Medtronic Resolute Onyx User Manual

2014/JUL/24 at 9:49 a.m. Doc number: M053607T001 [Multicol24(52)]
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Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Zotarolimus-елуираща коронарна стент система Resolute Onyx™
Systém koronárního stentu Resolute Onyx™ uvolňující zotarolimus
Resolute Onyx™-zotarolimusafgivende koronarstentsystem
Zotarolimus freisetzendes koronares Stentsystem Resolute Onyx™
Σύστημα στεφανιαίου stent με έκλυση zotarolimus Resolute Onyx™
Stent coronario con liberación de zotarolimus Resolute Onyx™
Tsotarolimuusia vapauttava Resolute Onyx™ -sepelvaltimostenttijärjestelmä
Système de stent coronaire à diffusion de zotarolimus Resolute Onyx™
Sustav koronarnog stenta Resolute Onyx™ koji otpušta Zotarolimus
Resolute Onyx™ zotarolimus-kibocsátó koronária sztentrendszer
Sistema di stent coronarico Resolute Onyx™ a rilascio di zotarolimus
Resolute Onyx™ 조타롤리무스 방출 관상동맥 스텐트 시스템
Zotarolimus-afgevend coronair Resolute Onyx™-stentsysteem
Resolute Onyx™ zotarolimusavgivende koronarstentsystem
Zestaw Resolute Onyx™ do stentowania tętnic wieńcowych uwalniający zotarolimus
Sistema de stent coronário com eluição de zotarolimus Resolute Onyx™
Sistem de stent coronarian farmacologic activ, acoperit cu zotarolimus, Resolute Onyx™
Система коронарного стента Resolute Onyx™ с покрытием зотаролимус
Systém koronárneho stentu Resolute Onyx™ uvoľňujúceho zotarolimus
Resolute Onyx™ sistem koronarnog stenta koji otpušta Zotarolimus
Resolute Onyx™ zotarolimus-avgivande koronarstentsystem
Resolute Onyx™ Zotarolimus Salınımlı Koroner Stent Sistemi
Resolute Onyx™ 唑他莫司 (Zotarolimus) 洗脱冠脉支架系统
Instructions for Use • Инструкции за употреба • Návod k použití • Brugsanvisning • Gebrauchsanweisung • Οδηγίες χρήσης • Instrucciones de uso • Käyttöohjeet • Mode d’emploi
Upute za upotrebu • Használati útmutató • Istruzioni per l’uso • 사용 지침 • Gebruiksaanwijzing • Bruksanvisning • Instrukcja użytkowania • Instruções de utilização • Instrucţiuni de utilizare
Инструкция по эксплуатации • Pokyny na používanie • Uputstva za upotrebu • Bruksanvisning • Kullanım Talimatları • 使用说明

Medtronic Resolute Onyx Specifications

General

Device Type	Drug-eluting stent
Drug	Zotarolimus
Delivery System	Rapid Exchange
Available Lengths	8 mm to 38 mm
Material	Cobalt Chromium
Stent Strut Thickness	81 µm
Stent Design	Open Cell Design
Radiopacity	Platinum-Iridium markers

Summary

Resolute Onyx™™ Zotarolimus-Eluting Coronary Stent System

1. EXPLANATION OF SYMBOLS

Provides explanations for various symbols found on product labeling and packaging.

1.3. Consult Instructions for Use

Symbol indicating the need to read the accompanying instructions.

1.5. Do Not Use if Package is Damaged

Warning symbol to check package integrity before use.

1.10. MR Conditional

Symbol indicating MR safety conditions for the device.

1.11. Do Not Reuse

Symbol indicating the device is for single use only.

Inflation Pressure

Symbol related to the pressure used during stent deployment.

Store at 15-30°C/ Store in original container

Symbol for storage conditions and original packaging requirement.

1. DEVICE DESCRIPTION

1.1. STENT

Describes the stent's material composition and construction.

1.2. DELIVERY SYSTEM

Details the delivery system's components and compatibility.

1.3. POLYMER SYSTEM

Explains the stent's coating composition.

1.4. DRUG-ZOTAROLIMUS

Describes the zotarolimus drug, its mechanism, and purpose.

2. INDICATIONS FOR USE

3. CONTRAINDICATIONS

4. WARNINGS AND PRECAUTIONS

5. POTENTIAL ADVERSE EVENTS

7. PATIENT COUNSELING

8. HOW SUPPLIED

9. DIRECTIONS FOR USE

9.1. MATERIALS REQUIRED

Lists all necessary materials for the procedure.

9.2. SELECTION OF STENT SIZE

Guides on choosing the correct stent size for optimal results.

9.3. PREPARATION OF THE DELIVERY SYSTEM

Details the steps to prepare the delivery system before use.

9.4. DELIVERY PROCEDURE

Outlines the process for delivering the stent to the target site.

9.5. DEPLOYMENT OF THE RESOLUTE ONYX™ STENT

Explains the crucial steps for deploying the stent.

9.6. FURTHER DILATATION OF STENTED SEGMENTS

Instructions for additional stent expansion if needed.

9.7. REMOVAL OF AN UNEXPANDED STENT

Steps for safely removing an unexpanded stent.

9.8. INSTRUCTIONS FOR SIMULTANEOUS USE OF TWO DEVICES IN GUIDE CATHETER (KISSING BALLOON TECHNIQUE)

10. Looper Device

DISCLAIMER OF WARRANTY

11. MRI GUIDELINES