Датчики для мониторинга гемодинамических показателей: датчики FloTrac:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Edwards Lifesciences LLC, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Edwards Lifesciences LLC

Дата Авторизация:

2020-02-06

Характеристики продукта

1
For Single Use Only
THESE ARE GENERAL INSTRUCTIONS FOR SETTING UP A PRESSURE MONITORING
SYSTEM
AND/OR EDWARDS COMPATIBLE HARDWARE WITH THE FLOTRAC IQ 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 IQ sensor may compromise
product integrity.
CONCEPT/DESCRIPTION
The FloTrac IQ sensor is a sterile, single use kit that monitors
pressures when attached to
pressure monitoring catheters. When connected to a compatible monitor,
the FloTrac IQ
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. The disposable sterile
cable 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 IQ sensor has a straight, flow-through design across the
pressure sensors with
an integral flush device.
INDICATIONS
The FloTrac IQ sensor is indicated for use in intravascular pressure
monitoring. It is also
indicated for use with the Edwards arterial pressure based cardiac
output monitoring
devices or hardware to measure cardiac output.
CONTRAINDICATIONS
There are no absolute contraindications for using the FloTrac IQ
sensor in patients requiring
invasive pressure monitoring.
WARNINGS
•
DO NOT ALLOW AIR BUBBLES TO ENTER THE SETUP. SEE COMPLICATIONS SECTION
OF THIS
IFU REGARDING AIR EMBOLI AND ABNORMAL PRESSURE READINGS.
•
DO NOT USE THE FLUSH DEVICE DURING INTRACRANIAL PRESSURE MONITORING.
•
HIGH PRESSURES, WHICH MAY BE GENERATED BY AN INFUSION PUMP AT CERTAIN
FLOW
RATES, MAY OVERRIDE THE FLUSH DEVICE RESTRICTION, RESULTING