AILE SA-102 Blood Glucose Monitor Kit for Diabetes Instructions

AILE SA-102 Blood Glucose Monitor Kit for Diabetes

Specifications

• Model: SA-102
• Test Method: Glucose oxidase
• Intended Use: For quantitatively measuring glucose in fresh capillary whole blood samples
• Single-patient use only
• Not for diagnosis or screening for diabetes or neonatal use
• For self-testing and in vitro diagnostic use only

Product Usage Instructions

Test Principle

• The test measures an electrical current generated by the reaction of glucose with the reagent on the test strip.
• The meter then converts this current to the corresponding blood glucose level.

Contents of Package

• Each kit contains test strips in varying quantities, along with an instruction manual.

Applying Blood Sample

• Ensure no foreign substances enter the strips. Obtain a fresh blood sample using the lancing device and fill the reaction area with a minimum volume of 0.7L for accurate results.

Test Strip Components

• Absorbent Hole – Apply blood here for automatic drawing
• Reaction Area – Must be completely covered with blood
• Handle – Insert the strip into the test port using this part
• Contact Bars – Insert into the meter firmly for proper connection

Main Components of Each Strip

• Glucose oxidase < 20 IU
• Mediator Potassium Ferricyanide < 0.12mg
• Buffer, Non-reactive Ingredient < 1.8 mg

What Else You Need

• Blood Glucose Test Meter (Models: A601, A602, A606, A608, or A609)
• Lancing device
• Sterile lancet
• Test control solution (Use only from the same manufacturer for accurate results)

Warnings and Precautions

• For in vitro diagnostic use only (external use)
• Do not reuse test strips
• Use only fresh capillary whole blood samples drawn from the fingertips for self-testing

FAQ

Q: Can the test strips be shared between multiple patients?

• A: No, the test strips are intended for single-patient use only and should not be shared.

Q: What should I do if the blood sample is clotted?

• A: If the blood in the fingertip is clotted, obtain a fresh blood sample using the lancing device again to ensure accuracy.

Q: What could cause inaccurate test results?

• A: Inaccurate results may occur if foreign substances enter the strips or if the contact bars are not fully inserted into the test port.

Blood Glucose Test Strips (Glucose oxidase method)

• Model: SA-102
• Before you start a test, please read the instructions for use carefully! Take note of warnings and cautions throughout this User Guide!

Intended Use

• Blood Glucose Test Strips (Glucose oxidase method) are for use with the Blood Glucose Test Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips of adults.
• They are intended for single-patient use only and should not be shared. They should not be used for the diagnosis of or screening for diabetes, or neonatal use. For self-testing only. For in vitro diagnostic use only.

Test principle 1

• The test is based on the measurement of an electrical current generated by the reaction of glucose with the reagent of the test strip.
• The meter measures the current and converts it to the corresponding blood glucose level.

Content of Package

One kit contains:

• bottle (vial) of Test Strips (10pcs/bottle, 15pcs/bottle, 20pcs/bottle, and 25pcs/bottle), or 2 bottles (vials) of Test Strips (25pcs/bottle)
•  x Instruction for use

Test Strips

• Absorbent Hole – Apply a drop of blood here. The blood will be drawn in automatically.
• Reaction area – If sufficient blood has been drawn into the absorbent hole of the test strip this area will be completely covered with blood.
• Handle – Hold this part to insert the test strip into the test port.
• Contact Bars – Insert this end of the test strip into the meter. Push it in firmly until it will go no further.

Description of main components for each strip:

• Each test strip contains the following chemicals: Glucose oxidase < 20 IU, Mediator Potassium Ferricyanide< 0.12mg, Buffer, Non-reactive Ingredient< 1.8 mg
• Attention: Test results might be inaccurate if the contact bars are not fully inserted into the test port.

What Else You Need

• Blood Glucose Test Meter (Model: A601, A602, A606, A608, or A609)
• Lancing device
• Sterile lancet
• Test control solution
• Note: For accurate results, only use the Blood Glucose Test Meter and Test control solution manufactured by our company.

Warning and Precautions

• For in vitro diagnostic use (external use only).
• Do not reuse.
• For self-testing only.
• Use only fresh capillary whole blood samples drawn from the fingertips.
• Please review this instruction sheet and the instructions for the Blood Glucose Test Meter manufactured by our company before you use the test strips.
• For reliable results and to maintain the manufacturer’s complete service, support, and warranty, use the Blood Glucose Test Meter and quality control solution manufactured by our company only.
• As with all small parts, the test strips and lancets should be kept away from small children. If any parts are swallowed, promptly see a doctor for help.
• If you have questions or need assistance outside the Customer Service days and times, please contact your healthcare provider.
• Please wash your hands thoroughly with soap and water after handling the meter, lancing device, or test strips.
• The meter and lancing device should be cleaned and disinfected. Please refer to the Cleaning and Disinfection section of the Owner’s Manual for cleaning and disinfection procedures.
• Used lancet and test strips may be potentially hazardous. Please discard them carefully according to the instructions for use.
• Never make significant changes to your diabetes control program or ignore physical symptoms without consulting your healthcare professional.
• When the test strips are not used, please store them in the package bag for safekeeping or carrying about.
• If your test result is below the normal values, consult a healthcare professional immediately.
• Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
• Critically ill patients should not be tested with blood glucose meters.
• Inaccurate results may occur in patients undergoing oxygen therapy.
• The procedures should be followed precisely for accurate results.
• Do not use the strips out of doors.
• Testing at high altitudes up to 3,048 m may affect results.
• Please test at a temperature of 10℃ to 40℃, relative humidity of 10% to 85%.
• Please put the cap on the vial at once to avoid moisture after taking the test strips out,

Disposing of Test strips

• Disposal of the used strips properly in an appropriate container, to prevent any infection. Used test strips may be considered biohazardous waste in your area.
• Be sure to follow your healthcare professional’s recommendations or local regulations for proper disposal. For information about correct disposal, please contact your local council or authority.

Limitations

• Blood glucose test strip (glucose oxidase method) can only use fresh fingertip whole blood, do not use venous whole blood, arterial whole blood, newborn whole blood, plasma or serum
• Extreme thirst or severe dehydration may result in coma or hypoglycemia during measurement. If you experience these symptoms, your blood glucose test value may be incorrect, please consult your specialist or medical professional immediately.
• Do not ignore the symptoms of hyperglycemia or hypoglycemia.
• When the results of the test do not reflect your opinion, retest using the fingertip test. If the fingertip result still does not reflect the way you feel, please consult your healthcare professional.
• Do not rely on the results of the meter to change your treatment method.
• The amount of glucose in alternate sites differs from person to person.
• Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with glucose test meters.
• Dehydration may lower test results.
• Glucose test strips used in altitudes above 3,048 meters (10,000 feet) will have an impact on test results.

Storage, Transportation, and Handling

1. The strips should be stored in a special test strips vial, and the vial cover should be sealed.
2. Store at 4 ºC to 40 ºC temperature and 10% to 85% humidity in a well-ventilated room without any corrosive gas up to the expiration date.
3. Do not refrigerate or freeze.
4. The shelf life of the strips is 24 months, and the use life after opening is 90 days.
5. Use all the test strips within the expiration date printed on the test strip box and vial label.
6. Dispose of test strips past the expiration date immediately. Using test strips past their expiration date can product incorrect test results.
7. Test strips in new, unopened vials and test strips in vials that have been opened can be used up until the expiration date printed on the test strip box and vial label if the test strips are used according to their storage and handling methods.
8. Keep away from direct sunlight, moisture, heat, dust, high temperature, and high humidity.
9. Please cover back the vial cover to protect the test trips from moisture after taking the strips out, to avoid affecting testing data.
10. Only store the strips in their original vial to avoid damage or contamination, and don’t separate the strips into other containers.
11. Handle test strips with your dry and clean hands.
12. Use the test strip immediately after taking it out of the vial.
13. Don’t bend, cut, or damage the strips in any way.
14. Do not force a test strip into the meter. Gently push it into the meter’s test strip port.
15. Apply only fresh capillary whole blood for testing.

Sample Requirements

1. The sample should only be fresh capillary whole blood samples drawn from the fingertips.
2. If you swab your blood sampling site with alcohol, please ensure the alcohol evaporates completely before obtaining a blood sample. Please wash your hands thoroughly and keep them dry before blood sampling.
3. Sampling blood volume: ≧0.7uL. If there is too much sample at first time sampling, use alcohol cotton to wipe off the excess after the sample is obtained; if there is too little sample, gently press and rub to extract blood.
4. Take blood glucose measurements immediately after the sample is obtained. If the blood in the fingertip is clotted, the blood sample should be obtained using the lancing device again to ensure that the capillary whole blood samples drawn from the fingertip are fresh.
5. The blood volume ratio (HCT, the proportion of red blood cells in blood) of this product ranges from 35% to 50%. When the blood volume ratio exceeds the above range, the measurement results may be inaccurate. Please consult your physician before testing. (HCT range refers to EN ISO 15197: 2015)
6. Do not squeeze the puncture site.
7. Normal blood metabolites (such as uric acid) or substances produced by drugs (such as vitamin C) do not affect blood glucose readings. However, compounds above the limits listed in the table below may cause inaccurate blood glucose readings. Please consult your physician or caregiver first.

How To Do The Test

1. Prepare the Lancing Device
   • Step 1
   • Wash hands and sample site with soap and warm water. Rinse and dry thoroughly.
   • Prepare the lancing device carefully according to the instructions of the lacing device.
2. Prepare the Meter and Test Strip

Step 2

• Insert a test strip with the contact bars facing upwards into the meter’s test strip port. Push the strip gently until the meter beeps.
• File No.: JXZH-WI-YF180 Version: A/2 Date of Issue: Apr 25th, 2022
• Do not allow any foreign substances, such as dirt, blood, or water, to enter into the strips.
• Do not apply the blood sample directly to the test strip port.
• Do not apply the blood sample to the test strip while holding the meter in a way that the tip of the test strip faces upwards. The blood sample may run down the surface of the test strip and flow into the test strip port.

Apply Blood Sample

Step 3

• Obtain a blood sample using the lancing device carefully according to the instructions of the lancing device. Take blood glucose measurements immediately after the sample is obtained.
• If the blood in the fingertip is clotted, the blood sample should be obtained using the lancing device again to ensure that the capillary whole blood samples drawn from the fingertip are fresh. A minimum volume of 0.7μL is needed to fill the reaction area.

Step 4

• If there is too much sample at first time sampling, use alcohol cotton to wipe off the excess after the sample is obtained; if there is too little sample, gently press and rub to extract blood.
• Apply the blood sample to the narrow end of the test strip till the reaction area is filled up with blood. Make sure that the reaction area is filled by blood in time before the meter starts counting down, or otherwise, the error message occurs or the test result is not accurate.
• It is recommended that the application of the blood sample to the test strip be performed virtually vertically to the sample site as shown in the diagram below.
• Note: Do not squeeze the puncture site.
• You may get an inaccurate result if the blood sample is not filled in a single action.

Step 5

• When the blood sample reaches the narrow end of the test strip and the meter beeps, the display segments will rotate clockwise while the blood is going in.
• The test result will appear after the meter counts down from 5 to 1.
• The result will be automatically stored in the meter’s memory.

Note:

1. Please see the instructions for the Blood Glucose Test Meter from our company for more detailed steps.
2. Results from alternate sites and fingertip samples may differ from each other as there is a time lag for the glucose levels to reach the same value. Use a fingertip for testing if you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms.
3. If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm, do not use that sample. Try puncturing again in a smoother area.

Reference Values 2, 3

Diabetes values:

Normal values

• Fasting is defined as no caloric intake for at least eight hours.
• The test strips have been tested before delivery to ensure that qualified finished products can be shipped.
• If your actual blood glucose value is too high or too low during use, please check the following steps if the test meter and test strips work normally:

1. If your testing steps are correct? If the testing environment temperature complies with the requirement?
2. Is the blood sample sufficiently absorbed by the test strip?
3.  Is the test strip complete and in the shelf life?
4. Is the test strip is used at once after taken out? If the cover of the vial is fastened down?
5. If the test strips are stored at 4℃ to 40℃, and avoided from moisture or high-temperature exposure?
6. If all the above are confirmed correct, please retest. If the retesting result is still abnormal, please contact with local distributor or customer service staff.

Interpretation of Results

1. Testing time: 5 seconds.
2. If your test blood glucose is lower than 3.9 mmol/L or higher than 11mol/L, please contact with healthcare professional.
3. For accurate test results, please use fresh capillary whole blood samples drawn from fingertips, do not use plasma or serum, which will affect the results.
4. Testing at high altitudes up to 3,048 m may affect results.
5. Not testing at temperatures of 10℃ to 40℃, and relative humidity of 10% to 85% may affect the results.
6. When the following situations occur, an invalid result will appear, and the corresponding error symbol will be prompted on the display screen of the meter:
   • Test strips are used
   • The operation temperature is lower than 10℃ or higher than 40℃;
   • Blood volume (sample volume) is insufficient;
   • Test failure;
   • The measurement range is lower than 20 mg/dL or higher than 600 mg/dL For the detailed error message information, please refer to the instructions for use of the AICARE Blood Glucose Meter.
7. Too much or too little sample may affect the results.
8. The blood volume ratio (HCT, the proportion of red blood cells in blood) of this product ranges from 35% to 55%. When the blood volume ratio exceeds the above range, the measurement results may be inaccurate.
   • Please consult your physician before testing. (HCT range refers to ISO 15197:2013).
9. Compounds: Normal blood metabolites (such as uric acid) or substances produced by drugs (such as vitamin C) do not affect blood glucose readings. However, if blood compounds exceed the limits listed in the table in Section Sample Requirement, they may cause inaccurate blood glucose readings. Consult your physician or caregiver first.
10. Glucose in the blood will change with diet, body condition, and medication, and different results will be obtained when the blood glucose is tested at different times of the day. It is recommended that you discuss with a medical professional to work out a suitable measurement period and range of blood glucose values for you when you conduct blood glucose management.
11. Your blood glucose test results will be shown in mmol/L (millimoles/liter).
12. Please ask your doctor or medical professional for the standard blood glucose level before and after meals for your diet, exercise, and medication.

Quality Control

When to test with control solution

• If you suspect the meter and test strips are not working properly.
• If you have had repeated unexpected blood glucose results.
• If you drop or damage the meter.

How to test with a control solution

• Please use the control solution manufactured by our company, because using other control solutions may generate other inaccurate results. Three rangers Level 0, Level 1, and Level 2 are shown on the test strip vial label. Control Solution 1 is sufficient for most all self-testing needs. If you think your meter or strips may not be working correctly, you may also want to do a level 0 or level 2 test. Follow the test procedure below to run a quality control test:

Step 1

• Take one test strip out of the vial and put on the cap tightly.
• Note: Make sure the test strip is complete and in the shelf life.

Step 2

• Test according to the test method referenced from the test meter.

Step 3

• Shake the bottle gently to make sure the quality control fluid is mixed well before opening the bottle of quality control solution.

Step 4

• Squeeze a small drop of quality control solution onto a non-absorbent surface. Do not add quality control liquid directly from the bottle to the test paper. Put the cap on the quality control fluid bottle.

Step 5

• After the test strip absorbs the quality control solution, the meter counts down from 5 to 1, and the test result appears.

Note:

• For confirmation of results, Control Solution 0 tests should fall within the Level 0 range, Control Solution 1 tests should fall within the Level 1 range, and Control Solution 2 tests should fall within the Level 2 range.
• When testing with Control Solution 1, make sure you are matching the results to the Level 1 range on the vial label.
• Quality control solution is not included in the content of the package of test strips, and please contact after-sale service to purchase the solution you need to perform quality control testing.

Caution:

• If your quality control test result falls outside the control range shown on the test strip vial, do not use the meter and test strips to test your blood, as the system may not be working properly.
• If you cannot correct the problem, contact your distributor for help.

Performance Characteristics

Specifications

Yes
Sample volume| Minimum 0.7 μL
Hematocrit (HCT) range| 30%–55%
The test strip of shelf life| 24 months
In-use stability| 90 days
Code type| No code
Test time| 5 seconds
Assay method| Electrochemical
**** Operation Condition| Temperature: 10℃ to 40℃; Relative humidity: 10% to 85%; Altitude: ﹤3,048 m
Transport and Storage Condition| Temperature: 4℃ to 40℃; Relative humidity: 10% to 85%

Clinical Accuracy

The system accuracy of the meter was assessed by comparing blood glucose results with those obtained using the Blood Glucose Test System (Accu-Chek Performa) from Roche.

The test results are shown in the table below:

• Clinical Study – AICARE Result vs. Roche Result
  • System Accuracy Results for Glucose Concentration ≥ 100 mg/dL (5.55 mmol/L)

System Accuracy Results for Glucose Concentration

< 100 mg/dL (5.55 mmol/L)

Within ± 5 mg/dL (Within ± 0.28 mmol/L)| Within ± 10 mg/dL (Within ± 0.56 mmol/L)| Within ± 15 mg/dL (Within ± 0.83 mmol/L)
156/204 (76.5%)| 196/204 (96.1%)| 202/204 (99.0%)
System Accuracy Results for Glucose Concentration Between 46.8 mg/dL (2.6 mmol/L) and 478.8 mg/dL (26.6 mmol/L)
Within ± 15 mg/dL (± 0.83 mmol/L) or ± 15 %
598/600 (99.7%)

Precision

• The precision studies were performed in a laboratory using a Blood Glucose Meter and Blood Glucose Test Strips (Glucose oxidase method).

Within Run Precision (mg/dL)

Lot 1
Sample concentration level (mg/dL)|

YSI

| ARE
Average| SD| CV
30-50| 36.3| 39.9| 1.4| 3.6%
35.9
51-110| 72.1| 79.9| 3.3| 4.2%
71.9
111-150| 117| 130.5| 5.8| 4.4%
116
151-250| 179| 200.4| 6.2| 3.1%
181
251-400| 293| 325.3| 9.5| 2.9%
295
Lot 2
Sample concentration level (mg/dL)|

YSI

| ARE
Average| SD| CV
30-50| 36.5| 40.1| 1.4| 3.4%
35.4
51-110| 72.6| 80.1| 3.2| 4.0%
72.1
111-150| 117| 128.3| 5.8| 4.5%
117
151-250| 180| 199.5| 6.3| 3.2%
181
251-400| 294| 326.1| 9.2| 2.8%
295
Lot 3
Sample concentration level (mg/dL)|

YSI

| ARE
Average| SD| CV
30-50| 36.2| 40.0| 1.4| 3.4%
35.4
51-110| 71.9| 80.0| 3.5| 4.3%
72.5
111-150| 117| 130.5| 5.8| 4.4%
118
151-250| 180|

200.8

|

6.1

|

3.0%

181

251-400

| 293| 325.4| 9.2| 2.8%
292
Between Run Precision (mg/dL)

Sample concentration level (mg/dL)|

Lot

|

Average

|

SD

|

CV

30-50| 1| 40.2| 1.5| 3.6%
2| 39.8| 1.3| 3.3%
3| 40.0| 1.4| 3.5%
96-144| 1| 125.0| 4.1| 3.3%
2| 124.6| 4.6| 3.7%
3| 125.6| 4.4| 3.5%
280-420| 1| 349.7| 5.8| 1.7%
2| 349.3| 5.6| 1.6%
3| 351.2| 6.1| 1.7%|

Linearity

• The linearity studies were performed in a laboratory using a Blood Glucose Meter and Blood Glucose Test Strips (Glucose oxidase method).
• For Lot 1: Y = 0.99860x + 1.62061, R2 = 0.99885
• For Lot 2: Y = 1.00489x + 1.25294, R2 = 0.99834
• For Lot 3: Y = 1.01388x – 0.99857, R2 = 0.99857
• Studies have shown that this reagent has a good linear relationship between 10mg/dL and 650mg/dL, so the linear range of this reagent is determined to be 10mg/dL to 600mg/dL.

Packed Cell Volume (Hematocrit)

• The test results show that accurate readings can be obtained when testing within the hematocrit range of 30%–55%.

Interferences

• The effect of various interfering substances was evaluated in whole blood samples on glucose measurements.

User Performance Evaluation

• A study evaluating glucose values from fingertip capillary blood samples obtained by 100 lay persons showed the following results: 99.0% within ±15 mg/dL (± 0.83 mmol/L) of the medical laboratory values at glucose concentrations below 100 mg/dL (5.55 mmol/L), and 100% within ±15% of the medical laboratory values at glucose concentrations at or above 100 mg/dL (5.55 mmol/L).
• 100.0% within ±15 mg/dL (± 0.83 mmol/L) of the layer person values at glucose concentrations below 100 mg/dL (5.55 mmol/L), and 100% within ±15% of the layer person values at glucose concentrations at or above 100 mg/dL (5.55 mmol/L).

Reference

• Electrochemical Glucose Sensors and Their Applications in Diabetes Management.
• Chemical Reviews. 2008, 108(7): 2482-2505.
• American Diabetes Association Professional Practice Committee.
• Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes [J]. Diabetes Care, 2022, 45 (Supplement_1): S17–S38.
• Definition and Diagnosis of Diabetes Mellitus and its intermediate hyperglycemia. World Health Organization. 2006.

Meaning of Symbols

• Jiangxi AICARE Medical Technology Co., Ltd.
• No. 6, South Side of Nanhuan Road, Qianping Industrial Park, Le’an County, Fuzhou City, Jiangxi Province, China Caretechion GmbH
• Niederrheinstr. 71,40474 Dusseldorf,Germany.

Documents / Resources

| AILE SA-102 Blood Glucose Monitor Kit for Diabetes [pdf] Instructions
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