MediSure Blood Glucose Test Strips Instructions

MediSure Blood Glucose Test Strips

Warnings

• For in vitro diagnostic use (for use outside of the body only).
• For single use only.
• For blood glucose test only.
• Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%.
• The meter and lancing device are for single-patient use. Do not share them with anyone including other family members! Do not use on multiple patients!
• All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
• Please read this sheet and your Owner’s Manual before you use this test strip. Use only MediSure Empower Blood Glucose Test Strips with MediSure Empower Blood Glucose Monitoring System to obtain accurate results, and be covered by the manufacturer’s warranty.
• Results may be inaccurate when testing on patients with abnormally low blood pressure or those who are in shock.
• Low results may be inaccurate when testing on patients in the hyperglycemic-hyperosmolar state, with or without ketosis.
• Please do not use this Blood Glucose Monitoring System on critically ill patients. While the blood glucose result is extremely hyperglycemia (over 33.3 mmol/L ), the collection of capillary blood from the approved sample sites is not advised when the peripheral circulation is impaired as the delivery of physiological blood glucose level might not be a true reflection. The following circumstances may apply: severe dehydration as a result of diabetic ketoacidosis or due to stress hyperglycemic, hyperosmolar non-ketotic coma, shock, decompensated heart failure NYHA Class IV or peripheral arterial occlusive disease.
• Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for advice.

Intended Use

MediSure Empower Blood Glucose test strips, when used together with MediSure Empower Blood Glucose Monitoring System, allow blood glucose levels to be measured in an individual. It uses fresh whole blood samples from the finger, palm, forearm and upper arm. It should not be used for the diagnosis of or screening for diabetes.

Limitations

• Xylose: Do not test blood glucose during or soon after a xylose absorption test. Xylose in the blood can give falsely elevated results.
• Hematocrit: The hematocrit level is limited to between 20% and 65%. Please ask your healthcare professional if you do not know your hematocrit level.
• Neonatal Use: This test strip must not be used for the testing of newborns.
• Metabolites: Dopamine, L-Dopa, methyldopa, uric acid, ascorbic acid, and acetaminophen at normal blood concentration do not significantly affect blood glucose test results.
• There are no significant interference in the presence of maltose, or fructose observed in blood glucose tests.
• Lipemic Effects: Blood triglycerides up to 33.9 mmol/L do not affect the results significantly, but may affect results at higher levels.
• Use only heparin for anticoagulation of fresh capillary or venous whole blood.
• Altitude Effects: Altitudes up to 10,742 feet (3,275m) does not affect test results
• Blood Pralidoxime Iodide up to 0.1894 mmol/L does not affect the results significantly but may produce elevated glucose results at higher levels. The following compounds when determined to be in excess of their limitation and tested with the MediSure Empower Blood Glucose Monitoring System may produce elevated glucose results: Summary of substances and concentrations in excess of limitation with interference

The substance is indicated by ISO 15197: 2013.

Storage and Handling

IMPORTANT: Do not use the test strips if they have expired.

• For the unopened strip vial, the strip’s expiry date is 24 months from the production date.
• Test strips expire 6 months after the first opening. Write the first opening date on the test strip vial when you first opened it. (For strip vial only)
• Store the test strips in a cool, dry place between 2°C and 30°C (35.6°F and 86°F) and 10% to 85% relative humidity.
• Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.
• Store the test strips in their original vial ONLY. Do not transfer them to a new vial or any other container.
• Do not touch the test strips with wet hands.
• Use each test strip immediately after taking it out of the vial or individual foil packet. Close the vial immediately after taking out a strip.
• Keep the vial closed at all times.
• Do not bend, cut, or alter the test strip.

Strip Appearance

1. Absorbent Hole
   Apply a drop of blood here. The blood will automatically be absorbed.

2. Confirmation Window
   This is where you confirm if enough blood has been drawn into the absorbent hole of the strip.

3. Test Strip Handle
   Hold this part to insert the test strip into the slot.

4. Contact Bars
   Insert this end of the test strip into the meter. Push it in firmly until it will go no further.

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

Testing Your Blood Glucose

PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTING.

STEP 1
Insert the test strip fully into the slot of the meter until it will go no further. When the strip is fully inserted, the meter will do several self- checks.

STEP 2
Collect a blood sample for about 0.5 μL with the test strip. A sufficient quantity of blood is required for the test to provide accurate results. Touch the blood drop with the absorbent hole of the test strip, and wait until the confirmation window is fully covered. Do NOT apply a smeared blood sample. The meter will start counting down.

STEP 3
After a few seconds, the meter will display your blood glucose level. The last reading will be automatically saved in the meter. Turn it off by removing the test strip and throwing away the used test strip.

Cleaning and disinfection of your meter are required to reduce the risk of bloodborne pathogen transmission.

The meter must be cleaned prior to disinfection. Use one disinfecting wipe to clean exposed surfaces of the meter thoroughly and remove any visible dirt, blood, or any other body fluid with the wipe. Use a second wipe to disinfect the meter by following the disinfecting procedure. Please refer to your Owner’s Manual for more information about the cleaning and disinfection procedures with a disinfecting wipe. Please refer to your Owner’s Manual for more information.

The used lancet and test strip are potentially biohazardous. Please dispose of them carefully according to your local regulations.

Reading Your Result

Your blood glucose readings deliver plasma equivalent results and are displayed in millimoles of glucose per liter of blood (mmol/L). The measurement range of this meter is 1.1 to 36.1 mmol/L.

Reference values

• Time of day: Normal plasma glucose range for people without diabetes
• Fasting and before a meal: < 5.6 mmol/L
• 2 hours after meals: < 7.8 mmol/L

American Diabetes Association. Standards of medical care in diabetes- 2016;39 (supp.1 Diabetes Care): S16.

Please consult your doctor to determine a target range that works best for you

Questionable or inconsistent results
If your test results are unusual or inconsistent with how you are feeling:

• Make sure the confirmation window of the test strip is completely filled with blood.
• Check the expiry date of the test strips
• Check the performance of your meter and test strip with the control solutions.

PLEASE NOTE:
Unusually high or low blood glucose levels may be symptoms of a serious medical condition. If most of your results are unusually high or low, please contact your healthcare professional.

Quality Control Testing

Our control solutions contain a known amount of glucose that can react with test strips. You can check the performance of the meter, test strip and your technique by comparing the control solution results with the range printed on the label of test strip vial or on the package. Checking regularly can ensure your test results are accurate. Please refer to the Owner’s Manual for complete testing instructions.

IMPORTANT:
The reference range of the control solutions may vary with each new vial or package of test strips. Make sure you check the range on the label of your current vial or on the current package.

Chemical Components

• Glucose dehydrogenase (E. coli) 8%
• Electron shuttle 55%
• Enzyme protector 8%
• Non-reactive ingredients 29%

Performance Characteristics

• Sample Size: 0.5 μL
• Reaction Time: 6 seconds
• System Measurement Range: 1.1 to 36.1 mmol/L
• Hematocrit Range: 20% to 65%

Accuracy
Diabetes experts have suggested that glucose meters should be within ±0.83 mmol/L of the reference method when the glucose concentration is lower than 5.55 mmol/L, and be within ±15% of the reference method when the glucose concentration is 5.55 mmol/L or higher. The tables below display how often Medisure Empower test strips achieve this target. The chart is based on a study carried out on 160 patients (each patient was tested six times which had 960 test results) to see how well MediSure Empower test strips performed compared to YSI-2300 reference method results.

Table 1 Accuracy results for glucose concentration <5.55 mmol/L (Capillary)

Table 2 Accuracy results for glucose concentration≧5.55 mmol/L (Capillary)

Table 3 Accuracy results for glucose concentrations between 1.79 mmol/L to 31.78 mmol/L (Capillary)

• Within ±0.83 mmol/L or ±15%
• 98.8% (948/960)

Acceptance criteria in EN ISO 15197: 2013, 95% of all differences in glucose values (i.e., YSI-2300 reference values minus MediSure Empower’s glucose values) should be within ±0.83 mmol/L for glucose concentration < 5.55 mmol/L, and within ±15% for glucose concentration ≥ 5.55 mmol/L.

Note:
When MediSure Empower Test Strips results are compared to the reference values, difference values below 5.55 mmol/L are expressed in mmol/L, while those above 5.55 mmol/L are in percent.

Table 4 Difference distribution for glucose concentration <5.55 mmol/L

Tested sites| Difference within

±0.28 mmol/L

| Difference within

±0.55 mmol/L

| Difference within

±0.83 mmol/L

---|---|---|---
Palm| 160/252 (63.5%)| 241/252 (95.6%)| 252/252 (100%)
Forearm| 171/252 (67.9%)| 233/252 (92.5%)| 250/252 (99.2%)
Upper arm| 169/252 (67.1%)| 223/252 (88.5%)| 248/252 (98.4%)
Table 5 Difference distribution for glucose concentration ≥5.55 mmol/L
Tested sites| Difference within ±5 %| Difference within ±10 %| Difference within ±15 %
Palm| 282/708 (39.8%)| 535/708 (75.6%)| 689/708 (97.3%)
Forearm| 260/708 (36.7%)| 514/708 (72.6%)| 680/708 (96.0%)
Upper arm| 283/708 (40.0%)| 537/708 (75.8%)| 690/708 (97.5%)

User performance

160 subjects tested on the fingertip and the alternative sites, the palm, the forearm and the upper arm. The tables show how well MediSure Empower performed compared to YSI-2300 reference method results.

Table 6 Difference distribution for glucose concentration < 5.55 mmol/L

Table 7 Difference distribution for glucose concentration ≥ 5.55 mmol/L

Precision
The CV (%) is less than 5% both in intermediate precision and repeatability precision.

Symbol Information

Referent

• In vitro diagnostic medical device
• Consult instructions for use
• Temperature limitation
• Use by
• Batch code
• Use within 6 months after first opening.
• Manufacturer
• Caution, consult accompanying documents
• Do not reuse
• Serial number
• Humidity limitation

Use only with MediSure Empower Blood Glucose Monitoring System.

References

• Medisure Canada

Read User Manual Online (PDF format)

Download This Manual (PDF format)

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