BG-Pro Blood Glucose Monitoring System

Principle Of The Process
The BG-PRO II test strip analysis is based on the GDH-FAD, which is specific to β-D-glucose with the biosensor technology used. The blood sample is drawn into the reaction zone by way of capillary forces. The glucose’s chemical reaction with the GDH-FAD enzyme results in a measurable current of electrons.which is analysed by the BG-PRO II blood glucose meter. The strength of the current correlates with the concentration of blood glucose, which is shown on the display as a measurement result.The result is displayed as a plasma value.

Note
Determining the blood glucose level is an important way of monitoring diabetes. The BG-PRO II test strips help you to adjust your blood glucose optimally. However, before you start measuring your blood glucose, you should first familiarise yourself with the entire measurement system (refer to the BG-PRO II blood glucose meter user manual).

Control Solution Testing for Performance Checking
You can use the Ecare GDH Control Solution (Model: SC03) to check the performance of your meter and/or test strips. When do you need the quality control ?

• When you open a new vial of test strips.
• If you leave the vial of test strips opened.
• When you drop your meter.
• If you have repeated a test, the result is still out of the expected range. (Please read your User’s Guide for more detailed information.)

Prepare Your Blood Sample
Select the puncture area：

1. Wash the selected puncture site with warm water and soap, rinse well and DRY thoroughly.
2. You can also use an alcohol prep pad. If an alcohol prep pad is used, the puncture site must be allowed to dry thoroughly before sampling.
3. Hold the lancing device firmly against the side of your finger. Press the release button. To help blood drop form, lower your hand below your waist and gently massaging finger.

Testing Your Blood Glucose
Please read your User’s Guide for more detailed information:

1. Insert a test strip into the test strip slot of your meter.
2. Obtain a good drop of blood from your fingertip.
3. Apply your drop of blood to the absorbent hole of the test strip until the confirmation window is fully filled with blood.
4. Remove the test strip from your meter. Discard the used test strip and lancet.

Note

• Make sure the confirmation window of the test strip is completely filled with your sample.
• Wear gloves when testing for others and replace them for next person

Storage and handling
In order to ensure that your test strips are effective, please perform according to follow-ing information:

1. Store between 42.8～107.6 °F (6～42°C) / RH 10~90%.
2. Keep away from direct heat and sunlight.
3. Store test strips in their original vial with the cap tightly closed. When taking a test strip out of the vial, replace the vial cap immediately and close it tightly.
4. When you first open the test strip vial, write the date on the vial label. The test strips should be used within 120 days after first opening.
5. Do not use the test strips beyond the expiry date.
6. Do not bend, cut, or alter the test strips in any way.

Warning and Precautions

1. Store between 42.8～107.6 °F (6～42°C) / RH 10~90%.
2. Keep away from direct heat and sunlight. Handle the strips with dry and clean hand.
3. For vial pack test strips：
   – Sotre test strips in their original vial with the cap tightly closed. When taking a test strip out of the vial, replace the vial cap immediately and close it tightly.
   – When you first open the test strip vial, write the date on the vial label. The test strips should be uesd within 120 days after first opening.
4. For foil pack test strips：
   – Do not ues the test strips if its foil has a puncture or tear in it.
   – Do not bend, cut, or alter the test strips in any way.
   – Do not cut the foil to take out the test strips from the foil.

Limitations

1. Use only venous whole blood and fresh capillary blood from the finger. Do not use arterial blood, plasma, or serum.
2. Abnormal red blood cell counts (hematocrit levels below 20% and above 60%) may cause inaccurate test results.

Assessing User Performance
A study conducted to assess glucose values in blood samples from capillary fingertip blood, obtained from 100 lay persons who had not received any special instruction, yielded the following results:

• 95.7 % within ± 0.83 mmol/L (± 15 mg/dL) of the laboratory procedure results for glucose concentrations below 5.55 mmol/L (100 mg/dL)
• 97.4 % within ± 15 % of the values obtained in a medical laboratory setting for glucose concentrations of at least 5.55 mmol/L (100 mg/dL).

Chemical Components in Test Strip
Each test strip contains the following chemical components:

• FAD Glucose Dehydrogenase (Aspergillus sp.): >1.65 IU
• Potassium Ferricyanide: >72.5μg
• Nonreactive ingredients: 31.5 μg

Product Contents
Each strip box contains test strip vial and strip instructions. Questionable or Inconsistent Results Your User’s Guide contains more information. If you have any questions and/or need assistance, please contact your local authorized distributor of the BG-PRO II Blood Glucose Monitoring System.

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