BGSTAR

BGSTAR test strips

Product Features

BGStar Blood Glucose Test Strips

Important: Please read this information and the owner's manual for your BGStar or MyStar meters before using BGStar test strips. Use BGStar test strips exclusively with BGStar and MyStar meter systems. BGStar test strips are intended for use with BGStar or MyStar meters.

Important Safety Information:

• The blood glucose meter and lancing device are for your personal use only. Do not share them with other people or family members! Do not use with multiple patients.
• All components of the meter kit can be infectious and potentially transmit contagious diseases, even if disinfected.

Intended Use

BGStar test strips are for use with BGStar and MyStar meter systems for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples. For the full scope of system functions, please refer to your meter's owner's manual. BGStar or MyStar meter systems are not suitable for:

• The diagnosis of diabetes.
• Blood glucose measurement in newborns (children under 4 weeks).
• The determination of blood glucose from arterial or venous blood.

Test Principle

The BGStar test strip contains the enzyme glucose oxidase (GOx) along with a chemical mediator, which generates an electrochemical signal proportional to the glucose concentration of the blood sample. The meter measures the signal and corrects for common analytical interferences, such as those caused by hematocrit, using dynamic electrochemistry.

Checking the Function of the Meter and Test Strips with BGStar Control Solution

The BGStar control solution contains a defined amount of glucose that reacts with a BGStar test strip in the BGStar or MyStar meters. This ensures that both function correctly in combination. Control solution tests should be performed:

• When you have received your new meter and want to perform initial practice tests.
• If you suspect that your meter or test strips are not functioning correctly.
• If you believe your test results are incorrect.
• If you have dropped or damaged your meter, or if it has come into contact with liquids.
• If your doctor or healthcare professional has instructed you to do so.

If the control solution test results are not within the target range indicated on the test strip vial for the control solution you are using, repeat the test.

Results outside the target range may be due to one or more of the following factors:

• Control solution expired or faulty.
• Test strips expired or faulty.
• Error in performing the test.
• Diluted control solution.
• Meter malfunction.
• Control solution test performed at a temperature outside the permissible operating temperature range of 10°C to 40°C.
• Control solution bottle not shaken well before use.
• The first drop was not discarded, and the tip of the bottle was not cleaned.

If the results continue to be outside the target range indicated on the BGStar test strip vial, the test strips and meter may not be functioning properly. In this case, do not use the system and call the ServiceCenter Diabetes of Sanofi-Aventis Deutschland GmbH at the following number: 0800 52 52 010. Diabetes-Care line of sanofi-aventis (schweiz) ag at the following toll-free number: 0800 87 0800.

Test Procedure

1. To avoid inaccurate results, wash your hands with soap and water. Make sure there is no grease, oil, or lotion on the test site. Dry your hands thoroughly.
2. Remove the cap from the lancing device, insert a new lancet, and twist off the lancet cap. Replace the lancing device cap, set the penetration depth, and prime the device.
3. Insert a new test strip into the meter.
4. Perform the puncture with the lancing device on a fingertip.
5. Once the blood drop symbol appears on the meter, hold the blood sample to the tip of the BGStar test strip.
6. When the blood glucose measurement result, including time and date, is displayed on the screen, the test is complete, and the result is stored.
7. Remove the used BGStar test strip from the meter and dispose of it safely. The meter will turn off automatically.
8. Wash your hands thoroughly with soap and water after using the meter, lancing device, and test strips.

Please refer to the owner's manual of your BGStar or MyStar meter for more detailed step-by-step instructions on how to perform the test.

Interpretation of Your Test Results

Results below 20 mg/dl (1.1 mmol/l): If the test result is below 20 mg/dl (1.1 mmol/l), a message indicating hypoglycemia (low blood sugar) will appear on the display. For details, refer to the owner's manual. You should immediately perform another measurement. If the result is again below 20 mg/dl (1.1 mmol/l), follow the treatment plan recommended by your healthcare professional or contact your doctor immediately.

Results above 600 mg/dl (33.3 mmol/l): If the test result is above 600 mg/dl (33.3 mmol/l), a message indicating hyperglycemia (high blood sugar) will appear on the display. For details, refer to the owner's manual. You should immediately perform another measurement. If the result is again above 600 mg/dl (33.3 mmol/l), follow your healthcare professional's instructions for treating hyperglycemia (high blood sugar). Checking ketone levels may be advisable.

The normal fasting blood sugar level for people without diabetes is in the range of 70 to 99 mg/dl (3.9 to 5.5 mmol/l). Be sure to ask your healthcare professional about the target ranges recommended for you.

Important Notes on the

Test Procedure

• Results may be inaccurate in individuals with very low blood pressure or patients in shock. Falsely low results may occur in individuals who are in a hyperglycemic-hyperosmolar state with or without ketosis. Severely ill patients should not be tested with blood glucose meters.
• Severe dehydration and excessive water loss can lead to inaccurate results. If you suspect you are severely dehydrated, consult your healthcare professional immediately.
• Results may be inaccurate in patients undergoing oxygen therapy.
• Results below 70 mg/dl (3.9 mmol/l) may indicate low blood sugar (hypoglycemia).
• Results above 240 mg/dl (13.3 mmol/l) may indicate high blood sugar (hyperglycemia). Checking ketone levels may be advisable.
• If you get results below 70 mg/dl (3.9 mmol/l) or above 240 mg/dl (13.3 mmol/l) but have no symptoms of low or high blood sugar, repeat the test. If you have symptoms or the results are again below 70 mg/dl (3.9 mmol/l) or above 240 mg/dl (13.3 mmol/l), follow the treatment plan recommended by your healthcare professional or contact your doctor immediately.
• If you experience symptoms that do not match your measured blood glucose level, and you have followed all instructions in the owner's manual of your BGStar or MyStar meter, follow the recommendations of the healthcare professional treating you.
• Do not use test strips that are expired or appear damaged, as they can lead to inaccurate results.
• Always follow the recommendations of the healthcare professional treating you.
• Healthcare professionals should comply with the regulations applicable in their facilities to prevent infection risks.

Storage and Handling:

• Store BGStar test strips in a cool, dry place at 8°C to 30°C.
• Use BGStar test strips only within the operating temperature range of 10°C to 40°C.
• Protect from direct sunlight and heat.
• Always store BGStar test strips in their original vial. Under no circumstances use another vial or container for storage, and do not leave the test strips outside the vial.
• Immediately close the vial tightly after removing a BGStar test strip.
• Handle BGStar test strips carefully and with clean, dry hands when removing them from the vial and inserting them into the meter.
• Do not use BGStar test strips after the expiration date or 180 days after first opening the vial. Otherwise, inaccurate results could occur. Note the date on which the test strips are to be discarded (date of first opening + 180 days) on the test strip vial.
• Do not bend, cut, or alter BGStar test strips.
• Apply only fresh capillary blood or control solution to the sample area of the BGStar test strip.

WARNINGS AND PRECAUTIONS

• Keep test strips and test strip vial out of reach of children. There is a risk of choking if test strips are swallowed. The vial contains desiccant, which can be harmful if inhaled or swallowed. It can also irritate the skin and eyes.
• Test strips are for single use only. Do not reuse. Dispose of used test strips properly.
• If a test strip does not absorb the blood sample, contact the ServiceCenter Diabetes of Sanofi-Aventis Deutschland GmbH at 0800 52 52 010. Diabetes-Care line of sanofi-aventis (schweiz) ag at the following toll-free number: 0800 87 0800.

Performance Data:

• System measurement range: 20 to 600 mg/dl (1.1 to 33.3 mmol/l)
• Hematocrit range: 20% to 60%
• Maximum altitude: 3,048 meters
• Sample: Capillary whole blood
• Calibration: Plasma equivalent
• Blood sample size: 0.5 microliters
• Average time for blood glucose measurement: 5 seconds

The analytical performance of BGStar test