Haemonetics Cell Saver 5+ User manual

Cell Saver®5+
Autologous Blood Recovery System
- Operator’s Manual -
Haemonetics Corporation
400 Wood Road
Braintree, Massachusetts 02184, USA P/N 53063-50, Manual revision: B
©1993, 2000, 2004, Haemonetics Corporation. All rights reserved. November 2004

Preface P/N 53063-50, Manual Revision: B
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P/N 53063-50, Manual Revision: B Preface
iii
Proprietary Information and descriptions 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 Haemonetics
Corporation. 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’s Manual 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 a procedure 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 the donor, the operator, or the
blood product recipient.

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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 salvage and 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 basic information 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 manual by
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.
!Secure training 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 the Buyer.

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Inquiries Please direct any written inquiries to the appropriate address:
Haemonetics Corporation
Patient Division
400 Wood Road
Braintree, Massachusetts 02184, U.S.A.
Haemonetics S.A.
Signy Centre
P. O. B ox 2 62
CH-1274 Signy 2, Switzerland
Haemonetics Japan Co., Ltd.
Shin-Kojimachi Building, 1+2F
4-3-3 Kojimachi
Chiyoda-ku 102, Tokyo, Japan
In the United States, telephone inquiries may be made by using the toll-free
number: 1 [phone], or by calling [phone].
All Haemonetics products are manufactured in accordance with ISO 9000
standards.
Authorized European Representative
HAEMONETICS U.K. LTD.
5 Ashley Drive, Bothwell
Scotland G71 8DA
Great Britain

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CONTACTING HAEMONETICS WORLDWIDE
Use the following list when contacting the appropriate Haemonetics
representative for each region.
Haemonetics Asia Inc.
Taiwan Branch
26F-1, No. 102 Roosevelt Road Sec. 2
Taipei, Taiwan
Tel. [+886 2] 2369 0722
Fax [+886 2] 2364 3698
Haemonetics
Handelsges.m.b.H.
Berlagasse 45/B2-02
1210 Wien, Austria
Tel. [+43 1] 294 29 00
Fax [+43 1] 294 29 05
Haemonetics Belgium NV
Leuvensesteenweg 542-BP. 14
Planet II Complex
1930 Zaventem, Belgium
Tel. [+32 2] 720 7484
Fax [+32 2] 720 7155
Haemonetics BV
Tinstraat 107
NL - 4823 AA Breda
The Netherlands
Tel. [phone]
Fax [phone]
Haemonetics Medical Devices
(Shanghai) International
Trading Co. Ltd.
Room 28032, Shanghai HSBC Tower
101 Yin Cheng East Road
Shangai 200120, PRC
Tel. [+86 21] 5066 3366
Fax [+86 21] 6841 3688
Haemonetics CZ, spol. s r.o.
Ptašínského C.8
60200 Brno, Czech Republic
Tel. [+42 05] 4121 2400
Fax [+42 05] 4121 2399
Haemonetics France S.A.R.L.
46 bis, rue Pierre Curie
Z.I. Les Gatines
78370 Plaisir, France
Tel. [+33 1] 30 81 41 41
Fax [+33 1] 30 81 41 30
Haemonetics GmbH
Rohrauerstrasse 72
81477 München, Germany
Tel. [+49 89] 785 8070
Fax [+49 89] 780 9779
Haemonetics Hong Kong Ltd.
Suite 1314, Two Pacific Place
88 Queensway, Hong Kong
Tel. [+852] 2868 9218
Fax [+852] 2801 4380
Haemonetics Italia S.R.L.
Via Donizetti 30
20020 Lainate (MI), Italy
Tel. [+39 2] 9357 0113
Fax [+39 2] 9357 2132
Haemonetics Japan K.K.
Kyodo Building 3F
16, Ichiban-cho, Chiyoda-ku
Tokyo, Japan, 102-0082
Tel. [+81 3] 3237 7260
Fax [+81 3] 3237 7330
Haemonetics Scandinavia AB
Beta Huset, Ideon
Scheelegatan 17
223 70 Lund, Sweden
Tel. [+46 46] 286 2320
Fax [+46 46] 286 2321
Haemonetics (UK) Ltd.
Beechwood House
Beechwood Estate
Elmete Lane, Roundhay
Leeds LS8 2LQ, United Kingdom
Tel. [+44 113] 273 7711
Fax [+44 113] 273 4055

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Table of Contents
Chapter 1: Introduction
Introducing the Cell Saver 5+ System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Autologous blood transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Autologous vs. Allogeneic Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Cell Saver Systems and Autologous Transfusion . . . . . . . . . . . . . . . . . . . 1-5
Historical Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Haemonetics Cell Saver Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Special features of the CS5+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Automated Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Computer Guided Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Performance Readouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Maneuverability and Portability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Fluid Management Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Processing Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Construction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Machine Symbol Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Disposable Packaging Symbol Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Bowl symbol chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Primary Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Storage and Transport Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Ordering information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

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Chapter 2: Equipment and Disposable Description
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Controls and indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
ON/OFF Power Switch and Fusing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Major components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
General operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Blood Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Filling the Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Cell Separation and Concentration in the Bowl . . . . . . . . . . . . . . . . . . 2-19
Red Cell Washing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Washing Partial Bowls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Emptying the Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Chapter 3: Safety and Patient Care Precautions
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Safety and patient care precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Storage and Handling of Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Flammable Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Electrical Shock Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Rotating Machinery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Communicable Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Restrictions to Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Twists and Kinks in Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Plasma Hemoglobin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Continuous Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Overheating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Red Cell Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Managing the Inventory of Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Pressure Reinfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Depletion of Clotting Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Anticoagulant Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Factors affecting processing time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Cell Salvage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Sequestering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

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Chapter 4: Setup Procedures for Cell Salvage
General operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Power On Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Installing the Cell Saver Disposables. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Chapter 5: Automatic Operation: Cell Salvage
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Processing in the automatic mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Modifying the preset parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Additional functions in automatic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
CONC (Concentrate) Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
PUMP REGULATION Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
EMPTY RBCs TO BLUE/RED LINE (RETURN Option) . . . . . . . . . . . . . . 5-13
VOLUME TO RESERVOIR/CIRCUIT . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
NO WASH Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
EMERGENCY Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
EMPTY BLUE LINE Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
System status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Wash Volume Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Volume Accounting Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Chapter 6: Manual Operation
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Controls and indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Manual operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
EMERGENCY Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Chapter 7: Sequestering on the Cell Saver 5+ System
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Overview of the sequestering protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Loading the Disposable Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Setting the Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Method 1 — Manual sequestration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
System Breakdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Method 2 — Assisted sequester mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Sequester Setup Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
System Breakdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-25

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Chapter 8: Maintenance
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Maintenance and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Cleaning the Centrifuge Well . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Optics Lens Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Cleaning the Effluent Line Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Air Detector Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Cleaning the Tubing Valves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Blood Pump Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Cleaning After a Spill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Cleaning the Air Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Field service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Technical services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Installation and Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Hotline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Returned goods authorization (RGA) system . . . . . . . . . . . . . . . . . . . . . . . . 8-8
RGA Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Chapter APP: Appendices
Appendix A: Complications and contraindications . . . . . . . . . . . . . . . . . APP-2
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . APP-6
Appendix B: Cleaning procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . APP-7
Appendix C: Machine messages/troubleshooting . . . . . . . . . . . . . . . . . . . APP-8
Appendix D: IEC 60601-1 standard requirements . . . . . . . . . . . . . . . . . APP-11
Operation precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . APP-11
Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . APP-11

1-1
Chapter 1
Introduction
INTRODUCING THE CELL SAVER 5+ SYSTEM . . . . . . . . . . . . . . . . . . . . . . 1-2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
AUTOLOGOUS BLOOD TRANSFUSION . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Autologous vs. Allogeneic Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Cell Saver Systems and Autologous Transfusion . . . . . . . . . . . . . . . . . . . 1-5
Historical Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Haemonetics Cell Saver Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
SPECIAL FEATURES OF THE CS5+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Automated Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Computer Guided Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Performance Readouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Dimensions and Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Maneuverability and Portability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Fluid Management Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Processing Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Construction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Machine Symbol Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Disposable Packaging Symbol Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Bowl symbol chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Primary Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Storage and Transport Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
ORDERING INFORMATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

Introduction P/N 53063-50, Manual Revision: B
1-2
INTRODUCING THE CELL SAVER 5+ SYSTEM
The Haemonetics Cell Saver 5+ Autologous Blood Recovery System, shown in
Figure 1-1, represents the fifth generation of autologous blood recovery systems.
Using the latest microprocessor technology, the Cell Saver 5+ System (CS5+)
delivers a new level of automation in the processing of autologous blood.
Operator interaction and surveillance are minimized by the use of a sensor which
automatically senses the fluid level in the reservoir and initiates the machine’s
operation. Processing time has also been reduced while maintaining a high
quality end product.
Cell Saver Systems salvage blood shed during or after a surgical procedure or as
the result of trauma. The shed blood, which is collected in a sterile reservoir, is
processed by the Cell Saver System in a centrifuge bowl. The red blood cells
(RBCs) are concentrated and washed to remove cell stroma, platelets, activated
clotting factors, extracellular potassium, free hemoglobin, anticoagulant, and
cardioplegia. The washed, concentrated RBCs may then be returned to the
patient.
Use of the CS5+ should be considered when the anticipated blood loss from a
clean wound can be retrieved at a rate permitting aspiration without undue
hemolysis. The presence of any of the following criteria may be an indication for
blood salvage: the anticipated blood loss is 20% or more of the patient’s
estimated blood volume; blood would ordinarily be crossmatched for the
procedure; more than 10% of the patients undergoing the procedure require
transfusion; the mean transfusion for the procedure exceeds one unit. Specific
types of surgery where cell salvage is especially useful include open heart and
vascular surgery, total joint replacement and spine surgery, liver transplantation,
ruptured ectopic pregnancy, and selected neurosurgical procedures.
Postoperative salvage is employed most often following cardiac and certain types
of orthopedic procedures.1
Haemonetics
introduced the first
successful autologous
blood collection
system, the original
Cell Saver 1 System.

P/N 53063-50, Manual Revision: B Introduction
1-3
Figure 1-1: The Haemonetics Cell Saver 5+ Autologous Blood Recovery System

Introduction P/N 53063-50, Manual Revision: B
1-4
Indications for
Use
The Haemonetics Cell Saver 5+ System and its related accessory components are
intended to be used for the recovery and processing of blood shed during or
subsequent to an operation or as a result of trauma. The recovered blood is
processed by a centrifugation and washing procedure before pumping the red
cell product to either a bag for gravity reinfusion into the patient or an
extracorporeal circuit. The Haemonetics Cell Saver 5+ System may also be used
for preoperative platelet and plasma sequestration.
Contraindications
for Use
The risk/benefit ratio of blood salvage must be determined on an individual basis
by the surgeons, anesthesiologists and transfusion medicine specialists involved
in the patient’s care. Refer to Appendix A for a chart of contraindicated
substances, the effects of their use, and the recommended corrective actions to
perform.
Warning: The use of reinfused blood from the Cell Saver 5+ System may be
contraindicated, for example, in the case of sepsis or malignancy. The
responsibility for the use of this device belongs solely to the physician in charge.

P/N 53063-50, Manual Revision: B Introduction
1-5
AUTOLOGOUS BLOOD TRANSFUSION
The term, autologous blood, refers to blood derived from the same individual. An
autologous blood transfusion therefore, is one in which a patient receives his or
her own blood. The blood may have been donated earlier or salvaged from shed
blood during surgery or postoperatively. Allogeneic blood, on the other hand, is
donor blood from sources other than the patient who is receiving it.
Autologous vs.
Allogeneic
Transfusion
The advantages of autologous transfusion are well documented. The major
advantages are as follows:
!No disease transmission risk
!Reduced risk of transfusion reactions
!Minimal compatibility testing
!Reduced demand on blood bank inventory
Cell Saver
Systems and
Autologous
Transfusion
In addition to the general benefits of autologous transfusion, Cell Saver
Systems provide the following benefits:
!Portability
!Rapid setup
!Rapid return of patient’s own cells
!Reduction of net blood loss
!Removal of red cell stroma
!Removal of plasma-free hemoglobin
!Removal of anticoagulant
!Removal of activated clotting factors
!Removal of extracellular potassium
!Cost-effectiveness
!General acceptance by Jehovah’s Witnesses
Autologous blood is
now widely accepted
as the first choice for
reinfusion.

Introduction P/N 53063-50, Manual Revision: B
1-6
Historical
Overview
The following paragraphs are a brief summary of the history of transfusion
methods.
Early Experiments with Transfusion
Some of the earliest recorded attempts at transfusion were undertaken by a
French physician, Jean Denys, who in the 1660’s performed transfusions between
animals and humans with predictably disastrous results.2
Quite reasonably, the French government stepped in and forbade the transfusion
of blood except with the permission of a member of the Faculty of Medicine of
Paris (which was strongly opposed to the practice). Rumors of Denys’
experiments and his results were circulated throughout Europe, and fear of such
practices spread to other countries.
In 1818 an English surgeon, James Blundell, reported on a human-to-human
transfusion that he had performed (though unsuccessfully). Blundell later did
perform successful transfusions, and his are the first recorded successes.3
More importantly, Blundell’s attempts were relatively scientific and he recorded
much useful information on transfusion. He also noted that the donation of a
small quantity of blood produced no harmful effects on the donor.4
First Recorded Uses of Autologous Transfusion
In the late 1800’s James Highmore, an English surgeon, proposed the use of
autotransfusion (as autologous transfusion is also known), and suggested that a
patient’s shed blood was an overlooked source that could be used to great
advantage. His article, appearing in The Lancet in 1874, advocated intraoperative
autotransfusion, specifically in the case of post-partum hemorrhage.5Highmore
later recorded his successful use of autotransfusion in a variety of cases.6
The Use and Acceptance of Allogeneic Blood
In the early 1900’s techniques for typing and matching blood were developed.
Gradually, allogeneic transfusions became accepted, though the general method
was to transfuse blood directly from donor to recipient rather than to use banked
blood.
The first blood bank was established at Cook County Hospital, Chicago on March
15, 1937, but the real rise of allogeneic transfusions came during World War II.7
The need for blood during the war was large, as would be expected, and the
donor pool in the United States grew enormously to meet this need. Using
banked blood was, quite simply, the easiest alternative, and allogeneic
transfusions became the norm.
Naturally, doctors returning from the war continued to rely on donor blood
though several factors were developing which would make this less and less
practical. The Korean and later the Vietnam wars followed World War II placing
the usual high demands on the donor pool. Concurrently, other large demands

P/N 53063-50, Manual Revision: B Introduction
1-7
were being placed on the donor pools with the development and refinement of
sophisticated surgical procedures such as open heart surgery.
The shortages of donor blood during the Vietnam War revived interest in
autotransfusion. In Vietnam, an American military surgeon named Klebanoff
began using the open heart pump to capture, anticoagulate, filter, and reinfuse
the blood lost in surgery.8
Klebanoff’s machine was introduced in the 1970’s by Bentley Laboratories in a
commercial version. Klebanoff’s machine was effective though unsophisticated.
Blood was simply anticoagulated, filtered, and reinfused. The Bentley machine
was the first attempt to modernize autologous blood recovery in decades.
Haemonetics Cell
Saver Systems
Haemonetics Cell Saver Systems are aptly named. Their primary purpose is the
recovery of red blood cells (RBCs). The RBCs are recovered from the shed blood
that has, in the past, simply been discarded after an operation. Cell Saver Systems
collect, concentrate, and wash the RBCs, removing unwanted components, and
then return them to the reinfusion bag or a extracorporeal circuit for reinfusion.
The first Haemonetics Cell Saver System was released in 1975. With each
generation of Cell Saver System, Haemonetics has improved performance and
increased automation. Today, Haemonetics Cell Saver Systems are used in a wide
range of surgical procedures.

Introduction P/N 53063-50, Manual Revision: B
1-8
SPECIAL FEATURES OF THE CS5+
The CS5+ improves upon the design and performance of its predecessors. The
CS5+ processes shed blood faster without compromising the quality of the end
product (concentrated RBCs). Haemonetics has improved and streamlined the
features and functions of earlier units and introduced the latest microprocessor
and sensor technologies to produce a significant advance in autologous blood
recovery systems, one which meets the demands and needs of the modern
operating room.
Automated
Operation
The bowl optics sensor in the centrifuge well, an ultrasonic air detector on the
tubing line and an optical effluent line sensor provide information to the CS5+
microprocessor. The processor determines the optimal processing parameters for
each individual cycles of the machine.
These parameters have been thoroughly tested and carefully calculated to
produce consistently optimal results under most operating conditions. Although
it is possible to reprogram the parameters, changes should be carefully
considered.
The ultrasonic air detector monitors the fluid flow in the tubing. When air in the
pump tubing is detected, the pump is stopped, the appropriate tubing is clamped
and a message is sent to the display.
The bowl optics sensor monitors the red blood cell level in the bowl. This sensor
initiates tripping to the WASH mode when the RBC level reaches the sensor trip
point.
Note: Bowl optics sensor is disabled when processing the 70mL bowl.
The effluent line sensor monitors the quality of the effluent as it leaves the bowl.
Among the actions the system might initiate are determining when the RBCs are
adequately washed or slowing the pump rate in WASH or FILL mode if RBC
spillage is detected. Additionally, with the 70mL bowl algorithm, the effluent line
sensor monitors the red blood cell level to initiate tripping to WASH mode.
An onboard computer
(microprocessor) uses
data from a variety of
sensors to control the
processing of blood,
allowing an
unprecedented level
of automation.

P/N 53063-50, Manual Revision: B Introduction
1-9
Computer
Guided Setup
The on-board microprocessor guides the operator through system setup by
displaying instructions on the display panel. For help in setting up the CS5+, press
the HELP key on the control panel. Figure 1-2 illustrates typical setup
instructions.
Figure 1-2: HELP display
Operators with multiple responsibilities involving frequent interruptions find the
setup instructions useful as a checklist. When called away from setup to attend to
another duty, the operator leaves the setup instruction as a reminder. When
returning to complete the setup, the operator checks the instruction and
continues from that point.
Caution: The instructions provided by the display panel are not intended to
replace formal training by Haemonetics in the operation of the Cell Saver 5+
System, nor do they relieve the operator of the obligation to read this manual.
Performance
Readouts
The right hand side of the display panel provides information relative to the
operation of the system. Pump rate, wash volume, processed volume, number of
bowls processed, and product volume as well as current mode of operation are
constantly updated and displayed. The status of the CS5+ is available at a glance.
HELP
1. Prepare the collection (reservoir and suction).
2. Ready the machine and bowl disposable.
3. Install the bowl.
4. Hang the bags.
5. Install the tubing harness.
7. Inspect and finish.
Press START to resume
6. Set up the saline.

Introduction P/N 53063-50, Manual Revision: B
1-10
SPECIFICATIONS
Dimensions and
Weight
Maneuverability
and Portability
The CS5+ is provided with a cart that has four caster wheels that ensure
maneuverability. The unit may be tipped back on the rear wheels to get over
power cords, door sills, and other obstructions. The front two casters may be
locked to secure the CS5+ cart in position. The CS5+ can be removed from the
cart to allow for easy transport in cars and vans.
There are two different types of carts supplied with the CS5+ system.
Machine Removal
There is a locking mechanism on the back of the cart. Depress the release button
on the right of the latch. A handle will pivot outward from the left side of the latch.
Pull on the handle to ensure the lock is completely disengaged. To remove the
machine from the cart, lift the machine.
Machine Installation
There is a visible locking mechanism on the back of the cart, depress the release
button on the right of the latch. A handle will pivot outward from the left side of
the latch. If necessary, pull on this handle until it is in the fully open position. Set
the machine on the cart and push the latch handle inward until it locks into place.
Table 1-1: Dimensions and weight*
Depth/in. (cm) Height/in. (cm) Width/in. (cm)
Machine alone
IV Pole extended 14.5 (37) 74.5 (189) 16 (41)
IV Pole down 14.5 (37) 37 (94) 16 (41)
Machine with Cart
IV Pole extended 23 (58) 88.5 (225) 19 (48)
IV Pole down 23 (58) 54.5 (138) 19 (48)
Weight of
Machine
71 lb (32.2 Kg)
Weight of Cart 35 lb (15.9 Kg)
* All dimensions nominal