Edwards HemoSphere ClearSight Manual De Instrucciones página 2

environment. 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
HemoSphere advanced monitor and compatible
Edwards finger cuff(s) noninvasively measures
blood pressure and associated hemodynamic
parameters. Refer to the ClearSight finger cuff and
Acumen IQ finger cuff indications for use
statements for information on target patient
population specific to the finger cuff being used.
The Edwards Lifesciences Acumen Hypotension
Prediction Index (HPI) feature provides the clinician
with physiological insight into a patient's
likelihood of future hypotensive events (defined as
mean arterial pressure < 65 mmHg for at least one
minute in duration) and the associated
hemodynamics. The Acumen HPI feature is
intended for use in operating room (OR) patients
receiving advanced hemodynamic monitoring. The
Acumen HPI feature is considered to be additional
quantitative information regarding the patient's
physiological condition for reference only and no
therapeutic decisions should be made based solely
on the Acumen Hypotension Prediction Index (HPI)
parameter.
Intended Use
The HemoSphere advanced monitoring platform
is intended for use with compatible Edwards
Swan-Ganz and oximetry catheters, FloTrac,
Acumen IQ, and TruWave DPT sensors, and
Edwards finger cuff(s).
A comprehensive list of parameters available while
monitoring with the HemoSphere advanced
monitor and a connected HemoSphere ClearSight
module or connected HemoSphere ClearSight
module and oximetry cable are listed in
tables 2 and 3.
Contraindications
In some patients with extreme contraction of the
smooth muscle in the arteries and arterioles in the
lower arm and hand, such as may be present in
patients with Raynaud's disease, blood pressure
measurement can become impossible.
Warnings
Compliance to IEC 60601-1 is only maintained
when the HemoSphere ClearSight module (applied
part connection) is connected to a compatible
monitoring platform. Connecting external
equipment 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
The HemoSphere ClearSight module is electrostatic
discharge (ESD) sensitive. Do not attempt to open
the module housing or use if the housing has been
damaged.
Do not force the module into the HemoSphere
advanced monitor slot. Apply even pressure to slide
and click the module into place.
Do not use if the package or module is damaged.
Damage may include cracks, scratches, dents or any
signs that the housing may be compromised.
Module Setup
1. Align and insert the HemoSphere ClearSight
module into an large technology (L-Tech)
module slot. This is located on the top left
panel of the HemoSphere advanced monitor.
The module will click in place when properly
engaged.
Note: Once inserted, the module does not
need to be removed unless maintenance or
cleaning is necessary.
2. Setup and initiate the compatible monitor.
3. Connect the pressure controller to the
HemoSphere ClearSight module.
4. Wrap the pressure controller band around the
patient's wrist and attach the pressure
controller to the band.
5. Follow detailed instructions contained in the
finger cuff IFU for proper cuff size selection and
placement.
6. Apply the compatible Edwards finger cuff to
the patient's finger and connect cuff to the
pressure controller.
7. Follow on-screen prompts for heart reference
sensor (HRS) connection and proper zeroing.
8. Refer to the HemoSphere advanced monitor
operator's manual, available at
eifu.edwards.com, for comprehensive
monitoring and troubleshooting instructions.
MRI Information
MR Unsafe
This device is MR-unsafe and poses hazards in the
MRI environment. This device contains metallic
components, which can experience RF-induced
heating in the MRI environment.
2
Specifications
Physical Specifications
Weight: approximately 0.9 kg (2 lb)
Height: 13 cm (5.1 in)
Width: 14 cm (5.6 in)
Depth: 10 cm (3.9 in)
Operating conditions
Temperature: 10 to 32.5 °C
Humidity range: 20 to 85% non-condensing
Altitude (Atmospheric Pressure): 0 m/0 ft
(1,013 hPa) to 3,000 m/9,483 ft (700 hPa)
IP Rating: IPX1