CL plus Instructions for Use June 2010

Content: Page:

1 Intended Use ... 4 2 Safety precautions to be observed during the use of therapy lasers ... 4 2.1 Alignment Laser Spectacles (Therapist’s Spectacles): ... 5 2.2 Laser Protection Spectacles (Patient’s Spectacles): ... 6 2.3 Indications ... 6 2.4 Contraindications ... 7 3 Compact - Laser CL plus : View ... 8 3.1 Accessory ... 8 3.2 Initial use ... 9 4 Use of the Compact – Lasers CL plus ... 9 4.1 Commissioning ... 9 4.2 Laser-point and distance of irradiation... 13 4.3 Irradiation Angle... 14 4.4 Use of the assessory ... 14 4.5 Location of Acupuncture points with the Compact – Laser plus:... 15 4.5.1 Preparation of the assembly ... 15 4.5.2 Acupuncture point detection on the body ... 15 4.5.3 Detection of ear- and skull acupuncture points ... 16 4.6 Irradiation period and Absorption Doses ... 16 4.6.1 Formule ... 16 4.6.2 Measuring units ... 16 4.6.3 Calculation of the correct dose ... 17 4.7 Checking the output power of the laser ... 17 4.8 Charge of the NiMH- Battery ... 18 5 Possible dysfunctions of the laser ... 19 6 Cleaning and maintenance ... 20 7 Waste management of laser and accessory ... 20 8 Warranty ... 21 9 Laser inspection ... 22 9.1 Scope of inspection: ... 22 9.2 Inspection Certificate... 23 10 Laser dispatch ... 23 11 Warning advices and Label Information : ... 24 12 Technical Data: ... 25 Declaration of Conformity 23 Calibration Certificate ...24 CL_plus_BED2_e.doc

June 15, 2010

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Compact - Laser Series CL plus

Delivery :  2 ea. NiMH – Batteries „Green“, 2050mAh,  Charger for NiMH- Batteries,  Laser – Storage, Acrylic Glass,  lockable Casket, Aluminum,  Instructions for use  Applications of the Soft–Laser  Laser goggles „Comfort“ ( = for the patient),  Laser goggles „Mini-Soft-Caps“ (= for children),  Laser adjustment goggles „Comfort“ (=for the therapist),  Measurement templet for wounds  Instruments book  Laser sign board (Attention Laser Beam) Admitted Assessory: Lightning cable bent (Dental top) Power reducing tip

Admitted Protection Goggles: see also page 2 – 3! Soft-Caps Laser goggles (=glasses for the patient) Mini-Soft-Caps Laser goggles for children Comfort Laser goggles (=glasses for the patient) Comfort Laser adjust glasses (=glasses for the therapist) Comfort Laser goggles for children Admitted Device in connection with the CL plus Laser: Point Detector PS3, with Connection Cable

Instructions for use

1 Intended Use The Compact – Laser plus is a Soft Laser (Low Level Laser) for radiation of skin, mucous membrane and dental applications in human and veterinary medicine (LLLT = Low Level Laser Therapy). It is a “Medical Product“ in accordance with the EU Medical Product Law and with the Essential Requirements 93/42 EWG and 2007/47 EC. This unit is also approved by TGA. The main applications are divided into the parts  Acceleration of wound healing and to avoid obstructions in healing, especially for older patients, for diabetics and patients with wound healing complications,  Reduction of pain e.g. after traumata and post surgeryand at chronicdegenerative diseases,  Acupuncture instead of needles.

2 Safety precautions to be observed during the use of therapy lasers

  

The appropriate legal security precautions are to be observed! Direct irradiation of the opened eye should be avoided at all costs! Irreparable

damage can be expected! even the closed eye should not be irradiated! During radiation to the face use Soft Caps! Laser therapy should be conducted by trained personnel only! The use of the operating facilities or installation contingencies in any methods other than mentioned in these user instructions can lead to dangerous irradiation! CL plus- Laser must be used and stored within the following temperature range: Case Temperature: during use 10 to 45 oC (50 to 112 oF),

   

Storage temp. 5 bis 50 oC (40 to 122 oF)! Being the maximum temperature of the crystal, it is required! Caution is recommended during its transport by car in the summer! Permissible humidity: 30 till 95 %rel,



The humidity should not condense on the case/body (no dew-drops)! The use of inflammable anaesthetic gases or oxidized gases like nitrogen (N 2O) and oxygen should be avoided. Some materials like cotton, that are saturated with oxygen, could be set on fire at these high temperatures, created at the because of the laser’s direction. Before the laser is put into operation, there should be a specific period for evaporation of solvents in adhesives and inflammable solvents, which are used for cleaning and disinfection. Attention should be drawn to the fact that the body’s gases too can set on fire. It is further recommended that: Therapy duration for babies being treated at the cranial region should be short (approx. 50%)!

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Compact - Laser Series CL plus

Instructions for use

2.1 Alignment Laser Spectacles (Therapist’s Spectacles): At the use of lasers of the laser-protection-class 2M the therapist can wear the laser alignement spectacles as in accordance with the current edition of international standard EN208. For class 3B lasers and especially for infraret lasers the therapist MUST wear those spectacles. Minimal specifications of these spectacles for the CL plus corresponding to EN208: for CL plus until 100 mW: R2 for all other CL plus models: R3 and admitted for laser mode D (continuous operation)  Silberbauer - laser alignment spectacles offer only protection against accidental irradiation through laser up to these levels!  They are NOT ALLOWED to be used for the deliberate view of beam!  They are only protection against casual irradiation, when the eye lid closure reflex is not suppressed or slowed down (medical treatment, illness ...); and thus repeated irradiations of the eye have to be reduced.

 

Attention! Colour identification is disturbed by the glasses!

Clean glasses only with a glasses-cleaning-cloth or cloth and windowsdetergent.

Appropriate Protection eyewear from the Silberbauer – Programme: For all RED lasers until 200 mW: Comfort Justierbrille (green); for all other models (IR also) until 500 mW: Comfort- Schutzbrille for Patient and Therapeut (dark blue).

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Compact - Laser Series CL plus

Instructions for use

2.2 Laser Protection Spectacles (Patient’s Spectacles): At the use of lasers of the laser-protection-class 2M the patient can wear the laser protection spectacles. For class 3B lasers and especially for infraret lasers the patient MUST wear those spectacles. Minimal Specification of laser protection spectacles correspond to EN 207 for Model CL plus: Protection level at the wavelength of the laser : L3; Laser mode: D (continuous operation)  The Silberbauer laser protection spectacles offer only protection against accidental irradiation through laser up to these powers!  They are NOT ALLOWED to be used for the deliberated view into the beam!  They protect only then against casual irradiation, when the eye lid closure reflex is not suppressed or slowed down (medical treatment, illness ...); and thus repeated irradiations of the eye have to be reduced.

 

Attention! Colour identification is disturbed by the glasses!

Clean glasses only with a glasses-cleaning-cloth or cloth and windowsdetergent.

Appropriate Protection eyewear from the Silberbauer – Programme: Adults: for all Laser models (IR also) until 500 mW: Soft-Caps; for red Lasers until 500 mW: ComfortSchutzbrille (blue); for infrared Lasers until 1000 mW: Comfort-Schutzbrille IR (pink coloured). Children: for all Laser models (IR also) until 400 mW: Mini-Soft-Caps; for red Lasers until 500 mW: Comfort-Schutzbrille for Children; for infrared Lasers until 1000 mW: Comfort-Schutzbrille IR for children (pink).

2.3 Indications See scientific literature and soft laser courses!

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Compact - Laser Series CL plus

Instructions for use

2.4 Contraindications The laser treatment has a low risk only. Different authors have controversial positions because the laser is especially successful in applications where you for forensic reasons might have concerns. However, if no sufficient tests are available, some contraindications should be observed:

 

Direct irradiation of the open eye, it is essential to avoid!

In the area of open fontanelles or open skullcaps, as well as growth gaps in childhood and adolescence should not be irradiated.



During pregnancy, the penetration of the abdominal area is to be avoided. Attention! Sopme acupuncture points can trigger labour (Bl31, Bl32, Bl60, Bl67, Di4, Di5, Gbl21, Gbl34, LG20, MP6)

  

Endocrine organs may not be treated! For epileptics, the scalp region may not be treated.

In the literature, there are notes at the one side that tumors and malignant skin diseases should not be treated, at the other side tumor pains and damages due to radiation are a successful field of application. In the veterinary medicine there are good results after laser penetration of tumors because the lymphatic jam and the pain eases back.



In case of higher photosensibility, it is not allowed to penetrate (for all kinds of dermatoses which react with formation of erythems or vesicles to small doses of light).



Pacemakers cannot be affected by penetration with the cw- laser, so there are no contraindications.



Too long therapy time does not give better results, but also no harmful side effects. Exceptions are penetrations in the scalp region (more minutes), which can cause headache, and daily penetration with high doses which can cause that pain comes again. See also scientific literature!

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Compact - Laser Series CL plus

Instructions for use

3 Compact - Laser CL plus : View 1

2

3

4

5

6

7

8 9

"Hidden Monitor" Ser.Nr.: xxxx H

Compact - Laser CL plus xx-658

11 1 Laser Point 2 Aluminium Body 3 Lamp multi colour (performance monitoring) 4 Push-button (Start / Stop) 5 Lamp (ready / battery low) 6 Rotary Switch 1 (Function / Area)

7 Rotary Switch 2 (Dose) 8 Type Plate and Details 9 Socket for Silberbauer Point Detector PS3 10 Battery Cap 11 Laser Warning Label

3.1 Accessory Optic Fibre, bent: D i r e c ti o n o f th e Las er B eam

Power loss with optic fibre: 25 % almost!

Power-reducing-tip: D i re c ti o n o f th e Las er B eam

Transmission 50%

10

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Compact - Laser Series CL plus

Instructions for use

3.2 Initial use The Silberbauer Compact Laser plus is delivered together with NiMH- Batteries in size AA and with a charger. These batteries have a very low self discharge rate: after ONE year, yet 85% of the initial charge are available! Turn Rotary Switch 1 (6) into „Off“ position. Open Battery Cap (10) at the end of the laser and insert battery with negative end pointing into the tube; close the cap and turn it clockwise until it stops. Now your Silberbauer Compact - Laser mini is ready to use!

4 Use of the Compact – Lasers CL plus 4.1 Commissioning The left Rotary Switch 1 (6) is for switching the device on and off and to select the function or the area. In “Off“ – position the device is switched off completely, no waste of battery power. Nevertheless the battery should be removed from the laser if it is not used for a longer period because there is the risk of the battery leaking and then the risk of oxidation of the contacts. This causes a defect of the device! In position „Acup. Child“ the laser power will be set to ¼ of the nominal output power and the penetration time to 5 sec., in position „Acup. Adult“ to ½ of output power and to 15 sec. The other positions of this Rotary Switch are for setting the area which should be penetrated if the laser is used to penetrate larger areas. The right Rotary Switch 2 (7) is used to adjust the Dose in Joule/cm2. After switching in the laser cannot be started promptly, but only after a security delay of 2 sec. During this time there sounds a warning signal and the lamp (3) blinks in orange colour. The green lamp (5) flashes slowly and shows that the device is switched on and the battery is charged enough. If this lamp flashes fast the charge will soon come to an end. Now the laser can be started by shortly pressing the Push Button (4). The laser can be stopped soddenly by pressing this Push Button again during penetration.

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Compact - Laser Series CL plus

Instructions for use

Place the laser perpendicular to the area to be irradiated ( see chapters 4.2 and

4.3).

The built-in timer will start immediately after pressing the start button. The Lamp (3) will lit yellow and shows that the laser power has the desired value. A short warning tone resounds. The Timer will automatically switch off the laser after the necessary therapy time, the yellow lamp extinguishes and again a short tone is audible. Shorter Treatment Times than choosed: press Push-Button during treatment and the laser will stop immediately.

 At the end of every session the Rotary Switch 1 must be turned again into "Off" position.

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Compact - Laser Series CL plus

Instructions for use

For your information only – it calculates automatically:

Therapy time depending of the position of the switches (in minutes : seconds): (for blank cells, time is over 1 hour)

60 mW- Model: Geriatrics Pain therapy new scars

old scars

Gynecology, Surgery Dermatology Children, depending of age

Sports, Physiotherapy

Dose (J/cm2): 

0,5

1

2

3

4

5

6

8

Acup. Child

5s

5s

5s

5s

5s

5s

5s

5s

Power: 25%

Acup. Adult

15s

15s

15s

15s

15s

15s

15s

15s

50%

2

1 cm

8s

17s

33s

50s

1m:7s

1m:23s

1m:40s

2m:13s

100%

2

2 cm

17s

33s

1m:7s

1m:40s

2m:13s

2m:47s

3m:20s

4m:27s

100%

5 cm2

42s

1m:23s

2m:47s

4m:10s

5m:33s

6:57s

8m:20s

11m:7s

100%

2

10 cm 1m:23s

2m:47s

5m:33s

8m:20s

11m:7s

13m:53s 16m:40s 22m:13s

100%

20 cm2 2m:47s

5m:33s

11m:7s

16m:40s 22m:13s 27m:47s 33m:20s 44m:27s

100%

2

8m:20s

16m:40s

25min

100%

30 cm 4m:10s

33m:20s 41m:40s

50 min

50 cm2 6m:57s 13m:53s 27m:47s 41m:40s 55m:33s

100%

100 mW- Model: Geriatrics Pain therapy new scars

old scars

Gynecology, Surgery Dermatology Children, depending of age

Sports, Physiotherapy

Dose (J/cm2): 

0,5

1

2

3

4

5

6

8

Acup. Child

5s

5s

5s

5s

5s

5s

5s

5s

Power: 25%

Acup. Adult

15s

15s

15s

15s

15s

50%

15s

15s

15s

2

1 cm

5s

10s

20s

30s

40s

50s

1min

1m:20s

100%

2 cm2

10s

20s

40s

1min

1m:20s

1m:40s

2min

2m40s

100%

2

5 cm

25s

1m:40s 2m:30s

10 cm2

50s

3m:20s

4m:10s

5min

6m:40s

100%

1m:40s 3m:20s

50s

5min

6m:40s

8m:20s

10min 13m:20s

100%

20 cm2 1m:40s 3m:20s 6m:40s

10min

13m:20s 16m:40s 20min 26m:40s

100%

30 cm2 2m:30s 5min

15min

20min

100%

10min

50 cm2 4m:10s 8m:20s 16m:40s 25min

25min

30min

33m:20s 41m:40s 50min

For long treatments you can fix the laser into a tripod.

40min

100%

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Compact - Laser Series CL plus

Instructions for use

Kind of operation of the indicator lamps: Back lamp

green

dark

green

orange

blinks slowly blinks fast blinks

yellow

glows

red red

blinks glows

green Front lamp

If the laser is turned off or if the battery is wholly empty If the device is turned on and the battery is ok If the battery is charged poor During the safety delay of 2 secounds Laser is working and power is ok Power too low Power was too high (Laser switches off in this case) or temperature is still too high (Laser cannot be switched on)

Buzzer: sounds  At startup of the laser,  At stopping (at the end of the penetration time);  If the output power is too high and the laser has switched off because of security.

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Compact - Laser Series CL plus

Instructions for use

4.2 Laser-point and distance of irradiation D i r e c ti o n o f th e Las er B eam

The point of the Silberbauer - CL-plus Laser is made of stainless steel. It is created in the shape of a small tube that follows the cone. So it is easy to watch the point where the laser beam comes to the skin. Normally, nearly inaccessible points, like behind the ear are easily radiated with no problems. At the point there is a short light conductor. This light conductor serves among other things as mechanical protection for the heart of your therapy equipment, the laser diode. The impact point or the areas of operation are specified by this laser point. With all models the light emerges, whereby the size of points can be changed according to requirements through the choice of the distance from the skin. The irradiation distance can be selected at will! Therefore the laser is allowed to be set on the skin's surface. The skin can also be pressed in with smooth pressure by the laser-point, to reduce the distance between deeper-set areas needing to be irradiated (e.g. area of abdomen). Apart from this the laser-point is conductive and is connected with the socket at the rear end of the laser battery. The point-searcher PS3 can be connected to this socket with a connecting cable. Herewith the laser-point can be used at the same time as searching point-peak for acupuncture points.

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Compact - Laser Series CL plus

Instructions for use

4.3 Irradiation Angle To obtain optimal success during treatment, the laser must be positioned perpendicular to the skin's surface.

Low reflection, Optimal penetration depth = optimal success

wide reflection, lower penetration depth = less success

4.4 Use of the assessory If necessary put the bent light conductor or the power reducing tip onto the point until a limit is reached (see drawing): D i r e c ti o n o f th e Las er B eam

D i r e c ti o n o f th e Las er B eam

P o w e r -r e d u c i n g -ti p

L i g h t Co n d u c to r , D i r e c ti o n to p u t o n

bent

D i r e c ti o n o f th e Las er B eam

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Compact - Laser Series CL plus

Instructions for use

4.5 Location of Acupuncture points with the Compact – Laser plus: 4.5.1 Preparation of the assembly As well as the Silberbauer Compact - Laser mini (without power reducing tip!) a Silberbauer Point Detector PS3 and a connection cable is required. Put one plug of the connecting cable into the rear socket of the laser. The other cable plug is required to be inserted into the golden socket of the Silberbauer PS3 instead of the point-search-tip. The point finder Silberbauer Punktsucher PS 3 must now be handed over into the hand of the patient. The laser-tip can now serve now as a point finder.

4.5.2 Acupuncture point detection on the body The Silberbauer Point Detector PS 3 indicates the electrical conductivity of the skin both optically (with higher or lower frequency of the installed light-diode) and acoustically (with a varying tone pitch). The latter can be heard by the doctor while focussing his eyes on the acupuncture point. Turn Rotary Switch 1 in position „Acup. Child“ or „Acup. Adult“. Set the laser point close to the acupuncture point which you want to seek, slightly diagonally onto the skins surface. The area assumed to be an acupuncture point is sought out; then search the area, where you suppose the acupuncture point is, without lifting the tip from the skin. The pressure of the tip should be light and consistent while searching. Continue the search in the direction of a higher tone or a quicker signal. The tone pitch reaches its maximum light and maximum pitch or frequency at the centre of the acupuncture point. The push-button must be pressed on the laser above the acupuncture point thus beginning the irradiation. The time of therapy programmed in the Silberbauer Compact-Laser plus is optimised for this kind of application required in every model.

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Compact - Laser Series CL plus

Instructions for use

4.5.3 Detection of ear- and skull acupuncture points The acupuncture points at the cranial zone because of Yamamoto and at the ear are “silent“ in contrast to acupuncture points for the rest of the body. This indicates that the electrical conductivity of the skin is very low there. However if a disturbance in the organism is projected to the reflexion zones, the electric conductivity of the skin changes at the relevant acupuncture points and zones. These points can be located like with the body’s acupuncture. Very high tones appear at points with strong disturbances which should be irradiated.

4.6 Irradiation period and Absorption Doses Suggested references: e.g.:

Baxter: Therapeutic Lasers – Theory and Practice Füchtenbusch/Bringmann: Laser Therapy and Laser Acupuncture, Treatment tables Tunér/Hode: Laser Therapy – Clinical Practice and Scientific Background Tunér/Hode: The Laser Therapy Handbook A large number of scientific papers, books, announcements of exhibitions and congresses about Soft Lasers you will find at www.laser.nu .

4.6.1

Formule

Energy = Laser power x irradiation period Irradiation dose = Energy /unit area 4.6.2

Measuring units

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Compact - Laser Series CL plus

Instructions for use

Energy: in Joules (J) = Watt-seconds (Ws) Power: in milli-watt (mW)

1 mW = 0,001 W

Time: in seconds (s) Unit area: in cm² Irradiation-doses: in Joule / cm²

4.6.3

Calculation of the correct dose

Checking the area of a wound with the card: Place the card close to the wound. Seek a circle which has approximately the same area like the wound. Close to this circle you will find a number which shows the size of this area in cm² . Set the size switch at the laser in this position.

4.7 Checking the output power of the laser The Silberbauer Compact - Laser plus has a mechanism for control of the laser output power:

A yellow lamp which glows only if the laser works between 90% und 110% of ist nominal output power, and a red one which will blink 2x per secound if the power is too low, and which will glow permanently together with a 5 secound long warning

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Compact - Laser Series CL plus

Instructions for use

tone if the power is too high. In this case the laser will switched off automatically and can be switched in after the Rotary Switch 1 is turned into ist off- position.

4.8 Charge of the NiMH- Battery Attention! Don’t try to charge normal one use batteries!

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Compact - Laser Series CL plus

Instructions for use

5 Possible dysfunctions of the laser Attention must be paid to the existing danger involved in meddling with a damaged instrument and being exposed to dangerous laserradiations! If the green lamp (5) doesn’t glow after switching in the laser:

 Battery is totally empty; turn out battery cap, put out battery and replace it by a charged one; close battery cap.

If the yellow lamp (3) diesn’t glow after pressing the start buttom, then release buttom and check:

 

are there several secounds since you switched in the device? ( it will last 2 secounds delay time until the laser can be started) is the green lamp (5) blinking?

It is enough to charge the empty battery for several minutes to make a short treatment! If the lamp (3) blinks red, so the laser power is too low for any reason. If this lamp glows permanently, either the laser power was too high or the case was too hot; the device has made a security switchoff. You have to turn the rotary switch 1 (6) into ist off- position to resert the device. (Only after switching off respectively after cooling the device may be used again. If the red lamp glows again please bring or send the device to our service station! If the laser doesn’t work althouigh the battery is charged, so please do not use the device and do not make any further attempts, but bring or send the laser and the battery to our service station for checking! Fluid traces or small colorless or white crystals at the battery or at contacts indicate that a battery or a rechargeable battery has leaked and the contacts do not work. In this case, please send the device to the service for professional cleaning!

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Compact - Laser Series CL plus

Instructions for use

6 Cleaning and maintenance To avoid any danger of infection, the laser point must be disinfected before and after each treatment (and the power-reducing-tip and the bent light conductor). The laser can be cleaned carefully with a cloth moistened with alcohol or surgical disinfection. No liquid should be allowed to enter the openings. The laser point itself can be cleaned with a pad or cloth moistened with alcohol. The drill of the “power-reducing-tip“ can be cleaned with a toothpick and thereafter be washed with alcohol. For this, the power-reducing-tip must be pulled out of the laser always. The "bent light conductor" can be cleaned like the laser top. The rear surface is well protected with a black hull made out of synthetic material. If this surface does get soiled the hull must be taken off. The lighting cable can then be proceeded to be cleaned, see laser-point. Ensuing which the hull must remain attached to the lighting cable again, in such a way that the lighting cable just touches the front-surface of the laser point after the hull is pulled up, whereby the hull has to loom until the end of the cylindrical area of the laser point. L i g h t c o n d u c to r , b e n t D i r e c ti o n o f th e Las er B eam D i r e c ti o n to p u t o n

Cleaning of the Laser storage:

As this storage is made from acrylic it must be cleaned with lukewarm water with some dishwashing or soap added. Take the best with a soft cloth or with the water sucked sponge. Regard! Do not use disinfectants, abrasive cleaners, glass cleaners or cleaners containing alcohol, because they attack the material! As a result, the formation of hairline cracks and breaks the clipboard! There is no additional maintainance necessary by the user.

7 Waste management of laser and accessory For waste management please regard the valid legal regulations of each country/region! Disposal of the device: Not like household waste, but in the nearest receiving depot for disposal of electric devices! The batteries have to be brought to the next receiving depot for special waste disposal.