16.01.2013 Views

Handylaser sprint - RJ Laser

Handylaser sprint - RJ Laser

Handylaser sprint - RJ Laser

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

<strong>Handylaser</strong> <strong>sprint</strong><br />

Instructions for Use


Contents<br />

1. General Notes 3<br />

1.1. Exclusion of liability ............................................................................................................................... 3<br />

1.2. <strong>Handylaser</strong> <strong>sprint</strong> standard .................................................................................................................. 3<br />

1.3. <strong>Handylaser</strong> <strong>sprint</strong> principle of function .................................................................................................. 3<br />

2. Safety Precautions 4<br />

2.1. <strong>Laser</strong>-protection goggles ...................................................................................................................... 4<br />

2.2. Explanation of the pictograms ............................................................................................................ 5<br />

2.3. Position of the labels and warning signs .......................................................................................... 6<br />

2.4. Shutdown in an emergency.................................................................................................................. 6<br />

2.5. Radiation injuries .................................................................................................................................... 6<br />

2.6. Treatment room ....................................................................................................................................... 6<br />

2.7. Safeguarding against unauthorized usage ....................................................................................... 7<br />

2.8. Registering (valid for Germany, please refer to your national regulations) ............................ 7<br />

3. Intended use and personnel 8<br />

3.1. Proper usage and field of application ................................................................................................ 8<br />

3.2. Indication for use .................................................................................................................................... 8<br />

3.3. General treatment exclusions .............................................................................................................. 9<br />

4. Device description 10<br />

4.1. Technical data ....................................................................................................................................... 10<br />

4.2. Technical data of the laser diodes (depending on the model) ................................................. 11<br />

4.3. Contents of delivery ............................................................................................................................ 11<br />

5. Connectors and functional components 12<br />

5.1. Indicators (LED, Display) ..................................................................................................................... 12<br />

5.2. Applicators ............................................................................................................................................. 13<br />

6. Starting and using the device 15<br />

6.1. Releasing the laser beam, 40 (60 dental version) seconds energy timer .............................. 16<br />

6.2. Control displays .................................................................................................................................... 16<br />

6.3. <strong>Laser</strong> indicator lamp ............................................................................................................................ 16<br />

6.4. Power control ........................................................................................................................................ 16<br />

6.5. Audible indicator .................................................................................................................................. 16<br />

7. Charging the battery 17<br />

8. Charging the battery 17<br />

8.1. Charger Ansmann ACS 110 Traveller .............................................................................................. 18<br />

9. Maintenance 19<br />

9.1. Annual inspection of the device ...................................................................................................... 19<br />

9.2. Cleaning / Disinfecting ....................................................................................................................... 19<br />

| 1/23


9.3. Maintenance/Calibration ................................................................................................................... 20<br />

9.4. Disposal .................................................................................................................................................. 20<br />

9.5. Warranty ................................................................................................................................................ 20<br />

10. Electromagnetic compatibility - Warning instructions 21<br />

10.1. Guidelines and manufacturer’s declaration – Electromagnetic radiation ............................ 21<br />

10.2. Guidelines and manufacturer’s declaration - Electromagnetic immunity ........................... 21<br />

10.3. Guidelines and manufacturer’s declaration – Electromagnetic immunity – for the laser<br />

device without life supporting function ........................................................................................................... 22<br />

10.4. Recommended protective distance between portable and mobile HF-telecommunication<br />

devices and the laser device without life supporting function .................................................................. 22<br />

11. Manufacturer 23<br />

12. Distributor 23<br />

| 2/23


1. General Notes<br />

These operating instructions must be read carefully before starting the device.<br />

These operating instructions describe the correct usage of the <strong>Handylaser</strong> <strong>sprint</strong> and also point out any<br />

potential risks. These operating instructions are to be read and observed by all persons who operate, use,<br />

service and inspect the device.<br />

Please contact your supplier, representative for any related questions or you may direct your inquiries to:<br />

1.1. Exclusion of liability<br />

REIMERS & JANSSEN GmbH<br />

Medical — <strong>Laser</strong> — Technology<br />

Fabrikstraße 22 D-79183 Waldkirch-Kollnau, Germany<br />

Tel. +49-7681-4934149 Fax +49-7681-4934150<br />

service@rj-laser.com www.rj-laser.com<br />

Quality management according to EN ISO 13485:2003<br />

The <strong>Handylaser</strong> <strong>sprint</strong> should only be used for the purpose described in these operating instructions. The<br />

manufacturer will not be liable for any damage or injuries resulting from usage not contained in these<br />

operating instructions. The manufacturer reserves the right to make modifications in keeping with<br />

technological advances.<br />

1.2. <strong>Handylaser</strong> <strong>sprint</strong> standard<br />

The <strong>Handylaser</strong> <strong>sprint</strong> meets or exceeds the requirements of the following international standards:<br />

EN 60601-1: 2007 Safety of Medical Electrical Equipment<br />

EN 60601-2-22: 2007 Safety of Diagnostic / Therapeutic <strong>Laser</strong>s<br />

EN 60825-1: 2007 Safety of <strong>Laser</strong> Devices<br />

EN 60601-1-2:2007 Electromagnetic compatibility<br />

1.3. <strong>Handylaser</strong> <strong>sprint</strong> principle of function<br />

The <strong>Handylaser</strong> <strong>sprint</strong> will emit monochromatic, coherent laser light to the cells and tissue. The photon<br />

energy will be absorbed by the cells, which shall lead e.g. to an improvement of the metabolism.<br />

| 3/23


The special features of the <strong>Handylaser</strong> <strong>sprint</strong> are proven through several years of intensive research and<br />

offer an exact supply of photon energy to the area being treated.<br />

Further information on the wide range of uses for laser therapy can be found in technical literature and<br />

with scheduled seminars <strong>RJ</strong>-LASER GmbH (www.rj-laser.com).<br />

2. Safety Precautions<br />

Caution - Using the operating equipment or settings in a way not described here can result in dangerous<br />

exposure to radiation.<br />

2.1. <strong>Laser</strong>-protection goggles<br />

Both personnel and patients are to wear laser protection safety goggles during treatment sessions.<br />

The only types of safety goggles which may be worn are those which meet DIN 58215 standards. The<br />

effective range of wavelengths of the protective glasses must include the laser light wavelength of the<br />

equipment. There are two types of safety goggles available:<br />

Number 530, which may be used for wavelengths from: 655 nm to 904 nm<br />

| 4/23


2.2. Explanation of the pictograms<br />

Main unit<br />

Carry case<br />

0123<br />

Transport and storage<br />

Room temperature -20° C a +40 C<br />

Relative humidity 30% to 75%<br />

Atmospheric pressure 700 hPa to 1060 hPa<br />

Protection against electric shock regarding allowable leakage<br />

current limitations are specified in standard 60601-1.<br />

The device meets the requirements of 93/42/EEC for medical<br />

products.<br />

“Attention” Observe the instructions in the manual for safe and<br />

effective usage of this device.<br />

Symbol for the laser beam: “Warning for laser beam”. Aiming of<br />

laser beam must be adhered to, avoiding any other part of the<br />

body other than the treatment area follow treatment protocol of<br />

this manual.<br />

“Caution” Explanatory Label Symbol (International):<br />

"<strong>Laser</strong> radiation" including the standard which was used for the<br />

classification of the laser, power, wave length, pulse.<br />

Aperture labels according to EN 60825-1:<br />

- <strong>Laser</strong> aperture and laser beam direction<br />

Label indicating technical data, serial number, manufacturer.<br />

Date of manufacturing<br />

Label with information of transport and storage conditions on the<br />

package.<br />

| 5/23


2.3. Position of the labels and warning signs<br />

Side/below<br />

above (front panel)<br />

2.4. Shutdown in an emergency<br />

The laser can be shut down in the event of an emergency by pressing the ON/Off button or by pulling out<br />

the safety plug.<br />

2.5. Radiation injuries<br />

Do not look directly into the laser beam outlet. <strong>Laser</strong> radiation can cause eye damage. Protective gear<br />

must be worn inside the treatment room during treatment at all times, caution during therapy in the<br />

head area.<br />

2.6. Treatment room<br />

Technical sign<br />

Type plate<br />

<strong>Laser</strong> warning sign<br />

Warning sign<br />

Attention! Risk of burns in case of pigmented skin, birth marks, tattoo etc. because of the<br />

photon absorption of melanin or colors in the tissue. In case of pigmented or colored skin<br />

use low power or low energy density (larger distance).<br />

The laser may only be operated in a room with the door closed. The treatment<br />

room in which laser therapy is performed must meet the requirements of the<br />

Accident Prevention Regulation BGV B2 ”<strong>Laser</strong> radiation”. Attach a warning<br />

sign to all inputs in accordance with DIN IEC 76 (CO) 6. Reflecting objects,<br />

mirrors and chrome parts must be removed.<br />

| 6/23


2.7. Safeguarding against unauthorized usage<br />

To safeguard against unauthorized usage, the <strong>Handylaser</strong> <strong>sprint</strong> is equipped with a removable safety plug.<br />

The laser can only be operated when the safety plug is inserted. If the <strong>Handylaser</strong> <strong>sprint</strong> is not being used<br />

store it separately to prevent unauthorized usage.<br />

2.8. Registering (valid for Germany, please refer to your national regulations)<br />

The <strong>Handylaser</strong> <strong>sprint</strong> operator must be registered at the professional association as an operator of a class<br />

3 B laser device. <strong>Laser</strong> safety representative: The operator must be able to name a laser safety<br />

representative.<br />

| 7/23


3. Intended use and personnel<br />

3.1. Proper usage and field of application<br />

The <strong>Handylaser</strong> <strong>sprint</strong> is a therapeutic medical device which is to be used exclusively in medical offices,<br />

clinics and rehab centers, and should only be operated under constant supervision.<br />

In order to perform the therapy for pain and healing, the probe tip has to be placed 1 cam above the<br />

skin.<br />

Therapy duration for 150 mW version<br />

In cw mode please use: 5 min ON / 1 min Stand-by.<br />

Therapy recommendation: The international recommended dosage is 4-6 Joule/cm 2 (WALT) apply it step<br />

by step until the full area is completed. Increase or reduce the dosage individually according to the<br />

patients reaction.<br />

Please refer to the training manual to obtain further information regarding the applications.<br />

3.2. Indication for use<br />

The laser device (including all available wavelengths) was designed for treatment of the body.<br />

• Acupuncture<br />

• Bone healing<br />

• Wound healing<br />

• Pain<br />

• Synositis / tendinitis<br />

• Rheumatic disease<br />

For dental use and aPDT/PAD with 632-670 nm the following indications are valid:<br />

• Alveolic ostitis<br />

• Caries in general<br />

• Endotonia<br />

• Parodontitis<br />

• Periimplantitis<br />

• Wound healing after tooth extraction and implantation<br />

• Treatment of pockets<br />

USA/Canada<br />

The <strong>Handylaser</strong> <strong>sprint</strong> is intended to emit energy in the infrared spectrum to provide topical heating<br />

for the purposes of elevating tissue temperature when heat is indicated for the<br />

• temporary relief of minor muscle and joint pain and stiffness,<br />

• temporary relief of minor joint pain associated with arthritis<br />

• temporarily increase local blood circulation where applied and the relaxation of muscles.<br />

| 8/23


3.3. General treatment exclusions<br />

As producer of the device we do not recommend the use of the laser for<br />

• irradiation around the eyes<br />

• over the thyroid gland and endocrine glands, testicles<br />

• on patients with pace makers<br />

• no treatment on the head on patients with a tendency for epilepsy<br />

• irradiation of the fetus and over the uterus during pregnancy<br />

• irradiation of the epiphysis (children), open fontanella<br />

• on patients taking zytostatics/immune suppressions<br />

• over cancerous or malignant areas, tumor patients<br />

• irradiation of dark, coloured or pigmented skin, birth marks, tattoos, hairy body parts, especially<br />

dark hair.<br />

This is a prescription only device.<br />

| 9/23


4. Device description<br />

4.1. Technical data<br />

<strong>Laser</strong> therapy device type <strong>Handylaser</strong> <strong>sprint</strong><br />

<strong>Laser</strong> class 3B<br />

Protection class IPX0<br />

Device Type B<br />

Absolute failure of the measurement of the<br />

laser power<br />

5%<br />

Modulation frequency Cw, 10 Hz<br />

Risk class according to RL 93/42/EWG IIa<br />

Current supply Batteries<br />

Charger<br />

Weight <strong>Handylaser</strong> 0,2 kg<br />

Weight charger 0,5 kg<br />

3 x 1,2 V-Akku (AAA, MICRO)<br />

Model Ansmann ACS 110 Traveller<br />

Mains Voltage = 100-240V~<br />

Mains frequency = 50-60Hz<br />

Output current = 800mA<br />

Protection class II<br />

Dimension main unit (L x W x H) 15 cm x 3 cm x 4 cm<br />

Dimension power supply (L x W x H) 7 cm x 5 cm x 4 cm<br />

Operating conditions<br />

Room temperature + 10°C a +30°C<br />

Relative humidity 30% - 75%<br />

Atmospheric pressure 700 hPa - 1060 hPa<br />

Transport and storage<br />

Room temperature -20° C a +40 C<br />

Relative humidity 30% - 75%<br />

Atmospheric pressure 700 hPa - 1060 hPa<br />

| 10/23


4.2. Technical data of the laser diodes (depending on the model)<br />

Nr.: Wave<br />

length<br />

Output power <strong>Laser</strong> type / pulse<br />

duration<br />

NOHD *) m Beam divergence<br />

1 785 nm max. 50 mW cw 0,10 0,140 rad<br />

2 638 nm max. 150 mW cw 0,09 0,157 rad<br />

3 810 nm max. 150 mW cw 0,12 0,209 rad<br />

*) Safety distance (NOHD). Distance at which the radiation intensity or the radiation is equivalent to the limiting value of the maximum<br />

permitted radiation of the cornea (MZB).<br />

For more information, please refer to the device plate.<br />

4.3. Contents of delivery<br />

<strong>Handylaser</strong> <strong>sprint</strong> main unit, 1 key (coding bridge), charger Ansmann ASC 110 Traveller, instruction<br />

manual, 2 protection glases, therapy manual, warning sign "<strong>Laser</strong> radiation" according to EN 60825-1,<br />

carry case.<br />

| 11/23


5. Connectors and functional components<br />

<strong>Laser</strong> aperture<br />

Pilot beam L1/2<br />

Indicator L3<br />

<strong>Laser</strong> READY<br />

<strong>Laser</strong> Start/Stop cw<br />

(dental: 60 sec. energy timer)<br />

Indicator L4<br />

<strong>Laser</strong> ON<br />

5.1. Indicators (LED, Display)<br />

LED Color Status Meaning<br />

L1/L2 red flashes<br />

on<br />

Pilot + laser beam lights in the rhythm of the frequency<br />

or continuous if one of the Start-buttons is pressed<br />

L3 red on Flashes two seconds after pressing the Start button to<br />

warn you of the ensuing laser radiation and then it is on<br />

continuous<br />

to glow.<br />

<strong>Laser</strong> Start/Stop 10 Hz<br />

40 seconds energy timer<br />

(dental: 60 sec. energy timer)<br />

L4 red on Will glow after pressing the ON/OFF to inform you that the<br />

laser is READY.<br />

Socket for the charger<br />

L5 yellow on Will glow if the power is out of range.<br />

Coding bridge/remote<br />

control<br />

Emergency OFF<br />

ON/OFF switch<br />

Indicator L5<br />

<strong>Laser</strong> out of range<br />

| 12/23


5.2. Applicators<br />

5231 Convex head Ø 4,5mm<br />

Stainless steel<br />

resterilizable<br />

523 Convex head lens Ø 10mm<br />

Stainless steel, glass<br />

resterilizable<br />

5241 Point applicator w/lens L20mm Ø D2mm<br />

5251 Point applicator w/lens L20mm Ø D4mm<br />

Stainless steel, glass<br />

resterilizable<br />

527 Medicament applicator<br />

Stainless steel<br />

resterilizable<br />

| 13/23


5204 Dental applicator L70mm Ø2mm, bent<br />

Stainless steel, glass<br />

resterilizable<br />

5202 Dental applicator L70mm Ø4mm, bent<br />

Stainless steel, glass<br />

resterilizable<br />

5208 Dental bar L50mm Ø8mm, straight<br />

Stainless steel, glass<br />

resterilizable<br />

5207 Dental bar L70mm Ø8mm, bent<br />

Stainless steel, glass<br />

resterilizable<br />

5206 Universal Tip Ø 0,8mm<br />

PDD / PDT<br />

Macrolon disposable<br />

5205 Endo Tip Ø 0,4mm<br />

PDD / PDT<br />

Macrolon disposable<br />

The tips contain special optical quartz glass to offer high energy density and will keep the opening clean.<br />

Attach/screw the applicators onto the probe tip. According to the area to be treated (point or larger surface) select<br />

the applicators. The lens does not focus the beam, it will protect the laser diode against damage or contamination<br />

during skin contact. The applicators should be sterilized before and after the therapy.<br />

Note: Depending on the applicator, the pilot beam may be not visible.<br />

| 14/23


Application<br />

Nr. 5201 Dental applicator for radiation of mouth and throat<br />

Nr. 523-5231 Lens applicator for skin treatment, small areas, trigger points, acupressure<br />

Nr. 524-525 Point applicator for the radiation of points, acupuncture<br />

Nr. 527 Point applicator for the radiation of Body openings (e.g. inner ear)<br />

After and before the therapy the applicators should be sterilized.<br />

6. Starting and using the device<br />

Inserting the coding bridge<br />

To safeguard against unauthorized use, the <strong>Handylaser</strong> <strong>sprint</strong> is equipped with a removable coding<br />

bridge. Insert the coding bridge in the socket on the back part of the case. The socket of the coding<br />

bridge can be used for the remote control.<br />

Installing the storage batteries or the rechargeable batteries<br />

The battery compartment is located at the back of the <strong>Handylaser</strong> <strong>sprint</strong>.<br />

Remove the cover. Insert three new storage batteries or three fully-charged rechargeable batteries.<br />

Please observe the proper polarity when installing the batteries. Replace the battery cover.<br />

Coding bridge Socket for the charger<br />

O/I Switch<br />

Battery compartment<br />

| 15/23


6.1. Releasing the laser beam, 40 (60 dental version) seconds energy timer<br />

1. Press one of the Start button. The Pilot (L1, L2) will indicate the beam direction.<br />

The READY LED L4 will light continuously thereafter.<br />

a) Pressing button [Start cw] and will run on continuous mode for 40 (60) seconds (energy timer: supply<br />

of 2 Joule at 50 mW).<br />

b) Pressing [Start 10 Hz] and will run on 10 Hz frequency mode for 40 (60) seconds (energy timer:<br />

supply of 1 Joule at 50 mW).<br />

Pressing the button again will shut of the laser prior to 40 seconds.<br />

L3 will glow continuously as long as the laser is active.<br />

L5 will glow if the power is out of range.<br />

6.2. Control displays<br />

The indicator lamps indicate that the <strong>Handylaser</strong>’s various functions are operating faultlessly. All of the<br />

functions are continually checked using special electronic devices and the values registered are<br />

compared with programmed values. A breakdown is indicated if the lamps do not illuminate while the<br />

unit is operating.<br />

6.3. <strong>Laser</strong> indicator lamp<br />

The red pilot diodes in the handylaser <strong>sprint</strong> head under and above the laser outlet indicates the<br />

direction of the invisible laser beam (pilot beam). The pilot beam meets the laser beam 20 mm away from<br />

the laser outlet.<br />

The lamps (L4) indicate if the <strong>Handylaser</strong> <strong>sprint</strong> is READY.<br />

The lamps (L3) indicate if the <strong>Handylaser</strong> <strong>sprint</strong> is operating.<br />

6.4. Power control<br />

The output is adjusted for value selection once the laser has been switched on. The output is indicated<br />

L3. L5 will glow when the power has not been reached (e.g. broken laser diode, empty battery), +/- 20%.<br />

6.5. Audible indicator<br />

An audible signal (beep) is heard as soon as the laser is activated, one beep every five seconds. This signal<br />

does not differentiate between types of frequency modulation.<br />

| 16/23


7. Charging the battery<br />

In order to charge the batteries attach the plug of the Ansmann ACS 110 Traveller<br />

into the socket on the devices. Shut off the device with the O/I switch.<br />

8. Charging the battery<br />

The display will indicate the condition of the battery. If it is on low the battery shall be charged. For<br />

charging insert the plug of the charger into the socket on the back side of the <strong>Handylaser</strong> <strong>sprint</strong> and<br />

connect it with the mains supply.<br />

The batteries can be charged at any time because they do not have a memory effect.<br />

LED indicators on the charger<br />

Power (mains<br />

current)<br />

Socket for charging<br />

Battery compartment<br />

red continuous Charge is connected to the mains supply<br />

Charge red continuous Accumulators will be charged<br />

Ready green flashing Charging still in progress<br />

Ready green continuous Accumulators are fully charged<br />

| 17/23


8.1. Charger Ansmann ACS 110 Traveller<br />

| 18/23


9. Maintenance<br />

9.1. Annual inspection of the device<br />

Due to the advanced technology and precision of the <strong>Handylaser</strong> <strong>sprint</strong> must undergo a safety inspection<br />

and calibration at least one year from the purchase date (various test are performed in order to insure<br />

that the device is operating within the tolerances that the device was originally designed). This annual<br />

inspection/calibration must be submitted to an authorized facility. Repairs or maintenance performed by<br />

an unauthorized facility or personnel will void your warranty.<br />

Inclusive with your device will be shipping labels and instructions for deliver to the repair and<br />

maintenance facility.<br />

For repair and maintenance, devices must be sent directly to:<br />

9.2. Cleaning / Disinfecting<br />

REIMERS & JANSSEN GmbH<br />

Medical — <strong>Laser</strong> — Technology<br />

Fabrikstraße 22 D-79183 Waldkirch-Kollnau, Germany<br />

Tel. +49-7681-4934149 Fax +49-7681-4934150<br />

service@rj-laser.com www.rj-laser.com<br />

Quality management according to EN ISO 13485:2003<br />

Please observe that cleaners for plastics, soap are used for periodic cleaning of the plastic parts. No<br />

penetrative or corrosive agents (such as acetone) should be used. Keep fluids from entering the housing.<br />

Standard disinfectants may be used. When this is done, the unit is to be wiped with a soft cloth which<br />

has been dampened with a mild, approved disinfectant (50% diluted propyl alcohol solution).<br />

Clean/sterilize the applicators with medical approved disinfections before and after therapy.<br />

Under no circumstances is the unit to be flooded with the disinfectant or to be treated with solvents!<br />

Autoclaving must not be used on the unit.<br />

| 19/23


9.3. Maintenance/Calibration<br />

9.4. Disposal<br />

The laser diodes will be calibrated by the software at each start. <strong>RJ</strong> recommends an annual service of the<br />

laser at the <strong>RJ</strong> service facilities or an authorized service station.<br />

Always ensure that operational and sufficiently charged batteries are used.<br />

The interior of the <strong>Handylaser</strong> <strong>sprint</strong> contains no elements or components which require servicing by the<br />

user.<br />

Therefore, there is no need to open the housing. To meet the requirements of DIN VDE 0837, “Radiation<br />

safety for laser devices,” the unit is to be tested and recalibrate after one year of use to ensure that the<br />

laser is operating properly. Please send the unit to the manufacturer for testing and recalibration.<br />

The producer will supply spare parts up to 10 years after delivery date.<br />

Due to the hazards of laser beams, the <strong>Handylaser</strong> <strong>sprint</strong> is not to be disposed of as standard electronic<br />

scrap. The device is to be delivered to either the supplier or to the manufacturer for proper disposal.<br />

9.5. Warranty<br />

There is a 2 years warranty from the manufacturer. The manufacturer guarantees operation of all<br />

<strong>Handylaser</strong> <strong>sprint</strong> features described in the user’s guide, provided the equipment is used in accordance<br />

with the instructions detailed in the user’s guide and is treated with proper care.<br />

New settings, maintenance or repairs may only be performed by the manufacturer or an authorized<br />

workshop; otherwise the warranty is rendered null and void. Interventions in the device by third parties<br />

will lead to loss of warranty claims and will release the manufacturer from all product liability.<br />

Only use original spare parts and accessories.<br />

| 20/23


10. Electromagnetic compatibility - Warning instructions<br />

Precautionary measures<br />

There are special precautionary measures for medical electric devices as fare as electromagnetic compatibility is<br />

concerned. This device may be used only for the purpose described in the manual, set up and put into operation<br />

according to the notes for electromagnetic compatibility.<br />

Influence of mobile and portable communication equipment<br />

High-frequency energy radiation from mobile communication equipment may influence on the operation of the<br />

medical electric device. It is not allowed to use those devices (for instance mobile phones and GSM telephones)<br />

close to the medical electric device.<br />

10.1. Guidelines and manufacturer’s declaration – Electromagnetic radiation<br />

The laser device is designed for the operation only with original accessories in ambient conditions indicated below.<br />

Client and user have to make sure that the device is operated in such ambient conditions.<br />

Radiated disturbance measurements Conformity Electromagnetic ambient conditions - guideline<br />

HF-radiation to<br />

CICPR 11<br />

Group 1 The laser device uses HF-energy only for its internal function. Therefore HF<br />

radiation is very low. The influence on neighbouring electric devices is<br />

unlikely...<br />

HF-radiation to CICPR 11 Class B The laser device may be used in all kinds of buildings, including residential<br />

Radiation of harmonic oscillation Conforms buildings and those directly connected to mains for the public supply which<br />

according to EC 61000-3-2<br />

are also servicing buildings used for residential purposes.<br />

Radiation of voltage variations/ Flicker<br />

effect according to IEC 61000-3-3<br />

Not applicable<br />

10.2. Guidelines and manufacturer’s declaration - Electromagnetic immunity<br />

Immunity tests IEC 60601-Test level Conformity<br />

level<br />

Electromagnetic ambient conditions - guidelines<br />

Discharge of static electricity (ESD ± 6 kV Contact discharge conforms The floor should be made from wood or concrete or<br />

)according to IEC 61000-4-2 ± 8 kV Air discharge<br />

covered with ceramic tiles. If the floor is covered with<br />

synthetic material the relative humidity should be<br />

minimum 30%<br />

Fast transient electric disturbance ± 2kV<br />

conforms The quality of the supply voltage should be typical for<br />

variable / Bursts<br />

for network leads<br />

business or hospital ambient conditions.<br />

according to IEC 61000-4-4 ± 1 kV<br />

for input and output leads<br />

Impulse voltage (Surges) according ± 1 kV<br />

conforms The quality of the supply voltage should be typical for<br />

to IEC 61000-4-5<br />

opposed mode voltage<br />

± 2 kV<br />

common mode voltage<br />

business or hospital ambient conditions.<br />

Voltage dips, short interruptions < 5% UT<br />

conforms The quality of the supply voltage should be typical for<br />

and voltage variations according to (> 95% dip of UT) for ½ period<br />

business or hospital ambient conditions. If the user<br />

IEC 61000-4-11<br />

40% UT<br />

wants to continue operation in case of an interrupted<br />

(60% dip of UT) for 5 periods<br />

energy supply it is recommended to feed the laser<br />

70% UT<br />

(30% dip of UT) for 25 periods<br />

< 5% UT<br />

(> 95% dip of UT) for 5 s<br />

device from a system without interruption or a battery.<br />

Magnetic field at supply frequency 3 A/m conforms Magnetic fields at mains frequency should have the<br />

(50/60 Hz)<br />

typical values for business and hospital ambient<br />

according to IEC 61000-4-8<br />

conditions.<br />

Note: UT - alternating voltage mains before the application of the test level.<br />

| 21/23


10.3. Guidelines and manufacturer’s declaration – Electromagnetic immunity – for the laser device<br />

without life supporting function<br />

Immunity tests IEC 60601-test level Conformity level Electromagnetic ambient conditions - guidelines<br />

HF-disturbance variables<br />

(transmission) according to IEC<br />

61000-4-3<br />

HF-disturbance variables (radiation)<br />

according to IEC 61000-4-3<br />

3 Veff<br />

150 kHz up to 80 MH<br />

3 V/m<br />

80 MHz up to 2,5 GHz<br />

Note 1 At 80 MHz and 800 MHz the higher frequency range is applied.<br />

conforms<br />

conforms<br />

Portable and mobile radio sets must not be operated in<br />

a distance to the laser device and the leads less than<br />

the recommended protective distance what was<br />

calculated according to the equation for the<br />

transmission frequency.<br />

Recommended protective distance:<br />

d = 1,2 √ P<br />

d = 1,2 √ P for<br />

80 MHz up to 800 MHz<br />

d = 2,3 √ P for<br />

800 MHz up to 2,5 GHz<br />

with P as power rating of the transmitter in Watt (W)<br />

according to data from the manufacturer of the<br />

transmitter and as recommended protective distance in<br />

meter (m).<br />

According to a local a investigation the field intensity<br />

for all frequencies of immobile radio transmitters should<br />

be less than the conformity level b .<br />

Interference is possible in the surroundings of devices<br />

carrying the following signs.<br />

Note 2 These guidelines are not applicable in all cases. The propagation of electromagnetic quantities is influenced by the absorption and reflection of buildings, items and human beings.<br />

a It is not possible to predict theoretically the field strength of immobile transmitters like base stations of mobile phones and mobile land radio sets, amateur radio stations, AM and<br />

FM television and radio broadcasting transmitters. In order to determine electromagnetic ambient conditions with regard to immobile transmitters a study of the location should be taken into<br />

consideration. If the field strength measured in the place where the laser device is operated exceeds the above mentioned conformity level the laser device should be watched to proof its<br />

function in accordance to the requirements. Unusual performance data may require additional measures, for instance change of orientation or different location of the laser device.<br />

b Above the frequency range from 150 kHz to 80 MHz the field strength should be less than 3 V/m.<br />

10.4. Recommended protective distance between portable and mobile HF-telecommunication devices and<br />

the laser device without life supporting function<br />

Recommended protective distance between portable and mobile HF-telecommunication devices and the laser device<br />

The laser device is designed for the operation in electromagnetic ambient conditions where HF-disturbance variables are controlled. Client or<br />

user of the laser device can help to avoid electromagnetic disturbances by keeping the minimum distance between portable and mobile HFtelecommunication<br />

devices (transmitters) and the laser device as indicated below, dependent on the power output of the communication<br />

device.<br />

Power rating of the<br />

transmitter<br />

W<br />

Protective distance dependent on the transmitting frequency m<br />

150 kHz up to 80 MHz<br />

d = 1,2 √ P<br />

80 MHz up to 800 MHz<br />

d = 1,2 √ 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 />

800 MHz up to 2,5 GHz<br />

d = 2,3 √ P<br />

If the maximum power rating for certain transmitters is not given in the above table the recommended protective distance d in metres (m) can<br />

be determined by using the equation indicated in the respective column, where P is the maximum power rating of the transmitter in Watt (W)<br />

according to the manufacturer of the transmitter.<br />

Note 1 At 80 MHz and 800 MHz the higher frequency range is applied<br />

Note 2 These guidelines are not applicable in all cases. The propagation of electromagnetic quantities is influenced by the absorption and<br />

reflection of buildings, items and human beings.<br />

| 22/23


11. Manufacturer<br />

12. Distributor<br />

V. 2.9, 07.04.2011<br />

REIMERS & JANSSEN GmbH<br />

Medical — <strong>Laser</strong> — Technology<br />

Fabrikstraße 22 D-79183 Waldkirch-Kollnau, Germany<br />

Tel. +49-7681-4934149 Fax +49-7681-4934150<br />

service@rj-laser.com www.rj-laser.com<br />

Quality management according to EN ISO 13485:2003<br />

| 23/23

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!