Tracoe 720 Instrucciones De Uso página 6

The TRACOE cuff pressure monitor is available for "over the counter
use".
Sterilisation: The TRACOE cpm is provided non sterile. A sterile con-
necting tube is provided which has been sterilized with ethylene ox-
ide. The connecting tube is considered sterile unless the packaging
seal is broken or the package is opened or damaged.
Storage: The TRACOE cpm must be stored in a cool dry place.
2.1 Testing the TRACOE cuff pressure monitor
The TRACOE cpm functionality must be checked prior to use with the
following procedure:
Close the air release valve by turning the knurled screw. Then place a
finger over the male Luer connector air outlet valve to seal the open-
ing. Squeeze the bulb to a pressure of 60 cmH
pressure gauge (manometer) for three to five seconds to insure the
pressure indicated on the display remains constant. If the pressure
decreases, repeat the test. If the pressure decreases again, do not
use the TRACOE cpm.
The pressure gauge needle must be at 0 cmH
not, do not use the TRACOE cpm.
Failure of the TRACOE cpm can occur following improper use or ex-
cessive increase (more than 100 cmH
CAUTION: An internal interlock inhibits the manometer needle to
rotate more than 360°. This prevents the movement of the pressure
gauge needle over 100 cmH
the bulb above 100 cmH
measuring accuracy of the device.
CAUTION: While the TRACOE cpm is in use, all components should
be movable and free of kinking or obstruction to ensure accurate
pressure values are displayed.
2.2 Metrological Inspection of the TRACOE cuff pressure monitor
An accuracy check of the TRACOE cpm must be carried out and doc-
umented every 24 months, or immediately following mishandling or
failure of the functionality tests (see 2.1). Testing must be performed
by an indivual meeting the requirements for meterological control,
with the results documented. The inspection should be performed
according to the following procedure:
6
O) in pressure.
2
O. Therefore, excessive squeezing of
2
O will not be displayed, and may impair the
2
O, and observe the
2
O when not in use. If
2