preparation.<br />

In case the automatic beam control is turned off, it is not the responsibility of ExacTrac <strong>Dynamic</strong><br />

to stop the beam if the patient moved outside the defined patient thresholds.<br />

Breath-hold Settings<br />

Setting<br />

Imaging Window +/-<br />

Description<br />

Allowed tolerance for how much the breath-hold level<br />

can deviate from the planning CT level during imaging.<br />

The software displays a warning if the imaging level is<br />

outside of this window.<br />

Slider from 0.5 to 3 mm.<br />

NOTE: Only available for breath-hold treatments in surface-only<br />

modality.<br />

Reference <strong>Surface</strong> Window +/-<br />

Treatment Gating Window +/-<br />

Allowed tolerance for how much the breath-hold level<br />

can deviate from the imaging level when the reference<br />

surface is captured.<br />

The software displays a warning if there is a deviation<br />

from this tolerance. Deviations can influence the isocentric<br />

accuracy.<br />

Slider from 0.5 to 3 mm.<br />

Beam-on is allowed within this window with respect to<br />

the reference surface (today's treatment) level.<br />

Slider from 0.5 to 3 mm.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 73


Treatment Plan Settings<br />

Patient Position Tolerances<br />

Figure 18<br />

Patient Position Tolerances set in Preparation apply to all patient sessions. Changes made to<br />

the tolerances via ExacTrac <strong>Dynamic</strong> are applied to the current session.<br />

If Treatment is allowed to hold the beam and one of the dimensions exceeds its threshold, the<br />

software will interrupt the treatment until the patient is either back in tolerance or the user actively<br />

decides to disable the safeguards and continue treatment.<br />

For any setting, select the ⊕ or ⊖ symbols or move the slider with your mouse.<br />

The tolerance values (in mm) apply for all translational deviations:<br />

• Lateral<br />

• Longitudinal<br />

• Vertical<br />

• Distance<br />

NOTE: Distance is defined by the lateral, longitudinal and vertical values.<br />

The tolerance values (in °) apply for all rotational deviations (pitch, roll and couch angle). The<br />

following tolerances are calculated:<br />

• Pitch<br />

• Roll<br />

• Yaw<br />

<strong>Surface</strong> Camera<br />

Figure 19<br />

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PREPARATION<br />

It may be necessary to adjust the Patient Skin Tone to achieve the best surface reconstruction<br />

possible.<br />

Use the slider to adjust to the best possible skin tone. Any changes made to the Patient Skin<br />

Tone, in either Preparation or Treatment, are stored for all patient sessions.<br />

Slider<br />

Patient Skin Tone<br />

Options<br />

• Light<br />

• Fair<br />

• Medium<br />

• Dark<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 75


Preparation Workflows<br />

5.6 Preparation Workflows<br />

Patient Preparation Workflows<br />

The following pages provide ex<strong>amp</strong>les for preparing a patient in Preparation using the available<br />

workflows.<br />

External Positioning with <strong>Surface</strong> Monitoring<br />

Step<br />

1. Start Preparation.<br />

Plan Selection opens.<br />

2. Select a plan (if one did not load automatically).<br />

3. Select Load.<br />

NOTE: Only beams with couch angles up to ± 30° are allowed.<br />

4. Select a template from the list and select Confirm to proceed with the import.<br />

The plan settings are initialized by the template.<br />

5. Review and adjust plan settings as required.<br />

Under Workflow, select <strong>Surface</strong> Only.<br />

Under Positioning Device, select External (e.g. CBCT).<br />

6. Select Finish Patient Preparation.<br />

The software returns to plan selection.<br />

7. From the Menu, select Quit Preparation App to leave the application.<br />

Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

Step<br />

1. Start Preparation.<br />

Plan Selection opens.<br />

2. Select a plan (if one did not load automatically).<br />

NOTE: Breath-hold workflows require two patient contours.<br />

NOTE: Only coplanar beams are allowed.<br />

3. Select Load.<br />

4. Select a template from the list and select Confirm to proceed with the import.<br />

The plan settings are initialized by the template.<br />

5. Review and adjust plan settings as required.<br />

• Under Workflow, select <strong>Surface</strong> Only.<br />

• Under Positioning Device, select External (e.g. CBCT).<br />

• Toggle on Breathing Management and confirm that Breath-hold is selected.<br />

6. Continue to Contour Objects page and review the breath-hold reference contours.<br />

7. Select Finish Patient Preparation.<br />

The software returns to plan selection.<br />

8. From the Menu, select Quit Preparation App to leave the application.<br />

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PREPARATION<br />

5.7 Isocenters Overview<br />

About Multiple and Virtual Isocenters<br />

ExacTrac <strong>Dynamic</strong> supports plans with multiple and virtual isocenters:<br />

• A multi isocenter plan uses several treatment beams with different isocenters. The setup fields<br />

have the same isocenter position as the associated treatment beam.<br />

• A virtual isocenter plan uses several treatment beams with the same isocenter. The isocenter<br />

of the setup beams differs from that of the treatment beams. When prepositioning with virtual<br />

isocenters, the maximum offset should not be greater than 10 - 15 cm in the dorsal direction. If<br />

the offset is higher, the patient may no longer be visible to the camera.<br />

In the case of a plan with multiple or virtual isocenters, you must prepare each isocenter (i.e., set<br />

the plan settings for each isocenter). The available isocenters are displayed on the Multi<br />

Isocenter Overview page.<br />

You cannot finalize plan preparation unless all isocenters contained in the plan have been<br />

prepared. If an isocenter is not prepared, any changes made will be deleted.<br />

Using Varian with Multiple Isocenters<br />

If you are using multiple isocenter plans with Varian integrations, no additional steps are required.<br />

ExacTrac <strong>Dynamic</strong> will automatically recognize all different isocenter positions of the treatment<br />

plan.<br />

Using Elekta with Multiple Isocenters<br />

Certain additional steps are necessary for planning, exporting and importing multiple and virtual<br />

isocenter plans with Elekta integrations to ensure that ExacTrac <strong>Dynamic</strong> can correctly recognize<br />

the different isocenter positions.<br />

To correctly import multiple or virtual isocenter plans into MOSAIQ, a site setup must be created<br />

for each isocenter. This step can be efficiently performed directly in your treatment planning<br />

system by using an associated prescription for each additional isocenter.MOSAIQ should now<br />

automatically create a site setup for each isocenter during import.<br />

Alternatively, you can manually create site setups in MOSAIQ. In this case, a site setup must be<br />

created for each isocenter. It is essential to enter the correct coordinates of the isocenter in the<br />

site setup.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 77


Isocenters Overview<br />

How to Prepare an Isocenter<br />

Step<br />

1.<br />

1<br />

2.<br />

On the Multi Isocenter Overview page, select an isocenter to prepare from the Isocenters<br />

menu 1.<br />

Select Prepare 1.<br />

1<br />

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PREPARATION<br />

Step<br />

3.<br />

Review the information for the isocenter.<br />

• Adjust plan settings as necessary.<br />

• If you are satisfied, select Confirm.<br />

After review, a check mark appears next to the prepared isocenter in the Isocenters<br />

menu.<br />

1<br />

4. Repeat steps 1 - 3 until all isocenters are prepared.<br />

5.<br />

1<br />

When all isocenters are prepared, a green check mark is displayed next to Isocenters 1,<br />

indicating that all isocenters in the plan have been prepared.<br />

6. Select Finish Patient Preparation 2 to continue.<br />

2<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 79


Finish Patient Preparation<br />

5.8 Finish Patient Preparation<br />

About Finishing Patient Preparation<br />

When all steps of the preparation workflow are complete, select Finish Patient Preparation.<br />

Plan Selection opens. You can:<br />

• Select and prepare a new patient.<br />

• Select Quit Preparation App from the Menu to leave the application.<br />

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TREATMENT<br />

6 TREATMENT<br />

6.1 Overview of Available Workflows<br />

ExacTrac <strong>Dynamic</strong> Workflows<br />

The following pages describe typical surface-only treatment workflows for ExacTrac <strong>Dynamic</strong> as<br />

well as information regarding the usage of specific linacs. Which features are available for your<br />

system depends on your configuration, equipment and licenses.<br />

Brainlab recommends users follow the general provided workflows. Specific details within the<br />

workflows (e.g., default settings and thresholds) need to be specified by the user according to<br />

hospital or national guidelines.<br />

NOTE: Beam delivery automation is not supported by ExacTrac <strong>Dynamic</strong>.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 81


External Positioning Workflow<br />

6.1.1 External Positioning Workflow<br />

About External Positioning Treatments<br />

The following workflow allows you to position the patient using an external device, such as CBCT.<br />

External Positioning with <strong>Surface</strong> Monitoring<br />

Step<br />

1. Open patient plan on the linac.<br />

2. Perform prepositioning.<br />

Align the PTV to the linac isocenter.<br />

3. Select a surface tracking area that will be tracked by surface tracking throughout the external<br />

imaging procedure and treatment.<br />

4. Perform external positioning (e.g., CBCT) and confirm that the patient is in final treatment<br />

position.<br />

The reference for monitoring is set and patient tracking starts.<br />

5. Perform and monitor treatment.<br />

6. Perform repositioning if the patient moves out of tolerance.<br />

Related Links<br />

Loading and Confirming Plans on page 86<br />

Patient Prepositioning on page 92<br />

External Positioning with <strong>Surface</strong> Monitoring Workflows on page 96<br />

<strong>Surface</strong> Tracking Area on page 100<br />

External Imaging on page 123<br />

Patient Monitoring on page 125<br />

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TREATMENT<br />

6.1.2 Breath-hold Workflow<br />

Requirements for Breath-hold Treatments<br />

To perform a breath-hold treatment, the following requirements must be fulfilled:<br />

• The system requires two reference contours from two different CT scans, which are used in<br />

irradiation planning and must be fused in the planning software (spinal fusion).<br />

- Free-Breathing Contour Plan: Derived from a CT acquired while the patient is breathing<br />

freely.<br />

- Breath-hold Planning CT: Derived from a CT acquired during a deep inspiration breath<br />

hold.<br />

• The system accepts treatment plans without couch rotations only. Plans with a couch rotation<br />

of more than 0° will be rejected.<br />

• To ensure that the reference contours can be assigned correctly for treatment, the naming<br />

convention has to be fulfilled. The names for the Free-Breathing Contour Plan and the<br />

Breath-hold Planning CT must be defined in the service settings following the naming<br />

convention of the treatment plan.<br />

• The contours of the Free-Breathing Contour Plan and Breath-hold Planning CT may only<br />

contain the external contour of the patient (i.e., the body shape). No internal structures and no<br />

artificial structures (e.g., table top) may be included in these contours.<br />

NOTE: The exception is a bolus that is part of the CT scan.<br />

• The Free-Breathing Contour Plan and Breath-hold Planning CT may not contain anything<br />

else but the patient's skin.<br />

NOTE: The exception is a bolus that is part of the CT scan.<br />

Using a Bolus<br />

If desired, you can use either a virtual or CT-scanned bolus with ExacTrac <strong>Dynamic</strong>.<br />

• A virtual bolus is added virtually (e.g., not physically) during planning and is not part of the CT<br />

scan.<br />

• A CT-scanned bolus is a physical bolus placed on the patient during CT scanning.<br />

How to Acquire a Free-Breathing CT<br />

To acquire the Free-Breathing CT, the patient should be relaxed with shallow, normal breathing.<br />

A slower scan technique is recommended to avoid that the scan is taken at inhalation/exhalation<br />

only.<br />

Step<br />

1. Position the patient.<br />

• Take as much time as necessary and encourage the patient to achieve a shallow, normal<br />

breathing pattern.<br />

• If patients are nervous and breathing fast and heavy compared to their normal breathing,<br />

give them time to relax and calm down. A Free-Breathing CT acquired with a<br />

heavily breathing patient will result in a reduced upstroke, which is unfavorable for a<br />

breath-hold treatment.<br />

2. Scan the patient.<br />

NOTE: The calculation of the upstroke between the Free-Breathing Contour Plan and Breathhold<br />

Contour is based on an average breathing level (baseline) that is calculated in free<br />

breathing. A Free-Breathing CT acquired at inhalation/exhalation only might result in an incorrect<br />

upstroke calculation.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 83


Breath-hold Workflow<br />

How to Acquire a Breath-hold CT<br />

For the Breath-hold CT, a fast scan protocol is recommended to make sure the scan can be<br />

completed within one breath hold.<br />

Step<br />

1. Position the patient in same position as for the Free-Breathing Contour.<br />

The patient should be relaxed with normal breathing.<br />

2. Guide the patient into a test breath hold and at the same time visually check that there is<br />

good upstroke. An upstroke of 10 to 20 mm on the patient sternum is recommended to<br />

achieve good results (depending on patient condition).<br />

Ensure that the breath hold is reached by normal inhalation only and not by a physical<br />

lifting of the chest.<br />

Allow the patient to breathe normally again.<br />

3. Guide the patient into a breath hold again and perform the scan while the patient is in the<br />

breath-hold state.<br />

Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

Step<br />

1. Open patient plan on the linac.<br />

2. Perform prepositioning of the patient in free-breathing state.<br />

3. On the Respiratory Point page:<br />

• Select a respiratory point.<br />

• Calculate the baseline.<br />

4. On the Breath-hold Navigation page, acquire external imaging data:<br />

• Perform couch centering (Varian only), if required.<br />

• Guide the patient into a breath hold and the planned target.<br />

• Perform external imaging and mark external imaging events.<br />

• If external imaging events were marked, the reference surface is acquired automatically<br />

by ExacTrac <strong>Dynamic</strong>. Acquire the reference surface manually if the marking feature<br />

was not used.<br />

5. Verify the levels.<br />

• If the patient is within tolerance of the thresholds defined in Preparation, the workflow<br />

continues to step 6.<br />

• If they are not within tolerance, repeat steps 2 - 5, as required:<br />

- Modify external imaging level<br />

- Modify reference surface<br />

- Reacquire external imaging<br />

6. On the <strong>Surface</strong> Tracking Area page:<br />

Define an area of the patient's surface that will be tracked throughout the treatment.<br />

7. Perform and monitor treatment.<br />

Related Links<br />

Loading and Confirming Plans on page 86<br />

Patient Feedback System on page 89<br />

Patient Prepositioning on page 92<br />

Breath-hold Respiratory Point on page 104<br />

Breath-hold Navigation on page 106<br />

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TREATMENT<br />

External Imaging on page 123<br />

<strong>Surface</strong> Tracking Area on page 100<br />

Patient Monitoring on page 125<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 85


Loading and Confirming Plans<br />

6.2 Loading and Confirming Plans<br />

About Importing Plans<br />

All patient plans have to be imported (pushed) from the hospital's R&V system to the ExacTrac<br />

<strong>Dynamic</strong> system.<br />

If a plan has not been previously imported and the plan is opened at the linac while Treatment is<br />

running, the software informs you that the plan is not available for treatment with ExacTrac<br />

<strong>Dynamic</strong> but the treatment will still be authorized.<br />

If a plan has been imported previously and the plan is opened on the linac, how you proceed is<br />

determined by whether or not the plan has been prepared in Preparation:<br />

Options<br />

Not prepared<br />

Prepared<br />

Description<br />

• The plan opens in Preparation and you must go through the planning<br />

steps.<br />

• Exit the application.<br />

• The plan opens in Treatment.<br />

The plan opens in Treatment.<br />

About Loading Plans<br />

To load a plan, you must open a treatment plan on the linac.<br />

The plan loads in Treatment if it:<br />

• Was prepared with Preparation<br />

• Was exported to ExacTrac <strong>Dynamic</strong><br />

• Should be treated using ExacTrac <strong>Dynamic</strong><br />

NOTE: If the patient should not be treated using ExacTrac <strong>Dynamic</strong> (e.g., to a single day<br />

condition of the patient), you can select Reject and auto-authorize, which gives the authorization<br />

to proceed with treatment excluding ExacTrac <strong>Dynamic</strong>.<br />

If the plan has already been prepared, the Patient Confirmation page opens in ExacTrac<br />

<strong>Dynamic</strong>. You must review the patient data to ensure that the correct plan is loaded. The main<br />

treatment settings are also displayed for review. If the correct patient plan with the correct settings<br />

has been loaded, you can select Confirm Plan to proceed with patient setup.<br />

Notes on Loading Plans<br />

Warning<br />

Verify that the treatment plan loaded in the ExacTrac <strong>Dynamic</strong> system matches the<br />

treatment plan loaded on the linac, and ensure that the isocenter coordinates (ExacTrac<br />

<strong>Dynamic</strong> will always show the isocenter as DICOM coordinates) are correct by comparing<br />

them to the printout from the treatment planning system. This is especially important if the<br />

treatment plan has been updated in order to take possible problems (e.g., gantry/table<br />

collision, tumor shrinkage, boost planning) into account.<br />

Warning<br />

Verify that the correct patient data (e.g., patient name and ID, and plan date) is shown in the<br />

plan confirmation page.<br />

Warning<br />

Always verify that the patient on the couch is the patient opened for treatment on the linac<br />

and on ExacTrac <strong>Dynamic</strong>.<br />

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TREATMENT<br />

Treatment Authorization for Varian Linacs<br />

The ExacTrac <strong>Dynamic</strong> system must always be running in order to authorize treatments on the<br />

linac using the ADI interface as all patient treatments must be authorized by the ExacTrac<br />

<strong>Dynamic</strong> system.<br />

NOTE: Authorization is given for each individual beam, not per patient plan.<br />

Warning<br />

Once an authorization is given by the ExacTrac <strong>Dynamic</strong> system, it cannot be withdrawn<br />

via the ADI interface. Use automatic beam hold for patient monitoring during treatment<br />

instead.<br />

For details regarding ADI, as well as for general safety precautions, refer to the system<br />

documentation provided with your linear accelerator.<br />

Treatment Authorization for Elekta Linacs<br />

If the Elekta Service is running, the ExacTrac <strong>Dynamic</strong> system must also be running in order to<br />

remove the beam inhibit and start treatment. This also applies for treatment plans where the<br />

ExacTrac <strong>Dynamic</strong> system should not participate.<br />

• If the Elekta Service is not running, no beam inhibit is set and treatment is possible.<br />

• If the Elekta service is not running and a plan that had been exported to the ExacTrac<br />

<strong>Dynamic</strong> system is opened on the linac, treatment is also possible without ExacTrac <strong>Dynamic</strong><br />

participating.<br />

Conditions for Beam Inhibit with Elekta Linacs<br />

A beam inhibit is set if any of the following occurs:<br />

• A plan is loaded and/or a beam is loaded<br />

• No patient has been positioned<br />

• There is a software or hardware error<br />

The beam is released when one of the following occurs:<br />

• The plan is rejected<br />

• The beam is approved<br />

• The system is powered down<br />

NOTE: As a result of this behavior, only load a patient plan after performing an iGUIDE daily<br />

check, if one is to be performed.<br />

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Loading and Confirming Plans<br />

Plans with Multiple Isocenters<br />

Figure 20<br />

If your plan contains multiple isocenters, ExacTrac <strong>Dynamic</strong> loads the plan settings<br />

corresponding to the first beam treatment position.<br />

1<br />

Figure 21<br />

When a new beam with a different isocenter 1 is loaded on the linac, ExacTrac <strong>Dynamic</strong> saves<br />

the changes related to the old isocenter, and loads the plan settings corresponding to the linac<br />

treatment position.<br />

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TREATMENT<br />

6.3 Patient Feedback System<br />

About the Patient Feedback System<br />

NOTE: The Patient Feedback System is applicable to breath-hold workflows only.<br />

The Patient Feedback System comprises both hardware and software and is intended for use<br />

during breath-hold workflows and supports the patient in reaching the correct breath-hold position.<br />

The system helps to visually guide the patient into a stable breath-hold position so that breathing<br />

can be maintained at an ideal breath-hold level throughout the treatment process.<br />

• Patient Feedback System: The mirror has a flexible arm and can be attached with a screw<br />

cl<strong>amp</strong> to the head of the couch. The software is displayed on the ceiling-mounted monitor in<br />

the treatment room.<br />

• Patient Feedback Glasses: These can be used as an alternative to the mirror.<br />

For further information about the hardware, see the ExacTrac <strong>Dynamic</strong> System and Technical<br />

User Guide.<br />

Feedback Software on the Ceiling-Mounted Monitor<br />

4<br />

3<br />

5<br />

2<br />

1<br />

6<br />

Figure 22<br />

The patient feedback software on the Ceiling-Mounted Monitor helps patients visualize their own<br />

respiration and to achieve a correct breath hold, with or without the Patient Feedback System<br />

mirror or Patient Feedback Glasses.<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

Description<br />

The gray circle represents the baseline position (average free-breathing position).<br />

The solid blue circle shows the live respiratory status of the patient. The circle moves up<br />

and down with each breath.<br />

The small unfilled orange circle shows the ideal respiratory status for breath hold.<br />

The large unfilled orange circle represents the breath-hold window in which the respiration<br />

(solid blue circle) must be before external imaging can be acquired (during the navigation<br />

step) or the treatment beam can be activated (during the monitoring step).<br />

The orange circle turns green as soon as patient respiration is within the breath-hold window.<br />

• If the Patient Feedback System is used with the mirror, select Flip Display to show a<br />

mirror image of the feedback software on the Ceiling-Mounted Monitor in the mirror.<br />

• If the Patient Feedback Glasses are used, no display flip is required.<br />

• The Patient Feedback System works with or without the mirror or glasses, as required.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 89


Patient Feedback System<br />

How to Cl<strong>amp</strong> the Patient Feedback System to the Couch<br />

The Patient Feedback System mirror is cl<strong>amp</strong>ed at the head-end of the couch, at the central<br />

axis. Attaching the system at any other point is not supported because it could result in a collision<br />

with the gantry or interfere with the X-ray imaging and linac beam.<br />

NOTE: Attaching the system to any device other than the couch (e.g., breast boards) can result in<br />

insufficient and instable fixation of the Patient Feedback System mirror.<br />

Step<br />

1. Ensure that both surfaces of the couch are clean and accessible.<br />

2. Open the screw cl<strong>amp</strong> mechanism far enough that you can slide it onto the couch without<br />

damaging the surface.<br />

3. Adjust the cl<strong>amp</strong> to the correct position on the central axis of the couch.<br />

4. Rotate the knob until both the upper and lower rubber pads touch the couch without being<br />

compressed.<br />

To avoid damaging the couch top or the device itself, a maximum rotation of two full turns<br />

is recommended from this point.<br />

NOTE: Do not use the cl<strong>amp</strong> without the rubber pad. This could result in permanent damage<br />

to the couch.<br />

5. Check that the cl<strong>amp</strong> is firmly in place. The cl<strong>amp</strong> must not move while the mirror is being<br />

adjusted.<br />

NOTE: Tightening the cl<strong>amp</strong> too firmly can damage the couch or the device itself.<br />

NOTE: Ensure that the device is correctly cl<strong>amp</strong>ed to the couch before starting the treatment.<br />

NOTE: The device should not be used if the sleeve around the flexible arm shows any signs of<br />

deteriorating.<br />

How to Use the Patient Feedback System<br />

Step<br />

1. Position the Ceiling-Mounted Monitor near the foot of the patient couch, facing the patient.<br />

2. Attach the cl<strong>amp</strong> of the Patient Feedback System mirror at the head of the patient<br />

couch.<br />

3. Without touching the reflective surface, position the mirror at an angle of approximately<br />

45°, until the patient can see the ceiling-mounted monitor clearly.<br />

4. Select Flip Display to show a mirror image of the feedback software on the Ceiling-<br />

Mounted Monitor.<br />

5. The patient (or clinic personnel) can now finely adjust the mirror without touching the reflective<br />

surface.<br />

6. Confirm with the patient that the monitor screen is fully visible in the mirror.<br />

NOTE: Prior to treatment, rotate the gantry and perform a visual inspection to detect possible<br />

collisions.<br />

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TREATMENT<br />

How to Use the Patient Feedback Glasses<br />

Step<br />

1. Position the Ceiling-Mounted Monitor near the foot of the patient couch, facing the patient.<br />

2. Ask the patient to wear the prism glasses.<br />

It is possible to wear them on top of normal optical glasses, although the result is dependent<br />

on their frame shape and size.<br />

3. Check if the blue light reflections from the Patient Feedback Glasses are reflected back<br />

onto the camera.<br />

If yes, readjust the position of the glasses, preferably by moving the head of the patient<br />

horizontally.<br />

4. If needed, the clinical personnel can now adjust the height of the monitor, until the patient<br />

can see the ceiling-mounted monitor clearly.<br />

5. Confirm with the patient that the monitor screen is fully visible through the glasses.<br />

Reducing <strong>Surface</strong> Tracking Disruptions Caused by Blue Light<br />

At certain angles, surface tracking may be disrupted by the camera's blue light reflecting off of the<br />

Patient Feedback Glasses. In this case, the surface tracking on the monitor may go dark (either<br />

partially or completely) or result in an overall reduced surface quality.<br />

You can improve this situation by adjusting the patient's head position accordingly or by changing<br />

the position of the glasses to modify the angle of reflection of the blue light.<br />

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Patient Prepositioning<br />

6.4 Patient Prepositioning<br />

Requirements for Prepositioning<br />

ExacTrac <strong>Dynamic</strong> uses the available surface tracking to determine a deviation shift. Send this<br />

shift to the couch to perform automatic prepositioning.<br />

• Always set up the patient correctly and be aware that rotational setup corrections using the<br />

treatment hardware are determined by the hardware used: The treatment hardware determines<br />

the limitations and the allowed setup tolerance on the treatment machine.<br />

• The linac gantry may either be in the top or bottom position while the couch rotation must be<br />

level before beginning patient positioning.<br />

• With automatic prepositioning, ExacTrac <strong>Dynamic</strong> corrects translations only. Correct rotational<br />

errors manually.<br />

NOTE: Depending on the selected workflow, prepositioning is possible at coplanar and noncoplanar<br />

beams. Breath-hold workflows allow coplanar beams only.<br />

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TREATMENT<br />

6.4.2 Prepositioning<br />

About Prepositioning<br />

Align the patient to the linac isocenter using the live surface tracking and the planning CT<br />

Contour.<br />

Prepositioning with Elekta<br />

If you are prepositioning with Elekta to acquire an external position using Elekta, a setup beam<br />

has to be loaded on the linac. Setup beams cannot be recognized by ExacTrac <strong>Dynamic</strong> and<br />

therefore cannot be used for ExacTrac <strong>Dynamic</strong> prepositioning.<br />

Prepositioning Using a Virtual Isocenter<br />

Figure 23<br />

To use a virtual isocenter to preposition your patient, load the virtual isocenter beam on the linac<br />

and perform prepositioning as usual.<br />

ExacTrac <strong>Dynamic</strong> will not allow you to proceed with the workflow using this beam. In order to<br />

send the residual shift to achieve the treatment position, load the treatment beam and then<br />

continue with positioning the patient.<br />

Page Overview: Prepositioning<br />

2<br />

1<br />

3<br />

4<br />

Figure 24<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 93


Prepositioning<br />

No. Component Description<br />

1<br />

View area<br />

A crosshair marks the isocenter.<br />

• White lines: Outer contour taken from the planning CT.<br />

- Breath-hold workflows: Outer contour taken from<br />

Free-Breathing CT.<br />

- External Positioning with <strong>Surface</strong> Monitoring:<br />

Outer contour taken from the planning CT or live reference<br />

surface from previous fractions.<br />

• Orange lines: Outer contour taken from the live surface.<br />

- If the live surface is red, move the patient closer to<br />

the isocenter or near the planned free-breathing position<br />

(for breath-hold workflows).<br />

- If the live surface is green, the patient is near the isocenter<br />

or near the planned free-breathing position<br />

(for breath-hold workflows).<br />

2 Shift values Displays values of the current shift.<br />

3 Send Shift Select to send the shift.<br />

4 Confirm Prepositioning Select to continue.<br />

How to Perform Prepositioning<br />

For all workflows, the following steps are required for patient prepositioning.<br />

Warning<br />

Always perform initial patient positioning at a couch angle of the first beam (treatment<br />

beam or setup beam).<br />

Step<br />

1. Open Treatment and carry out all required steps through Confirm Plan.<br />

2. Prepositioning opens.<br />

Use zoom to enlarge the image, if necessary.<br />

Use the live surface and contour of the patient as well as the values displayed to bring the<br />

patient close to isocenter position.<br />

If no values are displayed, this may result from:<br />

- A rotational offset of the patient above 15°. Ensure that the couch position is close<br />

to the planned couch position.<br />

- A missing detection of a matching surface. Ensure that the correct patient and plan<br />

are selected, that the treatment area is in the field of view of the 3D Camera, and<br />

that the treatment area is not covered by loose or bulky clothing.<br />

NOTE: If you select Send Shift, only translations are corrected. Rotational offsets must<br />

be corrected manually.<br />

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TREATMENT<br />

Step<br />

3.<br />

Review values and contours before selecting Confirm Prepositioning.<br />

Warning<br />

Every single prepositioning fusion result must be inspected visually for correctness<br />

before sending the prepositioning shift.<br />

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External Positioning with <strong>Surface</strong> Monitoring Workflows<br />

6.4.3 External Positioning with <strong>Surface</strong> Monitoring Workflows<br />

Prepositioning Prior to External Imaging<br />

• To use ExacTrac <strong>Dynamic</strong> prepositioning, load a treatment beam on the linac before acquiring<br />

the external position and perform prepositioning on the treatment beam.<br />

• It is recommended to perform prepositioning on a coplanar treatment beam to reduce<br />

movement of the couch between prepositioning and the external device positioning.<br />

• If external positioning has already been performed, do not send the ExacTrac <strong>Dynamic</strong><br />

prepositioning shift (e.g., do not use ExacTrac <strong>Dynamic</strong> prepositioning to move the patient<br />

away from an externally-defined position).<br />

Page Overview: External Prepositioning<br />

2<br />

3<br />

1<br />

4<br />

5<br />

Figure 25<br />

No. Component Description<br />

1<br />

View area / live surface<br />

• A crosshair marks the isocenter. The outer contour taken<br />

from the planning CT or acquired live reference surface<br />

from the previous fraction.<br />

Live surface.<br />

• If the live surface is red, move the patient closer to the<br />

isocenter.<br />

• If the live surface is green, the patient is near the isocenter.<br />

2 Reference <strong>Surface</strong> Select a reference for prepositioning (see below).<br />

3 Shift values Displays values of the current shift.<br />

4 Send Shift Select to send the shift.<br />

5 Confirm Prepositioning Select to continue.<br />

For External Positioning with <strong>Surface</strong> Monitoring, the information about the prepositioning<br />

reference selection changes depending on which treatment session you are currently in.<br />

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TREATMENT<br />

1 2 3<br />

Figure 26<br />

Description<br />

1<br />

2<br />

3<br />

In the first treatment session, prepositioning based on the outer contour is taken from the<br />

planning CT (if CT Contour is available).<br />

In the second treatment session, prepositioning can be based on:<br />

• The planning CT Contour (if available)<br />

• Live reference surface acquired from the first fraction<br />

In the third treatment session and onwards, prepositioning can be based on:<br />

• The planning CT Contour (if available)<br />

• Live reference surface acquired from the first fraction<br />

• Live reference surface acquired from the latest fraction<br />

NOTE: The First Reference <strong>Surface</strong> (first fraction) is permanently available, while the<br />

Latest Reference <strong>Surface</strong> will be overwritten in every session.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 97


Prepositioning in Breath-hold Workflows<br />

6.4.4 Prepositioning in Breath-hold Workflows<br />

Patient Prepositioning Quality<br />

In breath-hold workflows, the prepositioning quality has direct impact on the overall treatment<br />

accuracy.<br />

Always set up the patient correctly and be aware that rotational setup corrections using the<br />

treatment hardware is limited according to the hardware used. This relates to hardware limitations<br />

and the allowed setup tolerance on the treatment machine.<br />

If you confirm a prepositioning that exceeds tolerances or without a calculated shift, a pop-up is<br />

displayed. The pop-up reminds you that inaccurate prepositioning could result in inaccuracies<br />

during treatment. You can go back and preposition the patient again or continue with the workflow.<br />

NOTE: Imprecise prepositioning can result in inaccuracies during treatment. If the patient is<br />

prepositioned imprecisely, a warning is displayed and you must confirm that the positioning is<br />

intentional.<br />

Importance of Correct Patient Prepositioning<br />

4<br />

1<br />

2<br />

3<br />

5<br />

Figure 27<br />

Correct Patient Positioning<br />

• The expected position of the Breath-hold Contour on the Breath-hold Planning CT corresponds<br />

to line 1.<br />

• The Free-Breathing Contour on the Free-Breathing Contour Plan corresponds to line 2<br />

before treatment.<br />

• A respiratory point 3 is selected on the surface of the patient (e.g., on the sternum), that<br />

shows a steady and clear respiratory signal.<br />

• The respiratory signal is monitored at the respiratory point. A vertical axis 4 runs through the<br />

selected respiratory point.<br />

• The upstroke 5 is the difference in vertical <strong>amp</strong>litude between the Free-Breathing Contour<br />

and the Breath-hold Contour at a specific point (typically the respiratory point) on the patient<br />

surface.<br />

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TREATMENT<br />

1<br />

3<br />

2<br />

4<br />

Figure 28<br />

Incorrect Patient Positioning<br />

• The upstroke 1 does not correspond with the respiratory point 2, meaning that the live respiratory<br />

signal shown in the software will be at the wrong anatomical position.<br />

• The expected upstroke 3 and the real upstroke 4 are not the same. The patient would then<br />

be guided into a wrong breath-hold target level, which could result in incorrect treatment.<br />

Using a Bolus with Breath-hold Workflows<br />

Bolus Type<br />

Requirements<br />

Warning<br />

The CT-scanned bolus must be part of the<br />

Breath-hold Contour and the Free-Breathing<br />

Contour (e.g., it is placed on the patient and<br />

CT scanned in free-breathing and breath-hold<br />

state).<br />

CT-scanned bolus<br />

Warning<br />

If the CT-scanned bolus is incorrectly positioned<br />

during prepositioning, it can negatively<br />

influence prepositioning shift.<br />

Warning<br />

Not placing the CT-scanned bolus in the freebreathing<br />

prepositioning can negatively influence<br />

the prepositioning shift, because the bolus<br />

is part of the Free-Breathing Contour (but<br />

not of the live surface).<br />

Virtual bolus<br />

Warning<br />

The virtual bolus must be placed when entering<br />

the <strong>Surface</strong> Tracking Area and/or Respiratory<br />

Point selection page.<br />

Warning<br />

The virtual bolus must not be placed in freebreathing<br />

prepositioning.<br />

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<strong>Surface</strong> Tracking Area<br />

6.5 <strong>Surface</strong> Tracking Area<br />

About the <strong>Surface</strong> Tracking Area<br />

To track the patient's movement via surface tracking, select an area on the patient to be tracked<br />

by surface tracking. The surface tracking area should be selected in a way that it reflects<br />

movements of the PTV.<br />

NOTE: To track the patient's surface reliably, the surface tracking area should not be covered by<br />

loose or bulky clothing.<br />

Warning<br />

Significant changes in the patient's surface temperature might require new reference<br />

images for the surface tracking system.<br />

<strong>Surface</strong> Tracking Area Tools<br />

1<br />

2<br />

4 3<br />

Figure 29<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

Description<br />

Currently defined surface tracking area<br />

Confirm Area<br />

Thermal map<br />

• Brush size: Change the size of the brush as required<br />

• Revert: Clears the currently defined tracking area<br />

Use the supplied tools (e.g., Brush Size) to indicate the tracking area.<br />

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TREATMENT<br />

Figure 30<br />

You can paint arbitrary shaped areas on the patient. Those areas do not necessarily have to be<br />

connected to each other. However, all painted areas will be treated as exactly one rigid surface<br />

tracking area.<br />

With this information, the surface tracking algorithm estimates the motion of this tracking area,<br />

similar to the way a sensor in a shoe moves along exactly with the moving foot.<br />

To reliably track patient movement, ensure that no parts of the linac are included in the surface<br />

tracking area. For arc treatments, no gantry information can be included with the tracking area. If<br />

this happens, the rotation of the gantry may be considered as a tracked movement even if the<br />

patient does not move. As a result, the patient may be detected as out of tolerance and the beam<br />

may be held.<br />

ExacTrac <strong>Dynamic</strong> uses a smart tracking area concept. All parts outside of a predefined box<br />

centered at the isocenter of the patient plan will be considered irrelevant for tracking and<br />

excluded. Those parts are marked gray.<br />

When defining a surface tracking area, you may draw into a gray area, but it will not be<br />

considered for the final tracking area. Once you confirm the defined area, the gray parts will be<br />

removed from the tracking area.<br />

<strong>Surface</strong> Tracking Area Quality<br />

Although the thermal information provided by surface tracking improves the reliability of the<br />

tracking, it is nevertheless necessary to have enough 3D information in the tracking area to<br />

guarantee precise tracking results.<br />

When you select a tracking area, the system evaluates how well this area is suited for tracking. If<br />

the tracking quality is too low, Confirm Area remains grayed out, and you cannot proceed with<br />

the workflow.<br />

Always consider the overall "landscape" of the area you are interested in: A varied topography<br />

(e.g., facial hills and valleys) contributes more to improving surface tracking quality than a large,<br />

flat surface area can.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 101


<strong>Surface</strong> Tracking Area<br />

Troubleshooting Tracking Area<br />

Figure 31<br />

If you have trouble selecting a tracking area with a good quality, try to erase redundant (e.g., flat)<br />

parts from the area first. The selected surface tracking area shown here is too flat and too<br />

symmetrical to be effective.<br />

Tracking Area on Subsequent Beams<br />

Once you have defined a tracking area, it is usually not necessary to redefine it for subsequent<br />

beams.<br />

However, if not enough points of the tracking area are visible after transferral and the calculated<br />

quality is too low, the system will force you to adjust the tracking area for the new couch angle to<br />

continue.<br />

Notes<br />

Warning<br />

Heated or heating blankets are not suitable for use with ExacTrac <strong>Dynamic</strong> because these<br />

can lead to incorrect temperature shifts during positioning and monitoring.<br />

Warning<br />

If the tracking area is placed on the iGUIDE reference frame, the monitoring based on<br />

surface tracking tracks couch movements only, which might not correspond to the patient<br />

movement.<br />

Warning<br />

In cases where closed face masks are used as a patient fixation device, only the mask itself<br />

is tracked by the surface tracking and not the patient's surface.<br />

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TREATMENT<br />

How to Define the <strong>Surface</strong> Tracking Area<br />

Step<br />

1.<br />

The <strong>Surface</strong> Tracking Area page opens.<br />

2. Define a tracking area appropriate for your procedure.<br />

3. Use the brush to mark the boundaries of the tracking area.<br />

Adjust the brush size with the slider.<br />

Reset the brush and/or tracking area, if necessary.<br />

NOTE: You can use the right mouse button to erase the selected area.<br />

4. Once the tracking area is satisfactory, select Confirm Area.<br />

If the patient was already treated, the tracking area is preselected and will be displayed.<br />

Select Confirm Area if the area displayed is correct, or use the tools to adjust the area.<br />

Confirm that the tracking area is still at the expected position because the tracking area is<br />

defined according to the camera field of view, not patient or linac coordinates. As an ex<strong>amp</strong>le,<br />

the treatment machine has changed since the previous fraction, and as a result<br />

the tracking area is shown at a slightly different position.<br />

How to Define the <strong>Surface</strong> Tracking Area for Breath-hold Workflows<br />

The surface tracking area is defined after Breath-hold Navigation, after positioning.<br />

The surface tracking area is defined on the static reference surface in top view, acquired in the<br />

breath-hold state.<br />

NOTE: In breath-hold workflows, an appropriate surface tracking area includes an area located on<br />

a structure, which moves with the breathing motion.<br />

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Breath-hold Respiratory Point<br />

6.6 Breath-hold Respiratory Point<br />

About the Respiratory Point<br />

To accurately track the patient's breathing during navigation and treatment in breath-hold<br />

workflows, use the Breath-hold Respiratory Point page to:<br />

• Set a respiratory point<br />

• Calculate the baseline<br />

To generate the patient's respiratory signal for tracking, define a respiratory point. The respiratory<br />

point is a position on the surface of the patient (e.g., the sternum), that shows a steady and clear<br />

respiratory signal. The respiratory signal is the vertical motion of this surface point due to<br />

respiration.<br />

Page Overview: Breath-hold Respiratory Point<br />

1<br />

4<br />

Figure 32<br />

3<br />

2<br />

No. Component Description<br />

1 View area Shows the patient's surface.<br />

2<br />

3<br />

4<br />

Confirm Baseline<br />

Respiratory Signal and Levels<br />

Set Respiratory Point and<br />

Calculate Baseline<br />

Select when respiratory point and baseline are acceptable.<br />

Shows the respiratory signal and the levels in parallel<br />

graphs (in mm). After successfully calculating the baseline,<br />

the respiratory gating window for the breath hold is<br />

also shown here.<br />

• Select to set a respiratory point, or change the position<br />

of the currently saved point.<br />

• Select to calculate a baseline, or delete the currently<br />

saved baseline and calculate a new one.<br />

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TREATMENT<br />

Respiratory Point<br />

• The respiratory point should be positioned on an even surface with no significant gradient<br />

changes surrounding it.<br />

• Select a respiratory point on an area of the patient's surface where the breathing of the patient<br />

provides a large and stable upstroke with low signal noise. The upstroke should be significantly<br />

larger than the breath-hold window size.<br />

• A good respiratory point is typically around the patient's sternum.<br />

Baseline<br />

The baseline (the average respiratory signal of the patient breathing freely) is calculated from the<br />

respiratory signal at the respiratory point.<br />

After the baseline is generated, the upstroke at the respiratory point is calculated, being the<br />

vertical distance between the contours on the Free-Breathing Contour Plan and the Breathhold<br />

Planning CT at the respiratory point on the patient surface.<br />

How to Select a Respiratory Point and Calculate a Baseline<br />

Step<br />

1. Use the respiratory point tools to define a respiratory point on the patient surface.<br />

2. Evaluate the drawn respiratory curve and ensure that it shows a steady and clear respiratory<br />

signal.<br />

3. Calculate a baseline while the patient is breathing freely and inspect the calculated upstroke<br />

for plausibility (e.g., around 20 mm).<br />

4. Select Confirm Baseline to continue.<br />

Using a Bolus<br />

Warning<br />

For both CT-scanned bolus and virtual bolus:<br />

• Place the respiratory point in a way that it either always or never intersects the bolus on<br />

the live surface.<br />

• Do not place the respiratory point close to a border of the bolus.<br />

• When switching from a non-bolus field to a bolus field or vice versa, it is strictly<br />

recommended to restart from free-breathing prepositioning because the acquired<br />

references will be influenced by physically adding or removing the bolus.<br />

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Breath-hold Navigation<br />

6.7 Breath-hold Navigation<br />

6.7.1 Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

About Breath-hold Navigation with External Positioning<br />

In the navigation workflow step, you guide the patient into one or more consistent and stable<br />

breath-holds and acquire the external imaging data. The external imaging data can be a conebeam<br />

CT (CBCT) or any 2D image modality. The data is then used to position the patient for<br />

treatment.<br />

Generally, there are three main steps in Breath-hold Navigation:<br />

• Getting the patient to perform a breath hold as close to the planned level as possible.<br />

• Performing external imaging, which also includes marking imaging events on ExacTrac<br />

<strong>Dynamic</strong> and monitoring patient movement.<br />

• Confirming imaging is complete and then positioning the patient.<br />

The following section will explain the steps in more detail.<br />

Planned Level<br />

The Planned Level is the breath-hold level goal for the patient during treatment, as established in<br />

the plan.<br />

The Planned Level is calculated from the vertical difference (upstroke) between the Free-<br />

Breathing Contour and the Breath-hold Contour at the respiratory point.<br />

Imaging Window<br />

Figure 33<br />

When the navigation step first opens, the respiratory graph shows only the Baseline, Planned<br />

Level and the imaging window. As you progress through the workflow, other levels become<br />

available.<br />

The imaging window is a guidance tool for the user and the patient to achieve a stable breath hold<br />

close to the Planned Level. The size of the imaging window can be defined in Preparation. It is<br />

independent of the treatment gating window, which defines the breath-hold tolerance for<br />

treatment.<br />

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TREATMENT<br />

Only perform imaging when the patient's respiratory signal is within the imaging window and is as<br />

close as possible to the Planned Level.<br />

Figure 34<br />

If used with the Patient Feedback System, the imaging window corresponds to the outer circle<br />

(e.g., green circle) in the patient feedback software.<br />

Imaging Level<br />

NOTE: Imaging Level applies to Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

only.<br />

Figure 35<br />

The Imaging Level is the average respiratory level during CBCT or 2D imaging acquisition. To<br />

achieve a precise treatment, ensure that imaging events are marked correctly in ExacTrac<br />

<strong>Dynamic</strong>. A correct Imaging Level can now be calculated.<br />

• For CBCT, marking external imaging events ensures that ExacTrac <strong>Dynamic</strong> continuously<br />

records and calculates an average respiratory level.<br />

• For 2D imaging, marking the 2D imaging time ensures that ExacTrac <strong>Dynamic</strong> records and<br />

calculates an average respiratory level.<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

Treatment Level (Reference)<br />

While performing treatment, the live surface of the patient is matched with a Reference <strong>Surface</strong>.<br />

Because the external imaging shift is used to position the patient in the navigation step, the<br />

surface reference should also match the patient surface during external imaging.<br />

There are two ways to create the Reference <strong>Surface</strong>:<br />

• Automatically generate one via ExacTrac <strong>Dynamic</strong> and the provided marking functionality.<br />

This ensures a more precise treatment, because both the Imaging Level and Reference<br />

<strong>Surface</strong> will be calculated correctly.<br />

• Manually generate one in a second step. This option requires asking the patient to perform<br />

another breath hold to acquire a Reference <strong>Surface</strong>. See the related links for further<br />

information.<br />

NOTE: A Reference <strong>Surface</strong> that deviates from the average surface during external imaging<br />

would result in treatment errors.<br />

NOTE: The Treatment Level (Reference) is the respiratory level at which the Reference <strong>Surface</strong><br />

was acquired.<br />

Related Links<br />

How to Manually Define Imaging Level on page 120<br />

How to Manually Acquire the Reference <strong>Surface</strong> on page 121<br />

Target Adjusted<br />

If the patient cannot reach a breath-hold level at the level displayed in the imaging window or the<br />

achieved breath-hold level deviates significantly from the Planned Level, you may decide to<br />

adjust the planned level. For ex<strong>amp</strong>le, if the patient:<br />

• Is unable to reach the planned breath-hold level (e.g., because the patient is in poor condition<br />

on the day of treatment).<br />

• Exceeds the planned breath-hold target level, which could be the case if the Breath-hold CT<br />

scan was not performed at a correct breath hold.<br />

If you have sufficient user rights, you can adjust the level using the option Enable breath-hold<br />

target level adjustment.<br />

The adjusted level is called Target Adjusted and should match the patient breath-hold level of the<br />

day.<br />

NOTE: With a shallower breath hold, organs at risk such as the heart could be closer to the<br />

treatment beam and therefore receive a higher dose of radiation than calculated by the treatment<br />

plan.<br />

How to Adjust Breath-hold Level<br />

You can only adjust breath-hold level if you have sufficient user rights.<br />

Adjustment alters the planned treatment, resulting in a deviation from the treatment plan. It<br />

requires in-depth clinical knowledge and treatment-plan specifics of the patient.<br />

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TREATMENT<br />

Step<br />

1.<br />

Open the menu and select Breath-hold.<br />

2. Select Enable breath-hold target level adjustment.<br />

3.<br />

A pop-up informs you why adjusting the levels could potentially cause harm to the patient.<br />

4. Select OK.<br />

5.<br />

1<br />

2<br />

• Adjust the Planned Level 3 using the Adjust Target + and - buttons 1.<br />

• Once an adjustment is done, a new level called Target Adjusted 2 appears in the<br />

graph. The adjustment should be done in a way that the Target Adjusted level matches<br />

today's breath-hold level of the patient.<br />

• The Target Adjusted is only valid for the current fraction and will be reset for the next<br />

fraction.<br />

NOTE: The imaging window is connected to the Target Adjusted level and will move with the<br />

level as this is adjusted. The imaging window does not remain at the initial Planned Level.<br />

3<br />

NOTE: An adjusted target level will result in a different lung inflation state compared to treatment<br />

planning. This means OARs (especially the heart) may be at a different position than the planned<br />

position.<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

How to Perform Couch Centering with Varian<br />

If you are using CBCT scans and a Varian TrueBeam system, it is sometimes necessary to move<br />

the couch to a centered position that is different from the isocenter position.<br />

Step<br />

1.<br />

Before entering the navigation page, a pop-up is displayed.<br />

• Select Perform Couch Centering to start the couch centering process.<br />

• Select Skip Couch Centering to proceed directly to navigation.<br />

2.<br />

If Perform Couch Centering was selected, move the couch to the centered position.<br />

3. Select Confirm & Continue to proceed to Navigation.<br />

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TREATMENT<br />

Step<br />

4.<br />

1<br />

3<br />

2<br />

• If couch movement is detected, the dialog closes and the workflow continues to Navigation.<br />

• If no couch movement is detected 1 the software asks you to ensure that the couch is<br />

in the intended position.<br />

- If you want to continue to Navigation without moving the couch, select Continue<br />

with Zero Shift 3.<br />

- To correct the position, move the couch to the centered position and select Update<br />

Shift & Continue 2.<br />

Page Overview: <strong>Surface</strong> Breath-hold Navigation<br />

2<br />

3<br />

1<br />

7<br />

6<br />

5<br />

4<br />

Figure 36<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

No. Component Description<br />

1<br />

2<br />

3<br />

Respiratory Signal and<br />

Levels pane<br />

Legend<br />

External Imaging Done<br />

Displays live patient respiratory signal over time and<br />

imaging window.<br />

<strong>Dynamic</strong> Zoom toggle: Zooms in automatically when the<br />

breath hold is within the imaging window.<br />

Shows the difference between the actual surface and the<br />

target surface using gradients.<br />

NOTE: On the Breath-hold Navigation page, the target<br />

surface is now the Breath-hold Contour, not the Free-<br />

Breathing Contour, as seen on the Free-Breathing<br />

Prepositioning page.<br />

Becomes active when the patient is in a free-breathing<br />

state and at least one breath hold was performed.<br />

4 Workflow guidance Displays information about next steps or tasks.<br />

5 Live Respiration pane Live respiratory signal of the patient.<br />

6 CBCT or 2D Imaging Select an imaging modality.<br />

7<br />

Mark CBCT Start or Mark<br />

2D Image<br />

Begin marking defined imaging events.<br />

Treatment Level (Reference <strong>Surface</strong>) with CBCT<br />

If the CBCT imaging events are marked, ExacTrac <strong>Dynamic</strong> will continuously calculate an<br />

average respiratory level for the times when the CBCT was in acquisition mode (as defined by the<br />

controls Mark CBCT Start and Mark CBCT Stop).<br />

ExacTrac <strong>Dynamic</strong> automatically acquires a Reference <strong>Surface</strong>. If an incoming surface is closer<br />

to the average level than the existing reference surface, this new surface becomes the new<br />

Reference <strong>Surface</strong>.<br />

After external imaging is completed, the calculated average respiratory level becomes the<br />

Imaging Level and the latest Reference <strong>Surface</strong> defines the Treatment Level (Reference).<br />

Treatment Level (Reference <strong>Surface</strong>) with 2D Imaging<br />

For 2D imaging, ExacTrac <strong>Dynamic</strong> will record the surface at the first defined imaging event<br />

(Mark 2D Image) and store it as a Reference <strong>Surface</strong>.<br />

The Imaging Level is calculated as the average respiratory level of all imaging events.<br />

Therefore, if you are acquiring multiple 2D images, it is important to acquire all 2D images ideally<br />

at the Planned Level, or at least at an identical respiratory level for all 2D images. Otherwise the<br />

Treatment Level Reference and the Imaging Level will deviate and it may be necessary to<br />

manually acquire a new Reference <strong>Surface</strong> at the Imaging Level.<br />

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TREATMENT<br />

How to Acquire a CBCT and Record the Acquisition Time in ExacTrac <strong>Dynamic</strong><br />

Figure 37<br />

Depending on your system, you may wish to acquire CBCT images.<br />

Step<br />

1. Prepare your CBCT imaging device.<br />

Set it up so that you can begin acquisition as soon as the patient is in a stable breath<br />

hold.<br />

2. Ensure that CBCT Imaging is selected.<br />

3. Guide the patient into a stable breath hold, so that the respiratory signal is inside the<br />

imaging window and as close as possible to the Planned Level.<br />

NOTE: ExacTrac <strong>Dynamic</strong> will indicate a breath hold has been detected by zooming in in<br />

the imaging window. However, it cannot detect the quality or stability of the breath hold.<br />

4. Simultaneously:<br />

• Start CBCT acquisition on your imaging device.<br />

• Start the marking of an imaging event in ExacTrac <strong>Dynamic</strong> by selecting Mark CBCT<br />

Start.<br />

5. The CBCT acquisition is now indicated in the respiratory graph (shaded pink). Monitor the<br />

patient respiratory signal.<br />

6. After a sufficient time span (e.g., the time that the patient can typically maintain a stable<br />

breath hold), simultaneously:<br />

• Select Mark CBCT Stop in ExacTrac <strong>Dynamic</strong>.<br />

• Stop CBCT acquisition on your imaging device.<br />

7. Tell the patient to breathe freely again.<br />

8. If you are done with acquisition, select External Imaging Done.<br />

NOTE: Only apply external imaging correction shift after confirming External Imaging<br />

Done.<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

Step<br />

9. When confirming External Imaging Done, ExacTrac <strong>Dynamic</strong> checks for the defined<br />

settings (e.g., imaging window, treatment reference window).<br />

• If you are within the set tolerances, you are directed to the shift retrieval dialog.<br />

• If you are not within the set tolerances, you must verify the respiratory levels.<br />

How to Acquire 2D Images and Record the Acquisition Time in ExacTrac <strong>Dynamic</strong><br />

Figure 38<br />

Depending on your system, you may wish to acquire 2D images and move the couch between<br />

images to improve accuracy.<br />

Step<br />

1. Prepare your 2D imaging device.<br />

Set it up so that you can begin acquisition as soon as the patient is in a stable breath<br />

hold.<br />

2. Ensure that 2D Imaging is selected.<br />

3. Guide the patient into a stable breath hold, so that the respiratory signal is inside the<br />

imaging window and as close as possible to the Planned Level.<br />

NOTE: ExacTrac <strong>Dynamic</strong> will indicate a breath hold has been detected by zooming in in<br />

the imaging window. However, it cannot detect the quality or stability of the breath hold.<br />

4. Simultaneously:<br />

• Acquire a 2D image acquisition on your imaging device.<br />

• Acquire an imaging event in ExacTrac <strong>Dynamic</strong> by selecting Mark 2D Image.<br />

5. Tell the patient to breathe freely again.<br />

6. If you want to acquire another 2D image with a couch move in between the two acquisitions:<br />

• Select Intermediate Shift and move the couch as soon as the shift dialog appears. After<br />

the couch move, you can then repeat steps 3 - 5.<br />

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TREATMENT<br />

Step<br />

7. If you are done with your acquisition, select External Imaging Done.<br />

NOTE: Only apply external imaging correction shift after confirming External Imaging<br />

Done.<br />

8. When confirming External Imaging Done, ExacTrac <strong>Dynamic</strong> checks for the defined<br />

settings (e.g., imaging window, treatment reference window).<br />

• If you are within the set tolerances, you are directed to the shift retrieval dialog.<br />

• If you are not within the set tolerances, you must verify the respiratory levels.<br />

How to Retrieve a Shift for Varian Linacs<br />

Figure 39<br />

NOTE: Apply external imaging correction shift only when the shift retrieval pop-up is displayed.<br />

Step<br />

1. If you are using a Varian linac system, ExacTrac <strong>Dynamic</strong> will automatically retrieve<br />

couch positions before and after patient positioning and calculate the applied shift.<br />

2. An automatic check detects whether couch movement has occurred.<br />

If couch movement is detected, the dialog closes and the workflow continues to the <strong>Surface</strong><br />

Tracking Area page.<br />

If no couch movement is detected, the software asks you to ensure that the couch is in<br />

the intended position.<br />

• To continue to the <strong>Surface</strong> Tracking Area page without moving the couch, select<br />

Continue with Zero Shift.<br />

• To correct the position, move the couch to the final treatment position and select Update<br />

Shift & Continue.<br />

NOTE: You can always go back to Navigation to verify levels and treatment accuracy by<br />

selecting Show Respiratory Levels.<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

How to Retrieve a Shift for Elekta Linacs<br />

Figure 40<br />

If you are using an Elekta linac system, the applied couch shift for the base table can be retrieved<br />

the same way as shown in the Varian case above. However, the shift needs to be entered<br />

manually in ExacTrac <strong>Dynamic</strong> for the HexaPOD couch. A dialog box allows the user to select<br />

which table to use.<br />

Step<br />

1. If you are using a HexaPOD system and you have a large shift that cannot be applied by<br />

the HexaPOD alone, make sure you enter the entire shift before it is split between the<br />

base table and HexaPOD. Be careful to enter the shift correctly.<br />

2. An automatic check detects whether couch movement has occurred.<br />

If couch movement is detected, the dialog closes and the workflow continues to the <strong>Surface</strong><br />

Tracking Area page.<br />

If no couch movement is detected, the software asks you to ensure that the couch is in<br />

the intended position.<br />

• To continue to the <strong>Surface</strong> Tracking Area page without moving the couch, select<br />

Continue with Zero Shift.<br />

• To correct the position, move the couch to the final treatment position and select Update<br />

Shift & Continue.<br />

NOTE: You can always go back to Navigation to verify levels and treatment accuracy by<br />

selecting Show Respiratory Levels.<br />

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TREATMENT<br />

How to Enter the Shift<br />

1<br />

3<br />

Figure 41<br />

2<br />

Step<br />

1. Enter the shift values in the fields provided 1.<br />

2. Select OK 2.<br />

3.<br />

NOTE: You can always go back to Navigation by selecting Show Respiratory Levels<br />

3.<br />

1<br />

2<br />

Review the values again and edit them if they are incorrect 1.<br />

If the shift is acceptable and the values are correct, select Confirm & Continue 2.<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

How to Verify Levels and Treatment Accuracy<br />

1<br />

2<br />

3<br />

4<br />

Figure 42<br />

If you want to review the treatment accuracy (e.g., you selected Show Respiratory Levels before<br />

entering a shift), you can evaluate the correctness of the Imaging Level and a Reference<br />

<strong>Surface</strong> by following these steps.<br />

NOTE: In most cases, if the patient is within tolerance of the thresholds defined in Preparation,<br />

you will not need to perform this step.<br />

Step<br />

1. Check the position of the Reference <strong>Surface</strong> acquisition time within the respiratory<br />

graph. Verify that:<br />

• The Reference <strong>Surface</strong> was acquired at a stable respiratory level (e.g., not during<br />

coughing or quick inhalation/exhalation).<br />

• The Reference <strong>Surface</strong> was acquired as close as possible to the Imaging Level.<br />

2. Verify that the levels are within the thresholds defined in Preparation. Compare:<br />

• Planned Level and Imaging Level (e.g., the imaging window size).<br />

• Treatment Level (Reference) and Imaging Level.<br />

3. If the Reference <strong>Surface</strong> and levels are acceptable and within tolerance, select Confirm<br />

4.<br />

4. If any of the thresholds set in Preparation are exceeded, a warning is displayed. Available<br />

options:<br />

• Select Discard & Repeat External Imaging 1. You can go back to the navigation<br />

page and repeat the external imaging procedure.<br />

• Select Edit Imaging Level 2. You can adjust the imaging level based on the breathhold<br />

signals.<br />

• Select Re-Acquire Reference 3. You can re-acquire the reference surface manually.<br />

• Select Accept & Continue. Enter your credentials to accept the deviation.<br />

NOTE: To accept the deviation, you must have sufficient user rights.<br />

Adjustment alters the planned treatment, resulting in a deviation from the treatment plan.<br />

It requires in-depth clinical knowledge and specific information from the patient's treatment<br />

plan.<br />

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TREATMENT<br />

Ex<strong>amp</strong>le: Verifying Levels<br />

Figure 43<br />

Good ex<strong>amp</strong>le:<br />

• The Reference <strong>Surface</strong> was acquired at a stable respiratory level and as close as possible to<br />

the Imaging Level.<br />

• The levels between Planned Level and Imaging Level and the levels between Treatment<br />

Level (Reference) and Imaging Level are within the thresholds defined in Preparation.<br />

Ideally, all three are at the identical respiratory levels with zero or minimal deviations.<br />

1<br />

Figure 44<br />

2<br />

Bad ex<strong>amp</strong>le:<br />

• Warnings are displayed that some levels exceed thresholds defined in Preparation 1. In this<br />

ex<strong>amp</strong>le, there is a deviation between breath-hold levels and reduced isocenter accuracy.<br />

• Additional information is displayed under the imaging window about how the displayed levels<br />

will affect treatment 2.<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

How to Manually Define Imaging Level<br />

Figure 45<br />

If an Imaging Level was not calculated automatically, you must define it manually.<br />

This may be necessary if you selected Imaging finished after completing external imaging but<br />

without marking any imaging events.<br />

Step<br />

1. Examine the frozen respiratory graph and remember where the external imaging was performed<br />

in the shown breath holds.<br />

2. Estimate the average respiratory level across the external imaging times.<br />

3.<br />

Set the Imaging Level to the average respiratory level that you estimated via the mouse<br />

wheel and/or the positioning arrows.<br />

NOTE: If the manually defined imaging level does not correspond to the level where<br />

imaging was performed on the linac, the treatment plan will be inaccurate. This changes<br />

the planned treatment, resulting in a deviation from the treatment plan. It requires in-depth<br />

clinical knowledge and specific information from the patient's treatment plan.<br />

4. Confirm the correctness of the manually defined Imaging Level.<br />

NOTE: It is important to monitor the patient position between finishing the external imaging<br />

and the manual acquisition of a Reference <strong>Surface</strong>. Any undetected patient motion<br />

during this time will result in an inaccuracy during patient treatment.<br />

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TREATMENT<br />

How to Manually Acquire the Reference <strong>Surface</strong><br />

Figure 46<br />

When no Reference <strong>Surface</strong> is available, you must acquire a new one manually. Reasons for a<br />

missing reference surface include:<br />

• No imaging events were marked<br />

• The calculated Imaging Level was adjusted<br />

• An existing Reference <strong>Surface</strong> was deleted<br />

Step<br />

1. Guide the patient into a breath hold. The target is the Imaging Level.<br />

Use the reference surface window as a tolerance around the target for the acquisition of<br />

the reference surface.<br />

2. When the patient respiratory level matches the Imaging Level, select Acquire.<br />

A new reference surface is acquired.<br />

3. Verify that the levels and treatment accuracy.<br />

Deviations Between Different Levels<br />

Deviation Between Cause Result<br />

Planned Level and Imaging<br />

Level<br />

External imaging was not performed<br />

at the identical respiratory<br />

level as the Breath-hold<br />

CT.<br />

The treatment will be performed<br />

with a different amount<br />

of inhalation (lung filling) when<br />

compared to the treatment<br />

plan.<br />

The target and/or OARs may<br />

be at different locations compared<br />

to treatment planning.<br />

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Breath-hold External Positioning with <strong>Surface</strong> Monitoring<br />

Deviation Between Cause Result<br />

Treatment Level (Reference)<br />

and Imaging Level<br />

The Reference <strong>Surface</strong> was<br />

not acquired at the Imaging<br />

Level. Potentially, the Reference<br />

<strong>Surface</strong> deviates from<br />

the average patient surface<br />

during imaging.<br />

The patient is positioned<br />

based on the external imaging,<br />

but is treated based on the<br />

Reference <strong>Surface</strong>.<br />

A treatment inaccuracy the<br />

size of the deviation between<br />

the two levels may occur.<br />

Intended and Unintended Couch Shifts<br />

Intended couch shifts coming from third-party linac can only be applied once you have confirmed:<br />

• The correctness of the various respiratory levels and the Reference <strong>Surface</strong> in the final<br />

navigation screen.<br />

(If the patient is within tolerance of the thresholds defined in Preparation, you will not need to<br />

perform this step.)<br />

• The correctly retrieved/entered couch shift<br />

Any couch shift outside this defined time slot will bring the workflow automatically back to the<br />

prepositioning step. All generated data will be lost.<br />

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TREATMENT<br />

6.8 External Imaging<br />

About External Imaging<br />

You can choose an external imaging device (e.g., CBCT) to define the planned treatment position<br />

of the patient.<br />

For all workflows where external imaging is selected as a positioning modality, the patient can be<br />

tracked while performing the imaging.<br />

Page Overview: External Positioning<br />

1 2 3<br />

Figure 47<br />

5<br />

4<br />

No. Component Description<br />

1 <strong>Surface</strong> pane Live surface of the tracked patient.<br />

2<br />

Movement pane<br />

Shows surface movement of the patient during external<br />

imaging.<br />

3 Workflow guidance Displays steps to be performed.<br />

4<br />

5<br />

Positioning Finished<br />

Reset Tracking<br />

For surface monitoring, the reference surface is updated<br />

and used for patient monitoring during treatment.<br />

Deletes deviations shown on the surface view, resets deviations<br />

to zero and sets a new tracking reference.<br />

This page displays possible patient movement represented in the surface views and distance<br />

bars.<br />

Patient tracking is triggered once entering the page. Hence, shown patient movements may result<br />

before, during or after external imaging.<br />

NOTE: ExacTrac <strong>Dynamic</strong> will not hold the beam if the patient is out of tolerance (e.g., there is<br />

no gated external imaging possibility).<br />

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External Imaging<br />

How to Use Reset Tracking<br />

If you are using external imaging and you have not yet started the imaging acquisition, you can<br />

select Reset Tracking to set a new tracking reference. This is helpful if the patient moves before<br />

starting the acquisition or when performing couch centering (only applicable for Varian users).<br />

Step<br />

1. Acquire images (e.g., CBCT).<br />

2. If the patient moves during the acquisition procedure and you want to restart your image<br />

acquisition, select Reset Tracking to delete any displayed movement.<br />

• Deviations are reset to zero (+/- breathing motion, depending on selected surface<br />

tracking area). Any new patient movement can be accurately assessed.<br />

• You can select Reset Tracking at any time to set a new reference and delete displayed<br />

movement.<br />

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TREATMENT<br />

6.9 Patient Monitoring<br />

About Patient Monitoring<br />

NOTE: This chapter will provide general information about patient monitoring applicable to most<br />

workflows. It is recommended to read this information first, then read the additional information<br />

related to breath-hold or surface-only workflows found in the subsequent subchapters and related<br />

links.<br />

During the monitoring phase, ExacTrac <strong>Dynamic</strong> provides information from the 3D Camera and<br />

Thermal Camera and visualizes patient movement as detected during surface tracking on the<br />

Patient Monitoring page.<br />

Depending on your workflow, you can use the information displayed on the Patient Monitoring<br />

page to verify that the patient has not moved out of tolerance during treatment.<br />

Tolerances and Beam Hold Settings<br />

• Tolerance and/or beam hold settings were set in Preparation.<br />

• The tolerance and/or beam hold settings established in Preparation determine the range of<br />

tolerance for patient movement during treatment.<br />

• If required, you can change the tolerance values via the menu during patient monitoring. These<br />

changes apply only to the current session.<br />

Visual Status Information<br />

• Information from surface tracking system is displayed in the view pane on the workflow's<br />

Patient Monitoring page. The Patient Position pane provides visual status information about<br />

surface tracking, tolerance status and beam status.<br />

• For breath-hold workflows, information is displayed in the view panes on the workflow's Patient<br />

Monitoring page. The Breath-hold Gating Status pane provides visual status information<br />

about surface tracking, the respiratory signal and the beam status.<br />

Notes<br />

Warning<br />

If you need to enter the treatment room while the beam hold interlock is set, turn off the<br />

MV.<br />

Warning<br />

Use only an image fusion with a defined, restricted region/volume during monitoring that<br />

resulted in an accurate image fusion during positioning.<br />

Warning<br />

While using surface tracking to monitor patient movements, be aware that the camera<br />

needs a clear and unblocked view on the patient during the entire treatment.<br />

Warning<br />

Keep a constant temperature in the treatment room, to avoid that the patient's surface<br />

cools down.<br />

Related Links<br />

Breath-hold Settings on page 73<br />

Status Information on page 163<br />

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Patient Monitoring<br />

Notes Applying to External Positioning Workflows<br />

After performing positioning with an external device, you can use ExacTrac <strong>Dynamic</strong> for<br />

monitoring.<br />

If the patient moved during treatment, and repositioning is performed by ExacTrac <strong>Dynamic</strong>,<br />

ExacTrac <strong>Dynamic</strong> will always position the patient at the defined external reference position.<br />

Warning<br />

Be aware that ExacTrac <strong>Dynamic</strong> monitoring is limited to detecting movements via surface<br />

tracking, which is not reliable for detecting soft tissue. After external positioning<br />

acquisition, any soft tissue target movement that occurs relative to the bony structure and<br />

the patient's surface cannot be detected reliably.<br />

Beam Authorization Prerequisites<br />

To be able to start the MV beam on the linac, the beam needs to be authorized by ExacTrac<br />

<strong>Dynamic</strong>. Authorization is only given if:<br />

• The couch is at the planned treatment position.<br />

• The 3D Camera with thermal overlay displays the patient in the correct treatment position.<br />

(This does not apply if a beam hold by ExacTrac <strong>Dynamic</strong> in which the patient was out of<br />

tolerance has been ignored.)<br />

Always select the current field/beam to inform ExacTrac <strong>Dynamic</strong> about the expected treatment<br />

position. ExacTrac <strong>Dynamic</strong> can only continue treatment if the beam is prepared.<br />

Page Overview: <strong>Surface</strong>-Based Patient Monitoring<br />

1<br />

2<br />

5<br />

Figure 48<br />

4<br />

3<br />

No. Component Description<br />

1 <strong>Surface</strong> pane Visual of patient with surface tracking and legend.<br />

2<br />

Movement pane<br />

Values show how closely patient remains within or out of<br />

tolerance (in mm).<br />

3 Patient Position pane Visual monitoring status of patient position.<br />

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TREATMENT<br />

No. Component Description<br />

4<br />

<strong>Dynamic</strong> (All):<br />

Select to view:<br />

• Distance<br />

• Lateral<br />

• Longitudinal<br />

• Vertical<br />

<strong>Dynamic</strong> (All): Shows the dimension that is currently<br />

most critical in relation to its own tolerance.<br />

Distance: Shows the length of the vector of all translation<br />

offsets.<br />

5 Patient Movement pane Live respiratory signal of the patient.<br />

Legends<br />

1 2 3<br />

Figure 49<br />

Images from both the 3D Camera and the Thermal Camera are accompanied by legends to help<br />

users determine if the patient is properly positioned.<br />

No. Component Description<br />

1<br />

2<br />

3<br />

3D Camera<br />

Tracking Area<br />

Thermal Camera<br />

Uses a green-to-red legend.<br />

This view shows the distance of the surface points of the<br />

current position compared to the moment tracking was<br />

started.<br />

The default values are:<br />

• Green is 1 mm or less<br />

• Red is 10 mm or more<br />

Represents the tracking area selected by the user.<br />

Appears as a white overlay with white contour.<br />

3D Camera: To be in tolerance, the tracking area should<br />

be visible in the green range.<br />

Uses a yellow-to-purple legend.<br />

• Yellow is Warm<br />

• Purple is Cold<br />

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Patient Monitoring<br />

Page Overview: Breath-hold Patient Monitoring Without X-rays<br />

1<br />

2<br />

3<br />

5<br />

6<br />

4<br />

Figure 50<br />

No. Component Description<br />

1<br />

Beam, couch angle and gantry<br />

information<br />

If Door Open is displayed, one of three things are possible:<br />

• The treatment room door is open.<br />

• XVI is active.<br />

• The patient table brakes are not locked.<br />

2 <strong>Surface</strong> monitoring pane Visual of patient with surface tracking and legend.<br />

3<br />

4<br />

Breath-hold Gating Status<br />

pane<br />

Respiratory Signal and Levels<br />

pane<br />

Visual monitoring status of patient position, respiratory<br />

state and treatment beam state.<br />

Patient's live respiratory signal with Baseline, Treatment<br />

Level (Reference) and breath hold shown.<br />

Out of Tolerance Options<br />

If the patient is out of tolerance, you have the following options from the Patient Monitoring page:<br />

Option<br />

Select External Repositioning<br />

Select Ignore (prerequisite: At<br />

least 1 MU was previously<br />

radiated)<br />

Result<br />

Go back to prepositioning and reposition using an external<br />

imaging device.<br />

Continue treatment, but without using ExacTrac <strong>Dynamic</strong>.<br />

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TREATMENT<br />

Next Beam with Different Couch Angle<br />

Figure 51<br />

NOTE: Next beam is not applicable for breath-hold workflows.<br />

If the planned couch angle differs from the previous beam, a couch rotation dialog is shown on the<br />

Monitoring page when switching to the next beam.<br />

The dialog closes automatically when the couch rotation reaches the planned value.<br />

NOTE: Ensure that the beam is selected on the linac before rotating the couch to the new target<br />

angle.<br />

The area tracked by surface tracking might get lost in case of unknown large rotational<br />

movements that are not indicated to ExacTrac <strong>Dynamic</strong> by beam selection.<br />

Using Automatic Beam Hold<br />

Figure 52<br />

During treatment, when automatic beam hold is on, the software automatically holds the beam<br />

when patient movement exceeds the tolerance values set in Preparation.<br />

When automatic beam hold is off, the software does not hold the beam during treatment when<br />

patient movement exceeds the tolerance values set in Preparation, but it does warn the user that<br />

the patient is out of tolerance. The user must manually stop the beam from the linac console.<br />

Even when automatic beam hold is on, the user can stop the beam at any time via the linac<br />

console.<br />

Use the Menu to return to the settings during treatment to change tolerances, if required, or toggle<br />

automatic beam hold on or off.<br />

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Patient Monitoring<br />

NOTE: For breath-hold workflows, this setting cannot be turned off.<br />

NOTE: Automatic beam cut off may not be used for respiratory gating.<br />

NOTE: Use the <strong>Surface</strong> out of tolerance action delay slider to determine how long (in seconds)<br />

the patient must be out of tolerance before holding the beam.<br />

Warning<br />

In case of a beam hold failure (beam remains active while ExacTrac <strong>Dynamic</strong> indicates<br />

beam hold), immediately hold the beam via the linac console and do not resume treatment<br />

until proper functioning of the beam hold function has been verified.<br />

References Used in Breath-hold Patient Monitoring<br />

Workflow Step Reference/Target <strong>Surface</strong> Breathing Target<br />

Patient monitoring<br />

Breath-hold Reference <strong>Surface</strong><br />

(acquired on Breath-hold<br />

Navigation page)<br />

Treatment Level (Reference)<br />

• During the monitoring workflow step, the target surface is the acquired reference surface at the<br />

time of image acquisition (shown on Breath-hold Navigation), and called Breath-hold<br />

Reference <strong>Surface</strong>.<br />

• The target level for the respiratory signal is Treatment Level (Reference), which is in line with<br />

the imaging level and the Breath-hold Reference <strong>Surface</strong>.<br />

Breath-hold Gating Status Indicator<br />

2<br />

3<br />

1<br />

4<br />

Figure 53<br />

Breath-hold Gating Status: This indicator provides color-coded information about the surface<br />

tracking, the respiratory signal and the beam status. If any of the elements is not within expected<br />

levels (e.g., the patient's surface is out of tolerance because the patient moved), it will be shown<br />

here.<br />

No.<br />

1<br />

Description<br />

Respiratory signal status (text and lower half of ring).<br />

• Gray: Outside parameters set in the Breath-hold Navigation step.<br />

• Green: Within set parameters.<br />

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TREATMENT<br />

No.<br />

2<br />

and<br />

4<br />

3<br />

Description<br />

<strong>Surface</strong> tracking area status. Text and upper half of ring may be gray or red (out of tolerance)<br />

or green (within tolerance).<br />

Status of treatment beam on linac.<br />

• Gray:<br />

- Treatment beam on linac active, but paused by ExacTrac <strong>Dynamic</strong>.<br />

- Treatment beam off.<br />

• Green: Treatment beam on linac active.<br />

Beam status.<br />

• Beam Hold. Circle is gray.<br />

• Beam Off. Circle is gray.<br />

• Beam On. Circle is green.<br />

Warning<br />

In case of a Beam Hold failure (e.g., beam remains active while ExacTrac <strong>Dynamic</strong> indicates<br />

Beam Hold), immediately stop the beam via the linac console and do not resume treatment<br />

until proper functioning of the Beam Hold function has been verified.<br />

For further information about different indicator combinations, see the related links.<br />

Related Links<br />

Breath-hold Settings on page 73<br />

Status Information on page 163<br />

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7 BEAM MAPPING<br />

7.1 About Beam Mapping<br />

Background<br />

Beam Mapping is a specific workflow that is only required for the combination of TrueBeam linacs<br />

and MOSAIQ as an R&V system. In this scenario, the PlanInstance UID of the plan loaded on the<br />

linac may vary from the one available in ExacTrac <strong>Dynamic</strong>. To make sure that the same plan is<br />

loaded on the linac and ExacTrac <strong>Dynamic</strong>, it is necessary to select a treatment plan and map all<br />

beams by preparing every single beam on the linac.<br />

If no plan with the PlanInstance UID of the plan loaded on the linac is available, ExacTrac<br />

<strong>Dynamic</strong> checks if a treatment plan with the same patient ID is available. If so, all plans with this<br />

patient ID are displayed for selection. If no plan with this patient ID is available, the treatment is<br />

authorized by ExacTrac <strong>Dynamic</strong> automatically.<br />

NOTE: If a plan is supposed to be treated without ExacTrac <strong>Dynamic</strong> (e.g., to a single day<br />

condition or a patient with the same patient ID is available on ExacTrac <strong>Dynamic</strong>), it is possible<br />

to reject and authorize the treatment plan before beam mapping needs to be performed.<br />

Frequency<br />

If the clinic has a setup that requires beam mapping, the workflow is enforced every time<br />

ExacTrac <strong>Dynamic</strong> does not find the plan that is loaded on the linac (because the UIDs are<br />

different) or if not all beams were mapped in a previous session.<br />

This procedure has to be repeated each time a patient treatment plan is modified in MOSAIQ and<br />

receives a new PlanUID as the existing beam mapping will be invalidated by this.<br />

How Beam Mapping Works<br />

For every beam in Varian, beam mapping searches for the corresponding beam in the plan<br />

selected by the user according to the following properties:<br />

• Beam Type<br />

• Beam Name<br />

• Start Angle<br />

• Stop Angle<br />

• Gantry Rotation Direction<br />

• Couch (patient support angle)<br />

• Isocenter<br />

Prepare every beam on the linac to map the beam in ExacTrac <strong>Dynamic</strong>. Beam mapping<br />

provides color indicators to show if a beam is unmapped (no color), mapped (green), or cannot be<br />

mapped (red). Only successfully mapped beams can be loaded and authorized by ExacTrac<br />

<strong>Dynamic</strong>.<br />

Beam Type consists of either treatment beams or setup beams. The initial list of beams known to<br />

ExacTrac <strong>Dynamic</strong> might not include a setup beam. When you start mapping beams, if a setup<br />

beam is found, it will be added to the ExacTrac <strong>Dynamic</strong> list (e.g., making the list longer by one<br />

beam).<br />

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BEAM MAPPING<br />

In some instances, if two unmapped beams known to ExacTrac <strong>Dynamic</strong> are very similar (e.g.,<br />

identical except for the number of monitor units), ExacTrac <strong>Dynamic</strong> will map to the first beam. If<br />

this is incorrect, select Reset Mapping and map the beams again in a different order.<br />

How to Perform Beam Mapping<br />

If you are using MOSAIQ with Varian and the PlanInstance UIDs vary, you must perform beam<br />

mapping.<br />

Step<br />

1. Select ExacTrac <strong>Dynamic</strong> in Content Manager.<br />

2. Plan Selection opens.<br />

All plans available for the patient ID of the plan loaded on the linac are listed in ExacTrac<br />

<strong>Dynamic</strong>.<br />

Select the plan that matches to the plan on the linac.<br />

3. Patient Confirmation opens.<br />

4. Review patient data and plan settings and select Confirm Plan.<br />

5.<br />

1<br />

2<br />

The Beam Mapping page opens.<br />

All beams recognized by ExacTrac <strong>Dynamic</strong> are displayed on the left 1. At this stage,<br />

no beams are displayed on the right 2.<br />

6. Select and prepare one of the beams on the linac to start beam mapping.<br />

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About Beam Mapping<br />

Step<br />

7.<br />

1<br />

Once you have prepared a beam, the beam information is provided by the linac to Exac-<br />

Trac <strong>Dynamic</strong>.<br />

If a matching beam is found, it is displayed with green marks in the middle to indicate a<br />

perfect match. Beams are indicated as either Setup beams or Treatment beams.<br />

If you do not want to map any beam (e.g., you have loaded the wrong patient plan), quit<br />

the software via the Menu.<br />

8. If the beam was successfully mapped, Confirm Mapping 2 is enabled.<br />

NOTE: If you select Confirm Mapping before all beams are mapped, and later try to load<br />

an unmapped beam, a pop-up will warn you that the beam has not been mapped and you<br />

will not be able to load it.<br />

9. You can now:<br />

10.<br />

• Select a new beam on the linac to continue mapping beams.<br />

• Select Confirm Mapping 2.<br />

• Select Reset Mapping 1 to start over.<br />

2<br />

If you try to map a beam and no match is found, it is indicated with red in the middle and<br />

no corresponding beam is shown in the other column.<br />

11. Continue mapping beams.<br />

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BEAM MAPPING<br />

Step<br />

12.<br />

1<br />

2<br />

When you are finished, the status of each beam is indicated 1, 2.<br />

Select Confirm Mapping 3 to continue.<br />

3<br />

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8 SYSTEM CALIBRATION<br />

AND DAILY CHECK<br />

SURFACE<br />

8.1 About Performing Calibrations<br />

Calibration Routine<br />

Perform all calibrations regularly to ensure that ExacTrac <strong>Dynamic</strong> performs accurately. Brainlab<br />

recommends performing the calibrations in the following order and frequency:<br />

Calibration Application<br />

Thermal to 3D Camera Calibration<br />

Isocenter Calibration <strong>Surface</strong><br />

Frequency<br />

Once a month<br />

Periodically, or if system becomes decalibrated (e.g., after<br />

a component collision or after modifying the system setup)<br />

Warning<br />

Perform all calibration steps in order to minimize the difference between ExacTrac <strong>Dynamic</strong><br />

isocenter and linac radiation isocenter.<br />

• To ensure optimal safety and efficient use of the system, you must perform the Daily Check<br />

every day prior to clinical use of the system. At midnight, the Daily Check becomes invalid.<br />

• If you are using iGUIDE, it is recommended to do the iGUIDE calibration before performing<br />

other calibrations in ExacTrac <strong>Dynamic</strong> in order to detect misalignment of the lasers.<br />

• Always perform all calibrations with a warmed-up system.<br />

Authorized Users<br />

To perform any calibration procedure, you must have sufficient user rights.<br />

Each calibration of the system carries the risk of miscalibration. For optimal safety, Brainlab<br />

recommends only giving expert users the rights to calibrate the system.<br />

Calibration Limitations<br />

NOTE: Calibration must be performed at a constant room temperature.<br />

Warning<br />

After an update of software or hardware from the linac, always verify that the ExacTrac<br />

<strong>Dynamic</strong> calibration is still valid.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

Warning<br />

Be careful when using equipment with a height greater than 1.8 m (e.g., drip rails) close to<br />

the surface tracking system, and ask your patients to take special care. Inadvertent<br />

collision could misalign the system. In such cases, the system must be recalibrated. In the<br />

case of extreme collisions, contact Brainlab support.<br />

Warning<br />

Always calibrate the system after an equipment collision occurs. In the case of extreme<br />

collisions, contact Brainlab support.<br />

Warning<br />

Ensure that the pitch and roll device is at zero/home position prior to performing any<br />

calibration/QA tasks.<br />

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About 3D Camera Warm-Up<br />

8.2 About 3D Camera Warm-Up<br />

Technical Information<br />

The 3D Camera is subject to two types of warm-up:<br />

• Power On warm-up: Starts when the camera is powered on (System On LED is green in<br />

Computer Cabinet).<br />

• Blue Light Projector On warm-up: Starts when the blue light projector is on. Note that this<br />

warm-up occurs in addition to the Power On warm-up.<br />

The effect of both types of warm-up is that a stationary point in the isocenter drifts, with a<br />

magnitude that may exceed 1 mm.<br />

According to the two independent types of warm-up, there are three related temperature<br />

equilibrium states of the 3D Camera (note that depending on the use of the system, the camera<br />

may also be between the mentioned equilibrium states):<br />

Thermal Equilibrium<br />

State<br />

A<br />

B<br />

System Power<br />

ON for very short time (< ten minutes)<br />

ON for extended time (> one hour)<br />

Blue Light Projector<br />

ON for very short time (< ten minutes)<br />

ON for very short time (< ten minutes)<br />

C ON for extended time (> one hour) ON for extended time (> one hour)<br />

It takes approximately one hour with blue light projector OFF to return from state C to state B.<br />

Implications During Clinical Use<br />

The potential impact during clinical use of the 3D Camera system warm-up behavior is as follows:<br />

Position accuracy<br />

The 3D Camera is used to preposition the patient and also to provide information<br />

about patient movement during treatment monitoring.<br />

In a typical clinical routine with 10-15 minute treatment slots, the camera<br />

stays in state B and the blue light projector is turned off between patients. No<br />

drifts occur.<br />

A drift caused by camera warm-up behavior does not have an effect on the<br />

accuracy of the absolute patient position since the final patient treatment position<br />

is determined by using an external device (e.g., CBCT).<br />

If the blue light projector is turned on for an extended time, the system<br />

moves from state B to state C. This may typically be the case for extended<br />

treatments that last for more than 10-15 minutes. The occurring warm-up<br />

drift may introduce inaccuracies to the relative tracking of the patient position.<br />

Recommendations<br />

To minimize the effects of 3D Camera system warm-up, consider the following recommendations.<br />

Warm-up Period<br />

Depending on the environment, a warm-up period of up to one hour may be<br />

required.<br />

This ensures that the 3D Camera is in thermal equilibrium state B and not<br />

subject to any potential temperature-induced, temporary decalibration, which<br />

could have an undesired effect during the Daily Check.<br />

ExacTrac <strong>Dynamic</strong> must be powered (System On) for the corresponding<br />

time (e.g., up to one hour) before clinical use.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

System Power<br />

On/Off<br />

Because the timer module allows the system to be turned on automatically<br />

before clinical use to ensure proper warm-up of the 3D Camera, Brainlab no<br />

longer recommends turning off the system only during periods of extended<br />

inactivity.<br />

To save energy, the system can be turned off daily after treatments.<br />

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Calibration Workflows<br />

8.3 Calibration Workflows<br />

General Calibration Recommendations<br />

Regular calibration and verification of the system is necessary to ensure accuracy. You must<br />

perform the Daily Check every day. After mechanical impact to one of its components, perform<br />

the Daily Check again.<br />

Warning<br />

Calibration must be performed according to the calibration instructions. A wrongly<br />

performed system calibration can lead to ionizing radiation exposure to tissue outside the<br />

target volume.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

8.3.1 Performing Thermal to 3D Camera Calibration<br />

About Thermal to 3D Camera Calibration<br />

ExacTrac <strong>Dynamic</strong> uses surface detection to determine the exact position of the patient.<br />

The purpose of the Thermal to 3D Camera Calibration is to ensure that the Thermal Camera is<br />

calibrated relative to the 3D Camera. Use the Thermal to 3D Calibration Phantom to perform<br />

calibration.<br />

Frequency of Calibration<br />

Perform calibration at least every 35 days.<br />

How to Heat Up the Phantom<br />

The Thermal to 3D Calibration Phantom needs about 10-15 minutes to warm up.<br />

NOTE: The warm-up time may be shortened if the lid is left closed.<br />

Step<br />

1. Plug in the phantom and wait until it is warm enough to perform the calibration.<br />

2. When it is warm enough, position the Thermal to 3D Calibration Phantom on the couch.<br />

Use the laser engravings on the phantom to position it close to the isocenter.<br />

3. Leave the phantom plugged in during calibration.<br />

Warning<br />

The Thermal to 3D Calibration Phantom needs to be heated before calibration<br />

tasks can be performed. Using a cold phantom will result in a failed calibration.<br />

How to Perform Thermal to 3D Camera Calibration<br />

Step<br />

1. Ensure that the Thermal to 3D Calibration Phantom is sufficiently warm.<br />

2. Ensure that the phantom's lid is open before starting calibration.<br />

3. From Content Manager, open Calibration, then select Thermal to 3D Camera Calibration.<br />

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Performing Thermal to 3D Camera Calibration<br />

Step<br />

4.<br />

1<br />

Ensure the Thermal to 3D Calibration Phantom is within the camera field of view: The<br />

software displays a thermal image of the phantom and the markers (left), and a blackand-white<br />

image of the phantom taken from the 3D camera with cross hairs over the projected<br />

isocenter (right).<br />

To help you position the phantom, use the guide mark at the top and the laser marks on<br />

the sides of the phantom.<br />

5. Select Start calibration 1.<br />

6.<br />

ExacTrac <strong>Dynamic</strong> starts calibration.<br />

1<br />

2<br />

4<br />

3<br />

An image and the calibration result are displayed. Detected thermal markers, shown as<br />

white circles 1, should correspond with the thermal markers in the image on the left. Detected<br />

3D markers, shown as white spheres, should correspond with the 3D markers in<br />

the image on the right. If all markers are correctly detected, Calibration successful 2<br />

appears below the image.<br />

7. If calibration is satisfactory, select Save & Exit 3.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

Step<br />

8.<br />

If calibration is not satisfactory:<br />

• Select Start Calibration to perform calibration again.<br />

• Select Cancel 4 to leave the application. A message is displayed informing you that<br />

the calibration has not been updated.<br />

Troubleshooting Thermal to 3D Camera Calibration<br />

If calibration fails, consider the following reasons and solutions.<br />

Problem<br />

Phantom too cold<br />

Phantom too hot<br />

Not all phantom markers are<br />

visible<br />

Phantom partially covered<br />

Phantom not close enough to<br />

the isocenter<br />

Phantom not visible to camera<br />

Phantom not plugged in<br />

Description<br />

Ensure the phantom is sufficiently warm before performing calibration.<br />

Warm-up takes about 10-15 minutes.<br />

Ensure the phantom has not been plugged in too long before<br />

performing calibration.<br />

If any phantom markers are not visible to the camera, calibration<br />

will fail.<br />

Placement in the isocenter does not need to be precise, but<br />

may fail if phantom is too far from the isocenter.<br />

Placement in the isocenter does not need to be precise, but will<br />

fail if the phantom is not in camera field of view.<br />

Ensure the phantom remains plugged in during calibration.<br />

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Performing Isocenter Calibration <strong>Surface</strong><br />

8.3.2 Performing Isocenter Calibration <strong>Surface</strong><br />

About Isocenter Calibration <strong>Surface</strong><br />

Isocenter Calibration <strong>Surface</strong> calibrates the surface tracking system to the linac coordinate<br />

system and isocenter. For the surface tracking, the detected phantom's surface is used to define<br />

the system geometry and position.<br />

Isocenter Calibration <strong>Surface</strong> can be done using the room lasers, the linac lightfield or an<br />

external positioning scan (e.g., CBCT).<br />

NOTE: To compensate the limited setup accuracy of the room lasers and/or linac lightfield, an<br />

IGRT positioning of the phantom to the linac isocenter is highly recommended.<br />

Frequency of Calibration<br />

Perform calibration when the Daily Check fails and/or according to your hospital's calibration<br />

schedule.<br />

Prerequisites<br />

Prerequisites for a successful Isocenter Calibration <strong>Surface</strong>:<br />

• Ensure that the System Calibration Phantom is positioned in the isocenter as exactly as<br />

possible. This may require adjusting the laser or linac crosshair to the linac isocenter.<br />

Alternatively, to use a scan from an external positioning device (e.g., CBCT) to position the<br />

System Calibration Phantom at isocenter, a phantom plan must be created.<br />

• Ensure that the camera is warmed up to temperature state B. For further information, see the<br />

section about 3D Camera Warm-Up in this user guide.<br />

The treatment plan must be created based on a good, high-resolution scan of the System<br />

Calibration Phantom with correct axis alignment.<br />

• The isocenter of the test treatment plan has to be located in the exact center of the middle<br />

sphere of the System Calibration Phantom.<br />

• The external positioning should then position the middle sphere of the System Calibration<br />

Phantom exactly in the external positioning imaging isocenter. The ExacTrac <strong>Dynamic</strong><br />

calibration will then calibrate the ExacTrac <strong>Dynamic</strong> isocenter to the external positioning<br />

imaging isocenter of your linac.<br />

NOTE: If an external positioning device is used to position the phantom, ensure that the external<br />

device is calibrated to the linac isocenter.<br />

How to Position the System Calibration Phantom<br />

Step<br />

1. Ensure that the couch is level.<br />

2. Place the System Calibration Phantom on the couch top.<br />

3. Align the phantom so it is exactly in the isocenter in regard to position and rotation.<br />

You can use the lasers, linac lightfield or cone beam for this process. Ensure that the<br />

used alignment system is correctly aligned to the linac coordinate system and the linac<br />

isocenter.<br />

Warning<br />

Proceed with special care when aligning the isocenter phantom with the<br />

treatment room lasers. Incorrect isocenter phantom alignment will result in<br />

incorrect patient positioning.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

How to Perform Isocenter Calibration <strong>Surface</strong><br />

Step<br />

1. Ensure the couch is level.<br />

2. From Content Manager, open Calibration & QA, and then select Isocenter Calibration<br />

<strong>Surface</strong>.<br />

Isocenter Calibration <strong>Surface</strong> opens. Wait until the camera is ready.<br />

3. Ensure that the System Calibration Phantom is aligned exactly in the isocenter.<br />

If necessary, move the gantry to a non-obscuring position.<br />

4. Select Confirm.<br />

5.<br />

Adjust the bounding box around the phantom. The box should include the entire phantom<br />

but exclude everything else (e.g., the gantry).<br />

6. Start calibration.<br />

7.<br />

1<br />

<strong>Surface</strong> tracking registers the known geometry of the phantom, which has been positioned<br />

at the linac isocenter. If successful, the deviation from the last stored isocenter calibration<br />

is displayed 1.<br />

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Performing Isocenter Calibration <strong>Surface</strong><br />

Step<br />

8.<br />

9.<br />

If the new isocenter position differs significantly from the last Isocenter Calibration <strong>Surface</strong><br />

result, a pop-up is displayed with the deviation. You must select Confirm to continue<br />

or Cancel if the result is unacceptable.<br />

After confirming the deviation, select Save & Exit. The new isocenter calibration is saved.<br />

Troubleshooting Isocenter Calibration <strong>Surface</strong><br />

If calibration fails, consider the following reasons and solutions:<br />

Problem<br />

Camera calibration failed<br />

New isocenter position differs<br />

significantly from stored isocenter<br />

calibration<br />

Description<br />

Ensure that phantom is correctly aligned to linac isocenter (especially<br />

rotations).<br />

Restart calibration.<br />

Ensure that phantom is correctly aligned to linac isocenter.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

8.4 Daily Check <strong>Surface</strong><br />

Verifying Consistency<br />

The Daily Check is a consistency check that verifies:<br />

• That the system setup geometry has not changed.<br />

• That the phantom's position corresponds with the saved isocenter position (users must confirm<br />

this).<br />

The Daily Check is not an indication of the achievable positioning accuracy to the linac isocenter.<br />

Frequency of Daily Check<br />

You must perform the Daily Check at least once a day before the first patient treatment. If not, the<br />

software is blocked until the Daily Check is performed.<br />

After a mechanical impact to one of the system components, always verify system geometry and<br />

calibration by performing a Daily Check.<br />

Prerequisites<br />

Prerequisites for a successful Daily Check:<br />

• Ensure that the system used for ExacTrac <strong>Dynamic</strong> calibration is calibrated to the linac<br />

isocenter. Depending on the system used for calibration, the Daily Check can be done<br />

according to laser, linac lightfield, MV imaging or CBCT.<br />

• Ensure that the camera is warmed up to temperature state B. For further information, see the<br />

section about 3D Camera Warm Up in this user guide.<br />

Alternatively, to use the CBCT scan to position the System Calibration Phantom at isocenter, a<br />

phantom plan must be created. The treatment plan must be created based on a good, highresolution<br />

scan of the System Calibration Phantom with correct axis alignment.<br />

• The isocenter of the test treatment plan has to be located in the exact center of the middle<br />

sphere of the System Calibration Phantom.<br />

• The CBCT positioning should then position the middle sphere of the System Calibration<br />

Phantom exactly in the CBCT imaging isocenter.<br />

NOTE: If the CBCT is used to position the phantom, ensure that the CBCT is calibrated to the<br />

linac isocenter.<br />

How to Perform a Daily Check <strong>Surface</strong><br />

Step<br />

1. From Content Manager, select Daily Check <strong>Surface</strong>.<br />

2. Position the System Calibration Phantom on the couch top, exactly at isocenter. Use<br />

CBCT positioning or the laser marks on the sides of the phantom to line it up with the linac<br />

axis.<br />

3. Select Confirm.<br />

4. Adjust the bounding box around the phantom. The box should include the entire phantom<br />

but exclude everything else (e.g., the gantry).<br />

5. Start the Daily Check.<br />

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Daily Check <strong>Surface</strong><br />

Step<br />

6.<br />

1<br />

2<br />

The software checks if the phantom position seen by the camera corresponds to the<br />

saved isocenter position of the phantom.<br />

If the check was acceptable, Daily check successful 1 and the translational and rotational<br />

deviations between the current phantom position and isocenter position are displayed<br />

in Deviation from isocenter 2.<br />

Select Quit 3 to save and exit the Daily Check.<br />

3<br />

How to Perform an Isocenter Check<br />

In order to check that the ExacTrac <strong>Dynamic</strong> isocenter corresponds to the linac isocenter,<br />

perform positioning of the calibration phantom with an appropriate method (e.g., laser, lightfield,<br />

CBCT, MV images). Always use the same method for verification that was used for positioning the<br />

phantom during system calibration.<br />

Troubleshooting the Daily Check<br />

If the Daily Check fails, consider the following reasons and solutions.<br />

Problem<br />

Daily Check <strong>Surface</strong><br />

cannot be<br />

performed at all<br />

Check fails<br />

No valid calibration available<br />

Incorrect tracking area<br />

User has not confirmed<br />

that phantom is aligned to<br />

isocenter<br />

Description<br />

Daily Check cannot be performed without a<br />

valid calibration. Recalibrate the system.<br />

The camera calibration failed. Adjust the bounding<br />

box around the phantom and reacquire images.<br />

If phantom isocenter position cannot be confirmed,<br />

recalibrate the system.<br />

Notes<br />

Warning<br />

If the system calibration is interrupted due to any reason, always perform a calibration<br />

verification (Daily Check) to ensure a valid calibration. If the check fails, a recalibration is<br />

highly recommended.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

Warning<br />

If the calculated deviation of the Daily Check exceeds 1 mm in translation (vector length),<br />

and 1° in any rotational dimension, the verification of the system calibration fails. It is<br />

highly recommended to invalidate the calibration and recalibrate the system.<br />

Warning<br />

The deviations detected during this test are representative of the accuracy you can expect<br />

during patient treatments. If the deviations shown exceed acceptable values, patients<br />

should not be treated until the system has been recalibrated.<br />

Warning<br />

If the Daily Check fails, recalibrating ExacTrac <strong>Dynamic</strong> is highly recommended.<br />

Warning<br />

For safety reasons, the calibration of the system needs to be verified by Daily Check after<br />

mechanical impact to one of its components.<br />

Warning<br />

For safety reasons, the calibration of the system needs to be verified by Daily Check at<br />

least once a day before patient treatment is started.<br />

Warning<br />

For safety reasons, the calibration of the system needs to be verified by Daily Check after<br />

software has been updated.<br />

Warning<br />

For safety reasons, after substantial changes to the clinic environment (e.g., building<br />

construction), verify the system calibration via a Daily Check.<br />

NOTE: Huge and quick temperature changes during a single treatment can cause an inaccuracy<br />

in the system. The user must perform calibration verification in case of huge temperature<br />

changes.<br />

Daily Check Pass/Fail Criteria<br />

In addition to confirming that the isocenter was reached, the following criteria must be met in the<br />

Daily Check:<br />

Value<br />

Translation deviation check (vector length)<br />

1 mm<br />

Threshold values<br />

Rotational deviation check (each component) 1°<br />

Agreement of measured 3D surface point cloud with 3D model<br />

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<strong>Surface</strong> Tracking QA<br />

8.5 <strong>Surface</strong> Tracking QA<br />

About <strong>Surface</strong> Tracking QA<br />

Clinics using surface-guided radiation therapy (SGRT) are required to ensure its accuracy, safety<br />

and quality. Users must perform regular quality control tests for acceptance and commissioning on<br />

a regular basis to ensure optimal system performance.<br />

Page Overview: <strong>Surface</strong> Tracking Area Selection<br />

1<br />

3<br />

Figure 54<br />

2<br />

No. Component Description<br />

1<br />

Intensity slider<br />

Based on the external appearance of the object on the<br />

couch (e.g., color, skin tone), adjust camera intensity using<br />

the slider on the top, or adjust the settings in Preparation.<br />

2 Start Tracking Select when the surface tracking area is satisfactory.<br />

3<br />

Drawing tools<br />

Use the brush to draw a <strong>Surface</strong> Tracking Area. This is<br />

the area to be tracked.<br />

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SYSTEM CALIBRATION AND DAILY CHECK SURFACE<br />

Tracking Page<br />

3<br />

4<br />

2<br />

1<br />

5<br />

6<br />

Figure 55<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

Quit<br />

Tracking pane<br />

<strong>Surface</strong> pane<br />

Movement pane<br />

Tracking Quality pane<br />

Description<br />

Select to leave the application. Your tracking results will<br />

not be saved.<br />

Displays a progress bar with the time recorded and the<br />

maximum possible recorded length. By default, the maximum<br />

tracking length is 30 minutes.<br />

Displays the tracking result via a heat map.<br />

• Green = 1 mm<br />

• Red = 10 mm<br />

The corresponding values are shown in the Movement<br />

pane.<br />

Displays the corresponding values for the <strong>Surface</strong> pane:<br />

• Distance<br />

• Lateral<br />

• Longitudinal<br />

• Vertical<br />

• Pitch<br />

• Roll<br />

• Yaw<br />

Quality of tracking.<br />

• Green = good tracking quality.<br />

• Red = poor tracking quality. Tracking should be considered<br />

lost.<br />

6 Stop Tracking Stop tracking. Tracking results saved to a .json file.<br />

About .json Files<br />

The .json file stores tracking results, and includes the following information:<br />

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<strong>Surface</strong> Tracking QA<br />

• The computer name<br />

• The phantom color setting used (this controls how much blue light is emitted). This information<br />

corresponds to the options in Preparation: Light, fair, medium or dark<br />

• The exact time tracking started<br />

• The time st<strong>amp</strong> of the result in milliseconds relative to the start of the tracking<br />

Additional information included:<br />

• If tracking was lost (e.g., the root-mean-square-error is not sufficient)<br />

• The root-mean-square error of the 3D surface match<br />

• The root-mean-square error of the thermal match<br />

• The tracking shift as a 4x4 matrix (e.g., rotation and translation expressed in matrix form)<br />

• The tracking shift as 6DoF values (+ distance)<br />

Notes<br />

• If the couch is rotated more than 5°, tracking might become less reliable and may cause<br />

tracking to be lost.<br />

• If the couch is rotated, tracking is not updated because it takes place during the transition to a<br />

new PSA.<br />

• A .json file can be opened with Excel. You can then plot graphs or perform calculations.<br />

• When you open <strong>Surface</strong> Tracking QA, a message is displayed that informs you where<br />

tracking results will be stored if the original path is not available. This path is defined by the<br />

user as a .bls setting.<br />

• To display a .json file with formatting, use a coding program (e.g., Visual Studio Code) or use a<br />

website.<br />

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REVIEWING PATIENT DATA<br />

9 REVIEWING PATIENT<br />

DATA<br />

9.1 Reviewing Patient Data<br />

Import DICOM RT Data from Third-Party Software<br />

You can import data from third-party systems. For further information, contact Brainlab support.<br />

• Data must be transmitted from third-party systems to ExacTrac <strong>Dynamic</strong> via DICOM push<br />

using a designated AET<br />

• The AET is configured by BL-Service and must end with the letters _ARC<br />

• Pushed data is evaluated for import conversion<br />

• For RT Elements, It is possible to import third-party DICOM RT data through the "Browse"<br />

feature of Patient Selection.<br />

In order to receive the import result in a timely manner, the folder provided via "Browse" should<br />

best be chosen small, avoiding folders containing multiple exported plans.<br />

DICOM RT Import Limitations<br />

There are some limitations for importing third-party DICOM RT data:<br />

• Beams import is limited to isocenters and beam information<br />

• Electron-density overrides are currently not imported<br />

• RT structure set contours of type POINT are currently not imported<br />

• Spatial registrations are not imported<br />

• Dose import is limited to physical plan dose<br />

DICOM Conformance<br />

DICOM conformance statements can be found on the Brainlab website at: www.brainlab.com/<br />

dicom.<br />

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Repeat Export<br />

9.2 Repeat Export<br />

About Repeat Export<br />

1<br />

Figure 56<br />

Use Repeat Export 1 to re-export data (push data to R&V again) and to the PDF treatment<br />

printout. In most cases, data is exported automatically during the treatment session, but it is<br />

possible to export patient data later (e.g., in case a network connection was not available).<br />

How to Use Repeat Export<br />

Step<br />

1. From Content Manager, open Repeat Export.<br />

2.<br />

A plan selection page opens showing all treated plans (default).<br />

3. Select a plan for export.<br />

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REVIEWING PATIENT DATA<br />

Step<br />

4. Select Export.<br />

5.<br />

A pop-up is displayed.<br />

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Archive/Delete Patients<br />

9.3 Archive/Delete Patients<br />

About Archive/Delete Patients<br />

Use Archive/Delete Patients to archive and delete patient data on your ExacTrac <strong>Dynamic</strong><br />

system. This is useful for managing patient data and available storage space.<br />

You can archive or delete patients only via this workflow.<br />

How to Archive a Patient<br />

2<br />

1<br />

Figure 57<br />

3<br />

Step<br />

1. Start Archive/Delete in Content Manager.<br />

The Patient Selection page opens.<br />

By default, patient names are displayed alphabetically, last name first 1. Available storage<br />

space is also displayed 2.<br />

2. Select a patient.<br />

3. Select Archive 3.<br />

4.<br />

A dialog box is displayed.<br />

5. You can now select another patient, delete a patient, or leave the Archive/Delete workflow.<br />

NOTE: It is not possible to archive multiple patients at once.<br />

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REVIEWING PATIENT DATA<br />

How to Delete a Patient<br />

Figure 58<br />

You can delete a patient only if all ExacTrac <strong>Dynamic</strong> data has already been archived. If a patient<br />

has not been archived, the delete option is grayed out.<br />

NOTE: If you have configured the PACs (Archiving Proxy), then you can delete the data without<br />

archiving it first. In this case, the delete option is available, and data is automatically archived by<br />

the proxy to the PACs.<br />

Step<br />

1. Select a patient.<br />

2. Select Delete.<br />

The patient is deleted from the ExacTrac <strong>Dynamic</strong> system.<br />

3. You can now select another patient, delete a patient, or leave the Archive/Delete Patient<br />

workflow.<br />

NOTE: It is not possible to delete multiple patients at once.<br />

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Generating Treatment Reports<br />

9.4 Generating Treatment Reports<br />

Available Reports<br />

After treatment, the software generates a report that contains a summary for the current session<br />

for this patient.<br />

The report is provided in PDF format and can be saved and printed as required. Reports are also<br />

available for MOSAIQ and ARIA.<br />

The PDF printout storage location can be partly adjusted to hospital requirements. Contact<br />

Brainlab support to reconfigure the storage location of the PDF export.<br />

Contents of the Detailed Report<br />

The heading of each page shows the treatment date, plan date, patient name and patient ID. It<br />

also contains:<br />

• Isocenter<br />

• Coordinate system<br />

• Assigned physician<br />

• Logged-in user<br />

The different chapters include:<br />

• Performed workflow.<br />

• Information from TPS.<br />

• Treatment data (per beam): Beam data, ExacTrac <strong>Dynamic</strong> positioning information, surface<br />

monitoring graph, surface deviation per monitor units applied.<br />

• <strong>Surface</strong> data per beam at selected points in time (e.g., when beam is enabled or when surface<br />

is out of tolerance).<br />

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ALGORITHMS<br />

10 ALGORITHMS<br />

10.1 Calibration<br />

Isocenter Calibration<br />

The determination of the linac's isocenter position is an important and mandatory calibration. This<br />

position is the basis for all ExacTrac <strong>Dynamic</strong> calculations. All distances are displayed relative to<br />

this point. By using the System Calibration Phantom, the linac isocenter as well as the definition<br />

of the linac axis is set with the help of the wall lasers or alternatively by CBCT positioning.<br />

From this point, the system knows the geometric alignment of the linac isocenter and axis in<br />

relation to the ExacTrac surface system.<br />

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<strong>Surface</strong> Tracking<br />

10.2 <strong>Surface</strong> Tracking<br />

Principles of Structured Light Scanning<br />

<strong>Surface</strong> imaging measures x, y, and z coordinates on a surface, which is then reproduced as a<br />

map (the depth z is a function of the position x, y). To acquire the surface imaging data, the<br />

system projects "structured light" in a pseudo-random pattern onto the patient surface. An imaging<br />

sensor then records the 2D image of the pattern onto the surface.<br />

• If the surface is flat without any variations in depth, the projected structured light pattern is<br />

similar to the original projection.<br />

• If the surface is not flat, the projected structured light pattern appears distorted.<br />

If the spatial relation between projector and camera is defined, the depth information z can be<br />

recalculated using the following formula:<br />

The addition of thermal information is an additional dimension, or virtual topography, allowing for<br />

higher tracking accuracy.<br />

Patient Positioning<br />

1<br />

Figure 59<br />

2<br />

The positioning of the patient surface in relation to the incidence angle of the structured blue light<br />

from the 3D Camera has a direct impact on the quality of the surface tracking.<br />

It is disadvantageous for surface tracking if the angle between structured blue light and tracked<br />

patient surface is very small or even 0° 1.<br />

To improve the quality of the surface tracking the user should consider different positioning<br />

possibilities (e.g., elevated through a breast board), as seen in 2.<br />

<strong>Surface</strong> Tracking Limitations and Availability of Internal Information<br />

<strong>Surface</strong> tracking systems are based on the assumption of a perfect correlation between surface<br />

and internal organ or tumor motion, since precise, real-time information about internal anatomy is<br />

generally not available during treatment. A lack of internal information can also compromise the<br />

calculation of couch shifts.<br />

SGRT systems can compare and register a live patient surface to a reference surface and<br />

therefore detect spatial positioning deviations of the patient. Sliding effects (e.g., misalignment of<br />

the live patient surface with the reference surface) may force the clinician to choose larger regions<br />

of interest to provide enough topographical information for sufficient surface registration instead of<br />

smaller, more precise regions which may more closely represent the desired treatment location.<br />

Using surface registration in conjunction with internal imaging is a crucial verification of the<br />

accuracy of the surface system for a particular patient and fraction.<br />

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ALGORITHMS<br />

ExacTrac <strong>Dynamic</strong> 4D Thermal Camera<br />

1 2 3<br />

Figure 60<br />

ExacTrac <strong>Dynamic</strong> consists of two kV X-ray tubes mounted on the floor next to the linac, two<br />

ceiling-mounted flat panel detectors and a single ceiling-mounted 4D thermal camera that<br />

contains a structured light projector, two high-resolution cameras, and an integrated thermal<br />

camera. The 4D thermal camera is positioned centrally above the treatment couch, enabling a<br />

clear field of view during treatment without any risk of occlusions caused by gantry or gantrybased<br />

imagers.<br />

The system is used:<br />

• To roughly preposition the patient before treatment by matching the live 3D surface 1 with the<br />

reference contour.<br />

• To perform final positioning based on the stereoscopic X-ray images of internal anatomy using<br />

the integrated IGRT system.<br />

• To track intra-fraction patient motion.<br />

ExacTrac <strong>Dynamic</strong> combines the 3D and 2D thermal data by projecting the 3D information over<br />

the thermal image plane, using the perspective-n-point algorithm 2 to calculate a 3D-to-thermal<br />

matrix used for the projection. This enriches every 3D point (x, y, z) with thermal information T:<br />

The weighting factor α ensures the comparability between geometric and thermal data and allows<br />

it to be utilized while matching the reference data P i and the live surface P j 3:<br />

With every stereoscopic X-ray acquisition, ExacTrac <strong>Dynamic</strong> records a new reference surface<br />

including updated thermal information. Sliding effects are reduced. With thermal information,<br />

ExacTrac <strong>Dynamic</strong> algorithms achieve more robust matching of live and reference surfaces,<br />

especially in challenging scenarios (e.g., flat surfaces, small regions of interest). The system is<br />

able to track the patients’ position with up to 20 frames per second and with a system latency as<br />

low as 50 ms. This enables ExacTrac <strong>Dynamic</strong> to trigger a beam hold within milliseconds if the<br />

patient moves out of tolerance.<br />

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11 APPENDIX<br />

11.1 Preparation Software Revalidation Workflow<br />

Background<br />

This is the recommended system revalidation test for the Preparation software following minor<br />

changes to your system, including:<br />

• Operating system hotfixes<br />

• Installation of virus scanners<br />

• Third-party software installation<br />

At least one test DICOM patient should be available for this procedure.<br />

For major operating system changes (new operating system, new service pack, etc.) contact<br />

Brainlab support.<br />

How to Perform Software Revalidation for Preparation<br />

Step<br />

1. Start Brainlab Elements.<br />

2. Select Preparation to start the workflow.<br />

3. Select an appropriate test patient.<br />

4. Select a random template.<br />

5. Check that the patient settings match the selected template.<br />

6. Change the settings slightly and save the changes.<br />

7. Close the patient.<br />

8. Open Treatment.<br />

9. Select the same test patient.<br />

10. Review the settings and verify that they match the changes you made earlier.<br />

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APPENDIX<br />

11.2 Status Information<br />

General<br />

Displayed<br />

Description<br />

Displayed when something unexpected has happened and ExacTrac<br />

<strong>Dynamic</strong> has to recover from an error, such as:<br />

• The linac rejects a shift that was sent from ExacTrac <strong>Dynamic</strong>.<br />

• The couch movement was cancelled or interrupted after the software<br />

has sent a shift to the linac.<br />

• The software recognizes that the wrong beam is loaded on the linac<br />

when trying to approve the treatment.<br />

Displayed when the user has to be aware that the patient might not be<br />

in the correct treatment position, such as:<br />

• The software recognizes an unexpected couch movement.<br />

• The deviation between the expected patient position and the position<br />

after performing external positioning differs significantly during the External<br />

Positioning with X-ray & <strong>Surface</strong> Monitoring workflow.<br />

• The patient is out of tolerance but the user chooses to continue the<br />

treatment (e.g., the user selects Ignore) during monitoring.<br />

Patient Position Indicator<br />

Displayed<br />

Description<br />

In Tolerance: Displayed when both monitoring systems (X-ray fusion<br />

and surface tracking) report that the patient position does not differ from<br />

the planned position by more than the defined tolerance.<br />

Out of Tolerance: Displayed when surface monitoring detects that the<br />

patient position is outside the defined tolerance but the time defined by<br />

the setting <strong>Surface</strong> out of tolerance action delay is not up yet. In this<br />

situation, treatment continues.<br />

When the patient remains outside defined tolerances for longer than the<br />

time defined, the icon turns red.<br />

Out of Tolerance (Beam Hold Control off):<br />

• One of the monitoring systems detects that the patient is not at the intended<br />

treatment position.<br />

• Beam Hold Control is off.<br />

ExacTrac <strong>Dynamic</strong> is unable to hold the beam and treatment will continue.<br />

To avoid mistreatment, manually stop treatment on the linac.<br />

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Status Information<br />

Displayed<br />

Description<br />

Out of Tolerance (Beam Hold Control on):<br />

• One of the monitoring systems detects that the patient is not at the intended<br />

treatment position.<br />

• Beam Hold Control is on.<br />

In this situation, ExacTrac <strong>Dynamic</strong> holds the beam until the patient is<br />

back in tolerance.<br />

<strong>Surface</strong> Tracking Lost (Beam Hold Control off):<br />

• <strong>Surface</strong> tracking can no longer determine the patient position.<br />

• Beam Hold Control is off.<br />

ExacTrac <strong>Dynamic</strong> is unable to hold the beam and treatment will continue.<br />

Stop treatment on the linac and acquire stereoscopic X-ray images to<br />

reset the tracking region of surface tracking.<br />

<strong>Surface</strong> Tracking Lost (Beam Hold Control on):<br />

• <strong>Surface</strong> tracking can no longer determine the patient position.<br />

• Beam Hold Control is on.<br />

ExacTrac <strong>Dynamic</strong> prevents patient treatment until the surface tracking<br />

recovers on its own or the user acquires stereoscopic X-ray images.<br />

Fusion Failed (Beam Hold Control off):<br />

• X-ray fusion is not possible (e.g., X-ray image contrast is insufficient<br />

for a proper fusion and/or patient moved too much).<br />

• Beam Hold Control is off.<br />

ExacTrac <strong>Dynamic</strong> is unable to interrupt treatment.<br />

Ensure that X-ray generator settings (kV and mAs) are correct and acquire<br />

new X-ray images. Brainlab recommends manually turning off the<br />

beam on the linac.<br />

Fusion Failed (Beam Hold Control on):<br />

• X-ray fusion is not possible (e.g., X-ray image contrast is insufficient<br />

for a proper fusion and/or patient moved too much).<br />

• Beam Hold Control is on.<br />

ExacTrac <strong>Dynamic</strong> will interrupt treatment until the X-ray and surface<br />

camera systems report that the patient is in the correct position.<br />

Ensure that X-ray generator settings (kV and mAs) are correct and acquire<br />

new X-ray images.<br />

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APPENDIX<br />

Breath-hold Gating Status Indicator<br />

Displayed<br />

Description<br />

• Respiratory signal is within breath-hold window.<br />

• Treatment beam on linac enabled and not held by ExacTrac <strong>Dynamic</strong>.<br />

• <strong>Surface</strong> tracking area within tolerance.<br />

• Respiratory signal is within breath-hold window.<br />

• Treatment beam on linac off.<br />

• <strong>Surface</strong> tracking area within tolerance.<br />

• Respiratory signal is within breath-hold window.<br />

• Treatment beam enabled on linac but held by ExacTrac <strong>Dynamic</strong>.<br />

• <strong>Surface</strong> tracking area out of tolerance.<br />

• Respiratory signal is not within breath-hold window.<br />

• Treatment beam enabled on linac but held by ExacTrac <strong>Dynamic</strong>.<br />

• <strong>Surface</strong> tracking area within tolerance.<br />

• Respiratory signal is not within breath-hold window.<br />

• Treatment beam on linac off.<br />

• <strong>Surface</strong> tracking area within tolerance.<br />

• Respiratory signal is not within breath-hold window.<br />

• Treatment beam enabled on linac but held by ExacTrac <strong>Dynamic</strong>.<br />

• <strong>Surface</strong> tracking area out of tolerance.<br />

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Status Information<br />

Displayed<br />

Description<br />

• Respiratory signal is not within breath-hold window.<br />

• Treatment beam on linac off.<br />

• <strong>Surface</strong> tracking area out of tolerance.<br />

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APPENDIX<br />

11.3 System Messages<br />

System Messages<br />

The following pages provide system messages you might encounter in ExacTrac <strong>Dynamic</strong> in the<br />

different applications..<br />

System Messages - All Applications<br />

Notification / Information<br />

The current user is not authorized to run this application. The application will be closed.<br />

ExacTrac is busy...<br />

Error Messages<br />

Critical error detected. Safe treatment cannot be ensured. Restart ExacTrac.<br />

Insufficient performance of the graphical user interface detected.<br />

An internal error occurs. Contact Brainlab support.<br />

A background service is not connected at the moment.<br />

A background service has an incompatible or an invalid version.<br />

A background service encounters an internal failure. Contact Brainlab support if the problem persists.<br />

Warnings<br />

Global patient lock checking failed.<br />

Patient is currently being prepared or used for treatment by another user.<br />

Another user has opened the patient for preparation or treatment.<br />

Failed to export data.<br />

Failed to transfer exported data.<br />

System Messages - Calibration Applications<br />

Notification / Information<br />

Acquire X-ray images<br />

Press X-ray console acquisition button to restart calibration.<br />

Calibration data not saved. Exit anyway?<br />

Calibration has not been updated.<br />

Current calibration is invalid. Recalibrate the system.<br />

Enable automatic X-ray mode on X-ray console to continue tubes warm-up.<br />

Enable automatic X-ray mode on X-ray console to start tubes warm-up.<br />

Enable automatic X-ray mode to restart X-ray Correction Image Acquisition.<br />

Remove all objects between X-ray tubes and detectors:<br />

1. Retract couch<br />

2. Rotate gantry to 90°<br />

3. Retract all imaging acquisition arms (kV and MV)<br />

Calibrating: Press X-ray console stop button to cancel.<br />

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System Messages<br />

Notification / Information<br />

Place Thermal to 3D Camera Calibration Phantom in center of 3D Camera view.<br />

Press 'Save & Exit' to update calibration and close application.<br />

Remove objects interfering between tubes and detectors.<br />

Align System Calibration Phantom as accurately as possible with linac isocenter. Consider translations<br />

and rotations.<br />

Adjust 3D Camera bounding box to encompass System Calibration Phantom. Acquire X-ray images<br />

to start calibration.<br />

Adjust bounding box to encompass the isocenter calibration phantom.<br />

Make sure phantom is aligned correctly and restart calibration.<br />

Save new Isocenter Calibration?<br />

Note: This action will invalidate an existing Radiation Isocenter Calibration.<br />

Save new Isocenter Calibration?<br />

Wait until 3D Camera is ready.<br />

Image saved to<br />

Press X-ray console acquisition button to restart test acquisition.<br />

Press X-ray console acquisition button to restart sphere detection.<br />

Align a radiopaque sphere with Radiation Isocenter.<br />

Authorization failed.<br />

Cannot update Daily Check timest<strong>amp</strong>.<br />

Ensure that calibration file is not write protected.<br />

Extend Daily Check Validity<br />

Enter the treatment room. Is phantom aligned with isocenter?<br />

Perform warm-up of X-ray tubes?<br />

Acquire X-ray images to start Daily Check<br />

Place System Calibration Phantom at isocenter.<br />

Align System Calibration Phantom as accurately as possible with linac isocenter. This position is<br />

used for the daily check.<br />

Make sure phantom is aligned correctly and restart Daily Check.<br />

Daily Check failed. Select further procedure.<br />

Press X-ray console acquisition button to restart Daily Check.<br />

Calibration invalidated.<br />

Thermal to 3D Camera Calibration may be incorrect. Recalibrate Thermal to 3D Camera?<br />

System Calibration is incorrect. This may result in patient mistreatment. Continue?<br />

Daily check failed. This may result in patient mistreatment. Exit without updating daily check?<br />

Daily check result not saved. Exit anyway?<br />

Extend Daily Check validity?<br />

Daily check failed. This may result in patient mistreatment. Extend validity of previous daily<br />

check?<br />

Tube warm-up was interrupted. Restart the tube warm-up?<br />

Select Phantom Color and define <strong>Surface</strong> Tracking Area.<br />

New Tracking<br />

Tracking stopped. Maximum tracking length reached. ${additionalMessage}<br />

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APPENDIX<br />

Notification / Information<br />

Quitting will stop tracking. Tracking results will be discarded. Quit anyway?<br />

<strong>Surface</strong> Tracking results automatically saved to: ${folder}<br />

Error saving tracking results. Your results are temporarily stored in: ${folder} The file will be deleted<br />

when the application is closed.<br />

Saving tracking results...<br />

The calibration failed. See log files for details.<br />

The calibration was successful and has been saved.<br />

A severe error occurred. Close the application.<br />

A settings file is read-only, or the current user is not allowed to modify it.<br />

Ensure that the user is in the correct Windows user group and contact Brainlab Support if the<br />

problem persists.<br />

The application will be closed.<br />

Error Messages<br />

Failed to write to the folder: ${folder}<br />

The $ {calb} Calibration is invalid.<br />

X-ray tubes are overheated.<br />

X-ray service is currently nonoperational. Trying to recover...<br />

Warnings<br />

Authorization failed. Calibration cannot be invalidated.<br />

Calibration cannot be saved. Ensure that calibration file is not write protected.<br />

New isocenter position differs significantly from last Isocenter Calibration result (calibrated on: $<br />

{timest<strong>amp</strong>}, calibration status: ${status}).<br />

Translational deviation (threshold: ${maxTranslation} mm): ${translation} mm<br />

Rotational deviation (threshold: ${maxRotation}°): Lat: ${rotation_0}°, Long: ${rotation_1}°, Vert:<br />

${rotation_2}°<br />

Confirm that System Calibration Phantom is correctly positioned.<br />

Radiation Isocenter position differs significantly from last isocenter position (calibrated on: $<br />

{timest<strong>amp</strong>}).<br />

Deviation: ${distance} mm (threshold: ${maxDistance} mm)<br />

Confirm that radiopaque sphere is correctly positioned.<br />

System Messages - Preparation Application<br />

Notification / Information<br />

Enter a template name.<br />

This template name already exists. Select different name.<br />

Export was successful.<br />

Export finished with errors. More detailed error messages can be found in the log file.<br />

Export failed. More detailed error messages can be found in the log file.<br />

Plan settings were updated to the current version. Please verify the plan settings before saving.<br />

Plan settings were adapted to the Local Shared Settings. Please verify the plan settings before<br />

saving.<br />

X-ray tolerances were adapted to the respective <strong>Surface</strong> tracking tolerances. Please verify the<br />

plan settings before saving.<br />

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System Messages<br />

Notification / Information<br />

Patient is currently open in Treatment App. Close patient in Treatment App before modifying it.<br />

Unprepared patient plan has been loaded on linac. Do you want to save the current plan and<br />

load the new plan?<br />

There are unsaved changes. Do you want to save before closing?<br />

The changes cannot be saved because at least one OAR has to be selected. Do you want to<br />

continue and discard the changes?<br />

The changes cannot be saved. Do you want to continue and discard the changes?<br />

There are unsaved changes. Do you want to save before closing the patient plan?<br />

Not all isocenters prepared. All changes will be lost when proceeding. Proceed anyway?<br />

Patient plan is missing required breath-hold contour objects:<br />

${value_dibh_contour}<br />

${value_fb_contour}<br />

.Patient plan can not be treated in breath-hold workflow.<br />

Patient plan holds multiple breath-hold and/or free-breathing contour objects:<br />

${value_dibh_contour}<br />

${value_fb_contour}<br />

Patient plan can not be treated in breath-hold workflow.<br />

Saving is in progress.<br />

Current plan settings will be discarded. Do you want to assign a new template to this patient?<br />

Failed to archive selected patient. Contact Brainlab support if the problem persists.<br />

Failed to delete selected patient. Contact Brainlab support if the problem persists.<br />

Patient plan preparation failed:<br />

${reasons}<br />

Reload patient plan and prepare again.<br />

Contact Brainlab support if the problem persists.<br />

This patient plan is license dependent. To continue with this patient plan you must have the following<br />

license(s): ${missingLicenses}<br />

Close this patient plan and select a different one or change the template to proceed with this patient<br />

plan.<br />

Plan has been treated with previous version of ExacTrac <strong>Dynamic</strong>. No information is available<br />

whether the Marker Pattern tool has been used.<br />

The plan has been treated with a previous version of ExacTrac <strong>Dynamic</strong>. The CT was restricted<br />

using a VOI. The VOI that was used for the current X-ray/DRR fusion is not available for display.<br />

Failed to save template.<br />

Failed to delete the template.<br />

No patient plan settings available.<br />

No template assigned.<br />

<strong>Surface</strong> tolerances invalid.<br />

X-ray tolerances invalid.<br />

Fusion Settings incompatible with selected workflow.<br />

Select patient plan to reexport treatment data.<br />

To prepare or edit patient plan settings, select and load the patient plan.<br />

Select and load patient plan.<br />

Open Session for Review and Approval.<br />

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APPENDIX<br />

Notification / Information<br />

Select a template to proceed with the import procedure.<br />

Adjust plan settings if necessary.<br />

Plan settings saved.<br />

Define marker in the center of the marker structure in the CT images.<br />

Define marker endpoints at the outer edges of the marker structure in the CT images.<br />

Finish defining long markers. Delete the most recently defined marker.<br />

Invalid number of markers defined. Select both end points of 1 to 5 markers.<br />

Invalid number of markers defined. Select 2 to 11 markers.<br />

Changing the marker type will delete all planned markers. Continue?<br />

Select objects of interest.<br />

Verify breath-hold reference contours and select at least one OAR.<br />

Verify breath-hold reference contours.<br />

Restrict CT volume (VOI).<br />

Adjust contrast and restrict CT volume (VOI).<br />

Adjust the contrast between bony and tissue.<br />

Choose isocenter to prepare.<br />

Saving patient plan settings...<br />

Archiving patient. Please wait.<br />

Deleting patient. Please wait.<br />

Select master template to initialize new template<br />

Enter name of new template<br />

Enter New Template Name<br />

Are you sure you want to delete template ${templateName}?<br />

Template updated<br />

Invalid template name. Note: Only 'a' - 'z' , 'A' - 'Z' , '0' - '9' , '-' , '_' are allowed.<br />

Template saving failed:<br />

${reasons}<br />

Reload template and try again.<br />

Contact Brainlab support if the problem persists.<br />

This session does not contain X-ray DRR Fusions.<br />

Loaded patient plan not valid. Load a valid plan.<br />

Not supported for <strong>Surface</strong> Only.<br />

Not supported for Breathing Management with X-ray.<br />

"X-ray and <strong>Surface</strong>" license is not available.<br />

"<strong>Surface</strong> Only" license is not available.<br />

"Breath-hold" license is not available.<br />

"Respiratory Gating" license is not available.<br />

"External Positioning" license is not available.<br />

"Internal Anatomy" license is not available.<br />

"Implanted Marker" license is not available.<br />

No message was registered for the message identifier.<br />

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System Messages<br />

Notification / Information<br />

No Templates Available.<br />

Not supported for beams with couch angle larger than ±${maxPSA}°.<br />

Warnings<br />

Connection error. Patient plan settings could not be updated. ExacTrac will update the plan settings<br />

once the connection is re-established.<br />

Review if plan settings were updated before patient treatment!<br />

Technical help:<br />

Check DICOM Proxy connection. In case the problem persists contact Brainlab support.<br />

Patient is currently being prepared or used for treatment by another user. Deleting, archiving and<br />

exporting patient not possible.<br />

System Messages - Treatment Application<br />

Notification / Information<br />

Beam delivered. Waiting for next beam or patient plan closing...<br />

Failed to authorize beam. Select/Prepare a beam on linac.<br />

Turn off treatment beam on linac to start External Repositioning process.<br />

Deviation from breath-hold target level is now allowed. Consider possible location changes of<br />

OAR.<br />

Threshold Exceeded Reference <strong>Surface</strong> was acquired too far from Imaging Level. This results in<br />

a deviation from isocenter position during treatment.<br />

Threshold Exceeded Imaging was performed too far from Planned Level. Patient breath-hold<br />

level during treatment will deviate from plan.<br />

Reference <strong>Surface</strong> was acquired too far from Imaging Level. This results in a deviation from isocenter<br />

position during treatment. Imaging was performed too far from Planned Target. Patient<br />

breath-hold level during treatment will deviate from plan.<br />

Review acquired reference and deviation between levels<br />

Perform Couch Centering<br />

Move couch to centered position<br />

Set imaging marks will be deleted. Continue?<br />

External imaging needs to be re-acquired to ensure treatment accuracy. Discard existing imaging?<br />

Reference <strong>Surface</strong> will be discarded. Continue?<br />

Select system retrieving shift<br />

No couch movement detected. Ensure couch is in intended position.<br />

Move patient to final treatment position<br />

Apply external imaging shift<br />

Open "Positional Error" dialog in iGUIDE®<br />

Compare Shift Values<br />

Enter Shift Values<br />

Do not press "Move" in iGUIDE® until you put in the values.<br />

Guide patient into breath-hold to enable the treatment beam.<br />

Enable automatic X-ray mode via ExacTrac console.<br />

New beam loaded on linac.<br />

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APPENDIX<br />

Notification / Information<br />

Beam with different isocenter loaded on linac.<br />

Modify Area<br />

The patient plan does not contain any Prepositioning Contour. Position the patient manually.<br />

Virtual isocenter loaded. Load a treatment beam to proceed.<br />

Position the patient approximately at isocenter position.<br />

Patient surface not detected. Manually move the patient closer to treatment position. Verify that<br />

patient surface matches the reference contour and is not covered.<br />

Patient surface not detected. Manually move the patient closer to the free-breathing position.<br />

Verify that patient surface matches the planning CT data and is not covered.<br />

Select/Prepare beam on linac.<br />

Verify surface position at time of X-ray acquisition, X-ray quality and X-ray acquisition timing.<br />

Patient surface not detected. Verify that patient surface matches the planning CT data and is not<br />

covered.<br />

Define point for respiratory signal tracking and calculate baseline.<br />

Baseline computation was not successful. Calculation must be restarted.<br />

Preposition the free-breathing patient.<br />

This patient plan is license dependent. To use this patient plan following license(s) is/are required:<br />

${missingLicenses}.<br />

Align images to set a start point for the fusion.<br />

Align images for manual fusion or as a start point for the automatic fusion.<br />

Mark areas in the X-ray image to exclude them from the fusion.<br />

Insufficient image information. Reduce the restricted area (ROI) in the X-ray images.<br />

For automatic fusion, restrict the image information in X-rays (ROI) and/or CT (VOI) to breathdependent<br />

structures.<br />

Restrict the CT volume (VOI) to exclude structures from the fusion.<br />

Carefully verify X-ray image quality.<br />

Accept the fusion.<br />

Verify X-ray/DRR fusion.<br />

Verify and accept the implanted marker fusion.<br />

Verify fusion result in both, Restricted DRR (VOI) and Full DRR.<br />

Patient position is out of tolerance. Verify fusion result in both, Restricted DRR (VOI) and Full<br />

DRR.<br />

Patient position is out of tolerance. Verify X-ray/DRR fusion.<br />

Carefully verify the fusion before accepting the externally defined patient position as ExacTrac<br />

Reference.<br />

Verify positions of detected markers in X-rays.<br />

Acquire X-ray images to verify patient position.<br />

Patient within tolerance. Verify fusion and continue to treatment.<br />

Modify the 'Bony to Tissue' slider to change DRR generation to your preference.<br />

For automatic fusion, restrict the image information in X-rays (ROI) and/or CT (VOI) to breathdependent<br />

structures.<br />

Verify OAR.<br />

No patient plan loaded on linac.<br />

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System Messages<br />

Notification / Information<br />

Linac beam already loaded and mapped.<br />

More than one beam matches the prepared beam on linac. First beam will be chosen.<br />

Current manual alignment will be taken as final fusion result.<br />

No automatic optimization will be performed.<br />

The shift is restricted to 3 DoF.<br />

Prepare patient plan loaded on linac for treatment with ExacTrac or auto-authorize to treat without<br />

ExacTrac.<br />

Patient plan was prepared with an old plan settings version. Reprepare patient plan loaded on<br />

linac for treatment with ExacTrac or auto-authorize to treat without ExacTrac.<br />

CT scanner orientation ("${sliceSetOrientation}") differs from patient plan orientation ("${patient-<br />

Orientation}").<br />

Acquire X-rays via console<br />

Additional messages generated during the treatment:<br />

Patient plan was unloaded on linac. Close patient plan?<br />

Quit Treatment App?<br />

No stereoscopic X-ray images available. It is not possible to proceed in workflow.<br />

The X-ray generator settings have changed since the last X-ray acquisition.<br />

Original settings:<br />

Generator 1: ${image1}<br />

Generator 2: ${image2}<br />

Current generator settings:<br />

Generator 1: ${generator1}<br />

Generator 2: ${generator2}<br />

Reacquire new X-ray images or restore the original settings to continue.<br />

Enable ExacTrac as beam control device on the linac.<br />

Disable ExacTrac as Beam Hold device on the linac.<br />

Patient is currently open in Preparation App. Close patient in the Preparation App to continue.<br />

ExacTrac has recovered from a severe error. Workflow will be restarted to ensure safe treatment.<br />

Showing DRR with restricted angle(s) for<br />

${label}: ${compromiseAngle}${unit} instead of ${actualAngle}${unit}<br />

Setting externally defined position as reference for ExacTrac.<br />

Detecting Markers<br />

Fusing Markers<br />

Setting excluded rotations as monitoring reference:<br />

${label}: ${zeroAngle}${unit} instead of ${actualAngle}${unit}<br />

External Positioning (e.g. CBCT) accepted as ExacTrac reference. Continue to treatment.<br />

Select a patient plan to proceed in the workflow.<br />

Verify compromise fused DRR.<br />

Verify compromise fused marker positions.<br />

Confirm Isocenter<br />

The PDF generation failed. Go to the Repeat Export workflow to trigger PDF generation again.<br />

Perform External Imaging (e.g. CBCT)<br />

Apply shift to move patient to final treatment position.<br />

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Notification / Information<br />

Plan settings above can only be changed in the ExacTrac Preparation App.<br />

Changes made to the patient plan settings above will be reset when patient plan is closed in<br />

Treatment App.<br />

Changes made to the plan setting above will be reset when a new beam is loaded in Treatment<br />

App.<br />

X-ray generator setting changes are only applied to the current couch angle. They will be saved<br />

for future treatment sessions.<br />

Changes made to the plan settings above will be saved for future treatment sessions.<br />

X-ray monitoring not possible<br />

X-ray generator busy...<br />

Fast gating condition detected. Treatment has been paused. Press 'OK' to continue treatment.<br />

Rotate couch to planned treatment position.<br />

Waiting for linac...<br />

Loading patient plan...<br />

Rotate gantry on linac to an angle that allows stereoscopic X-ray acquisitions.<br />

Daily Check will expire in ${days_left} day(s).<br />

Saving treatment data...<br />

Confirm or modify <strong>Surface</strong> Tracking Area.<br />

Loaded beam on linac is missing in the patient plan.<br />

Reason(s): ${details}<br />

Load a different beam on the linac.<br />

Error Messages<br />

Loaded beam is inconsistent with patient plan loaded on linac.<br />

Error occurred during reference surface acquisition. Adapt tracking area and retry to start surface<br />

tracking.<br />

Insufficient performance of the surface tracking system detected.<br />

Insufficient performance of the respiratory signal calculation detected.<br />

Insufficient performance of the X-ray acquisition detected.<br />

Insufficient performance of fusion detected.<br />

Failed to start tracking. Reacquire X-ray images to determine the patient position.<br />

The Calibration is invalid. Recalibrate ExacTrac.<br />

The Calibration has expired. Recalibrate ExacTrac.<br />

The X-ray Calibration time st<strong>amp</strong> does not match with the time st<strong>amp</strong> of the Camera Isocenter<br />

Calibration. Recalibrate ExacTrac.<br />

The quality assurance check has expired. Perform Daily Check to reenable treatment.<br />

Patient plan information not available. Unload and load patient plan on linac.<br />

Session recovery failed.<br />

The ${calib} Calibration is invalid.<br />

The ${calib} Calibration is expired.<br />

X-ray service is nonoperational. Recovering...<br />

There are no X-ray correction images. Please go to X-ray Correction Image Acquisition and acquire<br />

correction images.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 175


System Messages<br />

Error Messages<br />

No beam loaded.<br />

No patient plan loaded.<br />

Unexpected beam loaded - no beam loaded on linac. Load a valid beam on linac.<br />

Beam not found.<br />

An internal application error occurred. Contact Brainlab support.<br />

The desired function is not supported by the linac.<br />

Gantry operations are not supported by the linac.<br />

The positioning procedure is not supported by the available iGUIDE version.<br />

The positioning procedure is not supported by the available ADI version.<br />

Linac is not responding. Verify network connection and linac status.<br />

iGUIDE® is not responding. Make sure iGUIDE® is ready for positioning.<br />

MOSAIQ is not responding. Make sure MOSAIQ and CMA are ready for positioning.<br />

iCOM interface is not responding. Make sure TCS and iCOM are started properly.<br />

External Beam Inhibit device is not responding. Restart ExacTrac workstation to solve the problem.<br />

If problem persists, contact Brainlab support.<br />

ILK device is not responding. Restart ExacTrac workstation to solve the problem. If problem persists,<br />

contact Brainlab support.<br />

ADI interface is not responding. Make sure linac and ADI are configured and started properly.<br />

Position information from linac is currently not available. Try to perform the workflow again later.<br />

If problem persists, contact Brainlab support.<br />

Unexpected linac configuration or behavior is detected. Contact Brainlab support.<br />

Actual linac machine configured on linac is not consistent with ExacTrac configuration. Contact<br />

Brainlab support.<br />

Actual linac machine name from MOSAIQ interface is not consistent with ExacTrac configuration.<br />

Contact Brainlab support.<br />

A fatal error of Beam Inhibit device is detected. Contact Brainlab support.<br />

Actual ADI and DoF configurations are not consistent with ExacTrac. Contact Brainlab support.<br />

An internal workflow violation was detected. If problem persists, contact Brainlab support.<br />

The positioning procedure encountered an internal workflow violation. If problem persists, contact<br />

Brainlab support.<br />

An internal configuration failure was detected. If problem persists, contact Brainlab support.<br />

Shift cannot be sent because the target yaw rotation exceeds the linac tolerance. Make sure that<br />

the couch is at the planned angle and that the patient is correctly positioned on the table, e.g. by<br />

returning to prepositioning.<br />

Shift cannot be sent due to unsupported couch tilt mode (3/4 DOF to 6 DoF mismatch). Inspect<br />

shift values or position patient manually.<br />

Shift cannot be sent. MOSAIQ and base table can only perform 3 DoF. Inspect shift values or<br />

position patient manually.<br />

Shift cannot be sent due to incompatible DoF from available linac and ADI configuration. Inspect<br />

shift values or position patient manually.<br />

There is another pending couch movement on linac.<br />

There is another pending couch movement on MOSAIQ.<br />

There is another pending couch movement on iGUIDE®.<br />

Select an appropriate beam on linac and continue with the workflow.<br />

176 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


APPENDIX<br />

Error Messages<br />

Select an appropriate beam on MOSAIQ and continue with the workflow.<br />

Missing treatment information from iGUIDE®. Make sure an appropriate beam is loaded on both<br />

MOSAIQ and iGUIDE.<br />

Select an appropriate patient plan or beam on linac and try to approve treatment again.<br />

Select an appropriate beam on MOSAIQ and try to approve the treatment again.<br />

Open an appropriate patient plan on MOSAIQ and try to approve the treatment again.<br />

Prepare an appropriate beam on linac and try to approve the treatment again.<br />

Open an appropriate patient plan on linac and try to approve the treatment again.<br />

Shift cannot be sent. The request was rejected by the linac. Inspect shift values or any issue on<br />

linac and then try again.<br />

Couch movement was interrupted on linac. The expected couch position might not be reached.<br />

Couch movement was interrupted on iGUIDE®. The expected couch position might not be<br />

reached.<br />

Couch movement was interrupted on MOSAIQ. The expected couch position might not be<br />

reached.<br />

The couch movement request was cancelled. Make sure to cancel any pending couch movement<br />

procedure on the linac.<br />

The couch movement request was cancelled. Make sure to cancel any pending couch movement<br />

procedure on the iGUIDE®.<br />

The couch movement request was cancelled. Make sure to cancel any pending couch movement<br />

procedure on MOSAIQ.<br />

The couch movement procedure is completed but an unexpected position deviation is detected.<br />

Verify patient position or restart positioning workflow.<br />

The couch is moved with unexpected deviation. Restart Daily Check workflow.<br />

A couch positioning procedure has been completed but the couch position gets invalidated due<br />

to user action on linac.<br />

A mismatched beam is detected. Select an appropriate beam on linac again.<br />

Mismatched beam detected due to possible ADI communication failure. Prepare an appropriate<br />

beam again and continue with the workflow.<br />

Mismatched patient plan detected. Open an appropriate plan on linac again and continue with<br />

the workflow.<br />

Mismatched patient plan from linac detected due to possible ADI communication failure. Prepare<br />

an appropriate beam again and continue with the workflow.<br />

Gating device hardware error. Contact Brainlab support.<br />

ExacTrac gating service has an unhandled error.<br />

Warnings<br />

Turn off treatment beam. Inconsistent information about treatment beam state.<br />

Radiation delivery of less than 2s occurred. This can cause gantry position errors and incorrect<br />

dose.<br />

Reestablish surface tracking or modify tracking area to restart surface tracking.<br />

It seems that after External Positioning (e.g. CBCT) shifts were sent by ExacTrac.<br />

1. Bring patient into treatment position as defined by External Positioning.<br />

2. Confirm when patient is in final treatment position.<br />

Unintended couch move detected. Please return to Prepositioning or move couch to initial position.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 177


System Messages<br />

Warnings<br />

<strong>Surface</strong> tracking not possible. Treatment beam is on hold.<br />

Check patient posture.<br />

Other options:<br />

Continue without surface tracking (only using respiratory signal). This will be applied for the remaining<br />

and all following beams.<br />

OR<br />

Return to Prepositioning and redefine the <strong>Surface</strong> Tracking Area.<br />

Implanted marker positions could not be determined. Turn off treatment beam and verify X-ray<br />

generator settings.<br />

One X-ray image has too low contrast. System is performing fusion with only one X-ray image.<br />

Turn off treatment beam and modify generator settings to improve X-ray images.<br />

The fusion has failed. Ensure patient is positioned close to isocenter and valid X-ray images are<br />

available.<br />

Acquire stereoscopic X-ray images to restart surface tracking.<br />

If surface tracking does not recover, restart from prepositioning and define a new <strong>Surface</strong> Tracking<br />

Area.<br />

Patient may be treated out of defined tolerances.<br />

Patient may be treated out of defined tolerances.<br />

Automatic safeguard will be disabled:<br />

- No beam hold control by ExacTrac for current beam<br />

Patient may be treated out of defined tolerances. Automatic safeguard will be disabled:<br />

- No automatic X-ray triggers for current beam<br />

Patient may be treated out of defined tolerances.<br />

Automatic safeguards will be disabled:<br />

- No beam hold control by ExacTrac for current beam<br />

- No automatic X-ray triggers for current beam<br />

Reposition the patient with external device to restart surface tracking.<br />

The <strong>Surface</strong> Tracking Area could not be transformed with sufficient quality. A new <strong>Surface</strong> Tracking<br />

Area must be defined.<br />

Invalid respiratory point position. Redefine respiratory point.<br />

Invalid respiratory point position. Redefine respiratory point and/or verify contour assignment.<br />

Implanted marker positions could not be determined. Adjust marker positions manually or exclude<br />

mismatching planned marker(s).<br />

The fusion has failed. Check that valid X-ray images are available.<br />

The fusion has failed. Check image alignment in manual fusion settings.<br />

The fusion has been interrupted. Acquire new X-rays.<br />

Patient position exceeds hardware limits, values in parentheses cannot be applied completely.<br />

Manual repositioning of patient is recommended.<br />

Patient position is out of tolerance. Verify fusion and send shift to continue treatment.<br />

Error occurred during X-ray acquisition. Reacquire new X-ray images.<br />

Error occurred during X-ray acquisition. Discard and reacquire X-ray images.<br />

Breathing signal outside of imaging window. Discard and reacquire X-ray images.<br />

Turn off treatment beam if treatment is ongoing. Error occurred during X-ray acquisition. Reacquire<br />

new X-ray images.<br />

Error occurred during X-ray acquisition. Reacquire new X-ray images.<br />

No X-ray acquisition possible. Let tubes cool down.<br />

178 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


APPENDIX<br />

Warnings<br />

Information contained in one or both X-ray images is insufficient for the fusion. Verify the X-ray<br />

generator exposure settings.<br />

Turn off treatment beam. No patient monitoring possible. Return to Monitoring workflow step to<br />

continue.<br />

Shift cannot be sent. Ensure that the treatment system is in a state to receive shift.<br />

Detected marker positions not suitable for X-ray monitoring.<br />

X-ray fusion will most likely fail during patient monitoring.<br />

Options:<br />

- Adjust X-ray generator settings to improve X-ray quality<br />

- Review marker detection<br />

- Continue (to avoid failing X-ray fusions, disable automatic X-ray trigger in the menu)<br />

The number of active markers does not allow a 6 DoF match. A 3 DoF match to the center of<br />

gravity will be performed instead, excluding rotational correction.<br />

Correction shift exceeds typical limits. Consider reinspecting the fusion result.<br />

An unexpected error occurred. Please reload the plan.<br />

X-ray based monitoring is disabled for Marker Pattern mode.<br />

Turn off treatment beam. X-ray quality insufficient for patient monitoring. Verify X-ray generator<br />

settings.<br />

X-ray tubes were blocked. No acquisition was possible.<br />

Patient position out of tolerance.<br />

Continue despite exceeded tolerances?<br />

Incorrect prepositioning may influence the accuracy of the breath-hold target level calculation.<br />

Prepositioning Shift Calculation Failed<br />

Ensure no unwanted structures are included in the Free-Breathing Contour.<br />

It is possible to continue with manual prepositioning using the live surface information.<br />

Incorrect prepositioning may influence the accuracy of the Plan breath-hold Level calculation.<br />

Turn off treatment beam if treatment is ongoing. Patient monitoring and beam hold control not<br />

possible. Restart ExacTrac if this error persists.<br />

Large deviation between ExacTrac and External Positioning detected. Ensure that patient is still<br />

in final treatment position.<br />

Turn off treatment beam if treatment is ongoing. No X-ray monitoring possible. Let tubes cool<br />

down.<br />

No X-rays can be acquired. Let tubes cool down.<br />

Fusion is not approved. Continue?<br />

Only 3 DoF positioning possible<br />

An unexpected couch movement was detected during positioning workflow. Verify patient position<br />

or restart positioning workflow.<br />

An unexpected couch movement was detected. Restart Daily Check workflow.<br />

Define <strong>Surface</strong> Tracking Area.<br />

Selected <strong>Surface</strong> Tracking Area does not provide enough information for reliable tracking. Adjust<br />

<strong>Surface</strong> Tracking Area.<br />

System Messages - Treatment and Calibration Applications<br />

Notification / Information<br />

The following calibration will expire in ${days_left} day(s): ${calib}.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 179


System Messages<br />

Notification / Information<br />

The X-ray generators are now linked.<br />

Exposure settings were changed from:<br />

X-ray Generator 1: ${genExp1} X-ray Generator 2: ${genExp2}<br />

to:<br />

X-ray Generator 1&2: ${genExpAll}.<br />

Error Messages<br />

ExacTrac gating service is temporarily disconnected<br />

ExacTrac linac service is temporarily disconnected<br />

ExacTrac X-ray service is temporarily disconnected<br />

No surface data available or no object detected in camera's field of view.<br />

<strong>Surface</strong> tracking failed.<br />

Unable to connect to the thermal camera.<br />

Unable to connect to the 3D camera.<br />

Unable to start image acquisition on the thermal camera.<br />

Unable to start image acquisition on the 3D camera.<br />

Unable to start the tracking because there is no valid image available.<br />

System Messages - Treatment and Preparation Applications<br />

Notification / Information<br />

This feature is disabled when ExacTrac is not run from Content Manager.<br />

Free Space: ${value} GB (Below Suggested Minimum Free Space)<br />

Free Space: ${value} GB (Below Required Minimum Free Space)<br />

The local DICOM Proxy is offline.<br />

The upstream DICOM Proxy is offline.<br />

The local DICOM Proxy is not compatible.<br />

The default export platform is not available.<br />

There are more slices not part of the imported image data than the allowed setting.<br />

A newer version of this patient plan is available.<br />

Patient plan data could not be loaded.<br />

Not all patient plan data could be loaded.<br />

DICOM import failed. No DICOM RT plan object available.<br />

DICOM import failed. No DICOM CT Image Set available.<br />

Beam includes less than two control points.<br />

Beam includes no treatment delivery type.<br />

Beam includes an unexpected treatment delivery type.<br />

Beam includes no treatment position.<br />

Beam is missing a patient support angle (PSA) value in at least one control point.<br />

The Beam has no cumulative meterset weight at all control points.<br />

Beam includes patient support angle (PSA) changes.<br />

Beam is missing a gantry angle in at least one control point.<br />

180 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


APPENDIX<br />

Notification / Information<br />

Beam includes invalid gantry route.<br />

Beam includes a non-zero couch pitch angle.<br />

Beam includes a non-zero couch roll angle.<br />

Beam includes no MU per single fraction.<br />

Beam includes an unsupported patient support angle (PSA) rotation direction.<br />

Beam includes an unsupported couch pitch rotation direction.<br />

Beam includes an unsupported couch roll rotation direction.<br />

The patient plan has no patient orientation.<br />

The patient plan has no treatment beams, or its beams could not be imported.<br />

DICOM images are missing in CT Reference set.<br />

Patient plan data could not be loaded.<br />

Patient plan settings were removed during loading.<br />

Patient plan does not contain a Slice Set.<br />

Patient plan contains a Slice Set with unsupported modality (not a CT).<br />

Patient Slice Set has an invalid geometry.<br />

Patient Slice Set has an invalid patient orientation.<br />

Patient Slice Set has an invalid head-feet orientation.<br />

Patient plan contains unsupported treatment orientation.<br />

Patient Slice Set orientation is inconsistent with patient plan.<br />

Patient slice set has slice distance, which is greater than the allowed maximum distance.<br />

A beam has more MU than the allowed maximum MU.<br />

Patient plan has more MU than the allowed maximum MU.<br />

Patient plan has not been prepared yet.<br />

Not supported for non-coplanar beams.<br />

Auto X-ray trigger not supported for consolidated fields.<br />

Positioning restricted by couch configuration.<br />

X-ray tubes are blocked for some gantry angles.<br />

Not all planned X-ray verifications can be acquired.<br />

Prepositioning Contour missing.<br />

Patient plan is not prepared or contains invalid number of implanted markers.<br />

Patient plan was prepared with older version of plan settings.<br />

Plan settings have changed.<br />

Warnings<br />

ExacTrac could not save treatment data.<br />

Could not save patient plan data.<br />

A Free-Breathing and a Breath-hold contour are required.<br />

Prepositioning contour with name "${objectName}" not found. Automatic prepositioning based on<br />

CT Contour will not be supported.<br />

Current patient plan is not supported by this template:<br />

Gantry angle based automatic X-ray triggers are not supported for consolidated fields.<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 181


System Messages<br />

Warnings<br />

DICOM Proxy is offline.<br />

The upstream DICOM Proxy is offline.<br />

The Archiving Proxy is offline.<br />

The DICOM Proxy is not compatible.<br />

The free disk space is low.<br />

Not enough free disk space available for safe operation.<br />

Unsaved patient plan data was archived.<br />

182 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


APPENDIX<br />

11.4 Abbreviations<br />

Abbreviations Used in this User Guide<br />

Abbreviation<br />

3DoF<br />

6DoF<br />

CBCT<br />

CLAHE<br />

AET<br />

CTV<br />

DAP<br />

DRR<br />

GTV<br />

IGRT<br />

MU<br />

OAR<br />

PSA<br />

PTV<br />

ROI<br />

R&V<br />

SGRT<br />

VOI<br />

Meaning<br />

3 degrees of freedom<br />

6 degrees of freedom<br />

Cone-beam CT<br />

Contrast-limited adaptive histogram equalization<br />

Application entity title<br />

Clinical target volume<br />

Dose area product<br />

Digitally reconstructed radiograph<br />

Gross tumor volume<br />

Image-guided radiotherapy<br />

Monitor units<br />

Organs at risk<br />

Patient support angle (couch angle)<br />

Planned target volume<br />

Region of interest (X-ray restriction)<br />

Record and verify system<br />

<strong>Surface</strong>-guided radiotherapy<br />

Volume of interest<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 183


INDEX<br />

INDEX<br />

A<br />

ADI............................................................................................. 39<br />

algorithms<br />

camera calibration................................................................ 159<br />

isocenter calibration..............................................................159<br />

archiving proxy<br />

PACS.................................................................................... 157<br />

axes<br />

couch/linac..............................................................................34<br />

B<br />

background services<br />

Elekta integration....................................................................54<br />

Varian integration....................................................................54<br />

backup<br />

protection against data loss....................................................19<br />

bolus<br />

physical...................................................................................83<br />

prepositioning with..................................................................99<br />

respiratory point....................................................................105<br />

virtual...................................................................................... 83<br />

Brainlab customer service.......................................................... 31<br />

Brainlab service<br />

user management...................................................................27<br />

C<br />

calibration<br />

isocenter position..................................................................144<br />

CE label........................................................................................7<br />

CFS............................................................................................ 39<br />

console<br />

Elekta......................................................................................41<br />

TrueBeam...............................................................................41<br />

consolidated field sequencing.................................................... 39<br />

coordinate system<br />

couch/linac..............................................................................35<br />

lateral angle............................................................................ 37<br />

lateral axis.............................................................................. 35<br />

longitudinal axis...................................................................... 35<br />

point of origin.......................................................................... 34<br />

table angles............................................................................ 37<br />

tilt angles................................................................................ 37<br />

vertical angle.......................................................................... 37<br />

x, y, z axes..............................................................................34<br />

D<br />

data consistency<br />

CT scanning........................................................................... 49<br />

DICOM RT..................................................................................16<br />

display coordinate system.......................................................... 35<br />

disposal instructions..................................................................... 8<br />

duty cycle restrictions................................................................. 39<br />

E<br />

Elekta<br />

60601-1.................................................................................. 20<br />

beam inhibit............................................................................ 87<br />

beam release conditions.........................................................87<br />

console................................................................................... 41<br />

HexaPOD..............................................................................116<br />

integration..........................................................................20,39<br />

multiple isocenters..................................................................77<br />

pendant...................................................................................41<br />

Precise Table........................................................................ 116<br />

prepositioning......................................................................... 93<br />

shift retrieval......................................................................... 116<br />

treatment authorization...........................................................87<br />

virtual isocenters.....................................................................77<br />

H<br />

hardware<br />

shutdown................................................................................ 58<br />

I<br />

iGUIDE<br />

daily check..............................................................................87<br />

isocenter calibration................................................................. 144<br />

algorithms............................................................................. 159<br />

L<br />

longitudinal angle....................................................................... 37<br />

M<br />

MOSAIQ<br />

multiple isocenters..................................................................77<br />

virtual isocenters.....................................................................77<br />

O<br />

operating environment................................................................12<br />

P<br />

pacemakers................................................................................13<br />

PACS<br />

archiving proxy..................................................................... 157<br />

passwords.................................................................................. 27<br />

user management...................................................................27<br />

pdf............................................................................................ 158<br />

pendant<br />

Elekta......................................................................................41<br />

TrueBeam...............................................................................41<br />

position on couch....................................................................... 44<br />

positioning<br />

recommendations................................................................... 44<br />

positioning accuracy<br />

CT scanning........................................................................... 49<br />

prepositioning the patient<br />

manually................................................................................. 44<br />

R<br />

recovery key............................................................................... 27<br />

registration, evaluation and authorization of chemicals<br />

REACH..................................................................................... 7<br />

184 Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


INDEX<br />

reports...................................................................................... 158<br />

rights<br />

user management...................................................................27<br />

rotational angles......................................................................... 31<br />

X<br />

X-ray calibration<br />

verification............................................................................ 147<br />

S<br />

safe disposal................................................................................ 8<br />

shift tolerance............................................................................. 74<br />

shutdown<br />

hardware.................................................................................58<br />

software.................................................................................. 57<br />

software<br />

shutdown................................................................................ 57<br />

startup.....................................................................................53<br />

startup<br />

ExacTrac <strong>Dynamic</strong> software...................................................53<br />

support....................................................................................... 31<br />

support numbers.......................................................................... 5<br />

surface tracking........................................................................ 160<br />

sustainability..............................................................................7,8<br />

T<br />

thermal camera........................................................................ 161<br />

third-party software.......................................................................6<br />

tilt angles.................................................................................... 37<br />

tracking area<br />

closed face masks................................................................ 103<br />

heated blankets.................................................................... 102<br />

iGuide................................................................................... 102<br />

subsequent beams............................................................... 102<br />

troubleshooting..................................................................... 102<br />

trademarks<br />

Brainlab.................................................................................... 6<br />

non-Brainlab............................................................................. 6<br />

treatment approval<br />

passwords.............................................................................. 27<br />

treatment reports...................................................................... 158<br />

TrueBeam<br />

console................................................................................... 41<br />

pendant...................................................................................41<br />

U<br />

user console<br />

shutdown................................................................................ 58<br />

user logs.....................................................................................27<br />

V<br />

Varian<br />

ADI..........................................................................................39<br />

automations............................................................................ 39<br />

couch centering.................................................................... 110<br />

Hyper ARC............................................................................. 39<br />

integration...............................................................................39<br />

multiple isocenters..................................................................77<br />

MV port film fields................................................................... 39<br />

shift retrieval......................................................................... 115<br />

treatment authorization...........................................................87<br />

unplanned treatment...............................................................39<br />

virtual isocenters.....................................................................77<br />

verification of X-ray calibration................................................. 147<br />

W<br />

warranty........................................................................................8<br />

waste electrical and electronic equipment (WEEE)......................8<br />

Clinical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 185


ainlab.com<br />

Art-No. 60922-36EN<br />

*60922-36EN*


EXACTRAC<br />

DYNAMIC<br />

EXACTRAC DYNAMIC<br />

EXACTRAC DYNAMIC SURFACE<br />

Version 2.0<br />

System and Technical User Guide<br />

Revision 1.0<br />

Date of issue: 2023-11-15 (ISO 8601)<br />

Copyright 2023, Brainlab AG Germany. All rights reserved.


TABLE OF CONTENTS<br />

TABLE OF CONTENTS<br />

1 GENERAL INFORMATION.............................................................................................4<br />

1.1 Contact Data ........................................................................................................................................4<br />

1.2 Legal Information ...............................................................................................................................5<br />

1.3 Symbols................................................................................................................................................8<br />

1.4 Using the System .............................................................................................................................10<br />

1.5 Compatibility with Medical Devices .............................................................................................14<br />

1.6 Cybersecurity and Software Environment..................................................................................16<br />

1.7 ExacTrac <strong>Dynamic</strong> Network Integration (IEC 80001) ................................................................22<br />

1.8 User Management.............................................................................................................................25<br />

1.9 Training and Documentation..........................................................................................................27<br />

2 HARDWARE OVERVIEW ..............................................................................................29<br />

2.1 ExacTrac <strong>Dynamic</strong> Hardware Components ................................................................................29<br />

2.1.1 4D Thermal Camera ........................................................................................................................30<br />

2.1.2 Control Room Components ..............................................................................................................31<br />

2.1.3 Treatment Room Components .........................................................................................................33<br />

2.1.4 System Control Unit .........................................................................................................................38<br />

2.1.5 Phantoms.........................................................................................................................................42<br />

2.1.6 X-ray Components ...........................................................................................................................45<br />

2.1.7 Radiation Safety...............................................................................................................................60<br />

2.2 Other Devices....................................................................................................................................61<br />

3 SYSTEM STARTUP AND SHUTDOWN............................................................62<br />

3.1 About System Startup and Shutdown .........................................................................................62<br />

3.2 Starting the ExacTrac <strong>Dynamic</strong> Software....................................................................................65<br />

3.3 Restarting the System .....................................................................................................................66<br />

3.4 Background Services ......................................................................................................................67<br />

3.5 Shutting Down the Software ..........................................................................................................69<br />

3.6 Shutting Down the System.............................................................................................................70<br />

3.7 Overview of Available Applications..............................................................................................72<br />

2 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


TABLE OF CONTENTS<br />

4 CLEANING AND DISINFECTION...........................................................................74<br />

4.1 Cleaning Guidelines.........................................................................................................................74<br />

4.2 Disinfection Guidelines...................................................................................................................78<br />

5 SYSTEM MAINTENANCE.............................................................................................79<br />

5.1 System Maintenance........................................................................................................................79<br />

5.2 Aspects and Types of Recurrent Inspections ............................................................................80<br />

5.3 Authorized Personnel for Recurrent Inspections......................................................................81<br />

5.4 Warnings and Maintenance Advice ..............................................................................................82<br />

5.5 Maintenance Schedule ....................................................................................................................83<br />

5.6 Description of the Maintenance Tasks.........................................................................................84<br />

5.6.1 Visual Inspection (STI), Monthly .......................................................................................................85<br />

5.6.2 Functional Test, Monthly...................................................................................................................86<br />

5.6.3 Accuracy Check, Monthly.................................................................................................................87<br />

5.6.4 Functional Test (STI), Yearly.............................................................................................................89<br />

5.6.5 Accuracy Check, Yearly....................................................................................................................92<br />

5.6.6 Functional Test, Yearly .....................................................................................................................93<br />

5.6.7 Electrical Safety Measurements (STI) ..............................................................................................95<br />

5.7 Handling Damaged Equipment....................................................................................................101<br />

5.8 Returning Damaged Equipment ..................................................................................................102<br />

6 COMPLIANCES AND SAFETY INFORMATION.....................................103<br />

6.1 ExacTrac <strong>Dynamic</strong> System Electronics.....................................................................................103<br />

6.2 Electromagnetic Compatibility Information..............................................................................106<br />

7 MAINTENANCE TEMPLATES ................................................................................ 111<br />

7.1 Maintenance Templates ................................................................................................................ 111<br />

7.2 Maintenance Task Test Protocol: Monthly, Qualified Clinical Personnel...........................112<br />

7.3 Maintenance Task Test Protocol: Yearly, Brainlab Support or Brainlab-Authorized<br />

Support.....................................................................................................................................................114<br />

INDEX ..................................................................................................................................................116<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 3


1 GENERAL INFORMATION<br />

1.1 Contact Data<br />

Support<br />

If you cannot find information you need in this guide, or if you have questions or problems, contact<br />

Brainlab support:<br />

Region Telephone and Fax Email<br />

United States, Canada, Central<br />

and South America<br />

Tel: +1 800 597 5911<br />

Fax: +1 708 409 1619<br />

us.support@brainlab.com<br />

Brazil Tel: 0800 892 1217 brazil.support@brainlab.com<br />

UK Tel: +44 1223 755 333<br />

Spain Tel: +34 900 649 115<br />

France and French-speaking<br />

regions<br />

Africa, Asia, Australia, Europe<br />

Japan<br />

Tel: +33 800 676 030<br />

Tel: +49 89 991568 1044<br />

Fax: +49 89 991568 5811<br />

Tel: +81 3 3769 6900<br />

Fax: +81 3 3769 6901<br />

support@brainlab.com<br />

Expected Service Life<br />

Brainlab provides ten years of service for system components. During this period of time, spare<br />

parts as well as field support are offered. If the software remains in service after the end of<br />

support, the cybersecurity risks may increase over time.<br />

Feedback<br />

Despite careful review, this user guide may contain errors. Please contact us at<br />

user.guides@brainlab.com if you have improvement suggestions.<br />

Manufacturer<br />

Brainlab AG<br />

Olof-Palme-Str. 9<br />

81829 Munich<br />

Germany<br />

4 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.2 Legal Information<br />

Copyright<br />

This guide contains proprietary information protected by copyright. No part of this guide may be<br />

reproduced or translated without express written permission of Brainlab.<br />

Brainlab Trademarks<br />

Brainlab ® , Brainlab Connected Care ® , Brainlab Elements ® , ExacTrac <strong>Dynamic</strong> and ExacTrac<br />

<strong>Dynamic</strong> <strong>Surface</strong> ® are registered trademarks of Brainlab AG or an affiliated company.<br />

NOTE: See brainlab.com/trademarks for details.<br />

Non-Brainlab Trademarks<br />

To the knowledge of Brainlab AG, the following trademark information applies:<br />

• ARIA OIS, Edge, TrueBeam, VitalBeam and PerfectPitch are registered trademarks of Varian<br />

Medical Systems, Inc.<br />

• eBUS is a registered trademark of Pleora Technologies Inc.<br />

• Elekta, iGUIDE, HexaPOD, MOSAIQ and Response are registered trademarks of Elekta AB.<br />

• Laird is a registered trademark of Laird Thermal Systems GmbH.<br />

• Bitlocker, Microsoft and Windows are registered trademarks of Microsoft Corporation.<br />

• NVIDIA is a trademark and/or registered trademark of NVIDIA Corporation in the US and/or<br />

other countries.<br />

• Varex and Varex Imaging are registered trademarks of Varex Imaging Corporation in the US<br />

and/or other countries.<br />

Patent Information<br />

This product may be covered by one or more patents or pending patent applications. For details,<br />

see: www.brainlab.com/patent.<br />

Integrated Third-Party Software<br />

This software is based in part on the following work. Full license and copyright notices can be<br />

found here: https://blguides.com/third-party-software-licenses<br />

Software Version Software Version<br />

ACE 6.5.8 LightBurst 1.6.0<br />

Chromium Embedded<br />

Framework (CEF)<br />

79.1.38+gecefb59<br />

+chromium-79.0.3945.13<br />

0<br />

Merge DICOM Toolkit 5.12.0<br />

C++ REST SDK 2.10.14 meta 0.1.0<br />

cryptopp 8.1.0 Modernizr 2.8.3<br />

d3js 3.5.17 nicescroll 3.6.0<br />

durandal 2.1.0 node.js 12.13.1<br />

eigen 3.4.0 Nvidia NVAPI release 367<br />

Filament 1.4.0 OpenCV 4.7.0<br />

FTD2XX 2.12.36 openjpeg 2.4.0<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 5


Legal Information<br />

Software Version Software Version<br />

FX11 4.2.0 pdf.js 1.4.20<br />

ICU 1.8.1 range-v3 0.5.0<br />

jquery 2.1.4 react.js 16.8.6<br />

jqueryui 1.11.1 RenderDocAPI 1.4.0<br />

knockout 3.5.1 requirejs 2.3.5<br />

LAPACK 3.2.1 SolvOpt 1.2<br />

libjpeg 2.1.2, 6b UltraVNC 1.3.8.1<br />

libjpeg-turbo 2.1.2 Xerces-C++ 3.2.3<br />

LibJpeg16, LibJpeg8 3.6.0, 6b yajl 2.1.0<br />

LibJpeg2k 2.4.0 zlib 1.2.12<br />

libpng 1.6.37 Xerces-C++ 3.2.3<br />

libtiff 3.6.0<br />

CE Label<br />

The CE label indicates that the Brainlab product complies with the General Safety<br />

and Performance Requirements of European Regulation 2017/745, the Medical<br />

Device Regulation ("MDR").<br />

ExacTrac <strong>Dynamic</strong> is a Class IIb product according to the rules established by<br />

the MDR.<br />

Report Incidents Related to This Product<br />

You are required to report any serious incident that may have occurred related to this product to<br />

Brainlab, and if within Europe, to your corresponding national competent authority for medical<br />

devices.<br />

Registration, Evaluation and Authorization of Chemicals (REACH)<br />

REACH is the European chemicals law that came into force to improve the protection of human<br />

health and the environment from risks that can be posed by chemicals. The identification of a<br />

substance as a substance of very high concern and its inclusion in the candidate list for REACH<br />

creates certain legal obligations for the importers, producers and suppliers of an article that<br />

contains such a substance. Brainlab requests suppliers to inform whether and to what extent<br />

substances from the list are used in their products. For further information regarding REACH<br />

processes at Brainlab, contact us here:<br />

www.brainlab.com/reach/<br />

Electronic Product Radiation Control (EPRC) Program (US Only)<br />

According to the EPRC program of the FDA, ExacTrac <strong>Dynamic</strong> is classified as a medical<br />

charged-particle radiation therapy system (Accelerator, Linear, Medical), radiation-emitting product<br />

code IYE.<br />

Based on 21 CFR (Code of Federal Regulations Title 21) of the CDRH, no performance standard<br />

is applicable and General Radiological Health requirements apply (21 CFR 1000-1005).<br />

Packaging and Packaging Disposal<br />

No special disposal of the packaging material is required.<br />

6 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

Disposal Instructions<br />

When a medical device reaches the end of its functional life, clean the device of all biomaterial/<br />

biohazards and safely dispose of the device in accordance with applicable laws and regulations.<br />

Only dispose of electrical and electronic equipment in accordance with statutory regulations.<br />

For information regarding the WEEE (Waste Electrical and Electronic Equipment)<br />

directive or relevant substances that could be present in the medical equipment,<br />

visit:<br />

https://www.brainlab.com/sustainability/<br />

https://www.brainlab.com/about-brainlab/technology/weee/<br />

Warranty<br />

Warranties do not apply to products that have been damaged due to accidents, misuse,<br />

improper reinstallation, or inadequate packaging in the case of return shipments.<br />

Warranties do not apply to product components that have been modified or replaced<br />

without the written authorization of Brainlab.<br />

IEC Compliance<br />

In accordance with radiation protection, ExacTrac <strong>Dynamic</strong> is compliant to IEC 60601-2-68:2014.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 7


Symbols<br />

1.3 Symbols<br />

Warnings<br />

Warning<br />

Warnings are indicated by triangular warning symbols. They contain safety-critical<br />

information regarding possible injury, death or other serious consequences associated<br />

with device use or misuse.<br />

Cautions<br />

Cautions are indicated by circular caution symbols. They contain important information<br />

regarding potential device malfunctions, device failure, damage to device or damage to<br />

property.<br />

Notes<br />

NOTE: Notes are formatted in italic type and indicate additional useful hints.<br />

Product Symbols<br />

The below symbols may be found on the system.<br />

Symbol<br />

Explanation<br />

Unique device identifier<br />

Medical device<br />

Manufacturer's serial number<br />

Manufacturer's batch code<br />

Article number<br />

Swiss authorized representative<br />

Manufacturer<br />

Date of manufacture<br />

NOTE: The date is expressed as in ISO 8961 as YYYY-MM-DD.<br />

Consult instructions for use<br />

U.S. federal law restricts this device to sale by or on order of a physician<br />

8 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

Symbol<br />

Explanation<br />

Temperature limit<br />

NOTE: Indicates the temperature limits to which the medical device can be safely<br />

exposed.<br />

Humidity limitation<br />

NOTE: Indicates the range of humidity to which the medical device can be safely exposed.<br />

Atmospheric pressure limitation<br />

NOTE: Indicates the range of atmospheric pressure to which the medical device can<br />

be safely exposed.<br />

Follow the instructions for use<br />

Waste Electrical and Electronic Equipment<br />

Warning; radioactive material or ionizing radiation<br />

Warning; electricity<br />

Hot surface<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 9


Using the System<br />

1.4 Using the System<br />

Abbreviated Device Description<br />

ExacTrac <strong>Dynamic</strong> (ETD) is a patient positioning and monitoring device used in a radiotherapy<br />

environment as an add-on system to standard linear accelerators (linacs). It uses radiotherapy<br />

treatment plans and the associated computed tomography (CT) data to determine the patient's<br />

planned position and compares it via oblique X-ray images to the actual patient position. The<br />

calculated correction shift will then be transferred to the treatment machine to align the patient<br />

correctly at the machine's treatment position. During treatment, the patient is monitored with a<br />

thermal-surface camera and X-ray imaging to ensure that there is no misalignment due to patient<br />

movement. Positioning and monitoring are also possible in combination with implanted markers.<br />

By defining the marker positions, ExacTrac <strong>Dynamic</strong> can position the patient by using X-rays and<br />

thereafter monitor the position during treatment.<br />

Additionally, ExacTrac <strong>Dynamic</strong> features a breath-hold (BH) functionality to serve as a tool to<br />

assist respiratory motion management. This functionality includes special features and workflows<br />

to correctly position the patient at a BH level and thereafter monitor this position using surface<br />

tracking. Regardless of the treatment indication, a correlation between the patient’s surface and<br />

internal anatomy must be evaluated with Image-Guided Radiation Therapy. The manually<br />

acquired X-ray images support a visual inspection of organs at risk (OARs). The aim of this<br />

technique is to treat the patient only during breath hold phases where the treatment target is at a<br />

certain position to reduce respiratory-induced tumor motion and to ensure a certain planned<br />

distance to OARs such as the heart. In addition to the X-ray based positioning technique, the<br />

system can also monitor the patient after external devices such as Cone-Beam CT (CBCT has<br />

been used to position the patient).<br />

The ExacTrac <strong>Dynamic</strong> <strong>Surface</strong> (ETDS) is a camera-only platform without the X-ray system and<br />

is available as a configuration which enables surface-based patient monitoring. This system<br />

includes an identical thermal-surface camera, workstation, and interconnection hardware to the<br />

linac as the ETD system. The workflows supported by ETDS are surface based only and must be<br />

combined with an external IGRT device (e.g., CBCT).<br />

Intended Purpose<br />

The device supports radiotherapy and radiosurgery.<br />

Intended Use and Indications for Use<br />

ExacTrac <strong>Dynamic</strong> is intended to position patients at an accurately defined point within the<br />

treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures,<br />

to monitor the patient position and to provide a beam hold signal in case of a deviation in order to<br />

treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.<br />

Intended Patient Population<br />

ExacTrac <strong>Dynamic</strong> is intended for all patients undergoing Radiotherapy or Radiosurgery<br />

treatments. There are no physiological limitations or restrictions regarding age, weight, gender,<br />

etc.<br />

Intended Part of the Body or Type of Tissue Applied to or Interacted With<br />

The system consists of many components with different functions and locations. Body contact<br />

does not affect all components in the same way.<br />

Most components of the system, like X-ray generators, are out of reach for the user and patient.<br />

Other components, like covers and units mounted on the ceiling, are not reachable or not meant<br />

to be touched by users or patients during intended use.<br />

Body contact is instead expected for the following categories of components:<br />

• Phantoms, required to calibrate the system, have only user contact. They are handled by the<br />

user and no patient contact is expected nor foresee. The user picks them up from the storage<br />

10 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

location and positions them where appropriate according to the selected calibration procedure<br />

and proceed with the calibration or daily check. Optional tools (e.g., X-ray QA support device)<br />

needed to carry out specific tests can also be included in this category.<br />

• Electronic interfaces required for the user to interact with the system. No patient contact is<br />

expected for these components.<br />

• ExacTrac <strong>Dynamic</strong> Patient Feedback System is a component of the system that is meant to<br />

help the patient follow the breathing instructions when using breath-hold functionality. The<br />

device is firstly cl<strong>amp</strong>ed to the couch-top by the user and it requires afterwards a fine<br />

adjustment to reach the desired position. This adjustment can be performed by the user or<br />

directly by the patient. The adjustment is done by means of handles located at both sides of the<br />

mirror. As an alternative to this device, the customer is provided also with the article ExacTrac<br />

<strong>Dynamic</strong> Patient Feedback Glasses. The article is worn directly by the patient during a BH<br />

treatment similarly to standard optical glasses.<br />

Intended User Profile<br />

The intended users of ExacTrac <strong>Dynamic</strong> are medical professionals, who are qualified according<br />

to country and hospital specific regulations to provide (apply) radiation therapy treatments (e.g.,<br />

Radiation Therapist, Radiation Oncologist/Physician, Medical Physicist/Physicist, Dosimetrists).<br />

ExacTrac <strong>Dynamic</strong>-specific roles:<br />

• Radiation Technologist, Technician, Radiographer (MTR)<br />

- Schedule, prepare patient for patient positioning<br />

- Patient positioning<br />

- Patient's motion monitoring during treatment<br />

- QA task, if they have extended education<br />

• Medical Physicist (MP):<br />

- Schedule, prepare patient for patient positioning<br />

- Patient positioning<br />

- Patient's motion monitoring during treatment<br />

- System calibration<br />

• Radiation Oncologist (RO):<br />

- Supervise patient's motion monitoring during treatment<br />

• Patients<br />

- Adjust and use mirror and user interface for breathing feedback<br />

Intended Use Environment<br />

For both ExacTrac <strong>Dynamic</strong> and ExacTrac <strong>Dynamic</strong> <strong>Surface</strong> shall be installed in a treatment<br />

room within a hospital radiation therapy department.<br />

ExacTrac <strong>Dynamic</strong> and ExacTrac <strong>Dynamic</strong> <strong>Surface</strong> have a surface-tracking-camera system<br />

installed in the treatment room.<br />

For ExacTrac <strong>Dynamic</strong> two flat panels are mounted to the ceiling and two X-ray tubes are<br />

embedded in the floor or placed on top of the floor (on-floor installations).<br />

For both versions the main device used to control ExacTrac <strong>Dynamic</strong> or ExacTrac <strong>Dynamic</strong><br />

<strong>Surface</strong> is a console that is located outside of the treatment room. Keyboard and monitor are also<br />

provided. A touchscreen is mounted inside the treatment room.<br />

A stable electrical and IT environment (min 1000 Base-T, Latency > 100 ms) is prerequisite for the<br />

use of ExacTrac <strong>Dynamic</strong>.<br />

Environmental conditions are as follows:<br />

Operating Conditions<br />

Storage Conditions<br />

Humidity range 30% to 70% 15% to 75%, non-condensing<br />

Ambient temperature 16 °C to 35 °C -10 °C to 50 °C<br />

Atmospheric pressure 800 hPa to 1013 hPa 700 hPa to 1013 hPa<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 11


Using the System<br />

Performance Characteristics<br />

ExacTrac <strong>Dynamic</strong> shall provide a translation accuracy better than 1.0 mm and a rotational<br />

accuracy better than 1.0° for a rigid body.<br />

The surface deviation shall be better than 1.5 mm and 1° for rigid body. For the breath-hold the<br />

accuracy shall be better than 2 mm.<br />

Essential Performance Characteristics<br />

A<br />

B1<br />

B2<br />

C<br />

D<br />

E<br />

If a surface based deviation between reference and detected patient position is indicated<br />

and if an allowed tolerance for these values is defined, this deviation is calculated and<br />

shown with an accuracy of 1.5 mm and 1° for a rigid body.<br />

If an X-ray and anatomy based deviation between planned and detected patient position<br />

is indicated, this deviation is calculated and shown with an accuracy of 1 mm and 1° for a<br />

rigid body.<br />

If an X-ray and implanted marker based deviation between planned and detected patient<br />

position is indicated, this deviation is calculated and shown with an accuracy of 1 mm and<br />

1° for a rigid body.<br />

Providing shift values to a third-party patient support system as confirmed by the user.<br />

Providing a "beam hold" signal at the ExacTrac <strong>Dynamic</strong> hardware output to the thirdparty<br />

linac within 1s after a deviation between planned and actual patient position exceeding<br />

tolerance limits was detected.<br />

Indicating a deviation between actual and planned patient position during breath-hold<br />

based on surface tracking with an accuracy of 2 mm.<br />

Contraindications<br />

ExacTrac <strong>Dynamic</strong> X-ray imaging radiation, and the therapeutic treatment radiation, can<br />

potentially have detrimental interaction with active implantable medical devices such as<br />

pacemakers and active medical devices worn on the body. To prevent injury to patients wearing<br />

pacemakers or other active implants, the implant manufacturer should be contacted regarding<br />

possible hazards resulting from radiation exposure.<br />

Side Effects and Complications<br />

ExacTrac <strong>Dynamic</strong> uses ionizing radiation (kV X-ray) with its generally known potential side<br />

effects of predominantly skin irritation. There are of course known side-effects of radiotherapy.<br />

However these are associated with linear accelerator treatments in general and not with the use<br />

of ETD for patient positioning.<br />

Residual Risks<br />

There is a danger of ionizing radiation (MV) if the treatment beam is delivered to tissue outside the<br />

target volume tolerances in cranial or non-cranial mode. If the user does not recognize an<br />

incorrect fusion due to incorrect shift values (e.g., the user is unable to distinguish between similar<br />

repetitive structures, such as vertebrae and ribs, in the image fusion), healthy tissue or non-target<br />

structures could be exposed to substantial unintended radiation.<br />

Clinical Benefit<br />

• ExacTrac <strong>Dynamic</strong> assists clinicians to accurately align the patient to the radiotherapy<br />

treatment device as defined in the treatment plan.<br />

• ExacTrac <strong>Dynamic</strong> assists clinicians to monitor the treatment position of a patient during<br />

treatment.<br />

12 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

• ExacTrac <strong>Dynamic</strong> enables clinicians to keep the IGRT imaging dose delivered to the patient<br />

as low as reasonably possible.<br />

Careful Handling of Hardware<br />

System components and accessory instrumentation are comprised of precise mechanical<br />

parts. Handle them carefully.<br />

Plausibility Review<br />

Warning<br />

Before patient treatment, review the plausibility of all information input to and output from<br />

the system.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 13


Compatibility with Medical Devices<br />

1.5 Compatibility with Medical Devices<br />

Compatible Brainlab Medical Devices<br />

ExacTrac <strong>Dynamic</strong> is compatible with the following Brainlab medical devices.<br />

Device Name Article Number UDI-DI<br />

Cranial 4Pi CT Overlay 43420A 04056481144241<br />

Cranial 4Pi Treatment Overlay 43421A 04056481144234<br />

Cranial 4Pi Headrest Standard 43440A 04056481144227<br />

Cranial 4Pi Headrest Low-Neck 43441A 04056481144210<br />

Cranial 4Pi Headrest Inlay Standard 2pcs 43446A 04056481144203<br />

Cranial 4Pi Headrest Inlay Openface 2Pcs 43447A 04056481144197<br />

Cranial 4Pi Headrest Inlay H&N 2Pcs 43448A 04056481144180<br />

Cranial 4Pi Stereotactic Mask (5 Pcs.) 43450 04056481141936<br />

Cranial 4Pi Basic Mask (5 Pcs.) 43451 04056481141943<br />

Cranial 4Pi Open Face Mask (5 Pcs.) 43452 04056481141950<br />

SRS 4Pi CT Table Overlay 43430 04056481141363<br />

Cranial 4Pi is an assembly of the following medical device/ accessory groups:<br />

• Cranial 4Pi Overlays<br />

• Cranial 4Pi Headrests<br />

• Cranial 4Pi Headrest Inlays<br />

• Cranial 4Pi Masks<br />

The Cranial 4Pi Overlays are medical devices used for fixation of the patient in a CT- resp. linear<br />

accelerator - environment.<br />

The Cranial 4 Pi Headrests and the Cranial 4Pi Headrest Inlays are accessories to the Cranial 4Pi<br />

Overlays to allow an indication specific positioning of the patient's head and neck.<br />

The Cranial 4Pi Masks are accessories to the Cranial 4Pi Overlays used for producing individual<br />

custom-made masks for patient immobilization to the Cranial 4Pi Overlay Boards.<br />

The Cranial 4Pi Immobilization group of devices is used for fixation and repositioning of the<br />

patient’s head and neck in a CT- and linear accelerator environment. The SRS 4Pi CT Table<br />

Overlay (43430) is a medical device used for fixation and repositioning of the patient's head and<br />

neck in a CT-environment.<br />

The mask sets Cranial 4Pi Stereotactic Mask (43450) / Cranial 4Pi Basic Mask (43451) /<br />

Cranial 4Pi Open Face Mask (43452) are medical devices used for producing custom-made<br />

masks for patient fixation to the Overlay Board in a CT- and linear accelerator environment.<br />

NOTE: For further details, refer to the Cranial 4Pi Hardware User Guide and Cranial 4Pi<br />

Immobilization Hardware User Guide.<br />

NOTE: ExacTrac <strong>Dynamic</strong> is not compatible with Brainlab Robotics.<br />

Non-Brainlab Medical Devices<br />

ExacTrac <strong>Dynamic</strong> is compatible with the following non-Brainlab medical devices only. Do not<br />

use with any other devices.<br />

It is a prerequisite that the linac is calibrated correctly.<br />

For further questions about compatibility, contact Brainlab support.<br />

14 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

Device Description Interface Manufacturer<br />

Data and signal lines:<br />

TrueBeam Radiotherapy<br />

System<br />

Linear Accelerator<br />

TrueBeam Auxiliary<br />

Device Interface (ADI<br />

3.0)<br />

TrueBeam External<br />

gating interface (EXGI<br />

2.0)<br />

Varian Medical Systems,<br />

Inc.<br />

3100 Hansen Way<br />

Palo Alto, CA 94304<br />

ARIA oncology information<br />

system<br />

Record & Verify (R&V)<br />

System<br />

LAN connection, DI-<br />

COM<br />

Data and signal lines:<br />

Elekta Linear Accelerator<br />

MOSAIQ, Patient Positioning<br />

Systems Interface<br />

(PPS WebIF)<br />

Linear Accelerator<br />

Record & Verify System<br />

Elekta iGUIDE GMI<br />

Elekta Response gating<br />

interface<br />

Elekta iCOM Vx<br />

LAN connection, DI-<br />

COM<br />

Elekta Limited Cornerstone<br />

London Road Crawley<br />

West Sussex RH10<br />

9BL<br />

United Kingdom<br />

NOTE: Brainlab recommends contacting Brainlab support if any linac software or hardware needs<br />

to be changed or updated.<br />

Warning<br />

Brainlab recommends contacting Brainlab support if settings on the linac need to be<br />

changed after installation.<br />

Non-Brainlab Devices<br />

Warning<br />

Using medical device combinations that have not been authorized by Brainlab may<br />

adversely affect safety and/or effectiveness of the devices and endanger the safety of the<br />

patient, user and/or environment.<br />

DICOM Conformance<br />

DICOM conformance statements can be found on the Brainlab website at: www.brainlab.com/<br />

dicom.<br />

DICOM Functionality and Interoperability<br />

DICOM, by itself, does not guarantee interoperability. However, the conformance statement<br />

facilitates a first-level validation for interoperability between different applications supporting the<br />

same DICOM functionality. The conformance statement should be read and understood in<br />

conjunction with the DICOM standard.<br />

NOTE: ExacTrac <strong>Dynamic</strong> requires a DICOM RT data set to perform as intended.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 15


Cybersecurity and Software Environment<br />

1.6 Cybersecurity and Software Environment<br />

Bill of Materials of Integrated Third-Party Software<br />

Software Version Software Version<br />

ACE 6.5.8 Merge DICOM Toolkit 5.12.0<br />

AltSoft XML2PDF Formatting<br />

Engine<br />

2.1.2.230 meta 0.1.0<br />

Brainlab Connected Care 1.2.2.4 Modernizr 2.8.3<br />

Chelsio viewwire 6.16.1.0 nicescroll 3.6.0<br />

Chromium Embedded<br />

Framework (CEF)<br />

79.1.38+gecefb59<br />

+chromium-79.0.3945.13<br />

0<br />

node.js 12.13.1<br />

cpprest 2.10.14 Notepad++ 8.5.4<br />

cryptopp 8.1.0 Nvidia NVAPI release 367<br />

d3js 3.5.17 Nvidia Quadro Driver 535.98<br />

durandal 2.1.0 OpenCV 4.7.0<br />

eBusSDK 3.1.0 openjpeg 1.4.0<br />

FX11 4.2.0 pdf.js 1.4.20<br />

eigen 3.4.0 range-v3 0.5.0<br />

Elekta Gmp 2.1.0 react.js 16.8.6<br />

Elekta iCOM, iCOMx86 5.14 renderdocapi 1.4.0<br />

Elekta MSQ 2.0.0 requirejs 2.3.5<br />

Elekta Responsex86 1.0.13 SolvOpt 1.2<br />

Filament 1.4.1 SpinnakerSDK 2.7.0.128<br />

Finder Toolbox NFC 3.6.1 SQLite 3.26.0<br />

FTD2XX 2.12.36 Thingworx 8.5.18<br />

ICU 1.8.1 UltraVNC 1.3.8.1<br />

Intel wired driver 27.7 Varex Viva64 Virtual CP L08 2.2<br />

jquery 2.1.4<br />

jqueryui 1.11.1<br />

kineticjs 5.1.0<br />

knockout 3.5.1<br />

LAPACK 3.2.1<br />

libjpeg<br />

2.1.2, 6b<br />

libjpeg-turbo 2.1.2<br />

LibJpeg16, LibJpeg8 3.6.0, 6b Windows 10<br />

Varex Virtual CP Software<br />

Interface<br />

Visual C++ redistributable<br />

x86 2008<br />

Visual C++ redistributable<br />

x86 2010<br />

Visual C++ redistributable<br />

x64 2010<br />

Visual C++ redistributable<br />

x64 2012<br />

Visual C++ redistributable<br />

x64 2013<br />

Visual C++ redistributable<br />

x86 & x64 2015-2019<br />

L08 2.2<br />

9.0.30729<br />

10.0.30319<br />

10.0.40219<br />

11.0.61030<br />

12.0.21005<br />

14.22.27821.0<br />

IoT Enterprise<br />

version<br />

16 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

Software Version Software Version<br />

LibJpeg2k 2.4.0 Xerces-C++ 3.2.3<br />

libpng 1.6.37 yajl 2.1.0<br />

libtiff 3.6.0 zlib 1.2.12<br />

LightBurst 1.6.0<br />

Cybersecurity Use Environment<br />

Cybersecurity considerations were made in accordance with the nature of the device, including<br />

the device type and the use environments of the system during its lifetime.<br />

The following common best practice security controls ("security hygiene") in the use environment<br />

are expected to be followed, independently of the status of the system (powered on / powered off):<br />

• Good physical security to prevent unauthorized physical access to the system.<br />

If the system is powered on, follow these additional security controls:<br />

• Access control measures (e.g., role based) to ensure only authenticated and authorized<br />

personnel are allowed access to network elements, stored information, services and<br />

applications.<br />

• Network access controls, such as segmentation, to limit medical device communication.<br />

• General patch management practices that ensure timely security patch updates on adjacent<br />

devices in the use environment.<br />

• Malware protection to prevent unauthorized code execution on adjacent devices in the use<br />

environment.<br />

• Ensure that prescribed maintenance is done as required, including installation of security<br />

patches.<br />

• Security awareness training of the users.<br />

Using the device outside of the intended operating environment may lead to cybersecurity<br />

incidents that may affect safety and effectiveness of the device.<br />

Hospital administration is responsible for limiting access to the system and the patient data to<br />

appropriate personnel.<br />

Be aware that screenshots created by the software contains patient-specific data. Saving the<br />

screenshot locally thereby saves patient information to the system.<br />

Warning<br />

Always follow medical network protection standards.<br />

Regional Legislation<br />

In the ExacTrac <strong>Dynamic</strong> software, patient data is identified by the patient's name and a unique<br />

ID. For this reason, it must be handled in accordance with the relevant confidentiality legislation<br />

and protected against unauthorized access. In the United States, patient data must be handled in<br />

accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).<br />

Data Access<br />

ExacTrac <strong>Dynamic</strong> receives data via DICOM Proxy from an R&V System. The externally<br />

accessible DICOM Proxy is located on the Patient Preparation Server. Data is stored within the<br />

Treatment Workstation or on the Patient Preparation Server. The two DICOM Proxys store data<br />

on the local file system. Access to this file system is controlled by the hospital via user access<br />

rights.<br />

For anonymization of patient data, use a certified third-party product.<br />

Access to Printouts<br />

As ExacTrac <strong>Dynamic</strong> treatment reports contain the patient name and ID, the printer must be<br />

located in a secure area and the printouts protected against unauthorized access.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 17


Cybersecurity and Software Environment<br />

Data Backup<br />

In order to protect against patient data loss, both patient data folders need to be backed up via<br />

network or similar.<br />

Data Protection and System Disposal<br />

Because confidential patient data is stored on several hard drives or virtually, it is therefore<br />

necessary to securely erase all workstations and/or server locations where ExacTrac <strong>Dynamic</strong> or<br />

the Patient Preparation Server is running or physically destroy the hard drives before system<br />

disposal.<br />

Cybersecurity Vulnerability<br />

If you detect a cybersecurity vulnerability or weakness of the device or if a cybersecurity incident<br />

takes place involving the device, contact Brainlab support. Depending on the actual event,<br />

Brainlab support will advise which steps to take.<br />

Microsoft Security Updates for Windows and Driver Updates<br />

Brainlab allows the installation of security patches only. Do not install service packs and optional<br />

updates. Verify your settings to ensure updates are downloaded and installed correctly at a<br />

suitable time outside of clinical hours. For more information about settings and a list of Microsoft<br />

Security Updates blocked by Brainlab support, see the Brainlab website (brainlab.com/updates).<br />

Only perform Windows updates according to the Brainlab website.<br />

Do not update drivers on Brainlab platforms. Note that automatic driver updates are disabled.<br />

These shall only be performed by Brainlab support or with Brainlab approval. Neither manual<br />

steps nor Windows update functionality should be used to update drivers on Brainlab ExacTrac<br />

<strong>Dynamic</strong> Workstations.<br />

Updates<br />

Updates to the operating system or third-party software should be performed outside clinical hours<br />

and in a test environment to verify correct operation of the Brainlab system. Brainlab monitors the<br />

released Windows security updates and will know, for some updates, if problems can be<br />

expected. Contact Brainlab support if any problems to operating system security updates are<br />

encountered.<br />

Virus Scanning and Malware<br />

If the system is connected to a local area network (LAN), Brainlab recommends using malware<br />

protection software (e.g., virus scanner) and keeping the definition files up to date. Be aware that<br />

the malware protection settings can affect system performance (e.g., if each file access is<br />

monitored, patient data loading and saving might be slow). Therefore Brainlab recommends<br />

disabling real-time scans and regularly performing virus scans during non-clinical hours using an<br />

administrative account.<br />

The default Windows virus scanner, Microsoft Defender, is installed and active.<br />

Other anti-virus protection can be used if it does not block the communication between ExacTrac<br />

<strong>Dynamic</strong> and the associated hardware. The anti-virus software has to have the option to not<br />

interfere with the network communication between the 3D Camera, the Thermal Camera, Flat<br />

Panel Detectors and the treatment application (e.g., by enabling firewall exceptions).<br />

Requirements<br />

• Do not update the virus scanner software during treatment.<br />

• The virus scanner must not perform a hard disk drive scan during patient treatment.<br />

18 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

• Do not use the virus scanner in a high security mode during treatment.<br />

• During scans of the ExacTrac <strong>Dynamic</strong> folder (D:/Brainlab and E:/Patient), do not delete<br />

any files or put any files into quarantine.<br />

Configuration<br />

Brainlab recommends:<br />

• Configure the anti-virus software so it does not modify:<br />

- D:\Brainlab<br />

- E:\Patient<br />

- D:\RVExport\<br />

- %userprofile%\AppData\Local\Brainlab<br />

• Deactivate any other anti-virus software feature such as browser/email-scanners, additional<br />

firewall, etc.<br />

Compatible Brainlab Software<br />

Only Brainlab software specified by Brainlab may be installed and used with the system. Contact<br />

Brainlab support for clarification regarding compatibility with Brainlab software.<br />

Non-Brainlab Software<br />

Only authorized Brainlab employees may install software on the Brainlab system. Do not<br />

install or remove any software applications.<br />

Information for Hospital Medical IT Network Risk Manager<br />

The following information is intended for the hospital Medical IT-Network Risk Manager.<br />

1.<br />

2.<br />

3.<br />

Item<br />

Purpose of the connection<br />

to the IT network<br />

Required IT-network characteristics<br />

Required IT-network configuration<br />

Description<br />

The Brainlab device can load and save patient data.<br />

These are transferred via DICOM Proxy from ExacTrac<br />

<strong>Dynamic</strong> to R&V, linac.<br />

The Brainlab device transfers medical imaging data and<br />

patient data between ExacTrac <strong>Dynamic</strong> and the Patient<br />

Preparation Server or between the Positioning and<br />

ExacTrac <strong>Dynamic</strong> applications via the local DICOM<br />

Proxy.<br />

The DICOM Proxy on the Patient Preparation Server also<br />

transfers medical images and data to the R&V systems<br />

or linac.<br />

The average size of a medical imaging data set transferred<br />

through the network is 100 - 500 MB.<br />

Required:<br />

• User management is achieved by joining the Brainlab<br />

device to the hospital domain and adding users to<br />

dedicated user groups with group management.<br />

• Brainlab offers remote system support which requires<br />

internet access.<br />

The Brainlab device requires firewall permissions for the<br />

services listed under point 4, below.<br />

4.<br />

Technical specifications of<br />

the network connection, including<br />

security specifications<br />

The Brainlab device includes the following network connections<br />

(4.1 - 4.8):<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 19


Cybersecurity and Software Environment<br />

4.1<br />

4.2<br />

4.3<br />

4.4<br />

4.5<br />

4.6<br />

Item<br />

Physical connection of the<br />

Brainlab device<br />

Logic connection between<br />

the Brainlab device and<br />

other Brainlab devices or<br />

hospital file storage<br />

Logic connection between<br />

the Brainlab device and<br />

hospital domain controller<br />

Logic connection between<br />

the Brainlab device and<br />

Brainlab support<br />

Logic connection between<br />

the Brainlab system and<br />

other linac (Varian)<br />

Logic connection between<br />

the Brainlab device and<br />

other linac (Elekta)<br />

Intended information flow<br />

between the Brainlab device<br />

and the IT network<br />

Description<br />

The system is connected to the IT-network with a<br />

100/1000 Base-T connection.<br />

• Recommended speed is 1 GBit. Minimum speed is 100<br />

MBit.<br />

• Network latency must be less than 100 ms.<br />

• The network must be fully switched on.<br />

• Protocols: CIFS<br />

• Ports: 445/TCP/in- and outbound<br />

• Protocols: Microsoft-DS, Kerberos, LDAP, DNS<br />

• Ports: 445/TCP/UDP/outbound, 88/TCP/UDP/<br />

outbound, 389/UDP/outbound, 53/TCP/UDP/outbound<br />

• Protocols: Brainlab Connected Care<br />

• Ports: 443/TCP/outbound to: support.brainlab.com,<br />

gas-aus.axeda.com, ghjap1.axeda.com, ghsj1.axeda.com,<br />

ghsom1.axeda.com, ghuk1.axeda.com<br />

• Protocol: ADI (Auxiliary Device Interface)<br />

• Port: 56050/TCP/in- and outbound<br />

• Protocol: Elekta protocol<br />

• Port: 135, 1801, 2101 /TCP/in- and outbound<br />

The Brainlab device typically consists of the following information<br />

flow:<br />

5.1 User authentication<br />

User authentication at the Brainlab device is processed<br />

with the help of local user accounts or the hospital domain<br />

controller.<br />

5.<br />

5.2<br />

Loading of medical imaging<br />

data<br />

Medical imaging data is transferred via DICOM Q/R or<br />

pushed between the R&V.<br />

5.3<br />

Storing of modified medical<br />

imaging data<br />

Modified medical imaging data is stored on the local hard<br />

drive or hospital network shared drives.<br />

5.4<br />

Patient positioning and<br />

beam approval<br />

ExacTrac <strong>Dynamic</strong> and the linac system perform internal<br />

communication for patient positioning and beam approval.<br />

5.5<br />

Remote support through<br />

Brainlab<br />

Remote support for the Brainlab device requires a connection<br />

to the Brainlab support servers.<br />

6.<br />

Hazardous situation resulting<br />

from an IT-network failure<br />

A failure of the IT Network connection can cause that the<br />

treatment cannot be continued or must be repeated. This<br />

can lead to unnecessary KV Imaging of the patient.<br />

The following documents are available upon request:<br />

7.<br />

Technical descriptions and<br />

technical manuals<br />

• Preinstallation manual<br />

• FDA and CE declarations<br />

• DICOM conformance statements: (www.brainlab.com/<br />

dicom)<br />

8.<br />

Recommended product<br />

configurations<br />

The Brainlab device will be installed and configured according<br />

to customer needs by the Brainlab service engineer.<br />

Subsequent modifications can affect the safety and<br />

effectiveness of the product.<br />

9.<br />

Known incompatibilities and<br />

restrictions<br />

The Brainlab device requires a network supporting IPv4.<br />

20 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

10.<br />

Item<br />

Product corrective actions<br />

and recalls<br />

Description<br />

Brainlab will inform every customer in case of identified<br />

anomalies.<br />

11. Cybersecurity notices<br />

Brainlab will inform every customer in case of identified<br />

cybersecurity issues and provide software updates accordingly.<br />

12.<br />

Background according to<br />

IEC 60601-1 3rd edition,<br />

chapter 14.13 (Connection<br />

of PEMS by NETWORK/<br />

DATA COUPLING to other<br />

equipment)<br />

Connecting the Brainlab device to networks that include<br />

other equipment could result in previously unidentified<br />

risks to patients, operators or third parties. The responsible<br />

organization should identify, analyze, evaluate and<br />

control these risks. Subsequent changes to network<br />

could introduce new risks and require additional analysis.<br />

Changes to the network include:<br />

• Changes to the network configuration<br />

• Connection of additional items to the network<br />

• Disconnecting items from the network<br />

• Updating equipment connected to the network<br />

• Upgrade of equipment connected to the network<br />

Warning<br />

Do not use Brainlab Connected Care during linac Beam On.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 21


ExacTrac <strong>Dynamic</strong> Network Integration (IEC 80001)<br />

1.7 ExacTrac <strong>Dynamic</strong> Network Integration (IEC<br />

80001)<br />

Ensuring a Safe IT Network<br />

• Ensure a safe network connection during transferring patient data and during treatment.<br />

Minimum network specifications are defined by Brainlab.<br />

• Only install release updates from original manufacturers.<br />

• After the ExacTrac <strong>Dynamic</strong> and the linac installation, both systems must have dedicated,<br />

static IP addresses. Do not use dynamic IP addresses.<br />

• A stable, reliable and safe network environment and connection are required to guarantee a<br />

safe and effective use of the ExacTrac <strong>Dynamic</strong> system when ExacTrac <strong>Dynamic</strong> is<br />

connected to a network. Network problems during patient data transfer or patient treatment can<br />

interrupt the workflow and cause a repetition of parts of the treatment such as X-ray imaging for<br />

patient position.<br />

Standard Integration<br />

The following image shows a typical network setup for a standard ExacTrac <strong>Dynamic</strong>:<br />

1<br />

10<br />

2<br />

3<br />

11<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

Figure 1<br />

22 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

10<br />

11<br />

Description<br />

Hospital Network<br />

Varian/ADI<br />

Treatment Workstation<br />

DICOM Data<br />

Patient Preparation Server (mandatory for multiple systems, optional for single system<br />

sites)<br />

Hospital R&V<br />

Internet<br />

Remote Access<br />

Brainlab Connected Care Support<br />

Linac Network<br />

Linac<br />

NOTE: The system for the ExacTrac <strong>Dynamic</strong> Patient Preparation Server should be provided by<br />

the customer (Server or Virtual Machine) or purchased from Brainlab (Server).<br />

Elekta Integration<br />

The following image shows a typical network setup for ExacTrac <strong>Dynamic</strong> with an Elekta<br />

integration:<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 23


ExacTrac <strong>Dynamic</strong> Network Integration (IEC 80001)<br />

10<br />

3<br />

11<br />

2<br />

1<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

Figure 2<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

7<br />

8<br />

9<br />

10<br />

11<br />

Description<br />

Hospital Network<br />

Elekta Firewall<br />

Treatment Workstation<br />

DICOM Data<br />

Patient Preparation Server (mandatory for multiple systems, optional for single system<br />

sites)<br />

Hospital R&V<br />

Internet<br />

Remote Access<br />

Brainlab Connected Care Support<br />

Elekta Network<br />

Linac<br />

NOTE: The system for the ExacTrac <strong>Dynamic</strong> Patient Preparation Server should be provided by<br />

the customer (Server or Virtual Machine) or purchased from Brainlab (Server).<br />

24 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.8 User Management<br />

Windows Users<br />

The following Windows users are implemented by default in ExacTrac <strong>Dynamic</strong>:<br />

User Group Windows OS Permissions BL User Groups<br />

Administrator<br />

Administrator rights<br />

BL Service Administrator rights BL_ET_Service<br />

EmergencyUser<br />

ExacTrac <strong>Dynamic</strong><br />

Administrator rights<br />

Power user rights<br />

BL_ET_Therapist<br />

BL_ET_TherapistRestricted<br />

Approver Power user rights BL_ET_Physician<br />

Physicist Power user rights BL_ET_Physicist<br />

• To use ExacTrac <strong>Dynamic</strong>, the user needs power user rights as a minimum.<br />

• Do not use accounts with administrator rights for treatment tasks.<br />

• Upon request, hospitals can have an emergency user/generic user account set up. It should<br />

only be used to access the system in case of an emergency. The hospital IT administrator is<br />

responsible for communicating the account information to the relevant employees.<br />

• Service tools and BL Service accounts are intended solely for Brainlab service and must not be<br />

used while treating patients.<br />

NOTE: Only members of the Windows user group Administrator can add, modify or delete user<br />

accounts. The Administrator account is preconfigured by Brainlab support and cannot be deleted.<br />

If your hospital needs to designate additional roles of user rights other than the standardized<br />

roles, Brainlab support must add the roles. For further information, contact Brainlab support.<br />

Windows Login and User Logs<br />

• The Windows login defines the user rights for the password-protected ExacTrac <strong>Dynamic</strong> user<br />

login. The hospital is responsible for administration of passwords and user logins.<br />

• Every ExacTrac <strong>Dynamic</strong> user login and ExacTrac <strong>Dynamic</strong> patient opening and closing<br />

event is logged and saved in an encrypted log. To access this information, contact Brainlab<br />

support.<br />

• In case of a technical or clinical issue with ExacTrac <strong>Dynamic</strong>, the folder "Log Files" shall be<br />

zipped and provided to Brainlab support.<br />

• Manually lock any account that has not been used for more than three months, except for<br />

Brainlab service. It is recommended to check for unused accounts at least every six months.<br />

Configuring Rights and Passwords<br />

Users must access ExacTrac <strong>Dynamic</strong> with a personal user name and password. User accounts<br />

have varying permissions, divided into roles. Upon setup, Brainlab support will create the following<br />

standardized roles:<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 25


User Management<br />

Role<br />

Task<br />

Treatment preparation<br />

Treatment<br />

Fusion approval<br />

X-ray calibration<br />

Camera calibration<br />

Template editor<br />

ET_SuperUser ✔ ✔ ✔ ✔ ✔ ✔<br />

ET_Physicist ✔ ✔ ✔ ✔ ✔<br />

ET_Physician ✔ ✔ ✔ ✔<br />

ET_Therapist ✔ ✔<br />

ET_TherapistRestricted<br />

✔<br />

ET_Service ✔ ✔ ✔ ✔ ✔ ✔<br />

When assigning rights to new users, adhere to the principle of least privilege (e.g., only assign<br />

rights that are needed).<br />

Your hospital IT administrator can configure selected users as registered users with:<br />

• Approval rights so that image fusion can be approved (e.g., physicians for billing purposes)<br />

• Calibration rights (e.g., for physicists)<br />

• Basic rights for standard users (e.g., such as therapists)<br />

NOTE: Personnel who are still in training are typically assigned ET_TherapistRestricted.<br />

Accessing Password Settings<br />

Only the hospital IT administrator can change or reset a password.<br />

26 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


GENERAL INFORMATION<br />

1.9 Training and Documentation<br />

ExacTrac <strong>Dynamic</strong> Installation and Preplanning Information<br />

Only trained personnel are permitted to install and service ExacTrac <strong>Dynamic</strong>. For further<br />

information, contact Brainlab support.<br />

Brainlab Training<br />

Before using the system, Brainlab recommends that all users should participate in a training<br />

program held by a Brainlab representative to ensure safe and appropriate use.<br />

Supervised Support<br />

After a sufficient number of complete procedures have been successfully simulated, and following<br />

a rigorous quality assurance review, the system can be used in selected treatments.<br />

A Brainlab representative should be present at such treatments to provide medical staff with<br />

supervision and guidance where necessary.<br />

Numerical Values Used in This User Guide<br />

In this user guide, all values and parameters describing imaging performance use standardized SI<br />

units: metric, Gy, mm and Gy*mm 2 .<br />

With the exception of angular measurements (indicated by the ° symbol), all numerical values<br />

displayed by ExacTrac <strong>Dynamic</strong> are in millimeters (mm).<br />

Responsibility<br />

Warning<br />

This system solely provides assistance to the physician and does not substitute or replace<br />

the physician's experience and/or responsibility during its use. It must always be possible<br />

for the user to proceed without the assistance of the system.<br />

Only trained medical personnel may operate system components and accessory instrumentation.<br />

Reading User Guides<br />

This guide describes complex medical software or medical devices that must be used with care.<br />

It is therefore important that all users of the system, instrument or software:<br />

• Read this guide carefully before handling the equipment<br />

• Have access to this guide at all times<br />

Available User Guides<br />

Available user guides vary depending upon your configuration. If you have questions regarding<br />

the user guides you received, please contact Brainlab support.<br />

User Guide<br />

ExacTrac <strong>Dynamic</strong> Elekta Linacs Site Planning<br />

Manual<br />

ExacTrac <strong>Dynamic</strong> Varian Truebeam Linacs<br />

Site Planning Manual<br />

Description<br />

Installation and preplanning information and requirements<br />

for use with Elekta linacs<br />

Installation and preplanning information and requirements<br />

for use with Varian Truebeam linacs<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 27


Training and Documentation<br />

User Guide<br />

ExacTrac <strong>Dynamic</strong> Clinical User Guide (all<br />

workflows)<br />

ExacTrac <strong>Dynamic</strong> Clinical User Guide (ExacTrac<br />

<strong>Dynamic</strong> <strong>Surface</strong> workflows)<br />

ExacTrac <strong>Dynamic</strong> System and Technical<br />

User Guide<br />

Description<br />

• Software setup and shutdown instructions<br />

• Detailed instructions on available workflows<br />

• Information on the clinical use<br />

• Software setup and shutdown instructions<br />

• Detailed instructions on available workflows<br />

• Information on the clinical use<br />

Detailed information on system setup, technical<br />

information on the system, specifications and<br />

compliances<br />

Additional Documentation<br />

For further information about X-ray components, see the following documents.<br />

Device Document Manufacturer<br />

Housing Data sheet "Housing B-130" Varian Medical Systems<br />

Tube<br />

Data sheet "G-892"<br />

(Varex Imaging Corporation only for the<br />

X-ray tubes)<br />

HV Cables<br />

Data sheet "CA1-type Connector"<br />

"L3-type cable"<br />

Claymount<br />

Collimator This user guide Brainlab<br />

Generator<br />

Operating instructions "EDITOR<br />

Hfe"<br />

Service manual "EDITOR Hfe"<br />

Spellman High Voltage Electronics<br />

GmbH (formerly K&S Röntgenwerk)<br />

Customer Acceptance Test<br />

The accuracy of the specific system being used is outlined in the customer acceptance test.<br />

28 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

2 HARDWARE OVERVIEW<br />

2.1 ExacTrac <strong>Dynamic</strong> Hardware Components<br />

About ExacTrac <strong>Dynamic</strong> Hardware Components<br />

The ExacTrac <strong>Dynamic</strong> system is available in different configurations and versions depending on<br />

your selected hardware and linac manufacturer. The following table shows which hardware<br />

components are installed depending on the selected configuration.<br />

Hardware Components<br />

ExacTrac<br />

<strong>Dynamic</strong><br />

ExacTrac<br />

<strong>Dynamic</strong><br />

<strong>Surface</strong><br />

See<br />

4D thermal camera ✔ ✔ Page 30<br />

Control room components ✔ ✔ Page 31<br />

Treatment room components ✔ ✔ Page 33<br />

System control unit ✔ ✔ Page 38<br />

Phantoms ✔ ✔ Page 42<br />

X-ray components ✔ Page 45<br />

Only trained personnel are permitted to install and service ExacTrac <strong>Dynamic</strong>. For further<br />

information, contact Brainlab support.<br />

For installation and preplanning information and requirements, see the ExacTrac <strong>Dynamic</strong> Elekta<br />

Linacs Site Planning Manual and the ExacTrac <strong>Dynamic</strong> Varian Truebeam Linacs Site<br />

Planning Manual.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 29


4D Thermal Camera<br />

2.1.1 4D Thermal Camera<br />

About the 4D Thermal Camera<br />

1<br />

2<br />

3<br />

Figure 3<br />

No.<br />

1<br />

2<br />

3<br />

Description<br />

Stereoscopic low latency data camera lenses<br />

High definition structured light projector<br />

Integrated thermal camera lens<br />

NOTE: Ensure that the camera system is not touched by anyone or anything while ExacTrac<br />

<strong>Dynamic</strong> is in use. Users may not affix or deposit anything onto the camera (e.g., blankets, cloth,<br />

medical equipment).<br />

NOTE: Users who requested that the camera be installed at a divergent position (e.g., not 0°)<br />

must be aware that:<br />

• A divergent camera position could cause limited visibility of some body parts and therefore<br />

potentially limit performance.<br />

• Later upgrades/new or upgraded features of ExacTrac <strong>Dynamic</strong> may not be compatible with<br />

divergent (i.e., not 0°) camera positions.<br />

For further information, contact Brainlab support.<br />

NOTE: Users and patients must not look directly into the light emitted by the camera.<br />

NOTE: Patients who may be sensitive to blue light should close their eyes during treatment.<br />

Warning<br />

Users and patients with a known history of photosensitivity may experience photic- and<br />

pattern-induced seizures (PPIS) during the use of ExacTrac <strong>Dynamic</strong>. It is the responsibility<br />

of the physician in charge to decide how to proceed in such a situation.<br />

30 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

2.1.2 Control Room Components<br />

About Control Room Components<br />

ExacTrac <strong>Dynamic</strong> includes a console for remote control of the X-ray Generator as well as a<br />

Control Room Monitor, mouse and keyboard.<br />

ExacTrac Console<br />

2<br />

3<br />

4<br />

5<br />

1<br />

6<br />

7<br />

8<br />

9<br />

Figure 4<br />

No. Component Description Relevant Configuration<br />

ExacTrac<br />

<strong>Dynamic</strong><br />

ExacTrac<br />

<strong>Dynamic</strong><br />

<strong>Surface</strong><br />

1<br />

Fluoro sequence<br />

start<br />

Start an X-ray fluoroscopic sequence. Indicator ring is illuminated<br />

in green when a fluoroscopic sequence can be<br />

started.<br />

✔<br />

2 System On Starts the system. ✔ ✔<br />

3<br />

4<br />

System standby indicator<br />

System power indicator<br />

Indicates in green when the system is on. ✔ ✔<br />

Indicates in orange when building power is available. ✔ ✔<br />

5 System Off Shuts down the system. ✔ ✔<br />

6<br />

Fluoro sequence<br />

stop<br />

Stops an X-ray fluoroscopic sequence. Indicator ring blinks<br />

orange when a fluoroscopic sequence is running.<br />

✔<br />

7<br />

Radiation warning<br />

light<br />

Illuminated when an X-ray image is taken.<br />

✔<br />

8<br />

9<br />

X-ray image acquisition<br />

Takes an X-ray image. Indicator ring is illuminated in green<br />

when an X-ray image can be taken.<br />

Currently no supported function with ExacTrac <strong>Dynamic</strong>.<br />

✔<br />

X-ray buzzer Beeps when an X-ray image is taken. ✔<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 31


Control Room Components<br />

Control Room Monitor, Mouse and Keyboard<br />

Figure 5<br />

Component<br />

Description<br />

Screen size<br />

24.1" (518.4 x 324.0 mm)<br />

Resolution<br />

1920 dots x 1200 lines<br />

Pixel pitch<br />

0.270 x 0.270 mm<br />

Display colors<br />

8-bit, 16.77 million colors<br />

Viewing angle (H / V, typical) 178° / 178°<br />

Luminance (Typ.) 350 cd/m 2<br />

Contrast ratio (Typ.) 1000 : 1<br />

Color depth<br />

8-bit, 16.7 million colors<br />

32 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

2.1.3 Treatment Room Components<br />

About Treatment Room (In-Room) Equipment<br />

ExacTrac <strong>Dynamic</strong> includes an In-Room Monitor (wall- or ceiling-mounted). Depending on your<br />

configuration, the Patient Feedback System and Patient Feedback Glasses are additional<br />

hardware components of the ExacTrac <strong>Dynamic</strong> system for use during breath-hold workflows.<br />

In-Room Monitor<br />

1 – 8<br />

Figure 6<br />

Component<br />

Screen size<br />

Resolution<br />

Description<br />

24.1" (518.4 x 324.0 mm)<br />

1920 dots x 1200 lines<br />

Aspect ratio 16:10<br />

Pixel pitch<br />

Display colors<br />

0.270 x 0.270 mm<br />

8-bit, 16.77 million colors<br />

Viewing angle (H / V, typical) 178° / 178°<br />

Luminance (Typ.) 350 cd/m 2<br />

Contrast ratio (Typ.) 1000 : 1<br />

Color depth<br />

8-bit, 16.7 million colors<br />

The In-Room Monitor provides software control via touch interface in the treatment room. The<br />

monitor can be attached to the treatment room wall or to the treatment room ceiling.<br />

To avoid patient or operator harm due to collision, always bring ceiling-mounted monitors into a<br />

parked position. Be careful to avoid collision with any other equipment while positioning the<br />

monitor.<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

Component<br />

Power button<br />

Menu/enter button<br />

Exit/input button<br />

Left button<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 33


Treatment Room Components<br />

No.<br />

5<br />

7<br />

8<br />

Component<br />

Right button<br />

Port A button<br />

Port B button<br />

About Attaching the Monitor<br />

1<br />

2<br />

Figure 7<br />

No. Component Description<br />

1<br />

2<br />

Ceiling-Mounted Monitor<br />

Arm (standard)<br />

Wall-Mounted Monitor Arm<br />

(optional)<br />

Monitor can be moved to a convenient position for user<br />

interaction or moved out of the way if not in use.<br />

1884 mm x 734/1134 mm x ~100 mm<br />

292 mm x 122 mm x 122 mm<br />

Wall channel: 483 mm x 102 mm x ~ 20 mm<br />

NOTE: If you request an extension of the vertical movement range (e.g., in order to get the<br />

ceiling-mounted monitor completely out of the way when not in use). You must be aware that the<br />

monitor or monitor arm may collide with the 4D Thermal Camera, which must be recalibrated<br />

after any collision.<br />

34 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

Patient Feedback System<br />

Figure 8<br />

Component<br />

Patient Feedback System<br />

Description<br />

The Patient Feedback System allows the patient to see<br />

the feedback software displayed on the In-Room Monitor<br />

display. The Patient Feedback System consists of a<br />

mirror with a flexible arm to position it as well as a screw<br />

cl<strong>amp</strong> to attach the arm to the couch.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 35


Treatment Room Components<br />

Couch Top Screw Cl<strong>amp</strong>s<br />

Figure 9<br />

Brainlab supports the use of the device with rectangular couch tops that have two parallel flat<br />

surfaces at a cl<strong>amp</strong>ing distance of 28 to 50 mm. The device can be also used on non-rectangular<br />

couch tops if the cl<strong>amp</strong>ing volume is not farther than 62 mm from the couch head's edge.<br />

Some ex<strong>amp</strong>les are:<br />

• Varian IGRT Couch Top<br />

• Brainlab Imaging Couch Top<br />

• Civco MTIL6669 - Universal Couchtop Long Extension, Rectangle, 36.6" (92.9 cm)<br />

• Civco MTIL6660 - Universal Couchtop Long Extension, Rectangle, 53.1" (134.9 cm)<br />

• Civco MTIL6676 - Universal Couchtop Long Extension, Rectangle, 64.9" (164.8 cm)<br />

• Elekta iBEAM evo Couchtop (e.g., CA, EP)<br />

• Elekta iBEAM evo Extension 650 (P10105-423)<br />

• Elekta HexaPOD evo Extension Long (P10105-426)<br />

• Elekta Connexion Imaging Module (P10105-210)<br />

• Elekta Connexion Lateral Opening Module (P10105-241)<br />

• QFIX kVue Standard Insert (RT-4551KV1)<br />

• QFIX kVue Short Insert (RT-4551KV2)<br />

• QFIX kVue Calypso Insert<br />

Patient Feedback Glasses<br />

Figure 10<br />

36 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

The Patient Feedback Glasses are an alternative to the mirror system. It consists of a pair of<br />

eyeglasses with prisms mounted at a 60° angle on the eye pieces that show the image without<br />

flipping or rotating the reflected image and allows the patient to see the feedback software<br />

displayed on the In-Room Monitor display.<br />

A cleaning cloth and a protective case are included. The composition of the cleaning cloth is 80%<br />

polyester, 20% nylon.<br />

In general, the device can also be worn in combination with standard optical glasses.<br />

NOTE: Some users who wear glasses may not be able to use the Patient Feedback Glasses<br />

because of the size and shape of their standard optical glasses.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 37


System Control Unit<br />

2.1.4 System Control Unit<br />

About the System Control Unit<br />

1<br />

Figure 11<br />

2<br />

The standard ExacTrac <strong>Dynamic</strong> configuration includes the following components.<br />

No. Component Description<br />

1 Treatment Workstation Contains various operating and connection interfaces.<br />

2<br />

Computer Cabinet<br />

Not shown<br />

Contains the Treatment Workstation together with Power<br />

Distribution Unit, Control Interface Unit, power cables,<br />

electrical safety devices, etc.<br />

System internal power and data cables between components<br />

via building structure.<br />

Additional elements included within the Control Interface Unit (CIU) and Power Distribution<br />

Unit are described on the following pages.<br />

The air conditioning system must be able to maintain a constant room temperature.<br />

The Treatment Workstation should be shut down at least once every week and preferably at the<br />

end of each workday.<br />

ExacTrac <strong>Dynamic</strong> does not provide interfaces for connecting external non-system devices<br />

because it is not permissible to connect ExacTrac <strong>Dynamic</strong> to such devices.<br />

Ensure that any external device (e.g., a USB flash drive or USB hard drive) has been removed<br />

from the Treatment Workstation prior to patient treatment.<br />

To prevent unauthorized access to the Treatment Workstation, the Computer Cabinet doors are<br />

to be locked and the key stored in a secure location. Alternatively, it may be installed in a location<br />

that can be supervised at all times. It is the hospital's responsibility to ensure Computer Cabinet<br />

security at all times. The front interfaces and controls are not intended for user interaction during<br />

normal operation.<br />

NOTE: Do not cover the ventilation slots on the cabinet door or the back side.<br />

NOTE: Depending on your configuration, your system may contain a larger Computer Cabinet<br />

that includes an isolation transformer unit (ITU) instead of the power distribution unit (PDU).<br />

For further information regarding this Computer Cabinet, see the ExacTrac <strong>Dynamic</strong> Clinical<br />

User Guide (Version 1.1).<br />

Tested Cables<br />

The power supply line is non-detachable and not part of the ExacTrac <strong>Dynamic</strong> installation.<br />

38 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

Control Interface Unit (CIU)<br />

1 2 3 4 5<br />

12 11<br />

10<br />

9<br />

Figure 12<br />

8<br />

7<br />

6<br />

The CIU is the system control interface unit to external components, for interlock and fail-safe<br />

handling, and for the generator service mode.<br />

No. Inscription Description<br />

1 EXGI Varian MV Beam gating interface "EXGI"<br />

2 USB1 Internal USB connection 1 (EXGI protocol)<br />

3 CAN 1 / 2 CAN bus connections (floor box illumination)<br />

4 RACK PWR CIU DC power input connector<br />

5<br />

ITU<br />

System power remote switch interface and standby power<br />

supply<br />

6 CONSOLE ExacTrac Console connection<br />

7 USB 2<br />

Internal USB connection 2 (generator and interlock protocols)<br />

8 GENERATOR Dual X-ray Generator remote connection<br />

9 WL 1 / 2 X-ray Signal Light connection<br />

10<br />

EXT ILK<br />

External interlock connections to building installation<br />

(Door)<br />

11 VARIAN Varian interlock connection (EMO)<br />

12 ELEKTA Elekta interlock connection (Beam inhibit, EMO, Door)<br />

Control Interface Unit (CIU) LEDs<br />

1<br />

2 3 4 5 6 7<br />

Figure 13<br />

10<br />

9<br />

8<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 39


System Control Unit<br />

The CIU also displays LEDs.<br />

No. Inscription Description<br />

1 GATING LEDs Gating function status indicator lights<br />

2 USB 1 LED USB bus connect indicator USB 1<br />

3 CAN 1 LED CAN bus traffic indicator<br />

4 WARNING LIGHT LEDs X-ray Signal Light status indicators<br />

5<br />

STATUS LEDs<br />

Differential interlock status indicators and SSG controller<br />

activity<br />

6 POWER LED CIU DC Power indicator<br />

7 POWER LEDs Power interlock states and standby power indicator<br />

8 ILK LEDs Non-differential interlock status indicators<br />

9 USB 2 LED USB bus connect indicator USB 2<br />

10 GENERATOR LEDs X-ray Generator interface status indicators<br />

Power Distribution Unit<br />

2<br />

1<br />

9<br />

8<br />

7<br />

6 5 4 3<br />

Figure 14<br />

No. Component Description<br />

1<br />

2<br />

START button<br />

STOP button<br />

• Manual system switch ON<br />

• Green indicator: PDU is ON<br />

• Manual system switch OFF<br />

• Red indicator: PDU STDBY power 24V DC<br />

3 Main circuit breaker Overload protection for PDU, main system circuit breaker<br />

4 Circuit breaker Overload protection for Control Room Distribution Box<br />

5<br />

6<br />

7<br />

Circuit breaker<br />

Circuit breaker<br />

AUTO-START TIMER<br />

Overload protection for In-Room Distribution Box (camera,<br />

Flat Panel Detectors and In-Room Monitor)<br />

Overload protection for cabinet parts (Treatment Workstation<br />

and KVM extenders)<br />

Automatic system start on workdays at a pre-defined<br />

time<br />

8 CIU POWER Blue indicator: 12V DC CIU power is ON<br />

40 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

No. Component Description<br />

9<br />

Start mode switch<br />

• CIU: System ON/OFF via ExacTrac Console (default<br />

configuration)<br />

• MANUAL: System ON/OFF via buttons 1 and 2 (for<br />

service only)<br />

NOTE: In the default configuration, the system can be started and shutdown via the ExacTrac<br />

Console.<br />

Auto-Start Timer<br />

The Auto-Start Timer included in the PDU automatically turns on the system so that the camera<br />

reaches temperature equilibrium state B by a predetermined time, without the need to manually<br />

turn on the system. This means that the system can be turned off during the night (e.g., to save<br />

energy).<br />

Setting a daily system startup time helps address implications during clinical use due to 3D<br />

Camera system warm up (e.g., failing the Daily Check).<br />

The system start time can be set according to a weekly schedule (i.e., it is possible to exclude<br />

weekends from the schedule).<br />

Ex<strong>amp</strong>le:<br />

Day of the Week<br />

Monday<br />

Tuesday<br />

Wednesday<br />

Thursday<br />

Friday<br />

Saturday<br />

Sunday<br />

System Startup Time<br />

6 a.m.<br />

6 a.m.<br />

6 a.m.<br />

6 a.m.<br />

6 a.m.<br />

No system start<br />

No system start<br />

For further information about the Auto-Start Timer, temperature equilibrium state B and the<br />

relationship to the Daily Check, see the ExacTrac <strong>Dynamic</strong> Clinical User Guide.<br />

NOTE: The Auto-Start Timer can be used to switch on the system only. You cannot use it to turn<br />

off the system. If the system is already on, the timer has no influence on the system if it triggers a<br />

system start at this time.<br />

NOTE: Depending on your configuration, the placement of the Auto-Start Timer in the large<br />

cabinet varies from the description here. Functionality and instructions for configuring the timer is<br />

identical.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 41


Phantoms<br />

2.1.5 Phantoms<br />

About Phantoms<br />

The phantoms described on the following pages are required or recommended for use with<br />

ExacTrac <strong>Dynamic</strong>.<br />

Warning<br />

If you have multiple ExacTrac <strong>Dynamic</strong> systems, ensure to always use the correct<br />

calibration phantom.<br />

Warning<br />

Accurate calibration cannot be guaranteed after deformation or damage of the system<br />

calibration phantoms. Handle the phantoms with care.<br />

Warning<br />

Do not move the phantom on the couch top during the calibration process. Otherwise<br />

subsequent patient positioning will be incorrect.<br />

NOTE: If the system experiences a mechanical impact to any of the thermal camera components,<br />

it is necessary to perform both a Daily Check and Thermal to 3D Camera Calibration.<br />

System Calibration Phantom<br />

Figure 15<br />

Calibrate the X-ray imaging system and 3D Camera to ensure accurate correction and verification<br />

of patient positioning. Use the laser marks provided to position the phantom. The phantom is also<br />

used for the Daily Check routine.<br />

The calibration phantom can be used for calibration with ExacTrac <strong>Dynamic</strong> and ExacTrac<br />

<strong>Dynamic</strong> <strong>Surface</strong>. For further information, see the System Calibration and Daily Check chapter in<br />

the ExacTrac <strong>Dynamic</strong> Clinical User Guide.<br />

42 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

Thermal to 3D Calibration Phantom<br />

Figure 16<br />

The ExacTrac <strong>Dynamic</strong> system uses structured light scanning and a thermal heat signature to<br />

reconstruct the patient's position in relation to the isocenter. The Thermal to 3D Calibration<br />

Phantom has circular markers that are visible to the components of the 4D Thermal Camera to<br />

ensure calibration of the 4D Thermal Camera to the 3D Camera.<br />

Verification Phantoms<br />

1<br />

2<br />

Figure 17<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 43


Phantoms<br />

No. Component Description<br />

1<br />

2<br />

Pelvic Verification Phantom<br />

Cranial Verification Phantom<br />

This optional pelvis replica is used for quality assurance<br />

and therapist training. It is made of a tissue-like material<br />

inset with a bone-like material.<br />

For hidden target tests, one tungsten sphere is embedded<br />

at the approximate position of the prostate, and four<br />

implanted markers (copper rods) are placed around the<br />

tungsten sphere.<br />

This optional head replica is used for quality assurance<br />

and therapist training. It is made of a tissue-like material<br />

inset with a bone-like material.<br />

For hidden target tests, three tungsten spheres are inserted.<br />

NOTE: Depending on your configuration, your verification phantoms may have a different color<br />

(brown) without the implanted markers (copper rods) in the Pelvic Verification Phantom.<br />

ExacTrac <strong>Dynamic</strong> Adjustable Target Phantom<br />

Figure 18<br />

The ExacTrac <strong>Dynamic</strong> Adjustable Target Phantom can be used for Radiation Isocenter<br />

Calibration. It must be used together with ExacTrac <strong>Dynamic</strong> and Cranial 4Pi.<br />

The ExacTrac <strong>Dynamic</strong> Adjustable Target Phantom contains a tungsten sphere with a diameter<br />

of 5 mm which is located coincident with the crosshair of the cap. The cap is made of PEEK<br />

(polyether ether ketone).<br />

For further information about mounting the ExacTrac <strong>Dynamic</strong> Adjustable Target Phantom and<br />

when to use it, see the System Calibration and Daily Check chapter in the ExacTrac <strong>Dynamic</strong><br />

Clinical User Guide.<br />

44 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

2.1.6 X-ray Components<br />

About X-ray Components<br />

ExacTrac <strong>Dynamic</strong> uses diagnostic X-rays in the kV energy range for registering the patients<br />

bony structure for determining the exact 3D position for treatment.<br />

• Two Flat Panel Detectors for stereo X-ray detection<br />

• Two X-ray Generators to provide energy for each X-ray tube<br />

• Two X-ray Tubes with collimators, covers and optional water cooling parts<br />

Flat Panel Detectors<br />

1<br />

Figure 19<br />

2<br />

No. Component Description<br />

1<br />

Flat Panel Detector<br />

• Two units: Varex model 3030DX<br />

• Total pixel area: 298 x 298 mm<br />

• Pixel resolution: 768 x 768<br />

• Receptor type: Amorphous silicon<br />

• Conversion screen: Integral columnar Csl<br />

The flat panels record the X-ray images generated using<br />

the X-ray tubes.<br />

2<br />

Device Mounts and Flat Panel<br />

Detector Covers<br />

Two Flat Panel Detectors are mounted to the ceiling,<br />

one on each side of the treatment couch. The device<br />

mounts are the carrying structure for holding each detector<br />

in position while acquiring the stereo images. The detachable<br />

covers protect the underlying structures of detector,<br />

holders and connecting cables.<br />

NOTE: Ensure that the Flat Panels are not touched by anyone or anything while the system is in<br />

use. Users may not affix or deposit anything onto the Flat Panels (e.g., blankets, cloth, medical<br />

equipment).<br />

NOTE: Do not hang additional objects/weights from the flat panels, cameras or ceiling mounts.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 45


X-ray Components<br />

On-Floor Covers and In-Floor Boxes and Covers<br />

1<br />

Figure 20<br />

2<br />

No. Component Description<br />

1<br />

2<br />

On-Floor Cover<br />

In-Floor Box<br />

Covers the X-ray tube. Two boxes with an illuminated<br />

area are set on top of the floor, one on either side of the<br />

linac.<br />

Contains the X-ray tube. Two boxes are recessed into<br />

the floor, one on either side of the linac.<br />

1<br />

2<br />

Figure 21<br />

3<br />

No. Component Description<br />

1<br />

2<br />

3<br />

In-Floor Box Cover<br />

Top cover (Elekta)<br />

Top cover (Varian)<br />

Covers the In-Floor Box and contains a light panel to illuminate<br />

the top cover (Elekta version shown in picture).<br />

Covers the In-Floor Box Cover (Elekta version shown in<br />

picture).<br />

Covers the In-Floor Box Cover (Varian version shown in<br />

picture).<br />

Do not sit on the On-Floor Cover or use it as a seat or step.<br />

The On-Floor Covers are installed outside of the passageway of the user/patient/personnel.<br />

If cracks are visible on the cover, inform Brainlab support to exchange it.<br />

Warning<br />

If water is spilled on the In-Floor Box / On-Floor Cover and/or if you suspect water leakage<br />

or damage of any kind, switch off the system and the X-ray Generator. Inform Brainlab<br />

support and do not use the system anymore.<br />

46 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


HARDWARE OVERVIEW<br />

On-Floor Cover Placement<br />

6<br />

5<br />

4<br />

4<br />

3<br />

3<br />

2<br />

1<br />

2<br />

Figure 22<br />

No.<br />

1<br />

2<br />

3<br />

4<br />

5<br />

6<br />

Component<br />

Patient couch<br />

Medical equipment<br />

On-Floor Covers<br />

Do not place medical equipment in this area.<br />

Linear accelerator<br />

Raceway<br />

NOTE: Anyone entering the room during work (e.g., physicians, cleaning personnel, electricians)<br />

must be made aware of the room situation and the potential tripping hazards. The hospital is<br />

responsible for repeating this training regularly and training new personnel.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 47


X-ray Components<br />

X-ray Tubes and X-ray Collimators<br />

1<br />

2<br />

Figure 23<br />

No. Component Description<br />

1<br />

2<br />

X-ray Tube<br />

X-ray Collimator<br />

Water hoses<br />

Two Varex G892 tubes with HE221. Generates X-ray images<br />

for verification of patient positioning accuracy.<br />

When facing the linear accelerator:<br />

• Left tube = Tube 1<br />

• Right tube = Tube 2<br />

Ensures that the radiation emitted by the tube exclusively<br />

covers the sensitive area of the flat panel detector.<br />

Allows installation connection for cooling system.<br />

NOTE: It is absolutely essential to ensure that the tube is not rotating at high speed if the<br />

generator is turned off. An uncontrolled deceleration of the anode can cause damage to the<br />

bearings of the anode plate and thereby damage the tube.<br />

The tube runs for approximately 20 seconds on high speed after an exposure.<br />

If the generator is switched off while the tube is running at high speed, immediately turn the<br />

generator back on. The tube will automatically decelerate after switching on.<br />

X-ray Tube Warm-up and Seasoning<br />

To prevent system damage, always use the tube warm-up in the Daily Check or the dedicated<br />

Tube Warm-Up to warm up the X-ray tubes.<br />

Additional seasoning should be performed:<br />

• If the tubes have not been used for a longer period of time (3-4 weeks).<br />

• If sparking occurs. Different generator error messages can provide a hint that sparking is<br />

occurring, especially if the messages only appear for higher energies. With the seasoning<br />

procedure, it is possible to find out the highest possible energy without sparking.<br />

Tube seasoning should be performed in X-ray Test Acquisition mode. Tube seasoning can be<br />

necessary because:<br />

• A cold anode leads to thermal effects resulting from exposure to high power and can cause the<br />

anode body to crack, irreparably damaging the tube.<br />

• Gas and other particles may dissipate from the inner surface of the tubes into the vacuum,<br />

resulting in vacuum degradation. If a tube is then operated at a high voltage and current<br />

setting, sparking occurs. These sparks can damage the tube and the generator electronics.<br />

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HARDWARE OVERVIEW<br />

Step<br />

1. Take initial exposures at:<br />

• A minimum current setting (10 mA or less) and medium voltage (70 kV), and using<br />

long exposure times.<br />

• Low mAs (about 1 mAs) and medium voltage (70 kV).<br />

Irreparable damage can occur if sparking still occurs. Contact Brainlab service for further<br />

information.<br />

2. Increase the voltage in increments of 10 kV and repeat the exposures. Continue up to the<br />

maximum required voltage.<br />

NOTE: For further information, see the System Calibration and Daily Check chapter in the<br />

ExacTrac <strong>Dynamic</strong> Clinical User Guide.<br />

X-ray Tube Overheating<br />

In order to prevent X-ray tube overheating, ExacTrac <strong>Dynamic</strong> has implemented a mechanism<br />

based on the specific heating and cooling curve of the tube. If the tube becomes too hot,<br />

ExacTrac <strong>Dynamic</strong> does not allow any further X-ray acquisitions. The tube must cool down for a<br />

few minutes before further X-ray acquisition is possible.<br />

X-ray Generators<br />

Figure 24<br />

Component<br />

X-ray Generator<br />

Description<br />

Powers two X-ray tubes used to create X-ray correction<br />

and verification images for patient positioning.<br />

Provided in two separate cabinets connected with cables:<br />

• X-ray Generator Main (1)<br />

• X-ray Generator Sub (2)<br />

With the X-ray Generator, images can be taken nearly<br />

simultaneously with both tubes.<br />

With the generator tube combination used in ExacTrac <strong>Dynamic</strong>, a maximum tube voltage of<br />

150 KV can be selected, resulting in a maximum tube current of 400 mA, restricted by the<br />

maximum output power of the X-ray generator of 65 kW and rounded to the next lower step in the<br />

settings value table.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 49


X-ray Components<br />

The generator can provide all combinations of KV values and tube currents up to a KV-MA<br />

product of the nominal output power of 65 kW. These values are all valid for the only used<br />

exposure time of 100 ms with the ExacTrac <strong>Dynamic</strong> system.<br />

ExacTrac <strong>Dynamic</strong> provides an accuracy of X-ray tube loading factors complying with IEC<br />

60601-2-54:<br />

• Tube voltage error less than 10%<br />

• Tube current error less than 20%<br />

• Loading time error maximum 10%<br />

• MAS product error less than 10%<br />

Only qualified service personnel are allowed to install and service the following components:<br />

• X-ray Generator<br />

• HE tube unit<br />

• external cooling device<br />

Connection to hospital mains has to be done by an electrician familiar with the local regulatory<br />

requirements.<br />

NOTE: It is recommended to switch off the generator and cooling system at night.<br />

NOTE: Before activating X-rays, always leave the treatment room. Before acquiring X-rays,<br />

always verify that no one other than the patient is in the treatment room.<br />

The X-ray Generator and tubes are not designed for use in areas where there is a danger of<br />

explosion (e.g., in the presence of combustible mixtures such as anesthetics with air or oxygen, or<br />

in the vicinity of flammable substances such as detergents). Local regulations concerning the<br />

formulation of combustible gas mixtures when cleaning the system and during patient treatment<br />

must be observed.<br />

Never place objects on the X-ray Generator cabinet ventilation screen. Improper handling<br />

can lead to overheating and damage to the X-ray Generator.<br />

It is absolutely essential to ensure that the tube is not rotating at high speed if the<br />

generator is turned off. An uncontrolled deceleration of the anode can cause damage to the<br />

bearings of the anode plate and thereby damage the tube.<br />

The tube runs for approximately 20 seconds on high speed after an exposure.<br />

If the generator is switched off while the tube is running at high speed, immediately turn<br />

the generator back on. The tube will automatically decelerate after switching on.<br />

Geometrical X-ray Setup<br />

On-Floor installation:<br />

Factor<br />

Distance from X-ray tube focus to the flat panel<br />

Distance from X-ray tube focus to the isocenter<br />

Size of the flat panel's radiation-sensitive area<br />

Geometrical radiation field at the nominal reference<br />

distance<br />

Measurements<br />

3200 mm<br />

1900 mm<br />

300 mm x 300 mm<br />

178.125 mm x 178.125 mm<br />

In-Floor installation:<br />

Factor<br />

Distance from X-ray tube focus to the flat panel<br />

Distance from X-ray tube focus to the isocenter<br />

Measurements<br />

Varian Truebeam: 3500 mm<br />

Elekta: 3500 mm<br />

Varian Truebeam: 2200 mm<br />

Elekta: 2100 mm<br />

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HARDWARE OVERVIEW<br />

Factor<br />

Size of the radiation sensitive area of the flat<br />

panel<br />

Geometrical radiation field at the nominal reference<br />

distance<br />

Measurements<br />

300 mm x 300 mm<br />

Varian Truebeam: 188.57 mm x 188.57 mm<br />

Elekta: 180 mm x 180 mm<br />

Acceptable levels of extra-focal radiation are in compliance with IEC 60601-2-54.<br />

Permanent Filtration in the X-ray Beam<br />

The aluminum filtration of the system must be at least 2.5 mm. To reach this filtration, sufficient<br />

permanent aluminum plates must be placed within the X-ray beam path.<br />

NOTE: Do not remove the On-Floor Covers.<br />

On-Floor Cover<br />

On-Floor Cover<br />

X-ray Tube<br />

X-ray Collimator<br />

Additional aluminum disk (permanent filtration<br />

disk)<br />

Total Filtration 3.21 mm Al @ 75 kV<br />

0.71 mm Al @ 75 kV<br />

0.7 mm Al @ 75 kV<br />

0.0 mm Al<br />

1.0 mm Al + 0.8 mm Al<br />

In-Floor Box<br />

Top cover<br />

X-ray Tube<br />

X-ray Collimator<br />

Additional aluminum disk<br />

In-Floor Box cover plate<br />

Total Filtration 4.51 mm Al @ 75 kV<br />

0.98 mm Al @ 75 kV<br />

0.7 mm Al @ 75 kV<br />

0.0 mm Al<br />

None<br />

2.83 mm Al<br />

NOTE: The X-ray Collimator is adjusted to the size of the Flat Panel Detector. Unintended<br />

movement of the tube can displace the collimator and therefore the image on the Flat Panel<br />

Detector. The collimator must be readjusted by a service engineer and calibrated if displacement<br />

of the X-ray image is detected.<br />

If X-ray images appear eccentric and/or partial, stop treatment and contact Brainlab support.<br />

The patient couch induces additional filtration. Depending on the couch top that is used with<br />

ExacTrac <strong>Dynamic</strong>, the corresponding filtration equivalent should be taken into account.<br />

For further information, consult the information provided by the original manufacturer of the table<br />

top.<br />

X-ray Field Size<br />

The field size of the Varian G-892 X-ray tube is 430 mm x 430 mm without collimator at 1000 mm<br />

distance and a target angle (angle of beam) of 12°.<br />

The final field size with collimator depends on the installation. The maximum used area of the flat<br />

panel is 300 mm x 300 mm after installation.<br />

Calculating Dose Area Product<br />

As well as the image intensity, the dose area product can be calculated and shown if desired or<br />

legally required. To do this, additional system calibrations and measurements must be performed<br />

by Brainlab support.<br />

The dose area product is given in µGy*m² and is calculated for the image taken with the adjusted<br />

X-ray Generator Exposure Settings. The dose area product does not take into account the<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 51


X-ray Components<br />

filtration of the couch top or other accessories in the X-ray field after the X-ray Tube, X-ray<br />

Collimator and In-Floor Box filtration is considered.<br />

For safety reasons, the calibration of the system needs to be verified by Daily Check after<br />

performing a dose area product measurement.<br />

Notes<br />

Warning<br />

For safety reasons, the calibration of the system needs to be verified by Daily Check after<br />

mechanical impact to one of its components.<br />

Warning<br />

For safety reasons, the calibration of the system needs to be verified by Daily Check at<br />

least once a day before patient treatment is started.<br />

X-ray Cooling System Components<br />

X-ray tube cooling is required to cool down the X-ray tube housing during treatment applications<br />

of intense X-ray exposure sequences. It consists of the HE221 Heat Exchanger Unit, a water/<br />

water heat exchanger or water/air cooler and a Cooling System Distribution Box. The cooling<br />

parts are connected using hoses and quick connectors.<br />

Only qualified service personnel are allowed to install and service the HE tube unit and external<br />

cooling device.<br />

Brainlab recommends switching off the generator and cooling system overnight.<br />

Figure 25<br />

Component<br />

HE221 Heat Exchanger Unit<br />

Description<br />

• Mounted on the X-ray tube. The heat exchanger unit<br />

contains an oil pump that circulates the X-ray tube oil<br />

inside of the heat exchanger. The pump is powered via<br />

the X-ray Generator.<br />

• Provides inlet and outlet quick connectors for external<br />

cooling fluid.<br />

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HARDWARE OVERVIEW<br />

1<br />

Figure 26<br />

2<br />

No. Component Description<br />

1<br />

2<br />

Water/Air Cooler<br />

Water/Water Heat Exchanger<br />

Laird WL3004. Transfers the X-ray tubes' thermal load to<br />

the hospital chiller.<br />

Laird WW3001. Transfers the X-ray tubes' thermal load<br />

to ambient.<br />

Figure 27<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 53


X-ray Components<br />

Component<br />

Cooling System Distribution Box<br />

Description<br />

• Distributes cooling fluid to both X-ray tubes at a constant<br />

pressure.<br />

• Monitors cooling liquid temperature, pressure and flow.<br />

X-ray Signal Light<br />

Figure 28<br />

The ExacTrac <strong>Dynamic</strong> X-ray components provide different options as X-ray signal systems:<br />

• Brainlab X-ray Signal Light<br />

• Interface for customer warning light<br />

If the X-ray Signal Light starts flashing while you are in the treatment room, immediately notify<br />

the operator at the linac control console of your presence and leave the treatment room as quickly<br />

as possible.<br />

The lights remain on until you exit the X-ray Acquisition page in the software.<br />

Depending on the installed version and local regulations, the X-ray signal light may have different<br />

colors or distinguish between steady and flashing illumination. The following description is related<br />

to the Brainlab X-Ray Signal Light default configuration, when the dual color signal light is used:<br />

State<br />

Steady yellow light<br />

Steady red light<br />

Flashing red light<br />

Description<br />

The X-ray Generator is switched on and may be used<br />

by the ExacTrac <strong>Dynamic</strong> system. The system is in<br />

standby mode.<br />

Steady red light indicates that X-ray exposures can be<br />

triggered with the next user interaction by pressing the<br />

exposure button.<br />

The red light will start flashing when an X-ray exposure is<br />

triggered, and continues to flash for at least 5 seconds<br />

after the last X-ray exposure.<br />

The X-ray Signal Light can be configured in case local regulations require different signal<br />

patterns. For further information, contact Brainlab support.<br />

For customer light installations: Different signals may be visible.<br />

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HARDWARE OVERVIEW<br />

If no door interlock is installed, the customer is responsible to ensure that no one is harmed by KV<br />

dose. This can either be through technical or workflow measures.<br />

X-ray Image QA Phantom Holder<br />

Figure 29<br />

The X-ray Image QA Phantom Holder can be used for various measurement tests, such as dose<br />

area product tests or image quality tests of the Flat Panel Detectors.<br />

Maximum weight of measuring device: 4.8 kg.<br />

Warning<br />

For safety reasons, the calibration of the system needs to be verified by Daily Check after<br />

mechanical impact to one of its components or after performing a measurement test.<br />

1<br />

2<br />

3<br />

Figure 30<br />

4<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 55


X-ray Components<br />

No. Component Description<br />

1<br />

2<br />

3<br />

4<br />

X-ray Image QA Phantom<br />

Holder Frame<br />

X-ray Image QA Phantom<br />

Holder Ball Head<br />

X-ray Image QA Phantom<br />

Holder Tripod<br />

X-ray Image QA Phantom<br />

Holder Case<br />

Adjustable for measurement devices with a width between<br />

200 and 350 mm and a thickness between 12 and<br />

35 mm, and a maximum weight of 4.8 kg.<br />

Interface between X-ray Image QA Phantom Holder<br />

Frame and X-ray Image QA Phantom Holder Ball<br />

Head.<br />

Maximum adjustable height: 2500 mm.<br />

Store and transport the X-ray Image QA Phantom Holder<br />

in this case.<br />

How to Use the X-ray Image QA Phantom Holder<br />

Step<br />

1.<br />

2.<br />

Mount the X-ray Image QA Phantom Holder Ball Head to the X-ray Image QA Phantom<br />

Holder Tripod.<br />

Assemble the X-ray Image QA Phantom Holder Frame as shown in the picture.<br />

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HARDWARE OVERVIEW<br />

Step<br />

3.<br />

Mount the measurement test device to the X-ray Image QA Phantom Holder Frame by<br />

using the two knobs.<br />

4.<br />

Mount the dosimeter to the front or back side of the measuring device by using the carbon<br />

rail and the hook-and-loop fabric.<br />

5.<br />

Mount the X-ray Image QA Phantom Holder Frame together with the measurement device<br />

to the X-ray Image QA Phantom Holder Tripod by inserting it into the dovetail<br />

guide and fastening the silver turning handle.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 57


X-ray Components<br />

Step<br />

6.<br />

Adjust the angle accordingly by loosening the silver lever. If the friction of the ball head<br />

needs to be readjusted due to the weight of the measuring device, see next page, How to<br />

Adjust the Friction of the X-ray Image QA Phantom Holder Ball Head.<br />

7.<br />

Position everything in front of and in parallel to the Flat Panel Device.<br />

How to Adjust the Friction of the X-ray Image QA Phantom Holder Ball Head<br />

If necessary, adjust the friction of the ball head with the following steps.<br />

1 2 3 4<br />

Figure 31<br />

Step<br />

1. Adjust the friction of the X-ray Image QA Phantom Holder Ball Head by adjusting the<br />

lever 1.<br />

2. Push the lever towards you 2.<br />

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HARDWARE OVERVIEW<br />

Step<br />

3. Hold the lever and turn it gently downwards at the same time 3.<br />

4. Release it. If the friction is still too weak, repeat steps 1-3 4.<br />

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Radiation Safety<br />

2.1.7 Radiation Safety<br />

Basic Radiation Safety<br />

In ExacTrac <strong>Dynamic</strong>, radiological equipment is part of your system. Safe usage of this<br />

equipment can only be assured if:<br />

• The X-ray equipment is used in an appropriately shielded medical environment.<br />

• The system is operated by qualified personnel familiar with radiological diagnostics, X-ray<br />

generator operation and the radiation safety requirements for clinical radiation treatments.<br />

• The relevant safety instructions are observed.<br />

Radiation Safety Authorities<br />

Warning<br />

Serious hazards are associated with the operation of X-ray equipment. Unauthorized<br />

persons may not operate the X-ray equipment. The customer is responsible for ensuring<br />

that local regulatory requirements are followed when the equipment is installed or<br />

operated. The X-ray equipment should only be operated with regard to the safety<br />

information and additional instructions provided by the X-ray generator supplier as well as<br />

the competent safety authorities.<br />

The responsible organization shall ensure that access to ExacTrac <strong>Dynamic</strong> is restricted in<br />

accordance with local regulations for radiation protection. Additional information regarding<br />

radiation safety can also be obtained from your national radiation safety authority.<br />

X-ray Dosage During Patient Positioning<br />

The ExacTrac <strong>Dynamic</strong> X-ray components fulfill the requirements specified by IEC with regard to<br />

minimizing the X-ray dose to the patient during the positioning workflow.<br />

The typical image dose for a patient positioning is approximately 1 mGy for one pair of X-ray<br />

images.<br />

ExacTrac <strong>Dynamic</strong> has a reproducibility of radiation output of 0.05 of the Air Kerma (IEC<br />

60601-2-54, clause 203.6.3.2.101).<br />

Warning<br />

The user must verify each X-ray setting after modification and prior to X-ray exposure. This<br />

is required as in some cases the generator does not accept settings for technical reasons.<br />

If the settings are not accepted, the user will be notified by the software.<br />

Warning<br />

Verify that only the patient is in the treatment room before X-ray activation.<br />

Supported Values<br />

• The kV settings can be adjusted between 40 and 150 kV in steps of 10 kV.<br />

• The MAS-product for exposure time and tube current can be adjusted in steps between 1.3 and<br />

80 mAs. ExacTrac <strong>Dynamic</strong> always uses an exposure time of 100 ms and selects the tube<br />

current accordingly. If a selected combination of kV and mAs is not possible due to restrictions<br />

to the maximum tube peak power, the software will switch to the nearest possible value.<br />

• When adapting the X-ray Generator Exposure Settings, the generator double-checks if the<br />

combination of mAs and kV is possible. If not, the values are set to the closest possible<br />

combination.<br />

• ExacTrac <strong>Dynamic</strong> uses Varex X-ray tubes G-892 in B-130H housings with heat exchangers<br />

HE-221. The loading factors for leakage radiation for each tube are: 150 kV / 6.7 mA, limited by<br />

the anode with 635 kJ heat capacity.<br />

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HARDWARE OVERVIEW<br />

2.2 Other Devices<br />

Other Devices Compatible with ExacTrac <strong>Dynamic</strong><br />

Depending on your configuration, the components listed on the following pages may be<br />

compatible.<br />

Cranial 4Pi Immobilization System<br />

Figure 32<br />

Brainlab frameless Cranial 4Pi immobilization system can be used for head and neck treatment. It<br />

is intended for use with ExacTrac <strong>Dynamic</strong>.<br />

For further information, see the Cranial 4Pi Hardware User Guide.<br />

Component Description Variants<br />

Treatment overlays<br />

Masks<br />

Fixes the mask system in place.<br />

Fixes the patient in place during<br />

treatment.<br />

Use with the Cranial 4Pi Headrest<br />

and headrest inlays.<br />

• Cranial 4Pi Treatment Immobilization<br />

Overlay Varian IGRT<br />

• Cranial 4Pi Treatment Immobilization<br />

Overlay Elekta iBEAM evo<br />

• Cranial 4Pi Treatment Immobilization<br />

Overlay Qfix kVue<br />

• Cranial 4Pi Open Face Mask<br />

• Cranial 4Pi Basic Mask<br />

• Cranial 4Pi Stereotactic Mask<br />

Couch Motion<br />

Elekta<br />

You can automatically position the couch and<br />

HexaPOD.<br />

Elekta linacs use the software interface MO-<br />

SAIQ, which allows ExacTrac <strong>Dynamic</strong> to automatically<br />

correct couch position.<br />

Varian<br />

You can automatically position the PerfectPitch<br />

couch. For automatic control of TrueBeam<br />

couches, no additional hardware is required.<br />

TrueBeam linacs use the software interface<br />

ADI, which allows ExacTrac <strong>Dynamic</strong> to automatically<br />

correct couch position.<br />

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3 SYSTEM STARTUP AND<br />

SHUTDOWN<br />

3.1 About System Startup and Shutdown<br />

About This Chapter<br />

This chapter provides general information related to the ExacTrac <strong>Dynamic</strong> system. Which<br />

features are available for your system depends on your configuration, equipment and licenses.<br />

For further information, contact Brainlab support.<br />

About Startup<br />

This section describes how to correctly start up the system as well as the background services.<br />

How to Use the Console to Start the System<br />

By default, use the ExacTrac Console to start the system.<br />

Step<br />

1.<br />

2.<br />

Ensure that the orange standby indicator on the console is lit.<br />

Press the System ON button (I) on the console. The green indicator light should turn on<br />

and remain lit.<br />

Booting Up the Treatment Workstation<br />

The Treatment Workstation starts up automatically after the system is powered up. Booting up<br />

the Treatment Workstation separately is not required.<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

How to Power Up the System Via the Power Distribution Unit<br />

By default, use the ExacTrac Console to power up the system. System startup via the Power<br />

Distribution Unit (PDU) is for troubleshooting purposes only.<br />

Step<br />

1.<br />

2.<br />

In the PDU, set all circuit breakers to the ON position.<br />

Ensure that the red indicator of the PDU STOP button is lit (i.e., the start mode switch<br />

must be in the CIU position).<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 63


About System Startup and Shutdown<br />

Step<br />

3.<br />

To start the system, press the START button of the PDU. Ensure that the START button's<br />

green indicator and the CIU POWER blue indicator are continuously lit.<br />

Auto-Start Timer<br />

The Auto-Start Timer included in the PDU automatically turns on the system so that the camera<br />

reaches temperature equilibrium state B by a predetermined time, without the need to manually<br />

turn on the system. For further information, see the System Calibration and Daily Check chapter in<br />

the ExacTrac <strong>Dynamic</strong> Clinical User Guide.<br />

The start time must be set to at least one hour before planned clinical use. If the timer is<br />

programmed to start the system automatically, you can shut down the system every day after use<br />

(e.g., to save energy).<br />

Setting a daily system startup time helps address implications during clinical use due to 3D<br />

Camera system warm-up (e.g., failing the Daily Check).<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

3.2 Starting the ExacTrac <strong>Dynamic</strong> Software<br />

Background<br />

Once you have booted the ExacTrac <strong>Dynamic</strong> system, and accessory components such as the<br />

camera and Treatment Workstation are running, you can start the Preparation or Treatment<br />

software.<br />

Ensure that any external devices (e.g., a USB flash drive or USB hard drive) has been removed<br />

from the Treatment Workstation prior to patient treatment.<br />

How to Start the Software<br />

Step<br />

1. To start the software, select Brainlab Elements.<br />

Content Manager opens.<br />

2. Select a workflow under ExacTrac <strong>Dynamic</strong> (e.g., Treatment).<br />

3. When starting Treatment, the following actions are performed. ExacTrac <strong>Dynamic</strong> system<br />

connects to:<br />

• Xray Service for configurations with X-ray capability<br />

• The Gating Service: Either EXGI Service for Varian linac integrations or Elekta<br />

Gating Service for Elekta linac integrations<br />

• Varian Service or Elekta Service (including iCOM Service)<br />

NOTE: The services start automatically during boot up of the ExacTrac <strong>Dynamic</strong> system.<br />

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Restarting the System<br />

3.3 Restarting the System<br />

How to Restart the System<br />

Figure 33<br />

Step<br />

1. From the menu, select Quit Treatment App.<br />

2. Shut down Windows.<br />

3. Press System Off (O) on the console to power down ExacTrac <strong>Dynamic</strong> completely.<br />

4. Restart the system by selecting either:<br />

• System On (I) on the ExacTrac Console.<br />

• START on the Power Distribution Unit (System startup via the Power Distribution<br />

Unit is for troubleshooting purposes only.).<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

3.4 Background Services<br />

Background Services for Software<br />

Figure 34<br />

The background services must be running before starting the ExacTrac <strong>Dynamic</strong> software.<br />

Services start automatically during boot up of the system. This can take up to a few minutes.<br />

Once the services are started properly, ExacTrac <strong>Dynamic</strong> is ready to be started.<br />

You can check the status of any service relevant to ExacTrac <strong>Dynamic</strong> by accessing the<br />

Windows Services tab of the Task Manager.<br />

Background Services for Integrations<br />

Some services that appear under the Windows Services tab of the Task Manager are relevant for<br />

ExacTrac <strong>Dynamic</strong> integrations.<br />

Varian-Relevant Services<br />

Xray Service<br />

Varian Service<br />

EXGI Service<br />

Elekta-Relevant Services<br />

Xray Service<br />

Elekta Service<br />

Elekta Gating Service<br />

iCOM Service<br />

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Background Services<br />

Background Services Failure<br />

Figure 35<br />

If ExacTrac <strong>Dynamic</strong> is running when a failure occurs in the background services, a warning<br />

dialog is displayed. In most cases, the corresponding service auto-recovers and the dialog<br />

disappears.<br />

If it does not, you can restart the disconnected service by selecting the button to restart it.<br />

If the problem continues, shut down and restart the system.<br />

If the issue persists, contact Brainlab support.<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

3.5 Shutting Down the Software<br />

Background<br />

Once patient treatment has been completed, the software can be shut down.<br />

If the Windows user changes, the user must close the ExacTrac <strong>Dynamic</strong> application before<br />

locking Windows. Otherwise, other users will be able to log in to Elements, but will not be able to<br />

use ExacTrac <strong>Dynamic</strong>.<br />

If the system is shut down before the software is closed, data can be lost.<br />

How to Close the Patient File<br />

Step<br />

To close the current patient file, close the patient on the linac.<br />

How to Exit the ExacTrac <strong>Dynamic</strong> Software<br />

Before shutting down the system, you must exit the ExacTrac <strong>Dynamic</strong> software correctly.<br />

Step<br />

1. Open the menu.<br />

2. Select Quit Treatment App.<br />

3. An exit prompt is shown.<br />

4. Select Yes to close the software.<br />

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Shutting Down the System<br />

3.6 Shutting Down the System<br />

About Shutting Down the System<br />

By default, use the ExacTrac Console to shut down the system.<br />

For optimum system performance and reduced power consumption, Brainlab recommends<br />

shutting down the system every day after treatment ends (if the automatic start function is<br />

enabled).<br />

Emergency Stop/Off<br />

In the event of an emergency, push the emergency off switch installed in the room.<br />

How to Shut Down the System<br />

Step<br />

1. Shut down the Windows operating system by selecting Shut Down in the Start menu.<br />

2. Wait until the Treatment Workstation shuts down and the monitor goes black.<br />

3.<br />

1<br />

Turn off the system power by pressing the System Off button 1 on the ExacTrac Console<br />

for three seconds. The orange standby LED will flash during this time.<br />

• When the green POWER LED turns off, this indicates that system mains power is<br />

turned off.<br />

• As long as the system is OFF, the orange standby LED remains ON (indicating standby<br />

voltage 24 V DC).<br />

How to Power Down the System Via the Power Distribution System<br />

By default, use the ExacTrac Console to shut down the system. System shutdown via the Power<br />

Distribution Unit is for troubleshooting purposes only.<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

Step<br />

1.<br />

2.<br />

Press STOP on the Power Distribution Unit.<br />

The green and blue indicators turn off.<br />

Only the red indicator remains ON (indicates 24V DC Standby power).<br />

Additional Notes on Shutdown<br />

• The circuit breakers of the Power Distribution Unit should remain always ON. Otherwise, the<br />

daily automatic start function cannot start up the system.<br />

• If you prefer to always keep the system on, the Treatment Workstation must be restarted daily<br />

before treatment. Otherwise, its performance may be affected.<br />

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Overview of Available Applications<br />

3.7 Overview of Available Applications<br />

About the Applications<br />

• This user guide includes a description of available ExacTrac <strong>Dynamic</strong> applications. Which<br />

applications are available with your system depends on your configuration, equipment and<br />

licenses.<br />

• All of the applications are described in the ExacTrac <strong>Dynamic</strong> Clinical User Guide<br />

Preparation and Treatment Applications<br />

Option<br />

ExacTrac <strong>Dynamic</strong> Preparation<br />

Application<br />

ExacTrac <strong>Dynamic</strong> Treatment<br />

Application<br />

Description<br />

Select a plan (if one did not load automatically), review plan settings<br />

and confirm a patient plan in this application.<br />

Select a template with predefined treatment settings, which can be<br />

reviewed and adjusted to match patient-specific needs.<br />

From this point forward in this user guide, ExacTrac <strong>Dynamic</strong><br />

Preparation Application will be referred to as Preparation.<br />

Perform positioning and monitoring for multiple workflows. Adjust<br />

settings, position the patient and monitor treatment from this application.<br />

From this point forward in this user guide, ExacTrac <strong>Dynamic</strong><br />

Treatment Application will be referred to as Treatment.<br />

Quality Assurance Tools - X-ray<br />

ExacTrac <strong>Dynamic</strong> offers several primary and secondary quality assurance and calibration tools.<br />

Which tools are available is license dependent and based on your system configuration.<br />

Application<br />

Thermal to 3D Camera<br />

Calibration<br />

X-ray Correction Image<br />

Acquisition<br />

Isocenter Calibration<br />

Radiation Isocenter Calibration<br />

Daily Check<br />

<strong>Surface</strong> Tracking QA<br />

Sphere Detection<br />

X-ray Test Acquisition<br />

Tube Warm-Up<br />

Description<br />

Establishes a relative calibration between the Thermal Camera<br />

and the 3D Camera using a heated phantom.<br />

Acquires and computes X-ray correction images.<br />

Calibration the surface tracking system and the X-ray system to the<br />

isocenter.<br />

Calibrates the ExacTrac <strong>Dynamic</strong> isocenter calibration to the linac<br />

isocenter using a metal radio-opaque sphere.<br />

Perform at least once each day to verify that:<br />

• The cross-calibration of the 3D Camera and X-ray isocenter.<br />

• The system setup geometry has not changed.<br />

• The phantom's position corresponds with the saved isocenter<br />

position.<br />

• The tubes are warmed up.<br />

Quality control test to ensure optimal system performance of surface<br />

tracking system.<br />

Calculates the distance of a metal radio-opaque sphere to the ExacTrac<br />

<strong>Dynamic</strong> isocenter. Measures how well the system is currently<br />

calibrated.<br />

Manually acquires X-ray images for additional quality assurance.<br />

Warm up the X-ray tubes.<br />

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SYSTEM STARTUP AND SHUTDOWN<br />

Quality Assurance Tools - <strong>Surface</strong><br />

ExacTrac <strong>Dynamic</strong> offers several primary and secondary quality assurance and calibration tools.<br />

Which tools are available is license dependent and based on your system configuration.<br />

Application<br />

Thermal to 3D Camera<br />

Calibration<br />

Isocenter Calibration <strong>Surface</strong><br />

Daily Check <strong>Surface</strong><br />

<strong>Surface</strong> Tracking QA<br />

Description<br />

Establishes a relative calibration between the Thermal Camera<br />

and the 3D Camera using a heated phantom.<br />

Calibrates the surface tracking system to the linac coordinate system<br />

and isocenter.<br />

Perform at least once each day to verify that:<br />

• The system setup geometry has not changed.<br />

• The phantom's position corresponds with the saved isocenter<br />

position.<br />

Quality control test to ensure optimal system performance of surface<br />

tracking system.<br />

Additional Tools - X-ray<br />

Application<br />

Template Editor<br />

Repeat Export<br />

Review and Approval<br />

Archive/Delete Patients<br />

Description<br />

Creates or adapts the templates (e.g., to use hospital-specific settings).<br />

Re-exports the patient treatment report to the R&V system.<br />

Opens completed treatment sessions for review and approval of X-<br />

ray/DRR image fusions.<br />

Exports or deletes local patient data.<br />

Additional Tools - <strong>Surface</strong><br />

Application<br />

Template Editor<br />

Repeat Export<br />

Archive/Delete Patients<br />

Description<br />

Creates or adapts the templates (e.g., to use hospital-specific settings).<br />

Re-exports the patient treatment report to the R&V system.<br />

Exports or deletes local patient data.<br />

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4 CLEANING AND<br />

DISINFECTION<br />

4.1 Cleaning Guidelines<br />

General Cleaning Guidelines<br />

The following cleaning instructions are provided for cleaning the housing, cables or other items<br />

not specifically listed in the following pages.<br />

• Ensure that the system is powered down before cleaning any parts.<br />

• Use non-toxic solvents only, as permitted by local regulations. Cleaning should only be<br />

performed in well-ventilated areas and solvents disposed of in accordance with local<br />

regulations.<br />

• Never use corrosive cleaning agents, solvents or abrasive detergents. If you are not sure about<br />

the properties of a cleaning agent, do not use it.<br />

How to Clean the Camera Covers<br />

Clean the device and remove dust on the air inlet on the back side of the camera unit with a<br />

slightly moistened cloth. Ensure that liquids do not get into the device. This can cause a short<br />

circuit. Do not spray the device with liquids.<br />

How to Clean the 3D Camera Lenses<br />

Step<br />

1. To remove dust from the camera windows, use a pressurized air duster.<br />

The air must be free of oil, moisture or other contaminants that could remain on the windows.<br />

2. To clean the window, use a small amount of isopropyl alcohol on a cleaning cloth and<br />

gently clean the window surface.<br />

Do not scratch the windows. Do not pour the alcohol directly on the windows.<br />

How to Clean the Thermal Camera Lens<br />

Step<br />

1. Use a commercial cleaning liquid with more than 30% isopropyl alcohol or 96% ethyl alcohol<br />

(C 2 H 5 OH) applied to cotton wool.<br />

2. Soak cotton wool in liquid, twist to remove excess liquid, clean the lens.<br />

Use wool once only; discard afterwards.<br />

Be careful when you clean the infrared lens. The lens has a delicate anti-reflective<br />

coating. Do not clean the infrared lens too vigorously. This can damage<br />

the anti-reflective coating.<br />

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CLEANING AND DISINFECTION<br />

How to Clean the Flat Panel Detector Covers<br />

Clean the device with a slightly moistened cloth. Ensure that liquids do not get into the device.<br />

This can cause a short circuit. Do not spray the device with liquids.<br />

How to Clean the Top Covers (In-Floor Configuration) and On-Floor Covers<br />

Clean the cover plates or covers with a slightly moistened cloth. Ensure that liquids do not get into<br />

the covers.<br />

How to Clean the Calibration Phantoms<br />

Clean all phantoms using a soft and dry or slightly moistened cloth only.<br />

Do not touch the marker insets/marker spheres or bring them into contact with moisture. They<br />

contain sensitive surfaces that are required for calibration purposes.<br />

Ensure that liquids do not get into the Thermal to 3D Calibration Phantom. This can cause a<br />

short circuit.<br />

Do not spray the phantoms with liquids.<br />

Do not attempt to t<strong>amp</strong>er with the System Calibration Phantom in any way (e.g., by removing or<br />

unscrewing the markers).<br />

How to Clean the Ceiling- and Wall-Mounted Monitor Arm<br />

For the ceiling-mounted monitor arm:<br />

• For all cleaning/disinfection work, disconnect pendant system from power supply system and<br />

protect it against accidental reconnection. Do not allow cleaning/disinfection fluid to enter the<br />

pendant system.<br />

• To avoid damage to plastic parts, do not use scouring agents and alkaline, acidic or alcoholcontaining<br />

cleaning agents.<br />

• Allow end device to cool down, if required.<br />

• Wipe surfaces with a slightly moistened cloth; if required, add a mild solution of soap<br />

(dishwashing agent). Wipe the surfaces dry with a clean cloth.<br />

For the wall-mounted monitor arm:<br />

• The mounting assembly may be cleaned with most mild, non-abrasive solutions commonly<br />

used in the hospital environment (e.g., diluted bleach, ammonia, or alcohol solutions).<br />

• The surface finish will be permanently damaged by strong chemicals and solvents such as<br />

acetone or trichloroethylene.<br />

• Do not use steel wool or other abrasive material.<br />

• Never submerge or allow liquids to enter the arm. Wipe any cleaning agents off of the arm<br />

immediately using a slightly moistened cloth. Dry the arm thoroughly after.<br />

How to Clean the Computer Cabinet and Distribution Boxes<br />

Step<br />

1. Switch off the Computer Cabinet and distribution boxes before starting cleaning.<br />

2. Clean the Computer Cabinet and distribution boxes with a slightly moistened cloth.<br />

Ensure that liquids do not get into the Computer Cabinet and distribution boxes. This<br />

can cause a short circuit.<br />

Do not spray the Computer Cabinet and distribution boxes with liquids.<br />

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Cleaning Guidelines<br />

How to Clean the ExacTrac Console<br />

Step<br />

1. Switch off the system before starting cleaning.<br />

2. Clean the devices with a slightly moistened cloth.<br />

Ensure that liquids do not get into the devices. This can cause a short circuit.<br />

Do not spray the devices with liquids.<br />

How to Clean the X-ray Generators<br />

Never use abrasive cleaning agents, organic solvents or cleaning agents containing solvent.<br />

Step<br />

1. Switch off the generator before starting cleaning.<br />

2. Clean the generator with a slightly moistened cloth.<br />

Ensure that liquids do not get into the devices. This can cause a short circuit.<br />

Do not spray the generator with liquids.<br />

How to Clean the Cooling System Components<br />

Always switch off the cooling unit by switching off the generator before starting to clean. Never<br />

use abrasive cleaning agents, organic solvents or cleaning agents containing solvent.<br />

To clean the cooling system components (e.g., the water/water or water/air cooler and the<br />

Cooling System Distribution Box):<br />

• Clean the cooling unit and distribution box with a slightly moistened cloth. Ensure that liquids<br />

do not get into the devices. This can cause a short circuit.<br />

• Do not spray the cooling unit with liquids.<br />

NOTE: The cooling system uses water-propylene glycol mixture as a coolant. The coolant is not<br />

classified as a hazardous substance. However, if it leaks from the system, it must be disposed of<br />

following local regulations.<br />

How to Clean the In-Room Monitor<br />

When the liquid crystal panel becomes dusty or dirty, wipe gently with a soft cloth.<br />

• Do not rub the LCD panel with a hard or coarse material.<br />

• Do not apply pressure to the LCD surface.<br />

• Do not use OA cleaner as it will cause deterioration or discolor the LCD surface.<br />

How to Clean the Control Room Monitor, Keyboard and Mouse<br />

The Control Room Monitor should be cleaned using a soft dry or slightly moistened cloth only.<br />

Note that chemicals such as alcohol or disinfectants can cause a deterioration of the monitor<br />

housing and display and may lead to a reduction in image quality.<br />

The keyboard and mouse can be cleaned using compressed air (to blow out dust and debris from<br />

the keys) and a soft, dry or slightly moistened cloth with or without surface disinfectant.<br />

Do not spray the devices with liquids.<br />

How to Clean the Patient Feedback System<br />

Clean the device with a slightly moistened cloth. Ensure that liquids do not get behind the sleeve<br />

that covers the flexible arm. Do not spray the device with liquids.<br />

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CLEANING AND DISINFECTION<br />

NOTE: The patient feedback system should not be used if the sleeve shows any signs of<br />

deterioration.<br />

How to Clean the Patient Feedback Glasses<br />

Clean the device with a slightly moistened cloth. Do not spray the device with liquids.<br />

How to Clean the X-ray Image QA Phantom Holder<br />

Clean the X-ray Image QA Phantom Holder with a slightly moistened cloth.<br />

Ensure that liquids do not get into the device. This can cause a short circuit.<br />

Do not spray the device with liquids.<br />

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Disinfection Guidelines<br />

4.2 Disinfection Guidelines<br />

About Disinfection<br />

Disinfection is prescribed between patients for:<br />

• Patient Feedback System<br />

• Patient Feedback Glasses<br />

Perform disinfection with the tested disinfectants (below).<br />

NOTE: Alcohol-based cleaning and disinfection agents (e.g., Meliseptol, Mikrozid AF Liquid) are<br />

not suitable for the Patient Feedback Glasses. The use can influence the surface coating of the<br />

frame negatively.<br />

Disinfection is not prescribed for the following parts, but can be performed with the tested<br />

disinfectants (below), if desired.<br />

• ExacTrac Console<br />

• In-Floor Top Cover and On-Floor Cover<br />

• 4D Thermal Camera<br />

• Flat Panel Detector<br />

Tested Disinfectants<br />

Disinfectant Type<br />

Alcohol based<br />

Ex<strong>amp</strong>le<br />

Meliseptol, Mikrozid AF Liquid<br />

Alkylamine based Incidin Plus 2%<br />

Active oxygen based<br />

Aldehyde/chloride based<br />

Perform<br />

Antiseptica Kombi - Flächendesinfektion<br />

NOTE: Use only surface disinfectants released in your specific market.<br />

NOTE: <strong>Surface</strong> disinfectants may leave a residue. This can easily be removed using a dry cloth.<br />

NOTE: Use only cleaning and disinfection agents that are suitable for patient contact.<br />

NOTE: Brainlab evaluated the general ability of reprocessing and recommends compatible<br />

detergents, but the user is responsible for performing the actual disinfection in accordance with<br />

general regulatory requirements and the instructions of the detergent manufacturer.<br />

NOTE: Always closely follow the directions of the disinfectant manufacturer. Using cleaning fluids,<br />

disinfection wipes or cleaning procedures other than those specified may damage equipment. It is<br />

suggested to only use disinfectants verified by Brainlab to avoid damaging the system.<br />

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SYSTEM MAINTENANCE<br />

5 SYSTEM MAINTENANCE<br />

5.1 System Maintenance<br />

Introduction<br />

Brainlab recommends performing recurrent maintenance tasks for ExacTrac <strong>Dynamic</strong>, as<br />

described in the first part of this chapter. It covers different aspects for proper operation and shall<br />

be executed in certain time intervals. Depending on the type of the maintenance tasks, only<br />

certain groups of people are authorized to perform the tasks.<br />

Depending on the purchased system configuration, some devices may be missing and/or related<br />

tests may not be applicable.<br />

NOTE: If you are upgrading to ExacTrac <strong>Dynamic</strong> from a previous version with older system<br />

parts, some tests may still be required that are described in the previous user guide. For further<br />

information, see the final chapter of this user guide and the corresponding ExacTrac <strong>Dynamic</strong><br />

Clinical User Guide (version 1.1).<br />

The second part of this chapter gives guidance for handling damaged equipment and what to do<br />

in case the system fails in operation.<br />

Inspections by Brainlab Support<br />

• If a suitably qualified person is not available at the customer site, Brainlab support will carry out<br />

this inspection for a set fee. If you require a Brainlab support specialist, contact Brainlab<br />

support.<br />

• Brainlab recommends contacting Brainlab support to arrange for yearly inspections or to<br />

conclude a service contract.<br />

Inspections by Non-Brainlab Personnel<br />

The safety inspection must be performed by a qualified engineer:<br />

• Only qualified, trained and skilled personnel are allowed to perform safety inspections on<br />

electrical medical equipment.<br />

• Qualification shall include training on the subject, test equipment, knowledge, experience and<br />

acquaintance with the relevant technologies, standards and local regulations.<br />

• Personnel accessing the safety must be able to recognize possible consequences and risks<br />

arising from non-conforming equipment.<br />

Brainlab must be informed in writing immediately if equipment is deemed unsafe.<br />

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Aspects and Types of Recurrent Inspections<br />

5.2 Aspects and Types of Recurrent Inspections<br />

Types of Maintenance Tasks<br />

The different maintenance tasks can be divided into general periodic maintenance inspection<br />

tasks (PMI) and safety technical inspection tasks (STI). The tests marked with STI are important<br />

and mandatory to keep the system safe and functional during its expected service life.<br />

The different aspects of the tasks are:<br />

• Visual inspections<br />

• Calibration checks<br />

• Functional tests<br />

• Electrical safety measurements<br />

Before You Begin<br />

• Depending on the purchased system configuration, some devices may be missing and/or<br />

related tests may not be applicable.<br />

• If you are upgrading to ExacTrac <strong>Dynamic</strong> from a previous version with older parts, some<br />

tests of the old system parts may still be required. For further information, see the<br />

corresponding ExacTrac <strong>Dynamic</strong> Clinical User Guide (Version 1.1).<br />

• The recurrent maintenance inspections described in this chapter do not cover regulations for<br />

repair actions.<br />

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SYSTEM MAINTENANCE<br />

5.3 Authorized Personnel for Recurrent Inspections<br />

Authorized Personnel<br />

Two groups of people are authorized to carry out the recurrent maintenance tasks as described in<br />

this chapter.<br />

Qualified Clinical Personnel<br />

Brainlab Support or Brainlab-Authorized<br />

Support<br />

• ExacTrac <strong>Dynamic</strong> users who are familiar with the<br />

system. Knowledge and training for operating the system<br />

is sufficient.<br />

• This group shall not disassemble any part of the system.<br />

• Brainlab service engineers or electrically skilled technicians<br />

who were trained and authorized by Brainlab.<br />

• Extended knowledge in electrical safety and detailed<br />

training and authorization in certain installation tasks<br />

for ExacTrac <strong>Dynamic</strong> is required.<br />

Only Brainlab support specialists or Brainlab authorized support are permitted to perform annual<br />

inspections.<br />

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Warnings and Maintenance Advice<br />

5.4 Warnings and Maintenance Advice<br />

Warnings<br />

Warning<br />

Only qualified service personnel are allowed to install and service the HE tube unit and<br />

external cooling device.<br />

Warning<br />

Only trained service engineers/qualified service personnel are allowed to install or service<br />

the distribution boxes and Computer Cabinet. Connection to hospital mains has to be done<br />

by an electrician familiar with the local regulatory requirements.<br />

Warning<br />

Do not service or maintain the system while patient treatment is ongoing.<br />

User-Serviceable Parts<br />

The ExacTrac <strong>Dynamic</strong> system does not contain any user-serviceable parts: No component shall<br />

be exchanged with non-Brainlab authorized articles. For exchange of damaged or lost parts,<br />

contact Brainlab service.<br />

Maintenance Advice<br />

Maintenance Advice<br />

Electromagnetic compatibility (EMC)<br />

Service contracts<br />

Test preconditions<br />

No extra test steps are required for EMC.<br />

If a service contract has been purchased, Brainlab will<br />

automatically perform the annual inspection.<br />

If you do not have a service contract, contact Brainlab<br />

support to arrange the inspection.<br />

Once installed, do not attempt to disconnect the Exac-<br />

Trac <strong>Dynamic</strong> system from the mains power supply or<br />

the potential equalization network. The system has no<br />

detachable power cord, the connection is permanent.<br />

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5.5 Maintenance Schedule<br />

When to Conduct Maintenance Tests<br />

Interval<br />

Authorized Personnel<br />

Test Group Test Relevant Configuration<br />

See<br />

Housings, surfaces<br />

Visual inspection (STI)<br />

Connectors and cables<br />

Documentation<br />

All Page 85<br />

Labels and symbols<br />

Qualified clinical<br />

personnel<br />

Functional test<br />

Cooling system pressure<br />

Cooling system performance<br />

X-ray with cooling<br />

system<br />

Page 86<br />

Workstation clock<br />

All<br />

Accuracy check<br />

Image quality<br />

X-ray<br />

Page 87<br />

Dose area product<br />

X-ray with DAP*<br />

Emergency stop interlock<br />

Door contact interlock<br />

X-ray<br />

Brainlab support<br />

or Brainlab-authorized<br />

support<br />

Functional tests (STI)<br />

MV beam status interlock<br />

X-ray exposure redundancy<br />

System off interlock redundancy<br />

X-ray signal light<br />

MV beam inhibit<br />

All<br />

X-ray<br />

All<br />

X-ray<br />

Elekta<br />

Page 89<br />

Page 93<br />

Accuracy checks<br />

Cooling system fluid level<br />

PDU clock<br />

X-ray with cooling<br />

system Page 92<br />

All<br />

Electrical safety<br />

measurement (STI)<br />

PE resistance<br />

Touch current<br />

All Page 95<br />

* DAP: dose area product<br />

Interval and Authorized Personnel<br />

= Monthly Qualified clinical personnel<br />

= Annually Brainlab support or Brainlab-authorized support<br />

= Every two years Brainlab support or Brainlab-authorized support<br />

Maintenance Templates<br />

Templates for monthly and annual checks are available in Chapter 7, Maintenance Templates. You<br />

can copy them and fill them out for your records.<br />

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Description of the Maintenance Tasks<br />

5.6 Description of the Maintenance Tasks<br />

Maintenance Tasks<br />

The following pages describe the specific tests to be performed. Related links to the following<br />

chapters are in the maintenance schedule table.<br />

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5.6.1 Visual Inspection (STI), Monthly<br />

Visual Inspection<br />

For safety reasons, a qualitative visual inspection of the connections, wiring of all potential<br />

equalization conductors and parts of the system should be conducted.<br />

Test/Component<br />

Housings, surfaces<br />

Inspection<br />

• Inspect all accessible ExacTrac <strong>Dynamic</strong><br />

device surfaces and search for damage.<br />

The test is passed if the surfaces are not<br />

cracked, no internal parts get accessible<br />

and the normal function can be maintained.<br />

• All parts and accessories are complete (no<br />

missing parts).<br />

• No fan outlets are blocked.<br />

• Control Room Monitor<br />

• Keyboard and mouse<br />

• ExacTrac Console<br />

• In-Room Monitor<br />

• Flat Panel Detector Cover<br />

• On-Floor Cover and In-Floor Cover<br />

• Camera cover<br />

• Computer Cabinet<br />

• X-ray Generator<br />

Connectors and cables<br />

• Inspect the accessible cables and connectors for correct attachment and wear. The test is<br />

passed if the connector is fully attached and fixed with its holdings screws.<br />

• Confirm the cable sheath is fully closed and has no signs of exceeded tension or drill.<br />

• Confirm accessible potential earth (PE) wires are correctly connected: The green-yellow PE<br />

wire that connects the In-Room Monitor with the ceiling-mounted monitor arm is subject to<br />

several bending movements. The test is passed if the wire has no sign of wear and is fixed<br />

on both ends.<br />

Documentation<br />

Labels and symbols<br />

Confirm that all accompanying system documentation<br />

is accessible.<br />

• Consult chapter 1 of this guide to identify important<br />

labels and symbols, such as button<br />

symbols on the console or device type labels<br />

with serial numbers.<br />

• Inspect the labels and markings for readability.<br />

• User guides<br />

• Generator documentation<br />

• Maintenance reports<br />

• Computer Cabinet: Type label<br />

• X-ray Generator:<br />

- Type label<br />

- Warning: Electricity<br />

• In-room distribution boxes: Warning: Electricity<br />

• ExacTrac Console:<br />

- Follow the instructions for use<br />

- Radioactive material or ionizing radiation<br />

• Control room distribution box: Warning:<br />

Electricity<br />

• X-ray Signal Light: Radioactive material or<br />

ionizing radiation<br />

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Functional Test, Monthly<br />

5.6.2 Functional Test, Monthly<br />

Pressure Check and Performance Check<br />

Test/Component<br />

Cooling System Distribution Box<br />

Water/Air Cooler or Water/Water<br />

Heat Exchanger<br />

Inspection<br />

Pressure check:<br />

Check that the pressure gauge of the distribution box indicates<br />

a correct pressure level (2-3 bar).<br />

Performance check:<br />

If there is a significant increase of pump noise in the<br />

cooling system, call Brainlab service for filter cleaning.<br />

Otherwise the cooling system may get damaged by a<br />

clogged pump.<br />

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SYSTEM MAINTENANCE<br />

5.6.3 Accuracy Check, Monthly<br />

Workstation Clock<br />

Confirm that the time displayed on the Windows task bar (ExacTrac <strong>Dynamic</strong> Workstation<br />

and/or R&V workstation in the control room) is correct and synchronized.<br />

Image Quality<br />

ExacTrac <strong>Dynamic</strong> X-ray is not a diagnostic X-ray device. The image quality is not suitable for<br />

medical diagnosis in common clinical questions because of the needed distance between X-ray<br />

source and flat panels. For image-guided radiotherapy (IGRT), the image quality must be<br />

sufficient for an accurate positioning relative to the imaging source of the IGRT treatment<br />

planning.<br />

Prerequisites:<br />

• Phantom with implanted target sphere (e.g., System Calibration Phantom) and a suitable<br />

plan loaded on the linac.<br />

• A calibrated ExacTrac <strong>Dynamic</strong> system.<br />

To ensure a sufficient image quality for IGRT:<br />

Step<br />

1. Place the phantom on the couch with an angle and deviation to the target position.<br />

2. Acquire X-rays with ExacTrac <strong>Dynamic</strong>.<br />

3. Inspect the fusion result with Spyglass or other Fusion Verification Tools to confirm that<br />

the image quality is sufficient to verify the fusion result.<br />

4. Using the drawing tools, exclude the target sphere from the area of interest.<br />

5. Position the phantom with ExacTrac <strong>Dynamic</strong>.<br />

6. Acquire images with the linac to verify position of the target sphere.<br />

7. Confirm that the target sphere is positioned within 1 mm/1° of the target position.<br />

8. Repeat steps 1-7 with different starting positions.<br />

An end-to-end test from a CT to position is strongly recommended.<br />

The test is passed if the position of the sphere is always within 1 mm/1° of the target position.<br />

Dose Area Product<br />

Validates that the dose area produced by the system is within limits.<br />

NOTE: Only applicable if the dose area product functionality is installed.<br />

Step<br />

1. Measure the dose area product with an appropriate measurement device.<br />

2. Mount the device in the X-ray field.<br />

The simplest way is to mount it in front of the Flat Panel Detector.<br />

For the test it is sufficient to test these key values:<br />

Left Tube<br />

Right Tube<br />

40 kV 40 kV<br />

80 kV 80 kV<br />

140 kV 140 kV<br />

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Accuracy Check, Monthly<br />

The measured dose area product for the above-mentioned exposure settings must be within 25%<br />

of the dose area product that ExacTrac <strong>Dynamic</strong> calculates. If the dose area product is out of<br />

range, Brainlab service must recalibrate the system.<br />

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SYSTEM MAINTENANCE<br />

5.6.4 Functional Test (STI), Yearly<br />

About Interlock Tests<br />

1 2 3<br />

Figure 36<br />

The scope of this test includes all interlock lines of the CIU, which represent critical control signals<br />

for ExacTrac <strong>Dynamic</strong> operation. They are indicated with LED patterns on the STATUS 1,<br />

POWER 2 and ILK 3 parts of the CIU.<br />

The interlock tests are split into two test categories, depending on the nature of the interlock<br />

circuits: Functional single line and redundancy differential lines.<br />

Signal<br />

EMO OFF<br />

DOOR CLOSED<br />

MV OFF<br />

Inspection (Functional Single Line)<br />

• Within Brainlab circuits, these signals are designed so<br />

that any damage will lead to an assertion with safe<br />

blocking of the related function. The interlocks have to<br />

be checked on a regular basis.<br />

• The functional check is executed by forcing the signal<br />

input to the inactive state and check the correct system<br />

reaction and status LEDs.<br />

Signal<br />

EXP<br />

SYS_OFF<br />

Inspection (Redundancy Differential Lines)<br />

• These interlocks provide signal redundancy because<br />

two independent channels propagate the status information.<br />

If one of the signals fail by permanent assertion,<br />

the system will fall back into a safe inoperative<br />

state, which is detected by the user immediately.<br />

• If one signal is permanently active and unable to assert<br />

the inhibiting function, system operation remains safe<br />

and normal due to the redundancy of the second channel.<br />

• Nevertheless, in this scenario, redundancy is lost and<br />

must therefore be checked regularly: The redundancy<br />

check is performed by inspecting the related interlock<br />

indicator LEDs at the CIU front panel. For the test, the<br />

LEDs must be inspected in normal operation, inactive<br />

status and in a forced, invalid status by unplugging the<br />

related cable.<br />

The LEDs can show three states:<br />

• Off (valid inactive)<br />

• Red (invalid, inactive)<br />

• Green (valid, active)<br />

Depending on the test steps, certain LED colors are to be verified.<br />

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Functional Test (STI), Yearly<br />

Before You Begin<br />

• Some tests might not apply because they depend on the system configuration. Identify which<br />

interlock signals are not used in the installation and mark them N/A.<br />

• Depending on the linac type, the linac must be online as it is a source for interlock signals.<br />

How to Perform the Functional Interlock Tests<br />

Prepare for the tests by powering up the ExacTrac <strong>Dynamic</strong> system. Enter the X-ray Test<br />

Acquisition page. Close the treatment door and ensure that the linac is in Beam Off status.<br />

Verify that X-ray exposures can be acquired with ExacTrac <strong>Dynamic</strong>.<br />

Verify the LED activation. Go to the Computer Cabinet, inspect the CIU front panel and inspect<br />

the following LEDs:<br />

• EMO OFF LED<br />

• DOOR CLOSED LED<br />

• MV OFF LED<br />

Step<br />

1. Emergency stop interlock. The following options must be considered:<br />

Varian installation: Unplug the Varian ILK connector (MC-22-a) or EXT ILK connector<br />

(MC-22-b) depending on the purchased configuration of the system.<br />

Elekta installation: Unplug the Elekta ILK connector (MC-25-b).<br />

• Verify that the EMO OFF LED is switched off at the CIU front panel.<br />

• Verify that the X-ray Generator is switched off and that the GENERATOR ON LED<br />

has turned off.<br />

2. Door contact interlock (applicable if door contact is installed).<br />

Open the treatment door and check that:<br />

• The DOOR CLOSED LED is switched off at the CIU front panel.<br />

• Exposures are not possible at the console.<br />

3. Check MV beam OFF interlock.<br />

Varian installation: Unplug the EXT ILK connector (MC-22-b).<br />

Elekta installation: No unplug is required.<br />

• Verify that the MV OFF LED turned on at the CIU front panel.<br />

• Check that the menu (upper left) on the screen is inactive on the console.<br />

4. Plug in all removed connectors.<br />

5. Check that the EMO OFF LED is on and the system interlocks DOOR CLOSED and MV<br />

OFF work normally again.<br />

Test fail criteria:<br />

In case of a fail, call Brainlab service for repair actions. Be aware that the system is degraded and<br />

may introduce a higher risk in clinical operation as it is no longer reacting on an interlock.<br />

How to Perform the Redundancy Interlock Tests<br />

Prepare for the tests by powering up the ExacTrac <strong>Dynamic</strong> system. Enter the X-ray Test<br />

Acquisition page. Close the treatment door and assure that the linac is in Beam Off status. Verify<br />

that X-ray exposures can be acquired with ExacTrac <strong>Dynamic</strong>.<br />

Step<br />

1. Check valid inactive interlock states.<br />

CIU front panel: Both the SYS_OFF and EXP_CON LEDs must be off.<br />

If the LEDs show red or green in this step, the test fails.<br />

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SYSTEM MAINTENANCE<br />

Step<br />

2. Unplug the console cable plug MC-22-c.<br />

3. Check invalid interlock states.<br />

CIU front panel: Both the SYS_OFF and EXP_CON LEDs must be showing invalid (red).<br />

If the LEDs show either green or off in this step, the test fails.<br />

4. Plug in all removed connectors.<br />

5. Repeat step 1 to return system to normal operation.<br />

Test fail criteria:<br />

In case of a fail, call Brainlab service for repair actions, even though the system may work<br />

normally and without degradation due to the initial redundancy. Be aware that the safety<br />

redundancy is lost in that case.<br />

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Accuracy Check, Yearly<br />

5.6.5 Accuracy Check, Yearly<br />

Accuracy Checks<br />

Test/Component<br />

Cooling system heat exchanger unit<br />

Inspection<br />

Check the cooling fluid level in the reservoir. If it is 2 cm<br />

below maximum, perform a leakage test and add coolant<br />

to 1 cm below the neck top of the reservoir cap. Use only<br />

the cooling liquid provided by Brainlab.<br />

PDU clock synchronization: Power<br />

Distribution Unit (PDU) in the Computer<br />

Cabinet<br />

Confirm that the time displayed on the Auto-Start Timer<br />

in the Power Distribution Unit is correct.<br />

Warning<br />

If you notice or suspect coolant is leaking, switch off the X-ray generator. Contact Brainlab<br />

support and do not use the system.<br />

NOTE: The used cooling fluid consists of a mixture of propylene glycol (ca. 34%) and water (ca.<br />

66%). If there is a coolant system leak, wear gloves while cleaning up.<br />

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SYSTEM MAINTENANCE<br />

5.6.6 Functional Test, Yearly<br />

X-ray Signal Light Test<br />

This test checks the function of the Brainlab X-ray Signal Light in the control room and the<br />

treatment room.<br />

Observe the warning lights and check whether they respond as intended. As you cannot be in the<br />

treatment room while X-rays are possible, it might be necessary to record the warning lights in the<br />

treatment room while you operate the ExacTrac <strong>Dynamic</strong> software.<br />

The customer is responsible for verifying prior to installation if the X-ray Signal Light is compliant<br />

with local safety regulations. The customer is also responsible for deciding whether the X-ray<br />

Signal Light shall be installed at their location.<br />

Signal light functionality tests shall be performed periodically.<br />

For the performance of custom warning lights, use the Indicator Light Visual Tests.<br />

For correct operation of the X-ray Signal Light, check that the installed light behaves according<br />

to this table:<br />

ExacTrac <strong>Dynamic</strong> Operational<br />

States<br />

Brainlab X-ray<br />

Signal Light –<br />

Yellow L<strong>amp</strong><br />

Brainlab X-ray<br />

Signal Light –<br />

Red L<strong>amp</strong><br />

External Signal<br />

Light Output<br />

Corresponding<br />

Console<br />

Status<br />

X-ray Generator is off Off Off Off<br />

ExacTrac <strong>Dynamic</strong> is<br />

started, X-ray Generator is<br />

on<br />

ExacTrac <strong>Dynamic</strong> waits<br />

for an exposure with the<br />

next user interaction<br />

ExacTrac <strong>Dynamic</strong> processes<br />

an X-ray exposure<br />

(radiation)<br />

Continuing five seconds after<br />

exposure<br />

On Off Off<br />

On Steady, red Active<br />

On Flashing red Active<br />

On Flashing red Off<br />

X-ray button<br />

is illuminated<br />

green<br />

Trefoil symbol<br />

is illuminated<br />

yellow during<br />

exposure<br />

This table represents the default configuration of the system. Different configurations are available<br />

for local requirements. In case of such deviations, adapt the table as defined in the customization.<br />

MV Beam Inhibit (Elekta Only)<br />

1<br />

Figure 37<br />

For this test, certain operational workflow steps have to be entered on ExacTrac <strong>Dynamic</strong> and<br />

the linac from the control room, while certain LEDs on the CIU in the Computer Cabinet have to<br />

be observed.<br />

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Functional Test, Yearly<br />

A video recording device for Computer Cabinet LED observation (e.g., laptop with webcam) is<br />

required for this test. Set up the video recording device to record the LED on the CIU front panel<br />

for the GATE ILK CLOSED LED 1.<br />

Prepare the ExacTrac <strong>Dynamic</strong> and linac systems for operation.<br />

An error can be detected in the active or in the inactive status of the examined MV Beam Inhibit<br />

Interlock. Both states must be entered for this test.<br />

• Active status (LED ON): The MV Beam Inhibit signal is set with the intent that the linac MV<br />

beam can be activated.<br />

• Inactive status (LED OFF): The MV Beam Inhibit signal is cleared with the intent that the linac<br />

MV beam is blocked and cannot be started.<br />

Perform the tests as described and fill in the RESULT column of the test with PASS or FAIL.<br />

How to Test the MV Beam Inhibit Interlock<br />

Step<br />

1. Inactive test: Perform a patient positioning workflow for a treatment on the ExacTrac <strong>Dynamic</strong><br />

system.<br />

Ensure that the ExacTrac <strong>Dynamic</strong> system shows an inaccurate position.<br />

2. Try to start the MV Beam on the linac console.<br />

The test passed if:<br />

• ExacTrac <strong>Dynamic</strong> shows the position "inaccurate" when the GATE-ILK CLOSED<br />

LED is off, and the linac MV Beam is inhibited.<br />

3. Active test: Perform a patient positioning workflow for a treatment and on the ExacTrac<br />

<strong>Dynamic</strong> system.<br />

Ensure that the ExacTrac <strong>Dynamic</strong> system shows an accurate position.<br />

4. Try to start the MV Beam on the linac console.<br />

The test passed if:<br />

• ExacTrac <strong>Dynamic</strong> shows the position "accurate" when the GATE-ILK CLOSED LED<br />

is on, and the linac MV Beam can be started.<br />

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SYSTEM MAINTENANCE<br />

5.6.7 Electrical Safety Measurements (STI)<br />

Electrical Safety Measurements<br />

Test/Component<br />

PE resistance measurement<br />

Touch current measurement<br />

Inspection<br />

• Switch off the system and remove certain data cables.<br />

• The limit value is 0.2 Ω for the initial test and for recurrent<br />

tests as described below. If the electrical impedance<br />

between the reference point and ExacTrac <strong>Dynamic</strong><br />

rises above the specified level, it must be reduced.<br />

• The measurement device used for initial and recurrent<br />

tests must be able to drive 200 mA into 500 mΩ. The<br />

open circuit voltage must not exceed 24 V.<br />

• All data and power cables must be reconnected, and<br />

the system must be switched on and fully operational.<br />

• AC measurements must be taken for every component.<br />

To do so, use a calibrated multimeter and a suitable<br />

measuring device as described in IEC 60601-1.<br />

The limit for all measurements is 100 μA in AC measurement<br />

mode.<br />

• Reference point for all current measurements is the<br />

central PE point of the treatment room as used in the<br />

PE resistance test.<br />

How to Perform a PE Resistance Test<br />

1<br />

2<br />

3<br />

Figure 38<br />

Step<br />

1. Disconnect the following data cables from the device to be tested.<br />

• At the workstation computer, inside the computer cabinet:<br />

- Disconnect flat panel sync cable 1 from COM1 port<br />

- Disconnect both LAN data cables for the flat panel devices 2 from the left Ethernet<br />

slot card (remember which cable is in top position for proper reconnection afterwards)<br />

• At the CIU:<br />

3 Remove and isolate CAN BUS cable<br />

2. Ensure that there is no contact between the removed cables and other device surfaces.<br />

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Electrical Safety Measurements (STI)<br />

Step<br />

3. Measure the electrical impedance between each test point of the devices in the steps below<br />

and the potential equalization bar or star point ground of the treatment room.<br />

4.<br />

Note down each test point resistance measurement value. All values must be below the<br />

limit to pass the PE test.<br />

5.<br />

In-Room Monitor: Handle bar (part of ceiling arm structure).<br />

Flat Panel Detector (left and right):<br />

• Remove the magnetic Flat Panel Detector Cover Plate.<br />

• Plug the testing cable to the marked PE test socket.<br />

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SYSTEM MAINTENANCE<br />

Step<br />

6.<br />

1<br />

X-ray Tubes (left and right):<br />

For On-Floor installations 1:<br />

• Remove the On-Floor Cover.<br />

• Attach the tip of the test device to a fixation screw of the collimator device on top of the<br />

tube.<br />

For In-Floor installations 2:<br />

• Remove the top cover sheet from the floor-boxes and remove the plate with the illumination<br />

element.<br />

• Attach the tip of the test device to the height-adjustable metal frame of the entire box.<br />

2<br />

7.<br />

Computer Cabinet:<br />

• Open the front cabinet door.<br />

• Attach the tip of the test device to the earthing bolt of the door.<br />

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Electrical Safety Measurements (STI)<br />

Step<br />

8.<br />

X-ray Generator Sub (2):<br />

• Open the front cover of the sub generator cabinet.<br />

• Attach the tip of the test device to the earthing bolt of the cover.<br />

How to Perform the Touch Current Test with ESA 620 Tester and Flexible Foil Pad<br />

Figure 39<br />

• The required touch current tests are from each related test point to the central PE point.<br />

• Use a hand-sized conductive pad to cover the test points.<br />

• Avoid touching the conductive part of the pad.<br />

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SYSTEM MAINTENANCE<br />

Step<br />

1. Connect the cables from the measurement device to the measurement points using conductive<br />

foil such as self-adhesive copper foil or standard tin foil.<br />

2.<br />

Connect the pad via cable to the measurement device and close the circuit toward the PE<br />

point.<br />

Minimum foil size: 20 x 10 cm (8" x 4").<br />

3.<br />

Attach the foil to the measurement surface, or wrap the foil around the component to be<br />

tested. The image shows the AC µA setup for the touch current measurement.<br />

Measure the electrical impedance of the devices in the steps below. Note the highest<br />

reading for your records.<br />

In-Room Monitor: Attach the pad to the screen surface.<br />

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Electrical Safety Measurements (STI)<br />

Step<br />

4.<br />

5.<br />

Flat Panel Detector: Remove the magnetic cover of the panel screen area and attach the<br />

pad to the detector surface. Avoid touching the PE grounded metal structure.<br />

In-Floor Box:<br />

1<br />

• In-Floor Box (Varian) 1: Remove the top cover and apply the pad to the plastic cover<br />

with the illumination element. Avoid touching the grounded metal frame during the<br />

measurement.<br />

• In-Floor Box (Elekta) 2: Remove the top cover and apply the 3 pad to the plastic cover<br />

with the illumination element. Avoid touching the grounded metal frame during the<br />

measurement.<br />

NOTE: For detailed information on completing touch current tests, consult the instruction manual<br />

provided with the measurement device, or refer to the relevant sections in the IEC 60601-1<br />

standard.<br />

2<br />

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SYSTEM MAINTENANCE<br />

5.7 Handling Damaged Equipment<br />

Detected Damage<br />

Do not use the system or system components if:<br />

• The power cable or plug is damaged or frayed.<br />

• Liquid has been spilled into the system.<br />

• The system does not operate normally when the operating instructions are followed.<br />

• System components have been dropped or the cabinet has been damaged.<br />

• System components exhibit a distinct decrease in performance, indicating the need for<br />

servicing.<br />

• Liquids leak from the system.<br />

• Smoke is emitted by the system.<br />

Corrective Action<br />

• Switch off the system and immediately disconnect from the utility power.<br />

• Contact Brainlab support.<br />

• Attach a suitable notice such as "DO NOT USE" to the equipment to prevent it from being used<br />

inadvertently.<br />

If you continue to use equipment that has been found to be defective during an inspection, you<br />

risk causing injury to the patient.<br />

Should any power supply malfunction, only qualified personnel are permitted to perform<br />

troubleshooting.<br />

Information Available Upon Request<br />

Upon request, circuit diagrams, component part lists, descriptions, calibration instructions or other<br />

information to assist service personnel to repair ExacTrac <strong>Dynamic</strong> parts specified as repairable<br />

by service personnel, will be supplied by Brainlab.<br />

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Returning Damaged Equipment<br />

5.8 Returning Damaged Equipment<br />

Reporting Damaged Equipment<br />

Any damaged equipment should be immediately reported to Brainlab support.<br />

Brainlab support will ask you for the following information:<br />

• Serial number of the faulty component (inscribed on the component).<br />

• A description of the problem.<br />

• Did the defect occur during the treatment?<br />

• Was any unintended radiation delivered to the customer?<br />

• Did any user or third-party injury occur?<br />

If the damaged happened because of a collision with the linac gantry (e.g., the couch extension<br />

fell to the floor), support will also need to know:<br />

• Was a patient on the couch when the collision happened?<br />

• Was a Brainlab device (e.g., ExacTrac <strong>Dynamic</strong>) controlling the movement, or if it was a<br />

manual movement, was the moving part a Brainlab device?<br />

Repair and Replacement<br />

The Brainlab support specialist will:<br />

• Provide you with cost estimate for repair or replacement.<br />

• Inform you when your system is expected to be operational again (usually within 48 hours).<br />

Removing Damaged Equipment<br />

Only remove defective components if instructed to do so by Brainlab support.<br />

Return Instructions<br />

• Use suitable packaging material and properly wrap and package each defective component in<br />

its original box, in the replacement product box, or in a suitable box so that it will not sustain<br />

further damage.<br />

• Where applicable, clean and disinfect component before returning it. Ensure that equipment is<br />

not activated due to neutron radiation within the treatment room (e.g., Flat Panel Detectors).<br />

In case of activation, contact Brainlab Support prior to sending activated equipment.<br />

• Complete and return the Return Material Authorization form (RMA) that was sent to you or<br />

accompanied the replacement part.<br />

• Securely tape the box shut.<br />

• Ship the defective product to one of the return addresses. Contact your Brainlab support<br />

specialist to find out where to return the product.<br />

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COMPLIANCES AND SAFETY INFORMATION<br />

6 COMPLIANCES AND<br />

SAFETY INFORMATION<br />

6.1 ExacTrac <strong>Dynamic</strong> System Electronics<br />

Regulatory Background<br />

All ExacTrac <strong>Dynamic</strong> system components located in the patient vicinity fulfill safety<br />

requirements for electrical medical devices and systems, either as a result of individual<br />

component certification, or as a result of specific additional installation measures. The procedures<br />

in both cases are generally derived from the General Safety and Performance Requirements of<br />

European Regulation 2017/745, Medical Device Regulation ("MDR"), and implemented in<br />

accordance with the following standards and its collateral documents:<br />

• IEC 60601-1 [Medical electrical equipment - Part 1 General Requirements for Safety]<br />

Notes<br />

Warning<br />

If this equipment is modified, appropriate inspection and testing must be conducted to<br />

ensure continued safe use of the equipment.<br />

Be aware that electronic devices can be damaged by X-ray radiation. Keep ExacTrac<br />

<strong>Dynamic</strong> components away from the beam path.<br />

Safety Features<br />

Two main electrical safety features are implemented in the ExacTrac <strong>Dynamic</strong> system to ensure<br />

patient safety in accordance with IEC 60601-1:<br />

• An additional protective earth that provides potential equalization for the system and its<br />

components so that patient touch current is kept to a minimum.<br />

• Where required, a medical separation device ensures galvanic insulation of electrical parts in<br />

the patient vicinity.<br />

Operating and Storage Conditions<br />

Operating Conditions<br />

Storage Conditions<br />

Humidity range 30% to 70% 15% to 75%, non-condensing<br />

Ambient temperature 16 °C to 35 °C -10 °C to 50 °C<br />

Atmospheric pressure 800 hPa to 1013 hPa 700 hPa to 1013 hPa<br />

Large temperature changes (> 5°) can cause an inaccuracy in the system. The user must perform<br />

calibration verification in case of large temperature changes.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 103


ExacTrac <strong>Dynamic</strong> System Electronics<br />

Do not block or cover slots on system cover or housing or other delivered equipment (e.g.,<br />

monitor or workstation). Air must be allowed to circulate through these slots to ensure that the<br />

system operates properly and does not overheat.<br />

NOTE: If parts of the system are standing in the water or water was spilled over parts of the<br />

system (e.g., generator), switch off the system and the generator and inform Brainlab support.<br />

Warning<br />

Do not operate the system in d<strong>amp</strong> or humid environments. Otherwise, the system may<br />

short circuit or be irreparably damaged.<br />

Warning<br />

Do not place system components near a heat radiator or heater register.<br />

Electrical Safety – ExacTrac <strong>Dynamic</strong> Classification<br />

ExacTrac <strong>Dynamic</strong> is classified as Class 1 medical electrical equipment according to IEC<br />

60601-1.<br />

Classification<br />

Class 1<br />

Definition<br />

Classification regarding protection against electric shock.<br />

Refers to electrical equipment in which protection against electric shock does<br />

not rely on basic insulation only, but which includes an additional safety precaution<br />

in that means are provided for accessible parts of metal or internal<br />

parts of metal to be protectively earthed.<br />

Power Specifications<br />

The ExacTrac <strong>Dynamic</strong> system has the following power requirements:<br />

• Nominal power consumption: 500 W (continuous)<br />

• 1.6 kVA (rated power input)<br />

• 100 to 240 VAC, single-phase, 50/60 Hz<br />

The X-ray generator has the following power requirements:<br />

• 35 kVA (rated power input)<br />

• 200 to 480 VAC, triple-phase, in steps<br />

• 65 kVA maximum peak power input (100 ms duration, related to exposure time)<br />

Procedure in the Case of Critical Malfunctions<br />

In the event of an electrical malfunction, follow established emergency procedure.<br />

Only personnel trained in fire fighting procedures should attempt to put out an electrical fire. Only<br />

fire extinguishers designed to put out electrical fires should be used. Do not use water under any<br />

circumstances.<br />

Warning<br />

In case of malfunctions, discontinue treatment immediately and contact your Brainlab<br />

support specialist.<br />

Connection Restrictions<br />

Do not connect miscellaneous equipment to the ExacTrac <strong>Dynamic</strong> data interfaces or the<br />

integrated power rail. Only equipment specified by Brainlab may be connected to the system.<br />

Do not connect the ExacTrac <strong>Dynamic</strong> system components directly to the mains power supply.<br />

To guarantee electrical safety for both the user and patient, ExacTrac <strong>Dynamic</strong> system<br />

components may only be powered via the integrated power rail.<br />

104 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


COMPLIANCES AND SAFETY INFORMATION<br />

Warning<br />

The use of accessories and cables other than those specified (with the exception of<br />

transducers and cables sold by Brainlab as replacement parts) may result in increased<br />

emissions or decreased immunity of the equipment.<br />

Proper Handling of Generator Errors to Prevent Severe Damage<br />

Be aware that certain generator error messages (such as "KV DIFF") can hint at internal<br />

high voltage arcing effects during exposures. Continuous arcing can burn carbon traces<br />

into the surfaces, making major component changes necessary (e.g., the X-ray tubes).<br />

If such generator errors occur only occasionally, there is little cause for concern. If they<br />

occur repeatedly, avoid further such events by using other operational parameters or stop<br />

using the generator. Ask for Brainlab support as long as minor cleaning and re-greasing<br />

with silicone of insulation surfaces is sufficient.<br />

Do not attempt to reproduce the error. Instead, notify Brainlab support.<br />

Electrical Safety with the X-ray Generator<br />

Warning<br />

Even if the system is switched off, voltage is still applied to the X-ray generator in the<br />

power cabinet, at the power supply connections, and in the control circuits. To prevent<br />

serious injury or death, only trained technicians may remove the panels of the cabinet or<br />

exchange X-ray tubes.<br />

ExacTrac <strong>Dynamic</strong> Power Distribution<br />

In the ExacTrac <strong>Dynamic</strong> system, power is distributed by the Computer Cabinet.<br />

The Computer Cabinet provides the overall power for all parts of the system, such as cameras,<br />

monitors and X-ray flat panels.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 105


Electromagnetic Compatibility Information<br />

6.2 Electromagnetic Compatibility Information<br />

Background<br />

The following information will provide instructions about how to maintain and operate ExacTrac<br />

<strong>Dynamic</strong> to keep it safe and functional with regard to EMC during its expected service life.<br />

ExacTrac <strong>Dynamic</strong> does not contain any device which needs maintenance to ensure EMC<br />

compliance of the device.<br />

Warning<br />

Use of this equipment adjacent to or stacked with other equipment should be avoided<br />

because it could result in improper operation. If such use is necessary, this equipment and<br />

the other equipment should be observed to verify that they are operating normally.<br />

Electromagnetic Immunity<br />

ExacTrac <strong>Dynamic</strong> is designed and tested for reliable operation in the environment of<br />

radiotherapy sites. Nevertheless there is a small residual risk of electromagnetic interference<br />

between systems.<br />

ExacTrac <strong>Dynamic</strong> may show side effects like short image outages in the control room or<br />

flickering of control keys. Such effects do not have an influence on the ExacTrac <strong>Dynamic</strong><br />

functions. The effects may be reduced by rearranging the system cable traces relative to other<br />

systems in the room. For further information, contact Brainlab support.<br />

Portable and mobile RF communications equipment can affect the systems.<br />

The equipment has been tested for radiated RF immunity only at selected frequencies. If emitters<br />

are used nearby at other frequencies, it could result in improper operation.<br />

Warning<br />

Portable RF communications equipment (including peripherals such as antenna cables and<br />

external antennas) should be used no closer than 30 cm (12 inches) to any part of the<br />

ExacTrac <strong>Dynamic</strong> system, including its cables specified by Brainlab. Otherwise,<br />

degradation of the performance of this equipment could result.<br />

ExacTrac <strong>Dynamic</strong> is intended for use in an electromagnetic environment in which radiated RF<br />

disturbances are controlled.<br />

Guidance and Manufacturer's Declaration – Electromagnetic Emissions<br />

Electromagnetic Emission<br />

Emission test<br />

Conducted and radiated RF emissions<br />

Standard<br />

CISPR11<br />

Harmonic distortion IEC 61000-3-2<br />

Voltage fluctuations and flicker IEC 61000-3-3<br />

ExacTrac <strong>Dynamic</strong> is intended for use in the following specified electromagnetic environment.<br />

The customer or the user of ExacTrac <strong>Dynamic</strong> should ensure that it is used in such an<br />

environment:<br />

ExacTrac <strong>Dynamic</strong> complies with RF emissions CISPR 11, Group 1, Class A: ExacTrac<br />

<strong>Dynamic</strong> uses RF energy for its internal function only. Therefore, its RF emissions are very low<br />

and are not likely to cause any interference in nearby electronic equipment. It is suitable for use in<br />

all establishments other than domestic and those directly connected to the public low-voltage<br />

power supply network that supplies buildings used for domestic purposes. Harmonic emissions<br />

comply with IEC 61000-3-2, Class A. Voltage fluctuations and flicker emissions comply with IEC<br />

61000-3-3.<br />

106 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


COMPLIANCES AND SAFETY INFORMATION<br />

Warning<br />

ExacTrac <strong>Dynamic</strong> is intended for use by healthcare professionals only. The system may<br />

cause radio interference or may disrupt the operation of nearby equipment. It may be<br />

necessary to take corrective action, such as reorienting or relocating the device or<br />

shielding the location.<br />

• Reposition or relocate the affected device(s).<br />

• Increase the distance between the equipment and the affected device.<br />

• Attach the affected device to a different power source.<br />

• Do not operate ExacTrac <strong>Dynamic</strong> if electromagnetic interference is suspected.<br />

• Brainlab is not responsible for interference caused by the use of interconnected cables<br />

other than those recommended.<br />

• Contact Brainlab support for further advice.<br />

Electromagnetic Compatibility – Test Level Summary<br />

Electromagnetic Immunity, ExacTrac <strong>Dynamic</strong> System<br />

ExacTrac <strong>Dynamic</strong> is intended for use in professional healthcare facility environment only. The customer or the user of<br />

the ExacTrac <strong>Dynamic</strong> should assure that it is used in such an environment.<br />

The table below lists all applicable emissions tests, standards and compliance levels.<br />

Immunity test<br />

Standard<br />

IEC 60601-1-2 test<br />

level<br />

Compliance Level<br />

Guidance<br />

Electrostatic discharge<br />

(ESD) – contact<br />

Electrostatic discharge<br />

(ESD) – air<br />

IEC 61000-4-2<br />

± 8 kV<br />

± 15 kV<br />

± 8 kV<br />

(complies)<br />

± 15 kV<br />

(complies)<br />

Floors should be<br />

wood, concrete or ceramic<br />

tile. If floors are<br />

covered with synthetic<br />

material, the relative<br />

humidity should be at<br />

least 30%.<br />

Electrical fast transient/burst<br />

– input AC<br />

power port<br />

Electrical fast transient/burst<br />

– signal input/output<br />

ports<br />

IEC 61000-4-4<br />

± 2 kV<br />

100 kHz repetition frequency<br />

± 1 kV<br />

100 kHz repetition frequency<br />

± 2 kV<br />

100 kHz repetition frequency<br />

(complies)<br />

± 1 kV<br />

100 kHz repetition frequency<br />

(complies)<br />

Mains power quality<br />

should be that of a<br />

typical commercial or<br />

hospital environment.<br />

Surge – input AC<br />

power port line-to-line<br />

Surge – input AC<br />

power port line-toearth<br />

IEC 61000-4-5<br />

± 1 kV<br />

± 2 kV<br />

± 1 kV<br />

(complies)<br />

± 2 kV<br />

(complies)<br />

Mains power quality<br />

should be that of a<br />

typical commercial or<br />

hospital environment.<br />

Power frequency<br />

(50/60 Hz) magnetic<br />

field<br />

IEC 61000-4-8<br />

30 A/m<br />

30 A/m<br />

(complies)<br />

Power frequency<br />

magnetic fields should<br />

be at levels characteristic<br />

of a typical location<br />

in a typical commercial<br />

or hospital environment.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 107


Electromagnetic Compatibility Information<br />

Electromagnetic Immunity, ExacTrac <strong>Dynamic</strong> System<br />

Voltage dips/Voltage<br />

interruptions<br />

IEC 61000-4-11<br />

0% U T for 10 ms<br />

0% U T for 20 ms<br />

(0°, 45°, 90°, 135°,<br />

180°, 225°, 270°,<br />

315°)<br />

70% U T for 50 ms<br />

0% for 5 s<br />

0% U T for 10 ms<br />

0% U T for 20 ms<br />

(0°, 45°, 90°, 135°,<br />

180°, 225°, 270°,<br />

315°)<br />

70% U T for 50 ms<br />

0% for 5 s<br />

(complies)<br />

Mains power quality<br />

should be that of a<br />

typical commercial or<br />

hospital environment.<br />

If the user of Exac-<br />

Trac <strong>Dynamic</strong> requires<br />

continued operation<br />

during power<br />

mains interruptions, it<br />

is recommended that<br />

ExacTrac <strong>Dynamic</strong><br />

be powered from an<br />

uninterruptible power<br />

supply or a battery.<br />

30 kHz/CW: 8 A/m,<br />

30 kHz/CW: n/a,<br />

Proximity magnetic<br />

fields<br />

IEC 61000-4-39<br />

134.2 kHz/PM:<br />

65 A/m,<br />

13.56 kHz/PM:<br />

134.2 kHz/PM:<br />

65 A/m,<br />

13.56 kHz/PM:<br />

--<br />

7.5 A/m<br />

7.5 A/m<br />

IEC 61000-4-6, IEC 61000-4-4<br />

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity<br />

ExacTrac <strong>Dynamic</strong> is intended for use in the electromagnetic environment specified below. The customer or the user<br />

of ExacTrac <strong>Dynamic</strong> should assure that it is used in such an environment.<br />

Immunity Test Standard Compliance Level Guidance<br />

Portable and mobile RF communications<br />

equipment should be used no closer to any<br />

part of ExacTrac <strong>Dynamic</strong>, including cables,<br />

than the recommended separation distance<br />

calculated from the equation applicable to the<br />

frequency of the transmitter.<br />

Recommended separation distance:<br />

Conducted disturbances<br />

induced by RF<br />

IEC 61000-4-6<br />

3 Vrms<br />

0.15 MHz to 80 MHz<br />

d = 1.17√P<br />

Radiated RF EM<br />

Fields<br />

IEC 61000-4-3<br />

3 V/m<br />

d = 1.17√P<br />

d = 2.3√P<br />

80 MHz to 800 MHz<br />

800 MHz to 2.5 GHz<br />

Proximity fields from<br />

RF wireless communication<br />

equipment –<br />

385 MHz<br />

IEC 61000-4-3<br />

27 V/m<br />

Where P is the maximum output power rating<br />

of the transmitter in watts (W) according to the<br />

transmitter manufacturer and d is the recommended<br />

separation distance in metres (m).<br />

Proximity fields from<br />

RF wireless communication<br />

equipment –<br />

450 MHz<br />

28 V/m<br />

Field strengths from fixed RF transmitters, as<br />

determined by an electromagnetic site survey a<br />

should be less than the compliance level b in<br />

each frequency range.<br />

Proximity fields from<br />

RF wireless communication<br />

equipment –<br />

710 MHz, 745 MHz,<br />

780 MHz<br />

9 V/m<br />

Interference may occur in the vicinity of equipment<br />

marked with the following symbol:<br />

108 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


COMPLIANCES AND SAFETY INFORMATION<br />

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity<br />

Proximity fields from<br />

RF wireless communication<br />

equipment –<br />

810 MHz, 870 MHz,<br />

930 MHz<br />

Proximity fields from<br />

RF wireless communication<br />

equipment –<br />

1720 MHz, 1845 MHz,<br />

1970 MHz<br />

Proximity fields from<br />

RF wireless communication<br />

equipment –<br />

2450 MHz<br />

Proximity fields from<br />

RF wireless communication<br />

equipment –<br />

5240 MHz, 5500 MHz,<br />

5785 MHz<br />

28 V/m<br />

28 V/m<br />

28 V/m<br />

9 V/m<br />

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.<br />

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection<br />

from structures, objects and people.<br />

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile<br />

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.<br />

To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.<br />

If the measured field strength in the location in which the ExacTrac <strong>Dynamic</strong> is used exceeds the applicable<br />

RF compliance level above, ExacTrac <strong>Dynamic</strong> should be observed to verify normal operation. If abnormal performance<br />

is observed, additional measures may be necessary, such as re-orienting or relocating ExacTrac <strong>Dynamic</strong>.<br />

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.<br />

Separation Distances<br />

Recommended separation distances between portable and mobile RF communications equipment and Exac-<br />

Trac <strong>Dynamic</strong><br />

ExacTrac <strong>Dynamic</strong> is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.<br />

The customer or the user of the ExacTrac <strong>Dynamic</strong> can help prevent electromagnetic interference by maintaining<br />

a minimum distance between portable and mobile RF communications equipment (transmitters) and the ExacTrac<br />

<strong>Dynamic</strong> as recommended below, according to the maximum output power of the communications equipment.<br />

Rated maximum output<br />

power of transmitter<br />

W<br />

Separation distance according to frequency of transmitter m<br />

150 kHz to 80 MHz<br />

d = 1.17√P<br />

80 MHz to 800 MHz<br />

d = 1.17√P<br />

800 MHz to 2.5 GHz<br />

d = 2.3√P<br />

0.01 0.12 0.12 0.23<br />

0.1 0.38 0.38 0.73<br />

1 1.2 1.2 2.3<br />

10 3.8 3.8 7.3<br />

100 12 12 23<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 109


Electromagnetic Compatibility Information<br />

Recommended separation distances between portable and mobile RF communications equipment and Exac-<br />

Trac <strong>Dynamic</strong><br />

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters<br />

(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output<br />

power rating of the transmitter in watts (W) according to the transmitter manufacturer.<br />

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.<br />

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection<br />

from structures, objects and people.<br />

110 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


MAINTENANCE TEMPLATES<br />

7 MAINTENANCE<br />

TEMPLATES<br />

7.1 Maintenance Templates<br />

About Maintenance Templates<br />

Use the templates on the following pages for documenting maintenance tests and inspections.<br />

Documentation of Tests<br />

Brainlab recommends logging all measurements for the purposes of comparison. In the event of<br />

significant deviations compared with previous measurements, system failure is likely to occur. In<br />

such cases, further detailed investigation should be completed in cooperation with Brainlab<br />

support.<br />

Record Requirements<br />

The test protocol must contain at least the following information:<br />

• Description of executing organization<br />

• Name of technician carrying out test<br />

• Serial number and exact system description (version)<br />

• Test description and results of tests<br />

• Overall evaluation<br />

• Date and signature<br />

About Upgraded Systems Using Older Components<br />

If your ExacTrac <strong>Dynamic</strong> 2.0 system was upgraded from an older version (ExacTrac <strong>Dynamic</strong><br />

1.x), older system components may have been reused that differ from the latest hardware<br />

revision, such as:<br />

• High computer cabinet instead of the new small cabinet<br />

• The power supply ITU instead of the new PDU supply<br />

• Different KVM extenders on LAN cable-based signal transmissions instead of the new optical<br />

fiber cable-based<br />

For the periodic maintenance tests, the general components and test value limits stay the same,<br />

but the test procedure must be adapted to the old hardware. For ex<strong>amp</strong>le, to perform the PE<br />

resistance test with the older hardware, you must detach more data cables to prevent damaging<br />

the system during the test.<br />

If during testing you find deviating, older hardware components than those described parts for<br />

ExacTrac <strong>Dynamic</strong> 2.0, refer to the user guide of the previous system for descriptions of how to<br />

perform the maintenance test.<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 111


Maintenance Task Test Protocol: Monthly, Qualified Clinical Personnel<br />

7.2 Maintenance Task Test Protocol: Monthly,<br />

Qualified Clinical Personnel<br />

Monthly Safety Technical Inspection Checklist<br />

ExacTrac <strong>Dynamic</strong> 2.0<br />

System Information<br />

System location<br />

• Hospital name<br />

• Room ID / System ID<br />

ExacTrac version<br />

ExacTrac serial number or workstation host ID<br />

ExacTrac system description<br />

Test Operator Information<br />

Company name<br />

Test operator name<br />

Test operator job title<br />

Test Protocol Information<br />

Test purpose<br />

☐ Monthly maintenance<br />

☐ Yearly maintenance<br />

☐ Repair/changes<br />

Bundled with other maintenance, which documents?<br />

Obvious incident before test?<br />

Test execution date<br />

Test Group: Visual Inspections<br />

Visually inspect the system parts and the accompanying documents as described in the System and Technical User<br />

Guide, chapter 5.6.1. Enter the results below.<br />

• Housings, surfaces<br />

• Connectors and cables<br />

• Documentation<br />

• Labels and symbols<br />

☐ PASS / ☐ FAIL<br />

☐ PASS / ☐ FAIL<br />

☐ PASS / ☐ FAIL<br />

☐ PASS / ☐ FAIL<br />

Observations, reason for fail:<br />

Test Group: Functional and Accuracy Checks<br />

Conduct the following test actions as described in the System and Technical User Guide, chapter 5.6.2 and 5.6.3. Enter<br />

the results below.<br />

• PC clock synchronization<br />

• Image quality<br />

• Dose area product<br />

• Cooling system (between 2-3 bar)<br />

• Cooling system pump noise is low (no clogging)<br />

☐ PASS / ☐ FAIL<br />

☐ PASS / ☐ FAIL<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

Observations, reason for fail or N/A:<br />

112 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


MAINTENANCE TEMPLATES<br />

ExacTrac <strong>Dynamic</strong> 2.0<br />

Overall evaluation<br />

Enter the overall test result here. In case of fail: Inform the system operator and Brainlab Service. Mark the system<br />

accordingly.<br />

Overall result for this test protocol<br />

☐ PASS / ☐ FAIL<br />

Reason for fail or other observations and conclusions<br />

Test operator name, signature and date<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 113


Maintenance Task Test Protocol: Yearly, Brainlab Support or Brainlab-Authorized Support<br />

7.3 Maintenance Task Test Protocol: Yearly, Brainlab<br />

Support or Brainlab-Authorized Support<br />

Yearly Safety Technical Inspection Checklist<br />

ExacTrac <strong>Dynamic</strong> 2.0<br />

System Information<br />

System location<br />

• Hospital name<br />

• Room ID / System ID<br />

ExacTrac version<br />

ExacTrac serial number or workstation host<br />

ID<br />

ExacTrac system description<br />

Test Operator Information<br />

Company name<br />

Test operator name<br />

Test operator job title<br />

Test Protocol Information<br />

Test purpose<br />

☐ Yearly maintenance<br />

☐ Repair/changes<br />

Bundled with other maintenance, which<br />

documents?<br />

Obvious incident before test?<br />

Test execution date<br />

Test Group: Monthly Maintenance Tasks<br />

Conduct the monthly maintenance checks and attach the related template.<br />

DONE: ☐<br />

Test Group: Yearly functional tests (STI)<br />

Conduct the following test actions as described in the System and Technical User Guide, chapter 5.6.4 - 5.6.6. Enter<br />

the results below.<br />

• Emergency stop signal test<br />

• Door contact signal test<br />

• MV beam-off signal test<br />

• MV beam inhibit test (Elekta)<br />

• X-ray exposure interlock redundancy test<br />

• System-off interlock redundancy test<br />

• X-ray signal light test<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

Test Group: Yearly Accuracy Checks<br />

Conduct the following test actions as described in the System and Technical User Guide, chapter 5.6.5. Enter the results<br />

below.<br />

• Cooling system flow interlock test<br />

• Cooling system accuracy. Read the water<br />

pressure.<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

____ [bar], ☐ N/A<br />

114 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


MAINTENANCE TEMPLATES<br />

ExacTrac <strong>Dynamic</strong> 2.0<br />

• Cooling level is at least 2 cm below max,<br />

pressure is 2-3 bar?<br />

• Fill up the cooling level if required. Enter<br />

the amount.<br />

• PDU timer synchronization and setup<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

____ [liter], ☐ N/A<br />

☐ PASS / ☐ FAIL / ☐ N/A<br />

Test Group: Bi-Annual Electrical Safety Measurements (STI)<br />

Conduct the following test actions as described in the System and Technical User Guide, chapter 5.6.7. Enter the results<br />

below.<br />

PE resistance measurement (STI)<br />

• Measured PE resistance: In-room touch<br />

monitor<br />

• Measured PE resistance: X-ray flat panel 1<br />

(right)<br />

• Measured PE resistance: X-ray flat panel 2<br />

(left)<br />

• Measured PE resistance: X-ray tube unit 1<br />

(left)<br />

• Measured PE resistance: X-ray tube unit 2<br />

(right)<br />

• Measured PE resistance: ExacTrac computer<br />

cabinet<br />

• Measured PE resistance: X-ray sub generator<br />

cabinet<br />

PE pass confirmation: All values are below<br />

200 mΩ<br />

Enter the selected test current (min. 200 mA): _____ [mA]<br />

_____ [mΩ], ☐ N/A<br />

_____ [mΩ], ☐ N/A<br />

_____ [mΩ], ☐ N/A<br />

_____ [mΩ], ☐ N/A<br />

_____ [mΩ], ☐ N/A<br />

_____ [mΩ]<br />

_____ [mΩ], ☐ N/A<br />

☐ PASS / ☐ FAIL<br />

Touch current measurement (STI)<br />

• Measured AC touch current: In-room touch<br />

monitor<br />

• Measured AC touch current: X-ray flat panel<br />

1 (right)<br />

• Measured AC touch current: X-ray flat panel<br />

2 (left)<br />

• Measured AC touch current: X-ray in-floor<br />

cover 1 (left)<br />

• Measured AC touch current: X-ray in-floor<br />

cover 2 (right)<br />

Touch current pass confirmation: All values<br />

are below 100 μA<br />

_____ [μA], ☐ N/A<br />

_____ [μA], ☐ N/A<br />

_____ [μA], ☐ N/A<br />

_____ [μA], ☐ N/A<br />

_____ [μA], ☐ N/A<br />

☐ PASS / ☐ FAIL<br />

Overall evaluation<br />

Enter the overall test result here. In case of fail: inform the system operator and Brainlab Service. Mark the system accordingly.<br />

Overall result for this test protocol<br />

☐ PASS / ☐ FAIL<br />

Reason for fail or other observations and<br />

conclusions<br />

Test operator name, signature and date<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 115


INDEX<br />

INDEX<br />

A<br />

Al-equivalent, casings................................................................ 51<br />

B<br />

background services<br />

Elekta integration....................................................................67<br />

Varian integration....................................................................67<br />

backup<br />

protection against data loss....................................................18<br />

Brainlab customer service.......................................................... 27<br />

Brainlab service<br />

user management...................................................................25<br />

C<br />

cabinet........................................................................................38<br />

ExacTrac <strong>Dynamic</strong> power distribution.................................. 105<br />

cabling, inspection......................................................................85<br />

calibration<br />

components............................................................................ 42<br />

calibration phantoms.................................................................. 42<br />

CE label........................................................................................6<br />

cleaning guidelines.....................................................................74<br />

collimator.................................................................................... 51<br />

console<br />

ExacTrac.................................................................................31<br />

D<br />

damaged equipment.................................................................101<br />

detector covers...........................................................................45<br />

DICOM RT..................................................................................15<br />

disposal instructions..................................................................... 7<br />

dose area product...................................................................... 52<br />

E<br />

electrical equipment<br />

electrical safety.....................................................................103<br />

electrical safety<br />

power specifications............................................................. 104<br />

regulatory background..........................................................103<br />

safety features...................................................................... 103<br />

X-ray generator.....................................................................105<br />

electronics<br />

rack.........................................................................................39<br />

Elekta<br />

60601-1.................................................................................. 19<br />

integration...............................................................................19<br />

ExacTrac <strong>Dynamic</strong> components.................................................29<br />

ExacTrac verification phantom................................................... 43<br />

F<br />

filtration, X-ray beam.................................................................. 51<br />

flat panel detectors..................................................................... 45<br />

flat panels<br />

safe handling.......................................................................... 45<br />

floor boxes<br />

cleaning.................................................................................. 75<br />

G<br />

generator<br />

dual.........................................................................................49<br />

H<br />

handling calibration phantoms....................................................42<br />

hardware.................................................................................... 29<br />

shutdown................................................................................ 70<br />

X-ray components.................................................................. 45<br />

housing, inspection.....................................................................85<br />

I<br />

inspection guidelines.................................................................. 79<br />

L<br />

labeling, inspection.....................................................................85<br />

M<br />

monitor<br />

ceiling-mounted...................................................................... 33<br />

wall-mounted.......................................................................... 33<br />

O<br />

operating environment.........................................................11,103<br />

P<br />

pacemakers................................................................................12<br />

passwords.................................................................................. 25<br />

user management...................................................................25<br />

phantoms....................................................................................43<br />

isocenter calibration phantom.................................................42<br />

power distribution..................................................................... 105<br />

power specifications................................................................. 104<br />

protective earth.........................................................................103<br />

protective earth resistance......................................................... 95<br />

R<br />

rack electronics.......................................................................... 39<br />

radiation safety........................................................................... 60<br />

recovery key............................................................................... 25<br />

reference points..........................................................................95<br />

registration, evaluation and authorization of chemicals<br />

REACH..................................................................................... 6<br />

returning damaged equipment................................................. 102<br />

rights<br />

user management...................................................................25<br />

rotational angles......................................................................... 27<br />

S<br />

safe disposal................................................................................ 7<br />

shutdown<br />

hardware.................................................................................70<br />

116 System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0


INDEX<br />

software.................................................................................. 69<br />

software<br />

shutdown................................................................................ 69<br />

startup.....................................................................................65<br />

startup<br />

ExacTrac <strong>Dynamic</strong> software...................................................65<br />

STI..............................................................................................95<br />

storage conditions...................................................................... 74<br />

storage environment.................................................................103<br />

support....................................................................................... 27<br />

support numbers.......................................................................... 4<br />

sustainability..............................................................................6,7<br />

T<br />

third-party software.......................................................................5<br />

touch current.............................................................................. 95<br />

trademarks<br />

Brainlab.................................................................................... 5<br />

non-Brainlab............................................................................. 5<br />

treatment approval<br />

passwords.............................................................................. 25<br />

U<br />

user console............................................................................... 31<br />

shutdown................................................................................ 70<br />

user logs.....................................................................................25<br />

V<br />

verification<br />

components............................................................................ 42<br />

W<br />

warning lights............................................................................. 54<br />

warranty........................................................................................7<br />

waste electrical and electronic equipment (WEEE)......................7<br />

workstation................................................................................. 38<br />

X<br />

X-ray acquisition<br />

non-gated treatments............................................................. 60<br />

X-ray correction<br />

image acquisition....................................................................60<br />

X-ray equipment<br />

electrical safety.....................................................................105<br />

radiation safety....................................................................... 60<br />

safe handling.......................................................................... 60<br />

system components................................................................45<br />

user console........................................................................... 31<br />

warning system.......................................................................54<br />

X-ray tubes<br />

seasoning............................................................................... 48<br />

sparking.................................................................................. 48<br />

System and Technical User Guide Rev. 1.0 ExacTrac <strong>Dynamic</strong> Ver. 2.0 117


ainlab.com<br />

Art-No. 60922-37EN<br />

*60922-37EN*

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