CellaVision DM1200 User Manual
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CellaVision DM1200 User Manual

Digital cell morphology system
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CellaVision
DM1200
USER'S MANUAL
3.1 - 3.2

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Summary of Contents for CellaVision DM1200

  • Page 1 ® CellaVision DM1200 USER’S MANUAL 3.1 - 3.2...
  • Page 3 ® CellaVision DM1200 User’s Manual...
  • Page 4 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.

  • Page 5: Table Of Contents

    1.2.2 Body Fluid Application..........9 1.3 General Description of CellaVision DM1200 ....... . .10 1.3.1 Peripheral Blood Application .
  • Page 6 CellaVision DM1200 4.1.5 Order Data ............52 4.1.6 Signing a Slide .
  • Page 7 ® CellaVision DM1200 7 DIGITAL SLIDES 7.1 Scanning a Slide ............82 7.1.1 Slide and Magazine Requirements .
  • Page 8 12.1 CellaVision® Remote Review Software ........
  • Page 9 ® CellaVision DM1200 APPENDIX D — RECOMMENDED WORKFLOW Workflow Single Slides / Confirm Cell Counter Results ....149 Workflow Duplicate Slides......... .150 APPENDIX E —...
  • Page 10 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.

  • Page 11: Introduction

    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.
  • Page 12 ® CellaVision DM1200 (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.

  • Page 13: Intended Use Of Cellavision Dm1200

    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...

  • Page 14: General Description Of Cellavision Dm1200

    DM1200 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 —...
  • Page 15 ® CellaVision DM1200 (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.

  • Page 16: Body Fluid Application

    ® CellaVision DM1200 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;...

  • Page 17: Components And Mechanical Operation

    – 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. User’s Manual User’s Manual...
  • Page 18 ® CellaVision DM1200 Slide Scanning Unit: Control Immersion Motorized Digital color Hood unit oil unit microscope camera (inside) Gripper Barcode Status lamp Power on Magazine Main switch reader lamp holder WARNING Never tamper with sensors or other safety devices. These make sure that the system can operate without any risk of personal injury.
  • Page 19 ® CellaVision DM1200 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.

  • Page 20: Control Unit Wiring

    ® CellaVision DM1200 1.4.2 Control Unit Wiring The image shows intenal cable connections to the CCU. User’s Manual...

  • Page 21: Operating Procedures

    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.

  • Page 22: System Control View

    ® CellaVision DM1200 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.

  • Page 23: Slides And Magazines

    ® CellaVision DM1200 2.3 Slides and Magazines 2.3.1 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.

  • Page 24: Loading Slides Into A Magazine

    ® CellaVision DM1200 Slide ID The Slide ID is the barcode printed on the slide's label. Note! The slide ID may not begin with ‘PB’ or ‘BFS’. When processing a slide the system searches for order data in the following order: 1.

  • Page 25: Processing Slides

    ® CellaVision DM1200 2.5 Processing Slides View the processing in the animated tutorial. Open the animated tutorial, goto Help&Tutorial. Click Analyze. 2.5.1 Adding Magazine Slide the magazine into the magazine holder. The magazine must have the barcode turned upwards and the open end of the magazine inwards.

  • Page 26: Magazine Status

    ® CellaVision DM1200 (Cont'd) The tree in the System Control panel displays a status log of processed magazines and slides. Magazine Slide To empty the log from all information, click Clear Log. 2.5.3 Magazine Status The following information is available for each magazine: Magazine status Magazine ID (barcode).

  • Page 27: Slide Status

    ® CellaVision DM1200 2.5.4 Slide Status The following information is available for each slide: Order/Slide ID Error/warning Slide status Slide position (barcode) text PB2345678912 Default values Slide Status: Processing Slide processed with no warning or error. Slide processed with a warning, see Warning warning texts below.

  • Page 28: Ejecting Magazine

    ® CellaVision DM1200 2.6 Ejecting Magazine The magazine currently being processed can be ejected. 1. Click Stop. Note! Always stop processing before ejecting the magazine. 2. Select Eject in Tools menu. 2.7 Shutting Down the System Shut down the system as follows: 1.

  • Page 29: Quality Control

    ® CellaVision DM1200 3 Quality Control 3.1 Cell Location Performance The Cell location test is used to verify the slide preparation process and the system hardware. The cell location performance shall be verified at regular intervals and after changes in staining procedure or staining solutions by running the Cell location test.
  • Page 30 ® CellaVision DM1200 (Cont'd) Examining a Cell Location Slide Select the slide in question from the list of cell location slides. Slide status Empty Slide has no result (not all images have been examined). Slide has a result and no missed nucleated cells (all images have been examined).
  • Page 31 ® CellaVision DM1200 (Cont'd) Looking at image X of a total of Y images. Step one image back or forth. Number of nucleated cells in the image shown. Number of missed nucleated cells in the image shown (number entered by the user).
  • Page 32 ® CellaVision DM1200 (Cont'd) Total number of nucleated cells and non- nucleated cells found in all the images. Manual correction of nucleated cells found. Total number of nucleated cells missed in all the images. Percentage of how many nucleated cells were found compared to the actual number of nucleated cells on the images.

  • Page 33: Cell Location For Body Fluids

    ® CellaVision DM1200 3.1.2 Cell location for Body Fluids The cell location performance shall be verified at regular intervals and after changes in staining procedure or staining solutions by examining the Cell location test. It is also recommended to run cell location test for each new body fluid specimen analysed in the laboratory.
  • Page 34 ® CellaVision DM1200 (Cont'd) Examining a Cell Location Slide Open the slide in question from the database view. Mini Map Analysis Located area cells The analysis area used for collecting cells is represented by the bright part of the mini map.
  • Page 35 ® CellaVision DM1200 (Cont'd) Black boxes mark the cells that were located but not needed for the test, indicating that the system has located enough cells for the test and is coming to an end. Note! On screen, cell images are not always presented in the same order as the system is working.

  • Page 36: Self Tests

    ® CellaVision DM1200 3.2 Self Tests The system performs self-tests during startup of the software, and at certain points during the operation of the system. When the software starts, the system is checked before the operator can start analyses. During this phase, both the hardware and the software components are tested for anomalies, as well as various requirements for the operation of the system.

  • Page 37: Verifying Processed Slides

    ® CellaVision DM1200 4 Verifying Processed Slides 4.1 Peripheral Blood Opening an unsigned slide leads directly to the Verification View, where various tabs can be selected in order to review WBC, RBC and PLT and to Sign the Slide. To open a slide, see 6.1.3 Opening an Order/Slide.
  • Page 38 ® CellaVision DM1200 (Cont'd) All cell classes handled by the system are displayed in the figure on the following page. WBCs and non-WBCs automatically preclassified by the system are marked with a small dot or an arrow. In settings (see 9.4 Adjusting Reclassification...
  • Page 39 ® CellaVision DM1200 An arrow indicates that pre-classified WBCs are auto-forwarded to another cell class, for settings see 9.4 Adjusting Reclassification Settings. Place the cursor over the arrow to see the destination cell class. Arrow indicating an auto-forwarded cell class...
  • Page 40 Reference Cells: A library of reference cells for different cell classes is provided with the system. These cells are marked with a CellaVision logo. The main gallery always displays WBCs from the slide, while the other show reference cells when checkbox Reference cells is activated.
  • Page 41 ® CellaVision DM1200 (Cont'd) Cell Class Comments: Click Comment in the galleries to add a cell class comment. A pen icon will appear to the right in the WBC and Non-WBCs panels. Click this icon to view, edit or add more comments (see 4.1.4 Comments).
  • Page 42 ® CellaVision DM1200 (Cont'd) Individual settings can also be switched using Toggle Color/Brightness. Toggle Color/Brightness Adjusting Magnification: Click Zoom In or Zoom Out to change the magnification in all galleries and in the WBC Full Screen View. Zoom In Zoom Out Note! You may also double-click on a WBC to enlarge it, and use the scroll wheel to zoom in/out.
  • Page 43 ® CellaVision DM1200 Cell Marker When the Cell Marker function is turned on, a green square marking the cell the system has identified, appears in every cell image. The Cell Marker is used to split cells and identify duplicate cells.
  • Page 44 The image has been manually captured on a CellaVision Image Capture System WBC attributes are shown by default. Click WBC Attributes to show/hide them. Note! It is not possible to hide the CellaVision Image Capture System symbol. WBC Attributes (Cont'd)
  • Page 45 5. Select cell for e-mail. 6. Save cell as custom reference cell. 7. Save images to disk. Note! All alternatives are not available for images captured on a CellaVision Image Capture System. E-mail You may send cell images by e-mail.

  • Page 46: Red Blood Cell Characterization

    ® CellaVision DM1200 Copying Images to Disk You may copy selected images to disk. 1. Select cells for copying. 2. In the right-click menu select Copy images to disk… and the Copy images to disk dialog appears. 3. Specify the destination path where you want the images to be saved, use the browse button to navigate to a suitable folder.
  • Page 47 A thin window frame appears around the ruler when the mouse pointer is moved over it to indicate that the ruler can be moved or have its shape changed. Note! The RBC precharacterization is not available for images captured on a CellaVision Image Capture System User’s Manual...
  • Page 48 ® CellaVision DM1200 Customizing the Red Blood Cell Overview Image Change the magnification of the image by using these buttons: Zoom In Zoom Out Entire RBC Image - Shows the entire RBC image. Navigate the image by switching between different control modes. The mouse pointer changes accordingly.
  • Page 49 ® CellaVision DM1200 Characterizing Red Blood Cell Morphology There are two ways to report the RBC result: a) Report all as normal 1. Select radio button Report all as 0 - Normal. b) Use characterization 1. Select radio button Use characterization.

  • Page 50: Estimating Platelets

    By clicking Help Lines in the toolbar, a grid of lines is drawn over the image to facilitate the counting of PLTs. Note! Help Lines are disabled for images captured on a CellaVision Image Capture System. There are two ways, or modes to perform the PLT estimation. This is determined in PLT settings (see 9.6 Adjusting PLT Settings).
  • Page 51 3. Estimate the average PLT count per grid square and type this value in the field. Note! It is not possible to count PLTs per grid square or to specify an approximate PLT count per grid square for images captured on a CellaVision Image Capture System.
  • Page 52 "0". Note! In the calculations, several decimals are used. The presented results are truncated to 1 decimal. Note! It is not possible to calculate a PLT result for images captured on a CellaVision Image Capture System. User’s Manual...
  • Page 53 CellaVision Image Capture System Select Concentration level. Important The area covered by each square may vary between different CellaVision Image Capture Systems. Excluding the Platelet Analysis Click Exclude PLT Analysis to exclude PLT analysis results from the slide.

  • Page 54: Comments

    ® CellaVision DM1200 4.1.4 Comments For each slide, you can add comments to the WBC, RBC and PLT results. For WBC analyses, you can also add comments to cell classes and individual cells. WBC, RBC and PLT comments are added in Verification View in each tab respectively.
  • Page 55 ® CellaVision DM1200 Adding Comments The system records the author of each comment, except for comments to cell classes and individual cells. If another operator logs in, each comment is tagged with the name of the operator who wrote it. An operator can view all comments but can only edit his/her own.

  • Page 56: Order Data

    ® CellaVision DM1200 (Cont'd) You may activate the Comment types you want to display. Standard comments of type WBC, RBC or PLT will only be available in the respective tab. Standard comments can be added and edited in Settings, see 9.8 Adjusting Standard Comments Settings.

  • Page 57: Signing A Slide

    ® CellaVision DM1200 4.1.6 Signing a Slide A summary of the WBC, RBC and PLT analyses is presented in the Sign Slide tab. The signing procedure is as follows: 1. Click Sign. The Sign Slide dialog appears. 2. Enter User name and Password.
  • Page 58 ® CellaVision DM1200 White Blood Cells, Red Blood Cells and Platelets Before signing a slide, all ordered analyses must have been viewed by the operator. The following conditions must be fulfilled: WBC: • All cell classes must have been viewed, i.e. there should be tick marks after each cell class.

  • Page 59: Body Fluids

    ® CellaVision DM1200 4.2 Body Fluids Opening an unsigned slide leads directly to the Verification View, where the tabs for Overview, WBC and Sign Slide are shown. To open a slide, see 6.1.3 Opening an Order/Slide. Click Verification View in the toolbar.
  • Page 60 ® CellaVision DM1200 (Cont'd) All cell classes handled by the system are displayed in the figure below. WBCs and non-WBCs automatically preclassified by the system are marked with a small dot. Green - Contains no reclassified cells or objects Preclassified by the...
  • Page 61 ® CellaVision DM1200 Customizing Views To Customize views, see Customizing Views. Reclassifying Cells To reclassify cells, see Reclassifying White Blood Cells. E-mail To email cell images, see E-mail. Copying Images to Disk To copy cell images, see Copying Images to Disk.

  • Page 62: Body Fluids Overview Image

    ® CellaVision DM1200 4.2.2 Body Fluids Overview Image The body fluid overview image displays the entire sample area (see 9.13 Adjusting BF Analysis Area). The overview image can be used to find cells of interest and for getting an overall impression of the sample. The overview image can either have one 10x zoom level or both 10x and 50x zoom levels.
  • Page 63 ® CellaVision DM1200 Navigating in the Overview Image Navigate in the overview image by using the keyboard arrow buttons or the navigation buttons. The image shown in the right part of the screen is an enlargement of the area inside the red rectangle shown in the Mini map.
  • Page 64 ® CellaVision DM1200 Tagging Regions of Interest The image shown in the right part of the screen can be saved as a region of interest for later reference. 1. To save the current image, click Tag region. 2. Add a comment as an identifier for the region of interest and click OK.

  • Page 65: Comments

    ® CellaVision DM1200 Copying Regions of Interest to Disk You can copy an individual region of interest image to disk. 1. Select a region of interest. 2. On the right-click menu select Copy image to disk… and the Copy the image to disk dialog appears.

  • Page 66: Reporting Results

    ® CellaVision DM1200 5 Reporting Results For detailed information on settings, see 9.7 Adjusting Report/Sign Settings. Click Report View in the toolbar. Compare slide results and exclude slides from the reported result in the Report View. You can also: • Sign or cancel an order •...

  • Page 67: Merging Slides

    ® CellaVision DM1200 5.1 Merging Slides Compile analysis results for the whole order based on one or several slides in the Slide Merge tab. You can also view all comments associated with an order. Result Panel Here you see the results of each slide in the order. In the Reported Result column you see the summarized results.
  • Page 68 ® CellaVision DM1200 (Cont'd) Including and Excluding Slides in/from the Reported Result Signed slides are automatically included in the reported result.To include or exclude a slide, activate/deactivate the checkbox next to the Slide ID. When excluding slides, a dialog is shown where you may write a comment explaining the exclusion.
  • Page 69 ® CellaVision DM1200 (Cont'd) Comment Panel View all comments associated with the order in the Comment panel. All comments will be included in the report. Note that only the beginning of the comment is shown. To view the whole comment, click on it.

  • Page 70: Report Preview

    ® CellaVision DM1200 5.2 Report Preview Click on the tab Report Preview to preview the report. The report’s format is template based and can be selected in Settings. Refer to 9.7 Adjusting Report/Sign Settings for more details. 5.3 Signing an Order (result) 1.

  • Page 71: Canceling An Order

    ® CellaVision DM1200 5.5 Canceling an Order To cancel an order: sign the order with no included slides. 1. Open the order in the Database View. 2. Select the Slide Merge tab in the Report View. 3. Make sure no slides are included.

  • Page 72: Database And Archiving Data

    ® CellaVision DM1200 6 Database and Archiving Data Click Database View in the toolbar. Processed and pending orders are stored in the database. Switch between the two using the tabs Processed Orders and Pending Orders. 6.1 Database: Processed Orders You can search for and open processed orders and slides stored in the system.
  • Page 73 An order/slide opened by another operator on a CellaVision Remote Review/ CellaVision DM is written in red text. In the Order data and Slide data panels, Locked by indicates who has opened the order/slide (the person logged on to Windows) and on which computer.

  • Page 74: Order List

    ® CellaVision DM1200 6.1.1 Order List The Order List displays an overview of the orders. Click on the column headers to sort the list. The date in column “Analyzed” corresponds to the processing date for the last slide in an order.
  • Page 75 Comments exist. Multi-slide status Empty field One slide in order. More than one slide in order. The order contains a cell counter confirmed result. Order type Empty field Peripheral blood order. CellaVision Image Capture System order. Body fluid order. User’s Manual...

  • Page 76: Slide List

    ® CellaVision DM1200 6.1.2 Slide List Comments, slide- and processing status are indicated in the slide list. Comments Slide status Processing status Process status Slide processing OK. Slide processing stopped. No result exists. The required numbers of WBCs were not found, one of the ordered analyses failed, or the order was not found in the LIS, slide processed with default values.

  • Page 77: Opening An Order/Slide

    ® CellaVision DM1200 6.1.3 Opening an Order/Slide Opening an order automatically opens a slide belonging to it. In the same manner, opening a slide automatically opens the order it belongs to. The currently opened order and slide are always shown in the toolbar.

  • Page 78: Searching For An Order/Slide

    You may also add search strings for patient data, order data and comments. If the database contains a slide which is captured on a CellaVision Image Capture System and you choose “View CellaVision Image Capture System”...

  • Page 79: Copying Images To Disk

    • Orders imported to an Export database will always have a "protected" flag preventing them from being autodeleted (if autodelete is enabled). • Only peripheral blood orders can be exported to CellaVision Competency Software databases. • Orders residing in a Scan database cannot be exported.

  • Page 80: Printing Orders

    ® CellaVision DM1200 6.1.9 Printing Orders Print order data and data for all slides belonging to it by selecting the order or slide of choice in the Database View and then Print in the File menu. Note! Order results exist only if the order contains at least one signed slide.

  • Page 81: Database: Pending Orders

    Order is marked as a STAT order. Order type Empty field Peripheral blood order. CellaVision Image Capture System order. Body fluid order. 1. Click Add to add a new pending order. 2. Double-click on a pending order, or click Edit, to view/edit the Order Data.

  • Page 82: Peripheral Blood: Pending Orders Dialog

    ® CellaVision DM1200 6.2.1 Peripheral Blood: Pending Orders Dialog User’s Manual...

  • Page 83: Body Fluid: Pending Orders Dialog

    ® CellaVision DM1200 6.2.2 Body Fluid: Pending Orders Dialog 6.3 Archiving Data Initially, make sure valid archiving settings have been specified.Refer to 9.11 Adjusting Archiving Settings for details. Select Tools and Archive. The Archiving Guide will appear, explaining the procedure on how to archive data.

  • Page 84: Usage Log

    ® CellaVision DM1200 6.4 Usage Log The system continuously saves data of processed slides and stores it in a Usage Log. To view the log select Tools and View Log. The log consists of two pages: Statistics and Specification. 6.4.1...

  • Page 85: Export Log Files

    It is important to backup the database quite often. If a hard disk crash occurs, the whole database will be lost. It will only be possible to recover the data up to the time when the last backup was made. For more information, see CellaVision IT Configuration Guidelines or contact your distributors.

  • Page 86: Digital Slides

    7.1 Scanning a Slide Make sure that a Scan Database is available on your CellaVision DM. To create a Scan Database, see 9.1.1 Creating a New Database.

  • Page 87: Scan Overview Image

    ® CellaVision DM1200 7.2 Scan Overview Image Opening a scanned slide leads directly to the Scan Verification View. To open a slide, see 6.1.3 Opening an Order/Slide. 7.2.1 Overview The Mini Map shown in the Overview displays the entire sample area. To enlarge a specific area of the sample, click in the Mini Map.

  • Page 88: Navigating

    ® CellaVision DM1200 7.2.2 Navigating Move efficiently in the Mini Map by using the keyboard arrows or the Navigation Buttons. The image shown in the right part of the screen is an enlargement of the area inside the red rectangle shown in the Mini map. Click on the Mini map to enlarge another part of the sample.

  • Page 89: Tagging Regions Of Interest

    ® CellaVision DM1200 7.2.3 Tagging Regions of Interest To save an enlarged area as a region of interest for later reference, click Tag region. Identify your region of interest by adding a comment. User’s Manual...

  • Page 90: Copying Regions Of Interest To Disk

    ® CellaVision DM1200 7.2.4 Copying Regions of Interest to Disk You can copy a region of interest to disk. 1. Select a tagged region of interest in the list. 2. Right-click and select Copy the image to disk…. 3. Specify the destination path where you want the image to be saved.

  • Page 91: Database View

    ® CellaVision DM1200 7.3 Database View To view processed and pending orders, click Database View. Click Database View in the toolbar. 7.3.1 Processed Orders Scanned slides are automatically signed. For more details about Processed orders, see 6.1 Database: Processed Orders.
  • Page 92 ® CellaVision DM1200 (Cont'd) To define scan area for the slide, click Area. Define the area that you want to scan on this particular slide. Note! If no scan area is defined, the default scan area setting will be used.

  • Page 93: Customizing The System

    ® CellaVision DM1200 7.4 Customizing the System To customize the system, go to the Tools menu and select Settings. 7.4.1 Adjusting Database, Users and Language To adjust the settings for database, users and language, see 9.1 Adjusting Database Settings, 9.2 Adjusting Users Settings and 9.12 Adjusting Language Settings.

  • Page 94: Adjusting Analysis

    ® CellaVision DM1200 7.4.3 Adjusting Analysis To adjust the default analysis settings, 10x or 10x and 50x magnification, go to Tools/Settings/Analysis. To adjust the analysis settings for individual slides, click Database View and choose Pending Orders. See 7.3.2 Pending Orders.

  • Page 95: Adjusting Autodelete

    ® CellaVision DM1200 7.4.4 Adjusting Autodelete It is not possible to archive the orders. All orders will be autodeleted after a specified number of days. Autodelete Strategy The autodelete strategy depends on your throughput and the need for saving images for future use. The autodelete settings are database specific, enabling each database to have its own autodelete strategy.

  • Page 96: System Information

    ® CellaVision DM1200 8 System Information In the toolbar, click Help and then System Information for information about your system. The information presented depends on your system and installed software. Some of the following information is present in the System Information dialog: •...

  • Page 97: Customizing The System

    ® CellaVision DM1200 9 Customizing the System Settings are stored in either the system or the database. A setting that is stored in the system applies to that system only. Other systems connected to the same database as the system may have other values of the setting.

  • Page 98: Adjusting Database Settings

    ® CellaVision DM1200 9.1 Adjusting Database Settings Here you create new databases and new database connections. In the Log On dialog you select which database to use. It is also possible to compress an existing local database. Local database Remote database...

  • Page 99: Creating A New Database

    Creating a database requires that there is sufficient free disk space. A processing database requires 20 GB, a scan database requires 20 GB, an export database requires 1 GB and a CellaVision Competency Software database requires 100 MB. Note! Having many databases affects system performance negatively.

  • Page 100: Deleting A Database

    ® CellaVision DM1200 9.1.2 Deleting a Database 1. Select the database in the list. 2. Click Delete. 9.1.3 Creating a New Database Connection 1. Click Connect. A dialog appears where you may enter Database name, Description and Remote computer. 2. Click OK. A new connection will be shown in the list.

  • Page 101: Setting User Restrictions

    ® CellaVision DM1200 9.1.6 Setting User Restrictions Here you set the available database search criteria for the Restricted user. Select the desired Restricted user search options. 9.2 Adjusting Users Settings Show inactive users: Activate this checkbox if inactive users shall be shown in the list.
  • Page 102 ® CellaVision DM1200 (Cont'd) There are 5 levels of user authorization: Observer: Only allowed to view images and results. User: Can reclassify and recharacterize WBC, RBC and PLT, but not sign slides. Authorized: Same as User, but can sign slides and orders.

  • Page 103: Adjusting Analysis Settings

    ® CellaVision DM1200 9.3 Adjusting Analysis Settings Default values These values are used if the order to analyze is not found in the database or in the LIS. Type of order is the analysis to perform. Enable LIS Activate this checkbox and restart the program if the LIS will be used.

  • Page 104: Adjusting Reclassification Settings

    ® CellaVision DM1200 9.4 Adjusting Reclassification Settings Forward preclassified cells: Select your forwarding criteria using the checkboxes. User’s Manual...

  • Page 105: Adjusting Rbc Precharacterization Settings

    ® CellaVision DM1200 9.5 Adjusting RBC Precharacterization Settings Here you adjust the percentage limits for the different levels of the morphology characteristics. It is also possible to disable the RBC precharacterization. Enable RBC precharacterization: Deactivate this checkbox if RBC precharacterization shall not be performed. Manual RBC characterization will still be possible.

  • Page 106: Adjusting Plt Settings

    ® CellaVision DM1200 9.6 Adjusting PLT Settings In the PLT tab you set the PLT estimate factor and the limits for the PLT concentration levels. You also set the default settings for the grid size, PLT count and PLT concentration result. It is also possible to enable the option to use manual PLT concentration estimation.

  • Page 107: Adjusting Report/Sign Settings

    ® CellaVision DM1200 (Cont'd) Defaults for PLT tab: Sets the default values for Grid size, PLT count and PLT concentration. Intervals for average PLTs/HPF value: These intervals are used to calculate the PLT result Calculated level. 9.7 Adjusting Report/Sign Settings In the Report/Sign tab you set the template to use in printed reports and the default settings for the signing dialogs.

  • Page 108: Adjusting Standard Comments Settings

    ® CellaVision DM1200 9.8 Adjusting Standard Comments Settings Include code in comment: If activated, the code is written together with the standard comment. Always show expanded: If activated, the standard comments are visible by default when the comment dialog is opened.
  • Page 109 ® CellaVision DM1200 (Cont'd) Adding a New Standard Comment 1. Click New. 2. The Standard Comments Editor appears. 3. Enter Code, Comment type and Comment. Standard comments of type WBC, RBC, PLT or BF will only be available in the respective tab. General comments are always accessible.

  • Page 110: Adjusting Reference Cells Settings

    ® CellaVision DM1200 9.9 Adjusting Reference Cells Settings Click on a cell class to see a list of all Custom reference cells belonging to it. Click on a specific cell to display it in the Preview window. Click Add to add custom reference cells from disk. Valid file formats are JPEG (".jpg") and bitmap (".bmp").

  • Page 111: Adjusting E-Mail Settings

    ® CellaVision DM1200 9.10 Adjusting E-mail Settings Enter Default recipient of e-mail, specify Mail server and E-mail from, i.e. sender of e-mail. 9.11 Adjusting Archiving Settings For storage safety reasons and limited hard disk capacity, it is recommended that you regularly archive the cell images or delete the orders. When you archive, the cell images and comments are transferred from the database to a CD or a hard disk.
  • Page 112 ® CellaVision DM1200 (Cont'd) Note! Only images from signed slides can be archived. Orders Archiving Strategy The archiving strategy depends on your daily throughput and the need for saving images for future use. The autodelete/archiving settings are database specific, enabling each database to have its own archiving strategy.
  • Page 113 ® CellaVision DM1200 (Cont'd) 1. Autodelete (Autodelete instead of archive, activated) All signed orders are permanently deleted when the time has expired. However, autodelete will not begin until the specified number of candidates has been reached. Example: With the setting above, autodelete will not begin until there are 300 orders older than 30 days.
  • Page 114 ® CellaVision DM1200 (Cont'd) PB Cell images Overview images: RBC and PLT Normal cells: Segmented neutrophils Monocytes Basophils Lymphocytes Eosinophils Abnormal cells: Band neutrophils Lymphocytes variant forms Prolymphocytes Promyelocytes Plasma cells Large granular lymphocytes Myelocytes Immature eosinophils Hairy cells Metamyelocytes Immature basophils Sézary cells...
  • Page 115 ® CellaVision DM1200 Archiving Recommendations It is recommended to keep the size of the database below 20 GB for optimal database performance. Always combine archiving with a backup of the database. The database contains the path to the archived images. If a hard disk crash occurs, it will not be possible to restore the archived images, unless a backup exists.

  • Page 116: Adjusting Language Settings

    ® CellaVision DM1200 9.12 Adjusting Language Settings In the Language tab you set language for the user interface and manual. User’s Manual...

  • Page 117: Adjusting Bf Analysis Area

    ® CellaVision DM1200 9.13 Adjusting BF Analysis Area 9.13.1 Centering the Analysis Area Before using the system for the first time or when necessary, define the sample spot location. This is done in Tools/Settings/BF Analysis Area. 1. Go to Tools/Settings/BF Analysis Area and select the desired setting for Centrifuge.
  • Page 118 ® CellaVision DM1200 (Cont'd) The Diameter setting was 8 mm in the example below. In order to center the analysis area on the sample spot, the analysis area needs to be offset by 1.5 mm in the positive x direction and 1.5 mm in the negative y direction.

  • Page 119: Adjusting The Size Of The Analysis Area

    ® CellaVision DM1200 9.13.2 Adjusting the Size of the Analysis Area To adjust the size of the analysis area, do as follows: 1. Go to Tools/Settings/BF Analysis Area and select the desired setting for Diameter. 2. Restart the program, delete the order and rerun the slide to verify your new setting.

  • Page 120: Maintenance

    ® CellaVision DM1200 10 Maintenance Caution Be careful not to bend or put excessive force to any part of the system interior. 10.1 Weekly Maintenance 10.1.1 Cleaning of Objectives and LED table Clean the objectives and the LED table folllowing the intructions in the animated tutorial.

  • Page 121: Clean Bottom Plate

    ® CellaVision DM1200 10.1.3 Clean Bottom Plate Pull out the bottom plate and wipe clean any immersion oil. 10.1.4 Restart the System Computer Restart the system computer at least once a week. User’s Manual...

  • Page 122: Preventive Maintenance

    WARNING The oil may cause sensitization by skin contact. We recommend using gloves. Caution Use only immersion oil recommended by CellaVision AB (see Appendix A — System Specification). Change Oil Pack a) Open the hood. b) Place clip on hose.
  • Page 123 ® CellaVision DM1200 (Cont'd) d) Change the oil pack and connect the hose. e) Remove the clip from the hose. f) Goto Maintenance/Oil. g) Click Reset Oil Drop Counter. Note! If the oil pack and all hoses are emtpy, Click Prime Oil before Reseting oil drop counter.

  • Page 124: Database Performance

    ® CellaVision DM1200 10.4 Database Performance To maintain a high database performance, it is very important to control the size of the database. It is also recommended to restart the system computer at least once a week. It is allowed to install an anti virus program, but it is not recommended to scan the database files.

  • Page 125: Troubleshooting

    ® CellaVision DM1200 11 Troubleshooting 11.1 Troubleshooting Steps If a problem occurs, follow these steps: 1. Observe any unusual circumstances surrounding the problem. 2. Note any error messages displayed. 3. See 11.2 Troubleshooting Chart to find possible remedies. 4. If the problem remains, contact your distributor for assistance.

  • Page 126: Error Message List

    ® CellaVision DM1200 11.2.2 Error Message List Error Message Cause Action Startup error messages The system is not ready Temporary Restart the SSU and the system software error. computer. The configuration of the The Control unit Contact your local vendor’s technical...
  • Page 127 ® CellaVision DM1200 Error Message Cause Action Hardware errors during analysis/eject/maintenance This operation can not be Communication Restart the SSU and the program. performed at this time error between SSU and system computer. Communication failure No connection Check the connection between the between the SSU and the system computer.
  • Page 128 ® CellaVision DM1200 Error Message Cause Action The slide gripper has Gripper has Pull out bottom tray and remove slide. unexpectedly lost the dropped the Restart the SSU and the program. slide slide. The slide could not be Magazine is...

  • Page 129: General Processing Problems

    ® CellaVision DM1200 11.2.3 General Processing Problems Problem Cause Action WBC images are not System needs Contact your local vendor’s technical centered on the cell, but calibration or support. the cell can still be alignment. seen. Slide status: Too small monolayer Prepare the slides with longer blood found.
  • Page 130 ® CellaVision DM1200 Problem Cause Action Database access is The database server Restart the system computer, or the slow. needs to be computer on which the database is restarted. stored. The database is too Keep the database size at the large.

  • Page 131: Lis Errors

    ® CellaVision DM1200 11.2.4 LIS Errors Problem Cause Action Slide status: The orders are not in Make sure that orders for the slides that the LIS. are to be processed are already Default values available in the LIS. The connection to the...

  • Page 132: Cell Location Problems

    ® CellaVision DM1200 11.2.5 Cell Location Problems Cell Location Problems Peripheral Blood Problem Cause Action Too many non- Too many smudge Run another slide with less smudge nucleated cells. cells. cells. Verify smear preparation process. Too many artefacts. Increase wash step.
  • Page 133 ® CellaVision DM1200 Cell Location Problems Body Fluids Problem Cause Action Too many non- Too many smudge Run another slide with less smudge WBCs. cells. cells. Verify sample preparation process. Decrease centrifuge speed. Too many artefacts. Increase wash step. Filter the stain.

  • Page 134: Barcode Problems

    ® CellaVision DM1200 11.2.6 Barcode Problems Problem Cause Action The barcode could Blurry barcode, Make sure the barcode is resistant to not be read. caused by immersion oil. immersion oil on the Print the barcode as defined in Appendix barcode.

  • Page 135: Staining Problems

    ® CellaVision DM1200 11.2.7 Staining Problems Problem Cause Action The red cells appear Understaining. The fixation and staining time may be bright red, the white increased. cells will appear Overwashing. The washing technique may be indistinct with pale corrected so that it is adequate but not blue rather than excessive.

  • Page 136: Gripper Service

    ® CellaVision DM1200 Problem Cause Action Samples have dark Drying is occurring Ensure the adequate drying of samples areas of stain or during the period of previous to staining. other artefacts. staining. Unclean slides. Use clean slides. Inadequate washing Increase wash step.

  • Page 137: Cellavision® Software

    Database The operating procedures in Database View, Verification View and Report View are the same for CellaVision Remote Review as CellaVision DM. Note! It is not possible to process slides or archive data using CellaVision Remote Review Software. User’s Manual...

  • Page 138: Working With Orders/Slides

    12.1.1 Working with Orders/Slides When opening an order/slide with CellaVision DM1200 or a CellaVision Remote Review the order and the slide will be locked for other operators. In all other CellaVision Remote Review and CellaVision DM systems connected to the database this is indicated with red text in the Order list and Slide list in the Database View (see 6.1 Database: Processed Orders).

  • Page 139: Appendix A - System Specification

    Climate Specification ® CellaVision DM1200 is designed to be safely operated at 18 °C to 31 °C (64 °F to 88 °F), at a maximum relative humidity of 90% with no condensation allowed, indoor use and altitudes up to 2000 m.
  • Page 140 (100 WBCs) containing both 10x and 50x overview images (6 mm analysis area). To evaluate the Accuracy and Short-term imprecision of the Body Fluid application for DM1200, a comparison study was conducted at two sites with 5 operators. CellaVision DM1200 running the body fluid application was compared to CellaVision DM96 running the body fluid application.
  • Page 141 ® CellaVision DM1200 (Cont'd) Accuracy results for CellaVision DM1200 with the body fluid application: Specimen Cell class Slope Intercept (%) # of samples Neutrophils 1.0005 0. 16 0.9919 Lymphocytes 0.9703 0. 27 0.9897 Eosinophils 0.7573 0. 05 0.7893 Macrophages 0.9944 -0.
  • Page 142 ® CellaVision DM1200 (Cont'd) A reproducibility study was conducted at three different sites on three different instruments, each site processing the samples in duplicates. The study was performed during 20 days at each site and run by in total 10 operators. The results are an extract from the study and based on pre-classification data presented in the table below.
  • Page 143 Refractive index 1.5150. Viscosity 300 cSt. PCB free. 150 ml oil bag should be sufficient for approximately 3000 analyses. CellaVision slide magazines. Stain: May Grünwald Giemsa, Wright, or Wright Giemsa. Slide requirements (mm): glass, 75.0-76.0 x 25.0-26.0 x 0.9-1.2*, ground edges, clipped or round corners.
  • Page 144 ® CellaVision DM1200 (Cont'd) Slide descriptions: Round corner Clipped corners Images provided by Erie Scientific (www.eriesci.com) Caution Use only clipped/round corner slides. Failing to do so may cause jams and excessive wear on magazines and the system. Caution Using the magazines more than 100 times may damage the system.
  • Page 145 ® CellaVision DM1200 (Cont'd) The label should be positioned as shown in the figure below. The edges of the label shall be at least 1 mm from the edges of the slide. Note! Avoid oil on the slide label. Barcode length...
  • Page 146 If the barcode is printed directly onto a slide, it must be printed on a white, smooth, frosted area of the slide. Barcode size The following barcode resolutions have been verified at CellaVision. Supported code resolution Code Cell size, mil...
  • Page 147 ® CellaVision DM1200 (Cont'd) Quiet zone The recommended quiet zone is listed in the table below. Vertical quiet zone, cells Horizontal quiet zone, cells Symbology Bottom Bottom DataMatrix Barcode position The barcode shall be positioned within the area as illustrated in the figure below.
  • Page 148 ® CellaVision DM1200 Firefighting Procedures Fire and explosion hazard: Flash point (immersion oil) : >300ºF / 149ºC Upper explosive limit: N/A Lower explosive limit: N/A Fire fighting media: Carbon dioxide, foam, dry chemical, and waterfog. Fire response procedures: Fire fighters must use self-contained breathing apparatus.

  • Page 149: Appendix B - Storage And Handling

    (50 °F to 104 °F), at a maximum relative humidity of 80% with no condensation allowed. Transporting the System The system shall be packaged, transported and unpacked by CellaVision authorized personnel/carrier only. We recommend saving the package for possible future transports.

  • Page 150: Appendix C - Buttons And Indicators

    ® CellaVision DM1200 Appendix C — Buttons and Indicators If you place the mouse-pointer over the buttons or indicators, you can view tool tips in the Status bar (bottom left-hand corner). Buttons ® CellaVision DM software System Control View Database View...
  • Page 151 ® CellaVision DM1200 Adjusts image color and Color/Brightness brightness. Toggles between default color Toggle Color/Brightness and lights settings and personal settings. Shows/Hides square for cell Cell Marker identification. WBC Attributes Shows/Hides WBC attributes. Entire RBC Image Shows the entire RBC image.

  • Page 152: Appendix D — Recommended Workflow

    ® CellaVision DM1200 Appendix D — Recommended Workflow Laboratories handle their peripheral blood differential counts in different ways making it hard to suggest one general workflow suitable for all laboratories. See flowcharts of the three workflows below. Recommended Settings (see 9.7 Adjusting Report/Sign Settings) 1.

  • Page 153: Workflow Single Slides / Confirm Cell Counter Results

    ® CellaVision DM1200 Workflow Single Slides / Confirm Cell Counter Results Go to Database View (Shift+F1). Select orders. Click Add to worklist. Double-click on the first slide in the Worklist. Verify WBC. Click RBC tab. Perform RBC review. Click PLT tab.

  • Page 154: Workflow Duplicate Slides

    ® CellaVision DM1200 Workflow Duplicate Slides Go to Database View (Shift+F1). Select orders. Click Add to worklist. Click on the Slide Nbr header in the Worklist. Select all slides with Slide Select all slides with Slide Nbr 2. Click Remove.

  • Page 155: Appendix E — User Authorization Levels

    ® CellaVision DM1200 Appendix E — User Authorization Levels Action/Setting Observer User Restricted Authorized Administrator Start slide processing Search in the database on Order ID and Patient ID Search in the database on other criteria Verify and comment WBC, RBC and PLT...
  • Page 156 ® CellaVision DM1200 Action/Setting Observer User Restricted Authorized Administrator PLT settings Use only manual PLT concentration estimation Defaults for PLT PLT estimate factor Intervals for average PLTs/HPF Report/Sign settings Standard comments settings Reference cells settings Cell Location E-mail settings Archiving settings...
  • Page 157 ® CellaVision DM1200 Appendix F — Determining the Platelet Estimate Factor Follow the procedure below to determine the PLT estimate factor. 1. Perform automated PLT counts with a cell counter on 30 consecutive blood samples. 2. Prepare and stain one smear for each sample.

  • Page 158: Appendix G — Slide Preparation Guidelines

    ® CellaVision DM1200 Appendix G — Slide Preparation Guidelines Slide Preparation for Peripheral Blood WARNING Always use protective gloves when in contact with blood. Sample Collect blood from a vein or by skin puncture in an EDTA sample tube (K...
  • Page 159 ® CellaVision DM1200 (Cont'd) 4. Dry the slide rapidly. 5. Stain the slide within one hour. 33 mm 5-15 mm The dot in the image indicates the analysis starting point. The analysis proceeds from the starting point towards the thinner part of the smear.

  • Page 160: Example Smears

    The line in the images indicates the analysis starting point. Accepted These slides are all prepared according to the specifications. Not Accepted These slides are not prepared according the specifications and might not be accepted in the DM1200. (Cont'd) User’s Manual...
  • Page 161 ® CellaVision DM1200 (Cont'd) Recommended Staining Recipes ® CellaVision DM is optimized to analyze samples stained with May Grünwald Giemsa (MGG) stain, Wright stain and Wright Giemsa stain. Dip the slides in the solutions according to one of the following recipes.
  • Page 162 ® CellaVision DM1200 (Cont'd) May Grünwald stain, stock solution: Merck M1424 Eosin-methylenblue solution, modified for microscopy (contains methanol). Store at +15 ºC to +25 ºC. May Grünwald working solution: Dilute 1 part of May Grünwald stock solution with 1 part buffer work solution.
  • Page 163 ® CellaVision DM1200 (Cont'd) Wright Stain Note! Differences in staining results may be cause by alterations in pH, reagents etc. Local adjustments may be needed to achieve best results. Be aware of pH variations in water. Alternative 1: Sysmex SMS SP 100 slide stainer...
  • Page 164 ® CellaVision DM1200 (Cont'd) Wright Giemsa Stain Note! Differences in staining results may be cause by alterations in pH, reagents etc. Local adjustments may be needed to achieve best results. Be aware of pH variations in water. Beckman Coulter LH755 slide stainer or manual dip method.

  • Page 165: Slide Preparation For Body Fluids

    ® CellaVision DM1200 Slide preparation for Body Fluids WARNING Always use protective gloves when in contact with Body Fluids. Sample Quantitative assessment of cell counts and preparation of slides should be performed within 2 hours of collection. Preparing the Sample Count the WBC and RBC concentration of the fluid.

  • Page 166: Appendix H— Glossary

    ® CellaVision DM1200 Appendix H— Glossary Description Analysis Starts with the loading of slides and ends with the finished report. Confirmation The operator approves the preclassification. Duplicate slide differential Two different persons sign one slide each in the order. The average result is presented.
  • Page 167 ® CellaVision DM1200 Region of interest Part of the BF or Scan overview image tagged by the operator. Romanowsky stain An eosin-methylenblue solution for staining of blood smears. Wright and MGG are examples of different Romanowsky stains. Signing Finally confirming analysis results before locking and reporting them.
  • Page 168 ® CellaVision DM1200 ® CellaVision DM1200 Archive status ..... . . 71 Indicators ..... 146, 147 Archiving .
  • Page 169 ® CellaVision DM1200 ® CellaVision DM1200 Scanning a Slide ..... .82 Settings ......148 Shut down .
  • Page 170 ® CellaVision DM1200 ® CellaVision DM1200 User’s Manual...
  • Page 172 CellaVision AB • Ideon Science Park • SE-223 70 Lund, Sweden Phone +46 (0) 46 286 44 00 • Fax +46 (0) 46 286 44 70 info@cellavision.com • www.cellavision.com PM-10291 2012-01-03...

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