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All labels on the equipment must be kept in good, legible condition by the provider and
the user during the entire product lifetime.
Use only original GCE components/spare parts!
Any medical device sent back to GCE (or GCE authorised centre) for repair or maintenance
shall be properly packaged to prevent contamination or damage during storage, transportation
and handling.
EN
For medical device to be repaired, the fault short description or some reference to a claim nr.
should be indicated.
10.2. SERVICE
There is no determined preventive check for combination valves during the entire life of
the valve.
11. MEDICAL DEVICE LIFETIME
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the medical device must be withdrawn from service.
BATTERY LIFETIME
The typical battery lifetime is 3 years of which the device is constantly in operation. Decrease in
the battery voltage by the end of its lifetime is indicated by the icon on the display of the device.
See chapter 5.1.2.2.
The operation of the device below -10 °C and above + 40 °C negatively affects the battery
lifetime.
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) 220100 shows the medical device with the production date
of January 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.
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