SORIN GROUP CARBOMEDICS CARBO-SEA AP-021 User Manual

CARBOMEDICS CARBO-SEAL
®
AND CARBOMEDICS CARBO-SEAL
®
VALSALVA
ASCENDING AORTIC PROSTHESIS - INFORMATION FOR USE
CARBOMEDICS CARBO-SEAL
®
E CARBOMEDICS CARBO-SEAL
®
VALSALVA
PROTESI DELL'AORTA ASCENDENTE - INFORMAZIONI PER L’USO
CARBOMEDICS CARBO-SEAL
®
ET CARBOMEDICS CARBO-SEAL
®
VALSALVA
PROTHÈSE DE L’AORTE ASCENDANTE - MODE D’EMPLOI
CARBOMEDICS CARBO-SEAL
®
UND CARBOMEDICS CARBO-SEAL
®
VALSALVA
AORTA-ASCENDENS-PROTHESE - VERWENDUNGSHINWEISE
CARBOMEDICS CARBO-SEAL
®
Y CARBOMEDICS CARBO-SEAL
®
VALSALVA
PRÓTESIS DE LA AORTA ASCENDENTE - INFORMACIÓN DE USO
CARBOMEDICS CARBO-SEAL
®
E CARBOMEDICS CARBO-SEAL
®
VALSALVA
PRÓTESE DE AORTA ASCENDENTE - INFORMAÇÃO DE UTILIZAÇÃO
CARBOMEDICS CARBO-SEAL
®
EN CARBOMEDICS CARBO-SEAL
®
VALSALVA
AORTA ASCENDENS-PROTHESE - GEBRUIKSINFORMATIE
CARBOMEDICS CARBO-SEAL
®
OCH CARBOMEDICS CARBO-SEAL
®
VALSALVA
AORTA ASCENDENS-PROTES - INFORMATION FÖR ANVÄNDARE
CARBOMEDICS CARBO-SEAL
®
OG CARBOMEDICS CARBO-SEAL
®
VALSALVA
PROTESE FOR AORTA ASCENDENS - BRUKSINFORMASJON
CARBOMEDICS CARBO-SEAL
®
OG CARBOMEDICS CARBO-SEAL
®
VALSALVA
OPADGÅENDE AORTISK PROTESE - INFORMATION OM BRUG
CARBOMEDICS CARBO-SEAL
®
ΚΑΙ CARBOMEDICS CARBO-SEAL
®
VALSALVA
ПΡΟθEΣH ANIOYΣAΣ AOPTHΣ - ΠΛΗΡΟΦΟΡΙΕΣ ΧΡΗΣΗΣ
CARBOMEDICS CARBO-SEAL
®
a CARBOMEDICS CARBO-SEAL
®
VALSALVA
PROTÉZA VZESTUPNÉ AORTY - INFORMACE O POUŽITÍ
CARBOMEDICS CARBO-SEAL
®
ja CARBOMEDICS CARBO-SEAL
®
VALSALVA
ÜLENEVA AORDI PROTEESIDE - KASUTAMIST PUUDUTAV TEAVE
CARBOMEDICS CARBO-SEAL
®
UN CARBOMEDICS CARBO-SEAL
®
VALSALVAS
ASCENDĒJOŠĀS AORTAS PROTĒZE - LIETOŠANAS INFORMĀCIJA
CARBOMEDICS CARBO-SEAL
®
IR CARBOMEDICS CARBO-SEAL
®
VALSALVA
KYLANČIOSIOS AORTOS DALIES PROTEZAS - NAUDOJIMO INFORMACIJA
CARBOMEDICS CARBO-SEAL
®
ÉS CARBOMEDICS CARBO-SEAL
®
VALSALVA
AORTA ASCENDENS PROTÉZIS - HASZNÁLATI ÚTMUTATÓ
CARBOMEDICS CARBO-SEAL
®
I CARBOMEDICS CARBO-SEAL
®
VALSALVA
PROTEZA AORTY WSTĘPUJĄCEJ - INFORMACJE DOTYCZĄCE UŻYCIA
CARBOMEDICS CARBO-SEAL
®
IN CARBOMEDICS CARBO-SEAL
®
VALSALVA
ASCENDENTNA AORTNA ZAKLOPKA - NAVODILA ZA UPORABO
CARBOMEDICS CARBO-SEAL
®
A CARBOMEDICS CARBO-SEAL
®
VALSALVA
PROTÉZA ASCENDENTNEJ AORTY - NÁVOD NA POUŽITIE
CARBOMEDICS CARBO-SEAL
®
JA CARBOMEDICS CARBO-SEAL
®
VALSALVA
NOUSEVAN AORTAN PROTEESI - KÄYTTÖOHJEET
CARBOMEDICS CARBO-SEAL
®
VE CARBOMEDICS CARBO-SEAL
®
VALSALVA
ASENDAN AORT PROTEZİ - KULLANIM BİLGİLERİ
CARBOMEDICS CARBO-SEAL
®
ŞI CARBOMEDICS CARBO-SEAL
®
VALSALVA
PROTEZA DE AORTĂ ASCENDENTĂ - INFORMAŢII PRIVIND UTILIZAREA
CARBOMEDICS CARBO-SEAL
®
および CARBOMEDICS CARBO-SEAL
®
VALSALVA
上行大動脈プロテーゼ - 使用方法
CARBOMEDICS CARBO-SEAL
®
和 CARBOMEDICS CARBO-SEAL
®
瓦氏
升主动脉假体 - 使用资料
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SORIN GROUP CARBOMEDICS CARBO-SEA AP-021 Specifications

General

Brand	SORIN GROUP
Model	CARBOMEDICS CARBO-SEA AP-021
Category	Medical Equipment
Language	English

Summary

SYMBOLS

SIZE

Explains symbols related to valve size.

SN

Explains symbols for serial numbers.

REF

Explains symbols for catalog numbers.

Use by

Explains symbols for expiration dates.

CAUTION

Warning to refer to instructions for use.

DEVICE DESCRIPTION

INDICATIONS FOR USE

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Warnings

General safety warnings for the device.

Precautions

Guidelines for safe handling and use.

Warnings Prior to Use

Specific safety advice before product use.

Precautions During Use

Recommendations for safe implantation procedures.

COMPLICATIONS

Observed Adverse Events

Lists risks associated with the prosthetic heart valve.

Potential Adverse Events

Details possible complications from valve and graft use.

CLINICAL STUDIES

INDIVIDUALIZATION OF TREATMENT

Anticoagulant and/or Antiplatelet Therapy

Discusses therapy needs after cardiac valve replacement.

PATIENT COUNSELLING

DIRECTIONS FOR USE

PATIENT INFORMATION

Registration Form and Identification card

Information on patient registration and ID cards.

Patient's Card

Details on the patient identification card.

Magnetic Resonance Imaging (MRI) information

Information regarding MRI compatibility of the device.

HOW SUPPLIED

INSTRUMENT WASHING, DISINFECTION AND STERILIZATION INSTRUCTIONS

Manual Cleaning and Disinfection

Procedure for manual instrument cleaning and disinfection.

Washer-disinfector procedure with Alkaline Detergent

Cycle details for washer-disinfector with alkaline detergent.

Washer-disinfector procedure with Enzyme Detergent

Cycle details for washer-disinfector with enzyme detergent.

RETURN OF EXPLANTED DEVICES

WARRANTY

FIGURES

SPECIFICATIONS

INSTRUMENTS TABLES

DATA SUPPORTING OBSERVED ADVERSE EVENTS AND CLINICAL STUDIES, ACCORDING TO FDA REQUIREMENTS

TABLES

Table 1. Adverse Event Rates in the Carbomedics Prosthetic Heart Valve Clinical Investigation

Summarizes adverse event rates for patient groups.

Table 2. Patient Characteristics

Provides demographic and clinical characteristics of patients.

Table 3. Postoperative Echocardiography Results – Aortic Position

Echocardiographic data for aortic valve position.

Table 4. Postoperative Echocardiography Results – Mitral Position

Echocardiographic data for mitral valve position.

Table 5. Percent of Patients in NYHA Class III or IV

Patient functional class distribution pre- and post-operation.

REFERENCES