cellavision dm96 operator s manual

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. 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. It is important that slide preparation is performed according to standardized methods (see Appendix G — Slide Preparation Guidelines). 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. 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.

• cellavision dm96 operator s manual, cellavision dm96 operator s manual pdf, cellavision dm96 operator s manual download, cellavision dm96 operator s manual free, cellavision dm96 operator s manual online.

Contact Us to Register Your Interest Already a member. 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. All rights reserved. References are made to appendices providing additional information. Some self-explaining dialogs have been left out in the text. 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. 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.

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 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. WARNING Never tamper with sensors or other safety devices. These make sure that the system can operate without any risk of personal injury. 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.

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). 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. 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. Sample Preparation Body fluid samples are prepared by using a cytocentrifuge and a staining unit. 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. WARNING Do not remove the rear cover, dangerous voltages inside. WARNING The oil may cause sensitization by skin contact. It has a motorized 5-position objective turret and a 100 W halogen illumination system.

3 Magazine Status The following information is available for each magazine: Magazine status Magazine ID (barcode). 012345678912 Magazine Status: Analyzing User’s User’sManual Manual Finished The slide holder is processed and all slides have status OK. Warning A slide with status Warning, Stopped, Failed or Cancelled exists in the magazine. Warning Slide processed with a warning, see warning texts below. Results exist. Stopped Slide processing stopped by user. No results exist. All ordered analyses failed, see error texts below. No results exist. The slide was cancelled in the LIS. Slide not Cancelled processed. Empty slide position in the magazine or no Empty or no slide PID barcode on slide. Error Empty Warning Texts: Default values The order was not found in the LIS. The required number of WBCs were not found or one Incomplete analysis of the ordered analyses failed. Error Texts: Invalid slide PID Analysis failure Critical failure Invalid barcode on the slide. Slide processing failed. A critical error occurred. Slide Information Dialog Double-click on a slide to open the Slide Information dialog. Handling of STAT Slides 1. Eject the magazine. 2. Load the STAT slide in slide position 1 in a magazine. 3. Open the input hatch and put the magazine to the left of the other magazines. Note! The leftmost magazine can be hard to pull out. Open and close the input hatch and the conveyor will move the magazines to the right. 4. Click Start. 2.8 Shutting Down the System Shut down the system as follows: 1. 2. 3. 4. User’s User’sManual Manual Eject any remaining magazine from the system. Select Exit in the File menu. Switch off the system computer. Click Verification View in the toolbar. Note! With DMConfiguration tool it is possible to add user defined WBC cell classes and RBC characteristics. To do this, contact your service personnel. 3.1 White Blood Cell Classification You can view all WBCs identified by the system. You may also reclassify WBCs and add comments.

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. Use only barcode formats appropriate for the system (see Appendix A — System Specification). Magazine ID The barcode on the magazine is the magazine ID. Note! LIS order will override the magazine barcode in determining analysis type. In the database, pending orders. From the LIS. Default values defined in the Analysis tab in Settings. 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. 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. The magazines must have the barcode turned upwards and the open end of the magazine inwards. When all slides in a magazine have been processed, the magazine is automatically ejected into the output drawer. 2.5.2 Starting the Slide Processing Click on the Start button to start the slide processing. If you want the processing to start automatically when a magazine is inserted into the system, you can enable autostart in Analysis Settings. You still have to manually start the processing if the system has been stopped, restarted or if an error has occurred. Start button Autostart - Replaces the Start button. Magazine Slide To empty the log from all information, click Clear Log. 2.5.

The decrease of cytology proficiency in the daily practice, the need for development of new innovative techniques in hematology laboratories in the face of limited human resources, and finally, the increase and the complexity of pathologies attributable to population aging create a need for automation of the cytology platform in all laboratories. Adult and pediatric hematology account for 10% of the demands, oncology represents 15% and surgical and intensive cares about 20%. A slide autoloader facilitates the automatic analysis of up to 96 smears with continuous loading access. The number of WBC to be analyzed is user definable from 100 up to 400. To perform a differential count, a thin film of blood is wedged on a glass slide (a blood smear) from a peripheral blood sample and stained according to the May-Grunwald Giemsa protocol. The analyzer performs the acquisition and preclassification of cells and the operator subsequently verifies and modifies, if necessary, the suggested classification of each cell ( Figure 2 ). The operator can also introduce additional observations and comments when needed. The system makes the following WBC classifications: band neutrophils, segmented neutrophils, eosinophils, basophils, monocytes, lymphocytes, promyelocytes, myelocytes, metamyelocytes, blast cells, variant form lymphocytes and plasma cells. The system has four flag levels for the following RBC morphological characteristics: polychromasia, hypochromasia, anisocytosis, microcytosis, macrocytosis, and poikilocytosis. Staining program and reagents were as follows: May Grunwald (MG) and Giemsa (Biolyon, France), MG pure time: 2.5 min, MG dilute time: 3 min, Giemsa time: 7 min, rinse 0 min and drying time 5 min. Finally, we analyzed the sensitivity for detection of pathological cells in case of hematological disease. Efficiency of recognition has been calculated for each cell category.

Malignant hematological diseases We focused then on 84 patients with malignant hematological disorders from various types. The classification of these 84 patients was made according to the WHO criteria ( Harris et al.,1999 ) and is described in table 1. Three patients were excluded for the analysis in the absence of blasts cells in the peripheral blood. All these three patients had myelodysplasic syndromes (MDS). In total, when reclassifying unidentified cells by medical technologist, accuracy is judged excellent up to 98%. For most common parameters, false positive and false negative ratio are very good ( Table 2 ). Additionally, it appears very easy to distinguish myeloid blasts from lymphoid blasts. In patients with chronic myeloproliferative disorders or myelodysplastic syndromes, both the quantitative and qualitative analysis of immature granulocytes was comparable with the one observed for routine patients. Basophiles were clearly identified even when they show abnormal aspects. Blast count for these patients appeared to be reliable. Open in a separate window Figure 3 Blasts log scale. The recommended procedure in this case is still to use the lymphocyte count from the analyzer as the most reliable result. Such classification remains under the responsibility of medical technologist. Open in a separate window Figure 4 The overview of tumoral lymphoid cells facilitates the efficient distinction between typical chronic lymphocytic leukemia and other B-cell chronic lymphoproliferative disorders. Modern characterization of acute malignant hematological disease is a multidisciplinary process. Initially, it requires the integration of clinical, morphological and cytochemical information. A correct and rapid hematological evaluation is necessary to follow-up with the appropriate laboratory tests, specifically immunophenotyping, metaphase cytogenetics and molecular studies.

Please enable it to take advantage of the complete set of features!Get the latest public health information from CDC. Get the latest research from NIH. Find NCBI SARS-CoV-2 literature, sequence, and clinical content:.An evaluation of the CellaVision DM96 automated image analysis systemAn evaluation of the CellaVision DM96 automated image analysis systemOver the last 20 years, automated imaging processes have started to be introduced where stained blood films are scanned by a computer-driven microscope and leucocytes classified; however, early methods were slow and had difficulty in classifying abnormal cells. More recently the CellaVision DM96 (CellaVision AB, Lund, Sweden) has been introduced with added features such as continuous loading of slides and a faster throughput than previous instruments. The accuracy of CellaVision DM96 has been evaluated by comparing results to reference manual differentials. Results from different operators using the DM96 were compared with their own manual differential and to a 400-cell reference manual differential. Precision of the instrument was compared to the manual differential. The preclassification accuracy of the DM96 was 89.2%. Precision was similar to that of the 100-cell manual differential. The DM96 was faster than the manual method, even after reclassification by a laboratory scientist of any cells wrongly categorized by the instrument. The DM96 accuracy in morphological classification of leucocytes and red blood cells; depends upon both blood pathology and experience of the laboratory scientist using the instrument. For some cell types and operators, DM96 accuracy was better than the individual's 100 cell manual differential. The system also partially characterizes of the red blood cell morphology and is able to perform platelet counts. For most common parameters, false positive and false negative ratios are also very good.

The system is a useful tool for assisting in the diagnosis and classification of most acute or chronic leukemia. Automatic cell location and preclassification, along with unique cell views on the computer screen, could reduce the time spent performing differentials and make real-time collaboration between colleagues a natural part of the classification process. The workstation also provides an ergonomically correct and relaxed working environment. We suggest its use in routine analysis; the system could be very helpful for the accurate morphological diagnosis of samples from patients with malignant hematological disease. Keywords: Hematology analyzer, DM96, automation Introduction In recent years, there have been rapid developments in new techniques for the optimal management of patients with malignant hematological disease. Despite the increased contribution of immunological, cytogenetical and molecular investigations, morphological examination remains the first step for rapid and accurate diagnosis and optimal follow-up of patients with malignant blood diseases. This step requires a high quality stained blood smear preparation for the accurate assessment of cellular morphology. Despite the significant improvements during the last years in hematology analyzers, no significant progress has been made in terms of automatic examination of peripheral blood cells. Irrespective of the analyzer, approximately 15% of the blood samples require manual microscopic observation either because of biological rules or analyzer flags. The relative number of samples to be reviewed will probably not decrease in years to come. Smear examinations are time consuming and require well-trained medical technologists and biologists. Microscopy automation should be available in hematology laboratories.

However, the interpretation of morphological and cytochemical stains remains central to the diagnosis and classification of AML. The identification of multilineage dysplasia is entirely dependent on light microscopic assessment of the leukemia cells. Despite the advances in diagnostic technologies, the maintenance and improvement of morphological skills still remain essential requirements in the diagnosis of AML. In cases of B-ALL and more generally in cases of myeloperoxydase (MPO) negative blast cells, immunophenotyping is always still required for the initial diagnosis. DM96 is also able to detect blast cells but is unable to classify blast cells as lymphoblasts. In this context, it makes sense to rely upon conventional microscopy. If the sample quality is poor, it will be also necessary to survey the entire smear in manual mode. As an example, we rapidly identified binucleated lymphocytes characteristic of polyclonal lymphocytosis with binucleated lymphocytes ( Mossafa et al. 1999 ), hairy cells in patients with HCL and atypical lymphocytes in patients with B-CLL. An overview of all lymphoid cells is of great interest in lymphocyte analysis. The validation and screening of abnormal smears is one of the core competencies of the technical staff, which is under the supervision of a biologist. For such a routine process, a significant timesaving could be realized by implementing such a reliable automatic system. Therefore, these observations should provide food for thought when considering modalities for improving the efficiency of a hematology laboratory. In addition, the easy and clear presentation of all patient samples on a computer screen will help ensure the quality of follow-up care in cancer patients. The images can be transmitted to other experts for consultation and confirmation and will facilitate validation of clinical protocols.

We also can hope for shorter response times, a reduction in errors, an improvement in continued and advanced education, possibly a redeployment of human resources and a significant cost reduction for a hemogram. References Ceelie H, Dinkelaar RB, van Gelder W. Examination of peripheral blood films using automated microscopy; evaluation of Diffmaster Octavia and Cellavision DM96. Performance evaluation of the CellaVision DM96 system. Recent developments in automated peripheral blood differentials using a computerized system have shown many advantages as a viable alternative. The purpose of this paper was to determine the reliability and accuracy of the CellaVision DM 96 system with regards to platelet counts. One hundred twenty seven peripheral blood smears were analyzed for platelet count by manual microscopy, an automated hematology analyzer (Beckman Counter LH 780 or Unicel DXH 800 analyzers) and with the CellaVision DM96 system. Results were compared using the correlations and Bland-Altman plots. Platelet counts from the DM96 system showed an R(2) of 0.94 when compared to manual platelet estimates and an R(2) of 0.92 when compared to the automated hematology analyzer results. Bland-Altman plots did not show any systematic bias. Download full-text PDF Recent developments in automated peripheral blood differentials using a computerized system have shown many advantages as a viable alternative. Materials and Methods: One hundred twenty seven peripheral blood smears were analyzed for platelet count by manual microscopy, an automated hematology analyzer (Beckman Counter LH 780 or Unicel DXH 800 analyzers) and with the CellaVision DM96 system. Results were compared using the correlations and Bland?Altman plots. Results: Platelet counts from the DM96 system showed an R 2 of 0.94 when compared to manual platelet estimates and an R 2 of 0.92 when compared to the automated hematology analyzer results. Bland?Altman plots did not show any systematic bias.

INTERPRET A TION The overall performance of the DM96 system for platelet counts was similar to both automated hematology analyzer and manual platelet estimates. BACKGROUND Rapid and accurate determination of platelet counts is an important factor in diagnostic pathology. Platelet counts are generally performed by automated analyzers using the coulter counter technology. These automated hematology analyzers usually provide accurate platelet counts with generally good precision; however, in some clinical situations interference with the automated count can occur, requiring a manual method of platelet estimation. The aim of this study was to determine the reliability and accuracy of the CellaVision DM96 system with regards to platelet count determination by comparing CellaVision This article may be cited as: Gao Y, Mansoor A, W ood B, Nelson H, Higa D, Naugler C. Platelet count estimation using the CellaVision DM96 system. J Pathol Inform 2013;4:16.This process is exempted from ethics review under institutional policies. Blood Samples Peripheral blood smears (PBS) of 127 patients from five medical centers (F oothills Medical Center, Alberta Children’s Hospital, Rockyview General Hospital, P eter Lougheed Center, Diagnostic and Scientific Center) located in the greater Calgary (Alberta, Canada) area were used. The elapsed time between venipuncture and sample analysis was within 12 h. Automated Anal yzer Platelet Counts Automated platelet counts (as part of complete blood counts) were performed utilizing automated hematology analyzers (LH 780 or Unicel DXH 800, Beckman Coulter, Brea, CA). These analyzers use electrical impedance to determine numbers of various cellular elements. Each cellular component (WBC, RBC or Platelet) generates a channelized pulse that is proportional to its size and volume, which are sorted based on the size to determine final counts for each cellular component. The pulse with a volume between 2?20 fL were considered and counted as platelets.

Coulter analyzers will provide “flagging” if abnormal platelet size (i.e., giant platelets or platelet clumping) is encountered, which will then prompt the technologist to review a slide (standard microscopy or utilizing CellaVision DM96 software). Automated slide makers (LH 780 Beckman Coulter Brea, CA) were used to prepare PBS, which was stained with the W right?Geimsa stain. Manual Platelet Estimation The PBS slides were independently examined by two experienced technologists (of a total of 10 technologists reading slides for this study) for platelet estimation and morphology (giant platelets, platelet clumps etc.) assessment. Platelet estimation was made according to established laboratory procedures. The analyzer pre?classifies the white blood cells, pre?characterizes parts of the red morphology and provides functionality for platelet estimation. The digitized system gives a useful overview of the sample and allows for discussion between physicians regardless of physical location. Regions of interest can be tagged, comments added and exported into presentations, and educational material. Platelet Evaluation Utilizing CellaVision DM96 System CellaVision provides the technologist with an equivalent slide area corresponding to 8 microscopic high power fields (HPF). Statistical Analysis Analyses were performed using an Excel spreadsheet (Microsoft, Redmond, W ashington).Platelets morphology between standard microscopic examination and CellaVision DM96 evaluation did not show any significant disparity (data not shown). CONCLUSIONS Platelet count estimates obtained via the CellaVision DM96 system compared very well with both manual estimates and hematology analyzer results on the same cases. Although, automated analyzer methods will undoubtedly remain the principle diagnostic modality for platelet count estimates, our study suggests that when PBS are analyzed with the CellaVision DM96 system, the automated platelet count estimates are reliably accurate.

In routine clinical practice, two relevant and important components of platelet morphology are considered to be giant platelets and platelet clumps. Miscroscopic examination of slides by a trained technologist is mandated, if automated analyzer flags the possible presence of these features in a given specimen. Our study did not find any discrepancy between standard microscopic examination and CellaVision DM96 evaluation for these morphological features. Figure 2: Correlation of manual platelet counts with CellaVision DM96 platelet counts Figure 3: Difference versus mean plots for CellaVision DM96 and manual platelet counts according to the Bland and Altman design.The CellaVision DM96 system offers several potential advantages in this regard. F irst, because it is fully automated, it eliminates the need for technologists to perform time?consuming manual platelet estimates. Second, consistency in scanning the defined area of the slide and provision of a grid could be expected to enhance the reproducibility of estimates over successive samples in clinical practice. In our own institution, we have additionally found that the use of this digitized system has also been beneficial in training laboratory technologists and improving their competency and proficiency in performing platelet estimates. REFERENCES 1. Pinkowski R. Difference between impedance and optical platelet counts in patients with microcytosis of red blood cells. Lab Hematol 1999;5:22?7. 2. Hagner R. The manual differential enters the digital age. MLO Med Lab Obs 2012;44:20?1. 3. Y amamoto T, T abe Y, Ishii K, Itoh S, Maeno I, Matsumoto K, et al. Performance evaluation of the CellaVision DM96 system in WBC differentials. Rinsho Byori 2010;58:884?90. 4. Kratz A, Bengtsson HI, Casey JE, Keefe JM, Beatrice GH, Grzybek DY, et al. Performance evaluation of the CellaVision DM96 system: WBC differentials by automated digital image analysis suppor ted by an arti?cial neural network. Am J Clin Pathol 2005;124:770?81.