Standards; Package Contents - Myray ZEN-X Instrucciones De Uso

At the end of the appliance working life, dispose of in accordance with the applicable regulations in force. We recom-
mend to disinfect all the appliance external parts before disposal and to sort out the stripped materials for separate
waste collection.
In compliance with Directives 2002/95/EC, 2002/96/EC and 2003/108/EC regarding restriction of the use of certain
hazardous substances in electrical and electronic equipment along with waste electrical and electronic equipment, it
is forbidden to dispose of this equipment in the municipal waste stream as unsorted municipal waste. This equipment
must be sorted and disposed of separately. When new equipment that is similar is purchased, the old equipment must
be given to the dealer for disposal. As regards reuse, recycling and other forms of recovery of waste electrical and
electronic equipment, the producer carries out the functions set forth by laws and regulations currently in force in the
individual countries. A high level of separate collection of waste electrical and electronic equipment is indispensable to
efficiently recycle, treat and dispose of the equipment. Recycling and treatment operations should comply with mini-
mum standards to assure human health and high environmental protection as well as favor recycling of the materials
included in the equipment. The symbol indicating separate collection for electrical and electronic equipment consists of
the crossed out bin marked on the equipment. Illegal waste clearance and disposal shall be punished as established
by laws and regulations currently in force in the individual countries.

3 Standards

The ZEN-X / ZEN-Xi system is a class IIa medical device for taking intraoral x-rays.
The ZEN-X / ZEN-Xi system and its accessories are designed and constructed in compliance with the following stand-
ards:
93/42/CEE and subsequent changes
EN 60601-1
EN 60601-1-2
EN 60878
UNI CEI EN ISO 14971

4 Package Contents

The package contains:
ZEN-X package (stand alone)
ZEN-X / ZEN-Xi
- OPERATING INSTRUCTION
Electromedical appliance directive
General regulations for electromedical appliance safety
Electromedical appliances: Electromagnetic compatibility – Prescriptions
and tests
Graphic symbols for electromedical appliance functions
Medical appliances: Risk management application to medical appliances
ZEN-X system
CD-Rom with the software and drivers
Warranty certificate
Compliance certificate
EN 29