Elektronika SensoLite Nova Test User manual

Test strips for quantitative measurement of glucose concentration
in whole blood using with the SensoLite Nova and
SensoLite Nova Plus blood glucose meter.
Before you begin
Carefully read this entire guide. If you have any question
and/or need assistance, please, contact our authorised
distributor in your country.
Summary
SensoLite Nova blood glucose test strip was designed to
provide an easy, accurate method for the determination of
capillary whole blood glucose content. This analysis applies
the enzyme glucose oxidase and is based on advanced
electromechanical technology that is specific for ß-D-glucose
measurement. Test strips are designed in such a way that
blood sample absorbs into the reaction zone, after blood has
been applied to the tip of test strip. In the reagent zone glucose
oxidase triggers the oxidation of glucose in blood. Intensity of
formed electrons is measured by the meter and correlates
well with the concentration of glucose in the blood sample.
Package contents
•10, 25 or 50 strips in a vial
•Code-card
•Instructions for use
Measuring range
Measurement range of SensoLite Nova Test System is
1.1-33.3 mmol/l (20-600 mg/dl).
Sample volume
One blood drop is enough to determine blood glucose value with
SensoLite Nova Test strip. Minimum sample volume is 0.5 μl.
Reagents
Each test strip contains the following ingredients in the
approximate concentrations listed below:
•Glucose oxidase 2.7 I.U.
•Hexaamineruthenium(III)chloride 45.7μg
•Other ingredients 1.6 μg
Each vial cap contains 2-3 g silica gel.
Warnings and precautions
SensoLite Nova Test blood glucose strips are for
IN VITRO diagnostic use only (external use only).
•Do not use test strips after their expiration date.
•Do not use test strips that are wet, bent, scratched,
or damaged in any way.
•Do not re-use the strips.
•If you have symptoms which are not consistent with your
blood test results always contact your health care professional
immediately.
•If your reading result is above or below your expected
range of blood glucose values, always repeat the test
and prove that the values are consistent.
•Abnormal red blood cell quantity (hematocrit below 30% or
above 55%) may cause incorrect results.
•Never make significant changes in your diabetes treatment
program or ignore symptoms without consulting your
physician.
•You must calibrate (code) the meter before the first use of
the system or when a new box of test strips is to be used.
SensoLite Nova and SensoLite Nova Plus systems use
internal coding system. A Code-card, being included in
theteststrippackage,holdsencodedalfanumericalinfor-
mation that matches the Code value being affixed to
the bottle of test strips. Setting the code in the meter
means entering the same code value into SensoLite Nova
glucose meter that is written on the strips’ bottle
label whenever you open a new bottle of test strips
(either by using the Code-card, or manually). The code
value entered into the meter should match the code value
indicated on the strip bottle’s label and being encoded on
Code-card. On how to enter the code number refer to the
chapter „Strip code setting” in the Instructions for Use of
Sensolite Nova and Sensolite Nova Plus glucose meters.
Storage and Handling
SensoLite Nova Test blood glucose strips are packaged in
bottles. Store test strips at temperature between 8°C and
30°C (47°F-and 86°F) and between 30-70% relative humidity
and far from direct sunlight. Do not refrigerate or freeze. When
stored properly, the unopened test strips are stable until the
expiration date, indicated on the bottle. The month indicated,
refers to the END of that month. Use the strips within
3 months after first opening of their bottles. Never touch the
test strips with wet or contaminated hands.
Sample collection and preparation
Preparation
SensoLite Nova Test blood glucose strips are designed
specifically for use with fresh capillary whole blood taken from
fingertip or earlobe. Venous blood, plasma, or serum samples
cannot be used. Blood testing must be performed immediately
after the sample is obtained. Common anticoagulants and
preservatives such as heparine and sodium EDTA are allowed
to be used, but fluoride preservatives should be avoided.
Testing your blood
Refer to information described in chapter „Measuring with the
meter” of the Instructions for Use of the SensoLite Nova and
SensoLite Nova Plus meters.
Used strip and lancet are contaminated with
blood. Be careful, follow the relevant, local
instructions when you throw the used strip and
lancet away.
Quality Control
It is recommended to run the quality control test in (see
“SensoLite Nova and SensoLite Nova Plus system checking”
chapter in instruction for use) cases:
•When your test results do not agree with your expectation
based on your actual feeling.
•When the test strips have been exposed to temperature,
not conforming to prescribed storage conditions (8°C to
30°C or 47°F to 86°F).
•When you open a new bottle of test strips.
•If the meter has been dropped.
•At least once per week to verify that the meter and test
strips are working properly together.
When using Control Solution for system checking apply only
CareSens Control Solution, designed specifically for this
system. CareSens Control Solution can be obtained from
Manufacturer upon user’s request for additional charge (see
exact address and phone number of manufacturer at the end
of this manual). Other control fluids provide incorrect results,
therefore cannot be used. When control solutions are used,
test results should be within the expected range indicated on
test strips bottle (L1, L2). Test results being within the given
range, indicate that the system (your meter and test strips) is
working properly. If test results obtained with control solution
are not within the indicated range, always repeat the control
solution test. If the incorrect result still stands, contact your
local distributor.
Blood Glucose Test Strip
0197
SensoLite Nova Test

Test results
Blood glucose test results are shown on the meter's LCD
display in either mg/dl or mmol/l measurement unit. Units can
be set prior the tests (see chapter “Selecting measurement
unit” in Instructions for Use of SensoLite Nova or SensoLite Nova
Plus). The exchange rate of the units is: 1 mmol/l = 18 mg/dl.
If you get an unusual test result, always check the physical
circumstances being applied as follows:
1. Check if the drop of blood is completely fills the reaction
zone.
2. Check if the expiration date indicated on the test strips bottle
is not over yet.
3. Check if the code number of the test strip in use matches
the number set in the meter.
4. Check meter ability to function properly with the „Check
strip”.
5. Check the system performance with CareSens Control
Solution.
When test results are still questionable or inconsistent, and
your blood glucose results are less than 50 mg/dl (2.8 mmol/l)
or greater than 300 mg/dl (16.7 mmol/l), consult your health
care professional before making any changes in your
diabetes medication program.
Limitations
•SensoLite Nova Test strip is designed to be used with
fresh capillary whole blood samples. NEVER use serum
or plasma samples.
•Hematocrit variation in sample: hematocrit between 30%
to 55% have no significant effect on test results. Very high
(above 55%) and very low (below 30%) hematocrits may
cause inaccurate test results.
•Neonates: Do not use SensoLite Nova Test strip to test
neonates. The performance of SensoLite Nova and
SensoLite Nova Plus system has not been validated with
neonatal samples.
•Do not use fluoride as a preservative in blood samples.
•Abnormal blood specimens (i.e., high ascorbic acid, high
uric acid) may effect test results. Blood glucose readings
in these cases should be interpreted for diagnoses with
caution.
•Therapeutic levels of tetracycline may result inaccurate
(decreased) glucose readings.
•Therapeutic levels of acetylsalicylic acid(e.g.: Aspirin) may
result inaccurate(decreased) glucose readings.
Accuracy
Accuracy of SensoLite Nova Test strip was assessed by
comparison of patients with diabetes in one tipical clinical
evaluation. Reference measurements were done by another
approved blood glucose monitor. Specimens ranged from
1.0 mmol/l to 26.4 mmol/l, as measured by the reference method.
The linear regression data from one tipical clinical site study
is presented in the table below.
Number of Samples: 198
Range (mmol/l): 1.2 - 27.8
Bias (%): -4.45%
Slope: 1.055
Intercept (mmol/l): -0.7182
Correlation Coefficient: 0.994
Precision
Test based on Standard EN ISO 15197:2003.
A laboratory study was conducted with SensoLite Nova Test
strip using fresh sodium EDTA venous blood with a broad
range of glucose levels. Results from a single typical run of
this study, shown in the table, exhibit excellent precision
characteristics for SensoLite Nova Test strip. From all the
studies taken together, estimates of system precision were
calculated within-run precision, 3.65% between run precision,
3.42%.
Individual Use Method
Number of Reading 100 100 100 100 100
Average (mmol/l) 2.9 4 6.9 11.4 17.1
SD (mmol/l) 0.12 0.15 0.22 0.35 0.68
CV (%) 4.1 3.75 3.2 3.1 4.0
References:
N.Tietz, Fundamentals of Clinical Chemistry,
W.B.Sanders Co., 1987.
A.E.G. Cass, Biosensors: A practical approach,
IRL Press, 1990.
D. Schade, „101 Tips for Improving your blood sugar", p 4-5.
77 ELEKTRONIKA Kft.
Fehérvári u. 98.
Budapest 1116, HUNGARY
Phone: [phone],
Fax: [phone]
e-mail: [email protected]
Web: www.e77.hu
SNT-9901-1 25 pcs. strips/vial
SNT-9907-1 10 pcs. strips/vial
SNT-9908-1 50 pcs. strips/vial
Symbols
In Vitro Diagnosticum
Warning!
Manufacturer
Batch No.
Date of Expiry
Temperature Range
Information inside
Biological risks
Keep away from direct sunlight!
Humidity Range
Catalog Number
98/79/EC IVD directiva
SNT-9210-1 v1.0 2007.12.
0197