Dr.Muller SUPER GL easy Instructions For Use Manual

Dr.Muller SUPER GL easy Instructions For Use Manual

Measurement glucose / lactate / hemoglobin
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Instructions for use
SUPER GL easy
SUPER GL easy+
Valid from Version: 3.23
Effective from August, 2012
Manufacturer / Copyright:
Dr. Müller Gerätebau GmbH
Burgker Str. 133
D – 01705 Freital
Distributor:
Service – Hotline:
Monday – Friday from 7 a.m. until 6 p.m.
If you have any questions concerning our products or would like to
place an order, please contact:
+49 (0)351 649 12 93
+49 (0)351 64 50 42
Or contact us via:
Fax: +49 (0)351 649 15 04
Email:
support@glukose.de
or
info@glukose.de
You will find the current version of this manual on our website
www.glukose.de

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Summary of Contents for Dr.Muller SUPER GL easy

  • Page 1 Instructions for use SUPER GL easy SUPER GL easy+ Valid from Version: 3.23 Effective from August, 2012 Manufacturer / Copyright: Dr. Müller Gerätebau GmbH Burgker Str. 133 D – 01705 Freital Distributor: Service – Hotline: Monday – Friday from 7 a.m. until 6 p.m.
  • Page 2: Table Of Contents

    Contents Contents Page Rev. Contents List of illustrations List of symbols Preface Introduction The SUPER GL easy / SUPER GL easy+ 1.2.1 Basic matters 1.2.2 Equipment and accessories 1.2.3 Overview of functions Indication / Contraindication Manufacturer's liability Warranty Safety Introduction...
  • Page 3 Contents Operation - Part 2 Introduction Menu functions 5.2.1 Stand by / „Measurement Menue“ 5.2.2 Stand by / “Function Menue” 5.2.2.1 Calibration 5.2.2.2 Display results 5.2.2.3 Delete results 5.2.2.4 Copy results 5.2.2.5 Output results 5.2.2.6 Washing 5.2.2.7 Set time 5.2.2.8 Plasma reference glucose Functions when switching on device DIL switch settings...
  • Page 4: A Contents 2

    List of illustrations List of illustrations Page Rev. General view SUPER GL easy / easy+ Fig. 1.1 View of equipment Fig. 1.2 Accessories Fig. 1.3 Flow chart Type SUPER GL easy Fig. 3.1 Flow chart Type SUPER GL easy+ Fig. 3.2 Diagram of measuring principle Fig.
  • Page 5: List Of Symbols

    List of symbols List of symbols Symbols on the equipment Symbol Description Biohazard Enter - key for selecting a menu item or changing the menu area Menu button for selecting menu items Follow instructions for use in vitro diagnostics Manufacturer CE - conformity serial number Symbols on consumables...
  • Page 6: Preface

    Congratulations on purchasing the SUPER GL easy / easy+ analyser. We hope you will find working with your analyser satisfying and successful. In the following chapter "The SUPER GL easy / easy+" you will find a first overview of your analyser: what parameters you can measure, what further devices and accessories belong to your analyser, and an overview of the device's functionality.
  • Page 7: Basic Matters

    Preface 1.2.1 Basic matters The SUPER GL easy / easy+ was developed with the use of modern technical resources, associated with decades of experience in the field of clinical-chemical analyser production. In construction and manufacture it fulfils all the legal EU regulations pertaining to equipment for use in in-vitro diagnostics.
  • Page 8: Equipment And Accessories

    Fig. 1.2 View of equipment Fig. 1.3 Accessories 1.2.3 Overview of functios The SUPER GL easy / easy+ analyser is an automatic analyser for the determination of glucose and / or lactate and / or hemoglobin in 1+50 pre- ...
  • Page 9: Indication / Contraindication

    Preface Indication / Contraindication Indication The SUPER GL easy / easy+ analyser determines glucose and / or lactate and /  or hemoglobin in human sample material and supplies measurement values for  the diagnosis and treatment of diabetes. Possible sample material can include:...
  • Page 10: Safety

    Responsibility / Training of user The SUPER GL easy / easy+ provides measured values for the diagnosis and treatment of diabetes. Use for personal use is expressly forbidden. An introduction to the correct use of the equipment can be given by a member of staff from the manufacturer or authorised sales partner in agreement with the persons working on the equipment.
  • Page 11: Product-Specific Safety Instructions

    Maintenance intervals The SUPER GL easy / easy+ needs servicing once a year by assigned specialist staff. A warning will appear on the screen once the service interval has elapsed.
  • Page 12: Description Of The Analyser

    “Operation – Part 1” and “Operation – Part 2”. Purpose The SUPER GL easy / easy+ analyser is an automatic analyser for the determination glucose and / or lactate and / or hemoglobin in 1+50 diluted ...
  • Page 13: Measuring Principle

    3.3.1 Measuring principle glucose and lactate determination Determination of glucose and lactate with the SUPER GL easy / easy+ is based on an electro-chemical measuring principle with a biosensor. System solution, calibration, control or patient material is extracted with the aid of a piston pump.
  • Page 14 Description of the analyser Fig. 3.3 Diagram of measuring principle Fig. 3.4 Reactions in glucose sensor Fig. 3.5 Reactions in lactate sensor 20.08.2012 Page 14 of 42 Rev. 04...
  • Page 15: Measuring Principle Hemoglobin Determination

    Description of the analyser Fig. 3.6 Flow chart photometer 3.3.2 Measuring principle for hemoglobin determination The hemoglobin in the blood is photometrically determined. To avoid serious environmental load, the sodium dodecyl sulfate method is used instead of the hemoglobin cyanide method. The photometer unit, consisting of LED, flow cuvette, interference filter, photo detector and electronic evaluation unit, is arranged in front of the biosensor and the pump.
  • Page 16: Displaying Plasma Reference Glucose Values

    Printer cable EDP cable Accessories As described and illustrated above, the SUPER GL easy / easy+ is supplied with standard accessories. Additional optional accessories can be ordered. The manufacturer or the authorised sales company will be happy to provide information on the relevant options.
  • Page 17: Consumables

    Description of the analyser Consumables The following consumable materials are required for operating the analyser. Prefilled reaction cups without capillary tubes or with end-to-end capillary tubes or with open-end capillary tubes for taking samples Calibration solution Containerkit for haemolysis system solution and waste Glucose sensor or glucose/lactate sensor Control materials Please find the details for using these consumable materials in the operating...
  • Page 18: Introduction

    Operation – Part 1 Operation – Part 1 Introduction This part of the instructions for use summarises all the information needed for daily operation of the equipment. In Part 2 there is a summary of all the additional information important for understanding the functions, additional functions and certain sources of error.
  • Page 19: Installing The Equipment

    “DC 12V”) and insert the mains connection lead plug into the socket. Connecting the printer (see Fig. 4.1): If the SUPER GL easy / easy+ is used with the DPU 414 printer, the printer’s voltage supply comes via the second power supply unit connection. The voltage adapter must be switched between the printer and the power supply unit.
  • Page 20: Setting Up The Equipment

    Operation – Part 1 The following illustration shows the connections on the right side of the housing of the SUPER GL easy / easy+: also PS/2 – keyboard possible DIL - switch Control lamp for using battery device Fig. 4.1 View of connector panel...
  • Page 21 Please note that in this case there is a higher risk of the drift of measuring values. SUPER GL easy / easy+ is operated by using MENUE or ENTER key. There are two main program menus, the „Measurement menue“ and the „Function Menue“. The „Measurement menue“...
  • Page 22 Operation – Part 1 Fig. 4.2 Menu structure 20.08.2012 Page 22 of 42 Rev. 04...
  • Page 23: Preparing Of Measuring Process

    The SUPER GL easy / easy+ works with pre-diluted reagents. A prefilled reaction cup with appropriate capillary tube is required for each analysis. For measurements on the SUPER GL easy / easy+ you also need the appropriate biosensor, calibrator cups and appropriate control material.
  • Page 24: Sample Preparation

    Operation – Part 1 4.5.2 Sample preparation Please follow the instructions in the packaging inserts for the reaction cups and calibrator for sample preparation. Please follow the following instructions additional to the above instructions: When taking samples of capillary blood, the tissue must not be squeezed under any circumstances.
  • Page 25 Operation – Part 1 Taking capillary blood from an earlobe or finger pad and filling the capillary tube to above both markings Make sure you fill the tube correctly (sufficient quantity of blood, no air bubbles, no drops of blood on the end of the capillary tube, etc.) Carefully wipe the outside of the capillary tube Break the capillary tube at the correct spot (the correct...
  • Page 26: Measuring Operation

    Note that the calibration cups are not fully emptied and that a small residue remains in them. When the SUPER GL easy / easy+ requests a new calibration cup, a new one must be inserted, even though there is still some residue in the old one.
  • Page 27: Measure Samples With Bar Code

    This menu item is only available if a bar code reader (or a PS/2 keyboard) is connected. The SUPER GL easy / easy+ automatically recognizes a supported bar code reader. Please ask the manufacturer or your supplier for supported bar code readers.
  • Page 28: Printer Settings

    The DPU 414 printer provided for use with the equipment has several connection options. To set/program the printer for use with the SUPER GL easy / easy+ the following steps are needed: 1. When switching on the printer keep the “on line” button pressed. You will then receive a printout of the current settings.
  • Page 29: Introduction

    Menue button repeatedly. Apart from specialist knowledge, you also need precise knowledge of the menu construction of the SUPER GL easy / easy+ for the following functions. You can find an overview of the menu guide in Fig. 4.3.
  • Page 30: Calibration

    Operation – Part 2 5.2.2.1 Calibration By pressing the Menue key you reach the menu item “Calibration” if the measuring method for glucose or lactate is active. In the second row of the display, you can choose between “yes” or “no” assigned to the two device buttons.
  • Page 31: Washing

    After reaching the desired time, press ENTER to confirm. 5.2.2.8 Plasma reference glucose As described in chapter 3.3.3, the SUPER GL easy+ could display the measured whole blood samples as plasma reference values. So it is necessary to adjust this function.
  • Page 32 Operation – Part 2 If a control is activated, a sub-menu for this control is stepped through consisting of three items: The number in the middle of the second row of the display is for internal purposes only and is of no importance for the set-up.
  • Page 33: Dil Switch Settings

    Operation – Part 2 DIL switch settings At the SUPER GL easy / easy+ could be chosen which parameter could be measured and in which unit the values of several parameters should be displayed. This happens by using the DIL switches, but note that the selected parameter depends on the sensor in the device.
  • Page 34: Functions Of The Cards

    Functions of the cards The Super GL easy / easy+ is equipped with a card reader allowing various functions to be made more user friendly. Various cards with the following designations and functions are available:...
  • Page 35: Quality Control

    Quality Assurance in Medical Laboratories (RiliBÄK)” in their valid version. The responsible person for the device has to catch up the valid rules. Self contained the software of the SUPER GL easy / easy+ affords following support of quality control: The Super GL easy stores the measuring values of active controls in separate control memories.
  • Page 36: Maintenance And Troubleshooting

    Our service hotline is available by telephone free of charge. Maintenance The SUPER GL easy / easy+ needs servicing once a year by specialist staff assigned and authorised by the manufacturer. A warning will appear on the display once the service interval has elapsed.
  • Page 37: Change Of Sensor

    6.3.3 Changing the containerkit The SUPER GL easy / easy+ is operated with what is known as a containerkit. This is a system solution/waste bottle combination specially produced for this type of analyser. It is hung on the back of the analyser and connected by the tubes to the analyser tubing.
  • Page 38: Change Of Pump Head

    Maintenance and troubleshooting To avoid disruption in the work process of the analyser and soiling, we recommend changing the containerkit only when the operating status is “Stand by” and when there is an inbuilt rinse vessel and sample canula. Changing the containerkit should be carried out quickly, as liquid is expelled during the rinse processes carried out from time to time.
  • Page 39: Taking Equipment Out Of Operation

    Maintenance and troubleshooting Please note for installing the pump head (is situated under the sensor – fig. 6.4) that rounded side of the pump head is shown to the door and the flat side is shown to the black panel. If you install the pump head you have to hear a Click and after installing you should not remove it from the axle.
  • Page 40: Reporting And Repairing Faults

    Maintenance and troubleshooting Reporting and repairing faults 6.4.1 Warnings Before reading out the results, the analyser checks whether the set warning limits have been exceeded. The following warnings are given on the display and the printer: Warning Meaning ++++ Measurement range exceeded ---- Measurement range below limits Sample...
  • Page 41: Equipment Errors

    Maintenance and troubleshooting 6.4.3 Equipment errors There is the possibility that you can’t read anything at the display; in this case switch off the device and switch it on again. If you to see the last measuring values follow the steps described in chapter “display measuring results”. If the display is everlasting unreadable you have to call the service.
  • Page 42: Technical Data

    Technical data Technical data Measuring time per sample Glucose and/or lactate 40 sec  Additional hemoglobin 90 sec Measurement range Glucose 0.8 – 50 mmol/l (11 - 910 mg/dl) Lactate 0.5 – 30 mmol/l (4.5 - 270 mg/dl) 1.86 – 15,52 mmol/l (3.0g/dl - 25 mg/dl) Sample quantity 10 / 20 µl sample diluted with 500 / 1000...

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