GE Vivid i, User Manual

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Safety
Vivid i User’s Manual
361
2378958-100 Rev. 02
Electrical safety
Device classifications
The Vivid i ultrasound unit is a Class I device, type BF,
according to Sub-clause 14 of IEC 60601-1 (1988).
Internally connected peripheral devices
The system, together with peripheral devices, such as video
tape recorders and printers, meets UL2601-1 and IEC 60601-1
(1988) standards for electrical isolation and safety. These
standards are applicable only when the specified peripheral
devices are plugged into the AC outlets provided in the unit.
Internally connected battery
Remove the primary battery if the internal battery in not likely to
be used for some time.
External Connection of other peripheral
devices
Other external devices, such as laser cameras, printers, VCRs
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 UL2601-1 and
IEC 60601-1 (1988) standards for electrical leakage.
CAUTION
External devices can be used only if CE marked and in
compliance with related standards (EN 60601-1 or EN 60950).
Conformance to EN 60601-1-1 (2000) must be verified.
External devices meeting EN 60950 should be kept outside of the
patient environment, as defined in IEC 60601-1-1 (2000).