TD Gluco TD 4279 Blood Sugar Control System manual
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TD Gluco TD 4279 Blood Sugar Control System

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— answers from the official manual

Answers from the official manual.

Common questions

Common Questions

10 total
1

What error codes can appear on the GlucoRx HCT & Ketone TD-4279, and what do they mean?

The meter displays several error codes: E-b (batteries too low), E-C (wrong code strip or coding error), E-2 (expired code strip), E-U (used test strip inserted), E-t (temperature outside operating range), E-0/E-A/E-E (meter problem), and E-F (test strip removed during countdown or insufficient blood volume). For E-t, move the meter and test strip to within the operating range of 10°C to 40°C (50°F to 104°F) before retesting. If any error persists, contact GlucoRx Customer care on 01483 755133. (Page 29)

2

How do I set up the meter for the first time, including date, time, and alarms?

With the meter off and no test strip inserted, press the S (SET) button to enter setting mode. You will be guided through setting the year, month, and day, then time format (12h or 24h), then the hour and minute, then the buzzer on/off, up to four reminder alarms, and finally the backlight on/off — pressing M to adjust values and S to confirm each step. If the meter is idle for 3 minutes during setup, it will switch off automatically. (Page 13)

3

How do I replace the batteries in the TD-4279 meter?

Make sure the meter is turned off, then press the edge of the battery cover and lift it up to remove it. Remove the old batteries and insert two fresh 1.5V AAA size alkaline batteries, then close the battery cover — if inserted correctly, the meter will emit a beep. Replacing the batteries does not affect test results stored in the memory. (Page 24)

4

How do I calibrate the meter for β-Ketone testing?

You must calibrate the meter each time you begin a new vial of β-Ketone test strips by inserting the code strip while the meter is off and waiting for the code number to appear on the display. Ensure the code number on the display matches the number on your individual foil packet, then remove the code strip — the display will show 'OK' to confirm coding is complete. If the codes do not match, repeat the calibration procedure, and if the problem persists contact GlucoRx Customer care on 01483 755133. (Page 15)

5

How do I perform a blood glucose test with the TD-4279?

Insert a glucose test strip to turn on the meter and wait for the display to show the blood drop and 'GLU' symbols, then select your measuring mode (Gen, AC, or PC) by pressing M. Lance your fingertip, wipe away the first drop of blood, and gently apply a second drop of at least 1.0 microliter (μL) to the absorbent hole of the test strip at a tilted angle until the confirmation window is completely filled. Do not remove your finger until you hear a beep, then read your result after the meter counts down to 0. (Pages 19–20)

6

When should I perform a control solution test on my meter?

You should perform a control test when you first receive the meter, at least once a week for routine checks, when you begin using a new vial or foil packet of test strips, if you suspect the meter or strips are not working properly, if results are inconsistent with how you feel, when practising the testing process, or if you have dropped or may have damaged your meter. The control test range printed on the test strip vial is for control testing only and is not a recommended range for your actual blood glucose or ketone level. (Page 16)

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Full Manual

32 pages
Page 1

3 Dear GlucoRx HCT & Ketone TD-4279 System Owner: Thank you for purchasing the GlucoRx HCT & Ketone Blood Glucose Monitoring System. This manual provides important information to help you to use the system properly. Before using this product, please read the following contents thoroughly and carefully. The System measures both blood glucose and β-ketone. Regular monitoring of your blood glucose and β-ketone levels can help you and your doctor gain better control of your diabetes. Due to its compact size and easy operation, you can use the GlucoRx HCT & Ketone Blood Glucose Monitoring System to easily monitor your blood glucose and β-ketone levels by yourself anywhere, any time. If you have other questions regarding this product, please contact GlucoRx Customer care on 01483 755133. Intended Use This system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples from the finger, and to measure β-hydroxybutyrate (ketone) in fresh whole blood samples from the finger and palm. It should not be used for the diagnosis of or screening for diabetes mellitus. The test for haematocrit (HCT) as part of the system, is intended for use in the in vitro quantification of packed red blood cell volume fraction in capillary whole blood as an aid in monitoring the status of total volume of red blood cells. The test reading of haematocrit (HCT) is used only to determine whether the blood test sample is within the acceptable range of blood glucose system. It should not be used for the diagnosis of anaemia or erythrocytosis. Version 2.0 2015/09 311-4279300-006

Page 2

4

Important Safty Instructions

Read Before Use

  • 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 is damaged.
  • This device does NOT serve as a cure for any symptoms or diseases.
  • The data measured is for reference only. Always consult your doctor to

    have the results interpreted.

  • The blood glucose test strip can be used for the testing of newborns;
  • The β-ketone test strip must not be used for the testing of newborns.

  • Before using this device to test blood glucose or β-ketone, read all
  • instructions thoroughly and practice the test. Carry out all the quality

    control checks as directed.

  • Keep the device and testing equipment away from young children.
  • Small items such as the battery cover, batteries, test strips, lancets

    and vial caps are choking hazards.

  • 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.

  • Do NOT use this instrument in close proximity to sources of strong
  • electromagnetic radiation, as these may interfere with accurate

    operation.

  • Proper maintenance and periodic control testing are essential to the
  • longevity of your device. If you are concerned about your accuracy of measurement, please contact GlucoRx Customer care on

    01483 755133.

    Keep These Instructions In A Safe Place

    Page 3

    5

    Before You Begin

    09

    Important Information 09

    Contents of System 10

    Meter Overview 11

    Display Screen 12

    Test Strip 12

    Setting The Meter

    13

    The Three Measuring Modes

    14

    Before Testing

    15

    Calibration 15

    How to Code Your Meter (for β-Ketone Test) 15

    Checking the Code Number 15

    Control Testing 16

    Performing a Control Test 17

    Testing With Blood Sample

    18

    Preparing the Lancing Device for Blood Testing 18

    Preparing the Puncture Site 18

    Performing a Blood Glucose or β-Ketone Test 19

    Alternative Site Testing (for β-Ketone Test) 21

    Meter Memory

    22

    Reviewing Test Results of Blood Glucose or β-Ketone 22

    Reviewing Blood Glucose Day Average Results 22

    Downloading Results Onto A Computer

    23

    Maintenance

    24

    Battery 24

    Caring for Your Meter 25

    Caring for Your Test Strips 25

    Caring for Your Carry Case 26

    Important Control Solution Information 27

    Table Of Contents

    Page 4

    6

    System Troubleshooting

    28

    Result Readings 28

    Error Messages 29

    Troubleshooting 30

    Detailed Information

    31

    Symbol Information

    32

    Specifications

    33

    Page 5

    7 (e) (f) (g) (h) (d) (i) (k) (l) (a) (b) (c)

    Set

    832 code 832 code 832

    Page 6

    8 (n) (m) (j) (p) (o) (q) 1 2

    Page 7

    9

    Before You Begin

    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 higher than usual, and you do not have any symptoms of illness, first repeat the test. If you have symptoms or continue to get results which are higher or lower than usual, follow the treatment advice of your

    healthcare professional. ● Use only fresh whole blood samples to test your blood glucose or β-ketone. Using other substances will lead to incorrect results. ● If you are experiencing symptoms that are inconsistent with your blood glucose or β-ketone test results and you have followed all the instructions given in this owner’s manual, contact your healthcare professional. ● We do not recommend using this product on severely hypotensive individuals or patients in shock. Please consult your healthcare professional before use. ● 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 in mg/dL is: For example: 1) 120 mg/dL ÷ 18 = 6.6 mmol/L 2) 7.2 mmol/L x 18 = 129 mg/dL approximately. ● The HCT is the volume percentage (%) of red blood cells in blood sample. The Hb is haemoglobin (g/dL) levels in blood sample. The approximate calculation rule for Hb is: Hb= HCT*0.34 (Note: Haematocrit =HCT; Haemoglobin=Hb) mg/dL mmol/L Divided by 18 Times 18 = mmol/L = mg/dL

    Page 8

    10 Contents of System Your new GlucoRx HCT & Ketone TD-4279 System kit includes:

  • A meter
  • Owner’s manual
  • Protective wallet
  • Quick start user guide
  • Daily log book
  • Warranty card
  • Lancing device with AST cap
  • Batteries
  • Glucose test strips vial
  • Single foil ketone test strip
  • Control solution
  • Lancets
  • Note:

    If any items are missing from your kit or opened prior to use, please contact GlucoRx Customer care on 01483 755133.

    Page 9

    11 Meter Overview Front Top Right Side Left Side Back 1

    Set

    2 6 7 4 3 5 Test Strip Slot Insert test strip here to turn the meter on for testing. Display Screen Main Button (M) Enter the meter memory Test Strip Ejector Eject the used strip by pushing up this button. Data Port Download test results with a cable connection. SET Button (S) Enter and confirm the meter settings. Battery Compartment 1 2 3 5 4 6 7

    Page 10

    12 Display Screen Ketone Symbol / Ketone Warning Glucose Level / Ketone Level Error Warning Low Battery Symbol Day Average Memory Symbol Hb Level / Time / Date Hb Unit HCT Level Glucose / Ketone Measurement Unit Measurement Modes Gen – any time of day AC – before meal PC – after meal 1 2 3 4 5 6 7 9 8 10 Test Strip Symbol Blood Drop Symbol Code Glucose Symbol Alarm reminder 13 12 14 15 16 11

    Attention:

    The front side of test strip should face up when inserting test strip. Test results may be wrong if the contact bar is not fully inserted into the test slot.

    Note:

    The GlucoRx HCT & Ketone monitor should only be used with GlucoRx HCT Glucose or β-Ketone Test Strips. Using other test strips with this meter can produce inaccurate results. Test Strip 1 Absorbent Hole Confirmation Window 1 2 Test Strip Handle Contact Bars 3 4 3 4 (for glucose test) (for ketone test) 2 14 13 12 1 15 3 7 2 4 5 6 8 11 9 10 16 (characterised as "AL1", "AL2", "AL3", "AL4" in the middle of meter display)

    Page 11

    13

    Setting The Meter

    Before using your meter for the first time or if you change the meter battery, you should check and update these settings. Entering the Setting Mode (a) Start with the meter off (no test strip inserted). Press S.
  • Setting the date
  • The sequence of the date setting is: YEAR → MONTH → DAY. With the YEAR / MONTH / DAY flashing in sequence, press M until the correct year/month/day appears. Press S.
  • Setting the time format
  • Press M to select the desired time format --- 12h or 24h. Press S.
  • Setting the time
  • With the HOUR / MINUTE flashing in sequence, press M until the correct hour/minute appears. Press S.
  • Setting the buzzer
  • With the buzzer displays, press M to switch between “On” and “OFF”. Press S.
  • Setting the reminder alarm
  • Your meter has four reminder alarms. The meter will display “OFF” and “AL1 ”. If you don’t want to set an alarm, press S to skip this step; Or press M to select “On”, then press S. With the hour/minute flashing in sequence, press M to select the correct hour/minute. Press S and go to the next alarm setting.

    Notice:

    When the alarm is beeping: Press M to silence it or press and hold M to switch it off. Otherwise, it will beep for 2 minutes then switch off.

    Page 12

    14

    The Three Measuring Modes

    This meter provides you with three modes for measuring; General, AC, and PC. You can switch between each mode by:
  • Start with the meter switched off. Insert a test strip to turn on the
  • meter. The screen will display a flashing “ ” and “Gen”.
  • Press M to switch between General, AC, and PC modes.
  • Congratulations! You have completed all settings!

    Note:

  • These parameters can ONLY be changed in the setting mode.
  • If the meter is idle for 3 minutes during the setting mode, it will switch
  • off automatically.

  • Setting the backlight
  • The default setting for meter backlight ("8L") is set to ON. Press M to switch between “On” and “OFF”.Press S.

    Page 13

    15

    Before Testing

    Calibration You must calibrate the meter every time you begin to use a new vial of β-Ketone test strips by setting the meter with the correct code. Test results may be inaccurate if the code number displayed on the monitor does not match the number printed on your individual foil packet. How to Code Your Meter (for β-Ketone test)(b)
  • Insert the code strip when the monitor is off. Wait until the code
  • number appears on the display.

    Notice:

    Make sure the code number on display, and individual foil packet are the same. The code strip should be within the expiry date, otherwise an error message may appear.
  • Remove the code strip, the display will show “OK”. This tells you
  • that the meter has finished coding and is ready for β-ketone testing. Checking the Code Number (c) You need to make sure that the code number displayed on the meter matches the number on your ketone test strip vial or individual foil packet before you proceed. If it matches, you can proceed with your test. If the codes do not match, please stop testing and repeat the calibration procedure. If the problem persists, contact GlucoRx Customer care on 01483 755133 for help.

    Notice:

    The codes used in this manual are examples only; your meter may display a different ketone code.

    Page 14

    16 Control Testing Our Glucose Control Solution contains a known amount of glucose that reacts with the glucose test strips and is used to ensure your meter and glucose test strips are working together correctly. Do a control test when: ● you first receive the meter, ● at least once a week to routinely check your meter and test strips, ● you begin using a new vial or new individual foil packet of test strips, ● you suspect your meter or test strips are not working properly, ● your blood glucose or ketone test results are not consistent with how you feel, or if you think the results are not accurate, ● practicing the testing process, or ● you have dropped or think you may have damaged your meter. Test strips (e), control solution (f), lancing device (g) or sterile lancets (h) may not be included in the kit (please check the contents in your product box). They can be obtained separately from GlucoRx Customer care (telephone 01483 755133). Please make sure you have all items needed for a blood glucose or ketone test beforehand. Performing a Control Solution Test To perform a control solution test, you will need: (d), (e), (f) or (p).

    Warning:

  • It is important to make sure that the LCD displayed code is the same as
  • the code on your ketone test strip vial or individual foil packet before testing. Failure to do so will get inaccurate results.
  • The code number for β-Ketone strip is three-digits; please ensure you are
  • using the correct strips for the test.
  • If the LCD displayed code is not the same as the code on your ketone
  • individual foil packet, and the code number cannot be updated, please contact GlucoRx Customer care on 01483 755133 for assistance.

    Page 15

    17 For Blood Glucose Control Test

  • Insert the glucose test strip to turn on your meter
  • Wait for the meter to display “ ” and “ ”.
  • Apply blood glucose control solution (i)
  • Shake the control solution vial thoroughly before use. Squeeze out the first drop and wipe it off, then squeeze out another drop and place it on the tip of the vial cap. Hold the meter to move the absorbent hole of the test strip to touch the drop. Once the confirmation window fills completely, the meter will begin counting down.

    Notice:

    To avoid contaminating the control solution, do not directly apply control solution onto a strip. For ß-ketone Control Test
  • Insert Ketone Control Key (q)
  • Insert the ketone control key into your meter. The meter displays the following in sequence: code number, CH, ambient temperature and then “ ” and a flash “ ”.
  • Turn on the switch on the front side of the ketone control key.
  • Read and compare the result
  • After counting down to 0, the control test result will appear on the display. Compare this result with the range printed on your individual foil packet and it should fall within this range. If not, please read the instructions again and repeat the control test. With the ß-ketone control test, make sure you turn off the switch on the front side of the ketone control key after removing it from your meter.

    Note:

  • There is no HCT and Hb display function while the meter is in QC mode.
  • The control test range printed on the test strip vial or individual foil packet
  • is for control testing use only. It is not a recommended range for your blood glucose or ketone level.
  • See the MAINTENANCE section for important information about your
  • control solution.

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    18

    Warning:

    To reduce the chance of infection:
  • Never share a lancet of the lancing device. GlucoRx Lancing device is for
  • self-use only.
  • 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. Preparing the Puncture Site Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the accuracy of the glucose or β-ketone value obtained. Blood from a site that has not been rubbed exhibits a measurably different glucose or β-ketone concentration than blood from the finger. If the puncture site was rubbed prior to blood extraction, the difference is significantly reduced. Please follow the suggestions below before obtaining a drop of blood: ● Select the puncture site at fingertips (for glucose test). ● Select the puncture site either at fingertips or palm (please see section 'Alternative Site Testing' [AST]). ● Hand wash the puncture site with warm water and dry thoroughly before testing ● Rub the puncture site for about 20 seconds before penetration. ● Use a clear cap (included in the kit) while setting up the lancing device (for β-ketone test). Preparing the Lancing Device for Blood Testing Please follow the instructions in the lancing device insert for collecting a blood sample.

    Testing With Blood Sample

    Page 17

    19 ● Fingertip testing (j) Press the lancing device’s tip firmly against the lower side of your fingertip. Press the release button to prick your finger; a click indicates that the puncture is complete. ● Blood from site other than the fingertip (o) (for β-ketone test) Replace the lancing device cap with the clear cap for AST. Pull the cocking control back until it clicks. When lancing the palm, avoid lancing the areas with obvious veins because of excessive bleeding.

    Note:

  • Choose a different spot each time you test. Repeated punctures at the
  • same spot may cause soreness and calluses.

  • Please consult your health care professional before you begin AST (for
  • β-ketone test).

  • It is recommended that you discard the first drop of blood as it may
  • contain tissue fluid, which may affect the test result. Performing a Blood Glucose or β-Ketone Test To perform a blood glucose or β-ketone test, you will need: (d), (e), (g) and (h).

  • Insert the test strip to turn on the meter
  • Wait for the meter to display “ ”, “ ”, and "GLU" or "KETONE"
  • Select the appropriate measuring mode by pressing M
  • Obtaining a blood sample (k)
  • Use your pre-set lancing device to puncture the desired site. Wipe off the first drop of blood with a clean cotton swab. The size of the drop should be at least as big as (actual size), which is 1.0 microliter (μL) of volume. Gently squeeze the punctured area to obtain another drop of blood. Be careful NOT to smear the blood sample.
  • Apply the sample (l)
  • Gently apply the drop of blood to the absorbent hole of the test strip at a tilted angle. Confirmation window should be completely filled if

    Page 18

    20

    Warning:

    The used lancet and test strip may be biohazardous. Please discard them carefully according to your local regulations.

    Note:

  • Do not press the punctured site against your test strip or try to smear the
  • blood.
  • If you do not apply a blood sample to the test strip within 3 minutes, the
  • meter will automatically turn off. You must remove and reinsert the test strip to start a new test.
  • The confirmation window should be filled with blood before the meter
  • begins to count down. NEVER try to add more blood to the test strip after the drop of blood has moved away. 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.

  • Read your result
  • The result of your blood glucose test with HCT/ Hb levels or the result of your β-ketone test will appear after the meter counts down to 0. The blood glucose result with HCT/ Hb levels or the β-ketone result will be stored in your memory automatically.
  • Eject the used test strip (m)
  • Eject your test strip by pushing the eject button on the side. Use a sharps bin to dispose of used test strips. The meter will switch itself off automatically. Always follow the instructions in the lancing device insert when removing the lancet. enough blood sample has been applied. Do NOT remove your finger until you hear a beep sound.

    Page 19

    21 Alternative Site Testing (for β-Ketone Test) In addition to using your fingertips, you can test on your palms. Important: There are limitations with AST (Alternative Site Testing). Please consult your health care professional before you perform AST. Suggested Test Areas for the Hand When to use AST? Food, medication, illness, stress and exercise can affect ketone levels. Capillary blood at the fingertip reflects these changes faster than capillary blood at other sites. Thus, when testing ketone during or immediately after a meal, physical exercise, or any other event, take a blood sample from your finger only. We strongly recommend that you perform AST ONLY at the following times: ● In a pre-meal or fasting state (more than 2 hours since the last meal). ● Two hours or more after taking insulin. ● Two hours or more after exercise. Do NOT use AST if: ● You think your ketone is low. ● Your AST results do not match the way you feel. ● Your routine ketone results often fluctuate.

    Page 20

    22

    Meter Memory

    This meter stores the 1000 most recent blood glucose test results along with respective HCT/Hb values, dates and times or β-ketone test results along with respective dates and times in its memory. To enter the meter memory, start with the meter switched off. Reviewing Test Results
  • Press and release M.
  • “ ” will appear on the display. Press M again, and the first reading you see is the last blood glucose result along with HCT/Hb value, date, time and the measuring mode or you will see the last β-ketone result along with date, time and the measuring mode.
  • Press M to recall the test results stored in the meter. After the last
  • glucose or β-ketone test result, press M again and the meter will switch off. Reviewing Blood Glucose Day Average Results
  • Press and release M. When “
  • ” appears on the display, keep pressing M for 3 seconds until the flashing “ ” appears. Release M and then your 7-day average result measured in general mode will appear on the display.
  • Press M to review 14-, 21-, 28-, 60- and 90- day average results
  • stored in each measuring mode in the order of Gen, AC, then PC.
  • Exit the meter memory. Keep pressing the M and the meter will
  • switch off after displaying the last test result.

    Note:

  • Any time you wish to exit the memory, keep pressing M for 5 seconds or
  • leave it without any action for 3 minutes. The meter will switch off

    automatically.

  • Control test results are NOT included in the day average.
  • Page 21

    23

    Downloading Results Onto

    A Computer

    Data Transmission Via Cable You can use your meter with a USB cable and the GlucoRx Healthcare Software System to view test results with HCT/Hb levels on your personal computer. To learn more about the GlucoRx Healthcare Software System or to obtain a USB cable separately, please contact GlucoRx Customer care on 01483 755133 for assistance.
  • Obtaining the required cable and installing the software
  • To download GlucoRx Healthcare Software System, please visit GlucoRx's website www.glucorx.co.uk.
  • Connecting to a personal computer
  • Connect the cable to a USB port on your computer. With the meter switched off, connect the other end of the USB cable to the meter data port. “USb” will appear on the meter display, indicating that the meter is in communication mode.
  • Data transmission
  • To transmit data, follow the instructions provided with the software. Results will be transmitted with the date and time. Remove the cable and the meter will automatically switch off.

    Note:

    While the meter is connected to the PC, it is unable to perform a blood glucose or β-ketone test.

    Page 22

    24

    Maintenance

    Battery Your meter comes with two 1.5V AAA size alkaline batteries. Low Battery Signal The meter will display one of the messages below to alert you when the meter power is getting low.
  • The “
  • ” symbol appears along with display messages: The meter is functional and the result remains accurate, but it is time to change the batteries.
  • The “
  • ” symbol appears with E-b and : The power is not enough to do a test. Please change the batteries immediately. Replacing the Battery (n) To replace the batteries, make sure the meter is turned off.
  • Press the edge of the battery cover and lift it up to remove.
  • Remove the old batteries and replace with two 1.5V AAA size
  • alkaline batteries.
  • Close the battery cover. If the batteries are inserted correctly, you
  • will hear a “beep” afterwards.

    Note:

  • Replacing the batteries does not affect the test results stored in the
  • memory.

  • As with all small batteries, these batteries should be kept away from
  • children. If swallowed, promptly seek medical assistance.

  • Batteries may leak chemicals if unused for a long time. Remove the
  • batteries if you are not going to use the device for an extended period (i.e., 3 months or more).

  • Properly dispose of the batteries according to your local environmental
  • regulations.

    Page 23

    25 Caring for Your Meter Cleaning ● To clean the meter exterior, wipe it with a disinfecting wipe

    (Example:Micro-Kill Plus™) to clean exposed surfaces thoroughly and remove any visible dirt, blood or any other body fluid with the wipe. Then dry the device with a soft, dry and clean cloth. Do NOT rinse the meter with water. ● Do NOT use organic solvents to clean the meter. Meter Storage ● Storage conditions: -20°C to 60°C (-4°F to 140°F), below 95% relative humidity. ● Always store or transport the meter in its original storage case. ● Avoid dropping and heavy impact. ● Avoid direct sunlight and high humidity. Meter Disposal A used meter should be treated as contaminated and may carry a risk of infection during measurement. The batteries in this used meter should be removed and the meter should be disposed in accordance with local regulations. The meter falls outside the scope of the European Directive 2002/96/ EC-Directive on waste electrical and electronic equipment (WEEE). Caring for Your Test Strips ● Storage conditions: 2°C to 32°C (35.6°F to 89.6°F) for glucose test strip and 2°C to 30°C (35.6°F to 86°F) for β-ketone test strip, below 85% relative humidity. Do NOT freeze. ● Store your blood glucose test strips in their original vial only. Do not transfer to another container. ● Store test strip packages in a cool dry place. Keep away from direct sunlight and heat. ● After removing a glucose test strip from its vial, immediately close the vial cap tightly.

    Page 24

    26 Caring for Your Carry Case

  • Remove protective film attached to the sticky sheet before using for
  • first time. NOTE: To prevent splitting, do not forcefully pull the sticky sheet out. ● Touch the glucose and ketone test strips with clean and dry hands. ● Use each test strip immediately after removing it from the vial or individual foil packet. ● Write the opening date on the vial label of blood glucose strip when you first opened it. Discard remaining blood glucose test strips after 6 months. ● Do not use test strips beyond their expiry date. This may cause inaccurate results. ● Do not bend, cut, or alter a test strip in any way. ● Keep the strip vial away from children since the cap and the test strip may be a choking hazard. If swallowed, promptly see a doctor for help. For further information, please refer to the test strip package insert.
  • If the stickiness of the sticky sheet
  • eventually worsens when too dirty, please remove the sticky sheet lightly.
  • Rinse the sticky sheet with tap water, gently rubbing
  • the surface with your fingers to remove dirt.

    Page 25

    27

  • After rinsing with water, allow the sticky sheet to air
  • dry for 3 to 5 minutes.
  • After drying completely, the sticky sheet can be
  • restored. Place it back in the carry case for use. 3~5min NOTE: Never use any object to wipe off the sticky sheet. NOTE: The sticky sheet will become less sticky the more you touch it, through transfer of your skin oils. Important Control Solution Information ● Use only GlucoRx control solution with your meter. ● Do not use the control solution beyond the expiry date or 3 months after first opening. Write the opening date on the control solution vial and discard the remaining solution after 3 months. ● It is recommended that the control solution test be done at room temperature 20°C to 25°C (68°F to 77°F). Make sure your control solution, meter, and test strips are at this specified temperature range before testing. ● Shake the vial before use, discard the first drop of control solution, and wipe off the dispenser tip to ensure a pure sample and an accurate result. ● Store the control solution tightly closed at temperatures between 2°C to 30°C (35.6°F to 86°F). Do NOT freeze.

    Page 26

    28 Result Readings (for glucose test) Result Readings (for β-ketone test)

    System Troubleshooting

    If you follow the recommended action but the problem persists, please call GlucoRx Customer care on 01483 755133.

    Message

    What It Means

    Your blood glucose level is below 0.5mmol/L Your blood glucose level is 15mmol/L or more Your blood glucose level is above 35mmol/L

    Message

    What It Means

    Your blood ketone level is below 0.1mmol/L. (please see below 'Interpretation' table) Any result between 0.1 and 8mmol/L (for example 0.6mmol/L) Your blood ketone level is between 0.1mmol/L and 8mmol/L. (please see below 'Interpretation' table) Your blood ketone level is above 8mmol/L. (please see below 'Interpretation' table) (warning) How to interpret blood Ketone results Your Ketone reading Interpretation Below 0.6mmol/L This is normal Between 0.6 and 1.5 mmol/L You may require medical assistance; contact your Diabetes healthcare team for advice. Above 1.5mmol/L Risk of Diabetic ketoacidosis; call your Diabetes healthcare team immediately. (Reference: adapted from Information provided in The Balance Guide to Meds & Kit, 2011 - 2012, p15)

    Page 27

    29 Error Messages

    Message

    What It Means

    What To Do

    E-b Appears when the batteries are too low. Replace the batteries immediately.

    E-C

    Appears when the wrong code strip is inserted or other coding errors. Check if the code numbers on the display and ketone foil packet are the same. If the problem persists, please contact GlucoRx Customer care on 01483 755133 for help.

    E-2

    Expired code strip. Repeat the test with a new lot of test strip.

    E-U

    Appears when a used test strip is inserted. Repeat with a new test strip. E-t Appears when ambient temperature is above or below system operation range. System operation range is 10°C to 40°C (50°F to 104°F). Repeat the test after the meter and test strip are in the above temperature range.

    E-0,

    E-A,

    E-E.

    Problem with the meter. Repeat the test with a new test strip. If the meter still does not work, please contact GlucoRx Customer care on 01483 755133 for assistance.

    E-F

    Appears when test strip is removed while counting down, or insufficient blood volume. Review the instructions and repeat test with a new strip. If the problem persists, please contact GlucoRx Customer care on 01483 755133 for help.

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    30

  • If the meter does not display a message after inserting a test strip:
  • Possible Cause

    What To Do

    Batteries exhausted. Test strip inserted upside down or incompletely. Defective meter or test strips. Replace the batteries. Insert the test strip with contact bars end first and facing up. Please contact GlucoRx Customer care on 01483 755133.
  • If the test does not start after applying the sample:
  • Possible Cause

    What To Do

    Insufficient blood sample. Defective test strip. Sample applied after automatic switch-off (3 minutes after last user action). Defective meter. Repeat the test using a new test strip with larger volume of blood sample. Repeat the test with a new test strip. Repeat the test with a new test strip. Apply sample only when flashing “ ” appears on the display. Please contact GlucoRx Customer care on 01483 755133. Troubleshooting
  • If the control testing result is out of range:
  • Possible Cause

    What To Do

    Error in performing the test. Control solution vial was poorly shaken. Expired or contaminated control solution. Control solution that is too warm or too cold. Defective test strip. Meter malfunction. Improper working of meter and test strip. Read instructions thoroughly and repeat the test again. Shake the control solution vigorously and repeat the test again. Check the expiry date of the control solution. Control solution, meter, and test strips should be at room temperature 20°C to 25°C ( 68°F to 77°F) before testing. Repeat the test with a new test strip. Please contact GlucoRx Customer care on 01483 755133. Please contact GlucoRx Customer care on 01483 755133.

    Page 29

    31 The β-Ketone test measures Beta-Hydroxybutyrate (ß -OHB), the most important of the three β-Ketone bodies in the blood. Normally, levels of ß -OHB are expected to be less than 0.6 mmol/L. ß -OHB levels may increase if a person fasts, exercises vigorously or has diabetes and becomes ill. If your β-Ketone result is 0.0 mmol/L, repeat the β-Ketone test with new test strips. If the same message appears again or the result does not reflect how you feel, contact your healthcare professional. Follow your healthcare professional’s advice before you make any changes to your diabetes medication programme. If your β-Ketone result is between 0.6 and 1.5 mmol/L, this may indicate development of a problem that could require medical assistance. Follow your healthcare professional’s instructions. If your β-Ketone result is higher than 1.5 mmol/L, contact your healthcare professional promptly for advice and assistance. You may be at risk of developing diabetic ketoacidosis (DKA). Please consult your doctor to determine a target range that works best for you.

    Detailed Information

    The meter provides you with plasma equivalent results. Source: Diabetes UK. Blood glucose target. Balance: No.234, 2010 April. P.69 Time of day Normal blood glucose range for people with diabetes (mmol/L) Fasting and before meal 4 to 7 mmol/L 2 hours after meals< 9 mmol/L

    Page 30

    32

    Symbol Information

    Symbol

    Referent

    Referent

    In vitro diagnostic medical device Consult instructions for use Temperature limitation Use by Batch code Humidity limitation CE mark

    Symbol

    Manufacturer Serial number Authorised representative in the European Community

    Ec Rep

    Caution, consult accompanying documents Collection for electrical and electronic equipment

    Page 31

    Note

    This device has been tested to meet the electrical and safety requirements of:

    Iec/En 61010-1, Iec/En 61010-2-101, En 61326-1, Iec/En 61326-2-6.

    Specifications

    Model No.: TD-4279 Dimension & Weight: 96 (L) x 61 (W) x 26 (H) mm, 67.2 g Power Source: Two 1.5V AAA alkaline batteries Display: LCD Memory: 1000 measurement results with respective date and time External Output: USB Auto electrode insertion detection Auto sample loading detection Auto reaction time count-down Auto switch-off after 3 minutes without action Temperature Warning Operating Condition: 10°C to 40°C (50°F to 104°F), below 85% R.H. (non-condensing) Meter Storage / Transportation Conditions: -20°C to 60°C (-4°F to 140°F), below 95% R.H. Strip Storage / Transportation Conditions: 2°C to 32°C (35.6°F to 89.6°F) for glucose test strip and 2°C to 30°C (35.6°F to 86°F) for β-ketone test strip, below 85% R.H. Measurement Units: mmol/L Measurement Range: 0.5 to 35 mmol/L for glucose test and 0.1~8.0 mmol/L for β-ketone test Expected service life: 5 years 33

    Page 32

    For self-testing TaiDoc Technology Corporation B1-7F., No. 127, Wugong 2nd Rd., Wugu Dist., New Taipei City 248, Taiwan (R.O.C.) www.taidoc.com Distributed by GlucoRx Ltd. 4 Wintonlea, Monument Way West, Woking, Surrey, GU21 5EN, UK Website: www.glucorx.co.uk Customer care number: 01483 755133 MedNet GmbH Borkstraβe 10, 48163 Münster, Germany

    Ec Rep

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