English
INTENDED uSE
The Cuff Pressure Gauge is used for inflation, deflation and pressure control of tracheal tubes
with high volume low pressure cuffs. The vacuum valve is used for deflation of low pressure
cuffs.
SAFETY INFORMATION
Read and follow the instructions for use carefully before using the product.
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The product must only be used by trained medical personnel.
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Before use, the products must be inspected visually for damages (cracks, breakage, etc.)
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and a functional check must be performed (see section "Functional check").
The cuff pressure gauge is not suitable for MRI!
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In case that the cuff pressure gauge is used for monitoring and remains on the infla-
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tion 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 elec-
tronically and maintains the pre-set pressure.
When disconnecting the cuff pressure gauge from the inflation line, it has to be discon-
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nected together with the connecting tube as otherwise the system is open.
A mechanical stop is integrated in the housing to prevent that the release valve gets
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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. Reprocessing influ-
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ences 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) Seal Luer nozzle with the finger (picture 1).
1b) Inflate with the inflation bulb to 40 cmH
case of pressure decrease, the device must be returned to the manufacturer for repair.
If a connecting tube is used, the system consisting of Cuff pressure Gauge and
connecting tube has to be checked (additionally to 1):
2a) Attach the connecting tube to the Luer nozzle of the Cuff Pressure Gauge (picture 2).
2b) Seal the end of the connecting tube with the finger (picture 3).
2c) Inflate with the hand inflation bulb to 40 cmH
in case of a pressure decrease, the connecting tube is leaking and must be replaced. Check
again with the new connecting tube (repeat steps 2a - 2c).
O; the value must be constant for 2 - 3 sec.; in
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O; the value must be constant for 2 - 3 sec.;
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