GCE MEDIMETER Gebrauchsanleitung Seite 9

11. MEDICAL DEVICE LIFE TIME
11.1. LIFE TIME
Maximum life time of the medical device is 10 years.
At the end of the medical device's life time, the medical device must be
withdrawn from service (max. 10 years).
EN
11.2. SERIAL NUMBER AND DATE OF MEDICAL DEVICE
The nine digit serial number stamped on the medical device is in the following
format:
YY MM XXXXX
YY: year of production
MM: month of production
XXXXX : sequence number
Example: serial number 050300521 shows the medical device produced in
March 2005, with sequence number 521.
11.3. MARKING UDI CODING IMPLEMENTATION
There are 4 marked identifi ers on the medical device surface:
14 numbers with prefi x (01): GTIN - Global Trade Identifi cation Number
(identifi cation of the selector type)
10 numbers with prefi x (10): batch number (LOT)
9 numbers with prefi x (21): serial number in format YY MM XXXXX
6 numbers with prefi x (17): the end of the medical device´s life time in format
YYMMDD
Example: marking number (17) 290227 shows the medical device with end of
lite time on 27th of February 2029.
As the integral part of UDI marking is a Data Matrix, which consists of the
same data.
11.4. DISPOSAL OF WASTE MANAGEMENT
The owner of the medical 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 from GCE.
11.5. REACH AND R HS
In accordance to 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 used for bodies and other brass
components contain 2-3% of lead (Pb), EC no. 231-100-4, CAS no. 7439-92-1.
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