Катетер направляющий Climber™ (размеры: диаметр: 5F; 6F; 7F; 8F; длина: 100 см; 125 см)

Страна: Беларусь

Язык: русский

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

Доступна с:

PendraCare International B.V., НИДЕРЛАНДЫ

класс:

изделия медицинского назначения

Производитель:

PendraCare International B.V.

Дата Авторизация:

2022-05-12

Характеристики продукта

ENGLISH
INSTRUCTIONS FOR USE - GUIDING CATHETER
CONTENTS
Intravascular guiding catheter.
DEVICE DESCRIPTION
The hydrophilic coated guiding catheter is a single use device that
facilitates the
passage of intravascular devices.
INDICATIONS
The guiding catheter is designed to provide a pathway through which
therapeutic
and diagnostic devices are introduced. The guiding catheter is
intended to be
used in the coronary or peripheral vascular system.
CONTRAINDICATIONS
None known.
WARNINGS
y
For the definitions of the warning symbols, refer to the symbol
section of the
Instructions for Use
y
Use prior to the “use by” date as indicated on the label.
y
Contents supplied STERILE using an ethylene oxide (EO) process. Do not
use if the product’s sterile barrier or packaging is compromised. If
damage is
found, contact your company representative.
y
For single patient use only. Do not reuse, reprocess or resterilize.
Reuse,
reprocessing or resterilization may compromise the structural
integrity of
the device and/or lead to device failure which, in turn, may result in
patient
injury, illness or death. Catheters are extremely difficult to clean
after
exposure to biological materials. Reuse, reprocessing or
resterilization may
create a risk of contamination of the device and/or cause patient
infection
or cross-infection, including, but not limited to, the transmission of
infectious
disease(s) from one patient to another. Contamination of the device
may
lead to injury, illness or death of the patient.
y
Inspect the catheter before use to verify that labelled dimensions,
shape and
condition are suitable for the specific procedure, and to ensure
compatibility
with other devices.
y
Do not use damaged products.
y
Do not expose to organic solvents.
y
Following use, devices may pose a biological hazard. Handling,
disposal
and destruction of used devices and its packaging should be performed
in
accordance with applicable laws and regulations and following adequate
processes.
y
When there is limited clearance between devices and the