Dr. Mach MACH M3 User manual

Mach M3 Dr. Mach
Lamps and Engineering
Operating instructions
MACH M3
Mach M3 stand lamp, F- / F/H / DF- / DF/H-model
Mach M3 emergency stand lamp, F- / F/H /DF- / DF/H-model
Mach M3, wall lamp, F- / F/H / DF- / DF/H-model
Mach M3 ceiling lamp for room heights up to 2,8m, F- / F/H / DF- / DF/H-model
Mach M3 ceiling lamp for room heights between 2,8m – 3m, F- / F/H / DF- / DF/H-model
Dr. Mach GmbH u. Co., Floßmannstrasse 28, D-85560 Ebersberg
Tel.: [phone], Fax [phone]
Internet: www.dr-mach.com, E-mail: [email protected]
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Mach M3 Dr. Mach
Lamps and Engineering
List of contents
1. Safety instructions ....................................................................................page 4
2. Operating the lamp MACH M3..................................................................page 5
2.1 Brief description of the lamp...............................................................page 5
2.1.1 Merging of light fields (F-model)..................................................page 5
2.1.2 Focusing (DF-model) ..................................................................page 5
2.1.3 Light intensity control (/H-model).................................................page 5
2.2 Adjusting the illuminated area by........................................................page 6
merging of light fields (for F and F/H-models)
2.3 Adjusting the illuminated area by........................................................page 6
merging of light fields and focusing –
Duo Focus system (for DF and DF/H-models)
2.4 Overview of the lamp functions ..........................................................page 7
2.5 Adjusting the light intensity.................................................................page 8
2.6 Positioning..........................................................................................page 9
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 Removing the upper housing part ......................................................page 13
4.3 Changing of spare parts .....................................................................page 14
4.3.1 Changing the halogen bulbs........................................................page 14
4.3.2 Changing the dispersing lens ......................................................page 15
5. Data..........................................................................................................page 16
5.1 Electrical data.....................................................................................page 16
5.2 Environmental conditions ...................................................................page 16
6. CE-mark ...................................................................................................page 16
7. Disposal....................................................................................................page 16
8. Spare parts...............................................................................................page 17
9. Spare parts list..........................................................................................page 19
10. Appendix: Setting the primary voltage at the block transformer
300VA (extra) ........................................................................page 20
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Mach M3 Dr. Mach
Lamps and Engineering
Dear customer!
Congratulations for achieving our new OT-lamp MACH M3.
The MachVISION optical system provides an illuminated field with improved contrast and
excellent homogeneity. 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 lighting system is characterised by a previously inconceivable general colour rendition
value of Ra = 96. In other words, the colours are reproduced naturally and in high
contrast. The wound area is shown in a comfortable light.
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
unwanted build-up of heat in the head area and the heat radiated on the illuminated
wound area to a minimum.
Pay attention to the special mounting instructions for ceiling and wall lamps.
All information quoted here relates only to the illuminants. Details of ceiling or wall installation
can be found in the mounting instructions.
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Mach M3 Dr. Mach
Lamps and Engineering
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
repairs 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 assembly-locking device has been inserted
and secured since the arm is under spring tension.
Make sure that the lamp is in perfect working order before every use.
Attention, external transformer!
The lamp works only with an external transformer 300VA.
The external transformer (Order No. 6701 0208) must be tested and validated
according to IEC 60601-1.
If the external transformer is not tested and validated according to IEC 60601-1, it
is not allowed to use it with Dr. Mach OT-lamps.
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Mach M3 Dr. Mach
Lamps and Engineering
2. Operating the lamp MACH M3
2.1 Brief description of the lamp
The OT-lamp MACH M3 is available in following versions:
- Standard OT-lamp (F) with merging of light fields
- Duo-Focus OT-lamp (DF) with merging of light fields and focusing
- F- or DF- lamps with light intensity control (/H)
2.1.1 Merging of light fields
(F- model)
The F-model offers light field adjustment by
merging the individual light fields of each
reflector by swivelling them.
NOTE: This feature is activated by turning the
sterilisable handle.
2.1.2 Focusing (DF- model)
The DF-model offers a second additional
facility to further adjust the illuminated field to
an extra small or extra large size, depending
on the specific requirements, by focusing
through moving the bulbs up or down.
NOTE: This feature is activated by turning the
ring at the top of the sterilisable handle.
2.1.3 Light intensity control (/H- model)
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.
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Mach M3 Dr. Mach
Lamps and Engineering
2.2 Adjusting the illuminated area by
merging the light fields
(for F and F/H-models)
All F and F/H lamp models offer the feature of
“merging the light fields”. This feature is activated by
turning the sterilisable handle 1.
Remark:
The ring 2 has no function here.
2.3 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”
function (Duo-Focus).
The combination of merging of light fields and
focusing (Duo-Focus-system) enables the ideal
adjustment of the light field to the wound area in a
range from 8 cm to 35 cm diameter. Such a large
range of adjustment is not possible with conventional
technique.
To activate the focusing function turn the adjusting
ring 2on the handle or, -if the lamp is equipped with
a keypad at the cardan bow (for DF/H-models) –
press touch buttons 5,6.
Press touch button 5to expand the focus and touch
button 6to bundle the light on a minimum area. The
current focused diameter is shown in the LED-display
4.
1
2
6
5
4
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Mach M3 Dr. Mach
Lamps and Engineering
2.4 Overview of the lamp functions
Merging of light fields and focusing
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 sterilisable
handle (1).
Focusing is done by moving the bulbs inside the
reflectors up or down. In this way you can further
adjust the illuminated field to an extra small or extra
large size, depending on the specific requirements.
This feature is activated by turning the ring (2) at the
top of the sterilisable handle.
FOCUSING
MERGING OF LIGHT FIELDS
Ring (2)
Handle (1)
Always activate merging of light fields first by turning the handle (1), then activate
focusing when necessary by turning the ring (2) !!
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Mach M3 Dr. Mach
Lamps and Engineering
Key pad
2.5 Adjusting the light intensity
(for F/H and DF/H models only)
Select the desired light intensity before the
operation.
At these models the adjustment is done by the
keypad at the cardan bow. The intensity can be
infinitely adjusted between 50% and 100%.
Press push button 2to increase the light intensity
and press push button 3to reduce the light intensity.
The light intensity set is shown by LED-display 1.
For other light models we recommend a dimmer in
the supply line.
1
2
3
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Mach M3 Dr. Mach
Lamps and Engineering
2.6 Positioning
Use the sterile handle 2or the handle rails 1to
position the lamps.
Use the handle rail to position the lights before the
operation.
Use the sterile handle for positioning during the
operation. This handle can be removed for
sterilization.
1
1
The working distance of the F-lamps is 0,7m to
1,4m.
The working distance of the DF-lamps is 0,6m to
1,5m.
The handle is supplied with a detectable mechanical
catching. When the handle catches in this position,
the lamp is optimally set for a working distance of 1
meter.
2
1,4m
(1,5m)
1m
0,7m
(0,6m)
0
Two or more lamps can be used for an intensive
illumination of large operation fields.
It is also possible to illuminate two operation fields
simultaneously.
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Mach M3 Dr. Mach
Lamps and Engineering
3. Cleaning
3.1 Sterilisable handle
At delivery the lamp is equipped with the handle
sleeve 1. The handle sleeve is removable and
sterilisable. Before using the first time and before
every use the handle sleeve must be cleaned,
disinfected and sterilised.
The handle sleeve must be removed for sterilisation:
• To remove press the lock V and pull off the
sterilisable handle sleeve 1while keeping the
lock pressed.
• To attach, push on and slightly twist the handle
until the lock V engages securely.
Handles often become unsterile during an OP;
therefore always keep additional handles available
for exchange.
V
1
Cleaning / disinfection and sterilisation
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
validated 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
process 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
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Mach M3 Dr. Mach
Lamps and Engineering
When cleaning / disinfecting, the following procedures must be followed:
Process Time (sec.)
Zone 1 Pre-rinse, external, cold, 10 – 15°C 45
Washing, acidic, external 35°C 120
Draining time 10
Re-rinse, external approx. 80°C *10
Draining time *15
Re-rinse, external approx. 80°C *15
Draining time 15
Zone 2 Washing, alkaline, external, 93°C 135
Draining time 10
Re-rinse, external, acidic, 90°C 10
Draining time 15
Re-rinse, external 90°C 15
Draining time 15
Zone 3 Drying, external 100 – 120°C 200
Zone 4 Drying, external 100 – 120°C 200
Door open / close & transport 60
(sluice discharge)
Cycle time overall ca. 290
≈5 minutes
* 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
sterilisation 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.
ethylene oxide, formaldehyde and low-temperature plasma sterilisation) are not permissible.
Steam sterilisation procedure
Validated in accordance with DIN EN 554/ISO 11134
Maximum sterilisation temperature 134°C
Proof in principle of the handles’ suitability for effective sterilisation was provided using a fractional
vacuum 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.
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Mach M3 Dr. Mach
Lamps and Engineering
3.2 Lamp housing, dispersing lens
and support system
The OT-lamp MACH M3 has a high-quality surface,
which can be cleaned with conventional cleaning
agents.
The lens system 2is made of a high-quality plastic.
Pay attention to the following during cleaning:
- Never wipe over the lens system 2with a dry
cloth (always clean with a wet cloth).
- Only use disinfectants with less than 20%
alcohol.
Wipe the lens system 2 after cleaning with an
antistatic, non-fluffy cloth.
2
Alc. ≤20 %
4. Maintenance
MACH lamps are supplied with brakes on the suspension fixture and on the lamp housing. Adjust these
brakes as necessary after installation.
If the lamp is difficult to move or if it does not stay in 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.
When adjusting the brakes or the hinges at the ceiling attachment please consult the mounting
instructions “Ceiling attachment with heavy central axis” or “Ceiling / wall attachment”.
4.1 Adjustments at the lamp head
The fine adjustment for handling the lamps can be
carried out at points 2and 3.
To adjust the brakes use a screw driver with
appropriate size.
If you cannot adjust the brakes at points 2and 3
anymore as tight as necessary, you will have to
replace them.
Remark:
In order to adjust brake 2, the upper housing
part must be removed.
Upper housing part
3
4
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Mach M3 Dr. Mach
Lamps and Engineering
4.2 Removing the upper housing part
The upper housing part can be removed by turning
the turn-lock fastener 8.
The upper housing part has two markings, 6
(Lock) and 5 (Up). The notch 7at the turn-lock
fastener 8shows the open or close status of the
upper housing part.
Turn the turn-lock fastener 8to the left over the
marking 5until stop and hold it in this position.
Lift the upper housing part with the other hand at
the cardanic suspension 9and remove it uniformly.
Be careful when removing the upper housing
part, do not damage the sealing profile 10!
Mount the upper housing part in reverse order:
Turn the turn-lock fastener 8again to the left over
the marking 5until stop and hold it in this position.
Put the upper housing part flush on the bottom
housing part.
Be careful when mounting the upper housing
part, do not damage the sealing profile 10!
Turn the turn-lock fastener 8under slight pressure
on the upper housing part to the right until the
marking 6 (Lock).
Check by eye-control, if the upper housing part is
mounted uniformly on the bottom housing part of
the lamp.
5
6
7
8
5
8
9
10
9
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Mach M3 Dr. Mach
Lamps and Engineering
4.3 Changing of spare parts
4.3.1 Changing the halogen bulbs
Dr. Mach uses special halogen bulbs as illuminants.
Only original Dr. Mach replacement bulbs may
be used.
The use of other bulbs can lead to a considerable
reduction of the light power and increase in the
thermal load.
The halogen bulbs have a service life of approx.
1200 hours. We recommend changing all halogen
bulbs in a lamp at the same time to keep
maintenance work to a minimum.
• Turn off the lamp.
• Remove the upper housing part of the lamp as
described in chapter 4.2.
ATTENTION: Parts of the housing and the
halogen bulb may be very hot immediately
after use.
• Loosen the red knurled screw 1and remove the
lamp socket 2without removing the electrical
connection 3.
• Remove the faulty halogen bulb 4from the
socket.
ATTENTION: Never touch new halogen bulbs
with your fingers. Always use the original
packaging or a clean cloth.
• Carefully insert the new halogen bulb
(22.8V/50W).
• Re-assemble the lamp in reverse order
1 3
2
4
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Mach M3 Dr. Mach
Lamps and Engineering
4.3.2 Changing the dispersing lens
The dispersing lens is made of a high-quality plastic.
In case the dispersing lens looses its optical
characteristics, this can reduce the luminous
intensity and the light quality, which can be provided.
It may be necessary to exchange the dispersing
lens.
To change the dispersion lens proceed as follows:
Always place the dispersing lens on a soft, non-
scratching base to preserve its surface.
• Turn off the lamp.
• Remove the upper housing part of the lamp as
described in chapter 4.2.
ATTENTION: Parts of the housing may be
very hot immediately after use.
• Loosen the six screws 1at the bottom housing
part 2with a cross screw driver.
ATTENTION: Hold the dispersing lens 3 and
the retaining ring 4 while loosening the
screws 1, so the lens and the ring cannot fall
down.
• Remove the dispersing lens 3 and the retaining
ring 4 downwards.
• Replace the dispersing lens.
• Fix the dispersing lens and the retaining ring at
the bottom part of the lamp housing.
ATTENTION: Secure the screws 1 against
loosening with safety lake and adhesive at the
screw head.
1
2
1
1
2
3
4
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Mach M3 Dr. Mach
Lamps and Engineering
5. Data
5.1 Electrical data
Mach M3
Power consumption 150 W to max. 162 W, depending on design
Voltage AC/DC 22,8 V
Current 6,5 A to max. 7,1 A
Frequency 50 / 60 Hz
Degree of protection Type B
Class of protection I.
Standards IEC 601-1
5.2 Environmental conditions
Operation
Min. Max.
Temperature +10°C +40°C
Relative atmospheric humidity 30 % 75 %
Air pressure 700 hPa 1060 hPa
Transport / storage
Min. Max.
Temperature -10°C +50°C
Relative atmospheric humidity 20 % 90 %
Air pressure 700 hPa 1060 hPa
6. CE-mark
The products Mach M3 comply with the standards 93/42/EEC for medical products of the
European Community’s Council.
Dr. Mach GmbH is certified according to DIN EN 46001:1996 and DIN EN ISO 9001:1994
by TÜV München.
7. Disposal
The OT-lamp doesn’t contain any danger 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.
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Mach M3 Dr. Mach
Lamps and Engineering
8. Spare parts
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Mach M3 Dr. Mach
Lamps and Engineering
8. Spare parts - continuation
11 12 25
Bowden control
3938 37 36 35
Detail A
Detail A
40
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Mach M3 Dr. Mach
Lamps and Engineering
9. Spare parts list
Item Qty. Name EDVNO Remarks
1 1 Lower housing part for lamp without camera 20012204
2 1 Lower housing part for lamp with camera 20012205
3 1 Upper housing part 20011201
4 1 Turn-lock fastener 20088209
5 1 Locking washer 20088201
6 1 Locking sheet metal 20089208
7 1 Adjusting sheet metal 0,5 20088205 alternative
8 1 Adjusting sheet metal 1,0 20088206 alternative
9 1 Adjusting sheet metal 1,5 20088207 alternative
10 1 Adjusting sheet metal 2,0 20088208 alternative
11 1 Sterilisable handle 21150002
1 Coupling DF for sterilisable handle 20220001 DF-model
1 Coupling F for sterilisable handle 20220002 F-model
12
1 Coupling DF-M for sterilisable handle 20220003 DF-M-model
13 1 Cardanic suspension
14 1 Brake screw M12
15 1 Keypad OPLT DF/H-model
16 1 Keypad holder 21115003
17 1 Sealing cord RAL 5018 20088211
18 3 Reflector unit DF 20060001 DF-model
19 3 Reflector unit F 20060002
20 12 Fixing screw M3x16 DIN 912
with washer
65052012
21 3 Halogen bulb 22,8V 50W 67100201
22 3 Socket for halogen bulb 67320007
23 3 Knurled screw 28060213
24 2 Fuse 0,63 AT 5x20 67370003
25 1 Dimmer module OPDIM V3.0 24080001 Check version and
number
26 1 PCB board OPDX-M3 V0.10 67250101 Check version and
number
27 1 Gear motor 67030105
28 3 Filter disk 23250201
29 12 Spring holder 20086001
30 3 Retaining ring
31 18 Fixing screw M3x10 DIN 912
with lock washer
65052078
32 18 Washer 65512017
33 3 Dispersing lens 21200201
34 1 Acrylic glass box for transformer 300VA 67610101 Accessory
Bowden control
35 1 Primary shaft 20080201
36 1 Screw M3x6:Ni ULF 65052002
37 1 Screw M3x6 DIN 912,
turned-to-size head
28082203
38 1 Tension bolt 20080206
39 6 Cable holder 67900006
40 1 Round stranded rope 20080202
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Mach M3 Dr. Mach
Lamps and Engineering
10. Appendix
Setting the primary voltage at the
block transformer 300VA (extra)
Clamps on the transformer
Pos.1 earthing connection at the
transformer
Pos.2 primary side
Pos.3 secondary side
3
1
2
• 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
attachment” no. 59500001 / edition 05.
Overview of the possible settings of the primary voltage
Setting for115V
Setting for 132V
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