64
EN
I. FOREWORD
This instruction applies for the
MUCOPROTECT
®
cuff pressure gauge (REF 19500).
These instructions for use serve to inform the physician, nursing staff and patient/user
in order to ensure technically correct handling.
Please read the instructions for use carefully before using the product for the
first time!
II. INTENDED USE
The cuff pressure gauge is used for ventilation as well as for pressure regulation and
control of a tracheostomy tube/ tracheal tube with cuff.
III. WARNINGS
When using the cuff pressure gauge for monitoring, the cuff pressure must be
checked and adjusted by the user every 15 minutes.
Upon attachment of the connecting tube to the control balloon of the tracheo-
tomy tube/tracheal tube, the connecting tube opens the balloon valve. When
removing the cuff pressure gauge, the cuff pressure gauge must be removed
together with the connecting tube, as otherwise the air will escape uncontrolla
-
bly from the cuff of the tracheotomy tube/tracheal tube.
The cuff pressure gauge is permitted to be used only by medical professionals.
The cuff pressure gauge is not compatible with MRT!
CAUTION!
The connecting tube is a single-patient product and thus intended exclusively
for use in a single patient. Re-use of any kind in other patients and thus also
reconditioning for re-use in other patients is not allowed!
IV. COMPLICATIONS
It is recommended that the balloon internal pressure be kept above 20 cm H
2
O becau-
se of the risk of aspiration or pneumonia, but also below the value of 30 cm H
2
O
because of the risk of ischemia of the tracheal mucosa. The recommended values
may be varied by doctor‘s orders.
V. INSTRUCTIONS
Before use, the cuff pressure gauge must be tested!
Testing the cuff pressure gauge during use without connecting tube:
1.
Seal the Luer port with a finger ➊.
2.
While the Luer port is sealed, use the manual inflation bulb to inflate the cuff
pressure gauge to 100 cm H
2
O ➋. The reading must remain constant for 2-3
seconds.
3.
If the pressure drops, the device is no longer permitted to be used, and repair
by the manufacturer is necessary.
When a connecting tube is used, the following leak test must be additionally
performed:
1.
Connect the connecting tube to the Luer port of the cuff pressure gauge ➌.
2.
Seal the end of the connecting tube with your finger. While the connecting
tube is sealed, use the manual inflation bulb to inflate the cuff pressure gauge
to 100 cm H
2
O ➍. The reading must remain constant for 2-3 seconds. If the
pressure drops, the connecting tube has a leak and must be replaced then
retested.
Performing the cuff pressure check:
1.
The cuff of the tracheostomy tube must be checked for leaks as described by
the manufacturer in the instructions for use.
2.
Before use, check the low-pressure balloon of the tracheostomy tube, and
before intubation or extubation, completely evacuate the balloon by means of
a syringe.
3.
Connect the cuff pressure gauge with the connecting tube ➎ or directly with
the balloon supply line ➏ of the tracheostomy tube. Inflate the low-pressure
balloon to a pressure of 60 to 90 cm H
2
O. This guarantees that the balloon
will press firmly against the tracheal wall. Turn the red outlet valve slightly to
release air until the pointer has reached the green part of the scale.
MUCOPROTECT
®
CUFF PRESSURE GAUGE
