Edwards EV1000

Chapter 1: EV1000 Clinical Platform NI
Overview
he EV1000 Clinical Platform NI monitors key
hemodynamic parameters derived from continuous
noninvasive measurement of the arterial pressure
waveform. The EV1000 Clinical Platform NI assists
the clinician in assessing the patient’s physiologic status and
supports clinical decisions related to hemodynamic
optimization.
ClearSight™ Technology
Noninvasive Arterial
Pressure and Cardiac
Output Monitoring
The EV1000 Clinical Platform NI consists of the EV1000
Monitor in conjunction with the EV1000 Noninvasive
System, which is comprised of the EV1000 Pump-Unit
(PMP), Pressure Controller (PC2), Heart Reference Sensor
(HRS) and ClearSight Finger Cuff. The ClearSight Finger
Cuff has a built in plethysmograph sensor to noninvasively
measure the continuous finger arterial blood pressure using
Volume Clamp and Physiocal™ methods. The brachial
arterial pressure waveform is then reconstructed from the
measured finger blood pressure pulsations to monitor
Systolic (SYS), Diastolic (DIA) and Mean Arterial (MAP)
pressures. Hemodynamic parameters, Cardiac Output (CO),
Cardiac Index (CI), Stroke Volume (SV), Stroke Volume
Index (SVI), Stroke Volume Variation (SVV), and Pulse Rate
(PR) are calculated using a novel pulse contour method
(ClearSight Algorithm). Systemic Vascular Resistance (SVR)
and Systemic Vascular Resistance Index (SVRI) can also be
calculated after the user manually inputs a CVP value. In
addition, the Heart Reference Sensor is used to compensate
for hydrostatic pressure differences due to changes in height
of the finger relative to the heart, with one end placed at the
level of the patient’s finger and the other at heart level.
Monitored Parameters
The following hemodynamic parameters can be measured
noninvasively, using ClearSight technology, and displayed on
the EV1000 Monitor.
Indications for Use
Intended Medical Indication. The EV1000 Clinical
Platform NI and ClearSight™ Finger Cuffs are indicated for
patients over 18 years of age in which the balance between
cardiac function, fluid status and vascular resistance needs
continuous assessment. In addition, the noninvasive system is
indicated for use in patients with co-morbidities for which
hemodynamic optimization is desired and invasive
measurements are difficult. The EV1000 Clinical Platform
NI and ClearSight™ finger cuffs noninvasively measures
blood pressure and associated hemodynamic parameters
.
CAUTION
Federal (USA) law restricts this device to sale by or on
the order of a physician.
T
Table 1-1 EV1000 Clinical Platform NI
Parameters
Parameter Description
Cardiac Output (CO) Continuous measurement of the
volume of blood pumped by the
heart measured in liters per minute
Cardiac Index (CI) Cardiac output relative to body
surface area (BSA)
Diastolic Pressure (DIA) Diastolic blood pressure
Mean Arterial Pressure
(MAP)
Averaged systemic blood pressure
over one cardiac cycle
Pulse Rate (PR) Number of arterial blood pressure
pulses per minute
Stroke Volume (SV) Volume of blood pumped with each
heart beat
Stroke Volume Index (SVI) Stroke volume relative to body
surface area (BSA)
Systemic Vascular
Resistance (SVR)
The resistance that the left ventricle
must overcome to eject stroke
volume with each beat
Systemic Vascular
Resistance Index (SVRI)
SVR relative to body surface area
Stroke Volume Variation
(SVV)
The percent difference between
SVmin, max and mean
Systolic Pressure (SYS) Systolic blood pressure