Reliaty Pacing System Analyzer - BIOTRONIK USA - News

Cardiac Rhythm Management 

External Devices 

User's Guide 

Reliaty 

Pacing System Analyzer

1 

Table of Contents 

Indications/Contraindications/Warnings/Precautions/ 

General Safety Instructions....................................................................3 

Overview............................................................................................... 18 

System Overview.................................................................................. 19 

Starting Reliaty.................................................................................... 20 

Connecting to Reliaty........................................................................... 22 

External Monitor......................................................................................22 

Patient Cables.........................................................................................23 

User Interface...................................................................................... 24 

Buttons....................................................................................................24 

Graphical Interface..................................................................................26 

Channel Selection...................................................................................29 

Testing.................................................................................................. 30 

Sensing....................................................................................................30 

Threshold and Impedance......................................................................31 

Conduction and Wenckebach..................................................................32 

Burst Pacing............................................................................................34 

Maximum Pacing.....................................................................................35 

Safe Program....................................................................................... 36 

Print and Export................................................................................... 37 

Report Screen..........................................................................................37 

Report List...............................................................................................38 

Device Settings..................................................................................... 40 

Preferred Settings...................................................................................40 

System Settings.......................................................................................41 

Visual and Audio Signals...................................................................... 43 

Patient Cables...................................................................................... 44 

Power Supply........................................................................................ 45 

Battery Exchange....................................................................................46 

Power Supply Management....................................................................47 

Technical Specifications....................................................................... 49 

Cleaning...................................................................................................49 

Device Specifications..............................................................................49 

Specifications/System Messages/Symbols.......................................... 53

3 Indications and Contraindications for Use 

Note: Federal (USA) law restricts this device to sale by, or on 

the order of, a physician (or properly licensed practitioner). 

Indications / Contraindications / 

Warnings / Precautions / General 

Safety Instructions 

Indications for Use: 

The Reliaty pacing system analyzer is indicated for use 

in pacing lead system analysis during the implantation of 

pacemakers and defibrillators. 

Note: During implantation of cardiac pacemaker and ICD 

systems, the device does not measure shock impedance and 

defibrillation threshold (DFT). 

Intended Use 

The Reliaty is intended to be used during the implantation of 

pacemakers and defibrillators to evaluate the placement and 

integrity of pacing leads and to determine the appropriate 

pacing parameters for the implanted device. 

Only trained medical personnel may use the device. While 

the device is in use, the medical staff must continuously 

monitor the patient with the aid of a surface ECG monitor, 

and always have cardiac emergency equipment (e.g., external 

pacemaker, defibrillator) in an operational status available 

for immediate life support. Consider additional pre-emptive 

measures in patients where loss of pacing could cause lifethreatening 

danger. 

In support of this intended use, the device provides the 

following measurement/diagnostic capabilities:


• For the sensing of intrinsic events of the heart: 

-- 

P/R wave amplitudes and slew rate 

-- 

Rates (PP, RR interval) 

-- 

Intrinsic AV delay (PR interval) 

-- 

Conduction times 

-- 

Wenckebach point 

-- 

VV delay 

• For the pacing of the heart: 

-- 

Pacing threshold in up to 3 chambers 

-- 

Lead impedances 

-- 

Burst pacing 

Note: The device may not be used as a life-support system. 

During the implantation, the device is suitable for temporary 

external pacing in up to three chambers while the medical 

staff must continuously monitor the patient with the aid of a 

surface ECG monitor. 

Contraindications: 

The following applications are contraindicated: 

• With AV conduction disorders: 

-- 

Atrial single-chamber pacing 

• With competing intrinsic rhythms: 

-- 

Asynchronous modes 

• With chronic atrial tachycardia as well as chronic atrial 

fibrillation or flutter: 

-- 

Modes with atrial control (DDD, VDD) 

• With poor tolerance of high ventricular rates (e.g., with 

angina pectoris): 

-- 

Tracking modes (i.e., atrial control modes) and 

propensity for atrial tachycardia 

• Use as an external pacemaker outside of the 

implantation procedure.

5 

Indications and Contraindications for Use 

Possible Complications 

Depending on the patient's condition and depending on the 

scope and type of pacing program, the following possible 

complications associated with the use of pacing system 

analyzers are reported in medical references: life-threatening 

atrial and ventricular arrhythmia, bradycardia, tachycardia, 

and asystole. 

Warnings: 

Danger from loss of power 

Operating the device with depleted batteries, unapproved 

battery types or no batteries can endanger the patient if linepower 

is temporarily interrupted. 

• Do not use the device with depleted batteries, unapproved 

battery types, or when the battery magazines are not fully 

populated with batteries. 

When the battery level indicator is red, the device has less 

than 30 minutes of remaining battery service time. 

• For additional patient safety connect the external power 

supply at this point. 

• When operating on battery power, do not attempt to 

replace the batteries in either battery magazine when the 

battery level indicator is red. 

• Do not plug in a USB device or attach an external VGA 

monitor when the battery level indicator is red. 

Fatal injury if exposed to fluids 

Before cleaning and disinfecting device surfaces, disconnect 

the external power supply.

6 


Danger of explosion if exposed to cleaning and 

disinfecting agents 

Before operating the device, let cleaning and disinfection 

agents evaporate. 

Danger from contamination 

The device cannot be sterilized. 

• Do not allow the device to enter a sterile area. 

Danger from loss of pacing support 

After the device is switched on, the pacing functions are 

switched off for approximately 15 seconds while a self-test is 

conducted, so that no pacing is possible in this time. 

• Keep a separate pacing device ready for emergencies. 

Single chamber atrial modes are contraindicated for patients 

with impaired AV conduction. 

• If the patient has impaired AV conduction, a Wenckebach 

test must not be performed. 

Connecting the patient cable to the wrong lead may result 

in ineffective sensing and pacing behavior and loss of 

pacing support. 

• Verify that the RV patient cable is connected to the RV 

lead before selecting cross-chamber LV pacing. 

Danger from electrical leakage currents 

Electrical currents can be dangerous to the patient. 

• Never touch the patient and the device's electrical 

contacts at the same time. 

Danger from electrostatic charges 

The lead system is in electrical contact with the patients’ 

heart and blood. Touching the metal clips on the patient cable 

or the pacing lead may induce dangerous electrical currents

7 


in the patient’s heart. 

• Do not touch the metal clips on the patient cable or the 

pacing lead. 

Electrical currents can be dangerous to the patient. 

• Discharge any electrical static charge on your person before 

touching the patient, the patient cables or the device. 

Danger from loss of function 

Moisture from wet cable can impair cable function and 

endanger the patient. 

• Do not use wet cables. 

Incorrect positioning of the protective sleeves over the cable 

clip(s) can cause unintended electrical connections that can 

impair cable function and endanger the patient. 

• Before connecting cables ensure correct position of 

protective sleeves. 

Danger from allergic reaction 

The contact of the cable and open wounds may result in 

allergic reaction of the patient. 

• Do not allow the cable to come into contact with an open 

wound. 

Danger from electrical currents 

Unused cable connections can induce electrical currents into 

the patient's heart. 

• Attach unused cable connections close to the patient. 

Danger from defibrillation 

While the device is designed and tested to be defibrillator 

safe, the patient can be endangered and the device can be 

damaged.

8 


• Whenever possible disconnect the device from the patient 

when defibrillating. 

• If the device is connected to the patient during 

defibrillation, check its operations afterwards. 

Danger from HF surgery 

The device is equipped with protective circuitry to prevent 

damage when used with HF surgery. Although this circuitry 

has been tested to and exceeds standard requirements, its 

efficiency is limited and depends on the strength, waveform, 

and conduction path of the induced current. 

In addition, use of HF surgery may induce dangerous 

currents into the patient cables which may be conducted 

into patient’s heart. 

Therefore: 

• Disconnect the patient cables from the device when 

performing HF surgery procedures. 

• Check the operations of the device if HF surgery has 

been used. 

Danger from abruptly terminating pacing 

Abruptly terminating pacing may result in extended periods 

of asystole in some patients. 

• Gradually decrease the pacing rate until the patient's 

intrinsic rate is detected for a controlled transition from 

pacing to intrinsic action. 

Danger from loss of capture 

Pacing threshold testing implies loss of capture. At loss of 

capture, asystole and pacing during vulnerable periods 

can occur. 

• Consider the health of the patient prior to performing a 

pacing threshold test.

9 


Danger from induction 

Always have cardiac emergency equipment (e.g., external 


for immediate life support. Consider additional pre-emptive 

measures in patients where loss of pacing could cause lifethreatening 

danger. Only activate the burst pacing when all 

necessary provisions have been made. 

Precautions: 

Functional impairment due to external damage. 

Mechanical impact, for example dropping the unit – 

unpackaged, from a height of over 5 cm (2 inches) – can 

permanently impair the function of the system. 

• Do not use the device if there is apparent damage. 

• If damage has occurred, contact BIOTRONIK to test, and 

if necessary, repair the device. 

Danger from unauthorized modification of the equipment 

Modification of the device or its accessories may place the 

health and safety of the operator and/or patient at risk. 

• Do not modify the device or its accessories. 

Damage by cleaning agents 

Do not use strong, abrasive cleaning agents or other organic 

solvents such as ether or benzine. These agents corrode the 

surface of the device. 

General Safety Instructions: 

Technical Manual 

The device may be used only in accordance with this 

technical manual. 

Risks of improper handling 

Disregarding the safety warnings can endanger the patient,

10 


the user, or others, as well as the equipment. 

Note: Failure to observe the safety precautions voids all 

damage claims and manufacturer liability. 

The following dangers may arise in the event of improper use: 

• Failure of important device functions. 

• Personal endangerment due to electrical effects. 

No modification of equipment 

Do not modify the device or its accessories. Modifications 

may put the health and safety of the operator and/or patient 

at risk. 

Physician supervision 

The device may only be operated under the constant 

supervision of a physician. During a procedure, the patient 

must be continuously monitored by medical personnel with 

the aid of a surface ECG monitor. 

Emergency equipment 

During the procedure, always have emergency resuscitation 

equipment (e.g., external pacemaker, defibrillator) in an 

operational status available for immediate life support. 

Consider additional pre-emptive measures in patients where 

loss of pacing could cause life-threatening danger. 

External pacing 

The device may not be used as a life-support system. During 

the duration of the implantation, the device is suitable 

for temporary external pacing while the patient is being 

continuously monitored by medical personnel. 

Touching clips of cables and leads 

Do not touch the metal clips on the patient cable or the 

pacing lead. The device is in electrical contact with the 

patient's heart and blood via the implanted leads. Touching

11 


the metal clips on the patient cable or the pacing lead may 

expose the patient's heart to dangerous electrical currents. 

Connecting cables to leads 

Verify that RV patient cable is connected to the RV lead before 

selecting cross-chamber LV pacing polarities. Connecting 

the patient cable to the wrong lead may result in ineffective 

sensing and pacing behavior and loss of pacing support. 

Patient cables 

Patient cables should not be connected to the device before 

it has reached the ready-for-operation status. After the 

device is "ready-for-operation", securely attach all patient 

cable connections. 

Wet cables 

Do not use wet cables. 

Cables and wounds 

Do not allow the cable to come into contact with an 

open wound. 

Unused cable connections 

Attach unused cable connections close to the patient. 

Protective sleeves of cables 

Before connecting cables ensure correct position of 

protective sleeves. 

Liquids 

Avoid spilling liquids on the device or its accessories. While 

the device is designed for limited protection against the 

ingress of particulate matter, it is not protected against the 

ingress of fluids. 

Electrostatic potentials 

Avoid delivering dangerous electrostatic shocks to the patient 

or equipment. Before handling the device, the patient cable or

12 


the corresponding leads, the electrostatic potential between 

physician or medical technicians and the patient must be 

equalized, for instance by touching the patient at a point as 

far as possible from the leads. 

Leakage currents 

Avoid leakage currents between all connected devices, the 

patient cable, and the patient if line-powered devices are 

used in the vicinity of the patient. Such leakage currents may 

trigger lethal arrhythmias. 

Potential equalization cables, if present, must be attached to 

all connected components. 

National and international regulations concerning the use of 

electromedical devices also apply to patient cables. 

Self-test 

Be aware that the when the device is turned on, it performs 

an internal self-test for approximately 15 seconds. During 

this time the device's pacing outputs are inactive and the 

device is unavailable for use. 

Pacing threshold test 

Consider the health of the patient prior to performing a 

pacing threshold test. A loss of capture, asystole and pacing 

during vulnerable periods can occur. 

Termination of pacing 

Do not abruptly terminate pacing. The sudden termination 

of pacing can lead to extended periods of asystole in some 

patients. Gradually decrease the pacing rate until the 

patient's intrinsic rate is detected. 

External ECG device 

During the implantation, the medical staff must continuously 

monitor the patient with the aid of a surface ECG monitor.

13 


Pacing mode selection 

Select a pacing mode that is consistent with the patient 

cable connections to the leads. Loss of pacing may be a 

consequence of inconsistent selection and may cause lifethreatening 

danger to the patient. 

Wenckebach test 

Because atrial single chamber pacing is contraindicated for 

use in patients with no AV conduction, the Wenckebach test 

may not be performed on such patients. 

Burst pacing 

Burst pacing can induce or accelerate dangerous arrhythmias. 

Always have cardiac emergency equipment (e.g., external 


for immediate life support when using this feature. Consider 

additional pre-emptive measures in patients where loss of 

pacing could cause life-threatening danger. 

High-frequency surgery 

The device is equipped with protective circuitry to prevent 

damage when used with HF surgery. Although this circuitry 

has been tested to and exceeds standard requirements, its 

efficiency is limited and depends on the strength, waveform 

and conduction path of the induced current. 

In addition, use of HF surgery may induce dangerous 

currents into the patient cables which may be conducted 

into patient’s heart. 

Therefore: 

• Disconnect the patient cables from the device when 

performing HF surgery procedures. 

• Check the operations of the device if HF surgery has 

been used.

14 


Defibrillation 

While the device is designed and tested to be defibrillator 

safe, whenever possible, disconnect the device from the 

patient when defibrillating. If the device is attached during 

defibrillation, check its operations afterwards. 

Basic advice 

Only the manufacturer may perform corrective maintenance, 

enhancements or modifications to the device. 

Connecting accessories 

Do not connect a USB flash memory stick, a Bluetooth 

adapter or an external VGA monitor while the device is 

operating on low battery power (i.e., when the battery gauge 

is displayed red). Connecting one of these devices may cause 

a sudden increase in power consumption and cause the 

device to prematurely shut off. 

Sensitivity 

Electromagnetic interference may cause noise on the IEGM 

traces and spurious sense events and as a consequence may 

influence the timing of the pacing delivered to the patient. 

Lower sensitivity settings increase the susceptibility of 

the device to interfere with electromagnetic fields of other 

devices or equipment. A sensitivity setting at or above 1 mV is 

strongly recommended, if clinically suitable. 

Replacement parts and accessories 

Ensure safety compliance by using only original replacement 

parts and accessories authorized by BIOTRONIK. Using any 

other parts voids the liability for subsequent events, the 

guarantee, and the warranty. 

Defects 

Do not put defective or damaged devices into operation.


Installation site 

The device may only be operated in an environment that 

meets the following conditions: 

• The ambient temperature, relative humidity and 

atmospheric pressure are within the specified operating 

conditions. 

• Sterile operating conditions can be maintained. 

• There are no explosive gases in the vicinity of the device. 

• There is always a cardiac emergency equipment (e.g., 

external pacemaker, defibrillator) in an operational status 

available for immediate life support. Consider additional 

pre-emptive measures in patients where loss of pacing 

could cause life-threatening danger. 

• The patient is monitored with a surface ECG monitor. 

The device should stand on a level, dry surface. It should 

be placed so that it cannot slide, especially when cables 

are connected. 

Cable and lead connections 

• Inspect cables prior to use. Replace cables if they are 

worn or damaged. 

• Arrange cables to avoid entanglement with equipment or 

medical staff. 

• Cable connections and plugs must be cleaned as defined 

in Cleaning on page 49 and Patient Cables on page 44. 

Soiled contacts can lead to signal distortions and 

false diagnoses. 

• All electrical contacts must be dry. 

• Make sure that cables are securely connected. When 

disconnecting cables from the device, clasp the locking 

connector and pull. Do not pull on the cable. 

• All lead connections are swap-safe and encoded at the 

lead connectors. Do not force cables to connect together 

or force lead connectors into the connector ports.

16 


Note: Before connecting the patient cable to the leads, 

ensure that the leads are securely implanted in the 

patient’s heart. 

• Patient cables may only be used by healthcare 

professionals that are qualified for intracardial 

examinations and therapy. 

• Precautionary measures must be maintained while 

conducting an intracardial examination. Use in suitable 

rooms featuring X-ray facility and cardiac emergency 

equipment (e.g., external pacemaker, defibrillator) in an 

operational status available for immediate life support. 

Consider additional pre-emptive measures in patients 

where loss of pacing could cause life-threatening danger. 

• No patient cables should be connected to the device 

before it has reached the ready-for-operation status. 

Current parameter settings should be verified, prior to 

connecting the patient cables to the device. 

Note: It is possible to connect or disconnect the patient 

cables while the device is on. 

Possible electromagnetic interferences 

When used with its approved accessories and configure and 

operated in accordance with the instruction in this document, 

this device meets the electromagnetic compatibility 

requirements of IEC 60601-1-2. 

However, strong electromagnetic interference can occur in 

close proximity to other electrical equipment. Therefore the 

device should not be placed adjacent to or stacked on other 

electrical equipment. 

Electromagnetic interference may cause interference with 

the device, including:

17 


• Resetting of the device. 

• Noise on the IEGM traces, spurious sense events. 

If electromagnetic interference occurs, try the following, as 

appropriate: 

• Switching off the source of interference. 

• Moving the source of interference away from the device. 

• Disconnecting any electrical connections between the 

device and the source of interference. 

• Switching the device off and back on, again. 

• If the interference continues, contact your local 

BIOTRONIK representative immediately. 

Note: 

• Portable and mobile RF communication equipment can 

affect the operation of the device. 

• Use of accessories that are not approved by BIOTRONIK 

can increase the device’s electromagnetic emissions and/ 

or electromagnetic susceptibility. 

Note: Electromagnetic interference may cause noise 

on the IEGM traces and spurious sense events and as a 

consequence may influence the timing of the pacing delivered 

to the patient. Lower sensitivity settings increase the 

susceptibility of the device to interfere with electromagnetic 

fields of other devices or equipment. A sensitivity setting at or 

above 1 mV is strongly recommended, if clinically suitable. 

Note: Prolonged exposure to electromagnetic interference 

may cause the device to pace asynchronously.

18 Overview 

Overview 

Reliaty is a portable medical diagnostic device intended 

to be used during the implantation of pacemakers and 

defibrillators to evaluate the placement and integrity of 

pacing leads and to determine the appropriate pacing 

parameters for the implanted device. 

The user controls the operations of Reliaty through the LCD 

touch-screen, parameter wheel, and control buttons. Figures 

1 and 2 provide an overview of external features. The device 

provides three-chamber pacing and sensing and can display 

up to three channels of real-time IEGMs and markers. The 

device provides standard PSA functionality, including lead 

impedance measurements, intrinsic amplitude, timing 

measurements, and pacing thresholds. It has a report feature 

that provides a summary of device measurements, along with 

optional IEGM traces.

19 System Overview 

System Overview 

Connectors for patient cables 

Secondary power 

Tilt stand 

AC power 

VGA interface 

USB port 

Figure 1: Reliaty PSA 

LED indicators 

Safe program 

Measurement 

keys 

Maximum stimulation 

Preferred settings 

Parameter wheel 

Figure 2: Reliaty PSA front panel

20 Starting Reliaty 

Starting Reliaty 

Check battery cartridges and power supply before turning the 

device on. The ON/OFF button is located on the right side of 

the device. Press the ON/OFF button to turn on Reliaty. The 

start screen appears shortly after the device is turned on. A 

self-test then runs for approximately 15 seconds. After the 

self-test, the device is ready for use. To turn the device off, 

press the ON/OFF button again. 

Checkup prior to use 

• Perform a checkup on the device and the approved 

accessories before each use: 

-- 

Inspect the housing for mechanical damage, 

dents, loose parts, cracks or tampering. 

-- 

Inspect the legibility of the labeling. 

-- 

Inspect cables for damage to the insulation, 

connectors or electrical contacts. 

-- 

Replace damaged or worn cables. 

-- 

Turn the device on. 

-- 

Verify that all indicator lights flash briefly. 

-- 

Wait 15 seconds to allow an internal self-test to 

complete. 

-- 

Verify that no error messages are displayed. 

• If the device has mechanical damage or does not pass its 

internal self-test, do not use the device and contact your 

local BIOTRONIK representative immediately.

21 Starting Reliaty 

Periodic Inspection 

• A complete inspection of the device needs to be 

performed: 

-- 

in suspicion of malfunction; 

-- 

every two years. 

• Excessive electrical power, e.g. combined use of HF 

surgery equipment or a defibrillator on a patient 

during use of the pacing system analyzer, may damage 

the device. Check the operation of the device after 

such usage and initiate this inspection if any signs of 

malfunction exist, especially if failure messages during 

start-up self-test occur on the display. 

• This inspection needs to be performed according to 

manufacturer’s instructions. These instructions can be 

provided on demand and state all required test steps and 

devices related to the check. 

• If you have any questions, please contact your local 

BIOTRONIK representative.

22 Connecting to Reliaty 

External 

Monitor 

Connecting to Reliaty 

Figure 3: Reliaty VGA port 

It is possible to connect or disconnect an external monitor 

while the device is on. Connect the VGA plug of the monitor 

to the VGA port, as shown in Figure 3. If the VGA port is set 

to Auto and Reliaty detects a connection to a VGA monitor, 

Reliaty will enable its external VGA port. The device may 

not detect some VGA monitors, so it may be necessary 

to manually enable the external port. For instructions 

on enabling or disabling this feature, refer to the Device 

Settings section on page 40.

23 Connecting to Reliaty 

Patient 

Cables 

Figure 4: Patient cables port 

For a list of compatible cables, see the Patient Cables 

section on page 44. 

Connect to right side of the heart 

• To connect to the right side of the heart (RA/RV), insert 

the patient cable’s locking connector into port , 

shown in Figure 4. 

• Ensure that the plug has locked into the port. 

• Connect the patient connections of the patient cable or 

adapter to the RA/RV leads of the patient. 

Connect to the left side of the heart 

• To connect to the left side of the heart (LV), insert the 

patient cable’s locking connector into port , shown 

in Figure 4. 

• Ensure that the plug has locked into the port. 

• Connect the patient connections of the patient cable or 

adapter to the LV leads of the patient. 

Remove the cables 

• Disconnect the patient cable or adapter from the pacing 

lead by opening the clips and removing the pacing lead. 

• Disconnect the patient cable from Reliaty by pulling on 

the cable’s locking connector.

24 User Interface 

User Interface 

Buttons 

Figure 5: User interface and buttons 

LEDs: The LEDs, shown in Figure 5, along the top of the 

front panel indicate pacing or sensing in each of the three 

chambers. See Visual and Audio Signals section on page 43 

for more information. 

VVI: Selecting the red button to the left of will start 

pacing in the safe program immediately, which is VVI at 60 

bpm. For more information on safe program, see the Safe 

Program section on page 36.


Parameter wheel: To adjust a selected parameter, turn 

the wheel to the right or left. The new values are effective 

immediately. To increment the value, turn the wheel 

clockwise. To decrement the value, turn the wheel 

counter-clockwise. 

Max Stim: This button delivers pacing at 10 V at 2.0 ms. For 

more information, see the Maximum Pacing section on page 35. 

Pref. Set.: This button activates the user-defined preferred 

settings. See the Preferred Settings section on page 40 for 

more information. 

Measurement keys: Pressing the Sensing, Threshold, or 

Impedance key will save the current measured value in the 

selected channel to the report. See the Testing section on 

page 30 for more information. 

Timing/Freeze: Pressing the Timing/Freeze key will open the 

Freeze window, which displays the most recent IEGM. See 

the Testing section on page 30 for more information.


Graphical 

Interface 

Figure 6: User interface 

Information bar: Along the top of the screen, the current 

mode, rate in each channel, and power supply indicator are 

displayed to provide basic information. 

Modes: Pressing the Mode button opens a drop down menu 

with common single- and dual-chamber modes. The Mode 

button is indicated by the black rectangle in Figure 6. 

Sensing button: Pressing the Sense button, available in 

each chamber, toggles to ON or OFF to adjust the mode to 

enable or disable sensing in a particular chamber. When 

sensing is ON in a particular channel, the circle on the 

button is filled in. When sensing is OFF in a particular 

channel, the circle is not filled. The Sense button is marked 

by the blue rectangle in Figure 6.


Pacing button: Pressing the Pace button, available in each 

chamber, toggles to ON or OFF to adjust the mode to enable 

or disable pacing in a particular chamber. Like the Sense 

button, the Pace button indicates whether pacing is ON or 

OFF in a particular channel using a filled in or empty circle. 

The Pace button is marked by the red rectangle in Figure 6. 

Channel button: Pressing a channel button activates or 

deactivates each channel. When deactivated, the channel 

will be grayed out. The Channel button is indicated by the 

green rectangle in Figure 6. 

Tracking button: Pressing the Tracking button will switch the 

mode between a tracking mode and a non-tracking mode 

(e.g., DDD to DDI). The Tracking button is indicated by the 

yellow rectangle in Figure 6. 

Tests: Selecting the Tests button will send the user to the 

Tests screen to perform basic lead tests. See page 30 for 

more information on testing. 

Report: Selecting the Report button will send the user to 

the Report screen to view, export, or print a measurement 

report. See page 37 for more information on reports. 

Burst: Selecting the Burst button will send the user to the 

Burst pacing screen to perform high rate pacing. See page 34 

for more information on burst pacing. 

Pref. set.: Selecting the Pref. set. button will send the user 

to the Preferred Settings screen to view or change system 

settings and user-defined settings. See page 40 for more 

information on preferred settings.


Basic rate: Selecting the Rate button will allow the user 

to increase or decrease the basic rate by adjusting the 

parameter wheel. The Rate button is indicated by the orange 

rectangle in Figure 6. 

Amplitude and pulse width: Selecting the Amplitude or Pulse 

Width buttons, available in each chamber, allows the user 

to adjust the output by adjusting the parameter wheel. The 

Amplitude and Pulse Width buttons are indicated by the 

purple rectangle in Figure 6. If a chamber is not pacing due to 

the current mode, the output buttons for that chamber will be 

grayed out, as shown by the LV channel in Figure 6. The user 

can still make changes to the amplitude and pulse width, but 

the chamber will remain grayed out and inactive. 

More: Selecting the More button opens the following 

additional adjustable parameters: AV delay, VV offset, 

sensitivity in each channel, and LV polarity.


Channel 

Selection 

Figure 7: Selecting a Channel 

Reliaty is capable of testing in three channels: atrium, right 

ventricle, and left ventricle. Each channel can be inactive, 

active, or selected. 

Inactive: The channel is not being tested and is not used in 

the current mode. Its inactivity is indicated by a grayed out 

appearance. The output on this channel can still be adjusted, 

and the new output will be in effect when the channel is 

activated again. In Figure 7, the LV channel is inactive. 

Active: The channel will have an associated IEGM and will no 

longer be grayed out. To activate an inactive channel, select 

the associated channel button. In Figure 7, the RV and A 

channels are active. 

Selected: Only one active channel can be selected at a time. 

To conduct and save measurements for a channel, the 

associated channel must be selected. When pressing one 

of the measurement buttons on the front panel, only the 

measurements of the selected channel are saved. In Figure 7, 

the A channel is active and selected.

30 Testing 

Sensing 

Testing 

All tests can be performed from the Tests screen, accessible 

by pressing the Tests button, located along the bottom of 

the Reliaty screen. 

Figure 8: P/R wave amplitude measurements in Reliaty 

P/R wave amplitude measurements are used to assess the 

ability of the implanted device to sense the intrinsic activity 

of the heart at the current lead position within the heart. If 

the intrinsic heart rate of the patient is above the set pacing 

rate or pacing is disabled, the heart’s intrinsic activity can 

be measured. See below for instructions on performing a 

sensing test. 

• Select the desired channel. 

• Press the Sense button to adjust the mode to allow for 

sensing in that channel. 

• Adjust the mode, rate, and AV delay to promote intrinsic 

activity. Sensed values are displayed on that channel’s 

IEGM, as shown in Figure 8.

31 Testing 

Threshold 

and 

Impedance 

• Press the Sensing button on the front panel to save 

the displayed sensing measurements on the selected 

channel and a 5-second IEGM to the report. 

• Repeat the procedure for other channels as necessary. 

Figure 9: Threshold and impedance measurements in Reliaty 

Pacing threshold measurements are used to assess the 

ability of the implanted device to effectively and efficiently 

pace the heart at the current lead position. Lead impedance 

measurements are used in assessing the integrity of the 

lead and the connection of the lead’s electrodes with the 

myocardium. A lead impedance measurement is made on 

each paced event. The last lead impedance measurement, 

in each channel, is displayed on the left-side of the IEGM 

window next to the IEGM trace for that channel, as shown 

with the red boxes in Figure 9. Also, the pacing amplitudes 

are displayed with their respective event on each channel’s 

IEGM, also shown in Figure 9. Perform the threshold and 

impedance measurements as follows:

32 Testing 

• Press the Channel button to activate and select the 

desired channel. 

• Press the Pace button to adjust the mode to allow pacing 

in that channel. 

• Adjust the rate and/or AV delay to force pacing in 

that channel. 

• Use the parameter wheel to decrease the pacing 

amplitude until loss of capture occurs. 

• Increase the pacing amplitude until capture is 

re-established. 

• Press the Threshold measurement key on the front 

panel to save the current pacing settings of the selected 

channel and save a 5-second IEGM to the report. 

• Use the parameter wheel to increase the pacing 

amplitude to a safe value (5 V to 10 V). 

• Press the Impedance measurement key on the front panel 

to save the displayed impedance measurement, the current 

pacing settings, and a 5-second IEGM to the report. 

Conduction 

and 

Wenckebach 

Figure 10: Freeze screen to allow timing measurements

33 Testing 

Conduction 

Conduction measurements are used to determine 

appropriate pacing parameters for the implanted device. 

Antegrade conduction time is measured by sensing in the 

ventricle and measuring from atrial event to ventricular 

sensed event. The retrograde conduction time is measured 

by pacing in the ventricles and measuring the time interval 

between the ventricular pace and any subsequently induced 

P-wave. Perform a conduction test as follows: 

• Adjust the mode and rate to allow for antegrade or 

retrograde conduction. 

• Press the Timing/Freeze key on the front panel, which will 

bring up the Timing/Freeze window, shown in Figure 10. 

• Adjust the slide bar to move the viewing window. 

• Use the calipers to make time-based measurements. 

• Use the grid to make amplitude-based measurements. 

• Press the Save button to save the strip to the report. 

Wenckebach 

The patient’s intrinsic Wenckebach point measurements 

are useful in determining the appropriate pacing settings 

for the implanted device. For instructions on measuring the 

Wenckebach point, see below. 

• Adjust the mode to allow for pacing in the atrium and 

sensing in the ventricle. 

• Increase the pacing rate until Wenckebach behavior is 

displayed on the IEGM. 

• Press the Timing/Freeze key. 

• Adjust the slide bar to move the viewing window. 

• Use the calipers to make time-based measurements. 

• Use the grid to make amplitude-based measurements. 

• Press the Save button to save the strip to the report.

34 Testing 

Burst 

Pacing 

Figure 11: Burst pacing pop-up window 

Figure 12: Burst pacing screen 

Burst pacing can be used to terminate certain types of 

arrhythmias. During burst pacing, the currently selected 

channel is stimulated with a fixed pulse amplitude (7.5 V), 

fixed pulse width (1.0 ms), and an adjustable pacing rate.

35 Testing 

Maximum 

Pacing 

Burst pacing is possible on all three channels, but with only 

one channel at a time. For instructions on performing burst 

pacing, see below. 

• Go to the Burst screen by pressing the Burst button from 

any other screen. 

• A window will pop up, as shown in Figure 11. Click OK. 

• Select the respective burst rate button to select the 

chamber where the burst pacing shall be applied, as 


• Use the parameter wheel to adjust the burst rate. 

• Press the burst deliver button to apply burst pacing with 

the selected burst rate. 

The burst is delivered as long as the button is pressed. 

Maximum burst duration is 30 seconds. If the burst deliver 

button is held longer than 30 seconds, Reliaty will stop 

delivering burst pacing. 

While burst pacing in the atrium, the device will provide 

ventricular backup pacing if the pacing mode is a ventricular 

pacing mode when starting the burst. If the pacing mode is 

not a ventricular pacing mode, ventricular pacing support will 

not be provided. 

The Maximum pacing amplitude is used to assess whether 

the extracardiac muscle or phrenic nerve can be inadvertently 

stimulated by paces with the lead in its current position 

within the heart. During maximum pacing, the currently 

selected channel is paced with an output of 10 V at 2.0 ms. 

For instructions on delivering maximum pacing, see below. 

• Activate and select the desired channel. 

• Adjust the mode to allow pacing in this channel. 

• Deliver maximum pacing by pressing the Max Stim key on 

the front panel and holding it. 

• Terminate maximum pacing by releasing the Max Stim key.

36 Safe Program 

Safe Program 

The Safe program function sets critical pacing parameters 

to preset, safe values. The Safe program, when initiated, 

immediately interrupts all other Reliaty functions. 

The Safe program settings (non-programmable) are 

listed below: 

Mode: 

VVI RV 

Rate: 

60 bpm 

Output: 

7.5 V at 1.0 ms 

Sensitivity: 2.5 mV 

Refractory Period: 250 ms 

To deliver the Safe program, press the Safe program key 

on the front panel. The Safe program is immediately active 

without any other confirmation. To change the Safe program 

parameters back to their original values, select each 

parameter and use the parameter wheel on the front panel to 

make the adjustments or press the Pref. set. key on the front 

panel to activate preferred settings.

37 Print and Export 

Report 

Screen 

Print and Export 

Figure 13: Report screen 

To print or export a report, navigate to the Report screen by 

selecting the Report button along the bottom of the Reliaty 

screen, as shown in Figure 13. To view a detailed report with 

both measured values and 5 second snapshots of the IEGM 

window, press the Details button. 

To export a PDF, connect a USB flash drive to the USB port. 

The Report screen will display measurements from the 

current report. From the Report screen, select the Print/ 

Export button. A pop-up window will show export options. 

Select the USB to export the report to the USB drive. 

To print a report to an external Bluetooth ® printer, connect 

a Bluetooth ® module to the USB port. The Report screen 

displays a summary of the measurements saved in the 

current report. Press the Print/Export button. A pop-up 

window will show export options. Select the printer to 

print the report.


Report 

List 

Press the Details button to see the associated IEGM strips. 

Press the Print/Export button to print or export the report 

with all details. 

Figure 14: Report list 

To manage the reports, go the Reports screen. Press the 

Report List button to see the list of all stored reports, as 


View a report: Select an entry from the list and press the View 

Report button to display a report. 

Name a report: Select an entry from the list and press the 

Rename Report button to rename a report. Use the screen 

keyboard to change the name of the report. 

Create a report: Press the New Report button to add a new 

report. All following measurements will be saved to this 

report until a new report is created or Reliaty is turned off.


Edit a report: To store new measurements on an existing 

report, select the report from the list. The report is then 

marked blue and all further testing and additional testing 

measurements will be stored in this report. This is useful for 

documenting different configurations during implant or to 

store more than one Freeze screen per implantation. Reliaty 

allows the user to store one Freeze screen per report to 

document timing. A new Freeze screen recorded overwrites 

the previously saved Freeze screen. 

Up to 15 reports can be stored in the Report list. Each report 

is displayed in the Report list with date and time or a name. 

Once 15 reports have been stored and a new report is added, 

the oldest report is automatically deleted. The Report list 

remains stored when the device is switched off.

40 Device Settings 

Device Settings 

Figure 15: Preferring settings 

Preferred 

Settings 

Access the Preferred Settings screen by pressing the Pref. 

set. button on the screen. In this screen, the user can 

configure the pacing parameters (preferred settings) and the 

system settings such as date, time, language, or illumination 

as shown in Figure 15. 

Reliaty begins with the preferred parameters when it is 

initially turned on. To adjust these parameters, select the 

parameter and use the parameter wheel to change the value 

or select the new setting from a list. Use the slide bar to view 

the complete list of settings. As these settings are changed, 

the new system settings are effective immediately and no 

confirmation is required. Changes to preferred settings can 

be made without affecting current device operations. Any 

changes made to preferred settings will be saved. 

The preferred settings can be activated in the Tests screen by 

pressing the Pref. set. key on the front panel.


System 

Settings 

System settings are the general settings of the device. A change 

in the system settings can be made without affecting the current 

operation of the device. All changes to system settings are saved 

permanently in Reliaty, even after it is turned off. 

To change a system setting, select the Pref. set. button to 

move to the Preferred Settings page. Select the value and 

change it using the control knob on the front panel. The new 

value is immediately effective. From this screen, adjustments 

can be made to the following parameters: date, time, date 

format, language, and illumination. 

Illumination brightness: The illumination brightness of the 

display is preset to a basic value (Normal) to provide an 

optimal compromise between light intensity of the display 

and service time for battery operation. To change the 

illumination brightness on the Pref. set. screen, press the 

Illumination button repeatedly to activate one of the following 

settings: Normal, Bright, Long life. Note: The Bright setting 

will decrease battery life. 

Factory settings: All system settings can be reset to the 

factory default values. To reset all settings to factory values, 

press the Reset pref. settings button. The system settings 

are changed to the factory settings. The current operational 

settings are not affected by this change. 

VGA settings: To change the VGA settings, press the VGA 

button, seen in Figure 15, to switch among OFF, ON, and 

Auto detect (recommended). The auto detect setting will 

automatically turn on the VGA port when a VGA monitor 

connection is detected. If the device is not detecting the 

monitor, switch the VGA settings to ON. To conserve battery 

when not using a VGA monitor, switch to the VGA settings to OFF.


Maintenance code: The Maintenance code is used for service 

purposes only. 

Export system logfile: This option is used during unexpected 

device behavior. A logfile is exported via a USB stick, and the 

exported information is then used for analysis.

43 Visual and Audio Signals 

Visual and Audio Signals 

Reliaty includes audio and visual signals to alert the user. These 

signals include a tone for confirmation of user input, a beep to 

warn for low battery, and LEDs to indicate pacing and sensing. 

Confirmation of user input: Reliaty emits audible signals to 

confirm user input. A high tone indicates a successful action 

that changes the behavior of Reliaty. A deep tone confirms 

the user input, but there is no direct effect if the action was 

not successful. For example, if changes are made to the 

output of an inactive channel, a deep tone will confirm that 

these changes were successful even though the changes do 

not directly affect current device function. 

Battery: Reliaty emits a beep every 20 seconds when the 

battery gauge is red (< 30 minutes of battery life remaining) to 

warn the user to switch to a different power source. 

LED: The LEDs along the top of the front panel indicate 

pacing and sensing in each channel. Each channel has two 

LEDs: a green LED to indicate sensing and a yellow LED to 

indicate pacing.

44 Patient Cables 

Patient Cables 

See Table 1 for a list of cables that are compatible 

with Reliaty. 

Cable Description Length Sterilization Cycles 

PK-141 

Alligator clips 

2.8 m 

(110.2 in) 

Re-sterilizable 

with steam at 

134°C 

50 cycles of 

re-sterilization 

PK-67-L 

and 

PK-67-S 

with 

adapters 


with PA-4 adapter; 

Connector for 2 mm 

pins with adapter 

PA-1-B; IS-1 

connector with PA-2 

adapter 

2.6 m (L) 

(102.4 in) 

and 

0.8 m (S) 

(31.5 in) 

Re-sterilizable 

with steam at 

121°C 

20 cycles of 

re-sterilization 

PK-67-L 

and 

PK-67-S 

with 

PK-155 


2 m 

(78.7 in) 

(PK-155) 

PK-155 is 

disposable 

and cannot be 

re-sterilized 

N/A 

Table 1: Cables compatible with Reliaty

45 Power Supply 

Power Supply 

Secondary power 

AC power 

Figure 16: Power supply 

Reliaty has a redundant power supply, which includes two 

separate battery cartridges (only one is shown in Figure 16) 

and an external power supply, as shown in Figure 16. The 

primary power source is the external power source, which can 

be attached while Reliaty is operating on secondary supply, i.e., 

the batteries. When the external power supply is unavailable, 

the device automatically switches from the primary to the 

secondary power source without loss of function. 

Reliaty includes two battery cartridges, that serve as the 

secondary power source for the device. Each cartridge 

requires four disposable AA batteries. With Duracell MN 1500 

or Energizer E91 LR6 batteries, operating time with these 

batteries is at least 12 hours * when the batteries are new. 

Also, the batteries should be removed if Reliaty will not be 

used for a prolonged period of time to avoid draining battery 

life. Rechargeable batteries are contraindicated for Reliaty 

because they do not allow for a precise calculation of the 

remaining operation time. Rechargeable batteries cannot be 

recharged via Reliaty. 

* 

With two chamber stimulation at 70 bpm, 5 V, 0.5 ms, 500 ohm and 

no external devices connected


Battery 

Exchange 

Figure 17: Replacing Reliaty batteries 

Batteries can be replaced while the device is still in use 

and operates using the second battery cartridge or external 

power source. Battery replacement while the device is in use 

will not interrupt Reliaty operation when a second battery 

cartridge or external power source is also used. The battery 

compartments are located on the right and left side of the 

device. See below for instructions regarding replacing the 

batteries and refer to Figure 17. 

• Open the battery compartment by pushing up on the 

locking mechanism. 

• Pull the battery cartridge out. 

• Remove all old batteries. For optimal device performance, 

replace all four batteries at the same time with new 

batteries. 

• Insert the four new batteries as indicated by the terminal 

notations on the battery cartridge. 

• Push the battery cartridge into the battery compartment 

until the locking mechanism latch is heard.


Power 

Supply 

Management 

To ensure operation of Reliaty during battery replacement, 

replace the batteries in the depleted cartridge first. Reliaty 

comes with a third battery cartridge for quick 

battery exchange. 

Replace left 

cartridge 

Replace right 

cartridge 

Immediately connect the external power supply! 

Do not replace any battery cartridge. 

Figure 18: Reliaty Test screen with Power Supply Indicators 

The Power Supply Indicator displays the type of power supply 

and also indicates overall battery status. See Table 2 for a 

description of the different indicators and their meaning. The 

images on the lower left and right corners indicate which 

cartridge needs to be replaced, as shown in Figure 18. The 

images on the lower left and right corners are not used when 

the device is using an external power supply.


Image 

Definition 

External power supply connected, 

batteries not used 

Remaining operation time is currently 

being calculated 

Using battery only, remaining operation 

time is longer than 4 hours 

Using battery only, remaining operation 

time is between 2 and 4 hours 

Using battery only, operation time is 

below 30 minutes 

Table 2: Reliaty power supply indicators

49 Technical Specifications 

Cleaning 

Technical Specifications 

• Use soft, lint-free cloth. 

• Housing: Clean with a damp cloth and mild soap solution 

or a mixture of 70% isopropanol and 30% water. Disinfect 

with alcohol or aldehyde-based agents. 

• Connectors: Visually inspect the connectors to make sure 

that the ports are free of debris. 

• Patient cables and adapters: Clean with a mixture of 70% 

isopropanol and 30% water. Disinfect by exposing to water 

with a 2% concentration of Lysoformin for 15 minutes. 

• Sterilization: Reliaty cannot be sterilized. The PK-155 

cable is for single use only and cannot be sterilized. Other 

approved cables can be re-sterilized and re-used. 

Device 

Specifications 

Dimensions 

Parameter 

Length x Width x Height 

Weight (including batteries) 

Housing material 

Display/Touch screen 

Specification 

220 x 180 x 60 mm (8.7 x 7.1 x 2.4 in) 

1.2 kg (2.6 lbs) 

ABS flame resistant 

Parameter 

Specification 

Size (diagonal) 

177.8 mm (7.0 in) 

Resolution 

800 x 480 pixel 

Backlight 

LED 

Screen brightness 350 cd/m 2 

Touch screen 

Resistive 

Pace/sense indicators 6 LEDs (3 green, 3 yellow)


Input/Output 

Parameter 

USB port 

Bluetooth ® interface 

VGA interface 

External power supply 

Patient connectors 

Specification 

USB 2.0 standard (12 MBit/S) 

Support external HP PCL5 

compatible printer 

DE-15 DDC2 only for 

medical monitor 

Socket for barrel connector 

5.5 mm / 2.5 mm (0.19 in / 0.098 in) 

2 Redel connectors PKN06 

Environmental conditions 

Parameter 

Temperature (Storage) 

Humidity (Storage) 

Atmospheric Pressure 

(Storage) 

Temperature (Operation) 

Humidity (Operation) 

Atmospheric Pressure 

(Operation) 

Specification 

0…50°C (32...122°F) 

30…75% 

50…106 kPa 

10…40°C (50...104°F) 

30…75% 

70…106 kPa


Parameters 

Parameter 

Mode 

Active channels 

Pace 

Sense 

Specification 

DDD, DDI, VDD, VDI, 

VVI, VOO, AAI, AOO, 

OAO, OVO, ODO 

A: ON, OFF; RV: ON, 

OFF; LV: ON, OFF 





Factory 

Settings 

VVI 

A: ON, RV: ON, 

LV: ON 

A: OFF, RV: OFF, 

LV: OFF 

A: ON, RV: ON, 

LV: ON 

Tracking ON, OFF OFF 

AV delay 0…(5)…300 ms 120 ms 

VV delay (RV→LV) -100…(5)…100 ms +5 ms 

Basic rate (A, RV, LV) 

30…180 bpm, with 

30…(1)…100 bpm 

and 100…(2)…180 

90 bpm 

bpm 

Pulse amplitude 

(A, RV, LV) 

0.1…(0.1)…10 V 5 V 

Pulse width (A, RV, LV) 0.1…(0.1)…2.0 ms 0.5 ms 

Sensitivity, atrium 0.2…(0.1)…20 mV 1.0 mV 

Sensitivity, ventricle 0.5…(0.1)…20 mV 2.5 mV 

LV: Pacing polarity 

BIPL, CRBP, IVBP, 

RRBP 

BIPL 

IEGM Filter ON/OFF OFF a) 

Burst frequency 80…(10)…1000 bpm 100 bpm


Parameter 

Burst time maximum 

High rate protection 

Blanking after 

pace-cross-chamber 

Blanking after 

pace-same chamber 

Autoshort after pace 

(A, RV, LV) 

Measurement time 

sense (A, RV, LV) 

Noise interval 

Atrial Refractory 

Period 

Ventricular Refractory 

Period 

Specification 

30 s 

200 bpm 

25 ms 

125 ms 

15 ms 

60 ms 

70 ms 

425 ms 

250 ms 

Factory 

Settings 

a) 

In certain environments, switching the IEGM Filters on may result in a reduction 

of EMI interferences or noise on the IEGM traces. However, activated IEGM Filters 

may attenuate peak IEGM potentials from cardiac activity, thus influencing the 

morphology of the IEGM signal. The default setting for the IEGM Filters is off upon 

start of the device.

53 

System Messages/Symbols 

Specifications / System Messages / Symbols 

Scope of Delivery and Accessories 

Name Quantity Order no. 

Reliaty 1 365 530 

Bag 1 370 109 

External power supply 1 367 905 

Power cord 1 380 080 

Battery cartridge 3 (2 inside device) 365 382 

Batteries 8 370 736 

Technical Manual 1 

Quick Reference Guide 1 

Available Accessories 

Name Order no. Details 

Patient cable PK-67-L 123 672 Applicable with PK-155 

Patient cable PK-67-S 123 438 Applicable with PA-2, PA-4 

Patient cable PK-141 353 181 -

54 System Messages/Symbols 

System Messages 

System Messages: Meaning and Measures 

Message text Meaning Measures 

Error while creating 

the *.pdf - file! 

Storage medium 

out of space! 

Storage device not 

ready! 

Storage device 

write-protected! 

Bluetooth device 

not ready! 

Printer 

communication 

error! 

Printer not ready! 

No storage/ 

Bluetooth device 

connected! 

PDF file is corrupt. 

Insufficient 

remaining memory 

on storage device. 

Files cannot be 

exported to storage 

device. 

Files cannot be 

exported to storage 

device. 

Data cannot be 

transferred to 

Bluetooth adapter. 



Bluetooth printer. 



Bluetooth printer. 



storage device or 

Bluetooth adapter. 

• Delete unused data on 

storage device. 

• Use storage device with 

greater capacity. 

Ensure the following: 

• Storage device is compatible. 

• Storage device is properly 

connected. 

Ensure that the storage device 

does not have write protection 

enabled. 


• Bluetooth adapter is 

compatible. 

• Bluetooth adapter is properly 

connected. 


• Printer is Bluetooth enabled, 

powered on, and within close 

proximity. 


• Printer is Bluetooth enabled, 

powered on, and within close 

proximity. 


• Storage device or Bluetooth 

adapter is compatible. 

• Storage device or Bluetooth 

adapter is properly connected.


Critical Error Messages 

Triggered by a built-in self-test routine, the device can also 

show a critical error message. The message consists of a 

condition code number and a proposed measure. In case 

the device repeatedly shows such error message, note 

the condition number and contact your local BIOTRONIK 

representative. 

Country-Related Information 

UL certification 

Reliaty has been certified by Underwriters Laboratories Inc. 

with respect to electrical shock, fire and mechanical hazards 

only in accordance with: 

• UL 60601-1 

• CAN/CSAC22.2 No. 601.1 

• IEC 60601-1: 1988 + A1 + A2 

• IEC 60601-2-31: 1994 + A1 

UL-certified devices are identified as follows:


Legend for the Label 

The label icons symbolize the following: 

Pacing system analyzer 

BIOTRONIK order number 

Serial number of device 

Date of manufacture 

Storage and transport temperature limitation 

Storage and transport atmospheric 

pressure limitation 

Storage and transport humidity limitation 

CE conformity marking 

Caution: Federal (U.S.A.) law restricts this 

device to sale by, or on the order of, a physician. 

Contents 

Consult instructions for use

57 System Messages/Symbols

BIOTRONIK, Inc. 

6024 Jean Road 

Lake Oswego, OR 97035-5369 

(800) 547-0394 (24-hour) 

(800) 291-0470 (fax) 

www.biotronik.com 

M4144-A 06/12 

© 2012 BIOTRONIK, Inc. 

All rights reserved. MN015r1 6/14/12

Reliaty Pacing System Analyzer - BIOTRONIK USA - News

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