10 Technical data
10 Technical data
10.1 Technical specifications
Manufacturer
Instrumentarium Dental, PaloDEx Group
Oy, Nahkelantie 160, 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
IEC 60601-1-1
IEC 60601-1-4
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32
IEC 60601-2-63
IEC 60601-1-2
IEC 60601-1-3
UL 60601-1
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 unit is in conformity with the provisions of
Council Directive 93/42/EEC as amended by the
Directive 2007/47/EC concerning medical devices.
Performance Standards and European Union
Directive 93/42/EEC (Medical Devices Directive).
Product name
OP3D Pro
Model:
OP300-1
Product type:
Digital dental imaging system with panoramic,
cephalometric and Cone Beam 3D imaging
programs.
92
ORTHOPANTOMOGRAPH
™
OP 3D Pro