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10.2. SERVICE
There is no determined preventive check for combination valves during the entire life of
the valve.
11. MEDICAL DEVICE LIFETIME
EN
11.1. LIFETIME
Maximum lifetime (also known as service life) of the medical device is 15 years from
the manufacturing date. At the end of the medical device´s lifetime (15 years maximum),
the medical device must be withdrawn from service.
11.2. SERIAL NUMBER AND DATE OF MEDICAL DEVICE
Form of nine-digit serial number stamped on the medical device is following:
YY MM XXXXX
YY: year of medical device
MM: month of medical device
XXXXX: sequence number
Example: serial number 130300521 shows the medical device produced in March 2013, with
sequence number 521.
11.3. MARKING UDI CODING IMPLEMENTATION
There are 4 marked identifiers on the medical device surface:
14 numbers with prefix (01): GTIN - Global Trade Identification Number
(identification of the selector type)
10 numbers with prefix (10): batch number (LOT)
9 numbers with prefix (21): serial number in format YY MM XXXXX
6 numbers with prefix (11): the medical device´s production date in format YYMMDD
Example: marking number (11) 220300 shows the medical device with the production date
of March 2022.
As an 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 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 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 efficient 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.
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