Laserpen Practice English - RJ Laser

LaserPen ® practice
Your magic wand for successful therapy
Instructions for Use

Contents
1. General Notes 3
1.1. Exclusion of liability ............................................................................................................................... 3
1.2. LaserPen® standard ................................................................................................................................. 3
1.3. LaserPen® principle of function.............................................................................................................. 3
2. No operation in case of danger and damage 4
3. Safety Precautions 4
3.1. Laser-protection goggles ...................................................................................................................... 4
3.2. Explanation of the pictograms ............................................................................................................ 5
3.3. Position of the labels and warning signs .......................................................................................... 6
3.4. Shutdown in an emergency.................................................................................................................. 6
3.5. Radiation injuries .................................................................................................................................... 6
3.6. Treatment room ....................................................................................................................................... 6
3.7. Safeguarding against unauthorized usage ....................................................................................... 7
3.8. Registering (valid for Germany, please refer to your national regulations) ............................ 7
4. Intended use and personnel 7
4.1. Proper usage and field of application ................................................................................................ 7
4.2. Indications, contra indications ............................................................................................................ 7
Contra indications ..................................................................................... Fehler! Textmarke nicht definiert.
5. Device description 9
5.1. Technical data .......................................................................................................................................... 9
5.2. Technical data of the laser diodes (depending on the model) ................................................. 10
5.3. Contents of delivery ............................................................................................................................ 10
5.4. Connectors and functional components ........................................................................................ 11
5.5. Indicators (LED, Display) ..................................................................................................................... 12
5.6. International plugs .............................................................................................................................. 12
5.7. Applicators ............................................................................................................................................. 13
5.8. Battery pack .......................................................................................................................................... 15
6. Starting and using the device 16
6.1. Short description to operate the laser ........................................................................................... 16
6.2. Operation Starting operation ............................................................................................................ 17
6.3. Pre-settings ........................................................................................................................................... 17
6.4. Display after switching on ................................................................................................................. 17
6.5. Frequency selection during therapy ................................................................................................ 17
6.6. Release of the laser beam .................................................................................................................. 18
6.7. Pilot beam, Laser control diodes ...................................................................................................... 18
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6.8. Stop of the laser beam ....................................................................................................................... 19
6.9. Acoustic control and acoustic signals ............................................................................................ 19
6.10. IR-Test ..................................................................................................................................................... 19
6.11. Modulation frequencies ..................................................................................................................... 19
7. Maintenance 20
7.1. Charging the battery ........................................................................................................................... 21
7.2. Annual inspection of the device ...................................................................................................... 21
7.3. Cleaning / Disinfecting ....................................................................................................................... 23
7.4. Maintenance/Calibration ................................................................................................................... 23
7.5. Disposal .................................................................................................................................................. 23
7.6. Warranty ................................................................................................................................................ 23
8. Electromagnetic compatibility - Warning instructions 24
8.1. Precautionary measures ..................................................................................................................... 24
8.2. Influence of mobile and portable communication equipment ................................................ 24
8.3. Guidelines and manufacturer’s declaration – Electromagnetic radiation ............................ 24
8.4. Guidelines and manufacturer’s declaration - Electromagnetic immunity ........................... 24
8.5. Guidelines and manufacturer’s declaration – Electromagnetic immunity .......................... 25
8.6. Recommended protective distance between portable and mobile HF-telecommun ......... 26
9. Manufacturer 27
10. Distributor 27
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1. General Notes
These operating instructions must be read carefully before starting the device.
These operating instructions describe the correct usage of the LaserPen® and also point out any potential
risks. These operating instructions are to be read and observed by all persons who operate, use, service
and inspect the device.
Please contact your supplier, representative for any related questions or you may direct your inquiries to:
1.1. Exclusion of liability
REIMERS & JANSSEN GmbH
Medical — Laser — Technology
Fabrikstraße 22 D-79183 Waldkirch-Kollnau, Germany
Tel. +49-7681-4934149 Fax +49-7681-4934150
service@rj-laser.com www.rj-laser.com
Quality management according to EN ISO 13485:2003
The LaserPen® should only be used for the purpose described in these operating instructions. The
manufacturer will not be liable for any damage or injuries resulting from usage not contained in these
operating instructions. The manufacturer reserves the right to make modifications in keeping with
technological advances.
1.2. LaserPen® standard
The LaserPen® meets or exceeds the requirements of the following international standards:
EN 60601-1: 2007 Safety of Medical Electrical Equipment
EN 60601-2-22: 2007 Safety of Diagnostic / Therapeutic Lasers
EN 60825-1: 2007 Safety of Laser Devices
EN 60601-1-2:2007 Electromagnetic compatibility
1.3. LaserPen® principle of function
The LaserPen® will emit monochromatic, coherent laser light to the cells and tissue. The photon energy
will be absorbed by the cells, which shall lead e.g. to an improvement of the metabolism.
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Additionally special impulse frequencies are applied (acc. to Dr. NOGIER, France, BAHR, Germany) in
order to stimulate the body, cell and tissue.
The special features of the LaserPen® are proven through several years of intensive research and offer an
exact supply of photon energy to the area being treated.
Further information on the wide range of uses for laser therapy can be found in technical literature and
with scheduled seminars RJ-LASER GmbH (www.rj-laser.com).
2. No operation in case of danger and damage
In case it the device cannot be operated without risk, it must be taken out of usage. It must be send for
repair to the manufacturer or authorized repair facility. Such case is obvious if the:
- housing of the charger or other housing components show visible damages
- device does not work properly
- device was stored under bad conditions for a longer period or was transported
- display is not readable or shows false characters
3. Safety Precautions
Please check the device and functional components directly after receiving the laser.
Pay attention to the boot function and the laser selftest.
Caution - Using the operating equipment or settings in a way not described here can result in dangerous
exposure to radiation.
3.1. Laser-protection goggles
Both personnel and patients are to wear laser protection safety goggles during treatment sessions.
The only types of safety goggles which may be worn are those which meet DIN 58215 standards. The
filter glasses’ effective wavelength range include the laser light wavelength of the equipment in use.
There are two types of safety goggles available:
Number 530, which may be used for wavelengths from: 655 nm to 904 nm
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3.2. Explanation of the pictograms
Main unit
Carry case
0123
Transport and storage
Room temperature -20° C a +30 C
Relative humidity 30% to 75%
Atmospheric pressure 700 hPa to 1060 hPa
Protection against electric shock regarding allowable
leakage current limitations are specified in standard
60601-1.
The device meets the requirements of 93/42/EEC for
medical products.
“Attention” Observe the instructions in the manual for safe
and effective usage of this device.
Symbol for the laser beam: “Warning for laser beam”.
Aiming of laser beam must be adhered to, avoiding any
other part of the body other than the treatment area follow
treatment protocol of this manual.
“Caution” Explanatory Label Symbol (International):
"Laser radiation" including the standard which was used for
the classification of the laser, power, wave length, pulse.
Aperture labels according to EN 60825-1:
- Laser aperture and laser beam direction
Label indicating technical data, serial number,
manufacturer.
Date of manufacturing
Label with information of transport and storage conditions
on the package.
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3.3. Position of the labels and warning signs
below
above (front panel)
3.4. Shutdown in an emergency
The laser can be shut down in the event of an emergency by pressing the ON/Off button or by pulling out
the safety plug.
3.5. Radiation injuries
Do not look directly into the laser beam outlet. Laser radiation can cause eye damage. Protective gear
must be worn inside the treatment room during treatment at all times, caution during therapy in the
head area.
3.6. Treatment room
Warning sign Type plate, Display Technical sign, Display
Warning sign
Attention! Risk of burns in case of pigmented skin, birth marks, tattoo etc. because
of the photon absorption of melanin or colors in the tissue.
In case of pigmented or colored skin use low power or low energy density. The ideal
wave length with reduced melanin absorption is 904 nm (pulsed).
The laser may only be operated in a room with the door closed. The treatment room
in which laser therapy is performed must meet the requirements of the Accident
Prevention Regulation BGV B2 ”Laser radiation”. Attach a warning sign to all inputs
in accordance with DIN IEC 76 (CO) 6. Reflecting objects, mirrors and chrome parts
must be removed.
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3.7. Safeguarding against unauthorized usage
To safeguard against unauthorized usage, the LaserPen® is equipped with a removable safety plug. The
laser can only be operated when the safety plug is inserted. If the LaserPen® is not being used store it
separately to prevent unauthorized usage.
3.8. Registering (valid for Germany, please refer to your national regulations)
The LaserPen® operator must be registered at the professional association as an operator of a class 3 B
laser device. Laser safety representative: The operator must be able to name a laser safety representative.
4. Intended use and personnel
4.1. Proper usage and field of application
The LaserPen® is a therapeutic medical device which is to be used exclusively in medical offices, clinics
and rehab centers, and should only be operated under constant supervision.
In order to perform the therapy for pain and healing, the probe tip has to be placed 1 cam above the
skin.
Therapy recommendation: The international recommended dosage is 4-6 Joule/cm 2 (WALT) apply it step
by step until the full area is completed. Increase or reduce the dosage individually according to the
patient´s reaction.
Please refer to the training manual to obtain further information regarding the applications.
4.2. Indications, contra indications
The laser device (including all available wavelengths)was designed for treatment of the body.
• Acupuncture
• Bone healing
• Wound healing
• Pain
• Synositis / tendinitis
• Rheumatic disease
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For dental use and aPDT/PAD with 632-670 nm the following indications are valid:
• Alveolic ostitis
• Caries in general
• Endotonia
• Parodontitis
• Periimplantitis
• Wound healing after tooth extraction and implantation
• Treatment of pockets
USA/Canada
The Photonic 500 is intended to emit energy in the infrared spectrum to provide topical heating for the
purposes of elevating tissue temperature when heat is indicated for the
• temporary relief of minor muscle and joint pain and stiffness,
• temporary relief of minor joint pain associated with arthritis
• temporarily increase local blood circulation where applied and the relaxation of muscles.
4.3. General treatment exclusions
As producer of the device we do not recommend the use of the laser for
• irradiation around the eyes
• over the thyroid gland and endocrine glands, testicles
• on patients with pace makers
• no treatment on the head on patients with a tendency for epilepsy
• irradiation of the fetus and over the uterus during pregnancy
• irradiation of the epiphysis (children), open fontanella
• on patients taking zytostatics/immune suppressions
• over cancerous or malignant areas, tumor patients
• irradiation of dark, coloured or pigmented skin, birth marks, tattoos, hairy body parts, especially
dark hair.
This is a prescription only device.
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5. Device description
5.1. Technical data
Laser therapy device type LaserPen practice
Laser class 3B
Protection class IPX0
Device Type B
Absolute failure of the measurement of the
laser power
Modulation frequency 1 Hz - 49999 Hz (± 0,05%)
Risk class according to RL 93/42/EWG IIa
Current supply (charger) Model FRIWO FW 7555M/05, =5 V
Weight LaserPen
5%
Mains voltage = 100-240V~
Mains frequency = 50-60Hz
Output current = 400mA
Protection class II
0,2 kg
Weight power station 0,5 kg
Weight charger 0,3 kg
Dimension main unit (L x W x H) 20 cm x 3 cm x 4 cm
Dimension power station (L x W x H) 17 cm x 7 cm x 9 cm
Dimension power supply (L x W x H) 7 cm x 5 cm x 4 cm
Operating conditions
Room temperature + 10°C a +30°C
Relative humidity 30% - 75%
Atmospheric pressure 700 hPa - 1060 hPa
Transport and storage
Room temperature -20° C a +40 C
Relative humidity 30% - 75%
Atmospheric pressure 700 hPa - 1060 hPa
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5.2. Technical data of the laser diodes (depending on the model)
Wave
length
Output power Laser type / pulse
duration
NOHD *) m Beam divergence
785 nm max. 50 mW cw 0,10 0,140 rad
*) Safety distance (NOHD). Distance at which the radiation intensity or the radiation is equivalent to the limiting value of the
maximum permitted radiation of the cornea (MZB).
For more information, please refer to the device plate.
5.3. Contents of delivery
LaserPen® main unit, applicator, coding bridge, power supply FRIWO FW7555M/08, instruction
manual, warning sign "Laser radiation" according to DIN EN 60825-1, power station.
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5.4. Connectors and functional components
Indicator laser active
Pilot beam
Laser outlet
Connector remote control
Laser start/Laser stop
Key plug
(back side), Display
Setting/changes of indicated value:
min./sec./mW
Single frequency selection (therapy menu)
Selection of functions
Connector for
power station
ON/OFF
Remo
Set menu:
Pulse width/signal/language
Therapy menu:
Frequency group/time/power
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5.5. Indicators (LED, Display)
LED Color Status Meaning
Laser active red Flashing
on
2 sec. after starting the laser as a warning: Laser beam
will be emitted.
Laser is on.
Pilot-LED red on Indicates 2 sec before irradiation the point where the
laser beam will meet the surface.
Display value
5.6. International plugs
Meaning
e.g. 50 mW Power in mW at the laser start
e.g. 01.20 Energy in Joule (indication of already supplied energy)
e.g. 00:15 Therapy time in minutes/seconds (with remaining time)
e.g. 292 Modulation frequency
Symbols in the lower left corner of the display:
: Pre-selected power is correct
< Pre-selected power is not obtained
> Pre-selected power is exceeded
Battery condition
As an optional accessory you can use various interchangeable plugs corresponding to the international
electric systems (Australia, USA, England, Europe).
Australia USA GB Europe
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5.7. Applicators
523 Convex head w/lens Ø 10mm
Stainless steel, glass
resterilizable
5241 Point applicator w/lens L20mm Ø D2mm
5251 Point applicator w/lens L20mm Ø D4mm
Stainless steel, glass
resterilizable
527 Medicament applicator
Stainless steel
resterilizable
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5204 Dental applicator L70mm Ø2mm, bent
Stainless steel, glass
resterilizable
5202 Dental applicator L70mm Ø4mm, bent
Stainless steel, glass
resterilizable
5208 Dental bar L50mm Ø8mm, straight
Stainless steel, glass
resterilizable
5207 Dental bar L70mm Ø8mm, bent
Stainless steel, glass
resterilizable
5206 Universal Tip Ø 0,8mm
PDD / PDT
Macrolon disposable
5205 Endo Tip Ø 0,4mm
PDD / PDT
Macrolon disposable
The tips contain special optical quartz glass to offer high energy density and will keep the opening clean.
Attach/screw the applicators onto the probe tip. According to the area to be treated (point or larger surface) select
the applicators. The lens does not focus the beam, it will protect the laser diode against damage or contamination
during skin contact. The applicators should be sterilized before and after the therapy.
Note: Depending on the applicator, the pilot beam may be not visible.
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Application
Nr. 5201 Dental applicator for radiation of mouth and throat
Nr. 523 Lens applicator for skin treatment, small areas, trigger points, acupressure
Nr. 524-525 Point applicator for the radiation of points, acupuncture
Nr. 527 Point applicator for the radiation of Body openings (e.g. inner ear)
After and before the therapy the applicators should be sterilized.
5.8. Battery pack
The battery pack increases the therapy duration to several hours. In order to charge the battery pack
connect the FRIWO Power Supply to the socket in the battery pack.
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6. Starting and using the device
6.1. Short description to operate the laser
Start/Stop ← Select
Release of the laser beam:
Individual Power
Press 1 x short
Reduced power (5 mW)
Press 1 x long
Pre-Setting (SET-Modus)
Press Select button and switch
ON the LaserPen via the switch
at the rear.
Selection of the values indicated
in the display:
Single frequency
A´-G´, continuous beam
1-7 (Bahr)
Will forward the value in steps of:
5 sec./min., 00:05-60:00 Time
5 mW, 10-70 mW Power
Language
Signal
Impulse width (10-100% for cw
diode and 200-400 nsec. for
impulse diode)
Selection of the values
indicated in the display:
Frequency modulation
NOGIER (potency)
BAHR (potency)
Therapy beep Keyboard beep 0-30 sec.
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6.2. Operation Starting operation
Key switch
On the back side you will find the socket for the key switch (plug). The key switch is used to prevent the
use of the laser to unauthorized personal. Insert the plug into the socket of the LaserPen®.
ON/OFF switch
Turn the LaserPen® on or off via the switch at the rear.
Note: If the LaserPen® will not be used for 6 minutes, it will shut off automatically. Turn it on by
moving the ON/OFF switch.
6.3. Pre-settings
Press the button [Select] and turn on the LaserPen® with the ON/OFF switch. Choose the following
settings with the button [Select]:
1. Language
2. Signals
3. Therapy beep
4. Battery condition
5. Version number
6.4. Display after switching on
After switching on the LaserPen® will perform a battery and settings check. The display will indicate e.g.:
NOGIER
F´: 9344
6.5. Frequency selection during therapy
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Frequency selection during therapy is possible, especially for the RAC diagnosis. If you are using the
LaserPen with an impulse diode, you must set the time to 0, otherwise you can not forward the
frequencies during therapy.
6.6. Release of the laser beam
Release the laser beam by pressing the [Start/Stop] button. The pilot LED will glow and indicate the
direction of the beam 2 seconds before the release of the laser beam. In the upper row of the display a
bar diagram will be visible for 2 seconds, thereafter the laser beam will be released.
Maximum power or individual power
Tip onto the [Start/Stop] button for less than 1 second (3 beeps, full bar diagram) will release the laser
with maximum or individual power.
Reduced power for RAC diagnosis (10 mW)
Pressing the [Start/Stop] button for a longer period approx. 2 seconds (1 beep, short bar diagram) will
release the laser beam with 5 mW power. This is recommended for RAC diagnosis.
During the therapy you will see the following messages in the display:
Single frequency Frequency in Hz Supplied energy in Joule
A´ 292.00 03.12
� : 200 02:14
Battery Laser power control Power Progressed time (minutes and seconds)
Laser power indication
< more than 5% below the pre-selected power
: correct power
> more than 5% above the pre-selected power)
Battery indication: According to the charging condition the bar is full ���� reduced ���� or empty _.
6.7. Pilot beam, Laser control diodes
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If the tip of LaserPen® will be placed approx. 20 mm above a surface and the laser beam will be released,
the red dot of the LED-pilot beam will indicate the irradiation area already 2 seconds before the laser
starts, red LED will flash.
During laser therapy the display will show the technical data and the red LED on the panel of the probe
will glow.
6.8. Stop of the laser beam
After releasing the laser beam it will stop automatically when the selected time expired.
The beam can be stopped at any time by pressing the [START/STOP] button again (as well by removing
the safety plug, switching the ON/OFF button).
6.9. Acoustic control and acoustic signals
6.10. IR-Test
During the release of the laser you will hear a beep and during the therapy a five second beep is released.
The beep can be adjusted in the pre-setting menu.
Acoustic signal ON/OFF
The acoustic signal can be modified in the SETTING menu.
1. Press SELECT and move the ON/OFF switch
2. Set SIGNAL TON (button beep) to OFF
3. Safe with the START/STOP button
To test the laser radiation, simply beam to the sensor (LED in the middle) on the front of the power
station, you will hear a sound if the laser is active (the sensor is frequency related, no sound on
continuous beam).
6.11. Modulation frequencies
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The LaserPen® practice contains various frequencies according to
• NOGIER
• BAHR
Choose the frequency range with the button [Select]
Nogier
A' = 292 Hz
B' = 584 Hz
C' = 1168 Hz
D' = 2336 Hz
E' = 4672 Hz
F' = 9344 Hz
G' = 18688 Hz
Continuous beam
Bahr
B1 = 599,50 Hz
B2 = 1199,00 Hz
B3 = 2398,00 Hz
B4 = 4796,00 Hz
B5 = 9592,00 Hz
B6 = 19184,00 Hz
B7 = 38368,00 Hz
Pain= 963,50 Hz
More information about the use of BAHR and NOGIER frequencies are available on seminars of RJ and the „DAAA“ (Deutsche
Akademie für Akupunktur und Aurikulomedizin e.V.) and OGKA (www.ogka.at).
DAA e.V.
Ambazacstraße 4, 90542 Eckental
Telefon 09126/295210, Fax 09126/29521-59, E-Mail akademie@eCompetenceCenter.de
www.akupunktur-arzt.de
7. Maintenance
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7.1. Charging the battery
The display will indicate the condition of the battery. If it is on low the battery shall be charged. For
charging insert the plug of the charger into the socket on the back side of the power station and connect
it with the mains supply (the green LED on the power station will glow). Put the LaserPen® into the
opening of the power station.
During the charging procedure the red LED on the front of the power station will glow and the display of
the LaserPen® will indicate the charging process until the battery is fully charged.
The batteries can be charged at any time because they do not have a memory effect.
Charging data
Current control
Power supply: 115/230 V/50-60 Hz, wall adapter FRIWO FW7555 M/05
Batteries: 2 x AA, type NiMH
Criteria for complete charge: 50-75% of the capacity of the battery
Max. charging cycles: approx. 1000
Max. charging time: 2.5h Min. charging time: 0.5h
As current supply for charging the batteries use only FRIWO FW7555M/05.
7.2. Annual inspection of the device
IR-Test
Charge control
Socket for
Friwo power supply
(back side)
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Due to the advanced technology and precision of the LaserPen® must undergo a safety inspection and
calibration at least one year from the purchase date (various test are performed in order to insure that
the device is operating within the tolerances that the device was originally designed). This annual
inspection/calibration must be submitted to an authorized facility. Repairs or maintenance performed by
an unauthorized facility or personnel will void your warranty.
Inclusive with your device will be shipping labels and instructions for deliver to the repair and
maintenance facility.
For repair and maintenance, devices must be sent directly to:
REIMERS & JANSSEN GmbH
Medical — Laser — Technology
Fabrikstraße 22 D-79183 Waldkirch-Kollnau, Germany
Tel. +49-7681-4934149 Fax +49-7681-4934150
service@rj-laser.com www.rj-laser.com
Quality management according to EN ISO 13485:2003
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7.3. Cleaning / Disinfecting
Please observe that cleaners for plastics, soap are used for periodic cleaning of the plastic parts. No
penetrative or corrosive agents (such as acetone) should be used. Keep fluids from entering the housing.
Standard disinfectants may be used. When this is done, the unit is to be wiped with a soft cloth which
has been dampened with a mild, approved disinfectant (50% diluted propyl alcohol solution).
Under no circumstances is the unit to be flooded with the disinfectant or to be treated with solvents!
Autoclaving must not be used on the unit.
Before and after usage the probe tips and all parts which had contact with the patient
must be sterilized.
7.4. Maintenance/Calibration
7.5. Disposal
The laser diodes will be calibrated by the software at each start. RJ recommends an annual service of the
laser at the RJ service facilities or an authorized service station.
Always ensure that operational and sufficiently charged batteries are used.
The interior of the LaserPen® contains no elements or components which require servicing by the user.
Therefore, there is no need to open the housing. To meet the requirements of DIN VDE 0837, “Radiation
safety for laser devices,” the unit is to be tested and recalibrate after one year of use to ensure that the
laser is operating properly. Please send the unit to the manufacturer for testing and recalibration.
The producer will supply spare parts up to 10 years after delivery date.
RJ Spare parts and accessories: The laser may only be used with original RJ spare parts and accessories.
The producer will supply spare parts and accessories up to 10 years after delivery date.
Interventions in the device by third parties will lead to loss of warranty claims and will release the
manufacturer from all product liability.
Due to the hazards of laser beams, the LaserPen® is not to be disposed of as standard electronic scrap.
The device is to be delivered to either the supplier or to the manufacturer for proper disposal.
7.6. Warranty
There is a 3 years warranty from the manufacturer. The manufacturer guarantees operation of all
LaserPen® features described in the user’s guide, provided the equipment is used in accordance with the
instructions detailed in the user’s guide and is treated with proper care.
New settings, maintenance or repairs may only be performed by the manufacturer or an authorized
workshop; otherwise the warranty is rendered null and void. Interventions in the device by third parties
will lead to loss of warranty claims and will release the manufacturer from all product liability.
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8. Electromagnetic compatibility - Warning instructions
8.1. Precautionary measures
There are special precautionary measures for medical electric devices as fare as electromagnetic compatibility is
concerned. This device may be used only for the purpose described in the manual, set up and put into operation
according to the notes for electromagnetic compatibility.
8.2. Influence of mobile and portable communication equipment
High-frequency energy radiation from mobile communication equipment may influence on the operation of the
medical electric device. It is not allowed to use those devices (for instance mobile phones and GSM telephones)
close to the medical electric device.
8.3. Guidelines and manufacturer’s declaration – Electromagnetic radiation
The laser device is designed for the operation only with original accessories in ambient conditions indicated below.
Client and user have to make sure that the device is operated in such ambient conditions.
Radiated disturbance measurements Conformity Electromagnetic ambient conditions - guideline
HF-radiation to
Group 1 The laser device uses HF-energy only for its internal function. Therefore HF
CICPR 11
radiation is very low. The influence on neighbouring electric devices is
unlikely...
HF-radiation to
Class B The laser device may be used in all kinds of buildings, including residential
CICPR 11
buildings and those directly connected to mains for the public supply which
Radiation of harmonic oscillation
according to
EC 61000-3-2
Conforms are also servicing buildings used for residential purposes.
Radiation of voltage variations/ Flicker
effect according to IEC 61000-3-3
Not applicable
8.4. Guidelines and manufacturer’s declaration - Electromagnetic immunity
Immunity tests IEC 60601-Test level Conformity
level
Electromagnetic ambient conditions - guidelines
Discharge of static electricity (ESD ± 6 kV Contact discharge conforms The floor should be made from wood or concrete or
)according to IEC 61000-4-2
covered with ceramic tiles. If the floor is covered with
± 8 kV Air discharge
synthetic material the relative humidity should be
minimum 30%
Fast transient electric disturbance ± 2kV
conforms The quality of the supply voltage should be typical for
variable / Bursts
according to IEC 61000-4-4
for network leads
± 1 kV
for input and output leads
business or hospital ambient conditions.
Impulse voltage (Surges) according ± 1 kV
conforms The quality of the supply voltage should be typical for
to IEC 61000-4-5
opposed mode voltage
business or hospital ambient conditions.
Voltage dips, short interruptions
and voltage variations according to
IEC 61000-4-11
± 2 kV
common mode voltage
< 5% UT
(> 95% dip of UT) for ½ period
40% UT
(60% dip of UT) for 5 periods
conforms The quality of the supply voltage should be typical for
business or hospital ambient conditions. If the user
wants to continue operation in case of an interrupted
energy supply it is recommended to feed the laser
device from a system without interruption or a battery.
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Magnetic field at supply frequency
(50/60 Hz)
according to IEC 61000-4-8
70% UT
(30% dip of UT) for 25 periods
Note: UT - alternating voltage mains before the application of the test level.
< 5% UT
(> 95% dip of UT) for 5 s
3 A/m conforms Magnetic fields at mains frequency should have the
typical values for business and hospital ambient
conditions.
8.5. Guidelines and manufacturer’s declaration – Electromagnetic immunity – for the laser device
without life supporting function
Immunity tests IEC 60601-test level Conformity level Electromagnetic ambient conditions - guidelines
HF-disturbance variables
(transmission) according to IEC
61000-4-3
HF-disturbance variables (radiation)
according to IEC 61000-4-3
3 Veff
150 kHz up to 80 MH
3 V/m
80 MHz up to 2,5 GHz
Note 1 At 80 MHz and 800 MHz the higher frequency range is applied.
conforms
conforms
Portable and mobile radio sets must not be operated in
a distance to the laser device and the leads less than
the recommended protective distance what was
calculated according to the equation for the
transmission frequency.
Recommended protective distance:
d = 1,2 √ P
d = 1,2 √ P for
80 MHz up to 800 MHz
d = 2,3 √ P for
800 MHz up to 2,5 GHz
with P as power rating of the transmitter in Watt (W)
according to data from the manufacturer of the
transmitter and as recommended protective distance in
meter (m).
According to a local a investigation the field intensity
for all frequencies of immobile radio transmitters should
be less than the conformity level b .
Interference is possible in the surroundings of devices
carrying the following signs.
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.
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
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
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
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.
b Above the frequency range from 150 kHz to 80 MHz the field strength should be less than 3 V/m.
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8.6. Recommended protective distance between portable and mobile HF-telecommunication devices and
the laser device without life supporting function
Recommended protective distance between portable and mobile HF-telecommunication devices and the laser device
The laser device is designed for the operation in electromagnetic ambient conditions where HF-disturbance variables are
controlled. Client or user of the laser device can help to avoid electromagnetic disturbances by keeping the minimum distance
between portable and mobile HF-telecommunication devices (transmitters) and the laser device as indicated below, dependent on
the power output of the communication device.
Power rating of the
transmitter
W
Protective distance dependent on the transmitting frequency
m
150 kHz up to 80 MHz
d = 1,2 √ P
80 MHz up to 800 MHz
d = 1,2 √ P
0,01 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
800 MHz up to 2,5 GHz
d = 2,3 √ P
If the maximum power rating for certain transmitters is not given in the above table the recommended protective distance d in
metres (m) can be determined by using the equation indicated in the respective column, where P is the maximum power rating of
the transmitter in Watt (W) according to the manufacturer of the transmitter.
Note 1 At 80 MHz and 800 MHz the higher frequency range is applied
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.
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9. Manufacturer
Version 4.8, 07.04.2011
10. Distributor
REIMERS & JANSSEN GmbH
Medical — Laser — Technology
Fabrikstraße 22 D-79183 Waldkirch-Kollnau, Germany
Tel. +49-7681-4934149 Fax +49-7681-4934150
service@rj-laser.com www.rj-laser.com
Quality management according to EN ISO 13485:2003
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