sorin XTRA Autotransfusion System Manuals

Manuals and User Guides for sorin XTRA Autotransfusion System. We have 2 sorin XTRA Autotransfusion System manuals available for free PDF download: Operator's Manual, Instructions For Use Manual

sorin XTRA Operator's Manual (304 pages)

Brand: sorin | Category: Medical Equipment | Size: 15.3 MB

Table of Contents
3
Chapter 1: Introduction and Safety

15
- About the Operating Instructions
  15
- Introducing the X
  15
- TRA System
  15
Chapter 2: Overview

16
Chapter 3: System Description

16
- Indications for Use
  17
- Contraindication for Use
  17
- General Warnings
  17
- Storage and Transporting Warnings
  23
- Electrical Warnings
  23
- General Precautions
  24
- Operating Conditions
  28
- Warning
  28
- Cautions
  28
- Adverse Effects
  28
- Installation of the Unit
  28
- Installation
  28
- Unpacking and Inspection
  29
- Storage and Transport Conditions
  29
- Electrical Requirements
  29
- Addresses
  30
- Service Information
  31
- Return of Used Product
  31
- For North American Customers
  31
- For International Customers
  31
- Disposal in Accordance with Environmental Regulations
  32
- Chapter 2: Overview
  33
- Advantages of Intra- and Postoperative Red Cell Recovery
  33
- Clinical Applications
  33
- Description of the X
  33
- TRA System
  33
- How the XTRA System Works
  35
- Collection and Anticoagulation
  35
- Processing
  35
- Figure 2-1 Position of Separated Whole Blood Components in Centrifuge Bowl
  35
- Reinfusion
  36
- The Basic XTRA
  36
- Options Available with XTRA
  37
- Programmability Option
  37
- Emergency Option
  37
- Vacuum System
  37
- Vac )
  37
- Preoperative Sequestration Option (PPP and PRP)
  37
- Data Management Options (USB, Printer, RS232)
  37
- Quality Control Options
  37
- Chapter 3: System Description
  39
- Machine Components
  39
- Figure 3-1 XTRA Front View
  39
- Figure
  40
- XTRA Rear View
  40
- Handles
  41
- Hooks and Tray Holders
  41
- Figure 3-3 Front Handle (Left), Rear Handle (Center), and Rear Transport Handle (Right)
  41
- Figure 3-4 Hooks on Left Side of
  41
- Cart
  42
- Figure 3-5 Left: Disposable Tray on Tray Holders; Right: Waste Bag on Right-Side Hooks
  42
- Figure 3-6 Cart
  42
- Figure 3-7 Spring Lever Releases Cart
  43
- Figure 3-8 Lifting Body from Cart
  43
- Figure
  43
- IV Pole and Reservoir Pole
  44
- Figure 3-9 XTRA Body and Cart
  44
- Figure 3-10 Reservoir and IV Pole
  44
- Reservoir Holder
  45
- Touch Screen Display Panel
  45
- Figure 3-11 Reservoir Holder
  45
- Centrifuge Assembly
  47
- Figure 3-13 Centrifuge Assembly
  47
- Figure 3-14 Centrifuge Well Fluid Container
  48
- Clamps
  49
- Left: Clamps with Clamp Lid Open | Right: Clamp Lid Closed and Latched
  49
- Figure
  49
- Processing Pump
  50
- Air Detector
  50
- Visible Parts of the X
  50
- TRA Processing Pump
  50
- Figure
  50
- Location of the Air Detector
  50
- Quality Control Indicators
  51
- Xvac
  51
- Figure 3-18 Location of the Hematocrit and Waste Line Color Indicators
  51
- Figure 3-19 Left: Vacuum Module | Right: Integrated Vacuum Module
  51
- Essential Performance
  52
- Order Guide
  52
- XVAC Release Screw
  52
- Figure
  52
- XVAC Control Panel
  52
- Xtra
  52
- Disposable Description
  53
- Figure
  53
- Figure
  54
- Collection Set
  55
- Figure 3-24 XTRA Collection Kit (CARDIO TOP)
  55
- Xtra
  55
- Figure
  56
- Collection Reservoir Lid Ports
  56
- Figure 3-27 Left: Reservoir with TOP Outlet | Right: Reservoir with BOTTOM Outlet
  57
- Aspiration Line
  57
- Figure
  58
- Vacuum Line
  58
- Bowl Set
  59
- Figure 3-30 Cardio Kit
  59
- Cross-Section of Latham Centrifuge Bowl
  60
- Figure 3-34 Red Blood Cells (RBC) Bag
  62
- Procedure Set
  63
- Figure 3-31 Bowl Set
  63
- Selecting the Disposable
  64
- Selecting the Bowl
  64
- Order Guide
  65
- Figure 3-35 Procedure Set
  65
- Anticoagulant Solution
  67
- Wash Solution
  68
- Accessories and Optional Devices
  68
- Cables
  69
- Figure 3-33 Waste Bag
  69
Chapter 4: Installing the Disposables

71
Chapter 5: Processing

83
- Operating the Touch Screen
  83
- Figure 5-1 Example of an Enabled Button
  83
- Figure
  83
- Example of in Inactive (Left) and Active (Right) Toggle Button
  83
- Figure 5-3 Example of a Disabled Button
  83
- Screen Structure
  84
- Typical Autotransfusion Processing Screen Structure
  84
- Figure
  84
- The Displets
  85
- Reservoir Displet (Open and Closed)
  85
- Figure
  85
- Vacuum Displet
  85
- Rbc's Displet
  86
- Figure
  86
- Waste Bag Displet
  86
- PPP/PRP Displet
  86
- Processing Displet
  86
- Modification of Parameters
  87
- Running a Case with the XTRA System
  87
- Before You Begin
  87
- Figure 5-11 a Text Box before and after Being Selected for Editing
  87
- Loading the Pump Segment for a New Case
  88
- Figure 5-12 Rear Panel of the
  88
- Figure
  88
- Processing a Cycle in Automatic or 1 Touch Mode
  89
- Setup Screen
  89
- Figure
  89
- Figure 5-14 Ready Screen
  90
- Fill Phase of the Processing Screen
  91
- Figure
  91
- Wash Phase of the Processing Screen
  92
- Figure
  92
- Pausing and Resuming the Cycle
  93
- Empty Phase of the Processing Screen
  93
- Figure
  93
- Figure 5-18 Fill Phase Paused
  94
- Figure 5-19 Wash Phase Paused
  94
- Figure 5-20 Wash Phase Paused with Pfat Protocol
  95
- Figure 5-21 Empty Phase Paused
  95
- Ending the Current Case
  96
- Unloading the Pump Loop
  97
- Figure 5-22 End of Case Screen
  97
- Emptying the RBC Line Without Ending the Case
  98
- Closing the End of Case Screen Without Ending the Case
  98
- Retaining Case Data between Power Cycles
  98
- Dealing with Expected Warnings During a Cycle
  99
- Reservoir Empty
  99
- Figure 5-23 Reservoir Empty Warning
  100
- Wash Bag Empty
  101
- Figure 5-24 Wash Bag Empty Warning
  101
- RBC Bag Full
  102
- Figure 5-25 RBC Bag Full Warning
  102
- Waste Bag Full
  103
- Figure 5-26 Waste Bag Full Warning
  103
- Factory Protocols
  104
- The Autotransfusion Protocols
  105
- Figure 5-27 Disposable Setup for ATS Protocols
  105
- Popt
  106
- Pstd
  107
- Pfat
  108
- Emergency
  108
- Figure 5-28 Emergency Activation Screen
  109
- Post-Op
  111
- Protocol Parameters (ATS)
  112
- The Operating Modes
  113
- Automatic
  113
- Touch
  113
- Manual
  114
- Figure 5-29 Ready Screen in Manual Mode
  114
- Figure 5-30 Fill Phase in Manual Mode
  114
- Figure 5-31 Wash Phase in Manual Mode
  115
- Figure 5-32 Empty Phase in Manual Mode
  115
- Selecting the Active Protocol and Operating Mode
  116
- Figure 5-33 Protocol/Mode Tab
  116
- Set the Active Protocol
  117
- Set the Active Operating Mode
  117
- Touch Screen User Interface
  118
- Alarms Disabled Confirmation Screen
  118
- Figure 5-34 Example Alarms Disabled Confirmation Screen
  118
- Setup Screen
  119
- Figure
  119
- Ready Screen
  120
- Figure
  120
- Processing Screen
  121
- Figure 5-37 Fill Phase of the Processing Screen
  121
- Figure 5-38 Wash Phase of the Processing Screen
  122
- Fat Removal Screens
  123
- Figure 5-39 Empty Phase of the Processing Screen
  123
- Fat Removal - Wash Processing Screen
  124
- Figure
  124
- Fat Removal - Empty Processing Screen
  124
- Fat Removal - Conc Processing Screen
  125
- Figure
  125
- Menu Screen
  126
- Tally Tab of the Menu Screen
  126
- Figure
  126
- Figure 5-44 ID Tab of the Menu Screen
  128
- Protocol/Mode Tab of the Menu Screen
  129
- Figure
  129
- Figure 5-46 Settings Tab of the Menu Screen
  130
- Figure 5-47 Reset Confirmation Screen
  131
- End of Case Screen
  132
- Figure
  132
- Help Screen
  133
- Figure
  133
- Past Cases Screen
  134
- Figure 5-50 Past Cases Screen
  134
- Automatic Reseparation Screen
  137
- Stop Button
  137
- Power Loss
  137
Chapter 6: Special Cycles

139
- Description
  139
- Enabling Purge and Prime IV Special Cycles
  139
- The Special Cycles Screen
  139
- Figure
  139
- Special Cycles Screen
  139
- Returning Fluid to the Reservoir: the Return Cycle
  140
- Figure 6-2 Return Screen
  140
- Adding Fluid to a Partially Filled Bowl: the Concentrate Cycle
  141
- Figure 6-3 Concentrate Screen
  141
- Priming the Reinfusion Line: Prime IV
  142
- Figure 6-4 Prime IV Screen (Paused)
  143
- Removing Air from the RBC Bag: the Purge Cycle
  144
- Figure
  144
- Purge Screen
  144
- Reinfusion
  145
- Description
  145
- Connecting the Blood Administration Set to the X
  146
- TRA RBC Bags
  146
- Figure
  147
- Top: "Y"-Type Blood Administration Set with Integral Filter Bottom: Filter with "Y"-Type Blood Administration Set
  147
Chapter 7: Automated Functions

149
- Description
  149
- Enabling Optional Automated Functions
  149
- Autostart Function
  149
- Figure 7-1 Autostart Activation Screen
  150
- Continue Function
  151
- Last Bowl
  152
- Figure 7-2 Last Bowl Activation Screen
  152
- Double Volume Wash Function
  154
- Better Quality Wash (BQW) Function
  154
- Better Empty
  155
Chapter 8: Configuring X

157
- Description
  157
- The Settings Tab of the Menu Screen
  158
- Configuration Mode
  158
- How to Enter the Configuration Mode
  158
- Figure
  158
- Settings Tab of the Menu Screen
  158
- Exit from the Configuration Mode
  159
- Predefined Feature Sets
  159
- Figure
  159
- Configuration Mode Password Screen
  159
- Configuration Mode Screen Tabs
  160
- Figure
  160
- Features Tab of the Configuration Mode
  160
- Figure 8-4 Protocol Set Tab of the Configuration Mode
  162
- Figure 8-5 Wakeup Tab of the Configuration Mode
  163
- Figure
  163
- Display Tab of the Configuration Mode
  164
- Figure
  164
- Warnings Tab of the Configuration Mode
  164
- Figure 8-8 ID Tab of the Configuration Mode Screen
  166
- Figure 8-9 Edit Field List Screen
  167
- Figure 8-10 Language Tab of the Configuration Mode
  168
Chapter 9: Programmability Option

169
- Description
  169
- Enabling Programmability Option
  169
- Creating Custom Protocols
  169
- Entering Values and Text
  169
- Figure 9-1 Keyboard Screen (Caps & Numbers ON)
  170
- Figure
  170
- Creating a New Protocol
  171
- Adjusting Parameters of a Protocol
  171
- Fill Phase Screen with Modifiable Parameter
  172
- Figure
  172
- Renaming a Protocol
  174
- Changing the Wakeup Protocol
  174
- Deleting a Protocol
  174
- The Protocol/Mode Tab
  175
- Mode Buttons
  175
- Protocol/Mode Tab of the Menu Screen
  175
- Protocol Area
  176
- Mode Area
  177
- Save Modifications and Close Buttons
  177
Chapter 10: Preoperative Sequestration (PPP and PRP)

179
- Description
  179
- Enabling the Preoperative Sequestration Protocols
  180
- Overview of Preoperative Sequestration
  180
- Sequestration Set
  181
- Figure
  181
- Order Guide
  182
- Before You Begin
  182
- Setup for Preoperative Sequestration
  183
- Supplies Required
  183
- Installing the Blood Collection Reservoir, Connecting the Aspiration Line, Setup of the Vacuum Line, Installing the Bowl Set
  184
- Connecting the 4-Way Adapter
  184
- Figure
  184
- Sequestration Set 4-Way Connection
  184
- Connecting and Hanging the Blood Transfer Bags
  185
- Figure 10-3 Blood Transfer Bag Setup: for PPP, PRP1, and PRP2 Procedures
  185
- Figure 10-4 Hang the Blood Transfer Bags, Keeping the Inlet Line Facing up
  185
- Connecting the Blood Bag Connection Line
  186
- Selecting the Active Protocol and Operating Mode
  186
- Figure
  186
- Running a Preoperative Sequestration Case
  187
- Processing Considerations
  187
- Loading the Pump Segment for a New Case
  188
- Processing a Cycle
  188
- Figure
  188
- Setup Screen
  188
- Figure 10-7 Ready Screen (PRP2)
  189
- Figure
  189
- Figure 10-8 Sequestration Fill Phase of the Processing Screen
  190
- Spill Phase (PPP) of the Processing Screen
  191
- The Concentrate Cycle (with the PPP/PRP Protocols)
  194
- Figure 10-11 Concentrate Screen (Preoperative Protocols)
  194
- Dealing with Expected Warnings During a Cycle
  195
- Whole Blood Bag Empty
  195
- PPP Bag Full
  196
- PRP Bag Full
  196
- RBC Bag Full
  196
- Finishing Preoperative Separation and Preparing for Blood Recovery
  197
- Tally Information
  198
- The Preoperative Sequestration Factory Protocols
  199
- Overview of the Preoperative Sequestration Protocols
  199
- Figure 10-13 Disposable Setup for Sequestration Protocols
  199
- Ppp
  200
- Prp1
  201
- Prp2
  201
- Protocol Parameters (PPP and PRP)
  202
- Preoperative Sequestration Operating Modes
  203
- Spill Screen
  203
- Figure 10-15 Spill PRP Phase of the Processing Screen
  204
Chapter 11: Data Download Option

207
- Description
  207
- Enabling Data Download Option
  207
- XTRA Output Devices
  207
- Printer
  207
- Figure
  207
- Data Ports Panel on Rear of Machine
  207
- USB Ports
  208
- Figure 11-2 Integrated Dot-Matrix Printer
  208
- RS232 Ports
  209
- Case Data Download
  209
- Entering and Modifying Optional Case Data Fields
  209
- Figure
  209
- Tally Tab of the Menu Screen
  209
- Selecting Past Cases
  210
- Figure 11-4 ID Tab of the Menu Screen
  210
- Selecting the Output Device for Data Download
  211
- Figure 11-5 Past Cases Screen
  211
- Sending Tallies to the Printer
  212
- Sending Tallies to the XTRA USB Memory Device
  212
- Figure 11-6 Destination Drop-Down Menu (Expanded)
  212
- Sending Tallies to the Stöckert Data Management System
  213
- Sending Tallies to a PC through the RS232 Port
  213
- XTRA Data Output
  215
- General Report Data
  215
- Additional Cycle Data
  217
Chapter 12: Quality Management Option

219
- Description
  219
- Figure
  219
- Location of the Hct and WLC Indicators
  219
- Enabling Quality Management Options
  220
- Hematocrit (Hct) Indicator
  220
- User Interface
  220
- Calibration
  220
- Supernatant Removal Indicator
  221
- User Interface
  221
- Waste Line Color Indicator
  221
- User Interface
  222
- Warnings Related to Waste Line Color Indicator
  222
Chapter 13: Vacuum Module

223
- Description
  223
- XVAC Vacuum Module
  223
- Operating Modes
  224
- Intraoperative Mode
  224
- Postoperative Mode
  224
- Setting Wakeup Values for Vacuum Module
  224
- Preliminary Setup
  225
- Performing a Blood Collection Procedure with the X
  225
- VAC Module
  225
- XVAC Used through the
  225
- TRA System Touch Screen Interface (Remote Control)
  225
- Figure 13-2 Vacuum Line Connecting Reservoir to Inlet Port
  225
- Figure 13-3 Cable Connections from the
  226
- Vac Xtra
  226
- Figure
  226
- XVAC Rear Panel
  226
- Vacuum Displet
  226
- Use of the X VAC System through the
  228
- VAC Control Panel (Local Control)
  228
- Xvac
  228
- Alarms
  230
- List of Fatal Alarms
  230
- Alarm Management in Local Control
  230
- Alarm Management in Remote Control
  230
Chapter 14: Troubleshooting

233
- General Precautions
  233
- Supervision and Checks
  233
- Alarms and Warnings
  233
- Visual Alert
  234
- Audible Alert
  234
- Figure 14-1 Example Warning Screen
  234
- Stop Button
  235
- Alarms and Warnings During Setup
  235
- During Processing
  240
- Equipment Malfunctions (Fatal Errors)
  255
- Therapy Concerns Unrelated to the Equipment
  257
- Quality of Salvaged Blood and Blood Product
  259
- Glossary
  261
- Routine Maintenance
  261
- General Maintenance Instructions
  261
Chapter 15: Maintenance

261
Chapter 16: Technical Data

271
- Technical Features of the Equipment
  271
- Operating Features of the Equipment
  272
Chapter 17: Warranty

273
Appendix A: Safety Standards en 60601-1-2

277
- Information on Electromagnetic Compatibility (EMC
  277
- Technical Description
  281
Appendix B: Approvals and Test Certificate

283
- EMC Standards
  283
- EMC Emission
  283
- EMC Immunity
  283
- Electrical and Mechanical Safety Standards
  283
- Certification
  283
Appendix C: Quick Operating Instructions

285
- Setting up the Disposables
  287
- Setting the Active Protocol and Mode
  292
- Running an ATS Case
  293
- Running a PRP Sequestration Case
  294
- Creating a Custom Protocol
  295
- Printing a Report for the Current Case
  296
Appendix D: Recommended Fluid Bag Configurations

297
Appendix E: Symbols and Abbreviations

299
- Symbols
  299
- Electrical Symbols on the Unit
  299
- Symbols on the Unit and on the Packaging
  299
- Abbreviations
  301
- Units Conversion Table and Measuring Units
  301

sorin XTRA Instructions For Use Manual (88 pages)

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sorin XTRA Autotransfusion System Manuals

sorin XTRA Operator's Manual (304 pages)

Table of Contents

Chapter 1: Introduction and Safety

Chapter 2: Overview

Chapter 3: System Description

Chapter 4: Installing the Disposables

Chapter 5: Processing

Chapter 6: Special Cycles

Chapter 7: Automated Functions

Chapter 8: Configuring X

Chapter 9: Programmability Option

Chapter 10: Preoperative Sequestration (PPP and PRP)

Chapter 11: Data Download Option

Chapter 12: Quality Management Option

Chapter 13: Vacuum Module

Chapter 14: Troubleshooting

Chapter 15: Maintenance

Chapter 16: Technical Data

Chapter 17: Warranty

Appendix A: Safety Standards en 60601-1-2

Appendix B: Approvals and Test Certificate

Appendix C: Quick Operating Instructions

Appendix D: Recommended Fluid Bag Configurations

Appendix E: Symbols and Abbreviations

sorin XTRA Instructions For Use Manual (88 pages)

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