Sinocare Safe AQ UG Blood Glucose Test Strip Instructions

: June 16, 2024
: Sinocare

Table of Contents

Safe AQ UG Blood Glucose Test Strip
Intended Use
Test Principle
Composition
Explanation of Test Results
Explanation of Symbols
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Download This Manual (PDF format)

Safe AQ UG Blood Glucose Test Strip
Instructions

Safe AQ UG Blood Glucose Test Strip

Package nsert for Safe AQ UG Blood Glucose Test Strip Suitable for self- testing or professional use
[ Product Name l
Generic name: Blood Glucose Test Strip
Product Model: Safe AQ UG
[ Packing Size l
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 UG Blood Glucose Test Strip s intended to be used with the Safe AQ UG Blood Glucose and Uric Acid Meter to quantitatively measure glucose (sugar) n capillary whole blood samples drawn from the fingertips or venous whole blood samples. The Test Strip requires No Coding.
The Safe AQ UG blood glucose test strip, used with Safe AQ UG Blood Glucose and Uric Acid Meter, is intended for use by people with diabetes mellitus n the home and by healthcare professionals n clinical setting as an aid in monitor ng the effectiveness of diabetes control. The Safe AQ UG blood glucose test strip is ntended for use outside the body (in v tro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The Safe
AQ UG blood glucose test strip should not be used for the diagnosis of or screening of diabetes.
[ Patient Cautions l

For In Vitro Diagnostic Use ( external use only )
Please review this sheet and the Safe AQ UG user manual before you use Safe AQ UG Blood Glucose Test Strips. Use Safe AQ UG Blood Glucose Test Strips only with Safe AQ UG Blood Glucose and Uric Acid Meter to get results and you will be accessible to the complete service, support and warranty from Sinocare.
The Safe AQ UG Blood Glucose and Uric Acid Meter should not be used on critically patients.

WARNINGS:

Do not use for neonates (newborns or infants).
Do not use to screen or diagnose diabetes mellitus.
Do not use for cr tically patients.
All parts of the Safe AQ UG kit should be treated as biohazard and can transmit infect ous diseases, even after you clean and dis nfect.
Keep test strip vial away from children. A child could choke on the cap or be harmed if the drying agent nvals swallowed, inhaled, or contacts skin.

Test Principle

A blood 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 sample is drawn nto the tip of the test strip through capillary action. Glucose n the sample reacts with the special chemicals and electrons are generated, produc ng electrical current. The Safe AQ UG meter measures the strength of the electrical current and calculates your blood glucose level.

Composition

The reagent n test strip s composed of FAD glucose dehydrogenase, potassium ferricyanide, buffer solution and stabilizer.etc
Test Strip Storage and Shelf Life

Shelf ife: 24 months f stored between 1°C-30°C.
Store the test strips at temperatures between 1°C-30°C. Do not freeze.
Do not store the test strips in high heat and moisture areas such as the bathroom or kitchen.
Store unused test strips n their original vial with cap closed.
Close the vial tightly mmediately after you take a test strip out.
Use the test strip immediately after removing it from the container.
Do not use test strips beyond the expiration (printed on package) or discard date, because t may cause naccurate results.
Write the discard date (6 months after first opening the vial) on the vial abel when you first open t. Discard remaining test strips after the discard date.
Do not tamper with the test strip.
Avoid gett ng dirt, food or liquids on the test strip. With clean, dry hands you may touch the test strips anywhere on its surface.
Never reuse a test strip that has had either blood or control solution applied to it.
Never make significant changes n your diabetes treatment program or ignore symptoms without consulting your healthcare provider.

Test Environment
Temperature: 10°C-35°C
Relative Humidity: ,;,80%
Applicable Meter
The Safe AQ UG blood glucose test strip is ntended to be used with the Safe AQ UG Blood Glucose and Uric Acid Meter .
Sample requirements
Sample size: 0.6yL
Test range: 20~600mg/dL (1.1~33.3 mmol/L)
Test time: 5 seconds.
Sample type: capillary blood samples or venous whole blood samples. (Please request professional medical staff to apply blood of venous whole blood. The blood sample would be better without anticoagulation, if needed, prepare the blood sample with heparin as the anticoagulation. Test immediately after the blood sample is being applied, otherwise, the test results will be on the low side for the reason of glycolysis.)
Test Method
Getting ready to test
Refer to the Safe AQ UG Meter User Manual for more detailed informat on.

Required materials: the meter, a test strip, the lancing device and a lancet.
Wash hand with warm, soapy water. Rinse and dry completely.

Performing a blood glucose test
Please refer to the Safe AQ UG Meter User Manual for more detailed informat on.

Insert a Safe AQ UG Test Strip with the end of contact bar placed nto the test strip slot first. The meter turns on.
Obtain a blood drop using the lancing device.
Blood will be applied nto the Safe AQ UG Test Strip until the reaction chamber is full indicated by a short beep sound.
f the reaction chamber does not fill completely before the meter begins to count down, do not add more blood to the test strip; discard the test strip and retest.
After the meter counts down from 5 to 1, it will display test result.

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

Time	Range, mg/dL
Fasting	Less than 1 OOmg/dL (5.5 mmo

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, test ng 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 meter displays blood concentrations that refer to plasma although you always apply whole blood to the test strip. For further nformation please visit our website at www.sinocareintl.com or contact your ocal Sinocare representative.

Explanation of Test Results

Unusual test results
If “LO” is displayed on your meter, your blood glucose may be below 20 mg/dL (1.1 mmol/L).
If “HI” is displayed on your meter, your blood glucose may be over 600 mg/dL (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 the test with a new test strip.
Perform a control test with blood glucose control solution. For detailed information, please refer to your user manual.
Check this list to help you solve the problem.
• Check the use by date of the test strips.
• Ensure that the cap on the test strip container is always closed tightly.
• Ensure that you used the test strip immediately after removing it from the container.
• Check if the test strips were stored in a cool, dry place.
• Check if 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 cons derations

Please refer to the User Manual for operating temperature and humidity range for the meter.
Due to the meter siphon function, sample over size will not affect test results; insufficient sample may ead to ncorrect test results.
If the test result does not match how you feel, repeat the test and refer to User Manual. If this does not confirm the way you feel, contact your healthcare professional mmediately.
The test is used for monitoring glucose level of diabetics and cannot be used to diagnose and screen diabetes, neither for testing the glucose relating to any other disturbance of carbohydrate metabolism.
Test result will be inaccurate when under special states (dehydration, hyperosmotic state under high blood glucose, hypotension, shock, acidosis and so on.
Test result will be inaccurate if hematocrit beyond 30%~60%.
Vitamin C, uric acid, acetaminophen and other reducing substance occurring in normal concentration or therapeutic concentrations do not affect test results.
Cholesterol below 600 mg/dL, triglyceride below 750 mg/dL, Bilirubin below 25 mg/dL has no effect on blood glucose test results.
Do not perform test during or soon after xylose absorption testing. Xylose in the blood will cause false results. Maltose below 200 mg/dL or Galactose below 60 mg/dL do not affect test results.

Performance Character stics

The Safe AQ UG blood glucose str p complies with the requirements of ISO 15197:2013 ( In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing n managing diabetes mellitus).
System measurement range: 20 -600 mg/dl or 1.1-33.3 mmol/L
User performance evaluation:

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

Within ± 5mg/dL ( ± 0.28mmol/L)| Within ± 10mg/dL ( ± 0.56mmol/L)| Within ± 15mg/dL ( ± 0.83mmol/L)
17/27(62.9%)| 23/27(85.2%)| 27/27(100%)
Results for glucose concentrations ..- 100 mg/dL (?–5.55mmol/L)| Total
---|---
Within ± 5mg/dL| Within ± 10mg/dL| Within ± 15mg/dL| Within ± 15mg/dL ( ± 0.83mmol/L) or ± 15%
53/73(72.6%)| 64/73(87.7%)| 73/73(100%)| 100/100(100%)

Accuracy:

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

Repeatability (n=300):

Blood Glucose Level	Si	S2	S3	S4	S5
SD/CV	2.65mg/dL	2.60mg/dL	3.%	3.%	2.%

Intermediate precision (n=300):

Concentration	S1	S2	S3
SD	3.3mg/dL	3.8mg/dL	4.7mg/dL
CV	—	3.%	1.%

Matters Needing Attent on
Testing your blood glucose regularly may help you better manage your diabetes.
Since this product compr ses small parts that could be swallowed and lead to choking hazard, please keep it away from children.
Please readthe package nsert before you perform blood glucose testing. If any information n the package nsert s dilficult to understand, please contact your ocal Sinocare representative.
For an explanation of symbols used please refer to the end of the nsert.
References

American Diabetes_Association, Position Statement, Diaqnosis and Classification of Diabetes Mellitus, Diabetes Care35:S4-S10, 2012.
D’ Orazio et al.: Approved IFCC Recommendat on 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 instructions for use
Temperature limit
Batch code
Use—by date
Do not re—use
Keep away from sunlight
Keep dry
Manufacturer
Authorized representative in the European Community
CE Marking and Notified Body Number

Shanghai International Holding Corp. GmbH (Europe)
EiffestraBeB0 20537 Hamburg.Germany
Tel: +49-40-2513175 Fax: +49-40-255726
E-mail: shhoding@hotmail.com
Changsha Sinocare Inc
– No. 265, Guyuan Road, Hi-Tech Zone, Changsha,
Hunan Provnce, 410205, People’s Republic of China
E-ma l: ntl_mkt@sinocare.com
Webs te: www.sinocarent.com
Customer service: +86- 731-89935929
www.sinocareintl.com
f you need to contact us, please call Customer Service at
+86-731-89935929 or visit our website at
CE 0123
P/N: 3720027 4-B.4