Page 1
Blood Glucose Test Strips
REF 24118 REF 24119 REF 24120
English
• Test Strips
• Package Insert
• Meter
• Sterile Lancets
• Lancing Device
• Control Solution
Time
Range, mg/dL
Range, mmol/L
Fasting and Before Meals
70 – 100
3.9 – 5.6
2 Hours After Meal
Less than 140
Less than 7.8
2.37 mmol/L
(42.6 mg/dL)
4.57 mmol/L
(82.2 mg/dL)
7.41 mmol/L
(133.3mg/dL)
11.39 mmol/L
(205.1mg/dL)
18.59 mmol/L
(334.6 mg/dL)
Standard Deviation
Coefficient of Variation
Standard Deviation mmol/L (mg/dL) or
Coefficient of Variation (CV)
2.00 mmol/L (36.0 mg/dL)
0.051 mmol/L (0.91 mg/dL)
7.12 mmol/L (115.3 mg/dL)
2.3 %
17.83 mmol/L (321.0 mg/dL)
2.1 %
1.99 mmol/L (35.8 mg/dL)
0.061 mmol/L (1.09 mg/dL)
7.10 mmol/L (115.3 mg/dL)
2.3 %
17.83 mmol/L (320.9 mg/dL)
2.0 %
2.00 mmol/L (36.0 mg/dL)
0.058 mmol/L (1.05 mg/dL)
7.08 mmol/L (114.7 mg/dL)
2.7 %
17.77 mmol/L (319.9 mg/dL)
1.6 %
Linear Regression Results: GIMA (y) vs. YSI Reference (x)
Sample Site
Slope
Intercept
R N Fingertip
0.9892
-3.2734
0.9964
798
Palm
0.9750
-2.5412
0.9929
666
Forearm
0.9821
0.4242
0.9913
666
Fingertip Site: System Accuracy Results for Glucose Concentration ≥ 5. 55 mmol/L (100 mg/dL)
Within ± 5 %
Within ± 10 %
Within ± 15 %
335/582 (57.6 %)
530/582 (91.1 %)
582/582 (100.0 %)
Fingertip Site: System Accuracy Results for Glucose Concentration < 5.55 mmol/L (100 mg/dL)
Within ± 0.28 mmol/L
(±5 mg/dL)
Within ± 0.56 mmol/L
(±10 mg/dL)
Within ± 0.83 mmol/L
(±15 mg/dL)
156/216 (72.2 %)
214/216 (99.1 %)
216/216 (100.0 %)
Palm Site: System Accuracy Results for Glucose Concentration ≥ 5.55 mmol/L (100 mg/dL)
Within ± 5 %
Within ± 10 %
Within ± 15 %
246/516 (47.7 %)
447/516 (86.6 %)
514/516 (99.6 %)
Palm Site: System Accuracy Results for Glucose Concentration < 5. 55 mmol/L (100 mg/dL)
Within ± 0.28 mmol/L
(±5 mg/dL)
Within ± 0.56 mmol/L
(±10 mg/dL)
Within ± 0.83 mmol/L
(±15 mg/dL)
95/150 (63.3 %)
146/150 (97.3 %)
150/150 (100.0 %)
Forearm Site: System Accuracy Results for Glucose Concentration ≥ 5.55 mmol/L (100 mg/dL)
Within ± 5 %
Within ± 10 %
Within ± 15 %
297/516 (57.6 %)
469/516 (90.9 %)
513/516 (99.4 %)
Forearm Site: System Accuracy Results for Glucose Concentration < 5.55 mmol/L (100 mg/dL)
Within ± 0.28 mmol/L
(±5 mg/dL)
Within ± 0.56 mmol/L
(±10 mg/dL)
Within ± 0.83 mmol/L
(±15 mg/dL)
99/150 (66.0 %)
141/150 (94.0 %)
150/150 (100.0 %)
System Accuracy Results for Glucose Concentration between 1.1 m mol/L (19.6 mg/dL)
and 29.7 mmol/L (534 mg/dL)
Within ± 15 % or ± 0.83 mmol/L ( ± 15 mg/dL )
Fingertip Site
Palm Site
Forearm Site
798/798 (100.0 %)
664/666 (99.7 %)
663/666 (99.5 %)
Within ± 12 % or ± 0.56 mmol/L ( ± 10 mg/dL )
Fingertip Site
780/798 (97.7 %)
Linear Regression Results: GIMA (y) vs. YSI Reference (x)
Sample Site
Slope
Intercept
R N Fingertip
0.9865
0.7919
0.9904
100
Palm
0.9817
0. 2111
0.9874
100
Forearm
1.0152
-2.3603
0.9888
100
Blood Sample
Slope
Intercept R N
Venous
1.0124
4.5900
0.9959
762
Blood Sample
Slope
Intercept R N
Neonatal
1.0054
2.5101
0.9780
354
Consult instructions
for use
Use by
Control Range
In vitro diagnostic
medical device
Lot Number
Catalogue number
Temperature limit
Manufacturer
Contains sufficient for
<n> tests
Authorized
representative in the
European Comm unity
Do not reuse
Model Number
Number: 1151434601
Effective Date: 20xx-xx-xx
0123
MDSS GmbH
ACON Laboratories, Inc.
Manufacturer
PRINCIPLE AND INTENDED USE
The GIMA Blood Glucose Test Strips are thin strips with a chemical reagent system. They work
with the GIMA Blood Glucose Meter to measure the glucose concentration in whole blood. Blood is
applied to the end tip of the test strip. The blood is then automatically absorbed into the reaction
cell where the reaction takes place. A transient electrical current is formed during the reaction
which is detected by the meter. The blood glucose concentration is then calculated based on the
electrical current. The result is then shown on the meter display. The meters are calibrated to
display plasma equivalent results per the recommendation of the International Federation of
Clinical Chemistry and Laboratory Medicine (IFCC).
For in vitro diagnostic use. Test strips are to be used only outside the body for testing purposes.
For self-testing and professional use. GIMA Test Strips are used by people with diabetes at home
and by healthcare professionals for the quantitative measurement of glucose in capillary whole
blood from the finger, forearm, and palm. It is also used as an aid in monitoring the effectiveness of
diabetes control programs. Professionals may also test neonatal, arterial and venous blood
samples.
COMPOSITION
Each test strip has reac tive and non-reactive chemicals. These chemicals are: FAD-dependent
Glucose Dehydrogenase < 25 IU, Mediator < 300 μg, Buffer, and Non-reactive Ingredient.
Each test strip vial contains a drying agent.
STORAGE AND HANDLING
• Test strips should be stored in their protective vial. The vial’s cap must be tightly closed to
keep the test strips in good working condition.
• Store test strips in a cool, dry place at room temperature, 2–35 °C (36–95 °F). Store them
away from heat and direct sunlight.
• Do not freeze or refrigerate.
• To ensure accurate results, use the test strips at room temperature.
• Keep the text side up and blank side down when you insert the strip contact bars into the
strip port.
• Do not store or use the test strips in a humid place such as a bathroom.
• Do not store the meter, the test strips or control solution near bleaches or cleaners that
contain bleaches.
• Do not transfer the test strips to a new vial or any other container.
• Repeated insertion and removal of a test strip into the meter strip port may result in reading
errors.
• Replace the vial cap immediately after removing a test strip.
• Use the test strip immediately after removing it from the vial.
• Do not use your test strips past the unopened expiration date printed on the vial. Using test
strips past the expiration date may produce incorrect test results.
Note: All expiration dates are printed in Year-Month-Date format .
• A new vial of test strips may be used for 18 months after first being opened. Write the
opened vial expiration date on the vial label after opening.
PRECAUTIONS
• For in vitro diagnostic use. The test strips are to be used only outside the body for testing
purposes.
• Do not use test strips after the expiration date that is shown on the vial. Expired test strips
may give incorrect blood glucose readings.
• Do not use test strips that are torn, bent, or damaged in any way.
• Do not reuse test strips.
• The sample must only be applied to the tip of the test strip. Do not apply blood or control
solution to the top of the test strip as this may result in an inaccurate reading.
• Discard the vial and any unused strips 18 months after you first open it. Constant exposure to
air may destroy chemicals in the test strip. This damage can cause incorrect readings.
• Keep the test strip vial away from children and animals.
• Consult your healthcare professional before making any changes in your treatment plan.
• Dispose of blood samples and materials carefully. Treat all blood samples as if they are
infectious materials. Follow proper precautions when disposing of materials.
MATERIALS PROVIDED
MATERIALS REQUIRED BUT NOT PROVIDED
INSTRUCTIONS FOR USE
See your User's Manual for complete instructions for blood sample collection before use.
1. Open the cap of the test strip vial only to remove a test strip for testing. Replace the cap
immediately to protect the remaining test strips from moisture in the air.
2. Run the blood glucose test following the instructions contained in your User’s Manual.
3. The blood glucose test result will be shown on the meter display window. This result should
fall within the target range. Your healthcare professional should recommend your target
range. If your blood glucose test results are higher or lower, ask your healthcare
professional what to do. Always consult your healthcare professional before making any
changes to your treatment plan.
IMPORTANT: GI MA Blood Glucose Monitoring System allow alternative sites testing for
forearm and palm testing in additional to fingertip testing. There are important differences
between forearm, palm and fingertip samples that you should know.
Important information about forearm and palm glucose testing:
• When blood levels are changing rapidly such as after a meal, insulin dose or exercise, blood
from the fingertips may show these changes more rapidly than blood from other areas.
• Fingertips should be used if testing is within 2 hours of a meal, insulin dose or exercise and
any time you feel glucose levels are changing rapidly.
• You should test with the fingertips anytime there is a concern for hypoglycemia or you
suffer from hypoglycemia unawareness.
RANGE OF EXPECTED VALUES
Blood glucose monitoring requires the help of a healthcare professional. Together you can set
your own range of expected blood glucose values, arrange your testing times, and discuss the
meaning of your blood glucose results.
Package Insert
Expected blood glucose levels for people without diabetes
1
:
CHECKING THE SYSTEM
Your blood glucose meter must be handled carefully. See your User's Manual for detailed
instructions for meter care. The quality control test should be used to check that the meter and
test strips are working together properly. Follow the test procedure in your User's Manual to run
a quality control test. Three ranges CTRL 0, CTRL 1 and CTRL 2 are shown on the test strip
vial label. Control Solution 1 is sufficient for most all self-testing needs. If you think your meter
or strips may not be working correctly, you may also want to do a Control Solution 0 or Control
Solution 2 test. Contact your dealer for information on purchasing control solution.
For confirmation of results, Control Solution 0 tests should fall within the CTRL 0 range, Control
Solution 1 tests should fall within the CTRL 1 range and Control Solution 2 tests should fall
within the CTRL 2 range. When testing with Control Solution 1, make sure you are matching
the results to the CTRL 1 range on the vial label.
CAUTION: If your quality control test result falls outside the control range shown on the test
strip vial, DO NOT use the system to test your blood, as the system may not be working
properly. If you cannot correct the problem, contact your distributor for help.
LIMITATIONS
• The GIMA meters, GIMA test strips and other components of the GIMA Blood Glucose
Monitoring System have been designed, tested and proven to work together effectively to
provide accurate blood glucose measurements. Do not use components from other brands.
• The GIMA Test Strips are for testing fresh capillary, venous, arterial or neonatal who le
blood. Do not use with serum or plasma samples.
• The venou s, arterial and neonatal blood must be obtained and tested by healthcare
professionals.
• Blood glucose measurement with venous or arterial whole blood samples must be
performed within 15 minutes of sample collection.
• Anticoagulant preservatives such as heparin or EDTA are recommended for best results in
using venous or arterial whole blood samples. Use of anticoagulants such as iodoacetate,
sodium citrate, or those containing fluoride is not advised.
• Very high (above 70%) and very low (below 10%) hematocrit levels can cause false
results. Talk to your healthcare professional to find out your hematocrit level.
• Abnormally high levels of Vitamin C or other reducing substances will produce false high
blood glucose measurements.
• Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an
interference.
• The system is tested to accurately read the measurement of glucose in whole blood within
the range of 0.6 - 33.3 mmol/L (10 to 600 mg/dL).
• Fats(Triglycerides up to 3,000 mg/dL or Cho lesterol up to 500 m g/dL) have no major effect
on blood glucose test results.
• The GIMA Blood G lucose Monitori ng System shows to work properly in studies at altitudes
up to 10,000 ft (3,048 meters).
• Severely ill persons should not run the glucose test with the GIMA Blood Glucose
Monitoring System.
• Blood samples from patients in shock, or with severe dehydration or from patients in a
hyperosmolar state (with or without ketosis) have not been tested and are not
recommended for testing with GIMA Glucose Monitoring System.
PERFORMANCE CHARACTERISTICS
The GIMA Blood Glucose Monitoring System comply with the requirements of EN ISO
15197:2015 / ISO 15197:2013 (In vitro diagnostic test systems - requirements for b lood
glucose monitoring systems for self-testing in managing diabetes mellitus). The GIMA meter is
calibrated by using YSI (Model 2300 STAT PLUS) Glucose Analyzer reference instrument,
which is traceable to NIST reference standard.
Repeatability Precision
Ten replicate assays were each run on ten GIMA Blood Glucose Meters. Heparinized venous
blood samples at five concentration levels were used in the testing. The results provided the
following estimates for reproducibility, precision.
MEAN
mmol/L (mg/dL) or
Intermediate Precision
Ten replicate assays drawn from three strip lots were run on ten GIMA Blood Glucose Meters.
These tests were run each day for a total of ten days. Control solutions at three concentration
levels were used in the testing. The results provided the following precision estimates.
# MEAN
Strip Lot 1
Strip Lot 2
Strip Lot 3
System Accu racy
A trained technician tested the capillary blood using the GIMA Blood Glucose Meter (y). The blood
samples were from more than 100 participants. Capillary blood samples were taken from fingertip,
palm and forearm. Fingertip samples from the same subjects were also analyzed with YSI Model
2300 STAT PLUS Glucose Analyzer (x). The results were compared.
Fingertip samples were used for YSI reference measurement.
The sample range was 1.1 to 29.6 mm ol/ L (19.6 to 534 mg/dL) for GIMA Blood Glucose Meter
0.069 mmol/L
(1.24 mg/dL)
0.127 mmol/L
(2.28 mg/dL)
2.5 % 2.5 % 2.6 %
testing with blood sampled from fingertip sites. The sample range was 3.2 to 21.3 m mol/ L (57
to 384 mg/dL) for GIMA Blood Glucose Met er testing with b lood sampled from pa lm and
forearm sites.
System accuracy according to EN ISO 15197:2015 / ISO 15197:2013, >99% of measured glucose
values fall within the minimum acceptable performance criteria.
Consumer Study
A consumer study was performed by testing one test strip lot. Participants used the GIMA
Blood Glucose Monitoring System. This study showed that the patient can run the test
properly.
The study evaluating glucose values from fingertip capillary blood samples o btained by 100 lay persons
showed the following results:
100 % within ± 0.83 mmol/L (± 15 mg/dL) of the medical laboratory v alues at glucose concentrations
below 5.55 mmol/L (100 mg/dL), and 100 % within ± 15% of the medical laboratory values at glucose
concentrations at or above 5.55 mmol/L (100 mg/dL).
Venous Study
The venous blood glucose measurements from more than 103 participants were taken by a
trained technician using the GIMA Blood Glucose Meter (y). The venous blood samp le from the
same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer (x).
The results were compared in the table below.
Neonatal Study
The neonatal blood glucose measurements from 59 participants were taken by a trained
technician using the GIMA B lood Glucose Meter (y). The neonatal blood samples fro m th e
same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer (x).
The results were compared in the table below.
For complete instructions, please refer to the GIMA Blood Gluco se Monitoring S ystem Us er's
manual. For additional questions or issues with this product, please contact your dealer for
help.
1. ADA, Standards of Medical Care in Diabetes-2021
Linear Regression Results: GIMA (y) vs. YSI Reference (x)
Linear Regression Results: GIMA (y) vs. YSI Reference (x)
INDEX OF SYMBOLS
5850 Oberlin Drive, #340
San Diego, CA 92121, USA
www.aconlabs.com
REFERENCES
30175 Hannover, Alemania
MODEL
Schiffgraben 41
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