•
Do not allow air bubbles to enter the setup, especially when
monitoring atrial 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.
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 (Refs. 1,
2 & 7).
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 (Ref. 6).
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 (Ref. 3).
Abnormal Pressure Readings
Pressure readings can change quickly and dramatically because of loss
of proper calibration, loose connection, or air in the system (Refs. 3 & 6).
Warning: Abnormal pressure readings should correlate with the
patient’s clinical manifestations. Verify sensor function with a
known amount of pressure before instituting therapy.
How Supplied
The FloTrac sensor is supplied sterile in preconnected monitoring kits
(either standard design or special order). Contents sterile and fluid path
nonpyrogenic if package is undamaged or unopened. Do not use if
package is opened or damaged. Do not resterilize.
Technical Assistance
For technical assistance, please call Edwards Technical Support at the
following telephone numbers:
Inside the U.S. and Canada
(24 hours): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 800.822.9837
Outside the U.S. and Canada
(24 hours): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 949.250.2222
In the UK: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 (0) 8706 062040
Caution:
Federal (USA) law restricts this device to sale by or on the
order of a physician.
Prices, specifications, and model availability are subject to change
without notice.
This product is manufactured and sold under one or more of the
following US patent(s): US Patent No. 5,564,951; 5,803,770; and
corresponding foreign patents. Likewise, additional patents pending.
Refer to the symbol legend at the end of this document.
STERILE
EO
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