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Table of Contents
Related Manuals for Convergent Convergys X3
Summary of Contents for Convergent Convergys X3
- Page 1 ® Convergys Hematology analyzer ’ User’s Manual Release 1.5 X3User20140304 Convergent Technologies GmbH & Co. KG Ringstrasse 14, 35091 Coelbe, Germany Tel.: +49 6421 8869948 Fax: +49 6421 8869958 www.convergent-technologies.de info@convergent-technologies.de CT_X3_ENG_Ver1.5...
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Page 2: Table Of Contents
Convergent Technologies GmbH & Co. KG User manual Table of contents 1 INTRODUCTION...................... 3 1.1 Intended Use ..................... 3 1.2 The Instrument ....................3 1.3 Patient Testing....................4 1.4 Reagents ......................4 1.5 Technical Operation ..................5 1.6 Calibration and Quality Control ................5 1.7 Instrument features .................... - Page 3 Convergent Technologies GmbH & Co. KG User manual 5 ROUTINE UTILIZATION and MEASUREMENT ........... 27 5.1 Sample handling ....................28 5.2 Sample analysis ....................30 5.2.1 Sample preparation ................... 30 5.2.2 Modifying lyse quantity ................30 5.2.3 Sample information ................... 31 5.3 Results ......................
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Page 4: Introduction
Convergent Technologies GmbH & Co. KG User manual 1 INTRODUCTION 1.1 Intended Use ® Convergys X3 hematology analyzer is a fully automated cell counter designed for in vitro diagnostic use. The instrument was developed for small clinics or laboratories. 1.2 The Instrument ®... -
Page 5: Patient Testing
Convergent Technologies GmbH & Co. KG User manual 1.3 Patient Testing The analyzer can process 60 samples per hour. Samples can have individual sample data, and additional parameters. You can print results to an external or to the optional built in printer. -
Page 6: Technical Operation
Convergent Technologies GmbH & Co. KG User manual 1.5 Technical Operation ® As Convergys X3 is a fully automated instrument, operating it requires minimal training or technical support. Operator interaction is reduced to the following: - Perform a Blank Measurement in case the instrument is not used for a specific time... -
Page 7: Instrument Features
Convergent Technologies GmbH & Co. KG User manual 1.7 Instrument features HARD Shortcut keys Graphical SOFT Shortcut Cursor keys keys & OK key Numerical keypad Sample rotor with adapter START key 1-1 Front view Power switch Power Vent holes adapter... - Page 8 Convergent Technologies GmbH & Co. KG User manual Figure 1-3 shows the open built-in printer using roll paper inside. Lid opener button Press the protruding button to open the lid. Let the thermal printer paper fall into the housing with its open end...
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Page 9: Parts Of The Analyzer
Convergent Technologies GmbH & Co. KG User manual 1.8 Parts of the Analyzer ® Convergys X3 hematology analyzer is composed of three main units: Fluidic System: Performs sampling, diluting, mixing, and lysing functions. Generates the regulated vacuum used for moving cells through the aperture during the counting process. -
Page 10: Control Panels
Convergent Technologies GmbH & Co. KG User manual 1.10 Control Panels START button - Pressing and releasing the START button triggers an analysis cycle. Status indicator - A two-color (red/blue) LED is located near the START button. Its actual color indicates the status of the analyzer. - Page 11 Convergent Technologies GmbH & Co. KG User manual Function keys Below is a list of icons and functions assigned to the soft-keys (function keys) Information Measuring process Data base Utilities menu Print function Exit menu...
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Page 13: Control Material
Convergent Technologies GmbH & Co. KG User manual 1.13 Control Material ® ® X3 allows continuous monitoring with Convergys Check-3P (control blood). Specification Convergys for this material (assay values and allowed tolerances along with expiry date) is always enclosed with the approved control material. -
Page 14: Specifications
Up to 5000 results, with RBC, PLT, WBC 3-part histogram Host computer interface USB B port or RS-232 serial link. Data back-up method USB mass storage device; Convergent Technologies Lab data management software. Software upgrade method USB A port using USB mass storage device Printer interface USB with support for HP printers, color and monochrome printout. -
Page 15: Installation
Convergent Technologies GmbH & Co. KG User manual 2 INSTALLATION 2.1 General information ® This chapter provides instructions for the installation of the Convergys X3 hematology analyzer. Follow the procedures described below correctly to ensure proper operation and service. Please carefully read and follow all instructions in this User’s Manual before ®... -
Page 16: Peripherals
Convergent Technologies GmbH & Co. KG User manual - Leave at least 0.5 m space on both sides and above the instrument to access pneumatics and (optional) built in printer. Provide a minimum of 0.2 m between the rear panel and the wall to allow for heat dissipation and tube clearance. -
Page 17: Maintenance
Convergent Technologies GmbH & Co. KG User manual Waste generated by the unit is biohazard material. Handling and disposal must happen according to regulations regarding reagent systems. 2.7 Maintenance The user should check the following components weekly: - bottom of washing head for salt build up – should be wiped off with a damp cloth - tubing system –... -
Page 18: Keyboard And External Printer
Convergent Technologies GmbH & Co. KG User manual Place the instrument on a firm work surface in the designated work area, near an appropriate AC electrical outlet. The connection MUST be grounded. NOTE: Before making connections: Make sure that all power is in “OFF” setting before connections (printer, external keyboard) are made. -
Page 19: Turning The Instrument On
Convergent Technologies GmbH & Co. KG User manual 2.9 Turning the Instrument ON In case you use an external printer (for information, read manual shipped with the printer) connect it and turn it on. ® Turn Convergys X3 on using the power switch on the rear panel. The On position is marked by the ( I ) symbol. -
Page 20: Turning The Instrument Off
Convergent Technologies GmbH & Co. KG User manual 2.10 Turning the Instrument OFF The instrument should never be switched off by simply flipping the power switch on the rear panel. Doing so may result in erroneous operation during later use. It can be so, because the instrument uses different kinds of solutions, one of which is the so-called diluent. -
Page 21: Emergency Handling
Convergent Technologies GmbH & Co. KG User manual Next, you should connect the cleaning tube kit to the reagent inputs, submerging the free end in a bottle containing at least 100 ml of distilled water. Cleaning tube kit connected The analyzer will flush any remaining reagents from the system into the waste container. -
Page 22: Menu System
Convergent Technologies GmbH & Co. KG User manual 3 MENU SYSTEM 3.1 General Information This chapter contains information about the structure and usage of the software implemented menu structure. This integrated software controls instrument operations including calculation and evaluation of measured data, displaying results and information screens, storage and recalling of data. -
Page 23: Menu Structure
Convergent Technologies GmbH & Co. KG User manual Pressing the numeric key corresponding to the menu item allows selection and access of an item without the need to additionally press the OK key. This method is more efficient after the user knows the menu structure. - Page 24 Convergent Technologies GmbH & Co. KG User manual Needle height setting Adjust sampling depth for the next sample (how deep the needle should go into the sampling tube ) The following fields are displayed Date Actual timestamp of sample (always synchronized with...
- Page 25 Convergent Technologies GmbH & Co. KG User manual saved to a USB memory device Opens dialog for editing patient information (patient ID, patient name, birthdate, sex, doctor). Utilities 1. Maintenance 1. Cleaning 2. Priming 3. Drain chamber 4. Reagent status 5.
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Page 26: Operating Principles
Contact the reagent manufacturer for safety measures. The manufacturer (Convergent Technologies) is not liable for any damage caused by using cyanide based reagents with any of its analyzers. -
Page 27: Parameters
Convergent Technologies GmbH & Co. KG User manual 4.3 Parameters ® Convergys X3 measures and calculates 20 parameters, listed below. For each parameter we list the name, abbreviation and measurement unit in the first column. Short description for each parameter is in the second column. -
Page 28: Absolute And Linearity Ranges Of Measured Parameters
Convergent Technologies GmbH & Co. KG User manual 4.4 Absolute and Linearity Ranges of Measured Parameters The instrument is guaranteed to provide specified accuracy within its linearity range. Beyond this linearity range, the instrument is able to display results, but may not guarantee accuracy characteristics. -
Page 29: Routine Utilization And Measurement
Convergent Technologies GmbH & Co. KG User manual 5 ROUTINE UTILIZATION and MEASUREMENT 5.1 Sample handling Since some time will usually elapse between collection of samples and counting, it is necessary to preserve the sample with an anti-coagulant to prevent large groups of cells forming into clots or lumps of cell matter that will clog the cell counter. - Page 30 Convergent Technologies GmbH & Co. KG User manual 5-1 Vacutainer with sample blood (cap 5-2 Sample tube with 5 ml control blood removed) Below you can see 3 types of tubes (microtainers) used in micro adapters. These are only examples given by us, you can try to use other type of microtainers as well.
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Page 31: Sample Analysis
Convergent Technologies GmbH & Co. KG User manual 2 ml control blood 2. Position the sample tube in the sample rotor. 3. Push START key. The sample rotor will turn into the inside of the instrument and the needle draws sample from the tube. -
Page 32: Sample Information
Convergent Technologies GmbH & Co. KG User manual The two important parameters influencing lysing are lysing time and lyse quantity. You cannot change the lysing time, as it is adjusted to the lysing reagent supplied by Convergent Technologies. 5.2.3 Sample information The software allows the user to enter information for each sample that has been, or will be measured. -
Page 33: Results
Convergent Technologies GmbH & Co. KG User manual 5.3 Results When analysis is complete, the following screen show all measured and calculated parameters as well as the WBC, RBC and PLT histograms. Results, histograms and other terms will be stored automatically in the memory. - Page 34 Convergent Technologies GmbH & Co. KG User manual Warning flags in lowercase refer to RBC or PLT problems: Warning flags are grouped according to measurement conditions and according to the problems relating to the blood sample. Measurement conditions: when the flags are related to clogging (c, C), probably hemolysing problems (E, b, B, p) and pressure problems (Fatal pressure error).
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Page 35: Measurement
Convergent Technologies GmbH & Co. KG User manual 5.4 Measurement 5.4.1 Measure local menu 5.4.1.1 Blank Measurement The system uses blank measurements to check cleanliness of the system and reagents. Blank measurement must be performed: - Once daily, before sample analysis (this is done automatically before the first ysis in MEASURE function). -
Page 36: Using Pre-Diluted Mode
Convergent Technologies GmbH & Co. KG User manual There are 3 regions for blank value handling: 1. Optimal - all results are within acceptable ranges. 2. Blank is high - ! flag is displayed at relevant results. 3. Blank exceeds acceptability - no results displayed. - Page 37 Convergent Technologies GmbH & Co. KG User manual To perform the analysis: 1. Press the Measurement/Analysis key then press the soft key. Select Prediluted Mode Prediluted mode appears on the left side of the measure screen now.
- Page 38 Convergent Technologies GmbH & Co. KG User manual If you are processing a new sample. Press the soft key and enter the patient information, then press If you are processing a sample that has already been tested as non-prediluted: select Repeat Last Sample to avoid having to re-enter patient information.
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Page 39: Database
Convergent Technologies GmbH & Co. KG User manual 6 DATABASE Patient results are stored in the memory in chronological order, and can be retrieved at any time. Memorizing capacity is 5,000 measurements, including the complete parameter list, histograms, flags, sample data, and date/time of measurements. If memory is full, latest (actual) record will overwrite oldest record. - Page 40 Convergent Technologies GmbH & Co. KG User manual DATABASE LOCAL MENU From the database table screen, enter the Database local menu by pressing the Menu key. The menu contains the following items...
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Page 41: Utilities
Convergent Technologies GmbH & Co. KG User manual 7 UTILITIES 7.1 Maintenance By selecting item (1) of the UTILITIES you can access the MAINTENANCE menu. 7.1.1 Regular Maintenance Jobs From Maintenance submenu, the user can initiate maintenance procedures such as cleaning, priming, draining chamber, reagent status. -
Page 42: Priming
Convergent Technologies GmbH & Co. KG User manual 7.2 Priming During the priming cycle, the fluidic system is rinsed with a large amount of diluent. It differs from the process in a start-up procedure; as in the latter case a simple filling of the fluidics is performed. -
Page 43: Empty Waste Container
Convergent Technologies GmbH & Co. KG User manual 7.4.1 Empty waste container The software counts the waste container capacity and gives warning message when the tank is full. Empty the waste tank when this warning message appears. Service Personnel can modify the waste container capacity on Service level. -
Page 44: Maintenance
Convergent Technologies GmbH & Co. KG User manual 8 MAINTENANCE 8.1 User-accessible parts On the left side of instrument there is a side door, which allows reaching the fluidic system and the mechanical parts easily (Figure 11). Figure 11. Fluidic and mechanical parts 1. -
Page 45: Maintenance Schedule
Convergent Technologies GmbH & Co. KG User manual 8.2 Maintenance schedule 8.2.1 Daily, before daily routine: Check reagent condition: go to reagent status screen, check if the liquid amount in reagent containers is enough for the expected number of daily measurements. -
Page 46: Semi-Annual
Convergent Technologies GmbH & Co. KG User manual Exit the Measurement menu. Open the side Wash head door after the needle has stopped moving. Chambers Gently rub the lower surface of the washing head to remove the salt Apertures build-up. - Page 47 Convergent Technologies GmbH & Co. KG User manual Calibration can be performed in two ways: 1. User can enter calibration factors - without any calibration measurements – using the numerical keypad. 2. One-, or three-fold measurements of control or special calibration material with known parameters.
- Page 48 Convergent Technologies GmbH & Co. KG User manual If automatic (1 or 3 measurement) calibration is selected, upon starting the calibration you will have to enter assay values for each parameter from the calibrator package insert. Target values for calibrated parameters can be set within the following ranges: Table 7.
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Page 49: Quality Control Procedure
Convergent Technologies GmbH & Co. KG User manual 8.4 Quality Control Procedure By analyzing control materials, day-to-day reproducibility can be monitored. In this submenu, both target values and acceptable ranges for each parameter can be specified for different QC levels. -
Page 50: Diagnostics
Convergent Technologies GmbH & Co. KG User manual Viewing the Accepted QC Database Press the Utilities key, then select Quality Control. Select QC database. 8.5 Diagnostics 8.5.1 Device Information 8.5.2 Self Test The Self test is a procedure to verify proper operation of essential components of the instrument. -
Page 51: Settings
Convergent Technologies GmbH & Co. KG User manual 8.6 Settings Selecting item five (5.Settings) of the UTILITIES you can access to this menu. Printers, fluid sensors, date and time can be set and defined. 8.6.1 Printer settings Selecting item one (1.Printers) from SETTINGS menu brings up the Printers submenu. -
Page 52: Customize
Convergent Technologies GmbH & Co. KG User manual Print parameter limits: Enable or disable parameter limit printing. Print warnings: Select to print warning flags that appeared in the result. Print histograms: Enable / disable graph printing. Print technical information: Selecting... - Page 53 Convergent Technologies GmbH & Co. KG User manual Select General Settings This is a collection of settings influencing instrument operation, customization. The table below describes available settings.
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Page 54: Units
Convergent Technologies GmbH & Co. KG User manual 8.6.3 Units ® Use the unit menu to set the measurement units the Convergys X3 will use. Press the Utilities key Select Settings. Select Customize. Select Units Set the units as needed: Us e ↑... -
Page 55: Laboratory Information
Convergent Technologies GmbH & Co. KG User manual 8.6.4 Laboratory information Enter your clinic or laboratory information as follows, to be printed automatically on report headers. You can also use this procedure to edit or change this information. Enter the name and address of your clinic or laboratory. -
Page 56: Date And Time
Convergent Technologies GmbH & Co. KG User manual 8.6.6 Date and time The date and time of each analysis is stored with the results. This menu allows setting the built-in clock and the format of the date displayed. Press the Utilities key, and then select Settings. -
Page 57: Printing
Convergent Technologies GmbH & Co. KG User manual 9 Printing This chapter covers information on making reports on measured samples. 9.1 Printouts When required, the following items can be sent to an external printer or to a built-in printer by pressing the function key button. - Page 58 Convergent Technologies GmbH & Co. KG User manual...
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Page 59: Fluidic Schematics
Convergent Technologies GmbH & Co. KG User manual 10 Fluidic Schematics Fludic Schematics ® Convergys... -
Page 60: Warning Labels On The Analyzer
Convergent Technologies GmbH & Co. KG User manual 11 Warning labels on the analyzer 12 Warranty Information ® Every Convergys X3 H e m a t o l o g y A n a l y z e r u n i t is tested thoroughly before delivery to the customers’... - Page 61 Convergent Technologies GmbH & Co. KG User manual Revision history Version Section affected Edited by Date 07.10.2009 Support Team 02.09.2010 Markus Gross 20.01.2012 Markus Gross 04.04.2012 Release dates 14.03.2013 Parameters, Address SK, DJW 04.03.2014 Manufactured by: Convergent Technologies GmbH & Co. KG...
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