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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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
4. Maintenance
The lamp has 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 be
greased once a year with an acid-free grease.
4.1 Adjustments at the ceiling /
wall attachment
♦ Adjusting the spring arm
Note:
Maximum additional load at spring arms: Spring
arms are equipped with different springs to com-
pensate the lamp / device weight.
To adjust the spring force make sure that the spring
arm with the lamp / device can come to rest in any
desired position.
• A hole 1is located at the position marked by
detail X.
• Position the spring arm 2with the lamp / device
approximately 10° above horizontal.
• Insert Allan key (width 5, included in the scope of
supply) into the hole 1.
If the spring arm drops, the spring force is too low:
- Rotate the adjustment screw to the left (counter
clockwise) in the +direction.
If the spring arm rises, the spring force is too high:
- Rotate the adjustment screw to the right (clock-
wise) in the -direction.
If the spring arm with the lamp / device cannot
come to rest in any desired position after the
spring force has been adjusted, the springs must
be replaced by a service technician.
Hole 1
2
10°
X
Width 5
1
-
+
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
4.2 Adjustments at the stand
♦ Swivel arm
You can fasten the move of the swivel arm 1by ad-
justing lever 2.
♦ Adjusting the brake pins
Push the sliding sleeve 3backwards as shown in the
figure.
Tighten the brake pins 4M4 using a screwdriver
(turn clockwise).
1
23
4
4.3 Adjustments at the lamp head
♦ Adjusting the lamp bow
In case you notice that the lamp no longer remains at
its set position, it may be necessary to adjust the
lamp bow 4.
• Turn off the lamp.
• Unscrew the raised countersunk screw 1using a
cross screwdriver.
• Remove the upper part of the lamp housing.
• Screw the nuts 2on both sides a little tighter
using an open-ended or ring wrench SW14, or
loosen these nuts, while at the same time holding
the screw slot 3in each case with a screwdriver.
• Put the upper part of the lamp housing back on
the lower part of the lamp housing.
• Fix the upper part of the lamp housing with the
raised countersunk screw 1.
1
2
4
3
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
4.4 Changing of spare parts
4.4.1 Changing the halogen bulbs
Dr. Mach uses special halogen bulbs as illuminants.
Only original Dr. Mach spare bulbs may be used.
The use of other bulbs can lead to a considerable
reduction of the light power and increase in the ther-
mal load.
• Turn off the lamp.
• Rotate the three quick-release fasteners 1half a
turn anticlockwise so that the corresponding disk
bearer can be removed from the bottom part of
the lamp housing.
• Carefully remove the halogen bulb 2(22,8-
24V/40W) from its socket, change and replace.
• Replace the disk bearer onto the bottom part of
the lamp housing and rotate the quick-release
fasteners 1clockwise.
Do not touch the halogen bulb with naked hands!
Remove stains with a clean cloth and alcohol since
otherwise these can burn into the glass and lead to
early failures.
Attention:
The halogen bulbs have a service life of ap-
prox. 1200 hours without any deterioration in
their luminosity.
If after approx. six months of average use of 8 hours
daily one of the halogen bulbs should fail, we recom-
mend that the whole set should be replaced.
2
1
1
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
1
4.4.2 Changing the fuses
♦ Ceiling /wall /stand model,
emergency power lamp
Power supply with 24V AC/DC
In the case of designs for power supply with 24V
AC/DC the necessary fuses are provided by the cus-
tomer.
Pay attention to the instructions from the local
installer.
♦ Ceiling /wall model
Power supply with 230V/120V AC
Built in toroid transformer
The fuses in the lamp housing (toroid transformer
design) prevent the transformer burning through in
the event of a short circuit.
Visible type 5x20/1,25A/250V/T for 230V
Visible type 5x20/2,50A/250V/T for 120V
If the bulb is no longer on, check the bulb first, then
the fuses.
• Turn off the lamp.
• Turn the black fuse holder 1¼ of a rotation anti-
clockwise with a screwdriver.
• Change the fuses.
• Insert the fuse holder 1under slight pressure and
rotate in a clockwise direction (bayonet catch).
1,3 2 1,3
♦ Stand model
Power supply with 230V AC
The fuses 1are positioned in the counter balance 2
as shown in the figure.
Visible type 5x20/1,25A/250V/T for 230V
• Turn off the lamp.
• Turn the black fuse holder 3¼ of a rotation anti-
clockwise with a screwdriver.
• Change the fuses.
• Insert the fuse holder 3under slight pressure and
rotate in a clockwise direction (bayonet catch).
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
4.4.3 Changing the filter disk
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 this filter.
• Turn off the lamp.
• Rotate the three quick-release fasteners 1half a
turn anticlockwise so that the corresponding disk
bearer can be removed from the bottom part of
the lamp housing.
• Slightly loosen nuts 2, carefully bend the retain-
ing springs 3apart and replace the filter disk 4.
Only use filter disks which have been cleaned
accordingly.
4.4.4 Changing the splinter protection disk
In case the light quality is getting worse because of a
dull splinter protection disk, it may be necessary to
change the disk.
• Turn off the lamp.
• Rotate the three quick-release fasteners 1half a
turn anticlockwise so that the corresponding disk
bearer can be removed from the bottom part of
the lamp housing.
• Remove the filter disk 4as described under point
4.4.3.
• Loosen the three nuts 2, remove retaining spring
3 and retaining ring 5.
• Replace splinter protection disk 6and lay stay
tube 7, retaining ring and retaining spring in the
correct order on the disk bearer according to the
illustration.
• Place nuts 2onto the threaded bolts according to
the illustration and tighten.
• Carefully bend the retaining springs apart and
insert filter disk.
Only use splinter protection disks which have
been cleaned accordingly.
• Replace disk bearer and fasten by turning the
three quick-release fasteners 1.
4
2
3
5
6
7
1
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
5. Data
5.1 Technical data
Power supply with 24 Volt
alternating current
rated voltage
rated current
frequency Hertz
fuse
class of protection
Power supply with 230 Volt
alternating current
primary side
secondary side
frequency Hertz
fuse
class of protection
Power supply with 120 Volt
alternating current
primary side
secondary side
frequency Hertz
fuse
class of protection
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
5.2 Wiring
Power supply with 24 Volt
22,8/24V
Power supply with 230 Volt
N
L0V
230V
1
23,5V
250V
1– two-step switch (lamps with built in transformer only)
Power supply with 120 Volt
N
L0V
110V
1
23,5V
127V
1– two-step switch (lamps with built in transformer only)
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
5.3 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. Marking
Protective conductor
Switch “ON/OFF”
6.1 Specification of bulb
Voltage, power
Socket
Mode of operation
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
6.2 Specification of fuse
Power supply with 24 Volt
There are no fuses in the lamp housing.
Power supply with 230 Volt
Visible fuse 5x20
Delay action 1,25A
Power supply with 120 Volt
Visible fuse 5x20
Delay action 2,00A
6.3 CE-mark
The products Triaflex R96 comply to the standards 93/42/EEC for medical products of the
European Community’s Council.
7. Disposal
The OT-lamp Triaflex R96 does not 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 separated accordingly.
For disposal proceed as follows:
• PC-boards should be submitted to an appropriate recycling.
• The rest of the components should be disposed according to the contained materials.
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Triaflex R96 Ceiling, Wall, Stand Model Dr. Mach
Lamps and Engineering
8. Spare parts
8.1 Lamp head (Ceiling- /wall- /stand model, emergency power lamp)
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