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Nipro GlucoKey Connect TD-4183D/GD82a Owner's Manual
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Nipro GlucoKey Connect TD-4183D/GD82a Owner's Manual

Blood glucose plus b-ketone monitoring system
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June 7, 2025

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Summary of Contents for Nipro GlucoKey Connect TD-4183D/GD82a

  • Page 1 β...
  • Page 3 Dear Owner of GlucoKey Connect Blood Glucose Plus β-Ketone Monitoring System: Thank you for purchasing the GlucoKey Connect Blood Glucose Plus β-Ketone Monitoring System. This manual provides important information to help you to use the system properly. Before using this product, please read and follow the instructions in this Owner's Manual.
  • Page 4 TABLE OF CONTENTS i l a i t s i t r i n i Perform a Blood Glucose or β-Ketone Test...

  • Page 5: Table Of Contents

    Disposing Used Test Strip and Lancet Data Transmission Via Bluetooth i r t Important Control Solution Information Result Readings (for glucose test) Result Readings (for β-Ketone test)
  • Page 6 WARRANTY TERMS AND CONDITIONS...
  • Page 7 SAFETY INFORMATION Read the following Safety Information thoroughly before using the device. Use this device ONLY for the intended use described in  this manual. DO NOT use accessories which are not specified by the  manufacturer. DO NOT use the device if it is not working properly or if it ...
  • Page 8 Keep the device and testing supplies away from young  children. Small items such as the battery cover, batteries, test strips, lancets and vial caps are choking hazards. The use of this instrument in a dry environment,  especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges that may cause erroneous results.
  • Page 9 Important Information Severe dehydration and excessive water loss may cause  readings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. If your blood glucose or β-Ketone results are lower or ...
  • Page 10 The measurement unit used for indicating the  concentration of blood glucose is mmol/L. The measurement unit used for indicating the  concentration of β-Ketone is mmol/L.
  • Page 11 INTRODUCTION Intended Use This system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) with capillary from fingertip, venous, arterial and to measure β-hydroxybutyrate (Ketone) in fresh whole blood...
  • Page 12 Product Overview 1 Test Strip Slot Strip Indication Light 3 Test Strip Ejector 4 Battery Compartment 5 Display Screen 6 Down Button 7 MAIN Button 8 UP Button...
  • Page 13 Meter Display Blood Drop Symbol Low Battery Symbol Ketone Warning / Blood Glucose Symbol Ketone Symbol Test Result Measurement Unit Measurement Mode Date & Time Memory Symbol Day Average Warning Symbol Test Strip Symbol...
  • Page 14 GETTING STARTED Initial Set-up Please follow the initial set-up procedure before using the device for the first time or after you have replaced the battery When the battery power is extremely low and “E-b & ” appears on the screen, the meter cannot be turned on. Step 1: Enter the Setting Mode 1.
  • Page 15 Note: Press to select Beep On or Beep Off then press  MAIN button to confirm. When Beep is turned off, the alarm function will remain  effective. During memory deletion, select “no” to keep all saved  results. You may set it up to four reminder alarms. ...
  • Page 16 To turn off the alarm, press to change On to OFF.  Press MAIN button to confirm. When the alarm goes off, the device will automatically  turn on. Press to mute the alarm. If you do not press the device will beep for 2 minutes then switch off.
  • Page 17 BEFORE TESTING Calibration You must calibrate the device every time you begin to use a new box of β-Ketone test strips by setting the meter with the correct code. To ensure test accuracy, make sure the code number displayed on the display screen matches the number printed on the test strip vial or individual foil pack.
  • Page 18 If it matches, you can proceed with your test. Otherwise, please stop testing and repeat the calibration procedure. If the problem persists, contact customer service for further assistance. Important It is important to make sure that the LCD display code is the same as the code on the test strip vial or individual foil pack before testing.
  • Page 19 Do a control solution test when:  you first receive the device.  you begin using a new vial of test strips.  you suspect the device or test strips are not working properly.  your blood glucose or β-Ketone test results are not consistent with how you feel or if you think the results are not accurate.
  • Page 20 touch the drop of control solution. Once the confirmation window is filled completely, the device will begin counting down. Note: To avoid contaminating the control solution, do not directly apply the control solution onto a strip. 4. Read and compare the result. After counting down to 0, the test result of the control solution will appear on the display.
  • Page 21 individual foil pack is for control solution use only. It is not a recommended range for your blood glucose level. Refer to the Maintenance section for important  information about your control solutions. Out of range results: If you continue to get results that fall outside the range printed on the test strip vial, it means that the meter and strips may not be working properly.
  • Page 22 TESTING YOUR BLOOD GLUCOSE Test Strip Appearance Absorbent Hole Apply a drop of blood here. The blood will be Confirmation Window automatically absorbed. This is where you confirm if enough blood has been applied to the absorbent Test Strip Handle hole in the strip.
  • Page 23 Inserting a Test Strip Insert the test strip into its slot. Important The front side of test strip should face up when inserting the test strip. Test results may be inaccurate if the contact bar is not fully inserted into the test slot. To reduce the chance of infection: Never share a lancet or a lancing device.
  • Page 24 4. Replace the cap until it snaps or clicks into place. 5. Rotate the dial to set the desired lancing depth. 6. Pull the cocking control out until the orange bar appears on the release button window. Obtaining a Blood Sample Please follow the suggestions below before obtaining a drop of blood: Wash and dry your hands before starting.
  • Page 25 2. Press the release button to prick your nger. A click indicates that the puncture is complete. ＊ Blood from sites other than the fingertip (For Blood Glucose Test Only) Important AST is not available for β-Ketone test.  Alternative site testing (AST) is when individuals check their blood glucose levels using other areas of the body other than the ngertips.
  • Page 26 Two hours or more after taking insulin.  Two hours or more after exercise.  DO NOT use AST if: You think your blood glucose is low.  You may not notice if you are hypoglycemic.  Your AST results are inconsistent with the way you feel. ...

  • Page 27: Perform A Blood Glucose Or Β-Ketone Test

    Perform a Blood Glucose or β-Ketone Test 1. Insert the test strip into its slot. Wait for the device to display the test strip “ ”, blood drop “ ” and GLU or KETONE. 2. Press ▲ or ▼ to adjust the measuring mode, and press MAIN button to confirm it.
  • Page 28 4. Apply the blood sample. Move your finger to meet the absorbent hole of the test strip and the drop will be automatically be drawn onto the test strip. Remove your finger until the confirmation window is filled. The meter begins to countdown. Do not remove your finger until you hear a beep sound.

  • Page 29: Disposing Used Test Strip And Lancet

    Disposing Used Test Strip and Lancet To remove the used test strip, simply push the Test Strip Ejector button upward to eject the used test strip. The device will automatically turn off after the test strip is removed. Remove the used lancet from the lancing device after you have finished testing.
  • Page 30 REVIEWING TEST RESULTS Your device stores the 1000 most recent test results along with respective dates and times in its memory. To enter the device memory, start with the device switched off. To review all test results, do the following: 1.
  • Page 31 To review the day-average test results, do the following: 1. Press and release ▼ to enter memory mode for average results with “ ” and DAY AVG displayed on the screen. Release MAIN and then your 7-day average result measured in general mode will appear on the display. 2.
  • Page 32 Note: Press and hold MAIN for 5 seconds to exit the memory  mode or leave it without any action for 3 minutes. The device will turn off automatically. If using the device for the first time, the “---” icon will ...

  • Page 33: Data Transmission Via Bluetooth

    TRANSFERRING DATA Data Transmission Via Bluetooth You can use your device with an iOS (5.0.1 or higher) or Android (2.3.3 or higher) download data from your GlucoKey Connect via Bluetooth. Follow the steps below to transmit data from your GlucoKey Connect. Please contact your customer service or place of purchase for assistance.
  • Page 34 Note: This step is recommended when the user needs to pair this meter to a Bluetooth receiver for the first time or when the user needs to pair this meter to another Bluetooth receiver. 4. If your device with an iOS or Android is within the receiving range, the data transmission will start and the Bluetooth signals in blue.
  • Page 35 MAINTENANCE Changing the Battery You must change the battery immediately and reset the date and time when the battery power is extremely low and “ & E-b” appears on the screen. The meter cannot be turned on. To change the battery, do the following: 1.
  • Page 36 Keep the battery away from small children. If swallowed,  seek medical assistance immediately. Battery may leak chemicals if unused for a long time.  Remove the battery if you are not going to use the device for an extended period. Properly dispose of the used battery according to your ...

  • Page 37: Important Control Solution Information

    Caring for Your Test Strips Storage condition: 2°C to 30°C , below 85% relative  humidity. DO NOT freeze. Store your test strips in their original vial only. Do not  transfer to another container. Store test strip packages in a cool and dry place. Keep ...
  • Page 38 It is recommended that the control solution test be done  at room temperature 20°C to 25°C. Make sure your control solution, device and test strips are at this specified temperature range before testing. Shake the vial before use, discard the first drop of control ...

  • Page 39: Reference Value

    REFERENCE VALUE The device provides you with plasma equivalent blood glucose results. Time of day Normal plasma glucose range for people without diabetes Fasting and before meals < 5.6 mmol/L 2 hours after meals < 7.8 mmol/L Source: American Diabetes Association (2012). Clinical Practice Recommendations.
  • Page 40 If your -Ketone result is between 0.6 and 1.5 mmol/L, β  this may indicate a development of a problem that may require medical assistance. Follow your healthcare professional’s instructions. If your β-Ketone result is higher than 1.5 mmol/L, contact ...
  • Page 41 SYMBOL INFORMATION SYMBOL REFERENT SYMBOL REFERENT In vitro Caution, consult diagnostic accompanying medical device documents Consult Humidity instructions for Limitation Temperature Collection for limitation electrical and Use by CE mark Batch code Manufacturer Dispose of the packaging Serial number properly after Sterilized using Do not reuse irradiation...

  • Page 42: Result Readings (For Glucose Test)

    TROUBLESHOOTING If you follow the recommended steps but the problem persists or error messages other than the ones below appear, please call customer service on 1800 451 737. Do not attempt to repair the device yourself and never try to disassemble the device under any circumstances.
  • Page 43 Error Messages MESSAGE Cause What To Do The batteries Replace the battery cannot provide immediately and reset enough power for date and time on the a test. meter setting. Strip has been Repeat the test with a used. new strip. Problem in Review the instructions operation.
  • Page 44 Blood Glucose Measurement Symptom Cause What To Do Batteries Replace the battery The device immediately and reset exhausted. does not date and time on the meter setting. display a message Test strip inserted Fully insert the test strip after upside down or with contact bars end inserting a incompletely.
  • Page 45 Insufficient blood Repeat the test using a sample. new test strip with larger volume of blood sample. Defective test Repeat the test with a The test strip. new test strip. does not Repeat the test with Sample applied start after anew test strip.
  • Page 46 Control solution, device Control solution and test strips should that is too warm or be at room temperature too cold. (20°C to 25°C) before testing. Defective test Repeat the test with a strip. new test strip. Device Please contact malfunction. customer service.
  • Page 47 SPECIFICATIONS Model No. TD-4183D / GD82a Memory 1000 measurement results with respective date and time Dimensions 89.8 (L) x 54.9 (W) x 18 (H) mm Power Source One 1.5V AAA alkaline battery Weight 46.1 g (without battery) External output Bluetooth Auto electrode insertion Features detection...
  • Page 48 Hematocrit range 0~70% for glucose testing and 10~70% for β-Ketone test Test Result Glucose measurements are reported as plasma equivalents This device has been tested to meet the electrical and safety requirements of: IEC/EN 61010-1, IEC/EN 61010-2-101, EN 61326-, IEC/EN 61326-2-6, EN 301 489-17, EN 300 328.
  • Page 49 WARRANTY TERMS AND CONDITIONS With respect to disposable products, the manufacturer warrants to the original purchaser that at time of delivery, each standard product manufactured by the manufacturer shall be free from defects in material and workmanship and when used for the purposes and indications described on the labeling is fit for the purposes and indications described on the labeling.
  • Page 50 conditioned upon proper storage, installation, use and maintenance in accordance with applicable written recommendations from the manufacturer. The warranty furnished hereunder does not extend to damaged items purchased hereunder resulting in whole or in part from the use of components, accessories, parts or supplies not furnished by the manufacturer.
  • Page 52 Distributed in Australia by: TaiDoc Technology Corporation NIPRO AUSTRALIA PTY LTD B1-7F, No.127, Wugong 2nd Rd., SUITE 2.02, LEVEL 2, Wugu Dist., 24888 New Taipei City, 657 PACIFIC HIGHWAY, Taiwan ST. LEONARDS, NSW 2065, AUSTRALIA www.taidoc.com For assistance, please call 1800 451 737.
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