GlucoRx HCT Connect Owner's Manual
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GlucoRx HCT Connect Owner's Manual

Integrated multiparameter diabetes monitoring system
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Integrated Multiparameter
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Owner's Manual

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Summary of Contents for GlucoRx HCT Connect

  • Page 1 Integrated Multiparameter Monitoring System Owner’s Manual...

  • Page 3: Intended Use

    Dear GlucoRx HCT Connect System Owner: Thank you for choosing the GlucoRx HCT Connect Integrated Multiparameter Monitoring System. This manual provides important information to help you use the system properly. Before using this product, please read the following contents thoroughly and carefully.

  • Page 4: Important Safety Precautions

    10. Proper maintenance and periodic control testing is essential to the longevity of your device. If you are concerned about accuracy of measurement, please contact GlucoRx Customer care on 01483 755133 for help. 11. You should not use this product with a broken iOS device.

  • Page 5: Table Of Contents

    BEFORE YOU BEGIN Important Information GETTING STARTED About your GlucoRx HCT Connect System Test Strips How to Install and Update the GlucoRx HCT App IMPORTANT INFORMATION ABOUT PERFORMING CONTROL TESTS How to Perform a Control Test IMPORTANT INFORMATION ABOUT TESTING YOUR BLOOD GLUCOSE OR ß-KETONE LEVEL...

  • Page 6: Before You Begin

    BEFORE YOU BEGIN Important Information Severe dehydration and excessive water loss may cause readings which are lower than your actual values. If you believe you are suffering from severe dehydration, consult your healthcare professional immediately. If your blood glucose or ß-ketone results are lower or higher than usual, and you do not have any symptoms of illness, first repeat the test.

  • Page 7: Getting Started

    GETTING STARTED About your GlucoRx HCT Connect System Ear Phone Connector Test Strip Slot...

  • Page 8: Test Strips

    GlucoRx HCT Ketone Test Strip NOTE: The GlucoRx HCT Connect Integrated Multiparameter Monitoring System should only be used with GlucoRx HCT Glucose Test Strips and GlucoRx HCT Ketone Test Strips. Using other test strips with this device can produce inaccurate results.

  • Page 9: How To Install And Update The Glucorx Hct App

    You must connect to the internet to download the APP. The APP Store can be accessed by tapping the APP Store icon on your iOS device. GlucoRx HCT APP is designed to assist you in easy testing, recording, tracking and monitoring of your blood glucose and ß-ketone.

  • Page 10: Important Information About Performing Control Tests

    Please check the contents of your box; contact GlucoRx Customer care on 01483 755133 for replacement accessories. Please make sure you have all items needed for a blood glucose or ketone test beforehand.
  • Page 11 1. Plug in GlucoRx HCT Connect Tap GlucoRx HCT icon to enter this app, press Measure on the main menu bar, a “Waiting Hardware Connection” message will appear on the screen. Connect the device with your smart phone, a “connecting” message will appear on the screen followed by the message “insert the test strip into the device".
  • Page 12 If the codes do not match, please contact GlucoRx Customer care on 01483 755133 for help. NOTE: The codes used in this manual are an example only; your device may display a different code.
  • Page 13 No need to select any measuring modes, your device will automatically identify this measurement as QC test; please move to next step. 4. Apply Blood Glucose Control Solution or Insert Ketone Control Key 4.1 for Blood Glucose test Shake the glucose control solution vial thoroughly before use. Squeeze out a drop and wipe it off, then squeeze out another drop and place it on the tip of the vial cap.
  • Page 14 “processing” message will appear on your Smart phone screen. Your device will tag this measurement as QC test automatically. 5. Read and Compare the Result After the “Processing” message appears, the glucose control solution or ketone control result will then show on the display. Compare this result with the range printed on your test strip vial or ketone strip foil packet respectively;...

  • Page 15: Important Information About Testing Your Blood Glucose Or Ss-Ketone Level

    IMPORTANT INFORMATION ABOUT TESTING YOUR BLOOD GLUCOSE OR ß-KETONE LEVEL WARNING: To reduce the chance of infection: ● Never share a lancet or the lancing device. ● Always use a new, sterile lancet. Lancets are for single use only. ● Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing device.

  • Page 16: Performing A Blood Glucose Test

    “Alternative Site Testing” (AST) on how to select the appropriate sites. ● Clean the puncture site using soap and warm water and let it air dry. ● Rub the puncture site for about 20 seconds before penetration. ● Use a clear AST cap while setting up the lancing device for ketone testing on your palms.
  • Page 17 1. Insert a blood glucose test strip into the device Press Measure on the main menu bar, a “Waiting Hardware Connection” message will appear on the screen. Connect the device with your smart phone, a “connecting” message will appear on the screen followed by the message “insert the test strip into the device".
  • Page 18 3. Obtaining a blood sample Use your pre-set lancing device to puncture the desired site. Wipe off the first drop of blood that appears with a clean cotton swab. Gently squeeze the punctured area to obtain another drop of blood. The volume of blood sample must be at least 1.0 microliter (μL).

  • Page 19: Performing A Ss-Ketone Test

    NOTE: Only a blood glucose test will show the corresponding haematocrit value. 6. Pull out the used test strip Pull out the used test strip and dispose carefully in a sharps bin. Performing a ß-Ketone Test To perform a ß-ketone test, you will need your device, ß-ketone test strip, sterile lancet and lancing device.
  • Page 20 NOTE: Always make sure you have the correct test strips for insertion, corresponding to the test you wish to do. 2. Select the appropriate measuring mode by touching the screen. The device provides you with four measurement modes which are: Before-Meal, After-Meal, Night and...
  • Page 21 3. Obtaining a blood sample Use your pre-set lancing device to puncture the desired site. Wipe off the first drop of blood that appears with a clean cotton swab. Gently squeeze the punctured area to obtain another drop of blood. The volume of blood sample must be at least 1.0 microliter (μL).
  • Page 22 ● NEVER try to add more blood to the test strip after a result has been displayed. Discard the used test strip and retest with a new one. ● If you have trouble filling the confirmation window, please contact your health care professional or GlucoRx Customer care on 01483 755133 for assistance.

  • Page 23: Alternative Site Testing

    Alternative Site Testing You can also test on your palms for ß-ketone testing. AST is NOT recommended when blood glucose testing. IMPORTANT: There are limitations with AST (Alternative Site Testing). Please consult your healthcare professional before you perform AST. Suggested Test Areas for the Hand When to use AST? Food, medication, illness, stress and exercise can affect blood...

  • Page 24: Introduction On Glucorx Hct App

    ● You are testing for hyperglycaemia. ● Your AST results do not match the way you feel. ● Your usual glucose results often fluctuate. INTRODUCTION ON GlucoRx HCT APP Data The device stores your blood glucose with HCT and ß-ketone test results, along with respective dates and times in memory under iOS.
  • Page 25 NOTE: Only a blood glucose test will show the corresponding haematocrit value. 2. Tap the record on the Data page to recall individual results; a pop-up window will appear. Next you can type in a personal note to add new results for that individual measurement. You also can edit anytime by tapping the existing notes.

  • Page 26: Analysis

    Analysis The analysis feature is designed to let you understand your latest test result through a piechart or diagram display, to have an overview or a 7-14-30- day average analysis. 1. To review the analysis on your iOS phone, press Analysis on the main menu bar;...
  • Page 27 3. Next you can see the trend graph by swiping upwards. The first page you will see is the 7-day data record, displayed by day-average test result with a colour dot. You can swipe right or left to review the testing trend. You also can select the 7/14/30 button on the top side to switch between 7-14-30 days view.

  • Page 28: Setting

    4. An additional item is available only with blood glucose test results. You can view your average reading compared with estimated HbA1c value for the past 3 months to better understand the effectiveness of your diabetes control. Tap the HbA1c Estimate to enter the comparison page, and then tap the Input Measured HbA1c button on the bottom to input the recorded percentage.

  • Page 29: Caring For Your Device

    CARING FOR YOUR DEVICE Cleaning 1. To clean the device exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry with a soft dry cloth. Do NOT rinse with water. 2. Do NOT use organic solvents to clean the device. Device Storage ●...

  • Page 30: Caring For Your Test Strips

    If swallowed, promptly see a doctor for help. For further information, please refer to individual glucose and ketone test strip package inserts. Important Control Solution Information ● Use only TaiDoc control solution for your GlucoRx HCT Glucose Test Strips with this device.

  • Page 31: System Troubleshooting

    If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call GlucoRx Customer care on 01483 755133. Do not attempt to ever repair or disassemble the device yourself. Result Readings (for glucose test)

  • Page 32: Result Readings (For Β-Ketone Test)

    (please see below 'Interpretation' table) Error Messages Error Error Error Message User action Type Code Displayed Please contact GlucoRx Customer Accessory Err42 Hardware error !!! Care on 01483 755133 for assistance. System operation Temperature is too range is 5°C to...

  • Page 33: Troubleshooting

    Device/smart phone battery died. Replace device battery/recharge smart phone. Test strip inserted upside down or Insert the test strip with contact incompletely. bars end first and facing up. Please contact GlucoRx Customer Defective device or test strips. Care on 01483 755133.
  • Page 34 Sample applied after automatic Repeat the test with a new test strip. switch-off. Defective device. Please contact GlucoRx Customer Care on 01483 755133. 3. If the glucose strips control solution test result is out of range. POSSIBLE CAUSE WHAT TO DO Error in performing the test.

  • Page 35: Detailed Information

    DETAILED INFORMATION The device provides you with plasma equivalent results. Normal blood glucose range for people with Time of day diabetes (mmol/L) Fasting and before meal 4 to 7 mmol/L 2 hours after meals< 9 mmol/L Source: Diabetes UK. Blood glucose target. Balance: No.234, 2010 April. P.69 The β-Ketone test measures Beta-Hydroxybutyrate (ß...
  • Page 36 The measurement unit used for indicating the concentration of blood or plasma glucose will have molarity (mmol/L). The approximate calculation rule for conversion of mmol/L to mg/dL is: mg/dL Divided by 18 = mmol/L mmol/L Times 18 = mg/dL For example: 1) 120 mg/dL ÷...

  • Page 37: Symbols

    SYMBOLS SYMBOL REFERENT In vitro diagnostic medical device Consult instructions for use Temperature limitation Use by Batch code Humidity Limitation CE mark Manufacturer Serial number Authorised representative in the European Union EC REP Caution, consult accompanying documents Collection for electrical and electronic equipment...

  • Page 38: Specifications

    SPECIFICATIONS Model No.: TD-4140 Dimensions: 50.8 (L) x 30.2 (W) x 11 (H) mm Weight: 7.6 g Power Source: iOS smart phone battery and device CR2032 battery. External output: Ear phone Auto electrode insertion detection Auto sample loading detection Auto reaction time count-down Temperature Warning Operating Condition: 5°C to 40°C (41°F to 104°F), below 85% R.H.
  • Page 40 Distributed by GlucoRx Ltd. 4 Wintonlea, Monument Way West, Woking, Surrey, GU21 5EN, UK Website: www.glucorx.co.uk Customer careline: 01483 755133 TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu Dist., 24888 New Taipei City, Taiwan www.taidoc.com For self-testing. MedNet GmbH EC REP Borkstraβe 10, 48163 Münster, Germany...

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