Dr. Mach Trigenflex R96 Manual

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 1/23
DIRECTIONS FOR USE
Trigenflex R96
Stand-Lamp ___________________________________ Order. No. 3502 3012 00
Wall-Lamp _____________________________________ Order. No. 3502 3021 00
Single-Ceiling-Lamp ____________________________ Order. No. 3502 3031 25
Order. No. 3502 3031 30
Ceiling-Lamps - Combinations
Dr. Mach GmbH u. Co., Flossmannstrasse 28, D-85560 Ebersberg
Tel.: [phone], Fax [phone]
Internet: www.dr-mach.com, E-mail: [email protected]

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 2/23
List of contents
1. Safety instructions ......................................................................................Page 3
2. Operating the lamp Trigenflex R96.............................................................Page 4
2.1 Checking the lamp Trigenflex R96 with light intensity control...............Page 4
2.2 ON/OFF switch, light intensity adjustment............................................Page 6
2.3 Positioning............................................................................................Page 7
2.4 Light field adjustment (merging of lightfields) .......................................Page 7
3. Cleaning .....................................................................................................Page 8
3.1 Sterilizable handle ................................................................................Page 8
3.2 Lamp head, splinter protection disk......................................................Page 8
4. Maintenance ...............................................................................................Page 9
4.1 Adjustments at the ceiling/ wall attachment..........................................Page 9
4.2 Adjustments at the stand model ...........................................................Page 10
4.3 Adjustments at the lamp head ..............................................................Page 10
4.4 Changing of spare parts .......................................................................Page 11
4.4.1 Changing the halogen bulbs .......................................................Page 11
4.4.2 Changing the fuses .....................................................................Page 12
4.4.3 Changing the filter disk................................................................Page 13
4.4.4 Changing the splinter protection disk ..........................................Page 13
5. Data............................................................................................................Page 14
5.1 Technical data ......................................................................................Page 14
5.2 Wiring ...................................................................................................Page 15
5.3 Environmental conditions .....................................................................Page 16
6. Marking.......................................................................................................Page 16
6.1 Specification of bulb .............................................................................Page 16
6.2 Specification of fuse .............................................................................Page 17
6.3 CE-mark ...............................................................................................Page 17
7. Disposal......................................................................................................Page 17
8. Spare parts .................................................................................................Page 18
8.1 Design with power supply 230V/120V ..................................................Page 18
8.2 Design with power supply 24V .............................................................Page 19
8.3 Swivel arm - stand model .....................................................................Page 19
8.4 Spare parts list .....................................................................................Page 20

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 3/23
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= 96.5 which had hitherto been unat-
tainable 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 R 96 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 product, you have acquired many of the latest developments in lighting technology and mechan-
ics in combination with more than 40 years of experience in manufacturing lights for operating theatres
and general medical use.
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 light is in perfect working order before use.

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 4/23
2. Operating the lamp Trigenflex 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.
2.1 Checking the lamp Trigenflex R96 with light intensity control
• Voltage measurement and setting
Before using the OT-lamps, a voltage measurement and, if necessary, a voltage setting has to be done.
Only in this way a perfect functioning can be ensured.
If the location of the lamp is changed, the voltage measurement and setting must be repeated.
♦ Voltage measurement at the halogen bulbs
To measure the voltage proceed as follows:
Mount the lamp to the ceiling or wall attachment.
Switch on the lamp.
In order to make the measurement remove the
cover. Remove the screw in the middle of the cover
and take off the cover.
The measuring points for checking the voltage are
in the same position on all Trigenflex-lamps.
The measuring points are shown in the figure.
At measuring points 1 + 2 measure the voltage
applied at the halogen bulbs. The lamp is set to
the maximum light intensity.
The AC or DC voltage depends on the external
power supply.
Rated voltage 22,8-23,8V.
Screw
Measuring points 3+4
♦ Voltage setting at the halogen bulbs
If the voltage measured is too high or too low, the
value must be adjusted at the power supply.
The setting at the transformer is made by recon-
necting the wires on the secondary side.
Measuring points 1+2
Measuring points 1+2

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 5/23
♦ Voltage measurement at the control board
Please check, whether the power supply is supplying AC or DC.
Voltage measurement at DC
Pay attention to the polarisation during the installation.
If the light intensity control does not function as desired, the PLUS- and MINUS-pole at the power
supply have to be changed.
Voltage measurement at AC
For installation at AC proceed as described below:
• Preparation
The lamp is already switched on. Set the lamp to
the lowest light intensity.
• Measurement
Measure the voltage at measuring points 3 + 4. The
voltage must be less than 40V DC.
If this value is exceeded, reset it as described be-
low:
Measuring points 3+4
♦ Voltage setting at the control board
Switch the lamp off.
The position of the control board is shown in the
figure.
Adjust the standard setting by changing the jump-
ers (see arrow).
Three settings enable you to ideally set your lamp
system (J4 and J5).
Take off one jumper and put it into position as
shown figure II. or III.
Switch on the lamp. Set the lamp to the lowest
light intensity.
Repeat the voltage measurement at measuring
points 3 + 4.
If the voltage is less than 40V DC, keep the chosen
setting.
J4 J5
Control board
J5 J5 J5
J4 J4 J4
I. II. III.
J5
J4

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 6/23
If you measure a voltage in excess of 40V DC, switch off the lamp.
Return the first jumper to the initial position.
Take off the second jumper and place it back on one of the two pins.
Switch on the lamp again. Finally repeat the voltage measurement. The voltage is now adjusted.
Close the lamp by replacing the cover.
2.2 ON/OFF switch,
light intensity adjustment
♦ Design for power supply 24V (Figure A)
Ceiling/ wall model
There are no ON/OFF switches on the lamp.
The customer must provide a two-pole ON/OFF switch
(see also point 5 of the mounting instructions).
Remark: In case of Trigenflex R96 lights for power
supply 24V there is no switch for two-step light inten-
sity adjustment.
♦ Toroid transformer design for
power supply 230V/120V AC (Figure B)
Ceiling/ wall model
The rocker switch 1switches the lamp ON and OFF.
The rocker switch 2adjusts the light intensity from
bright to dark.
A
B
21
♦ Stand model (Figure C)
The ON/OFF switch is in the counter
balance 3.
There are no ON/OFF switches on the
lamp.
C
3
ON/OFF

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 7/23
2.3 Positioning
♦ Ceiling/ wall model
For positioning use sterilizable handle 3.
Handle rail 4is used for adjusting the lights from
the outside.
The cardan bow 5is used for convenient, fully car-
danic adjustment of the lamp.
The cardan bow is delivered separately.
The coupling for the bow of the lamp body is fitted
with a needle bearing. The inner ring 6of this nee-
dle bearing has already been pushed onto the axis
of the lamp body bow.
♦ Stand model
For positioning use sterilizable handle 3.
Handle rail 4is used for adjusting the lights from
the outside.
For free-standing models, the bow of the lamp body
is directly coupled to the bracket 7. Neither part 5or
6are used in this case.
5
3 4
6
7 3 4
2.4 Light field adjustment
(merging of lightfields)
The lights Trigenflex R96 are equipped with the
function of lightfield-realignment.
That means, you can merge the separated light-
fields to one spot as shown in the figure.
To activate the merging of lightfields turn the han-
dle 3.
3

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 8/23
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 sterilisa-
tion:
• 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
8
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

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 9/23
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. eth-
ylene 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.

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 10/23
3
2
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 then 20% alco-
hol.
Wipe the splinter protection disks 3after cleaning
with an antistatic, non-fluffy cloth.
Alc. ≤20 %

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 11/23
4. Maintenance
The light 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
compensate 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
(clockwise) 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
-
+

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 12/23
4.2 Adjustments at the standmodel
♦ Swivel arm
You can fasten the move of the swivel arm 1by
adjusting lever 2.
1
2
3
4
5
2
1
4.3 Adjustments at the lamp head
♦ Adjusting the lamp bow
In case you notice that the light no longer remains
at its set position, it may be necessary to adjust the
lamp bow 5.
For adjusting proceed as follows:
• Turn off the light.
• 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 SW 14, or
loosen these nuts while at the same time holding
the screw slot 3in each case with a screw
driver.
• Once the adjustment has been made, place seal
4correctly on the housing lower part and posi-
tion the upper part of the lamp housing slightly
diagonally from one side so that the seal lies
cleanly around the circumference.
• Using a round object (drawing pin or small
screwdriver) lift the seal and lower the lamp
housing upper part until it sits evenly around the
whole circumference.
• Tighten using the raised countersunk screw 1.

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 13/23
32
1
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 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.
To change the halogen bulbs proceed as follows:
• Turn off the light.
• 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.
• Press outward security clip 2and turn shade-
holder 3down.
• Carefully remove the halogen bulb
(22,8-24V/50W) from its socket, change and re-
place.
• Replace shadeholder and 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 approx.
1200 hours without any deterioration in their
luminosity.
If after approx. 1/2 year of average use of 8 hours
daily one of the halogen light bulbs should fail, we
recommend that the whole set should be replaced.

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 14/23
1
4.4.2 Changing the fuses
♦ Ceiling/ wall/ stand model
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
customer.
♦ Ceiling/ wall model
Power supply with 230V/120V AC -
built in toroid transformer
The fuses in the lamp housing (in the toroid trans-
former design) prevent the transformer burning
through in the event of a short circuit.
Visible type 5x20/2,00A/250V/T for 230 V
Visible type 5x20/4,00A/250V/T for 120 V
If the bulb is no longer on, check the bulb first, then
the fuses.
To change the fuses proceed as follows:
• Turn off the light.
• Turn the black fuse holder 11/4 of a rotation
anticlockwise with a screwdriver.
• Change the fuses.
• Insert the fuse holder under slight pressure and
rotate in a clockwise direction (bayonet catch).
Pay attention to the instructions from the local
installer.
121
♦ Stand model
Power supply with 230V AC
The fuses are in the counter balance 2as shown in
the figure.
Visible type 5x20/2,00A/250V/T for 230 V
To change the fuses proceed as follows:
• Turn off the light.
• Turn the black fuse holder 11/4 of a rotation
anticlockwise with a screwdriver.
• Change the fuses.
• Insert the fuse holder under slight pressure and
rotate in a clockwise direction (bayonet catch).

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 15/23
8
7
6
4
3
2
5
4
1
5
4.4.3 Changing the filter disk
The dielectric filter disk between reflector and splin-
ter protection disk prevents a damaging heating of
the illuminated area.
The lamp may not be used without this filter
To change the filter disk proceed as follows:
• 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 4apart and replace the filter disk 5.
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.
To change the splinter protection disk proceed as
follows:
• 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 filter disk 5as described under 4.4.3.
• Loosen the three M3 nuts 2, remove retaining
spring 4and retaining ring 6.
• Replace splinter protection disk 7and lay stay
tube 8, retaining ring, retaining spring and clamp
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 4apart and
replace filter disk.
Only use filter disks which have been cleaned
accordingly.
• Replace disk bearer and fasten by turning the
three quick-release fasteners 1.

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 16/23
5. Data
5.1 Technical data
Design with 24 Volt
alternating current
rated voltage
rated current
frequency Hertz
fuse
class of protection
Design with 230 Volt
alternating current
primary side
secondary side
frequency Hertz
fuse
class of protection
Design with 120 Volt
alternating current
primary side
secondary side
frequency Hertz
fuse
class of protection

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 17/23
5.2 Wiring
Design with 24 Volt
22,8/24V
Design with 230 Volt
N
L0V
230V
1
23,5V
250V
1- two-step switch, depending on design
Design with 120 Volt
N
L0V
110V
1
23,5V
127V
1- two-step switch, depending on design

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
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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

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 19/23
6.2 Specification of fuse
Design with 24 Volt
The lights do not have fuses in the lamp housing.
Design with 230 Volt
Visible fuse 5x20
Delay action 2,00A
Design with 120 Volt
Visible fuse 5x20
Delay action 4,00A
6.3 CE-mark
The products Trigenflex R96 comply to the standards 93/42/EEC for medical products of
the European Community’s Council.
7. Disposal
The OT- light Trigenflex R96 does not contain any danger goods.
The components of the OT- light should be properly disposed at the end of their 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.

Trigenflex R96 Ceiling, Wall, Standmodel Dr. Mach
Lamps and Engineering
59230001 Edition 01 18.02.2002 / Bak Page 20/23
8. Spare parts
8.1 Design with 230/120 Volt - built in transformer (Ceiling/ wall model)
24
44
14
31
8
10
9
42
32
21
30
20
19
11
22
23
33
34
36,37,38
39,40
17,18
1
11
3
27
4,5,6,7
12,13
16
27
2829
325
45
47
49
50
52
48