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Cedex Bio System
Roche Cedex Bio System User Manual
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Roche Diagnostic
s
G-4
Operator’s Manual · Version 3.1
18
Revisions
Cedex
Bio Syste
m
495
Table of Contents
Table of Contents
4
Operator's Manual · Version
5
Safety
11
Table of Contents
11
Safety Classification
13
Safety Information
13
Transport
13
Electrical Safety
13
Optical Safety
14
Mechanical Safety
14
Instrument Covers
14
Operation and Maintenance
14
Biohazardous Materials
14
Waste
15
Reagents and Other Working Solutions
15
Installation
15
Environmental Conditions
15
Power Interruption
16
Electromagnetic Devices
16
Approved Parts
16
Third-Party Software
16
Operator Qualification
17
Operation over an Extended Period of Time
17
Cross Contamination of Sample
17
Insoluble Contaminants in Sample
17
Spillage
17
Data Security
18
Disposal Recommendation
19
Disposal Label
19
Disposal of External Components
19
Disposal of the Instrument
19
Constraint
20
Legal Liability
20
Safety Labels
21
Introduction to the Instrument
23
Overview
25
Introduction to the Instrument Overview
25
Principles of Operation
27
User Interface
28
Wizards
29
Daily Operation
30
Overview
30
Reagent and Diluent Handling
32
Calibration
34
Calibration Type
34
Calibration Sequence
35
Calibration Status of a Set
36
Calibration Result Storage
36
Validating Calibration Results
36
Calibration Procedures
36
Quality Control (QC
37
Sample Handling
38
Order Handling
39
Results
40
Maintenance
41
System Status
42
Hardware
45
Covers and Panels
47
Hardware
47
Leds
49
Main Components
51
Hardware Overview
52
Sample Area
52
Fluid System
53
Probe and Syringe
54
Syringe Assembly
54
Wash Station
55
External Fluid Connectors
55
Transfer Unit
56
Fluid Containers
58
Waste Containers
58
Water Container
59
Cleaner Bottle
60
Reagent Bottles
61
Tubes
61
Cuvettes
62
Cuvette Segments
63
Handling Cuvettes
63
Reagent Handling
64
Rotor
64
Reagent Disk
65
Reagent Disk Container
66
Reagent Cooler
66
Cuvette Ring
67
Barcode Scanner
67
Printer
69
Absorbance Photometer
69
Connectors
71
Fuses
72
Technical Specifications
73
Software
75
Introduction
77
Software Introduction
77
Screen Layout
78
Display Items
79
Color Concept
80
Workflows and Wizards
80
Navigation
80
Working with the User Interface
81
Adjusting the Touchscreen
81
Scrolling
81
Expanding and Collapsing Lists
82
Typing Text
82
Using the Filter Function
84
Printing Information
86
Using Online Help
87
Messages
88
Message Screen
88
Alarm Monitor
88
Key Screens
90
Overview Tab
90
Sample Overview
92
Orders
93
Stat
95
Tests
95
Log off
97
Prepare
97
End Shift
97
Cuvette Status
97
Disk and Reagent Status
98
ISE Status
99
System Status
100
Workplace Tab
102
Orders
102
Result List
104
QC Status List
106
QC History
107
Calibrations List
109
Lot Data
110
Lot List
111
Loadlist
112
Worklist
112
Utilities Tab
113
Configuration
113
Maintenance
113
Applications Related Functions
116
Applications
116
Extra Wash Cycles
116
Host Codes
116
Reagent Mixing
116
Process Sequence
116
System Diagnostics
120
Inventory
121
Import
122
Users
123
Export
123
Stopping a Run
124
Color Interpretation for Leds
125
Buttons
127
Daily Operation
133
Introduction
135
Safety Information
135
Daily Operation Introduction
135
Overview
137
Working with a Host System
139
Starting the Shift
140
Switching on the Instrument
140
Preconditions
140
Logging on to the System
141
Preparing the System
142
Short Guide
143
Starting the Prepare Wizard
145
Checking the Status of the External Fluid Containers
145
Performing Maintenance Actions
149
Preparing the Reagent Disk
151
Preparing the Reagents
152
Checking the Status of Reagent Sets
153
Preparing Reagents
155
Preparing Cuvettes
158
Performing Reagent Mixing
159
Performing the Calibrations (Prepare Phase
160
Analyzing Samples
164
Safety Information
164
Short Guide
165
System Setup and Order Definition Workflow
167
Defining Orders
168
Defining Routine Orders
169
Defining STAT Orders
171
Making Changes to an Order
172
Starting the Run
174
Monitoring the Analysis Progress
174
Checking the Sample Tube Status
174
Checking the Instrument Status Buttons
176
Checking for Alarm Messages
178
Acoustic Signal
178
Stopping and Restarting a Run
179
Removing Sample Tubes
180
Validating Sample Results
181
Repeating Tests
185
Rerunning Tests
186
Accepting Results
187
Printing Sample Results
188
Performing Calibrations
189
Safety Information
189
Short Guide
190
Process of Performing Calibrations
191
Deleting Ordered Calibrations
193
Validating Calibration Results
194
Performing QC
198
Safety Information
198
Short Guide
199
Performing Default QC
200
Performing Interval QC Measurements
201
Validating QC Results
202
Interpreting the QC History
204
Performing Reagent Mixing
206
Finishing the Shift
207
Safety Information
207
Short Guide
208
Checking for Unfinished Tasks
210
Checking for Unfinished Orders
210
Checking for Not Accepted Sample Results
210
Checking the Transmission of Results
211
Starting the End Shift Wizard
211
Performing the Daily Backup
212
Exporting the Result Data
213
Cleaning up the Database
214
Performing Maintenance Actions
215
Replacing Cuvettes
215
Dealing with the External Fluid Bottles
216
Emptying the Waste Container
216
Refilling the External Water Bottle
216
Removing the Reagent Disk
217
Logging off
218
Shutting down the System and Switching off the Instrument
218
Using the Barcode Scanner
219
Reading Reagent Bottle Barcodes
219
Reading Barcodes from Sheets
220
Reading Sample Tube Barcodes
220
Special Operations
221
Deleting Sample Orders
223
Deleting Sample Results
224
Calibration
225
Deleting Calibration Results
225
Setting up Your Calibration Schedule
226
Deleting QC Results
226
Lot Handling
228
Viewing the Current Lot Definitions
228
Calibrator and QC Lots
228
Reagent Lots
229
Viewing the Lot Details of Fluids that Were Used
230
Adding a New Lot
231
Exporting Data
234
Exporting the Database
234
Exporting Results
235
Interpreting Result Data
236
Exporting Log Files
240
Importing Data
241
Importing Applications
241
Importing Software
243
Importing a Database
243
Importing Certificates
245
Importing Automatic Mixing and Extra Wash Cycle Definitions
245
Preparing a New Disk
246
Assigning Tests to Test Tabs
249
Deleting Bottle Sets from the Inventory List
250
Refilling Printer Paper
252
Removing Condensation Water from the Reagent Cooler
254
Replacing the Probe
255
Connecting and Disconnecting the External Fluid Containers
257
Adjusting the Touchscreen
261
Cleaning the Touchscreen
261
Configuration
263
Introduction
265
Viewing Values
265
Changing Values
265
Configuration Introduction
265
Applications
267
Installing Applications
267
Activating and Deactivating Applications
269
Preparing Applications
270
Uninstalling Applications
273
Deleting Applications
274
Defining the Processing Order
275
Defining Ratio Applications
276
Profiles
278
Defining Profiles
278
Adding Tests to a Profile
278
Removing Tests from a Profile
279
Deleting Profiles
279
Defining Control Definitions and Lots
279
Defining Calibrator Definitions and Lots
280
Short Guide to Application Definitions
282
Version
282
Code
282
General Application Definitions
282
Calibration Definitions
283
Control Definitions
284
Calculation Definitions
285
Calculation Definitions (Ratio Applications
285
Laboratory Correlations (Ratio Applications
286
Reference Range Definitions (Ratio Applications
286
Result Conversion Definitions
286
Configuration
287
Scheduling Maintenance Actions
288
User Management
289
Defining a User
289
Deleting a User
289
Editing the Acceptable Flags List
290
Mapping the Host Codes
290
Short Guide to Configuration Definitions
291
Workflow Definitions
291
Host Definitions
293
Result Handling
295
Calibration
295
System
296
Date and Time
297
Maintenance
297
Abs Adjustment
297
Defining Extra Wash Cycles
298
Activating, Deactivating and Deleting Extra Wash Cycles
299
Short Guide to Extra Wash Cycle Definitions
300
Extra Wash Cycle Definitions
300
Short Guide to Reagent Mixing Rules
301
Reagent Mixing Rule Definitions
301
Printing Mixing Rules
301
Deleting Mixing Rules
302
General Maintenance
305
Overview
307
General Maintenance Overview
307
Performing Maintenance Actions
308
Maintenance Actions and Their Intervals
309
Maintenance Actions
310
Safety Information
310
Deproteinize the Probe
312
Prime the Fluid System
313
Clean the Probe Manually
314
Clean Reagent Disk and Sample Area
316
Clean the Water and Waste Containers
318
Replace Water Inlet Filter
321
Clean and Disinfect Housing
323
Clean up the Database
325
Replace Photometer Lamp
326
Contact Service Representative
329
Perform an Air/Water Calibration
330
Initialize Degasser Fluid Sensor
332
Clean Rotor and Heating Channel
334
Messages and Alarms
341
About Messages
343
Message Screen
343
Acoustic Signals
344
Alarm Monitor
345
Reacting to Alarm Messages
345
Printing Alarm Messages
346
Confirming Alarm Messages
347
Exporting the Alarm Message Log
347
List of Alarm Messages
348
Result Flags
361
About Flags
363
List of Flags
364
Safety
365
Ag Excess
366
List of Flags
366
Cal
367
Cal Error
367
Calc Error
367
Curv dir
368
Ep Unstab
368
High Abs
369
High Act
369
Kin Read
370
Low Act
370
Non Linear
371
Non Mono
371
Out of Rng
372
R 1(2.5S
372
R 1(3S
373
R 2(2S
373
Reag Rng
374
Repl Dev
374
Troubleshooting
377
Introduction
379
Troubleshooting Introduction
379
Dealing with Exceptional Situations
380
Reacting to Messages
382
Detailed Procedures
384
Checking the Printer Status
384
Clearing a Paper Jam
384
Changing the Mains Fuses
385
Changing the Low Voltage Fuses
387
Realigning the Reagent Disk
388
Exporting Diagnostics Screens to USB
389
Ise Description
393
Overview
395
Abbreviations
395
ISE Description Overview
395
Measuring Modes
396
Principles of Operation
397
ISE Solutions
398
Hardware
399
Panels
399
Ise Led
400
Main Components
400
Fluid Containers
401
Basic Operation
402
Samples
402
Calibration
402
ISE Standby
402
Maintenance Actions
403
Technical Specifications
403
Ise Operation
405
Daily Operation
407
Safety Information
409
Preparing the System
410
Short Guide
410
Starting the Prepare Wizard
411
Checking the Status of the External Fluid Containers
411
Checking the ISE Status
411
Performing Maintenance Actions
412
Completing the Preparation Tasks
413
Defining Orders
413
Monitoring the Progress
414
Validating Sample Results
415
Main Calibration
416
Performing QC
416
Finishing the Shift
417
Short Guide
418
Replacing ISE Fluid Bottles
420
Replacing Electrodes
422
Cleaning the ISE Tower off the Instrument
426
Ise Maintenance
429
Introduction
431
ISE Maintenance Actions and Their Intervals
431
ISE Maintenance Actions
432
Safety Information
432
Daily Prepare Actions
434
Activate Electrodes
435
Condition ISE Tubing
436
Initialize ISE Reference Solution Sensor
437
Prime ISE Reference and Calibrator
438
Electrode Service
439
Clean ISE Tower Automatically
440
Clean ISE Tower Manually
441
Initialize ISE Unit
443
Replace ISE Pump Tubing
444
Replace ISE Unit Tubing
447
Deactivating the ISE Unit
454
Ise Troubleshooting
457
Introduction
459
Information about the ISE Unit Status
459
Safety
460
List of ISE Flags
461
Air Isecal
462
Calc Error
463
Ise Unstab
463
No Fluid
464
No Isecal
464
Out of Rng
465
Seg Isecal
468
Sol1 F Dev
468
Test Rng
469
Reacting to Error Messages
470
Glossary
471
Index
481
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Roche Cedex Bio System Specifications
General
Brand
Roche
Model
Cedex Bio System
Category
Measuring Instruments
Language
English
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