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DIRECTIONS FOR USE Triaflex Stand lamp Order No. 3001 1012 00 Wall lamp Order No. 3001 1021 00 Single ceiling lamp Order No. 3001 1031 25 Order No. 3001 1031 30 Ceiling lamps combinations Emergency power lamp Order No. 3001 1015 00 GmbH u. Co., Floßmannstrasse 28, D-85560 Ebersberg Tel.: +49 (0)8092 2093 0, Fax +49 (0)8092 2093 50 Internet: www.dr-mach.com, E-mail: info@dr-mach.de 59220002 Edition 08 14.08.2007 / Bak Page 1/24

List of contents 1. Safety instructions...page 3 2. Operating the lamp Triaflex R86...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 Sterilisable 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 part list...page 22 59220002 Edition 08 14.08.2007 / Bak Page 2/24

Dear customer! 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 stand tube. 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 authorized by ourselves. The manufacturer is only responsible for the safety of the lamp if repairs and alterations 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 misappropriately or incorrectly operated or misused. Make sure that the lamp is in perfect working order before use. 59220002 Edition 08 14.08.2007 / Bak Page 3/24

2. Operating the lamp Triaflex 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. 2.1 ON/OFF switch, light intensity adjustment Design for power supply 24V (fig. A) Ceiling-/wall model, emergency power lamp The rocker switch 1 switches the lamp ON and OFF. Additional to the rocker switch 1 the customer must provide a two-pole ON/OFF switch. Remark: In case of Triaflex R86 lamps for power supply 24V there is no two-step light intensity adjustment. 1 Design for power supply 230/120V AC Built in toroid transformer (fig. B) Ceiling-/wall model The rocker switch 2 switches the lamp ON and OFF. The rocker switch 3 adjusts the light intensity from strong to weak. 2 3 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 balance 4. ON/OFF switch 4 59220002 Edition 08 14.08.2007 / Bak Page 4/24

2.2 Positioning 4 Ceiling-/wall model For positioning use sterilisable handle 3. The cardan bow 4 is used for convenient, fully cardanic adjustment of the lamp. It is available as extra accessory. It is only applicable in ceiling- and wall models. For stand models this bow is not necessary. 3 Full cardanic suspension (surcharge) Mounting the cardan bow 5 4 3 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 2 1 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. 59220002 Edition 08 14.08.2007 / Bak Page 5/24

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 sterilisable handle 3. For stand models, the bow of the lamp body is directly coupled to the bracket 5. 5 3 59220002 Edition 08 14.08.2007 / Bak Page 6/24

2.3 Lightfield adjustment Merging of light fields (available as accessory) 3 The lamps Triaflex R86 offer the function of lightfield adjustment (merging of lightfields) as extra accessory. That means, you can merge the separated lightfields to one spot as shown in the figure. To activate the merging of lightfields turn the sterilisable handle 3. 59220002 Edition 08 14.08.2007 / Bak Page 7/24

3. Cleaning 3.1 Sterilisable handle 1 V 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 1 while 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. 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 59220002 Edition 08 14.08.2007 / Bak Page 8/24

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 sterilisation 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. ethylene 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 vacuum 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. 59220002 Edition 08 14.08.2007 / Bak Page 9/24

2 3.2 Lamp head, splinter protection disk The lamp head 2 has a high-quality surface, which can be cleaned with conventional cleaning agents. The splinter protection disks 3 are made of a highquality plastic. Pay attention to the following during cleaning: - Wipe the splinter protection disks 3 always with a wet cloth. Do not wipe dry! - Only use disinfectant with less than 20% alcohol. Wipe the splinter protection disks 3 after cleaning with an antistatic, non-fluffy cloth. 3 Alc. 20 % 59220002 Edition 08 14.08.2007 / Bak Page 10/24

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. Hole 1 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. 2 A hole 1 is located at the position marked by detail X. Position the spring arm 2 with the lamp / device approximately 10 above horizontal. Insert Allan key (width 5, included in the scope of supply) into the hole 1. X 1 10 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. Width 5 59220002 Edition 08 14.08.2007 / Bak Page 11/24

1 4.2 Adjustments at the stand Swivel arm 2 You can fasten the move of the swivel arm 1 by adjusting lever 2. 4 3 Adjusting the brake pins Push the sliding sleeve 3 backwards as shown in the figure. Tighten the brake pins 4 M4 using a screwdriver (turn clockwise). 4.3 Adjustments at the lamp head Adjusting the lamp bow 8 5 6 7 In case you notice that the lamp no longer remains at its set position, it may be necessary to adjust the lamp bow 8. Turn off the lamp. Unscrew the raised countersunk screw 5 using a cross screwdriver. Remove the upper part of the lamp housing. Screw the nuts 6 on 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 7 in 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 5. 59220002 Edition 08 14.08.2007 / Bak Page 12/24

1 2 4.4 Changing of spare parts 4.4.1 Changing the halogen bulbs uses special halogen bulbs as illuminants. Only original spare bulbs may be used. The use of other bulbs can lead to a considerable reduction of light power and increase in the thermal load. Turn off the lamp. Rotate the three quick-release fasteners 1 half 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 1 clockwise. 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. six months of average use of 8 hours daily one of the halogen bulb should fail, we recommend that the whole set should be replaced. 59220002 Edition 08 14.08.2007 / Bak Page 13/24

4.4.2 Changing the fuses Ceiling /wall /stand model, emergency power lamp Power supply with 24V AC/DC In case of designs for power supply with 24V AC/DC the necessary fuses are provided by the customer. 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 (designs with built in toroid transformer) prevent the transformer burning through in the event of a short circuit. Visible type 5x20/1,25A/250V/T for 230V Visible type 5x20/2,00A/250V/T for 120V If the bulbs are no longer on, check the bulbs first, then the fuses. Turn off the lamp. Turn the black fuse holder 1 ¼ of a rotation anticlockwise with a screwdriver. Change the fuses. Insert the fuse holder 1 under slight pressure and rotate in a clockwise direction (bayonet catch). 1 Stand model Power supply with 230V AC The fuses 1 are positioned in the counter balance 2 as shown in the figure. 1,3 2 1,3 Visible type 5x20/1,25A/250V/T for 230V To change the fuses proceed as follows: Turn off the lamp. Turn the black fuse holder 3 ¼ of a rotation anticlockwise with a screwdriver. Change the fuses. Insert the fuse holder 3 under slight pressure and rotate in a clockwise direction (bayonet catch). 59220002 Edition 08 14.08.2007 / Bak Page 14/24

1 4 2 3 5 6 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 1 half 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 retaining springs 3 apart and change 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 1 half a turn anticlockwise so that the corresponding disk bearer can be removed from the bottom part of the lamp housing. Remove the filter disk 4 as described at chapter 4.4.3. Loosen the three nuts 2, remove retaining spring 3 and retaining ring 5. Replace splinter protection disk 6 and lay stay tube 7, retaining ring and retaining spring in the correct order on the disk bearer according to the illustration. Place nuts 2 onto the threaded bolts according to the illustration and tighten. Carefully bend the retaining springs apart and insert the 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. 7 59220002 Edition 08 14.08.2007 / Bak Page 15/24

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 59220002 Edition 08 14.08.2007 / Bak Page 16/24

5.2 Wiring Power supply with 24 Volt 22,8/24V Power supply with 230 Volt N 1 250V 230V 23,5V L 0V 1 two-step switch (lamps with built in transformer only) Power supply with 120 Volt N 1 127V 110V 23,5V L 0V 1 two-step switch (lamps with built in transformer only) 59220002 Edition 08 14.08.2007 / Bak Page 17/24

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 59220002 Edition 08 14.08.2007 / Bak Page 18/24

6.2 Specification of fuse There are no fuses in the lamp housing Power supply with 24 Volt 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 R86 comply to the standards 93/42/EEC for medical products of the European Community s Council. 7. Disposal The OT-lamp Triaflex R86 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. PC-boards should be submitted to an appropriate recycling. The rest of the components should be disposed according to the contained materials. 59220002 Edition 08 14.08.2007 / Bak Page 19/24

8. Spare parts 8.1 Lamp head (Ceiling- /wall- /stand model, emergency power lamp) 59220002 Edition 08 14.08.2007 / Bak Page 20/24

Remark: The lamps Triaflex R86 with power supply for 24V do not have a built in transformer, do not have fuses in the lamp head and no change-over switch at the lamp head. For spare parts see point 8.1 8.2 Swivel arm (stand model) 54 53 55 56 57 58 43 59 65 60 61 30,31 62,63,6 4 5x20 T1.25 A 34,35 59220002 Edition 08 14.08.2007 / Bak Page 21/24

8.3 Spare part list Item Qty. Name EDVNO Remarks 01 1 Lamp bow complete, standard 22100002 alternate 02 1 Lamp bow complete, 90 turned 22101002 alternate 03 Sliding contact (pin) 22102003 04 2 Bolt 22080203 05 2 Corrugated washer DIN 137 A10 FSt Zn 65542002 06 2 Pressure washer 07011204 07 2 Hexagonal nut M10x1 DIN439 67900001 08 1 Sterilisable handle sleeve 21150002 09 10 1 Handle coupling fix-focus 45080201 Plastic 10 1 Handle coupling 45080203 Aluminium 11 12 1 Housing lower part for toroid transf. without focus 22012011 13 1 Housing lower part for toroid transf. with focus 22012010 14 1 Housing lower part for ext. transf. without focus 22012009 15 1 Housing lower part for ext. transf. with focus 22012012 16 1 Upper housing part 22011201 17 1 Raised countersunk screw DIN 966 HM4x12 4,8Ni 65112007 18 1 Washer 22080206 19 20 3 Reflector unit complete 22060001 21 3 Reflector 22060201 22 3 Clip 74011003 23 24 1 Cardan bow, complete 22110001 special tool 25 26 27 3 Socket with cable length 140mm 67320005 28 3 Halogen bulb 22,8V 40W 67100101 29 30 1 Two-pole illuminated ON/OFF switch 67340002 int. transformer 31 1 Change-over STRONG/WEAK 67340001 int. transformer 32 1 Single pole ON/OFF switch 67340004 ext. transformer 33 34 2 Fuse holder 67370001 35 2 Visible fuse 5x20 1,25A/250V/t 67370004 power supply 230V 36 2 Visible fuse 5x20 2,0A/250V/t 67370005 power supply 120V 37 1 Toroid transformer 22051001 130VA prim. 230V AC/ sec. 22/24V AC 38 1 Toroid transformer 67010111 130VA prim. 120V AC/ sec. 22/24V AC 39 Central-axle compl. for toroid transf. without focus 22050004 40 1 Central-axle compl. for toroid transf. with focus 22050001 41 Central-axle compl. for ext. transf. without focus 22050003 42 1 Central-axle compl. for ext. transf. with focus 22050002 43 1 Block transformer 120VA 67010202 Swivel arm 44 3 Disk bearer complete 22160002 45 3 Disk bearer ring with quick-release fastener 22161001 46 9 Stay tube 65702003 47 3 Splinter protection disk 07200201 59220002 Edition 08 14.08.2007 / Bak Page 22/24

Item Qty. Name EDVNO Remarks 48 3 Dielectric filter disk 07250201 49 3 Retaining ring 07012202 50 9 Retaining spring 23160201 51 52 9 Nut M3 DIN 934 65332002 53 1 Raised head screw DIN 7985 HM4x10 4,8Ni 65152010 54 2 Lock washer A4,3 DIN 6797 Zn 65582004 55 1 Brake ring 53220206 56 1 Semi-circular spring 74011001 57 1 Countersunk screw DIN 966 HM3x12 4,8Zn 65112009 58 1 Housing 53220202 59 1 Sliding sleeve 53070208 60 1 Sliding contact (receptacle) 53223001 61 1 Sliding contact (pin) 53222002 62 1 Washer A8,4 DIN 125 Zn 65512008 63 2 Brake disk 53230202 64 1 Adjusting lever 74503002 65 4 Thread pin DIN 551 M4x14 14H 65212002 66 1 Acrylic glass box for transformer 120VA Not shown 59220002 Edition 08 14.08.2007 / Bak Page 23/24

59220002 Edition 08 14.08.2007 / Bak Page 24/24