KAUKO XI-M, User Manual, Page: 7 / 14

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external condensation with a clean, antistatic cloth and leave it standing without packaging material
for at least 2 hours before connecting the Kauko Xi-M computer to the mains supply. The unit can
only be connected when no further condensation forms.
Choice of location
The Kauko ST-M computer system must be placed in a dust-free, vibration-free and dry location,
and it must not come into direct contact with liquids and combustible gases. Ensure that the
computer has a firm, horizontal and level platform. The Kauko Xi-M computer must be operated in
a horizontal position. In a vertical operating position, there is the danger of injury if the unit tips
over. If a vertical position is desired, the original VESA mount should be used. Do not place the
power supply on the floor, as there is a danger of moisture ingress, for example, when the floor is
cleaned. Make sure the computer has enough room on each side to prevent the build-up of heat.
Under no circumstances must the power supply or the housing cover be covered up or blocked off,
as the unit will no longer be sufficiently cooled. If the unit is operated in a closed container or
cabinet, enough air circulation must be ensured. Otherwise there will be a danger of overheating. If
other installation options are chosen, it is to be ensured that nobody can be injured due to the
improper fixation of the computer. Kauko Xi-M has a unique VESA mounting solution integrated on
the housing.
2. Patient environment
To protect your patients from electrical influences, prevent contact between the patients and the
computer housing.
The Kauko Xi-M is a computer that was developed and tested for use in the vicinity of patients. It
fulfills the requirements of the EN/IEC 60950 and EN/IEC 60601-1-2 standards and the power
supply fulfills the requirements of the EN/IEC 60601-1 standard with respect to the electrical limit
values.
Electrical safety according to IEC/EN 60601-1
For the manufacture of a system consisting of computers from the Kauko Xi-M series and other
electrical devices used in the medical environment, the requirements of the valid version of IEC/EN
60601-1 and EN 60601-1-1 must be considered.
Furthermore, it is the responsibility of the system manufacturer to market the complete system
according to the medical product directive 93/42/EEC, as amended by 2007/47/EC, and to bring it
into operation in the framework of in-house production according to related national legislation. A
computer system without medical software cannot be a medical product as defined by the
guidelines of 93/42/EEC. Therefore, a new system is based on medical and non-medical products.
The Kauko Xi-M computer is not a medical device, but it is tested according to IEC/EN 60601-1-2,
and its power supply meets the requirements of IEC/EN 60601-1. Compliance with the limits of
these standards allows the system manufacturer to carry out the (simplified) conformity
assessment procedure according medical product guidelines.