Edwards Lifesciences TruWave Mode D'emploi page 2

Warning: Moisture within the connector may
result in the device malfunctioning or in
inaccurate pressure readings. If this occurs,
replace wet part or parts.
Note: Refer to compatible monitor
instructions for proper cable to monitor
connection.
2. Using aseptic technique, remove the
transducer and kit from the sterile packaging.
3. Add additional components as needed to
complete the monitoring system per hospital
policy.
4. Ensure that all connections are secure.
Note: Wet connections promote over-
tightening by lubricating the fittings. Over-
tightened connections may result in cracks or
leaks.
5. Connect the transducer cable to the reusable
cable.
6. Remove all air from the IV flush solution bag,
which is heparinized per hospital policy.
Caution: If all air is not removed from the bag,
air may be forced into the patient's vascular
system when the solution is exhausted.
7. Close the roller clamp on the IV set and connect
it to the IV flush bag. Hang the bag
approximately 2 feet (60 cm) above the patient.
This height will provide approximately
45 mmHg of pressure to the prime setup.
8. Fill the drip chamber halfway, or per hospital
policy, with flush solution by squeezing the
drip chamber. Open the roller clamp.
9. To fill system:
a. For transducers without integral flush
device (Snap-Tab), fill system per hospital
policy.
b. For transducers with integral flush device,
flow is provided by pulling on the
Snap-Tab, and discontinued by releasing
the Snap-Tab.
10. For kits with IV sets attached, open the
transducer vent port by turning the stopcock
handle towards pressure tubing. Allow gravity
to deliver flush solution first through the
transducer and out through the vent port, then
through the remaining pressure tubing by
turning the appropriate stopcocks. Remove all
air bubbles.
Caution: Significant distortion of the pressure
waveform or air emboli can result from air
bubbles in the setup.
11. Replace all vented caps on sideports of the
stopcocks with non-vented caps.
12. Mount the transducer either on the patient's
body per hospital procedure or on an IV pole
using the appropriate clamp and holder.
13. Pressurize the IV flush solution bag. Flow rate
will vary with pressure across the flush device.
The flow rates with the IV bag pressurized to
300 mmHg are as follows:
• 3 ± 1 mL/hr (DPT with blue Snap-Tab)
14. Connect pressure tubing to the catheter per
manufacturer's instructions.
15. Flush system per hospital policy.
Caution: After each fast-flush operation,
observe the drip chamber to verify that the
continuous flush rate is as desired (see
Complications).
Caution: All steps should be done prior to
connecting to the patient's catheter or access
site.
Zeroing and Calibration
1. Adjust the level of the transducer vent port
(the fluid-air interface) to correspond to the
chamber where pressure is being measured.
For example, in cardiac monitoring zero at
level of the right atrium. This is at the
phlebostatic axis, determined by the
intersection of the midaxillary line and the
fourth intercostal space.
2. Remove the non-vented cap and open the vent
port to the atmosphere.
3. Adjust the monitor to read zero mmHg.
4. Check monitor calibration using procedure
recommended by the monitor manufacturer.
5. Close the vent port to the atmosphere and
replace the non-vented cap.
6. System is ready to begin monitoring pressure.
Testing Dynamic Response
The assembly may be tested for dynamic response
by observing the pressure waveform on a monitor.
Bedside determination of the dynamic response of
the catheter, monitor, kit, and transducer system is
done after the system is flushed, attached to the
patient, zeroed, and calibrated. A square-wave test
may be performed by pulling the Snap-Tab and
releasing quickly.
Note: Poor dynamic response can be caused by air
bubbles, clotting, excessive lengths of tubing,
excessively compliant pressure tubing, small bore
tubing, loose connections, or leaks.
Routine Maintenance
Follow hospital policies and procedures for frequency
of zeroing the transducer and monitor and for
replacing and maintaining pressure monitoring lines.
The TruWave disposable pressure transducer is
precalibrated and has a negligible drift with time
(see Specifications).
1. Adjust zero pressure reference each time level
of the patient is changed.
Caution: When rechecking zero or verifying
accuracy, ensure that the non-vented cap is
removed before opening the transducer vent
port to the atmosphere.
2. Periodically check fluid path for air bubbles.
Ensure that connecting lines and stopcocks
remain tightly fitted.
3. Periodically observe the drip chamber to verify
that the continuous flush rate is as desired.
4. The Centers for Disease Control recommends
replacing IV lines and disposable or reusable
transducers at 96-hour intervals.
2
MRI Safety Information
MR Conditional
The following device was determined to be
MR-conditional according to the terminology
specified in the American Society for Testing and
Materials (ASTM) International, Designation:
F2503-08. Standard Practice for Marking Medical
Devices and Other Items for Safety in the Magnetic
Resonance Environment:
TruWave disposable pressure transducer
Non-clinical testing demonstrated that these
devices are MR Conditional according to the
following conditions:
-Static magnetic field of 3-Tesla or less
- Maximum spatial gradient field of 4000‐Gauss/cm
(40.0 T/m) or less
- This device and the associated cable are not
intended for use inside of the bore of the MR
system and should not be in contact with the
patient
- This device and the associated cable may be in the
MR system room but not in operation or
connected to a pressure monitoring system during
an MR examination
- The pressure tubing connected to the TruWave
DPT is MR safe and can be placed inside the bore
during an MR examination
Complications
Sepsis/Infection
Positive cultures can result from contamination of
the pressure setup. Increased risks of septicemia
and bacteremia have been associated with blood
sampling, infusing fluids, and catheter related
thrombosis.
Air Emboli
Air can enter the patient through stopcocks that
are inadvertently left open, from accidental
disconnection of the pressure setup, or from
flushing residual air bubbles into the patient.
Clotted Catheter and Bleed-Back
If the flush system is not adequately pressurized
relative to the patient's blood pressure, blood
bleed-back and catheter clotting may occur.
Overinfusion
Excessive flow rates may result from pressures
greater than 300 mmHg. This may result in a
potentially harmful increase in blood pressure and
fluid overdose.
Abnormal Pressure Readings
Pressure readings can change quickly and
dramatically because of loss of proper calibration,
loose connection, or air in the system.
Warning: Abnormal pressure readings should
correlate with the patient's clinical
manifestations.
How Supplied
TruWave disposable pressure transducers are
supplied sterile in preconnected monitoring kits
(either standard design or special order). This
product is for single use only. Contents sterile and
fluid path nonpyrogenic if package is unopened
and undamaged. Do not use if package is opened
or damaged. Do not resterilize.