Расходные материалы одноразового применения к системе экстракорпорального мониторинга параметров крови CDI 550/CDI500: сенсор шунтовый CDI с гепарином (кат. №: CDI510Н)

Страна: Беларусь

Язык: русский

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

Доступна с:

Terumo Cardiovascular Systems Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Terumo Cardiovascular Systems Corporation

Дата Авторизация:

2021-05-06

Характеристики продукта

ENGLISH
TERUMO CARDIOVASCULAR SYSTEM - CDI™ PRODUCTS
CDI™ SHUNT SENSOR WITH HEPARIN TREATMENTS, MODEL CDI510H
THE CDI™ BLOOD PARAMETER MONITORING SYSTEM
OPERATOR’S MANUAL CONTAINS COMPLETE INSTRUCTIONS
FOR ASSEMBLY AND USE OF THE SENSORS WITH THE CDI
BLOOD PARAMETER MONITORING SYSTEM. IT MUST BE READ
IN ITS ENTIRETY BEFORE ATTEMPTING TO ASSEMBLE AND USE
THE SYSTEM.
INDICATIONS
The disposable CDI™ Shunt Sensor with heparin treatment is intended
for use with the CDI™ Monitor during cardiopulmonary bypass
procedures when continuous blood gas, pH, and potassium monitoring
is desired.
CONTRAINDICATIONS
The CDI510H is not intended for use in situations in which there is no
flow of blood through the extracorporeal circuit. A minimum blood flow
of
35 ml/min is recommended for optimal measurement perfor- mance of
the shunt sensor. Restoration of minimum blood flow through the shunt
line after an interruption will restore optimal performance of the
system.
THE CDI SHUNT SENSOR WITH HEPARIN TREATMENT, MODEL CDI510H
(FIGURE I)
The Shunt Sensor contains porcine derived heparin.
The shunt sensors are sterile, heparin-coated, non-toxic, non-pyrogen-
ic, and for single use only. This device is sterilized by
γ-irradiation.
THE HEPARIN TREATMENT PROVIDES A NON-LEACHING HEPARINIZED
SURFACE. IT IS APPLIED BY A PROCESS WHICH COVALENTLY BINDS HEPARIN
TO THE BLOOD CONTACTING SURFACES OF THIS DEVICE. THE HEPARIN
TREATMENT IMPROVES THE THROMBORESISTANCE OF THE NON-BIOLOGICAL
MATERIALS. SURFACES WITH HEPARIN TREATMENT HAVE DEMONSTRATED
STABILITY IN THE PRESENCE OF BLOOD.
WARNING: FOR SINGLE USE ONLY. DO NOT REUSE. DO NOT
RESTERILIZE. DO NOT REPROCESS. REPROCESSING MAY COM-
PROMISE THE STERILITY, BIOCOMPATIBILITY AND FUNCTIONAL
INTEGRITY OF THE DEVICE.
CAUTION: DO NOT USE THE SHUNT SENSOR AFTER THE DATE
PRINTED ON THE PACKAGE LABEL. USE BEYOND THE DATE MAY
RESULT IN INACCURATE PERFORMANCE.
CAUTION: DO NOT USE THE SHUNT SENSOR IF THE FOIL POUCH
HAS BEEN DAMAGED OR DEFLATED. DAMAGE TO THE POUCH
MAY LEAD TO THE LOSS OF STORAGE GA