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11.4. DISPOSAL OF WASTE MANAGEMENT
The owner of the device shall prevent the reuse of the medical device and handle the medical
device in compliance with "Directive of European Parliament and Council 2008/98/EC on
waste ". Contact your local GCE representative for further details, before returning or removing
the medical device. All components should be disposed of according to local environmental
laws applicable in the country of disposal. If required, a list of component materials is available
EN
from GCE.
11.5. REACH AND ROHS
In accordance with Article 33 of REACH GCE, s.r.o. as the legal manufacturer shall inform all
customers if any materials exist containing 0.1% or more of substances included in the list of
Substance of Very High Concern (SVHC). The most commonly used brass alloys for valve bodies
and other brass components contain 2-3% of lead (Pb),EC no. 231-100-4, CAS no. 7439-92-1.
The lead will not be released to the gas or surrounding environment during normal use.
After the end of life the medical device shall be scrapped by an authorized metal recycler to
ensure effi cient material handling with minimal impact on the environment and health. To date
we have no information that indicates that other materials containing SVHC of concentrations
exceeding 0.1% are included in any GCE medical device.
11.6. REPORTING OF A SERIOUS INCIDENT
If any suspected serious incident has been occurred in relation to this medical device, notify
the manufacturer, e-mail: adverse_events@gcegroup.com and the competent authority of
the State in which the user and/or patient is established.
By reporting a suspected serious incident, you can help obtain more information about
the safety of this medical device.
12. GLOSSARY
REF
LOT
P1
Consult instructions for use
Caution
Keep away from heat and
fl ammable materials
Manufacturer
Catalogue number
Batch code
Inlet parameter
Keep away from oil and
grease!
Medical Device
Inlet pressure
Suitable for Home care use
Suitable for Hospital care use
Suitable for Emergency care
use
Temperature limit
REF 1
Customer number
Fragile, handle with care
Outlet parameter
Keep dry
Weight of medical device
Contains hazardous
substances
10/286
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