HemoCue Glucose 201 DM Instructions For Use Manual
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HemoCue Glucose 201 DM Instructions For Use Manual

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Glucose 201 DM Analyzer
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Instructions for Use

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Summary of Contents for HemoCue Glucose 201 DM

  • Page 1 HemoCue Glucose 201 DM Analyzer ® Instructions for Use...

  • Page 2: Table Of Contents

    CONTENTS Introduction ....................1 Unpacking ......................2 Functional description ..................2 1.2.1 System Components ....................2 1.2.2 Analyzer overview ....................3 General operations ..................6 Getting started – Analyzer ................6 2.1.1 Power source ......................6 2.1.2 Turning on the Analyzer ..................9 2.1.3 Power saver mode ....................10 2.1.4 Turning the Analyzer off ..................
  • Page 3 QC Test Procedure ..................35 Stored data ......................37 4.4.1 Reviewing Stored Data ..................37 4.4.2 Deleting Stored Data .................... 38 4.4.3 Review Latest Download ..................38 4.4.4 Log Input ......................... 38 Maintenance ....................39 Cleaning the Cuvette holder and the optronic unit ........ 39 Cleaning the Display ..................41 Cleaning of the Analyzer Outer case and the Docking Station .....41 Calibrating the Display ...................

  • Page 4: Introduction

    It is ideally suited for health care facilities that require central lab quality values within a few minutes, at the point of care location. The System consists of the HemoCue Glucose 201 DM Analyzer, the HemoCue 201 DM Docking Station and the HemoCue Glucose 201 Microcuvettes. The HemoCue Glucose 201 DM Analyzer utilizes whole blood in the determination of the glucose concentration.

  • Page 5: Unpacking

    1.2 Functional description 1.2.1 System Components FIGURE 1-2 The System consists of a specially designed Analyzer (1), the HemoCue Glucose 201 DM Analyzer, specially designed Cuvettes (2), the HemoCue Glucose 201 Microcuvettes and a specially designed Docking Station (3), the HemoCue 201 DM Docking Station.

  • Page 6: Analyzer Overview

    1.2.2 Analyzer overview Front panel FIGURE 1-3 The Analyzer (1) is started when the On/Off button (2) is pressed. The screen images will be visible on the Display (3). All navigation and information handling is performed by pressing the appropriate touch buttons directly on the Display (3). To perform a measurement, the Cuvette is filled with sample material and placed in the Cuvette holder (4).
  • Page 7 Back panel FIGURE 1-4 The following items are found on the back panel of the Analyzer. • Power inlet (1) for the Power Adapter • Power + USB signal inlet (2) for connection to the Docking Station • Built-in Barcode Scanner (3) • IR Transmitter/Receiver (4) for data transfer to/from the Docking Station The Power inlet (1) for the Power Adapter can only be used when the Analyzer is out of...
  • Page 8 Placing the Analyzer in the Docking Station FIGURE 1-5 Always slide the Analyzer into and out of the Docking Station by means of the Tracks (1). Make sure the Analyzer is fully inserted. Never try to lift the Analyzer out of the Docking Station or press the Analyzer downwards into the Docking Station.

  • Page 9: General Operations

    2 General operations This chapter describes the general operations necessary for Analyzer use. 2.1 Getting started – Analyzer Always follow the operating and storage conditions listed under section Technical Specifications. Allow the Analyzer to reach operating temperature before use. 2.1.1 Power source The Analyzer can be powered either by the rechargeable Battery or by a standard electrical outlet via the Power Adapter.
  • Page 10 Replacing the Battery FIGURE 2-2 Only the HemoCue 201 DM Battery can be used in the Analyzer. Lithium-ion battery. Never try to open the battery casing. Risk of explosion. The Battery lasts for several years. It should be replaced when it fails to retain its charge for an acceptable period.
  • Page 11 Connecting the Power Adapter FIGURE 2-3 Only use the Power Adapter listed in section Technical Specifications. Other Power Adapters, although physically able to be plugged into the Analyzer, may cause serious damage or fire. a) Insert the Power Adapter’s DC plug (2) into the Power inlet (3) on the back panel of the Analyzer.

  • Page 12: Turning On The Analyzer

    Turn on the Analyzer by pressing the On/ Off button (1). b) The Start Image, beginning with the HemoCue logo, will be displayed. • If the Cuvette holder is in the Measuring position (see FIGURE 2-8), the following text will be displayed: Please Pull out The Cuvette Holder •...

  • Page 13: Power Saver Mode

    2.1.3 Power saver mode When no procedures have been performed within the time predefined in the Analyzer settings, the Analyzer will switch to power save mode. If the Analyzer is powered via the Power Adapter, the user will be logged off, the image on the display will disappear, but the power will remain on.

  • Page 14: Loading The Analyzer With A Cuvette

    2.1.5 Loading the Analyzer with a Cuvette The Loading position FIGURE 2-6 FIGURE 2-6 shows the Analyzer with the Cuvette holder (1) open, referred to as the Loading position. Cuvette holder Inserting a Cuvette FIGURE 2-7 Obtain a blood sample according to the procedure described in section 3 Sampling and Measuring.

  • Page 15: Docking Station Led

    2.2 Docking Station LED Green light FIGURE 2-9 A steady green light from the LED indicates that the Docking Station is receiving power and that the Battery is fully charged. A flashing green light from the LED indicates that the Battery in the docked Analyzer is charging.

  • Page 16: How To Operate The Display

    2.3 How to operate the Display 2.3.1 Display buttons FIGURE 2-11 The Buttons (1) appearing on the Display (2) activate the specific functions symbolized by the image on the button. The Buttons (1) should only be pressed using the fingertip. Do not use sharp-edged objects as these can damage the Display.
  • Page 17 Changing a function FIGURE 2-13 a) Keep pressing while moving the fingertip over to another button. FIGURE 2-14 b) The original button will cease to appear highlighted and the new button will appear highlighted. c) When the new Button is released, the new function will be activated.
  • Page 18 Cancelling a function FIGURE 2-15 a) Keep pressing while moving the fingertip over to an area without Buttons. FIGURE 2-16 b) No Button will appear highlighted. c) When the finger is released from the Display, the first Button choice will be ignored and no action will be activated.

  • Page 19: Using The Barcode Scanner Button

    2.3.2 Using the Barcode Scanner button 10-30 FIGURE 2-17 Important: Be aware of the laser radiation – 4-12 do not stare into the beam. inches To read barcodes, use the built-in Barcode Scanner in the back panel of the Analyzer. The Scanning range (3) of the Barcode Scanner, is approximately 10–30 cm (4–12 inches) from the Scanner.

  • Page 20: Main Menu And Help

    2.3.3 Main Menu and Help FIGURE 2-18 08/09/03 10:55 AM FIGURE 2-18 is referred to as the Main Menu. JAMES SMITH It is displayed as the Startup Image for all Tests, Setting procedures, etc. The Help button (1) may be used to display information about other buttons, procedures, etc.

  • Page 21: Display Buttons And Symbols

    Display buttons and symbols 2.4.1 Navigation buttons Button Designation Function Erase button Erases the last input. Previous image Returns to the previous image. button Note that inputs/changes made in the current image will not be saved. Text mode button Switches to text input mode. Numeric mode Switches to the numeric input mode.

  • Page 22: Procedure Buttons

    2.4.2 Procedure buttons Button Designation Function Patient test button Activates the Patient Test procedure. STAT test button Activates the STAT (Short Turn Around Time) Test procedure. QC test button Activates the QC (Quality Control) Test procedure. Stored data button Activates the Stored Data function. Settings button Activates the Settings menu.

  • Page 23: Other Display Buttons

    2.4.3 Other display buttons Button Designation Function Help button Displays help regarding other buttons, procedures, etc. Confirm button Saves text or numbers and/or displays the next screen image. All inputs/changes will be saved. Log Out button Logs out the operator. The Log Out button is only displayed if the Operator ID is required.
  • Page 24 Button Designation Function Letter buttons Allows input of a text. Example: To enter a “G” – press once To enter an “H” – press twice To enter an “I”– press three times Only capital letters will be entered. Lower-case letters can be entered into the Analyzer by means of the Barcode Scanner.
  • Page 25 Button Designation Function Reject button Rejects a result. Reject Reject A rejected result will be saved and flagged as rejected. Save button Stores the entered information. Save No button The entered information will not be stored. Continue button Continues the current operation. Continue Statistics button Displays statistics on the chosen subject.

  • Page 26: Display Symbols

    2.4.4 Display symbols Symbol Designation Function Battery Indicates the voltage status of the Battery in four levels. The furthest to the left is fully charged, the one to the right is almost empty. Date Indicates the Date format chosen (from 03/03/04 three possibilities) in the Settings Menu.
  • Page 27 Symbol Designation Function QC Lockout QC Lockout, i.e. no more Patient Test measurements can be made. The required QC Test has not been performed. Lockout Supervisory Lockout. The Analyzer has been locked by the Supervisor.

  • Page 28: Entering Information With Letters And Digits

    2.4.5 Entering information with letters and digits 08/09/03 10:55 AM FIGURE 2-19 Inputs to the Analyzer such as Operator ID, Patient ID, etc. can be made via the display Enter or via the Barcode Scanner. Operator ID The display can be set to two different modes, text mode for entering letters (including a few special characters) and numeric mode for entering digits.
  • Page 29 Text mode FIGURE 2-20 Operator ID Only capital letters and a few special characters can be used in the text mode. Lower-case letters can only be entered into the Analyzer by means of the Barcode Scanner. a) In the text mode, inputs are made using the Letter buttons (1) and the Special Character button (2).
  • Page 30 Numeric mode FIGURE 2-21 Operator ID a) In the numeric mode, inputs are made using the Digit buttons (1). b) The Erase button (2) erases the last input. c) If a letter or a special character is to be entered, switch to the text input mode by pressing the Text mode button (3).

  • Page 31: Sampling And Measuring

    3 Sampling and Measuring This chapter describes how to obtain and measure a sample. Capillary, venous or arterial whole blood may be used. Capillary blood In cases of severe hypotension or peripheral circulatory failure, glucose measurements from capillary samples may be misleading. In such circumstances it is recommended that the glucose level should be measured using venous or arterial whole blood.
  • Page 32 FIGURE 3-3 c) Using your thumb, lightly press the finger from the top of the knuckle towards the tip. This stimulates the blood flow towards the sampling point. FIGURE 3-4 d) Whilst lightly pressing towards the fingertip, puncture the finger using a lancet. FIGURE 3-5 e) Wipe away the first 2 or 3 drops of blood.
  • Page 33 FIGURE 3-8 h) Visually inspect the Cuvette. Important: If the Cuvette is not completely filled with blood or if there are air bubbles, discard and fill a new Cuvette. Small bubbles around the filling end can be ignored. FIGURE 3-9 i) Place the filled Cuvette into the Cuvette holder and start the measurement no later than 40 seconds after filling the Cuvette.

  • Page 34: Control Material, Venous Or Arterial Blood

    Control Material, Venous or Arterial Blood Always wear protective gloves. Handle blood with care, as it may be infectious. Follow local safety procedures for disposal of used Cuvettes. Appropriate anticoagulants in solid form (e.g. EDTA and Heparin) and glycolysis inhibitors (e.g.

  • Page 35: Routine Use

    4 Routine Use This chapter describes the procedure for performing Patient Tests, STAT Tests and QC Tests, as well as describing the process of reviewing stored data. Patient Test Procedure The Patient Test procedure may vary, depending on which information requirements have been activated in the Settings.
  • Page 36 3. Fill and insert a Cuvette as described in section 3 Sampling and Measuring. If the sample is diluted, press the Dilution button. This function is not available in all markets. The result will be displayed when all required information has been entered and the measurement has been completed.

  • Page 37: Stat Test Procedure

    STAT Test Procedure The STAT Test fulfills the same function as a Patient Test but can be performed by overriding the requirement of performing any type of QC Test. When performing a STAT Test, it is optional whether or not to enter Cuvette Batch, Patient ID or Lab Number in order to make the measuring procedure quicker.

  • Page 38: Qc Test Procedure

    QC Test Procedure Based on the settings made for the QC Test Reminder, the QC Reminder icon will be displayed in the Main menu to warn of an impending QC lockout. If the impending QC is not performed within the pre-defined reminder time, the Analyzer will perform a lockout.
  • Page 39 The result will be displayed when all required information has been entered and the measurement has been completed. For a result within the Approved area (the blank area), the Qualitative Test Result will indicate “Pass”. For a result within the Warning area (the dotted area), the Qualitative Test Result will indicate “Pass, Warning”.

  • Page 40: Stored Data

    Stored data 4.4.1 Reviewing Stored Data Access to the Stored Data functions is dependent on the operator’s user level and on the predefined setting of Operator ID use. Only a Supervisor can delete data, change an accepted or rejected result, or add comments. In the Main Menu, press the Stored Data button.

  • Page 41: Deleting Stored Data

    4.4.3 Review Latest Download When the Latest Download button is pressed in the Stored Data menu, data regarding the latest information exchange with the HemoCue 201 DM - DMS Software or an Observation Reviewer is displayed. Press the Confirm button.

  • Page 42: Maintenance

    5 Maintenance This chapter describes the maintenance procedure for the Analyzer. 5.1 Cleaning the Cuvette holder and the optronic unit The Cuvette holder should be cleaned after each day of use. A dirty optronic unit may cause the Analyzer to display an error code. To clean the Cuvette holder and the optronic unit, proceed as follows: a) Check that the Analyzer is turned off.
  • Page 43 Move the HemoCue Cleaner from the right to the left 5–10 times, and then pull it out. i) If the HemoCue Cleaner is stained, repeat with a new HemoCue Cleaner. A cotton tip swab moistened with 70% alcohol (without additives) or water may also be used for cleaning.

  • Page 44: Cleaning The Display

    5.2 Cleaning the Display The display can be cleaned with alcohol, without additives. 5.3 Cleaning of the Analyzer Outer case and the Docking Station FIGURE 5-4 a) Make sure that the Analyzer is turned off. The display should be blank. b) The outer case of the Analyzer and the Docking Station may be cleaned with alcohol or a mild soap solution.

  • Page 45: Calibrating The Display

    5.4 Calibrating the Display If the function on the display is not responding when pressed, the display may need to be recalibrated. FIGURE 5-5 a) Make sure that the Analyzer is turned off. The display should be blank. b) To recalibrate the display, press the On/ Off button (1) for at least 10 seconds.
  • Page 46 f) If the verification of the calibration is successful, the Analyzer will continue with the normal startup (see 2.1.2 Turning on the Analyzer). If the verification of the calibration fails, then the display calibration procedure will start over again. If the procedure fails more than five times the normal startup procedure will continue, but the Analyzer probably needs service.

  • Page 47: Troubleshooting

    This chapter describes the Error Codes that may be displayed while using the Analyzer. If you are unable to resolve the problem by following this troubleshooting guide, please contact the local HemoCue distributor or HemoCue AB. Customers in the US should contact HemoCue America, Technical Support. There are no serviceable parts inside the Analyzer.
  • Page 48 Symptom Explanation Action The absorbance is too a) Check that the Analyzer and Cuvettes high. are used according to the instructions for use. Light blocking item in the Cuvette holder. b) Analyzer needs service. Contact the distributor. Hardware Error Analyzer needs service. Contact the distributor.
  • Page 49 Cuvettes, not under-filled If the Empty Cuvette message appears Cuvettes. again, contact your local distributor or 2) No chemical reaction is HemoCue AB. Use another HemoCue identified in the blood analyzer or a suitable laboratory filled Cuvette. reference method to analyze the...
  • Page 50 Symptom Explanation Action Overrange Whole blood: Whole blood: The measured value The measuring range may be extended to 800 mg/dL (44.4 mmol/L) exceeds 400 mg/dL by using the dilution function. (22.2 mmol/L). Plasma Equivalent: The measuring Plasma Equivalent: range may be extended to 888 mg/dL The measured value exceeds 444 mg/dL (49.2 mmol/L) by using the dilution...
  • Page 51 Reference Manual. communication error. Disconnect and then reconnect the 2) Steady red light Power Adapter. - internal error in the 2b) Contact HemoCue AB or the Docking Station. distributor. No transfer of Refer to the Refer to the troubleshooting in the...
  • Page 52 10a)If a quality control test is to be and/or has not reached performed, only use quality controls room temperature. recommended by HemoCue, see relevant package insert for more 10a)Control solution not information. compatible. 10b)Check the expiry date and the 10b) Control solution storage conditions of the control.

  • Page 53: Specifications

    1.11 and displays a plasma equivalent glucose result. The HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only. The HemoCue Glucose 201 DM Analyzer is only to be used with HemoCue Glucose 201 Microcuvettes. Principles of the method and procedure The Cuvette serves as pipette, reaction vessel and as a measuring cuvette, and is for single use only.

  • Page 54: Storage And Handling

    Storage and handling HemoCue Glucose 201 Microcuvettes Use the HemoCue Glucose 201 Microcuvettes prior to their expiry date. The expiry date is printed on each package. For information regarding storage and handling, refer to HemoCue Glucose 201 Microcuvettes Package Insert.

  • Page 55: Results

    Whole Blood: Measuring range is 0 - 400 mg/dL (0 - 22.2 mmol/L). Plasma Equivalent: Measuring range is 0 - 444 mg/dL (0 - 24.6 mmol/L) Any results with HemoCue Glucose Systems suggesting clinical intervention in the hyperglycemic range on pre-term neonates (<37 weeks), should be verified against a suitable laboratory method.

  • Page 56: Emc And Electrical Safety

    The electromagnetic environment in which the HemoCue Glucose 201 DM system will be operated should be evaluated prior to operation of the device. Do not use the HemoCue Glucose 201 DM system in close proximity to sources of strong electromagnetic radiation (e.g.

  • Page 57: Materials Required But Not Provided

    7.11 Materials required but not provided • HemoCue Glucose 201 Microcuvettes • Lancet* • Pipette or other transfer device** • Lint-free wipe • Hydrophobic surface ** * For capillary samples ** For venous/arterial samples 7.12 Spare parts • Power Adapter •...

  • Page 58: Symbols Used

    7.14 Symbols used Consult instructions for Caution CE mark Biological risk In Vitro diagnostic medical device Temperature limitation Manufacturer Humidity limitation Alternating current Catalogue number Serial number Ethernet DC inlet Lithium-ion Battery. Only valid within the Danger of explosion. European Community. Replace the battery with Indicates separate the same type...

  • Page 59: References

    Fogh-Andersen et al, Recommendation on Reporting Results for Blood Glucose (From an IFCC Stage 1 Document) IFCC Scientific Division Working Group on Selective Electrodes, JiCC, Vol 12 No 4 HemoCue Glucose 201 Microcuvettes Package Insert Tietz Fundamentals of Clinical Chemistry. 7th Edition, Edited by Burtis and Bruns, 2015...

  • Page 60: Technical Specifications

    FW7556M/06: 6 V /2500 mA FW8001/06: 5.9 V /3000 mA Battery HemoCue Li-Ion rechargeable power battery 201 DM 3.6V 2.6Ah Battery capacity ≥ 120 tests/100 hours using the Barcode Scanner and a power save setting of 5 minutes Battery charging time 75% of its capacity <...

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