G-425s manual

BioLand G-423AS Test Strip
G-423A Blood Glucose Meter for Glucose Test of Capillary Whole Blood Patient Cautions:
For in-vitro diagnostic use (extenal use only).
Healthcare professionals and others using this on multiple patients should be aware that all products or objects that come into contact with human blood should be handled as if capable of transmitting viral diseases, even after cleaning.
Please review this instruction sheet and the blood glucose meter owner's booklet before you use G-423AS Test Strips. For reliable results and to maintain the manufacturer's complete service, support, and warranty, use G-423AS Test Strips only.
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 patientsshould not be tested with blood glucose meters.
As with all small parts, the test strips and lancets should be kept away from smallchildren who still put things in their mouths. If they are swallowed, promptly see adoctor for help.
Intended Use
G-423AS Blood Glucose Test Strips, when use with the G-423A Blood Glucose Meter, areused to measure concentration of blood glucose by self-testing for both professional and home use. Routine blood glucose (sugar) testing with G-423A Blood Glucose Meter can provide you and your doctor well information on how your treatment of program affects your blood glucose level. Testing blood glucose regularly can help keep your diabetes under control too. Blood glucose mangement should be done in conjunction with advice from your qualified medical professional.
Storage and Handling
In order to ensure that your G-423AS Blood Glucose Test Strips are effective, please ensure that you observe proper storage and handling procedures.
Important: Do not use the Test Strips after their expiry date. Use of expired Test Strips may result in inaccurate readings.
To keep your test strips in the best possible condition, observe the following recommendations: Write the expiry date on the test strip vial after you have opened it. Test strips expire 90 days after opening.
Store the test strips in a cool, dry place between 39.2~104 F (4~40 C) and below 85% relative humidity. Keep the test strips away from direct sunlight. Do not store the test strips in areas of high humidity. Do not refrigerate.
Test strips must be stored in their original vial ONLY. Do not transfer them to a new vial or other container.
Do not touch the test strips when your hands are wet.
Use each strip promptly after removing it from the vial. Close the vial lid quicklyafter removing a new strip.
Keep the vial lid closed at all times.
Do not bend, cut or alter the test strip. doing so will lead to inaccurate results.
How It Works
G-423AS Blood Glucose Test Strips provide a quantitative measurement of glucose in whole blood. The absorbent hole fills automatically when contact is made with a drop ofblood through simple capillary action. The blood is drawn into the absorbent hole and its glucose level is read by the meter. Results are displayed on the glucose meter. Only a small amount of blood is required and reaction time is 7 seconds. G-423AS Blood Glucose Test Strips detect glucose levels from 1.1 to 33.3 mmol/L (20 to 600mg/dL).
For Accurate Results
Calibration
When using the system for the first time, or before using a new vial of test strips, you will
need calibration which can be easily done by selecting the correct code from the meter. It
is important to make sure that the LCD displayed code is the same as the code on the test
strip vial before you proceed. Only test blood glucose when the code matches with each
other, your test result can be accurate.
Sample Collection Procedure
Test strips should be used with a fresh blood sample. For best results it is recommended
that you read the following procedure and the glucose meter owner's booklet before you
obtain a blood sample. To get a drop of blood, follow these steps:
1. Wash your hands and the puncture site. Rinse and dry yourself thoroughly. If you use
an alcohol swab, ensure that the puncture site is completely dry prior to obtaining a
sample.
2. Lance the puncture site to obtain a drop of blood. You may massage or gently rub the
area in order to obtain the required amount of blood. Do not squeeze the puncture
site excessively.
Alternate site testing (off-finger):
You may also obtain blood sample from your palm to check blood glucose. But to obtain
accurate results, especially if you suffer from hypoglycemia, it is highly recommended that
you use fingertip testing. Please read the blood glucose meter owner's manual for
important information about puncture sites, and consult your healthcare professional
before you begin testing with blood sample obtained from arm or other parts of the body.
Set - Up and Testing
Calibration:
When using the system for the first time, or before using a new vial of the test strips, you
need to calibrate your meter. Press and hold "S" button until display "SEL" to release
button. Repeatedly press "S" button to select a correct code number. Only when code
displayed on LCD matches the code on strip vial can get accurate result. Please refer to
G-423A meter user's manual for details.
Blood Glucose Testing:
1. Fully insert the Test Strip into the meter with the contact bars end first. When the strip will go no further, the meter will perform several self-checks. After 2 seconds, the code number will appear. This code number should match the code number on the strip vial.
2. Obtain a blood sample for use with the test strip. The test requires at least 0.7 microliters of blood in order to provide accurate results. Hold the blood drop to the absorbent hole of the test strip to the until blood has completely filled the confirmation window. The meter will count down.
3. After 7 seconds, the test results will appear, showing you your blood glucose level.
The last reading is automatically stored in the G-423A Blood Glucose Meter memory. Shut the meter off by removing the strip. Discard the used strip.
Consult the blood glucose meter owner's booklet for detailed directions and illustrationsfor both procedures.
QC testing should be performed:
> When you begin using a new vial of test strips.
> At least once a week.
> Whenever you suspect that the meter or test strips are not working properly.
> When your blood glucose test results are not consistent with how you feel, or when you
think your results are not accurate.
> If you drop the meter.
Control solution is used to check testing technique and system performance. Three levels
of glucose control (low, normal, high) can be used with the G-423A Blood Glucose Meter.
When glucose control result fall within the control range given for the lot of test strips being
used, the system is working as it should, and your testing technique is good. The control
range can be found on the test strip vial label. Read your owner's booklet for complete
testing details.
IMPORTANT: The control range can change with each new vial of test strips. Always use
the control range on the label of your current vial of test strips.
Test Results:
Your blood glucose test results are displayed as millimoles of glucose per litre of blood
(mmol/L) or milligrams of glucose per deciliter of blood (mg/dL).
The meter displays test results between 1.1 to 33.3 mmol/L or from 20 to 600 mg/dL. If
your result is below the minimum value, the meter will read "LO". Repeat your test with a
new strip to confirm this reading. This indicates very low blood glucose levels or severe
hypoglycemia. You should immediately treat hypoglycemia following the
recommendations of your healthcare professional.
If your results are above the maximum value, the meter will read "HI". Repeat your test
with a new strip to confirm this reading. This indicates very high blood glucose levels, or
severe hyperglycmia. You should seek immediate medical attention.
Reference values:
Plasma glucose range (mg/dL) for people without diabetes *a: Sacks, DB in "Carbohydrates", Burtis, CA, Ashwood, ER (ed), Tietz Textbook of Clinical Chemistry, Philadelphia, WB Saunders Company, 1999.
*b: ADA Clinical Practice Recommendations 2003 Questionable or Inconsistent Results:If you are receiving test results that are unusual or inconsistent with how you are feeling:> Make sure that the drop of blood completely fills the test area of the test strip.
> Confirm that the test strips are not past their expiry date.
> Make sure that your meter has been properly coded, and that the code correspornds to the test strip vial you are using.
> Check the performance of the meter and test strips using the control solution.
High or low blood glucose levels can indicate a possibly serious medical condition. If youcontinue to get results that are unusually high or low, consult your healthcare professional.
Chemical components in sensor:1. Glucose oxidase (A niger) 10%2. Electron shuttle 50%3. Enzyme protector 8%4. Non-reactive ingredients 32% Test Principle
The test is based on the measurement of electrical current caused by the reaction of
glucose with the reagent of the strip. The monitor measures this current and displays the
corresponding blood glucose level. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.
Limitations:
Hematocrit: Below 20% or above 60% hematocrit levels can cause false results. Please consult your healthcare professional if you do not know your hematocrit level.
Neonatal Use: The test strips should not be used for the testing of newborns.
Metabolites: Ascorbic acid at normal blood concentration does not significantly affectglucose readings. High concentrations of acetaminophen, dopamine, L-Dopa,methyldopa and uric acid may cause inaccurate test results. Blood glucose readingsshould be interpreted with caution.
Lipemic Effects: Elevated blood triglycerides up to 2000 mg/dL do not significantly affect the results. However, the glucose test may be affected beyond these levels.
Do not use iodoacetic acid or fluoride as a preservative for blood specimens.
Use only fresh capillary whole blood. Do not use serum or plasma.
Altitude Effects: Test strips may be used at altitudes up to 10,742 feet (3,275m) without an effect on test results.
Performance characteristics
Accuracy:
Within + 15 mg/dL (0.83 mmol/L) at glucose concentration < 75 mg/dL(4.2 mmol/L)
and within +20% at glucose concentration > 75 mg/dL (4.2 mmol/L) .
Preciston:
This study shows the CVs (%) of intermediate precision and repeatability were less
than 5%.
Traceability of G-423A Blood Glucose Meter:
The results of blood glucose meter were compared to parallel results obtained on
YSI 2300, which is the manufactuer's standard measurement procedure. The study
shows that the G-423A Blood Glucose Meter correlated very well with
manufacturer's reference method.
The device was approved and met ISO 15197.
Manufactured for: Bioland Technology Ltd.

Source: http://www.bioland.com.hk/details/G-425S_manual_eng.pdf