CaridianBCT Spectra Optia User manual

Spectra Optia®
APHERESIS SYSTEM
SERVICE MANUAL

Spectra Optia®Apheresis System
Service Manual
Part No. 777401-042
2011-01

©2011CaridianBCT, Inc.
CaridianBCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215
USA
USA Phone: [phone]
Phone: [phone]
USA Fax: [phone]
Fax: [phone]
CaridianBCT Europe N.V.
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: [phone]
Fax: [phone]
www.caridianbct.com

Contents
Preface ................................................................................................................. 15
1: Operational Description
Operational 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 Description
System 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 Description
Software 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: Troubleshooting
Non-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
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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
Fan 2 malfunctioned. ............................................................................................................................. 4-178
Spectra Optia Apheresis System Service Manual v

Fan 3 failed. ........................................................................................................................................... 4-180
Fan 3 malfunctioned. ............................................................................................................................. 4-182
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