Fora GD40 Owner's Manual
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Fora GD40 Owner's Manual

Talking blood glucose monitoring system
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GD40
Dear
System Owner:
Thank you for purchasing the FORA GD40 Blood Glucose Monitoring
System. This manual provides important information to help you to use
the system properly. Before using this product, please read the follow-
ing contents thoroughly and carefully.
Regular monitoring of your blood glucose 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 FORA GD40 Blood Glucose Monitor-
ing System to easily monitor your blood glucose levels by yourself
anywhere, any time.
If you have other questions regarding this product, please contact the
place of purchase.
Version 1.0 2011/01 311-4272000-001
1

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Summary of Contents for Fora GD40

  • Page 1 Regular monitoring of your blood glucose 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 FORA GD40 Blood Glucose Monitor- ing System to easily monitor your blood glucose levels by yourself anywhere, any time.

  • Page 2: Important Safety Precautions

    IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE 1. Use this device ONLY for the intended use described in this manual. 2. Do NOT use accessories which are not specified by the manufacturer. 3. Do NOT use the device if it is not working properly or if it is damaged.
  • Page 3 8. 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. 9. Do NOT use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.

  • Page 4: Table Of Contents

    TABLE OF CONTENTS BEFORE YOU BEGIN Important Information Intended Use Test Principle Contents of System Meter Overview Display Screen Test Strip Setting the Meter THE FOUR MEASURING MODES BEFORE TESTING Calibration How to Code Your Meter Checking the Code Number Control Solution Testing Performing a Control Solution Test TESTING WITH BLOOD SAMPLE...
  • Page 5 MAINTENANCE Battery Caring for Your Meter Caring for Your Test Strips Important Control Solution Information SYSTEM TROUBLESHOOTING Result Readings Error Messages Troubleshooting DETAILED INFORMATION Reference Values Comparing Meter and Laboratory Results SYMBOL INFORMATION SPECIFICATIONS...

  • Page 6: Before You Begin

    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 immedi- ately. • If your blood glucose results are lower or higher than usual, and you do not have any symptoms of illness, first repeat the test.

  • Page 7: Intended Use

    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.

  • Page 8: Contents Of System

    Contents of System Your new FORA GD40 system kit includes: Meter Daily Log Book Owner ’ s Manual Protective Wallet Warranty Card 2 x 1.5V AAA alkaline batteries Quick Start User Guide Lancing Device Test strips, control solutions, or sterile lancets are not included in the kit.

  • Page 9: Meter Overview

    Meter Overview Side Front Back DATA PORT (for GD40a) Download test results with a Rear cable connection. TEST SLOT BT Switch (for GD40b) Insert test strip here to turn the Download test results with a meter on for testing. Bluetooth connection M BUTTON BT INDICATOR (for GD40b)

  • Page 10: Display Screen

    Display Screen Blood drop symbol Date Code Time Test result Day averag Ketone warning Reminder alarms Error warning Measurement unit Face/Low/High symbol Low battery symbol Memory symbol Measurement mode Test strip symbol...

  • Page 11: Test Strip

    Test results might be wrong if the contact bar is not fully inserted into the test slot. NOTE The FORA GD40 monitor should only be used with FORA GD40 Test Strips. Using other test strips with this meter can produce inaccurate results.

  • Page 12: Setting The Meter

    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. Make sure you complete the steps below and have your desired settings saved. ► Entering the Setting Mode Start with the meter off (no test strip inserted).
  • Page 13 Step 2 Setting the time format Press and release button to se- lect the desired time format --- 12h or 24h. Press SET button. Step 3 Setting the time With the hour flashing, press button until the correct hour appears. Press SET button. With the minute flashing, press button until the correct minute appears.
  • Page 14 To delete all the results, press button. and select “Yes” to delete “ the results in memory, then press SET button to confirm. “OK” and ” are displayed on the meter, which indicates that all data stored is deleted. Step 5 Setting the reminder alarm You may set up any or all of the reminder alarms (1-4).
  • Page 15 If you do not want to set an alarm, press SET button to skip this step. If you want to turn off an alarm, find the alarm number by pressing SET button in the setting mode, press M button to change from “ ON ’ to “...

  • Page 16: The Four Measuring Modes

    THE FOUR MEASURING MODES The meter provides you with four modes for measuring, General, AC, PC and QC. Use when Modes General (dis- any time of day without regard to time since last plays as “ Gen ” ) meal no food intake for at least 8 hours 2 hours after a meal testing with the control solution...

  • Page 17: Before Testing

    BEFORE TESTING Calibration You must calibrate the meter every time you begin to use a new vial of 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 the strip vial.

  • Page 18: Checking The Code Number

    Step 2 Remove the code strip, the display will show “ OK ” . This tells you that the meter has finished coding and is ready for blood glucose testing. Checking the Code Number You need to make sure that the code number displayed on the meter matches the number on the test strip vial before you proceed.

  • Page 19: Control Solution Testing

    Control Solution Testing Our Control Solution contains a known amount of glucose that reacts with test strips and is used to ensure your meter and test strips are working together correctly. Do a control solution test when: • you first receive the monitor •...
  • Page 20 Step 2 Press button to Mark this Test as a Control Solu- tion Test. With “ QC ” displayed, the meter will store your test re- sult in memory under “ QC ” . If you press the button again, the “ QC ” will disappear and this test is no longer a control solution test.
  • Page 21 Step 4 Read and Compare the Result After counting down to 0, the control solution test result will appear on the display. Compare this result with the range printed on the test strip vial and it should fall within this range. If not, please read the instructions again and repeat the Normal 100~165...

  • Page 22: Testing With Blood Sample

    TESTING WITH BLOOD SAMPLE 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 23: Preparing The Puncture Site

    Preparing the Puncture Site Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the glucose value obtained. Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.

  • Page 24: Performing A Blood Glucose Test

    Performing a blood glucose Test Step 1 Insert the test strip to turn on the meter There will be a strip light indicating the test strip is inserted into the test slot. Wait for the meter to dis- and blood play the test strip drop symbols.
  • Page 25 Step 4 Apply the Sample Hold the blood drop to touch the ab- sorbent hole of the test strip. Blood will be drawn in and after the confir- mation window is completely filled, the meter begins counting down. NOTE • Do not press the site against the test strip or try to smear the blood. •...
  • Page 26 Step 5 Read the Result The result of your blood glucose test will appear after the meter counts down to 0. This blood glucose result will automatically be stored in the memory. Step 6 Eject the Used Test Strip and Remove the Lancet To eject the test strip, point the strip at a sharp disposal container.

  • Page 27: Meter Memory

    METER MEMORY The meter stores the 1000 most recent blood glucose 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 Step 1 Press and release “...
  • Page 28 ► Reviewing Blood Glucose Day Average Results Step 1 Press and release When appears on the display, keep pressing for 3 seconds until the flashing “ ” appears. Release and then your 7-day average result measured in general mode will appear on the display. Step 2 Press to review 14-, 21-, 28-, 60- and 90- day average results...

  • Page 29: Downloading Results Onto A Computer

    DOWNLOADING RESULTS ONTO A COMPUTE ► Data transmission via cable (For FORA GD40a) You can use the meter with the USB cable and the Health Care Software System to view test results on your personal computer. To learn more about the Health Care Software System or to obtain the USB cable separately, please contact local customer services or the place of purchase for assistance.
  • Page 30 Step 1 Installing the software To download the Health Care Software System, please visit the FORA Care Inc. website at http://www.foracare.com. Step 2 Connecting to a personal computer The meter will automatically initiate searching...

  • Page 31: Maintenance

    MAINTENANCE Battery Your meter comes with two1.5V 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. Step 1 The “ ” symbol appears along with display mes- sages: The meter is functional and the result remains ac- curate, but it is time to change the batteries.

  • Page 32: Replacing The Battery

    ► Replacing the Battery To replace the battery, make sure that the meter is turned off. Step 1 Press the edge of the battery cover and lift it up to remove. Step 2 Remove the old batteries and replace with two 1.5V AAA alkaline bat- teries.

  • Page 33: Caring For Your Meter

    Caring for Your Meter To avoid the meter and test strips attracting dirt, dust or other con- taminants, please wash and dry your hands thoroughly before use. ► Cleaning • To clean the meter exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft and dry cloth.

  • Page 34: Caring For Your Test Strips

    Caring for Your Test Strips • Storage conditions: 2 ° C to 32 ° C (35.6 ° F to 89.6 ° F) below 85% relative humidity. Do not freeze. • Store your test strips in their original vial only. Do not transfer to another container.

  • Page 35: Important Control Solution Information

    Important Control Solution Information • Use only our control solutions 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. •...

  • Page 36: System Troubleshooting

    SYSTEM TROUBLESHOOTING If you follow the recommended action but the problem persists, or er- ror messages other than the ones below appear, please call your local customer service. Do not attempt to repair by yourself and never try to disassemble the meter under any circumstances. Result Readings MESSAGE WHAT IT MEAN...

  • Page 37: Error Messages

    Error Messages MESSAGE WHAT IT MEAN WHAT TO DO Appears when the Replace the batteries im- batteries cannot provide mediately. enough power for a test. Appears when a used Repeat the test with a new test test strip is inserted strip.

  • Page 38: Troubleshooting

    Troubleshooting 1. If the meter does not display a message after inserting a test strip: POSSIBLE CAUSE WHAT TO DO Batteries exhausted. Replace the batteries. Test strip inserted upside down or Insert the test strip with contact bars incompletely. end first and facing up. Defective meter or test strips.

  • Page 39: Detailed Information

    DETAILED INFORMATION Reference Values Blood Glucose Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that maintaining blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60% . The results provided by this system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.

  • Page 40: Comparing Meter And Laboratory Results

    Comparing Meter and Laboratory Results The meter provides you with plasma equivalent results. The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results may be affected by fac- tors and conditions that do not affect laboratory results in the same way.
  • Page 41 You may still have a variation from the result because blood glucose levels can change significantly over short periods of time, especially if you have recently eaten, exercised, taken medication, or experienced . In addition, if you have eaten recently, the blood glucose level stress from a finger prick can be up to 70 mg/dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for a lab test...

  • Page 42: Symbol Information

    SYMBOL INFORMATION Symbol Referent In vitro diagnostic medical device Do not reuse Consult instruction for use Keep away from sunlight Keep dry Temperature limitation Use by/ Expiry date Use within three months after first opening Batch code Manufacturer Serial number Caution, consult accompanying documents Do not use if package is damaged CE Mark...

  • Page 43: Specifications

    Power source: two 1.5V AAA alkaline batteries Display: LCD Memory: 1000 measurement results with respective date and time External output: USB Cable (FORA GD40a) or Bluetooth (FORA GD40b) Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down...

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