Silberbauer Infrared Moxa Device M3 User manual

SILBERBAUER
Infrarot – Moxa – Gerät M3
Instructions for Use
Seriennummer: (SAMPLE)
SILBERBAUER 0120
Medical Electronics, Vienna

Content:
Page
Infrared Moxa Device M 3:........................................................Fehler! Textmarke nicht definiert.
Principle...........................................................................................................................................3
View of the device:..........................................................................................................................3
Safety Instructions...............................................................................................................................4
Contraindications and Side effects ......................................................................................................4
Starting.................................................................................................................................................5
How to use the M 3..............................................................................................................................5
Tip, distance for penetration and angle of the tip............................................................................5
Penetration time...............................................................................................................................6
Control of the output power of the M 3...........................................................................................6
Possible faults..................................................................................................................................6
Cleaning and Maintenance ..............................................................................................................7
Waste management..........................................................................................................................7
Dispatch of the device .....................................................................................................................7
Warning advices and Labels................................................................................................................7
Technical Data.....................................................................................................................................8
EG – Declaration of Conformity .................................................Fehler! Textmarke nicht definiert.
Edition: May 3, 2012 Version 4

 Infrared – Moxa Device M 3 Instructions for use
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Infrared Moxa Device M 3:
Principle
The infrard radiation produced in the M3 goes through the skin and heats deeper parts of tissue
without burning of the skin surface (if used properly!! See Safety Instructions!).
The infrared source is a halogen lamp at lower voltage with
intensive infrared part of radiation. But it has also a visible component.
This lamp is adjusted in a special ellipsoidal reflector. At the other side
there is a light conductor made of quartz glass where the concentrated
beam comes out of the tip of the device.
The power supply is a mains adapter approved for Medical
Devices.
View of the device:
3 4
2 5
1
1 Light outlet 5 Connector for Power supply
2 Start button
3 Power adjustment
4 Time adjustment

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Safety Instructions


 Note the legal safety precautions!
Attention! The M 3 may be used ONLY together with the mains adaptor Friwo
FW7555M/05 ! Only in this way the M 3 has the electrical safety for patient and user in
accordance to the standard EN60601.
•Attention! To use the operation facilities or possible adjustments in another way than
explaned in this manual can cause dangerous irradiation or burns!
The M 3 may be operated only in the following temperature range:
Case temperature 10 bis 50 oC,
Storage temperature 5 bis 60 oC,
Admissible humidity: 30 to 60 %
rel
,
the humidity should in no condense on the device (no dew drops)!
•The irradiation of the eye (also if closed) is important to avoid!
•
••
•For penetrations in the face region the eyes of the patient must be closed.
•
••
•Treatments with the M3 are only allowed by trained people!
•
••
•It is prohibited to use burnable anaesthesia gases or oxidized gases like N2O or oxygen close
to the M3. Some materials like e.g. cotton can ignite at high temperatures in the beam of the
M3. For solvents of adhesives or burnable fluids which are used for cleaning and disinfecting
there should be enough time for evaporation before using the M3.
Contraindications and Side effects
•
••
• Direct irradiation of the eye has to be avoided absolutely!
•
••
• It is prohibited to irradiate in the region of open fontanelles or open skullcap!
•
••
• Moxibustion can cause burns of skin and mucous membrane!

 Infrared – Moxa Device M 3 Instructions for use
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Starting
The Silberbauer Infrared Moxa Device M 3 is delivered together with a special mains adapter
approved for Medical Devices. Connect this adaptor into a mains outlet. It can be connected
permanent.
How to use the M 3
Attention! The M 3 may be used ONLY together with the mains adaptor Friwo
FW7555M/05 ! Only in this way the M 3 has the electrical safety for patient and user.
This adaptor can be used international because there are different plugs available and the mains
voltage range is 100 V to 240 V.
Connect the small plug of the adaptor into the M 3.
Adjust the infrared output power and the time of irradiation at the M 3. Then put the tip of the
device at the point at the patient where you want to penetrate. The tip can be hold several mm in
distance to the skin or placed directly onto the skin.
Now press the start button and hold it during moxibustion. In case of danger release the button
and the M3 switches off suddenly.
Tip, distance for penetration and angle of the tip
The tip of the Silberbauer Infrared Moxa Device M3 has the shape of a tube looking out from a
conical part. So it is possible in any case to have a good view to the position where the beam goes into
the skin (Infrared beam with a visible component). Even poorly accessible points can be easily
irradiated.
In the tip there is a short light conductor which protects the heart of your M3, the Infrared
reflector and the Halogen lamp. The point where the beam impinges or the working region of
penetration is determined by the tip. The beam comes out conical. So you can adjust the size of the
point by adjusting the distance to the skin und adapt in accordance to the requirements.
The distance to the skin can be choosed how you want! The M 3 may touch the
skin surface. The skin also can be pressed with soft pressure of the tip to reduce the distance to deeper
parts of tissue (e.g. in the abdominal region).

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To get best results you should hold the tip perpendicular to the skin surface:
few reflection, much reflection,
optimal penetration depth fewer penetration depth
= optimal success = poorer success
Penetration time
Penetration time, power and distance have a relationship. The larger the distance (and so the larger the
area of penetration), the larger the power can be adjusted.
There are different techniques of application calling for different adjustments. In any case the patient
should work together with you: he must react suddenly in case of heat pain and move away from the
M3 tip.
Control of the output power of the M 3
To check if the device is still operating properly, do the following:
oAdjustments at the device: time to „permanent“, power to „strongly“.
oNow place the tip onto your palm and press the button; after approx. 2 to 3 seconds the
skin should become uncomfortable hot. In this case suddenly release the button.
Possible faults
! It should be noted that handling of a damaged device is dangerous and can cause
dangerous infrared irradiation or burns.
If the M3 does not glow after pressing the button, then release the button and check
• Power adaptor connected to the mains?
• Mains switched in?
If the M 3 does not work although the power adaptor is connected, so please do not do any
further tests and send or bring the device together with the power adaptor to our service for checking!

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Cleaning and Maintenance
To avoid possible danger of infections the tip of the M3 should be disinfected before and
after any treatment.
M 3 and mains adaptor can be cleaned carefully with a piece of clothe which is wetted with
alcohol or disinfectant. Before that disconnect the mains adaptor from mains! Be careful that no fluid
comes into the openings.
The tip of the M3 also can be cleaned with a wetted swab or clothe.
There is no additional maintenance necessary by the user.
Waste Management
The M 3 and also the mains adaptor have to be disposed like normal electronic equipment.
Dispatch of the device
In the tip of the M 3 there is a light conductor made of quartz glass, so please packing
protected against breaking!
Warning Advices and Labels
Disposal not like household waste, but like
electronic equipment!
Application part type BF
See instructions for use!
Year of manufacture: is shown coded at the end of the Serial Number:
Letter A for 2001, B for 2002 etc.
The manufacturer is only considered responsible to bearing on security, reliability and capacity of the instrument,
when
A. changes or repairs are made by personnel authorized by him,
B. the electrical installation of the room is according to the regulations of ÖVE-EN 7,
C. the instrument is used in accordance with the directions of use.
The instrument must not to be used with volatile gases or fumes during narcosis. This could cause sparks in the
button or at the contacts. Apart from the given valid regulations the “Instructions to avoid explosive dangers in operational
equipment“of BM for social administration Zl. V-88015-17 are to be considered in the advisory statement made by the
medical experts from 03.02.1968 and ÖVE-EN 7 regarding the use of the instrument in an atmosphere enriched with
oxygen.

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Technical Data
Infrared Moxa Device M 3:
Manufacturer: Prof. Dipl.Ing. Gerhard Silberbauer  0120
Medizinische und physikalische Elektronik
Hiessgasse 15, 1030 Vienna, Austria
Intended use: Moxibustion of the skin
Certificate: Federal Institute of Technology, Electrical and Electronic Engineering,
Vienna, Austria,
Ref. No. TGM-VA EE 33813 EMC, from June 7
th
, 2011
Accessory: none
Power supply: Mains adaptor Friwo Type FW7555M/05
Classification - Protection against electrical shock: external mains adaptor
Application part type BF
- Protection level against harmful water invasion:Common instrument
- Protection level during application together with explosive mixtures of anaethesias with air
or with oxygen or laughing-gas:
Instrument is not to be used in an explosive atmosphere or with explosive mixtures from
naesthesias with oxygen to laughing-gas
-Kind of operation: Permanent operation
-due to EU - direction 93 / 42 / EWG: II a
Therapy period: approx. 2s to continuous (adjustable by user)
Current: max. 1,5 A
Weight: 74 g
Measures: 20 x 233 mm (Diameter x Length)

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Mains Adaptor for the M 3:
Manufacturer: Friwo CEAG AG 
Bad Homburg, Germany
Type: FW7555M/05
Mains Voltage: 100 V to 240 V AC, 50 to 60 cps, 400 mA
Output: 5 V DC, 2,4A
Weight without/with cable / Measures: 110 g / 174 g / 88 x 51 x 72 mm (L x W x H)

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