Silberbauer Compact-Laser Series User manual


Compact - Laser
CL plus
Instructions for use
Type: CL plus 60-660 L 0120
Serial number: 60660 L 601 J
assembled by
Silberbauer India
with the European know how of
Silberbauer Medical Electronics, Vienna,
Austria, Europe

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 ofAcupuncturepointswiththeCompact –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

Compact - Laser Series CL plus Instructions for use
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

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 chronic-
degenerative 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 (N2O) 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%)!

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: R 2
for all other CL plus models: R 3
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 windows-
detergent.
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).

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 windows-
detergent.
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: Comfort-
Schutzbrille (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!

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!

Compact - Laser Series CL plus Instructions for use
3 Compact - Laser CL plus : View
1 2 3 4
Compact - Laser
CL plus xx-658
5 6
9
11
Ser.Nr.:
xxxxH
"Hidden Monitor" 10
78
1
Laser Point
7
Rotary Switch 2 (Dose)
2
Aluminium Body
8
Type Plate and Details
3
Lamp multi colour
(performance monitoring)
9
Socket for
Silberbauer Point Detector PS3
4
Push-button (Start / Stop)
10
Battery Cap
5
Lamp
(ready / battery low)
11
Laser Warning Label
6
Rotary Switch 1
(Function / Area)
3.1 Accessory
Optic Fibre, bent:
Direction of the
Las er B eam
Power loss with optic fibre: 25 % almost!
Power-reducing-tip:
Direction of the
Las er Beam
Transmission 50%

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.

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.

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 Sports, Physiotherapy
Children, depending of age
Dose (J/cm2): 0,5 1 2 3 4 5 6 8
Power:
Acup. Child 5s 5s 5s 5s 5s 5s 5s 5s 25%
Acup. Adult 15s 15s 15s 15s 15s 15s 15s 15s 50%
1 cm28s 17s 33s 50s 1m:7s 1m:23s 1m:40s 2m:13s 100%
2 cm217s 33s 1m:7s 1m:40s 2m:13s 2m:47s 3m:20s 4m:27s 100%
5 cm242s 1m:23s 2m:47s 4m:10s 5m:33s 6:57s 8m:20s 11m:7s 100%
10 cm21m:23s 2m:47s 5m:33s 8m:20s 11m:7s 13m:53s 16m:40s 22m:13s 100%
20 cm22m:47s 5m:33s 11m:7s 16m:40s 22m:13s 27m:47s 33m:20s 44m:27s 100%
30 cm24m:10s 8m:20s 16m:40s 25min 33m:20s 41m:40s 50 min 100%
50 cm26m:57s 13m:53s 27m:47s 41m:40s 55m:33s 100%
100 mW- Model:
Geriatrics Pain therapy
new scars old scars
Gynecology, Surgery
Dermatology Sports, Physiotherapy
Children, depending of age
Dose (J/cm2): 0,5 1 2 3 4 5 6 8
Power:
Acup. Child 5s 5s 5s 5s 5s 5s 5s 5s 25%
Acup. Adult 15s 15s 15s 15s 15s 15s 15s 15s 50%
1 cm25s 10s 20s 30s 40s 50s 1min 1m:20s 100%
2 cm210s 20s 40s 1min 1m:20s 1m:40s 2min 2m40s 100%
5 cm225s 50s 1m:40s 2m:30s 3m:20s 4m:10s 5min 6m:40s 100%
10 cm250s
1m:40s
3m:20s 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 10min 15min 20min 25min 30min 40min 100%
50 cm2
4m:10s
8m:20s
16m:40s
25min 33m:20s 41m:40s 50min 100%
For long treatments you can fix the laser into a tripod.

Compact - Laser Series CL plus Instructions for use
Kind of operation of the indicator lamps:
Back lamp
green
dark
If the laser is turned off or if
the battery is wholly empty
green
blinks
slowly
If the device is turned on
and the battery is ok
green
blinks
fast
If the battery is charged
poor
Front lamp
orange
blinks
During the safety delay of
2 secounds
yellow
glows
Laser is working and power
is ok
red
blinks
Power too low
red
glows
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.

Compact - Laser Series CL plus Instructions for use
4.2 Laser-point and distance of irradiation
Direction of the
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.

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, wide reflection,
Optimal penetration depth lower penetration depth
= optimal success = 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):
Power-reducing-tip
Direction to put on
Direction of the
Las er B eam
Direction of the
Las er B eam
Light Conductor,
bent
Direction of the
Las er B eam

Compact - Laser Series CL plus Instructions for use
4.5 Location ofAcupuncturepointswiththeCompact –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.

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

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

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!

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 laser-
radiations!
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!

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.
Direction to put on
Direction of the
Las er B eam
Light conductor, bent
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.