CellaVision DM1200 User manual

CellaVision
®
DM1200
USER’S MANUAL 3.1 - 3.2

CellaVision®DM1200
User’s Manual

CELLAVISION — DIGITAL CELL MORPHOLOGY
Software, Accessories and Consumables
CellaVision®Remote Review Software
CellaVision Remote Review Software gives remote users access to analyzed
slides, with the possibility to reclassify cells and sign slides from another location.
Smears needing a second opinion can easily be reviewed by a pathologist from
within or outside the hospital.
CellaVision®Competency Software
CellaVision Competency Software is a program for education and competency
testing of manual blood cell differentials in laboratories. The product allows labs
to ensure that staffs are trained to report results consistent with lab policies.
CellaVision®Body Fluid Application
By using CellaVision Body Fluid Application, body fluids, including cerebrospinal,
peritoneal and pleural fluids, can be analyzed on the CellaVision DM Analyzer.
Utilizing a cytocentrifuge slide preparation, the analyzer automatically performs
a preliminary differential of nucleated cells, and allows the user to scan the entire
sample area.
CellaVision®Light tower
The CellaVision® Light Tower provides visual and audible signals of the status of a
CellaVision DM Analyzer, easily identifiable even at a distance. It advises
laboratory professionals when an operation is running, is finished, or signals an
equipment malfunction.
HemaPrep®Automated Blood Smearing Instrument
With HemaPrep® the laboratory can standardize the smear quality irrespective of
the staff experience. By adjusting the speed of the spreader, the operator is able
to control smear length and thickness.
CellaVision®Barcode Label Printer Kit
The Barcode Label Printer Kit comes pre-configured and ready for use to read and
copy barcodes on vacutainer tubes and requisitions, and it generates 2D barcode
labels for microscope slides. The printed labels have an excellent resistance
against immersion oil and staining reagents. .
CellaVision®QC Labels
Preprinted labels to verify the cell location performance of a CellaVision DM
Analyzer.
CellaVision® Magazine Pack
Replacement magazines for clipped/rounded/beveled corner slides. Peripheral
Blood (orange) or Body Fluids (blue).
CellaVision®Immersion Oil
Immersion oil for fine resolution and brightness, optimized for CellaVision DM
analyzers.
Products may not be available in all markets

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1 INTRODUCTION 7
1.1 About this User's Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.1.1 Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.2 Intended Use of CellaVision DM1200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
1.2.1 Peripheral Blood Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
1.2.2 Body Fluid Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
1.3 General Description of CellaVision DM1200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
1.3.1 Peripheral Blood Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
1.3.2 Body Fluid Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
1.4 Components and Mechanical Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
1.4.1 Major Parts of the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
1.4.2 Control Unit Wiring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
2 OPERATING PROCEDURES 17
2.1 Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
2.2 System Control View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
2.3 Slides and Magazines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
2.3.1 Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
2.4 Loading Slides into a Magazine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
2.5 Processing Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
2.5.1 Adding Magazine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
2.5.2 Starting the Slide Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
2.5.3 Magazine Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
2.5.4 Slide Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
2.6 Ejecting Magazine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
2.7 Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
3 QUALITY CONTROL 25
3.1 Cell Location Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
3.1.1 Cell Location for Peripheral Blood. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
3.1.2 Cell location for Body Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
3.2 Self Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
4 VERIFYING PROCESSED SLIDES 33
4.1 Peripheral Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
4.1.1 White Blood Cell Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
4.1.2 Red Blood Cell Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
4.1.3 Estimating Platelets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
4.1.4 Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50

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4.1.5 Order Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.1.6 Signing a Slide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.2 Body Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
4.2.1 Body Fluids Differential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.2.2 Body Fluids Overview Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
4.2.3 Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.2.4 Order Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.2.5 Signing a Slide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5 REPORTING RESULTS 62
5.1 Merging Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
5.2 Report Preview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
5.3 Signing an Order (result). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
5.4 Sending an Order to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
5.5 Canceling an Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
6 DATABASE AND ARCHIVING DATA 68
6.1 Database: Processed Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.1.1 Order List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
6.1.2 Slide List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6.1.3 Opening an Order/Slide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.1.4 Protecting an Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.1.5 Searching for an Order/Slide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
6.1.6 Deleting an Order/Slide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
6.1.7 Exporting Orders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
6.1.8 Copying Images to Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
6.1.9 Printing Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.1.10 The Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.2 Database: Pending Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
6.2.1 Peripheral Blood: Pending Orders Dialog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
6.2.2 Body Fluid: Pending Orders Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
6.3 Archiving Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
6.4 Usage Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
6.4.1 Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
6.4.2 Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
6.5 Export Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.6 Backup and Recovery of the Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

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7 DIGITAL SLIDES 82
7.1 Scanning a Slide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
7.1.1 Slide and Magazine Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
7.2 Scan Overview Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
7.2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
7.2.2 Navigating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
7.2.3 Tagging Regions of Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
7.2.4 Copying Regions of Interest to Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
7.2.5 Adding Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
7.2.6 Order Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
7.3 Database View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
7.3.1 Processed Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
7.3.2 Pending Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
7.4 Customizing the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
7.4.1 Adjusting Database, Users and Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
7.4.2 Adjusting Default Scan Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
7.4.3 Adjusting Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
7.4.4 Adjusting Autodelete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
8 SYSTEM INFORMATION 92
9 CUSTOMIZING THE SYSTEM 93
9.1 Adjusting Database Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
9.1.1 Creating a New Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
9.1.2 Deleting a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
9.1.3 Creating a New Database Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
9.1.4 Deleting a Database Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
9.1.5 Compressing a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
9.1.6 Setting User Restrictions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
9.2 Adjusting Users Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
9.3 Adjusting Analysis Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
9.4 Adjusting Reclassification Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
9.5 Adjusting RBC Precharacterization Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101
9.6 Adjusting PLT Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
9.7 Adjusting Report/Sign Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
9.8 Adjusting Standard Comments Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
9.9 Adjusting Reference Cells Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
9.10 Adjusting E-mail Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107

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9.11 Adjusting Archiving Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
9.12 Adjusting Language Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
9.13 Adjusting BF Analysis Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
9.13.1 Centering the Analysis Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
9.13.2 Adjusting the Size of the Analysis Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
10 MAINTENANCE 116
10.1 Weekly Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
10.1.1 Cleaning of Objectives and LED table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
10.1.2 Delete Unsigned Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
10.1.3 Clean Bottom Plate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
10.1.4 Restart the System Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
10.2 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
10.3 Remedial Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
10.3.1 Change Immersion Oil Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
10.4 Database Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
10.4.1 Controlling the Database Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
11 TROUBLESHOOTING 121
11.1 Troubleshooting Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
11.2 Troubleshooting Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
11.2.1 General Startup Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
11.2.2 Error Message List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
11.2.3 General Processing Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
11.2.4 LIS Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
11.2.5 Cell Location Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
11.2.6 Barcode Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
11.2.7 Staining Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
11.2.8 Gripper Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
12 CELLAVISION® SOFTWARE 133
12.1 CellaVision® Remote Review Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
12.1.1 Working with Orders/Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
12.2 CellaVision® Competency Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
APPENDIX A — SYSTEM SPECIFICATION 135
APPENDIX B — STORAGE AND HANDLING 145
APPENDIX C — BUTTONS AND INDICATORS 146

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APPENDIX D — RECOMMENDED WORKFLOW 148
Workflow Single Slides / Confirm Cell Counter Results . . . . . . . . . . . . . . . . . . .149
Workflow Duplicate Slides. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
APPENDIX E — USER AUTHORIZATION LEVELS 151
APPENDIX F — DETERMINING THE PLATELET ESTIMATE FACTOR 153
APPENDIX G — SLIDE PREPARATION GUIDELINES 154
Slide Preparation for Peripheral Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154
Example Smears . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .156
Slide preparation for Body Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
APPENDIX H— GLOSSARY 162

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Preface
CellaVision®is a trademark of CellaVision AB.
All other trademarks used in this document are property of their respective owners.
No part of this document or the products it describes may be reproduced or
transmitted by any means or in any form without prior consent in writing from
CellaVision AB.
U.S. patents no. 7450762, 6341180, 6268611 and 7034883. Swedish patent no.
9902863. German patent no. 602004008471. French patent no. 1646964. U.K.
patent no. 1646964.
Caution
US federal law restricts this device to sale by or on the order of a physician (or
properly licensed medical practitioner).
Note! CellaVision Image Capture System is not available on all markets.
Article No. PM-10291
Revision 2012-01-03
Copyright © 2012 CellaVision AB. All rights reserved.
Headquarter
CellaVision AB
Ideon Science Park
SE-223 70 Lund
Sweden
Phone [phone]
Fax [phone]

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User’s Manual
CellaVision®DM1200
User’s Manual
1 Introduction
1.1 About this User's Manual
This User's manual will guide you step-by-step through the activity sequence of
normal use of CellaVision DM1200 (also referred to as the system), aiming for an
efficient way to give you good understanding and knowledge of the system and its
features. References are made to appendices providing additional information.
Some self-explaining dialogs have been left out in the text.
Typographical conventions:
• Names of keys and on-screen objects with which you interact are presented in
italics: e.g. click PRINT.
Note! This User's manual covers all applications (e.g. Peripheral Blood and Body
Fluid applications) available for the CellaVision DM1200 system. The
applicability of some sections in this User’s manual may therefore depend on the
applications installed on the system. Contact your local distributor for more
information.
1.1.1 Warnings and Precautions
Study the meaning of symbols and safety alerts carefully and always use the
system in the safest possible manner. Read all instructions carefully before starting
to use the system. Using it without being suitably qualified, or in a manner not
specified in this User's manual, may damage or deteriorate the system, cause
misleading results or even lead to injury.
Warning alerts appear in this manual as follows:
(Cont'd)
Alert Explanation
WARNING
May cause injury.
Caution
May cause damage to the system.
Important
May cause misleading results.

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(Cont'd)
Place the system on a steady table. Do not place it where it is exposed to bumps or
vibrations, excessive temperature variations or direct sunlight. The system must be
connected to grounded electrical sockets only. Authorized personnel should do the
initial installation and reinstallation after moving the system. Do not install or run
any software not supplied with the system. To maintain electromagnetic
compatibility, use only original components. Spillage of fluid on the surfaces of the
system may cause malfunctions or deterioration. Wipe off spilled fluids
immediately with a soft tissue.
WARNING
The system should be serviced by authorized personnel only.
WARNING
If the equipment is used in a manner not specified by the
manufacturer, the protection provided by the equipment may be
impaired.
The following symbols are found on the system:
Symbol Explanation
Documentation needs to be consulted.
In vitro diagnostic medical device.
Temperature limitation.
This symbol is only valid in the European Community and
indicates separate disposal of waste of electrical and
electronic equipment.
Standby (Supply).
10°C
40°C

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User’s Manual
1.2 Intended Use of CellaVision DM1200
DM1200 is an automated cell-locating device.
DM1200 automatically locates and presents images of blood cells on peripheral
blood smears. The operator identifies and verifies the suggested classification of
each cell according to type.
DM1200 is intended to be used by skilled operators, trained in the use of the device
and in recognition of blood cells.
1.2.1 Peripheral Blood Application
The peripheral blood application (PB) is intended for differential count of white
blood cells, characterization of red blood cell morphology and platelet estimation.
The system automatically locates and presents images of blood cells on peripheral
blood smears. The operator identifies and verifies the suggested classification of
each cell according to type.
1.2.2 Body Fluid Application
DM1200 is an automated system intended for in-vitro diagnostic use.
The body fluid application is intended for differential count of white blood cells.
The system automatically locates and presents images of cells on cytocentrifuged
body fluid preparations. The operator identifies and verifies the suggested
classification of each cell according to type.
DM1200 is intended to be used by skilled operators, trained in the use of the device
and in recognition of blood cells.

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1.3 General Description of CellaVision DM1200
CellaVision DM1200 consists of an optic unit consisting of a microscope and
camera (referred to as a slide scanning unit) and a computer system containing the
acquisition and classification software CellaVision DM software. It is important
that slide preparation is performed according to standardized methods (see
Appendix G — Slide Preparation Guidelines).
General Functionality of the System:
• Receives order information from and sends results to the LIS;
• Scans a user-defined area on a slide;
• Locates and presents images of every located cell or object found on the smear;
• Stores images and results in a database;
• Presents an overview image of a user-defined area on a slide.
1.3.1 Peripheral Blood Application
General Functionality
• Presents an image on a screen of every located cell or object;
• Organizes and suggests cell classification (preclassification) for white blood
cells;
• Makes it possible to identify, confirm or modify (reclassification) the suggested
classification of white blood cells;
• Presents and suggests morphological characteristics (precharacterization) in an
overview image of red blood cells;
• Makes it possible to confirm or modify the precharacterization of red blood cell
morphology;
• Presents an overview image and facilitates platelet estimation.
WBC Preclassification
The system preclassifies the following WBC classes: Band neutrophils, Segmented
neutrophils, Eosinophils, Basophils, Lymphocytes, Monocytes, Promyelocytes,
Myelocytes, Metamyelocytes, Blast cells, Lymphocytes variant forms and Plasma
cells.
The system preclassifies the following non-WBCs: Erythroblasts (NRBC), Giant
thrombocytes, Thrombocyte aggregations, Smudge cells and Artefacts. Non-WBCs
are reported as number of cells or objects /100 WBCs.
Unidentified is a class for cells and objects which the system has preclassified with
a low confidence level.
(Cont'd)

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User’s Manual
(Cont'd)
WBC Reclassification for Peripheral Blood
Besides the cell classes mentioned above, the operator can reclassify cells into the
following classes: Immature eosinophils, Immature basophils, Promonocytes,
Prolymphocytes, Large granular lymphocytes, Hairy cells, Sézary cells, Other,
Megakaryocytes, Not classed and 15 user defined cell classes.
Other should be used for cells which the operator identifies as a WBC, but of a
type other than those listed. WBCs put here will be included in the differential
count.
Not classed should be used for cells and objects which the operator cannot identify
and wants to exclude from the differential count.
RBC Precharacterization
The system precharacterizes the following RBC morphology characteristics in an
overview image: Polychromasia, Hypochromasia, Anisocytosis, Microcytosis,
Macrocytosis and Poikilocytosis.
RBC characterization
The operator can characterize to Target cells, Schistocytosis, Helmet cells, Sickle
cells, Spherocytosis, Elliptocytosis, Ovalocytosis, Tear drop cells, Stomatocytosis,
Acanthocytosis, Echinocytosis, Howell-Jolly bodies, Pappenheimer bodies,
Basophilic stippling, Parasites and 10 user defined characteristics.
Platelet Estimation
The operator counts or estimates platelets in an overview image.
Sample Preparation
To perform a peripheral blood differential count a thin blood film is wedged on a
glass slide (a blood smear) from a peripheral blood sample and stained with
Romanowsky stain (see Appendix G — Slide Preparation Guidelines) for
recommended staining recipes).

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1.3.2 Body Fluid Application
General Functionality
• Presents an image on a screen of every located cell or object;
• Organizes and suggests cell classification (preclassification) for the located
nucleated cells;
• Makes it possible to identify, confirm or modify (reclassification) the suggested
classification of the located cells;
• Presents an overview image.
Preclassification for Body Fluid
The system preclassifies the following WBC classes: Neutrophils, Eosinophils,
Lymphocytes, Macrophages (including Monocytes) and Other. Cells pre-classified
as Basophils, Lymphoma cells, Atypical lymphocytes, Blasts and Tumor cells are
automatically forwarded to the cell class Other.
Unidentified is a class for cells and objects which the system has pre-classified
with a low confidence level.
The system preclassifies the following non-WBCs: Smudge cells and Artefacts.
Non-WBCs are reported as number of cells or objects /100 WBCs.
WBC Reclassification for Body Fluid
Besides the cell classes mentioned above, the operator can reclassify cells into the
following cell classes: Not classed and 15 user defined cell classes.
Not classed should be used for cells and objects which the operator cannot identify
and wants to exclude from the differential count.
Sample Preparation
Body fluid samples are prepared by using a cytocentrifuge and a staining unit. The
sample is centrifuged onto a glass slide and stained with Romanovsky stain (see
Appendix G — Slide Preparation Guidelines for recommended staining recipes).

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User’s Manual
1.4 Components and Mechanical Operation
1.4.1 Major Parts of the System
The system comprises the following major units:
• Computer system
• Slide scanning unit (SSU)
– Motorized microscope
– Digital color camera
– Immersion oil unit
– Robot gripper unit
– Barcode reader
– Control unit
– Casing
Computer System
A PC system running Microsoft®Windows® XP and CellaVision®DM software.

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Slide Scanning Unit:
WARNING
Never tamper with sensors or other safety devices. These make sure
that the system can operate without any risk of personal injury.
Control
unit
Digital color
camera (inside)
Immersion
oil unit
Status lamp Power on
lamp
Magazine
holder
Barcode
reader
Motorized
microscope
Main switch
Hood
Gripper

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User’s Manual
Motorized Microscope
The motorized microscope is an upright light microscope with a LED illumination
system. It has one 10x objective and one 100x objective and intermediate optics
switching between 1.0x and 0.5x magnification which combined yields images
with 5x, 10x, 50x, or 100x magnification.
Digital Color Camera
The camera is a high-quality progressive-scan CCD color camera, for maximum
image quality and high speed image acquisition.
Immersion Oil Unit
The unit automatically applies drops of immersion oil to a slide. An optical drop
counter controls the procedure. The oil pack contains 150 ml.
Robot Gripper Unit
The robot gripper unit enables fully automated focusing and XY-positioning of the
slide during process. It transports a slide from a magazine and back again after the
slide has been processed.
Barcode Reader
The barcode reader scans the barcode of both the slide and the magazine. For
maximum safety, the barcode of the slide is scanned before processing. See
Appendix A — System Specification for more information about barcodes.
Magazine
The magazine can be loaded with up to 12 slides (clipped/round corner slides).
Control Unit
The control unit controls motors, sensors, oil applying and illumination. It
functions as a slave computer to the PC via an unshared 100 Mbit Ethernet
connection.
Casing
The casing comprises a metal cabinet and the main hood.

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1.4.2 Control Unit Wiring
The image shows intenal cable connections to the CCU.