Наборы для мониторинга давления: наборы TruWave:

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
INSTRUCTIONS FOR USE
For Single Use Only
Carefully read all instructions for use, warnings,
and precautions before using the device.
These are general instructions for setting up a
Pressure Monitoring system with the
Edwards Lifesciences TruWave Disposable Pressure
Transducer. 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 TruWave
Disposable Pressure Transducer may compromise
product integrity.
DESCRIPTION
The Edwards Lifesciences Pressure Monitoring Kit
with TruWave Disposable Pressure Transducer, is a
sterile, single-use kit that monitors pressures. The
disposable sterile cable (available in 12-inch/30 cm
and 48-inch/120 cm lengths) interfaces exclusively
with an Edwards Lifesciences cable that is
specifically wired for the monitor being used.
The TruWave Disposable Pressure Transducer has a
straight, flow-through design across the pressure
sensor, and is available with or without the integral
flush device.
INDICATIONS
The Pressure Monitoring Kit with TruWave
Disposable Pressure Transducer is for use on
patients requiring intravascular, intracranial, or
intrauterine pressure monitoring.
CONTRAINDICATIONS
There are no absolute contraindications for using
the TruWave Disposable Pressure Transducer in
patients requiring invasive Pressure Monitoring.
Flush devices should not be used when monitoring
intracranial pressure.
WARNINGS
•
DO NOT USE THE FLUSH DEVICE DURING
INTRACRANIAL PRESSURE MONITORING.
•
TO AVOID OVER INFUSING SEVERELY FLUID-
RESTRICTED PATIENTS SUCH AS NEONATES AND
CHILDREN, USE AN INFUSION PUMP IN SERIES
WITH THE FLUSH DEVICE TO ACCURATELY
REGULATE THE MINIMUM AMOUNT OF FLUSH
SOLUTION NEEDED TO MAINTAIN CATHETER
PATENCY WHILE ALLOWING CONTINUOUS
PRESSURE MONITORING. USE AN IV SET THAT IS
INDICATED FOR USE WITH THE IV PUMP. HIGH
PRESSURES, WHICH MAY BE GENERATED BY AN
INFUSION PUMP AT CERTAIN FLOW RATES, MAY
OVERRIDE THE FLUSH DEVICE RESTRICTI