mu_lasermed_4098_eng_rev05_092009

Lasermed

4098

User Manual

English

Revision: 05

Lasermed 4098

MU_LASERMED_4098_ENG_Rev.05_092009 1

Summary

02 .............Presentation 02 .............Equipment Accessories 03 .............General Information 06 .............Symbols 07 .............Warning 08 .............Installation/ Grid Connection 09 .............Display Languages 10 .............Functions of controls 12 .............Laser Probes 16 .............Modes of operation 16 .............Device Operation 18 .............Mode: Energy Therapy 19 .............Mode: Nogier Therapy 21 .............Mode: Free Therapy 22 .............Protocols 26 .............Operation of the toposcopic pen 27 .............Types of applications 27 .............Master Control Key and Remote Interlock Connector 28 .............Indications 31 .............Contraindications 31 .............Preventive maintenance and preservation 33 .............Safety Warning 34 .............Corrective maintenance 35 .............Technical features 37 .............Declarations 43 .............Final considerations 42 ..European Representative 42 .............Bibliographical references

Lasermed 4098


Presentation

Carci is proud to congratulate you for the aquisition of a high technology and security equipment. Where we are sure this equipment will satisfy the highest quality standards.

LASERMED 4098 was designed according to IEC 60601-1:1994 + amend 1:1997, IEC 60601-2-2006, and IEC 60601-2-22:1997 safety rules, which makes them a safe and reliable product.

Equipment Accessories

01 Laser Probe 905nm, 20mw (60Watts peak) - pulsed 01 Laser probe cable 01 Tripolar power cable 01 Toposcopic pen 01 User Manual

The Lasermed 4098 can be supplied with Laser probe in the lenght of 905nm (infrared) pulsed with 60W of peak, 830nm (infrared) continuous with 30mW continuous and 650nm (red) continuous with 12mW continuos.

To buy optional accessories, please verify the codes at page 36, Additional Accessories .

If you have any doubt, please contact: Technical Assistance Department Rua lvares Fagundes, 359 So Paulo SP Brasil -CEP 04338-000 Tel.: (0XX11) 5621 7024 / 5622 8205 e-mail : [email protected]

Lasermed 4098


General Information

The term LASER means Light Amplification by Stimulated Emission of Radiation.

This light radiation has unique characteristics, different from ordinary light, such as:

o Coherence: while ordinary light is made up of several wavelengths and spatially arranged in disorderly fashion, laser emission is formed by one wavelength only, bearing waves coherent between itself, both time wise and spatial wise;

o Polarization: laser radiation is polarized, which allows its parallelism, which does not occur in ordinary light;

o Monochromaticity: due to the existence of only one wavelength, laser radiation becomes monochromatic.

Since laser radiation is made up of photons that transport energy, on applying laser radiation on any surface, we are transferring Energy.

On applying laser radiation on a tissue, we are transferring a certain amount of energy. With this energys application, we obtain effects we can describe as direct (or primary), indirect and therapeutic.

Lasermed 4098


The effects of radiation on tissues are represented by the scheme below:

Radiation Absorbed

Direct Effects or Biochemical Effect Primary: Bioelectric Effect Bioenergetic Effect

Indirect Effects: Microcirculation stimulation Cellular trophic stimulation

Therapeutic Effects: Analgesic Anti-inflammatory Anti-edematous

Stimulates tissue trophism

Laser has been used successfully and efficiently in physiotherapy in the treatment of painful, inflammatory processes, ulcers, joint disorders, fracture repair and especially in traumatic lesions in sports practice.

Usually, laser therapy uses emitters with wavelengths between 600 nm and 1100 nm (nanometers), since wavelengths of less than 600 nm and greater than 1100 nm are strongly absorbed by the skin, consequently reducing penetration depth.

Lasermed 4098


Figure 1 shows laser radiation absorption by hemoglobin and water:

Hemoglobin absorbs wavelengths of less than 600 nm, where the Argon lasers (514 nm, green) are located, and water absorbs wavelengths of more than 1200 nm, where the CO2 and NdYg lasers are located.

Due to these particularities, Argon, CO2 and NdYg lasers are used for surgical incisions.

Through several scientific studies, one notes that variables in this radiations wavelength, as well as in its power of emission, are responsible for the success obtained in therapeutic pursuits.

With this in mind, CARCI developed a state-of-the-art laser emission equipment, with wavelength and power variables for precise and adequate treatment, according to the type of tissue involved, depth and pathological phase.

wavelength figure 1

Lasermed 4098


Symbols Equipment symbols

Equipment off

Equipment on

This equipment has physiological effects. Consult instructions manual.

Applied part is type BF

Manufacturing date

Serial number

IPX0 Not protected from harmful water penetration

Manufacturer identification

This symbol indicates Hazard Laser radiation

Class II Equipment

CE Mark and certifying body identification

European representative

Lasermed 4098


Symbols on the pack

Caution fragile. Handle with care

Keep in a dry place

This side up. This symbol indicates the right transport position

Maximum piling. Indicates the maximum number of boxes that can be piled. The

quantity is marked in the intermediary square.

Minimum and maximum temperature limits for transport and storage.

Warning

1. This equipment should only be used by a qualified person 2. The operation in short distance (example: 1meter) from a

shortwave diathermy or a Microwave equipment can produce instability on Lasermed operation.

3. Do not put the equipment in soft basis that can close the inferior ventilation holes.

Lasermed 4098


Installation/ Grid Connection

The equipment must be positioned for use such that there is no obstruction of the cabinets lower openings. For perfect operation of your equipment, we suggest that the electrical installations comply with the following standards: Brazil:

NBR 5410/1990 Low-voltage electrical installations; NBR13534/1995 Electrical installations in health establishments

Safety requisites. Other countries:

IEC 60364-7-710/2002 Electrical installations medical locations; Or another listed standard applied in the country of use.

The electric power supplys voltage must be within the range specified in the Technical Features, otherwise, there can be reduced equipment performance and safety risk.

Connect the power cable to the 3-pole connector located in the back panel and connect it to the electric power socket;

Figure 02

Lasermed 4098


Your equipment uses switched power supply and operates at any voltage between 100 and 240V ~ 50 or 60Hz;

If the protective fuse burns, change it, as shown in the figure above, for the value:

The fuses should be: 1.0A 250V (20AG)

Display language

LASERMED allows three display languages to be accessed: Portuguese English Spanish

In case you wish to change the current language, follow the steps below: 1. Connect the LASERMEDs power cable to the electric network.

2. Switch on the device the equipment will test the display and processor circuit, The display will give the following information:

3. Next, press and hold the key

LASERMED 4098

SN.: 00001 Rev.: 4.3

Lasermed 4098


4. After the equipment emits a beep, release the Keys .

5. The display will show the accessible languages: ENGLISH PORTUGUESE SPANISH

6. Select the desired language through the keys

7. Press the key

8. The equipment will exit the language selection mode, showing the Main menu.

Functions of Controls Laserrmed Panel

Set

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Infrared laser emission sensor.

Menu screens selection key

Key to enable the selected parameter.

Key to enable and disable the Lasermed probe.

Moves to the next field

Decreases Increases

Moves to the former field

Lasermed 4098


Laser Probes

Figure 03

LASER PROBE CABLE

Figure 04

Laser aperture

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CONECTION LASER CABLE + LASER PROBE

Figure 05

LASERMED PROBE LABELS.

Lasermed Probe Infrared 830 nm Continuous (Blue Body)

Lasermed Probe Infrared 905 nm Pulsed (Blue Body)

Lasermed 4098


Lasermed Probe Infrared 650 nm Continuous (White Body)

The laser probe label bears the following information: Laser source class Wavelength Laser type (infrared or red) Peak power/ Mean power Serial number Manufacturing date Invisible laser radiation hazard

OBS.: Lasermed automatically detect which Laser probe is being used at the moment.

Lasermed and toposcopic probe indication label

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Toposcopic Probe

1. Toposcopic probe connector to the Lasermed 2. Active electrode 3. Neutral electrode (dispersive)

Lasermed 4098


Modes of operation

LASERMED 4098 has two modes of operation:

Therapy Toposcopic

In the Therapy mode, select the form of application:

1. Therapy Energy Just set the value of the energy desired from 50 mJoules (0.05J) to 10.000 mJoules (10J). The application time is calculated automatically by the processor.

2. Therapy Nogier Select the Nogier frequency desired or the frequencies of 16Hz and 48Hz (calcium cycle), and the application time of

the frequency selected.

3. Therapy Free Set the application time from 1 to 999 seconds;

Toposcopic Mode

Used to locate acupuncture points, or Trigger Points.

Device operation

Connect the power cable in the device to the power network; Connect the laser cable to the laser pen and to the device (Figure 05

page 14); Position the Master Control Key to Press the ON / OFF switch at the back of the device (Figure 02 page

10);

Lasermed 4098


The display will give the following information:

Right after, the equipment enters the OPERATION MODE:

Use the keys to change to the Toposcope screen

Or to use the Therapy mode.

MODE THERAPY LASER 905 nm

ENERGY NOGIER FREE PROTOCOLS

MODE TOPOSCOPY LASER 905 nm

Sensitivity Low High XXXXXXXXXXXXXXXXXXXX



LASERMED 4098

SN.: 00001 Rev.: 4.3

Lasermed 4098


1. Mode: ENERGY THERAPY

Press the key to enable the mode: Therapy

Press the key to enable the mode: Power

Use the keys for the Energy desired.

The application time for the Energy desired is automatically adjusted by the microcontroller.

To enable the laser pen, press the key of the panel. The indication in the panel : LASER OFF , will change to : LASER Stand By and the pen's Green LED will remain on, showing that the probe is ready for application.

MODE ENERGY LASER 905 nm Set to Save ENERGY J 00.10 00.00 TIME S 000.5 000.0 Total SENSOR XXXXXXXXXX LASER OFF



MODE ENERGY LASER 905 nm Set to Save ENERGY J 00.00 00.00 TIME S 000.0 000.0 Total SENSOR XXXXXXXXXX LASER OFF

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To start the therapy, position the probe on the application site, and press the

probe's key.

To interrupt the application, press the key. Press again to restart

Press the key to return to the main screen

2. Mode: NOGIER THERAPY

In the main screen, press the

key to enable the therapy mode.

Use the keys to select the Nogier mode. Note : Just the probe 905nm is able for Nogier function.

Press the key Nogier mode.

MODE NOGIER LASER 905 nm Set to Save FREQUENCY 2.5 Hz TIME S 000.0 000.0 Total SENSOR XXXXXXXXXX LASER OFF





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Use the keys to select the desired time.

Use the keys to enable the FREQUENCY Function

Use the keys to select the desired frequency.

Nogier Frequencies: 2.5 Hz; 5 Hz; 10 Hz; 20 Hz; 40 Hz; 73 Hz; 80 Hz; 146 Hz; 160 Hz; 262 Hz; 292 Hz; 584 Hz; Calcium cycle activation frequencies: 16 Hz and 48 Hz. These Frequencies are enabled for the 905 nm pen only.

To enable the laser probe, press the key of the panel.



MODE NOGIER LASER 905 nm Set to Save FREQUENCY 48 Hz TIME S 010.0 000.0 Total SENSOR XXXXXXXXXX LASER OFF

Lasermed 4098


The indication in the panel : LASER OFF will change to : LASER Stand By and the probe's Green LED will remain on, showing that the probe is ready for application.


probe's key.

To interrupt the application, press the key. Press again to restart.

Press the key to return to the main screen

3. Mode: FREE THERAPY



Use the keys to select the Free mode.





Lasermed 4098


Press the key to enable the FREE mode of operation

Use the keys to select the desired TIME.

To enable the laser pen, press the key of the panel. The indication in the panel : LASER OFF will change to : LASER Stand By and the probe's Green LED will remain on, showing that the probe is ready for application.


probe's key.

To stop or reestart the aplication, press the key of the probe.

To desability the use of the laser probe, press the key

4. PROTOCOLS



MODE FREE LASER 905 nm Set to Save

TIME S 010.0 000.0 Total SENSOR XXXXXXXXXX LASER OFF



Lasermed 4098


Use the keys to select PROTOCOLS.

Press the key

Use the keys to select the desired PROTOCOL.

4.1. RETURN Go back to the main screen .

Press the key to Return.

4.2.SAVE Record the protocol in the memory.

Press the key to select the record mode.

The display will give the following screen :

Use the and keys to select the letter desired.

Press the key to write or the

key to erase.



PROTOCOLS RETURN SAVE USERS FIX

PROTOCOLS RETURN SAVE USERS FIX

1 2 3 4 5 6 7 8 9 0 a b c d e f g h i j k l m n o p q r s t u v w x y z , . Stp to DEL

11--------------

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To save the protocols, press

the key

4.3. USERS The display will give the following Protocols recorded

Press the key to enable the Selected mode Users.

Use the keys to select the Protocol desired, and Press the

key to enable the selected Protocol.

For erase the Protocol, select the Protocol desired and press the Key. The display will give the following screen :

For erase press the key, or the

to keep.

To return to main screen, you must to select a Protocol and press key

4.4. FIX The display will give the following Lasermed Protocols.

PROTOCOLS STP TO DEL XXXXX YYYYY ZZZZZ

PROTOCOLS STP TO DEL XXXXX YYYYY ZZZZZ DELETE ? SET = YES MENU = NO

Lasermed 4098


Use the keys to select the Protocol

desired, and Press the key to enable the selected Protocol.

Press the key to enable the probe.

PROTOCOLS ATM TORTICOLLIS ARTHROSIS ARTHRITIS TENDONITIS PERIARTHRITIS BURSITE

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5. TOPOSCOPY.

TOPOSCOPIC PEN OPERATION

In the main screen, use the

keys to select the screen: TOPOSCOPY

Press the key

Connect plug 1 (picture C, page 16) of the toposcopic probe to the TOPOSCOPE PROBE connector of the device. The patient must hold the negative electrode (3) of the toposcopic probe firmly;

Use the keys to increase the sensitivity to the maximum.

With the active electrode (2) of the toposcopic probe touching the patients skin, loop for the region of acupuncture points / trigger points. A sound signal will be emitted. Reduce the sensitivity gradually, and look for the acupuncture point in the region selected; the sound signal emitted must be continuous and clear.

PEN THERAPY MODE 905 nm


PEN TOPOSCOPY MODE 905 nm

Sensitivity Low High XXXXXXXXXXXXXXXXXXXX

PEN TOPOSCOPY MODE 905 nm

Sensitivity Low High

Lasermed 4098


Types of Application

The application may be point or scan.

POINT: Used when one wishes to deposit a determined energy at a point, or to stimulate the acupuncture points, placing the laser probe perpendicular to the skin. The modes of operation used are: Continuous Energy and Nogier.

SCAN: Used when one wishes to apply a determined energy on a previously determined area. The laser radiation is applied by scanning the entire area to be treated. The mode of operation used is Continuous - Free

NOTE: When asepsis of the location is required, do not touch the probe on the skin, leaving it at a maximum distance of 1 cm.

Master Control Key and Remote Interlock Connector

Lasermed 4098 has two safety keys called Master Control Key and Remote Interlock Connector to prevent use of the device by unqualified personnel.

Lasermed 4098


The Master Control Key locks the equipment, preventing enabling of the laser probe.

When the key is in , the device is locked, and in the device is unlocked.

When the key of the device is in (locked), and the key is pressed, a sound signal (beep) will be emitted and the information LOCKED will be displayed.

The Master Control Key is removable for user/owner safety.

The Remove Interlock Connector is an environmental protection device (accessory). The key is connected to the Lasermed and the rooms entrance door. If the door is opened, Lasermed suspends the operation, the display will display the information LOCKED and the sound signal (BEEP) will be emitted.

Indications

GENERAL INDICATIONS

- Traumatic lesions - Inflammatory processes - Dermatology : ulcers / wounds - Acupuncture - Esthetics : repairing surgeries - Muscular lesions - Ligament lesions - Tendinous lesions - Cartilage lesions - Bone lesions - Bed sores

MODE ENERGY PROBE 905 nm

ENERGY mJ 01.50 00.00 TIME S 001.5 000.0 LOCKED Total SENSOR XXXXXXXXXX

Lasermed 4098


DOSIMETRY : Point application

NOTE : The laser probes energy ,mentioned on table above, are for point application.

INDICATIONS REGARDING THE EFFECT (Point Application)

Analgesic Effect: - muscular pain : 2 to 4 Joules/cm2 - joint pain : 4 to 8 Joules/cm2

Anti-Inflammatory Effect : 1 to 3 Joules/cm2 Regenerative Effect : 3 to 6 Joules/cm2 Circulatory Effect : 1 to 3 Joules/cm2

Lasermed 4098


WAVELENGTH INDICATIONS

Pen 650 nm: skin lesions Pen 830 nm: superficial lesions up to 2 cm depth Pen 905 nm: deep lesions more than 2 cm depth

1 to 3 Joules/cm2 - acute lesions 4 to 6 Joules/cm2 - sub-acute lesions 6 to 10 Joules/cm2 - chronic lesions

DOSIMETRY SUGGESTIONS:

ATM : - 3 to 4 Joules/cm2 - Daily

Torticollis: - 4 to 5 Joules/cm2 - Daily

Arthrosis: - 4 to 6 Joules/cm2 - Alternate

Arthritis: - 6 to 8 Joules/cm2 - Daily

Tendonitis: - 4 to 8 Joules/cm2 - Daily

Periarthritis: - 4 to 8 Joules/cm2 - Daily / alternate

Bursitis: - 4 to 7 Joules/cm2 - Daily

Sciatic pain: - 4 to 8 Joules/cm2 Daily

Effort hernia: - 4 to 6 Joules/cm2 - Daily

Contusions: - 2 to 4 Joules/cm2 - Daily

Hematomas: - 4 to 6 Joules/cm2 - Alternate

Epicondylitis: - 4 to 6 Joules/cm2 - Daily

Lasermed 4098


MODULATION FREQUENCY INDICATIONS:

Calcium cycle activation 16 Hz and 48 Hz Immune system modulation

73 Hz, 146 Hz, 292 Hz Chronic pain 2.5 Hz, 5 Hz, 20 Hz Acute pain

80 Hz, 160 Hz, 262 Hz Acupuncture Points

2.5 Hz, 5 Hz, 10 Hz, 20 Hz, 40Hz, 80 Hz

Contraindications

ABSOLUTE CONTRAINDICATIONS

Retina Neoplasias Abdominal region of pregnant women Metastases

RELATIVE CONTRAINDICATIONS

Near gonads and breast nodules Hypo or hyperactive glands Corticoid intake Treatment with photosensitive drugs

Preventive and preservative maintenance

Avoid leaving the laser probe on Stand By for more than 5 minutes;

We recommend inspecting and calibrating the LASERMED 4098 once a year by CARCI;

Lasermed 4098


Always make sure that the device is disconnected from the power supply before cleaning. Avoid wetting the wire and connector electrical contacts;

Use a cloth wet with water and soap to clean the cabinet of your device and the probes, when necessary;

Check the equipment cables weekly, ensuring that they are not defective;

On disconnecting the laser cable from the laser pen and device, always remove it from the plug, thus preventing the cable from breaking;

Do not obstruct the laser emitter outlet

Do not let the probe suffer impacts or falls, since its interior contains sensitive components that can be damaged;

Avoid contact of the laser emitter with sharp objects, which can damage the emitters protector window;

This equipment has an estimated service life of 5 years. After this period, we recommend subjecting the equipment to a full inspection by CARCI in order to continue using it safety and efficiently;

Do not dispose of this equipment or its accessories in the common garbage at the end of its service life. This equipment contains substances that are harmful to nature, if not treated correctly. If the equipment or its accessories must be disposed of, submit the material to CARCI, which will dispose of it properly.

Lasermed 4098


Safety Warnings

Protect the eye region when applying on the face;

The use of safety goggles is recommended for both patient and therapist;

Avoid looking directly at the laser source when on, since the laser beam can damage the retina;

This equipment must be operated by qualified personnel only, according to the legislation of the country of use;

This equipment is not protected against water penetration (IPX0). If water enters the equipment by accident, do not connect it to the power network. Send it to technical assistance to check for possible damages;

Some materials, such as cotton, when saturated with oxygen, can be ignited at the high temperatures produced by the LASER equipment. Wait for the solvents from adhesives and inflammable solutions used in cleaning and disinfecting to evaporate before using the LASER equipment. Care must also be taken due to the possibility of ignition in the presence of endogenous gases.

When the equipment is not in operation, it should be protected against utilization by person non-qualified, removing the control master key of its receptacle;

Do not dispose of this equipment or its accessories in the common garbage at the end of its service life. This equipment contains substances that are harmful to nature, if not treated correctly. If the equipment or its accessories must be disposed of, submit the material to CARCI, which will dispose of it properly.

Lasermed 4098


Corrective maintenance

NOTE: Electrical diagrams, circuits and parts lists are not supplied to the end consumers. If necessary, contact the CARCI Authorized Technical Assistance.

Problem Solution

Equipment does not on (1) Check if the power cable is connected to the power network Check if the fuse is not damaged Contact technical assistance

Lasermed display informs: Laser Fault

Check if the probe and the cable are connected to the device, Check the probe cable connections, Change the probe cable.

After programming the laser, the Stand By LED (green) of the

probe does not come on

Check the connection of the cable with the probe and device Change the probe cable Contact technical assistance

The display informs: LOCKED

Check if the MASTER CONTROL KEY is in unlocked position Contact technical assistance

On changing to Test Mode, the device does not display.

Check the connection of the cable with the probe and device Change the probe cable Contact technical assistance

Lasermed 4098


Technical features

Origin : CARCI Brazil Model : LASERMED 4098 Function and application : laser equipment for therapy Power supply : 100230 V~ automatic ( 10%) 50 / 60 Hz Maximum Consumption : 30 VA ANVISA [National Health Surveillance Agency] Registration: AM-10314290030 -----------------------------------------------------------------------------------------------------

Classification according to EN 60601.1 and EN 60601.2.22 standards: - Type of protection against electric shock:...........................................class II - Level of protection against electric shock of the applied part:............type BF - Level of protection against harmful water penetration:...........................IPX0 - Disinfection methods:....................................see preventive maintenance - Level of safety of application in the presence of an anesthetic mixture inflammable with air, oxygen or nitrous oxide:.........................not suitable- Mode of operation:...........................................................................continuous ------------------------------------------------------------------------------------------------------

Fuse : 1.0 A 250 V 20 AG Laser type : Infrared and visible (red) Laser pen automatic identification Laser Emitters:

o GaAIAs MOCVD 650 nm 12 milli-Watts ( class 3b ) - Continuous o GaAIAs MOCVD 830 nm 30 milli Watts ( class 3b ) - Continuous o InGaAs MOCVD 905 nm 20 mili Watts average 60 Watts peak (

class 3b ) - Pulsed - uncertainty of the values indicated: 20%

Automatic dosimetry time Modulation frequency : 16 Hz, 48 Hz and Nogier ( 10%) Laser Probe 905 nm Operation Frequency : 2000 Hz ( 10%) Laser Probe 905 nm Pulse Width : 160 ns ( 10%)

Nominal ocular hazard distance (NOHD) : o Laser 905 nm = 1 meter o Laser 830 nm = 10 meters o Laser 650 nm = 100 meters

Lasermed 4098


Beam divergence : o Laser 905 nm = 110 x 25 0 (II x ) o Laser 830 nm = beam collimated by lens (for this applier pen type,

the divergence can be neglected) o Laser 650 nm = 0.8 mrad

Digital toposcopic probe Dimensions : 31 x 6 x 18 (WxHxL) (cm) Weight : 2.6 kg

Equipment operating conditions: Room temperature : +15C to +40C Relative humidity : 0% to 80% Atmospheric pressure : 700 hPa to 1060hPa

Environmental conditions for transport and storage: Room temperature : -10C to 50oC Relative humidity : 20% to 90% Atmospheric pressure : 500hPa to 1060hPa

Acessrios:

Cable for laser probe Code 16567G 3-pole power cable Code 14747G Toposcopic probe 4090/40 Code 20429G User manual Code 10391G Laser Probe pulsed 905 nm 60 Watts peak Code 4097

Optional accessories:

Laser Probe 830 nm 20 milli-Watts Code 4093 Laser Probe 650 nm 12 milli-Watts Code 4095 Remote Interlock Connector Safety goggles, with CE mark.

Code CARCI 21003G : wavelength : 600 to 700 nm, attenuation 90 %. Code CARCI 17323G : wavelength : 800 to 950 nm, attenuation 70 %.

Lasermed 4098


Note: When replacing accessories, only use those indicated by CARCI. Use of accessories not specified by CARCI can compromise equipment safety. CARCI will not be held liable for such procedure.

Terminologies and Definitions:

For purposes of the standard NBR IEC 60601-1:1994 + amendment 1997, the following conditions apply, used in the Manufacturer Declarations & Orientations :

- Meaning given to the verbal forms should and may

should means that compliance with the requirement or test in question is mandatory in order to comply with the Standard.

would means that compliance with the requirement or test in question is strongly recommended, but not mandatory in order to comply with the Standard.

may means that compliance with the requirement or test in question is only a particular way of obtaining compliance with the Standard.

MANUFACTURER DECLARATION AND ORIENTATION - ELECTROMAGNETIC EMISSIONS

LASERMED is intended for use in the electromagnetic environment described below. The purchaser or operator of LASERMED must ensure that it is being used in such an

environment.

Emission test Compliance Electromagnetic environment - orientation

RF Emission CISPR 11 Group 1

LASERMED uses RF energy for its internal operation only. Therefore, its RF emission is very low and not likely to cause any interference in another electronic equipment nearby.

RF Emission CISPR 11 Class B

LASERMED is intended for use in all establishments, including home establishments and those connected directly to the public power network that supplies power to constructions with domestic purposes.

Emission of harmonics IEC 61000-3-2 Class A

Voltage fluctuation / Flicker emission IEC 61000-3-3

Compliant

Lasermed 4098


MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC IMMUNITY

LASERMED is intended for use in the electromagnetic environment specified below. The purchaser or operator of LASERMED must ensure that it is being used in such environment.

Immunity test IEC 60601 Test level Compliance

level Electromagnetic

environment - orientation Electrostatic discharge IEC 61000-4-2

6 kV contact 8 kV air

6 kV contact 8 kV air

The floor can be of wood, concrete or ceramic. If the floor is covered with synthetic material, the airs relative humidity should be at least 30%.

Immunity test IEC 60601 Test level Compliance

level Electromagnetic environment

- orientation

Fast Transients Bursts IEC 61000-4-4

2 kV supply cable 1 kV signal input and output cable

2 kV supply cable

Not applicable

The quality of the power network must be that of a typical hospital or commercial environment.

Surge IEC 61000-4-5

1 kV differential mode 2 kV ordinary mode

1 kV differential mode 2 kV ordinary mode

Voltage drops, short interruptions and voltage variations in power supply. IEC 61000-4-11

95% drop in Ut) For 0.5 cycle

40% Ut (60% drop in Ut) For 5 cycles


95% drop in Ut) For 5 s

95% drop in Ut) For 0.5 cycle



95% drop in Ut) For 5 s

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Magnetic fields of the network frequencies (50/60 Hz) IEC 61000-4-8

3 A/m 3 A/m The magnetic fields of the network frequencies must be levels characteristic of a typical commercial or hospital environment.

Note: Ut is the AC network voltage before applying the test level.

MANUFACTURER DECLARATION AND ORIENTATION ELECTROMAGNETIC IMMUNITY

LASERMED is intended for use in the electromagnetic environment specified below. The purchaser or operator of LASERMED must ensure that it is being used in such environment. Immunity

test IEC 60601 Test level

Compliance level

Electromagnetic environment - orientation

RF Conducted IEC 61000-4-6

RF Irradiated IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 V

3 V/m

Portable and mobile RF communication equipment should not be used closer to any LASERMED part, including cables, more than the separation distance recommended calculated by the equation, applicable for the transmitter frequency. Recommended separation distance

Pd .17.1= 80 MHz to 800 MHz

Pd .3.2= 800 MHz to 2.5 GHz

Where P is the maximum output power of the transmitter in watts (W), according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).

The field generated by fixed RF transmitters, as determined by an electromagnetic field in the locationa, must be less than the level of compliance in each frequency range. b

There can be interference around equipment with the following symbol:

Lasermed 4098


NOTE 1: the greatest frequency in the range is applied in the range of 80 MHz and 800 MHz. NOTE 2: this procedure may not apply in all cases. Electromagnetic propagation is affected by absorption and reflection of structures, objects and people.

a. The intensity of fields generated by fixed transmitters, such as cell sites for telephones (cell/wireless) and land mobile radios, radio hams, AM, FM and TV radio-diffusion stations may not be theoretically prognosed accurately. To evaluate the electromagnetic environment due to the fixed RF transmitters, an electromagnetic field study in the site should be considered. If the field intensity measured at the site in which the LASERMED is used exceeds the compliance level above, the LASERMED must be observed to ascertain if it is working properly. If abnormal performance is noticed, additional measures may be required, such as reorientation or relocation of the LASERMED;

b. Above the frequency scale of 150 kHz to 80 MHz, the field intensity must be less than 3 V/m.

Recommended separation distances between portable and mobile RF communication equipment and the LASERMED

The LASERMED is intended for use in an electromagnetic environment in which the RF disturbances are controlled. The purchaser or operator of the LASERMED can help prevent

electromagnetic interference by keeping a minimum distance between portable and mobile RF communication equipment (transmitters) and the LASERMED, as recommended below,

according to the maximum output potential of the communication equipment.

Declared maximum output potential of the

transmitter (W)

Separation distance according to the transmitter frequency

150 kHz to 80 MHz

Pd 17.1=

80 MHz to 800 MHz

Pd 17.1=

800 MHz to 2.5 GHz

Pd 3.2= 0.01 11.70 cm 11.70 cm 23.00 cm 0.1 37.00 cm 37.00 cm 72.70 cm 1 1.17 m 1.17 m 2.30 m

10 3.70 m 3.70 m 7.27 m 100 11.70 m 11.70 m 23.00 m

For transmitters with declared maximum output power not listed above, the recommended separation distance (d in meters) can be determined using the equation applicable to the transmitter frequency; where P is the maximum output power of the transmitter in watts (W), according to its manufacturer. NOTE 1: the 80 MHz and 800 MHz apply to the separation distance for the highest frequency. NOTE 2: this procedure may apply in all cases. Electromagnetic propagation is affected by absorption and reflection of structures, objects and people.

Lasermed 4098


Final Considerations

It has been Carcis policy to continuously improve the quality of its products. Carci reserves the right to make modifications in the design and specifications, and to also add to and improve its products, without the obligation to install them in already manufactured products.

The text, illustrations and specifications contained in this manual are based on information available during the printing. All rights reserved.

This manual may not be reproduced in whole or in part without written consent from Carci.

Manufacturer Data

CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda. CGC [Corporate Taxpayers Roll]: 61.461.034/0001-78 . I.E. [State Tax ID]: 110.182.450.113 Rua lvares Fagundes, 359 Americanpolis So Paulo SP Brazil Zip Code 04338-000 Tel. : (0XX11) 3346 2100 e-mail: [email protected] website: www.carci.com.br

Carci Registration in the Ministry of Health: MS-10314290030

For Technical Assistance: Departamento de Assistncia Tcnica [Technical Assistance Department] Rua lvares Fagundes, 359 - So Paulo SP Brazil - Zip code 04338-000l Tel. (0XX11) 5621 7024 / 5622 8205

Technical Responsible: Orlando Orlandi Melo de Carvalho - CREA 5061377287/D

WARRANTY CERTIFICATE IN ANNEX

Lasermed 4098


EUROPEAN REPRESENTATIVE

EUROPEAN REPRESENTATIVE

OBELIS S.A. 34, Av. de Tervuren, bte 44 B-1040 Brussels, BELGIUM Tel: (32) 2.732.59.54 Fax: (32) 2.732.60.03 E-mail: [email protected]

Bibliographical references

1- La Terapia Laser , Hoy Josep Colls Edita Centro de Documentacion Laser Barcelona 3 edicion - 1986

2- Physical Agents in Rehabilitation From Research to Practice Michelle H. Cameron - W.B. Saujnders Company Philadelphia 1 Edition - 1999

3- Therapeutic Lasers - Theory and Practice G. David Baxter Churchill Livingstone - 1994

4- Tratamientos con Laser Metodo Diagnostrat Carlos Lasvi Minaguano Ediciones Madrid - 1986

5- Laser y Terapeutica em Medicina 6- J.L. Cisneiros M.A Trelles Centro Documentation Laser Barcelona

1 Edicion - 1987 7- Low Reactive Level Laserf Therapy Practical Application

T. Oshiro John Wiley & Sons Ltd 1 Edition 1991

mu_lasermed_4098_eng_rev05_092009

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