Edwards HEMPSC100 Manual Del Usuario página 2

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.
Precautions
Do not use if the package or the pressure cable is
damaged. Damage may include cracks, scratches, dents
or any signs that the housing may be compromised.
HemoSphere Pressure Cable Setup
Refer to the HemoSphere advanced monitor
operator's manual, available at eifu.edwards.com,
for comprehensive monitoring procedures with
that monitor.
1. Connect the HemoSphere pressure cable to
a compatible monitor at the end indicated
by ④ in figure 1.
2. Setup and initiate the compatible monitor.
3. Insert the appropriate color insert at ②
to indicate the 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 sensor to the pressure
cable. The pressure cable LED that surrounds the
zero button at ③ will flash green indicating
that the pressure 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 HemoSphere
pressure cable must be zeroed before monitoring.
Zero Pressure Cable
1. To initiate the zeroing process, press and hold the
zero button indicated by ③ in the figure or
initiate zeroing process on the connected monitor
screen. Refer to the compatible monitor operator' s
manual for on‑screen zeroing instructions.
Caution: To prevent cable damage, do not apply
excessive force to the pressure cable 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.
4. Press and hold the pressure cable zero button
or the on‑screen button to complete zeroing
process. The zero button LED will turn off when
properly zeroed.
5. Confirm stable zero pressure and turn stopcock
such that sensor is reading patient intravascular
pressure.
Table 1. Parameter Measurement Specifications
Parameter Specification
FloTrac cardiac display range
output (CO)
reproducibility
blood pressure2 live pressure display range
MAP/DIA/SYS display range 0 to 300 mmHg
CVP display range
MPAP display range
accuracy
bandwidth
3
pulse rate (PR) accuracy
1
Coefficient of variation measured using electronically generated data
2 Parameter specifications compliant with IEC 60601‑2‑34 standards. Testing performed under laboratory conditions
3
Accuracy tested under laboratory conditions
Table 2. HemoSphere Pressure Cable Available Parameters
Abbreviation Definition
CO continuous cardiac output
CI continuous cardiac index
CVP central venous pressure
DIA diastolic blood pressure
dP/dt* maximal slope of the arterial pressure
upstroke
Ea * dynamic arterial elastance
dyn
MAP mean arterial blood pressure
MPAP mean pulmonary artery blood
pressure
PPV pulse pressure variation
SV stroke volume
SVI stroke volume index
SVR systemic vascular resistance
SVRI systemic vascular resistance index
SVV stroke volume variation
SYS systolic blood pressure
HPI* Acumen Hypotension Prediction
Index
* Parameters only available if the Acumen HPI feature is activated. Not all parameters may be available in your region.
Table 3. HemoSphere Pressure Cable with Oximetry Cable Available Parameters
Abbreviation Description
DO2 oxygen delivery
DOI 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
MRI Information
MR Unsafe
2
1.0 to 20 L/min
1
±6% or 0.1 L/min, whichever is greater
‑34 to 312 mmHg
0 to 50 mmHg
0 to 99 mmHg
±4% or ±4 mmHg, whichever is greater, from ‑30 to 300 mmHg
1‑10 Hz
A ≤3 bpm
rms
Sub-System
Technology Used
HemoSphere
pressure cable
Sub-System
Technology Used
HemoSphere
pressure cable and
HemoSphere
oximetry cable
Do not use the HemoSphere pressure cable in an MR
environment. The pressure cable is MR unsafe since
the device contains metallic components, which can
experience RF‑induced heating in the MRI environment.
Patient Hospital
Population Environment
operating
room,
intensive care
adult only
unit,
emergency
room
operating
room only
Patient Hospital
Population Environment
operating
room,
intensive
adult only
care unit,
emergency
room