Safety; Compliance - Canon OMNERA 400A Operator's Manual

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 sta-
ted in the collateral standard IEC 60601–1–1 or 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 connec-
tors 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 lo-
cated outside the patient environment from the equipment located inside the patient environ-
ment. In particular such a separation device is required when a network connection is made.
The requirements on the separation device is defined in IEC 60601–1–1 and in IEC 60601–
1, edition 3.1, clause 16.
This product conforms to DHHS radiation Standards of 21 CFR subpart J as of the date of
manufacture.
Operator´s Manual
2020-09-25
0073-095-418-EN Rev. 5.1
Page 9
Safety
Compliance
OMNERA®