9 Technical data
9
Technical data
9.1
Technical specifications
General information
Manufacturer:
PaloDEx Group Oy
Nahkelantie 160, FI–04300 Tuusula, FINLAND
Quality system
In accordance with ISO13485 standard
Environmental management system
In accordance with ISO14001 standard
Conformity to standards:
IEC60601–1 (ed.3)+Am1
IEC60601–1–3: (ed.2)+Am1
IEC60601–1–6 (ed.3.1)
IEC60601–1–9 (ed.1)
IEC60601–2–28 (ed.2)
IEC60601–2–63 (ed.1)
IEC60601–1–2 (ed.4)
ANSI/AAMI ES60601–1: 2005+A1
CAN/CSA–C22.2 No. 60601–1:2014 standards
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 medical devices.
RoHS Directive 2011/65/EU without any exemptions
mentioned in Annex IV.
ORTHOPANTOMOGRAPH
™
OP 3D
87
