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Instructions for Use
For Single Use Only
Carefully read all instructions for use, warnings,
and precautions before using the device.
These are general instructions for setting up a
Pressure Monitoring system with the
Edwards Lifesciences TruWave disposable pressure
transducer. Since kit configurations and procedures
vary according to hospital preferences, it is the
responsibility of the hospital to determine exact
policies and procedures.
Caution: The use of lipids with the TruWave
disposable pressure transducer may compromise
product integrity.
Description
The Edwards Lifesciences Pressure Monitoring Kit
with TruWave disposable pressure transducer, is a
sterile, single-use kit that monitors pressures. The
disposable sterile cable (available in 12-inch/
30 cm and 48-inch/120 cm lengths) interfaces
exclusively with an Edwards Lifesciences cable that
is specifically wired for the monitor being used.
The TruWave disposable pressure transducer has a
straight, flow-through design across the pressure
sensor, and is available with or without the integral
flush device.
Indications
The Pressure Monitoring Kit with TruWave
disposable pressure transducer is for use on
patients requiring intravascular, intracranial, or
intrauterine pressure monitoring.
Contraindications
There are no absolute contraindications for using
the TruWave disposable pressure transducer in
patients requiring invasive pressure monitoring.
Flush devices should not be used when monitoring
intracranial pressure.
Warnings
• Do not use the flush device during
intracranial pressure monitoring.
• To avoid over infusing severely fluid-
restricted patients such as neonates and
children, use an infusion pump in series
with the flush device to accurately
regulate the minimum amount of flush
solution needed to maintain catheter
patency while allowing continuous
pressure monitoring. Use an IV set that is
indicated for use with the IV pump. High
pressures, which may be generated by an
infusion pump at certain flow rates, may
override the flush device restriction,
resulting in fast flushing at the rate set
bythe pump.
• Do not allow air bubbles to enter the
setup, especially when monitoring
arterial pressures.
• Avoid contact with any topical cream or
ointment that attacks polymeric
materials.
• Do not expose electrical connections to
fluid contact.
• Do not autoclave the reusable cable.
• This device is designed, intended, and
distributed for single use only. Do not
resterilize or reuse this device. There are
no data to support the sterility,
nonpyrogenicity, and functionality of the
device after reprocessing.
• Do not use this device if it has been
exposed to an environment outside the
range of 0 °C to 40 °C and 5 % to 90 % RH,
or if it has gone beyond its Use By date.
• For patients undergoing an MR
examination refer to the MRI Safety
Information section for specific
conditions.
•
Type CF Applied Part
Equipment
The Edwards TruWave disposable pressure
transducers are provided in pressure monitoring
kits. Pressure monitoring kits may comprise of the
following components or accessories:
1. Pressure tubing
2. Stopcocks
3. Flush device (3 mL/hr or 30 mL/hr)
4. IV set
5. VAMP (closed blood sampling system)
6. Disposable holder
7. Arm strap
8. Compatible monitor cable
Note: Refer to VAMP closed blood sampling system
Instructions for Use for closed blood sampling
instructions.
Procedure
1. Ensure that the cable is compatible with the
monitor being used. Connect the reusable
cable to the monitor. Turn the monitor on to
allow the electronics to warm up.
TruWave
Pressure Monitoring Kit with TruWave Disposable Pressure Transducer
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