Dr. Mach Lamps and Engineering

Transcription

1 Directions for use SOLOFLEX Stand lamp one-handed height adjustment Order No Stand lamp - swivel arm Order No Wall lamp Order No Ceiling lamp for room heights up to 2,50m Order No Ceiling lamp for room heights between 2,51m and 3,0m Order No Ceiling lamp - combinations GmbH u. Co., Flossmannstrasse 28, D Ebersberg Tel.: +49 (0) , Fax +49 (0) Internet: info@dr-mach.de Edition / Bak Page 1/22

2 List of contents 1. Safety instructions... Page 3 2. Operating the lamp Soloflex... Page ON/OFF switch, light intensity control... Page Positioning... Page Light field adjustment (focusing)... Page 5 3. Cleaning... Page Sterilizable handle... Page Lamp head, splinter protection disk... Page 8 4. Maintenance... Page Adjustments at the ceiling / wall attachment... Page Adjustments at the stand... Page Adjustments at the lamp head... Page Changing of spare parts... Page Changing the halogen bulbs... Page Changing the fuses (230V; 120V)... Page Changing the filter disk... Page Changing the splinter protection disk... Page Conversion to sterilizable handle... Page Data... Page Technical data... Page Environmental conditions... Page Characteristics... Page Specification of bulb... Page Specification of fuse... Page CE-mark... Page Disposal... Page Spare parts... Page Soloflex 230V/120V built in toroid transformer... Page Soloflex 22,8V external transformer... Page Short arm (stand model)... Page Swivel arm (stand model)... Page Spare part list... Page Edition / Bak Page 2/22

3 Dear customer! Please read the safety instructions and the directions for use carefully before handling the lamp. Pay attention to the special mounting instructions for ceiling and wall lights. 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. According to the Medical Device Regulation the lamp is classified under class I. 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 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. The lamp body may only be dismantled from the swivel arm (in reverse order to its assembly) after the assembly locking device has been inserted and tightened since the arm is under spring tension. Make sure that the lamp is in perfect working order before every use. The lamps Soloflex may not be used without the dielectric filter disk. The dielectric filter disk (blue) between reflector and splinter protection disk prevents a damaging heating of the illuminated area Edition / Bak Page 3/22

4 2. Operating the lamp Soloflex All Soloflex lamps are supplied with focusable light filed size and integrated dielectric filter disk. The reflector is adapted to the dielectric filter disk. The lamps are available as: Soloflex 22,8V / external transformer Soloflex 120V / integrated toroid transformer Soloflex 230V / integrated toroid transformer 2.1 ON/OFF switch, light intensity control The rocker switch 1 switches the lamp on and off. 1 2 The lamps with integrated toroid transformer are supplied with an additional rocker switch 2. The switch 2 adjusts the light intensity from bright to dark. At lamps with external transformer, in addition to the rocker switch 1, a two-pole switch ON/OFF must be provided by the customer. After finishing the work, and especially in the evening, both ON/OFF switches must be OFF Positioning Use the handle 3 to position the lamp. 6 5 There are two handle types available: Standard handle 3 The standard handle can be removed. Sterilizable handle 4 The sterilizable handle can be removed for sterilisation. It is fixed to the handle bar 6 by the coupling Edition / Bak Page 4/22

5 7 2.3 Light field adjustment (focusing) All Soloflex-lamps have a focusing function. That means, you can either enlarge the diameter of the light field or bundle the light to a smaller area, depending on the circumstances. To activate the function of focusing, turn the control knob 7 on the upper part of the lamp housing Edition / Bak Page 5/22

6 3. Cleaning V Sterilisable handle The removable handles for Soloflex lamps are steam-sterilisable and must be cleaned, disinfected and sterilised before first and subsequent use. The handle must be removed for sterilisation: to remove, press latch 1 and pull down the sterilisable handle 4 while the latch is pressed; to attach, push on and slightly twist the handle until the latch 1 engages securely. Handles often become unsterile during an OP; therefore always keep additional handles available for exchange. Cleaning / disinfection and sterilisation 4 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 Edition / Bak Page 6/22

7 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-Institut/DGHM). When using other procedures (e.g. a manual procedure), proof of 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). No cleaning agents/disinfectants must be used, which contain the following substances, as these may cause changes in the material: high-concentration organic and inorganic acids chlorinated hydrocarbons 2-ethoxyethanol When cleaning/disinfecting, the following procedures must be followed: Process Zone 1 Pre-rinse, external, cold, C 45 Washing, acidic, external, 35 C 120 Draining time 10 Re-rinse, external, ca. 80 C *10 Draining time *15 Re-rinse, external, ca. 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, C 200 Zone 4 Drying, external, C 200 Door open/close & transport 60 (sluice discharge) Time (sec.) Cycle time overall ca 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 for steam sterilisation and are ten 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 Edition / Bak Page 7/22

8 Steam sterilisation procedure Validated in accordance with DIN EN 554/ISO 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). When using other sterilisation procedures, proof of suitability and effectiveness in principle of the process must be provided within the scope of validation. 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 respiration hoses are re-used more than 1000 times, then this will be the responsibility of the hospital/clinic. 3.2 Lamp head, splinter protection disk The lamp has a high quality surface, which can be cleaned with conventional cleaning agents. The splinter protection disk 8 is made of a highquality plastic. Pay attention to the following during cleaning: - Wipe over the splinter protection disk 8 with a wet cloth (never use a dry cloth!). - Only use disinfectant with less than 20% alcohol. 8 Alc. 20 % Wipe the splinter protection disk 8 after cleaning with an antistatic, non-fluffy cloth Edition / Bak Page 8/22

9 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 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. X 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. 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 Adjustments at the stand Swivel arm 11 You can fasten the move of the swivel arm 10 by adjusting lever Edition / Bak Page 9/22

10 G Adjusting the brake pins Push the sliding sleeve 12 backwards as shown in the figure, by pressing the element G upwards with a screwdriver. Tighten the brake pins 13 M4 using a screwdriver (turn clockwise). One-handed height adjustment It is usually not necessary to adjust the spring force at stands with one-handed height adjustment. Stand for Mach 120 / 120F, Mach 115 and Makrolux ( 13,8mm) An adjustment of the spring force is not possible. AR SR II I Stand for Mach 130 / 130F and Soloflex design with short arm ( 22,8mm) Push the extension tube AR into the stand tube SR to the stop (I). Insert a screwdriver into the extension tube AR (II). Turn the screw inside the extension tube AR very carefully. A slight turn of the screw may change the height adjustment. 4.3 Adjustments at the lamp head 14 Manipulating the lamp The lamp bow 14 enables a perfect movability and positioning of the Soloflex lamps. The brake force in the axis 15 is set. It is usually not necessary to adjust it Edition / Bak Page 10/22

11 Changing of spare parts Changing the halogen bulb uses special halogen bulbs as illuminants. Only original replacement bulbs should 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 bulb proceed as follows: Loosen the knurled screw 16 on the side of the upper part of the lamp housing 17. Remove the lower part of the lamp housing 18. Draw halogen bulb 19 (22,8-24V/ 40W) carefully off its socket. Put in the new halogen bulb. Fix the lower part of the lamp housing 18 to the upper part of the lamp housing 17 using knurled screw 16. X 16 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. Remark: Einzelheit X 18 The halogen bulbs have a service life of approx hours without any deterioration in their luminosity Edition / Bak Page 11/22

12 4.4.2 Changing the fuses The fuses in the lamp housing (models with built in transformer only) prevent the transformer burning through in the event of a short circuit. Vsible type 5x20/0,63A/250V/t for 230V Visible type 5x20/1,25A/250V/t for 120V If the bulb is no longer on, check the bulb first, then the fuses. 31 To change the fuses proceed as follows: Turn the black fuse holder 31 ¼ of a rotation anticlockwise with a screwdriver and remove. Change the fuses. Insert the fuse holder 31 under light pressure and rotate in a clockwise direction (bayonet catch). In case of designs with external transformer or the lamp is connected to the 24V network, the fuses are provided by the customer. Pay attention to the instructions from the local installer Edition / Bak Page 12/22

13 4.4.3 Changing the filter disk The dielectric filter disk (blue) between reflector and splinter protection disk prevents a damaging heating of the illuminated area. The lamp may not be used without this filter. Y a 23 22b To change the filter disk proceed as follows: Loosen the knurled screw 16 on the side of the upper part of the lamp housing 17. Remove the lower part of the lamp housing 18. Loosen the three plastic nuts 20 on the lower part of the lamp housing 18. You can remove the filter disk 21 now. Change the filter disk 21. Replace nuts 20 according to the figure and tighten carefully by hand, so the filter disk 21 is not completely fixed. Fix the lower part of the lamp housing to the upper part of the lamp housing using knurled screw 16. Only use filter disks that have been cleaned properly. Detail X Detail Y X a Changing the splinter protection disk In case you notice a reduced light quality because of a dull splinter protection disk, it may be necessary to change the disk. To change the splinter protection disk proceed as follows: Remove the lower part of the lamp housing 18 as described at chapter Remove filter disk 21 as described at chapter Lift the first spacer ring 22a and remove it. Remove the three tubular rivets 23. Lift the second spacer ring 22b and remove it. Change splinter protection disk 24. Replace tubular rivets 23 and spacer rings 22a and 22b in reverse order according to the figure. Replace filter disk 21 as described at chapter Fix the lower part of the lamp housing 18 as described at chapter Only use splinter protection disks that have been cleaned properly. 22b Edition / Bak Page 13/22

14 Kabel Conversion to sterilizable handle For mounting the sterilizable handle proceed as follows: Turn off the lamp. Remove the standard handle: Loosen stop screw 25 and remove. Loosen wing nut 26 M10 and remove. Remove lamp bow 27. Caution: The inside cable keeps the lamp bow connected to the lamp housing. Notice the winding direction of the cable. Loosen two screws 28 M3x12 and remove. You can remove the standard handle 29 now. Mount the handle bar and coupling for the sterilizable handle: Extent of supply: - handle bar for sterilisable handle, completely pre-mounted - two screws M3x12 Put the handle bar 30 for sterilisable handle in the fixing boreholes on the lamp housing. Fix the handle bar with two screws 28 M3x12 (standard accessory). Replace the lamp bow 27. Caution: Insert the cable with the correct winding direction. Tighten wing nut 26 M10. Replace stop screw 25 and tighten Edition / Bak Page 14/22

15 5. Data 5.1 Technical data Design with 230 Volt ~ Wechselstrom alternating current Pr Primärseitig 230V / 0,21A primary side Sek Sekundärseitig 22,8V / 2,08A secondary side Hz Hertz-Frequenz 50 / 60Hz frequency Hertz Sicherung fuse Schutzgrad Typ B class of protection Design with 120 Volt ~ Wechselstrom alternating current Pr Primärseitig 120V / 0,42A primary side Sek Sekundärseitig 22,8V / 2,08A secondary side Hz Hertz-Frequenz 50 / 60Hz frequency Hertz Sicherung fuse Schutzgrad Typ B class of protection Design with 22,8 Volt (external transformer) ~ Wechselstrom alternating current Nennspannung 22,8V rated voltage Nennstrom 2,08A rated current Hz Hertz-Frequenz 50 / 60Hz frequency Hertz Schutzgrad Typ B class of protection Edition / Bak Page 15/22

16 5.2 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. Characteristics Protective conductor 6.1 Specification of bulb ON/OFF switch Voltage, power Socket Mode of operation 6.2 Specification of fuse Design with 230 Volt Visible fuse 5x20 Delay action 0,63A Design with 120 Volt Visible fuse 5x20 Delay action 1,25A Edition / Bak Page 16/22

17 Design with 22,8 Volt The Soloflex lamps with external transformer do not have any fuses in the lamp housing. 6.3 CE-mark The products Soloflex comply with the standard 93/42/EEC for medical products of the European Community s Council. 7. Disposal The lamp does not contain any danger goods. The components of the lamp should be properly disposed at the end of its shelf-life. Make sure, that the materials are carefully separated. For disposal proceed as follows: The lamp housing should be submitted to thermal disposal. The components should be disposed according to the contained materials Edition / Bak Page 17/22

18 8. Spare parts 8.1 Soloflex design with 230V;120V built in toroid transformer ,6, ,26 38, ,14 35,36, , Edition / Bak Page 18/22

19 8.2 Soloflex design with 22,8V external transformer Remark: For spare parts see lamp Soloflex design with 230V, except the toroid transformer, the fuses and the fuse holders. 8.3 Short arm (stand model) Swivel arm (stand model) , , Edition / Bak Page 19/22

20 9. Spare part list Item Qty. Name EDVNO Remark 01 1 Toggle joint complete alternate 02 1 Toggle joint complete alternate (2350) 03 1 Toggle joint complete only Pos Sliding contact (connector) Wing nut Washer Spring washer Handle Handle bar with coupling Handle sleeve, sterilisable Lamp housing with toroid transformer Lamp housing without toroid transformer Control knob with cover Reflector complete (metal sheet reflector) Focusing with toroid transformer Focusing without toroid transformer Lamp holder Halogen bulb 22,8V/50W Two-pole switch, illuminated ON/OFF Change-over switch STRONG/WEAK Single-pole switch ON/OFF Fuse holder Visible fuse 5x20/0,63A/250V/t /240V AC 37 2 Visible fuse 5x20/1,25A/250V/t /127V AC 38 1 Toroid transformer 60VA/prim. 220/240V AC/ sec. 22/24V AC 39 1 Toroid transformer 60VA/prim. 110/127V AC/ sec. 22/24V AC Lower part of lamp housing Nut Knurled screw Edition / Bak Page 20/22

21 Spare part list - continuation Item Qty. Name EDVNO Remark 47 2 Spacer ring Filter disk Tubular rivet Splinter protection disk Cover Housing Handle coupling Raised countersunk screw DIN 7985 HM4x10 4,8Ni 55 2 Lock washer A4,3 DIN 6797 Zn Brake bushing Semi-circular spring Countersunk screw DIN 966 HM3x12 4,8Zn Housing Block transformer 60VA Sliding bushing Sliding contact (pin) Sliding contact (plug) Washer A8,4 DIN 125 Zn Adjusting lever Thread pin DIN 551 M4x14 14H Change-over switch ON/OFF switch (illuminated) Fuse holder Edition / Bak Page 21/22

22 Edition / Bak Page 22/22