User's Manual

i-8 Vscan Air – User Manual
Direction GP092020-1EN
Rev 08
Certifications
• GE Vingmed Ultrasound AS is ISO 13485 certified.
Classifications
The following classifications are in accordance with the IEC/EN
60601-1:
Type and degree of protection against electric shock:
• The Vscan Air CL probe has an internal battery which allows
the operation during AC power absence.
• The AC adapter is Class II.
The Vscan Air CL probe is IP67 meaning that it can be
submerged in 1m of water for 30 minutes.
The AC adapter is IP20 meaning it must be limited to indoor use.
Class II Equipment
Equipment in which protection against electric shock does not
rely on basic insulation only, but in which additional safety
precautions such as double insulation or reinforced insulation
are provided, there being no provision for protective earthing or
reliance upon installation conditions.
Type BF Applied part
Type BF Applied Part providing a specified degree of protection
against electric shock, with particular regard to allowable
leakage current..
Original Documentation
• The original document was written in English.
Table i-2: Leakage Current
Normal condition Single fault condition
Total Patient leakage current <500 microA <1000 microA