Edwards FloTrac Jr Manuel D'instructions page 2

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.
When used with a compatible monitoring platform, the FloTrac Jr sensor provides information
regarding the hemodynamic status of the patient, which may lead to improved data driven clinical
decision making for medically necessary intervention and/or clinical re-evaluation.
2.0 Intended Use/Purpose
The sensors measure an electrical resistance to provide blood pressure and arterial pressure based
cardiac output.
3.0 Indications
The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated
for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to
measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of
age.
4.0 Contraindications
There are no absolute contraindications for using the FloTrac Jr sensor in patients requiring
invasive pressure monitoring.
5.0 Warnings
• Do not allow air bubbles to enter the setup. See complications section of this
IFU regarding air emboli and abnormal pressure readings.
Do not use the flush device during intracranial pressure monitoring.
•
6.0 Specifications*
FloTrac Jr sensor
Operating Pressure Range
Operating Temperature Range
Sensitivity
Nonlinearity and Hysteresis
Excitation Frequency
Excitation Impedance
Phase Shift
Signal Impedance
Zero Offset
Zero Thermal Drift
Output Drift
Sensitivity Thermal Drift
Natural Frequency
Defibrillator Challenge
Leakage Current
Overpressure Tolerance
Shock Resistance
Light Sensitivity
Volumetric Displacement
Flow rate across flush device with IV bag pressurized to 300 mmHg
Blue Snap-Tab device
*at 6.00 VDC and 25 °C unless otherwise stated.
All specifications meet or exceed the AAMI BP22 Standard for performance interchangeability of resistance bridge type blood pressure transducers.
7.0 Procedure
Step Procedure
1 Ensure that the cables are compatible with the monitors being used. Connect the
reusable cables to the monitors, and turn the monitors on to allow the electronics to
warm up.
2 Using aseptic technique, remove the sensor and kit from the sterile packaging.
CAUTION: Modifying any FloTrac Jr kit may reduce dynamic response
resulting in compromised hemodynamic monitoring performance.
3 Ensure that all connections are secure but are not overtightened.
4 Connect the sensor cable with the red shield to the reusable cable appropriate for the
pressure monitor.
5 Connect the sensor cable with the green shield to the Edwards' FloTrac Jr connecting
cable.
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 by the pump.
Avoid contact with any topical cream or ointment that attacks polymeric
•
materials. May affect product integrity.
• Do not expose electrical connections to fluid contact. May result in electrical
shock to user or patient, and/or arrhythmia.
Do not autoclave the reusable cable as it may affect product integrity.
•
• This device is designed, intended and distributed for SINGLE USE ONLY. DO
NOT RE-STERILIZE OR REUSE this device. There are no data to support the
sterility, non-pyrogenicity and functionality of the device after reprocessing.
Such action could lead to illness or an adverse event as the device may not
function as originally intended.
• Compliance to IEC 60601-1 is only maintained when the FloTrac Jr sensor is
connected to a patient monitor or equipment that has a Type CF defibrillation
proof rated input connector. If attempting to use a third party monitor or
equipment, check with the monitor or equipment manufacturer to ensure IEC
60601-1 compliance and compatibility with the FloTrac Jr sensor. Failure to
ensure monitor or equipment compliance to IEC 60601-1 and FloTrac Jr sensor
compatibility may increase the risk of electrical shock to the patient/
operator.
• Do not modify or alter the product in any way. Alteration or modification may
affect patient/operator safety or product performance.
For a patient undergoing an MRI examination, please refer to the MRI Safety
•
Information section for specific conditions to ensure patient safety.
-50 to +300 mmHg
15 to 40 °C
5.0μ V/V/mmHg ± 1%
± 1.5% of reading or ± 1 mmHg , whichever is greater
dc to 5,000 Hz
350 ohms ± 10% with typical Edwards Monitor Cable attached
<5°
300 ohms ± 5%
≤ ± 25 mmHg
≤ ± 0.3 mmHg/°C
± 1 mmHg per 8 hours after 20 second warm-up
≤ ± 0.1%/°C
40 Hz nominal for a standard kit (48"/12") ( 122 cm / 30.5 cm ); >200 Hz for sensor alone
withstands 5 repeated discharges of 360 Joules within 5 minutes delivered into a 50 ohm load
<2μ amps at 120V RMS 60 Hz
-500 to +5000 mmHg
withstands 3 drops from 1 meter
< 1 mmHg at 6 volts excitation when exposed to a 3400 °K tungsten light source at 3000 foot
candles (32,293 lumen/m 2 )
≤ 0.03 mm 3 / 100 mmHg for transducer without flush device
3 ± 1 ml /hr
Step Procedure
6 Remove all air from the IV flush solution bag.
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. See
complications section of this IFU regarding air emboli.
7 Heparin anticoagulation therapy to be administered per hospital protocol.
8 Close the roller clamp on the IV set and connect the IV set 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 prime the setup.
9 Fill the drip chamber halfway with flush solution by squeezing the drip chamber.
Open the roller clamp.
10 Flow is provided by pulling on the Snap-Tab device and discontinued by releasing the
Snap-Tab device.
11 Prime system using gravity only (do not pressurize bag) to decrease fluid turbulence
and mitigation of bubbles.
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