Technical Data; Technical Specifications - KaVo ORTHOPANTOMOGRAPH OP 3D User And Installation Manual

10 Technical data

10.1 Technical specifications

General information
Manufacturer:
Quality system
Environmental management system
Conformity to standards:
ORTHOPANTOMOGRAPH
Reviewed Suuronen Esa 2019-09-19 12:21
Approved Lassinen Juuso 2019-10-02 14:37
™
OP 3D
PaloDEx Group Oy
Nahkelantie 160, FI–04300 Tuusula, FINLAND
In accordance with ISO13485 standard
In accordance with ISO14001 standard
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.
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