Electrical Safety - GE Versana Essential Technical Publication

Electrical safety

Device classifications
Internally connected peripheral devices
External Connection of other peripheral devices
CAUTION
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Versana Essential
5759238-100 English Rev. 2
The ultrasound unit is a Class I device, type BF, type CF,
according to IEC 60601-1.
The system, together with peripheral devices, such as video
printer, meets IEC 60601-1 standards for electrical isolation and
safety. These standards are applicable only when the specified
peripheral devices are plugged into the AC outlets provided on
the unit.
External devices can be used only if CE marked and in
compliance with related standards (EN 60601-1 or EN 60950).
Conformance to EN 60601-1 must be verified.
Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC
standards (e.g. IEC 60950 for data processing equipment and
IEC 60601-1 for medical equipment). Furthermore all complete
configurations shall comply with the valid version of the system
standard IEC 60601-1. Anybody connecting additional
equipment to the signal input part or signal output part of the
ultrasound unit configures a medical system, and is therefore
responsible that the system complies with the requirements of
the valid version of IEC 60601-1. If in doubt consult the
technical service department or your local GE representative.
Other external devices, such as printers, and external monitors,
usually exceed allowable leakage limits and, when plugged into
separate AC outlets that are then connected to the unit, are in
violation of patient safety standards. Suitable electrical isolation
of such external AC outlets may be required in order to meet
UL60601-1 and IEC 60601-1 standards for electrical leakage.
User Guide
Safety Precautions
4-17