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2 Safety
2.1 Compliance
External equipment intended for connection to signal input, signal output or other connectors
shall comply with the relevant product standard e.g. IEC 60950–1 for IT equipment and the
IEC 60601–series for medical electrical equipment.
In addition, all such combinations – systems – shall comply with the safety requirements
stated in the general standard IEC 60601–1, edition 3.1, clause 16. Any equipment not
complying with the leakage current requirements in IEC 60601–1 shall be kept outside the
patient environment, i.e. at least 1.5 m from the patient support.
Any person who connects external equipment to signal input, signal output or other
connectors has formed a system and is therefore responsible for the system to comply with
the requirements.
If in doubt, contact qualified medical technician or your local representative.
If external equipment is connected, an isolation device is needed to isolate the equipment
located outside the patient environment from the equipment located inside the patient
environment. In particular such a separation device is required when a network connection is
made. The requirements on the separation device is defined in IEC 60601–1, edition 3.1,
clause 16.
Operator´s Manual
1000-095-071-EN Rev. 2.1
Page 11
Safety
Compliance
OMNERA 500A
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