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PHYSIOMED ELEKTROMEDIZIN AG
A.4 Electromagnetic Compatibility
Declaration
Medical electrical equipment is subject to special precautions with regard to EMC and must
be installed and commissioned in accordance with the EMC instructions contained in the ac-
companying documents. In particular, medical electrical equipment can be affected by port-
able and mobile HF communications equipment. The manufacturer guarantees the conformity
of the device with the EMC requirements only if the accessories listed in the EC Declaration of
Conformity are used. The use of other accessories may result in increased electromagnetic in-
terference or a reduced resistance against electromagnetic interference.
In order to ensure the basic safety and the essential performance characteristics of the device
with regard to the electromagnetic disturbances during the expected period of use, mainten-
ance must be performed within the specified interval and according to the instructions in the
technical service manual.
The device must not be placed directly adjacent to or stacked with other devices. If such an
arrangement is nevertheless required, the device must be monitored to verify its intended op-
eration in this arrangement. Further EMC information can be found under
page 6 as well as in the technical information on the following pages.
If there is a loss or a reduction of the essential performance characteristics due to electromag-
netic disturbances, it is to be expected that the device will issue an error message in the event
of more severe interference. The source of the error must be eliminated and the device be re-
started.
According to the EMC regulations for medical devices, the manufacturer is required by law to
provide the following information.
CAUTION
The use of accessories, converters and cables other than those specified may result in an in-
creased emission or reduced immunity to interference.
Portable HF communications equipment including its accessories such as antenna cables and
external antennas should not be used closer than 30 cm (or 12 inches) to the parts and cables
of the device designated by the manufacturer. Non-observance can lead to a reduction in the
performance characteristics of the device.
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The device has to be disposed of in compliance with legal regulation regarding electronic
devices. It is not allowed to put used devices into your domestic waste.
Environmentally responsible disposal of devices when service life has elapsed can be done
via the manufacturer.
Reference Information
General Notes on
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