MACH LED 5MC/SC
Contents
1. 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 light is classified under class l Store the OT light 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 lights 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 light 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 light is operated inexpediently or incorrectly or used for purposes other than those for which it is intended The light is to be dismantled from the spring arm in reverse order to its assembly This may only be carried out after the spring arm has been adjusted in height at horizontal position since the arm is under spring tension and can bounce up Make sure that the light is in perfect working order before every use Attention external power supply T2. 110 230V 50 60 Hz Wall panel Power suppl pele oe 28V DC Wandtableau optional Switch over relay Umschaltrelais 4 optional i Notstrom 3A Netz n 24V DC LED Emergency power auichie LED Light Net w S N Pa 59150001 Edition 21 06 05 2013 Bak Page 26 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 8 5 Environmental conditions Operation Relative atmospheric humidity 700 hPa 1060 hPa In case of higher temperatures please contact us Transport storage Relative atmospheric humidity 700 hPa 1060 hPa References on the package 50 C 20 90 700hPa 1060hPa Temperature range Atmospheric Air pressure for transport humidity for transport and storage for transport and storage and storage 99150001 Edition 21 06 05 2013 Bak Page 27 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 8 6 Important remarks When using more than one OT lamp at the same time OT lamp combinations due to the light fields overlapping of different lights the maximum permissible values according to EN 60601 2 41 for UV radiation lt 400 nm of 10 W m can be exceeded Due to production related reasons some LED modules can show colour nuances during operation These colour nuances greenish or reddish are no fault of the light The light quality and the function of the light are not affected When installing an OT lamp its fail safety must be guaranteed according to DIN VDE 0
3. 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in U7 for 0 5 cycle 40 Ur 60 dip in U for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines not applicable 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in U for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Edition 21 Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the MACH LED 5MC SC requires continued operation during power mains interruptions it is recommended that the MACH LED 5MC SC be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 06 05 2013 Bak Page 32 34 Mach LED 5MC SC Dr Mach Lamps and Engineering Table 4 Guidance a
4. Indication for disposal 99150001 Edition 21 06 05 2013 Bak Page 6 34 Mach LED 5MC SC Dr Mach A Lamps and Engineerin LASER CLASS 2 Keep the laser beam away from the patient s and employee s eyes Danger of injury 2 Brief description of the light MACH LED 5MC SC Intended use of the light Mach LED 5mcvsc e The light is used for treatment diagnosis and in operating theatres The light is used in medical rooms groups 0 1 and 2 according to DIN VDE 0100 710 The light is mounted to the ceiling Maintenance of the light should be scheduled every 2 years The light has a fixed electrical connection The OT light MACH LED 5MC SC is available in following versions Mach LED 5MC with merging of light fields light intensity control colour temperature adjustment and laser pointer Mach LED 5SC with merging of light fields and light intensity control Colour temperature adjustment and laser pointer against surcharge 2 1 Merging of light fields The OT lights Mach LED 5MC SC offer light field adjustment by merging the individual light fields of each LED unit by swivelling them This feature is activated by turning the sterilis able handle 2 2 Light intensity control The OT lights Mach LED 5MC SC offer the feature of light intensity control You can adjust the light intensity between 5 and 100 according to your requirements 99150001 Edition 21 06 05 2013 Bak Page 7 34 Mac
5. customer or the user of the MACH LED 5MC SC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MACH LED 5MC SC as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHZ to 2 5 GHz Rated maximum output d L17VP dq 117VP d 2 344 P of transmitter 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 117 117 2 33 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 59150001 Edition 21 06 05 2013 Bak Page 34 34
6. 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 99150001 Edition 21 06 05 2013 Bak Page 18 34 Mach LED 5MC SC Dr Mach Lamps and Engineering 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 pro cess 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 When cleaning disinfecting the following procedures must be followed poes OOOO o o O e Zone 1 Pre rinse external cold 10 15 C 45 Washing acidic external 35 C 120 Drain
7. guidelines may not apply in all situations Electromagnetic is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic envi ronment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the MACH LED 5MC SC is used exceeds the applicable RF compliance level above the MACH LED 5MC SC should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the MACH LED 5MC SC gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 99150001 Edition 21 06 05 2013 Bak Page 33 34 Mach LED 5MC SC Dr Mach Lamps and Engineering Table 6 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING see 5 2 2 2 Recommended separation distances between portable and mobile RF communications equipment and the MACH LED 5MC SC The MACH LED 5MC SC is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The
8. installation Preventive maintenance of the light should be done every two years This includes a technical and me chanical check up Please observe also the manufacturer s mounting instructions for the ceiling and wall attachment In order to keep the system easy running throughout its life span we recommend that the hinges should be greased once a year with acid free grease Attention Set the height adjustment if applicable of the spring arm to horizontal position before dismount ing the lamp Please observe also the manufacturers mounting instructions for the ceiling and wall attachment AN Attention During all maintenance work the light must be disconnected from mains and secured against resetting 6 1 Periodical maintenance work The following maintenance work tests has have to be done every six months e check on defects in paint work e check on fissures at plastic parts e check on deformation of the suspension The following maintenance work tests has have to be done once a year e check the function e electrical safety test e check the suspension A Check and grease the security segment once a year For adjustments at the ceiling attachment please observe also the mounting instructions Ceiling attachment with heavy central axis 59150001 Edition 21 06 05 2013 Bak Page 22 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 7 Troubleshooting In case of a malfunctio
9. m 59150001 0 7 0 7 0 7 0 7 0 7 0 9 A F 0 9 A F O N O T1 m 2 O STI B O 0 IN o1 B 0 7 0 7 0 7 0 7 0 9 0 9 0 9 0 9 NOCOMM no data received for too long a time LED error reset by switching ON and OFF Digit 3 LED channel 0 7 CW1 WW1 G1 R1 CW2 WW2 G2 R2 Digit 4 error code in case of multiple codes they are added MADATAID_CANPAR_STATUS_LED_ xxx OFFCURR current measured in driver OFF state UNDERCURR open circuit cannot reach target current OVERCURR short circuit measured current is too high Control unit error in software module 0 15 Control unit error in software module 16 31 Digit 2 Module code modulo 16 hex see source code pro ject h xxxx_MODULE_ID Digits 3 4 decimal error code 00 99 see source code ret val h MAIN _ TIMER __ WATCHDOG _ CAN _ CANCOM _ EEDATA _ FLASHCHK _ CONTROL _ CONTROL_REF_ MOTOR _ LEDCTRL_ SWITCH __ MMISLAVE_KEY __ MMISLAVE_LED _ LCD _ USER _ ADCINT _ DIPSW __ CRITVAR __ OK no error ERR general error ERR_ILLEGAL_CASE illegal case state in graph ERR_ILLEGAL_ACT illegal action state in graph E NULLPOINTER a function has received a null point er where not applicable E EXECFLAGNOTFALSE execution flag was not false in graph E WDFAIL watchdog test failed watchdog did not reset the CPU correctly E WDRESET an unintended watchdog reset has occurred E FLASHCHK_FAIL the FLASH CRC check fa
10. supply is connected to the OV line of the other power sup ply The function of the lights is OK the connection of the power supplies is not The power supplies are working one against the other Troubleshooting lf a communication error on an installed system must be found first of all the neutral point where all communication lines are connected must be disconnected The disconnection must be done only after the primary supply voltage was turned off On the free lines the open circuit voltage must be checked After switching on the supply voltage all displays must work and the voltage measured on every communication line must be 5V 6V The voltage is meas ured with the OV line of the power supplies normally the blue terminals on the flange lf the measured voltage is not correct i e 1V the communication pin is damaged and the con trol board of the light must be exchanged If the measured voltage is OV the line is not connect ed to the communication pin of the control board lf the measured voltages are correct please connect first of all the communication lines of the lights and check their correct function If there is a wall panel on site do not connect it yet to the communication line Transmit the values of one light to the other lights and check the function If the communication is not working the malfunction must be located in the light attachment In order to resolve the problem the spring arms the horizontal arms and the
11. 100 710 former DIN VDE 0107 Attention The test certificate for the electrical safety test can be requested when needed Please provide the serial number of the respective light The light must still be tested at commissioning D Protective conductor EN Alternating current ES The polarity is very important for the installation of the light In case the light does not function after installation the polarity must be checked at the secondary side of the power sup ply 9 CE mark products of the European Community s Council Dr Mach applies the standard EN 60601 2 41 C 3 The products Mach LED 5MC SC comply with the standards 93 42 EEC for medical Dr Mach GmbH is certified according to DIN EN ISO 13485 2003 AC 2009 10 Disposal The OT lamp doesn t contain any dangerous 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 materi als 59150001 Edition 21 06 05 2013 Bak Page 28 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 11 Spare parts 11 1 Mach LED 5MC se TS os 99150001 Edition 21 06 05 2013 Bak Page 29 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 11 2 Mach LED 5SC 11 3 Transformer housing
12. 99150001 Edition 21 06 05 2013 Bak Page 30 34 Mach LED 5MC SC Dr Mach Lamps and Engineering 12 Spare parts list Pos Pee meme oraerno Pomar a 4 feorase o ts 0001 merse o fr sensere erso werso 40 LED module MC 18064001 e a lema loroo orso e 5 custersorame 67180201 Nur Cluster board SC 67150206 Transformer housing incl 1x power supply ala 250W 28V DC 9300009905 MC SC Transformer housing incl 2x power supply 9300009906 MC SC 250W 28V DC 9300009906 MC SC Cover cap for LED 5 housing set 72000050 Cover cap for LED 3 housing set 72000051 99150001 Edition 21 06 05 2013 Bak Page 31 34 Mach LED 5MC SC Dr Mach Lamps and Engineering 13 Electromagnetic compatibility The Dr Mach OT and examination lights are subject to special preventive measures regarding the elec tromagnetic compatibility and must be installed according to the EMC instructions mentioned in the ac companying documents The function of the OT and examination lights can be affected by portable and mobile HF communication devices Table 1 Guidance and manufacturer s declaration electromagnetic emission for all EQUIPMENT AND SYSTEMS see 5 2 2 1 c Guidance and manufacturer s declaration electromagnetic emission 5 The MACH LED 5MC SC is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 5MC SC should assure that it is used in
13. Mach LED 5MC SC Dr Mach Lamps and Engineerin Instructions for use MACH LED 5MC SC Mach LED 5mc ceiling light for room heights up to 2 8m Mach LED 5sc ceiling light for room heights up to 2 8m Mach LED 5mc ceiling light for room heights between 2 8m 3m Mach LED 5sc ceiling light for room heights between 2 8m 3m Dr Mach GmbH u Co KG FloBmannstrasse 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 99150001 Edition 21 06 05 2013 Bak Page 1 34 Mach LED 5MC SC Dr Mach Lamps and Engineering Mie SAEY NSU UCU OINS eaters eters sce etecate sede stored E 5 2 Brief description of the light MACH LED SMC SC ccc cccccecceeeceeceeeeaeeeeeeeaees T Zle Merging ONG Neds zenei esd oieuaan ca tuedcenecauonsuaeth ones secanadsoamuaon ses 7 ZZ WIG MENTS MSINY CONTO accede cases casi thas teetnncuctiw sane tistaaidotorenuneakidiodecaddasets note tnadevuaniceee teats 7 3 Light functions operated at the sterilisable handle cccccccecceeeseeteeeeeeeeeeeeeaaes 8 4 Operating the light MACH LED SMC SC ccc cccccccceceeeeeeeeeeeeeeeeseeeseeeaeeeaeeeeees 9 A TUNNO Meg ONAN OF F aeaee a ET T TA 9 4 2 Adjusting the light field with the sterilisable handle cccccccccssseccesssssseeeeeesssseeeessssaeees 9 AS Adjusting heligt MATCIS NY sisser E OTT 10 4 4 Adjusting the colour temperature Mach LED 5MC only sess
14. anel to the orange terminals on the ceiling flange Connect the primary side of the power supplies to mains and check if the communication between wall and light is working 99150001 Edition 21 06 05 2013 Bak Page 17 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 4 10 Positioning Use the sterile handle 14 or the handle rails 13 to position the lamp Use the handle rail to position the lights before the operation Use the sterile handle for positioning during the oper ation This handle can be removed for sterilisation 5 1 Sterilisable handle At delivery the lamp is equipped with the handle sleeve 14 The handle sleeve is removable and Sterilisable Before using the first time and before every use the handle sleeve must be cleaned disin fected and sterilised The handle sleeve must be removed for sterilisation e To remove press the lock V and pull off the steri lisable handle sleeve 14 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 operation Therefore always keep additional handles available for exchange 14 V 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
15. ating mode of the communication on Dr Mach LED lights The communication of the Dr Mach LED lights is realized with a single wire bus The members of the communication bus have star shaped connections All the members of the commu nication bus need an explicit communication number which is to be set with the first two dip switches on the control board Due to the fact that two dip switches are reserved for addressing maximum four inde pendent lights can be connected to the communication bus The communication number of each light is pre set by the factory and can be changed during installation on site only by opening the light head The communication number is shown by the sticker Sync address on each 5 pole light head Usually at Dr Mach the LED 3 lights have the pre set sync address 0 and the LED 5 lights have the pre set sync ad dress 1 Although the sticker is labeled Sync Address it refers not only to the communication between the light heads but also to the communication to the wall panel The light heads of a system must have different sync addresses otherwise the communication is not working perfectly If it is known after placing the order that a combination LED 3 LED 3 and another combination LED 5 LED 5 was ordered these combinations will be pre set with different sync addresses This way it is ensured that the lights must not be opened at installation It means also that in case of deliveries with many lights for many
16. ceiling tube cables must be changed individually and one after another lf the communication between the lights is working the wall panel can be connected and the function can be tested If the communication is not working please check the connections in the wall panel and the settings of the DIP switches Please look also for damaged crimp connec tions where single strands can cause a short circuit 99150001 Edition 21 06 05 2013 Bak Page 15 34 Mach LED 5MC SC Dr Mach Lamps and Engineering Installation instructions for LED lights with communication synchronization After installing the ceiling flange the central axis the horizontal arm and the power supplies the lights must not be mounted to the spring arms yet Insert the 5 pole test adapter into the spring arm The test adapter can be purchased at Dr Mach Then the ceiling attachment is connected to mains On the marked terminals of the test adapter the voltages 28V DC and OV must be checked In the next step it must be checked if there is a connection between the communication wire on the test adapter and the corresponding wires on the ceiling flange The communication wires on the flange are not yet connected All the communication wires in the flanges are loosen If the supply line with 28V and OV is correct the light head can be mounted and connected That means that the test adapter has to be removed and the light head has to be connected Before connecting the
17. cu um process Euroselectomat 666 by MMM Munchner Medizin Mechanik GmbH sterilising temperature 134 C holding time 7 min Inspection durability The sterilisable handle sleeve must be dis posed after 1000 sterilisation cycles or at the latest after 2 years and replaced with a new one The year of manufacture can be determined with the help of a stamping on the inner side of the handle sleeve like shown in the pho to The stamping in the photo shows the number 12 which stands for the year 2012 99150001 Edition 21 06 05 2013 Bak Page 20 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 5 2 Lamp housing protective disk and support system The Dr Mach OT lamp system has a high quality surface which can be cleaned with conventional cleaning agents The protective disk 15 is made of a high quality plas tic Pay attention to the following during cleaning Never wipe over the protective disk 15 with a dry cloth always clean with a wet cloth Only use disinfectants with less than 20 alco hol The video camera is available against surcharge Wipe the protective disk 15 after cleaning with an antistatic non fluffy cloth Alc lt 20 99150001 Edition 21 06 05 2013 Bak Page 21 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 6 Maintenance MACH LED 5MC SC lights are supplied with brakes on the suspension fixture and on the lamp housing Adjust these brakes if necessary after
18. e handle press first push button 12 and then the ON OFF button on the key pad The LASER display is blinking The previous function on the ring is de activated A right turn of the ring at the handle activates the laser pointer a left turn of the ring turns it off 4 7 Deactivating all functions on the ring of the handle The functions on the ring of the handle can be com pletely deactivated Press first of all push button 6 ENDO and then the ON OFF button on the key pad The ring on the handle is without function In order to transfer a function on the ring please proceed as described in the chapters before 4 8 Synchronization and or commu nication with the wall panel The lights Mach LED 5MC SC can be equipped against surcharge with the function of synchroni zation combinations only and or communica tion with a wall panel The synchronization of two three or four OT lights enables the transmission of the light inten sity or color temperature values set at one light to the other OT lights Additionally the communication allows operating the single lights from a wall panel The settings from the wall panel can be transmitted to the other lights by pressing the SYNC button The transmission of the settings to the other lights is done by pressing the SYNC button on the key pad Edition 21 06 05 2013 Bak Page 13 34 Mach LED 5MC SC Dr Mach Lamps and Engineering 4 9 Basic oper
19. ensssensnsssseessssererssssrrresssere 11 AD DepMON esans a E a E a 12 4 6 Integrated OT laser pointer Mach LED SMC Only cccccsscccccsssseeceesssssseeeeesssseeeeeseeaes 12 4 7 Deactivating all functions on the ring of the Nandle ccc ecessseceeesssseeeesessseeeeeseees 13 4 8 Synchronization and or communication with the wall panel cccccsssseeeceeeeeeessrees 13 4 9 Basic operating mode of the communication on Dr Mach LED lights 14 4 10 FOS ION MIN eenen E A E EEE aeoeaoae aeesenees see 18 2 lt 1 2 01 e neem a on ete a ey NR ere ee ay ee er or 18 Dele sStenlisable MAGS siiestaisteshasdnasens cere tenausienanlncdep sau dehaniadnchautsitedne ate bawl loushewdap Madchen echauaaciess 18 5 2 Lamp housing protective disk ANd support system cccssssssseccccceeeeeeesssesssssseeeeeeeeees 21 G Manten anG Cig ccsecat necator a a c ate ta cae eat esate ese 22 6 1 Perodicalmantenance WOK michsiesscsthecsieatncndeatisaceasfutegscbacelag ENN ON 22 fs POUDIESNOOUMG sisas e e e EER 23 Oe Dala erroneu enee EEES 25 Oke Tecn Cardalda erien a aN aN 25 95 2 Elecmical dala ncss a E neuen oeund deers eaaimn 26 8 3 Information regarding the electrical installation ccccsccsssssccceesssseeecsssseeeeessssaeees 26 Oe ANIO n A eee ee Oe eee eon ee eee ee 26 820 Environmental Conditions wiser vsccvssesetbetecuseits cavlsssbrereieh Mcncessasebiebeeeise be cunedibideuadunieedali
20. h LED 5MC SC Dr Mach Lamps and Engineerin 3 Light functions operated at the sterilisable handle A j 59150001 Depth light The depth light can be activated by a tight turn of the ring at the sterilisable handle A left turn of the ring switches the depth light OFF The depth light function on the ring is pre set by Dr Mach at delivery The customer can transfer all other available functions of the LED light to the ring on request The transfer procedure is described in the following chap ters Merging of light fields The four light fields of the outer LED units are merged to one light field by turning the handle sleeve Edition 21 06 05 2013 Bak Page 8 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 4 Operating the light MACH LED 5MC SC 4 1 Turning the light ON and OFF Dr Mach SYNC aa The push button 1 on the control panel turns the light Mach LED 5MC SC ON and OFF INTENSITY 4 2 Adjusting the light field with the sterilisable handle The light field can be adjusted by turning the sterilis able handle 2 The current size of the light field is shown by the digi tal display 3 99150001 Edition 21 06 05 2013 Bak Page 9 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 4 3 Adjusting the light intensity Select the desired light intensity before surgery It is recommended to start with 80 of the maximum light intensity and to increase the
21. he light works only with an external power supply 250VA The external power supply used with the OT light must be tested and validated accord ing to IEC 60601 1 Attention A main control switch must be installed for turning the system power off A ATTENTION During the mounting of the OT lights the entire system incl the ceiling attachment must be disconnected from mains A later dismounting of the lights from the spring arms or dismount ing the sliding contacts inside the arms is to be done ONLY AFTER DISCONNECTING THE ENTIRE SYSTEM FROM MAINS Otherwise the main control board will be damaged 59150001 Edition 21 06 05 2013 Bak Page 5 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin Symbols and notes used in this user manual This symbol means possible hazard sources Please observe also the safety remarks and the hazard specifications mentioned in the mounting instructions and user manuals from Ondal company This symbol means possible hazard caused by electric current Please observe also the safety remarks and the hazard specifications mentioned in the mounting instructions and user manuals from Ondal company This symbol refers to important mounting indications useful information and operation hints This symbol indicates to observe the user manual Alternating current Bulb Fuse Indication on China RoHS Pollution control Logo China J Temperature range for transport and storage
22. ightly differ from the data mentioned above The values for Ra and Rg can differ with approx 5 The values for the colour temperature can differ with approx 200K 99150001 Edition 21 06 05 2013 Bak Page 25 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 8 2 Electrical data Mach LED 5MC Mach LED 5SC Power consumption Dee out p 165 W with camera 70 W with camera Operating voltage DC 24 V 30VDC 24 V 30 VDC Current 6 6 A 6 9 A with camera 2 5 A 2 7 A with camera 8 3 Information regarding the electrical installation When turned ON the OT light MACH LED 5MC SC is exposed to a current peak This peak can be seven times higher than the nominal current The OT light MACH LED 5MC SC is delivered with a Dr Mach power supply It is a electronic power supply with a wide range input input voltage 100 240V AC 50 60Hz output voltage 28V DC In case there is a switch over relay needed for an emergency power supply on site this switch over relay must be ordered separately at Dr Mach In case of a power supply provided by the customer the following points must be observed e The OT light works with 24V 30V DC direct voltage e The direct voltage provided by the hospital must have a maximum undulation of 5 e A higher voltage 28V 30V DC is recommended this causes a decrease in heat development of the light 8 4 Wiring plan
23. iled E TICKOV Ticker tasks overflow tasks too slow E SLOWTICKOV Slow Ticker tasks overflow tasks too slow Edition 21 06 05 2013 Bak Page 24 34 Dr Mach Lamps and Engineerin Mach LED 5MC SC 8 Data 8 1 Technical data Central light intensity Mach LED 5MC Mach LED 5SC E E irene ale ear cine 160 000 Lux 160 000 Lux Light field diameter dio 200 mm 200 mm Light field diameter dso 100 mm 100 mm Light intensity with one shadower 80 80 Light intensity with two shadowers 64 64 Light intensity on the ground of a normed tube Light intensity on the ground of a approx 90 approx 90 o o normed tube with one shadower e S Light intensity on the ground of a 5 5 normed tube with two shadowers oii o Illumination depth 20 1500 mm 1500 mm Illumination depth 60 400 mm 400 mm Colour rendering index Ra 96 95 Colour rendering index Rg 90 90 Max radiation intensity in the field 549 W m 549 W m at a distance of 1 meter Max radiation intensity in the field 786 W m 786 W m at a distance of 0 8 meters Focusable light field size RAEN SORRE 3750 4000 4250 Colour temperature Kelvin 4500 4750 K 4500 K Temperature increase 0 5 C 0 5 C in head area Number of LED s 160 40 Working distance 60 150 cm 60 150 cm Height adjustment 118 cm 118 cm 1 With without depth light Remark The technical data are subject to fluctuations Due to manufacturing reasons the real values can sl
24. ing 3750 4000 4250 4500 and 4750 Kelvin The surgeon has the possibility to choose the opti mum OR light according to the tissue type and the wound field texture By pressing push button 8 the colour temperature decreases By pressing the push button 9 the colour temperature increases The set colour temperature is shown by the digital display 10 Transferring the colour temperature adjustment function to the ring of the handle In order to transfer the colour temperature adjustment function to the ring of the sterilisable handle press first push button 8 or 9 and then the ON OFF button on the key pad The colour temperature display is blinking The previous function on the ring is de activated A right turn of the ring at the handle increases the colour temperature by one step a left turn of the ring decreases it with one step 3 This function is not available for the Mach LED 5sc lights 59150001 Edition 21 06 05 2013 Bak Page 11 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 4 5 Depth light You have the possibility to increase the light intensi ty of the central segment of the OT light This ena bles an optimum illumination of the wound field ac cording to its texture and the shadowing effects This is very important in case of small and deep wound channels The depth light is to be switched on only if an in creased depth illumination is needed When the depth
25. ing 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 Drying external 100 120 C Drying external 100 120 C Door open close amp transport 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 99150001 Edition 21 06 05 2013 Bak Page 19 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin A Sterilization 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 va
26. light head please disconnect the ceiling attachment from mains That means that the power supply must be disconnected from mains on the primary side After disconnecting from mains please wait 20 30 seconds until the capacitances on the power supplies are discharged In order to speed up this process the light can be turned on After the light head has been mounted and connected connect the power supply to the mains and check the function of the light All the functions on the keypad must work there must be no error code on the display no triangle must be shown on the display If the light function is OK then proceed the same way with the other lights of that ceiling attachment The communication wires are not yet connected That will follow with the next step After all the lights of the ceiling attachment are working please measure the voltages on the communica tion lines The measured voltage on the communication line must be between 5V and 6V The voltage must be measured between the communication line and the blue terminals on the flange This is the OV line or in correct electrical terms the minus line If these 5 6V are not measured on the communication line then there is a fault on the communication line In the worst case the communication pin on the control board is damaged If the communication pin on the control board is damaged the measured voltage is 0 6V up to 1 2V The 5 pole sliding contacts have 3 supply lines one comm
27. light intensity in time At these models the adjustment is done by the con trol panel at the cardanic bow The intensity can be adjusted between 5 and 100 By pressing push button 4 the light intensity de creases By pressing the push button 5 the light intensity in creases The current light intensity level is shown by the digi tal display 7 ENDO Light By pressing the push button 6 the outer LED units turn off while the central unit continues to burn The ENDO light function can be deactivated by pressing the button 6 again When the ENDO light function is activated the colour temperature information is faded out on the display of the light Transferring the light intensity adjust ment function to the ring of the handle In order to transfer the light intensity adjustment function to the ring of the sterilisable handle press first push button 4 or 5 and then the ON OFF button on the key pad The frame around the light intensity level display is blinking ew The previous function on the ring is de activated A right turn of the ring at the handle increases the light intensity by one step a left turn of the ring de creases it with one step 99150001 Edition 21 06 05 2013 Bak Page 10 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 4 4 Adjusting the colour temperature Mach LED 5MC only Five different colour temperature values can be set at the control panel on the lamp hous
28. light is activated the maximum central light intensity will not exceed 160 000 lux see also technical data at chapter 8 To activate the depth light press push button 11 on the control panel 4 6 Integrated OT laser pointer Mach LED 5MC only The built in laser pointer always indicates the middle of the light field and helps the surgeon to find the optimal position of the OT light to the wound field The push button 12 on the control panel turns the laser pointer ON and OFF The laser pointer turns off after approx 30 seconds i ae P F AAJ Ta gt 1 a _ Se if f F d F i aA s ef a gt l i a a ga E j e gt E OT laser pointer When the laser pointer is turned on the light intensity decreases automatically by three steps This is shown also by the digital display The light intensity can still be adjusted After the laser pointer is turned off the light in tensity increases to the initial setting LASER CLASS 2 Keep the laser beam away from the patient s and employee s eyes Danger of injury The Mach LED 5SC has no integrated laser pointer It is available against sur charge 99150001 Edition 21 06 05 2013 Bak Page 12 34 Mach LED 5MC SC Dr Mach Lamps and Engineerin 99150001 Transferring the colour laser pointer function to the ring of the handle In order to transfer the laser pointer function to the ring of the sterilisabl
29. n is working it means that the wiring of the communication wires is correct and the signal transmission is OK In case the synchronisation is not working a troubleshooting must be performed Assuming that the communication is working and a wall panel must be connected the next step is to supply the wall panel with 28V DC The wall panel is connected with four lines Two of these lines are for the power supply The lights are turned off the power supply must be disconnected on the primary side from mains Wait 20 30 seconds until the capacitances on the power supplies are discharged In order to speed up this process the light can be turned on Now the supply line for the wall panel is to be connected Connect these two lines on the ceiling flange so you can measure 28V DC and OV at the wall panel Do not connect the communication line for the wall panel yet After the connection has been done the power supplies are connected to mains Turn on the lights and check if the wall panel is supplied with power Please check if all functions are shown correctly on the display A communication with the lights doesn t work yet since the communication line is not yet connected If the wall panel is working correctly disconnect the power supplies from mains and wait until the capaci tances on the power supplies are discharged In order to speed up this process the light can be turned on Now connect the communication line from the wall p
30. n of the light an error code is shown on the display of the key pad as shown in the picture on the left The error codes consist of four digits The error shown on the display is always the error with the highest priority e Errors of the control board are prior to errors of the cluster boards gt e Clusters with lower adress have higher priority e General cluster errors are prior to errors of the LED channels e Incase of general cluster errors the lower num bers have the higher priority Decoding Digit1 Digit2 Digit3 Digit 4 C 0 7 7 i Cluster errors always begin with the letter c digit 2 is the cluster adress 0 7 C 0 7 No contact to the cluster C 0 7 General cluster error reported by the cluster reset by switch ing ON and OFF Digit 4 Bit number oft he error MADA TAID_ CANPAR_STATUS_ xxx Cc 0 7 0 WDRESET CPU was reset by WD C 0 7 1 SWRESET SW reset because of fatal error Cc 0 7 2 FLASHCRC FLASH CRC error C 0 7 3 RAMERR RAM test error C 0 7 4 NOEEDATA no EEPROM data defaults were used SerNum etc lost C 0 7 5 EEDEFAULT EEPROM paramater defaults were set SerNum etc preserved C 0 7 6 EEWRERR EEPROM write error when writing parameters C 0 7 7 reserved Cc 0 7 8 UNDERVOLT 24V supply undervoltage 99150001 Edition 21 06 05 2013 Bak Page 23 34 Mach LED 5MC SC Dr Mach Lamps and Engineering OJO T m T T T T m m m m m m m m m m m m m m
31. nd manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING see 5 2 2 2 Guidance and manufacturer s declaration electromagnetic immunity The MACH LED 5MC SC is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 5MC should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the MACH LED 5MC SC including cables than the recommended separation dis tance calculated from the equation applicable to the fre quency of the transmitter Recommended separation distance Conducted RF 3V d 1 7VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m d 1 174 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 344 P 800 MHz to 2 5 GHz where p is the maximum output power rating of the trans mitter in watts W according to the transmitter manufactur er and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol sy NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These
32. operation the atres it must be observed very carefully which lights are going to be combined The communication of the lights with the wall panel works with the same single wire bus On the control board inside the wall panel there is the dip switch 4 which defines that this control board is working as a wall panel The dip switch inside the wall panel must be in ON position The control boards inside the wall panel must have the same sync address as the lights they are assigned for The same communica tion address on the control board inside the light and the control board inside the wall panel makes sure that the communication with the wall panel is working Technical remarks regarding the communication The communication between the lights and between lights and wall panels is working through one cable The voltage on this cable in standby modus is approx 5 6V The communication wire can be found on the control board besides the connections for the power supply The wire leads directly to the controller chip The controller pin is quite sensitive to negative voltages This means that if there is a negative voltage bigger than 0 3V on the communication pin this pin gets dam aged and lies on a voltage of approx 1V After a correct installation and during regular operation no negative voltages occur However during the light installation and wiring equalizing currents can appear which lead to a negative potential on the communication
33. pin relative to the OV wire In this case the pin gets damaged This is the reason why dur ing installation the power supply of the entire system must be completely switched off and there must be no residual energy in the capacitors electronic power supply and light head The electronic power sup plies are equipped with quite big sized capacitors which have high voltages for several minutes after switching off the primary voltage The capacitors must be discharged before the communication lines of the light and the wall panel are connected The reference potential for the communication is the OV wire of the power supplies Due to the fact that each light needs its own power supply the OV wires of the power supplies must be connected to each other in order to create the same reference potential for the communication Usually the wiring on the flange is factory made However during installation it should be observed that the OV wires of all the pow er supplies that are used for lights with communication are bridged The protective conductor green yellow has no use for the communication There must not be any con nection between the protective conductor and the communication line because it cannot be ensured that the protective conductor has a OV potential all the time In case the communication line is in contact with the protective conductor due to an installation error it is possible that the communication does not work correct Eventually the f
34. such an environment 3 Emissionstest 7 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Class C Compliance Electromagnetic environment guidance The MACH LED 5MC SC is suitable for use in all establishments including domestic establishments and those directly con nected to the public low voltage power supply network that supplies buildings used for domestic purposes 42 RF emissions Combis The MACH LED 5MC SC is not suitable for interconnection CISPR 15 p with other equipment Table 2 Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS see 5 2 2 1 f Guidance and manufacturer s declaration electromagnetic immunit The MACH LED 5MC SC is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 5MC SC should assure that it is used in such an environment Immunity test enue Compliance level test level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Uz is the a c mains voltage prior to application of the test level 99150001 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines
35. t ase 27 O10 WMMDORAME FOTIA S aenea E abcsciadcaca socadueasevprdcuccons weaundeauseuaaasysdoscensusdecpesniadseor 28 9 CE mIKE ciaee a a 28 List of contents 59150001 Edition 21 06 05 2013 Bak Page 2 34 Mach LED 5MC SC Dr Mach Lamps and Engineering 10 sDISDOSAl ssxacuxarevsoesaeertenvansveceeiaasareaiareneteeter Pata Aa eee 28 ti Spare DAMS rareori aOR AA ORE REA ORCE AS aSa 29 11 1 MaCmiLE D o MO aee E E A S 29 11 2 MacMEED OSG orn N AA A NAN 30 113 Transformer NOUSIN recse craic iis isaisa E EEE E ET 30 12 Spar parts St erenneren ar a a aA 31 13y Elpcromagneuc COMP ATIDINGY seene e E EE EET 32 59150001 Edition 21 06 05 2013 Bak Page 3 34 Mach LED 5MC SC Dr Mach Lamps and Engineering Dear customer Congratulations for acquiring our new OT light MACH LED 5MC SC The new OT light generation with LED technology supports your professiona lity by innovative technology and design The advantages of the LED technology adjustable light colour a life span of minimum 40 000 hours and an almost nonexistent heat development in the surgeon s head area and in the wound field The advantages already provided by Dr Mach s light technology with halogen and gas discharge lamps have been maintained natural colour reproduction exact illumination of the wound field and easy positioning of the light head 99150001 Edition 21 06 05 2013 Bak Page 4 34 Mach LED 5MC SC Dr Mach Lamps and Engineering
36. unction failure is not directly visible and consists of sporadic malfunction or re peated pressing of the keys on the keypad in order to control the light 99150001 Edition 21 06 05 2013 Bak Page 14 34 Mach LED 5MC SC Dr Mach Lamps and Engineering Information about the power supply The Dr Mach LED lights need a direct current voltage of 24V 30V DC for correct operation The undula tion of the direct current voltage should not exceed 5 The LED control inside the light is current operated that means that a change of the supply voltage does not lead to a change of the light intensity Due to the fact that the power requirement of the light is constant an increase in the supply voltage means a decrease of the total current of the light and therefore to a decrease of the heat development inside the light That is why it is recommended to supply the light with a high voltage so the life span of the component parts is not shortened by an exceeding heat development The control electronics of the light has an initial voltage at starting of approx 17V This voltage value is too low for the light operation The light can be operated with 20V DC for a short time but in this case the heat development will be very high which has a negative influence on the life span of the component parts The initialisation phase of the control electronics is approx 1 second In case that the supply volt age does not reach 24V 30V within this second the cl
37. unication line and a fifth line which is not allo cated today This fifth line is not connected in the light head either There must not be measured any po tential on this line This means that in case a measurement is done on this line the measured value must be OV Due to the possibility of checking the lines by measuring the potential on them the colour markings of the wires are no longer the only criteria to install and connect the lights in a correct way Unfortunately we discovered that in the past the colours have been swapped because of changes of the colours of the wires and because of wiring errors at spring arms and horizontal arms In case the 5 6V are measured on the communication lines of each single light it means that the commu nication line is working correctly Please disconnect the primary side of the power supplies from mains again so all light heads are current less Please wait again for 20 30 seconds until the capacitances on the power supplies are discharged In order to speed up this process the light can be turned on Then the communication wires can be con nected to the orange terminals on the ceiling flange 99150001 Edition 21 06 05 2013 Bak Page 16 34 Mach LED 5MC SC Dr Mach Lamps and Engineering After the communication wires have been connected connect the primary side of the power supplies to the mains and the check the synchronisation function between the light heads If the synchronisatio
38. uster board of the lights can be damaged This is the reason why a soft start which makes sense for halogen lights is not allowed for LED lights The capacitances inside the light and the LED control cause quite high current peaks when turning on the power supply The current peaks are in the range of the sevenfold rated current A current limiting and a protection of the lights should not delimitate the current peak because the electronic boards would even tually consider this delimitation as a failure in power supply and would change to emergency operation mode The emergency operation mode does not ensure a normal functionality of the lights and must be avoided Swapping the polarity at the LED light does not lead to a malfunction After the polarity is changed the light works perfectly A wrong polarity can happen by swapping the wires inside the spring arm horizontal arm or ceiling flange tube but also inside the transformer housing or the light The error code for wrong polarity on the light display is CO The display is on but the light is not working If the polarity is swapped only at one of the lights and the lights are equipped with communication caution is advised when chang ing the polarity at the ceiling flange If the polarity at the power supplies is correct and the polarity on the ceiling flange is changed only for one light it may happen that due to the bridge between the OV lines of the power supplies the 28V line of one power
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