Negara: Belarus
Bahasa: Rusia
Sumber: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Spectranetics Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Spectranetics Corporation
2023-07-04
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 This page intentionally left blank 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 Baca dokumen lengkapnya