EKF Quo-Test User Manual
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EKF Quo-Test User Manual

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Summary of Contents for EKF Quo-Test

  • Page 1 Quo-Test User Manual Diagnostics for life...
  • Page 2 Copyright© 2016 EKF-diagnostic GmbH No part of this publication may be reproduced, transmitted, transcribed, stored Diagnostics in any retrieval system or translated into any for life human or computer language by any means or in any form, without the prior written permission of EKF-diagnostic GmbH.

  • Page 3: Table Of Contents

    Section 1 Safety Precautions Section 2 Introduction General Information Unpacking Warnings and Precautions Intended Use Quo-Test System Description Measurement Principle Section 3 Setting up the System Setting the Language Setting the Time Setting the Date Setting the Identification (ID) Options...

  • Page 4: Section 1 Safety Precautions

    Section 1 Safety Precautions Basic safety precautions must always be taken, including all those listed below. Danger - Misuse of electrical equipment can cause electrocution, burns, fire and other hazards. Close supervision is necessary when the system is used, on, or near children, or vulnerable persons.

  • Page 5: Section 2 Introduction

    Please read these instructions in full before performing a test The Quo-Test Analyzer is for in vitro diagnostic use only. The Quo-Test Analyzer is for use at the point of care. Only Quo-Test Cartridges can be used with the Quo-Test Analyzer.

  • Page 6: Intended Use

    EDTA tubes. The Quo-Test A1C System is indicated in the management and treatment of diabetes mellitus and for monitoring long term glycemic control in patients diagnosed with diabetes. The Quo-Test A1C System is designed for professional use only. Quo-Test Quality Controls are intended to check the correct operation of the Quo-Test A1C System. Quo-Test System Description The Quo-Test A1C System consists of the Quo-Test Analyzer, Quo-Test A1C Test Cartridges, Quo-Test A1C Control Kit and Thermal Label Printer (optional).

  • Page 7: Measurement Principle

    Read the Instructions For Use that come with the Test Cartridges. Refer to the Instructions For Use on how to prepare and perform the test. The Quo-Test Analyzer will provide on screen instructions at each stage of performing the test. At the end of the test the result is displayed on the screen, stored in the analyzer memory and can be printed on to a label with the optional printer.

  • Page 8: Section 3 Setting Up The System

    (100-240v AC 50-60Hz). Ensure that the supply has a protective earth connection. Once the analyzer has warmed up the screen will show the Quo-Test Quo-Test logo, this is the home screen. The keypad under the blue screen has 11:32 21/06/13 three buttons.

  • Page 9: Setting The Language

    When the analyzer is first switched on, you must set the local language, time, date, ID options and reported units before you perform a test. You only need to do this once. The analyzer should be switched off at the mains supply or unplugged when not required for long periods.

  • Page 10: Setting The Date

    Note: The analyzer will automatically adjust the time and date for leap years. Setting the Identification (ID) Options The Quo-Test Analyzer allows for operator and patient identification (ID) to be entered via the supplied barcode scanner. This feature allows recording of the ID of the person who ran the test and the person who was tested in the analyzer memory and on the result print-out (if the optional printer is attached).

  • Page 11: Calibration

    Results obtained using the Quo-Test A1C System are traceable to the IFCC reference method. Reported Units The Quo-Test A1C assay reports results in up to two user selectable units: % DCCT, mmol/mol IFCC, % JDS, eAG mg/dl or eAG mmol/l. mmol/mol IFCC = (% DCCT - 2.15) x 10.929 % JDS = (0.09274 x mmol/mol IFCC) + 1.724 eAG mg/dl = (28.7 x % DCCT) – 46.7 eAG mmol/l = (1.59 x % DCCT) –...
  • Page 12 The first screen allows you to select Primary Units DCCT (%), IFCC (mmol/mol) or select More to see additional units. DCCT IFCC More If you select More, JDS (%) or More Primary Units are the options. If you select More you are returned to the first menu screen.

  • Page 13: Functional Checking

    Functional Checking Each time the Quo-Test Analyzer is switched on it performs a series of functional checks of the system and optics. The analyzer must be powered off and powered on at least once a week to allow the analyzer to perform the internal self-checks.

  • Page 14: Section 4 Running A Test

    Always use protective gloves when handling blood samples. Preparing to Run a Test Step 1 When the Quo-Test Analyzer displays the home screen with ‘Quo-Test’, the time and date, the analyzer is ready to run a test. Step 2 Before using a new lot of test cartridges,...

  • Page 15: Collecting The Sample

    Do not use the cartridge if condensation is present. Collecting the Sample Step 4 The Quo-Test can be used with either venous whole blood collected with EDTA or with a finger prick blood sample. For fringer prick sample collection, the patient’s finger must be warm, dry and...
  • Page 16 Step 5 Lightly touch the pointed tip of the Blood collector to the top surface of the droplet of blood, as per the image. The blood will be taken up by the collector. The blood must completely fill the slot. Note: avoid taking up air bubbles and excess sample on the outside of the tip of the Blood collector.
  • Page 17 Step 8 Pull the red slide towards the front of the analyzer and close the door. The test will start automatically. You will be prompted to scan the Operator and Patient ID, if these features have been activated. Note: If the analyzer displays “Scan Lot ****** Data Card” then scan the calibration barcode (see Step 2). Step 9 When the test has finished the result will be displayed on the screen and printed on the (optional) printer, if connected.

  • Page 18: Scanning Operator And Patient Id

    Scanning Operator and Scan Operator ID Patient ID If the Operator and/or Patient ID features are enabled (see section 3), when the analyzer door is closed to start the test the screen will request that the user scans the Skip Operator and/or Patient ID, depending upon which features have been activiated in the analyzer setup.

  • Page 19: The Test Result

    Units). The image below shows an example of the result of a Quo-Test A1C Test. In this case, the test result was 7.1 % A1C. The letters “DCCT” below the test result show the selected primary reported units of the test at the time it was run.

  • Page 20: Retrieving A Result From The Analyzer Memory

    The results of the most recent 7,000 tests run on the analyzer are recorded in the memory. Only the most recent 1,000 test results can be viewed on the analyzer. Press the File button on Quo-Test home screen. The most recently performed test result will be shown on the screen. The sequential number of the test (in the...

  • Page 21: Running A Quality Control Sample

    Running a Quality Control Sample The Quo-Test A1C Control Kit must be used with Quo-Test A1C Test Cartridges to ensure that the system is operating correctly. Only Quo-Test A1C Controls should be used with the Quo-Test A1C Test. Please read the Instructions For Use included with each Quo-Test A1C Control Kit to ensure that the correct procedure is used.

  • Page 22: Section 5 Maintenance

    To power off the system, the Quo-Test Analyzer should be in the home screen, then either switch off at the mains supply or disconnect the power cable from the power socket on the back of the analyzer.

  • Page 23: Section 6 Troubleshooting Guide And Error Messages Operational Error Messages

    Section 6 Troubleshooting Guide and Error Messages Operational Error Messages To access the log files listing results or error messages please refer to the Retrieving a Result from the Analyzer Memory section of this User Manual. MESSAGE OR DESCRIPTION RESOLUTION PROBLEM Wait for the analyzer to Analyzer warming up...
  • Page 24 MESSAGE OR DESCRIPTION RESOLUTION PROBLEM Remove the old cartridge, if present, close Part of the optical system has Error 04/05 the door and allow the analyzer to return failed to the home screen* Error 06 / 07 The x- or z-axis motor has failed Error 08 The stirrer motor has failed Power off the analyzer, wait 10 seconds,...
  • Page 25 MESSAGE OR DESCRIPTION RESOLUTION PROBLEM Remove the cartridge and repeat with a new cartridge. 107 errors are most commonly seen when a cold cartridge is used with the system Make sure the cartridge has sufficient time to reach the same temperature as the analyzer before use Invalid Result A result was not able to be...
  • Page 26 Please contact your local supplier: Customer support +49 39203 511 414 support@ekf-diagnostic.de Section 6 - Page 4 of 4 3121-9001-0167_EN.03.00_QT_Manual 04/2016...

  • Page 27: Section 7 Customer Support

    Reporting Test System Problems analyzer has reached the end of its Users should report problems with useful life. their Quo-Test Analyzer, its reagents or The analyzer must then be disposed controls to their local distributor of according to local regulations...

  • Page 28: Returning An Analyzer

    Upon receipt of the analyzer, it will be investigated and providing it is within warranty and the tamper proof quality control label on the rear of the system is intact, EKF- diagnostic GmbHd will promptly repair or replace the analyzer.

  • Page 29: Section 8 Technical Specifications

    Section 8 Technical Specifications Quo-Test Analyzer ANALYZER Size 205mm(h) x 205mm(w) x 135mm(d) Weight 1.3kg Blue LCD backlit monochrome display 128x64 pixels. Display Visible area 70x39mm Connections USB 2.0 (slave), Printer (RS232), Barcode Scanner (PS2) Data Memory Capacity 7,000 data records...
  • Page 30 OPERATING CONDITIONS 18 to 30 °C (64 to 86 °F) or according to Test Cartridge Temperature temperature range Relative Humidity 10 to 80 %, non condensing Location Clean, dry, horizontal surface and away from direct sunlight STORAGE & TRANSPORT Temperature -20 to 50 °C (-4 to 122 °F) Relative Humidity 10 to 93 % at 40 °C (104 °F)

  • Page 31: Section 9 Packaging Symbols And Their Meaning

    Section 9 Packaging Symbols and their Meaning A number of symbols are used on the Quo-Test Analyzer, Test Cartridges and their packaging. The following table lists the symbols used and their meaning. SYMBOL MEANING Consult Instructions For Use / User Manual...
  • Page 32 3121-9001-0167...

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