Pocd.co.nz

Warnings and precautions
Sample collection and preparation
SensoCard
SensoCard blood glucose test strips are for IN VITRO
Preparation
diagnostic use only (external use only).
Blood Glucose Test Strip
SensoCard blood glucose test strips are designed specifically
• Do not use test strips after their expiration date.
for use with fresh capillary whole blood taken from fingertip or • Do not use test strips that are wet, bent, scratched, 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 Test strips for quantitative measurement of glucose concentration • If you have symptoms which are not consistent with your such as heparine and sodium EDTA are allowed to be used, but in whole blood using with the SensoCard blood glucose
blood test results always contact your health care professional fluoride preservatives should be avoided.
Before you begin
• If your reading result is above or below your expected range Testing your blood
Carefully read this entire guide. If you have any question of blood glucose values, always repeat the test and prove Refer to information described in chapter „Measuring with the and/or need assistance, please, contact our authorised meter” of the Instructions for Use of the SensoCard and
• Abnormal red blood cell quantity (hematocrit below 30% or SensoCard Plus meters.
above 55%) may cause incorrect results.
Used strip and lancet are contaminated with
• Never make significant changes in your diabetes treatment SensoCard blood glucose test strip was designed to
blood. Be careful, follow the relevant, local
program or ignore symptoms without consulting your provide an easy, accurate method for the determination instructions when you throw the used strip and
of capillary whole blood glucose content. This analysis lancet away.
• You must calibrate (code) the meter before the first use of applies the enzyme glucose oxidase and is based on the system or when a new box of test strips is to be used.
Quality Control
advanced electromechanical technology that is specific It is recommended to run the quality control test (see for ß-D-glucose measurement. Test strips are designed SensoCard glucose meter system uses internal coding
„SensoCard system checking” chapter in Instructions for Use)
in such a way that blood sample absorbs into the reaction system. A Code-card, being included in the test strip
zone, after blood has been applied to the tip of test strip. In the package, holds encoded alfanumerical information that
• When your test results do not agree with your expectation reagent zone glucose oxidase triggers the oxidation of glucose matches the Code value being affixed to the bottle
in blood. Intensity of formed electrons is measured by the of test strips. Setting the code in the meter means enter-
• When the test strips have been exposed to temperature, not meter and correlates well with the concentration of glucose ing the same code value into SensoCard glucose meter
conforming to prescribed storage conditions (8°C to 30°C that is written on the strips’ bottle label whenever
Package contents
you open a new bottle of test strips (either by using
• When you open a new bottle of test strips.
the Code-card, or manually). The code value entered into
the meter should match the code value indicated on the
• At least once per week to verify that the meter and test strips strip bottle’s label and being encoded on Code-card. On
Measuring range
how to enter the code number refer to the chapter „Strip
When using Control Solution for system checking apply only Measurement range of SensoCard Test System is
code setting” in the Instructions for Use of SensoCard
CareSens Control Solution, designed specifically for this
and SensoCard Plus glucose meters.
system. CareSens Control Solution can be obtained from
Sample volume
Storage and Handling
Manufacturer upon user’s request for additional charge (see One blood drop is enough to determine blood glucose value SensoCard blood glucose test strips are packaged in bottles.
exact address and phone number of manufacturer at the end of with SensoCard Test strip. Minimum sample volume is 0.5 μl.
Store test strips at temperature between 8°C and 30°C this manual). Other control fluids provide incorrect results, Reagents
(47°F-and 86°F) and between 30-70% relative humidity and far therefore cannot be used. When control solutions are used, test Each test strip contains the following ingredients in the from direct sunlight. Do not refrigerate or freeze. When stored results should be within the expected range indicated on test properly, the unopened test strips are stable until the expiration strips bottle (L1, L2). Test results being within the given range, date, indicated on the bottle. The month indicated, refers to the indicate that the system (your meter and test strips) is working • Hexaamineruthenium(III)chloride 45.7μg END of that month. Use the strips within 3 months after first properly. If test results obtained with control solution are not opening of their bottles. Never touch the test strips with wet or within the indicated range, always repeat the control solution Each vial cap contains 2-3 g silica gel.
test. If the incorrect result still stands, contact your local Test results
• Therapeutic levels of tetracycline may result inaccurate 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 • Therapeutic levels of acetylsalicylic acid (e.g.: Aspirin) may prior the tests (see chapter “Selecting measurement unit” in result inaccurate (decreased) glucose readings.
Instructions for Use of SensoCard or SensoCard Plus). The
exchange rate of the units is: 1 mmol/l = 18 mg/dl. If you Accuracy
get an unusual test result, always check the physical Accuracy of SensoCard Test strip was assessed by comparison
of patients with diabetes in one tipical clinical evaluation.
1. Check if the drop of blood is completely fills the reaction 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 2. Check if the expiration date indicated on the test strips bottle 3. Check if the code number of the test strip in use matches Precision
4. Check meter ability to function properly with the „Check Test based on Standard EN ISO 15197:2003. A laboratory study was conducted with SensoCard Test strip
5. Check the system performance with CareSens Control
using fresh sodium EDTA venous blood with a broad range of Solution.
glucose levels. Results from a single typical run of this study, shown in the table, exhibit excellent precision characteristics When test results are still questionable or inconsistent, and your for SensoCard Test strip. From all the studies taken together,
blood glucose results are less than 50 mg/dl (2.8 mmol/l) or estimates of system precision were calculated within-run precision, greater than 300 mg/dl (16.7 mmol/l), consult your health care professional before making any changes in your diabetes Limitations
• SensoCard Test strip is designed to be used with fresh
capillary whole blood samples. NEVER use serum or • 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 • Neonates: Do not use SensoCard Test strip to test
neonates. The performance of SensoCard System has not
References:
been validated with neonatal samples.
N.Tietz, Fundamentals of Clinical Chemistry, • 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 A.E.G. Cass, Biosensors: A practical approach, these cases should be interpreted for diagnoses with D. Schade, „101 Tips for Improving your blood sugar", p 4-5.

Source: http://www.pocd.co.nz/files/pdfs/sensocard_test_user_manual.pdf