KaVo 3D eXam, Operator'S Manual

Page: 116 / 170

Kavo 3D eXam ® Operators’ Manual
k990400 September 19, 2007
10-26
Equipment Class Determination
The equipment class was determined by reviewing the Essential
Requirements of the European Union Council Directive concerning
Medical Devices 93/42/EEC, Annex 9, rule 10, Food and Drug
Administration (FDA) 21CFR part 860, Canadian Medical Devices
Regulations (CMDR), schedule 1 and Health Canada “Medical
Device Keyword Index” for “X-ray” equipment and IEC standards
60601-2-7 and 60601-2-28. The following class of equipment was
determined:
Protection against electric shock: Class I
Applied part has a degree of protection against electric shock: Class
B
Class of equipment against ingress of liquids: Ordinary Equipment,
IPX0
Radiated Emissions: Class B
CE-MDD 93/42/EEC: Class IIb
CMDR (Canada): Class 2
FDA: Class 2
The next section describes how Patient data is converted into
DICOM images. This procedure is used to determine where these
DICOM image files are to reside.