Cable
—Philips is intended for use with compatible Philips
monitors, and Edwards pressure monitoring sensors and
compatible catheters.
The FloTrac Pressure Cable—Philips is a reusable device that
c
onnects with a compatible Philips monitor on one end
and an Edwards pressure monitoring sensor on the other
end to continuously measure hemodynamic parameters.
Refer to the Philips monitor's Instructions for Use for a
list of supported hemodynamic parameters and applicable
Edwards pressure monitoring sensor(s).
Note: The expected useful life of the FloTrac Pressure
Cable—Philips is 5 years from date of purchase. If your
equipmen
t experiences a malfunction, please contact
Technical Support or your local Edwards representative
for further assistance.
Device performance, including functional characteristics,
have been verified in a comprehensive series of testing
to support the safety and performance of the device
for its intended use when used in accordance with
the established Instructions for Use. Refer to the Philips
monitor's Instructions for Use for comprehensive monitoring
procedures and monitoring parameters.
2.0 Compatible Sensors
The FloTrac Pressure Cable—Philips is intended to be
used in c
ombination with a compatible Philips monitor,
an Edwards pressure monitoring sensor and compatible
pressure monitoring catheter to measure intravascular
pressure. Refer to the Philips monitor's Instructions for
Use for a list of supported Edwards-compatible pressure
monitoring sensors and catheters.
3.0 Intended Use/Purpose
The FloTrac Pressure Cable—Philips when used with an
E
dwards’ pressure monitoring sensor and connected
to a compatible monitor, offers continuous assessment
of hemodynamic parameters. It may be used for
monitoring hemodynamic parameters in conjunction with
a perioperative goal directed therapy protocol in a hospital
environment.
4.0 Indications for Use
The FloTrac Pressure Cable—Philips is indicated for use in
adult critical care patients in which the balance between
cardiac function, fluid status, vascular resistance and pressure
needs continuous assessment.
5.0 Contraindications
There are no known contraindications.
6.0 Warnings
Compliance to IEC 60601‐1 is only maintained when the
FloTrac Pressure Cable—Philips (applied part accessory,
defibrillation proof) is connected to a compatible Philips
monit
oring platform. Connecting external equipment or
configuring the sy
stem in a way not described in these
instructions will not meet this standard. Failure to use
the device as instructed may increase the risk of electrical
shock to the patient/operator.
Do not modify, service or alter the product in any
way. Servicing, alteration or modification may affect
patien
t/operator safety and/or product performance.
7.0 Precautions
Do not use if the package or the
FloTrac Pressure Cable—Philips is damaged. Damage
may
include cracks, scratches, dents or any signs that the
housing may be compromised.
Risks of the FloTrac Pressure Cable—Philips include
patient or clinician burns or electrical shock,
inappropriate/unintended treatment, and/or delay in
treatment.
8.0 FloTrac Pressure Cable
—Philips Setup
Refer to the c
ompatible Philips monitor's instruction for use
comprehensive monitoring procedures.
S
tep Procedure
1
Connect the FloTrac Pressure
Cable
—Philips to a compatible Philips
monitor at the end indicated by
in
Figure 1.
2
S
etup and initiate the compatible Philips
monitor.
3
I
nsert the appropriate color insert at to
indicate the monitored pressure type. The
colors are as follows:
• Red for arterial pressure (AP)
• Blue for central venous pressure (CVP)
• Yellow for pulmonary artery pressure
(PAP)
• Green for cardiac output (CO)
4
Connect the pressure monitoring sensor
to the FloTrac Pressure Cable
—Philips.
The FloTrac Pressure Cable—Philips LED
that sur
rounds the z
ero button at will
flash green indicating that the pressure
monitoring sensor is detected. A yellow
light indicates a sensor fault condition. If
this occurs, refer to the monitor screen for
specific fault condition details.
5
F
ollow all instructions found in pressure
monitoring catheter IFU for catheter
preparation and insertion procedures. The
FloTrac Pressure Cable—Philips must be
zer
oed before monitoring.
9.0 Zero FloTrac Pressure Cable
—Philips
S
tep Procedure
1
T
o initiate the zeroing process, press and
hold the zero button indicated by in
the figure or initiate zeroing process on
the connected monitor screen. Refer to the
compatible Philips monitor's Instruction for
Use for on‐screen zeroing instructions.
CAUTION: To prevent cable damage,
do not apply excessive force to the
FloTrac Pressure Cable—Philips zero
button.
2
L
evel the sensor stopcock valve (vent port)
to the patient's phlebostatic axis position
according to the instructions for use.
3
Open the stopcock valve to measure
atmospheric conditions.
4
Press and hold the
FloTrac Pressure Cable
—Philips zero
button or the on‐screen button to
complete zeroing process. The zero button
LED will turn off when properly zeroed.
5
C
onfirm stable zero pressure and turn
stopcock such that sensor is r
eading patient
intravascular pressure.
10.0 MRI Information
MR Unsaf
e
2
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