the manual for glucoCheck Test Strips Size

the manual for glucoCheck Test Strips Size
ver 1.0 2017/06
312-0000001-XXX
Strip Appearance
1
Test Strip
2
Warnings
► For in vitro diagnostic use (for use outside of the body only).
► For single use only.
► Healthcare professionals and other users testing multiple patients with this system should handle
everything that has come into contact with human blood carefully to prevent transmitting infectious
diseases, including sanitized objects.
► Please read this sheet and your Blood Glucose Monitoring System Owner’s Manual before you use this
test strip. Use only GlucoCheck Test Strips with GlucoCheck Logic, GlucoCheck Classic, GlucoCheck
Advanced, GlucoCheck-i and GlucoCheck EVOLVE Blood Glucose Monitoring Systems 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.
► For patients with impaired peripheral circulation, collection of capillary blood from the approved sample
sites is not advised as the results might not be a true reflection of the physiological blood glucose level. It
may apply under the following circumstances: severe dehydration as a result of diabetic ketoacidosis or
due to stress hyperglycemia, hyperosmolar non-ketotic coma, shock, decompensated heart failure NYHA
Class IV or peripheral arterial occlusive disease.
► Keep the test strips and lancets away from small children. If swallowed, consult a doctor immediately for
advice.
► Discard the used test strips and lancets according to your local infection control procedures.
► Patients undergoing oxygen therapy may yield falsely low results.
3
4
ATTENTION
Test results might be wrong if the contact bar is not fully inserted into the test slot.
The front side of the test strip should face up when inserting the test strip.
Testing Your Blood Glucose
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 switch on automatically and
display the blood drop symbol. No coding of the meter is needed.
Intended Use
STEP 2
Collect a blood sample of 0.7 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.
About Alternative Site Testing (AST)
Alternative site testing (AST) is when individuals check their blood glucose levels using areas of the body
other than the fingertip. The GlucoCheck Test Strips allow AST to be performed on sites other than the
fingertip. We strongly recommend that you perform AST ONLY at the following times:
■ During a pre-meal or fasting state (more than 2 hours since the last meal).
■ Two hours or more after taking insulin.
■ Two hours or more after exercise.
Do NOT use AST if:
■ You think your blood glucose is low.
■ You may not notice if you are hypoglycemic.
■ Your AST results are inconsistent with the way you feel.
■ You are testing for hyperglycemia.
■ Your routine glucose results often fluctuate.
To obtain a blood sample from the alternative sites, please rub the puncture site for approximately 20 seconds
before obtaining a blood drop as described in your Blood Glucose Monitoring System Owner's Manual.
Limitations
► Hematocrit: The hematocrit level is limited to between 30% and 55%. 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 xylose, 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.
► Altitude Effects: Altitudes up to 10,742 feet (3,275m) do not affect test results.
The following compounds when determined to be in excess of their limitation and tested with the GlucoCheck
Logic, GlucoCheck Classic, GlucoCheck Advanced, GlucoCheck-i and GlucoCheck EVOLVE glucose meter may
produce elevated glucose results:
Summary of substances and concentrations in excess of limitation with interference
Limiting Concentration
(mg/dL)
Therapeutic / Physiologic
Concentration Range
(or Upper Limit ) (mg/dL)
> 6.25
0.45 - 3
Ascorbic Acid
>5
2
Pralidoxime Iodide
>5
~ 10 (IV Dose 500 mg)
Substance
Acetaminophen (Paracetamol)
Storage and Handling
IMPORTANT: Do not use the test strips if they have expired.
► Test strips expire 6 months after first opening. Write the first opening date on the test strip vial when you
first opened it.
► Store the test strips in a cool, dry place between 4°C and 40°C and below 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. 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.
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.
EXAMPLE ONLY!
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 infection control procedures.
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 1.1-33.3 mmol/L.
Reference values
Time of day
Normal plasma glucose range for people with diabetes
Fasting and before meal
4.0 - 7.0 mmol/L
2 hours after meals
5.0 - 10.0 mmol/L
Source: The 2012 SEMDSA Guideline for the Management of Type 2 Diabetes (Revised).
JEMDSA 2012:17(2):S21.
Blood glucose reference values may be individualised for Type 1, newly diagnosed, young, elderly and high
risk patients.
Please consult your healthcare professional regarding the appropriate blood glucose reference range for you.
GlucoCheck Logic
Table 1 Accuracy results for glucose concentration < 5.55 mmol/L
Within ±0.28 mmol/L
Within ±0.55 mmol/L
Within ±0.83 mmol/L*
66.7% (208/312)
100% (312/312)
100% (312/312)
Table 2 Accuracy results for glucose concentration≧5.55 mmol/L
Within ±5 %
Within ±10 %
Within ±15 %*
48.1% (312/648)
84.3% (546/648)
96.3% (624/648)
Within ±0.83 mmol/L or ±15 %
97.5% (936/960)
GlucoCheck Classic
Table 1 Accuracy results for glucose concentration < 5.55 mmol/L
Within ±0.28 mmol/L
Within ±0.55 mmol/L
Within ±0.83 mmol/L*
78.8% (246/312)
99.7% (311/312)
100% (312/312)
Table 2 Accuracy results for glucose concentration≧5.55 mmol/L
Within ±5 %
Within ±10 %
Within ±15 %*
65.9% (427/648)
99.7% (646/648)
99.7% (646/648)
Table 3 Accuracy results for glucose concentrations between 1.88 mmol/L to 29 mmol/L
Within ±0.83 mmol/L or ±15 %
99.8% (958/960)
GlucoCheck Advanced
Table 1 Accuracy results for glucose concentration < 5.55 mmol/L
Within ±0.28 mmol/L
Within ±0.55 mmol/L
Within ±0.83 mmol/L*
76.3% (238/312)
100% (311/312)
100% (312/312)
Table 2 Accuracy results for glucose concentration≧5.55 mmol/L
Within ±5 %
Within ±10 %
Within ±15 %*
77.5% (502/648)
98.6% (639/648)
99.7% (646/648)
Table 3 Accuracy results for glucose concentrations between 1.77 mmol/L to 29.55 mmol/L
Within ±0.83 mmol/L or ±15 %
99.8% (958/960)
GlucoCheck-i
Table 1 Accuracy results for glucose concentration < 5.55 mmol/L
Within ±0.28 mmol/L
Within ±0.55 mmol/L
Within ± 0.83 mmol/L
54.3% (150/276)
89.5% (247/276)
100% (276/276)
Table 2 Accuracy results for glucose concentration≧5.55 mmol/L
Within ±5 %
Within ±10 %
Within ±15 %*
43.9% (300/684)
78.5% (537/684)
96.8% (662/684)
Table 3 Accuracy results for glucose concentrations between 1.88 mmol/L to 29 mmol/L
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 expiration 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 meter, test strip and your technique by comparing the control solution results with the range
printed on the label of test strip vial. 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 of test strips. Make
sure you check the range on the label of your current vial.
Within ±0.83 mmol/L or ±15 %
97.7% (938/960)
GlucoCheck EVOLVE
Table 1 Accuracy results for glucose concentration < 5.55 mmol/L
Within ±0.28 mmol/L
Within ±0.55 mmol/L
Within ± 0.83 mmol/L*
68.1% (192/282)
95.0% (268/282)
99.3% (280/282)
Table 2 Accuracy results for glucose concentration≧ 5.55 mmol/L
Within ±5 %
Within ±10 %
Within ±15 %*
46.5% (315/678)
78.6% (533/678)
97.9% (664/678)
Table 3 Accuracy results for glucose concentrations between 2.07 mmol/L to 30.06 mmol/L
Within ±0.83 mmol/L or ±15 %
98.3% (944/960)
Chemical Components
> Glucose oxidase (A. niger)
> Electron shuttle
> Enzyme protector
> Non-reactive ingredients
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
GlucoCheck Logic, GlucoCheck Classic, GlucoCheck Advanced, GlucoCheck-i and GlucoCheck EVOLVE
achieves this target respectively. 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 GlucoCheck Logic, GlucoCheck Classic,
GlucoCheck Advanced, GlucoCheck-i and GlucoCheck EVOLVE performed compared to YSI-2300 reference
method results.
Table 3 Accuracy results for glucose concentrations between 1.77 mmol/L to 29.55 mmol/L
PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTING.
GlucoCheck Test Strips, when used together with GlucoCheck Logic, GlucoCheck Classic, GlucoCheck
Advanced, GlucoCheck-i and GlucoCheck EVOLVE Blood Glucose Monitoring Systems, allow your blood
glucose levels to be measured by yourself at home or by healthcare professionals. It uses fresh whole blood
samples from the finger, palm, upper arm and forearm. This system is not intended for use in the
diagnosis or screening of diabetes mellitus, nor for the use on newborns.
IMPORTANT: There are limitations for performing AST. Please read the GlucoCheck Logic, GlucoCheck
Classic, GlucoCheck Advanced, GlucoCheck-i and GlucoCheck EVOLVE Blood Glucose Monitoring System
Owner’s Manual and consult your healthcare professional before you perform AST.
Accuracy
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 of the glucose meter
4. Contact Bars
Insert this end of the test strip into the meter. Push it in firmly until it will go no
further.
10%
50%
8%
32%
Additional Information for Healthcare Professionals
Always wear gloves and follow your facility’s biohazard control policy and procedures when performing tests
involving patient blood samples. Use fresh whole blood samples only. Healthcare professionals may use test
strips to test capillary whole blood.
Sample Size: 0.7 μL
Reaction Time: 7 seconds
System Measurement Range: 1.1 to 33.3 mmol/L
Hematocrit Range: 30% to 55%
*Acceptance criteria in EN ISO 15197: 2015, 95% of all differences in glucose values (i.e., YSI-2300
reference values minus GlucoCheck Logic, GlucoCheck Classic, GlucoCheck Advanced, GlucoCheck-i and
GlucoCheck EVOLVE's glucose values respectively) 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 GlucoCheck 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.
User performance
GlucoCheck Logic
A study evaluating glucose values from fingertip capillary blood samples obtained by 154 lay persons
showed the following results:
100% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L,
and 95.5% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55
mmol/L.
GlucoCheck Classic
A study evaluating glucose values from fingertip capillary blood samples obtained by 155 lay persons
showed the following results:
100% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L,
and 96.4% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55
mmol/L.
GlucoCheck Advanced
A study evaluating glucose values from fingertip capillary blood samples obtained by 155 lay persons
showed the following results:
100% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L,
and 97.4% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55
mmol/L.
GlucoCheck-i
A study evaluating glucose values from fingertip capillary blood samples obtained by 155 lay persons
showed the following results:
100% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L,
and 96.5% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55
mmol/L.
GlucoCheck EVOLVE
A study evaluating glucose values from fingertip capillary blood samples obtained by 160 lay persons
showed the following results:
100% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L,
and 97.4% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55
mmol/L.
Precision
The CV (%) is less than 5% both in intermediate precision and repeatability precision.
Symbol Information
Symbol
Referent
Symbol
Referent
In vitro diagnostic medical device
Authorised representative in
the European Community
Manufacturer
Use by
Consult instructions for use
Batch code
CE mark
Temperature limitation
Do not reuse
Humidity limitation
Authorised distributor:
Homemed (Pty) Ltd, Co Reg 2003/022932/07, Tel: 0861 106 150
Address: 100 Sovereign Drive, Route 21 Corporate Park,
Nellmapius Drive, Irene, 0157, South Africa
TaiDoc Technology Corporation
B1-7F, No. 127, Wugong 2nd Rd., Wugu Dist.,
24888 New Taipei City, Taiwan
www.taidoc.com
MedNet GmbH
Borkstraβe 10, 48163 Münster, Germany
85%
40°C
4°C
For self-testing.
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