Spectra Optia Service Manual - English, EN...Spectra Optia Apheresis System Service Manual v Fan 3 failed. ..... 4-180 Fan 3 Fluid balance change caused fluid balance to exceed limits

Spectra Optia®APHERESIS SYSTEM

SERVICE MANUAL

Spectra Optia®Apheresis SystemService Manual

Part No. 777401-0422011-01

©2011CaridianBCT, Inc.

CaridianBCT, Inc.10811 W. Collins AvenueLakewood, Colorado 80215USAUSA Phone: +1.877.339.4228Phone: +1.303.231.4357USA Fax: +1.866.715.6768Fax: +1.303.542.5215

CaridianBCT Europe N.V.Ikaroslaan 411930 ZaventemBelgiumPhone: +32.2.715.05.90Fax: +32.2.721.07.70

www.caridianbct.com

Contents

Preface ................................................................................................................. 15

1: Operational DescriptionOperational Description ..................................................................................................................................... 1-2

System Components ........................................................................................................................................... 1-3

Modes of Operation and Procedure States .......................................................................................................... 1-5

User Interface ..................................................................................................................................................... 1-7

Exchange Disposable Tubing Set ...................................................................................................................... 1-11

Collection Disposable Tubing Set .................................................................................................................... 1-15

Therapeutic Plasma Exchange .......................................................................................................................... 1-19

Mononuclear Cell Collection ........................................................................................................................... 1-22

Red Blood Cell Exchange Procedure Types ...................................................................................................... 1-24

RBCX Functional Description ......................................................................................................................... 1-26

2: System DescriptionSystem Description ............................................................................................................................................. 2-2

E-Box and Computer Systems ............................................................................................................................ 2-3

Control CCA ............................................................................................................................................. 2-5

Control Computer CCA ............................................................................................................................ 2-7

Control Ethernet CCA .............................................................................................................................. 2-8

Other Control Stack CCAs ........................................................................................................................ 2-9

Safety CCA .............................................................................................................................................. 2-11

Safety Computer CCA ............................................................................................................................. 2-12

Other Safety Stack CCA .......................................................................................................................... 2-14

AIM System CCAs .................................................................................................................................. 2-14

Motor Driver CCA .................................................................................................................................. 2-18

Display CCA ........................................................................................................................................... 2-26

Top Cap and Motherboard CCAs ........................................................................................................... 2-28

Spectra Optia Apheresis System Service Manual i

Power System .......................................................................................................................................... 2-29

Cooling Fans ........................................................................................................................................... 2-32

Display System ................................................................................................................................................. 2-33

Display Assembly ..................................................................................................................................... 2-35

Pump System ................................................................................................................................................... 2-38

Pump Assembly ....................................................................................................................................... 2-41

Valve System .................................................................................................................................................... 2-43

Valve Assembly ........................................................................................................................................ 2-45

Sensor System ................................................................................................................................................... 2-48

Pressure Sensors ....................................................................................................................................... 2-48

Reservoir Level Sensors ............................................................................................................................ 2-52

Reservoir Management ............................................................................................................................ 2-55

Fluid Sensors ........................................................................................................................................... 2-56

Return Line Air Detector ......................................................................................................................... 2-58

Set ID Detector ....................................................................................................................................... 2-60

RBC Detector .......................................................................................................................................... 2-63

Fluid Leak Detector ................................................................................................................................. 2-66

Linear Actuator System .................................................................................................................................... 2-68

AIM System ..................................................................................................................................................... 2-71

Camera System ........................................................................................................................................ 2-71

Lighting System ....................................................................................................................................... 2-73

Centrifuge System ............................................................................................................................................ 2-81

Centrifuge Drive Assembly ...................................................................................................................... 2-85

Filler Assembly ......................................................................................................................................... 2-87

Centrifuge Motor Controller ................................................................................................................... 2-89

Mechanical System ........................................................................................................................................... 2-92

Dual IV Pole ............................................................................................................................................ 2-92

Wheel and Brake System ......................................................................................................................... 2-95

3: Software DescriptionSoftware Description .......................................................................................................................................... 3-2

Base Layer Software States .................................................................................................................................. 3-4

Power Control State ................................................................................................................................... 3-4

Startup State .............................................................................................................................................. 3-7

T1 Pump Power Test State ...................................................................................................................... 3-12

T1 Device Test State ............................................................................................................................... 3-14

T1 APC Test State ................................................................................................................................... 3-16

T1 Centrifuge Power Test State ............................................................................................................... 3-18

Load Disposable State .............................................................................................................................. 3-21

RBC Detector Calibration State .............................................................................................................. 3-26

ii Spectra Optia Apheresis System Service Manual

Disconnect Test State .............................................................................................................................. 3-28

Unload Disposable State .......................................................................................................................... 3-30

Set Layer Software States .................................................................................................................................. 3-32

Collection States ...................................................................................................................................... 3-32

Exchange States ....................................................................................................................................... 3-54

Protocol Layer Software States .......................................................................................................................... 3-77

MNC Run State ...................................................................................................................................... 3-77

RBCX Run State ..................................................................................................................................... 3-82

TPE Run State ......................................................................................................................................... 3-88

4: TroubleshootingNon-Alarm Troubleshooting .............................................................................................................................. 4-2

Touchscreen Troubleshooting ................................................................................................................... 4-2

General AIM Troubleshooting ................................................................................................................... 4-3

Troubleshooting Failures During Start Up ................................................................................................ 4-5

Datalog Files ...................................................................................................................................................... 4-7

Alarm Troubleshooting ...................................................................................................................................... 4-8

Spectra Optia Alarms ....................................................................................................................................... 4-11

AC fluid detector detected fluid too soon. ................................................................................................ 4-12

AC fluid detector did not detect fluid. ..................................................................................................... 4-14

AC infusion data was invalid. ................................................................................................................... 4-16

AC infusion data was invalid. ................................................................................................................... 4-17

AC occlusion test failed. ........................................................................................................................... 4-18

AC pump did not stop when commanded. .............................................................................................. 4-20

AC pump malfunctioned. ........................................................................................................................ 4-22

AC pump software error occurred. ........................................................................................................... 4-24

AC pump speed was too high. ................................................................................................................. 4-25

AC pump turned faster than inlet pump. ................................................................................................. 4-26

AC volume limit was exceeded. ................................................................................................................ 4-28

AC was not detected. ............................................................................................................................... 4-29

AIM subsystem failed. .............................................................................................................................. 4-31

AIM system's interface measurement data was not updated. .................................................................... 4-33

AIM system could not establish target interface. ...................................................................................... 4-35

AIM system detected RBC interface near top of channel. ........................................................................ 4-37

AIM system did not complete calibration test. ......................................................................................... 4-40

AIM system did not complete channel imaging test. ................................................................................ 4-42

AIM system did not complete illumination test. ...................................................................................... 4-44

AIM system did not complete interface measurement. ............................................................................. 4-46

AIM system did not detect interface. ....................................................................................................... 4-48

AIM system did not respond to system command. ................................................................................... 4-51

AIM system failed calibration test. ........................................................................................................... 4-53

Spectra Optia Apheresis System Service Manual iii

AIM system failed channel imaging test. .................................................................................................. 4-55

AIM system failed illumination test. ........................................................................................................ 4-58

AIM system failed to measure interface. ................................................................................................... 4-61

Air may not have been removed from return line. .................................................................................... 4-64

Air removal is complete. ........................................................................................................................... 4-66

Air was detected in return line. ................................................................................................................ 4-67

Analog sensor data was not available. ....................................................................................................... 4-69

Bolus volume caused fluid balance to exceed limits. ................................................................................. 4-70

Calculation of pump rpm was not consistent. .......................................................................................... 4-72

Canceling custom prime recommendation. .............................................................................................. 4-74

Cassette mechanism that raises and lowers cassette malfunctioned. .......................................................... 4-75

Cassette sensor malfunctioned. ................................................................................................................ 4-77

Cassette software error occurred. .............................................................................................................. 4-79

Cassette tray was not correctly positioned. ............................................................................................... 4-80

Cassette was not detected in all positions. ................................................................................................ 4-82

Cassette was not lowered. ......................................................................................................................... 4-84

Centrifuge control malfunctioned. ........................................................................................................... 4-85

Centrifuge did not stop during alarm. ...................................................................................................... 4-87

Centrifuge did not stop when commanded. ............................................................................................. 4-88

Centrifuge door lock malfunctioned. ....................................................................................................... 4-90

Centrifuge door lock power circuit failed. ................................................................................................ 4-91

Centrifuge door lock sensor malfunctioned. ............................................................................................. 4-92

Centrifuge door lock software error occurred. .......................................................................................... 4-94

Centrifuge door lock test malfunctioned. ................................................................................................. 4-95

Centrifuge door position sensor malfunctioned. ....................................................................................... 4-97

Centrifuge door was not closed. ............................................................................................................... 4-99

Centrifuge door was opened or unlocked when centrifuge was spinning. ............................................... 4-100

Centrifuge exceeded maximum allowed speed. ....................................................................................... 4-102

Centrifuge motion detected was improper. ............................................................................................ 4-104

Centrifuge power could not be disabled. ................................................................................................ 4-106

Centrifuge power could not be enabled. ................................................................................................. 4-107

Centrifuge power did not turn off. ......................................................................................................... 4-108

Centrifuge pressure exceeded limit. ........................................................................................................ 4-110

Centrifuge pressure sensor failed calibration test. ................................................................................... 4-113

Centrifuge pressure sensor failed post-load test. ..................................................................................... 4-115

Centrifuge pressure sensor failed zero differential test. ............................................................................ 4-117

Centrifuge pressure sensor failed zero limit test. ..................................................................................... 4-119

Centrifuge pressure sensor failed zero range test. .................................................................................... 4-121

Centrifuge pressure sensor malfunctioned. ............................................................................................. 4-123

Centrifuge software error occurred. ........................................................................................................ 4-125

iv Spectra Optia Apheresis System Service Manual

Centrifuge speed sensors malfunctioned. ................................................................................................ 4-126

Centrifuge speed was not sufficient. ....................................................................................................... 4-128

Centrifuge speed was too high while procedure was paused. .................................................................. 4-130

Centrifuge was commanded to spin during alarm. ................................................................................. 4-132

Centrifuge was spinning in reverse. ........................................................................................................ 4-133

Chamber took too long to fill. ............................................................................................................... 4-135

Change replacement fluid to RBC for exchange. .................................................................................... 4-137

Change to patient data caused fluid balance to exceed limits. ................................................................. 4-138

Check connection from return line to blood warmer tubing. ................................................................. 4-141

Clamp inlet and return lines. ................................................................................................................. 4-142

Clamp inlet line. .................................................................................................................................... 4-143

Clamp return line. ................................................................................................................................. 4-144

Clamp return line. ................................................................................................................................. 4-145

Clear saline from drip chamber. ............................................................................................................. 4-146

Close inlet saline line. Clamp return line. .............................................................................................. 4-147

Close lines to prepare for tubing set test. ................................................................................................ 4-148

Close return saline line. .......................................................................................................................... 4-149

Close return saline line. .......................................................................................................................... 4-150

Close saline lines and clamp extra remove line. ...................................................................................... 4-151

Collection bag reached capacity. ............................................................................................................ 4-152

Collect recirculation flow path was not primed. ..................................................................................... 4-153

Confirming selection to begin rinseback. ............................................................................................... 4-155

Confirming selection to disable AIM system. ......................................................................................... 4-156

Confirming selection to disable RBC detector. ...................................................................................... 4-157

Confirming selection to disconnect patient and raise cassette. ................................................................ 4-158

Confirming selection to disconnect patient and raise cassette. ................................................................ 4-159

Confirm return line did not contain air. ................................................................................................ 4-160

Confirm saline lines were closed. ........................................................................................................... 4-161

Control flow was not consistent. ............................................................................................................ 4-162

Could not confirm saline lines were closed. ............................................................................................ 4-163

Current run targets could not be attained with run value entered. ......................................................... 4-164

Current run targets could not be attained with value entered. ................................................................ 4-165

Current run targets could not be attained with value entered. System paused. ....................................... 4-166

Custom prime volume was not sufficient. .............................................................................................. 4-167

Door-closed sensor was not consistent. .................................................................................................. 4-168

Door lock sensor was not consistent. ...................................................................................................... 4-170

Fan 1 failed. ........................................................................................................................................... 4-172

Fan 1 malfunctioned. ............................................................................................................................. 4-174

Fan 2 failed. ........................................................................................................................................... 4-176


Spectra Optia Apheresis System Service Manual v

Fan 3 failed. ........................................................................................................................................... 4-180


Fluid balance change caused fluid balance to exceed limits. .................................................................... 4-184

Fluid balance no longer exceeded limits. ................................................................................................ 4-186

Fluid leak detector failed self-test. .......................................................................................................... 4-188

Hall sensor and encoder in AC pump malfunctioned. ............................................................................ 4-189

Hall sensor and encoder in inlet pump malfunctioned. .......................................................................... 4-191

Hall sensor and encoder in plasma pump malfunctioned. ...................................................................... 4-193

Hall sensor and encoder in replace pump malfunctioned. ...................................................................... 4-195

Hall sensor and encoder in return pump malfunctioned. ....................................................................... 4-197

High-level reservoir sensor detected excess fluid. .................................................................................... 4-199

High-level reservoir sensor detected fluid too soon. ................................................................................ 4-202

High-level reservoir sensor did not detect fluid. ..................................................................................... 4-204

High-level reservoir sensor failed fluid check. ......................................................................................... 4-206

High-level reservoir sensor failed timing test. ......................................................................................... 4-208

High-level reservoir sensor malfunctioned. ............................................................................................. 4-210

Hypervolemia condition was possible. ................................................................................................... 4-212

Hypervolemia limit was exceeded. ......................................................................................................... 4-213

Hypovolemia condition was possible. .................................................................................................... 4-214

Hypovolemia limit was exceeded. .......................................................................................................... 4-216

Identification of tubing set did not match selected procedure. ............................................................... 4-217

Improper state transition occurred. ........................................................................................................ 4-219

Inlet:AC ratio data was invalid. .............................................................................................................. 4-220

Inlet:AC ratio data was invalid. .............................................................................................................. 4-221

Inlet:AC ratio was above maximum. ...................................................................................................... 4-222

Inlet:AC ratio was below minimum. ...................................................................................................... 4-223

Inlet line prime failed. ............................................................................................................................ 4-224

Inlet line was not clamped. .................................................................................................................... 4-225

Inlet pressure sensor failed calibration test. ............................................................................................. 4-226

Inlet pressure sensor failed post-load test. ............................................................................................... 4-228

Inlet pressure sensor failed zero differential test. ..................................................................................... 4-230

Inlet pressure sensor failed zero limit test. .............................................................................................. 4-232

Inlet pressure sensor failed zero range test. ............................................................................................. 4-234

Inlet pressure sensor malfunctioned. ...................................................................................................... 4-236

Inlet pressure was too low. ..................................................................................................................... 4-238

Inlet pump did not stop when commanded. .......................................................................................... 4-240

Inlet pump malfunctioned. .................................................................................................................... 4-242

Inlet pump software error occurred. ....................................................................................................... 4-244

Inlet saline line was obstructed. .............................................................................................................. 4-245

Inlet saline line was obstructed during rinseback. ................................................................................... 4-247

vi Spectra Optia Apheresis System Service Manual

Interface still took too long to establish. ................................................................................................. 4-248

Interface took too long to establish. ....................................................................................................... 4-251

Internal timing was not consistent. ........................................................................................................ 4-254

Leak was detected in centrifuge. ............................................................................................................. 4-256

LED sensor malfunctioned. ................................................................................................................... 4-259

Low-level reservoir sensor continued to detect excess fluid. .................................................................... 4-260

Low-level reservoir sensor detected air. ................................................................................................... 4-263

Low-level reservoir sensor detected excess fluid. ..................................................................................... 4-265

Low-level reservoir sensor detected fluid too soon. ................................................................................. 4-268

Low-level reservoir sensor did not detect fluid. ....................................................................................... 4-270

Low-level reservoir sensor failed timing test. .......................................................................................... 4-272

Low-level reservoir sensor malfunctioned. .............................................................................................. 4-274



Low-level reservoir sensor persisted in detecting excess fluid. ................................................................. 4-279

Minus twelve volt power supply was out of range. ................................................................................. 4-282

NVRAM safety test failed. ..................................................................................................................... 4-283

NVRAM test failed. ............................................................................................................................... 4-284

Open and close centrifuge door. ............................................................................................................ 4-285

Open inlet saline line. ............................................................................................................................ 4-286

Open return saline line. ......................................................................................................................... 4-287

Open saline lines. ................................................................................................................................... 4-288

Patient's fluid balance may be 10% higher than reported. ...................................................................... 4-289

Patient's fluid balance may be 10% lower than reported. ....................................................................... 4-291

Patient's fluid balance may be 15% higher than reported. ...................................................................... 4-293

Patient's fluid balance may be 15% lower than reported. ....................................................................... 4-295

Patient's fluid balance may be 5% higher than reported. ........................................................................ 4-297

Patient's fluid balance may be 5% lower than reported. ......................................................................... 4-299

Patient fluid balance may be lower than reported. .................................................................................. 4-301

Patient height was invalid. ..................................................................................................................... 4-303

Patient height was invalid. ..................................................................................................................... 4-304

Patient hematocrit data was invalid. ....................................................................................................... 4-305

Patient hematocrit data was invalid. ....................................................................................................... 4-306

Patient sex was invalid. .......................................................................................................................... 4-307

Patient sex was invalid. .......................................................................................................................... 4-308

Patient TBV was invalid. ....................................................................................................................... 4-309

Patient TBV was invalid. ....................................................................................................................... 4-310

Patient weight was invalid. ..................................................................................................................... 4-311

Patient weight was invalid. ..................................................................................................................... 4-312

Pause button was touched. ..................................................................................................................... 4-313

Spectra Optia Apheresis System Service Manual vii

Plasma bag reached capacity. .................................................................................................................. 4-314

Plasma pump did not stop when commanded. ....................................................................................... 4-315

Plasma pump malfunctioned. ................................................................................................................ 4-317

Plasma pump software error occurred. ................................................................................................... 4-319

Plasma recirculation flow path was not primed. ..................................................................................... 4-320

Plasma remove flow path was not primed. ............................................................................................. 4-322

Plasma valve malfunctioned. .................................................................................................................. 4-324

Plasma valve sensor malfunctioned. ........................................................................................................ 4-325

Plasma valve software error occurred. ..................................................................................................... 4-326

Plasma valve was not correctly positioned. ............................................................................................. 4-327

Predicted fluid balance exceeded limits. ................................................................................................. 4-328

Predicted procedure time exceeded 8 hours. ........................................................................................... 4-330

Prediction software malfunctioned. ........................................................................................................ 4-331

Pressure in collect line was too high. ...................................................................................................... 4-333

Pressure sensor 4 failed calibration test. .................................................................................................. 4-335

Pressure sensor 4 failed post-load test. .................................................................................................... 4-337

Pressure sensor 4 failed zero differential test. .......................................................................................... 4-339

Pressure sensor 4 failed zero limit test. ................................................................................................... 4-341

Pressure sensor 4 failed zero range test. .................................................................................................. 4-343

Prime saline has been diverted. Close return saline line. ......................................................................... 4-345

Prime saline was not diverted. ................................................................................................................ 4-346

Procedure configuration data was corrupt. ............................................................................................. 4-347

Procedure data error detected. ................................................................................................................ 4-348

Procedure data error detected. ................................................................................................................ 4-349

Procedure time exceeded 8 hours. .......................................................................................................... 4-350

Pump 1 failed rotation test. .................................................................................................................... 4-351





Pump did not function correctly. ........................................................................................................... 4-361

Pump motion detected was improper. ................................................................................................... 4-363

Pump power could not be disabled. ....................................................................................................... 4-364

Pump power could not be enabled. ........................................................................................................ 4-365

Pumps and centrifuge did not stop during alarm. .................................................................................. 4-366

Pumps continued to turn during alarm. ................................................................................................. 4-367

Pumps did not stop during alarm. .......................................................................................................... 4-368

Pumps have been paused for 10 minutes. ............................................................................................... 4-369

Pumps have been paused for 3 minutes. ................................................................................................. 4-370

Pumps were commanded to turn during alarm. ..................................................................................... 4-371

viii Spectra Optia Apheresis System Service Manual

Pumps were commanded to turn instead of stop. ................................................................................... 4-372

Pumps were paused for 3 minutes. ......................................................................................................... 4-373

Pumps were turned during alarm. .......................................................................................................... 4-375

RBC detector calibration error occurred. ............................................................................................... 4-376

RBC detector did not respond. .............................................................................................................. 4-378

RBC detector did not transmit data. ...................................................................................................... 4-380

RBC detector software error occurred. ................................................................................................... 4-382

RBC recirculation flow path was not primed. ........................................................................................ 4-383

RBC remove flow path was not primed. ................................................................................................ 4-385

RBC valve malfunctioned. ..................................................................................................................... 4-387

RBC valve malfunctioned. ..................................................................................................................... 4-388

RBC valve sensor malfunctioned. ........................................................................................................... 4-389

RBC valve software error occurred. ........................................................................................................ 4-390

RBC valve was not correctly positioned. ................................................................................................ 4-391

Read-type communication error from RBC detector occurred. .............................................................. 4-392

Recommending custom prime. .............................................................................................................. 4-394

Red blood cells were detected in collect line too soon. ........................................................................... 4-395

Red blood cells were detected in plasma line from centrifuge. ................................................................ 4-398

Remove bag reached capacity. ................................................................................................................ 4-401

Remove valve malfunctioned. ................................................................................................................ 4-402

Remove valve sensor malfunctioned. ...................................................................................................... 4-403

Remove valve software error occurred. ................................................................................................... 4-404

Remove valve was not correctly positioned. ............................................................................................ 4-405

Replacement fluid detector detected fluid too soon. ............................................................................... 4-406

Replacement fluid was not detected. ...................................................................................................... 4-408

Replace pump did not stop when commanded. ..................................................................................... 4-410

Replace pump malfunctioned. ............................................................................................................... 4-412

Replace pump software error occurred. .................................................................................................. 4-414

Reservoir did not contain enough fluid. ................................................................................................. 4-415

Reservoir sensors malfunctioned. ........................................................................................................... 4-416

Reservoir was full during air removal. .................................................................................................... 4-417

Return line air detector detected fluid too soon. ..................................................................................... 4-419

Return line air detector failed fluid check. .............................................................................................. 4-421

Return line prime failed. ........................................................................................................................ 4-423

Return line was not clamped during air removal. ................................................................................... 4-425

Return line was not primed. ................................................................................................................... 4-427

Return pressure sensor failed calibration test. ......................................................................................... 4-429

Return pressure sensor failed post-load test. ........................................................................................... 4-431

Return pressure sensor failed zero differential test. ................................................................................. 4-433

Return pressure sensor failed zero limit test. ........................................................................................... 4-435

Spectra Optia Apheresis System Service Manual ix

Return pressure sensor failed zero range test. .......................................................................................... 4-437

Return pressure was too high. ................................................................................................................ 4-439

Return pressure was too high when system was diverting saline. ............................................................. 4-441

Return pump did not stop. .................................................................................................................... 4-442

Return pump did not stop when commanded. ....................................................................................... 4-443

Return pump malfunctioned. ................................................................................................................ 4-445

Return pump malfunctioned. ................................................................................................................ 4-447

Return pump software error occurred. ................................................................................................... 4-449

Return pump speed was too high. .......................................................................................................... 4-450

Return pump turned too fast. ................................................................................................................ 4-452

Return saline line failed integrity test. .................................................................................................... 4-454

Return saline line was not closed during air removal. ............................................................................. 4-456

Return saline line was obstructed. .......................................................................................................... 4-458

Return saline line was obstructed during air removal. ............................................................................ 4-460

Run target will be attained before next collection phase. ........................................................................ 4-462

Safety system could not confirm position of collect valve. ...................................................................... 4-463

Safety system could not confirm valve position. ..................................................................................... 4-464

Safety system could not read backup configuration file. ......................................................................... 4-466

Safety system could not read default configuration file. .......................................................................... 4-467

Safety system could not read primary configuration file. ........................................................................ 4-468

Safety system detected air in return line. ................................................................................................ 4-469

Safety system detected air in return line. ................................................................................................ 4-470

Safety system detected excess AC infusion. ............................................................................................. 4-471

Safety system detected internal timing inconsistency. ............................................................................. 4-473

Safety system detected software communication error. ........................................................................... 4-475

Safety system detected that patient hematocrit was lower than minimum. ............................................. 4-477

Safety system detected too much fluid in collection bag. ........................................................................ 4-478

Safety system detected too much fluid in plasma bag. ............................................................................ 4-479

Safety system detected too much fluid in remove bag. ............................................................................ 4-480

Safety system detected valve open longer than expected. ........................................................................ 4-481

Safety system did not respond to power request. .................................................................................... 4-483

Safety system did not respond to request to turn off power. ................................................................... 4-484

Safety system did not respond to request to turn on power. ................................................................... 4-485

Safety system failed power test. .............................................................................................................. 4-486

Safety system failed start process. ........................................................................................................... 4-488

Safety system lost internal communication capability. ............................................................................ 4-490

Safety system stopped air removal. ......................................................................................................... 4-492

Saline lines were not closed. ................................................................................................................... 4-493

Saline line was obstructed. ..................................................................................................................... 4-494

Sixty-four volt power supply was out of range. ....................................................................................... 4-496

x Spectra Optia Apheresis System Service Manual

Software consistency error occurred. ...................................................................................................... 4-497

Software control data was not updated. .................................................................................................. 4-498

Software CRC failed. ............................................................................................................................. 4-500

Software memory for AIM system was not sufficient. ............................................................................. 4-501

Software memory for control system was not sufficient. ......................................................................... 4-502

Software memory for safety system was not sufficient. ........................................................................... 4-503

Software module was not consistent. ...................................................................................................... 4-504

Stop button was touched. ...................................................................................................................... 4-505

System cannot verify that patient was disconnected. .............................................................................. 4-506

System could not load correct software. ................................................................................................. 4-507

System could not read backup configuration file. ................................................................................... 4-508

System could not read default configuration file. ................................................................................... 4-509

System could not read primary configuration file. .................................................................................. 4-510

System did not correctly monitor AC infusion. ...................................................................................... 4-511

System malfunctioned when it raised or lowered cassette. ...................................................................... 4-513

System paused: Centrifuge door was not closed. .................................................................................... 4-514

System was reset. .................................................................................................................................... 4-516

System was reset. .................................................................................................................................... 4-518

System was reset. .................................................................................................................................... 4-520

TBV restricted volume available to confirm volume in reservoir. ........................................................... 4-521

Test of negative inlet pressure failed. ...................................................................................................... 4-522

Test of negative return pressure failed. ................................................................................................... 4-524

Timing discrepancy in low-level reservoir sensor occurred. .................................................................... 4-526

Too much AC was detected during prime. ............................................................................................. 4-528

Tubing set did not match selected procedure. ........................................................................................ 4-529

Tubing set failed dwell test for negative inlet pressure. ........................................................................... 4-531

Tubing set failed dwell test for negative return pressure. ........................................................................ 4-533

Tubing set failed dwell test for positive inlet pressure. ............................................................................ 4-535

Tubing set failed dwell test for positive return pressure. ......................................................................... 4-537

Tubing set failed test for negative inlet pressure. .................................................................................... 4-539

Tubing set failed test for positive inlet pressure. ..................................................................................... 4-541

Tubing set failed test for positive inlet pressure. ..................................................................................... 4-543

Tubing set failed test for positive return pressure. .................................................................................. 4-545

Tubing set failed test of negative return pressure. ................................................................................... 4-547

Tubing set identification error occurred. ................................................................................................ 4-549

Tubing set may have contained fluid. .................................................................................................... 4-552

Twelve volt power supply was out of range. ........................................................................................... 4-554

Twenty-four volt power supply was out of range. ................................................................................... 4-555

Unclamp return line. ............................................................................................................................. 4-556

Unclamp return line. ............................................................................................................................. 4-557

Spectra Optia Apheresis System Service Manual xi

Valve position error occurred. ................................................................................................................ 4-558

Vent bag contained fluid during prime. ................................................................................................. 4-560

Vent bag contained fluid during run. ..................................................................................................... 4-562

Verification test that patient was disconnected from inlet line failed. ..................................................... 4-564

Verification test that patient was disconnected from return line failed. ................................................... 4-565

Voltage of fluid leak detector was above normal range. .......................................................................... 4-566

Voltage of fluid leak detector was below normal range. .......................................................................... 4-567

Volume entered for custom prime was too low. ..................................................................................... 4-569

Volume in collection bag may be lower than reported. ........................................................................... 4-570

Write-type communication error to data logging subsystem occurred. ................................................... 4-572

Write-type communication error to RBC detector occurred. ................................................................. 4-573

5: Maintenance and CalibrationMaintenance and Calibration ............................................................................................................................. 5-2

Removing the Side Panels .......................................................................................................................... 5-2

Raising the Pump Panel ............................................................................................................................. 5-5

Removing the Linear Actuator ................................................................................................................... 5-8

Calibrating the Centrifuge Motor Controller ........................................................................................... 5-10

Making a Test Cassette ............................................................................................................................ 5-12

Positioning the Linear Actuator Sensors ................................................................................................... 5-14

Printer and FTP Connectivity .......................................................................................................................... 5-17

Connecting a Printer ............................................................................................................................... 5-18

Connecting a Computer .......................................................................................................................... 5-20

6: Spectra Optia Spare PartsLiterature Group ................................................................................................................................................ 6-2

Documentation Group ....................................................................................................................................... 6-2

Display Head Group .......................................................................................................................................... 6-3

Pump Panel Group ............................................................................................................................................. 6-4

Centrifuge Basin Group ..................................................................................................................................... 6-6

E-box Group ...................................................................................................................................................... 6-7

Seal Safe Group .................................................................................................................................................. 6-9

Exterior Parts Group ........................................................................................................................................ 6-10

Tools Group ..................................................................................................................................................... 6-11

Other Parts Group ........................................................................................................................................... 6-11

Software Group ................................................................................................................................................ 6-12

Software Multipack Group ............................................................................................................................... 6-14

xii Spectra Optia Apheresis System Service Manual

7: SpecificationsSpecifications ...................................................................................................................................................... 7-2

Glossary

Index

Spectra Optia Apheresis System Service Manual xiii

xiv Spectra Optia Apheresis System Service Manual

PrefaceThe Spectra Optia Therapeutic Apheresis System Service Manual provides the information neededto service and troubleshoot the system.

Spectra Optia Apheresis System Service Manual 15

Who Should Read This ManualThis manual is intended for CaridianBCT service technicians and employees, trained and qualifiedcustomer technical staff, and CaridianBCT service partners.

How to Use This ManualThis manual is divided into sections that can be read and used separately.

Title Description

OperationalDescription

Describes the operating principles of the machine. Includes information about systemcomponents, operator controls, disposables, and procedures.

System Description Describes the functional and electronic principles of the machine

Software Description Describes the software that the machine uses to operate.

Troubleshooting Describes non-alarm and alarm troubleshooting. Provides alarm text and alarminformation.

Maintenance andCalibration

Describes maintenance and service procedures for the machine.

Spare Parts Describes the spare parts available for the machine.

Preface

16 Spectra Optia Apheresis System Service Manual

1Operational Description

Spectra Optia Apheresis System Service Manual 1-1

Operational DescriptionThe Spectra Optia Apheresis System is a transportable, automatic blood component separator thatuses centrifugation and optical detection (automated interface management or AIM) to performexchange and collection procedures.

The apheresis system operator uses the Spectra Optia system’s touch screen to communicate with thesystem. The operator follows the instructions on the screens to enter patient and procedure data,load and prime the disposable tubing set, and perform and troubleshoot procedures. During theprocedure, the system displays detailed procedural information, enabling the operator to adjustvalues to achieve a specific outcome or troubleshoot a condition. After the procedure, the systemprovides a summary of procedure data for the patient record. The operator may copy the data fromthe screen, or print the data if the system is connected to a printer or a computer.

Operational Description

1-2 Spectra Optia Apheresis System Service Manual

System ComponentsThe Spectra Optia system components include the video display, front panel, centrifuge chamber,and electronics compartment.

Figure 1-1: Spectra Optia system, front and back views

Table 1-1: Spectra Optia System Components

Component Function

1 Monitor with touch screen Allows you to communicate with the system.

2 Dual IV pole Contains hooks for hanging bags and containers. Adjusts up anddown for transport.

3 Front panel Holds the pumps, valves, sensors and detectors.

4 Seal Safe system Seals the lines of the tubing set.

5 Cassette tray Holds the tubing set cassette in place.

System Components


Table 1-1: Spectra Optia System Components (continued)

Component Function

6 Power switch Allows you to turn power to the system on and off.

7 View port Allows you to look through the centrifuge door to see the interfacein the channel.

8 Centrifuge door Allows access to the centrifuge chamber.

9 Wheel pedal Allows you to adjust the direction of the wheels for moving thesystem, or lock the wheels in place so that the system does not roll.

10 Wheels Used to transport the system.

11 Handle wheels (2) Facilitates transport of the system in a horizontal position.

12 System serial number Unique number that identifies the system.

13 IV pole release button Allows you to lower the IV pole by pressing the button.

14 Power cord Connects the system to a power source.

15 Power cord holder Secures the power cord during transport.

16 Ethernet connection Allows you to connect the system to a printer or a computer to printa procedure report.

17 Blood warmer bracket (notshown)

Holds the blood warmer, if used.



Modes of Operation and Procedure StatesThe Spectra Optia system has three modes of operation: Automatic mode, Semi-Automatic andService mode. In Automatic mode, the AIM system controls the interface. While in Semi-Automaticmode, AIM system control of the interface is disabled. There are nine procedure states that performmany individual steps to complete a procedure.

Automatic ModeDuring Automatic mode, the system uses configured parameters and entered data to set and controlthe pump flow rates, centrifuge speed, packing factor, run targets, and establish the interface. Foroptimal separation in the channel, the target packing factor is 20. The system then uses feedback itreceives from the AIM system to control the interface, so it can collect a specific blood componentand return the rest to the patient.

Semi-Automatic ModeDuring Semi-Automatic mode, the operator monitors the interface and adjusts it, as needed. Thesystem displays the interface on the screen, but does not control it. When certain alarm conditionsoccur, you may be required to disable the AIM system before you continue the procedure in Semi-Automatic mode. Under those conditions, the interface position does not appear on the screen andyou must use the viewport to see the interface.

Service ModeService mode allows technicians to connect to the Spectra Optia system using service software fortroubleshooting and maintenance.

Procedure StatesThe procedure states listed in the following table describe system activity from the perspective of theoperator. For specific information on the software states, see the Software Description section of thismanual.

Table 1-2: Procedure States

State Description

Load Operator selects the procedure and loads theappropriate tubing set.

Tubing set test System verifies that the correct tubing set is loadedproperly, and confirms the function of the pumps,valves, and sensors.

Prime System primes the tubing set to remove air from theset, and performs volumetric tests.

Modes of Operation and Procedure States


Table 1-2: Procedure States (continued)

State Description

Run Patient is connected, and the system performsapheresis, according to the selected procedure.

Rinseback System returns the blood remaining in the tubing set tothe patient after the run is complete to reduce thepatient’s RBC loss. Operator may choose to perform orskip rinseback.

Disconnect test System verifies that the lines to the patient are clampedbefore it raises the cassette.

Unload System raises the cassette and unloads the pumps.

Procedure summary System displays the final procedure values.

Next procedure System prepares for the next procedure.



User InterfaceThe Spectra Optia system’s user interface allows you to perform, adjust, and monitor procedures.

Navigating the Screen

Figure 1-2: Example screen

Table 1-3: User Interface elements

Section Description

1 Menu bar Contains menu buttons that you touch to show or hide menu tabs.

2 Menu tabs Appear according to the menu button that you touch. Tabs provideaccess to screens that allow you to view information or modify theprocedure.

User Interface


Table 1-3: User Interface elements (continued)

Section Description

3 Message bar Displays information about what is currently occurring, andoccasionally displays instructions.

4 Activity area Displays tasks to complete, buttons that allow you to

• Navigate to another screen

• Change procedure conditions

• Change values or information about the procedure.

5 Action bar Contains buttons that you touch to perform the action stated on thebutton, or to navigate to a different screen.

Screen ColorsThe Spectra Optia system uses a color scheme to indicate the different states and conditions of theprocedure, allowing you to quickly determine the progress of the procedure.

Table 1-4: Corresponding color schemes for operating states and conditions

State or Condition Color

Load, prepare procedure, tubing set test, prime (patientnot connected)

Run, rinseback, disconnect test (patient connected)

Unload, procedure summary, next procedure (patientdisconnected)

Caution

Screen ButtonsTable 1-5: Active and Inactive Buttons

Active button Active buttons are colored andappear raised. Touch an activebutton to enter, change, or savedata, or to proceed to the nextactivity or action.

Inactive button Inactive buttons are gray. Theyrepresent an action or informationthat is not available.



The buttons and icons described in the following table appear on the monitor or the screens, andeither allow you to operate and adjust the Spectra Optia system during an apheresis procedure, orcommunicate important information.

Table 1-6: Button and Icons

Graphic Description Location Function

Go back button Bottom right side of thescreen

Returns you to theprevious screen. Availableonly when it is safe toreturn to the previousscreen. You must confirmany data you changedbefore touching the goback button or the datawill not be saved.

Mute button Bottom left side of thescreen

Allows you to mute thesound during an alarmcondition. The sound isrestored if another alarmoccurs.

Pause button Bottom right corner of themonitor

Pauses the pumps.

Stop button Bottom left corner of themonitor

Stops the centrifuge andthe pumps.

Active alarm button Bottom left side of thescreen Indicates an activealarm.

Takes you to the activealarm screen, or to a listof active alarms if morethan one has occurred.

Clock button Run and the exchangestatus screens

Allows you to view clocktime or elapsed time forthe procedure.

Up/down arrow button Main run screen Allows you to adjust theposition of the interfaceduring Semi- Automaticmode.

User Interface


Table 1-6: Button and Icons (continued)

Graphic Description Location Function

Left/right arrow button Strobe screen Adjusts the timing of thestrobe. Allow you to viewdifferent areas of thechannel.

Up/down scroll button Active alarm, alarmhistory, and reportscreens

Allows you to viewadditional information onthe screen.

Left/right scroll button Alarm action screens Allows you to scrollthrough the differentalarm action screens, soyou do not have to returnto the main alarm screento troubleshoot an alarm.

Check mark icon Buttons on the prepareprocedure screens

Indicates completion of arequired task, or confirmsa selection.

Do not connect patienticon

Bottom right side of thescreens

Safety feature thatreminds you that thepatient should not beconnected during thecurrent operating state.

Operator override icon Total Blood Volumebutton on the data entryscreen

Indicates that the operatorentered the patient’s totalblood volume whennecessary, or instead ofusing the volume that thesystem calculated.

Semi-Automatic modeicon

Bottom right side of therun screens

Indicates that the systemis operating in Semi-Automatic mode.



Exchange Disposable Tubing SetThe Exchange disposable tubing set is used for therapeutic exchange procedures.

Table 1-7: Exchange Set Catalog and Set ID Numbers

Catalog Number Set ID

10200 • 0020 (4 L remove bag)

• 0120 (6 L remove bag)

10220 0122

Note: The 10200 Exchange set can only be used with TPE procedures. The 10220 Exchange set can be usedwith both TPE and RBCX procedures.

Figure 1-3: The Exchange set (10200)

Exchange Disposable Tubing Set


Figure 1-4: The Exchange set (10220)

Table 1-8: Exchange Set Components

Component Function

1 Inlet line Carries anticoagulated blood from the patient to the channel. Theinlet luer (male) connects to the patient inlet site. The inlet lineclamp (red) is used to clamp the inlet line.

2 Inlet line manifold Consists of an injection site and connections for the inlet line,anticoagulant line, and inlet saline line.

3 Inlet saline clamp (red) Used to close the inlet saline line or control the flow of saline to thepatient.

4 Flow restrictor Allows AC to be pumped through the tubing but prevents the freeflow of AC.

5 Return line Carries blood components from the reservoir to the patient. Theluer (male) connects to the patient return access.



Table 1-8: Exchange Set Components (continued)

Component Function

6 Return line manifold Consists of an injection site and connections for the return line andreturn saline line.

7 Return saline clamp (blue) Used to close the inlet saline line or control the flow of saline to thepatient.

8 Anticoagulant (AC) line (orange) Carries AC to the inlet manifold. The spike (orange) is used to spikethe AC container.

9 Saline line (green) Line that carries saline to the inlet manifold and return manifold fordelivery to the patient. The spike (green) is used to spike the salinecontainer.

10 Inlet line trap Prevents large, solid cellular matter from entering the channel.

11 Inlet pressure sensor Diaphragm that attaches to the inlet pressure sensor on the frontpanel to monitor the pressure to the patient.

12 Centrifuge pressure sensor Diaphragm that attaches to the centrifuge pressure sensor on thefront panel to monitor centrifuge pressure.

13 Reservoir Contains the fluid that is returned to the patient. Includes a 200-micron filter.

14 Return pressure sensor Diaphragm that attaches to the return pressure sensor on the frontpanel to monitor return pressure to the patient.

15 Centrifuge loop Four-lumen tubing that carries fluids in and out of the channel. Thesleeves reinforce the tubing at flex points. The collars fix the twoends of the loop to the centrifuge. The bearings are the contactpoints between the centrifuge arm and the loop.

16 Channel Used during centrifugation to separate cellular components fromplasma.

17 Connector Holds the lines where the separated components exit the channel.

18 Vent bag Holds air displaced from the system.

19 Remove bag Holds removed blood components.

Exchange Disposable Tubing Set


Table 1-8: Exchange Set Components (continued)

Component Function

20 Remove line Carries the removed blood components to the remove bag.

21 Extra remove line Provides a connection (female luer) for an extra remove bag. Theclamp (yellow) is used to clamp the extra remove line.

22 Replace line Carries the replacement fluid from the containers to the reservoir.The spikes (white) are used to spike the replacement fluidcontainer. The clamps (white) are used to clamp the replacementline. The luer (male/female) allows connection of a filter or bloodwarmer tubing.



Collection Disposable Tubing Set

Figure 1-5: The Collection set

Catalog number: 10110. Set ID number: 0011.

Table 1-9: Collection Set Components

Component Function

1 Inlet line Inlet line: Used to carry anticoagulated blood from the patient to thechannel. Also includes:

• Luer connector (male): Connects the inlet line to the needle line.

• Inlet line clamp (red): Used to clamp the inlet line.

• Clamp (white): Used to clamp the needle line.

2 Diversion bag Used to capture a skin plug after performing a peripheralvenipuncture, or to collect a blood sample. Also includes:

• Clamp (yellow): Used to clamp the line to the diversion bag.

Collection Disposable Tubing Set


Table 1-9: Collection Set Components (continued)

Component Function

3 Inlet line manifold Provides a connection point for the inlet line, the AC line, and theinlet saline line. Includes an injection site.

4 Inlet saline line clamp (red) Used to close the inlet saline line or to control the flow of saline tothe patient.

5 AC check valve Allows the system to pump AC through the tubing, but prevents thefree flow of AC.

6 Return line Used to carry fluid from the reservoir to the patient. Also includes:

• Luer connector (male): Connects the return line to the patientreturn access.

• Return line clamp (blue): Used to clamp the return line.

7 Return line manifold Provides a connection point for the return line and the return salineline. Includes an injection site.

8 Return saline line clamp (blue) Used to close the return saline line or to control the flow of saline tothe patient.

9 Anticoagulant (AC) line (orange) Used to carry AC from the AC container to the inlet line manifold.Also includes:

• Spike (orange): Used to spike the AC container.

• Sterile barrier filter (0.2 microns): Prevents bacteria fromentering the system to maintain a functionally closed system.

10 Saline line (green) Used to carry saline from the saline container to the inlet linemanifold and the return line manifold. Also includes:

• Spike (green): Used to spike the saline container.

• Sterile barrier filter (0.2 microns): Prevents bacteria fromentering the system to maintain a functionally closed system.

11 Inlet line trap Prevents larger solid cellular matter from entering the channel.

12 Inlet pressure sensordiaphragm

Attaches to the inlet pressure sensor on the front panel to monitorpressure in the inlet line.

13 Centrifuge pressure sensordiaphragm

Attaches to the centrifuge pressure sensor on the front panel tomonitor pressure in the

Documents

Spectra Optia Service Manual - English, EN...Spectra Optia Apheresis System Service Manual v Fan 3 failed. ..... 4-180 Fan 3 Fluid balance change caused fluid balance to exceed limits