sorin XTRA - Appendix B: Approvals and Test Certificate; EMC Standards; EMC Emission; EMC Immunity

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XTRA Operator’s Manual 20077/021 US B-1

Appendix B: Approvals and Test Certificate

The XTRA and XVAC equipment have been tested and comply with the following:

EMC Standards

(See

Appendix A: Safety Standards EN 60601-1-2

)

EMC Emission

• IEC 60601-1-2 : 2007 and : 2014

EMC Immunity

• IEC 60601-1-2 : 2007 and : 2014

Electrical and Mechanical Safety Standards

• IEC 60601-1 Edition 3.1

Certification

•C-US NRTL Certification

• CB Certification

The LivaNova quality assurance system complies with the following standards:

• UNI - EN - ISO - 13485

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

sorin XTRA - Appendix B: Approvals and Test Certificate; EMC Standards; EMC Emission; EMC Immunity

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