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FORA standard operating procedure questions & answers

>> Meters and test strips

Q. My meter doesn’t match the laboratory’s results. My test results aren’t consistent. My test results often showed too high or low reading. Is my meter accurate?
Q. How do I know that my meter is accurate?
Q. Why is the different between the whole blood and plasma of test results?
Q. What is the control solution?
Q. How to perform right results of the control solution testing?
Q. Why is the control solution range not fall within the range printed on the meter vial label?
Q. What is automatic lancing device?
Q. Why do I must code the meters before use it?
Q. How do I change the code number on my meter when I get a vial of a new strip?
Q. How do I maintain my blood glucose meter?
Q. How can I check my meter’s performance?
Q. Can I test blood glucose from sites other than my fingertips?
Q. Does the blood sample not fill up confirmation sample size which affects the result?
Q. Can the hematocrit levels affect results?

 

Q. My meter doesn’t match the laboratory’s results. My test results aren’t consistent. My test results often showed too high or low reading. Is my meter accurate?

A.

Cause:

  1. Humidity or heat may damage test strips.
  2. Expired or defective test strips.
  3. Insufficient amount and improper placement of blood on the test strips.
  4. The code number displayed on the meter does not match the code number printed on the test strip vial label.
  5. The meters may have been dropped or its electrical components may have worn out.
  6. Meters and laboratory equipment may be calibrated or set to measure blood glucose in different ways and will give different results.
  7. User let test strips expose in an air more than a few minutes.

Perform:

  1. You should perform quality control testing to make sure that your glucose testing is accurate and reliable.
  2. Following suit the setup by a health care professional; obtain professional training and guidance for the use of your particular meter.
  3. You can test your glucose level while your health care provider watches your technique to make sure you are using the meter correctly.
  4. Use within 90 days after first opening or 18 months from production date.
  5. Storage condition for test strips: 10℃ ~40℃, < 85% RH.
  6. Use fresh capillary whole blood only.
  7. Make sure the blood sample used for testing is capillary whole blood.
  8. Make sure the code number displayed on the meter matches the test strips vial label.
  9. Make sure you are using fresh strips and supplies.
  10. Check your testing technique routinely with a professional.
  11. Follow the manufacturer’s meter instructions carefully.
  12. The test strips don’t expose in an air more than a few minutes.

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Q. How do I know that my meter is accurate?

A.

According to the owner’s manual instruction calibrate a control solution test to make sure the meter is accurate. If you suspect there is a problem with the meter, ask your health care professional about comparing results. If the result is more than 20% different with compared device, it’s time to check the meter, get a new strips vial to do a control solution testing or ask your health care professional observe your technique and offer pointers to improve your skills. Or ask our sales representative or service center to solve the problems.

Factors that affect glucose meter performance.

The accuracy of your test results depends partly on the quality of your meter and test strips and your training. Other factors can also make a difference in the accuracy of your results.

Hematocrit, this is the amount of red blood cells in the blood. Patients with higher hematocrit values will usually test lower for blood glucose than patients with normal abnormal hematocrit values you should discuss its possible effect on glucose testing (and HbA1C testing) with your health care provider. Anemia and sickle cell anemia are two conditions that affect hematocrit values.

Other substances, many other substances may interface with your testing process. These include uric acid (a natural substance in the body that can be more concentrated in some people with diabetes), glutathione (an “anti-oxidant” also called “GSH), and ascorbic acid (vitamin C). You should check the package insert for each meter to find what substances might affect its testing accuracy, and discuss your concerns with your health care provider.

Altitude, temperature and humidity, altitude, room temperature, and humidity can cause unpredictable effects on glucose results. Check the meter and test strips according to the instructions.

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Q. Why is the different between the whole blood and plasma of test results?
A.

In the world of blood glucose monitoring, there have two methods (whole blood and plasma) to measure blood glucose value. They are different methods of measuring the same things. All blood glucose meters are measuring the whole blood to gain blood glucose value. Laboratory equipment uses only plasma – the watery substance in your blood for measuring glucose. Your test results are either report as a whole blood reading or plasma calibrated.

You should understand that whole blood test results are about 10~15 percent lower than plasma test results. Blood glucose meter of test results are considered clinically accurate if it falls within +/- 20% of an accepted reference result. E.g. 200 mg/dL plasma/1.12 = 178.6 mg/dL whole blood. Plasma calibrated meter would be accurate if it gave you a result anywhere between 142.9 and 214.32.

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Q. What is the control solution?
A.

Control solution is using to check the meter and the test strips are working together as a system, and that you are doing the test correctly. When you test a strip using control solution instead of your blood which is the number on the meter should be within this range. This range printed on the test strips vial label.

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Q. How to perform right results of the control solution testing?
A.

This is important step -- Press the “M” button to enter the control solution mode. The word “CTL” appears on LCD.

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Q. Why is the control solution range not fall within the range printed on the meter vial label?
A.

Perform:

  1. Use TaiDoc control solution only.
  2. Don’t use it expired. Discard 90 days after opening.
  3. This control solution should be at room temperature (20 ~25℃ / 68~77℉)。
  4. You should be follow step 2 to perform this test of the control solution in the owner’s booklet.
  5. Shake the control solution gentle and discard a first drop, then repeat the test again.
  6. This test strip may corrupt; you have to repeat the test with a new test strip.
  7. When you perform this test for control solution testing, you must to squeeze the vial to get a hanging drop and place the drop on your fingertip.
  8. How to do a control solution testing? This is important step -- Press the “M” button to enter the control solution mode. The word “CTL” appears on LCD.

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Q. What is automatic lancing device?
A.

Lancing devices (lancets) are fine, sharp-pointed blades or needles used to pierce the skin to draw a sample of blood for glucose testing. There are many types of lancets and some have protective caps.
The systems are designed for use by individual at home (e.g. diabetic self-monitoring), and designed for alternative site puncture.

Most automatic lancing devices consist of a hand-held tube with a spring-loaded lancet. To obtain a blood sample, hold the device against your skin press a button to release the lancet. Most lancing devices come with different lancet covers to allow different amounts of skin penetration. Before the next use, you must clean your lancing device.

Depth setting: the length of the lancet tip available for puncture (in mm) is prevalent.

Available lancet tip length penetration Anticipated blood volume (flow)
0.7~1.5 Shallow Low
1.6~2.2 Intermediate Medium
2.3~3.0 deep high

Prevention of re-use: residual blood on the lancet can result in cross-infection. If the lancet applies to reuse, it is a risk of infection from needle reuse.

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Q. Why do I must code the meters before use it?
A.

Code numbers are used to calibrate the meters with the test strips for accurate results. You have to code the meter before using it for the first time, and you change to another vial of test strips every time.

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Q. How do I change the code number on my meter when I get a vial of a new strip?
A.

One Code: When you test your blood glucose every time, you do not need the code chip. Or you do not worry whether this code is correctly or not. You can directly insert test strip into the meter.

Step 1: You must match the model of the meter and the vial of test strips.

Step 2: Insert the test strip into the meter to turn the meter on.

Step 3:Match the code numbers for the meter, the vial of test strips.

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Q. How do I maintain my blood glucose meter?
A.
  •  Keep your meter clean.
  •  Test your meter regularly with control solution.
  •  Store your meter and supplies properly. Heat and humidity can damage test strips.
  •  Replace the bottle cap promptly after removing a test strip.

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Q. How can I check my meter’s performance?
A.

Use the control solution of FORA® series only.

  •  Every time you purchase a new box of test strips of FORA® series
  •  Sometimes you use the vial of test strips.
  •  Whenever you get unusual results.

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Q. Can I test blood glucose from sites other than my fingertips?
A.

Some FORA® blood glucose meter systems have allowed you to obtain blood sample from the alternative site of your palm, forearm, upper arm, calf, or thigh.

Notices: alternative site test is not fit for everyone, it may have some limitation. You have just taken insulin.

  • You think your blood glucose is low.
  • The test results do not agree with your feel.
  • You feel illnesses.
  • You are not aware of symptoms when you become hypoglycemia.
  • Alternative site results may be different than the fingertips when blood glucose levels are results may be different than the fingertips when blood glucose levels are changing rapidly such as after a meal, during or after exercise.

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Q. Does the blood sample not fill up confirmation sample size which affects the result?
 

Sample size can affect the result. Always follow the instructions in the Owner's Manual for applying blood to the test strip and make sure that the blood sample has completely filled the confirmation window of thetest strip.

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Q.

Can the hematocrit levels affect results?

A.

Hematocrit levels can affect results whether the sample is obtained from forearm or from finger stick. Hematocrit levels less than 30% may cause falsely high readings and hematocrit levels greater than 55% may cause falsely low readings. If the customer does not know their hematocrit level, they should consult their health care professional. Hematocrit levels may be affected by too much squeezing during site preparation.

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FORA Logo - Fora Care Company provide SMBG, Home health management, Doctor-patient communication, glucometer, Blood glucose, Blood sugar meter, Remote healthcare, Telehealth, Parent care, Talking monitor, Diabetes management, Diabetes management, blood sugar.
Fora Care Company - Fora Care Company provide SMBG, Home health management, Doctor-patient communication, glucometer, Blood glucose, Blood sugar meter, Remote healthcare, Telehealth, Parent care, Talking monitor, Diabetes management, Diabetes management, blood sugar.
810 Lawrence Drive, Suite 104 Newbury Park, CA 91320 USA
TEL: 1-805-498-8188 FAX: 1-805-498-7188
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