R&J LASER Physiolaser olympic 500 Instructions Manual

Physiolaser olympic 500

Version 1.4 June 2007

1

Physiolaser olympic 500

Instructions for Veterinary Use

Physiolaser olympic 500

Version 1.4 June 2007

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Contents

General Notes .............................................................................................................. 3

Physiolaser principle of function .................................................................................. 3

Safety standard ............................................................................................................ 4

Safety Precautions ....................................................................................................... 5

Device out of use.......................................................................................................... 5

Description of the Device / Proper Usage .................................................................... 6

Technical data .............................................................................................................. 6

Content of delivery ....................................................................................................... 6

Proper usage and field of application ........................................................................... 7

Indications .................................................................................................................... 7

Annual inspection of the device.................................................................................... 8

Explanation of the pictograms ...................................................................................... 9

Location of the labels ................................................................................................. 10

Laser probes .............................................................................................................. 11

Sockets and connections on the front cover and probe.............................................. 12

Buttons on the single laser probe ............................................................................... 12

Buttons on the cluster laser probe.............................................................................. 12

Cluster probes ............................................................................................................ 13

LED indicator, display................................................................................................. 14

Display after starting the device with the Key switch .................................................. 15

Button functions on the display (yellow color shows active function).......................... 16

Pre-settings, default setting........................................................................................ 21

Starting operation ....................................................................................................... 23

Operational modes ..................................................................................................... 25

Before starting the therapy mode ............................................................................... 25

Selecting the settings for the laser probe: Power, Energy, Time ................................ 26

Pilot beam, laser control LED on the probes .............................................................. 28

Acoustic control .......................................................................................................... 28

Laser Test .................................................................................................................. 29

NOGIER/BAHR program............................................................................................ 29

REININGER program ................................................................................................. 30

Free programmable frequencies ................................................................................ 31

Therapy programmes (based on Nogier / Bahr frequencies)...................................... 32

Diagnostic mode......................................................................................................... 33

Charging the battery................................................................................................... 35

International plugs ...................................................................................................... 36

New installation of the software, update..................................................................... 36

Error messages .......................................................................................................... 36

Applicators, optional ................................................................................................... 37

Laser-protection goggles............................................................................................ 38

Cleaning / Disinfecting................................................................................................ 38

Maintenance/Calibration............................................................................................. 38

Disposal...................................................................................................................... 38

Warranty..................................................................................................................... 38

Electromagnetic compatibility - Warning instructions ................................................ 39

Manufacturer .............................................................................................................. 41

Physiolaser olympic 500

Version 1.4 June 2007

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General Notes

These operating instructions must be read carefully before starting the device.

These operating instructions describe the correct usage of the Physiolaser olympic

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.

The laser device should only be operated by authorized, trained personnel that have

been properly instructed in using the device and have been made aware of the dangers

of laser radiation as well as the accident prevention regulation BGV 11 ”Laser radiation”

and the DIN VDE 0837 directive ”Radiation Safety for Laser Devices”.

Please contact your supplier, representative or REIMERS & JANSSEN GmbH in case

you have any related questions.

REIMERS & JANSSEN GmbH

Medical Laser Technology

Frohnacker 8 79297 Winden, Germany

Tel. +49-7682-6558 Fax +49-7682-6640v

[email protected] www.rj-laser.com

Certified according to EN ISO 13485:2003

Exclusion of liability

The Physiolaser olympic 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.

Physiolaser principle of function

The Physiolaser olympic will emit monochromatic, coherent laser light to the cells and

tissue. The photon energy will be absorbed by the cells (e.g. mitochondrials), which

leads e.g. to a higher oxygen level and further to an improvement of the metabolism.

Additionally special impulse frequencies are applied (acc. to Dr. NOGIER, France,

BAHR, Germany, REININGER, Austria) in order to stimulate the body, cell and tissue.

The special features of the Physiolaser olympic 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.

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Safety standard

The Physiolaser olympic is a high-quality, microprocessor-controlled, multi-function

device. It combines a high-output, universal therapy laser with a diagnostic device for

measuring skin conductance values.

The Physiolaser olympic software offers users a wide range of application

possibilities. The special features of the Physiolaser olympic are proven through

several years of intensive research and offer an exact supply of photon energy to the

body.

The Physiolaser olympic meets the requirements of the following International

standards:

EN 60601-1: 1996 Safety of Medical Electrical Equipment

EN 60601-2-22: 1996 Safety of Diagnostic / Therapeutic Lasers

EN 60825-1: 2003 Safety of Laser Devices

DIN EN 60601-1-2 Electro magnetic compatibility

DIN EN 60601-1-4 Programable Electronic Device

Further information on the wide range of uses for laser therapy can be found in technical

literature and in seminars of REIMERS & JANSSEN GmbH.



Physiolaser olympic 500

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Safety Precautions

Caution - Using the operating equipment or settings in a way not described here

can result in dangerous exposure to radiation.

Shutdown in an emergency

The laser can be shut down in the event of an emergency by pressing the Emergency

button or by pulling out the safety plug.

Personnel

The Physiolaser olympic should only be operated by trained medical personnel. The

personnel must be instructed in safe handling procedures and also made aware of the

potential risks of laser radiation.

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.

Registering (valid for Germany, please refer to your national regulations)

The Physiolaser olympic 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.

Treatment room

The laser may only be operated in closed rooms. The treatment room in which laser

therapy is performed must meet the requirements of the Accident Prevention Regulation

BGV 11 ”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.)

Safeguarding against unauthorized usage

To safeguard against unauthorized usage, the Physiolaser olympic is equipped with a

removable key, safety plug and safety code. The laser can only be operated when the

key and safety plug is inserted or the code is activated. If the Physiolaser olympic

laser is not being used, always remove the key and store it separately from the device

to prevent unauthorized usage.

Device out of use

If you assume that the device can not be used properly any more and could endanger

user or patient, it should be set out of use and has to be transferred to the manufacturer

or the authorized service station for repair. Such case could be e.g.:

Visible damage of the housing of charger or main unit

The device does not work properly

The device was stored or transported under harmful conditions

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Description of the Device / Proper Usage

Technical data

Laser therapy device for mobile and local use Physiolaser olympic 500

Laser class 3B

Protection class IP 21 (drop proof)

Absolute failure of the measurement of the laser

power

5%

Modulation frequency 0,1 Hz - 18 688 Hz (± 0,1%)

Precision of the electrical skin resistance

measurement

± 10 %

Risk class according to RL 93/42/EWG IIa

Current supply Charger Model FRIWO FW7555M/08

Weight 2 kg

Dimensions (L x B x H) 25 x 10 x 15 cm

Operating conditions

Room temperature + 10°C to +40°C

Relative humidity 30% to 75%

Atmospheric pressure 700 hPa to 1060 hPa

Transport and storage

Room temperature -20° C to +40 C

Relative humidity 30% to 75%

Atmospheric pressure 700 hPa to 1060 hPa

Content of delivery

incl. Current supply charger, safety goggles, manual, therapy guide, carrying case,

”Laser Radiation” warning sign (DIN IEC 76 (CO) 6).

For the usage an optional laser probe is required :

- Laser probe

- Multi-cluster probe

- Diagnostic probe incl. Hand electrode

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Proper usage and field of application

The Physiolaser 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.

The Physiolaser is designed for a veterinary therapy, treatment of wounds, joints

and pain. In order to perform the therapy for pain and healing, the probe tip has to be

placed with light contact to the skin.

In case of infected skin, eczema, open wounds, keep 1-2 cm distance or cover the area

with plastic wrap and keep the probe tip in light contact to the area

Use the cluster probe for the treatment of large areas and joints and the single probe on

small areas, joints and acupuncture points.

Therapy recommendation: Start with a setting of 4-6 Joule/cm2 and proceed on the

following treatment day at the same energy if improved or increase until healing is

performed.

You can modify the treatment parameters according to scientific research (e.g.

recommended average dosage of 4 Joule/cm2) or according to the reactions at any time.

Please refer to the training manual to obtain further information regarding the

applications.

Indications

Acupuncture: Stimulation of acupuncture points

Tissue: Ulceration, wound healing

Bones/joints: Traumata, carpal tunnel syndrome, joint pain, fracture healing

Nerves: Nerve pain, neuritis

Pain: Reduction of pain

Contra indications

-ophthalmologic therapy

-over cancerous or malignant areas

When the Physiolaser is used for symptomatic treatment, and is contraindicated

where analgesia may mask progressive pathology, and should not be used where the

clinician would normally avoid the use of any other analgesia in order to retain the

beneficial aspects of pain.

It is conceivable that laser-mediated vasodilatation may worsen a haemorrhage.

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Precautions

Patients may suffer an exacerbation of symptoms after laser therapy in conjunction with

a recent steroid injection. For this reason laser should not be used within 2-3 weeks of a

recent steroid injection on or near the same site.

Annual inspection of the device

Due to the advanced technology and precision of the Physiolaser must under go 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

Frohnacker 8 79297 Winden, Germany

Tel. +49-7682-6558 Fax +49-7682-6640

[email protected] www.rj-laser.com

Certified according to EN ISO 13485:2003

Physiolaser olympic 500

Version 1.4 June 2007

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Explanation of the pictograms

IP21

Equipment rating against harmful ingress of water as

defined in IEC529. (see std. 60601-1 clause 6.1(L) )

Protection against electric shock regarding allowable

leakage current limitations are specified in standard

60601-1.

0123

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”.

Explanatory Label Symbol (International):

" Visible and invisible laser radiation" including the

standard which was used for the classification of the

laser.

Singel probe

Multi cluster probe

Labels according to EN 60825-1:

- Laser aperture and laser beam direction

Type plate with technical data and address of the

manufacturer

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Version 1.4 June 2007

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Location of the labels

Front panel: Symbol for the laser beam

”Warning for laser beam”.

Left: Explanatory Label Symbol (International):

"Laser radiation" including the standard which was

used for the classification of the laser.

Right: Label indicating technical data, serial number

and address of the manufacturer.

Aperture labels according to

EN 60825-1:

Front (side on the cluster probe): Laser

aperture/laser beam direction and explanatory label

Rear: Label indicating technical data as probe type,

serial number, power, pulse.

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Laser probes

Single laser probes

Nr.: Wave

length Output power Laser type

Impulse duration NOHD *) m

a <= 1,5 Beam

divergence

510 785 nm max. 50 mW Continuous (CW) 0,10 0,140 rad

511 810 nm max. 500 mW Continuous (CW) 0,29 0,157 rad

512 670 nm max. 200 mW Continuous (CW) 0,14 0,209 rad

513 655 nm Max. 50 mW Continuous (CW) 0,09 0,157 rad

515 904 nm max.90 W Impulse 200 ns 0,05 0,190 rad

Multi-cluster probes

Nr.: Wave

length Output power Laser type

Impulse duration NOHD *) m

a <= 1,5 Beam

divergence

516 904 nm 5 x max. 30 W Impulse 200 ns 0,06 0,190 rad

517 785 nm

655 nm

4 x max. 55 mW

4 x max. 40 mW

4 x max. 5 mW

Continuous (CW)

0,10

0,09

0,04

0,140 rad

0,157 rad

0,155 rad

518 904 nm 12 x max. 10 W Impulse 200 ns 0,05 0,190 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.

The controller of the Physiolaser olympic will recognize automatically which probe is

connected and will adjust all relevant settings. Please observe that when the output is

set, the laser diodes’ maximum laser output may differ from one another. The probes

can be identified through their name plates, the first two digits in each number specify

the maximum laser output in mW (CW) or W (imp). You will find the recognized probe

shown in the display as:

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Sockets and connections on the front cover and probe

Buttons on the single laser probe

Laser Start/Stop

(Press: Short= full power, long= reduced power)

Selection of single frequencies

Selection of frequency main groups. Nogier/BAHR,

REININGER, free frequencies, therapy programmes

(Press: Short= rows, long= main groups)

Buttons on the cluster laser probe

Laser Start/Stop

(Press: Short= full power, long= reduced power)

Display

Slot for the memor

y

card

Lase

rTest

Sockets for the laser

p

robe

Socket for the

diagnostic probe,

hand electrode

Remote laser

stop

Ke

y

switch

Emergency stop

Dis

p

la

y

Current connected

Scroll

up/down

Frequency

group

Laser start/stop

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Selection of frequencies

Cluster probes

Universalsonde

4x5 mW/655 nm + 4x40 mW/655 nm + 4x55

mW/785 nm

12x10 W/904 nm

Brush mit Fiberoptiken

4x5 mW/655 nm + 4x40 mW/655 nm + 4x55

mW/785 nm

12x10 W/904 nm

Derma

4x5 mW/635 nm + 6x45 mW/655 nm + 2x55

mW/785 nm

Kompakt

5x 30 W/904 nm, Impuls 200 nsec.

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LED indicator, display

Main unit Display and LED

Color Status Meaning

Buttons blue off Buttons are ready for use

Buttons yellow on Button is active

Stand-by

Ready

yellow on Show Stand-by or Ready mode

Laser data blue off Connected probe is recognized but not active

Laser data yellow on Connected probe is recognized and active

LED red on

Main unit is connected with the power supply to

the mains current

30% red flash accumulator will soon be empty, please charge

Probe

LED red Flashes

on

2 seconds during start procedure

Laser is active

Pilot-LED red on Illuminates the area to be radiated (distance: 30

mm) 2 seconds before emitting the beam

Display white on Shows data: Frequency, power, time, Joule

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Display after starting the device with the Key switch

Touching the buttons on the display will activate the functions.

Ready (therapy mode), frequency

selection, laser setting, diagnosis

Pre settings, manufacturer´s data, version no.,

Language setting.

Indicates the

Stand by mode

Frequency group

Single frequency

Battery indicator

Stand by button

Frequency row

Frequency mix

Laser settings Single and multi

cluster

p

robe

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Button functions on the display (yellow color shows active function)

Display after pressing the Ready button. Active

buttons are yellow, inactive blue.

Upper buttons are corresponding with the frequency

groups , thereafter frequency rows and single

frequencies.

The green line above Stand-by indicates the condition

of the battery.

Lower buttons are corresponding with Stand by mode,

setting of Power/Energy/Time and probe selection.

Two probes connected, data valid for the single probe

(yellow).

Frequency selection: NOGIER

Frequency B´ for the single probe.

Frequency mix

Frequency selection NOGIER B´+ C´

Here frequency B´+ C´ for the single probe

In order to mix follow the steps:

- Select the first frequency and press the mix button

once (>B´) and again to go to safe the first frequency

(B´ >Freq. 2),

- thereafter select the second frequency (>2).

Physiolaser olympic 500

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Frequency selection: BAHR1

Frequency 5´ for the multi-cluster probe.

Frequency selection: BAHR2

Hysteria frequency for the multi-cluster probe

Frequency selection: Chakra 1-8 acc. to BAHR

Sexual Chakra

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Frequency selection: Chakra 9-15 acc. to BAHR

Protection Chakra

Frequency selection: Meridian 1 acc. REININGER

Small Intestine.

Frequency selection: Meridian 2 acc. REININGER

Liver.

Frequency selection: Reininger

Reininger 1

RI 2

Reininger I to II have a similar display design.

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Frequency selection: Reininger

Level 2

K-HWP

Frequency selection: Reininger

Anti-Freq. 2

Anti inflammation

Frequency selection: Reininger

Viral/Bacterial

Anti viral

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Frequency selection: Therapy program

General 1

Nerves

Available rows:

General 1 and 2

Orthopaedics

Derma

Dental

Vet

The mix button is not available for the therapy

programs.

Frequency selection: Free Frequency

Free Freq. 6

F 6

Available are 10 memories each with 11 spaces.

Individual programming of frequency and name is

possible, please press the button Edit.

Selection of power, energy, time, duty cycle and

therapy beep.

Press one of the buttons to change the value.

Enter will store the value.

Therapy leads back to the main therapy menu.

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R&J LASER Physiolaser olympic 500 Instructions Manual

R&J LASER Physiolaser olympic 500 Instructions Manual

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