Silberbauer Compact-Laser CL mini Manuale utente

Compact - Laser

CL mini

Instructions for use

Type: CL mini xx -658

0044

In Australia and New Zealand:

ACUPAK Pty Ltd,

9 Lawson St.,

East Hawthorn, VIC 3123

Tel: 03 98225454, Fax: 03 98225887

http://acupak.com.au

Content:

page:

Permitted Accessories: ........................................................................................ 0

Permitted Protection Goggles: ................................................................... 0

Permitted Device in connection with the CL mini Laser: ............................ 0

1 Description of the Compact Laser CL mini ...................................................... 1

2 Intended Use and Indications .......................................................................... 1

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

3.1 Alignment Laser Spectacles (Therapist’s Spectacles): ........................ 3

3.2 Laser Protection Spectacles (Patient’s Spectacles): ............................ 3

3.3 Contraindications ................................................................................ 4

3.4 Requirements for patients ................................................................... 4

3.5 Requirements for user ........................................................................ 5

4 Compact - Laser CL mini : View ....................................................................... 6

4.1 Accessory ............................................................................................ 6

4.2 Initial use .............................................................................................. 6

5 Use of the Compact – Lasers CL mini ............................................................... 7

5.1 Commissioning .................................................................................... 7

5.2 Laser-point and distance of irradiation ................................................. 8

5.3 Irradiation Angle ................................................................................... 9

5.4 Use of the accessories ......................................................................... 9

5.5 Location of Acupuncture points with the Compact – Laser mini: ....... 10

5.5.1. Preparation of the assembly ............................................... 10

5.5.2. Acupuncture point detection on the body ........................... 10

5.5.3. Detection of ear- and skull acupuncture points .................. 11

5.6 Irradiation period and Absorption Doses ............................................ 11

5.6.1 Formule .............................................................................. 11

5.6.2 Measuring units .................................................................. 11

5.6.3 Calculation of the correct dose ........................................... 12

5.7 Control of Use of Lasers ................................................................... 14

5.8 Charge of the NiMH- Battery .............................................................. 14

6 Possible dysfunctions of the laser ................................................................... 15

7 Cleaning, disinfection and maintenance .......................................................... 16

7.1 Laser, Laser Tip and Adapter for Light tube ...................................... 16

7.2 Power Reducing Tip ........................................................................... 16

7.3 Bent Light Tube.................................................................................. 16

8 Waste management of laser and accessory ................................................... 17

9 Warranty .......................................................................................................... 17

10 Laser inspection ............................................................................................ 18

10.1 Scope of inspection:......................................................................... 18

10.2 Inspection Certificate ....................................................................... 19

11 Laser dispatch ............................................................................................... 19

12 Warning advices and Label Information : ...................................................... 20

13 Technical Data: ............................................................................................. 21

EC Declaration of Conformity ............................................................................ 22

Manufacturers Declaration of Conformity (for Australia) .................................... 23

CL_mini_BED11_e.doc Version 11e 2021-02-03

Compact - Laser CL mini Instructions for use

Contents:

 2 ea. AAA size NiMH – Batteries „Green“

 Intelligent Charger for NiMH- Batteries

 Luxury Leather Case

 lockable Casket, Aluminum

 Instructions for use

 Applications of the Soft–Laser

 Laser goggles “Soft-Caps“

 Measurement template for wounds (for mini 30 only)

 Instruments book

 Laser sign board (Attention Laser Beam)

Permitted Accessories:

Adapter for Light tube

Light tube, bent (Dental top)

Power reducing tip

Laser storage

Permitted Protection Goggles:

Soft-Caps Laser goggles (=glasses for the patient)

Comfort Laser goggles (=glasses for the patient)

Comfort Laser adjust glasses (=glasses for the therapist)

Comfort Laser goggles for children

Permitted Device in connection with the CL mini Laser:

Point Detector PS3, with Safety Connection Cable

Compact - Laser CL mini Instructions for use

1 Description of the Compact Laser CL mini

The CL mini is a soft - laser (Low Level Laser) which you can hold in your hand. It is

The laser light is red and divergent, so that the device complies with the Laser Class

2M.

The light at the slender tip is almost point-like, so you very well may irradiate

punctiform. If you penetrate with a distance of a few centimeters between tip and skin, the

irradiation is circular, wherein the diameter of the circle becomes larger with increasing

distance.

The irradiation time can be adjusted in two stages. In addition, it can also be

selected manually as desired.

2 Intended Use and Indications

The Intended Use of the Compact – Laser CL mini is: radiation of skin, mucous

membrane and dental applications.

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 approved by TGA.

The main applications are divided into the sections

 Accellerating of wound healing and improvement of local defense in the wound

area,especially in older patients, diabetics and impaired wound healing,

 Reduction of pain, i.a. after trauma, surgery and chronic degenerative diseases,

 for Acupuncture (instead of needling).

Compact - Laser CL mini Instructions for use

3 Safety precautions to be observed during the use of

therapy lasers

The appropriate legal security precautions are to be observed!

 Open wounds may NOT be touched with the laser or its accessory! Risk of infection!

 Upon insertion of the laser tip or of the accessory part "optical fiber bent" in body

openings there is the risk of introducing contaminants into the body – danger of

infection!

 When printing with the laser tip on non-intact skin or mucous membrane that could be

pierced – danger of bodily injury and infection!

 Laser therapy should be conducted by trained personnel only (= according to the list of trained

persons enrolled in the Instruments Book)!

 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 mini- Laser must be used and stored within the following temperature range:

Case Temperature: during use 10 to 40 oC (50 to 104 oF),

Storage temp. 0 bis 50 oC (40 to 122 oF)!

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)!

Air pressure: not critically

 No modification of this equipment is allowed!

 Portable and mobile HF communication systems may interfere with this instrument!

 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%)!

Recommendation to avoid claims for damages by patients who believe that they are now

see worse after irradiation with the laser light:

 Avoid direct irradiation of the opened eye!

 Do not irradiate the closed eye with a power of over 10 mW!

 During radiation to the face use Soft Caps!

Compact - Laser CL mini Instructions for use

3.1 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.

Minimal specifications of these spectacles for the

CL mini corresponding to EN208:

Protection level at 658 nm: for CL mini 8: R 1

for all other CL mini lasers: R 2

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 - according to EN208 - 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.

3.2 Laser Protection Spectacles (Patient’s Spectacles):

The patient should wear laser-goggles. As per the

international standard EN 207 in its current edition.

Minimal Specification of laser protection spectacles

correspond to EN 207:

Protection level at 658nm : 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 - according to EN207 - 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.

Compact - Laser CL mini Instructions for use

3.3 Contraindications

The laser treatment with a Class 2M laser has according to EN60825 no risk. However,

different authors have controversial positions because the laser is especially successful in

applications where you might have concerns for forensic reasons. So some

contraindications should be observed:

 Avoid direct irradiation of the open eye!

 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 case of light dermatoses or 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.

 It is further recommended that:

Therapy duration for babies being

treated at the cranial region should be short (approx. 50%)!

3.4 Requirements for patients

a) Age: Newborn to geriatric patients

b) Weight: >2 kg

c) State of health: not relevant

d) Nationality: all

e) Patient condition: not relevant

Compact - Laser CL mini Instructions for use

3.5 Requirements for user

a) Education: at least school leaving certificate, no upper limit

b) Knowledge:

Minimum:

- Reading and understanding of Western Arabic numbers and letters in a language of

the country where the laser is used

- Mathematical knowledge (basic arithmetic, use of a simple formula) to determine the

settings for area and dose per cm²

- Contraindications according to instructions for use

- Basic hygiene knowledge for cleaning and disinfection in the medical sector

- for acupuncture, position of the acupuncture points

- Training on the device (names of the persons registered as trained in the device

book)

no upper limit

c) Experience:

Minimum:

Medical personnel:

- no additional requirements

All other persons:

- Basic knowledge of the human body,

- the names of body parts, joints, organs,

- Names of diseases treated with laser,

- Basic knowledge of wound management

no upper limit

d) permissible impairments:

- slight impairment of reading ability or vision, but Arial 8 must be readable

- 60% reduction of normal hearing ability

- Impairment by hand, but must be able to grip and hold pipes with 20mm diameter

securely

Compact - Laser CL mini Instructions for use

4 Compact - Laser CL mini : View

1 2 3 4

Compact - Laser

CL mini xx-658

5 6

Ser.Nr.:

xxxx H

"Constant Power" 8

Laser point 6

Type plate and details

Light Emitting Diode, yellow 7

Socket for Silberbauer Point

Detector PS3

Push-button 8

Battery Cap

Aluminium Body 9

Laser warning label

Rotary switch

4.1 Accessory

Adapter and Light tube, bent:

Power loss with optic fibre: 25 % almost!

Direction of the

Laser Beam

Power-reducing-tip:

Direction of the

Laser Beam

Transmission 50%:

e.g.: for CL mini 30 – Output Power reduces to approx. 15 mW

4.2 Initial use

The Silberbauer Compact - Laser mini is delivered with rechargable NiMH- Batteries

in Size AAA and with a charger for these batteries and can be used also with Alkali-Mangan-

Batteries, Type AAA.

Open battery cap (8) at the end of the

laser and insert battery with positive 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!

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