Edwards EVHRS Mode D'emploi 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.
3.0 Instructions for Use
Refer to the operator's manual of the compatible Edwards monitor for instructions for use.
CAUTION: Do not use a damaged heart reference sensor. This may result in inaccurate measurements or may damage the EV1000 clinical platform
NI or HemoSphere advanced monitoring platform.
4.0 Cleaning Instructions
The heart reference sensor can be cleaned using the following disinfectants:
• 70% isopropyl alcohol solution
• 10% sodium hypochlorite water solution
Step Procedure
1
Moisten a clean cloth with disinfectant and wipe the surfaces.
2
Dry the surface with a clean, dry cloth.
WARNING: Do not disinfect the heart reference sensor by autoclave or gas sterilization.
CAUTION: Do not immerse the heart reference sensor.
CAUTION: Do not immerse any cable connectors in fluid.
CAUTION: Conduct periodic inspections of all cables for defects. Do not coil cables tightly when storing.
CAUTION: Clean and store the heart reference sensor after each use.
5.0 Preventive Maintenance
The finger component of the heart reference sensor may be damaged if subjected to moderate to significant surface impact. Although the likelihood of
damage is small, the resulting displayed values would be biased by the difference in height from the heart to the finger cuff. Even though this damage cannot
be seen by looking at the heart reference sensor, it is possible to confirm whether the damage has occurred by following the below procedure prior to each
use:
Step Procedure
1
Connect the heart reference sensor to the port on compatible Edwards noninvasive monitoring system and go to the zeroing
screen.
2
As instructed in the Instructions for Use section, bring the two ends of the heart reference sensor level with each other.
3
Observe the value shown on the zeroing screen.
4
Raise one end of the heart reference sensor 6 inches (15 cm) above the other end.
5
Observe that the value shown has changed by at least 5 mmHg.
6
Reverse the ends such that the other end is now 6 inches (15 cm) above the first end.
7
Observe the value shown changed in the opposite direction by at least 5 mmHg from the original value.
If the value does not change as described, then the heart reference sensor may have been damaged. Contact your local Technical Support office as indicated
in the Technical Assistance section. A replacement unit shall be provided. If the value does change, the heart reference sensor is functioning normally and can
be used for hemodynamic monitoring.
6.0 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: . . . . . . . . . . . 0870 606 2040 - Option 4
In Ireland: . . . . . . . . . . . . . . 01 8211012 - Option 4
This document is subject to change without prior notice. Refer to the latest version of the EV1000 clinical platform NI or HemoSphere advanced monitoring
platform operator's manual for additional information.
Users and/or patients should report any serious incidents to the manufacturer and the Competent Authority of the Member State in which the user and/or
patient is established.
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