Изделия для рентгенэндоваскулярной хирургии: набор лазерного катетера GlideLight Laser Sheath (артикулы: 500-301, 500-302, 500-303)

País: Bielorrusia

Idioma: ruso

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

Disponible desde:

Spectranetics Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

clase:

изделия медицинского назначения

Fabricado por:

Spectranetics Corporation

Fecha de autorización:

2023-07-04

Ficha técnica

P002208-12 26OCT20 (2020-10-26)
1
INSTRUCTIONS FOR USE
for OTW and RX Catheter Models
ELCA™ Coronary Laser Atherectomy Catheter
Instructions for Use
OTW AND RX CATHETER MODELS
ENGLISH / ENGLISH
P002208-12 26OCT20 (2020-10-26)
2
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ELCA™ Coronary Laser Atherectomy Catheter
Instructions for Use
OTW AND RX CATHETER MODELS
P002208-12 26OCT20 (2020-10-26)
3
Instructions for Use - Sections by Language
PG
LANGUAGE
INSTRUCTIONS FOR USE
4
English
English
Instructions For Use
11
Czech
Česky
Návod k Použití
18
Danish
Dansk
Brugsanvisning
25
Dutch
Nederlands
Gebruiksaanwijzing
32
French
Française
Mode d’emploi
39
German
Deutsch
Gebrauchsanweisung
46
Greek
Ελληνικά
Οδηγίες χρήσης
53
Hungarian
Magyar
Használati útmutatóaz
60
Italian
Italiano
Istruzioni per l’uso
67
Norwegian
Norsk bokmål
Bruksanvisning
74
Polish
Polski
Instrukcja obsługi
81
Portuguese
Português
Instruções para Utilização
88
Russian
Pусский язык
Руководство по эксплуатации
96
Slovak
Slovensky
Návod na použitie
103
Spanish
Español
Instrucciones de uso
110
Swedish
Svenska
Bruksanvisning
117
Turkish
Türkçe
Kullanım Talimatları
ELCA™ Coronary Laser Atherectomy Catheter
Instructions for Use
OTW AND RX CATHETER MODELS
ENGLISH / ENGLISH
P002208-12 26OCT20 (2020-10-26)
4
1.
DESCRIPTION
OVER THE WIRE (OTW) CATHETERS are constructed of multiple fi ber
optics arranged concentrically around a guidewire
lumen and are intended for use in the coronary vasculature for
recanalization of obstructed arteries. A side arm
adapter located at the proximal end of the usable length facilitates
the use of the laser catheter over 0.014”, 0.016”
and 0.018” guidewires.
RAPID EXCHANGE (RX) CATHETERS consists of optical fi bers encased
within a polyester shaft. There are two major
portions of the laser catheter shaft, the proximal portion which
terminates at the laser connector, and the distal
portion which terminates at the tip having direct patient contact. The
fi b