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6.0 Warnings
Compliance to IEC 60601‐1 is only maintained when the FloTrac Pressure
Cable—BeneVision (applied part accessory, defibrillation proof) is connected to
a compatible monitoring platform. Connecting external equipment or
configuring the system 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 patient/operator safety and/or product performance.
7.0 Precautions
Do not use if the package or the FloTrac Pressure Cable—BeneVision is
damaged. Damage may include cracks, scratches, dents or any signs that the
housing may be compromised.
Risks of the FloTrac Pressure Cable—BeneVision include patient or clinician
burns or electrical shock, inappropriate/unintended treatment, and/or delay in
treatment.
8.0 FloTrac Pressure Cable—BeneVision Setup
Refer to the compatible monitor operator's manual for comprehensive
monitoring procedures.
Step
Procedure
1
Connect the FloTrac Pressure Cable—BeneVision to a
compatible monitor at the end indicated by
2
Setup and initiate the compatible monitor.
3
Insert the appropriate color insert at
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—BeneVision.
Cable—BeneVision LED that surrounds the zero 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
Follow all instructions found in pressure monitoring catheter
IFU for catheter preparation and insertion procedures. The
FloTrac Pressure Cable—BeneVision must be zeroed before
monitoring.
9.0 Zero FloTrac Pressure Cable—BeneVision
Step
Procedure
1
To 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 monitor's
operator manual for on‐screen zeroing instructions.
CAUTION: To prevent cable damage, do not apply
excessive force to the FloTrac Pressure
Cable—BeneVision zero button.
2
Level 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.
in Figure 1 .
to indicate the
The FloTrac Pressure
2
Step
Procedure
4
Press and hold the FloTrac Pressure Cable—BeneVision zero
button or the on‐screen button to complete zeroing process.
The zero button LED will emit a solid green light when properly
zeroed.
5
Confirm stable zero pressure and turn stopcock such that sensor
is reading patient intravascular pressure.
10.0 MRI Information
MR Unsafe
Do not use the FloTrac Pressure Cable—BeneVision in an MR environment. The
FloTrac Pressure Cable—BeneVision is MR unsafe since the device contains
metallic components, which can experience RF‐induced heating in the MRI
environment.
11.0 Specifications
Physical Specifications
Cable Length: 3 m ( 10 ft ) and 4.6 m ( 15 ft )
Operating Conditions
Temperature: 10 to 32.5 °C
Humidity range: 20 to 90% non-condensing
Altitude (Atmospheric Pressure): 0 m/0 ft (1013 hPa) to
3048 m/10,000 ft (697 hPa)
IP Rating: IPX4
12.0 Maintenance
When unplugging the FloTrac Pressure Cable—BeneVision from a compatible
monitor or pressure monitoring sensor from the FloTrac Pressure
Cable—BeneVision, always pull at the connection site. Do not pull from cables
or use tools to disconnect.
CAUTION: Excessive dropping of the FloTrac Pressure
Cable—BeneVision may result in cable damage and/or malfunction.
It is recommended to inspect the FloTrac Pressure Cable—BeneVision
periodically for signs of damage. Check the condition of the cable and replace if
any of the following are present: exposed wire, splits, cracks, or signs of stress.
The FloTrac Pressure Cable—BeneVision is a reusable device and can be surface
cleaned per hospital aseptic procedures. Device has been shown to handle cloth
wipe down using the following chemical agents: 70% isopropyl, 2%
glutaraldehyde, 10% bleach solution, or quaternary ammonium solution.
Disconnect the FloTrac Pressure Cable—BeneVision from the monitor to air dry
the transducer connector. To blow dry the transducer connector, use clean, dry
wall air, canned air, or CO2 aerosol for at least two minutes. If left to dry under
room conditions, allow the connector to dry for two days before using.
CAUTIONS: Do not use any other cleaning agents, spray, or pour
cleaning solution directly on the FloTrac Pressure Cable—BeneVision.
Do not steam, radiate, or EtO sterilize the FloTrac Pressure
Cable—BeneVision.
Device contains electronics. Handle with care.
Do not immerse.
Dispose of in accordance with hospital policy and local regulations.
13.0 Storage Conditions
Store in a cool, dry place.
Store in original packaging to prevent damage. Keep away from sunlight.
CAUTION: Do not coil the cable against its natural orientation or coil
the cable tightly.
