Изделия для рентгенэндоваскулярной хирургии: система защиты от эмболии FilterWire EZ / FilterWire™ EZ Embolic Protection System, длина, см: 190, 300.

Страна: Білорусь

мова: російська

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

Доступна з:

Boston Scientific Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

Клас:

изделия медицинского назначения

Виробник:

Boston Scientific Corporation

Дата Авторизація:

2020-04-30

Характеристики продукта

INSTRUCCIONES DE USO
8
MODE D’EMPLOI
15
GEBRAUCHSANWEISUNG
22
ISTRUZIONI PER L’USO
29
GEBRUIKSAANWIJZING
36
INSTRUÇÕES DE UTILIZAÇÃO
43
Boston Scientific (Master Brand DFU Template 8in x 8in Global,
90106041AS), DFU, MB, FilterWire EZ, Global, 50607386-01A
Black (K) ∆E ≤5.0
Black (K) ∆E ≤5.0
FILTERWIRE EZ
™
Embolic Protection System
DIRECTIONS FOR USE
2
2
Boston Scientific (Master Brand DFU Template 8in x 8in Global,
90106041AS), DFU, MB, FilterWire EZ, Global, 50607386-01A
Black (K) ∆E ≤5.0
Black (K) ∆E ≤5.0
ONLY
CAUTION: Federal Law (USA) restricts this device to sale by or on the
order of
a physician.
Refer to the instructions supplied with any interventional devices to
be used in
conjunction with the FilterWire EZ Embolic Protection System for their
intended
uses, contraindications, warnings and precautions.
WARNING
Contents supplied STERILE using a Radiation process. Do not use if
sterile barrier
is damaged. If damage is found, call your Boston Scientific
representative.
For single 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.
Reuse, reprocessing or resterilization may also 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.
After
use,
dispose
of
product
and
packaging
in
accordance
with
hospital,
administrative and/or local government policy.
DEVICE DESCRIPTION
The Boston Scientific FilterWire EZ Embolic Protection System is a
temporary
intravascular 0.014 in (0.36 mm) guidewire filtration system that is
placed distal to
the target lesion to be treated by interventional procedures. The
system consists of
a protection wire, an EZ Delivery Sheath, an EZ Retrieval Sheath and