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Roche Cedex Bio User Manual
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Roche Diagnostics
Operatorโ
s Manual ยท V
ers
ion 3.4
A-81
Cedex
Bio analyzer
4S
o
f
t
w
a
r
e
W
ork
ing with th
e user in
terface
Using online Help
The H
elp but
ton is a permanen
t feat
ure of all scr
e
ens.
A
The Help button is always in the top right corner of the screen.
Figure
A-44
Permanent Help button
A
90
92
Table of Contents
Safety
13
Operator's Manual ยท Version
7
Table of Contents
13
Safety Classification
15
Safety Information
15
Transport
15
Electrical Safety
15
Optical Safety
16
Mechanical Safety
16
Analyzer Covers
16
Operation and Maintenance
16
Biohazardous Materials
16
Waste
17
Reagents and Other Working Solutions
17
Installation
17
Environmental Conditions
17
Power Interruption
18
Electromagnetic Devices
18
Approved Parts
18
Third-Party Software
18
Operator Qualification
19
Operation over an Extended Period of Time
19
Cross Contamination of Sample
19
Insoluble Contaminants in Sample
19
Spillage
19
Data Security
20
Legal Liability
21
Disposal Recommendation
21
Disposal Label
21
Disposal of External Components
21
Disposal of the Analyzer
21
Constraint
21
Safety Labels on the Cedex Bio Analyzer
22
List of Safety Labels on the Cedex Bio Analyzer
22
Location of Safety Labels on the Cedex Bio Analyzer
23
Introduction to the Analyzer
25
Overview
27
Introduction to the Analyzer Overview
27
Principles of Operation
29
User Interface
30
Wizards
31
Daily Operation
32
Overview
32
Reagent and Diluent Handling
36
Calibration
38
Calibration Type
38
Calibration Sequence
39
Calibration Status of a Set
40
Calibration Result Storage
40
Validating Calibration Results
40
Calibration Procedures
40
Quality Control (QC
41
Sample Handling
42
Order Handling
43
Results
44
Maintenance
45
System Status
46
Hardware
47
Covers and Panels
49
Hardware
49
Leds and Color Indicators
51
Main Components
53
Hardware Overview
54
Sample Area
54
Fluid System
55
Probe and Syringe
56
Syringe Assembly
56
Rinse Station
57
External Fluid Connectors
57
Transfer Unit
58
Fluid Containers
60
Waste Containers
60
Water Container
61
Cleaner Bottle
62
Reagent Bottles
63
Tubes
63
Cuvettes
64
Cuvette Segments
65
Handling Cuvettes
65
Reagent Handling
66
Rotor
66
Reagent Disk
67
Reagent Disk Container
68
Reagent Cooler
68
Cuvette Ring
69
Barcode Scanner
69
Printer
71
Absorbance Photometer
72
Connectors
73
Fuses
74
Technical Specifications
75
Software
77
Introduction
79
Software
79
Software Introduction
79
Screen Layout
80
Display Items
81
Color Concept
82
Workflows and Wizards
82
Navigation
82
Working with the User Interface
83
Adjusting the Touchscreen
83
Scrolling
83
Expanding and Collapsing Lists
84
Typing Text
85
Using the Filter Function
88
Printing Information
90
Using Online Help
91
Messages
93
Message Screen
93
Alarm Monitor
94
Key Screens
96
Overview Tab
96
Sample Overview
98
Orders
99
Stat
102
Tests
102
Log off
105
Prepare
105
End Shift
105
Cuvette Status
105
Disk and Reagent Status
106
ISE Status
107
System Status
108
Workplace Tab
110
Orders
110
Result List
112
QC Status List
114
QC History
115
Calibrations List
117
Lot Data
118
Lot List
119
Loadlist
120
Worklist
121
Utilities Tab
122
Configuration
122
Maintenance
122
Applications Related Functions
125
Applications
125
Extra Wash Cycles
125
Host Codes
125
Reagent Mixing
125
Process Sequence
129
System Diagnostics
130
Inventory
131
Import
132
Users
133
Export
134
Stopping a Run
135
Color Interpretation for Leds and Global Action Buttons
136
Buttons
138
Daily Operation
143
Introduction
145
Safety Information
145
Daily Operation Introduction
145
Overview
147
Working with a Host System
150
Starting the Shift
151
Switching on the Analyzer
151
Preconditions
151
Logging on to the System
152
Preparing the System
153
Short Guide
154
Starting the Prepare Wizard
156
Checking the Status of the External Fluid Containers
157
Performing Maintenance Actions
161
Preparing the Reagent Disk
163
Preparing the Reagents
164
Checking the Status of Reagent Sets
165
Preparing Reagents
167
Preparing Cuvettes
170
Performing Reagent Mixing
172
Performing the Calibrations (Prepare Phase
173
Analyzing Samples
177
Safety Information
177
Short Guide
178
System Setup and Order Definition Workflow
180
Defining Orders
181
Defining Routine Orders
182
Defining STAT Orders
185
Making Changes to an Order
186
Starting the Run
188
Monitoring the Analysis Progress
189
Checking the Sample Tube Status
189
Checking the Analyzer Status Buttons
192
Checking for Alarm Messages
194
Acoustic Signal
194
Stopping and Restarting a Run
195
Removing Sample Tubes
196
Validating Sample Results
197
Repeating Tests
201
Rerunning Tests
202
Accepting Results
203
Printing Sample Results
204
Performing Calibrations
205
Safety Information
205
Short Guide
206
Process of Performing Calibrations
207
Deleting Ordered Calibrations
210
Validating Calibration Results
210
Performing QC
214
Safety Information
214
Short Guide
215
Performing Default QC
216
Performing Interval QC Measurements
217
Validating QC Results
218
Interpreting the QC History
221
Performing Reagent Mixing
223
Finishing the Shift
224
Safety Information
224
Short Guide
225
Checking for Unfinished Tasks
227
Checking for Unfinished Orders
227
Checking for Not Accepted Sample Results
228
Checking the Transmission of Results
229
Starting the End Shift Wizard
229
Performing the Daily Backup
230
Exporting the Result Data
231
Cleaning up the Database
232
Performing Maintenance Actions
233
Replacing Cuvettes
233
Dealing with the External Fluid Bottles
234
Emptying the Waste Container
234
Refilling the External Water Bottle
234
Removing the Reagent Disk
235
Logging off
236
Shutting down the System and Switching off the Analyzer
236
Using the Barcode Scanner
237
Reading Reagent Bottle Barcodes
237
Reading Barcodes from Sheets
238
Reading Sample Tube Barcodes
238
Special Operations
239
Deleting Sample Orders
241
Deleting Sample Results
242
Calibration
243
Deleting Calibration Results
243
Setting up Your Calibration Schedule
244
Deleting QC Results
244
Lot Handling
246
Viewing the Current Lot Definitions
246
Calibrator and QC Lots
246
Reagent Lots
247
Viewing the Lot Details of Fluids that Were Used
249
Adding a New Lot
250
Exporting Data
253
Exporting the Database
253
Exporting Results
254
Interpreting Result Data
255
Exporting Log Files
260
Importing Data
261
Importing Applications
261
Importing Software
263
Importing a Database
263
Importing Certificates
265
Importing Automatic Mixing and Extra Wash Cycle Definitions
265
Preparing a New Disk
266
Assigning Tests to Test Tabs
269
Deleting Bottle Sets from the Inventory List
270
Refilling Printer Paper
272
Removing Condensation Water from the Reagent Cooler
274
Replacing the Probe
275
Connecting and Disconnecting the External Fluid Containers
277
Adjusting the Touchscreen
280
Cleaning the Touchscreen
281
Configuration
283
Introduction
285
Viewing Values
285
Configuration Introduction
285
Changing Values
286
Applications
287
Installing Applications
287
Activating and Deactivating Applications
289
Preparing Applications
290
Uninstalling Applications
293
Deleting Applications
294
Defining the Processing Order
295
Defining Ratio Applications
296
Profiles
298
Defining Profiles
298
Adding Tests to a Profile
298
Removing Tests from a Profile
299
Deleting Profiles
299
Defining Control Definitions and Lots
299
Defining Calibrator Definitions and Lots
300
Short Guide to Application Definitions
302
Version
302
Code
302
General Application Definitions
302
Calibration Definitions
303
Control Definitions
304
Calculation Definitions
305
Calculation Definitions (Ratio Applications
305
Laboratory Correlations (Ratio Applications
306
Reference Range Definitions (Ratio Applications
306
Changing Your Password
307
Configuration
307
Scheduling Maintenance Actions
308
User Management
309
Defining a User
309
Deleting a User
310
User Levels and Access Rights
310
Editing the Acceptable Flags List
314
Mapping the Host Codes
314
Short Guide to Configuration Definitions
316
Workflow Definitions
316
Host Definitions
317
Result Handling
319
Calibration
319
System
320
Date and Time
321
Maintenance
321
Abs Adjustment
321
Defining Extra Wash Cycles
322
Activating, Deactivating and Deleting Extra Wash Cycles
323
Short Guide to Extra Wash Cycle Definitions
324
Extra Wash Cycle Definitions
324
Short Guide to Reagent Mixing Rules
325
Reagent Mixing Rule Definitions
325
Printing Mixing Rules
325
Deleting Mixing Rules
326
Data Analysis Methods
329
Photometric Measurements
331
Absorbance
332
Calculation of Absorbance
332
Cuvette Blank Correction
332
Volume Correction
332
Absorbance Checks
332
Rate
335
Calculation Model Endpoint
336
Calculation Model Kinetic
337
Reaction Direction
339
Antigen Excess Check
340
Test Range Check (Level Rate
342
Calculation of Mean Rate
342
Quantitative Calibration
343
Calibration Mode Linear Interpolation
343
Calibration Mode Linear Regression
344
Calibration Mode Logit/Log 4
345
Calibration Mode Logit/Log 5
346
Calibration Mode Exponential 5
347
Calibration Checks
347
Results
349
Quantitative Result Calculation
349
Corrections
351
Calculation of Replicate Mean
352
Result Calculation Checks
352
Laboratory Conversion
354
Quality Control
355
Quality Control Methods
355
Precision
355
Quality Control Checks
356
ISE Measurements
357
Test Principle
358
Nernst Equation
358
Calculation of Sol 1 Factor
358
Calibration
359
Slope Calculation (2-Point Calibration
359
Slope out of Range Check
359
Sol 1 Factor Check
360
Results
361
Calculation of Concentration
361
Calculation Checks
361
General Maintenance
365
Overview
367
Performing Maintenance Actions
368
Maintenance Actions and Their Intervals
369
Maintenance Actions
370
Safety Information
370
Deproteinize the Probe
372
Prime the Fluid System
373
Clean the Probe Manually
374
Clean Reagent Disk and Sample Area
376
Clean the Water and Waste Containers
378
Replace Water Inlet Filter
380
Clean and Disinfect Housing
382
Clean up the Database
383
Replace Photometer Lamp
384
Contact Service Representative
387
Perform an Air/Water Calibration
388
Initialize Degasser Fluid Sensor
389
Clean Rotor and Heating Channel
391
Recover the Database
396
Messages and Alarms
401
About Messages
403
Message Screen
403
Acoustic Signals
404
Alarm Monitor
405
Reacting to Alarm Messages
405
Printing Alarm Messages
406
Confirming Alarm Messages
407
Exporting the Alarm Message Log
407
List of Alarm Messages
408
Result Flags
421
About Flags
423
Safety
425
List of Flags
426
Ag Excess
426
Cal
427
Cal Error
427
Calc Error
427
Curv dir
428
Ep Unstab
428
High Abs
429
High Act
429
Kin Read
430
Low Act
430
Non Linear
431
Non Mono
431
Out of Rng
432
R 1(2.5S
432
R 1(3S
433
R 2(2S
433
Reag Rng
434
Repl Dev
434
Troubleshooting
437
Introduction
439
Troubleshooting Introduction
439
Dealing with Exceptional Situations
440
Reacting to Messages
442
Detailed Procedures
444
Checking the Printer Status
444
Clearing a Paper Jam
444
Changing the Mains Fuses
445
Changing the Low Voltage Fuses
447
Realigning the Reagent Disk
448
Exporting Diagnostics Screens to USB
449
Ise Description
453
ISE Description Overview
455
Overview
456
Measuring Modes
456
Principles of Operation
457
ISE Solutions
458
Hardware
459
Panels
459
Ise Led
460
Main Components
460
Fluid Containers
461
Basic Operation
462
Samples
462
Calibration
462
Maintenance Actions
463
Technical Specifications
463
Ise Operation
465
Daily Operation
467
Safety Information
471
Preparing the System
472
Short Guide
472
Starting the Prepare Wizard
473
Checking the Status of the External Fluid Containers
473
Checking the ISE Status
473
Performing Maintenance Actions
474
Completing the Preparation Tasks
475
Performing Calibrations
475
Defining Orders
475
Monitoring the Progress
476
Validating Sample Results
477
Main Calibration
478
Performing QC
478
Finishing the Shift
479
Short Guide
480
Replacing ISE Fluid Bottles
483
Replacing Electrodes
486
Cleaning the ISE Tower off the Analyzer
490
Ise Maintenance
493
Introduction
495
ISE Maintenance Actions and Their Intervals
495
ISE Maintenance Actions
496
Safety Information
496
Daily Prepare Actions
498
Activate Electrodes
499
Condition ISE Tubing
500
Initialize ISE Reference Solution Sensor
501
Prime ISE Reference and Calibrator
502
Electrode Service
503
Clean ISE Tower Automatically
504
Clean ISE Tower Manually
505
Initialize ISE Unit
507
Replace ISE Pump Tubing
508
Replace ISE Unit Tubing
511
Deactivating the ISE Unit
518
Ise Troubleshooting
521
Introduction
523
Information about the ISE Unit Status
523
Safety
524
List of ISE Flags
525
Air Isecal
526
Cal
526
Calc Error
527
Ise Unstab
527
No Fluid
528
No Isecal
528
Out of Rng
529
Seg Isecal
532
Sol1 F Dev
532
Test Rng
533
Reacting to Error Messages
534
4
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Roche Cedex Bio Specifications
General
Brand
Roche
Model
Cedex Bio
Category
Measuring Instruments
Language
English
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