CellaVision DM96 User's Manual ver 3.1

CellaVision® DM96

1 INTRODUCTION

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1.1 About this User's Manual... 7 1.1.1 Warnings and Precautions... 7 1.2 Intended Use of CellaVision DM96... 9 1.2.1 Peripheral Blood Application... 9 1.2.2 Body Fluid Application... 9 1.3 General Description of CellaVision DM96... 10 1.3.1 Peripheral Blood Application... 10 1.3.2 Body Fluid Application... 12 1.3.3 CellaVision® Remote Review... 13 1.4 Components and Mechanical Operation... 13 1.4.1 Major Parts of the System... 13 2 OPERATING PROCEDURES

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2.1 Starting the System... 16 2.2 System Control View... 17 2.3 Slides and Magazines... 18 2.3.1 Barcodes... 18 2.4 Loading Slides into a Magazine... 19 2.5 Processing Slides... 20 2.5.1 Adding Magazines... 20 2.5.2 Starting the Slide Processing... 20 2.5.3

Magazine Status... 21

2.5.4 Slide Status... 22 2.6 Ejecting Magazines... 23 2.7 Handling of STAT Slides... 23 2.8 Shutting Down the System... 23 3 VERIFYING PROCESSED SLIDES, PERIPHERAL BLOOD

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3.1 White Blood Cell Classification... 24 3.1.1 Customizing Views... 27 3.1.2 Reclassifying White Blood Cells... 29 3.1.3 E-mail... 31 3.1.4 Copying Images to Disk... 32 3.2 Red Blood Cell Characterization... 32 3.2.1 Customizing the Red Blood Cell Overview Image... 34 3.2.2 Characterizing Red Blood Cell Morphology... 35 3.2.3 Excluding the Red Blood Cell Analysis... 35

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3.3 Estimating Platelets... 36 3.3.1 Counting Platelets in the Overview Image... 37 3.3.2 Estimating the Platelet Concentration Level... 39 3.3.3 Excluding the Platelet Analysis... 39 3.4 Comments... 39 3.4.1 Adding Comments... 40 3.5 Order Data... 41 3.6 Signing a Slide... 42 3.6.1 White Blood Cells, Red Blood Cells and Platelets... 43 4 VERIFYING PROCESSED SLIDES, BODY FLUIDS

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4.1 Body Fluids Differential... 44 4.1.1 Customizing Views... 46 4.1.2 Reclassifying Cells... 46 4.1.3 E-mail... 46 4.1.4 Copying Images to Disk... 46 4.2 Body Fluids Overview Image... 47 4.2.1 Navigating in the Overview Image... 48 4.2.2 Tagging Regions of Interest... 49 4.2.3 Copying Regions of Interest to Disk... 50 4.3 Comments... 50 4.3.1 Adding Comments... 50 4.4 Order Data... 50 4.5 Signing a Slide... 50 5 REPORTING RESULTS

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5.1 Merging Slides... 51 5.2 Report Preview... 54 5.3 Signing an Order (result)... 54 5.4 Sending an Order to the LIS... 54 5.5 Canceling an Order... 55 6 DATABASE AND ARCHIVING DATA

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6.1 Database - Processed Orders... 56 6.1.1 Order List... 58 6.1.2 Slide List... 60 6.1.3 Opening an Order/Slide... 61 6.1.4 Protecting an Order... 61 6.1.5 Searching for an Order/Slide... 62

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6.1.6 Deleting an Order/Slide... 62 6.1.7 Exporting Orders... 62 6.1.8 Copying Images to Disk... 63 6.1.9 Printing Orders... 63 6.1.10 The Worklist... 63 6.2 Database - Pending Orders... 64 6.2.1 Pending Orders Dialog for Peripheral Blood... 65 6.2.2 Pending Orders Dialog for Body Fluid... 66 6.3 Archiving Data... 66 6.4 Usage Log... 67 6.4.1 Statistics... 67 6.4.2 Specification... 67 6.5 Export Log Files... 68 6.6 Backup and Recovery of the Database... 68 6.6.1 System Backup... 69 6.6.2 Online Backup... 69 6.6.3 Verify Backup... 71 6.6.4 Recovery... 71 7 DIGITAL SLIDES

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7.1 Scanning a Slide... 72 7.1.1 Slide and Magazine Requirements... 72 7.2 Scan Overview Image... 73 7.2.1 Overview... 73 7.2.2 Navigating... 74 7.2.3 Tagging Regions of Interest... 75 7.2.4 Copying Regions of Interest to Disk... 76 7.2.5 Adding Comments... 76 7.2.6 Order Data... 76 7.3 Database View... 77 7.3.1 Processed Orders... 77 7.3.2 Pending Orders... 77 7.4 Customizing the System... 79 7.4.1 Adjusting Database, Users and Language... 79 7.4.2 Adjusting Default Scan Area... 79 7.4.3 Adjusting Analysis... 80 7.4.4 Adjusting Autodelete... 81

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8 SYSTEM INFORMATION

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9 CELLAVISION® REMOTE REVIEW - MULTIPLE USERS

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9.1 Working with Orders/Slides... 83 10 CUSTOMIZING THE SYSTEM

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10.1 Adjusting Database Settings... 85 10.1.1 Creating a New Database... 86 10.1.2 Deleting a Database... 87 10.1.3 Creating a New Database Connection... 87 10.1.4 Deleting a Database Connection... 87 10.1.5 Compressing a Database... 87 10.1.6 Setting User Restrictions... 88 10.2 Adjusting Users Settings... 88 10.3 Adjusting Analysis Settings... 90 10.4 Adjusting Reclassification Settings... 91 10.5 Adjusting RBC Precharacterization Settings... 92 10.6 Adjusting PLT Settings... 93 10.7 Adjusting Report/Sign Settings... 94 10.8 Adjusting Standard Comments Settings... 95 10.9 Adjusting Reference Cells Settings... 97 10.10

Adjusting E-mail Settings... 98

10.11 Adjusting Archiving Settings... 98 10.12 Adjusting Language Settings... 103 10.13 Adjusting BF Analysis Area... 104 10.13.1 Centering the Analysis Area... 104 10.13.2 Adjusting the Size of the Analysis Area... 106 11 QUALITY CONTROL

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12 MAINTENANCE

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12.1

Daily Maintenance... 108

12.2 Weekly Maintenance... 108 12.2.1 Cleaning of Objectives... 108 12.2.2 Slide Guides... 109 12.3 Preventive Maintenance... 110 12.4 Remedial Maintenance... 110 12.4.1 Immersion Oil Refill... 110 12.4.2 Bulb Exchange... 112 12.5 Database Performance... 114

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12.5.1 Controlling the Database Size... 114 13 TROUBLESHOOTING

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13.1 Troubleshooting Steps... 115 13.2 Troubleshooting Chart... 115 13.2.1 General Startup Errors... 115 13.2.2 Hardware Startup Errors... 116 13.2.3 General Processing Problems... 117 13.2.4 Hardware Errors During Processing... 120 13.2.5 LIS Errors... 125 13.2.6 Archiving Errors... 125 13.2.7 Cell Location Problems... 126 13.2.8 Barcode Problems... 128 13.2.9 Staining Problems... 129 13.2.10 Slide Transport Jam... 131 13.2.11 Magazine Transport Jam... 132 APPENDIX A - SYSTEM SPECIFICATION

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APPENDIX B - STORAGE AND HANDLING

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APPENDIX C - BUTTONS AND INDICATORS

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APPENDIX D - RECOMMENDED WORKFLOW

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Workflow Single Slides / Confirm Cell Counter Results... 148 Workflow Duplicate Slides... 149 APPENDIX E - USER AUTHORIZATION LEVELS

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APPENDIX F - DETERMINING THE PLATELET ESTIMATE FACTOR

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APPENDIX G - SLIDE PREPARATION GUIDELINES

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Slide Preparation for Peripheral Blood... 153 Example Smears... 155 Slide preparation for body fluid... 159 APPENDIX H - CELL LOCATION

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Cell Location for Peripheral Blood... 160 Cell location for Body Fluids... 164 APPENDIX I - GLOSSARY

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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. 6268611 and 6341180. Swedish patent no. 517626 and 520829. Other patents pending.

Caution US federal law restricts this device to sale by or on the order of a physician (or properly licensed medical practitioner).

Article No.PM-10340 Revision 2010-04-26 Copyright © 2003-2010 CellaVision AB. All rights reserved.

CellaVision AB Ideon Science Park SE-223 70 Lund Sweden Phone : +46 (0) 46 286 44 00 Fax +46 (0) 46 286 44 70

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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® DM96 (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 DM96 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: Alert

Explanation WARNING

May cause injury.

Caution

May cause damage to the system.

Important

May cause misleading results. (Cont'd)

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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 Indicates that the surface becomes hot and should not be touched with bare hands. Documentation needs to be consulted.

In vitro diagnostic medical device 40°C

Temperature limitation 10°C

This symbol is only valid in the European Community and indicates separate disposal of waste of electrical and electronic equipment On (Supply). Off (Supply).

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1.2

Intended Use of CellaVision DM96 CellaVision® DM96 is an automated system intended for in-vitro diagnostic use. CellaVision DM96: • Scans a user-defined part of a microscope slide; • Automatically locates and presents images of cells on smears from various specimens; • Is intended to be used by skilled operators.

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 The body fluid application (BF) 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.

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CellaVision® DM96

1.3

General Description of CellaVision DM96 CellaVision DM96 consists of a slide feeder unit, 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: • • • •

1.3.1

Receives order information from and sends results to the LIS; 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.

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 WBC. Unidentified is a class for cells and objects which the system has preclassified with a low confidence level. (Cont'd)

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(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 blood 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 WBC. WBC Reclassification for Body Fluid

Besides the cell classes mentioned above, the operator can reclassify cells into the following cell classes: Not classed and 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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1.3.3

CellaVision® Remote Review CellaVision Remote Review is an additional software to CellaVision® DM96. The software gives remote users access to analyzed slides and the possibility to reclassify cells and sign slides from another location. A slide being verified on CellaVision DM96 can simultaneously be opened on a CellaVision Remote Review and vice versa. CellaVision® Remote Review is intended to be used with the Peripheral Blood and the Body Fluid applications. See 9 CellaVision® Remote Review - Multiple Users for more information.

1.4 1.4.1

Components and Mechanical Operation 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 – Slide feeder unit with barcode reader – Magazine feeder unit – Control unit – Casing

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Slide Scanning Unit: Control unit Casing

Digital color camera

Immersion oil unit

Status lamp

Power on lamp Main switch

Objective turret

Motorized microscope

Magazine feeder unit Side feeder unit with barcode reader

WARNING Keep your fingers clear from the objective turret, otherwise personal injury may result. WARNING Do not remove the rear cover, dangerous voltages inside. WARNING The oil may cause sensitization by skin contact. We recommend using gloves.

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Motorized Microscope

The motorized microscope is a fixed-XY-stage upright light microscope with a moving objective focus. It has a motorized 5-position objective turret and a 100 W halogen illumination system. The microscope is motorized for fully automated positioning and focusing of the slide during process. 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 canister capacity is about 500 ml. A sensor detects if the oil level is below 100 ml. Slide Feeder Unit with Barcode Reader

The slide feeder transports slides from a magazine to the stage and back again after the slide has been processed. It is equipped with a barcode reader which scans the barcode of both the slide and the magazine. For maximum safety, the barcode of the slide is scanned both before and after 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). Magazine Feeder Unit

The unit moves magazines from the conveyer to the slide feeder unit and from the slide feeder unit to the output drawer. It is equipped with a counter for the number of magazines in the conveyer and a sensor that warns if the output drawer is full. 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. Computer System

A PC system running Microsoft® Windows® XP and CellaVision® DM software. Casing

The casing comprises a metal cabinet including 5 hatches/drawers: main hatch, lamp hatch, input hatch, service hatch and output drawer. WARNING Never tamper with sensors or other safety devices. These make sure that the system can operate without any risk of personal injury.

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2 Operating Procedures 2.1

Starting the System The CellaVision® DM system computer is configured with a Windows policy restricting access to the operating system for the normal user. When starting the PC the user will automatically be logged onto Windows and then the CellaVision DM Software logon window will be displayed. Start the system as follows: 1. Switch on the slide scanning unit. 2. Switch on the system computer. Wait until the status lamp on the slide scanning unit is flashing or continuously lit (see picture in 1.4.1 Major Parts of the System). 3. In the Log On dialog, type username, password and select the desired database. The following icons indicate available database types: Processing database Export database Scan database CellaVision Competency Software database

4. Click OK.

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2.2

System Control View The System Control View shows the ongoing slide processing, gives an overview of the preclassification and presents a log of processed slide holders. The layout of the System Control View depends on the type of application. Click System Control View in the toolbar. Information in Toolbar

System indicators show oil level, number of magazines etc. For a description of these indicators, see Appendix C - Buttons and Indicators. System status is shown as a text: Idle, Analyzing, Stopped, Paused or Error. System status

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2.3 2.3.1

Slides and Magazines Barcodes Important Only slides labeled with barcodes can be processed. Use only barcode formats appropriate for the system (see Appendix A - System Specification).

Magazine ID

The barcode on the magazine is the magazine ID. When the system has no LIS connection, the magazine ID determines the analysis type. • Orange magazines with barcodes consisting solely of digits - a peripheral blood analysis will be performed. • Blue magazines with barcodes consisting of the prefix ‘BFS’ followed by digits - a body fluid analysis will be performed. Note! LIS order will override the magazine barcode in determining analysis type. Slide ID

The Slide ID is the barcode printed on the slide's label.

(Cont'd)

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(Cont'd) When processing a slide the system searches for order data in the following order: 1. In the database, unsigned orders with the same Order ID. 2. In the database, pending orders. 3. From the LIS. 4. Default values defined in the Analysis tab in Settings.

2.4

Loading Slides into a Magazine Load the slide into the magazine with the barcode upwards and towards the operator. 12 slides can be loaded into a magazine. The slide positions in the magazine are numbered 1-12 from the bottom up.

Caution Use only clipped/round/beveled corner slides. Failing to do so may cause jams and excessive wear on magazines and the system.

Note! The same magazine can be used up to 100 times. When this limit is reached a warning is shown.

Caution If you want to process an already processed slide, carefully wipe the oil off and make sure the barcode is clean and undamaged.

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