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Convergent Convergys X5 User Manual

Hematology analyzer
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Hematology Analyzer
Softwarecenter 1, D -35037 Marburg, Germany
Convergys
User's Manual
ConvergentTechnologies GmbH & Co. KG
Tel.: +49 6421 8869948
Fax: +49 6421 8869958
www.convergent-technologies.de
info@convergent-technologies.com
®
X5
Release 1.6
X5USER20120404
_

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  • Page 1 ® Convergys Hematology Analyzer User’s Manual Release 1.6 X5USER20120404 ConvergentTechnologies GmbH & Co. KG Softwarecenter 1, D -35037 Marburg, Germany Tel.: +49 6421 8869948 Fax: +49 6421 8869958 www.convergent-technologies.de info@convergent-technologies.com...
  • Page 2 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual This user manual is intended to give detailed information for end users of Convergent Technologies ® GmbH & Co. KG Convergys optical hematology analyzer. All information contained herein is the intellectual property of Convergent Technologies GmbH & Co.
  • Page 3 Exemptions Convergent Technologies obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Convergent Technologies or repairs by people other than Convergent Technologies authorized personnel.

  • Page 4: Table Of Contents

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Table of Contents For Your Safety ..........................11 Who Should Use This Manual..................11 Special Symbols Used In This Manual ................11 General Precautions ....................11 1.3.1 Environmental Factors........................12 1.3.2...
  • Page 5 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Using the Graphical User Interface ................35 5.6.1 Quick Links ............................. 35 5.6.2 The Interactive Display Area ......................35 5.6.3 The Status Display.......................... 35 5.6.4 Entering Information ........................36 The Menu System......................36 5.7.1...
  • Page 6 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Printing Reports ......................64 The Measurement Process................... 64 Result Interpretation ........................66 Results ........................66 Sample Identification Information................67 Parameter Information ....................67 8.3.1 Scatter Diagrams and Histograms....................68 8.3.2 Warnings............................
  • Page 7 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 12.2 Laboratory Settings ..................... 92 12.3 External Devices ......................92 12.4 System Settings ......................93 12.5 Units ........................... 95 12.6 Printer Settings......................96 12.7 Profile Limits Settings ....................97 12.8 Date and Time Adjustment ..................
  • Page 8 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 18 Accessories ..........................124 19 Known Problems.......................... 125 20 Appendices ..........................126 20.1.1 Reagent Consumption ......................... 126 20.1.2 Display Range..........................127 20.1.3 Fluidic System ..........................128 20.1.4 Printed Report Formats ....................... 129 20.1.5...
  • Page 9 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 27 Result Screen ......................... 53 Figure 28. Autosampler Info and AS Panel.................... 54 Figure 29. Full Scan Automatic Processing Mode ................. 56 Figure 30. Full Scan Mode Tray View Progress..................57 Figure 31.
  • Page 10 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Table of Tables ® Table 1. Convergys X5 Analyzer Parameters..................20 ® Table 2. Convergys Dil-Diff (D50) Diluent Information ............... 21 ® Table 3. Convergys Lyse-5P Information..................... 21 ® Table 4. Convergys Diff-5P Information ....................

  • Page 11: For Your Safety

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 1 For Your Safety 1.1 Who Should Use This Manual This user manual is written for clinical laboratory professionals using the Convergent Technologies ® automated hematology analyzer. The manual includes information about operation and Convergys ®...

  • Page 12: Environmental Factors

    Convergent Technologies certified service personnel should perform service actions • only Convergent Technologies supplied service material and spare parts should be used • The original reagents and service materials and spare parts are available from Convergent Technologies ® Service personnel should participate a Convergys Service Training and pass the service training examination.

  • Page 13: Space Requirements

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual ® Failure to properly ground the Convergys bypasses important safety features and may result in electrical hazard. The instrument should not be placed near potentially interfering devices capable of emitting radio frequencies (e.g.

  • Page 14: Figure 1. Convergys X5 With Autosampler Space Requirements

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Use the below sketch to find a suitable location for the analyzer ® (the images below shows Convergys with / without its optional Auto Sampler unit): ® Figure 1. Convergys...

  • Page 15: Weight Requirements

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual ® Figure 2. Convergys without Autosampler Space Requirements 1.3.4 Weight Requirements ® The Convergys analyzer weighs 35 Kg without the Autosampler and 47Kg the with optional Autosampler. Adding an external keyboard, documents etc. can bring the total weight up to 60 Kg. If you decide to store the reagents on the same surface, then the combined weight can reach 100 Kg.

  • Page 16: Known Limitations

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 1.3.6 Known Limitations ® analyzer waste contains human blood and reagents that are chemically and biologically Convergys active, and should be considered to be a potential infection and biohazard threat. Safe laboratory ®...

  • Page 17: Support Of The Product

    Would you have further inquiries regarding Convergys X5, feel free to ask for support directly from the manufacturer through your sales representative. Convergent Technologies makes all efforts to provide maximum support and up to date information ® and services regarding Convergys X5.

  • Page 18: First Time Use

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 3 First time use ® is a complex measuring device. As such, there are some precautions you must take Convergys before turning the analyzer on. First of all, you should read this manual, especially this chapter.

  • Page 19: The Convergys® X5

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4 The Convergys® X5 4.1 General Description ® The Convergys is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical measurement technology.

  • Page 20: Reagents And Control Materials

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Parameter Symbol Measurement method Platelet count Impedance measurement Mean Platelet Volume Derived Platelet Distribution Width** PDWcv Derived (for Research Use Only) Platelet Distribution Width** PDWsd Derived (for Research Use Only)

  • Page 21: Genuine Convergys

    Convergys Convergys analyzer. Reagents are manufactured and provided by Convergent Technologies GmbH & Co. KG., and are for in vitro diagnostic use only. If the eyes or skin come into contact with any of the reagents, flush abundantly with water.

  • Page 22: Table 4. Convergys Diff-5P Information

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.1.3.3 Convergys ® Diff-5P Description Multiple micro-filtered, particle free reagent solution, containing stabilizers, leucoprotective components, special additives and preservatives. Application Quantitative determination of WBC, leukocyte four-part differentiation (LYM, MON, NEU, EOS).

  • Page 23: Measurement Principles

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.2 Measurement principles ® uses combination of methods to provide hematology reports. Convergys Volumetric impedance method (the coulter method) is used to determine cellular the cellular • concentrations and volume distributions of leukocytes (WBC), erythrocytes (RBC), and platelets (PLT).

  • Page 24: Principle Of Hgb Measurement

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.2.2 Principle of HGB Measurement The lysed sample dilution can be analyzed for HGB based on stable chromogenic content. The reagent lyses the red blood cells, which release hemoglobin. Subsequently, the HGB concentration is measured in a photometrical way across the WBC chamber.

  • Page 25: Figure 6. Optical Signal Processing System

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Cells with greater volume or size or more granularity will tend to scatter greater amounts of light. The intensity of scattered light is detected by an optical signal processing system.

  • Page 26: Figure 8. 4Diff Scatter Diagram

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual The light scatter data are gathered and plotted as a two dimensional scatter diagram. Similar cells have similar scatter characteristics and tend to group together. This allows the analytical software to differentiate and identify the leukocyte populations and generate the 4DIFF and BASO scatter diagrams.

  • Page 27: Identifying The Convergys X5

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.3 Identifying the Convergys ® Touch screen 4.3.1 Front Panel Touch screen ® This is the primary user interface of the Convergys Analyzer. All user interactions and data input happen using this screen.

  • Page 28: Rear Panel (Electrical Connections)

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.3.2 Rear Panel (electrical connections) Power supply input: 110/230VAC ; 47Hz to 63Hz Power Consumption: maximum 400 VA Power Connection ® The Convergys should connect to the safety guarded socket outlet near ®...

  • Page 29: Left Side Assembly

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.3.3 Left Side Assembly To access the left or right side assemblies, the side panels must be removed. Please refer to section 14.1.3 for information about removing the side panels.

  • Page 30: Right Side Assembly

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.3.4 Right Side Assembly With side panel removed Optical Head Aspiration Needle Horizontal, vertical Motion unit Power Supply Washing Head Sample Rotor Auto Sampler Connector Figure 10. Right Side Assembly...

  • Page 31: Front Assembly

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 4.3.5 Front Assembly With front panel open Shear Valve Aspirating Needle Sample Rotor Dilutors (Syrings) Figure 11. Behind the Front Panel Dilutors establish controlled volume and speed streams of reagents...

  • Page 32: User Interface

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 5 User Interface ® The user interface of the Convergys analyzer is designed to be intuitive and easy to use, and ® provide access to all user level functions. You can interact with the Convergys...

  • Page 33: Using An External Keyboard

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 5.4 Using an External Keyboard An external keyboard provides the same data entry features as the on-screen virtual keypad presented by the touch screen user interface with faster typing. The “Settings/Customize/On screen keyboard active” check-box allows you to choose whether the on- screen virtual keypad is presented or not when data entry is required (name, sample ID, target value etc.).

  • Page 34: Figure 13. 'Sticky' Shift And Symbol Buttons

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 13. ‘Sticky’ Shift and Symbol Buttons Figure 14. Numeric Virtual On-screen Keypad Figure 15. Date Virtual On-Screen Keypad...

  • Page 35: Using The Graphical User Interface

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 5.6 Using the Graphical User Interface ® The graphical user interface (GUI) of the Convergys is divided into three main sections. Refer to Figure to see these sections: 1. Quick links to main functions (top section) 2.

  • Page 36: Entering Information

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 5.6.4 Entering Information ® The Convergys sometimes requires the operator to enter information such as sample ID or patient data. In order to enter information into a data field simply tap or click on it. The data field will change color to yellow indicating that data entry is active for that field.

  • Page 37: Start Automated Measurements

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 5.7.3 Start Automated Measurements Tapping or clicking the ‘AS’ icon with the multiple sample tube graphic allows access to the following functions: Initiate automated measurements in one of three modes: •...

  • Page 38: Autosampler Control Panel

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual ® Figure 18. Main Menu Convergys 5.7.7 Autosampler Control Panel If you have an optional Autosampler installed, the Autosampler control panel can be opened by double clicking/tapping the Autosampler status on the left side of the status display on the bottom of the screen.
  • Page 39 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual ® Shutdown: Prepares the for a complete shutdown Convergys ® See section 6.3 to learn how to power down the Analyzer correctly Convergys Settings Customize Language: Change the active language Limit Style: View parameter normal range status in numerical or graphical format ®...

  • Page 40: Safety Access Codes

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Calibration mode: Select type of calibration procedure to run Calibration type: Select human blood or calibrator material Target values: Enter the target ranges for each calibrated parameter Cancel: Cancels a calibration procedure...

  • Page 41: Start Up And Shut Down The Convergys X5

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 6 Start Up and Shut Down the Convergys ® 6.1 Start Up and Shut Down Overview ® The Convergys is an advanced instrument with computer and pneumatic subsystems that need to be properly started up and shut down for continuing reliable performance.

  • Page 42: Start Up The User Interface

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual If the optional Autosampler is installed, turn the power switch on the right side of the • Autosampler to the ‘on’ position labeled ‘1’ to power on the electrical system of the Autosampler.

  • Page 43: Pneumatic System Start And Blank Measurement

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 6.2.5 Pneumatic System Start and Blank Measurement Before measuring any blood or control samples, the pneumatic system components of the ® Analyzer need to be initialized and a blank measurement run and accepted. To start the Convergys pneumatic system and run a blank measurement, click or tap the ‘Measure’...

  • Page 44: Exiting Theconvergys® X5 Analyzer

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 6.3 Exiting theConvergys® X5 Analyzer After you have completed lab operations and you are ready ® to exit the Convergys Analyzer, you can: Log off • ® Shut down the Convergys •...

  • Page 45: Prepare For Shipment

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 6.3.3 Prepare for Shipment ® If the Convergys Analyzer is not used for a significant period of time or is being transported to a new location then the ‘prepare for shipment’ procedure should be performed instead the regular shutdown procedure.

  • Page 46: Figure 22. Connect Distilled Water Panel

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual After initiating the ‘Prepare for shipment’ procedure the system will prepare itself for the draining process. Do not power off the analyzer during these steps unless the system indicates that is safe to do so.

  • Page 47: Emergency Shut Down

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual When the process is over, the system will notify you about switching off the instrument. Click or tap the ® ® ‘OK’ button on the notification panel and wait until the Windows Embedded exits and power off the user interface computer.

  • Page 48: Repackaging The Convergys X5 Analyzer

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Immediate shut down should be avoided as a routine procedure. It should only be used if loss of electrical power is imminent such as thunderstorms or if loss of uninterruptible power supply (UPS) backup power is imminent.

  • Page 49: Sample Measurement

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 7 Sample Measurement ® 7.1 Sample Types Supported by the Convergys ® In this chapter you will find information about the samples usable with the Convergys instrument. 7.1.1 Supported Sample Tubes Types ®...

  • Page 50: Open Or Closed Sample Tubes

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 26. Sampling Needle 7.1.3 Open or Closed Sample Tubes ® The Convergys can process both open and closed sample tubes in manual mode using the sample rotor. Manually presented sample tubes must be mixed properly before being presented to the ®...

  • Page 51: Sample Types And Modes

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 7.2 Sample Types and Modes ® The Convergys Analyzer is designed to process the following sample types: Whole human blood to determine the hematology parameters of the blood • Quality control (QC) materials for quality control purposes •...

  • Page 52: Running Samples

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 7.4 Running Samples ® The Convergys supports both manual and automatic sample presentation modes. Automatic ® sample presentation requires the optional Autosampler. The Convergys Analyzer software automatically detects and initializes the Autosampler.

  • Page 53: Figure 27 Result Screen

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Select the sample mode: • Blank: a blank measurement will be processed. This is the only option available if the ® pneumatic system is not initialized, or the Convergys was inactive for an extended period of time.

  • Page 54: Automatic Mode

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual On the result screen you have the following options: You can print the results by clicking/ tapping on the ‘Print’ quick link at the top of the screen. • Please note that the printing is a feature that is always available. See section 5.6.1 for more details about printing.
  • Page 55 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual From the AS panel, you can initiate automated sample measurement in 3 modes: Full Scan mode: • The Autosampler will scan the whole sample tray The same sample mode (Human, Male, Female, Alternate 1, Alternate 2) will be used...

  • Page 56: Figure 29. Full Scan Automatic Processing Mode

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 7.4.2.1 Full Scan Mode Full Scan mode is suitable for laboratories where: There are batches of samples with the same sample mode, • Barcode labels are in use, and •...

  • Page 57: Figure 30. Full Scan Mode Tray View Progress

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 30. Full Scan Mode Tray View Progress After starting the automated measurement in Full Scan mode, the Autosampler will scan all the sample positions on the tray. Any rows with missing racks will be skipped. The Autosampler can detect the tube type and whether the tube has a cap.

  • Page 58: Figure 31. Full Scan Mode Tray And List Views

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 31. Full Scan Mode Tray and List Views The Autosampler allows the addition of sample tubes to a Full Scan process already in progress. To add more sample tubes, perform the following steps: ®...

  • Page 59: Figure 32. Free List Mode Selection

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual To start sample measurement in Free List mode, first perform and accept a blank measurement if one is needed. Click or tap the ‘AS’ quick link at the top of the screen and select ‘Free list mode’. The Free List mode only requires that samples be placed in the same sequence as in the free list.

  • Page 60: Figure 33. +Figure 34. Preparing A Free List

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 33. +Figure 34. Preparing a Free List As with the Full Scan mode, the Autosampler will scan all the sample positions on the tray and rows with missing racks will be skipped. The Autosampler will only process tube types it recognizes with caps attached.

  • Page 61: Figure 35. Free List Mode Progress: Tray View

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 36. Free List Mode Progress: Tray View Sample barcode labels are read and compared with the sample ID that was previously entered into the free list before starting automatic processing. If the two do not match, the barcode part of the tray view sample icon changes to red.

  • Page 62: Figure 36. Selected Sample Mode Panel

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Remove selected samples by clicking or tapping the “Remove” button. • Swap between the tray and list views by using the ‘View list’ and View tray’ functions. • Start the automated measurement by clicking or tapping on the ‘Start’ button on the GUI or by •...

  • Page 63: Figure 37. Control The Autosampler With Info Panel

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 7.4.2.5 Controlling the Autosampler Detailed information about the Autosampler is available from the Autosampler info panel. You can also reset the Autosampler from this panel. Double click or tap the Autosampler status in the bottom left corner of the screen to view the Autosampler info panel.

  • Page 64: Result Display

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 7.5 Result Display After the analysis is completed, the result screen displays all measured parameters, flags, histograms and scatter plots. This information is automatically stored in the database, and stored result data can be retrieved at any time from the database.
  • Page 65 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual W H O L E B L O O D W H O L E B L O O D S A M P L E S A M P L E...

  • Page 66: Result Interpretation

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 8 Result Interpretation This chapter provides description about interpreting and understanding reports provided by the ® Analyzer. Convergys 8.1 Results ® Figure 41. Result Screen Convergys ® The Convergys Analyzer result screen is divided into 4 major areas: 1.

  • Page 67: Sample Identification Information

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 8.2 Sample Identification Information This part of the results screen contains information that uniquely identifies a particular sample run. The Sample ID is the ID entered by the operator from a keyboard or hand-held barcode reader for a manually processed specimen.

  • Page 68: Scatter Diagrams And Histograms

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual The flags displayed in the parameter information area are as follows: Normal range flags are raised when a particular parameter is above or below Normal range flags the normal range, which is defined for the patient profile currently in effect.

  • Page 69: Warnings

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 44. Result Screen Scatter Diagrams RBC and PLT impedance-based measurements are represented by histograms. These diagrams show the number of cells on the Y axis and the cell size on the X axis. Smaller cells are displayed on the left side of the histogram, and larger cells are displayed on the right side.
  • Page 70 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual ® The Convergys Analyzer provides Warning flags, Morphological flags, and interpretive messages in the Warnings panel. The following tables describe these flags and messages in detail. It also provides guidance on actions the operator can take to correct the problem described by the flag.
  • Page 71 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Warning flags are raised when the analyzer detects a problem in the Warning flags analysis process that may cause incorrect or suspect results or the parameters in the valid blank measurement was too high.
  • Page 72 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Warning flags are raised when the analyzer detects a problem in the Warning flags analysis process that may cause incorrect or suspect results or the parameters in the valid blank measurement was too high.

  • Page 73: Table 11. Warning Flags

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Warning flags are raised when the analyzer detects a problem in the Warning flags analysis process that may cause incorrect or suspect results or the parameters in the valid blank measurement was too high.

  • Page 74: Table 12. Interpretive Flags

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Interpretive flags infer the presence of distributional abnormalities such as Interpretive flag leukocytosis Flag Meaning Leukopenia WBC -- Leukocytosis WBC + or WBC ++ Neutropenia NEU -- Neutrocytosis NEU ++...

  • Page 75: Database Functions

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 9 Database Functions ® The Convergys database stores all measured data including sample results, QC, and patient data. Each sample result stored includes the complete parameter list, histograms, flags, and identifying ®...

  • Page 76: Scrolling And Selection

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 9.2 Scrolling and selection The limited size of the interactive database display acts like a view port into the large amount of information inside your database. You can scroll the database view to bring desired information into ®...

  • Page 77: Manual Selection Of Database Records

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 9.4 Manual Selection of Database Records Clicking or tapping on a row in the database display single-selects a row. Clicking or tapping it again de-selects the row. Selecting another row will de-select previously selected rows in single selection.

  • Page 78: Statistics

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 9.7 Statistics After selecting a group of records, click or tap the ‘Statistics’ button on the database panel to view the coefficients of variation (CV) associated with each of the 24 parameters. This function is useful to quickly measure the imprecision of multiple runs of the same sample.

  • Page 79: Importing

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Select day Clicking or tapping the ‘Change’ button displays a virtual on-screen date keyboard. All records analyzed on the date entered will be selected. Select interval The two ‘Change’ buttons allow entry of a start and end date. All records on the start date, the end date, and all dates in between will be selected.

  • Page 80: Export

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 9.8.3 Export The database export panel allows you to select a directory location to store records in a selection for backup or reference purposes. To back up all records in the database, first use the select by function to select all records in the database and export them using the export function.

  • Page 81: Save Raw Data

    The save raw data function saves the raw data information associated with a selection of database records. Raw data files are only suitable for internal use by Convergent Technologies staff. Your service engineer may ask you to save raw data files to help diagnose a service issue.

  • Page 82: Calibrating The Convergys X5

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 54. Calibration Options 9.9 Calibrating the Convergys ® Selecting the ‘Calibrate’ option on the calibration options panel displays the calibration panel. Figure 55. Calibration Panel and Calibration Run Result Panel...
  • Page 83 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Commercial calibrator material and sample tube should be handled as a potentially biohazards material. All applicable laws, regulations, and laboratory practices should be followed in the handling and disposal of calibrator materials.

  • Page 84: View Calibrations

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Figure 56. Calibration Factor Panel The automatic calibration process can be skipped by selecting the ‘Manual’ calibration mode on the calibration panel and clicking or tapping the ‘Next’ button proceeds directly to the calibration factor panel for manual entry of calibration values.

  • Page 85: Figure 56. View Calibration Panel

    To delete a calibration, click or tap the ‘Delete’ button. The system will ask you for a confirmation password to avoid accidental deletion of calibration data. The confirmation password is set at the factory to 555, and can be changed by your Convergent Technologies certified service engineer.

  • Page 86: Quality Control

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 10 Quality Control ® Regular use of quality control (QC) ensures that the Convergys Analyzer is operating optimally. ® Stable recovery of standard QC material parameters assures the operator that the Convergys operating consistently on a day-to-day basis and is functioning correctly.

  • Page 87: Set Qc Reference

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 10.1 Set QC Reference Before taking any QC measurements, target values and acceptable ranges must be specified for a QC lot of control material. Click or tap the ‘Set QC reference’ button to display the Set QC panel.

  • Page 88: Qc Measurement

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 10.2 QC Measurement To run a QC measurement, please ensure that a valid blank measurement has been run and accepted. Associate the QC measurement to the correct control material lot by select the matching QC name in the selector below the ‘QC measure’...

  • Page 89: Patients Database

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 11 Patients database ® The Convergys Analyzer allows the operator to define and store patients in the patient database during manual measurement. Patients can also be predefined while creating a list for one of the automatic processing modes.

  • Page 90: Figure 61. Edit Patient Panel

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual You can select either Name or Patient ID to be displayed as the patient identifier in the Measurement panel by changing the settings in the ‘Patient’s displayed data’ in the Main Menu/Settings/Customize panel.

  • Page 91: Settings

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 12 Settings ® The Convergys Analyzer can be tailored to your laboratory’s needs by changing the settings. Click or tap the ‘Settings’ icon on the main menu to access the Settings panel.

  • Page 92: Customize Settings

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 12.1 Customize Settings ® The Customize panel allows you to customize the Convergys Analyzer user interface language and other preferences about the analyzer operation. Click or tap the ‘Customize’ button on the Settings panel to access the Customize panel.

  • Page 93: System Settings

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual The External Devices panel lets you change the following settings: Sending port baud rate – select 9600 or 115200 baud for serial LIS connection. • ® Automatic LIS – The Convergys will transmit every measurement result as soon as it is •...

  • Page 94: Figure 65. System Settings Panel

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Database display limit – select All or Last month to change the number of database records • displayed in the database panel. Last month only displays the last 30 days of measurement ®...

  • Page 95: Units

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 12.5 Units The Units panel allows the user to choose which units are displayed for certain parameters. The following options are available on the Units panel: HGB unit – choose g/dL or g/L to change the displayed units for the HGB and MCHC •...

  • Page 96: Printer Settings

    • Automatic print – check this check box to print every sample or control as it is run. • Logo visible – check this box to print the Convergent Technologies logo on every printed • report. Warning flags are visible – check this box to print Warning flags •...

  • Page 97: Profile Limits Settings

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 12.7 Profile Limits Settings The Profile Limits settings are used to view and modify the normal ranges associated with the ® Analyzer’s five sample modes: Human, Male, Female, Alternate 1, and Alternate 2.

  • Page 98: Date And Time Adjustment

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 12.8 Date and Time Adjustment Double-click or tap the time display on the bottom right side of the screen to display a time/date settings panel. Change the time and date as needed and select ‘OK’ to save or ‘Cancel’.

  • Page 99: Instrument Diagnostics

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 13 Instrument Diagnostics This section allows performing diagnostic steps and checking operation history, or so-called log files. 13.1.1 Self-Test of the Analyzer Initiating a self-test will test the key functions and components of the analyzer. The process takes approximately one minute and gives evaluation of each parameter.
  • Page 100 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Big puffer time Small puffer time Generate 3000 – 13000sec Generate1 800 – 4000sec Release 3000 – 5500sec Generate2 800 – 4000sec Release 500 – 2000sec Big puffer drift Small puffer drift Maximum 540 –...

  • Page 101: Daily Log

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 13.1.2 Daily Log option included service troubleshooting purposes. It lists events and possible problems related to operation or measurements. By using the swap-box on the top of the panel you can change if All the log entries are displayed;...

  • Page 102: Statistics

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 13.1.4 Statistics This menu item will display number of measurements and number of possible failure events experienced during operation. Statistical data can be reset by a certified service engineer only.

  • Page 103: Maintenance

    To ensure reliable operation, regular maintenance, or occasional corrective actions are required. This chapter describes necessary procedures and steps required to keep your analyzer in a good operating condition. ® is a complex automated hematology analyzer. Special Convergent Convergys ® Technologies Convergys Service Training’...

  • Page 104: Removing The Side Panels

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 14.1.3 Removing the Side Panels With the front panel open and secured, thumb screws become visible. Both side panels are fixed to the instrument with these screws: 2 in the front, and 2 in the back. The screws are designed to stay on the analyzer to avoid losing them.

  • Page 105: Maintenance Programs In The Analyzer

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 14.1.5 Maintenance programs in the analyzer Maintenance functions can be accessed from the menu system Cleaning • Shear valve cleaning: drains the shear valve to let the user open and clean the ceramic valve.

  • Page 106: Cleaning The Shear Valve

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 14.1.6 Cleaning the shear valve Any salt build-up on the inner surface of the shear-valve may cause malfunction during operation. To avoid this problem, it is recommended to clean the shear valve after every 1500 samples.
  • Page 107 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual ® As the preparations completed the Convergys displays the following message: Don’t press the ‘OK’ until the shear valve is assembled again! Perform the shear-valve cleaning according to the instructions below!
  • Page 108 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Step 3: Slide down the upper disk of the shear valve. Due to the extremely smooth surface of the ceramic discs it is not possible to simply lift up the upper part.
  • Page 109 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 14.1.6.1 Shear valve with one circle of nozzles Any salt build-up on the inner surface of the shear-valve may cause malfunction during operation. To avoid this problem, it is recommended to clean the shear valve after every 1500 samples.
  • Page 110 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Step 6: Put the “axis screw’ into the upper disk. There is a spring applied to the axis screw. This will guarantee the necessary closing force for the two disks. Gently press and rotate the “axis screw”...

  • Page 111: Cleaning The Washing Head

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 14.1.7 Cleaning the Washing Head The washing head cleans the outer surface of the aspirating tip with diluent. Any salt build-up on the lower surface may cause malfunction during operation. The wash head must be removed from the needle assembly for correct cleaning.

  • Page 112: Cleaning The Measuring Chambers (Hard Cleaning)

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 14.1.8 Cleaning the Measuring Chambers (Hard Cleaning) If the system keeps reporting high blank values, direct cleaning of measuring chambers must be carried out. Open the front panel, and secure it with the latch. Remove the left side panel. Loosen the 2+2 screws on the front and rear of the side panel.

  • Page 113: Replacing Reagents

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 14.1.11 Replacing Reagents Special Cleaning Procedure is designed to be able to run continuously without the need to stop if a reagent container needs to be replaced. To support this feature, internal buffers keep regents sufficient for one measurement cycle.

  • Page 114: Disposal Of Reagent Containers

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual To replace reagent containers: Prepare the new container, and place it near the • place of operation. Open the bottle (remove card board flaps if • necessary (1L, 5L and 20L containers).

  • Page 115: Reagent Locking

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 15 Reagent Locking ® Reagent locking is a commercial feature of the Convergys ensuring that only manufacturer recommended and approved reagents are used with the analyzer. This way analyzer performance cannot be impaired by incompatible reagents.

  • Page 116: The Daily-Routine

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 16 The Daily-Routine In this chapter a typical daily routine is described. Of course your daily routine can differ from the one described here. This chapter also contains some trick and trips.
  • Page 117 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Calibration: ® Calibrate the Convergys according to laboratory regulations. Calibration is due with every new control material lot. Also, if QC results or comparison of results to other instruments’ results shows permanent error in measurements;...

  • Page 118: Troubleshooting

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 17 Troubleshooting ® Your Convergys software is equipped with all the functions to keep the analyzer in good working conditions. Despite careful planning and SW features, the analyzer can still encounter problems where user interaction is required or the user needs to be informed of situations when further help is required.

  • Page 119: Pneumatic Errormessages

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 17.1.2 Pneumatic errormessages The analyzer software is designed to be error tolerant, and as such it is able to deal with minor problems. However, if some physical obstructions or extreme operating conditions cause some mechanical parts to behave unexpectedly, the system will give you an error message: With the OK button, you can return to the current operation and retry the actual process.

  • Page 120: Mechanical Problems

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 17.1.3 Mechanical Problems Most mechanical problems arise because of some physical blockage of the moving parts. Problems caused by severe blocks are most often accompanied by a grinding noise. The noise is a result of a motor not being able to move –...

  • Page 121: Needle Mechanics, Vertical Motor (Mvert) Problems

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 17.1.5 Needle Mechanics, Vertical Motor (Mvert) Problems 17.1.5.1 The Needle Carriage Keeps Dropping Back (Down) At Initialization Is the wash head and its surrounding free of any salt build-ups? •...

  • Page 122: Shear Valve (Sv) Related Errors

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 17.1.6 Shear Valve (SV) Related Errors 17.1.6.1 SV Error at the First Startup the SV cannot turn • o make sure that the pull tab has been removed o check free movement by hand (rotate the shear valve) The SV is stuck •...

  • Page 123: Electronics Related Problems

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 17.1.9 Electronics Related Problems 17.1.9.1 No Image on Display, No Backlight Contact Service • 17.1.9.2 Touch Sensitive Surface Not Working Connect an external USB mouse • o this will allow clicking on the screen elements o contact service for resolution of the problem 17.1.9.3 Touch (Click) Is Inaccurate...

  • Page 124: Accessories

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 18 Accessories The following items can be found along with the analyzer. Power cord Reagent tube kit Cleaning tube kit Waste container (20L) Card board box for waste container Sample tube adapter...

  • Page 125: Known Problems

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 19 Known Problems The following problems are known at the time of the releasing of the software and this user manual: Long Sample ID is not visible on printout and on display.

  • Page 126: Appendices

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20 Appendices 20.1.1 Reagent Consumption Function Reagent consumption / function (ml) ® ® ® Lyse-5P Diff-5P Dil-Diff Convergys Convergys Convergys Start Up Measure Blank Measure 5 part Measure Calibration Measure QC...

  • Page 127: Display Range

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.2 Display Range Parameter Range Selectable Dimensions 1.00 – 99.99 * 10 / µl cells/l, cells/µl 0.00 – 9.99 * 10 / µl cells/l, cells/µl 0 – 300 g/l g/dl, g/l, mmol/l 0 –...

  • Page 128: Fluidic System

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.3 Fluidic System...

  • Page 129: Printed Report Formats

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.4 Printed Report Formats...
  • Page 130 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual...
  • Page 131 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual...
  • Page 132 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual...

  • Page 133: Specifications

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.5 Specifications 20.1.6 Measured Parameters White Blood Cells – WBC Number of leukocytes (cells/l, cells/µl) WBC = WBCcal x (cells/l, cells/µl) Red Blood Cells – RBC Number of erythrocytes (cells/l, cells/µl) RBC = RBCcal x (cells/l, cells/µl)

  • Page 134: Technical Data

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual (percentage, absolute) PCTabsolute = PLT x MPV White blood cell, 4 part differential: Relative value are calculated from the optical 4 diff scatter populations LYM (%) : lymphocytes MON (%) : monocytes and some...
  • Page 135 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Auto-alignment system: Horizontal calibration of laser beam position. Fine calibration: with calibration material (Polystyrene micro-particle µ or Polystyrene microsphere, 5 ® Reagents: Dil-Diff (20 liter) Convergys ® Lyse-5P (5 liter) Convergys ®...

  • Page 136: Performance Data

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.8 Performance Data 20.1.8.1 Precision Parameters Range CV ≤ 3% 4.7 * 10 / µl ≤ WBC≤38 * 10 / µl All 5 part parameters (NEU, LYM, MON, EOS, BAS abs and %) at 4.7 * 10...
  • Page 137 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.8.2 Accuracy Values and Ranges Experienced coefficient Accuracy Against Reference Range (Cell-Dyn 3700) r = 1.00 0.5*10 / µl ≤ WBC ≤ 56.3*10 /µl r = 0.99 2.2 *10 / µl ≤ RBC ≤ 6.3 * 10 /µl...

  • Page 138: Reagent System

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.8.4 Carryover Values and Ranges Carryover High-to-low effect Range 0.5% or less LO ≤ 10*10 /µl 75*10 /µl 0.5% or less LO ≤ 2.3* 10 /µl 7.5* 10 /µl 0.5% or less LO ≤...

  • Page 139: Tab File Format

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 20.1.10 Tab File Format This file format is composed of a header line and consecutive lines containing records selected for saving. Each parameter is selected by the <TAB> (08h) character, allowing easy interfacing or importing into most data processing applications, like Microsoft®...

  • Page 140: Index

    Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual 21 Index aperture, 23, 24, 30 BASO, 26, 66, 69, 73, 74, 75, 76, 144 blank, 24, 37, 42, 44, 47, 52, 53, 54, 56, 57, 60, 62, 67, 68, 69, 72, 73, 74, 81, 86, 87, 91, 110, 117, 122, 123, 142...
  • Page 141 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual needle, 12, 27, 30, 44, 50, 55, 66, 116, 127 NEU, 20, 21, 22, 23, 25, 68, 72, 73, 76, 99, 136, 143, 144, 146, 147, 149, 150 noise, 75, 110, 126...
  • Page 142 Convergent Technologies GmbH & Co. KG Convergys X5 User`s Manual Revision history Version Section affected Edited by Date 07.10.2009 Support Team 02.09.2010 20.01.2011 08.06.2011 02.08.2011 15.03.2012 04.04.2012 Manufactured by: Convergent Technologies GmbH & Co. KG Software Centre 1 D-35037 Marburg, Germany...

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