Edwards HemoSphere ClearSight Manual De Instrucciones página 3

Table 1. Parameter Measurement Specifications
Parameter Specification
arterial blood display range
pressure
accuracy1
cardiac output (CO)
display range
accuracy
reproducibility2
update rate
1Accuracy tested under laboratory conditions compared to a calibrated pressure gauge
2Coefficient of variation - measured using electronically generated data
Table 2. HemoSphere ClearSight Module Available Parameters
Abbreviation Definition
CO continuous cardiac output
CI continuous cardiac index
DIA NI noninvasive diastolic blood pressure
dP/dt* systolic slope
Ea dyn * dynamic arterial elastance
MAP NI noninvasive mean arterial blood pressure
PPV pulse pressure variation
PR NI noninvasive pulse rate
SV stroke volume
SVI stroke volume index
SVR systemic vascular resistance
SVRI systemic vascular resistance index
SVV stroke volume variation
SYS NI noninvasive systolic blood pressure
HPI* Acumen hypotension prediction index
*HPI parameters are available when using an Acumen IQ finger cuff, heart reference sensor (HRS), and if the HPI feature is
activated. Activation is only available in certain areas. Please contact your local Edwards representative for more information
on enabling this advanced feature.
Table 3. HemoSphere ClearSight Module with Oximetry Cable Available Parameters
Abbreviation Description
DO2 oxygen delivery
DO2I oxygen delivery index
VO2 oxygen consumption
VO2I oxygen consumption index
VO2e estimated oxygen consumption when ScvO2
is being monitored
VO2Ie estimated oxygen consumption index when
ScvO2 is being monitored
Maintenance
Do not pull on the pressure controller cable when
unplugging it from the HemoSphere ClearSight
module. If it is necessary to remove the module
from the HemoSphere advanced monitor, press the
release button to unlatch and slide module out.
0 to 300 mmHg
1% of full scale (max 3 mmHg)
1.0 to 20.0 L/min
Bias ≤ ± 0.6 L/min or ≤ 10% (whichever is greater)
Precision (1σ) ≤ ± 20% over the range of cardiac output from 2 to 20 L/min
±6%
20 seconds
Sub-system
technology used
HemoSphere
ClearSight module
Sub-system
technology used
HemoSphere
ClearSight module
and HemoSphere
oximetry cable
It is recommended to perform a yearly pressure
calibration check and send the HemoSphere
ClearSight module to a qualified Edwards service
center for routine service and preventive
maintenance every two years. The HemoSphere
ClearSight module is a resusable device and can be
surface cleaned using a cloth
Patient Hospital
population environment
operating room
and intensive care
unit
adult only
operating room
only
Patient Hospital
population environment
operating room
adult only and intensive care
unit
3
dampened with 70% isopropyl alcohol,
2% glutaraldehyde, 10% bleach solution, or
quaternary ammonium solution. After cleaning,
allow the module to air dry before using.
Cautions:
Do not use any other cleaning agents or spray/pour
cleaning solution directly on the module.
Do not steam, radiate, or EtO sterilize the module.
Do not immerse.
Note: The expected useful life of the HemoSphere
ClearSight module is 5 years from date of
manufacture, at which point the module should be
replaced and returned to Edwards Lifesciences.
Please contact Technical Support or your local
Edwards representative for further assistance.
Storage
The HemoSphere ClearSight module can be stored
in the HemoSphere advanced monitor using the
environmental limits defined below. If it is
necessary to remove the module, store the module
in a cool, dry place in original packaging to prevent
damage.
Temperature: -18 to 45 °C
Relative humidity: 20 to 90% non-condensing
at 45 °C
Altitude: 0 to 19,685 feet (6,000 m)
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
Caution: Federal (USA) law restricts this
device to sale by or on the order of a
physician.
Prices, specifications and model availability are
subject to change without notice.
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.
Refer to the symbol legend at the end of this
document.