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Cell Saver®5+ Autologous Blood Recovery System - Operator’s Manual -

Haemonetics Corporation 400 Wood Road Braintree, Massachusetts 02184, USA ©1993, 2000, 2004, Haemonetics Corporation. All rights reserved.

P/N 53063-50, Manual revision: B November 2004

Preface

P/N 53063-50, Manual Revision: B

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P/N 53063-50, Manual Revision: B

Preface

Proprietary

Information anddescriptions contained herein are the property of Haemonetics Corporation. Such information and descriptions may not be copied or reproduced by any means, or disseminated or distributed without written permission of Haemonetics Corporation, 400 Wood Road, Braintree, Massachusetts 02184, U.S.A.

Trademarks used in this manual

Haemonetics® and Cell Saver® are registered trademarks of HaemoneticsCorporation. Betadine® is a registered trademark of The Purdue Frederick Company. Avitene® is a registered trademark of MedChem Products, Inc. Baxter, Bentley, Cell–3000/3000F, BCR–3000, and BCR–3500 are trademarks of Baxter Healthcare Corporation.

Scope

This manual is intended for users of the Haemonetics® Cell Saver® 5+ Autologous Blood Recovery System. The contents of this Operator’sManual explain the operation and basic maintenance for the Cell Saver 5+ System. Diagnostics and subsequent repairs to this system should only be attempted by a qualified technician.

Symbols found in this document

The terms Note, Caution and Warning are used in this manual with the following symbols to emphasize certain details for the operator. Note: provides useful information regarding aprocedure or operating technique when using Haemonetics material.

Caution: advises the operator against initiating an action or creating a situation which could result in damage to equipment, or impair the quality of the blood products; personal injury is unlikely. Warning: advises the operator against initiating an action or creating a situation which could result in serious personal injury to thedonor, the operator, or the blood product recipient.

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Preface

P/N 53063-50, Manual Revision: B

Buyer’s Use of Product

Warning: Haemonetics Corporation warrants only the Haemonetics Cell Saver 5+ system (CS5+) as supplied by it. When properly assembled, maintained and operated by a qualified operator, the CS5+ has the capability of safely and adequately performing Cell salvageand sequestering procedures. Warning: Bodily injury may result from the use of disposable sets manufactured by others with this system. Please contact Haemonetics Corporation to determine the safety of using disposables other than those supplied by Haemonetics. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Warning: This manual provides certain basicinformation concerning the maintenance and operation of the Haemonetics Cell Saver 5+ System and is intended to be used in conjunction with and as a supplement to the training supplied by a Haemonetics Clinical Specialist or other qualified personnel. Departures or deviations from the procedures contained in this manual should not be made except in conformity with official changes made to the manualby Haemonetics Corporation. Other departures or deviations are at the operator’s own risk. Safe and effective use of Haemonetics products requires application of proper techniques of setup and operation, and accordingly, should be undertaken only by trained personnel. Any Buyer that intends to use Haemonetics products should:
! !

Read carefully the instructions supplied herewith. Securetraining in the procedures to be used.

Information with respect to the availability of such training can be obtained by writing Haemonetics Corporation, Attention: Patient Division. The uses to which the Haemonetics products may be applied, and the results obtained therefrom, shall be the sole responsibility of the Buyer. Haemonetics expressly disclaims responsibility for the use of the products by...