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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