Edwards HemoSphere Instrucciones De Uso

English . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Français . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Italiano . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Nederlands . . . . . . . . . . . . . . . . . . . . . . . 11
Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Svenska . . . . . . . . . . . . . . . . . . . . . . . . . 15
Ελληνικά . . . . . . . . . . . . . . . . . . . . . . . . . 17
English
HemoSphere Oximetry Cable
Carefully read these instructions for use and all
contained warnings and cautions before using
this product.
Description
The HemoSphere oximetry cable is a reusable
device that connects with a compatible Edwards
monitor on one end ① and any approved Edwards
oximetry catheter on the other end ② to
continuously measure venous oxygen saturation
by reflectance spectrophotometry. LEDs within
the oximetry cable transmit light fiber optically to
the distal end of the catheter. The amount of light
absorbed, refracted, and reflected depends on the
relative amounts of oxygenated and deoxygenated
hemoglobin in the blood. This optical intensity data
is gathered by the oximetry catheter, processed by
the HemoSphere oximetry cable and displayed on a
compatible monitoring platform. Parameter output
is mixed venous oxygen saturation (SvO
venous oxygen saturation (ScvO ).
2
Note: The expected useful life of the HemoSphere
oximetry cable is 1.5 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 Catheters
The HemoSphere oximetry cable is intended to be
used in combination with Edwards compatible
monitors and oximetry catheters to measure
venous oxygen saturation (SvO /ScvO
2
The HemoSphere oximetry cable is compatible
with all Edwards pulmonary artery and central
venous catheters that have a compatible
fiber-optic connector.
Edwards, Edwards Lifesciences, the stylized E logo,
HemoSphere, Swan, and Swan-Ganz are trademarks
of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective
owners.
Português . . . . . . . . . . . . . . . . . . . . . . . . 19
Česky . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Magyar . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Slovensky . . . . . . . . . . . . . . . . . . . . . . . . 27
Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Suomi . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Български . . . . . . . . . . . . . . . . . . . . . . . 33
Română . . . . . . . . . . . . . . . . . . . . . . . . . 35
①
Indications for Use
The HemoSphere advanced monitor when used
with the HemoSphere oximetry cable and Edwards
oximetry catheters is indicated for use in adult and
pediatric critical care patients requiring monitoring
of venous oxygen saturation (SvO
derived hemodynamic parameters in a hospital
) or central
environment. Refer to the Edwards oximetry catheter
2
indications for use statement for information on
target patient population specific to the catheter
being used.
Refer to the intended use statement 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
2
compatible Edwards oximetry and Swan-Ganz
catheters. Comprehensive lists of parameters
available for adult and pediatric patient
populations while monitoring with the
HemoSphere advanced monitor and a connected
HemoSphere oximetry cable or connected
HemoSphere oximetry cable and Swan-Ganz
module, are listed in the tables below.
DIRECTORY
and ScvO ) and
2 2
1
Eesti . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Lietuvių . . . . . . . . . . . . . . . . . . . . . . . . . 39
Latviešu . . . . . . . . . . . . . . . . . . . . . . . . . 41
Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Русский . . . . . . . . . . . . . . . . . . . . . . . . . 45
Srpski . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
中文 . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
한국어 . . . . . . . . . . . . . . . . . . . . . . . . 51
日本語 . . . . . . . . . . . . . . . . . . . . . . . . 53
Warnings
Compliance to IEC 60601-1 is only maintained
when the HemoSphere oximetry cable (applied
part accessory, defibrillation proof) 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 wrap the main body of the oximetry cable in
fabric or place directly on the patient's skin. The
surface does get warm and needs to dissipate heat to
maintain its internal temperature level. A software
fault will trigger if the internal temperature exceeds
its limits.
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 oximetry cable is electrostatic
discharge (ESD) sensitive. Do not attempt to open the
cable housing or use if the housing has been damaged.
Do not use if the package or the oximetry cable is
damaged. Damage may include cracks, scratches, dents
or any signs that the housing may be compromised.
Unwind the cable carefully while removing it from
its packed configuration. Do not pull at the cable
to uncoil it.
CC1121
②