GCE MediFlowTec Notice D'instructions page 8

Do not use the product under any circumstances of the inner parts of
the product have been contaminated. It must be withdrawn from service.
8. MAINTENANCE
8.1. PRODUCT LIFE TIME
Depending on the date of production you can fi nd on the product the
marking in one of two versions are easy to see and easy to di erentiate.
EN
8.1.1. MARKING PRIOR TO IMPLEMENTING UDI CODING
Form of nine digits serial number stamped on the product is following:
YYMMXXXXX
YY: year of production
MM: month of production
XXXXX: sequence number
Example: serial number 190300521 shows the product produced in March
2019, with sequence number 521.
An additional 2D code (for internal usage in production process in GCE) is
also part of product's marking .
8.1.2. MARKING AFTER UDI CODING IMPLEMENTATION
There are 3 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)
9 numbers with prexix (21): serial number in format YYMMXXXXX
6 numbers with prefi x (17): the end of the product´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 2D code, which consists of the
same data. The batch number is included in the 2D code (prefi xed (10) )
and it is for manufacturer use.
8.1.3. MAINTENANCE
No special maintenance or service, apart from the tests before use, is
needed. However, to make sure the product is in good working order, it
would be good if the owner/cylinder distributor performs the checks (see
6.1) himself on a regular basis (ex. once every second year) and/or at every
cylinder exchange. This is just for the owner to ensure that the product
works well, especially in cases where the user has some health problems
and is not able to check the product himself properly.
8.1.4. PRODUCT LIFE TIME AND WASTE MANAGEMENT
Maximum life time of the product is 10 years. At the end of the product's life
time, the product must be withdrawn from service (max.10 years).
The owner of the device shall prevent the reuse of the product and han-
dle the product in compliance with "Directive of European Parliament and
Council 2008/98/EC on waste".
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