English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Français . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Italiano . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Nederlands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Svenska . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Ελληνικά . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Česky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Magyar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
English
FloTrac sensor
The devices described herein may not all be licensed in accordance with Canadian law or approved for sale in your specific region.
For Single Use Only
Carefully read these instructions for use, which address the warnings, precautions,
and residual risks for this medical device.
These are general instructions for setting up a pressure monitoring system and/or
Edwards compatible hardware with the FloTrac sensor. Since kit configurations and
procedures vary according to hospital preferences, it is the responsibility of the
hospital to determine exact policies and procedures.
CAUTION: The use of lipids with the FloTrac sensor may compromise product integrity.
1.0 Concept/Description
The FloTrac sensor is a sterile, single use kit that monitors pressures when attached to pressure
monitoring catheters. When connected to a compatible monitor, the FloTrac sensor minimally-
invasively measures cardiac output and key hemodynamic parameters, which assist the clinician
in assessing the patient's physiologic status and support clinical decisions related to
hemodynamic optimization. They are intended to be used in the surgical and critical care
environments by medical professionals who have been trained in the safe use of hemodynamic
technologies and clinical usage of arterial line pressure monitoring. The disposable sterile cable
Edwards, Edwards Lifesciences, the stylized E logo, and FloTrac are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the property of their respective
owners.
DIRECTORY
Slovensky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Suomi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Български . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Română . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Eesti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Lietuvių . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Latviešu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Русский . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Srpski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Hrvatski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
FloTrac sensor
1. To FloTrac compatible monitor (green)
2. To Pressure monitor (red)
3. To IV Set
4. Snap-Tab Device
5. Sensor Vent Port
6. To Patient
with a red connector interfaces exclusively with an Edwards cable that is specifically wired for the
pressure monitor being used. The disposable sterile cable with a green connector interfaces
exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiac
output monitoring devices or hardware.
The FloTrac sensor has a straight, flow-through design across the pressure sensors with an integral
flush device.
Device performance, including functional characteristics, have been verified in a comprehensive
series of testing to support the safety and performance of the device for its intended use when
used in accordance with the established Instructions For Use.
When used with a compatible monitoring platform, the FloTrac sensor provides information
regarding the hemodynamic status of the patient, which may lead to improved data driven clinical
decision making for medically necessary intervention and/or clinical re-evaluation.
2.0 Intended Use/Purpose
The sensors measure an electrical resistance to provide blood pressure and arterial pressure based
cardiac output.
1
Symbol Legend
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Zeichenerklärung
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Lijst met symbolen
Symbolforklaring
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συμβόλων
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Vysvetlivky
Jelmagyarázat
k symbolom
Symbolforklaring
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skaidrojums
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обозначения
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