38
DISPOSAL
Actuation of European directives 2002/95/EC,
2002/96/EC and 2003/108/EC, for reduction in use of
dangerous substances in the electric and electronic
device and for garbage disposal. The symbol applied
on the device or its packaging means that at the end
of its useful life the product must not be disposed of
with domestic waste.
At the end of devices useful life, the user must deliver
it to the able collecting centers for electric and
electronic garbage, or give back to the retailer when
purchasing a new device. Disposing of the product
separately prevents possible negative consequences
for the environment and for health, deriving from
inadequate disposal. It also allows the recovery of
materials of which it’s made up in order to obtain
an important saving of energy and resources and
to avoid negative effects to the environment and
health. In case of abusive disposal of device by the
user, will be applied administrative endorsements in
compliance with current standard. The device and its
parts is made with regard to disposal, as appropriate,
in accordance with national or regional regulations.
This product complies with RoHS Directive 2011/65/
EU and Amendment (EU) 2015/863.
CE COMPLIANCE
This device complies with the following normative
documents:
1. EN ISO 13485:2003 /AC: 2009: Medical devices -
Quality management stems – Requirements for
regulatory purposes (ISO 13485:2003) Reference to
standards contd.
2. IEC/EN 60601-1-11:2010 General requirements for
basic safety and essential performance –Collateral
Standard: Requirements for medical electrical
equipment and medical electrical systems used in
the home healthcare environment