Изделия и наборы хирургические: система для биопсии Temno®
Страна: Беларусь
Язык: русский
Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Характеристики продукта
(SPC)
02-11-2022
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Доступна с:
Merit Medical Systems, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
класс:
изделия медицинского назначения
Производитель:
Merit Medical Systems
Дата Авторизация:
2022-11-02
Характеристики продукта
INSTRUCTIONS FOR USE
MODE D’EMPLOI
ISTRUZIONI PER L’USO
GEBRAUCHSANWEISUNG
INSTRUCCIONES DE USO
INSTRUÇÕES DE UTILIZAÇÃO
INSTRUÇÕES DE USO
GEBRUIKSINSTRUCTIES
BRUKSANVISNING
BRUGSANVISNING
ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ
KULLANIM TALİMATLARI
РУКОВОДСТВО ПО ЭКСПЛУАТАЦИИ
INSTRUKCJE UŻYTKOWANIA
NÁVOD K POUŽITÍ
ИНСТРУКЦИИ ЗА УПОТРЕБА
HASZNÁLATI UTASÍTÁS
BIOPSY SYSTEM
BIOPSY SYSTEM
I N S T R U C T I O N S F O R U S E
DESCRIPTION OF THE PRODUCT
The Merit Corvocet™ Biopsy System is a sterile single patient use
device comprised of a core needle biopsy device and optional
coaxial introducer. It is available in several needle gauge sizes and
lengths. The top and rear actuator buttons on the device are
color coded according to the various gauge sizes, Yellow=20 gauge,
Pink=18 gauge, Purple=16 gauge and Green=14 gauge.
INDICATIONS FOR USE
The disposable Corvocet Biopsy System is intended for use in obtaining
core biopsy samples from soft tissues such as
liver, kidney, prostate, spleen, breast, lung, lymph nodes and various
soft tissue tumors. It is not intended for use in bone.
CONTRAINDICATIONS
Physician judgment is required when considering biopsy on patients
with bleeding disorders, or receiving anticoagulant
medications. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on
the order of a physcian trained and/or experienced
in the use of this device.
WARNINGS
•
After use, this product may be a potential biohazard. Handle and
dispose of in accordance with acceptable medical
practice and with applicable local, state, and federal laws and
regulations.
•
Unusual force applied to the needle or unusual resistance against the
needle may cause the needle to deform or bend.
A bent or deformed needle may not function properly.
•
Post-biopsy care may vary with the biopsy technique utilized and the
individual patient’s physiological condition.
Observation of vital signs and other precautions should be taken to
avoid and/or treat potential complicatio
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