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KAUKO XI-M User Manual
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8 / 14Depending on the medical purpose of the overall system, it may also be necessary to install agalvanic isolator between an active medical product and computer system for the Kauko Xi-Mcomputer to comply with the requirements of IEC/EN 60601-1. A galvanic isolator isolates thewanted signal of the respective PC interface such as network, USB or DVI interfaces. ContactKauko sales or your authorized Kauko dealer for validated isolators.Safety instructions for operation in the patient environmentUnder national legislation, standards and guidelines are always to be followed. If the Kauko Xi-Mcomputer is used in the patient environment in conjunction with active medical products that wereintroduced according 94/42/EEC guidelines, a new medical system is created and must be re-evaluated. Peripheral devices within the patient environment, such as printers or cameras, mustalso comply with the requirements of IEC 60601-1 and IEC 60601-1-2 or be additionally equippedwith two-stage protection for the patients. This additional protection can be ensured by usingisolation transformers or isolators in the connecting cable. Grossly negligent non-compliance withcurrent regulations places the lives of patients and those of uninvolved third parties in possibledanger. When in doubt, contact your Kauko support team to create a safe environment for you andyour patients. We will be happy to help you.3. Integration in a medical systemIn the case of integration of the Kauko Xi-M computers in a medical electrical system, therequirements of the valid version of IEC 60601-1 and possibly the requirements of the medicalproduct guidelines 93/42 EEC (2007/47/EC) are to be complied with, and the risk evaluation mustbe done by the system creator. The Kauko Xi-M computer must only be electrically connected andoperated with products and devices that comply with the requirements of the standards EN/IEC60601-1 and EN/IEC 60950-1. Before the integration of Kauko Xi-M computers in a system, besure to ask the manufacturer of the medical system if this requirement for the operation with acomputer is specified. If operation with the computer is permitted, keep strictly to the systemmanufacturer’s recommended performance values for the computer unit. Connected data cablesmust be separately isolated, where appropriate, as well as the connecting cable between theKauko Xi-M computer and other possible connected devices.4. Operation in a networkThe Kauko Xi-M computer may only be operated in a network that complies with the requirementsof EN 50173 and ISO/IEC 11801. We, as the manufacturer of Kauko Xi-M computers, will not beliable for transmission failures, data loss or electrical surges and short circuits in your networkstructure that could occur due to non-standard installation. Only allow the installation on yournetwork to be carried out by the network administrator or a person authorized by them. Do notcarry out any changes to your network without the authorization of the network administrator. Inaddition, in the case of use in the vicinity of patients, the instructions listed under Chapter 2.“Patient environment” are to be taken into account.5. Safe operationData protection |
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