Sinocare Safe-Accu 2 Blood Glucose Test Strips

Product Details

Product Name:

Safe-Accu 2 Blood Glucose Test Strip

Generic Name:

Blood Glucose Test Strip

Product Model:

Safe-Accu 2

Packing Size:

Available in 10, 25, 50, 100, and 150 test strips per box.

Intended Use

The Safe-Accu 2 Blood Glucose Monitoring System is intended for in vitro diagnostic use only. It is designed for quantitative measurement of glucose in capillary or venous whole blood samples. This system is intended for self-testing by individuals with diabetes mellitus and for use by healthcare professionals in clinical settings to monitor diabetes control effectiveness.

Important: This system should not be used for the diagnosis or screening of diabetes.

Warnings

• For in vitro diagnostic use only.
• Not for use on neonates (newborns or infants).
• Do not use to screen or diagnose diabetes mellitus.
• Not for use on critically ill patients.
• Treat all parts of the Safe-Accu 2 kit as biohazardous; they can transmit infectious diseases.
• Keep test strip vials away from children. The cap or drying agent can be a choking hazard or harmful if swallowed, inhaled, or comes into contact with skin.

Test Principle

Blood glucose testing relies on measuring the electrical current generated by the reaction between glucose in the sample and the reagents on the test strip's electrode. Glucose reacts with specific chemicals, producing electrons and generating an electrical current. The Safe-Accu 2 meter measures this current to calculate the blood glucose level.

Chemical Reaction: Glucose (C6H12O6) reacts with FAD-glucose dehydrogenase and potassium ferricyanide [K3Fe(CN)6] to produce gluconic acid (C6H12O7) and potassium ferrocyanide [K4Fe(CN)6]. The reaction generates an electrical current: K4Fe(CN)6 → K3Fe(CN)6 + e⁻.

Composition:

The test strip contains FAD glucose dehydrogenase, potassium ferricyanide, buffer solution, and stabilizers.

Test Strip Storage and Shelf Life

• Shelf life: 24 months when stored between 1°C and 30°C.
• Store test strips between 1°C and 30°C. Do not freeze.
• Avoid storing test strips in high heat and moisture areas (e.g., bathrooms, kitchens).
• Keep unused test strips in their original vial with the cap tightly closed.
• Close the vial tightly immediately after removing a test strip.
• Use test strips immediately after removing them from the vial.
• Do not use test strips beyond their expiration date, as this may lead to inaccurate results.
• Record the opening date on the vial label. Discard remaining test strips 6 months after opening the vial.
• Do not tamper with test strips.
• Avoid contact with dirt, food, or liquids on the test strip. Handle with clean, dry hands; the surface of the strip can be touched anywhere.
• Never reuse a test strip that has had blood or control solution applied.
• Never make significant changes to your diabetes treatment program or ignore symptoms without consulting your healthcare provider.

Test Environment

• Temperature: 10°C - 35°C
• Relative Humidity: Less than 80%

Applicable Meter

The Safe-Accu 2 Blood Glucose Test Strip is intended for use exclusively with the Safe-Accu 2 meter.

Sample Requirements

• Sample size: 0.6 μL
• Test time: 10 seconds
• Sample type: Capillary whole blood or venous whole blood samples.
• For venous blood, it is recommended that professional medical staff collect the sample.
• Blood samples are best without anticoagulation. If anticoagulation is needed, use heparin.
• Test immediately after applying the blood sample to prevent inaccurate results due to glycolysis.

Test Method

Getting Ready to Test

Refer to the Safe-Accu 2 User Manual for detailed instructions.

1. Gather required materials: meter, test strip, lancing device, and lancet.
2. Wash hands thoroughly with warm, soapy water. Rinse and dry completely.

Performing a Blood Glucose Test

Refer to the Safe-Accu 2 User Manual for more detailed information.

1. Insert a Safe-Accu 2 Test Strip into the meter's test strip slot, ensuring the contact bar is fully inserted. The meter will power on.
2. Obtain a blood drop using the lancing device. Apply the blood to the test strip's reaction chamber until it is full, indicated by a short beep.
3. If the reaction chamber does not fill completely before the meter starts counting down, do not add more blood. Discard the test strip and retest.
4. After the meter counts down from 10 to 1, the test result will be displayed.
5. Hold the meter with the test strip pointing downwards. Press the strip eject button to discard the used test strip into an appropriate container.
6. WARNING: Treat used test strips and lancets as biological hazards. Dispose of them in a designated container.

Reference Value Range

Expected blood glucose levels for people without diabetes:

For people with diabetes:

Consult your healthcare professional for personalized blood glucose ranges based on your specific region and group. If you have poor circulation, home blood glucose monitoring may not be suitable. Discuss this with your healthcare provider. Treat low or high blood glucose levels as recommended by your healthcare provider.

The meter displays results that refer to plasma values, even though whole blood is applied to the test strip.

Explanation of Test Results

Unusual Test Results:

• "LO" displayed: Blood glucose may be below 20 mg/dL (1.1 mmol/L).
• "HI" displayed: Blood glucose may be over 600 mg/dL (33.3 mmol/L).

For detailed information on error codes, refer to the user manual.

If Results Do Not Match How You Feel:

1. Repeat the test with a new test strip.
2. Perform a control test using blood glucose control solution (refer to user manual).
3. Check the following:
   • Test strip expiration date.
   • Test strip container cap is tightly closed.
   • Test strip was used immediately after removal from the container.
   • Test strips were stored in a cool, dry place.
   • Test steps were followed correctly.
4. If results remain doubtful, too low, or too high, contact your healthcare professional.

Refer to the user manual for proper maintenance and handling procedures.

Limitations and Considerations

• Refer to the User Manual for meter operating temperature and humidity ranges.
• The meter's siphon function prevents issues with sample overfill; insufficient sample may lead to incorrect results.
• If test results do not align with how you feel, repeat the test and consult the User Manual. If symptoms persist, contact your healthcare professional immediately.
• Hematocrit: Ensure your hematocrit (blood count) is between 30% - 60%. Consult your healthcare professional if unsure.
• Test results may be inaccurate under special conditions such as dehydration, hyperosmotic states with high blood glucose, hypotension, shock, or acidosis.
• Interference: Reducing substances in blood (uric acid) or from medications (ascorbic acid, acetaminophen, bilirubin) may not significantly affect results. However, abnormally high concentrations can impact accuracy.
• Lipemic Samples: Blood with cholesterol levels over 600 mg/dL or triglyceride levels over 750 mg/dL may affect blood glucose results.
• Xylose Testing: Avoid testing during or immediately after xylose absorption tests, as high xylose levels can cause inaccurate results.

Repeatability and Precision

Repeatability:

Standard deviation (SD) is ≤4.58 mg/dL and coefficient of variation (CV) is ≤4.5% for results below 100 mg/dL (5.55 mmol/L). For results above 100 mg/dL, SD is ≤4.58 mg/dL and CV is ≤4.5%.

Intermediate Precision:

Standard deviation (SD) is <0.14 mg/dL and coefficient of variation (CV) is ≤4.4% for results below 100 mg/dL (5.55 mmol/L). For results above 100 mg/dL, SD is <0.14 mg/dL and CV is ≤4.4%.

Matters Needing Attention

Regular blood glucose testing aids in diabetes management.

Choking Hazard: This product contains small parts that could be swallowed. Keep out of reach of children.

Read the package insert carefully before testing. If any information is unclear, contact your local Sinocare representative.

Refer to the end of the insert for an explanation of symbols used.

References

1. American Diabetes Association, Position Statement, Diagnosis and Classification of Diabetes Mellitus, Diabetes Care 35:S4-S10, 2012.
2. D'Orazio et al.: Approved IFCC Recommendation on Reporting Results for Blood Glucose (Abbreviated); Clinical Chemistry 51: 9 1573-1576 (2005).
3. ISO 15197:2013, In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

Explanation of Symbols

Performance Characteristics

The Safe-Accu 2 blood glucose monitoring system complies with ISO 15197:2013 requirements for self-testing blood glucose monitoring systems.

• Detection Limit (lowest value display): 20 mg/dL (1.1 mmol/L)
• System Measurement Range: 20-600 mg/dL (1.1-33.3 mmol/L)
• Calibration: The system is calibrated against venous blood with known glucose concentrations, using a validated test method traceable to NIST standards (hexokinase method).

Accuracy:

Results for glucose concentrations < 100 mg/dL (<5.55 mmol/L):

Results for glucose concentrations ≥ 100 mg/dL (≥5.55 mmol/L):

Manufacturer Information

Shanghai International Holding Corp. GmbH (Europe)

Eiffestraße 80, 20537 Hamburg, Germany.

Tel: +49-40-2513175 Fax: +49-40-255726 E-mail: shholding@hotmail.com

Changsha Sinocare Inc.

No. 265, Guyuan Road, Hi-Tech Zone, Changsha, Hunan Province, 410205, People's Republic of China

E-mail: intl_mkt@sinocare.com Website: www.sinocareintl.com Customer service: +86-731-89935929

For inquiries, please contact Customer Service at +86-731-89935929 or visit the website.

CE 0123

P/N: 37200279-B.2