MACH LED 130F / 130
Contents
1. 2 kV common mode lt 5 Us gt 95 dip in U for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in U7 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 Ur for 5 cycles 70 Ur 30 dip in U for 25 cycles lt 5 Us gt 95 dip in U7 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 hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the MACH LED 130F 130 requires continued operation during power mains interruptions it is recommended that the MACH LED 130F 130 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 59140001 Edition 08 05 05 2013 Bak page 16 18 Ma2. When using more than one OT lamp at the same time OT lamp combinations please make sure that the total radiation intensity in field is less than 1000 W m to avoid further temperature increase in the wound field 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 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 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 7 CE mark The products Mach LED 130F 130 comply with the standards 93 42 EEC for medical products of the European Community s Council Dr Mach applies the standard EN 60601 2 41 Dr Mach GmbH is certified according to DIN EN ISO 13485 2003 AC 2009 8 Disposal DS E The OT lamp doesn t contain any dangerous goods NZ 4 The components of the OT lamp should be properly disposed at the end of its shelf life i Make sure that the materials are carefully separated i O The electrical c
3. by MMM M nchner Medizin Mechanik GmbH sterilising temperature 134 C holding time 7 min Inspection durability The handles should be inspected for damage and changed before re use if required The handles may be cleaned disinfected sterilised and re used for a maximum of 1000 times If the handles are re used more than 1000 times then this will be the responsibility of the hospital clinic 59140001 Edition 08 05 05 2013 Bak page 9 18 Mach LED 130F 130 Dr Mach Lamps and Engineering 4 2 Lamp housing protective disk and support system 9 C lt a The Dr Mach OT lamp system has a high quality Y wv surface which can be cleaned with conventional cleaning agents VP The protective disk 9 is made of a high quality plas i l tic Pay attention to the following during cleaning Never wipe over the protective disk 9 with a dry cloth always clean with a wet cloth Only use disinfectants with less than 20 alco hol Wipe the protective disk 9 after cleaning with an antistatic non fluffy cloth Alc lt 20 59140001 Edition 08 05 05 2013 Bak page 10 18 Mach LED 130F 130 Dr Mach Lamps and Engineerin 5 Maintenance 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 runnin
4. for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MACH LED 130F 130 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MACH LED 130F 130 as recommended below ac cording 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 d LI7VP d 117VP d 2 344 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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 59140001 Edition 08 05 05 2013 Bak page 18 18
5. light to a smaller area depending on the circumstances To activate the function of focusing turn the handle 5 see figure 3 4 Positioning Use the handle 5 6 or the handle rail 7 to position the lamp Use the handle rail to position the lights before the operation Use the handle for positioning the light during the operation There are two handle types available e Standard handle 5 e Sterilisable handle 6 against surcharge The sterilisable handle can be removed for sterili sation Edition 08 05 05 2013 Bak page 7 18 Mach LED 130F 130 Dr Mach Lamps and Engineerin 4 Cleaning 4 1 Sterilizable handle The light can be equipped against surcharge with a the sterilisable handle 8 The handle sleeve is re W w movable and sterilisable Before using the first time Pa and before every use the handle sleeve must be je cleaned disinfected and sterilised oN F i F ___ 8 TAN V The handle sleeve must be removed for sterilisation e o remove press the lock V and pull off the steri lisable handle sleeve 8 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 Cleaning disinfection and sterilisation Basics Efficient cleaning disinfection is an essential requirement for effective sterilisation of the handl
6. 2 6ds Tecnicaldata nerse re emcee ene eter ne Uae eee at ce ee eNO es ere meee eee nee 12 02 Elecmcaldal arerin E A E E 13 63 ENVIIONMEnNlalCOnNdHoNS aserrea tntdaweunaiatnae eat uaa aautadercaeutatacatanabe 13 64 Generare ma KS ran past atte arog E O 14 Ph CE MAR rera 14 Oe MWISOOS a E wanidedaumetieeme a taee son 14 i SV NII a cel a E ieee 15 10 EICCIFOMAGNEIIC COMPATIONILY zgran T bone GeanGineGuentuaguccsutets 16 59140001 Edition 08 05 05 2013 Bak page 2 18 List of contents Mach LED 130F 130 Dr Mach Lamps and Engineering Dear customer Congratulations for acquiring our new OT light MACH LED 130F LED 130 The new OT light generation with LED technology supports your professional ism by innovative technology and design The advantages of the LED technology a life span of minimum 40 000 hours and an almost non existent 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 59140001 Edition 08 05 05 2013 Bak page 3 18 Mach LED 130F 130 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 t
7. 30F 130 should assure that it is used in 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 130F 130 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 omole The MACH LED 130F 130 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 130F 130 is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 130F 130 should assure that it is used in such an environment Immunity test EU GIGO 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
8. Mach LED 130F 130 Dr Mach Lamps and Engineerin Instructions for use MACH LED 130F 130 Mach LED 130F 130 mobile lights one handed height adjustment Mach LED 130F 130 mobile lights SWING Mach LED 130F 130 wall lights Mach LED 130F 130 ceiling lights 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 59140001 Edition 08 05 05 2013 Bak page 1 18 Mach LED 130F 130 Dr Mach Lamps and Engineering te Sde IAS MUCHON erea a a deel 4 2 Brief description of the light MACH LED 130 aannnannnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnrnsnrnsnnnne 6 3 Operating the light MACH LED 130F 130 ccc ceeeeeeeeeeeeeeeeeeeeeeseaeeeeeeeeeeeaees 6 eM FOI OR Sin aaa a E AEN E O O seasons 6 Oe KONFNMENSIY CONTO lce AS 6 Ios Ae OCUSIING n a E ested ceed creed een ueaseain ae ernagaenad eae 7 SA FO SONNO sorar dss ican cantata E T 7 d EANN aee ae ee re ee Ove a eee er 8 Ais eNe INGIMGIC acest ccitave shake oe ctstcc bance EE tetas canis 8 4 2 Lamp housing protective disk ANd support SYSTEM eee eececeeteeeesteeeessteeeeeees 10 Bie MOA UNG O atte tren la veka EE aa de dudetokesctetudetesetaty inte inte dndelnts sets 11 5 1 Periodical MAINTENANCE work cccccessssccssssceesseecssseeecsssssesssseecssseeeesssesesssseeeesenees 11 O Dalar ales shes aster ade lasee eles E saad tere ian eyes 1
9. ch LED 130F 130 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 immunit The MACH LED 130F 130 is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 130F 130 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 130F 130 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 117VP 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 symb
10. ch 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 electronic board will be damaged 59140001 Edition 08 05 05 2013 Bak page 4 18 Mach LED 130F 130 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 i 50 C Temperature range for transport and storage 10 C _ Indication for disposal 59140001 Edition 08 05 05 2013 Bak page 5 18 Mach LED 130F 130 Dr Mach Lamps and Engineerin 2 Brief description of the li
11. depth 20 1750 mm 1750 mm Illumination depth 60 650 mm 650 mm Colour rendering index Ra 95 95 fannie 14 25 cm 17 cm fixed focus Colour temperature Kelvin 4300 K 4300 K Fiend control 50 100 50 100 Hallas tab increase 0 5 C 0 5 C Number of LED s 19 19 Working distance 70 140 cm 70 140 cm Diameter of the light head 33 cm 33 cm Height adjustment 123 cm 123 cm 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 Ra can differ with approx 5 The values for the colour temperature can differ with approx 200K 59140001 Edition 08 05 05 2013 Bak page 12 18 Mach LED 130F 130 Dr Mach Lamps and Engineerin 6 2 Electrical data Mach LED 130F Mach LED 130 Power consumption 22 W 22 W Operating voltage DC 24V DC 24V DC Current 0 9 A 0 9 A 6 3 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 gt 20 90 700hPa 1060hPa Temperature range Atmospheric Air pressure for transport humidity for transport and storage for transport and storage and storage 59140001 Edition 08 05 05 2013 Bak page 13 18 Mach LED 130F 130 Dr Mach Lamps and Engineerin 6 4 General remarks
12. e Within the scope of responsibility for the sterility of the products it should be noted that only sufficiently validated equipment and product specific processes are used for cleaning disinfection and that the vali dated parameters are complied with in every cycle In addition the hospital clinic hygiene regulations must be observed Cleaning disinfection Cleaning and disinfection must be carried out immediately after use A mechanised process disinfector should be used for cleaning disinfection The efficiency of the 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 59140001 Edition 08 05 05 2013 Bak page 8 18 Mach LED 130F 130 Dr Mach Lamps and Engineering When cleaning disinfecting the following procedures must be follo
13. g 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 5 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 Acrobat Swing ceiling attachment 59140001 Edition 08 05 05 2013 Bak page 11 18 Mach LED 130F 130 Dr Mach Lamps and Engineerin 6 Data 6 1 Technical data Mach LED 130F Mach LED 130 a 60 000 Lux 50 000 Lux Light field diameter dio 142 mm 166 mm Light field diameter dso 73 mm 83 mm Light intensity with one shadower 0 15 0 16 Light intensity with two shadowers 60 60 amp P on the ground of a 100 100 mlb bie n 003 002 Ss con con Illumination
14. ght MACH LED 130 Intended use of the light Mach LED 130F 130 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 130 is available in following versions Mach LED 130F with focusing function and light intensity control Mach LED 130 fixed focus with light intensity control 3 Operating the light MACH LED 130F 130 3 1 ON OFF switch The push button 1 on the control panel turns the light MACH LED 130F 130 ON and OFF J o 3 2 Light intensity control The lights Mach LED 130F 130 offer the facili ty of light intensity control The adjustment range of the light intensity is from 50 to 100 The light intensity can be adjusted according to the requirements of the surgeon physician The light intensity can be decreased by press ing push button 2 The light intensity can be increased by pressing push button 3 The set light intensity is shown by the display 4 59140001 Edition 08 05 05 2013 Bak page 6 18 Mach LED 130F 130 Dr Mach Lamps and Engineerin 59140001 3 3 Focusing The lamp models Mach LED 130F have a focusing function That means you can either enlarge the diameter of the light field or bundle the
15. he 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 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 swit
16. ol 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 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 130 is used exceeds the applicable RF compliance level above the MACH LED 130F 130 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 130F 130 P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 59140001 Edition 08 05 05 2013 Bak page 17 18 Mach LED 130F 130 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 130 The MACH LED 130F 130 is intended
17. onducting boards should be submitted to an appropriate recycling pro al ceeding ee The rest of the components should be disposed according to the contained materials 59140001 Edition 08 05 05 2013 Bak page 14 18 Dr Mach Lamps and Engineerin Mach LED 130F 130 9 Wiring diagram power supply 60W DC contact bloc 1 and 2 2 5mm plue L raar D E E brown m See rere iil I I Be sS Pe llel 0 llow PE 5 ry geeoye CO III PEII IIe O gt 3 O E A T ES OIN A ES PA clamp 10mm lt 0 IPALI Q PA if available oe green yellow _ 59140001 Edition 08 05 05 2013 Bak page 15 18 Mach LED 130F 130 Dr Mach Lamps and Engineering 10 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 documenis 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 D The MACH LED 130F 130 is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 1
18. wed p OOOO O 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 Drying external 100 120 C Drying external 100 120 C Door open close amp transport 60 sluice discharge Cycle time overall ca 290 5 minutes When occupying the disinfection zone washing zone 2 the re rinse and draining times will depend on the respective objects being washed therein Sterilisation Only previously cleaned and disinfected handles may be sterilised The handles are placed in a suitable sterilisation pack one way sterilisation pack e g foil paper 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 vacu um process Euroselectomat 666
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