Soredex DIGORA Optime - Technical specifications; Device

9 Technical specifications
208396 rev 2 SOREDEX 47
9 Technical specifications
9.1 Device
Product name
DIGORA
®
Optime
Model
DXR-60
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 in-
traoral complex of the skull.
USA only
Federal law restricts this device to sale by or on the
order of a dentist or other qualified professional.
Manufacturer
SOREDEX, PaloDEx Group
Nahkelantie 160 (P.O. Box 20)
FIN-04300 Tuusula, FINLAND
Quality system
In accordance with ISO13485 and ISO9001
standard
Environmental management
system
In accordance with ISO14001
standard
Conformity to standards
IEC 60601-1: 1988 and A1+A2
IEC 60601-1-1: 2000
IEC 60601-1-4: 1996 and A1
IEC 60601-1-2: 2001
IEC 60601-1: 2005
EN 60825-1: 2007
UL 60601-1: 2003
CAN/CSA –C22.2 No. 601-1-M90 and S1+A2 /
DHHS 21 CFR Chapter I,
Subchapter J at the date of manufacture.
In conformity with the provisions of Council Directive
93/ 42/EEC as amended by the Directive 2007/47/
EC concerning medical devices..
DXR-60 Classification IEC60601-1
- Class 2 equipment
- No applied part
- Continuous operation
- IPX0 (enclosed equipment without protection
against ingress of liquids