User Manual - DeMeTec GmbH
Contents
1. 7 Contact Manufacturer If you have any questions or problems please contact your local dealer or the manufacturer DeMeTec GmbH Lutzelwiesen 5 35428 Langg6ns Germany Tel 49 6403 7874 0 Fax 49 6403 7874 30 email DeMeTec de http www DeMeTec de User Manual Nwl V4 4 Rev 2 Datum 2012 05 31 DeMeTec GmbH 2007 12 3 8 Technical Description 8 1 Classification Det eae DeMeTec GmbH Lutzelwiesen 5 35428 Langg ns Germany product designation Medical Network Isolation Nwl Giga mains voltage not applicable mains frequency not applicable power consumption not applicable classification protection class not applicable protection against penetration of liquids no protection protection class of the applied part against electric shock not applicable protection class against discharge of defibrillators not applicable protection in presence of explosive gases or aerosols e g nitrous oxide or anaesthetics according to EN 60601 no protection 1 2006 annex G cause G2 operation mode continuous operation temperature 32 F to 160 F 0 C to 70 C operating conditions relative humidity 10 to 90 non condensing temperature 15 F to 185 F 25 C to 85 C storage conditions relative humidity 10 to 95 non condensing dimensions LxWxH 90x50x25 mm weight 64g classification as defined by Annex IX MDD class 8 2 Technical Data2. IEEE 803 2 10 100 Base T Twisted Pair auto conf com network specification f p pletely transparent in the network voltage endurance between the network connectors 4kV connectors 2 x RJ45 10MBit 10 Base T lt 0 5dB Network cable length maximal 100m attenuation 100MBit 100 Base T lt 0 7dB max Network cable length min 95m 1000MBit 1000 Base T lt 2 3dB max Network cable length min 80m 8 3 Accessory The following accessory can be obtained for the Nwl e Patch cable 0 5m grey CAT5e item no WR 083 4 User Manual Nwl V4 4 Rev 2 Datum 2012 05 31 DeMeTec GmbH 2007 12
3. clicking sound The Nwl Giga should be installed near to the medical device system PC Take account of the safety instructions of chapter 1 2 Functional safety According to the operation purpose one of the following installations is advised 1 Linking a medical device or system PC to a local practice or clinical network ES Medical Network Insulation NwI Giga V4 4 Praxis Kliniknetzwerk Medizinprodukt system normales Netzwerkanschlusskabel kurzes Patchkabel von NwI zu PC 2 Direct link of a medical device or system PC to a work place in the doctor s or consulting room Medical Network Insulation Q Nwl Giga V4 4 Medizinprodukt system Aufnahmerechner Arbeitsplatz im Arzt oder Sprechzimmer normales Netzwerkanschlusskabel gekreuztes Patchkabel Crosslink von NwI zu PC 4 Cleaning and Disinfection Attention Switch off before cleaning the ME Device System Dis connect the Nwl before cleaning To clean the device you should use a cloth moisturised with a mild cleaning agent You can also use clinical cleaning and disinfection agents Vol Alcohol lt 70 Scouring agents or aggressive clean ing agents are not suitable You should also take care that no liquids get into the Nwl 5 Safety Technical Inspection Control STC We recommend that you regularly perform a STC by per sons who qualify for Operating Personne
4. User Manual Medical Network Isolation Type Nwl Giga V4 4 Galvanic Isolation for medical electrical devices and systems according to IEC 60601 1 2005 DIN EN 60601 1 2006 amp IEC 60601 1 2 2007 DIN EN 60601 1 2 2007 WARNING Prior to commission operation of the NwiI the user has to make himself familiar with the functionality of the Nwil by careful reading of this instruction manual Nia gavel Osi N3 1006 OSI N3 NIG saiBojouyoe JODIPSW pup Eaa juawanspou jo juewudojsnep JINAWI DA 1 General Safety Instructions The Nwl must be used solely for the purpose specified in Chapter 2 Purpose of Determination The Nwl must be in stalled and put into operation only by persons who qualify for Operating Personnel MPBetreibV 2 Abs 2 The case of the Nwl may not be opened There are no user serviceable parts inside the Nwl Do not perform any repairs or modi fications to the Nwl yourself Otherwise the correct func tioning of the Nwl and the security may be jeopardized Opening or modifying the Nwl voids the warranty The De MeTec GmbH reserves the right to modify the device without prior notice Before using the Nwl Giga contact the manufacturer of your medical device system and make sure that it is al lowed while sufficient galvanic Isolation is given to link your medical device system with local area networks LAN or other PCs 1 1 Application area Note that the Nwl is not protected agains
5. agnetic compatibility Requirements and tests 1 6 Declaration of Symbols AN Refer to documentation Network connection PC over patch cable 0O fo PC or cross link cable when linking PC to PC i Network connection LAN Hub Switch Tan Or LAN cable when linking PC to PC Must not be disposed of with household waste Dx 2 Purpose of Determination The device Medical Network Isolation Nwl Giga is espe cially designed for usage in the medical technology Its purpose is to connect a medical device or system which is equipped with a standard network interface to a local area network while relevant standards for electrical safety are met Linking two PCs with a cross link net work cable is possible too Other examples are 2 User Manual Nwl V4 4 Rev 2 Datum 2012 05 31 DeMeTec GmbH 2007 12 e Linking the PC of a long term EEG system to the prac tice or clinical network e Linking a EMG measuring system to a PC for analysis in the doctor s or consulting room Please refer to the fourth point of chapter 1 General Safety Instructions 3 Connection and Commissioning The Nwl Giga may only be installed and put into operation by qualified personnel Please contact your medical tech nical section or a system network administrator For the installation of the Nwl Giga two pluggable con nectors RJ45 are used Put the network cables into the sockets of the Nwl Giga until you hear the locks making a
6. kes back all equipment which put into circulation by DeMeTec GmbH for the purpose of proper disposal Please contact us in this regard if required and inform your customers when reselling 1 5 Instructions to suppliers manufacturers of Medical Electrical Device and Systems Networking The Nwl is a medical electrical device that was designed specifically for use in medical technology de veloped for various ME Devices Systems The existing in sulation distances in the Nwl meet the requirements of the standard IEC 60601 1 2005 Medical Electrical Equipment Part 1 General requirements for basic safety and essential per formance German Version EN 60601 1 2006 3 Edition The insulation chart is available upon request from the manufacturer of the Nwl The supplier manufacturer of the ME Devices Systems is recommended to consider the use of additional active safety measures such as an additional ground wire into account Basically to be considered by the supplier manufacturer of the ME Devices Systems device combinations with the requirements of the Medical Devices Act and the fol lowing standards IEC 60601 1 2005 EN 60601 1 2006 Medical electrical Equipment Part 1 General requirements for basic safety and essential performance e IEC 60601 1 2 2007 EN 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electrom
7. l 6 Abs 4 This includes the following steps e Visual inspection Visual inspection for external damage housing power cables connectors readable labels dirt etc Availability and completeness of documenta tion e Measurement of Isolation resistance All pins of one RJ45 have to be connected together and with the shield of the cable The Isolation resist ance between signal input and signal output part has to be higher than 50M Ohm EC Declaration of Conformity for medical devices as defined by directive for medical devices 93 42 EEC MDD 2007 Annex VII Ce DeMeTec development of measurement and medical technologies DeMeTec GmbH Litzelwiesen 5 35428 Langg ns Germany We hereby declare that the product Medical Network lsolation Gigabit Nwl Giga Version 4 4 was manufactured in harmony with the technical documentation as defined by Annex VII section 3 of the medical device directive and that it corresponds to the requirements of the following directive Medical Device Directive 93 42 EEC Meeting the following standards IEC 60601 1 2005 DIN EN 60601 1 2006 IEC 60601 1 2 2007 DIN EN 60601 1 2 2007 As well the following guideline will be followed Directive 2002 95 EC RoHS In compliance with the national law Electrical and Electronic Equipment WEEE Langgons 2012 05 31 Karl Winam Aajet Nobo Manager Quality Management Officer Head of Development Department Regulatory Affairs
8. t the effects of greater mechanical force and the penetration of liquids The Nwl is not intended for operation in combustible at mospheres 1 2 Functional safety When the electrical consumers are connected to the Nwl make sure that the following points are met e only network components according to IEEE 803 2 10 100 1000 Base T Twisted Pair are connected to the Nwl Giga Do not connect any telecommunic ation devices power supplies or similar things The Nwl Giga could be damaged or even persons could be harmed e only tested CAT 5e or better network cables with ac cording marks of conformity are used e the maximum length of network cables is reduced to 95m when using 100MBit network 100BaseT e the maximum length of network cables is reduced to 80m when using 1000MBit network 1000BaseT 1 3 Maintenance Warning The Nwl must be periodical inspected and maintained by by persons who qualify for MPBetreibV 6 Abs 4 will be subjected Repair of the Nwl must be carried out only by persons referred to above to ensure a hazard free opera tion See also 5 Safety Technical Inspection Control STC If in doubt please contact your supplier or the manufacturer DeMeTec GmbH 1 4 Environmental Protection disposal The DeMeTec GmbH is aware of its responsibility R towards the environment The Nwl may not be m disposed of into household waste According to the WEEE DeMeTec GmbH has been in volved since 2005 08 13 ta
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