FORA G40 Blood Glucose Monitoring System Owner’s Manual

FORA G40 Blood Glucose Monitoring System

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 that are not specified by the manufacturer.
• Do NOT use the device if it is not working properly or if it is damaged.
• Do NOT use the equipment in places where aerosol sprays are being used or where oxygen is being administered.
• Do NOT under any circumstances use the device on newborns, infants, or people who cannot communicate.
• 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.
• Before using this device to test blood glucose, 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 the accurate operation.
  KEEP THESE INSTRUCTIONS IN A SAFE PLACE

Important Information

• Severe dehydration and excessive water loss may cause readings that are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.

• If your blood glucose 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 that 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. Using other substances will lead to incorrect results.

• If you are experiencing symptoms that are inconsistent with your blood glucose 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. Readings that are lower
  than actual values may occur for individuals experiencing a hyperglycaemic- hyperosmolar state, with or without ketosis. Please consult the healthcare professional before use.

• The measurement unit used for indicating the concentration of blood glucose can have mg/dL or mmol/L. The approximate calculation rule for conversion of mg/dL in mmol/L is:

For example:

1. 120 mg/dL ÷ 18 = 6.6 mmol/L
2. 7.2 mmol/L x 18 = 129 mg/dL approximately

Introduction

Intended Use
This system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by health care professionals in clinical settings 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, palm, forearm and upper arm).
It should not be used for the diagnosis of diabetes, or testing on newborns.
Test Principle
Your system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter measures the current, calculates the blood glucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
Meter Overview

1. Test Slot
2. Display Screen
3. Test Strip Ejector
4. M Button
5. SET Button
6. Battery compartment

Screen Display

1. Blood drop symbol
2. Memory symbol
3. Test strip symbol
4. Time
5. Low battery symbol
6. Date
7. Measurement unit
8. Alarm
9. Control solution mode
10. General testing mode
11. Ketone warning
12. Day average
13. Face/Low/High symbol
14. Test result

Getting Started

Initial Setup
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:
Enter the Setting Mode
Start with the meter off (no test strip inserted). Press SET to turn on the meter.

Step 1: Setting the date.

• With the year flashing, press M until the correct year appears. Press SET.
• With the month flashing, press M until the correct month appears. Press SET.
• With the day flashing, press M until the correct day appears. Press SET.

Step 2: Setting the time format.
Press and release M to select the desired time format — 12h or 24h. Press SET.

Step 3: Setting the time.

• With the hour flashing, press M until the correct hour appears. Press SET.
• With the minute flashing, press M until the correct minute appears. Press SET.

Step 4: Deleting the memory.

With the “dEL” and “ ” symbol on the display, press M and select “no” to keep the results in memory then press SET to skip.
To delete all the results, press M and select “YES”. Then press SET button to delete all memory. “OK” is displayed in 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). The meter displays “On” or “OFF” and “ ” , press M to turn on or turn off to set the first reminder alarm. Press M to select “On”, then press SET to set the hour. When the hour is flashing, press M to add an hour. Press SET to confirm and go to minutes, press M to add one minute. Hold M longer to add faster. Press SET to confirm and go to the next alarm setting.

If you do not want to set an alarm, press SET to skip this step.

If you want to turn off an alarm, find the alarm number by pressing SET in the setting mode, press M to change from “ON’ to “OFF”. At the time of your alarm, the meter will beep and automatically turn on. You can press M to silence the alarm and insert a test strip to begin testing. If you do not press M, the meter will beep for 2 minutes then switch off. If you do not want to test at this time, press M to switch off the meter. Press SET to turn off the meter. The meter repeats all your settings before shutdown. 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.

Before Testing

Control Solution Testing
FORA 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 suspect the device or test strips are not working properly.
• your blood glucose test results are not consistent with how you feel, or if you think the results are not accurate,or
• you have dropped or think you may have damaged the meter.

Performing a Control Solution Test

Step 1: Insert the test strip to turn on the meter.
Insert the test strip into the meter. Wait for the meter to display the test strip and blood drop symbols.

Step 2: Press M to mark this test as a control solution test.
If you press M again, the “QC” will disappear and this test is no longer a control solution test.

Step 3: Apply the control solution.
Shake the 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. 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. To avoid contaminating the control solution do not directly apply control solution onto a strip.

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 control solution test.

Note:

• The control solution range printed on the test strip vial is for control solution use only. It is not a recommended range for your blood glucose level.
• See the Meter Maintenance section for important information about your control solutions.

Out-of-range results:
If you continue to have test results fall outside the range printed on the test strip vial, the meter and strips may not be working properly. Do NOT test your blood. Contact the local customer service or place of purchase for help.

Testing Your Blood Glucose

Test Strip Appearance

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

Note:
The FORA COMFORT check G40 meter should only be used with FORA COMFORT check G40 Test Strips.
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.

Preparing the Lancing Device for Blood  Testing

Please follow the instructions in the lancing device insert for collecting a blood sample.

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.

Please follow the suggestions below before obtaining a drop of blood:

• Wash and dry your hands before starting.
• Select the puncture site either at the fingertips or other body parts (please see section “Alternative Site Testing” (AST) on how to select the appropriate sites).
• Rub the puncture site for about 20 seconds before penetration.

Fingertip Testing
Press the lancing device’s tip firmly against the side of your fingertip. Press the release button to prick your finger, then a click indicates that the puncture is complete.

• Blood from Sites Other Than the Fingertip
  Press the lancing device’s tip firmly against the side of your fingertip. Press the release button to prick your finger, then a click indicates that the puncture is complete.

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.
• It is recommended to discard the first drop of blood as it might contain tissue fluid, which may affect the test result.

Alternative Site Testing

Important: There are limitations with AST (Alternative Site Testing). Please consult your health care professional before you perform AST.

• What is AST?
  Alternative site testing (AST) means that people use parts of the body other than the fingertips to check their blood glucose levels. This system allows you to test on the palm, the forearm or the upper arm

• What is the advantage?
  Fingertips feel pain more readily because they are full of nerve endings (receptors). At other body sites, since nerve endings are not so condensed, you will not feel as much pain as on the fingertips.

• When to use AST?
  Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at the fingertip reflects these changes faster than capillary blood at other sites. Thus, when testing blood glucose 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 blood glucose is low.
• You are unaware of hypoglycemia
• You are testing for hyperglycemia
• Your AST results do not match the way you feel.

Performing a Blood Glucose Test

• Step 1: Insert the test strip to turn on the meter.
  • Wait for the meter to display the test strip “ drop “ ” symbol ” and blood
• Step 3: Apply the sample.
  • Hold the blood drop to touch the absorbent hole of the test strip. Blood will be drawn in and after the confirmation window is completely filled, the meter begins counting down.

Note:

• Do not press the punctured site against the 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 the local customer service for assistance.

Step 4: Read your 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 5: Eject the used test strip and remove the lancet. To eject the test strip, point the strip at a disposal container for sharp items. The meter will switch itself off automatically after the test strip is ejected.

Step 6: Always follow the instructions in the lancing device insert when removing the lancet.
WARNING!
The used lancet and test strip may be biohazards. Please discard them carefully according to your local regulations.

Meter Memory
The meter stores the 450 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 M.
   will appear on the display. Press M again, and the first reading you see is the last blood glucose result along with date, time and the measuring mode.

• Step 2: Press M to recall the test results stored in the meter each time you press.

• Step 3: Exit the meter memory.
  After the last test results, press M again and the meter will be turned off.

Reviewing Blood Glucose Day Average

Results
Step 1: Press 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.

Step 2: Press M to review 14-, 21-, 28-, 60- and 90- day average results.
Step 3: Exit the meter memory.
Keep pressing M and the meter will turn 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 solution results are NOT included in the day average.
• If using the meter for the first time, “—” displays when you recall the test results or review the average result. It indicates that there is no test result in the memory.

Maintenance

Battery
Your meter comes with one 3V CR2032 lithium battery.

Low Battery Signal
The symbol appears along with display messages:
The meter is functional and the result remains accurate, but it is time to change the battery.

The symbol appears with E-b, Error, and low: The power is not enough to do a test. Please change the battery immediately.

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 battery and replace with one 3V CR2032 lithium battery.
• Step 3: Close the battery cover. If the battery is inserted correctly, you will hear a “beep” afterwards.

Note:

• Replacing the battery does not affect the test results stored in the memory.
• As with all small batteries, these batteries should be kept away from small children. If swallowed, promptly seek medical assistance.
• The battery might leak chemicals if unused for a long time. Remove the battery if you are not going to use the device for an extended period (i.e., 3 months or more).
• Properly dispose of the battery according to your local environmental regulations.

Caring for Your Meter

To avoid the meter and test strips attracting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.

Cleaning

• To clean the exterior of the device, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft dry cloth. Do NOT rinse with water.

• Do NOT use organic solvents to clean the meter.
  Meter Storage

• Storage condition: -20°C to 60°C (-4°F to 140°F), below 95% relative humidity.

• Always store or transport the device in its original storage case.

• Avoid dropping and heavy impact.

• Avoid direct sunlight and high humidity.
  Meter Disposal
  The 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 30°C (35.6°F to 86°F), 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 away from direct sunlight and heat.
• After removing a test strip from the vial, immediately close the vial cap tightly.
• Touch the test strip with clean and dry hands.
• Use each test strip immediately after removing it from the vial.
• Write the opening date on the vial label when you first opened it. Discard remaining test strips after 6 months.
• Do not use test strips beyond the 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.

Important Control Solution Information

• Use only FORA 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.
• 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 and 30°C (35.6°F and 86°F). Do NOT freeze.

System Troubleshooting

If you follow the recommended action but the problem persists, or error 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

Error Messages

Troubleshooting

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

contact bars end first and facing up.
Defective meter or test strips.| Please contact customer services.

If the test does not start after applying the sample:

volume of blood sample.
Defective test strip.| Repeat the test with a new test strip.
Sample applied after automatic switch-off (2 minutes after last user action).| Repeat the test with a new test strip.

Apply sample only when flashing “ ” appears on the display.

Defective meter.| Please contact customer services.

If the control solution testing result is out of range:

test again.
Control solution vial was poorly shaken.| Shake the control solution vigorously and repeat the test again.
Expired or contaminated control solution.| Check the expiry date of the control solution.
Control solution that is too warm or too cold.| Control solution, meter, and test strips should be at room temperature (20°C to 25°C / 68°F to 77°F) before testing.
Defective test strip.| Repeat the test with a new test strip.
Meter malfunction.| Please contact customer services.

Detailed Information

The device provides you with plasma equivalent results.

Time of day| Normal plasma glucose range for people without diabetes
---|---
Fasting and before meal| < 100 mg/dL (5.6 mmol/L)
2 hours after meals| < 140 mg/dL (7.8 mmol/L)

Source: American Diabetes Association (2012). Clinical Practice Recommendations. Diabetes Care, 35 (Supplement 1): S1-100.

Symbol Information

Specifications

Features

| 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)

Storage/Transportation Condition| -20°C to 60°C (-4°F to 140°F), below 95% R.H
Measurement Units| mg/dL or mmol/L
Measurement Range| 20 to 600mg/dL (1.1 to 33.3mmol/L)

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, and EN 300 328.

WARRANTY TERMS AND CONDITIONS

With respect to disposable products, ForaCare Suisse warrants to the original purchaser that, at time of delivery, each standard product manufactured by ForaCare Suisse 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. All warranties for a product shall expire as of the product expiration date, or if none, after two (2) years from the original date of purchase, as long as it has not been modified, altered, or misused. ForaCare Suisse warranty hereunder shall not apply if:

• a product is not used in accordance with its instructions or if it is used for a purpose not indicated on the labeling;
• any repairs, alterations or other work has been performed by the buyer or others on such item, other than work performed with ForaCare Suisse’s authorization and according to its approved procedures; or
• the alleged defect is a result of abuse, misuse, improper maintenance, accident or the negligence of any party other than ForaCare Suisse. The warranty set forth herein is conditioned upon proper storage, installation, use and maintenance in accordance with applicable written recommendations from ForaCare Suisse.

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 ForaCare Suisse.

References

• ForaCare Suisse AG - Comprehensive Disease Management Solutions

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