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Cell Saver Elite
Haemonetics Cell Saver Elite User Manual
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User manual
Not for use with softwar
e
prior to r
evision AM
P/N 120745-IE, Manual revision:
AA
June 2016
0123
2
Table of Contents
Default Chapter
6
Table of Contents
6
Chapter 1 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
27
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
Power Cord
33
Touch Screen Cable Entry
33
Equipotential Ground Terminal Connection
33
Reservoir Weigher Connection
33
Power Entry Module
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
52
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
62
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
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
76
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
Chapter 6, General Operation: Sequestration
100
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
122
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
134
Overview
134
Procedure Records
136
Record Tab
136
Volume by Cycle Tab
137
Disposables Tab
138
Events Tab
140
Event Records
141
Device Records
142
Exporting Records
143
Chapter 9, Help System
146
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
152
Cleaning and Maintenance
152
Cleaning/Maintenance Schedule
152
Cleaning Supplies
152
Cleaning the Device
153
Replacing the Biohazard Waste Bag
155
Cleaning the Optical Lenses
155
Cleaning the Centrifuge Well
155
Cleaning the Fluid Detector
156
Cleaning the Pump
156
Washing/Replacing the Air Filters
156
Replacing the Fuses
157
Inspecting the Power Cord
157
Customer Service
158
Clinical Training
158
Repair Service
158
Product Return Guidelines
158
Chapter 11, Troubleshooting
160
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
212
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
Appendix C: Assembling the Cart
219
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Haemonetics Cell Saver Elite Specifications
General
Brand
Haemonetics
Model
Cell Saver Elite
Category
Laboratory Equipment
Language
English
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