Haemonetics Cell Saver Elite User Manual
User manual
0123
Not for use with software
prior to revision AM
P/N 120745-IE, Manual revision: AA
June 2016
2 Publication Information
Publication Information
Publication
June 2016
Date
Part Number 120745-IE
Copyright
Notice
Confidential/
Proprietary
Notices
© 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 gen er al pu blic , or us ed in con jun ctio n
with any professional instruction without written consent of Haemonetics
Corporation, USA.
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 store d 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.
®
P/N 120745-IE, Manual revision: AA Haemonetics
Cell Saver® Elite® User Manual
Publication Information 3
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
Trademarks and
Patents
Reader
Comments
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. 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.
Haemonetics, Cell Saver, Elite, and SmartSuction are trademarks 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.
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.:+1 781 848 7100
Switzerland Fax:+1 781 848 5106
Tel.:+41 22 363 9011
Fax:+41 22 363 9054
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.
Haemonetics
Worldwide
®
Haemonetics
Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
Please direct any written inquiries to the appropriate address. For a list of
worldwide office locations and contact information, visit
www.haemonetics.com/officelocations.
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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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
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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
Haemonetics
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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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Cell Saver® Elite® User Manual
Table of Contents 9
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
Haemonetics
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
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
10 Table of Contents
Appendix C: Assembling the Cart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219
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Cell Saver® Elite® User Manual
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
Haemonetics® Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
12 Chapter 1, Introduction
The Haemonetics Cell Saver Elite Device
What is the Purpose of This Manual?
What is the Cell Saver Elite Autotransfusion System?
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
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.)
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.
®
personnel.
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
P/N 120745-IE, Manual revision: AA Haemonetics
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
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Cell Saver® Elite® User Manual
Chapter 1, Introduction 13
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
procedure after being powered down durin g transport from the operating
room to the post-anesthesia care unit (PACU).
A built-in barcode reader to re cord 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 ad va nc ed con fig ur at ion
options.
A fat reduction protocol
Haemonetics
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
14 Chapter 1, Introduction
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.
Table 1, RBC Product Criteria
Criteria Product Performance
HCT >
RBC Recovery >
Free Hemoglobin Washout >
Heparin and Albumin Washout >
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 meas ur e co ns titu en t was ho u t. Res ult s 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.
Table 2, 225 mL Bowl Test Results
Parameter Without Lysate With Lysate
HCT % 60 +
RBC Recovery % 94 +
WBC Removal % 24.7 +
40%
80%
95%
95%
0.2 56 + 0.3
1.0 95 + 0.1
5.01 39.6 + 9.92
Free Hemoglobin Washout % - 98.8 +
Albumin Washout % 97.7 +
Potassium Washout % - 96.4 +
Heparin Washout % 99.6 +
*Fat Washout % 99.6 +
*Fat reduction performance is applicable for the Fat Reduction setting.
P/N 120745-IE, Manual revision: AA Haemonetics
0.16 97.8 + 0.06
0.01 99.8 + 0.003
0.06
0.16
0.13
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Cell Saver® Elite® User Manual
Chapter 1, Introduction 15
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.
Haemonetics
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
16 Chapter 1, Introduction
IPX1
Symbols
Symbols Found in This Document
Symbols Found on the Device
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 rega rd in g a pr oce d ur e or opera tin g
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.
The following symbols may appear on the device or device packaging.
Caution
Consult accompanying documents.
Type CF
Type CF applied par t pro vides 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 collectio n m etho d
(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 protectio n
from drips, leaks and spills.
Manufacturer
Alternating current
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Cell Saver® Elite® User Manual
Chapter 1, Introduction 17
REF
250 mmHg
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
EC
REP
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 produ cts or materials for which,
at the end of life, there is a well-defined collection rout e an d
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.
Haemonetics
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
18 Chapter 1, Introduction
Storage conditions, humidity level
Storage conditions, temperature level
Storage conditions, keep dry
Fragile, handle with care
This end up
Read the instruction manual
P/N 120745-IE, Manual revision: AA Haemonetics
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Cell Saver® Elite® User Manual
Chapter 1, Introduction 19
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
Physical Specifications
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.
The approximate dimensions and weight of the Cell Saver Elite device are as
follows:
Table 3, Physical Specifications
Depth/cm (in.) Height/cm (in.) Width/cm (in.)
Device Alone 54.6 cm
(21.5 in)
Device With Cart
IV poles extended 67.3 cm
(26.5 in)
IV poles down 67.3 cm
(26.5 in)
Weight of device 25 kg (56 lbs)
Weight of cart 18 kg (39 lbs)
41.9 cm
(16.5 in)
182.9 cm
(72 in)
121.9 cm
(48 in)
29.8 cm
(11.75 in)
53.3 cm
(21 in)
53.3 cm
(21 in)
Environmental Specifications
Haemonetics
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
The noise level of the Cell Saver Elite device is < 70 dB.
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.
20 Chapter 1, Introduction
Note: Store disposables in a dry place away from solvent va pors and extremes
of temperature.
Table 4, Environmental Specifications
Conditions Values
Electrical Specifications
Ambient operating
temperature
Storage/transportation
temperature
Operating humidity level 8 to 80% R.H., non-condensing above 0
Atmospheric pressure range <
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.
Table 5, Electrical Input Power
Rated Voltage Rated Current Fuse Frequency
10 °C to 27 °C (50 °F to 80.6 °F)
-20 °C to 50 °C (-4 °F to 122 °F)
°C
2438 meters (8000 ft.)
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 Spec i fi ca ti o ns *
Condition Polarity Ground Max Value
Normal Normal 100 µΑ
Normal
Reverse Normal 100 µΑ
Reverse Open 500 µΑ
Single fault
Normal Open 500 µΑ
*In accordance with IEC/EN 60601-1 standard, medical electrical equipment,
general requirements for safety.
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Cell Saver® Elite® User Manual
Chapter 1, Introduction 21
Suction Specifications
The specifications for the Cell Saver Elite suction are as follows.
Table 7, Suction Specifications
Characteristics Values
SmartSuction
Recommended reservoir volume ≤ 3 L
Recommended A&A line length ≤ 12 ft [3.6 m]
Recommended A&A line inner
diameter
Recommended suction tip inner
diameter
Operating vacuum 20 to 150 mmHg
Vacuum cutoff 175 mmHg
Maximum free air flow 40 L/min
Manual Suction
Operating vacuum 50 to 250 mmHg
0.3 in [7.6 mm]
0.3 in [7.6 mm]
(2.7 to 20.0 kPa; 26.7 to 200 mbar)
(23.3 kPa; 233 mbar)
(6.7 to 33.3 kPa; 66.7 to 333.3
mbar)
Laser Specifications
Maximum free air flow 40 L/min
Post-Op Suction
Operating vacuum 25 to100 mmHg
(3.3 to 13.3 kPa; 33.3 to 133.3
mbar)
Maximum free air flow 40 L/min
The Cell Saver Elite device is a class 3R laser product.
The laser specifications for the Cell Saver Elite device are as follows:
Table 8, Laser Specifications
Characteristics Values
Max radiation output 3 mW
Wavelength 650 nm
Max light output 7 mW (bowl optics)
1.7 mW +/- 0.2 mW (barcode reader)
Standards IEC/EN 60825-1:2007
a
Haemonetics
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
22 Chapter 1, Introduction
a. The Cell Saver Elite device complies with IEC/EN 60825-1:2007 standard,
safety of laser products, equipment classification and requirements.
The following labels may appear on the device:
P/N 120745-IE, Manual revision: AA Haemonetics
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Cell Saver® Elite® User Manual
Chapter 1, Introduction 23
Ordering Information
Refer to the table below for ordering information regarding disposables.
Table 9, Disposables Ordering Information
Item Description List Number Quantity
Per Case
Waste bag, 10 L CSE-B-1000 10
Cell Saver Elite processing set (70 mL) CSE-P-70 8
Cell Saver Elite processing set (125 mL) CSE-P-125 8
Cell Saver Elite processing set (225 mL) CSE-P-225 8
Sequestration set CSE-SQ-1000 8
SmartSuction filtered vacuum line, non-sterile HAR-A-1000 10
SmartSuction aspiration & anticoagulation line HAR-A-1003 10
Cell Saver collection reservoir, 3 L, 150 μ
raised filter
Cell Saver aspiration & anticoagulation line 00208-00 20
Aspiration & anticoagulant line for use with
softshell reservoirs
Cell Saver collection reservoir, 3L, 20 μ filter 00220-00 4
Reservoir, 40u, softshell 00240-MTSA 6
Cell Saver RBC bag, 1000 mL 00245-00 40
Reservoir, 170u, softshell 00300-MTSA 6
Postoperative drainage wash system - big bore 01500-BB 10
Postoperative drainage wash system 01500-FR 10
Postoperative drainage wash system - luer lock 01500-LL 10
Postoperative drainage wash system - spike 01500-SP 10
Refer to the table below for a list of user-replaceable parts.
Table 10, User-Replaceable Parts
Item Description Part Number
00205-00 4
00208-MT 18
Haemonetics
Reusable reservoir holder for use with softshell
reservoirs
Cardiotomy bracket 02116-00
Biohazard drain bag 35643-00
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
02100-MT
24 Chapter 1, Introduction
Table 10, User-Replaceable Parts
Item Description Part Number
Wheel, 10 cm, locking, antistatic 49762-02
Wheel, 10 cm, locking 49762-03
Air exhaust filter cover 100875-00
Air exhaust filter 100878-00
Knob for touch screen mount and reservoir weigher 102924-00
Air intake filter 103003-00
Large cart bin 107090-00
Small cart bin 107094-00
2-hook saline bag hangers 107098-00
IV pole with 4-hook top 107099-00
70 mL centrifuge chuck adaptor 107581-00
Power cord, UK, 4.9m, 5A, 250VAC 109183-00
Power cord, European, 4.9m, 10A, 250VAC 109184-00
Printer kit 114282-00
User manual, IE 120747-IE
P/N 120745-IE, Manual revision: AA Haemonetics
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Cell Saver® Elite® User Manual
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
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
Haemonetics® Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
26 Chapter 2, Equipment Description
Removable Bins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
P/N 120745-IE, Manual revision: AA Haemonetics
®
Cell Saver® Elite® User Manual
Chapter 2, Equipment Description 27
1.
2.
9.
10.
5.
4.
11.
7.
3.
6.
8.
1. Device cover
2. Touch screen display
3. Effluent line sensor
4. Air detector
5. Pump cover and rotor
6. Pump platen
7. Handle
8. Reservoir weigher
9. Centrifuge system
10. Valve module
11. Ca rt
Overview
This chapter identifies the major components of the Cell Saver Elite system
and explains their intended functions. The components are located in the
following positions on the device:
Top deck
Front panel
Side panel
Rear panel
Touch screen
Cart
Note: Any references made to “left”, “right”, “top”, or “rear” are from the
perspective of a user facing the Cell Saver Elite device during a procedure.
Haemonetics
Figure 1, Cell Saver Elite system components
Refer to Chapter 3 for descriptions of the disposable set components.
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Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
28 Chapter 2, Equipment Description
Top Deck and Front Panel Components
Device Cover The clear plastic cover protects the top deck components and disposable set
while allowing the user to visually monitor both the flow of blood through the
tubing, and the action of the pump and centrifuge.
The cover can be freely raised and lowered during setup and locks into place
while the centrifuge and pump are rotating. The centrifuge and pump must
come to a complete stop before the cover can be opened.
Effluent Line Sensor
The effluent line sensor monitors the quality of the bowl effluent, adjusts the
pump speed, and advances the system to the next phase when appropriate. If
the effluent line sensor is disabled, a corresponding status icon appears on the
procedure diagram. (See “Status Icons” on page 43 for more information.)
Air Detector The ultrasonic air detector monitors the fluid flow in the pump tubing.
During the Fill phase, the air detector senses air when the reservoir is empty.
During the Concentrate (Conc) phase, the air detector senses when the RBC
bag is empty. During the Wash phase, the air detector senses air when the
saline bag is empty. If the air detector senses air during Wash and 90% or more
of the necessary wash volume has been used, the device advances to the next
phase.
The air detector is also used during the Empty and Return phases to determine
when the centrifuge bowl is empty. This minimizes air returned to the RBC bag.
Pump The three-roller, peristaltic pump moves fluids in and out of the centrifuge bowl.
At its maximum speed it is capable of a flow of 1000 mL/min. A pump platen
holds the tubing in place against the pump. The user can open and close the
platen using the lever located below the platen.
Handle There are two handles located on the front panel and the rear of the device.
The handles enable easy lifting of the device when it is not attached to the cart.
P/N 120745-IE, Manual revision: AA Haemonetics
®
Cell Saver® Elite® User Manual
Chapter 2, Equipment Description 29
1.
3.
4.
5.
6.
2.
1. Valve module cover
2. Manifold pressure
sensor
3. Latch
4. Yellow line valve
5. Red line valve
6. Blue line valve
Valve Module The valve module contains a manifold pressure sensor and four channels that
hold the processing set tubing in place. Three of the channels contain a pinch
valve that controls the flow of fluids through the set during a procedure.
Figure 2, Valve module
Pinch Valves
The three pinch valves occlude the three color-coded lines of the harness. The
function of each valve is as follows:
Yellow line valve: opens the pathway to the wash solution.
Red line valve: opens the pathway to the blood source, usually a
reservoir or extracorporeal circuit.
Blue line valve: opens the pathway to the RBC bag.
Manifold Pressure Sensor
The manifold pressure sensor monitors pressure levels in the blue and red
lines during Empty and Return and in the yellow line during Wash. If the clamp
on the RBC bag, collection bag, reservoir, or yellow line is inadvertently closed,
or the saline bag empties and collapses, the manifold pressure sensor stops
the pump and the device displays a message.
Valve Module Cover
The cover of the valve module secures the tubing in the channels. Push the
cover down and rotate the cover latch to close the cover.
The valve module cover is open, and the valves in the module are up when
loading the disposable set. The cover stays locked for the duration of the
procedure and unlocks automatically when the procedure is complete or if an
event message requires the user to access the valve manifold.
Haemonetics
®
Cell Saver® Elite® User Manual P/N 120745-IE, Manual revision: AA
30 Chapter 2, Equipment Description
4.
1.
3.
5.
6.
2.
1. Bowl optics (laser
apertures)
2. Fluid detector (not
shown)
3. Centrifuge chuck
4. Header arm latch
5. Header arm
6. Centrifuge drain port
(under the centrifuge
chuck)
Centrifuge System
The centrifuge system holds the processing set bowl during device operation
and monitors the fluids inside the bowl.
Figure 3, Centrifuge components
Bowl Optics
Warning: The bowl optics emit laser radiation. Do not look directly into the
beam.
P/N 120745-IE, Manual revision: AA Haemonetics
The bowl optics sensors mounted in the centrifuge well monitor the fluid inside
the bowl and advance the device to the next phase when the RBCs reach a
predetermined level within the bowl.
Example: the device automatically advances from the Fill phase to the Wash
phase.
Fluid Detector
The fluid detector is an electronic fluid detection device mounted on the wall of
the centrifuge well. The fluid detector detects the presence of liquid in the event
of a bowl leak.
Centrifuge Chuck
Warning: The bowl base (or centrifuge chuck adaptor) must be firmly
installed and evenly seated in the centrifuge chuck. If the centrifuge chuck
spins with the bowl base (or adaptor) not evenly seated, as indicated by bowl
wobbling or noise, bowl damage will occur and the procedure must be
discontinued.
Warning: Do not grease any part of the centrifuge or centrifuge chuck
adaptor. If grease has been applied to the chuck, contact the Haemonetics
hotline immediately.
®
Cell Saver® Elite® User Manual
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