PRINCIPLE AND INTENDED USE

The FiggHealth Control Solution contains a known concentration of glucose.

The FiggHealth Blood Glucose Control Solution is for use with the FiggHealth smart blood glucose meters and FiggHealth Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

For self-testing use only.

You should perform a quality control test:

• Once a week
• Before using a new box of test strip
• When you suspect that the meter or test strips are not working properly.
• If you suspect your meter is damaged.
• After cleaning your meter
• You dropped the meter
• When you suspect that your test results are inaccurate. Or if they do not match with how you feel.

Three levels of control solution are available. They are Control Solution 1 (level 1), Control Solution 2 (level 2) and Control Solution 3 (level 3). Control Solution 2 (level 2) is sufficient for most of self-testing needs. If you think your meter or strips may not be working correctly, you may also want to do level 1 or level 3 tests. If you want to purchase control solution kit, contact FiggHealth Customer Support: +1-800-391-2802, Or visited our website FiggHealth for help.

COMPOSITION

Control Solution 1 contains less than 0.1% glucose (active ingredient). Control Solution 2 contains less than 0.2% glucose (active ingredient). Control Solution 3 contains less than 0.3% glucose (active ingredient). Three levels control solution have preservatives in an aqueous based mixture.

STORAGE AND HANDLING

• Store between 36-86°F. Store at 10-90% humidity.
• If the control solution is cold, do not use until it has warmed to room temperature.
• Use before the expiration date. The date is shown on the bottle. Note: All expiration dates are printed in Year-Month format. 2019/01 indicates January, 2019.
• Use the control solution only for 4 months after you first open it. The control solution will expire 4 months after the bottle is opened for the first time. Record this opened expiration date on the bottle label.

PRECAUTIONS

• For in vitro diagnostic use. The control solution is for testing only outside the body. Do not swallow or inject. For self-testing use.
• Shake well before using.
• To get accurate results, do control solution testing between 50 and 104°F.
• The control ranges shown on the test strip vial (or on the foil pouch). The control ranges are not a recommended range for your blood glucose level. Figure out your personal blood glucose target ranges with your doctor.
• Do not touch the end of the test strip to the control solution bottle. This could cause contaminants to enter the control solution bottle.
• Do not use the control solution if the package is damaged.
• Use only FiggHealth brand control solution with your FiggHealth FiggGluco smart meters and FiggHealth test strips.
• Always wash your hands well with soap and water before and after testing, handling the meter, safety lancets or test strip.

MATERIALS PROVIDED

• Control Solution
• Package Insert

If you want to purchase control solution kit, or want to know more information, contact FiggHealth Customer Support: +1-800-391-2802, Or visited our website Figg.Health for help.

MATERIALS REQUIRED BUT NOT PROVIDED

• Meter
• Test Strips

INSTRUCTIONS FOR USE

1. Insert a new test strip. The meter turns on. Refer to your meter's User Manual details on how to record the result as a quality control test, and more details on operating the meter.

2. Shake the control solution bottle thoroughly.

3. Squeeze the control solution bottle gently. Discard the first drop. If the tip clogs, tap the tip gently on a clean, hard surface. Shake again, and then use.

4. Squeeze out a second small drop on a clean nonabsorbent surface. Touch the sample tip of the test strip to the control solution drop until the meter beeps.

Notes:

• Test immediately after the control solution has squeezed.
• Do not apply control solution to the test strip directly from the bottle.
• If the control solution sample does not completely fill the sample tip, do not add a second drop. Discard the test strip. Start with a new test strip.

5. Read the result from the meter display after a beep.

EXPECTED RESULTS

Control solution test results should be within the control range. The ranges for three levels (Level 1, Level 2 and level 3) are displayed on the test strip vial label (or on the foil pouch). For confirmation of results, Control Solution 1 tests should fall within the level 1 range, Control Solution 2 tests should fall within the level 2 range, and Control Solution 3 tests should fall within the level 3 range. If the test results are in the respective ranges, this means your Blood Glucose Monitoring System is working right and you are doing the procedure correctly. If the control solution tests results do not fall within the respective range:

• Check the expiration date of the test strip and control solution. Make sure that the test strip vial and the control solution bottle have not been opened for more than 4 months. Discard any expired test strips or control solution.
• Make sure you are testing at a temperature between 50 and 104°F (10-40°C).
• Make sure that the test strip vial and the control solution bottle have been tightly capped.
• Confirm that you are using FiggHealth brand control solution with your FiggHealth brand test strips.
• Make sure that you followed the test procedure correctly.

After checking everything listed above, repeat the control solution test with a new test strip. If your results still fall outside the range indicated on the test strip vial label or on the foil pouch, your meter may not be working properly. DO NOT use the system to test blood. Contact Customer Support for help. For complete instructions, please refer to the User’s Manual included with your meter. If attempts to correct a problem fail, contact FiggHealth Customer Support: +1-800-391-2802, Or visited our website FiggHealth for help.