Product Manual

i-2 Vscan – User Manual
GM092207
02
Country Specific Approvals
• JAPAN
MHLW Approved Number: 221ABBZX00252000
• CHINA
SFDA: SFDA (I) 20113231266
Product Standard Number: YZB/NOR 0732-2011
• KOREA
KFDA: 10-1194
Certifications
• GE Vingmed Ultrasound is ISO 9001 and ISO 13485
certified.
Classifications
The following classifications are in accordance with the IEC/
EN 60601-1.
Type and degree of protection against electric shock:
• Vscan is internally powered battery operated during hand
held scanning.
• The AC adapter is Class II.
• Vscan has type BF Applied Part.
• Degree of protection against harmful ingress of water:
Vscan parts and accessories except probe tip: ordinary
equipment (IPx0)
Probe tip: IPX1
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.