MediSure EMPOWER M Quick Start Manual

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 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
Concentration that interferes
Substance with glucose measurement
(mmol/L)
Acetaminophen (Paracetamol)** > 0.4139
Ascorbic Acid (Vitamin C)** > 0.2841
Bilirubin (UnConjugated)** > 0.3421
Dopamine** > 0.0659
Levo – Dopa** > 0.03553
Methyl – Dopa** > 0.02626
Reduced Glutathione** > 0.9772
Tolazamide** > 0.20096
Uric Acid** > 0.5263
Mannitol > 277.47
Mannose > 13.8735
Xylose** > 0.41667
Lipemic Samples (Triglycerides)** > 33.8983
Galactose** > 13.8889
Na-Fluoride/K-Oxalate > 59.538/47.63
Pralidoxime Iodide** > 0.1894
** 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 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
containers.
► 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
1
2
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
3
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
4
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 throw 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 the 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
Therapeutic / Physiologic
glucose per liter of blood (mmol/L). The measurement range of this meter is 1.1 to 36.1 mmol/L.
Concentration Range
Reference values
(or Upper Limit ) (mmol/L)
Time of day
0.029-0.199
Fasting and before meal
0.114
2 hours after meals
0-0.0342
American Diabetes Association. Standards of medical care in diabetes- 2016;39 (supp.1 Diabetes
0.00158
Care):S16.
0.00102-0.0142
Please consult your doctor to determine a target range that works best for you.
0.0042-0.021
Questionable or inconsistent results
0.7899 – 1.0489
If your test results are unusual or inconsistent with how you are feeling:
0.05145 ■ Make sure the confirmation window of the test strip is completely filled with blood.
■ Check the expiry date of the test strips
0.105-0.421
■ Check the performance of your meter and test strip with the control solutions.
0.00071
PLEASE NOTE: Unusually high or low blood glucose levels may be symptoms of a serious medical
0.06382
condition. If most of your results are unusually high or low, please contact your healthcare professional.
Quality Control Testing
N/A
0.339-3.39
Our control solutions contain a known amount of glucose that can react with test strips. You can check
< 0.27778
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
59.538/47.63
your test results are accurate. Please refer to the Owner's Manual for complete testing instructions.
~ 0.3788
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)
Electron shuttle
Enzyme protector
Non-reactive ingredients
Normal plasma glucose range for people without diabetes
< 5.6 mmol/L
< 7.8 mmol/L
MediSure Canada Inc.
785 Westney Rd. S Unit 23
Ajax, ON L1S 7G1 CANADA
8%
55%
www.medisure.ca
8%
1-855-MDI-SURE (634-7873)
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)
Within ±0.28 mmol/L Within ±0.55 mmol/L Within ± 0.83 mmol/L*
68.7% (202/294) 96.9% (285/294) 100% (294/294)
Table 2 Accuracy results for glucose concentration≧5.55 mmol/L (Capillary)
Within ±5 % Within ±10 % Within ±15 %*
64.3% (428/666) 90.2% (601/666) 98.2% (654/666)
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 Difference within
±0.28 mmol/L ±0.55 mmol/L
Palm 160/252 (63.5%) 241/252 (95.6%)
Forearm 171/252 (67.9%) 233/252 (92.5%)
Upper arm 169/252 (67.1%) 223/252 (88.5%)
Table 5 Difference distribution for glucose concentration ≥5.55 mmol/L
Tested sites Difference within ±5 % Difference within ±10 %
Palm 282/708 (39.8%) 535/708 (75.6%)
Forearm 260/708 (36.7%) 514/708 (72.6%)
Upper arm 283/708 (40.0%) 537/708 (75.8%)
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 performed compared to YSI-2300 reference method
MediSure Empower
results.
Table 6 Difference distribution for glucose concentration < 5.55 mmol/L
Tested sites Difference within Difference within
±0.28 mmol/L ±0.55 mmol/L
Fingertip 26/44 (59.1%) 42/44 (95.5%)
Palm 27/42 (64.3%) 41/42 (97.6%)
Forearm 31/42 (73.8%) 39/42 (92.9%)
Upper arm 29/42 (69.0%) 38/42 (90.5%)
Table 7 Difference distribution for glucose concentration ≥ 5.55 mmol/L
Tested sites Difference within ±5 % Difference within ±10 %
Fingertip 60/116 (51.7%) 103/116 (88.8%)
Palm 49/118 (41.5%) 92/118 (78.0%)
Forearm 43/118 (36.4%) 84/118 (71.2%)
Upper arm 49/118 (41.5%) 87/118 (73.7%)
Precision
The CV (%) is less than 5% both in intermediate precision and repeatability precision.
Symbol Information
Symbol Referent Symbol
In vitro diagnostic medical device Manufacturer
Caution, consult accompanying
Consult instructions for use
documents
Temperature limitation Do not reuse
Use by Serial number
Batch code Humidity limitation
Use within 6 months after first
opening.
6M
Use only with MediSure Empower Blood
Glucose Monitoring System.
10%
Difference within
±0.83 mmol/L
252/252 (100%)
250/252 (99.2%)
248/252 (98.4%)
Difference within ±15 %
689/708 (97.3%)
680/708 (96.0%)
690/708 (97.5%)
Difference within
±0.83 mmol/L
44/44 (100%)
42/42 (100%)
42/42 (100%)
41/42 (97.6%)
Difference within ±15 %
116/116 (100%)
118/118 (100%)
115/118 (97.5%)
116/118 (98.3%)
Referent
85%
30°C
2°C For self-testing.