Dr. Mach M5 - User Manual
Dr. Mach M5 - User Manual
Dr. Mach M5 - User Manual
Mach
Lamps and Engineering
MACH M5
Mach M5 ceiling lamp for room heights up to 2,8m, F- / F/H / DF- / DF/H-model
Mach M5 ceiling lamp for room heights between 2,8m – 3m, F- / F/H / DF- / DF/H-model
List of contents
3. Cleaning....................................................................................................page 10
3.1 Sterilisable handle ..............................................................................page 10
3.2 Lamp housing, dispersing lens and support system ...........................page 12
4. Maintenance .............................................................................................page 12
4.1 Adjustments at the lamp head ............................................................page 12
4.2 Changing of spare parts .....................................................................page 13
4.2.1 Changing the halogen bulbs........................................................page 13
4.2.2 Changing the filter disk ................................................................page 15
4.2.3 Changing the dispersing lens ......................................................page 17
5. Data ..........................................................................................................page 19
5.1 Technical specifications......................................................................page 19
5.2 Electrical data .....................................................................................page 20
5.3 Environmental conditions....................................................................page 20
5.4 General remarks.................................................................................page 20
6. CE-mark....................................................................................................page 21
7. Disposal ....................................................................................................page 21
Dear customer!
The MachVISION optical system provides an illuminated field with improved contrast and
excellent homogenity. Combined with the Duo-Focus feature this offers a unique possibility
for adaptation to the wound area.
With this lighting system you profit from a whole range of new developments, based on 50
years of experience in the production of operating and doctor’s lights.
The different reds of a wound area can now be recognised very precisely. For the doctor or
surgeon this means a considerable improvement in the recognition of details in the wound
area.
The R96 lighting system uses computer-optimised cold-light filters that reduce both the un-
wanted build-up of heat in the head area and the heat radiated on the illuminated
wound area to a minimum.
All information quoted here relates only to the illuminants. Details of ceiling or wall installation
can be found in the mounting instructions.
1. Safety instructions
Pay attention to the instructions for use when handling the lamp.
WARNING:
This device has not been designed for use in potentially explosive areas.
According to the Medical Device Regulation the lamp is classified under class I.
Store the OT-lamp in its package for at least 24 hours in the respective room before
mounting, in order to equal temperature differences.
Please read the instructions for use carefully to make the most of your lighting
system and to avoid any damages to the device.
The lamps may only be repaired and special assembly work may only be carried
out on the reflector or sockets by ourselves or a company that has been expressly
authorised by us.
The manufacturer can only be made responsible for the safety of the lamp if re-
pairs and alterations are carried out by the manufacturer himself or a company that
guarantees to observe the safety regulations.
The manufacturer cannot be made liable for personal or material damages if the
lamp is operated inexpediently or incorrectly or used for purposes other than
those for which it is intended.
The lamp is to be dismantled from the spring arm in reverse order to its assembly.
This may only be carried out after the spring arm has been adjusted in height at
horizontal position since the arm is under spring tension and can bounce up.
Make sure that the lamp is in perfect working order before every use.
The OT-lamp models offer an optional feature, the light intensity control.
You can adjust the light intensity between 50% and 100%; according to your requirements.
Remark:
The ring 3 has no function here.
2
2.4 Adjusting the illuminated area by
merging the light fields and
focusing – Duo-Focus system
(for DF- and DF/H-models)
DF- and DF/H-models also have a “focusing” func-
tion (Duo-Focus).
The combination of merging the light fields and focus-
4 ing (Duo-Focus system) enables the ideal adjust-
ment of the light field to the wound area in a range
from 8cm to 35cm diameter. Such a large range of
5 adjustment is not possible with conventional tech-
nique.
Ring (2)
Merging the individual light fields of each reflector
is done by swivelling the reflectors. The light fields
overlap.
This feature is activated by turning the sterilizable
handle (1).
FOCUSING
Handle (1)
Always activate merging of light fields first by turning the handle (1), then activate fo-
! cusing when necessary by turning the ring (2). !
2.7 Positioning
3. Cleaning
Basics
Efficient cleaning / disinfection is an essential requirement for effective sterilisation of the handle.
Within the scope of responsibility for the sterility of the products it should be noted that only sufficiently
validated equipment and product specific processes are used for cleaning / disinfection and that the vali-
dated parameters are complied with in every cycle.
In addition, the hospital / clinic hygiene regulations must be observed.
Cleaning / disinfection
Cleaning and disinfection must be carried out immediately after use.
A mechanised process (disinfector) should be used for cleaning / disinfection. The efficiency of the proc-
ess used must be recognised and validated in principle (e.g. listed under disinfectants and disinfection
procedures tested and recognised by Robert-Koch-Institute / DGHM).
When using other procedures (e.g. a manual procedure), proof and process efficiency in principle must
be provided within the scope of validation.
Proof in principle of the suitability of the handles for efficient cleaning / disinfection was provided using a
cyclic cleaning system (Netsch-Bellmed T-600-IUDT/AN, programme 2 for small parts; code B).
It is not allowed to use agents / disinfectants, which contain the following substances, as these may
cause changes in the material:
- High-concentration organic and inorganic acids
- Chlorinated hydrocarbons
- 2-ethoxyethanol
* When occupying the disinfection zone (washing zone 2), the re-rinse and draining times will depend on
the respective objects being washed therein!
Sterilisation
Only previously cleaned and disinfected handles may be sterilised.
The handles are placed in a suitable sterilisation pack (one-way sterilisation pack, e.g. foil / paper sterili-
sation bags, single or double pack) in accordance with DIN EN 868 / ISO 11607 for steam sterilisation
and then sterilised.
Use only the sterilisation procedure listed below for sterilisation. Other sterilisation procedures (e.g. ethyl-
ene oxide, formaldehyde and low-temperature plasma sterilisation) are not permissible.
Proof in principle of the handles’ suitability for effective sterilisation was provided using a fractional vac-
uum process (Euroselectomat 666 by MMM Münchner Medizin Mechanik GmbH, sterilising temperature
134°C, holding time 7 min.)
Inspection / durability
The handles should be inspected for damage and changed before re-use, if required.
The handles may be cleaned / disinfected, sterilised and re-used for a maximum of 1000 times. If the
handles are re-used more than 1000 times, then this will be the responsibility of the hospital / clinic.
4. Maintenance
DR. MACH lamps are supplied with brakes on the suspension fixture and on the lamp housing. Adjust
these brakes, if necessary, after installation.
If the lamp is difficult to move or if it does not keep its position, the brake forces should be adjusted.
The lamps and suspension fixtures have been designed and built, so that regular maintenance intervals
are not necessary.
In order to keep the system easy-running throughout its life span, we recommend that the hinges should
be greased once a year with acid-free grease.
Attention: Before dismounting the lamp, set the height adjustment of the spring arm to horizontal
position (see mounting instructions „Ceiling attachment – wall attachment“).
When adjusting the brakes or the hinges at the ceiling attachment, please consult the mounting instruc-
tions “Ceiling attachment with heavy central axis” or “Ceiling attachment – wall attachment”.
Remark:
In case there is no screw driver available, you
can use a coin.
ATTENTION!
The lamps must not be used without this filter.
1 Remark:
In case there is no screw driver available, you
can use a coin.
3
4
3
• Loosen the six screws 3 and remove them.
• Lift the filter disk 4 off the six retaining an-
gles 5.
Always place the filter disk on a soft, non-
scratching base to preserve its surface.
4
• Remove the six retaining angles 5.
• Remove the retaining ring 6 of the dispersion
lens.
5 • Remove the dispersion lens 7.
Always place the dispersion lens on a soft,
non-scratching base to preserve its sur-
face.
6
• Mount the new dispersion lens 7.
ATTENTION: Only use dispersion lenses,
that have been cleaned properly (see chap-
7 ter 3.2).
On request of the customer there are spare parts lists and wiring diagrams available for the lamps
Mach M5 F / Mach M5 DF.
5. Data
Mach M5 DF / M5 DF/H
Number of bulbs:
3
Halogen 22,8/24V 77W
Mach M5 DF / M5 DF/H
Current 10,1 A
Frequency 50/60 Hz
Class of protection I.
Operation
Min. Max.
Temperature +10°C +40°C
Relative athmospheric humidity 30 % 75 %
Air pressure 700 hPa 1060 hPa
Transport / storage
Min. Max.
Temperature -10°C +50°C
Relative athmospheric humidity 20 % 90 %
Air pressure 700 hPa 1060 hPa
When installing an OT-lamp, its fail-safety must be guaranteed according to DIN VDE 0100-710 (former
DIN VDE 0107).
Protective conductor
6. CE-mark
The products Mach M5 comply with the standards 93/42/EEC for medical products of the
European Community’s Council. Dr. Mach applies the standard EN 60601-2-41.
Dr. Mach GmbH is certified according to DIN EN 46001:1996 and DIN EN ISO
13485:2001.
7. Disposal
The OT-lamp doesn’t contain any dangerous goods.
The components of the OT-lamp should be properly disposed at the end of its shelf-life.
Make sure, that the materials are carefully separated.
The electrical conducting boards should be submitted to an appropriate recycling proceeding.
The rest of the components should be disposed according to the contained materials.
8. Spare parts
4,5
25 7 15,16 6
23,24
1,2
18
20,21,22 8
9
10
17
11 40
12,13
19 14
27
26
28
30,31
29
32
35,36
34
33
10. Appendix
Setting the primary voltage at the
block transformer 300VA
Clamps on the transformer
3
Pos.1 earthing connection at the trans-
former
• Connect the transformer to earth. Use the provided clamps pos.1 at the transformer, respectively at
the transformer plate.
See also the explanations on page 19/46 of the mounting instructions “Ceiling and wall at-
tachment” no. 59500001 / edition 05.
Setting for115V