VBM MONITOR, Instructions For Use Manual

Page: 10 / 36

-10-
English
INTENDED uSE
The Cuff Pressure Gauge is used for inflation, deflation and pressure control of
tracheal tubes with high volume low pressure cuffs.
SAFETy INFORMATION
• Read and follow the instructions for use carefully before using the product.
• The product must only be used by trained medical personnel.
• Before use, the products must be inspected visually for damages (cracks,
breakage, etc.) and a functional check must be performed (see section “Func -
tional check”).
• The cuff pressure gauge is not suitable for MRI!
• In case that the cuff pressure gauge is used for monitoring and remains on
the inflation line, the pressure must be checked regularly every 15 minutes by
the user. Pressure increase can be adjusted by pressing the red release valve
and pressure decrease can be adjusted by squeezing the inflation bulb. This
cuff pressure gauge is a manual system and can not hold the cuff pressure
constantly over a longer period. For such case, the manufacturer offers an
automatic “Cuff Controller” which monitors the cuff pressure electronically and
maintains the pre-set pressure.
• When disconnecting the cuff pressure gauge from the inflation line, it has to
be disconnected together with the connecting tubing as otherwise the system
is open.
• A mechanical stop is integrated in the housing to prevent that the release valve
gets stuck. The release valve can get stuck by excessive strong activation. In
this case, the device must not be used further and must be returned to the
manufacturer for repair.
• The connecting tube is for single use and must not be reprocessed. Repro -
cessing influences the function of the connecting tube. Any reuse involves the
potential risk for cross contamination.
FuNCTIONAl ChECK
Test the Cuff Pressure Gauge as follows:
1a) Close Luer noozle with the finger (picture 1).
1b) Inflate with the inflation bulb to 40 cmH
2
O; the value must be constant for
2 - 3 sec.; in case of pressure decrease, the device must be returned to the
manufacturer for repair.
If a connecting tubing is used, the system consisting of Cuff Pressure Gauge
and connecting tubing has to be checked as follows (additionally to 1):
2a) Attach the connecting tubing to the Luer nozzle of the Cuff Pressure Gauge
(picture 2).
2b) Seal the end of the connecting tubing with the finger (picture 3).
2c) Inflate with the hand inflation bulb to 40 cmH
2
O; the value must be constant for
2 - 3 sec.; in case of a pressure decrease, the connecting tubing is leaking and