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Terumo BCT Spectra Optia Apheresis System Manuals
Manuals and User Guides for Terumo BCT Spectra Optia Apheresis System. We have
1
Terumo BCT Spectra Optia Apheresis System manual available for free PDF download: Operator's Manual
Terumo BCT Spectra Optia Apheresis System Operator's Manual (310 pages)
Brand:
Terumo BCT
| Category:
Laboratory Equipment
| Size: 6 MB
Table of Contents
Table of Contents
3
Chapter 1: Preface
15
About this Operator's Manual
16
Conventions Used in this Manual
16
Numbered Steps
16
Touch Screen Buttons
16
Bullets
16
Warnings, Cautions, and Notes
16
Spectra Optia Apheresis System
17
Intended Use
17
Contraindications for Use
17
Warnings and Cautions for Use
17
Warnings for Use
17
System Warnings
17
Service Warnings
18
Electrical Warnings
18
General Procedural Warnings
18
Exchange Procedure Warnings
20
Collection and Depletion Procedure Warnings
21
General Tubing Set Warnings
21
Accessory Set Warnings
22
Fluid Warnings
22
Seal Safe System Warnings
22
Cautions for Use
23
System Cautions
23
Service Cautions
24
General Procedural Cautions
24
Collection and Depletion Procedure Cautions
25
General Tubing Set Cautions
26
Exchange Set Cautions
26
Collection Set Cautions
27
IDL Set Cautions
27
Fluid Cautions
27
Seal Safe System Cautions
28
Service Information
29
Special Use of Additional Equipment and Devices During Apheresis Procedures
29
Fluids Administered During Apheresis Procedures
30
Saline Solution
30
Anticoagulant
30
Acd-A
30
Hydroxyethyl Starch (HES)
30
Replacement Fluids
30
Adverse Events of Apheresis Procedures
31
Reactions to Blood Products Transfused During Procedures
32
Disposal of Infectious and Non-Infectious Waste
32
Return of Used Product
32
Chapter 2: Introduction
33
Spectra Optia System Description
34
Spectra Optia System Components
35
Front Panel
37
Pumps
37
Valves
38
Sensors and Detectors
38
Return Line Air Detector
38
Centrifuge Chamber
40
Filler
41
AIM System
43
Operating Modes
43
Automatic Mode
43
Semi-Automatic Mode
43
Procedure States
44
Packing Factor
44
Operation Status Screen
45
Caution Status
46
Fluid Balance Limits
47
Spectra Optia System Touch Screen
48
Navigating the Procedure Screens
48
Entering and Changing Numerical Data Using the Data Entry Pad
48
Screen Colors
49
Screen Buttons
49
Buttons, Icons, and Images
50
Chapter 3: Installing and Transporting the Spectra Optia System
55
Installing the Spectra Optia System
56
Setting up the Spectra Optia System
56
Turning the Spectra Optia System on and off
57
Transporting the Spectra Optia System
58
Preparing the Spectra Optia System for Transport
58
Transporting the Spectra Optia System in a Vehicle
59
Loading the System into the Vehicle
59
Securing the System Inside the Vehicle
60
Storing the Spectra Optia System
60
Chapter 4: Configuring the Spectra Optia System
61
Configuring the Spectra Optia System
62
Configuring Procedure-Independent Operating Parameters
63
System
63
Procedure
64
Report
65
Configuring Procedure-Specific Operating Parameters
66
Therapeutic Plasma Exchange (TPE)
66
Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD)
66
Red Blood Cell Exchange (RBCX)
67
Mononuclear Cell (MNC) Collection
68
Continuous Mononuclear Cell Collection (CMNC)
69
Granulocyte (PMN) Collection
70
White Blood Cell Depletion (WBCD)
71
Platelet Depletion (PLTD)
72
Bone Marrow Processing (BMP)
72
Configuring the Use of a Blood Warmer
73
Chapter 5: Preparing to Perform a Procedure
75
Supplies Required to Perform a Procedure
76
Selecting the Procedure
78
Installing the Filler
78
Removing the Filler
78
Re-Installing the Filler
79
Loading the Tubing Set
79
Unpacking the Lines and the Bags
80
Exchange Set
80
Collection Set
80
IDL Set
80
Snapping the Cassette into the Cassette Tray
81
Loading the Channel into the Centrifuge
81
Loading the Lower and Upper Bearings and the Upper Collar
84
Priming the Tubing Set
85
Chapter 6: Selecting Procedure Options
87
Selecting Procedure Options
88
Selecting Rinseback
89
Selecting and Performing a Custom Prime
90
Selecting the Custom Prime Option
90
Accepting a Custom Prime Recommendation
90
Entering Data for the Custom Prime
90
Starting the Custom Prime
91
Ending the Custom Prime before It Is Complete
91
Extending the Custom Prime
92
Indicating the Use of HES
92
Selecting and Performing a Saline Rinse
93
Selecting the Saline Rinse Option
93
Starting the Saline Rinse
93
Repeating a Saline Rinse
94
Selecting and Confirming the Single-Needle Option
94
Indicating Plasma Collection (BMP)
94
Indicating the Use of a Blood Warmer
94
Exchange Procedures
94
Collection and Depletion Procedures
95
Indicating the Timing of Plasma Collection (CMNC)
95
Chapter 7: Therapeutic Plasma Exchange (TPE) Procedures
97
Functional Description of a Therapeutic Plasma Exchange (TPE) Procedure
98
TPE Procedures Using a Single Needle
98
Preparing to Perform a Procedure
98
Supplies
98
Selecting the Procedure and Loading the Tubing Set
98
Navigating the TPE Procedure Screens
99
Menu Buttons and Tabs
99
Descriptions of Buttons, Icons, and Images
99
Entering and Changing Data During the Run
100
Entering and Confirming Patient and Procedure Data
103
Entering Patient Data
103
Entering Fluid Data
103
Selecting the Type of Replacement Fluid
103
Entering the Fluid Balance
104
Reviewing and Confirming the Run Values
104
Converting the Access to a Single Needle
105
Selecting and Confirming the Single-Needle Option
105
Connecting the Single-Needle Connector
105
Priming the Inlet Line, the Return Line, and the Replace Line
106
Connecting the Patient and Starting the Run
106
Monitoring the Run
107
Main Run Screen
107
Algorithm Control
107
Exchange Status Screen
107
Replacement Fluid
107
Monitoring the Patient
108
Managing Citrate Toxicity
108
Giving a Fluid Bolus
108
Bolus Volume and Reported Fluid Balance
108
Optimizing the Run
109
Prediction for Removing a Substance from the Patient's Plasma
109
Handling Turbulence or Platelet Swirling in the Connector
109
Decreasing the Run Time after Converting the Access to a Single Needle
110
Chapter 8: Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedures
111
Functional Description of a Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedure
112
Preparing to Perform a Procedure
112
Supplies
112
Selecting the Procedure and Loading the Tubing Set
112
Navigating the TPE-SPD Procedure Screens
113
Menu Buttons and Tabs
113
Descriptions of Buttons, Icons, and Images
113
Entering and Changing Data During the Run
114
Entering and Confirming Patient and Procedure Data
117
Entering Patient Data
117
Reviewing and Confirming the Plasma Device Data
117
Reviewing and Confirming the Run Values
118
Connecting the Plasma Device Using an Extension Tubing Set
119
Setting up and Priming the Extension Tubing Set
119
Connecting the Treated Plasma Bag
119
Saline Prime: Yes
119
Saline Prime: no
120
Priming the Inlet Line and the Return Line
120
Connecting the Patient and Starting the Run
121
Filling the Treated Plasma Bag
121
Monitoring the Run
122
Main Run Screen
122
Treatment Status Screen
122
Monitoring the Patient
123
Managing Citrate Toxicity
123
Giving a Fluid Bolus
123
Bolus Volume and Reported Fluid Balance
123
Optimizing the Run
124
Adjusting the Volume of Treated Plasma in the Treated Plasma Bag
124
Adjusting the Volume Currently in the Treated Plasma Bag
124
Adjusting the Volume Maintained in the Treated Plasma Bag
124
Managing a Positive Fluid Balance
125
Returning the Contents of the Treated Plasma Bag to the Patient
125
Rinsing the Plasma Device and Performing Rinseback
125
Managing a Prime Divert When the Patient Has a Low TBV
126
Manually Priming the Plasma Device with Albumin
126
Performing a Manual Prime Divert
126
Chapter 9: Red Blood Cell Exchange (RBCX) Procedures
129
RBCX Procedure Types
130
Functional Description of a Red Blood Cell Exchange (RBCX) Procedure
130
Preparing to Perform a Procedure
131
Supplies
131
Selecting the Procedure and Loading the Tubing Set
131
Navigating the RBCX Procedure Screens
131
Menu Buttons and Tabs
131
Descriptions of Buttons, Icons, and Images
131
Entering and Changing Data During the Run
132
Entering and Confirming Patient and Procedure Data
135
Entering Patient Data
135
Selecting the Exchange Type and Entering the Fluid Data
135
Selecting the Exchange Type
135
Entering the Replacement Fluid Data
136
Entering the Fluid Balance
136
Entering and Confirming Run Values
137
Exchange Procedures
137
Depletion/Exchange Procedures
137
Depletion Procedures
137
Priming the Inlet Line, the Return Line, and the Replace Line
139
Connecting the Patient and Starting the Run
139
Monitoring the Run
140
Main Run Screen
140
Exchange Status Screen
140
Replacement Fluid
140
Patient Hct
140
Monitoring the Patient
141
Managing Citrate Toxicity
141
Giving a Fluid Bolus
141
Bolus Volume and Reported Fluid Balance
141
Optimizing the Run
142
Impact of Patient Data and Procedure Data on the Procedure Outcome
142
Updating the Entered Patient Hct
142
Chapter 10: Mononuclear Cell (MNC) Collection Procedures
145
Functional Description of a Mononuclear Cell (MNC) Collection Procedure
146
Accumulation Phase
146
Collection Phase
146
Preparing to Perform a Procedure
146
Supplies
146
Selecting the Procedure and Loading the Tubing Set
146
Navigating the MNC Collection Procedure Screens
147
Menu Buttons and Tabs
147
Descriptions of Buttons, Icons, and Images
147
Entering and Changing Data During the Run
148
Entering and Confirming Patient and Procedure Data
152
Entering Patient Data
152
Reviewing and Confirming Run Values
152
Priming the Inlet Line and the Return Line
153
Connecting the Patient and Starting the Run
153
Monitoring the Run
154
Main Run Screen
154
Collection Status Screen
154
Collection Preference
154
Graph of Inlet Volume Processed
155
Advanced Control Screen
156
Flush Chamber
156
Clumping in Connector
156
Collection Phase Control
156
Chamber
156
Monitoring the Patient
157
Managing Citrate Toxicity
157
Optimizing the Run
158
Optimizing the Collection Preference
158
Minimizing Buffy Coat Accumulation
158
Decreasing the Run Time
158
Transferring Plasma from the Plasma Bag into the Collection Bag
159
Transferring Plasma When a Collection Phase Is Ready to Start
159
Handling the Contents of a Partially Full Chamber
160
Resuming the Current Accumulation Phase
160
Collecting the Contents During Rinseback
160
Recovering the Contents in the Chamber after Disconnecting the Patient
160
Recovering the Contents in the Chamber During Rinseback
160
Removing the Chamber
160
Chapter 11: Continuous Mononuclear Cell Collection (CMNC) Procedures
161
Functional Description of a Continuous Mononuclear Cell Collection (CMNC) Procedure
162
Preparing to Perform a Procedure
162
Supplies
162
Selecting the Procedure and Loading the Tubing Set
162
Navigating the CMNC Procedure Screens
163
Menu Buttons and Tabs
163
Descriptions of Buttons, Icons, and Images
163
Entering and Changing Data During the Run
164
Entering and Confirming Patient and Procedure Data
167
Entering Patient Data
167
Reviewing and Confirming the Run Values
167
Collecting Plasma
168
Priming the Inlet Line and the Return Line
169
Connecting the Patient and Starting the Run
169
Monitoring the Run
170
Main Run Screen
170
Collection Status Screen
170
Collection Preference
170
Return to Patient and Collect into Bag Buttons
170
Monitoring the Patient
171
Managing Citrate Toxicity
171
Optimizing the Run
172
Optimizing the Collection Preference
172
Monitoring the Contents in the Collect Line and Adjusting the Color
172
Minimizing Buffy Coat Accumulation
172
Collecting a Target Volume
173
Decreasing the Run Time
173
Addressing Clumping in the Connector
173
Chapter 12: Granulocyte (PMN) Collection Procedures
175
Functional Description of a Granulocyte (PMN) Collection Procedure
176
Preparing to Perform a Procedure
176
Supplies
176
Anticoagulant Solutions for PMN Collection Procedures
176
Using HES
176
Using ACD-A
176
Selecting the Procedure and Loading the Tubing Set
177
Navigating the PMN Collection Procedure Screens
178
Menu Buttons and Tabs
178
Descriptions of Buttons, Icons, and Images
178
Entering and Changing Data During the Run
179
Entering and Confirming Patient and Procedure Data
182
Entering Patient Data
182
Reviewing and Confirming the Run Values
182
Collecting Plasma
183
Priming the Inlet Line and the Return Line
184
Connecting the Patient and Starting the Run
184
Monitoring the Run
185
Main Run Screen
185
Collection Status Screen
185
Collection Preference
185
Return to Patient and Collect into Bag Buttons
185
Monitoring the Patient
186
Managing Citrate Toxicity
186
Optimizing the Run
187
Optimizing a PMN Collection Procedure When Using ACD-A
187
Optimizing the Collection Preference
187
Monitoring the Contents in the Collect Line and Adjusting the Color
187
Minimizing Buffy Coat Accumulation
188
Targeting a Lower Collect Volume
188
Decreasing the Run Time
188
Addressing Clumping in the Connector
189
Chapter 13: White Blood Cell Depletion (WBCD) and Platelet Depletion (PLTD) Procedures
191
Functional Description of a White Blood Cell Depletion (WBCD) or a Platelet Depletion (PLTD) Procedure
192
Preparing to Perform a Procedure
192
Supplies
192
Anticoagulant Solutions for WBCD Procedures
192
Using ACD-A
192
Using HES
192
Selecting the Procedure and Loading the Tubing Set
193
Navigating the WBCD and PLTD Procedure Screens
194
Menu Buttons and Tabs
194
Descriptions of Buttons, Icons, and Images
194
Entering and Changing Data During the Run
195
Entering and Confirming Patient and Procedure Data
198
Entering Patient Data
198
Reviewing and Confirming the Run Values and the Fluid Data
198
Entering and Changing the Fluid Data
199
Priming the Inlet Line and the Return Line
201
Positioning the IV Pole and the Replacement Fluid Container
201
Connecting the Patient and Starting the Run
201
Monitoring the Run
202
Main Run Screen
202
Collection Status Screen
202
Collection Preference
202
Return to Patient and Collect into Bag Buttons
202
Monitoring the Patient
203
Managing Citrate Toxicity
203
Optimizing the Run
204
Facilitating the Flow of Replacement Fluid
204
Improving the Flow of Replacement Fluid Contained in Bottles
204
Optimizing the Collection Preference
204
Monitoring the Contents in the Collect Line and Adjusting the Color
205
Minimizing Buffy Coat Accumulation
205
Targeting a Lower Collect Volume
205
Addressing Clumping in the Connector
206
Chapter 14: Bone Marrow Processing (BMP) Procedures
207
Functional Description of a Bone Marrow Processing (BMP) Procedure
208
Preparing to Perform a Procedure
208
Supplies
208
Filtering the Bone Marrow
208
Adding ACD-A to the Bone Marrow
208
Transferring the Bone Marrow into the BMP Accessory Set
209
Selecting the Procedure
210
Preparing the Tubing Set for Plasma Collection When Using an IDL Set with Catalog Number 10300
210
Spiking the Plasma Bag on the Replace Line
210
Using a Sterile Tubing Welder to Connect the Plasma Bag to the Replace Line
210
Loading and Priming the Tubing Set
210
Navigating the BMP Procedure Screens
211
Menu Buttons and Tabs
211
Descriptions of Buttons, Icons, and Images
211
Entering and Changing Data During the Run
212
Entering and Confirming Bone Marrow (BM) and Procedure Data
214
Entering BM Data
214
Reviewing and Confirming the Run Values
214
Preparing to Start the Run
215
Connecting the BMP Bag to the Tubing Set
215
Priming the Inlet Line
215
Starting the Run
215
Mixing the Contents of the BMP Bag During the Run
215
Monitoring the Run
216
Main Run Screen
216
Collection Status Screen
216
Collection Preference
216
Return to BMP Bag and Collect into Bag Buttons
217
Optimizing the Run
218
Optimizing the Collection Preference
218
Monitoring the Contents in the Collect Line and Adjusting the Color
218
Addressing Clumping in the Connector
218
Reducing the Concentration of Platelets in the Collection Bag
218
Changing the Target Plasma Volume
219
Concentrating the RBC in the BMP Bag
219
Chapter 15: Ending the Run and Completing the Procedure
222
Ending the Run before a Run Target Is Attained
222
Ending the Run after a Run Target Is Attained
222
Ending the Run
222
Extending the Run
223
Completing the Procedure
224
Disconnecting the Patient and Sealing the Lines
224
Sealing the Lines Using the Seal Safe System
224
Reviewing the Data on the Procedure Summary Screens
226
Starting a New Procedure
227
Removing the Tubing Set
228
Chapter 16: Troubleshooting
229
Troubleshooting Alarms
230
Navigating the Alarm Screens
230
Troubleshooting Multiple Alarms
232
Viewing Alarm History
232
Muting the Alarm Tone
232
Using Semi-Automatic Mode
233
Entering Semi-Automatic Mode with the AIM System Enabled
233
Entering Semi-Automatic Mode with the AIM System Disabled
233
Resuming the Procedure in Semi-Automatic Mode
234
Exchange Procedures
234
MNC Collection Procedures
234
CMNC, PMN Collection, and Depletion Procedures
234
Managing Anticoagulation of the Extracorporeal Circuit
235
Handling Fluid Leaks
235
Resuming a Procedure after a System Reset
236
Performing a Manual Rinseback
237
Clamping and Sealing the Lines
237
Draining the Channel
237
Returning the Fluid to the Patient
238
Manual Method for Opening the Centrifuge Door and Raising the Cassette
240
Manually Opening the Centrifuge Door
240
Manually Raising the Cassette
240
Chapter 17: Maintaining the Spectra Optia System
243
Cleaning and Disinfecting the Spectra Optia System
244
Compatible Cleaning Solutions
244
Compatible Disinfecting Solutions
244
Application of Cleaning and Disinfecting Solutions
245
Frequency of Cleaning and Disinfecting
245
Cleaning and Disinfecting the System Components
246
Surface of the System
246
Exterior Surfaces
246
Touch Screen
246
Components on the Front Panel
246
Sensors and Detectors
246
Valves
246
Pump Housings and Pump Rotors
247
Components in the Centrifuge Chamber
247
Fluid Leak Detector
247
Covers on the AIM System Lights
248
Filler
248
Seal Safe System: Jaw Cavity
248
Seal Safe System: Sealer Head
249
Disassembling of the Sealer Head
249
Cleaning the Sealer Head
250
Reassembling the Sealer Head
251
Attaching a New Splash Guard
252
Cleaning Schedule for the Spectra Optia System
253
Performing Preventive Maintenance
254
Chapter 18: Spectra Optia System Specifications
255
Spectra Optia System Specifications
256
General System Specifications
256
Electrical
256
Environmental
256
Physical
257
Sound Pressure Level
258
System Components
259
Centrifuge
259
Pumps
259
Sensors and Detectors
260
Monitor and Touch Screen
261
System Software
262
Safety System
262
Alarms
262
Extracorporeal Volume (ECV)
264
Tubing Set and Accessory Set Components
264
Electromagnetic Compatibility (EMC)
266
60601-1-2 (4Th Ed.) EMC Information
266
60601-1-2 (3Rd Ed.) EMC Information
269
Symbols and Certifications
275
Appendix A: Supplementary Information
279
Formula for Calculating Total Blood Volume (TBV)
280
TPE Procedures: Plasma and Platelet Removal Efficiency
280
Exchange Procedures: Using a Blood Warmer on the Replace Line
281
Tubing Sets: Using the Needleless Injection Ports
282
Collection Set and IDL Set: Additional Instructions for Use
283
Using the Needle Protector on the Inlet Needle of the Collection Set and the IDL Set
283
Inserting the Inlet Needle
283
Removing the Inlet Needle
283
Using the Diversion Bag to Collect a Sample from a Venipuncture
283
Adding Anticoagulant to the Collection Bag
284
Using the Sample Bulbs to Obtain a Product Sample
285
Obtaining a Product Sample
285
Removing a Product Sample from the Sample Bulb
285
Calculating the Volume of the Collected Product
287
Determining the Weight of the Collected Product
287
Preparing a Tare Bag and Establishing a Tare Weight
287
Printing Procedure Data Reports
288
Connecting a Printer to the Spectra Optia System
288
Connecting a Computer to the System
289
Printing a Report
289
Appendix B: Glossary of Terms
291
Index
301
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