BIONING RIGHTEST GM100 (01) PDF Document

The BIONING RIGHTEST GM100 is intended for in vitro (outside the body) diagnostic use and self-testing only. It is designed to measure blood glucose levels using fresh capillary whole blood samples from the fingertip, palm, or forearm. The results are calibrated to plasma equivalents.

The package contents can vary depending on the bundle, but typically include:

The BIONING RIGHTEST GM100 meter is only compatible with GS100 test strips. Using other test strips may cause inaccurate results or damage the meter.

Yes. The BIONING RIGHTEST GM100 has not been validated for use on neonates and is not intended for use with arterial blood testing. Additionally, it should not be used to diagnose diabetes mellitus.

The minimum blood sample size for testing is 1.4 microliters. It is suggested to use a sample between 1.4 to 2.5 microliters. A sample larger than 4.0 microliters is too large, and a sample smaller than 1.4 microliters may result in an inaccurate test result.

Store the test strips in a cool and dry location between 4 to 30 degrees Celsius (39 to 86 degrees Fahrenheit) and with relative humidity below 90 percent. Do not expose them to direct sunlight or heat. Always re-cap the vial immediately after removing a strip.

You should record the date of opening a new test strip vial for the first time. Discard the vial of test strips 3 months after opening or once they have reached their expiration date, whichever comes first.

The meter uses one CR2032 3V battery. To install it:

1. Turn the meter over and press/push the battery cover to open.

2. Install the battery, ensuring it is put in the correct direction.

3. Slide the battery cover back until it snaps into place.

4. The meter will perform a self-test with all symbols blinking. Press any button to exit the self-test and enter Setting Mode.

There are two ways to enter Setting Mode:

1. Reload the battery: After removing and reinserting the battery, the meter performs a self-test. Press the main button to enter Setting Mode.

2. With the battery inserted: Press the main button to turn the meter on. Then press and hold the main button for 5 seconds until you hear a beep, indicating you have entered Setting Mode.

In Setting Mode, use the following steps:

1. Year: Press the main button to adjust the year, then hold for 2 seconds to confirm.

2. Month: Press the main button to select the month, then hold for 2 seconds to confirm.

3. Day: Press the main button to adjust the day, then hold for 2 seconds to confirm.

4. Time Format: Choose between 12H and 24H formats by pressing the main button, then hold for 2 seconds to confirm.

5. Hour: Press the main button until the correct hour appears, then hold for 2 seconds to confirm.

6. Minute: Press the main button to adjust minutes, then hold for 2 seconds to confirm. The meter will then move to the unit setting.

To turn the power on, press the main button or insert a test strip. To turn the power off manually, keep pressing the main button for 2 seconds. The meter also features an auto power off function that will shut the device down automatically if it is not operated for over 2 minutes.

1. Hold the adjustable cap in one hand and the hub in the other. Bend the cap downward to pull it off.

2. Insert a new disposable lancet firmly into the lancet carrier.

3. Twist off and set aside the protective cover of the lancet.

4. Replace the depth adjustable cap.

5. Choose a depth of penetration by rotating the top portion of the cap until the setting matches the window.

Depth settings are based on skin type:

1. Wash hands with warm soapy water and dry thoroughly.

2. Take one strip from the vial and re-cap it immediately.

3. Insert the strip into the meter’s strip port with the indication symbol facing up. A click will sound.

4. When the blood drop symbol flashes, the meter is ready. Place the cocked lancing device against your fingertip and press the release button.

5. Touch and hold the blood drop to the edge of the strip sample entry until the meter beeps and the view window is totally filled with blood.

6. An 8-second countdown will begin, after which the result appears.

Pull off the depth adjustable cap. Without touching the used lancet, stick the lancet tip into the protective cover that was set aside earlier. Hold the release button in one hand and pull the plunger in the other hand to safely eject the lancet into a puncture-proof or biohazard container.

If the view window is not totally filled with blood or the test does not start, discard the test strip and repeat the test with a new test strip. Insufficient blood samples will cause inaccurate results.

The meter displays results between 0.6 and 33.3 mmol/L. If your result is below 0.6 mmol/L, “Lo” will appear. If the result is above 33.3 mmol/L, “Hi” will appear. In both cases, you should repeat the test with a new strip and contact a healthcare professional if the result persists.

The meter automatically stores 150 results. To recall them:

1. Start with the meter off and no test strip inserted.

2. Press the main button to enter memory function. You will first see the “AVG” symbol and averages for 1, 7, 14, 30, and 90 days.

3. Continue pressing the button to view individual results starting from the most recent (MEM 1) to the oldest (MEM 150).

Perform a Quality Control Test:

1. Before using the meter for the first time.

2. When opening a new vial of test strips.

3. If the meter is dropped or splashed with liquid.

4. Whenever you think the test results are inconsistent with how you feel.

5. To practice the testing procedure.

1. Insert a test strip into the meter.

2. While the blood drop symbol is flashing, press and hold the main button for over 5 seconds until the “CS” symbol appears.

3. Shake the Control Solution bottle well and drip a drop onto the top of its cap.

4. Touch the sample entry of the strip to the drop on the cap.

5. Wait for the result and compare it to the range printed on the test strip vial label.

Possible reasons include:

1. Expired Control Solution or test strips.

2. Control Solution has been open for more than 3 months.

3. Caps were left off the vial or solution bottle for a long time.

4. Incorrect testing procedure.

5. Meter malfunction.

Er1 indicates that the inserted test strip has already been used or is damaged. You should use a new test strip from the vial.

Er2 indicates the meter has malfunctioned. You should perform a Quality Control Test or reinstall the battery to see if the meter works properly.

Er3 indicates that signal transmission was disrupted. You should repeat the test with a new test strip.

The operating range is 10 to 40 degrees Celsius (50 to 104 degrees Fahrenheit). If the temperature is outside this range, a warning symbol will blink. If you move from one temperature extreme to another, wait 30 minutes for the meter to stabilize before testing.

One new CR2032 battery will provide power to perform approximately 1,000 tests under normal use.

Clean the outside of the meter with a damp cloth and mild soap or detergent. Do not immerse the meter in water and keep the test strip port from getting wet.

Inaccurate results may occur if the following substances are present in concentrations at or above these levels:

Yes. Inaccurate test results may be obtained at high altitudes more than approximately 10,000 feet (3,048 meters) above sea level.

If the battery symbol is blinking, the battery power is low. You can still perform tests, but you should change the battery as soon as possible. If the battery and error symbols both blink, the battery is too low and must be changed immediately before any further testing.

A sampling error occurs if you apply blood to the strip before the flashing blood drop symbol appears on the screen. The meter is performing an internal check during this time. If this happens, remove the strip and insert a new one to repeat the test.

1. Open the battery cover and take out the battery.

2. Wait for 5 minutes.

3. Reload a new battery. The meter should work normally. If it does not, contact authorized service support.

You must prevent water from entering the meter. Never immerse the meter in liquid or hold it under running water. If it is splashed, wipe it dry immediately.

No, coding is not required for the BIONING RIGHTEST GM100 blood glucose monitoring system.

Severe dehydration and excessive water loss may cause inaccurately low results when testing with the BIONING RIGHTEST GM100.

Quick press the main button twice while the meter is in memory mode. It will then automatically cycle through the averages and individual memory results. Press the main button again to stop at a specific reading.

The kit contains small parts, such as test strips and lancets, which could result in a choking hazard for children. Keep the kit components out of reach of children.

If you move the meter to a location with a significant change in temperature, you must wait at least 30 minutes before performing a test to allow the device to adjust to the new temperature.

Results are shown in either mmol/L or mg/dL, depending on the chosen setting. Note that in some countries, the unit is fixed and cannot be changed by the user.

Hold the hub in one hand and pull on the plunger with the other hand. The device will be cocked. Release the plunger, and it will automatically move back to its original position.

No. You must insert the test strip into the meter first. Apply the blood sample only when the blood drop symbol is flashing on the screen.

The view window on the GS100 strip is yellow before any blood is applied. It will gradually turn red as it is filled with the blood sample.

You can exit Setting Mode at any time by pressing and holding the main button for over 5 seconds. All settings confirmed up to that point will be saved, and the meter will return to the time screen.

The BIONING RIGHTEST GM100 is not intended for serum or plasma testing. It is designed to use fresh capillary whole blood, and the results are calibrated to plasma equivalents.

No. You should not drip or inject blood directly by syringe to the strip’s entry port. Doing so might contaminate the meter or cause damage.

The meter should be stored in conditions between -10 to 60 degrees Celsius (14 to 140 degrees Fahrenheit).

The “AVG” symbol indicates that the meter is displaying the average blood glucose value for a specific period (1, 7, 14, 30, or 90 days). Note that you must set the time and date for the average function to activate.

The following results are not calculated in the average:

1. Results marked with “Hi” or “Lo”.

2. Quality Control Solution results.

3. Results made outside the normal temperature range (below 10 degrees Celsius or above 40 degrees Celsius).

Once the 8-second countdown begins after blood is applied, the test is in progress and cannot be stopped. You must wait for the result to appear on the screen.

No, you should not touch the Control Solution. If you do happen to touch it, clean the area with water immediately.

If the error screen persists after performing a Quality Control Test or reinstalling the battery, contact an authorized representative for assistance.

The BIONING RIGHTEST GM100 provides averages for the last 1, 7, 14, 30, and 90 days.

Yes. You should grip the strip by the Hand Bar and insert it into the strip port with the Indication Symbol (an arrow-like symbol) facing up and pointing toward the meter.

The display area of the LCD is 38.0 mm x 29.0 mm.