BIOSENSORS BioMatrix Alpha BMX6-3514 User Manual

11265-000 – Rev.01
ENGLISH  INSTRUCTION FOR USE 3
FRANÇAIS  INSTRUCTRION D’EMPLOI 6
DEUTSCH  GEBRAUCHSANWEISUNG 10
ITALIANO  ISTRUZIONI PER L’USO 14
ESPAÑOL  INSTRUCCIONES DE USO 17
PORTUGUÊS  INSTRUÇÕES DE UTILIZAÇÃO 20
NEDERLANDS  GEBRUIKSAANWIJZING 23
DANSK – BRUGSANVISNING 26
SUOMI  KÄYTTÖOHJEET 29
SVENSKA  BRUKSANVISNING 32
NORSK  BRUKSANVISNING 35
ΕΛΛΗΝΙΚΑ  ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ 38
TÜRKÇE  KULLANMA TALIMATI 42
  ИНСТРУКЦИЯ ПО ПРИМЕНЕНИЮ 45
  ИНСТРУКЦИИ ЗА УПОТРЕБА 48
EESTI KEEL KASUTUSJUHEND 52
LIETUVIŲ K.  NAUDOJIMO INSTRUKCIJA 55
LATVISKI  LIETOŠANAS INSTRUKCIJA 58
POLSKI  INSTRUKCJA UŻYCIA 61
ČESKY  NÁVOD K POUŽITÍ 65
SLOVENSKY  NÁVOD NA POUŽITIE 68
MAGYAR  HASZNÁLATI ÚTMUTATÓ 71
ROMÂNĂ  INSTRUCŢIUNI DE UTILIZARE 74
HRVATSKI  UPUTE ZA KORIŠTENJE 77
SRPSKI  UPUTSTVO ZA UPOTREBU 80
SLOVENŠČINA  NAVODILA ZA UPORABO 83
简体中文 – 使用说明 86
繁體中文 – 使用說明 89

BIOSENSORS BioMatrix Alpha BMX6-3514 Specifications

General

Product Name	BioMatrix Alpha BMX6-3514
Category	Medical Equipment
Type	Drug-Eluting Stent
Material	Stainless Steel
Coating	Biolimus A9
Delivery System	Rapid Exchange
Length	14mm
Diameter	3.5mm
Indication	Coronary artery disease

Summary

DEVICE DESCRIPTION

1.1. Device Component Description

Describes the physical components of the stent delivery system.

1.2. Drug Component Description

Details the BA9 drug and its polymer carrier.

INDICATION

CONTRAINDICATIONS

ANTIPLATELET REGIMEN

WARNINGS

PRECAUTIONS

6.1. Drug Interactions

Discusses potential interactions of BA9 drug with other medications.

6.2. Stent / System Handling - Precautions

Guidance on safe handling and storage of the stent system.

6.3. Stent Placement - Precautions

Provides guidance on safely positioning the stent within the artery.

6.4. Stent/System Removal - Precautions

Instructions for safely removing the stent delivery system.

6.5. Post Implantation - Precautions

Precautions to be taken after the stent has been implanted.

6.6. MRI Information - Precautions

Information regarding MRI compatibility and precautions.

INDIVIDUALISATION OF TREATMENT

USE IN SPECIAL POPULATION

OPERATOR'S MANUAL

9.1. Inspection Prior to Use

Steps for checking the stent system before deployment.

9.3. Preparation of the Stent / Delivery System

Procedures for preparing the stent and delivery system.

9.4. Stent Delivery Procedure

Outlines the steps for delivering the stent to the target lesion.

9.5. Deployment Procedure

Details the process for inflating the balloon and deploying the stent.

9.6. Removal Procedure

Instructions for removing the stent delivery system.

POTENTIAL ADVERSE EVENTS

Adverse Events Associated with BA9 Drug Coating

Lists adverse effects specific to the BA9 drug coating.

HOW SUPPLIED

SYMBOLS USED IN LABELING

WARRANTY