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cobas b 221 system
Roche cobas b 221 system User Manual
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CO
B
A
S, COBAS B and L
I
F
E
NEE
D
S
A
N
SW
ER
S
are trademarks of Roche.
©2009 Roche Diagnostics
Roche Diagnostics GmbH
D-6829
8 Mannheim
Germany
www.roche.com
1
3
Table of Contents
Safety Information
13
Table of Contents
13
Important Information
15
Operating Safety Information
16
Important Notes and Warnings
16
Disinfectants
17
Deproteinizer
17
Other Disinfectants
17
ESD Protection Measures
18
Explanation of the Phenomenon
18
Influence of Electrostatic Charges on Components
18
Why Is ESD Protection so Important Today
19
How Can ESD Protection be Guaranteed
19
Conclusion
19
Fluid Actions
21
Cobas B 221<1> System
23
Fluid Actions Overview
23
Cobas B 221<2> System
24
Cobas B 221<3> System
25
Cobas B 221<4> System
26
Cobas B 221<5> System
27
Cobas B 221<6> System
28
Pin Assignment of S2 and S3 Fluid Packs
29
S2 Fluid Pack
29
S3 Fluid Pack a (Cobas B 221<5/6> Systems Only)
29
T&D Positions
30
Measurement
31
Sample Input
31
Sample Distribution
33
Aspirating MSS Standby Solution and Starting FMS
35
Washing the Measuring Chamber Vicinity
37
Washing Thb/So or COOX and Preparing Mix1
38
Recalibrating BG/ISE and Drying Thb/So or COOX
39
BG/ISE Cleaning
41
Calibration
41
Calibrating the Conductivity for CAL a or CAL B
42
O 2 Zero Point Calibration
44
Na Conditioning
45
Mix1/Mix2 Calibration, Aspirating BG/ISE Reference Solution
46
O2-Air Calibration
48
Aspirating MSS Reference Solution, Calibration with Standby Solution
49
CAL 1 Calibration
51
Protected Software Functions
57
Baro Settings
59
Protected Setup
59
Sample Counter
59
Instrument Type
60
Miscellaneous Settings
60
Serial Number
60
Autoqc Module
64
COOX Module (Cobas B 221<2/4/6> Systems Only)
64
Polarization Voltages
64
Log Monitor
65
Protected System Functions
65
System Backup / Restore
65
AQC Adjustment
66
Protected Infos
66
Service Log File Export
66
Delete All Databases
67
Delete Databases & Archives
67
Protected DB Functions
67
Components
69
Important Notes
73
Shutdown
73
The Cobas B 221 System Remains Switched off for more than 24 Hours
73
Folding up the Central Measuring Unit
74
Removing the Rear Panel
74
Replacing the T&D Module
75
T&D System (Turn & Dock)
75
Replacing the Fill Port
77
Replacing the Fill Port Holder
77
Replacing the Needle
77
Replacing the Bypass Nipple
78
Replacing the Sample Inlet Path
78
Replacing the Optical Sensor SS6
79
Replacing the T&D Disk
80
Replacing the T&D Sensor Cover
80
Replacing the T&D Tubing Set
81
Replacing the Plug Control
82
Replacing the Stepper Motor
84
Replacing the T&D Actuator Board
84
Replacing the T&D Linear Actuators
86
Fluid Mixing System (FMS)
87
Replacing the FMS
87
Replacing the FMS Control Board
89
Replacing the FMS Tubing Set
89
Replacing the Sample Distributor Cartridge
89
Sample Distributor (SD)
89
Replacing the Sample Distributor
91
Replacing the SS1, SS2, SS3 and SS4 Optical Sensors
93
BG Measuring Chamber
94
Replacing the BG Measuring Chamber
94
Replacing the Fan Protector (BG Module)
95
ISE Measuring Chamber (Cobas B 221<3>-<6> Systems Only)
96
Replacing the Center Seal (BG Module)
96
Replacing the Electrode Locking Lever (BG Module)
96
Replacing the ISE Measuring Chamber
96
Replacing the Center Seal (ISE Module)
97
Replacing the Electrode Locking Lever (ISE Module)
97
Replacing the Fan Protector (ISE Module)
97
MSS Measuring Chamber (Cobas B 221<5/6> Systems Only)
98
Replacing the MSS Measuring Chamber
98
Replacing the MSS MC Cover
99
Replacing the Electrode Locking Lever (MSS Module)
100
Replacing the Fan Protector (MSS Module)
100
Replacing the MSS Clip
100
Replacing the Center Seal (MSS Module)
101
Replacing the MSS Measuring Chamber Amplifier
101
Measuring Chamber Cartridge
102
Replacing the Measuring Chamber Cartridge
102
Replacing the MC Actor Control Board
104
COOX Module (Cobas B 221<2/4/6> Systems Only)
105
Overview
105
Replacing the Lamp Unit Bilirubin
105
Replacing the Polyox-KX Control Board
107
Replacing the Polychromator Bilirubin
108
Replacing the Primary Light Guide
110
Replacing the Cuvette Holder
112
Replacing the Cuvette
113
Replacing the Cuvette Seals
113
Replacing the Tubing Set Thb/Polyox
113
Replacing the Hemolyzer
114
Replacing the Hemolyzer Tube
115
Replacing the HSIN Board
115
Replacing the Thb/So 2 Module
116
Thb/So 2 Module (Cobas B 221<1/3/5> Systems Only)
116
Replacing the Hb Cartridge
117
Replacing the Thb/So Heating Unit
117
Replacing the Tubing Set Thb/Polyox
117
Peristaltic Pumps (PP)
118
Replacing a Peristaltic Pump
118
Replacing the Pump Head
120
Bottle Compartment
121
Replacing the Bottle Compartment Cover
121
Replacing the Pump Tube
121
Replacing the Gas Dampers
122
Replacing the Waste Separator
122
Replacing the Waste Docking Mechanism
123
Replacing the Docking Mechanism S1 (Rinse Solution)
124
Replacing the Docking Mechanisms S2 and S3 (Fluid Packs)
124
Replacing the Clamp Docking Mechanism
125
Replacing the Micro Switch Module
125
Replacing the Bacteria Filter
126
Replacing the Transponder Control (Waste, S1, S2, S3)
126
Replacing the Vacuum Pump Completely
127
Vacuum System
127
Replacing the Vacuum Pump
130
Replacing the Moisture Trap
131
Replacing the Waste Tube
131
Replacing the Vacuum Pump Protector
132
Replacing the VP Tube Set
132
Replacing the Actuator Board V4/V6
134
Replacing the Vacuum Control Board
134
Replacing the Valves of the Measuring Chamber Cartridge
135
Valves
135
Replacing the Valves from Sample Distributor Cartridge and Hb Cartridge
137
Replacing the Waste Valve V6
140
Replacing the Air Valve V4
142
Replacing the FMS Valve (MIX)
142
Mainboard Unit
143
Replacing the Mainboard Unit
143
Compatibility Chart
145
Interface Unit
145
Replacing the Sample Sensor Board
145
Replacing the Interface Unit
146
Replacing the Autoqc/Coox Cable
148
Compatibility Chart
149
Replacing the Touch Screen/Pc Unit
149
Touch Screen/Pc Unit
149
Replacing the Hard Disk
153
Replacing the Floppy Disk Drive
155
Replacing the Battery and Charger
156
Replacing the Screen Cable
157
Software Update
158
Printer
162
Replacing the Printer
162
Replacing the Paper Lid
163
Replacing the Printer-Cutter Lid
163
Replacing the Winder Unit
163
Fan Unit
164
Replacing the Main Fan Unit
164
Replacing the Valve Bus Cable
164
Replacing the Actuator Bus Main Controller Cable
166
Barcode Scanner
167
General
167
Autoqc Module
171
Autoqc Preparation for Maintenance
173
Initial Installation of the Autoqc Module
173
Replacing the Autoqc Module
174
Replacing the AQC Snap Lock
176
Replacing the AQC Magnetic Valve
177
Replacing the AQC Board
178
Replacing the YZ Distributor Board
179
Replacing the Z Distributor Board
180
Replacing the Flex Cable (Short)
181
Replacing the Flex Cable (Long)
182
AQC Sample Tube
183
Replacing the AQC Sample Tube Complete
183
Replacing the AQC Sample Tube Long
184
Replacing the AQC Sample Tube Short
184
Replacing the X Motor
185
Replacing the y Motor
186
Replacing the Z Motor
186
Replacing the Autoqc Steel Tube
187
Replacing the AQC Temperature Sensor
188
Replacing the Wash Port
189
Replacing the Toothed Belt (Short)
190
Replacing the Toothed Belt (Long)
191
Maintenance
195
Decontamination
197
Surfaces
197
Barcode Scanner
198
Input Unit
198
Modules and Tubing Paths
198
Screen
198
Cleaning of the Measuring Chambers BG, ISE and MSS
201
Cobas B 221<1/3/5> Systems (Thb/So 2 )
202
Yearly Replacement
202
Replace Every Three Years
203
Cobas B 221<2/4/6> Systems (COOX)
204
Yearly Replacement
204
Replace Every Three Years
205
Autoqc Module
206
Yearly Replacement
206
Troubleshooting
209
General Information
217
Hard Disk Information
217
Important Notes
217
MSS Information
217
Cobas Bge Link Screen Sharing
218
Fill Level Determination
218
Emergency Routine
219
Error 10001 "Flap W
219
Error 10002 "Out of Operation
219
Error 10003 "Warmup
219
Error 10004 "Economy Mode
219
System Stops
219
Error 10005 "Comm. Error PC-ΜC
220
Error 10006 "Download Error
220
Error 10008 "No Waste Container
220
Error 10009 "Current Overload Actor Bus
220
Error 10010 "Current Overload Valve Bus
221
Error 10011 "Database Not Ready
221
Error 10012 "ΜC Memory Overrun
221
Error 10016 "Bottle Compartment Cover Open
221
Error 10017 "Bypass Wash Error 1
221
Error 10018 "SD Wash Error 1
222
Error 10019 "Waste Container Full
222
Error 10020 "Rinse Bottle Empty
222
Error 10021 "Flap S1
222
Error 10022 "ΜC Reset
222
Error 10023 "Power Fail
222
Error 10024 "No Wash-Water Container
222
Error 10025 "Check Date and Time
223
Error 10026 "Bypass Wash Error 2
223
Error 10027 "SD Wash Error 2
223
Error 10028 "S1 on Board Time Expired
223
Error 10029 "S1 Expired
223
Error 10032 "Microcontroller Communications Error
224
Error 10033 "COOX Communications Error
224
Error 10034 "AQC Communications Error
224
Error 10039 "Vacuum Reduction Not Ok
224
Error 10040 "Vacuum Error
224
Error 10041 "Waste Error 1
225
Error 10042 "Waste Error 2
225
Error 10043 "Separator Sens. Error
225
Error 10044 "Separator Error
225
Error 10045 "Check Waste Fill Level
225
Error 10046 "Waste Line Blocked
226
Error 10047 "VPS Error
226
Error 10048 "Error SS1
226
Error 10049 "Error SS2
227
Error 10050 "Error SS3
227
Error 10051 "Error SS4
228
Error 10052 "Error SS6
228
Error 10054 "Baro Sensor Error
229
Error 10088 "ADC Error
229
Errors 10056
229
Errors 10089
229
Error 10098 "Timing Error COOX Measurement
230
Errors 10095
230
Errors 10099
230
Error 10106 "Timing Error
231
Error 10107 "Timing Error
231
Errors 10108
231
Errors 10113
231
Errors 10118
232
Errors 10120
232
Errors 10123
232
Error 10127 "Timing Error MSS
233
Error 10128 "Timing Error
233
Error 10130 "Timing Error COOX
233
Error 10152 "Measuring Chamber Cover BG Open
233
Error 10153 "Measuring Chamber Cover ISE Open
234
Error 10154 "Measuring Chamber Cover MSS Open
234
Error 10155 "AQC Drawer Open
234
Error 10288 "Program Error
234
Errors 10160
234
Error 10301 "Program Error
235
Error 10302 "Program Error
235
Errors 10291
235
Errors 10299, 10300 "Program Error
235
Errors 10303
235
Error 10340 "Program Error
236
Error 10343 "Program Error
236
Error 10346 "Program Error
236
Errors 10318
236
Errors 10341, 10342 "Program Error
236
Error 10347 "Program Error
237
Error 10348 "Program Error
237
Error 10349 "Program Error
237
Error 10350 "Program Error
237
Error 10351 "Program Error
237
Error 10352 "Program Error
238
Error 10389 "Program Error
238
Errors 10353, 10388 "Program Error
238
Errors 10416
238
Errors 10424
238
Error 10427 "Hardware Error
239
Error 10430 "Hardware Error
239
Error 10431 "Hardware Error
239
Error 10433 "Hardware Error
239
Error 10434 "Hardware Error
239
Error 10435 "Hardware Error
239
Errors 10428, 10429 "Hardware Error
239
Error 10436 "Hardware Error
240
Error 10437 "Hardware Error
240
Error 10438 "Hardware Error
240
Error 10439 "Hardware Error
240
Error 10440 "Hardware Error
240
Error 10443 "Hardware Error
240
Errors 10441, 10442 "Hardware Error
240
Error 10444 "Hardware Error
241
Error 10468 "EEPROM Error
241
Error 10469 "Vacuum ADC Error
241
Errors 10445
241
Errors 10449
241
Errors 10456
241
Error 10470 "Transponder Error
242
Error 10471 "T&D Error
242
Error 10472 "Transponder Error S1
242
Error 10488 "HW Test Error
242
Error 20000 "SD Temp. Nok
243
Message 10489 "Remote Lock
243
Message 10491 "QC Setup Wizard Active
243
Message 10492 "Data Transfer Active
243
Module Stops
243
Error 20016 "FMS Volume Error
244
Error 20017 "FMS Error
244
Error 20018 "Pack S2 Empty
245
Error 20019 "Flap S2
245
Error 20020 "No Pack S2
245
Error 20021 "ADC Error Cond BG/ISE
246
Error 20022 "Transponder Error S2
246
Error 20023 "S2 on Board Time Expired
246
Error 20024 "HW Test Error FMS
246
Errors 20032
246
Error 20035 "BG Temperature Nok
247
Error 20037 "ADC Error BG
247
Error 20038 "HW Test Error BG
247
Error 20051 "ISE Temperature Nok
248
Error 20053 "ADC Error ISE
248
Errors 20048
248
Error 20054 "HW Test Error ISE
249
Error 20065 "COOX Lamp Error
249
Error 20066 "COOX Lamp Error
249
Error 20067 "COOX Lamp Error
249
Error 20068 "COOX HW Error
249
Error 20069 "COOX HW Error
250
Error 20071 "COOX HW Error
250
Error 20072 "COOX Temperature Nok
250
Error 20073 "HW Test Error Hemolyzer
250
Error 20080 "PP Error
251
Error 20081 "MSS Pol. Running
251
Error 20082 "MSS Pol. Not Ok
251
Error 20083 "MSS Pol. Not Ok
252
Error 20084 "HW Test Error MSS
252
Error 20085 "Pack S3 Empty
252
Error 20086 "Flap S3
252
Errors 20087
252
Error 20091 "No Pack S3
253
Error 20092 "ADC Error MSS
253
Error 20093 "ADC Error MSS
253
Error 20094 "Transponder Error S3
253
Error 20095 "S3 on Board Time Expired
254
Error 20097 "ADC Error Thb
254
Error 20112 "SS5 Error
255
Error 20113 "Module Error AQC
255
Error 20114 "Module Error AQC
255
Error 20120 "AQC Wash Error
256
Errors 20115
256
Errors 20122
256
Error 20142 "AQC Temperature Nok
257
System Warnings
257
Warning 30005 "Cl Electrode Is Contaminated (Defective)
257
Warning 30008 "Pack S2 Level Is Low
257
Warning 30009 "Pack S3 Level Is Low
257
Warning 30010 "Rinse Level Is Low
258
Warning 30011 "Waste Is Nearly Full
258
Warning 30012 "Prep. of Rinse Not Ok
258
Warning 30013 "Prep. of CAL B Not Ok
258
Warning 30014 "Prep. of CAL a Not Ok
259
Warning 30015 "Prep. of Ref. BG Not Ok
259
Warning 30016 "Prep. of Ref. ISE Not Ok
259
Warning 30017 "Prep. of O2 Zero Not Ok
260
Warning 30018 "Prep. of Na Cond. Not Ok
260
Warning 30019 "Prep. of Clean. Sol. Not Ok
260
Warning 30020 "Prep. of Standby Not Ok
261
Warning 30021 "Prep. of Ref. MSS Not Ok
261
Warning 30022 "Prep. of CAL 1 Not Ok
261
Warning 30028 "Check AQC Material
262
Warning 30029 "Check Parameter Status
262
Warning 30030 "Perform Man. QC Measurement
262
Warnings 30023
262
Warning 30031 "Perform Maintenance
263
Warning 30032 "Printer - Lever Open
263
Warning 30033 "Printer - Paper Empty
263
Warning 30034 "HW Test Error Fan
263
Check Hct Result
264
Flag No. 1000 "Sample Pos. Error (1)
264
Flag No. 1001 "Sample Pos. Error (2)
264
Value Flags
264
Warning 30037 "Screen Sharing Active
264
Flag No. 1002 "Sample Sep. Error (1)
265
Flag No. 1003 "Ref. Sol. Asp. Error
265
Flag No. 1004 "Ref. Sol. Pos. Error
265
Flag No. 1005 "End of Sample Detected
266
Flag No. 1006 "Irregular Sample (1)
266
Flag No. 1007 "Cuvette Not Empty
266
Flag No. 1008 "Irregular Sample (2)
267
Flag No. 1009 "Sample Pos. Error (3)
267
Flag No. 1010 "Sample Pos. Error (4)
268
Flag No. 1011 "Sample Pos. Error (5)
268
Flag No. 1012 "Sample Pos. Error (6)
269
Flag No. 1013 "Sample Sep. Error (2)
269
Flag No. 1014 "Sample Pos. Error (7)
269
Flag No. 1015 "Sample Pos. Error (8)
270
Flag No. 1016 "Sample Pos. Error (9)
270
Flag No. 1017 "Sample Pos. Error (10)
270
Flag No. 1020 "Sample Distr. Error (1)
271
Flag No. 1021 "Sample Distr. Error (2)
271
Flag No. 1022 "Sample Distr. Error (3)
271
Flag No. 1023 "Sample Distr. Error (4)
272
Flag No. 1025 "No Sample Detected (2)
272
Flag No. 1026 "No Sample Detected (3)
272
Flag No. 1027 "No Sample Detected (4)
272
Flag No. 1028 "Insufficient Sample (1)
273
Flag No. 1029 "Insufficient Sample (2)
273
Flag No. 1030 "Insufficient Sample (3)
273
Flag No. 1031 "Insufficient Sample (4)
273
Flag No. 1032 "Sample Distr. Error (5)
274
Flag No. 1036 "Insufficient Sample (5)
274
Flag No. 1037 "No Sample Detected (8)
274
Flag No. 1038 "No Sample Detected (9)
275
Flag No. 1050 "No Sample in SIP
275
Flag No. 1051 "No AQC Sample Detected
276
Flag No. 1052 "No Vacuum
276
Flag No. 2004 "Repro. Not Ok
276
Flag No. 2009 "Recal. Not OK
277
Flag No. 2011 "Sensor Signal Instable
277
Flag No. 2012 "Sensor Signal Is Drifting
278
Flag No. 2016 "Signal too High
278
Flag No. 2021 "Drift Alarm
279
Flag No. 2022 "Ref. Drift Alarm
279
Flag No. 2023 "1 Point Sensitivity Drifts
280
Flag No. 2024 "Air Bubble Detected
280
Flag No. 2028 "Mean Not OK
280
Flag No. 2029 "ADC
281
Flag No. 2030 "ADC
281
Flag No. 2031 "Conditioning Not Ok
281
Flag No. 2035 "Linearity Not OK
282
Flag No. 2036 "Interference Sensitivity
282
Flag No. 2040 "Cuvette Not OK
282
Flag No. 2041 "Ref. Point Not OK
282
Flag No. 2042 "Wavelength Not OK
283
Flag No. 2043 "Hemolysis Not OK (1)
283
Flag No. 2044 "Hemolysis Not OK (2)
283
Flag No. 2070 "Sensor Signal Unstable
284
Flag No. 2071 "Measuring Path Dirty
284
Flag No. 3000 "D2/D3 Not Performed
284
Flag No. 3001 "FMS Volume Error
284
Flag No. 3002 "Temperature Error
285
Flag No. 3003 "FMS Error
285
Flag No. 3004 "AQC Module Error
285
Flag No. 3013 "Ref. Point D1 Not Ok
285
Flag No. 3014 "Ref. Point Not Ok
286
Flag No. 3015 "1P Not OK
286
Flag No. 3022 "Conductivity Not OK
286
Flag No. 3033 "0P Not OK
287
Flag No. 4003 "Calibration Pending (1)
287
Flag No. 4008 "Calibration Pending (2)
287
Flag No. 4024 "Calibration Pending (3)
287
Flag No. 5006 "Calculation Error (1)
287
Flag No. 5007 "Calculation Error (2)
288
Flag No. 6026 "ADC Error
288
Flags No. 5010
288
Flag No. 6030 "COOX HW Error
289
Flag No. 6031 "Neon Lamp Not OK
289
Flag No. 6032 "Halogen Lamp Not OK
289
Flag No. 7034 "Solution Exhausted
290
Flag No. 8036 "Ifs Not OK
290
Flag No. 8061 "Interferences (1)
290
Flag No. 8062 "Interferences (2)
291
Flag No. 8063 "Interferences (3)
291
Flag No. 8070 "Ifs Repro. Not OK
291
Flag No. 8071 "Ifs Calculation Error (1)
292
Flag No. 8072 "Ifs Calculation Error (2)
292
Flag No. 8073 "Ifs Sensor Signal Unstable
292
Flag No. 8074 "Ifs Ref. Point Not Ok
293
Flag No. 8075 "Ifs ADC Error
293
Flag No. 8076 "Ifs Mean Not OK
293
Flag No. 8077 "Ifs ADC
294
Flag No. 8078 "Ifs ADC
294
Flag No. 8080 "Interferences (4)
294
Flag No. 8081 "Interferences (5)
295
Flag No. 8082 "Interferences (6)
295
Flag No. 8083 "Sample Type Conflict
295
Flag No. 8084 "Invalid Sample Type
295
Flag No. 9000 "Calculation Error (3)
295
Flag No. 9001 "Not Activated
296
Flag No. 9002 "Not Calibrated
296
Flag No. 9003 "Measurement Running
296
Flag No. 9004 "Out of Range
296
Flag No. 9005 "Out of Range (+)
296
Flag No. 9006 "Thb Not OK
296
Flag No. 9008 "Missing Data
296
Flag No. 9009 "Measurement Aborted
296
Flag No. 9010 "System Stop Occured
296
Data Exported to Floppy Disk Instead of USB
297
Error Exporting Data
297
Touch Screen/Pc Unit Troubleshooting
297
USB Troubleshooting
297
Troubleshooting List
298
Contact Path Test
301
Important Test Routines
301
Aggregates
304
Control Sensors
307
Meas. Sensors
309
General Fluidics Test
314
Stability Monitor
326
General Hardware Test
333
Service Report
338
Sensor Limits (Sensor Report)
341
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Roche cobas b 221 system Specifications
General
Brand
Roche
Model
cobas b 221 system
Category
Medical Equipment
Language
English
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