Hemoglobin Test Strip

Hemoglobin Test Strip

For use with BeneCheck Hemoglobin Meter BKM35-H/ PD-G017/ BKA-30S.

IMPORTANT: Please read this instruction and user’s manual before using BeneCheck Hemoglobin Test Strip(Model: BK-H1).

Intended Use

• Measuring hemoglobin level in capillary whole blood from fingertip.
• The meter can be used by laypersons or healthcare professionals.
• in vitro diagnostic use only.

Principle of the Test

• Electrochemical biosensor technology.

Chemical Composition of Strip

• Electrode coating: 25 mg
• Buffer: 69%
• Polymer: 5%
• Mediator: 26%

Storage and Handling

• Storage the strips within 10-30°C (50-86°F), use within 3 months after first open.
• Handle the strips with dry and clean hand.
• Recap strip vial immediately after use.
• Use the strip immediately after taking out from the vial.
• Do not use expired strips. It may cause false result.
• Do not expose the strips under sunlight, heat or humid environment.
• Do not repack, change vial, refrigerate or freeze the strips.
• Do not bend, cut or fold the strips.

Coding Procedure

1. Step1. Insert the Code Strip
2. Step2. Code Number and Test Mode Display on Screen
3. Step3. Make Sure the Code on Screen/ Code Strip/ Strip Vial Label is the Same
4. Step4. Make Sure Test Mode on Top of Screen Display “Hb”

How to Perform the Test

1. Step1. Take a Strip
2. Step2. Recap Strip Vial Immediately
3. Step3. Insert the Strip
4. Step4. Make sure the Code is Correct
5. Step5. Sampling by Lancing Device
6. Step6. Touch the Blood Sample with Strip
7. Step7. Result will Show after Count Down
8. Step8. Discard Used Strip and Lancet to Waste Container

Please refer to User’s Manual for detail procedure.

Test Results

• Measuring Range: 7.0-26.0 g/dL (4.3-16.1 mmol/L); Hct Range: 21-78%
• The Normal Range for Healthy Male: 13-18 g/dL (8.1-11.2 mmol/L); The Normal Range for Healthy Female: 12-16 g/dL (7.4-9.9 mmol/L) (The range is only a reference.)

• If “Lo” is displayed on the meter, hemoglobin level may be below 7.0 g/dL (4.3 mmol/L) or 21% Hct.
• If “Hi” is displayed on the meter, hemoglobin level may be over 26.0 g/dL (16.1 mmol/L) or 78% Hct.

If the test result is unusually low, high or inconsistent with how you feel, please check the follows and repeat the test again with a new strip and make sure you have followed the instructions carefully.

• Strips are not expired.
• Meter has been coded properly, and the code number is consistent with the strip.
• Meter and strips is working properly.
• Blood sample has filled up the strip inlet sufficiently.

IMPORTANT:
· Please consult healthcare professional before making medical decision based on the tested results.
· Strips from other brand are not compatible to BeneCheck’s meter.
· POTENTIAL BIOHAZARD. The used test materials could be sources of infection, please beware especially when the system is used by multiple users.

Control Solution Test

Control solution is used to check the performance of the system. If the control solution test result falls within the range listed on the strip vial label, the system is working properly. Control solution is not included in the system. Please contact an authorized distributor for purchasing. A control test should be performed:

• When the system does not work properly.
• When the test result is unusual or inconsistent.

Out of range control solution test result may be caused by:

• Performing the test inaccurately.
• Contaminated or expired control solution.
• System deterioration or malfunction.
• The codes between meter and strip are inconsistent.

IMPORTANT: Each strip vial might have different control range. Please check every time when you perform a control solution test. Do not use the system if the control solution tests keep result wrongly. Please contact authorized distributor for assistance.

Limitations

For getting an accurate test result, please read the following limitation carefully.

• Single use only. Do not reuse the strips.
• Do not perform the test under strong electronic field with signal interference.
• Do not perform the test on newborns.
• The test strip can be used at altitude up to 10,000 feet (3048 meters).
• Hematocrit (Hct) should be between 21-78%.
• Use only fresh capillary whole blood from fingertip.
• Do not use serum, plasma or venous whole blood.

Additional Information for Healthcare Professionals

• Interference: Acetaminophen, Bilirubin, Cholesterol, Creatinine, Dopamine, Gentisic acid, Glucose, Ibuprofen, Methyl Dopa, Salicylate (Aspirin), Tetracycline, Tolazamide, Tolbutamide, Uric Acid, Triglyceride (at physiological orther apeutical levels) do not significantly affect the test results. However, abnormally high concentrations in blood may cause inaccurately test results.
• The fresh fingertip blood preserved in the blood collection tube with K2 EDTA, Sodium Fluoride, Buffered Cit.
  Na., or Sodium Heparin may affect the test result. The test strips are not recommended for critically ill patients.
• The test strips are not recommended for critically ill patients.

Accuracy

For fingertip hemoglobin tests, the meter gave the system accuracy for 95.7%, which meet the acceptance criteria for ≥95% within ±15％ of bias compared to laboratory hematology analyzer KX-21N.

Precision

Repeatability:

Intermediate precision:

Symbols

Please refer to User’s Manual for more information.