Sinocare C-37200688 Blood Glucose Test Strips Instruction Manual

Sinocare C-37200688 Blood Glucose Test Strips

Product Name: Gold AQ Plus Blood Glucose Test Strip.
Package Size: 150 test strips/box, 100 test strips/box, 50 test strips/box, 25 test strips/box, 10 test strips/box, 5 test strips/box.

Intended Use

• The Gold AQ Plus Blood Glucose Test Strip is for use outside the body (in-vitro diagnostic use). It should not be used for the diagnosis or screening of diabetes.
• The Gold AQ Plus Blood Glucose Test Strip is to be used with the Gold AQ Plus Blood Glucose Meter to quantitatively measure glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous) or from the artery ( arterial).
• It is intended for self-testing or professional use as an aid in the management of diabetes.
• The test strips requires No Coding.

Test Principle

A glucose test is based on the measurement of electrical current caused by the reaction of glucose with the FAD glucose dehydrogenase on the electrode of the strip. The blood or control solution is drawn into the test strip through capillary action. Glucose in the sample reacts with the FAD glucose dehydrogenase and generate electrons. The Gold AQ Plus blood glucose meter measures the electrical current and calculates the glucose result.

Chemical Composition

• FAD glucose dehydrogenase… ≥0.21U
• Potassium ferricyanide…. 25.2ug~37.8g
• Non-reactive ingredients… 20pg

Storage and Shelf Life

• Store test strips in a cool dry place between 1°C ~ 30°C, 10~90% R.H. Do not freeze.
• Shelf life: 24 months after the date of manufacture.
• Keep unused test strips in their original vial with the cap closed.
• Use test strip quickly after removing from vial. Recap vial right away.
• Mark open month on the vial label when you first open it. Do not use if after either expiry date printed on the test strip vial label or 6 months after open month, whichever comes first. Using test strips past these dates may cause inaccurate results.
• Do not store in your bathroom, or kitchen. Keep away from direct sunlight and heat.
• Discard any damaged test strips or vials.
• Do not bend, cut, or alter test strips in any way.
• Only apply blood to the tip of the test strip. Ensure that the reaction zone is completely filled. Do not place blood on any other part of the test strip. This may cause an inaccurate result.
• Keep the test strip vial away from children. The test strips can be choking hazards.

Important Safety Information

• Please review this insert and the Gold AQ Plus Blood Glucose Monitoring System User Manual before use.
• Use Gold AQ Plus blood glucose test strip only with Gold AQ Plus blood glucose meter and Sinocare blood glucose control solution. Using other test strip or control solution with your Gold AQ Plus blood glucose meter may cause inaccurate results.
• For in vitro diagnostic use only.
• Not for neonatal (newborn) use.
• Not for screening or diagnose of diabetes mellitus.
• Not for use on critically ill.
• Not for alternative site testing (AST) use.

Warnings

• Test Strips is for single use only. NEVER reuse test strips. NEVER wipe test strips with water, alcohol or any cleaner. DO NOT attempt to remove blood or control solution from test strips.
• NEVER add a second drop of sample to a test strip.
• Discard used test strips and lancets into an appropriate container. Contact with blood presents an infection risk.
• Do not change treatment plan based on results without advice of your doctor or healthcare provider.

Cleaning and Disinfection

• All parts of Gold AQ Plus blood glucose monitoring system can potentially transmit infectious diseases from bloodborne pathogens, even after cleaning and disinfecting.
• Cleaning and disinfecting lancing device and meter destroys most, but not necessarily all, blood-borne pathogens.
• Wash your hands with soap before and after handling the meter, lancing device, lancets or test strips. Contact with blood presents an infection risk.
• Disinfecting meter and lancing device before use by a second person
• Refer user manual for cleaning and disinfection procedures.

Test Environment

• Temperature: 10°C -40°C
• Relative Humidity: 10%~90%R.H.

Sample Requirements

Sample size: 0.8ML
Test time: 5 seconds.
Sample type: capillary blood samples, venous whole blood samples, arterial whole blood samples.

Note for professional user only:

1. Please request healthcare professional to collect venous whole blood samples and arterial whole blood samples.
2. The blood sample would be better without anticoagulation, if needed, prepare the blood sample with heparin sodium or heparin lithium as the anticoagulation.
3. Test within 30 minutes after collecting blood sample. otherwise, the test results will be inaccurate because of glycolysis.
4. If the blood sample need to be refrigerated, equilibrate it to ambient temperature before the test.

Control Solution Testing
Use Sinocare blood glucose control solution to check testing technique and system performance. Control results should fall within the control range printed on test strip vial. Refer Gold AQ Plus blood glucose monitoring system user manual for more information on control testing.

Blood Glucose Test

Read this instruction of use and Gold AQ Plus Blood Glucose Monitoring System User Manual before use.
Required Materials: meter, test strip, lancing device, and lancet.

1. Check open month and printed date on test strip vial label. Do not use if after either date printed on the test strip vial label or 6 months after open month, whichever comes first.
2. Allow meter and test strips to sit at room temperature for 30 minutes. If opening vial for the first time, write the discard date on vial label.
3. Wash your hands with soap and water. Be sure to dry your hands before performing a test.
4. Remove one test strip from vial. Recap vial right away.
5. Insert test strip into the meter until it stops. Meter turns on. Do not remove test strip from meter until testing is finished.
6. Obtain blood drop.
7. Hold the tip of test strip to the blood drop until the meter beeps. Visually confirm that blood sample fills entire reaction zone at the end of test strip. Do not place blood on any other part of the test strip.
8. Meter displays the test result after counting down.
9. Push test strip release button to discard used test strip in an appropriate container.
   WARNING! Treat used test strips and lancets as a biological risk. Dispose used test strips and lancets in appropriate container.

Reference Value Range
Expected blood glucose levels for people without diabetes:

Please consult your doctor for your target blood glucose ranges. If you have symptoms that suggest your glucose is too low or too high, contact your doctor right away. If comparing the Gold AQ Plus blood glucose monitoring system’ s results to laboratory test results, perform a finger-stick blood test within 15 minutes of the laboratory test.

Explanation of Test Results

Unusual test results
If “LO” is displayed on your meter, your blood glucose may be below 1.1 mmol/L or 20 mg/dL.
If “HI” is displayed on your meter, your blood glucose may be over 33.3 mmol/L or 600 mg/dL.

If your glucose result does not match how you feel, follow these steps:

1. Repeat test with a new test strip.
2. Perform a control test with Sinocare blood glucose control solution. Refer to the Gold AQ Plus blood glucose monitoring system user manual for steps on performing a control test.
3. Check this list to help you solve the problem.
   • Check the expiration date of the test strips.
   • Ensure that the cap on the test strip vial is always closed tightly.
   • Ensure that you use the test strip immediately after removing it from the vial.
   • Check that the test strips were stored in a cool, dry place.
   • Check that you followed the test steps.
   • Refer to the user manual for a trouble shooting guide.
4. If you think your blood glucose results are too low, too high, or doubtful, please contact your doctor.

Limitations

• Insufficient blood samples may lead to inaccurate test results.
• Hematocrit beyond 20% ~ 70% can cause false reading. Ask your doctor if you do not know your hematocrit.
• Elevated levels of blood triglyceride and normal therapeutic concentrations of Uric acid, Ascorbic acid, Acetaminophen and Bilirubin do not significantly affect results. However, abnormally high concentrations of these substances in blood may cause inaccurately high results.
• Cholesterol may cause interference at concentrations greater than 600 mg/dL.
• Triglyceride may cause interference at concentrations greater than 1500 mg/dL.
• Do not perform test after Xylose test.
• Capillary glucose testing may not be clinically appropriate for persons with impaired peripheral circulation. Shock, severe hypotension, hyperglycemia, and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood.
• If the test result does not confirm how you feel, repeat the test and refer to the Gold AQ Plus Blood Glucose Monitoring System User Manual. If the repeated test result still does not confirm the way you feel, call your doctor or healthcare professional.

Performance Characteristics

• Measuring Range: 1.1 ~ 33.3 mmol/L or 20-600 mg/dL
• System Accuracy: The table below shows how often professionals Gold AQ Plus blood glucose monitoring system fingertip values achieve the accuracy goals:

System accuracy results for glucose concentration between 1.1 ~ 33.3 mmol/L (20~600 mg/dL)

Lay User Performance: The table below shows how often lay user Golo AQ Plus system fingertip values achieve the accuracy goals:

System user performance results for glucose concentration between 1.1 ~ 33.3 mmol/L (20~600 mg/dL)

Precision: Precision describes the variation between results. Precision results were performed in a laboratory.

• Measurement Repeatability
• Intermediate Measurement Precision

References
American Diabetes Association, Diabetes Care 2017 Jan: 40 (Supplement 1): S11-S24. https://doi.org/10.2337/dc17-S005 EN ISO 15197:2015 In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

Explanation of Symbols

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: support@sinocare.com
Website: https://en.sinocare.com
Customer service: +86-731-89935987

If you need to contact us, please call Customer Service at +86-731-89935987 or visit our website at https://en.sinocare.com.

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>