BETACHEK C50 Blood Glucose Test Cassette Instruction Manual

BETACHEK C50 Blood Glucose Test Cassette

Specifications

• Product Name: BETACHEK C50 Blood Glucose Test Cassette
• Measurement Range: Glucose concentrations in blood
• Test Time: As little as 5 seconds
• Blood Volume Required: At least 0.3L
• Calibration: Traceable to NIST standard
• Compliance: EN ISO 15197:2013

Product Usage Instructions

Preparation
Before using a new cassette, open the sensor cover and clean the sensor without a cassette inserted. Refer to the provided video for cleaning instructions.

Infection Control
Never share your meter, lancet, or lancing device with others. Wash the puncture site with soap and water before testing and ensure it is dry.

Blood Glucose Testing
Ensure the meter has at least 0.3L of blood for accurate results. The test can be completed in as little as 5 seconds, but the time may vary based on blood glucose concentration.

Calibration
The system is calibrated using whole blood samples adjusted to a range of glucose concentrations traceable to an NIST standard. Control solution results are also traceable to this standard and expressed as plasma equivalents.

Interfering Substances
Maltose and Xylose do not affect test results. However, critically ill patients should not be tested with blood glucose meters. Lipemic samples with specified cholesterol and triglyceride levels do not affect results.

Performance Characteristics
The Betachek C50 system meets the requirements of EN ISO 15197:2013 for system accuracy in measuring glucose concentrations in blood.

Blood glucose test cassette instructions

These instructions are to be read in conjunction with the BETACHEK C50 meter instruction manual.

Before inserting a new cassette:
Open the sensor cover and clean the sensor without a cassette inserted. See Video: Cleaning the BETACHEK C50 blood glucose meter

Intended use
The Betachek C50 test cassette with the Betachek C50 meter are intended to quantitatively measure glucose in fresh capillary whole blood obtained from a finger prick. The system is intended for manual self testing, as an aid in monitoring the effectiveness of diabetes control.

General

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 healthcare professional. You should only adapt your treatment if you have been trained to do so.

Contents of the pack

Container with 1 or 2 test cassette(s), 1 package insert.

Storage and handling

• 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.

Performing a test
See the Betachek C50 user manual for instructions. (User manual and instructional videos are also available online.)

Test results
The normal fasting glucose level for a nondiabetic 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.

Limitations of the test

• 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.

Infection control
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.

Blood volume and test time
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).

Test principle
The test employs glucose aero dehydrogenase 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.

Checking the system
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 the Betachek control solution. See your meter user manual or control solution instructions for further details.

Chemical composition
Betachek C50 test zones contain glucose aero dehydrogenase 0.12%, chromagen 0.31%, stabilizer 1.2%, inert ingredients 98.28%. The cassette contains a silica-based drying agent.

Measurement range
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.

Calibration
The system is calibrated with whole blood samples adjusted to a range of glucose concentrations. A YSI (Yellow Springs Instruments) 2300 analyzer 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.

Interfering substances

• 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.
• Performance characteristics of the Betachek C50 system
• The Betachek C50 blood glucose monitoring system complies with the requirements of EN ISO 15197:2013.
• Performance characteristics according to EN ISO 15197:2013

System accuracy:
System accuracy results for glucose concentrations <5.55mmol/L (<100mg/dL)

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| 189/198| 194/198
(62.6%)| (95.4%)| (97.9%)

System accuracy results for glucose concentrations ≥5.55mmol/L (≥100mg/dL)

System accuracy results for glucose concentration between 37.9mg/dL (2.1mmol/L) and 458.8mg/dL (25.48mmol/L

Within ±15mg/L (±0.83mmol/L) and within ±15% 594/600 (99%)

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.

Explanation of symbols:

Customer support
Email: support@betachek.com www.betachek.com/uk/videos

• 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

BETACHEK is a trademark of National Diagnostic Products.

• Date issued: 2023-10
• Version: BC50-EN/DE/DU/FR

FAQ

Q: Can I reuse a cassette for multiple tests?
A: No, each cassette is designed for a single use only to ensure accurate results.

Q: How often should I calibrate the meter?
A: Calibration is not required by the user; the system is pre-calibrated with traceable standards.

Q: What should I do if I get an error message during testing?
A: Refer to the user manual or contact customer support if you encounter any error messages during testing.

References

• Betachek C50 Blood Glucose Monitor Home - USD
• Betachek | France
• User Guide Videos | Betachek C50
• Gebruikershandleiding video's
• User Guide Videos | Betachek C50
• BETACHEK Deutschland – Tel. 0241 9199 8866 (Aachen)
• Betachek Benutzerhandbuch Videos – BETACHEK Deutschland

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