KaVo Scan eXam One User Manual

9 Technical specifications
KaVo Scan eXam One 57
9 Technical specifications
9.1 Unit
Product name
KaVo Scan eXam™ One
Model
eXam6
Product type
Intraoral digital imaging plate system
Intended use
System is intended to be used only by dentist
and other qualified dental professionals to
process x-ray images exposed to the imaging
plates from the intraoral complex of the skull.
USA only
Federal law restricts this unit to sale by or on
the order of a dentist or other qualified pro-
fessional.
Manufacturer
PaloDEx Group Oy,
Nahkelantie 160 FI-04300 Tuusula, FINLAND
Quality system
In ac
cordance with ISO13485 standard
Environmental management
system
In accordance with ISO14001 s
tandard
Conformity to standards
• IEC 60601-1
• IEC 60601-1-2
• IEC 60825-1
• ANSI/AAMI ES60601-1:2005/
(R)2012 and A1:2012
• CAN/CSA –C22.2 No. 601-1-M90
This product complies with DHHS 21 CFR
Chapter I, Subchapter J at the date of
manufacture.
The device is in conformity with the provisions
of Council Directive 93/42/EEC as amended
by the Directive 2007/47/EC concerning med-
ical devices.

KaVo Scan eXam One Specifications

General

Brand	KaVo
Model	Scan eXam One
Category	Dental equipment
Language	English