Dr. Mach Mach M2 Series Manual

Mach M2 Dr. Mach
Lamps and Engineering
Directions for use
MACH M2
Mach M2 ceiling-, wall- and stand model
Mach M2 F ceiling-, wall- and stand 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 M2 Dr. Mach
Lamps and Engineering
List of contents
1. Safety instructions ....................................................................................page 4
2. Operating the lamp MACH M2..................................................................page 5
2.1 Brief description of the lamp ...............................................................page 5
2.2 Turning the lamp ON/OFF..................................................................page 5
2.3 Positioning..........................................................................................page 5
2.4 Adjusting the light field .......................................................................page 6
3. Cleaning ...................................................................................................page 6
3.1 Sterilisable handle ..............................................................................page 6
3.2 Lamp housing and splinter protection disk .........................................page 8
4. Maintenance .............................................................................................page 9
4.1 Adjusting the mobility .........................................................................page 9
4.1.1 Settings at the lamp head............................................................page 9
4.2 Changing of spare parts .....................................................................page 9
4.2.1 Changing the halogen bulbs........................................................page 9
4.2.2 Changing the filter disk................................................................page 12
4.2.3 Changing the splinter protection disk ..........................................page 14
5. Data..........................................................................................................page 17
5.1 Technical data ....................................................................................page 17
5.2 Electrical data.....................................................................................page 18
5.3 Environmental conditions ...................................................................page 18
5.4 General remarks.................................................................................page 18
6. CE-mark ...................................................................................................page 18
7. Disposal....................................................................................................page 19
8. Spare parts ...............................................................................................page 20
8.1 Mach M2 F .........................................................................................page 20
8.2 Mach M2.............................................................................................page 21
9. Spare parts list..........................................................................................page 22
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Mach M2 Dr. Mach
Lamps and Engineering
Dear customer!
Congratulations for acquiring our new lamp MACH M2.
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 lights.
The lighting system is characterised by a previously unreceivable 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 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, wall and stand in-
stallation can be found in the mounting instructions.
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Mach M2 Dr. Mach
Lamps and Engineering
1. Safety instructions
Pay attention to the directions 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 roombefore
mounting, in order to eqal temperature differences.
Please read the instructions for use carefully to make the most of your lighting sys-
tem 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 guar-
anteed 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.
All lamps are equipped with heat protection filter.
It is not allowed to use the lamps without this filter! Do not remove the heat protec-
tion filter, otherwise risk of burn!
The lamp is to be dismatled from the spring arm in reverse order to its assembly
and is to be done only after securing the spring arm by a second person.
Make sure that the lamp is in perfect working order before every use.
Attention, external transformer!
The lamp works only with an external transformer.
The external transformer must be tested and validated according to IEC 60601-1,
otherwise it is not allowed to use it with Dr. Mach lamps.
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Mach M2 Dr. Mach
Lamps and Engineering
2. Operating the lamp MACH M2
2.1 Brief description of the lamp
The lamp MACH M2 is available in following versions:
- Mach M2, examination and small surgery lamp with fix-focus;
- Mach M2 F, examination and small surgery lamp with focusable light field.
2.2 Turning the lamp ON/OFF
The lamp is turned ON and OFF by the rocker
switch 1.
2.3 Positioning
Use the sterilisable handle 2or the handle 3at the
lamp housing the position the lamp.
Use the sterilisable handle 2 for positioning during
treatment. This handle can be removed for sterilisa-
tion.
1
3
2
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Mach M2 Dr. Mach
Lamps and Engineering
2.4 Adjusting the light field
(only Mach M2 F)
The lamps Mach M2 F have a focusing function.
That means, the diameter of the light field can ei-
ther be enlarged or bundled to a smaller area, de-
pending on the circumstances.
For adjusting the light field size turn the handle
2 at the lamp (see figure).
2
3. Cleaning
3.1 Sterilisable handle
At delivery the lamp is equipped with the handle 2.
The handle is removable and sterilisable. Before using
the first time and before every use the handle sleeve
must be cleaned, disinfected and sterilised.
The handle must be removed for sterilisation:
• To remove press the lock 4and pull off the ster-
ilisable handle 2while keeping the lock pressed.
• To attach, push on and slightly twist the handle
until the lock 4 engages securely.
Handles often become unsterile during an operation.
Therefore always keep aditional handles available for
exchange.
4
2
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Mach M2 Dr. Mach
Lamps and Engineering
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 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 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!
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Mach M2 Dr. Mach
Lamps and Engineering
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.
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 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.
3.2 Lamp head, splinter protection disk
The lamp has a high-quality surface. The surface
can be cleaned with conventional cleaning agents.
The splinter protection disk 5is made of a high-
quality plastic. Pay attention to the following during
cleaning:
• Always clean the splinter protection disk 5
with a wet cloth (never clean with a dry cloth!).
• Only use disinfectants with less than 20% al-
cohol.
Wipe the splinter protection disk 5 after cleaning
with an antistatic, non-fluffy cloth.
5
Alc. ≤20 %
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Mach M2 Dr. Mach
Lamps and Engineering
4. Maintenance
4.1 Adjusting the mobility
The lamp MACH M2 is supplied with brakes on the
suspension fixture and on the lamp housing. Adjust
these brakes, if necessary, after installation.
If it is difficult to move the lamp, or if it does not
keep its set position, the brake forces should be
adjusted.
Service and a check of the lamp should be made
every two years.
In order to keep the system easy-running through-
out its life span, we recommend that the hinges
should be greased avery two years with acid-free
grease.
Attention: Before dismounting the lamp, set the
height adjustment of the spring arm to horizon-
tal position (see mounting instructions “Ceiling
attachment – wall attchment”).
4.1.1 Adjustments at the lamp head
Adjusting the mobility in the lamp joint 6is not
necessary.
In case the mobility in the lamp joint 7 is too easy-
going or too heavy-going, the brake screw 8 must
be adjusted with an appropriate screw driver.
6
8
7
4.2 Changing of spare parts
4.2.1 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.
• Turn off the lamp.
ATTENTION: Parts of the housing and the ha-
logen bulb may be very hot immediately after
use.
• Turn the lamp, so the light outlet points to the
ceiling.
• Turn the screw 9 anticlockwise with an appro-
priate screw driver.
Remark:
In case there is no screw driver available, you
can use a coin.
9
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Lamps and Engineering
• By turning the screw 9 anticlockwise, the re-
taining ring 10 turns clockwise off the lower
housing part.
• Turn the screw 9 until the two marking arrows
on the ring of the light and the lower housing
part of the lamp match as shown in the figure.
• Then remove the retaining ring 10 by pulling it
upwards.
• Now you can see the open reflector 11 in front
of you.
ATTENTION: Do not touch the inner surface
of the reflector, otherwise this surface can
be damaged.
10
9
11
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Mach M2 Dr. Mach
Lamps and Engineering
• Tilt the shadower 12 off-center as shown in the
figure on the left, until it snaps in in the provided
groove.
• Pull the halogen bulb 13 carefully off its
socket.
ATTENTION: Never touch new halogen bulbs
with your fingers. Always use the original pack-
aging or a clean cloth.
• Carefully insert the halogen bulb (22,8V, 77W)
in the socket.
• Tilt the shadower 12 in its original position.
13
12
• Mount the retaining ring 10 in reverse order
(anticlockwise rotation).
For mounting position the retaining ring 10 so
that the toothed wheel segment 14 of the ring
and the toothed wheel 7 in the lower housing
part work into each other.
• Fix the retaining ring by turning the screw 9
clockwise.
• Check the function of the new halogen bulb.
14 10
9
15
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Mach M2 Dr. Mach
Lamps and Engineering
4.2.2 Changing the filter disk
The filter disk mounted between reflector and splin-
ter protection disk prevents a damaging heating of
the illuminated area.
ATTENTION!
It is not allowed to use the lamp without this
filter.
Always place the filter disk on a soft, non-
scratching base to preserve its surface.
• Turn off the lamp.
ATTENTION: Parts of the housing and the ha-
logen bulb may be very hot immediately after
use.
• Turn the lamp, so the light outlet points to the
ceiling.
• Turn the screw 9 anticlockwise with an appro-
priate screw driver.
Remark:
In case there is no screw driver available, you
can use a coin.
9
• By turning the screw 9 anticlockwise, the re-
taining ring 10 turns clockwise off the lower
housing part.
• Turn the screw 9 until the two marking arrows
on the ring of the light and the lower housing
part of the lamp match as shown in the figure.
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Mach M2 Dr. Mach
Lamps and Engineering
• Then remove the retaining ring 10 by pulling it
upwards.
10
9
• The filter disk 16 is held by six retainers 17,
which are fixed with six recessed head screws.
• Loosen the screws at three adjacent retainers
17.
• Lift the filter disk 16 carefully and pull it off the
other three retainers.
• Mount the new filter disk in reverse order.
ATTENTION: Only use filter disks, that have
been cleaned properly (see chapter 3.2).
17
16
16
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Mach M2 Dr. Mach
Lamps and Engineering
• Mount the retaining ring 10 in reverse order
(anticlockwise rotation).
For mounting position the retaining ring 10 so
that the toothed wheel segment 14 of the ring
and the toothed wheel 7 in the lower housing
part work into each other.
• Fix the retaining ring by turning the screw 9
clockwise.
14 10
9
15
4.2.3 Changing the dispersing lens
The dispersing lens is made of a high-quality plastic.
In case the dispersing lens looses its optical charac-
teristics, this can reduce the luminous intensity and
the light quality provided.
It may be necessary to exchange the dispersing
lens.
Always place the dispersing lens on a soft, non-
scratching base to preserve its surface.
• Turn off the lamp.
ATTENTION: Parts of the housing and the ha-
logen bulb may be very hot immediately after
use.
• Turn the lamp, so the light outlet points to the
ceiling.
• Turn the screw 9 anticlockwise with an appropri-
ate screw driver.
Remark:
In case there is no screw driver available, you
can use a coin.
9
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Mach M2 Dr. Mach
Lamps and Engineering
• By turning the screw 9 anticlockwise, the re-
taining ring 10 turns clockwise off the lower
housing part.
• Turn the screw 9 until the two marking arrows
on the ring of the light and the lower housing
part of the lamp match as shown in the figure.
• By turning the screw 9 anticlockwise, the re-
taining ring 10 turns clockwise off the lower
housing part.
• Remove the retaining ring 10 by pulling it up-
wards.
10
9
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Mach M2 Dr. Mach
Lamps and Engineering
• Loosen the six screws 18 and remove them.
• Lift the filter disk 17 off the six retainers 16.
Always place the filter disk on a soft, non-
scratching base to preserve its surface.
• Remove the six retainers 16.
• Remove the ring 20.
• Remove the splinter protection disk 19.
Always place the splinter protection disk on
a soft, non-scratching base to preserve its
surface.
• Mount the new splinter protection disk 19.
ATTENTION: Only use splinter protection
disks, that have been cleaned properly (see
chapter 3.2).
• Mount the ring 20, the retainers 16 and the
filter disk 17 in reverse order and fix the six re-
tainers with the screws 18.
18
17
16
20
19
• Mount the retaining ring 10 in reverse order
(anticlockwise rotation).
For mounting position the retaining ring 10 so
that the toothed wheel segment 14 of the ring
and the toothed wheel 7 in the lower housing
part work into each other.
• Fix the retaining ring by turning the screw 9
clockwise.
14 10
9
15
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Mach M2 Dr. Mach
Lamps and Engineering
5. Data
5.1 Technical data
Mach M2 F Mach M2
Central light intensity
at a distance of 1 meter 40.000 – 80.000 Lux 60.000 Lux
Light field diameter d10 160 mm 170 mm
Light field diameter d50 90 mm 110 mm
Light intensity with one shadower 125 Lux 45 Lux
Light intensity with two shadowers 47.000 Lux 35.000 Lux
Light intensity on the ground of a
normed tube 79.200 Lux 59.600 Lux
Light intensity on the ground of a
normed tube with one shadower 85 Lux 30 Lux
Light intensity on the ground of a
normed tube with two shadowers 46.000 Lux 34.500 Lux
Illumination depth 1600 mm 1600 mm
Colour rendering index Ra
at 4300 Kelvin 96 96
Colour rendering index R9
at 4300 Kelvin > 90 > 90
Focusable light field size 140 – 240 mm 180 mm Fixfocus
Colour temperature (Kelvin) 4300 4300
Radiation intensity in field 130 W/m2130 W/m2
Temperature increase in head area 2 °C 2 °C
Total power consumption 80 VA 80 VA
Number of bulbs:
Halogen 22,8/24V 80W 1 1
Working distance 700 – 1400 mm 700 – 1400 mm
Height adjustment 1300 mm 1300 mm
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Mach M2 Dr. Mach
Lamps and Engineering
5.2 Electrical data
Mach M2 F / Mach M2
Power consumption 80 W
Voltage AC/DC 22,8 V
Current 3,5 A
Halogen bulb 22,8 V / 80 W IRC
Frequency 50/60 Hz
Degree of protection Type B
Class of protection I.
5.3 Environmental conditions
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
5.4 General remarks
When installing a 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 M2 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.
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Mach M2 Dr. Mach
Lamps and Engineering
7. Disposal
The 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 components should be disposed according to the contained materials.
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Mach M2 Dr. Mach
Lamps and Engineering
8. Spare parts
8.1 Mach M2 F
1
9
10
11
3
12
2
4
5
6
7
8
13
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