Edwards HEMPSC100 Manual Del Usuario

English . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Français . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Italiano . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Nederlands . . . . . . . . . . . . . . . . . . . . . . . 12
Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Svenska . . . . . . . . . . . . . . . . . . . . . . . . . 17
Ελληνικά . . . . . . . . . . . . . . . . . . . . . . . . . 19
English
HemoSphere Pressure Cable
Carefully read these instructions for use and all
contained warnings and cautions before using this
product. Refer to the HemoSphere advanced monitor
operator' s manual, available at eifu.edwards.com,
for comprehensive monitoring procedures.
Description
The HemoSphere pressure cable is a reusable device
that connects with a compatible monitor on one end
④ and any approved single Edwards disposable
pressure transducer (DPT) or sensor on the other end
① to continuously measure standard intravascular
pressure values or cardiac output (CO), pulse rate
(PR), stroke volume (SV), and stroke volume variation
(SVV) when using an Edwards arterial pressure based
cardiac output (APCO) sensor. When connected to a
Acumen IQ or FloTrac IQ sensor, additional parameters
are available that provide the clinician with
information on the likelihood of a hypotensive event.
Note: The expected useful life of the HemoSphere
pressure cable is 5 years from date of manufacture,
at which point the cable should be replaced and
returned to Edwards Lifesciences. Please contact
Technical Support or your local Edwards
representative for further assistance.
Compatible Sensors
The HemoSphere pressure cable is intended to be
used in combination with a compatible monitor,
an Edwards approved DPT or sensor, and
compatible pressure monitoring catheters to
measure intravascular pressure. Edwards approved
sensors include the TruWave DPT, FloTrac,
Acumen IQ, and FloTrac IQ sensors.
Edwards, Edwards Lifesciences, the stylized E logo,
Acumen, Acumen HPI, Acumen IQ, FloTrac, FloTrac IQ,
HemoSphere, HPI, Hypotension Prediction Index,
Swan, Swan‑Ganz, and TruWave are trademarks
of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective
owners.
DIRECTORY
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Česky . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Magyar . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Slovensky . . . . . . . . . . . . . . . . . . . . . . . . 30
Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Suomi . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Български . . . . . . . . . . . . . . . . . . . . . . . 37
Română . . . . . . . . . . . . . . . . . . . . . . . . . 39
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Figure 1. HemoSphere Pressure Cable (Model HEMPSC100)
Indications for Use
The HemoSphere advanced monitor when used with
the HemoSphere pressure cable is indicated for use in
critical care patients in which the balance between
cardiac function, fluid status, vascular resistance and
pressure needs continuous assessment. It may be used
for monitoring hemodynamic parameters in
conjunction with a perioperative goal directed
therapy protocol in a hospital environment. Refer
to the Edwards FloTrac sensor, Acumen IQ sensor,
FloTrac IQ sensor, and TruWave DPT indications for
use statements for information on target patient
population specific to the sensor/transducer 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
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Eesti . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Lietuvių . . . . . . . . . . . . . . . . . . . . . . . . . 44
Latviešu . . . . . . . . . . . . . . . . . . . . . . . . . 46
Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Русский . . . . . . . . . . . . . . . . . . . . . . . . . 50
Srpski . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
中文 . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
한국어 . . . . . . . . . . . . . . . . . . . . . . . . 57
日本語 . . . . . . . . . . . . . . . . . . . . . . . . 59
based solely on the Acumen Hypotension Prediction
Index (HPI) parameter.
Refer to the Intended Use statement and to tables 2
and 3 for a complete list of measured and derived
parameters available for each patient population.
Intended Use
The HemoSphere advanced monitoring platform is
intended to be used by qualified personnel or trained
clinicians in a critical care environment in a hospital
setting. The HemoSphere advanced monitoring
platform is intended for use with compatible
Edwards oximetry and Swan‑Ganz catheters, and
pressure monitoring sensors and catheters.
A comprehensive list of parameters available while
monitoring with the HemoSphere advanced
monitor and a connected HemoSphere pressure
cable or connected HemoSphere pressure cable and
oximetry cable are listed in tables 2 and 3.
Warnings
Compliance to IEC 60601‑1 is only maintained when
the HemoSphere pressure cable (applied part accessory,
defibrillation proof) is connected to a compatible
monitoring platform. Connecting external equipment
HMS‑1019
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