Easymax EasyMax MU User manual

Blood Glucose Test Strip
Instructions
IntendedUse
The EASYMAX® Series SMBG System is intended for the quantitative
measurement of glucose in fresh venous blood and capillary whole blood
samples drawn from the fingertip, palm and forearm. Testing is done outside
the body (In Vitro diagnostic use). It is indicated for self-testing by persons
with diabetes, or in clinical settings by healthcare professionals, as an aid to
monitor the effectiveness of diabetes control. The system is not to be used
on neonates (IMPORTANT: EASYMAX® MU model is excluded), is not for the
diagnosis of or screening for diabetes mellitus, and that alternate site testing
can only be used during steady-state blood glucose conditions.
Principle1,2
Apply a blood sample to the blood collection area at the tip of the strip. The
test strip will draw the blood sample into the reaction zone. The FAD-binding
glucose dehydrogenase catalyzes the glucose dehydrogenation. It will
produce gluconolactone.
During the reaction, a mediator transfers electrons to the electrode surface
and generates a current. The amount of the current is proportional to the
amount of glucose present in the blood sample. After 5 seconds, the
EASYMAX® Series meter will show glucose concentration on the screen.
ReagentComposition
Each test strip contains the following reagent:
6 (w/w) % FAD glucose dehydrogenase
(Aspergillus oryzae, 2.0 IU/test strip)
56 (w/w) % Potassium ferricyanide
38 (w/w) % Non-reactive ingredients
StorageandHandling
1. Store the test strip package in a cool, dry place. Temperature between
2°C to 30°C (36°F to 86°F).
2. Do NOT freeze. Keep out of direct sunlight and heat.
3. Write the date on the bottle when first opened.
4. Discard test strips 6 months after first opening date.
5. Replace the cap quickly after taking the test strip from the bottle.
6. Handle the test strip only with dry and clean hands.
7. Store your test strips in their original bottle only. Do not move them to
any other bottle or container.
Warnings and Precautions
1. For in vitro diagnostic use only. Do not swallow.
2. Do not use the test strip after the expiration date.
3. Do not re-use test strips.
4. Do not cut, bend, scratch, or alter the test strip in any way.
5. Warning for potential biohazard3:
This warning is for the healthcare professional who use this system on
multiple patients. They should know the product comes in contact with
human blood. After cleaning, dispose of the product properly as if avoid
transmitting viral disease.
6. If the readings are not consistent to your symptoms, check the manual
first. Make sure you have followed all instructions, and then contact your
healthcare professional.
7. Never make any changes to your diabetes control program without
consulting your healthcare professional.
8. Operational temperature of SMBG system is between 10°C to 40°C
(50°F to 104°F), which is able to avoid occurring error results from test
strips.
Supplies For Testing Your Blood Glucose
EASYMAX® Series Meter.
EASYMAX® Test Strip.
Lancing device.
Lancets.
EASYMAX® Series User’s Manual.
SampleCollectionAndPreparation
This system is for use in venous blood or fresh capillary blood. Use the blood
sample immediately. The blood sample volume requires at least 0.6
micro-liters. To obtain a drop of blood, follow these steps:
Step 1: Wash and dry your hands thoroughly.
Step 2: Prepare lancing device according to the manual.
Step 3: Use an alcohol swab. Make sure that your finger is entirely dry before
lancing.
Step 4: Puncture and get a drop of blood. Avoid pressing too hard against the
punctured site.
AlternateSiteTesting(AST)
1. AST results may differ from fingertip results when glucose levels are
changing rapidly (e.g., after a meal, after taking insulin, or during or after
exercise).
2. AST can only be used during
steady-state blood glucose
conditions. AST should only be
performed under the following
conditions:
♦Testing before a meal.
♦In a fasting state.
♦2 hours or more after a meal.
♦2 hours or more after insulin
dosing.
♦2 hours after physical activity.
Fingertip test only.
♦If sick.
♦If blood glucose is low.
♦After exercising.
♦When you have just taken
insulin
♦Two hours or less after eating.
♦If you often do not notice when
your blood glucose is low.
♦After injecting rapid-acting
insulin (2 hours or less).
3. Consult with your healthcare professional before you test palm or
forearm.
Testing Your Blood Glucose Level
Make sure check the system by using Control Solutions before testing.
Please follow these steps to test:
Step 1: Insert Test Strip.
Take a test strip and replace the bottle cap quickly. Insert the test
strip into the slot of the meter.
Step 2: Apply Sample.
Follow the sample collection procedures to get a drop of blood. While
the “” appears, bring your blood to the collection area. The test strip
will draw the blood sample into the reaction zone. The meter will
begin to run.
Step 3: Accurate Results after 5 seconds.
Your result will appear on the screen after 5 seconds and be stored in
the meter.
For detailed information on the test procedure, please refer to the User’s
Manual.
QualityControl
It is recommended to run control test whenever you:
1. Begin using a new bottle of test strips.
2. Question your blood readings.
3. Check that the meter and test strips are working properly, and that you
perform the test correctly at least once.
4. Suspect the meter or test strips are working incorrectly.
5. Drop the meter.
6. Expose the test strips to temperatures outside the storage conditions.
(2°C to 30°C, 36°F to 86°F)
Use the EASYMAX® Glucose Control Solution to check the SMBG system
performance. Please follow the “Control Solution Test” section in Manual.
Don’t use other control solution. Other control solution may provide incorrect
results.
When the results fall within the specified ranges printed on the strip bottle
label, the system is working properly. If your control solution readings are
outside the range, repeat the control solution test. Results that fall outside
the range may be caused by:
1. Expired or contaminated control solution.
2. Error in performing the test.
3. Meter malfunction.
4. Test strip deterioration.
DO NOT use the system to test your blood until you get a control solution test
result within the specified range.
Readings
If “LO” appears on the screen, your blood glucose level is lower than 20
mg/dL (1.1 mmol/L). If “HI” appears, that your blood glucose level is higher
than 630 mg/dL (35.0 mmol/L). When you get any questions for the readings,
check the following items first and then repeat the test. If the results are still
questionable, consult your healthcare professional:
1. If the strips are within the expiration date.
2. Make sure the drop of blood in the whole reaction zone.
3. Check meter and test strip performance with Glucose Control Solutions.
Expected Results:
The EASYMAX® Blood Glucose test strips are plasma referenced and
calibrated for easier comparison to lab results.
For Non-Diabetic4
The American Diabetes Association recommends a post-meal glucose
level of less than 140 mg/dL (7.8 mmol/L) and a pre-meal glucose of less
than 100 mg/dL (5.6 mmol/L).
For Non-Pregnant Adults with diabetes5
The American Diabetes Association recommends a post-meal glucose
level of less than 180 mg/dL (10.0 mmol/L) and a pre-meal glucose of
70–130 mg/dL (3.9-7.2 mmol/L)
CAUTION:
Any low or high blood glucose readings can indicate a potentially serious
medical condition. If the readings do not reflect your symptoms, repeat the
test with a new test strip. Contact your healthcare professional when your
reading is:
A. Not consistent with your symptoms.
B. Less than 60 mg/dL (3.3 mmol/L).
C. Higher than 240 mg/dL (13.3 mmol/L).
Limitations
EASYMAX® Blood Glucose Test Strips are used for fresh venous blood and
capillary whole blood samples.
1. DO NOT use serum or plasma sample.
2. DO NOT use anticoagulant NaF or potassium oxalate for venous sample
preparation.
3. DO NOT use neonate blood sample. (IMPORTANT: EASYMAX® MU model
is excluded.)
4. Extreme humidity may affect the results. A relative humidity greater than
90% may cause incorrect results.
5. The system is designed to use at temperatures between 10°C and 40°C
(50°F and 104°F). Outside this range, the system may yield erroneous
results.
6. DO NOT reuse the test strips. The test strips are intended for single use
only.
7. Hematocrit: the test strip results are not significantly affected by
hematocrits in range of 20% to 60%. Hematocrit level less than 20% may
cause incorrect high readings and hematocrit levels greater than 60%
may cause incorrect low readings.
8. Altitude up to 3048 meters above sea level has no effect on readings.
Healthcare providers – Please note these additional Limitations.
1. If the patient has the following conditions, the result may be inaccurate:
Severely dehydrated.
Severely hypotensive.(low blood pressure)
In shock.
In hypoglycemic-hyperosmolar state.(with or without ketosis)
2. Lipemic samples: Cholesterol level up to 500 mg/dL (12.92 mmol/L) and
triglycerides up to 3,000 mg/dL (33.6 mmol/L) do not affect the results.
Do not test grossly lipemic patient samples with EASYMAX® Series
SMBG system.
3. DO not use home-use blood glucose meters to test critically ill patients.
4. DO NOT use during xylose absorption testing. Xylose in the blood will
interfere the EASYMAX® Series Self-Monitoring Blood Glucose System.
5. Interfering Substances depend on the concentration. The below
substances up to the test concentration will not affect the readings.
80 mg/dL
(4.4
mmol/L)
250 mg/dL
(13.9
mmol/L)
500 mg/dL
(27.8
mmol/L)
Ascorbic Acid 4 mg/dL (0.26 mmol/L) 10.89% -1.76% 4.55%
Ibuprofen 50 mg/dL (2.43 mmol/L) 3.10% 2.88% 4.62%
L-Dopa 1.8 mg/dL (0.09 mmol/L) 10.59% 7.91% 4.90%
Sodium
Salicylate 50 mg/dL (3.12 mmol/L) -2.59% 9.42% -0.84%
Tetracycline 1.5 mg/dL (0.03 mmol/L) -5.32% 3.81% 3.20%
Tolbutamide 100 mg/dL (3.70 mmol/L) -2.60% 12.30% 0.89%
Bilirubin-
unconjugated 2.4 mg/dL (0.04 mmol/L) -2.52% 4.05% -0.23%
Uric acid 8 mg/dL (0.48 mmol/L) 2.71% 9.55% -1.75%
Xylose 4 mg/dL (0.27 mmol/L) -5.12% -1.64% -4.44%
Use the anticoagulant EDTA or sodium Heparin or Lithium Heparin to
preserve the venous blood and capillary blood specimens would not affect
the readings of EASYMAX® Series SMBG System. If the specimen was
preserved by the anticoagulant NaF/potassium Oxalate contained sodium
fluoride, the reading of EASYMAX® Series SMBG System would be
seriously interfered.
PerformanceCharacteristics
The test range is between 20 to 630 mg/dL (1.1~35.0 mmol/L). Validate the
test strips performance in both laboratory and clinical tests.
PRECISION
Precision of the EASYMAX® Series Self-Monitoring Blood Glucose System
was measured with both venous blood and control solution in the laboratory.
The results are shown in the table below:
Within-Run Blood
av mg/dL (mmol/L)
Blood av mg/dL (mmol/L)
Blood av mg/dL (mmol/L)
Blood av mg/dL (mmol/L)
Blood av mg/dL (mmol/L)
Blood av mg/dL (mmol/L)
40 (2.2)
108 (6.0)
137 (7.6)
223 (12.4)
399 (22.2)
512 (28.4)
SD=2.9
CV=3.5%
CV=3.3%
CV=3.1%
CV=2.8%
CV=2.7%
Total-Run Control
av mg/dL (mmol/L)
Control av mg/dL (mmol/L)
Control av mg/dL (mmol/L)
42 (2.4)
120 (6.7)
351 (19.5)
SD=2.5
CV=3.2%
CV=2.7%
ACCURACY STUDY
The accuracy of the EASYMAX® Series Self-Monitoring Blood Glucose
System was assessed by comparison which was used in laboratories. The
results below were obtained by 159 subjects with diabetes at three
independent clinical sites. The regression statistics are derived from a plot of
the EASYMAX® capillary data versus YSI plasma data.
Slope 0.9803
Intercept + 2.9625 mg/dL (+ 0.1646 mmol/L)
Correlation coefficient 13.6852
Number of subject 159
Range tested 47.5– 566.5 mg/dL or 2.64–31.74 mmol/L
R-square 0.9782
In comparison to the YSI, EASYMAX® met the EN ISO 15197:2013
standard, whereby 95% of the blood glucose values measured must lie
within the following ranges: either ±15 mg/dL (± 0.83 mmol/L) of the
measured average value when using the reference measuring procedure for
blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood
glucose concentrations of ≥100 mg/dL (≥5.55 mmol/L). 99% of the individual
measured blood glucose values must fall within zones A and B of the
Consensus Error Grid (CEG) for diabetes type 1.
References
1. Cass, A.E.G. et al., Anal. Chem., 56 (1984) p.667
2. Tietz N.: Fundamentals of clinical chemistry , 3rd Ed., W.B. Saunders Co.,
Philadelphia, PA, 1987, p.427
3. NCCLS document M29-A, Protection of the laboratory worker from
instrument biohazards and infectious disease transmitted by blood, body
fluids, and tissue, 1997.
4. American Diabetes Association. Standards of medical care in diabetes.
Diabetes care. 2013; Vol. 36, Suppl 1, S13.
5. American Diabetes Association. Standards of medical care in diabetes.
Diabetes care. 2013; Vol. 36, Suppl 1, S21.
LabelingAndInformation
Consult
instructions for use Caution
Batch code Do not reuse
In vitro diagnostic
medical device
Temperature limitation
Use by Catalogue number
Manufacturer Control
Serial number
Blood glucose test
result in mg/dL
Sufficient for
Blood glucose test
result in mmol/L
Authorized representative in the European Community
This product meets the requirements of Directive 98/79/EC
in vitro diagnostic medical devices
www.easymaxdiabetescare.com
Obelis s.a.
Boulevard Général Wahis 53, B-1030 Brussels, Belgium
Tel: [phone] Fax: [phone] E-Mail: [email protected]
EPS Bio Technology Corp.
Hsinchu Science Park, Hsinchu, Taiwan 30077
P/N: 718063920_0861_03
EASYMAX US Office
9550 S. Eastern Ave. Suite 253 Las Vegas, NV 89123
Important
If the control solution test results are outside the range, your meter and
test strip may not be working as a system. Follow the correct procedures
and repeat the control solution test. Make sure the control solution is
clean without contamination. (e.g. Turbid.) Do not use the meter until test
results fall within the appropriate range. If the problem continues, please
contact our local dealer.
Important
Please read this insert and the EASYMAX® Series User’s Manual
before using EASYMAX® Blood Glucose Test Strips. If you have any
questions and/or need assistance, please contact our authorized
distributors in your country.
Concentrations
of the interference tested
Bias Glucose
Level
EN/ES/AR/FR/NL/TR
EN