KaVo 3D eXam, Operator'S Manual

Page: 133 / 170

k990400 September 19, 2007
General Product Information
12-7
•
Consult Imaging Sciences International, the dealer or an
experienced technician for help.
Use only the interface cables provided with the System. Using other
interface cables may exceed the limits of Class B equipment,
pursuant to IEC 60601-1-2.
Equipment Standards
The System was tested and/or evaluated against and found
compliant to the following standards/requirements:
UL 60601-1 IEC/EN 60601-1-4
CSA C22.2 No. 601.1 IEC/EN 60601-2-32
JIS Z4701 IEC/EN 60601-2-44
JIS Z4703 IEC/EN 60825-1JIS T0601
JIS T0601 CE-MDD 93/42/EEC
IEC/EN 60601-1 LVFS 2003:11 (Swedish regulation,
transposing the MDD 93/42/EEC)
IEC/EN 60601-1-1 CMDCAS (Canadian Medical Device
Regulation)
IEC/EN 60601-1-2 ISO 10993-1:2003
IEC/EN 60601-1-3 ISO 14971:2000
Equipment Class
Protection against electric shock: Class I
Applied part has degree of protection against electric shock: Class B
Class of equipment against ingress of liquids: Ordinary Equipment,
IPX0
Radiated emissions: Class B
CMDR (Canada): Class 2
CE-MDD 93/42/EEC: Class IIb (Annex 9, Rule 10)
FDA: Class 2