TERUMOBCT Spectra Optia Apheresis System Operators Manual

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

©2018 Terumo BCT, Inc. Terumo BCT is a registered trademark of Terumo Corporation. Seal Safe is a trademark of Terumo BCT, Inc. Spectra Optia is a registered trademark of Terumo BCT, Inc. This product may be covered by one or more patents or pending patent applications. See TERUMOBCT.COM/patents for details.

Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, Colorado 80215 USA USA Phone: +1.877.339.4228 Phone: +1.303.231.4357 USA Fax: +1.866.715.6768 Fax: +1.303.542.5215

Terumo BCT Europe N.V. Ikaroslaan 41 1930 Zaventem, Belgium Phone: +32.2.715.05.90 Fax: +32.2.721.07.70 TERUMOBCT.COM

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

Contents Chapter 1: Preface... 1 About This Operator’s Manual... 2 Conventions Used in this Manual... 2 Numbered Steps... 2 Touch screen buttons...2 Bullets... 2 Warnings, Cautions, and Notes... 2 Spectra Optia Apheresis System... 3 Intended Use... 3 Contraindications for Use... 3 Warnings and Cautions for Use... 3 Warnings for Use... 3 System warnings...3 Service warnings...4 Electrical warnings...4 General procedural warnings...4 Exchange procedure warnings...6 Collection and depletion procedure warnings...7 General tubing set warnings...7 Accessory set warnings...8 Fluid warnings...8 Seal Safe system warnings...8 Cautions for Use... 9 System cautions...9 Service cautions...10 General procedural cautions...10 Collection and depletion procedure cautions...11 General tubing set cautions...12 Exchange Set cautions...12 Collection Set cautions...13 IDL Set cautions...13 Fluid cautions...13 Seal Safe system cautions...14 Service Information... 15 Special Use of Additional Equipment and Devices During Apheresis Procedures... 15 Fluids Administered During Apheresis Procedures... 16 Saline Solution... 16 Anticoagulant... 16 ACD-A...16 Hydroxyethyl Starch (HES)...16 Spectra Optia Apheresis System Operator’s Manual

i

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

Contents

Replacement Fluids... Adverse Events of Apheresis Procedures... Reactions to Blood Products Transfused During Procedures... Disposal of Infectious and Non-Infectious Waste... Return of Used Product...

16 17 18 18 18

Chapter 2: Introduction... 19 Spectra Optia System Description... 20 Spectra Optia System Components... 21 Front Panel... 23 Pumps... 23 Valves... 24 Sensors and detectors... 24 Return line air detector... 24 Centrifuge Chamber... 26 Filler... 27 AIM System... 29 Operating Modes... 29 Automatic Mode... 29 Semi-Automatic Mode... 29 Procedure States... 30 Packing Factor... 30 Operation Status Screen... 31 Caution Status... 32 Fluid Balance Limits... 33 Spectra Optia System Touch Screen... 34 Navigating the Procedure Screens... 34 Entering and changing numerical data using the data entry pad... 34 Screen Colors... 35 Screen Buttons... 35 Buttons, Icons, and Images... 36

Chapter 3: Installing and Transporting the Spectra Optia System... 41 Installing the Spectra Optia System... 42 Setting Up the Spectra Optia System... 42 Turning the Spectra Optia System On and Off... 43 Transporting the Spectra Optia System... 44 Preparing the Spectra Optia System for Transport... 44 Transporting the Spectra Optia System in a Vehicle... 45 Loading the system into the vehicle... 45 Securing the system inside the vehicle... 46 Storing the Spectra Optia System... 46

Chapter 4: Configuring the Spectra Optia System... 47 Configuring the Spectra Optia System... Configuring Procedure-Independent Operating Parameters... System... Procedure... Report... Configuring Procedure-Specific Operating Parameters... Therapeutic Plasma Exchange (TPE)... Therapeutic Plasma Exchange With A Secondary Plasma Device (TPE-SPD)... ii

48 49 49 50 51 52 52 52

Spectra Optia Apheresis System Operator’s Manual

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

Contents

Red Blood Cell Exchange (RBCX)... Mononuclear Cell (MNC) Collection... Continuous Mononuclear Cell Collection (CMNC)... Granulocyte (PMN) Collection... White Blood Cell Depletion (WBCD)... Platelet Depletion (PLTD)... Bone Marrow Processing (BMP)... Configuring the Use of a Blood Warmer...

53 54 55 56 57 58 58 59

Chapter 5: Preparing to Perform a Procedure... 61 Supplies Required to Perform a Procedure... 62 Selecting the Procedure... 64 Installing the Filler... 64 Removing the Filler... 64 Re-Installing the Filler... 65 Loading the Tubing Set... 65 Unpacking the Lines and the Bags... 66 Exchange Set... 66 Collection Set... 66 IDL Set... 66 Snapping the Cassette into the Cassette Tray... 67 Loading the Channel into the Centrifuge... 67 Loading the Lower and Upper Bearings and the Upper Collar... 70 Priming the Tubing Set... 71

Chapter 6: Selecting Procedure Options... 73 Selecting Procedure Options... 74 Selecting Rinseback... 75 Selecting and Performing a Custom Prime... 76 Selecting the custom prime option... 76 Accepting a custom prime recommendation... 76 Entering data for the custom prime... 76 Starting the custom prime... 77 Ending the custom prime before it is complete... 77 Extending the custom prime... 78 Indicating the Use of HES... 78 Selecting and Performing a Saline Rinse... 79 Selecting the saline rinse option... 79 Starting the saline rinse... 79 Repeating a saline rinse... 80 Selecting and Confirming the Single-Needle Option... 80 Indicating Plasma Collection (BMP)... 80 Indicating the Use of a Blood Warmer... 80 Exchange procedures... 80 Collection and depletion procedures... 81 Indicating the Timing of Plasma Collection (CMNC)... 81

Chapter 7: Therapeutic Plasma Exchange (TPE) Procedures... 83 Functional Description of a Therapeutic Plasma Exchange (TPE) Procedure... TPE Procedures Using a Single Needle... Preparing to Perform a Procedure... Supplies... Spectra Optia Apheresis System Operator’s Manual

84 84 84 84 iii

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

Contents

Selecting the Procedure and Loading the Tubing Set... 84 Navigating the TPE Procedure Screens... 85 Menu Buttons and Tabs... 85 Descriptions of Buttons, Icons, and Images... 85 Entering and Changing Data During the Run... 86 Entering and Confirming Patient and Procedure Data... 89 Entering Patient Data... 89 Entering Fluid Data... 89 Selecting the type of replacement fluid... 89 Entering the fluid balance... 90 Reviewing and Confirming the Run Values... 90 Converting the Access to a Single Needle... 91 Selecting and Confirming the Single-Needle Option... 91 Connecting the Single-Needle Connector... 91 Priming the Inlet Line, the Return Line, and the Replace Line... 92 Connecting the Patient and Starting the Run... 92 Monitoring the Run... 93 Main Run Screen... 93 Algorithm control... 93 Exchange Status Screen... 93 Replacement fluid... 93 Monitoring the Patient... 94 Managing Citrate Toxicity... 94 Giving a Fluid Bolus... 94 Bolus volume and reported fluid balance... 94 Optimizing the Run... 95 Prediction for Removing a Substance From the Patient’s Plasma... 95 Handling Turbulence or Platelet Swirling in the Connector... 95 Decreasing the Run Time After Converting the Access to a Single Needle... 96

Chapter 8: Therapeutic Plasma Exchange with a Secondary Plasma Device (TPE-SPD) Procedures... 97 Functional Description of a Therapeutic Plasma Exchange With a Secondary Plasma Device (TPE-SPD) Procedure... 98 Preparing to Perform a Procedure... 98 Supplies... 98 Selecting the Procedure and Loading the Tubing Set... 98 Navigating the TPE-SPD 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 Reviewing and Confirming the Plasma Device Data... 103 Reviewing and Confirming the Run Values... 104 Connecting the Plasma Device Using an Extension Tubing Set... 105 Setting Up and Priming the Extension Tubing Set... 105 Connecting the Treated Plasma Bag... 105 Saline prime: Yes... 105 Saline prime: No... 106 Priming the Inlet Line and the Return Line... 106 Connecting the Patient and Starting the Run... 107 Filling the Treated Plasma Bag... 107 iv

Spectra Optia Apheresis System Operator’s Manual

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

Contents

Monitoring the Run... 108 Main Run Screen... 108 Treatment Status Screen... 108 Monitoring the Patient... 109 Managing Citrate Toxicity... 109 Giving a Fluid Bolus... 109 Bolus volume and reported fluid balance... 109 Optimizing the Run... 110 Adjusting the Volume of Treated Plasma in the Treated Plasma Bag... 110 Adjusting the volume currently in the treated plasma bag... 110 Adjusting the volume maintained in the treated plasma bag... 110 Managing a Positive Fluid Balance... 111 Returning the Contents of the Treated Plasma Bag to the Patient... 111 Rinsing the Plasma Device and Performing Rinseback... 111 Managing a Prime Divert When the Patient Has a Low TBV... 112 Manually Priming the Plasma Device with Albumin... 112 Performing a Manual Prime Divert... 112

Chapter 9: Red Blood Cell Exchange (RBCX) Procedures... 115 RBCX Procedure Types... 116 Functional Description of a Red Blood Cell Exchange (RBCX) Procedure... 116 Preparing to Perform a Procedure... 117 Supplies... 117 Selecting the Procedure and Loading the Tubing Set... 117 Navigating the RBCX Procedure Screens... 117 Menu Buttons and Tabs... 117 Descriptions of Buttons, Icons, and Images... 117 Entering and Changing Data During the Run... 118 Entering and Confirming Patient and Procedure Data... 121 Entering Patient Data... 121 Selecting the Exchange Type and Entering the Fluid Data... 121 Selecting the exchange type... 121 Entering the replacement fluid data... 122 Entering the fluid balance... 122 Entering and Confirming Run Values... 123 Exchange procedures... 123 Depletion/Exchange procedures... 123 Depletion procedures... 123 Priming the Inlet Line, the Return Line, and the Replace Line... 125 Connecting the Patient and Starting the Run... 125 Monitoring the Run... 126 Main Run Screen... 126 Exchange Status Screen... 126 Replacement fluid... 126 Patient Hct... 126 Monitoring the Patient... 127 Managing Citrate Toxicity... 127 Giving a Fluid Bolus... 127 Bolus volume and reported fluid balance... 127 Optimizing the Run... 128 Impact of Patient Data and Procedure Data on the Procedure Outcome... 128 Updating the Entered Patient Hct... 128 Spectra Optia Apheresis System Operator’s Manual

v

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

Contents

Chapter 10: Mononuclear Cell (MNC) Collection Procedures... 131 Functional Description of a Mononuclear Cell (MNC) Collection Procedure... 132 Accumulation phase... 132 Collection phase... 132 Preparing to Perform a Procedure... 132 Supplies... 132 Selecting the Procedure and Loading the Tubing Set... 132 Navigating the MNC Collection Procedure Screens... 133 Menu Buttons and Tabs... 133 Descriptions of Buttons, Icons, and Images... 133 Entering and Changing Data During the Run... 134 Entering and Confirming Patient and Procedure Data... 138 Entering Patient Data... 138 Reviewing and Confirming Run Values... 138 Priming the Inlet Line and the Return Line... 139 Connecting the Patient and Starting the Run... 139 Monitoring the Run... 140 Main Run Screen... 140 Collection Status Screen... 140 Collection preference... 140 Graph of inlet volume processed... 141 Advanced Control Screen... 142 Flush chamber... 142 Clumping in connector... 142 Collection phase control... 142 Chamber... 142 Monitoring the Patient... 143 Managing Citrate Toxicity... 143 Optimizing the Run... 144 Optimizing the Collection Preference... 144 Minimizing Buffy Coat Accumulation... 144 Decreasing the Run Time... 144 Transferring Plasma from the Plasma Bag into the Collection Bag... 145 Transferring plasma when a collection phase is ready to start... 145 Handling the Contents of a Partially Full Chamber... 146 Resuming the Current Accumulation Phase... 146 Collecting the Contents During Rinseback... 146 Recovering the Contents in the Chamber After Disconnecting the Patient... 146 Recovering the contents in the chamber during rinseback... 146 Removing the chamber... 146

Chapter 11: Continuous Mononuclear Cell Collection (CMNC) Procedures... 147 Functional Description of a Continuous Mononuclear Cell Collection (CMNC) Procedure... Preparing to Perform a Procedure... Supplies... Selecting the Procedure and Loading the Tubing Set... Navigating the CMNC Procedure Screens... Menu Buttons and Tabs... Descriptions of Buttons, Icons, and Images... Entering and Changing Data During the Run... Entering and Confirming Patient and Procedure Data... Entering Patient Data... vi

148 148 148 148 149 149 149 150 153 153

Spectra Optia Apheresis System Operator’s Manual

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

Contents

Reviewing and Confirming the Run Values... 153 Collecting plasma... 154 Priming the Inlet Line and the Return Line... 155 Connecting the Patient and Starting the Run... 155 Monitoring the Run... 156 Main Run Screen... 156 Collection Status Screen... 156 Collection preference... 156 Return to patient and collect into bag buttons... 156 Monitoring the Patient... 157 Managing Citrate Toxicity... 157 Optimizing the Run... 158 Optimizing the Collection Preference... 158 Monitoring the contents in the collect line and adjusting the color... 158 Minimizing Buffy Coat Accumulation... 158 Collecting a Target Volume... 159 Decreasing the Run Time... 159 Addressing Clumping in the Connector... 159

Chapter 12: Granulocyte (PMN) Collection Procedures... 161 Functional Description of a Granulocyte (PMN) Collection Procedure... 162 Preparing to Perform a Procedure... 162 Supplies... 162 Anticoagulant Solutions for PMN Collection Procedures... 162 Using HES... 162 Using ACD-A... 162 Selecting the Procedure and Loading the Tubing Set... 163 Navigating the PMN Collection Procedure Screens... 164 Menu Buttons and Tabs... 164 Descriptions of Buttons, Icons, and Images... 164 Entering and Changing Data During the Run... 165 Entering and Confirming Patient and Procedure Data... 168 Entering Patient Data... 168 Reviewing and Confirming the Run Values... 168 Collecting plasma... 169 Priming the Inlet Line and the Return Line... 170 Connecting the Patient and Starting the Run... 170 Monitoring the Run... 171 Main Run Screen... 171 Collection Status Screen... 171 Collection preference... 171 Return to patient and collect into bag buttons... 171 Monitoring the Patient... 172 Managing Citrate Toxicity... 172 Optimizing the Run... 173 Optimizing a PMN Collection Procedure When Using ACD-A... 173 Optimizing the Collection Preference... 173 Monitoring the contents in the collect line and adjusting the color... 173 Minimizing Buffy Coat Accumulation... 174 Targeting a Lower Collect Volume... 174 Decreasing the Run Time... 174 Addressing Clumping in the Connector... 175 Spectra Optia Apheresis System Operator’s Manual

vii

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

Contents

Chapter 13: White Blood Cell Depletion (WBCD) and Platelet Depletion (PLTD) Procedures... 177 Functional Description of a White Blood Cell Depletion (WBCD) or a Platelet Depletion (PLTD) Procedure... 178 Preparing to Perform a Procedure... 178 Supplies... 178 Anticoagulant Solutions for WBCD Procedures... 178 Using ACD-A... 178 Using HES... 178 Selecting the Procedure and Loading the Tubing Set... 179 Navigating the WBCD and PLTD Procedure Screens... 180 Menu Buttons and Tabs... 180 Descriptions of Buttons, Icons, and Images... 180 Entering and Changing Data During the Run... 181 Entering and Confirming Patient and Procedure Data... 184 Entering Patient Data... 184 Reviewing and Confirming the Run Values and the Fluid Data... 184 Entering and changing the fluid data... 185 Priming the Inlet Line and the Return Line... 187 Positioning the IV Pole and the Replacement Fluid Container... 187 Connecting the Patient and Starting the Run... 187 Monitoring the Run... 188 Main Run Screen... 188 Collection Status Screen... 188 Collection preference... 188 Return to patient and collect into bag buttons... 188 Monitoring the Patient... 189 Managing Citrate Toxicity... 189 Optimizing the Run... 190 Facilitating the Flow of Replacement Fluid... 190 Improving the flow of replacement fluid contained in bottles... 190 Optimizing the Collection Preference... 190 Monitoring the contents in the collect line and adjusting the color... 191 Minimizing Buffy Coat Accumulation... 191 Targeting a Lower Collect Volume... 191 Addressing Clumping in the Connector... 192

Chapter 14: Bone Marrow Processing (BMP) Procedures... 193 Functional Description of a Bone Marrow Processing (BMP) Procedure... 194 Preparing to Perform a Procedure... 194 Supplies... 194 Filtering the Bone Marrow... 194 Adding ACD-A to the Bone Marrow... 194 Transferring the Bone Marrow Into the BMP Accessory Set... 195 Selecting the Procedure... 196 Preparing the Tubing Set for Plasma Collection When Using an IDL Set With Catalog Number 10300... 196 Spiking the plasma bag on the replace line... 196 Using a sterile tubing welder to connect the plasma bag to the replace line... 196 Loading and Priming the Tubing Set... 196 Navigating the BMP Procedure Screens... 197 Menu Buttons and Tabs... 197 Descriptions of Buttons, Icons, and Images... 197 viii

Spectra Optia Apheresis System Operator’s Manual

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

Contents

Entering and Changing Data During the Run... 198 Entering and Confirming Bone Marrow (BM) and Procedure Data... 200 Entering BM Data... 200 Reviewing and Confirming the Run Values... 200 Preparing to Start the Run... 201 Connecting the BMP Bag to the Tubing Set... 201 Priming the Inlet Line... 201 Starting the Run... 201 Mixing the Contents of the BMP Bag During the Run... 201 Monitoring the Run... 202 Main Run Screen... 202 Collection Status Screen... 202 Collection preference... 202 Return to BMP bag and collect into bag buttons... 203 Optimizing the Run... 204 Optimizing the Collection Preference... 204 Monitoring the contents in the collect line and adjusting the color... 204 Addressing Clumping in the Connector... 204 Reducing the Concentration of Platelets in the Collection Bag... 204 Changing the Target Plasma Volume... 205 Concentrating the RBC in the BMP Bag... 205

Chapter 15: Ending the Run and Completing the Procedure... 207 Ending the Run Before a Run Target is Attained... 208 Ending the Run After a Run Target is Attained... 208 Ending the Run... 208 Extending the Run... 209 Completing the Procedure... 210 Disconnecting the Patient and Sealing the Lines... 210 Sealing the lines using the Seal Safe System... 210 Reviewing the Data on the Procedure Summary Screens... 212 Starting a New Procedure... 213 Removing the Tubing Set... 214

Chapter 16: Troubleshooting... 215 Troubleshooting Alarms... 216 Navigating the Alarm Screens... 216 Troubleshooting Multiple Alarms... 218 Viewing Alarm History... 218 Muting the Alarm Tone... 218 Using Semi-Automatic Mode... 219 Entering Semi-Automatic Mode With the AIM System Enabled... 219 Entering Semi-Automatic Mode With the AIM System Disabled... 219 Resuming the Procedure in Semi-Automatic Mode... 220 Exchange procedures... 220 MNC collection procedures... 220 CMNC, PMN collection, and depletion procedures... 220 Managing Anticoagulation of the Extracorporeal Circuit... 221 Handling Fluid Leaks... 221 Resuming a Procedure After a System Reset... 222 Performing a Manual Rinseback... 223 Clamping and Sealing the Lines... 223 Spectra Optia Apheresis System Operator’s Manual

ix

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

Contents

Draining the Channel... Returning the Fluid to the Patient... Manual Method for Opening the Centrifuge Door and Raising the Cassette... Manually Opening the Centrifuge Door... Manually Raising the Cassette...

223 224 226 226 226

Chapter 17: Maintaining the Spectra Optia System... 229 Cleaning and Disinfecting the Spectra Optia System... 230 Compatible Cleaning Solutions... 230 Compatible Disinfecting Solutions... 230 Application of Cleaning and Disinfecting Solutions... 231 Frequency of Cleaning and Disinfecting... 231 Cleaning and Disinfecting the System Components... 232 Surface of the System... 232 Exterior surfaces... 232 Touch screen... 232 Components on the Front Panel... 232 Sensors and detectors... 232 Valves... 232 Pump housings and pump rotors... 233 Components in the Centrifuge Chamber... 233 Fluid leak detector... 233 Covers on the AIM system lights... 234 Filler... 234 Seal Safe System: Jaw Cavity... 234 Seal Safe System: Sealer Head... 235 Disassembling of the sealer head... 235 Cleaning the sealer head... 236 Reassembling the sealer head... 237 Attaching a new splash guard... 238 Cleaning Schedule for the Spectra Optia System... 239 Performing Preventive Maintenance... 240

Chapter 18: Spectra Optia System Specifications... 241 Spectra Optia System Specifications... 242 General System Specifications... 242 Electrical... 242 Environmental... 242 Physical... 243 Sound pressure level... 244 System Components... 245 Centrifuge... 245 Pumps... 245 Sensors and detectors... 246 Monitor and touch screen... 247 System Software... 248 Safety system... 248 Alarms... 248 Extracorporeal Volume (ECV)... 250 Tubing Set and Accessory Set Components... 250 Electromagnetic Compatibility (EMC)... 252 60601-1-2 (4th Ed.) EMC information... 252 x

Spectra Optia Apheresis System Operator’s Manual

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

Contents

60601-1-2 (3rd Ed.) EMC information... 255 Symbols and Certifications... 261

Appendix A: Supplementary Information... 265 Formula for Calculating Total Blood Volume (TBV)... 266 TPE Procedures: Plasma and Platelet Removal Efficiency... 266 Exchange Procedures: Using a Blood Warmer on the Replace Line... 267 Tubing Sets: Using the Needleless Injection Ports... 268 Collection Set and IDL Set: Additional Instructions for Use... 269 Using the Needle Protector on the Inlet Needle of the Collection Set and the IDL Set... 269 Inserting the inlet needle... 269 Removing the inlet needle... 269 Using the Diversion Bag to Collect a Sample From a Venipuncture... 269 Adding Anticoagulant to the Collection Bag... 270 Using the Sample Bulbs to Obtain a Product Sample... 271 Obtaining a Product Sample... 271 Removing a Product Sample From the Sample Bulb... 271 Calculating the Volume of the Collected Product... 273 Determining the Weight of the Collected Product... 273 Preparing a tare bag and establishing a tare weight... 273 Determining the weight of the collected product... 273 Calculating the Volume of the Collected Product... 273 Printing Procedure Data Reports... 274 Connecting a Printer to the Spectra Optia System... 274 Connecting a Computer to the System... 275 Printing a Report... 275

Appendix B: Glossary of Terms... 277 Index... 287

Spectra Optia Apheresis System Operator’s Manual

xi

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

Contents

xii

Spectra Optia Apheresis System Operator’s Manual

SpectraOptiaOpsManual.book Page 1 Thursday, May 17, 2018 11:24 AM

1 Preface

Spectra Optia Apheresis System Operator’s Manual

1

SpectraOptiaOpsManual.book Page 2 Thursday, May 17, 2018 11:24 AM

Preface

About This Operator’s Manual This manual contains information and instructions on how to safely operate, transport, troubleshoot, and maintain the Spectra Optia® Apheresis system. You should read and understand the information in this manual before using the system.

Conventions Used in this Manual This manual uses certain conventions to help you identify the tasks that you must perform. The conventions are described below.

Numbered Steps All step-by-step instructions are numbered and the numbers appear in bold, as shown in the following example: 1

Unpack the system from the shipping container.

When steps are numbered, the sequence in which they are performed is important. Always perform the steps in the order presented.

Touch screen buttons Many of the steps instruct you to touch a button on the screen. The text on the button appears in bold, as shown in the following example: 1

Touch Confirm.

Bullets Bullets (•) are used to indicate items in a list.

Warnings, Cautions, and Notes The following examples show how warnings, cautions, and notes appear in this document: Warning: Warnings alert the operator of serious hazards, consequences, or conditions that are likely to result in a harmful reaction, trauma, or death to the patient or operator.

Caution: Cautions alert the operator to the possibility of a problem with the device associated with its use or misuse. This includes device malfunction, failure, and damage to the device or other property.

Note: Notes emphasize important details.

2

Spectra Optia Apheresis System Operator’s Manual

SpectraOptiaOpsManual.book Page 3 Thursday, May 17, 2018 11:24 AM

Preface

Spectra Optia Apheresis System

1

Intended Use The Spectra Optia Apheresis System, a blood component separator, may be used to perform the following therapeutic apheresis, cell collection, and cell processing procedures*: •

Therapeutic plasma exchange

•

Therapeutic plasma exchange with a secondary plasma device

•

Red blood cell exchange, depletion, and depletion/exchange

•

Mononuclear cell collection from the peripheral blood

•

Granulocyte collection from the peripheral blood

•

White blood cell depletion

•

Platelet depletion

•

Processing of harvested bone marrow

*Procedure availability varies by country.

Contraindications for Use Leukocytapheresis is contraindicated in AML FAB M3 (APL) because of the accompanying disseminated intravascular coagulation. (Vahdat L, et al., “Early mortality and the retinoic acid syndrome in acute promyelocytic leukemia: impact of leukocytosis, low-dose chemotherapy, PMN/RAR-alpha isoform and CD13 expression in patients treated with all-trans retinoic acid.” Blood 1994; 84: 3843-3849. Daver, et al., “Clinical characteristics and outcomes in patients with acute promyelocytic leukaemia and hyperleucocytosis.” British Journal of Haematology 2015, 168, 646-653.) Other contraindications for the use of the Spectra Optia system are limited to those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure, and those associated with all types of automated apheresis systems.

Warnings and Cautions for Use Below is a complete listing of warnings and cautions that apply to the use of the Spectra Optia system and the Seal Safe system. Although the information may also appear in other sections of this manual, the operator should read and understand the information in these lists before using the system. Some of the warnings or cautions may instruct you to contact Terumo BCT. Customers in the U.S. should contact Terumo BCT Customer Support. Customers outside the U.S. should contact their local Terumo BCT representative.

Warnings for Use System warnings 1

DANGER: Do not use the Spectra Optia system in an explosive atmosphere.

2

To avoid possible patient injury or loss of life, use only operating procedures published by Terumo BCT.

3

Terumo BCT will not be responsible for patient safety if the procedures to operate the Spectra Optia system are other than those specified by Terumo BCT. Individuals performing the procedures must be appropriately trained and qualified.

Spectra Optia Apheresis System Operator’s Manual

3

SpectraOptiaOpsManual.book Page 4 Thursday, May 17, 2018 11:24 AM

Preface

4

Use only the filler and the tubing sets that Terumo BCT manufactures for the Spectra Optia system.

5

The manufacturer, assembler, installer, or importer regards itself as responsible for effects on the safety, reliability, and performance of the device, only if the device is employed in accordance with the instructions for use.

6

The Spectra Optia system can interfere with EKG monitoring when a patient is simultaneously undergoing apheresis and EKG monitoring.

7

The Spectra Optia system alarms are inactive when the system is turned off.

Service warnings 8

To avoid possible patient injury or loss of life, use only maintenance procedures published by Terumo BCT.

9

Terumo BCT will not be responsible for patient safety if the procedures to maintain and calibrate the Spectra Optia system are other than those specified by Terumo BCT. Individuals performing the procedures must be appropriately trained and qualified.

10

Only a qualified service representative should perform equipment modifications. Any modifications must be approved in writing by Terumo BCT.

11

Turn off the system before cleaning or disinfecting to prevent possible electrical shock or damage to the equipment.

12

The power cord should be unplugged from the wall to isolate the device from the power supply before servicing. Do not position the device to make it difficult to unplug the power cord.

13

Only a qualified service representative should service or repair the Spectra Optia system.

14

When cleaning and disinfecting equipment surfaces that might have been exposed to blood, take adequate precautions to prevent possible exposure to and transmission of infectious diseases.

Electrical warnings 15

All electrical installations must comply with all applicable local electrical codes and Terumo BCT’s specifications.

16

To avoid the risk of electric shock, plug the system into a properly installed, three-wire, grounded electrical receptacle that is protected by an approved branch circuit overcurrent protection and disconnection device. The branch circuit protection and disconnection device must be located away from, but close enough to, the system so that the system can be easily disconnected from the main power supply if the centrifuge malfunctions.

17

Non-medical electrical equipment connected to the Ethernet connection should not be located within the patient environment. The definition of “patient environment” can be found in the IEC standard 60601-1 Edition 3.1, definition 3.79.

18

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). The installer of accessory equipment is responsible for the integrated medical system compliance with requirements of IEC 60601-1 Edition 3.1. If you are in doubt, contact your Terumo BCT service representative.

General procedural warnings

4

19

Do not connect the patient before the system instructs you to do so.

20

Rigorous attention should be paid to proper venipuncture site selection and decontamination.

Spectra Optia Apheresis System Operator’s Manual

SpectraOptiaOpsManual.book Page 5 Thursday, May 17, 2018 11:24 AM

Preface

21

It is advisable to obtain the patient’s detailed drug history before each apheresis procedure. For those drugs potentially affected by apheresis procedures, the physician should either adjust the doses or give the medications immediately after the procedure.

22

To avoid potential side effects and complications during apheresis, patients taking angiotensin-converting enzyme (ACE) inhibitors should discontinue these medications before the procedure. The patient’s attending physician should prescribe and supervise this and any medication change before apheresis.

23

The operator must verify the correct input of information relevant to the safety of each apheresis procedure.

24

When preparing to perform a procedure, ensure that the lines are connected to the correct fluids, and that fluid is flowing into the drip chambers: •

AC line (orange) to the anticoagulant container

•

Saline line (green) to the saline (0.9%) container

25

Check that the tubing is correctly loaded in all pumps before starting a procedure. Visually inspect each pump to ensure that tubing does not protrude.

26

Before starting a procedure, inspect all lines, especially those in the centrifuge and on the front panel, to ensure that they are not obstructed. Tubing that is occluded or mechanically constrained can lead to malfunction or fluid imbalance. Inlet and return lines perform without difficulty as long as the interior diameter of the tubing is larger than the interior diameter of the patient’s inlet and return access.

27

Residual ethylene oxide (EO) found within a Spectra Optia system tubing set may cause allergic, including anaphylactoid and anaphylactic, reactions. The Spectra Optia system allows you to rinse the tubing set with saline solution when you are concerned about hypersensitivity reactions associated with the residual EO, which is a result of sterilization. This option is available to select before you connect the patient. Refer to ‘‘Selecting and Performing a Custom Prime’’ on page 79 for instructions on performing a saline rinse.

28

Only blood or blood products should be processed in the centrifuge.

29

If you are using a blood warmer on the return line, ensure that you completely prime the blood warmer tubing set to remove all the air in the set before you connect the patient.

30

When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight. Put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing.

31

Before connecting the patient, check the inlet and return lines for air. If air is present in the lines, remove the air before connecting the patient.

32

1

Monitor the return line for air. If you see air in the line, go to the operation status screen, touch Remove Air From Return Line, and follow the instructions on the screen.

33

Before connecting the patient, ensure that the AC line contains anticoagulant at the inlet manifold.

34

The inlet and return pressure sensors are not intended to detect infiltrations of the vein. Monitor the patient for infiltrations.

35

Tubing sets may occasionally fail, which could result in the loss of blood, blood products, or the introduction of air into the tubing set. It is very important that the operator watch for leaks in the cassette, all tubing and welds, and in the channel while the set is in use. Operators should take adequate precautions in handling blood and blood products in accordance with their facility’s standard operating procedures.

36

When handling extracorporeal blood circuits, take adequate precautions to prevent the possible exposure to and transmission of infectious diseases.

37

You must completely close the inlet saline line when the system instructs you to do so. If the line is left open, the additional saline will dilute the blood in the channel, which could result in an ineffective procedure.

Spectra Optia Apheresis System Operator’s Manual

5

SpectraOptiaOpsManual.book Page 6 Thursday, May 17, 2018 11:24 AM

Preface

38

The following can cause fluid imbalance: •

Administration of replacement fluid that is not at room temperature during a procedure

•

Use of improperly vented fluid containers

•

Equipment malfunction

•

Improperly clamped or closed lines, or improperly loaded valves

•

Use of inadequately primed or clotted filters on the replace line of the Exchange Set

•

Tubing that is incorrectly loaded in the pumps

39

The alarm system is inactive during a manual rinseback. If you must perform a manual rinseback, watch for air in the return line. If you see air, immediately discontinue the rinseback.

40

Do not apply excess pressure to the vent bag when pushing fluid from the reservoir to the patient during a manual rinseback or you could damage the red blood cells that you are returning to the patient.

41

Do not continue to squeeze the vent bag after the fluid in the reservoir reaches the level of the reservoir filter during a manual rinseback. If you continue to squeeze the bag, you could deliver air to the patient.

42

Do not touch Unload to unload the tubing from the pumps or remove the tubing set when a patient is connected to the Spectra Optia system, or the patient may receive surplus fluids through the inlet and return lines.

43

All used disposable materials should be considered hazardous, and should be handled and disposed of at the end of the procedure in accordance with all applicable regulations.

44

Turn off the system before cleaning to prevent possible electrical shock or damage to the equipment.

Exchange procedure warnings 45

6

Platelets are removed with red blood cells during a red blood cell exchange (RBCX) procedure. The approximate percentage of platelets removed depends on the number of total blood volumes (TBV) processed, as shown in the table below. It is the physician’s responsibility to determine the appropriate treatment for the patient. TBV Processed

Percentage Platelets Removed (Approximate)

0.5

39

1.0

63

1.5

78

2.0

86

46

Terumo BCT does not recommend performing rinseback during RBCX procedures. The data that the system uses to predict the run targets does not include rinseback volume. If rinseback is performed, the run targets may not be accurate.

47

Before performing a therapeutic plasma exchange procedure with a secondary plasma device (TPE-SPD procedure), carefully review the instructions for use provided by the manufacturer of the secondary plasma device.

48

Some secondary plasma devices can leach small amounts of potentially toxic substances to patients and must be flushed before use. Flush the device according to the manufacturer’s instructions to ensure patient safety.

Spectra Optia Apheresis System Operator’s Manual