Haemonetics Cell Saver Elite User manual

User manual
Not for use with software
prior to revision AM
P/N 120745-IE, Manual revision: AA
June 2016
0123

2Publication Information
P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
Publication Information
Publication
Date June 2016
Part Number 120745-IE
Copyright
Notice © 2016, Haemonetics Corporation
The contents of this manual are the property of the Haemonetics Corporation.
Any information or descriptions contained in this manual may not be
reproduced and released to any of the general public, or used in conjunction
with any professional instruction without written consent of Haemonetics
Corporation, USA.
Confidential/
Proprietary
Notices
Use of any portion(s) of this document to copy, translate, disassemble or
decompile, or create or attempt to create by reverse engineering (or otherwise)
the source code from the object code of Haemonetics products is expressly
prohibited.
Disclaimer This manual is intended as a guide to provide the user with necessary
instructions on the proper use and maintenance of certain Haemonetics
Corporation products. This manual should be used in conjunction with
instruction and training supplied by qualified Haemonetics personnel.
Any failure to follow the instructions as described, including use of materials or
products not provided or recommended by Haemonetics, could result in
impaired product function, injury to the user or others, or void applicable
product warranties. Haemonetics accepts no responsibility for liability resulting
from improper use or maintenance of its products.
Utilization of Haemonetics products may require the user to handle and
dispose of blood-contaminated material. Users must fully understand and
implement all regulations governing the safe handling of blood products and
waste, including the policies and procedures of their facility.
Handlinganduseof any blood products collected or stored using Haemonetics
equipment are subject to the decisions of the attending physician or other
qualified medical personnel. Haemonetics makes no warranty with respect to
such blood products.

Publication Information 3
Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
Patient diagnosis is the sole responsibility of the attending physician or other
qualified medical personnel.
Thescreenshotsappearinginthismanualareprovidedforillustrativepurposes
only and may differ from the actual software screens. All organization, donor/
patient, and user names in this manual are fictitious. Any similarity to the name
of an organization or person is unintentional.
Document
Updates The document is furnished for information use only, is subject to change
without notice and should not be construed as a commitment by Haemonetics
Corporation.HaemoneticsCorporation assumes no responsibilityorliabilityfor
any errors or inaccuracies that may appear in the informational content
contained in this material. For the purpose of clarity, Haemonetics Corporation
considers only the most recent version of this document to be valid.
Trademarksand
Patents Haemonetics,CellSaver,Elite,andSmartSuctionaretrademarks or registered
trademarks of Haemonetics Corporation in the United States and/or other
countries.
Microsoft, Excel, and Coverage Plus NPD are trademarks or registered
trademarks of their respective owners.
Reader
Comments Any comments or suggestions regarding this publication are welcomed and
should be forwarded to the attention of:
International Headquarters Corporate Headquarters
Haemonetics S.A. Haemonetics Corporation
Signy Centre 400 Wood Road
Rue des Fléchères 6 Braintree, MA 02184
P.O. Box 262 U.S.A.
1274 Signy-Centre Tel.:[phone]
Switzerland Fax:[phone]
Tel.:[phone]
Fax:[phone]
Rx Only Caution: USAFederal Law restricts the sale, distribution, or use of this device
to, by, or on the order of a licensed healthcare practitioner.
Haemonetics
Worldwide Please direct any written inquiries to the appropriate address. For a list of
worldwide office locations and contact information, visit
www.haemonetics.com/officelocations.

Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
Table of
Contents
Chapter 1, Introduction
The Haemonetics Cell Saver Elite Device . . . . . . . . . . . . . . . . . . . . . . . . . . 12
What is the Purpose of This Manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
What is the Cell Saver Elite Autotransfusion System? . . . . . . . . . . . . . . 12
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Features of the Cell Saver Elite System . . . . . . . . . . . . . . . . . . . . . . . . . 13
Blood Product Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Symbols Found in This Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Symbols Found on the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Device Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Device Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Suction Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Laser Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Chapter 2, Equipment Description
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Top Deck and Front Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Device Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Effluent Line Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Air Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Handle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Valve Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Centrifuge System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Rear and Side Panel Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Waste Bag Weigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Air Intake. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Air Exhaust Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Touch Screen Storage Mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Vacuum Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Touch Screen Cable Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Equipotential Ground Terminal Connection. . . . . . . . . . . . . . . . . . . . . . . 33
Reservoir Weigher Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Power Entry Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Touch Screen Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Status Beacon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Stop Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Touch Screen Mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
USB Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Device Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Cart Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
IV Poles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Device Mount. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Wheels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Reservoir weigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Saline Hangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Processing Set Tub Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Step Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Removable Bins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Chapter 3, Disposable Set Description
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
The A&A Line & Post-Op Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
A&A Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Post-Op Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Vacuum Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Processing Set Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Tubing Harness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Sequestration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Chapter 4, Safety and Patient Care Precautions
Storing and Handling the Device and Disposables . . . . . . . . . . . . . . . . . . .62
Storing and Handling the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Storing and Handling the Disposables . . . . . . . . . . . . . . . . . . . . . . . . . .62
Inspecting the Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Transporting the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Warnings for the User. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Electrical Shock Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Leakage Current Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Power Outlet Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Laser Radiation Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Mechanical Hazards/Rotating Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Communicable Disease Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . .66

Table of Contents 7
Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
Preventing Problems During a Procedure . . . . . . . . . . . . . . . . . . . . . . . . . .67
Understanding the Risk of Hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Avoiding Flow Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Avoiding Overheating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Avoiding Continuous Aspiration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Avoiding Red Blood Cell Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Managing the Inventory of Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Patient Care Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Reinfusing Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Replacing Depleted Clotting Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Using Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Factors Affecting Processing Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Cell Salvage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Sequestration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Chapter 5, General Operation: Cell Salvage
Preparing the Cell Saver Elite Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Connecting to Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Positioning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Unfolding the Biohazard Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Power-on procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Installing the Cell Salvage Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Inspecting the Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Collect First Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Installing the Processing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Connecting the Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Setting up the Saline Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Inspecting the Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Performing the Intraoperative Cell Salvage Procedure . . . . . . . . . . . . . . . .86
Initiating a Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Procedure Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
Additional Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Processing a Partial Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Monitoring the Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Reinfusing Processed Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Changing Processing Sets During a Procedure . . . . . . . . . . . . . . . . . . .89
Changing the Bowl Size During a Procedure . . . . . . . . . . . . . . . . . . . . .90
Completing a Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
Additional Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
Performing the Postoperative Cell Salvage Procedure . . . . . . . . . . . . . . . .94
Post-Op Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
Installing the Post-Op Set After Intra-Op Use . . . . . . . . . . . . . . . . . . . . .95
Transporting the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
Installing the Postoperative Set for Post-Op Only Use . . . . . . . . . . . . . .97

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P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
Chapter 6, General Operation: Sequestration
Preparing the Cell Saver Elite Device . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Connecting to Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Positioning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Unfolding the Biohazard Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Power-On Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Installing the Sequestration Disposables . . . . . . . . . . . . . . . . . . . . . . . . . .103
Inspecting the Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Loading the Reservoir and Vacuum Line. . . . . . . . . . . . . . . . . . . . . . . .103
Installing the Processing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Installing the Blood Bag Adaptor Harness . . . . . . . . . . . . . . . . . . . . . . .107
Installing the Collection Bag Harness . . . . . . . . . . . . . . . . . . . . . . . . . .108
Inspecting the Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Performing a Sequestration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Procedure Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Processing from Blood Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Initiating a Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Collecting PPP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Collecting PRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Emptying the Bowl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Concentration During Sequestration . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Ending the Sequestration Protocol Early. . . . . . . . . . . . . . . . . . . . . . . . 114
Changing to a Cell Salvage Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 115
Completing the Sequestration Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Transferring the RBCs for Reinfusion . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Removing the Plasma Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Removing the Sequestration and Processing Sets . . . . . . . . . . . . . . . . 119
Chapter 7, Protocol Settings
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Working with Settings Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Creating a New Settings Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123
Editing a Settings Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124
Locking a Settings Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Applying a Settings Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Deleting a Settings Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Modifiable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Cell Salvage Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .130
Chapter 8, Records
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .134
Procedure Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .136
Record Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .136
Volume By Cycle Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

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Disposables Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138
Events Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Event Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .141
Device Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142
Exporting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143
Chapter 9, Help System
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146
The Help System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .147
Accessing the Help System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Navigating the Help Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .147
Performing a Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .148
Chapter 10, Cleaning and Maintenance
Cleaning and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .152
Cleaning/Maintenance Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .152
Cleaning Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .152
Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .153
Replacing the Biohazard Waste Bag. . . . . . . . . . . . . . . . . . . . . . . . . . .155
Cleaning the Optical Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Cleaning the Centrifuge Well. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Cleaning the Fluid Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Cleaning the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Washing/Replacing the Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Replacing the Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157
Inspecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158
Clinical Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158
Repair Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158
Product Return Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158
Chapter 11, Troubleshooting
Troubleshooting Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Vacuum Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Decreased Air Flow / Aspiration Problems . . . . . . . . . . . . . . . . . . . . . .160
Touch Screen Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
Device Cover Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
Event Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
Chapter 12, Reference Information
Appendix A: IEC/EN 60601-1-2:2001 Standard Requirements . . . . . . . . .212
Operation Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213
Appendix B: System Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217
Cell Salvage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217

10 Table of Contents
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Appendix C: Assembling the Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219

Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
Chapter 1
Introduction
The Haemonetics Cell Saver Elite Device . . . . . . . . . . . . . . . . . . . . . . . . . . 12
What is the Purpose of This Manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
What is the Cell Saver Elite Autotransfusion System? . . . . . . . . . . . . . . 12
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Features of the Cell Saver Elite System . . . . . . . . . . . . . . . . . . . . . . . . . 13
Blood Product Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Symbols Found in This Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Symbols Found on the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Device Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Device Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Suction Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Laser Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

12 Chapter 1, Introduction
P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
The Haemonetics Cell Saver Elite Device
What is the
Purpose of This
Manual?
The Cell Saver®Elite®User Manual provides users with the information
needed to safely operate and maintain the Cell Saver Elite device and ensure
optimal performance.
The manual includes:
Detailed descriptions of the device and all components
How to safely operate the device and troubleshoot any difficulties
How to properly handle and maintain the device
Use this manual in conjunction with training supplied by qualified
Haemonetics®personnel.
This manual covers device list numbers CSE-E-XX and CSE-EA-1000. (-XX
refers to the regionalization code for the shipping destination of the device.)
What is the Cell
Saver Elite
Autotransfusion
System?
The Cell Saver Elite Autotransfusion System provides intraoperative and
postoperative blood salvage for surgical procedures with medium to high blood
loss. The shed blood is collected in a reservoir, processed in a centrifuge bowl
to pack red blood cells (RBCs), and then washed to remove cell stroma,
platelets, activated clotting factors, extracellular potassium, free hemoglobin,
anticoagulant, and cardioplegia. The washed, packed RBCs are then pumped
to a bag for gravity reinfusion to the patient, or, to the arterial line of an
extracorporeal circuit for reinfusion to the patient.
Prior to autotransfusion, the device can also sequester platelets using the
autotransfusion disposable in conjunction with a Sequestration set.
The Cell Saver Elite system consists of the following three parts:
Cell Saver Elite device: the electro-mechanical device and graphical
user interface (GUI) touch screen.
Disposables: the single-use collection material including reservoir,
aspiration and anticoagulant (A&A) line, processing set, vacuum line,
and post-op lines.
Solutions: anticoagulant and saline for collecting and processing
salvaged blood.
Indications for
Use The Haemonetics®Cell Saver®Elite®Autotransfusion System and its related
accessory components are intended for use to recover blood shed during or
subsequent to an operation or as a result of trauma, processing the blood by a
centrifugation and washing procedure, and pumping this processed red cell
product to either a bag for gravity reinfusion into the patient or to the arterial
line of an extracorporeal circuit for reinfusion into the patient. The intended use

Chapter 1, Introduction 13
Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
of the Sequestration Protocol is to collect an autologous, preoperative, platelet
rich plasma product for reinfusion to the same patient within 6 hours of
collection.
Contraindications
Warning: The Cell Saver Elite device is not intended to be used for chest
(pleural or mediastinal) wound drainage.
Follow the guidelines for general autotransfusion contraindications per the
AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma.
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. The use of reinfused blood from the Cell Saver
Elite 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.
Features of the
Cell Saver Elite
System
The Cell Saver Elite system includes key enhancements to the Cell Saver line
of products that increase device capabilities and ease of use. These
enhancements include:
Three suction options: on-board SmartSuction®technology, regulated
on-board suction, and post-op suction.
The ability to retain data for up to 100 procedures and continue a
procedureafterbeingpowereddownduringtransportfromtheoperating
room to the post-anesthesia care unit (PACU).
A built-in barcode reader to record disposable set(s), solutions, and
operator/patient information.
The ability to download data using a USB flash drive.
A touch-screen display that provides both a simple interface during
operation and allows users to easily access advanced configuration
options.
A fat reduction protocol

14 Chapter 1, Introduction
P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
Blood Product
Quality Caution: Actual performance results may vary depending on many in-use
variables.
Haemonetics recommends using the following RBC product criteria for quality
control procedures. Criteria are based on Haemonetics Default and standard
fat reduction protocol settings in laboratory performance with 10% hematocrit
blood pools.
Laboratory testing of the 225 mL bowl using Haemonetics Default settings
yielded the blood product quality results listed in the table below. Test results
are based on two-cycle procedures processing 10% hematocrit test pools.
Lysate and heparin were added to measure constituent washout. Results are
listed below for test pools prepared both with and without lysate. Mean values
are reported alongside standard error of the mean. Results may vary
depending on in-use variables.
*Fat reduction performance is applicable for the Fat Reduction setting.
Table 1, RBC Product Criteria
Criteria Product Performance
HCT > 40%
RBC Recovery > 80%
Free Hemoglobin Washout > 95%
Heparin and Albumin Washout > 95%
Table 2, 225 mL Bowl Test Results
Parameter Without Lysate With Lysate
HCT % 60 + 0.2 56 + 0.3
RBC Recovery % 94 + 1.0 95 + 0.1
WBC Removal % 24.7 + 5.01 39.6 + 9.92
Free Hemoglobin Washout % - 98.8 + 0.06
Albumin Washout % 97.7 + 0.16 97.8 + 0.06
Potassium Washout % - 96.4 + 0.16
Heparin Washout % 99.6 + 0.01 99.8 + 0.003
*Fat Washout % 99.6 + 0.13

Chapter 1, Introduction 15
Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
See “Appendix B: System Performance” on page 217 for complete blood
quality performance results for all bowl sizes and other settings, including Fat
Reduction, Emergency mode, and partial bowl.

16 Chapter 1, Introduction
P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
Symbols
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 user.
Note: provides useful information regarding a procedure or operating
technique when using Haemonetics material.
Caution: advises the user 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 user against initiating an action or creating a situation
which could result in serious personal injury to the patient or user.
Symbols Found
on the Device The following symbols may appear on the device or device packaging.
Caution
Consult accompanying documents.
Type CF
Type CF applied part provides a specific degree of protection
against electric shock, particularly regarding allowable
leakage current and reliability of the protective earth
connection.
Electrical and electronic equipment waste (applies to EU
only)
Dispose of the device using a separate collection method
(according to EU and local regulation for waste electrical and
electronic equipment).
Protection against ingress of vertically dripping water
Indicates that the enclosure of the device is designed to be
drip-proof, providing a higher than ordinary level of protection
from drips, leaks and spills.
Manufacturer
Alternating current
IPX1

Chapter 1, Introduction 17
Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
Fuse
Equipotentiality
Identifies the terminals which, when connected together, bring
the various parts of a system to the same potential.
Authorized representative in the European Community
Rx only (applies to USA only)
Federal (USA) Law restricts the device to sale to or on the
order of a physician.
Serial number
Catalog (list) number
Laser radiation
Shock hazard
General symbol for recovery/recyclable
To indicate that a material is part of a recovery/recycling
process.
Note:Applicable only to those products or materials for which,
at the end of life, there is a well-defined collection route and
recycling process, and which does not significantly impair the
effectiveness of other recycling schemes.
Maximum vacuum
Pollution control mark
Pollution control mark for products containing any of the six
referenced substances (Lead, Mercury, Cadmium, etc...)
according to Chinese regulations.
EC REP
REF
250 mmHg

18 Chapter 1, Introduction
P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
Storage conditions, humidity level
Storage conditions, temperature level
Storage conditions, keep dry
Fragile, handle with care
This end up
Read the instruction manual

Chapter 1, Introduction 19
Haemonetics®Cell Saver®Elite®User Manual P/N 120745-IE, Manual revision: AA
Device Specifications
Note: The use of materials not provided or recommended by Haemonetics is
the sole responsibility of the end-user, and the end-user will be responsible for
any personal injury and/or property damage related to such use.
Device
Classification The Cell Saver Elite is classified as a continuous operation, Class I, Type CF,
IPX1 device, as defined by IEC/EN 60601 standards for medical electrical
equipment.
Physical
Specifications The approximate dimensions and weight of the Cell Saver Elite device are as
follows:
The noise level of the Cell Saver Elite device is < 70 dB.
Environmental
Specifications The following environmental conditions should be respected pertaining to
operation and storage of the Cell Saver Elite device.
Warning: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
Table 3, Physical Specifications
Depth/cm (in.) Height/cm (in.) Width/cm (in.)
Device Alone 54.6 cm
(21.5 in)
41.9 cm
(16.5 in)
29.8 cm
(11.75 in)
Device With Cart
IV poles extended 67.3 cm
(26.5 in)
182.9 cm
(72 in)
53.3 cm
(21 in)
IV poles down 67.3 cm
(26.5 in)
121.9 cm
(48 in)
53.3 cm
(21 in)
Weight of device 25 kg (56 lbs)
Weight of cart 18 kg (39 lbs)

20 Chapter 1, Introduction
P/N 120745-IE, Manual revision: AA Haemonetics®Cell Saver®Elite®User Manual
Note: Store disposables in a dry place away from solvent vapors and extremes
of temperature.
Electrical
Specifications The electrical specifications for operating the Cell Saver Elite device are as
follows
Caution: The Cell Saver Elite device must be operated in an environment
compatible to the requirements of the IEC/EN 60601-1-2:2001 Standard,
Electromagnetic compatibility (EMC).
Additional IEC/EN compliance information is available in Chapter 12.
Note: The power source used must be properly grounded.
*In accordance with IEC/EN 60601-1 standard, medical electrical equipment,
general requirements for safety.
Table 4, Environmental Specifications
Conditions Values
Ambient operating
temperature
10 °C to 27 °C (50 °F to 80.6 °F)
Storage/transportation
temperature
-20 °C to 50 °C (-4 °F to 122 °F)
Operating humidity level 8 to 80% R.H., non-condensing above 0
°C
Atmospheric pressure range < 2438 meters (8000 ft.)
Table 5, Electrical Input Power
Rated Voltage Rated Current Fuse Frequency
100–120 V 3.0 A T3.15A250V 50/60 Hz
200–240 V 1.5 A T3.15A250V 50/60 Hz
Table 6, Enclosure/Chassis Leakage Current Specifications*
Condition Polarity Ground Max Value
Normal
Normal Normal 100 µΑ
Reverse Normal 100 µΑ
Single fault
Reverse Open 500 µΑ
Normal Open 500 µΑ