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gbo Medizintechnik AG Version 1.8

Laser therapy device

BodyLaser

Operating instructions

2 BodyLaser


gbo Medizintechnik AG has taken care in preparation of this manual, but makes no expressed or impliedwarranty of any kind and assume no responsibility for errors or omissions.

All rights reserved. No part of this manual may be reproduced, in any form or by any means (electronic,mechanical, or otherwise) without the prior written permission of the gbo Medizintechnik AG.

gbo Medizintechnik AG

gbo Medizintechnik AGKleiststrasse 6D-64668 RimbachPhone: +49 (0) 6 25 3/808-0Fax: +49 (0) 6 25 3/808-300E-Mail: [email protected]: http: // www.gbo-med.de

Manufacturer:

Livetec GmbHMarie-Curie-Strasse 8D-79539 Lörrach

Version: 1.8Date of issue: 2012-08-29

BodyLaser 3


Warnings and safety precautions

WarningWarnings which have to be observed by all means!

Attention!Observe the instructions for use!

!!Note

Information which facilitate your work.

4 BodyLaser


Contents

1 INTRODUCTION 5

1.1 Intended use 5

1.2 Short instructions 5

2 START OF OPERATION 7

2.1 Transport and installation 7

2.2 Connection and switch-on 7

2.2.1 Basic device 7

2.2.2 Point applicator LA-X 3020A 8

2.2.3 Laser shower LDU 3015B 8

3 DESCRIPTION OF FUNCTION 9

3.1 Basic device 9

3.2 Applicators 10

3.2.1 Point applicator LA-X 3020A 10

3.2.2 Laser shower LDU 3015B 10

4 THERAPY 11

4.1 Searching for acupuncture points / automatic mode 11

4.1.1 Measurement of the skin conductance 13

4.2 Contraindications 14

5 BEHAVIOR IN CASE OF FAILURES 15

5.1 Failure messages 15

6 MAINTENANCE 16

6.1 Safety controls 16

6.2 Cleaning, disinfection and care 16

6.2.1 Basic device 16

6.2.2 Applicators 16

7 WARNINGS AND SAFETY PRECAUTIONS 17

8 SIGNS USED AND WARNING PLATES 19

9 TECHNICAL DATA 20

10 ACCESSORIES 21

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1 Introduction

1.1 Intended use

The laser therapy device BodyLaser is a medicine product and is suited for:

local surface laser therapy and stimulation of acupuncture points.

1.2 Short instructions

Key operated switch (1) Therapy time (2) Indicator elements (3) - (8)

Frequency(9), (10)

Therapy time(11), (12)

Outlet A, Outlet B(13), (14)

File accessories

Figure 1: Front view of the basic device BodyLaser

Outlet A (13) for thepoint applicator

Outlet B (14) for the lasershower

Identification plate Mains connection

Figure 2: Side view and back view of the basic device BodyLaser

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Figure 3: Laser shower LDU 3015B

Figure 4: Point applicator LA-X 3020 A

1. Connect the applicators to the appropriate socket on the left device side of the basic device.2. Switch on the basic device with the key operated switch on the device front. The basic device executes

an automatic selftest of all functions.3. Press the key for the wished outlet A (13) for the point applicator or outlet B (14) for the laser shower.

The control LED Out A (5) or Out B (6) shows which outlet is activated. Only an outlet is alwaysactivated. Presetting: outlet B is activated.

4. Modify the therapy time with the keys + (11) and – (12). Presetting: 5 minutes therapy time.5. The applicators point applicator or laser shower are switched on with the laser key (15) or (22). With

the laser shower the LED on the right from the laser key is lit yellow. With the point applicator theLED before the laser key is lit yellow.

Warning

With the laser shower an internal selftest is inserted. With a defect one or several laserdiodes there the control LED (24) in the applicator is lit orange. In this case contact gboMedizintechnik AG or one of the service agencies authorized by gbo MedizintechnikAG.

6. At the end of the therapy time you switch off the appropriate applicator with the laser key (15) or (22)and the basic device with the key operated switch from.

Laser key (22)

Laser key (15)

Conductance key (16)

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2 Start of operation

2.1 Transport and installation

Warning

The unit is not designed to be used in non-explosion-proof areas. If it is used indangerous areas of anesthesia departments, the possibility of an explosion cannot beexcluded.

If the patient and/or the patient cable is directly exposed to a radiator of a medical devicefor high frequency heat therapy, damage of the device or a threat to the patient cannot beexcluded. As a rule, a distance of 3 m is sufficient.

The laser therapy device corresponds to the regulations DIN/VDE 0750, EN 60601. It is a device of theprotection class I. Within the scope of the Medical Device Directive (MDD) the laser therapy devicebelongs to the class II B (see also chapter 7).

The basic device is a portable unit. There is a carrying handle in the form of a recessed grip in the base plate.To place the unit, each flat surface is appropriate. A wall distance of at least 20 cm has to be provided. Thedevice should not be placed in front of radiators.

2.2 Connection and switch-on

2.2.1 Basic device

The basic device is for the connection with a supply voltage from 100 - 240 V and a frequency of50 to 60 Hz suitably.

The switch-on of the basic device takes place by the key operated switch-on the device front side → presetting.

Attention

The basic device must be switched off by connection, change, pulling of the applicators.

After the switch-on of the basic device a selftest of all functions is automatically executed.The outlet B is activated.The therapy time is preset on 5:00 min.

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2.2.2 Point applicator LA-X 3020A

Warning

The laser with changeable wave guide may be used only with inserted wave guide!

Laser performance measurement:

Before every treatment the laser performance measurement is to be executed.

1. Set the point applicator on the measuring surface to test (3) in the basic device.2. Press the laser key (15) of the point applicator.3. The control LED laser (4) in the basic device is lit.4. If the laser test was positive, you can start with the laser treatment.

Automatic mode:

Connect the counterelectrode to the LA-X (black socket above the cable resignation). Slightly moisten thearm of the patient and attach the rubber sleeve. Make sure it sits properly. In the case of self-Therapy, youmust touch one of the silver contact surfaces, and you do not need the rubber sleeve.

When moving the LA-X over the skin (always with direct contact and gentle pressure), zones with anincreased conductivity are displayed on the display. Skin conductivity values from 0 to 99 can be displayed.With higher conductivity values (> 99), the red LED below the second luminous bar lights up (overflow).

The luminous bar indicates the current range.

2.2.3 Laser shower LDU 3015B

The laser shower is activated by pressing the laser key (22) or is deactivated. The yellow LED (23) on theright of the key is lit. Besides four red LEDs are lit in the outlet surface of the laser beams.

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3 Description of function

3.1 Basic device

Freq.

Alpha

Multi

(9)

(10)

Modulation 10 Hz

Multifrequency spectrum

Figure 5: Frequency keys

(11)

(12)

Both therapy time keys serve the setting of the therapy time.

Figure 6: Therapy time keys

(13)

(14)

Both outlet keys select between outlet A and B.

Figure 7: Outlet keys

(3)

(4)

(5)

(6)

(7)

(8)

Hold the applicator vertically to the window test (3) and switch on. The control LEDlaser (4) is lit. Execute this laser test before every treatment! If the point applicator isfaulty, contact immediately gbo Medizintechnik AG or one of the service agenciesauthorized by gbo Medizintechnik AG.

Chosen outlet A (5) or B (6) which was activated by the appropriate outlet key (13)or (14).

Chosen operation mode Multi (8) or Alpha (7) which was activated by theappropriate frequency key (10) or (9).

Figure 8: Indicator elements

Display of the duration of treatment – after the switch on is set the therapy time of 5minutes. With the therapy time keys (11) and (12) the time can be modified by stepsper minute.

Figure 9: Therapy time

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3.2 Applicators

3.2.1 Point applicator LA-X 3020A

(25)(15)

(26)(16)

With the laser key (15) the laser is activated in the manual mode. The yellowcontrol LED (25) is lit above the laser key and the therapy time will pass.

With the conductance key (16) the skin conductance can be stored. If a skinconductance is stored, the yellow LED (26) is lit above the conductance key (16).

(17)

(18)

(19)

(20)

(21)

In the display (17) the skin conductance or the therapy time is indicated.

The yellow LED (18) indicates that the point applicator is switched on.

With the luminous bars (19) and (20) the skin conductivity is indicated optically. Inthe first field below the digital display the values from 1 to 9 are indicated. Thesecond field indicates the skin conductivity more than 10 in steps of 10.

The overflow (21) indicates skin conductivity greater than "99" with the red LED.

Figure 10: Functional keys and indicator elements of the point applicator

3.2.2 Laser shower LDU 3015B

(22)

(23)

(24)

With the laser key (22) the laser shower is activated. The yellow control LED (23) islit on the right near the laser key and the therapy time will pass.

If the yellow LED (23) is lit on the right near the laser key (22) (permanent lights)the laser shower is activated and the therapy time will pass.

If the orange LED (24) is lit on the left near the laser key (22) (permanent lights) thelaser shower is faulty contact immediately gbo Medizintechnik AG or one of theservice agencies authorized by gbo Medizintechnik AG.

Figure 11: Functional keys and indicator elements of the laser shower

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4 TherapyThe following must be observed if you wish to achieve optimum success with the therapy:

!! Notes To keep reflection losses as small as possible, skin must be grease-free, and the

applicator must be held perpendicular to the skin. With the treatment of body surfaces fundamentally only in longitudinal direction

work. The distance between the applicator and the skin is a few millimeters, ordirect contact.

Move the respective applicator over the skin slowly and uniformly, and activatethe applicator when it is in the position for treatment.

Only apply lotions, creams and ampoules when the laser treatment has beenfinished.

The laser beam outlet of the applied applicator is to be cleaned after every skincontact and when changing the patient with a cotton swab and some alcohol.

To get ideal conditions for a successful therapy, it is recommendable to irradiate theacupuncture point "Yin-Tang" (see picture) before each session. For this pupose, thealpha frequency is switched on with the alpha key (9). The switch-on position isindicated by the control LED Alpha (7).

The point "Yin-Tang" is irradiated for approx. 30 seconds. After that witch off thealpha frequency by pressing the multi-key (10). Now the device is again in themultifrequency mode. This condition is indicated by the control LED Multi (8).

Warning

Switch off the alpha frequency when irradiating surfaces or when treating otheracupuncture points, as the laser performance is reduced by about 50 %.

4.1 Searching for acupuncture points / automatic mode

Acupuncture points exhibit a different electronic response compared to immediately adjacent areas of skinwhich visibly appear to be identical. These points can be detected as zones with an increased skinconductivity (equivalent to a reduced electric resistance of the skin). This fact is the basis when workingwith a point searching unit.

It is advisable the following method of approach:

1. Connect the counterelectrode to the LA-X (black socket above the cable resignation). Slightly moistenthe arm of the patient and attach the rubber sleeve. Make sure it sits properly. In the case of self-Therapy, you must touch one of the silver contact surfaces, and you do not need the rubber sleeve.

2. Apply the point applicator vertically near the supposed acupuncture point (1 – 2 cm) with slight pressureonto the skin and press the conductance key (16).

3. There are skin zones where the skin conductivity is below the measuring range. This is the case if thedisplay indicates the value "00" with the skin conductivity measurement. In this case you must press thepoint applicator firmer onto the skin or better slightly moisten the area.

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4. Make sure you hold the point applicator steady during the measurement. If you press the conductance

key (16) briefly, the skin conductivity is measured and is stored. The value is indicated in the display.5. After the measurement release the conductance key (16). In the display (17) of the point applicator the

value "0000" appears briefly and then switches to "00".6. The yellow conductance LED (26) above the conductance key (16) is lit. The laser automatic function

has now been activated.

!! NoteIf you hold the conductance key (16) pressed for approx. 1 sec, the value is deletedagain.

7. Acupuncture points can be searched by moving the point applicator over the skin. During the pointsearching the stored value is compared permanently with the stored value.

8. If a point is found with a conductivity higher than the stored value, this is indicated in the display by avalue – always relative to the stored value.

9. If the point applicator is now no longer moved, and if the current measured value is greater than "0000",the laser is automatically switched on, and the point is treated with laser beam.

10. Now the display (17) in the point applicator indicates the therapy time, the yellow laser LED (25) islitabove the laser key (15), and an acustic signal will sound.

11. The therapy runs as long as the point applicator is set up.

Attention

The laser cannot switch on automatically as long as you have stored no skinconductivity and move the point applicator over the skin,.

If the laser has switched on automatically, the laser continous to run even if youcontinue to move the point applicator over the skin and the skin conductivity > to thestored skin conductivity.

Example: acupuncture point Lu 5

In this area (approx. 1 – 2 cm away from thepoint) measure the skin conductivity.

Following measurement of the skinconductivity, slowly move the LA-X in the

direction of Lu 5 while pressing gently.Measure the skin conductivity at various pointsas a check, and repeat the procedure.

If a conductivity measurement is made at the

point Lu 5, the LA-X does not show any furtherchanges in the skin conductivity in the vicinityof the point.

Figure 12: Acupuncture point Lu 5

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4.1.1 Measurement of the skin conductance

Measurement (A3) Measurement (A2) Measurement (A1)Measured value e.g. 90 Measured value e.g. 80 Measured value e.g. 60

For example, if you store the skin conductivityvalue at point A1 and then move the laser indirection of A2, the displayed skin conductivityvalues will be greaten than 60 in this example.

If you carry out the measurement with A2,conductivity values will only displayed where thecompared value is greater than 80. Any pointsbelow 80 will not be displayed, etc.

This method allows you to locate the center of theacupuncture point relatively accurately.

If you measure the skin conductivity at theacupuncture point, the unit will not display anyvalues in the immediate vicinity of this point.

Figure 13: Example measurement

To search for another point, first move the LA-X from the skin. The laser switches to the automatic statusagain, the measured value remains stored and the conductance LED (26) above the conductance key (16)is still lit.

You can delete the stored value by pressing the conductance key (16) for approx. 1 sec. Now theconductance LED (26) above the conductance key (16) is then off.

The complete procedure as described must be repeated each time you search for a new point .

!!Note

Switching-on of the laser does not necessarily mean that you have found anacupuncture point. It only means that the current conductivity value is higher thanthe stored value. It may well be the case that you have to carry out severalmeasurements before you find the point.

Working with the LA-X cannot replace knowledge of the positions of acupuncturepoints. Extremely moist, dry or hairy skin, or also an extremely high atmospherichumidity in the room, may lead to faulty results.

Acupuncture points exist which lie very deep and are extremely difficult to find.The same applies to points which not active. It is extremely difficult, andsometimes even impossible, to find such points using point searcher. Themeasurement is very accurate if the acupuncture points are located relatively farapart. It is understandable that point searchers have difficulties if the acupuncturepoints are located very close together.

14 BodyLaser


4.2 Contraindications

The following contraindications are referred to in the laser literature:

Absolute: ► Irradiation of eyes► Photosensitivity► Tumor patients► Open fontanels and epiphyseal cartilages in children► Thyroid gland hyperactivity

Relative: ► Patients with pacemaker (thorax), no point measurements with counterelectrode► Epilepsy (head)► Pregnancy (stomach and back regions)► Menstruation problems (lower stomach)► Endocrine organs (thyroid gland, testicle, ovaries)

Therapy hindrances: deep X-ray treatment, permanent medication, chemotherapy.

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5 Behavior in case of failures

5.1 Failure messages

The following failures are indicated by the laser therapy device optically.

Control indicator in the applicator laser shower LDU 3015B is constantly lit:

If the orange LED (24) to the left of the laser key (22) is constantly lit, contact immediately gboMedizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG.

Failure with the laser test – control LED Laser (4) is not lit:

Hold the applicator vertically to the window Test (3) and switch on. The control LED Laser (4) is lit.Execute this laser test before every treatment! If the point applicator is faulty, contact immediately gboMedizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG.

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6 MaintenanceFunctionality, reliability and safety characteristics of device are only guaranteed if properly used inaccordance with the operating instructions. Safety control, maintenance, repair and modifications shall becarried out by the manufacturer or the service agents authorized by him. In case of a failure, parts whichinfluence the safety of the device shall be replaced only by original spare parts of the manufacturer. Theelectric installation shall be carried out in accordance with the requirements of VDE/IEC. The device doesnot contain any parts which need maintenance work done by the user.

6.1 Safety controls

The device is subject to the provisions of the MDD. The safety controls have to be carried out on the basisof this directive. Thereby, the operator regulation has to be especially observed.

Irrespective of the legal rules or beyond the scope of the MDD, it is recommended to have the devicechecked by the manufacturer or by a service agency authorized by him at 12-months intervals.

The check shall consist of at least the following:

Electrical safety check in accordance with the test plan of the manufacturer, Check of the device in respect of external integrity, Check of all display and operating elements in respect of damage, Check of all inscriptions in respect of legibility.

6.2 Cleaning, disinfection and care

Warning

Before cleaning or disinfection unplug the mains plug out of the socket!

6.2.1 Basic device

For cleaning and disinfection of the device and its accessories there should not be used any agentscontaining higher portions of phenol derivates, alcohol, compounds of chlorine or peracetic acid. It isrecommended to use disinfectants on aldehyde basis. The device is not suited for heat sterilization or forsterilization with gases.

The device is suited for wiping disinfection. It has to be observed that no liquids enter the device. Nevershall the plug or socket get wet. For cleaning or disinfection the device must not be dizzled.

The device may be exposed to no direct sunshine.

6.2.2 Applicators

To guarantee safe and hygienic operation, observe the following:

1. Using a cotton bud, clean the laser beam outlet using 70 % ethanol (med. alcohol) following eachcontact with skon and when changing the patient.

2. The applicators may be exposed to no direct sunshine.

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3. The housings of the applicators can be cleaned with a gentle cleaning agent (see list of the federalPublic Health Office). Before cleaning unplug the electric connections.

7 Warnings and safety precautions

Attention !

Turn off cellular phones and radiophone or place them in a distance of 3 m fromthe device.

If the patient and/or the connection cables are in direct range of a high-frequency,short-wave or micro-wave therapeutic device, a damage to the device or an injury ofthe patient cannot be excluded. Please keep a distance of 3 m.

A simultaneous connection of the patient with a high frequency-surgery device canlead to burns under the electrodes.

The unit is not designed to be operated in places with the inherent risk ofexplosions. If it is used in dangerous areas of anaesthesia departments, the possibilityof an explosion cannot be excluded.

Protect the BodyLaser from unauthorized use by application of the key operatedswitch. The appropriate accident protection regulations for laser radiation must beobserved.

Because of its wavelength, the laser beam cannot be seen, or only very weakly. Donot look into the laser beam outlet, and do not point into the eyes of other persons.By laser applications in eye level the eyes are to be protected separately. Even theclosed eye must not be irradiated.

Only switch on the laser beam when you are in position of treatment (direct contactor only a few mm away from the treatment area). When changing of the treatmentarea, the applicator must be switched off and only may be switched on again in thenew treatment area. The yellow LED above or near of the laser key, as well as thetherapy time display (2) indicate whether an applicator is switched on. With thelaser shower 4 red light diodes are lit, in addition, in the laser beam outlet. Switch offthe BodyLaser following the treatment.

The laser system works according to applicator with an output power of 20 mW up toan output power of max. 280 mW. The safety distance when viewing directly into inthe laser beam amounts with the applicators LA-X 3020A with an output power of 40mW approx. 30 cm, with the laser showers LDU 3015B with an output power of 280mW approx. 30 cm.

Make sure that no mirrors or other reflecting surfaces are located within the safetydistance. The provided laser protection glasses “laser vision type P02-DI 780 - 800nm L2 WDIN “ are always to be wear.

Magnetic and electric fields may be influence the function of the device. Thereforedo not use the laser system in the vicinity of equipment which generate largeelectromagnetic fields, e.g. diathermy units or mobile telephones.

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Statutory regulations may apply to the disposal of the laser system. If you finallywish to terminate use of the laser system, please contact gbo Medizintechnik AG orone of the service agencies authorized by gbo Medizintechnik AG.

Contraindications (see chapter 4.2):► Irradiation of the eyes► Photosensitivity► Tumor patients► Open fontanels and epiphyseal cartilages in children► Thyroid gland hyperactivity► Patients with pacemaker (thorax), no point measurement with counterelectrode► Epilepsy (head)► Pregnancy (stomach and back regions)► Menstruation problems (lower stomach)► Endocrine organs (thyroid gland, testicle, ovaries).

Therapy hindrances: deep X-ray treatment, permanent medication, chemotherapy.

In case of all visible failures contact immediately gbo Medizintechnik AG or one ofthe service agencies authorized by gbo Medizintechnik AG.

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8 Signs used and warning plates

0366 CE – Conformity sign

Attention !Observe the instruction for use !

Application part, protection degree type B

This product complies with WEEE Directive2002/96/EG (waste electrical and electronicequipment). Separate collection for electrical andelectronic equipment.

Laser signs „ laser class 3B “with danger symbols

Laser signs "laser beam outlet"

Laser signs "laser specified performance data"

20 BodyLaser


9 Technical data

Mains voltage and frequency: 100 – 240 V AC, 50 - 60 Hz

Current consumption: max. 200 mA with 120 V with 60 Hz

Mains fuses: 0.8 AT (slow-acting) type H

Protection class: I

Protection degree: B

MDD Device class: II B

Protection against ingress of liquids: IPX 0

Dimensions: max. 12 cm x 27.5 cm x 32 cm (H x D x B)

Weight: max. 3 kg without accessories

Color: RAL 9002

Environmental conditions: Operation ofthe device:

Temperature range 10 °C... 30 °CRelative humidity 30... 75%

Transport andstorage:

Temperature range 5 °C... 40 °CRelative humidity < 90 %, none condensing

Laser: Semiconductor laser 785 nm

Laser class: 3B

Effective capacity withmultifrequency:

Laser shower: LDU 3015 B max. 14 x 10 mWPoint searching applicator: LA-X 3020 A max. 20 mW

Pulse peak power: Effective capacity x 2

Ray divergence: x direction 8 – 20 degrees, y direction 20 – 25 degrees

Modulation: Pulse modulation

Modulation frequency: Multifrequency: chance signal derived from quartz oscillator andalpha frequency 10 Hz

Impulse duration: max. 1 ms

gbo Medizintechnik AG reserves the right to modify the design and specification without prior notice.

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10 Accessories

Article designation Article number

BodyLaserExtent of supply

111111

Basic device BodyLaserLaser shower LDU 3015BPoint searching applicator LA-X 3020 AMains cableOperating instructionsLaser protection glasses

031-0-0020

Basic device BodyLaser 031-0-0010

Laser shower LDU 3015B 031-0-0012

Point applicator LA-X 3020 A 031-0-0014

Laser protection glasses 031-0-0015

Operating instructions BodyLaser 031-7-0005

Textbook: Laser Therapy and Laser Puncture 031-7-0011

22 BodyLaser


Notes in accordance with EC directive and MedicalDevices Directive (MDD)

The laser therapy device BodyLaser is one line-powered laser therapy device of the protection class I.

The device is in accordance with the EC directive for medical devices (93/42/EWG) and therefore carriesthe CE sign with the registration number of the notified body for medical devices. The according graphicalsymbol is placed on the type plate.

According to the MDD, BodyLaser is a class II B device.

The manufacturer is only responsible for the safety, operational reliability and functionality of the device if: the device is used in accordance with the instructions for use; the electrical installation of the location where the device will be used meets the respective current

requirements of electrical safety; the device is not used in hazardous environments and humid locations; mountings, amplifications, re-adjustments, modifications or repair works are carried out only by

personnel authorized by the manufacturer; the operator regulation of this EC directive is observed within the scope of MDD.

Technical support may be obtained by the manufacturer, dealers or service authorized by the manufacturer.The product’s duration of life as scheduled by the manufacturer is 10 years.

BodyLaser is an electronic device. For its disposal the according regulations for electronic devices have tobe observed.

Statutory regulations may apply to the disposal of the laser system. If you finally wish to terminate use ofthe laser system, please contact gbo Medizintechnik AG or one of the service agencies authorized by gboMedizintechnik AG.

Repairs may be executed only by the manufacturer or by persons authorized by Him. The laser-basic deviceBodyLaser and the applicators are sealed. Illegal opening leads to the loss of the guarantee. In the repaircase inform the service place of the gbo Medizintechnik AG.

Comments on electromagnetic compatibility (EMC)Medical, electrical devices are subject to special precautions concerning the EMC. They must be installed andoperated according to the EMC-advice given in the accompanying documents. In particular medical, electricaldevices may be influenced by portable and mobile RF-communication devices.

The manufacturer guarantees the conformity of the unit with the EMC-requirements only when usingaccessories which are listed in the EC declaration of conformity. The usage of other accessories my cause anincreased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity.

The unit must not be arranged physically close to other devices or stacked with them. If such an order isnecessary nevertheless, the unit must be observed in order to check it for the intentional operation.

You find more EMC-comments in the chapter “Warnings and Safety Precautions” of this manual as well asin the Technical Information on the next two pages.

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In accordance with the EMC-regulations for medical products we are obliged by law toprovide the following information.

Guidance and manufacturer’s declaration — electromagnetic emissions

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of theequipment should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidanceRF emissions,CISPR 11

Group 1 The equipment uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to causeany interference in nearby electronic equipment.

RF emissions,CISPR 11

Class B The equipment is suitable for use in all establishments, includingdomestic establishments and those directly connected to the publiclow-voltage power supply network that supplies buildings used fordomestic purposes.

Harmonic emissions,IEC 61000-3-2 (*)

Class A

Voltage fluctuation/flickeremissions, IEC 61000-3-3 (*)

Complies

(*) Note: For devices with a power consumption between 75 W and 1000 W only.

Guidance and manufacturer’s declaration — electromagnetic immunity


Immunity test IEC 60601- test level Compliance level Electromagnetic environment –guidance

Electrostatic discharge (ESD),IEC61000-4-2

6 kV contact

8 kV air

6 kV contact

8 kV air

Floors should be wood, concrete orceramic tile. If floors are covered withsynthetic material, the relative humidityshould be at least 30 %.

Electrical fast transient/burst,IEC 61000-4-4

2 kV for power supplylines

1 kV for input/outputlines

2 kV for power supplylines

1 kV for input/outputlines

Mains power quality should be that of atypical commercial or hospitalenvironment.

Surge,IEC 61000-4-5

1 kV differential mode

2 kV common mode

1 kV differential mode

2 kV common mode


Voltage dips, shortinterruptions and voltagevariations on power supplyinput lines,IEC 61000-4-11

<5% U

for ½ cycle(>95% dip)

40% U

for 5 cycles60% dip)

70% U


<95% U

for 5 s(>5% dip)

<5% U

for ½ cycle(>95% dip)

40% U


70% U


<95% U

for 5 s(>5% dip)


If the user of the equipment requirescontinued operation during power mainsinterruptions, it is recommended that theequipment be powered from anuninterruptible power supply or abattery.

Power frequency (50/60 Hz)magnetic field,IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields shouldbe at levels characteristic of a typicallocation in a typical commercial orhospital environment.

Note: U is the a.c. mains voltage prior to application of the test level.

24 BodyLaser


Guidance and manufacturer’s declaration — electromagnetic immunity


Immunity test IEC 60601- test level Compliance level Electromagnetic environment –guidance

Portable and mobile RF communicationsequipment should be used no closer to anypart of the equipment, including cables,than the recommended separation distancecalculated from the equation applicable tothe frequency of the transmitter.

Recommended separation distance:Conducted RF,IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz3 Veff d=1,2P

Radiated RF,IEC 61000-4-3

3 V/m80 MHz to 2,5 GHz

3V/m d=1,2Pfor 80 MHz to 800 MHzd=2,3Pfor 800 MHz to 2,5 GHzWhere P is the maximum output powerrating of the transmitter in watts accordingto the transmitter manufacturer and d is therecommended separation distance inmeters (m).

Interference may occur in the vicinity ofequipment marked with the followingsymbol:

Recommended separation distances to portable and mobile RF communication equipment

The equipment is intended to be operated in an electromagnetic environment, where radiated RF interference iscontrolled. The user can help in avoiding interferences by means of meeting minimum separation distances betweenportable and mobile RF communication equipment (transmitters) according to the maximum output power of thecommunication equipment.

Rated power of thetransmitter (W)

Separation distance according to the tranmission frequency (m)150 kHz to 80 MHz

d=1,2P80 MHz to 800 MHz

d=1,2P800 MHz to 2,5 GHz

d=2,3P0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

BodyLaser 25


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