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Warranty

17-4

20077/021 US XTRA Operator’s Manual

Identification of Manufacturer

While kindly asking you to scrupulously observe all the aforementioned provisions, please feel free to

contact LivaNova or the authorized LivaNova representative, for any further details and/or technical

assistance you might require.

LivaNova Deutschland GmbH

Lindberghstrasse 25

D-80939 München Germany

Tel: +49.(0)89.32301.0

Fax: +49.(0)89.32301.555

Main Page

Default Chapter3
- Table of Contents3
Chapter 1: Introduction and Safety15
- About the Operating Instructions15
- Introducing the X15
- TRA System15
Chapter 2: Overview16
Chapter 3: System Description16
- Indications for Use17
- Contraindication for Use17
- General Warnings17
- Storage and Transporting Warnings23
- Electrical Warnings23
- General Precautions24
- Operating Conditions28
- Warning28
- Cautions28
- Adverse Effects28
- Installation of the Unit28
- Installation28
- Unpacking and Inspection29
- Storage and Transport Conditions29
- Electrical Requirements29
- Addresses30
- Service Information31
- Return of Used Product31
- For North American Customers31
- For International Customers31
- Disposal in Accordance with Environmental Regulations32
- Chapter 2: Overview33
- Advantages of Intra- and Postoperative Red Cell Recovery33
- Clinical Applications33
- Description of the X33
- TRA System33
- How the XTRA System Works35
- Collection and Anticoagulation35
- Processing35
- Figure 2-1 Position of Separated Whole Blood Components in Centrifuge Bowl35
- Reinfusion36
- The Basic XTRA36
- Options Available with XTRA37
- Programmability Option37
- Emergency Option37
- Vacuum System37
- Vac )37
- Preoperative Sequestration Option (PPP and PRP)37
- Data Management Options (USB, Printer, RS232)37
- Quality Control Options37
- Chapter 3: System Description39
- Machine Components39
- Figure 3-1 XTRA Front View39
- Figure40
- XTRA Rear View40
- Handles41
- Hooks and Tray Holders41
- Figure 3-3 Front Handle (Left), Rear Handle (Center), and Rear Transport Handle (Right)41
- Figure 3-4 Hooks on Left Side of41
- Cart42
- Figure 3-5 Left: Disposable Tray on Tray Holders; Right: Waste Bag on Right-Side Hooks42
- Figure 3-6 Cart42
- Figure 3-7 Spring Lever Releases Cart43
- Figure 3-8 Lifting Body from Cart43
- Figure43
- IV Pole and Reservoir Pole44
- Figure 3-9 XTRA Body and Cart44
- Figure 3-10 Reservoir and IV Pole44
- Reservoir Holder45
- Touch Screen Display Panel45
- Figure 3-11 Reservoir Holder45
- Centrifuge Assembly47
- Figure 3-13 Centrifuge Assembly47
- Figure 3-14 Centrifuge Well Fluid Container48
- Clamps49
- Left: Clamps with Clamp Lid Open | Right: Clamp Lid Closed and Latched49
- Figure49
- Processing Pump50
- Air Detector50
- Visible Parts of the X50
- TRA Processing Pump50
- Figure50
- Location of the Air Detector50
- Quality Control Indicators51
- Xvac51
- Figure 3-18 Location of the Hematocrit and Waste Line Color Indicators51
- Figure 3-19 Left: Vacuum Module | Right: Integrated Vacuum Module51
- Essential Performance52
- Order Guide52
- XVAC Release Screw52
- Figure52
- XVAC Control Panel52
- Xtra52
- Disposable Description53
- Figure53
- Figure54
- Collection Set55
- Figure 3-24 XTRA Collection Kit (CARDIO TOP)55
- Xtra55
- Figure56
- Collection Reservoir Lid Ports56
- Figure 3-27 Left: Reservoir with TOP Outlet | Right: Reservoir with BOTTOM Outlet57
- Aspiration Line57
- Figure58
- Vacuum Line58
- Bowl Set59
- Figure 3-30 Cardio Kit59
- Cross-Section of Latham Centrifuge Bowl60
- Figure 3-34 Red Blood Cells (RBC) Bag62
- Procedure Set63
- Figure 3-31 Bowl Set63
- Selecting the Disposable64
- Selecting the Bowl64
- Order Guide65
- Figure 3-35 Procedure Set65
- Anticoagulant Solution67
- Wash Solution68
- Accessories and Optional Devices68
- Cables69
- Figure 3-33 Waste Bag69
Chapter 4: Installing the Disposables71
- Setup for Standby Collection71
- Supplies Required71
- Setup for Whole Blood Separation Program71
- Setup for Intraoperative Red Cell Recovery and Reinfusion72
- Power Requirements72
- Supplies Required72
- Step-By-Step Procedures for Installing Disposables73
- Step 1: Installing the Blood Collection Reservoir73
- Figure 4-1 Raising the Reservoir Holder73
- Figure73
- Step 2: Connecting the Suction Line74
- Figure 4-2 Positioning the Blood Collection Reservoir on the Reservoir Holder74
- Figure 4-3 Positioning the Blood Collection Reservoir on the Reservoir Holder75
- Step 3: Setup of the Vacuum Line76
- Figure 4-4 Positioning the Blood Collection Reservoir on the Reservoir Holder76
- Step 4: Installing the Bowl Set77
- Figure 4-5 Machine Top77
- Inserting the Centrifuge Bowl78
- Figure78
- Inserting the Bowl in Order to Avoid Wobbling78
- Figure 4-8 Seating the Pump Loop Cartridge (Left); Latching the Clamp Lid (Right)79
- Figure 4-9 Connecting the Bowl Set to the Top of the Blood Collection Reservoir79
- Figure 4-10 Connecting the Bowl Set to the Bottom of the Blood Collection Reservoir79
- Step 5: Connecting Wash Lines to the Saline Solution Containers80
- Step 6: Hanging the Waste Bag80
- Connecting the Wash Lines (Yellow) to the Washing Solution80
- Other Setups81
- Blood Collection81
- Figure 4-12 Connecting the Waste Bag81
- Procedure for Removing Disposables82
Chapter 5: Processing83
- Operating the Touch Screen83
- Figure 5-1 Example of an Enabled Button83
- Figure83
- Example of in Inactive (Left) and Active (Right) Toggle Button83
- Figure 5-3 Example of a Disabled Button83
- Screen Structure84
- Typical Autotransfusion Processing Screen Structure84
- Figure84
- The Displets85
- Reservoir Displet (Open and Closed)85
- Figure85
- Vacuum Displet85
- Rbc's Displet86
- Figure86
- Waste Bag Displet86
- PPP/PRP Displet86
- Processing Displet86
- Modification of Parameters87
- Running a Case with the XTRA System87
- Before You Begin87
- Figure 5-11 a Text Box before and after Being Selected for Editing87
- Loading the Pump Segment for a New Case88
- Figure 5-12 Rear Panel of the88
- Figure88
- Processing a Cycle in Automatic or 1 Touch Mode89
- Setup Screen89
- Figure89
- Figure 5-14 Ready Screen90
- Fill Phase of the Processing Screen91
- Figure91
- Wash Phase of the Processing Screen92
- Figure92
- Pausing and Resuming the Cycle93
- Empty Phase of the Processing Screen93
- Figure93
- Figure 5-18 Fill Phase Paused94
- Figure 5-19 Wash Phase Paused94
- Figure 5-20 Wash Phase Paused with Pfat Protocol95
- Figure 5-21 Empty Phase Paused95
- Ending the Current Case96
- Unloading the Pump Loop97
- Figure 5-22 End of Case Screen97
- Emptying the RBC Line Without Ending the Case98
- Closing the End of Case Screen Without Ending the Case98
- Retaining Case Data between Power Cycles98
- Dealing with Expected Warnings During a Cycle99
- Reservoir Empty99
- Figure 5-23 Reservoir Empty Warning100
- Wash Bag Empty101
- Figure 5-24 Wash Bag Empty Warning101
- RBC Bag Full102
- Figure 5-25 RBC Bag Full Warning102
- Waste Bag Full103
- Figure 5-26 Waste Bag Full Warning103
- Factory Protocols104
- The Autotransfusion Protocols105
- Figure 5-27 Disposable Setup for ATS Protocols105
- Popt106
- Pstd107
- Pfat108
- Emergency108
- Figure 5-28 Emergency Activation Screen109
- Post-Op111
- Protocol Parameters (ATS)112
- The Operating Modes113
- Automatic113
- Touch113
- Manual114
- Figure 5-29 Ready Screen in Manual Mode114
- Figure 5-30 Fill Phase in Manual Mode114
- Figure 5-31 Wash Phase in Manual Mode115
- Figure 5-32 Empty Phase in Manual Mode115
- Selecting the Active Protocol and Operating Mode116
- Figure 5-33 Protocol/Mode Tab116
- Set the Active Protocol117
- Set the Active Operating Mode117
- Touch Screen User Interface118
- Alarms Disabled Confirmation Screen118
- Figure 5-34 Example Alarms Disabled Confirmation Screen118
- Setup Screen119
- Figure119
- Ready Screen120
- Figure120
- Processing Screen121
- Figure 5-37 Fill Phase of the Processing Screen121
- Figure 5-38 Wash Phase of the Processing Screen122
- Fat Removal Screens123
- Figure 5-39 Empty Phase of the Processing Screen123
- Fat Removal - Wash Processing Screen124
- Figure124
- Fat Removal - Empty Processing Screen124
- Fat Removal - Conc Processing Screen125
- Figure125
- Menu Screen126
- Tally Tab of the Menu Screen126
- Figure126
- Figure 5-44 ID Tab of the Menu Screen128
- Protocol/Mode Tab of the Menu Screen129
- Figure129
- Figure 5-46 Settings Tab of the Menu Screen130
- Figure 5-47 Reset Confirmation Screen131
- End of Case Screen132
- Figure132
- Help Screen133
- Figure133
- Past Cases Screen134
- Figure 5-50 Past Cases Screen134
- Automatic Reseparation Screen137
- Stop Button137
- Power Loss137
Chapter 6: Special Cycles139
- Description139
- Enabling Purge and Prime IV Special Cycles139
- The Special Cycles Screen139
- Figure139
- Special Cycles Screen139
- Returning Fluid to the Reservoir: the Return Cycle140
- Figure 6-2 Return Screen140
- Adding Fluid to a Partially Filled Bowl: the Concentrate Cycle141
- Figure 6-3 Concentrate Screen141
- Priming the Reinfusion Line: Prime IV142
- Figure 6-4 Prime IV Screen (Paused)143
- Removing Air from the RBC Bag: the Purge Cycle144
- Figure144
- Purge Screen144
- Reinfusion145
- Description145
- Connecting the Blood Administration Set to the X146
- TRA RBC Bags146
- Figure147
- Top: "Y"-Type Blood Administration Set with Integral Filter Bottom: Filter with "Y"-Type Blood Administration Set147
Chapter 7: Automated Functions149
- Description149
- Enabling Optional Automated Functions149
- Autostart Function149
- Figure 7-1 Autostart Activation Screen150
- Continue Function151
- Last Bowl152
- Figure 7-2 Last Bowl Activation Screen152
- Double Volume Wash Function154
- Better Quality Wash (BQW) Function154
- Better Empty155
Chapter 8: Configuring X157
- Description157
- The Settings Tab of the Menu Screen158
- Configuration Mode158
- How to Enter the Configuration Mode158
- Figure158
- Settings Tab of the Menu Screen158
- Exit from the Configuration Mode159
- Predefined Feature Sets159
- Figure159
- Configuration Mode Password Screen159
- Configuration Mode Screen Tabs160
- Figure160
- Features Tab of the Configuration Mode160
- Figure 8-4 Protocol Set Tab of the Configuration Mode162
- Figure 8-5 Wakeup Tab of the Configuration Mode163
- Figure163
- Display Tab of the Configuration Mode164
- Figure164
- Warnings Tab of the Configuration Mode164
- Figure 8-8 ID Tab of the Configuration Mode Screen166
- Figure 8-9 Edit Field List Screen167
- Figure 8-10 Language Tab of the Configuration Mode168
Chapter 9: Programmability Option169
- Description169
- Enabling Programmability Option169
- Creating Custom Protocols169
- Entering Values and Text169
- Figure 9-1 Keyboard Screen (Caps & Numbers ON)170
- Figure170
- Creating a New Protocol171
- Adjusting Parameters of a Protocol171
- Fill Phase Screen with Modifiable Parameter172
- Figure172
- Renaming a Protocol174
- Changing the Wakeup Protocol174
- Deleting a Protocol174
- The Protocol/Mode Tab175
- Mode Buttons175
- Protocol/Mode Tab of the Menu Screen175
- Protocol Area176
- Mode Area177
- Save Modifications and Close Buttons177
Chapter 10: Preoperative Sequestration (PPP and PRP)179
- Description179
- Enabling the Preoperative Sequestration Protocols180
- Overview of Preoperative Sequestration180
- Sequestration Set181
- Figure181
- Order Guide182
- Before You Begin182
- Setup for Preoperative Sequestration183
- Supplies Required183
- Installing the Blood Collection Reservoir, Connecting the Aspiration Line, Setup of the Vacuum Line, Installing the Bowl Set184
- Connecting the 4-Way Adapter184
- Figure184
- Sequestration Set 4-Way Connection184
- Connecting and Hanging the Blood Transfer Bags185
- Figure 10-3 Blood Transfer Bag Setup: for PPP, PRP1, and PRP2 Procedures185
- Figure 10-4 Hang the Blood Transfer Bags, Keeping the Inlet Line Facing up185
- Connecting the Blood Bag Connection Line186
- Selecting the Active Protocol and Operating Mode186
- Figure186
- Running a Preoperative Sequestration Case187
- Processing Considerations187
- Loading the Pump Segment for a New Case188
- Processing a Cycle188
- Figure188
- Setup Screen188
- Figure 10-7 Ready Screen (PRP2)189
- Figure189
- Figure 10-8 Sequestration Fill Phase of the Processing Screen190
- Spill Phase (PPP) of the Processing Screen191
- The Concentrate Cycle (with the PPP/PRP Protocols)194
- Figure 10-11 Concentrate Screen (Preoperative Protocols)194
- Dealing with Expected Warnings During a Cycle195
- Whole Blood Bag Empty195
- PPP Bag Full196
- PRP Bag Full196
- RBC Bag Full196
- Finishing Preoperative Separation and Preparing for Blood Recovery197
- Tally Information198
- The Preoperative Sequestration Factory Protocols199
- Overview of the Preoperative Sequestration Protocols199
- Figure 10-13 Disposable Setup for Sequestration Protocols199
- Ppp200
- Prp1201
- Prp2201
- Protocol Parameters (PPP and PRP)202
- Preoperative Sequestration Operating Modes203
- Spill Screen203
- Figure 10-15 Spill PRP Phase of the Processing Screen204
Chapter 11: Data Download Option207
- Description207
- Enabling Data Download Option207
- XTRA Output Devices207
- Printer207
- Figure207
- Data Ports Panel on Rear of Machine207
- USB Ports208
- Figure 11-2 Integrated Dot-Matrix Printer208
- RS232 Ports209
- Case Data Download209
- Entering and Modifying Optional Case Data Fields209
- Figure209
- Tally Tab of the Menu Screen209
- Selecting Past Cases210
- Figure 11-4 ID Tab of the Menu Screen210
- Selecting the Output Device for Data Download211
- Figure 11-5 Past Cases Screen211
- Sending Tallies to the Printer212
- Sending Tallies to the XTRA USB Memory Device212
- Figure 11-6 Destination Drop-Down Menu (Expanded)212
- Sending Tallies to the Stöckert Data Management System213
- Sending Tallies to a PC through the RS232 Port213
- XTRA Data Output215
- General Report Data215
- Additional Cycle Data217
Chapter 12: Quality Management Option219
- Description219
- Figure219
- Location of the Hct and WLC Indicators219
- Enabling Quality Management Options220
- Hematocrit (Hct) Indicator220
- User Interface220
- Calibration220
- Supernatant Removal Indicator221
- User Interface221
- Waste Line Color Indicator221
- User Interface222
- Warnings Related to Waste Line Color Indicator222
Chapter 13: Vacuum Module223
- Description223
- XVAC Vacuum Module223
- Operating Modes224
- Intraoperative Mode224
- Postoperative Mode224
- Setting Wakeup Values for Vacuum Module224
- Preliminary Setup225
- Performing a Blood Collection Procedure with the X225
- VAC Module225
- XVAC Used through the225
- TRA System Touch Screen Interface (Remote Control)225
- Figure 13-2 Vacuum Line Connecting Reservoir to Inlet Port225
- Figure 13-3 Cable Connections from the226
- Vac Xtra226
- Figure226
- XVAC Rear Panel226
- Vacuum Displet226
- Use of the X VAC System through the228
- VAC Control Panel (Local Control)228
- Xvac228
- Alarms230
- List of Fatal Alarms230
- Alarm Management in Local Control230
- Alarm Management in Remote Control230
Chapter 14: Troubleshooting233
- General Precautions233
- Supervision and Checks233
- Alarms and Warnings233
- Visual Alert234
- Audible Alert234
- Figure 14-1 Example Warning Screen234
- Stop Button235
- Alarms and Warnings During Setup235
- During Processing240
- Equipment Malfunctions (Fatal Errors)255
- Therapy Concerns Unrelated to the Equipment257
- Quality of Salvaged Blood and Blood Product259
- Glossary261
- Routine Maintenance261
- General Maintenance Instructions261
Chapter 15: Maintenance261
- Routine Visual Inspection262
- Cleaning and Disinfecting262
- Figure 15-1 Power Supply Cable (A); Serial Cable and Vacuum Pump Power Supply (B)262
- Figure 15-2 Clamps and Pump Loop Ejector264
- Figure 15-3 Centrifuge Well264
- Figure264
- Removal of the Overflow Trap from the Vacuum Pump265
- Figure265
- Composition of the Overflow Trap265
- List of Operator-Replaceable Parts266
- Pump Rotor266
- Figure 15-6 Sensors Located on Machine Top266
- Figure 15-7 Sensors Located on Machine Top267
- Centrifuge Well Fluid Container268
- Figure 15-8 Replacement of the Paper Roll268
- Figure 15-9 Removal of the Centrifuge Well Fluid Container268
- Preventive Maintenance269
- Regular Maintenance Checks by Authorized Service Technicians269
- Machine Repair269
Chapter 16: Technical Data271
- Technical Features of the Equipment271
- Operating Features of the Equipment272
Chapter 17: Warranty273
- Limited Warranty and Contractual Conditions for Livanova Medical Equipment273
- Warranty Expiry273
- Contents and Necessary Requirements of the Warranty273
Appendix A: Safety Standards en 60601-1-2277
- Information on Electromagnetic Compatibility (EMC277
- Technical Description281
Appendix B: Approvals and Test Certificate283
- EMC Standards283
- EMC Emission283
- EMC Immunity283
- Electrical and Mechanical Safety Standards283
- Certification283
Appendix C: Quick Operating Instructions285
- Setting up the Disposables287
- Setting the Active Protocol and Mode292
- Running an ATS Case293
- Running a PRP Sequestration Case294
- Creating a Custom Protocol295
- Printing a Report for the Current Case296
Appendix D: Recommended Fluid Bag Configurations297
Appendix E: Symbols and Abbreviations299
- Symbols299
- Electrical Symbols on the Unit299
- Symbols on the Unit and on the Packaging299
- Abbreviations301
- Units Conversion Table and Measuring Units301

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