Dr. Mach Triaflex R96 Manual

Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
D
DI IR RE EC CT TI IO ON NS S F FO OR R U US SE E
T
Tr ri ia af fl le ex x R R9 96 6
Stand Lamp_____________________________________ Order No. 3002 3012 00
Wall Lamp ______________________________________ Order No. 3002 3021 00
Single Ceiling Lamp______________________________ Order No. 3002 3031 25
Order No. 3002 3031 30
Ceiling Lamps Combinations
Emergency Power Lamp __________________________ Order No. 3002 3015 00
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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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
List of contents
1. Safety instructions ......................................................................................Page 3
2. Operating the lamp Triaflex R96.................................................................Page 4
2.1 ON/OFF switch, light intensity adjustment............................................Page 4
2.2 Positioning............................................................................................Page 5
2.3 Lightfield adjustment (merging of lightfields) ........................................Page 7
3. Cleaning .....................................................................................................Page 8
3.1 Sterilizable handle ................................................................................Page 8
3.2 Lamp head, splinter protection disk......................................................Page 10
4. Maintenance ...............................................................................................Page 11
4.1 Adjustments at the ceiling-/wall attachment..........................................Page 11
4.2 Adjustments at the stand......................................................................Page 12
4.3 Adjustments at the lamp head ..............................................................Page 12
4.4 Changing of spare parts .......................................................................Page 13
4.4.1 Changing the halogen bulbs .......................................................Page 13
4.4.2 Changing the fuses .....................................................................Page 14
4.4.3 Changing the filter disk................................................................Page 15
4.4.4 Changing the splinter protection disk ..........................................Page 15
5. Data............................................................................................................Page 16
5.1 Technical data ......................................................................................Page 16
5.2 Wiring ...................................................................................................Page 17
5.3 Environmental conditions .....................................................................Page 18
6. Marking.......................................................................................................Page 18
6.1 Specification of bulb .............................................................................Page 18
6.2 Specification of fuse .............................................................................Page 19
6.3 CE-mark ...............................................................................................Page 19
7. Disposal......................................................................................................Page 19
8. Spare parts .................................................................................................Page 20
8.1 Lamp head ..........................................................................................Page 20
(Ceiling /wall /stand model, emergency power lamp)
8.2 Swivel arm – stand model ....................................................................Page 21
8.3 Spare parts list .....................................................................................Page 22
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
Dear customer!
Congratulations! You have just bought Dr. Mach’s newly developed light system R96. The outstanding
feature of this light system is its general colour rendition factor Ra=96 which had hitherto been unattain-
able for examination and surgery purposes. This means, that the colours are rendered naturally and in
full contrast, with a pleasant light around the operating site.
In particular, the differing red shades in the operating field can be recognised with accuracy. For the doc-
tor, this means considerably improved recognition of detail features in the operating site.
The light system R96 uses newly computer-optimised cold light filter which minimise unwanted heat
congestion in the head and reduce the radiation of heat onto the illuminated operating site.
With this lighting system you profit from a whole range of new developments, based on 50 years of ex-
perience in the production of operating and doctor's lights.
Please read the safety instructions and product description carefully before working with these
lights for the first time.
Please follow the separate mounting instructions for ceiling- and wall-mounted lamps, and for fitting the
stand foot and pipe.
1. Safety instructions
Please pay attention to the directions for use when handling the lamp.
Attention:
This device is not suitable for use in hazardous locations.
The lamp is classified as a Group 1 device according to the regulations for EEMP
Repairs to the lamp and special installation work on the reflector or plug-in socket
should only be carried out by ourselves or a company expressly authorised by our-
selves.
The manufacturer is only responsible for the safety of the lamp if repairs and altera-
tions have been carried out by themselves or a company who can guarantee that the
safety regulations have been observed.
The manufacturer is not liable for personal or material damages if the lamp is misap-
propriately or incorrectly operated or misused.
Make sure that the lamp is in perfect working order before use.
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
2. Operating the lamp Triaflex R96
The dielectric filter disk between reflector and splinter protection disk prevents a damaging heating of the
illuminated area.
The lamp may not be used without the dielectric filter disk.
1
2.1 ON/OFF switch,
light intensity adjustment
♦ Design for power supply 24V (fig. A)
Ceiling /wall model,
emergency power lamp
The rocker switch 1switches the lamp ON and OFF.
Additional to the rocker switch 1the customer must
provide a two-pole ON/OFF switch (see also point 5
of the mounting instructions).
Remark: In case of Triaflex R96 lamps for power
supply 24V there is no two-step light intensity ad-
justment.
23
♦ Design for power supply 230/120V AC
Built in toroid transformer (fig. B)
Ceiling /wall model
The rocker switch 2switches the lamp ON and OFF.
The rocker switch 3adjusts the light intensity from
bright to dark.
4
ON/OFF switch
ON/OFF switch
♦ Stand model (Fig. C)
The lamp is equipped with two
ON/OFF switches.
The switches are positioned on the
lamp head and on the counter bal-
ance 4.
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
2.2 Positioning
♦ Ceiling /wall model
For positioning use sterilizable handle 3.
The cardan bow 4is used for convenient, fully car-
danic adjustment of the lamp.
It is available as accessory.
It is only applicable in ceiling- and wall models. For
stand models this bow is not necessary.
♦ Full cardanic suspension (surcharge)
Mounting the cardan bow
Mounting overview
Pos. 1 – Cardan bow;
Pos. 2 – Securing sleeve;
Pos. 3 – Securing segment;
Pos. 4 – Securing screw M4x10 DIN 7985;
Pos. 5 – Serrated lock washer A4,3 DIN 6798
• Slide the securing sleeve pos. 2 onto the cardan
bow pos. 1.
• Insert the coupling journal of the lamp bow into
the receptacle of the cardan bow pos. 1.
4
3
5 4 3
2 1
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
• Insert the securing segment pos. 3.
• Tighten the four brake screws very carefully
with a slotted screw driver.
• Slide the securing sleeve pos. 2 forwards
and fix it with the securing screw pos. 4 and
the serrated lock washer pos. 5.
Check the easy-going movement of the
lamp.
♦ Stand model, emergency power lamp
For positioning use sterilizable handle 3.
For stand models, the bow of the lamp body is di-
rectly coupled to the bracket 5.
5
5
3
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
3
2.3 Lightfield adjustment
(merging of lightfields)
The lamps Triaflex R96 are equipped with the func-
tion of light field realignment.
That means, you can merge the separated lightfields
to one spot as shown in the figure.
To activate the merging of lightfields turn the steriliz-
able handle 3.
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Triaflex R96 Ceiling, Wall, Stand Model 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 ster-
ilisable. 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 ster-
ilisable 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; there-
fore 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 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
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Triaflex R96 Ceiling, Wall, Stand Model 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 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.
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
3.2 Lamp head, splinter protection disk
The lamp head 2has a high-quality surface, which
can be cleaned with conventional cleaning agents.
The splinter protection disks 3are made of a high-
quality plastic. Pay attention to the following during
cleaning:
- Wipe the splinter protection disks 3always with a
wet cloth. Do not wipe dry!
- Only use disinfectant with less than 20% alcohol.
Wipe the splinter protection disks 3after cleaning
with an antistatic, non-fluffy cloth.
2
3
Alc. ≤20 %
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