KAUKO XI-M, User Manual, Page: 8 / 14

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Depending on the medical purpose of the overall system, it may also be necessary to install a
galvanic isolator between an active medical product and computer system for the Kauko Xi-M
computer to comply with the requirements of IEC/EN 60601-1. A galvanic isolator isolates the
wanted signal of the respective PC interface such as network, USB or DVI interfaces. Contact
Kauko sales or your authorized Kauko dealer for validated isolators.
Safety instructions for operation in the patient environment
Under national legislation, standards and guidelines are always to be followed. If the Kauko Xi-M
computer is used in the patient environment in conjunction with active medical products that were
introduced 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, must
also comply with the requirements of IEC 60601-1 and IEC 60601-1-2 or be additionally equipped
with two-stage protection for the patients. This additional protection can be ensured by using
isolation transformers or isolators in the connecting cable. Grossly negligent non-compliance with
current regulations places the lives of patients and those of uninvolved third parties in possible
danger. When in doubt, contact your Kauko support team to create a safe environment for you and
your patients. We will be happy to help you.
3. Integration in a medical system
In the case of integration of the Kauko Xi-M computers in a medical electrical system, the
requirements of the valid version of IEC 60601-1 and possibly the requirements of the medical
product guidelines 93/42 EEC (2007/47/EC) are to be complied with, and the risk evaluation must
be done by the system creator. The Kauko Xi-M computer must only be electrically connected and
operated with products and devices that comply with the requirements of the standards EN/IEC
60601-1 and EN/IEC 60950-1. Before the integration of Kauko Xi-M computers in a system, be
sure to ask the manufacturer of the medical system if this requirement for the operation with a
computer is specified. If operation with the computer is permitted, keep strictly to the system
manufacturer
’s recommended performance values for the computer unit. Connected data cables
must be separately isolated, where appropriate, as well as the connecting cable between the
Kauko Xi-M computer and other possible connected devices.
4. Operation in a network
The Kauko Xi-M computer may only be operated in a network that complies with the requirements
of EN 50173 and ISO/IEC 11801. We, as the manufacturer of Kauko Xi-M computers, will not be
liable for transmission failures, data loss or electrical surges and short circuits in your network
structure that could occur due to non-standard installation. Only allow the installation on your
network to be carried out by the network administrator or a person authorized by them. Do not
carry out any changes to your network without the authorization of the network administrator. In
addition, 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 operation
Data protection