Terumo BCT Spectra Optia Apheresis System User Manual (English)

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Spectra Optia

Apheresis System

Operator’s Manual

Part No. 777379-124

Reorder No. 703261-001

2018-04

SpectraOptiaOpsManual.book Page i Thursday, May 17, 2018 11:24 AM

Default Chapter3
- Table of Contents3
Chapter 1: Preface15
- About this Operator's Manual16
- Conventions Used in this Manual16
- Spectra Optia Apheresis System17
- Special Use of Additional Equipment and Devices During Apheresis Procedures29
- Fluids Administered During Apheresis Procedures30
- Adverse Events of Apheresis Procedures31
  - Reactions to Blood Products Transfused During Procedures32
- Disposal of Infectious and Non-Infectious Waste32
- Return of Used Product32
Chapter 2: Introduction33
- Spectra Optia System Description34
- Spectra Optia System Components35
  - Front Panel37
  - Centrifuge Chamber40
    - Filler41
- AIM System43
- Operating Modes43
  - Automatic Mode43
  - Semi-Automatic Mode43
- Procedure States44
- Packing Factor44
- Operation Status Screen45
- Caution Status46
- Fluid Balance Limits47
- Spectra Optia System Touch Screen48
Chapter 3: Installing and Transporting the Spectra Optia System55
- Installing the Spectra Optia System56
  - Setting up the Spectra Optia System56
  - Turning the Spectra Optia System on and off57
- Transporting the Spectra Optia System58
  - Preparing the Spectra Optia System for Transport58
  - Transporting the Spectra Optia System in a Vehicle59
    - Loading the System into the Vehicle59
    - Securing the System Inside the Vehicle60
- Storing the Spectra Optia System60
Chapter 4: Configuring the Spectra Optia System61
- Configuring the Spectra Optia System62
- Configuring Procedure-Independent Operating Parameters63
- Configuring Procedure-Specific Operating Parameters66
- Configuring the Use of a Blood Warmer73
Chapter 5: Preparing to Perform a Procedure75
- Supplies Required to Perform a Procedure76
- Selecting the Procedure78
- Installing the Filler78
  - Removing the Filler78
  - Re-Installing the Filler79
- Loading the Tubing Set79
- Priming the Tubing Set85
Chapter 6: Selecting Procedure Options87
- Selecting Procedure Options88
Chapter 7: Therapeutic Plasma Exchange (TPE) Procedures97
- Functional Description of a Therapeutic Plasma Exchange (TPE) Procedure98
  - TPE Procedures Using a Single Needle98
- Preparing to Perform a Procedure98
  - Supplies98
  - Selecting the Procedure and Loading the Tubing Set98
- Navigating the TPE Procedure Screens99
  - Menu Buttons and Tabs99
  - Descriptions of Buttons, Icons, and Images99
- Entering and Changing Data During the Run100
- Entering and Confirming Patient and Procedure Data103
- Converting the Access to a Single Needle105
  - Selecting and Confirming the Single-Needle Option105
  - Connecting the Single-Needle Connector105
- Priming the Inlet Line, the Return Line, and the Replace Line106
- Connecting the Patient and Starting the Run106
- Monitoring the Run107
  - Main Run Screen107
    - Algorithm Control107
  - Exchange Status Screen107
    - Replacement Fluid107
- Monitoring the Patient108
  - Managing Citrate Toxicity108
  - Giving a Fluid Bolus108
    - Bolus Volume and Reported Fluid Balance108
- Optimizing the Run109
Chapter 8: Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedures111
- Functional Description of a Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedure112
- Preparing to Perform a Procedure112
  - Supplies112
  - Selecting the Procedure and Loading the Tubing Set112
- Navigating the TPE-SPD Procedure Screens113
  - Menu Buttons and Tabs113
  - Descriptions of Buttons, Icons, and Images113
- Entering and Changing Data During the Run114
- Entering and Confirming Patient and Procedure Data117
- Connecting the Plasma Device Using an Extension Tubing Set119
  - Setting up and Priming the Extension Tubing Set119
  - Connecting the Treated Plasma Bag119
    - Saline Prime: Yes119
    - Saline Prime: no120
- Priming the Inlet Line and the Return Line120
- Connecting the Patient and Starting the Run121
  - Filling the Treated Plasma Bag121
- Monitoring the Run122
  - Main Run Screen122
  - Treatment Status Screen122
- Monitoring the Patient123
  - Managing Citrate Toxicity123
  - Giving a Fluid Bolus123
    - Bolus Volume and Reported Fluid Balance123
- Optimizing the Run124
- Managing a Prime Divert When the Patient Has a Low TBV126
  - Manually Priming the Plasma Device with Albumin126
  - Performing a Manual Prime Divert126
Chapter 9: Red Blood Cell Exchange (RBCX) Procedures129
- RBCX Procedure Types130
- Functional Description of a Red Blood Cell Exchange (RBCX) Procedure130
- Preparing to Perform a Procedure131
  - Supplies131
  - Selecting the Procedure and Loading the Tubing Set131
- Navigating the RBCX Procedure Screens131
  - Menu Buttons and Tabs131
  - Descriptions of Buttons, Icons, and Images131
- Entering and Changing Data During the Run132
- Entering and Confirming Patient and Procedure Data135
- Priming the Inlet Line, the Return Line, and the Replace Line139
- Connecting the Patient and Starting the Run139
- Monitoring the Run140
  - Main Run Screen140
  - Exchange Status Screen140
    - Replacement Fluid140
    - Patient Hct140
- Monitoring the Patient141
  - Managing Citrate Toxicity141
  - Giving a Fluid Bolus141
    - Bolus Volume and Reported Fluid Balance141
- Optimizing the Run142
  - Impact of Patient Data and Procedure Data on the Procedure Outcome142
  - Updating the Entered Patient Hct142
Chapter 10: Mononuclear Cell (MNC) Collection Procedures145
- Functional Description of a Mononuclear Cell (MNC) Collection Procedure146
  - Accumulation Phase146
  - Collection Phase146
- Preparing to Perform a Procedure146
  - Supplies146
  - Selecting the Procedure and Loading the Tubing Set146
- Navigating the MNC Collection Procedure Screens147
  - Menu Buttons and Tabs147
  - Descriptions of Buttons, Icons, and Images147
- Entering and Changing Data During the Run148
- Entering and Confirming Patient and Procedure Data152
  - Entering Patient Data152
  - Reviewing and Confirming Run Values152
- Priming the Inlet Line and the Return Line153
- Connecting the Patient and Starting the Run153
- Monitoring the Run154
- Monitoring the Patient157
  - Managing Citrate Toxicity157
- Optimizing the Run158
- Handling the Contents of a Partially Full Chamber160
Chapter 11: Continuous Mononuclear Cell Collection (CMNC) Procedures161
- Functional Description of a Continuous Mononuclear Cell Collection (CMNC) Procedure162
- Preparing to Perform a Procedure162
  - Supplies162
  - Selecting the Procedure and Loading the Tubing Set162
- Navigating the CMNC Procedure Screens163
  - Menu Buttons and Tabs163
  - Descriptions of Buttons, Icons, and Images163
- Entering and Changing Data During the Run164
- Entering and Confirming Patient and Procedure Data167
  - Entering Patient Data167
  - Reviewing and Confirming the Run Values167
    - Collecting Plasma168
- Priming the Inlet Line and the Return Line169
- Connecting the Patient and Starting the Run169
- Monitoring the Run170
  - Main Run Screen170
  - Collection Status Screen170
    - Collection Preference170
    - Return to Patient and Collect into Bag Buttons170
- Monitoring the Patient171
  - Managing Citrate Toxicity171
- Optimizing the Run172
Chapter 12: Granulocyte (PMN) Collection Procedures175
- Functional Description of a Granulocyte (PMN) Collection Procedure176
- Preparing to Perform a Procedure176
- Navigating the PMN Collection Procedure Screens178
  - Menu Buttons and Tabs178
  - Descriptions of Buttons, Icons, and Images178
- Entering and Changing Data During the Run179
- Entering and Confirming Patient and Procedure Data182
  - Entering Patient Data182
  - Reviewing and Confirming the Run Values182
    - Collecting Plasma183
- Priming the Inlet Line and the Return Line184
- Connecting the Patient and Starting the Run184
- Monitoring the Run185
  - Main Run Screen185
  - Collection Status Screen185
    - Collection Preference185
    - Return to Patient and Collect into Bag Buttons185
- Monitoring the Patient186
  - Managing Citrate Toxicity186
- Optimizing the Run187
Chapter 13: White Blood Cell Depletion (WBCD) and Platelet Depletion (PLTD) Procedures191
- Functional Description of a White Blood Cell Depletion (WBCD) or a Platelet Depletion (PLTD) Procedure192
- Preparing to Perform a Procedure192
- Navigating the WBCD and PLTD Procedure Screens194
  - Menu Buttons and Tabs194
  - Descriptions of Buttons, Icons, and Images194
- Entering and Changing Data During the Run195
- Entering and Confirming Patient and Procedure Data198
  - Entering Patient Data198
  - Reviewing and Confirming the Run Values and the Fluid Data198
    - Entering and Changing the Fluid Data199
- Priming the Inlet Line and the Return Line201
  - Positioning the IV Pole and the Replacement Fluid Container201
- Connecting the Patient and Starting the Run201
- Monitoring the Run202
  - Main Run Screen202
  - Collection Status Screen202
    - Collection Preference202
    - Return to Patient and Collect into Bag Buttons202
- Monitoring the Patient203
  - Managing Citrate Toxicity203
- Optimizing the Run204
Chapter 14: Bone Marrow Processing (BMP) Procedures207
- Functional Description of a Bone Marrow Processing (BMP) Procedure208
- Preparing to Perform a Procedure208
- Navigating the BMP Procedure Screens211
  - Menu Buttons and Tabs211
  - Descriptions of Buttons, Icons, and Images211
- Entering and Changing Data During the Run212
- Entering and Confirming Bone Marrow (BM) and Procedure Data214
  - Entering BM Data214
  - Reviewing and Confirming the Run Values214
- Preparing to Start the Run215
  - Connecting the BMP Bag to the Tubing Set215
  - Priming the Inlet Line215
- Starting the Run215
- Mixing the Contents of the BMP Bag During the Run215
- Monitoring the Run216
  - Main Run Screen216
  - Collection Status Screen216
    - Collection Preference216
    - Return to BMP Bag and Collect into Bag Buttons217
- Optimizing the Run218
Chapter 15: Ending the Run and Completing the Procedure222
- Ending the Run before a Run Target Is Attained222
- Ending the Run after a Run Target Is Attained222
  - Ending the Run222
  - Extending the Run223
- Completing the Procedure224
- Removing the Tubing Set228
Chapter 16: Troubleshooting229
- Troubleshooting Alarms230
- Using Semi-Automatic Mode233
- Managing Anticoagulation of the Extracorporeal Circuit235
- Handling Fluid Leaks235
- Resuming a Procedure after a System Reset236
- Performing a Manual Rinseback237
- Manual Method for Opening the Centrifuge Door and Raising the Cassette240
  - Manually Opening the Centrifuge Door240
  - Manually Raising the Cassette240
Chapter 17: Maintaining the Spectra Optia System243
- Cleaning and Disinfecting the Spectra Optia System244
- Cleaning and Disinfecting the System Components246
- Cleaning Schedule for the Spectra Optia System253
- Performing Preventive Maintenance254
Chapter 18: Spectra Optia System Specifications255
- Spectra Optia System Specifications256
- Symbols and Certifications275
Appendix A: Supplementary Information279
- Formula for Calculating Total Blood Volume (TBV)280
- TPE Procedures: Plasma and Platelet Removal Efficiency280
- Exchange Procedures: Using a Blood Warmer on the Replace Line281
- Tubing Sets: Using the Needleless Injection Ports282
- Collection Set and IDL Set: Additional Instructions for Use283
- Calculating the Volume of the Collected Product287
  - Determining the Weight of the Collected Product287
    - Preparing a Tare Bag and Establishing a Tare Weight287
- Printing Procedure Data Reports288
Appendix B: Glossary of Terms291
Index301

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Terumo BCT Spectra Optia Apheresis System Specifications

General

Product Name	Spectra Optia Apheresis System
Category	Laboratory Equipment
Manufacturer	Terumo BCT
Type	Apheresis System
Applications	Therapeutic apheresis, cell collection
Fluid Balance Management	Automated fluid balance management
User Interface	Touchscreen interface
Power Requirements	100-240 VAC, 50/60 Hz
Compatibility	Compatible with various blood collection sets
Therapeutic Apheresis Procedures	Red Blood Cell Exchange
Cell Collection Procedures	Mononuclear Cell Collection
Anticoagulation	Citrate
Portability	Mobile
Regulatory Compliance	CE marked
Intended Use	To separate and collect specific blood components while returning the remaining components to the patient/donor.

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