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IMMAGE 800
Beckman Coulter IMMAGE 800 User Manual
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A11403AE
September 20
16
Oper
a
tions Manual
IMMAGE 800
Immunochemistry System
Fo
r
In Vitro
Diagnost
ic Use
Beckman Coulter, Inc.
250 S. Kraemer Bl
vd.
Brea, CA 92821 U.S.A.
2
Table of Contents
Chapter 1 1 General Information/Precautions and Hazards
9
Table of Contents
9
General Information/Precautions and Hazards
10
Introduction
10
How to Use this Manual
11
Warranty and Service Policy Information
13
Precautions
14
Hazards
15
Symbols and Labels
17
IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards September 2016 Page
21
Chapter 2 2 System Description
23
Hardware Components
24
Overview
24
Instrument
25
Reagent Compartment
26
Reagent Crane
28
Reaction Module
30
Sample Carousel
32
Sample Crane
34
Upper Instrument Subsystems
36
Wash Solution Box and Waste Container
39
Racks
41
Computer
43
Printer
47
Software Overview
48
Overview
48
Screen Format
49
Text Fields
52
Buttons
53
Toggle Buttons
54
Check Boxes
55
Performing Software Functions
56
Selecting Vs. Choosing
58
Dialog Boxes
59
Deleting Data from a Text Field and Printing Data from a Screen
60
Page Up/Page down
61
Program Structure
62
Sample Programming Overview
67
System Specifications and Characteristics
68
Instrument Specifications
68
Peripheral Devices Specifications
71
Sample Container Information
72
Sample Containers Allowed
72
Bar Code Types and Options
73
Bar Code Label Specifications
75
Applying Bar Code Labels
77
Sample Volume
78
Loading Tubes into Racks
79
Instrument Operation Overview
80
Instrument Operation
80
Chapter 3 3 Theory of Operations
83
Theory of Operations
84
Principles of Methodologies
84
Signal Measurement and Reaction Dynamics
85
Antigen Excess Testing
90
Out-Of-Range Testing
93
Calibration
94
Chapter 4 4 System Power On/Off
95
System Power On/Off
96
System Power on
96
System Power off
98
Database Recovery
99
Software Installation Instructions
100
Chapter 5 5 System Setup
101
System Software Configuration
102
Overview
102
Configuring the Chemistry Menu
104
Panel Setup
109
Bar Code Setup
113
Reference Interval Setup
117
Report Setup
125
Calculations Setup
128
Units Setup
137
Selecting Non-Standard Dilutions as Default for each Chemistry
140
Configuring Antigen Excess Testing
142
Date and Time Setup
144
Host Communications Setup
150
Default Setup
157
Sample Comments Setup
160
Demographics Setup
162
Printer Setup
164
Language Setup
165
Loading the Chemistry Protocol Diskette
166
Instrument Serial Number Setup
167
User-Defined Reagent Chemistry Setup
168
UDR Chemistry Overview and Precautions
168
Setting up a UDR Chemistry
169
Defining a UDR Chemistry
174
Defining UDR Calibration Information
183
Deleting UDR Chemistries
184
Editing UDR Definitions
185
Loading UDR Reagent Cartridges
187
Loading/Clearing UDR Buffer and Diluent
190
Programming Rate Mode
192
Calibrating a UDR Chemistry
195
Approving a Calibration
202
Printing UDR Reports
212
Setting up UDR Reference Intervals and Panels
214
Defining UDR Quality Control
215
Programming a UDR Sample
216
Instrument Setup
217
Overview
217
Placing Labels on a Rack
218
Wash Solution Box and Waste Container Placement
220
Chapter 6 6 Reagents/Calibration
221
Reagents
222
Overview
222
Reagent Status/Calibration Status Screen
223
Loading Reagent/Calibrator Bar Coded Parameters
225
Displaying/Deleting Reagent Parameters
227
Loading/Clearing Buffers and Diluents
229
Loading Wash Solution
233
Loading/Unloading Reagent Cartridges
234
Calibration
237
Overview
237
Checking Calibration Status
238
Calibration History
241
Cartridge-Specific Calibration
242
Requesting and Canceling Calibration
246
Loading Calibrators on the Sample Carousel
250
Starting a Calibration Run
253
Calibration Results
254
Re-Enabling Calibration
255
Cal Options
256
Chapter 7 7 Sample Programming
261
Preparing for Programming/Running
263
Overview
263
Checking and Clearing Sample Racks
264
Checking Status and Clearing/Replacing Dilution Segments
266
Checking Reagents, Buffers, and Diluents
268
Checking Wash Solution Volume
269
Programming a Sample
270
Overview
270
Program Sample Screen
271
Entering Sample Identification
274
Selecting Chemistry Tests by Panel
276
Selecting Chemistry Tests by Chemistry
278
Selecting a Sample Type
280
Entering a Sample Comment
282
Entering a Patient ID
284
Entering Patient Demographics
285
Selecting Sample Options
288
Selecting Replicates
289
Antigen Excess (AGXS) Testing
290
Selecting Non-Standard Dilutions
291
Entering an Off-Line Dilution Factor
293
Linking/Unlinking Samples
295
Setting Variables
297
Programming a Control
298
Programming a STAT
303
Selecting Save/Next
304
Programming a Batch of Samples
305
Overview
305
Entering/Editing a Batch Sample Program
305
Identifying Batch Samples
306
Loading and Starting a Run
310
Loading Samples
310
Pre-Run Checklist
313
Starting the Run
314
Pausing a Run
315
Overview
315
System Pause
316
Pausing to Load Samples
317
Rerunning a Sample
320
Overview
320
Selecting Samples to be Rerun
321
Editing Sample Programs before Rerunning
324
Rerunning Original Sample Programs
326
Rerunning Selected Chemistries
327
Rerunning Controls
328
Requesting a Load List or Post-Run Summary
329
Overview
329
Requesting a Load List
330
Requesting a Post-Run Summary
335
Clearing a Sample
336
Overview
336
Clearing a Sample by Sample ID
337
Clearing a Sample by Rack and Position
338
Routine Operation
339
Overview
339
Host Communication Status
343
Operating IMMAGE 800 in Japanese
344
Overview
344
Computer
345
Data/Text Entry
347
Language Conversions
351
Display Language
353
Host Communication Interface
355
Chapter 8 8 Results Recall
359
Overview
360
Results Recall
360
Recalling Results by Sample ID
361
Recalling Results by Rack and Position
363
Recalling Results by Patient ID
365
Recalling Results by Patient Name
366
Recalling Results by Run Date/Time
367
Displaying Recalled Results on the Screen
369
Printing Recalled Results
370
Sending Results to the Host
371
Chapter 9 9 Quality Control
373
Overview
374
Quality Control
374
QC Statistics and Rules
375
Defining a Control
378
Editing a Control
384
Reviewing a Control Definition
388
Deleting a Control Definition
390
Displaying the QC File List
392
QC Log
394
Displaying QC Summaries
399
QC Chart (Levey-Jennings)
401
QC Backup
403
Restoring and Reviewing Backup Data
406
Chapter 10 10 Utilities
409
CHAPTER 1 General Information/Precautionsandhazards
409
Utilities
410
Overview
410
Maintenance
412
Recommended Tools and Supplies
412
Maintenance Precautions
413
Maintenance Schedule
414
Auto Maintenance Procedures
415
Daily Maintenance Procedures
416
Monthly Maintenance Procedures
420
As-Indicated Maintenance
422
Troubleshooting
429
Errors
429
Event Log
451
Callable Diagnostics
457
Alignment
460
Backup/Restore
471
Fill Internal Wash Bottle
474
Calibrate Touch Screen
475
Replacing Parts/User Servicing
477
Overview
477
Syringe
478
Sample and Reagent Crane Mixer/Paddle
479
Sample and Reagent Crane Probe
480
CHAPTER 11 System Status/Instrument Commands
487
System Status/Instrument Commands
488
Checking Dilution Segment Status and Clearing Dilution Segments
488
Checking Sample Carousel Status
490
Checking the Instrument Status Monitor
492
Accessing Instrument Commands
493
APPENDIX A Instrument Codes
495
APPENDIX B Reports
497
4
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Beckman Coulter IMMAGE 800 Specifications
General
Brand
Beckman Coulter
Model
IMMAGE 800
Category
Measuring Instruments
Language
English
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