MACH LED 2SC HYBRID
Contents
1. DIN EN 554 ISO 11134 Maximum sterilisation temperature 134 C Proof in principle of the handles suitability for effective sterilisation was provided using a frac tional vacuum process Euroselectomat 666 by MMM M nchner Medizin Mechanik GmbH steri lising 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 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 con ventional cleaning agents The protective disk 12 is made of a high quality plastic Pay attention to the following during cleaning Never wipe over the protective disk 12 with a dry cloth always clean with a wet cloth Only use disinfectants with less than 20 alcohol Wipe the protective disk 12 after cleaning with an antistatic non fluffy cloth Alc lt 20 59160002 Edition 01 29 05 2013 Bak Page 18 28 Mach LED 2sc Hybrid 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 these2. G1 R1 CW2 WW2 G2 R2 Digit 4 error code in case of multiple codes they are add ed MADATAID_ CANPAR_STATUS_LED_ xxx Cc 0 7 0 7 1 OFFCURR current measured in driver OFF state Cc 0 7 0 7 2 UNDERCURR open circuit cannot reach tar get current 59160002 Edition 01 29 05 2013 Bak Page 20 28 Mach LED 2SC Hybrid Dr Mach Lamps and Engineering PY OTE T A m m 99160002 0 7 0 9 A 0 9 A OIN OlT mMm a OST Co N IOA Oo Nh 0 7 0 9 0 9 OIOIOIOIO el at a a om 0 9 0 9 AION Ol oF oF oF oO OT OT OO Oe Ol 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 oroject h xxxx_MODULE_ID Digits 3 4 decimal error code 00 99 see source code retval h MAIN _ TIMER _ WATCHDOG _ CAN _ CANCOM _ EEDATA _ FLASHCHK _ CONTROL _ CONTROL REF MOTOR __ LEDCTRL_ SWITCH _ MMISLAVE KEY _ MMISLAVE LED _ LCD _ USER _ ADCINT DIPSW __ CRITVAR _ OK ERR ERR_ILLEGAL CASE ERR_ILLEGAL_ ACT E NULLPOINTER E EXECFLAGNOTFALS E E WDFAIL E WDRESET E FLASHCHK_FAIL E TICKOV E SLOWTICKOV Edition 01 no error general error illegal case state in graph illegal action state in graph a function
3. adjustment is done by the control 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 increases The current light intensity level is shown by the digital display 6 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 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 decreases it with one step 4 4 Depth light You have the possibility to increase the light intensity of the central segment of the OT light This enables an optimum illumination of the wound field according 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 increased depth illumination is needed To activate the depth light press push button 7 on the control panel 59160002 Edition 01 29 05 2013 Bak Page 9 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 4 5 Dental mode The light can be used as a treatment light for
4. be necessary such as reorienting or relocating the MACH LED 2SC Hybrid P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 59160002 Edition 01 29 05 2013 Bak Page 27 28 Mach LED 2sc Hybrid 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 2SC Hybrid The MACH LED 2SC Hybrid is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MACH LED 2SC Hybrid can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MACH LED 2SC Hybrid 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 of transmitter a L17VP d L17VP d 2 344 P 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 rat
5. brakes if necessary after installation Preventive maintenance of the light should be done every two years This includes a technical and mechanical check up Please observe also the manufacturer s mounting instructions for the ceiling and wall attachment Em ie In order to keep the system easy running throughout its life soan 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 dismounting the lamp Please observe also the manufacturer s mounting instructions for the ceiling and wall attachment A 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 59160002 Edition 01 29 05 2013 Bak Page 19 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 7 Troubleshoot
6. communication line because it can not be ensured that the protective conductor has a OV potential all the time In case the com munication line is in contact with the protective conductor due to an installation error it is possi ble that the communication does not work correct Eventually the function 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 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 in crease 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 exceed ing 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
7. dentistry The outer LED units turn off and the illumi nated central LED unit creates an oval shaped light field for the glare free illumina tion of the oral cavity Dr Mach To activate the dental mode press push button 8 on the control panel Transferring the dental mode function to the ring of the handle In order to transfer the dental mode function to the ring of the sterilisable handle press first the DENTAL push button and then the ON OFF button on the key pad The display ON near the DENTAL push button is blinking Eg The previous function on the ring is de activated A right turn of the ring at the handle activates the dental mode a left turn of the ring deac tivates the dental mode 59160002 Edition 01 29 05 2013 Bak Page 10 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 4 6 Deactivating all functions on the ring of the handle The functions on the ring of the handle can be completely deactivated Press first of all push button RING OFF and then the ON OFF button on the key pad The ring on the handle is without func tion In order to transfer a function on the ring please proceed as described in the chapters before 4 7 Communication with a wall panel 0n 0F1 sY The lights Mach LED 2SC Hybrid can be a operated by communicating with a wall pan el This function is available against sur charge DEPTH The communication is activated and deac tivated by pressing the
8. has received a null pointer where not applicable execution flag was not false in graph watchdog test failed watchdog did not reset the CPU correctly an unintended watchdog reset has occurred the FLASH CRC check failed Ticker tasks overflow tasks too slow Slow Ticker tasks overflow tasks too slow 29 05 2013 Bak Page 21 28 Dr Mach Lamps and Engineering Mach LED 2SC Hybrid 8 Data 8 1 Technical data Mach LED 2SC Hybrid OT Mode Dental Mode 100 000 Lux 30 000 Lux Central light intensity Colour rendering index Ra 95 95 Colour rendering index Rg gt 90 gt 90 Focusable light field size 16 24 cm J pine Electronic light intensity control 50 100 50 100 Colour temperature Kelvin 4300 K 4300 K Temperature increase near head 0 5 C 0 5 C Number of LED s 21 6 Working distance 70 140 cm 70 140 cm Height adjustment 118 cm 118 cm 1 m distance 0 7 m distance Remark The technical data are subject to fluctuations Due to manufacturing reasons the real values can slightly differ from the data mentioned above The values for R and Rg can differ with approx 5 The values for the colour temperature can differ with approx 200K 8 2 Electrical data Mach LED 2SC Hybrid OT Mode Dental Mod Power consumption 30 W 10 W Operating voltage 28 V DC 28 V DC Current 1A 0 4 A 59160002 Edition 01 29 05 2013 Bak Page 22 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 8 3 Enviro
9. oe en tee nec CE Oo Oe ee ee eee 24 10 DISDOSAll E O E E E E E EEE EE E 24 lis OPE Ot ae 25 12 EIOCIFOMAGHENC COMPANY srra EE a AKERRETA 26 59160002 Edition 01 29 05 2013 Bak Page 2 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering Dear customer Congratulations for acquiring our new OT light MACH LED 2sc Hybrid The new OT light generation with LED technology supports your professionali ty by innovative technology and design The advantages of the LED technology adjustable light color 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 color reproduction exact illumination of the wound field and easy positioning of the light head 59160002 Edition 01 29 05 2013 Bak Page 3 28 Mach LED 2sc Hybrid 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 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 lightin
10. push button SYNC on the key pad of the light 59160002 Edition 01 29 05 2013 Bak Page 11 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering 4 8 Basic operating 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 ad dressing 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 instal lation 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 address 1 Although the sticker is labeled Sync Address it refers not only to the communication be tween 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 plac ing the order that a combination LED 3 LED 3 and another combination LED 5 LED 5 was ordered these combinations will b
11. special preventive measures regarding the electromagnetic compatibility and must be installed according to the EMC instructions men tioned in the accompanying 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 The MACH LED 2SC Hybrid is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 2SC Hybrid should assure that it is used in such an environment Electromagnetic environment guidance 7 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Class C The MACH LED 2SC Hybrid 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 12 RF emissions Cormpblies The MACH LED 2SC Hybrid 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 immunity The MACH LED 2SC Hybrid is intended for use in the electromagnetic e
12. Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin Instructions for use MACH LED 2SC HYBRID Mach LED 2SC Hybrid mobile light cscccccesseeceesescenseesenneeseenseseenseesenseeses 190 430 1200 Mach LED 2sc Hybrid mobile light with emergency power battery 190 430 1500 Mach LED 2SC Hybrid wall model cccsccseeeteeseeeeeeeeeeeeeenseeeeeeneeeseeseesenenneeeees 190 430 2100 Mach LED 2sc Hybrid wall model for room heights to 2 8M ccessecseeseees 190 430 2101 Mach LED 2sc Hybrid ceiling light for room heights to 2 8m 0008 190 430 3127 Mach LED 2sc Hybrid ceiling light for room heights 2 8m 3m 190 430 3130 Dr Mach GmbH u Co 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 59160002 Edition 01 29 05 2013 Bak Page 1 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering List of contents Tis oale WS UPICUOM Stas seceterecs eter cerata nes elone a satana ssa lo sasaanstes seats ianst ate aaed aened aati 4 2 Brief description of the light Mach LED 2SC Hybrid cceccccseseeeeeeeeeaeeeesaeeees 6 Zale Merging OF MNGMU NGOS esi dieiie eaten oieten ele E AE 6 252 LIQMUINIENSILY COMMON aesae ei EA E Ten aeie Ee 6 3 Light functions operated at the sterilisable handle cccccccseeeceeeeeeeeeeeeseeeseeeens 7 4 Operat
13. ch Lamps and Engineerin 3 Light functions operated at the sterilisable handle A D 59160002 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 01 29 05 2013 Bak Page 7 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 4 Operating the light Mach LED 2SC Hybrid 4 1 Turning the light ON and OFF The push button 1 on the control panel turns the light Mach LED 2sc ON and OFF 4 2 Adjusting the light field with the sterilisable handle The light field can be adjusted by turning the sterilisable handle 2 The current size of the light field is shown by the digital display 3 59160002 Edition 01 29 05 2013 Bak Page 8 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 4 3 Light intensity control Select the desired light intensity before surgery It is recommended to start with 80 of the max imum light intensity and to increase the light intensity in time At these models the
14. e 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 operation theatres it must be observed very carefully which lights are go ing 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 damaged and lies on a voltage of approx 1V After a correct installation and during reg
15. g 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 authorized 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 The light works only with an external power supply 250VA The external power supply used with the OT light must be tested and validated according to IEC 60601 1 Attention A main control switch must be installed for turning the system power off 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 a
16. icient cleaning disinfection are essential requirements for an effective sterilisation of the handle Within the scope of responsibility for the sterility of the products it should be noted that only suf ficiently 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 99160002 Edition 01 29 05 2013 Bak Page 16 28 Mach LED 2sc Hybrid 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 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 princi ple 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 Chlo
17. ing In case of a malfunction 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 er rors of the cluster boards 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 numbers have the higher priority Decoding Digit 1 Digit2 Digit3 Digit 4 Cc 0 7 i Cluster errors always begin with the letter c digit 2 is the cluster adress 0 7 Cc 0 7 No contact to the cluster c 0 7 General cluster error reported by the cluster reset by switching ON and OFF Digit 4 Bit number oft he error MADA TAID_CANPAR_STATUS xxx c 0 7 0 WDRESET CPU was reset by WD C 0 7 1 SWRESET SW reset because of fatal error C 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 pre served c 0 7 6 EEWRERR EEPROM write error when writ ing parameters C 0 7 7 reserved C 0 7 8 UNDERVOLT 24V supply undervoltage C 0 7 9 NOCOMM no data received for too long a time C 0 7 0 7 LED error reset by switching ON and OFF Digit 3 LED channel 0 7 CW1 WW1
18. ing 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 59160002 Edition 01 29 05 2013 Bak Page 28 28
19. ing the light Mach LED 2SC HYbrid ce cccececcceeeeeeeeeeseeeeseeeeeseseeeseeesaeeeeeas 8 Acte Tamno The lGntON ANG OFF ss scsscssvacsseeerscevressveasneuensadapcusperanseanstanccanseascuanetensues 8 4 2 Adjusting the light field with the sterilisable Nandle cccceccesseeeeeeeeeeeaeeees 8 4 3 LIGNTINIGCNSILY CONMOlsissectaicinsctonionctorndoostoenioent sexeeeatounteentarnanresvmauieis Qaateasvennee ss 9 Ae DEDIN secausdesesanedastedoutdaseaansaueasusaiue TA 9 45 Denta Mode sci asepereiadetren science n a i peli Red eeudyivdeiv E 10 4 6 Deactivating all functions on the ring of the handle cece secceeeeeeeeeeeeee 11 4 7 Communication with a wall panel cccccccccceseeceeeeeeesseeeeseeeeesseeeeseeeeesaaeeeeas 11 kds TOSCO MING ea 16 3 11 8 e se eee N se en ere 16 Ble StEHNSable Nand E nan 16 5 2 Lamp housing protective disk and support system cccccceeeeeeeeneeeseeeeeeeens 18 6 MAINVCN ANG sass dace sucess gtaxencsdearscdacinusidascananensGunwacau mean E R EREE 19 6 1 Periodical maintenance WOM assirinati 19 fa TROUDICSNOOUNG soei A 20 Oe Ae E T E AE IE E EE R 22 Gl 216919 672109 2 12 Tora ony oO mn RE PORN at oe PR UR AE OREO PURO Oe eNn eI 22 92 26 1 4 62 lt ene eee eee ce ee ee nee ere 22 8 3 TENVIFONIMENLAlCOMGINIONS eiretie EA E Geuiatn Sein gunn Gehan 23 G24 IMPONA TEMAK 2 wh uiss eposewenaianwnadaciaconegeradenabuiadensbesau E A 24 I ete 0
20. ion after installation the polarity must be checked at the secondary side of the power supply 9 CE mark products of the European Community s Council Dr Mach applies the standard EN 60601 2 41 C The products Mach LED 2SC Hybrid 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 eet proceeding The rest of the components should be disposed according to the contained materials 59160002 Edition 01 29 05 2013 Bak Page 24 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering 11 Spare parts Pos Spare pan PartNo LED module incl cooling body for Mach LED 2SC Hybrid 67100607 Cluster board for Mach LED 2SC Hybrid 67150206 EE 6 Handle adapter M for Mach LED 2SC Hybrid 18220001 8 Keypad incl holder for Mach LED 2SC Hybrid 16120001 9 Power supply 250W incl connecting cables 72000084 Set of cover caps for LED 2 housing 72000053 59160002 Edition 01 29 05 2013 Bak Page 25 28 Mach LED 2SC Hybrid Dr Mach Lamps and Engineering 12 Electromagnetic compatibility The Dr Mach OT and examination lights are subject to
21. ion 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 communication 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 potential on this line This means that in case a measurement is done on this line the measured value must be OV 59160002 Edition 01 29 05 2013 Bak Page 14 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering Due to the possibility of checking the lines by measuring the potential on them the colour mark ings 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 dis charged 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 Af
22. ite 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 ceiling tube cables must be changed individually and one after another If 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 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 supp
23. l environment Mains power quality should be that of a typical commercial or hospital environment If the user of the MACH LED 2SC Hybrid requires continued operation during power mains interruptions it is recommended that the MACH LED 2SC Hybrid 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 NOTE U is the a c mains voltage prior to application of the test level 99160002 Edition 01 29 05 2013 Bak Page 26 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering Table 4 Guidance and 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 2SC Hybrid is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 2SC Hybrid 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 2SC Hybrid including cables than the recommended separation dis tance calculated from the equation applicable to the fre quency of the transmitter Recommended separation distance Conduc
24. le stand Maintenance of the light should be scheduled every 2 years The light has a fixed electrical connection ceiling lights and wall lights The OT light MACH LED 2SC Hybrid is available in following versions Mach LED 2SC Hybrid with merging of light fields and light intensity control The OT light Mach LED 2SC Hybrid offers two different operating modes for the doctor e OT mode The light can be used as a normal OT light for the oral and maxillofacial surgery All functions of the light are available changing of the light field size depth light light inten sity control e Dental mode The light can be used as a treatment light for dentistry The photometric properties of the dental mode are orientated to the standard DIN EN ISO 9680 Dentistry Operating lights The outer LED units turn off and the illuminated central LED unit creates an oval shaped light field for the glare free illumination of the oral cavity 2 1 Merging of light fields The OT lights MACH LED 2SC Hybrid offer light field adjustment by merging the individual light fields of each LED unit by swiveling them NOTE This feature is activated by turning the sterilisable handle 2 2 Light intensity control The OT lights Mach LED 2SC Hybrid offer the feature of light intensity control You can adjust the light intensity between 50 and 100 according to your requirements 59160002 Edition 01 29 05 2013 Bak Page 6 28 Mach LED 2SC Hybrid Dr Ma
25. ly 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 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 at tachment 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 commu nication line In the worst case the communicat
26. nmental conditions Operation Relative atmospheric humidity 700 hPa 1060 hPa Transport storage Relative atmospheric humidity 700 hPa 1060 hPa References on the package 50 C RH P 10C 20 90 700hPa 1060hPa E Temperature range Athmospheric Air pressure for transport humidity for transport and storage for transport and storage and storage 59160002 Edition 01 29 05 2013 Bak Page 23 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 8 4 Important remarks ie 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 opera tion 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 0100 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 MN Alternating current ie The polarity is very important for the installation of the light In case the light does not funct
27. nvironment specified below The customer or the user of the MACH LED 2SC Hybrid should assure that it is used in such an environment Immunity test EO A060 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 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Us gt 95 dip in U for 0 5 cycle 40 Ur 60 dip in U7 for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Us gt 95 dip in U 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 U for 5 sec 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 hospita
28. on the life soan 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 cluster 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 changing the polarity at the ceiling flange If the polarity at the power
29. rinated hydrocarbons 2 ethoxyethanol When cleaning disinfecting the following procedures must be followed pe OOO 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 a 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 59160002 Edition 01 29 05 2013 Bak Page 17 28 Mach LED 2sc Hybrid 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 pa per 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 permissi ble Steam sterilisation procedure Validated in accordance with
30. rms is to be done ONLY AFTER DISCONNECTING THE ENTIRE SYSTEM FROM MAINS Otherwise the main control board will be damaged 59160002 Edition 01 29 05 2013 Bak Page 4 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin Symbols and notes used in this user manual This symbol means possible hazard sources Please observe also the safety re marks and the hazard specifications mentioned in the mounting instructions and us er 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 instruc tions and user manuals from Ondal company This symbol refers to important mounting indications useful information and opera tion hints This symbol indicates to observe the user manual Alternating current Bulb 50 Indication on China RoHS Pollution control Logo China z 50 C Temperature range for transport and storage 10 C ps Indication for disposal a 59160002 Edition 01 29 05 2013 Bak Page 5 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineerin 2 Brief description of the light Mach LED 2SC Hybrid Intended use of the light Mach LED 2sc Hybrid 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 to the wall or on a mobi
31. rom 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 panel to the orange terminals on the ceiling flange Connect the primary side of the power supplies to mains and check if the communication be tween wall and light is working 59160002 Edition 01 29 05 2013 Bak Page 15 28 Mach LED 2SC Hybrid Dr Mach Lamps and Engineerin 4 9 Positioning Use the sterile handle 10 or the handle rails 9 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 Cleaning Cleaning disinfection and sterilisation Basics 5 1 Sterilisable handle At delivery the lamp is equipped with the handle sleeve 11 The handle sleeve is removable and sterilisable Before using the first time and be fore every use the handle sleeve must be cleaned disinfected and sterilised The handle sleeve must be removed for sterili sation e o remove press the lock V and pull off the sterilisable handle sleeve 11 while keeping the lock pressed e To attach push on and slightly twist the handle until the lock V engages securely E m Handles often become unsterile during an operation Therefore always keep additional handles available for exchange Eff
32. 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 supply is connected to the OV line of the other power supply 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 If 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 59160002 Edition 01 29 05 2013 Bak Page 13 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering 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 s
33. ted RF 3V 3V d 1 17VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 17V P80 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 Q NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic is affected by absorption and reflection from structures objects and people a 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 2SC Hybrid is used exceeds the applicable RF compliance level above the MACH LED 2SC Hybrid should be ob served to verify normal operation If abnormal performance is observed additional measures may
34. ter 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 lf the synchronisation 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 f
35. ular 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 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 com pletely 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 capaci tors 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 ob served that the OV wires of all the power supplies that are used for lights with communication are bridged 59160002 Edition 01 29 05 2013 Bak Page 12 28 Mach LED 2sc Hybrid Dr Mach Lamps and Engineering The protective conductor green yellow has no use for the communication There must not be any con nection between the protective conductor and the
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