Haemonetics Cell Saver Elite+ User manual

User Manual
Not for use with software
prior to revision AQ
130859-US(AA)
October 2022

2Publication Information
P/N 130859-US, Manual Revision: AA Haemonetics®Cell Saver®Elite®+ User Manual
Publication Information
Copyright
Notice
© 2017, 2020, 2022 Haemonetics Corporation
The contents of this manual are the property of 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.
Handling and use of 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.
Patient diagnosis is the sole responsibility of the attending physician or other
qualified medical personnel.
The screenshots appearing in this manual are provided for illustrative purposes
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

Publication Information 3
Haemonetics® Cell Saver®Elite®+ User Manual P/N 130859-US, Manual Revision: AA
Corporation. Haemonetics Corporation assumes no responsibility or liability for
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.
Trademarks and
Patents
Haemonetics, Cell Saver, Elite, and SmartSuction are trademarks or registered
trademarks of Haemonetics Corporation in the US, other countries, or both.
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:.
Rx Only Caution: USA Federal Law restricts the sale, distribution, or use of this device
to, by, or on the order of a licensed healthcare practitioner.
Note: Availability of devices may vary from one country or region to another as
a result of specific local regulatory approval or clearance requirements.
Applicable laws may restrict 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.
Corporate Headquarters
Haemonetics Corporation
125 Summer Street
Boston, MA 02110
U.S.A.
Tel. [phone]
Fax [phone]
International Headquarters
Haemonetics SA
Signy Centre
Rue des Fléchères 6
P.O. Box 262
1274 Signy-Centre, Switzerland
Tel. [phone]
Fax [phone]

Haemonetics®Cell Saver®Elite®+ User Manual P/N 130859-US, 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
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Features of the Cell Saver Elite+ System . . . . . . . . . . . . . . . . . . . . . . . .13
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Blood Product Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Symbols Found in This Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Symbols Found on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Device Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Device Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Electrical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Laser Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Chapter 2, Equipment Description
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Top Deck and Front Panel Components. . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Device Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Effluent Line Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Air Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Valve Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Centrifuge System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Rear and Side Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Waste Bag Weigher. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Air Intake . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Air Exhaust Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Touch Screen Storage Mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Vacuum Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Touch Screen Cable Entry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Equipotential Ground Terminal Connection . . . . . . . . . . . . . . . . . . . . . . .32
Reservoir Weigher Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

6Table of Contents
P/N 130859-US, Manual Revision: AA Haemonetics®Cell Saver®Elite®+ User Manual
Power Entry Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Touch Screen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Status Beacon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Stop Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Touch Screen Mount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
USB Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Ethernet Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Graphical User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Device Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Cart Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
IV Poles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Device Mount. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Wheels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Reservoir Weigher. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Saline Hangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Processing Set Tub Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Step Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Removable Bins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Chapter 3, Disposable Components Description
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
The A&A Line and Post-Op Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
A&A Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Post-Op Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Vacuum Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Processing Set Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Tubing Harness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Centrifuge Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Sequestration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Chapter 4, Safety and Patient Care Precautions
Storing and Handling the Device and Disposable Components. . . . . . . . . .60
Storing and Handling the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Storing and Handling the Disposable Components. . . . . . . . . . . . . . . . .60
Inspecting the Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Transporting the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Warnings for the User. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Electrical Shock Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Leakage Current Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Power Outlet Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Laser Radiation Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63

Table of Contents 7
Haemonetics® Cell Saver®Elite®+ User Manual P/N 130859-US, Manual Revision: AA
Mechanical Hazards/Rotating Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Communicable Disease Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Preventing Problems During a Procedure . . . . . . . . . . . . . . . . . . . . . . . . . .65
Understanding the Risk of Hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Avoiding Flow Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Avoiding Overheating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Avoiding Continuous Aspiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Avoiding Red Blood Cell Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Managing the Inventory of Air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Patient Care Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Reinfusing Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Replacing Depleted Clotting Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Using Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Factors Affecting Processing Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Cell Salvage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Sequestration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Chapter 5, General Operation: Cell Salvage
Preparing the Cell Saver Elite+ Device . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
Connecting to Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
Positioning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
Unfolding the Biohazard Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Power-on Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Installing the Cell Salvage Components . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Inspecting the Disposable Components . . . . . . . . . . . . . . . . . . . . . . . . .77
Collect First Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Installing the Processing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Connecting the Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Setting up the Saline Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Inspecting the Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Performing the Intraoperative Cell Salvage Procedure . . . . . . . . . . . . . . . .84
Initiating a Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Procedure Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Cell Salvage Additional Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
Processing a Partial Bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
Monitoring the Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
General Precautions When Reinfusing Processed Blood . . . . . . . . . . . .93
Changing Processing Sets During a Procedure . . . . . . . . . . . . . . . . . . .93
Changing the Bowl Size During a Procedure . . . . . . . . . . . . . . . . . . . . .94
Completing a Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Additional Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
Performing the Postoperative Cell Salvage Procedure . . . . . . . . . . . . . . . .98
Post-Op Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Installing the Post-Op Set After Intra-Op Use . . . . . . . . . . . . . . . . . . . . .99
Transporting the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
Installing the Postoperative Set for Post-Op Only Use . . . . . . . . . . . . .100

8Table of Contents
P/N 130859-US, Manual Revision: AA Haemonetics®Cell Saver®Elite®+ User Manual
Chapter 6, General Operation: Sequestration
Preparing the Cell Saver Elite+ Device . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Connecting to Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Positioning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Unfolding the Biohazard Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Power-on Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
Installing the Sequestration Disposable Components . . . . . . . . . . . . . . . .105
Inspecting the Disposable Components . . . . . . . . . . . . . . . . . . . . . . . .105
Loading the Reservoir and Vacuum Line. . . . . . . . . . . . . . . . . . . . . . . .105
Installing the Processing Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
Installing the Blood Bag Adaptor Harness . . . . . . . . . . . . . . . . . . . . . . .109
Installing the Collection Bag Harness . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Inspecting the Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Performing a Sequestration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Procedure Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Processing from Blood Bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Initiating a Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Collecting PPP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Collecting PRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Emptying the Bowl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Concentration During Sequestration . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Ending the Sequestration Protocol Early. . . . . . . . . . . . . . . . . . . . . . . . 117
Changing to a Cell Salvage Procedure . . . . . . . . . . . . . . . . . . . . . . . . . 118
Completing the Sequestration Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
General Precautions When Transferring the RBCs for Reinfusion . . . .120
Removing the Plasma Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .120
Removing the Sequestration and Processing Sets . . . . . . . . . . . . . . . .121
Chapter 7, Protocol Settings
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124
Working with Settings Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Creating a New Settings Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Editing a Settings Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126
Locking a Settings Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Applying a Settings Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Deleting a Settings Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Modifiable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Cell Salvage Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .132
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .134
Making the Quick Transfer and Manual Mode Settings Available . . . . .136
Chapter 8, Records
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138
Procedure Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140
Record Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140

Table of Contents 9
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Volume By Cycle Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142
Disposables Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143
Events Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .144
Event Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145
Device Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146
Exporting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .147
Chapter 9, Help System
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
The Help System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151
Accessing the Help System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151
Navigating the Help Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151
Performing a Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .152
Chapter 10, Cleaning and Maintenance
Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Cleaning/ Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Cleaning Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .157
Replacing the Biohazard Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . .159
Cleaning the Optical Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159
Cleaning the Centrifuge Well. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159
Cleaning the Fluid Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Cleaning the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Washing/Replacing the Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Replacing the Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
Inspecting the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
Clinical Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
Repair Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
Equipment Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
Product Return Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .162
Chapter 11, Troubleshooting
Troubleshooting Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164
Vacuum Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .164
Decreased Air Flow / Aspiration Problems . . . . . . . . . . . . . . . . . . . . . .164
Touch Screen Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165
Device Cover Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165
Event Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166
Appendix A, IEC/EN 60601-1-2 Standard Requirements
Operation Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .216
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217

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Appendix B, System Performance
Cell Salvage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .224
Appendix C, Cart Assembly Instructions
Installing the Device on the Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .228

Haemonetics®Cell Saver®Elite®+ User Manual P/N 130859-US, 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
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Features of the Cell Saver Elite+ System . . . . . . . . . . . . . . . . . . . . . . . .13
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Blood Product Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Symbols Found in This Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Symbols Found on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Device Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Device Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Electrical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Laser Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

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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 applies to device list numbers CSE-EW-US and CSE-E-US and is
not for use with software prior to revision AN.
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 reinfusion bag.
Prior to autotransfusion, the device can also sequester platelets using the
autotransfusion processing set 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.
Disposable components: 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 the processed red blood
cells to a product bag. The intended use of the Sequestration Protocol is to
collect an autologous, preoperative, platelet rich plasma product for reinfusion

Introduction 13
Haemonetics® Cell Saver®Elite®+ User Manual P/N 130859-US, Manual Revision: AA
to the same patient within the recommended time guidelines of the American
Association of Blood Banks (AABB), 9th Edition.
Essential
Performance
The essential performance of the Cell Saver Elite+ device is to collect and
process red blood cells while maintaining red blood cell integrity to provide a
viable Red Blood Cell product for reinfusion. See Table 6, "RBC Product
Criteria", on page 16 for RBC Product Criteria.
Contraindications
Alert: 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:
Two suction options: on-board SmartSuction® technology and regulated
on-board suction.
The ability to retain data for up to 100 procedures and continue a
procedure after being powered down during transport from the operating
room to the post-anesthesia care unit (PACU).
A built-in barcode reader to record processing 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

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Cell Saver Elite+
Release AQ - Key
New Features
Table 1, Key New Features
See the Cell Saver Elite+ Release Notes for more information on the changes
made for release AQ.
Performance
Characteristics
Feature Description
Manual Mode Manual Mode enables users to operate the
device manually during the Fill, Wash, Empty,
Concentrate and Return phases.
Quick Transfer When time is of the essence, Quick Transfer
Mode can be used to quickly move shed blood
from the reservoir to the reinfusion bag and
bypass the wash phase completely.
Final Cycle Enables users to specify the End Procedure
behavior when air is detected during Fill.
Table 2, Vacuum Suction
Characteristic Value
Smart Suction
Operating vacuum 30 to 165 mmHg ±10%
(4.0 to 22.0 kPa; 40.0 to 220 mbar)
Vacuum cutoff 175 mmHg
(23.3 kPa; 233 mbar)
Maximum free air flow 40 L/min
Manual Mode
Operating vacuum 50 to 250 mmHg
(6.7 to 33.3 kPa; 66.7 to 333.3 mbar)
Maximum free air flow 40 L/min
Post-Op
Operating vacuum 25 to100
(3.3 to 13.3 kPa; 33.3 to 133.3 mbar)
Maximum free air flow 40 L/min

Introduction 15
Haemonetics® Cell Saver®Elite®+ User Manual P/N 130859-US, Manual Revision: AA
Table 3, Cell Savage Protocol (225 mL and 125 mL Bowls)
Characteristic Value
Centrifuge Speed (Fill) 5650 RPM ±300 RPM
Centrifuge Speed (Concentration) 3850 RPM ±300 RPM
Centrifuge Speed (Wash) 6050 RPM ±300 RPM
Pump Speed 25 mL to 1000 mL ±10%
Reservoir Level Up to 3 kg ±25 g
Waste Bag Scale Up to 10 L ±250 mL
Table 4, Cell Savage Protocol (70 mL Bowl)
Characteristic Value
Centrifuge Speed (Fill, Wash) 7500 RPM ±300 RPM
Centrifuge Speed (Concentration) 5000 RPM ±300 RPM
Pump Speed 25 mL to 1000 mL ±10%
Reservoir Level Up to 3 kg ±25 g
Waste Bag Scale Up to 10 L ±250 mL
Table 5, Sequestration Protocol
Characteristic Value
Centrifuge Speed (Fill) 5650 RPM ±300 RPM
Centrifuge Speed (PRP) 2450 RPM ±300 RPM
Pump Speed 10 mL to 250 mL ±10%

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Blood
Product
Quality
Attention: 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.
See Appendix B, “System Performance” for complete blood quality
performance results for all bowl sizes and other settings, including Fat
Reduction, Emergency Mode, and partial bowl and low wash.
Table 6, RBC Product Criteria
Criteria Product Performance
HCT > 40%
RBC Recovery > 80%
Free Hemoglobin Washout > 95%
Heparin and Albumin Washout > 95%
Table 7, 225 mL Bowl Test Results
Parameter Without Lysate With Lysate
HCT % 52 + 0.8 58 + 4.2
RBC Recovery % 95 + 1.3 94 + 1.8
WBC Removal % 40.7 + 4.3 36.9 + 11.3
Free Hemoglobin Washout % - 99.0 + 0.2
Total Protein Washout %a
a. Total protein measurement has been used as a surrogate instead of albumin only assay
(albumin being a sub-category of protein).
98.5 + 0.1 99.0 + 0.2
Potassium Washout % - 98.7 + 0.2
Heparin Washout % 99.6 + 0.1 99.7 + 0.1
Fat Washout %b
b. Fat reduction performance is applicable for the Fat Reduction setting.
99.6 + 0.13

Introduction 17
Haemonetics® Cell Saver®Elite®+ User Manual P/N 130859-US, Manual Revision: AA
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.
Attention: 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.
Alert: advises the user against initiating an action or creating a situation
which could result in serious personal injury to the patient or user.
Warning: Notifies the user of an electric shock risk.
Caution: Notifies the user of a laser beam exposure risk.
Symbols Found
on the Device
The following symbols may appear on the device or device packaging.
General warning, caution, risk of danger
Type CF applied part
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).

18 Chapter 1
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Protection against ingress of vertically dripping water
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
Maximum safe working load
Alternating current
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 (address for)
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
Warning; laser beam
IPX1
71kg
EC REP
REF

Introduction 19
Haemonetics® Cell Saver®Elite®+ User Manual P/N 130859-US, Manual Revision: AA
Non-ionizing electromagnetic radiation
Used to specify RF (radio frequency) transmission for data
communication.
General symbol for recovery/recyclable
To indicate that a material is part of a recovery/recycling
process. (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
Storage conditions, humidity limit
Storage conditions, temperature limit
Storage conditions, keep dry
Fragile, handle with care
This end up
Refer to instruction manual/booklet
MR Unsafe
Warning: Keep away from magnetic resonance imaging
(MRI) equipment.
250 mmHg

20 Chapter 1
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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+ device is classified as a continuous operation, Class I,
Type CF, IPX1 device, in accordance with IEC/EN 60529 and 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.
Alert: Equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
Note: Store disposable components in a dry place away from solvent vapors
and extremes of temperature.
Table 8, Physical Specifications
Depth/in. (cm) Height/in. (cm) Width/in. (cm)
Device Alone 21.5 in.
(54.6 cm)
16.5 in.
(41.9 cm)
11.75 in.
(29.8 cm
Device With Cart
IV poles extended 26.5 in.
(67.3 cm)
72 in. (182.9 cm) 21 in.
(53.3 cm)
IV poles down 26.5 in.
(67.3 cm)
48 in. (121.9 cm) 21 in.
(53.3 cm)
Weight of device 56 lbs. (25 kg)
Weight of cart 39 lbs. (18 kg)
Safe working load
of system
157 lbs. (71 kg)