Abbott CentriMag Reference Manual

File Specifications

Brand: Abbott
Category: Medical Equipment
Model: CentriMag (Reference Manual), primOstDDn4SM
File Type: PDF
File Size: —
Pages: 32 pages

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Key Pages of Document

CentriMag™ Circulatory Support System

Clinical Reference Manual READ ALL INDIVIDUAL CENTRIMAG SYSTEM COMPONENT INSTRUCTIONS FOR USE (IFU), THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM OPERATION MANUAL, AND THE ENTIRE CONTENTS OF THIS MANUAL BEFORE USING THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. Abbott Medical Clinical & Technical Support Phone number(s) United ...

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents © 2019 Abbott. All Rights Reserved. ...

Introduction .................................................................................................................................................... 6

Indications for Use ............................................................................................................................................ 6 Contraindications .. ...

Safety and Effectiveness and Results ............................................................................................................................... 27

Device Malfunctions and Failures .................................................................................................................................... 30 Clinical Study Safety ...

This manual is designed for healthcare professionals. It contains clinical and technical information for guidance in the proper and

safe use of the CentriMagTM Circulatory Support System when used as intended. The information in this manual supplements the CentriMag Circulatory Support System Operation Manual and each of the individual system ...

Terminology and Abbreviations

Abbreviations for terms used in this manual include:  ABP, arterial blood pressure  ACT, activated coagulation time  AMI, acute myocardial infarction  BiVAD, biventricular assist device  BUN, Blood Urea Nitrogen  CI, cardiac index  CPB, cardiopulmonary bypass  CVP, central venous pressure  ECMO, extr ...

The primary design features of the system include:

 Fully magnetically levitated impeller  No bearings, shafts, valves, or seals within pump  Low priming volume (31 cc) designed to reduce hemodilution  Disposable (polycarbonate) pump with standard 3/8” connectors  Reusable motor, console, non-invasive flow probe and accessories  Configu ...

WARNING: The safety and effectiveness of use of the CentriMag system in an ECMO circuit (i.e. cardiopulmonary support > 6

hours) has not been demonstrated. WARNING: The safety and effectiveness of use of the CentriMag system for use > 30 days has not been demonstrated. Patients undergoing cardiac surgery who fail to be weaned from cardiopulmonary bypass du ...

2nd Generation CentriMagTM console with motor and flow probe connected

 Preassembled circuit and priming pack  Two 3/8” two-sided, straight, barbed connectors (and backups), if not included with the cannula kits  Sterile tubing clamps and scissors  One liter of a warm balanc ...

Turn on the console, and set the speed to approximately 1500 RPMs with the clamps still on the drainage and return tubing in

the basin. 8. Remove the clamp from the drainage tubing and then remove the clamps from the return tubing. Allow the priming solution to recirculate until all visible air is removed. CAUTION: Ensure that the open ends of the tubi ...

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