Edwards EVHRS Quick Start Manual

Heart Reference Sensor (HRS)
EVHRS
Carefully read these instructions for use, which address the warnings, precautions, and residual risks for this medical
device.
1.0 Description
The heart reference sensor (also referred to as 'HRS') can be used with the EV1000 clinical platform NI and HemoSphere advanced monitoring platform to
noninvasively measure blood pressure and key hemodynamic parameters using a compatible Edwards finger cuff(s) wrapped around the finger. When using this
method it is necessary to use a heart reference sensor, which compensates the hydrostatic pressure changes due to difference in height between the finger and
heart. The heart reference sensor is a non-serviceable part.
2.0 Intended Use
The heart reference sensor is intended for use with a compatible Edwards noninvasive monitoring system - composed of compatible monitor, pressure source
(pump), heart reference sensor, compatible Edwards finger cuff(s) and pressure controller - for noninvasive measurement of blood pressure and associated
hemodynamic parameters. Refer to the operator's manual of the compatible Edwards monitor being used for specific information on the intended use
environment and patient population.
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.
Edwards, Edwards Lifesciences, the stylized E logo, EV1000, and HemoSphere are trademarks of Edwards Lifesciences Corporation. All other trademarks are the
property of their respective owners.
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