sinocare C-37200612 Safe Blood Glucose Test Strips Instructions

: June 14, 2024
: Sinocare

142
Package Insert for Safe AQ pro I Blood Glucose Test Strip

[ Product Name ]

Generic name: Blood Glucose Test Strip
Product Model: Safe AQ pro I

[ Package Size ]

5 test strips/box, 10 test strips/box, 25 test strips/box, 50 test strips/box, 100 test strips/box, 150 test strips/box.

[ Intended Use ]

The Safe AQ pro | blood glucose test strip is used only with Safe AQ pro | blood glucose meter to quantitatively measure glucose in human whole blood taken from the fingertip (capillary) or from the vein (venous).
It is intended for use outside the body only (in vitro diagnostic use) for self-testing or professional use as an aid in the management of diabetes. It should not be used for the screening or diagnosis of diabetes.
The test strips require No Coding.

[ Patient Cautions ]

For in vitro diagnostic use only.
For self-testing.
Please read this insert and the blood glucose meter user manual before test.
Using other test strips and control solutions with your blood glucose meter may produce inaccurate results.
Not for use on the critically patients.
Not for neonatal (newborn or infant) use.
Not for screening or diagnosis of diabetes mellitus.
Keep the test strip vial away from children. The vial and the test strip can be a choking hazard. Never chew or swallow a test strip.

[ Test Principle ]

A glucose test is based on measurement of electrical current caused by the reaction of glucose with the reagents (special chemicals) on the electrode of the strip. The blood or control solution sample is drawn into the tip of the test strip through capillary action. Glucose in the sample reacts with the special chemicals and generates electrons, which produce an electrical current. The blood glucose meter measures the electrical current and calculates the glucose result.

[ Composition ]

The reagent in test strip is composed of FAD glucose dehydrogenase, potassium ferricyanide, buffer solution and stabilizer. etc

[ Test Strip Storage and Shelf Life ]

Shelf life: 24 months if stored between (5°C~30°C), RH<95%.

Store the test strips at temperatures between 5°C~30°C.
Keep away from direct sunlight and heat. Do not store in your car. Do not freeze.
Keep your test strips in the original vial. Do not transfer them to any other vial or container.
Only remove the test strip from the vial when you are ready to perform a test. Firmly recap the vial immediately after use.
Do not use the test strips beyond the expiration date printed on the vial.
Record the discard date on the vial label, which is 6 months from when you first open it. Discard any test strips after 6 months.
Before handling the test strip, clean your hands with soap and water and dry your hands. You may hold the sides of the test strip when removing it from the vial or inserting it into the blood glucose meter.
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.

[ Test Environment ]

Temperature: 10°C-40°C
Relative Humidity: <90%

[ Applicable Meter ]

The Safe AQ pro | blood glucose test strip is intended to be used with the Safe AQ pro | blood glucose meter.

[ Sample requirements ]

Sample size: 1uL
Test time: 5 seconds.
Sample type: capillary blood samples or venous whole blood samples.
(Please request healthcare professional to collect venous whole blood samples. The blood sample would be better without anticoagulation, if needed, prepare the blood sample with heparin as the anticoagulation. Test within 20 minutes after the blood sample is being applied, otherwise, the test results will be inaccurate because of glycolysis.)

[ Test Method ]

Getting ready to test Refer to the blood glucose meter user manual for more detailed information.

Check opened date and printed expiry date on test strip vial label. Do not use if after either date printed on the test strip vial label or 6 months after date opened, whichever comes first. Discard vial and test with new vial.
Allow blood glucose meter and test strips to sit at room temperature for 30 minutes. If opening vial for the first time, write date opened on vial label.
Wash hands with warm water and wipe dry, and disinfect the blood collection site with 75% alcohol cotton ball/tablet.
Please do not use iodine and other disinfectants containing iodine.
Remove one test strip from vial. Recap vial right away.
Insert test strip into test strip port of blood glucose meter.
Blood glucose meter turns on. Do not remove test strip from blood glucose meter until testing is finished.
Obtain blood drop.
With test strip still in blood glucose meter, touch Sample Tip to top of blood drop and allow blood to be drawn into test strip. Remove test strip from drop immediately after the blood glucose meter beeps.
Result is displayed. Record result.
Hold blood glucose meter with test strip pointing down. Press strip eject button to discard test strip into 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 diabetes¹:

Time	Range, mg/dL
Fasting	Less than 100mg/dL

For people with diabetes: Please consult your healthcare professional for the blood glucose range for you own laboratory according to specific region and group.
If you have poor circulation, testing your own blood glucose may not be suit for you. Ask your healthcare provider.
You should treat your low or high blood glucose as recommended by your healthcare provider.
With these test strips, your blood glucose meter displays blood concentrations that refer to plasma although you apply whole blood to the test strip.
For further information, please visit our website at www.sino- careintl.com or contact your local Sinocare representative.

[ Explanation of Test Results ]

Unusual test results
If “LO” is displayed on your blood glucose meter, your blood glucose may be below 20 mg/dL or below 1.1 mmol/L.
If “HI” is displayed on your blood glucose meter, your blood glucose may be over 600 mg/dL or over 33.3 mmol/L.
For detailed information on error code, please refer to your user manual. If your blood glucose result does not match how you feel, follow these steps:

Repeat blood glucose test with a new test strip.
Perform a control test with blood glucose control solution.
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.
Please refer to user manual for proper maintenance and handling procedures.
If the blood glucose results are too low, too high, or doubtful, please contact your healthcare professional.

[ Limitations and considerations ]

Insufficient sample may cause inaccurate test results.
Hematocrit should between 10% -70%. Ask your healthcare professional if you do not know your hematocrit.
Normal therapeutic concentrations of uric acid, ascorbic acid, acetaminophen and other reducing substance do not significantly affect results. However, abnormally high concentrations of these substances in blood may cause inaccurately high results.
Lipemic samples: blood concentrations of cholesterol in excess 600 mg/dL or triglyceride concentrations in excess of 750 mg/dL may affect blood glucose results.
Bilirubin in excess 20 mg/dL may affect blood glucose results.
Xylose: Do not perform test during or soon after xylose absorption testing. High xylose level in the blood will cause inaccurate results.
Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.
Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may also occur in individuals experiencing a hyperosmolar—hypergly—cemic— state (HHS).
If you have symptoms that do not reflect your blood glucose test results, and you have followed all instructions described in this owner’ s manual, call your healthcare professional.

[ Performance Characteristics ]

The Safe AQ pro | blood glucose strip complies with the requirements of ISO 15197:2013 (In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus).
Detection limit (lowest value display): 20mg/dL or 1.1 mmol/L
System measurement range: 20 -600 mg/dL or 1.1-33.3 mmol/L
Calibration: The system is calibrated with venous blood containing various glucose concentrations. The reference values are obtained using a validated test method. This test method is referenced to the hexokinase method and is traceable to a NIST standard.

User performance evaluation:

Performance evaluation for lay users

Accuracy:

Accuracy for venous blood sample

Repeatability: In a typical series of tests, standard deviation(SD) of each concentration level is <1.4 mg/dL when test results are below 100mg/dL(5.55mmol/L) and coefficient of variations(CV) all are <2.8% when test results are above 100mg/dL(5.55mmol/L).

[ Matters Needing Attention ]

Testing your blood glucose regularly may help you better manage your diabetes.
Since this product comprises small parts that could be swallowed and lead to choking hazard, please keep it away from children.
Please read the package insert before you perform blood glucose testing. If any information in the package insert is difficult to understand, please contact your local Sinocare representative.
For an explanation of symbols used please refer to the end of the insert.

[ References ]

¹American Diabetes Association. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetesd2021; 44(Suppl.1): $15-S33
²D’ Orazio et al.: Approved IFCC Recommendation on Reporting
Results for Blood Glucose (Abbreviated); Clinical Chemistry 51: 9 1573-1576 (2005).

[ Explanation of Symbols ]

Symbol	Title of Symbol
In vitro diagnostic medical device
Consult the package insert
Temperature limitation (store at)
Batch code
Use by date, Expiry date
Do not re-use
Keep away from sunlight
Keep dry
Manufacturer
****	Authorized representative in the European Community
CE marking and notify body No.

**** Shanghai International Holding Corp. GmbH (Europe)
EiffestraRe 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
If you need to contact us, please call Customer Service at +86-731-89935929 or visit our website at www.sinocareintl.com

P/N:37200612-A.2

Documents / Resources

| sinocare C-37200612 Safe Blood Glucose Test Strips [pdf] Instructions
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