Table Of Contents - Beckman Coulter UniCel DxC 600 Instructions For Use Manual

Table of Contents

Instructions For Use1
Revision History3
Chapter 9: Maintenance,3
Safety Notice5
Summary Of Hazards5
Summary Of Precautions8
Hardware Symbols And Labels15
Keyboard Connection16
Documentation Symbols25
Table Of Contents27
Introduction33
Intended Use33
Manual Conventions33
How To Use This Manual35
Manual Format35
System Description37
Operational Conditions37
Shipping Damage37
Installation37
Clearances38
Sunlight And Drafts38
Drain38
Power Requirements38
Environmental Conditions39
Power Requirements – Dxc Console (Pc System And Monitor)39
Power Requirements – Okidata B4350 Led Printer39
Temperature, Humidity And Elevation39
Water Requirements40
Other System Specifications For Iec-1010 Compliance40
System Components41
Dxc Systems41
Sample Handling System42
Unicel Dxc 600/800 Analyzer (600 Shown)42
Sample Racks43
Rack Id Labels44
Autoloader/Offload Track45
Priority Load Position45
Sample Loading Area45
Priority Load Button46
Pushers46
Sample Gate46
Bar Code Reader (Sample)46
1-Blade Thick Cts (Closed Tube Sampling) Or 1-Blade Narrow Cts Cap Piercerassembly (Optional)47
Tubes Validated For Closed Tube Sampling47
Modular Chemistry (Mc) System48
Sample Carousel48
Reagent Storage Area49
Reagent Bar Code Reader (Modular)49
Modular Chemistry Reagent Storage Area49
Ratio Pump50
Electrolyte Injection Cup (Eic)51
Flow Cell Assembly52
Cartridge Chemistry (Cc) Reagent Handling System53
Chemistry Reaction Modules (Basic Components)53
Basic Components Of Modules (Ex: Albumin)53
Reagent Cartridges54
Reagent Carousel And Reagent Bar Code Readers55
Reagent Probe Assembly56
Reagent Mixer Assembly56
Reagent Mixer Wash Cup56
Cuvette Reaction System57
Reaction Carousel57
Photometer Assembly58
Lpia (Large Particle Immuno Assay)58
Reaction Carousel Area (Typical – Cover Removed)58
Cuvette Wash Station59
Hydropneumatic System60
Dxc 800 Hydropneumatics (Right Side)60
Function61
Dxc 800 Hydropneumatics (Left Side)61
Operation And Control Components62
Operator Controls62
Dxc Push-Button Controls62
Main Screen And Program Structure63
Unicel Dxc 800 Main Screen63
Status Functions64
Sample Status Indicators65
Menu Bar Icons And Program Structure66
Program Structure (Main, Samples)66
Program Structure (Results, Rgts/Cal)67
Program Structure (Qc, Setup)68
Program Structure (Utils)71
Program Structure (Utils – Continued, Status, Instr Cmd, And Help)73
Recall Results For On-Board Samples74
Accessing The Help System74
Print Data From A Screen74
Online Manual Links74
Rack Status Area75
Additional Function Keys75
Request A Sample For Unload75
Sample Log75
Request The Log76
Description Of Log Fields76
Operations With The Sample Log76
Pre Run Summary78
Post Run Summary78
Theory Of Operation79
Cartridge Chemistry: Calibration Theory79
Cartridge Chemistry (Cc): Sample And Reagent Processing79
Endpoint And First-Order Chemistries80
Endpoint And First-Order Calibration Formulas80
Calculation Of Calibration Factors For Endpoint And Rate Chemistries81
Non-Linear Chemistries86
Non-Linear Calibration Formulas86
Math Models For Non-Linear Chemistries87
Modular Chemistry: Calibration Theory89
Drugs Of Abuse Testing (Dat) Chemistries89
Enzyme Verification89
Calibration Error Detection89
Cartridge Chemistry: Principles Of Measurement90
Spectrophotometric Methods90
Beer's Law90
Methodology And Modules Used With Modular Chemistries90
Preparing Samples For Analysis91
Routine Operation Overview91
Daily Procedure91
Minimum Sample Volume92
Sample Preparation By Container Type93
Bar Code Labeling94
Bar Code Label Placement94
Sample Tubes Validated For Cts95
Closed Tube Sampling (Cts)95
How To Use Reserved Racks97
When Not To Use A Reserved Rack97
Reserved Racks For Hba1C, Or Ibct97
Assigning Or Reassigning Reserved Racks98
Overview99
Chapter 3: System Setup Options99
Password Setup100
Setup Screen (Scrolled To The Bottom)100
Defining/Editing Password Setup101
Auto Serum Index/Ordac102
Configuring The Chemistry Menu103
Configuring A Beckman Coulter Chemistry103
Configuring A User Defined Chemistry (Udr)103
Defining Chemistry Print Name104
Inserting A Chemistry104
Deleting A Chemistry104
Remove The Chemistry From Reagent/Calibration (Example: Dign)104
Remove The Chemistry From Sample Programming (Example: Dign)105
Remove The Chemistry From The Quality Control (Qc) Program106
Deleting A Chemistry From The System (Example: Dign)107
Beckman Coulter Defined Chemistries With Units And Precision108
Unicel Dxc 600/800 Beckman Coulter Defined Chemistries With Acronyms Unitsand Precision108
Setting The Default Sample Type111
Date/Time Setup111
Demographics Setup112
Patient Results - Immediate Reporting Setup112
Immediate Patient Results Reporting To Host And/Or Printer112
Panels113
Defining, Editing And Deleting Panels113
Selecting A Default Panel113
Replicates114
Report Setup114
Reportable Ranges Setup115
Analytical Range115
Instrument Printable Range115
Reportable Range116
Suppress Results Option116
Reference/Critical Ranges Setup117
Sample Comments Setup117
Special Calculations Definition118
Beckman Coulter Predefined Special Calculations Defaults119
Beckman Coulter Predefined Special Calculation Formulas119
Unicel Dxc 600 Predefined Special Calculation Formulas119
Unicel Dxc 800 Predefined Special Calculation Formulas120
Timed Urine And Creatinine Clearance Results121
Version Information121
Calculation Constants And Factors121
Units/Precision Setup122
User Defined Chemistries Setup122
Bar Code Setup123
Maximum Sample Program Age124
Reserved Racks/Obstruct Detect124
Disable Service Monitor125
Host Communications126
Dxc Host Communications Parameter Options For Astm, Lx20/Dxc, Cx7 Compatible126
Language/Keyboard Setup127
Printer Setup128
Service Setup128
Enabling Service Setup128
Disabling Service Setup128
System Configuration129
Version Upgrade129
View/Edit System Configuration129
Status Alarm/Annunciator130
Chemistry Update130
Auto Generation Of Control131
Reagent Load/Calibration133
Pre-Run Checklist134
Rgts/Cal Screen Overview134
Reagent Load/Calibration Screen134
Reagent Status Messages134
Sort Reagent Status135
Load/Unload Reagent136
Mc Reagent Information136
Dxc 800 Leftmost Compartment137
Dxc 600 Leftmost Compartment137
Load/Unload Modular Chemistries (Mc)138
Dxc 600/800 Center Compartment138
No Foam Container (Dxc 800 Shown)139
Cc Reagent Information140
Load/Unload Cartridge Chemistries (Cc)141
Reagent Parameters142
Reagent Carousel142
System Calibration144
Load A Calibrator Diskette144
Calibrator Assignment145
Calibration Status146
Calibration Status Messages146
Reagent And Calibration Status Warnings147
Conditions That Cause A Calibration Status Warning147
Request A Calibration148
Calibrate Dxc Chemistries With Bar Code Labels148
Calibrate Dxc Chemistries Using Assigned Calibrator Racks149
Calibration Failure Messages150
Cancel A Calibration Request150
Cc Subsystem Calibration Failure150
Within-Lot Calibration151
Mc Subsystem Calibration Failure151
Within-Lot Calibration Frequency151
Enable Within-Lot Calibration151
Within-Lot Calibration Dialog Box152
Within-Lot Calibration Status Screen153
Within-Lot Designations154
Within-Lot Calibration Limitations154
Enzyme Validator155
Calibration Override156
Remove Cal Overridden Status156
Chemistry Bypass157
Remove A Bypassed Status157
Extend Calibration Time158
Remove An Extended Status158
Calibration Acceptance Limits159
Calibrator Set Point Modifications160
Slope Offset Adjustment161
Slope Offset Recommendations162
Reprint Calibration Reports163
Reprint Previous Calibration Reports164
Quality Control165
Quality Control Program165
Determination Of Qc Flags165
Accuracy And Precision Flags166
Flags Generated On Printed Qc Reports167
Additional Qc Precision Rules167
Qc Accept/Reject Chart Using Westgard Rules167
Define A Control168
Special Or Unique Control Samples168
Control Description168
Delete Controls From Definition Screen170
Control Id Assignments171
Run Control Samples171
Introduction To Assignment Of Qc Bar Codes171
Assignment Of Qc Bar Codes171
Run Control Samples With Bar Code Labels And Auto Generationof Control Enabled172
Manually Programming Control Samples172
Edit A Control Definition173
Edit Precautions173
Modify Assigned Mean, Assigned Sd Or Constituent Code174
Add Chemistry(Ies)174
Remove Chemistry(Ies)175
Review A Control Definition176
Delete A Control176
Print Qc Ranges177
Qc File List178
Qc File Definition178
Display Qc File Lists178
Qc Summary179
Accessing The Qc Summary179
Qc Chart (Levey-Jennings)180
Accessing Qc Charts180
Qc Log182
Accessing Qc Logs182
Delete A Data Point183
Add A Qc Action Log Comment184
Quality Assurance Program (Qap) "Copy To Disk" Feature185
Create A Qap Disk185
Archive Qc187
Review Archived Data188
Chapter 6: Sample Programming And Processing191
Prior To Programming192
Program Sample Screen192
Rack Status193
Identify Samples194
Verify Sample Carousel Status: Main Screen194
Sample Status Designations194
Sample Id195
Limitations195
Valid Characters For Entries195
Create Sample Ids196
Processing Bar Coded Samples196
Sample Programming And Processing196
Manually Assigning Rack And Position197
Processing Samples Manually197
Add Tests Or Rerun A Sample199
Additional Programming Information200
Chemistry Identifiers200
Enter A Dilution Factor200
Programming A Manual Ordac200
Batch Programming201
Clear Samples202
When To Clear Samples203
Range Of Sample Ids203
Procedure For Clearing Samples204
Chapter 7: Results Recall205
Recall Results By Sample Id206
Recall Results By Rack And Position207
Recall Results By Patient Id208
Recall Results By Run Date/Time208
Display Recalled Results209
Date And Time Formats With Recall Results209
Edit Critical Rerun Result210
Delete Critical Rerun Result210
Print Recalled Results211
Send Results To The Host212
Absorbance Versus Time212
Send Data212
Recall Data212
Statistical Summary Report214
Additional Information214
Display Statistical Summary214
Requirements And Precautions215
Minimum Requirements For Operation215
Chapter 8: User Defined Reagents215
User Defined Reagent Cartridges216
Fill Volumes For Accurate Level Sensing216
User-Defined Reagent Setup217
Defining A User-Defined Reagent217
Chemistry Parameters218
Edit A User-Defined Reagent218
Define A Chemistry Test Name218
Reaction Type218
Units219
Precision219
Reaction Direction219
Options For Units219
Math Model220
Primary Wavelength220
Secondary Wavelength220
Options For Math Models220
Calculation Factor221
Number Of Calibrators221
Allowable Entries For A Calculation Factor221
Options For The Number Of Calibrators221
Processing Parameters222
Calibrator Values222
Calibration Time Limit222
First Inject: Component222
Second Inject: Component223
Second Inject: Dispense Volume223
Second Inject: Add Time223
Allowable Entries For Add Time For The Second Inject223
Dxc 600/800 Timing Chart224
Third Inject: Component224
Third Inject: Dispense Volume225
Third Inject: Add Time225
Sample Volume225
Blank Read Times225
Initial Read Times226
Reaction Read Times226
Error Detection Limits227
Usable Result Range227
Reagent Blank (Absorbance Or Rate)227
Reaction (Absorbance Or Rate)227
Initial Rate High And Substrate Depletion228
Multipoint Spans228
Allowable Entries For Multipoint Span Limits228
Allowable Entries For Initial Rate And Delta Absorbance228
Wavelength Selection229
Primary Wavelength Selection229
Secondary Wavelength Selection229
Determination Of Extinction Coefficients230
Summary230
Option 1230
Exit Check Criteria231
Option 2231
Wavelengths231
Calibration231
Blanking232
Measurement232
Volumes232
User Defined Reagent Removal233
Remove A User Defined Reagent233
Expanded User Defined Chemistry Feature234
Cal Save234
Ordac235
On Board Dilution236
Maintenance237
Basic Laboratory Practice237
Utilities,237
Common Abbreviations238
Maintenance Schedule238
Chassis Ground238
Twice Weekly Maintenance239
Weekly Maintenance239
Monthly Maintenance239
Two-Month Maintenance239
Electronic Maintenance Log240
Four-Month Maintenance240
Six-Month Maintenance240
Feature Summary240
Access The Scheduled Log Feature241
Screen Description241
Help241
Procedure241
Clean Sample And Reagent Probes, Mixers, Eic, And Flow Cell243
Check Reagent Levels246
Replace Cuvette Wiper246
Cuvette Wash Station Cover247
Clean Total Protein And Albumin Cup Modules (Dxc 800 Only)248
Cleaning Preparation249
Cleaning Procedure249
Clean Probes (Exterior)250
Clean Flow Cell, Cups And Cc Probes/Mixers (Automated)252
Materials Required252
Check Chloride Calibration Span253
Replace Alkaline Buffer253
Dxc 800 Ise Module254
Adjust The Fluid Level Of The Alkaline Buffer Damper Assembly257
Clean All Cup Modules259
Cup Cleaning Preparation259
Bunm/Uream Electrode Maintenance (Dxc 800 Only)261
Calibrate Lamps And Sensor265
Reassemble The Mc Components266
Clean Mixers267
Cc Sample And Reagent Mixers267
Replace Cts Blade (1-Blade Narrow Cts Option)268
Cap Piercer Blade268
Replace Cts Blade/Wick (1-Blade Thick Cts Option)272
Cap Piercer Blade With Cts Auto-Gloss Wick272
Change/Clean Air Filters277
Replace Syringe Plungers279
Cc Reagent Syringe (500 Μl)279
Prepare For Maintenance Mode And Remove The Plunger280
Mc And Cc Sample Syringes (100 Μl)280
Install The Syringe282
Prime The Syringes283
Return To Home Position283
Clean The Mc Reagent Lines284
Mc Line Cleaning Preparation284
Cleaning The Mc Lines, Cups, And Stir Bars284
Replace Calcium And Potassium Electrode Tip288
Ise Service290
Removal And Installation Of The Electrodes291
Replace Glucose Sensor294
Drain The Reaction Cup For Sensor Maintenance Or Replacement296
Sensor Replacement And Stir Bar Cleaning296
As-Needed/As-Required Maintenance299
Action Log300
Replace The Chloride Electrode Tip300
Ise Service Procedure300
Replace The Chloride Electrode301
Replace The Sodium Measure/Reference Electrode304
Removal And Installation Of The Sodium Electrode305
Prime The Flow Cell308
Replace The Co2 Membrane309
Replace The Ise Module Cover309
Remove The Old Co2 Membrane309
Prepare The New Co2 Measuring Electrode Membrane312
Reinstall The Co2 Measuring Electrode315
Co2 Measuring Electrode Reinstallation315
Clean The Eic Port316
Clean The Co2 Alkaline Buffer Lines322
Clean The Ise Drain324
Flush The Flow Cell (Manual)327
Clean The Ise Flow Cell Using Clenz Solution330
Flow Cell Cleaning Procedure331
Flush The Sample And Reagent Probe333
Weekly Maintenance,334
Replace The Sample And Reagent Probe335
Replace The Old Probe335
Install The New Probe336
Additional Procedures336
Confirm Instrument Performance338
Cc And Mc Sample Probe338
Reagent Probe A And B338
Clean The Cc Sample Probe, Reagent Probes And Mixers339
Clean The Mc Sample Crane And Collar Assembly340
Clean The Precipitate In Phosm (Dxc 800 Only)341
Inspect The Cuvette Washer Probe342
Wash All Cuvettes With System Wash345
Wash The Cc Reagent Cuvettes With Ccwa346
Clean The Work Surfaces347
Decontaminate The Sample Racks348
Decontaminate The Instrument348
Replace The Cts Wick352
Remove The Cap Piercer Cover353
Remove The Blade Assembly And Wick Clip Assembly354
Clean The Blade357
Lubricate The New Wick359
Install The Wick Clip Assembly And Blade Assembly360
Replace Ise Drain Pump Tube361
Show Status Summary365
Possible Status Messages365
Chapter 10: System Status And Commands,365
What To Do If There Is An Error366
Return To Status Summary366
Show Cycle Count366
Status-Cycle Count,366
Show Temperature Status367
Cycle Count Description367
Counters367
Temperatures,367
Hydropneumatics Subsystem368
Show The Power Subsystem Status368
Power Subsystems,368
Ics/Smart Modules369
Show The Hydropneumatics Subsystem Status369
What To Do If A Parameter Is Out Of Limits369
Show The Ics/Smart Module Status369
Show The Cuvette Water Blank Status370
What To Do If A Cuvette Is Dirty370
Do Not Clear The Sample Id Manually371
Show The Cts Tracking Status371
Cts Tracking,371
Home372
Why Use Home372
Instrument Commands,372
Pause,373
When To Use Pause374
When Not To Use Pause374
How Stop Print Works375
Shutdown,376
On/Off Switch377
Line Converter Device377
Dc Output Power Supplies377
Uninterruptible Power Supply (Ups)377
Power Cord Connections378
Power Up Sequence378
Full Boot378
System Power On/Boot,378
Pause/Resume Waste B379
After Boot-Up379
Reset379
Pause Waste B379
Resume Waste B380
Enable/Disable Modules,380
Disable Modules381
Enable Modules381
Unload All,382
Unload All Racks383
Utilities385
Prime385
A Prime For The Cc Subsystems385
A Prime For The Hydropneumatics Subsystem385
Accessing Prime386
A Prime For The Cups Of The Mc Subsystems386
A Prime For Other Components Of The Mc Subsystems386
A Prime For Cts Auto-Gloss And Blade Wash386
Stopping A Prime387
Priming All Subsystems387
Priming Cc Subsystems388
Priming Hydropneumatic Subsystems389
Priming Mc Subsystems389
Event Log390
Event Log Classes391
Event Information391
Select Specific Event Classes391
Information Options392
Show Events392
Copy To A Disk393
Specify The Date/Time394
Clear Events395
Print An Event Log395
Alignment/Diagnostics/Pvts396
Metering396
Modem396
Reagent Metering396
Backup/Restore397
System Parameters397
Alignment Data397
Backup The System397
Restore The System398
Touch Screen Calibration400
Parallax400
Index401
Related Documents408
Theory Of Operation,408
Contents411
Alignment/Diagnostics/Pvts,416
Troubleshooting Calibration And Result Errors417
Calibration Errors417
Calibration Error Checking417
Calibration Error Flags417
Mc Calibration418
Mc Calibration Checks418
Back-To-Back418
Calibrator Range (High/Low)419
Dac419
Digital-To-Analog Conversion (Dac) Check Limits419
Sample/Reference Deviation420
Span420
Calibration Reports420
Maximum Allowable Sample/Reference Deviations By Chemistry420
Cup Module Calibration Report Field Definitions422
Linear Calibration423
Linear Calibration Report424
Cc Linear Calibration Report Field Descriptions424
Non-Linear And Multipoint Calibrations426
Non-Linear Calibration Checks426
Multipoint Span426
Recovery426
Severe Recovery427
Sensitivity427
Math Errors427
Calibration Report427
Troubleshooting Result Errors429
Result Errors429
Error Types And Description429
Error Codes And Definitions430
Result Errors And Codes430
Error Type And Description430
Error Code – Definitions433
Common Error Messages And Corrective Actions439
Error Messages And Corrective Actions440
Backup/Restore,479
Glossary481
Theory,492
Touch Screen Calibration,495