sorin 75220 Manuals

Manuals and User Guides for sorin 75220. We have 1 sorin 75220 manual available for free PDF download: Operator's Manual

sorin 75220 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 Categories

Medical Equipment Oxygen Equipment

Freezer Heater

More sorin Manuals

sorin 75220 Manuals

sorin 75220 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

Related Products

sorin Categories