Intended Use; Safety Information; Functional Check - Medizintechnik VBM Manual Del Usuario

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INTENDED USE

The Cuff Pressure Gauge is used for inflation, deflation and pressure control of
tracheal tubes with high volume low pressure cuffs and Laryngeal Tubes. 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.
• 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 pres-
sure 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 tube 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) Seal Luer nozzle with the finger (picture 1).
1b) Inflate with the inflation bulb to 40 cmH
2 - 3 sec.; in 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).
O; the value must be constant for
2
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