Blood glucose test cassette instructions
Open the sensor cover and clean the sensor without a
cassette inserted. See Video: Cleaning the Betachek C50
blood glucose meter
The Betachek C50 test cassette with the Betachek C50
meter are intended to quantitatively measure glucose in
fresh capillary whole blood. The system is intended for in
vitro diagnostic self testing of blood glucose, as an aid in
monitoring the effectiveness of diabetes control.
Self-testing helps both you and your doctor check your blood
glucose management, however self-testing should not be
seen as a substitute for regular visits to your doctor. Please
remember that testing should only be undertaken after
you have received a thorough course of instruction from a
qualified health care professional. You should only adapt your
treatment if you have been trained to do so.
Container with 1 or 2 test cassette(s), 1 package insert.
• Store unopened cassettes in their original container in
a cool, dry place at 2-30°C (35-86°F). Do not freeze.
If stored in a refrigerator, remove and warm to room
temperature before opening the container.
• Testing should be performed between 10-40°C (50-
104°F)
• Do not use test cassettes past the expiration date. Test
cassettes must be used within three months (90 days) of
opening.
• Use the test cassette immediately after it is removed from
the container.
• Do not use a test cassette from a container that has been
damaged.
• All items in the pack may be discarded with your regular
household waste.
The meter requires at least 0.3μL of blood. The test can take
as little time as 5 seconds (time varies with blood glucose
concentration).
To ensure that your meter and cassette are functioning
properly and that you are carrying out the test correctly, you
must regularly check the performance of the system with
Betachek control solution. See your meter user manual or
control solution instructions for further details.
• For in vitro diagnostic use only.
• Test cassettes are for personal use only. They are not
suitable for doctor’s offices or other health care facilities.
• Do not carry out the test in direct sunlight.
• Not for neonatal use.
• Use fresh capillary blood only. Do not use plasma, venous
blood or serum.
• Abnormally low hematocrit (<35%) may produce falsely
high readings and abnormally high hematocrit (>55%)
may produce falsely low readings.
• Strong electromagnetic fields (e.g. large magnets,
microwave ovens) may affect performance. Move away
from electromagnetic fields before testing.
• Maltose and Xylose do not affect results.
• Test results may be falsely low if the patient is severely
dehydrated, in shock, or in a hyperosmolar state (with or
without ketosis).
• Critically ill patients should not be tested with blood
glucose meters.
• Lipemic samples: Cholesterol levels up to 700 mg/
dl (18.1mmol/l) and triglycerides up to 5000 mg/dl
(57.1mmol/l) do not affect the results.
Betachek C50 test zones contain: FAD GDH 0.12%,
chromagen 0.31%, stabiliser 1.2%, inert ingredients
98.28%. The cassette contains a silica based drying agent.
The Betachek C50 system is linear and displays results
between 20 and 600mg/dL or 1.1 and 33.3 mmol/L. The
units of measure are factory set and cannot be changed.
The system is calibrated with whole blood samples adjusted
to a range of glucose concentrations. A YSI (Yellow Springs
Instruments) 2300 analyser is used to measure the glucose
concentrations in the samples. This instrument is traceable to
an NIST standard. Control solution results obtained with the
cassettes are therefore also traceable to an NIST standard.
Results are expressed as plasma equivalents.
The Betachek C50 blood glucose monitoring system complies
with the requirements of EN ISO 15197:2013.
Within ±5mg/dL
(Within ±
0.28 mmol/L)
Within ±10mg/dL
(Within ±
0.56 mmol/L)
Within ±15mg/dL
(Within ±
0.83 mmol/L)
124/198
(62.6%)
189/198
(95.4%)
194/198
(97.9%)
System accuracy results for glucose concentrations
<5.55mmol/L (<100mg/dL)
Within ±5% Within ±10% Within ±15%
267/402
(66%)
366/402
(91%)
400/402
(99.5%)
System accuracy results for glucose concentrations
≥5.55mmol/L (≥100mg/dL)
Within ±15mg/L (±0.83mmol/L) and within ±15%
594/600 (99%)
System accuracy results for glucose concentration
between 37.9mg/dL (2.1mmol/L) and
458.8mg/dL (25.48mmol/L)
System accuracy:
Repeatability:
Mean value
mg/dL 40 92 146 221 288
mmol/L 2.2 5.1 8.1 12.3 16
Standard deviation
mmol/L 0.1 0.12 0.12 0.2 0.3
Coefficient of variation
% - - 1.4 1.7 1.9
Precision:
Mean value
mg/dL 50.4 108 288
mmol/L 2.8 6 16
Standard deviation
mmol/L 0.14 0.16 0.3
Coefficient of variation
% 4.7 2.6 1.7
Performance assessment by the user:
A study evaluating glucose values from fingertip capillary
blood samples obtained by 100 laypersons showed the
following results:
• For glucose concentrations less than 5.55mmol/L (100mg/
dL), 100% of test results were within ±0.83mmol/L
(±15mg/dL) of the results obtained by laboratory testing.
• For glucose concentrations equal to or greater than
5.55mmol/L (100mg/dL), 100% of test results were within
±15% of the results obtained by laboratory testing.
Email: support@betachek.com
Explanation of symbols:
The meaning of symbols used in the packaging is as follows:
Consult the package insert
Store at (temperature limitation)
Use by/Expiry date unopened
Use cassette within 90 days of opening the
container
Test cassettes can be disposed of in household
waste
Manufacturer
Catalogue number
Lot number
For in vitro diagnostic use
This product fulfills the requirements of the
European Directive 98/79/EC on in vitro
diagnostic medical devices.
Authorised representative in the European
Community
Betachek GmbH
Am Dorbach 12
Aachen 52076
Germany
Email: eu@betachek.com
National Diagnostic Products Pty Ltd
7-9 Merriwa Street
Gordon NSW 2072
Australia
www.betachek.com
© 2022 National Diagnostic Products
Date issued: 2022-02
Version: EN/DE Revision: 9
See Betachek C50 user manual for instructions. (User manual
and instructional videos are also available online.)
The normal fasting glucose level for a non diabetic adult
is below 100mg/dL (5.6mmol/L). Consult your healthcare
professional for the glucose range that is appropriate for
you. If your test result is lower than 20mg/dL (1.1mmol/L), a
‘Lo’ message will appear indicating a low glucose level. This
may indicate severe hypoglycemia (low blood glucose). You
should treat this immediately and repeat the test. If the result
is higher than 600mg/dL (33.3mmol/L) a ‘Hi’ message will
be displayed. This may indicate severe hyperglycemia. You
should repeat the test and if the ‘Hi’ message appears again
you should contact your healthcare professional.
The test employs FAD GDH and a chromagen along with
nonreactive ingredients to produce a colour change that is
directly proportional to the amount of D-glucose in the blood
sample. The meter measures this change and converts it to a
blood glucose result.
BETACHEK is a trademark of National Diagnostic Products.
www.betachekC50.co.uk/videos
Before inserting a new cassette:
Intended use
Contents of the pack
Storage and handling
Performing a test
Test results
Blood volume and test time
Checking the system
Limitations of the test
Test principle
Interfering substances
Chemical composition
Measurement range
Calibration
Performance characteristics of the Betachek C50
system
Performance characteristics according to EN ISO
15197:2013
Customer support
These instructions are to be read in conjunction with the
BETACHEK C50 meter instruction manual.
General
Never share your meter, a lancet or the lancing device with
anyone. Always wash the puncture site with soap and water
before testing. Dry thoroughly.
Infection control
EN
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