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Operating instructions - Frank's Hospital Workshop

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1. e Carefully insert the new _ halogen bulb 22 8V S0W e Re assemble the lamp in reverse order Edition 06 28 11 2002 Bak page 14 22 Mach M3 99200001 Dr Mach Lamps and Engineering 4 3 2 Changing the dispersing lens The dispersing lens is made of a high quality plastic In case the dispersing lens looses its optical characteristics this can reduce the luminous intensity and the light quality which can be provided It may be necessary to exchange the dispersing lens To change the dispersion lens proceed as follows Always place the dispersing lens on a soft non scratching base to preserve its surface e Turn off the lamp e Remove the upper housing part of the lamp as described in chapter 4 2 ATTENTION Parts of the housing may be very hot immediately after use e Loosen the six screws 1 at the bottom housing part 2 with a cross screw driver ATTENTION Hold the dispersing lens 3 and the retaining ring 4 while loosening the screws 1 so the lens and the ring cannot fall down e Remove the dispersing lens 3 and the retaining ring 4 downwards e Replace the dispersing lens e Fix the dispersing lens and the retaining ring at the bottom part of the lamp housing ATTENTION Secure the screws 1 against loosening with safety lake and adhesive at the screw head Edition 06 28 11 2002 Bak page 15 22 Mach M3 Dr Mach Lamps and Engineering 5 Data 5 1 Electrical data Mach M3 Power consump
2. position the lamps Use the handle rail to position the lights before the operation Use the sterile handle for positioning during the operation This handle can be removed for sterilization The working distance of the F lamps is 0 m to 1 4m The working distance of the DF lamps is 0 6m to 1 5m The handle is supplied with a detectable mechanical catching When the handle catches in this position the lamp is optimally set for a working distance of 1 meter Two or more lamps can be used for an intensive illumination of large operation fields It is also possible to illuminate two operation fields simultaneously 59200001 Edition 06 28 11 2002 Bak page 9 22 Mach M3 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 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 e To remove press the lock V and pull off the sterilisable handle sleeve 1 while keeping the lock pressed e 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 req
3. we recommend that the hinges should be greased once a year with acid free grease When adjusting the brakes or the hinges at the ceiling attachment please consult the mounting instructions Ceiling attachment with heavy central axis or Ceiling wall attachment Upper housing part 99200001 4 1 Adjustments at the lamp head The fine adjustment for handling the lamps can be carried out at points 2 and 3 To adjust the brakes use a screw driver with appropriate size If you cannot adjust the brakes at points 2 and 3 anymore as tight as necessary you will have to replace them Remark In order to adjust brake 2 the upper housing part must be removed Edition 06 28 11 2002 Bak page 12 22 Mach M3 Dr Mach Lamps and Engineering 4 2 Removing the upper housing part The upper housing part can be removed by turning the turn lock fastener 8 The upper housing part has two markings 6 Lock and 5 Up The notch 7 at the turn lock fastener 8 shows the open or close status of the upper housing part Turn the turn lock fastener 8 to the left over the marking 5 until stop and hold it in this position Lift the upper housing part with the other hand at the cardanic suspension 9 and remove it uniformly Be careful when removing the upper housing part do not damage the sealing profile 10 Mount the upper housing part in reverse order Turn the turn lock fastener 8 again to the left over the marking 5
4. Mach M3 Dr Mach Lamps and Engineering Operating instructions MACH M3 Mach M3 stand lamp F F H DF DF H model Mach M3 emergency stand lamp F F H DF DF H model Mach M3 wall lamp F F H DF DF H model Mach M3 ceiling lamp for room heights up to 2 8m F F H DF DF H model Mach M3 ceiling lamp for room heights between 2 8m 3m F F H DF DF H model Dr Mach GmbH u Co Flo mannstrasse 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 99200001 Edition 06 28 11 2002 Bak page 1 22 Mach M3 Dr Mach Lamps and Engineering List of contents dec DANE LY IMSUUCTIONS cererii n en Ee E Stat cet Sta temetacath sat Gtationatats page 4 2 Operating the lamp MACH MB cccccceccceecceecceeeeeeeaeeeseeeeeeeeeeseeeaeeeaes page 5 2 1 Brief description Of the lamp reniris page 5 2 1 1 Merging of light fields F model cccccccseceeeeeseeeeeeeeeeeeneees page 5 212 FOCUSING DF model resserre tonics tei alestcaletaddasdasaleedleneteeln page 5 2 1 3 Light intensity control H moOdel cccccccseeecseeeseeeeeeeeeeeneees page 5 2 2 Adjusting the illuminated area DY c ce cecc eee eeceeeeeeseeeeeeseeseeeeeeees page 6 merging of light fields for F and F H models 2 3 Adjusting the illuminated area DY ccc cceccecceeeceeeeeeseeeeeeseeseeeeeeees page 6 merging of light fields and foc
5. a 20012204 2 1 Lower housing part for lamp with camera 20012205 3 1 Upperhousingpart 20011201 4 1 Turnock fastener CST 20088209 5 1 Locking washer ST 20088201 6 1 Locking sheet metal _ 20089208 8 1 Adjusting sheet metal 1 0 20088206 alternative 9 1 Adjusting sheet metal 1 5 20088207 alternative 11 14 _ Sterilisable hande _ 21150002 12 1 Coupling F for sterilisable handle 20220002 F model 13 1 Cardanic suspension Brake screw M12 _ oo o Keypad OPLT CT SC DF H moocd 16 1 Keypad holder 21115003 17 1 Sealing cord RAL 5018 20088211 18 3 Reflector unit DF 20060001 DF model Reflector unit F 20060002 20 12 Fixing screw M3x16 DIN 912 65052012 n a Pe 21 3 Halogen bulb 22 8V 50W _ __ 67100201 22 3 Socket for halogen bulb 67320007 23 3 Knurled screw 28060213 24 2 Fuse0 63 AT5x20 67370003 gt 25 1 Dimmer module OPDIM V3 0 24080001 Check version and number 26 1 PCB board OPDX M3 V0 10 67250101 Check version and number 27 1 Gearmotor 7080105 PO 28 3 Filterdisk 28250201 S 29 12 _ Spring holder 20086001 30 3 Retainingring S o S 31 18 Fixing screw M3x10 DIN 912 65052078 with lock washer a E Washer Dispersing lens Acrylic glass box for transformer 300VA owden control Primary shaft 20080201 36 1 Screw M3x6 Ni ULF 605202 turned to size head 38 1 Tension bott 2080206 39 6 Cable hold
6. cess Euroselectomat 666 by MMM M nchner 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 99200001 Edition 06 28 11 2002 Bak page 11 22 Mach M3 Dr Mach Lamps and Engineering 3 2 Lamp housing dispersing lens and support system The OT lamp MACH M3 has a high quality surface which can be cleaned with conventional cleaning agents The lens system 2 is made of a high quality plastic ee attention to the following during cleaning Never wipe over the lens system 2 with a dry cloth always clean with a wet cloth Only use disinfectants with less than 20 alcohol Wipe the lens system 2 after cleaning with an antistatic non fluffy cloth 4 Maintenance MACH lamps are supplied with brakes on the suspension fixture and on the lamp housing Adjust these brakes as necessary after installation If the lamp is difficult to move or if it does not stay in position the brake forces should be adjusted The lamps and suspension fixtures have been designed and built so that regular maintenance intervals are not necessary In order to keep the system easy running throughout its life soan
7. er 67900006 gt gt Round stranded rope 2080202 59200001 Edition 06 28 11 2002 Bak page 19 22 Mach M3 Dr Mach Lamps and Engineering 10 Appendix Setting the primary voltage at the block transformer 300VA extra Clamps on the transformer Pos 1 earthing connection at the transformer Pos 2 primary side Pos 3 secondary side e Connect the transformer to earth Use the provided clamps pos 1 at the transformer respectively at the transformer plate See also the explanations on page 19 46 of the mounting instructions Ceiling and wall attachment no 59500001 edition 05 Overview of the possible settings of the primary voltage Setting for115V Setting for 132V eee 2e es8e 6 S es o o o S70 OG G5 Gp Gy 7 AGE E e TA K SZ Z zpi 59200001 Edition 06 28 11 2002 Bak page 20 22 Mach M3 Dr Mach Lamps and Engineering Setting for 230V Setting for 247V 59200001 Edition 06 28 11 2002 Bak page 21 22 Mach M3 Dr Mach Lamps and Engineering 99200001 Edition 06 28 11 2002 Bak page 22 22
8. ince the arm is under spring tension Make sure that the lamp is in perfect working order before every use Attention external transformer The lamp works only with an external transformer 300VA The external transformer Order No 6701 0208 must be tested and validated according to IEC 60601 1 If the external transformer is not tested and validated according to IEC 60601 1 it is not allowed to use it with Dr Mach OT lamps 99200001 Edition 06 28 11 2002 Bak page 4 22 Mach M3 Dr Mach Lamps and Engineering 2 Operating the lamp MACH M3 2 1 Brief description of the lamp The OT lamp MACH M3 is available in following versions Standard OT lamp F with merging of light fields Duo Focus OT lamp DF with merging of light fields and focusing F or DF lamps with light intensity control H 2 1 1 Merging of light fields F model The F model offers light field adjustment by merging the individual light fields of each reflector by swivelling them NOTE This feature is activated by turning the sterilisable handle 2 1 2 Focusing DF model The DF model offers a second additional facility to further adjust the illuminated field to an extra small or extra large size depending on the specific requirements by focusing through moving the bulbs up or down NOTE This feature is activated by turning the e ring at the top of the sterilisable handle 2 1 3 Light intensity control H model The OT lam
9. lowing procedures must be followed re Fri Pre rinse external cold 10 15 C Washing acidic external 35 C Draining time Re rinse external approx 80 C Draining time Re rinse external approx 80 C Draining time Washing alkaline external 93 C Draining time Re rinse external acidic 90 C Draining time Re rinse external 90 C Draining time Zone 3 Drying external 100 120 C Drying external 100 120 C 200 Door open close amp transport 60 sluice discharge Cycle time overall ca 290 x 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 pro
10. p models offer an optional feature the light intensity control You can adjust the light intensity between 50 and 100 according to your requirements 59200001 Edition 06 28 11 2002 Bak page 5 22 Mach M3 Dr Mach Lamps and Engineering 2 2 Adjusting the illuminated area by merging the light fields for F and F H models All F and F H lamp models offer the feature of merging the light fields This feature is activated by turning the sterilisable handle 1 Remark The ring 2 has no function here 2 3 Adjusting the illuminated area by merging the light fields and focusing Duo Focus system for DF and DF H models DF and DF H models also have a focusing function Duo Focus The combination of merging of light fields and focusing Duo Focus system enables the ideal adjustment of the light field to the wound area in a range from 8 cm to 35 cm diameter Such a large range of adjustment is not possible with conventional technique To activate the focusing function turn the adjusting ring 2 on the handle or if the lamp is equipped with a keypad at the cardan bow for DF H models press touch buttons 5 6 Press touch button 5 to expand the focus and touch button 6 to bundle the light on a minimum area The current focused diameter is shown in the LED display 4 Dr Mach assisiance iine 59200001 Edition 06 28 11 2002 Bak page 6 22 Mach M3 Dr Mach Lamps and Engineering 2 4 Overview of
11. ri nI page 19 10 Appendix Setting the primary voltage at the block transformer SOOVA extra 2 cee cecceecc cece eeeceeeeeeeeeeeeeeseeeseeeseeseeeseesseeteeeseeegs page 20 99200001 Edition 06 28 11 2002 Bak page 2 22 Mach M3 Dr Mach Lamps and Engineering Dear customer Congratulations for achieving our new OT lamp MACH M3 The MachVISION optical system provides an illuminated field with improved contrast and excellent homogeneity Combined with the Duo Focus feature this offers a unique possibility for adaptation to the wound area With this lighting system you profit from a whole range of new developments based on 50 years of experience in the production of operating and doctor s lights The lighting system is characterised by a previously inconceivable general colour rendition value of Ra 96 In other words the colours are reproduced naturally and in high contrast The wound area is shown in a comfortable light The different reds of a wound area can now be recognised very precisely For the doctor or surgeon this means a considerable improvement in the recognition of details in the wound area The R96 lighting system uses computer optimised cold light filters that reduce both the unwanted build up of heat in the head area and the heat radiated on the illuminated wound area to a minimum Pay attention to the special mounting instructions for ceiling and wall lamps All information quoted here relates only to the ill
12. the lamp functions Merging of light fields and focusing MERGING OF LIGHT FIELDS Ring 2 Merging the individual light fields of each reflector is done by swivelling the reflectors The light fields overlap This feature is activated by turning the sterilisable handle 1 FOCUSING Handle 1 Focusing is done by moving the bulbs inside the reflectors up or down In this way you can further adjust the illuminated field to an extra small or extra large size depending on the specific requirements This feature is activated by turning the ring 2 at the top of the sterilisable handle 99200001 Edition 06 28 11 2002 Bak page 7 22 Mach M3 99200001 Dr Mach assisiance iine Dr Mach Lamps and Engineering 2 5 Adjusting the light intensity for F H and DF H models only Select the desired light intensity before the operation At these models the adjustment is done by the keypad at the cardan bow The intensity can be infinitely adjusted between 50 and 100 Press push button 2 to increase the light intensity and press push button 3 to reduce the light intensity The light intensity set is shown by LED display 1 For other light models we recommend a dimmer in the supply line Edition 06 28 11 2002 Bak page 8 22 Mach M3 2 6 Positioning 1 4m 1 5m 1m 0 7m 0 6m Dr Mach Lamps and Engineering Use the sterile handle 2 or the handle rails 1 to
13. tion 150 W to max 162 W depending on design Voltage AC DC 22 8 V Current 6 5 Ato max 7 1A Frequency 50 60 Hz Degree of protection Type B Class of protection l Standards IEC 601 1 5 2 Environmental conditions Operation Relative atmospheric humidity 30 75 Air pressure 700 hPa 1060 hPa Transport storage Relative atmospheric humidity 700 hPa 1060 hPa 6 CE mark European Community s Council Dr Mach GmbH is certified according to DIN EN 46001 1996 and DIN EN ISO 9001 1994 C 4 The products Mach M3 comply with the standards 93 42 EEC for medical products of the by T V M nchen 7 Disposal The OT lamp doesn t 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 carefully separated The electrical conducting boards should be submitted to an appropriate recycling proceeding The rest of the components should be disposed according to the contained materials 59200001 Edition 06 28 11 2002 Bak page 16 22 Mach M3 Dr Mach Lamps and Engineering 8 Spare parts 43 f 8 9 10 99200001 Edition 06 28 11 2002 Bak page 17 22 Mach M3 Dr Mach Lamps and Engineering 8 Spare parts continuation Bowden control Detail A 99200001 Edition 06 28 11 2002 Bak page 18 22 Mach M3 Dr Mach Lamps and Engineering 9 Spare parts list emos ne O f omo Remake Lower housing part for lamp without camer
14. uirement 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 99200001 Edition 06 28 11 2002 Bak page 10 22 Mach M3 Dr Mach Lamps and Engineering When cleaning disinfecting the fol
15. uminants Details of ceiling or wall installation can be found in the mounting instructions 99200001 Edition 06 28 11 2002 Bak page 3 22 Mach M3 Dr Mach Lamps and Engineering 1 Safety instructions Pay attention to the instructions for use when handling the lamp WARNING This device has not been designed for use in potentially explosive areas According to the Medical Device Regulation the lamp is classified under class Store the OT lamp in its package for at least 24 hours in the respective room before mounting in order to equal temperature differences Please read the instructions for use carefully to make the most of your lighting system and to avoid any damages to the device The lamps may only be repaired and special assembly work may only be carried out on the reflector or sockets by ourselves or a company that has been expressly authorised by us The manufacturer can only be made responsible for the safety of the lamp if repairs and alterations are carried out by the manufacturer himself or a company that guarantees to observe the safety regulations The manufacturer cannot be made liable for personal or material damages if the lamp is operated inexpediently or incorrectly or used for purposes other than those for which it is intended The lamp is to be dismantled from the spring arm in reverse order to its assembly This may only be carried out after the assembly locking device has been inserted and secured s
16. until stop and hold it in this position Put the upper housing part flush on the bottom housing part Be careful when mounting the upper housing part do not damage the sealing profile 10 Turn the turn lock fastener 8 under slight pressure on the upper housing part to the right until the marking 6 Lock Check by eye control if the upper housing part is mounted uniformly on the bottom housing part of the lamp 99200001 Edition 06 28 11 2002 Bak page 13 22 Mach M3 4 3 Changing of spare parts 99200001 Dr Mach Lamps and Engineering 4 3 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 The halogen bulbs have a service life of approx 1200 hours We recommend changing all halogen bulbs in a lamp at the same time to keep maintenance work to a minimum e Turn off the lamp e Remove the upper housing part of the lamp as described in chapter 4 2 ATTENTION Parts of the housing and the halogen bulb may be very hot immediately after use e Loosen the red knurled screw 1 and remove the lamp socket 2 without removing the electrical connection 3 e Remove the faulty halogen bulb 4 from the socket ATTENTION Never touch new halogen bulbs with your fingers Always use the original packaging or a clean cloth
17. using Duo Focus system for DF and DF H models 2 4 Overview of the lamp functions cc cecccecceeeeeeceeeeeeeeeteeeseeeeeeeeeees page 2 5 Adjusting the light Intensity cccccsccceeceecceeseesaeeceeseeeceeseesaesaeeees page 8 ZO OSIMOMING orrera a E ee eae eee page 9 3 CIS AINA ase toed spas taaduiods taadwoda tedden cerndarndchiistntahianetes page 10 O Sterilisabie Handie sso page 10 3 2 Lamp housing dispersing lens and support systeM 0ccee page 12 A WIAILG ANG O ere E TE page 12 4 1 Adjustments at the lamp head ccccccsccseeceeceeeceeceeeeeeseesaeeceeeaes page 12 4 2 Removing the upper housing part a anonnnnanennnnnnennnnnnnnnnonrensrrnrnrennn gt page 13 4 3 Changing of spare parts ccc ccccceeccececeeeeeeeeseseeeseeeceeeseeeseeeseesaees page 14 4 3 1 Changing the halogen DuIbS cece cccceecceeeceeeaeeeaeeseeeeeeeaes page 14 4 3 2 Changing the dispersing lenS ccccccsecceeecececeeeseeeeeeeeeeeeeeaes page 15 S D a E O ees aae naaeuaae pasesae eases eee aee page 16 Sol ISCIICAl Gates n E E EA aipoietarc yb cdeauaec alae page 16 5 2 Environmental conditions cccccceccsecceeceeeceeceeceeseeeceesaeeseeseesaeeeas page 16 O CE MAIK srra EA EAE page 16 PADIS DOS Al sscscesasscnte saiain te taut saci haniadi gaa ancebaud cute Gans enen tail fade anaaweanuraaeaaanaaee nee page 16 8 Spate DANS aesir E page 17 9 Spale Pans lS opa

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