BIONING GM260 (01) PDF Document

The BIONING GM260 Blood Glucose Monitoring System is intended for in vitro diagnostic use (For self-testing) only (outside the body). The testing result is calibrated to be plasma equivalent for test with fresh capillary whole blood samples from the fingertip, palm and forearm. It is intended for self-testing and should not be used to diagnose diabetes mellitus.

Before using the BIONING GM260 Blood Glucose Monitoring System to test your blood glucose, please read all the instructions and practice the tests including quality control test (Refer to P.35).

Please do the quality control test regularly to make sure the test results are accurate.

The BIONING GM260 Blood Glucose Meter GM260 can only be used with the Rightest Blood Glucose Test Strips GS260. The use of any other brand Strips should not be used under any circumstances. The use of other brands of strips may give inaccurate results.

The BIONING GM260 Blood Glucose Monitoring System GM260 is intended for in vitro diagnostic use only. The testing result is calibrated to be plasma equivalent for test with fresh capillary whole blood samples from the fingertip, palm and forearm.

The BIONING GM260 Blood Glucose Monitoring System GM260 is intended for self-testing. It should not be used to diagnose diabetes mellitus.

Rightest Blood Glucose Monitoring System GM260 has not been validated for use on neonates. Therefore, it’s not intended for use of neonates.

Rightest Blood Glucose Monitoring System GM260 hasn’t been used for arterial blood testing yet, so it is still not suitable to be used for arterial blood testing so far.

Do the test at least 30 minutes after while entering another site with different ambient temperature.

Pay attention to the environment protection when disposal of batteries.

Using appliance in tropical and / or temperate climate.

Not to be exposed dripping or splashing.

The minimum blood sample size of BIONING GM260 Blood Glucose Monitoring System GM260 is 0.75µL (•).

The minimum blood sample size of BIONING GM260 Blood Glucose Monitoring System GM260 is 0.75µL. Please take a minimum of 0.75µL to do the test on BIONING GM260 Blood Glucose Monitoring System GM260. Blood sample size above 3.0µL might contaminate the test strip port and the meter. Blood sample size below 0.75µL might cause inaccurate test result or might not start on meter measurement. In this case, repeat the test with a new test strip.

To turn on the BIONING GM260 Blood Glucose Meter GM260, press the Main button or insert a test strip.

If you want to turn off the BIONING GM260 Blood Glucose Meter GM260, please keep pressing the Main button for 3 seconds.

Yes, the BIONING GM260 Blood Glucose Meter GM260 will power off automatically if you don’t operate it over 2 minutes.

1. Hold the Rightest Blood Glucose Test Strip GS260 between thumb and middle finger with indication symbol ” ” facing up.

2. Put forefinger on the side of strip as shown.

3. Insert the Rightest Blood Glucose Test Strip GS260 into test strip port until it snaps and firmly stops.

This is the easiest way to insert the strip.

1. Hold the Rightest Blood Glucose Test Strip GS260 same as insert it.

2. Rotate the Rightest Blood Glucose Test Strip GS260 counterclockwise and pull up at the same time.

Pulling the strip in a counterclockwise direction will make it easier to remove it from the meter.

3. Take the Rightest Blood Glucose Test Strip GS260 out of test strip port totally.

Please follow the local regulation and discard used strip properly.

Test Strip Port will not be contaminated by blood, if you follow the step correctly.

Before performing a blood glucose test, you have to prepare the items below:

• Rightest Blood Glucose Meter GM260
• Rightest Blood Glucose Test Strips GS260 (Please check the expired date on the vial. Don’t use the expired test strip)
• Rightest Lancing device GD500
• Sterile lancet
• Alcohol swab (optional)

1. Hold the adjustable cap in one hand and hold the hub in the other hand. Bend the cap towards the down side. When a gap appears between the cap and hub, pull them off in opposite directions.

2. Pull off the depth adjustable cap.

3. Insert a new disposable lancet firmly into lancet carrier.

4. Twist off and set aside the protective cover of the disposable lancet.

5. Replace the depth adjustable cap.

6. Choose a depth of penetration by rotating the top portion of the depth adjustable cap until the setting depth matches the window. Settings are based on skin type “” for soft or thin skin; “” for average skin; “” for thick or calloused skin.

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

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

2. Take one Rightest Blood Glucose Test Strip GS260 from the vial. Re-cap the vial cap immediately.

3. Insert the strip into the strip port of the BIONING GM260 Blood Glucose Meter GM260 with the indication symbol facing up. The meter confirms the insertion of the strip with a beep (if volume is turned on).

The BIONING GM260 Blood Glucose Meter GM260 will automatically detect Code number on strip. You don’t have to check the Code number on the meter display and strip vial.

4. A blood drop symbol appears and is accompanied by a further beep (if volume is turned on). Now you can apply the blood sample within 2 minutes.

5. Place the lancing device against your fingertip and press the release button.

6. Touch and hold the drop to the edge of sample entry until you hear a ” beep” (if volume is turned on) and the View Window is totally filled with blood. If the View Window is not totally filled with blood or the test does not start, please discard the test strip and repeat the test with a new Rightest Blood Glucose Test Strip GS260.

7. You will see the countdown mode on the screen. After 5 seconds, the test result appears.

Do not apply your blood drop to the sample entry on the strip until you see the ” ” appear. The BIONING GM260 Blood Glucose Meter GM260 is performing an internal test and will display ” ” and ” Error ” if you apply blood too soon. Please repeat the test with a new Rightest Blood Glucose Test Strip GS260.

Record the date of opening a new Rightest Blood Glucose Test Strip GS260 vial for the first time. Discard the vial of test strips after 3 months from opening.

1. Pull off the depth adjustable cap. Without touching the used disposable lancet, stick the lancet tip into the protective cover.

2. Holding the release button in one hand (see picture 16, step 1) and pulling on the plunger in the other hand (see picture 16, step 2) will safely eject the used disposable lancet.

3. Discard the used disposable lancet into an appropriate puncture-proof or biohazard container.

4. Replace the depth adjustable cap after finishing the test.

The glucose test results of blood samples taken from different sites might be varied in certain conditions such as your glucose is changing rapidly following a drink, a meal, an insulin dose or exercise. In these cases, only fingertip should be used.

DO NOT test on the palm or forearm if you are testing for hypoglycemia (Low blood glucose).

Fingertip samples can show the rapid change of glucose faster than palm or forearm samples.

Consult with your healthcare professionals whenever you want to conduct a sampler from palm or forearm.

As the blood flow taken from forearm is slower than fingertip or palm, we recommend using a special lancing device with Clear Cap for testing sites other than finger.

If you use normal lancing device for palm or forearm the blood sample might be not enough for meter.

Please periodically compare the test system to a laboratory test system known to be well maintained and monitored by a healthcare provider.

To do the alternative site testing, please install the clear cap for your Rightest Lancing Device GD500. (For detailed information of lancing device, please check the instruction manual for the Rightest Lancing Device GD500.)

To increase the blood flow, please massage the puncture area of palm or forearm for a few seconds.

Immediately after massaging the puncture area, press and hold the lancing device with the clear cap against palm or forearm.

Then press the release button.

Continue holding the lancing device against palm or forearm and gradually increase pressure for a few seconds until the blood sample size is sufficient.

Make sure your blood sample covers the whole area of the View Window to get an accurate test result. Insufficient blood sample might cause inaccurate test result. Repeat the test with a new test strip.

If your blood glucose result is unusually high or low, or if you question your testing results, repeat the test with a new Rightest Blood Glucose Test Strip GS260. You can also run a QUALITY CONTROL TEST with your Rightest Control Solutions to check your BIONING GM260 Blood Glucose Meter GM260 and Test Strip GS260 (Refer to P. 35). If the test result still remains unusually high or low, contact your healthcare professional immediately.

If you are experiencing symptoms that are not consistent with your blood glucose test results and you have made sure to follow all instructions of this manual, contact your healthcare professional immediately.

The BIONING GM260 Blood Glucose Meter GM260 displays results between 10 and 600 mg/dL. If your test result is below 10 mg/dL, “Lo” will appear on the screen. Please repeat your test again by a new strip. If you still get ” Lo” result, you should immediately contact your healthcare professional.

If your test result is above the high end of the system’s detective range (600 mg/dL), “Hi” will appear on the screen. Please repeat your test again by a new strip. If you still get ” Hi” result, you should immediately contact your healthcare professional.

1. Take one Rightest Blood Glucose Test Strip GS260 from vial and re-cap the vial cap immediately.

2. Insert the Rightest Blood Glucose Test Strip GS260 with view window, facing up, into test strip port.

3. While the blood drop symbol flashing, press and hold the main button for over 3 seconds until the ” CS ” symbol appears.

4. You will see blinking” ” symbol and ” CS ” symbol on the screen, prompting you to apply Rightest Control Solution.

5. Shake the bottle of Rightest Control Solution well before opening the cap. Then open the bottle and put the cap on the table.

6. Drip a drop of Rightest Control Solution on the top of the cap.

7. Gently touch sample entry of the strip with the Rightest Control Solution on the top of the cap.

8. When you hear a beep (if volume is turned on) please wait for the test result. The screen will display the countdown number from 5.

9. Tightly replace the cap on the Rightest Control Solution bottle.

10. The Control Solution result appears. Compare your Quality Control Test result to the Control Solution Range printed on the Rightest Blood Glucose Test Strip GS260 vial label.

Please use Rightest Control Solution tested with BIONING GM260 Blood Glucose Monitoring System GM260 under Control Solution Mode. If the test result is within the Control Solution Range printed on the strip vial label, the Rightest Blood Glucose Monitoring System GM260 passes Quality Control Test. That means your Rightest Blood Glucose Monitoring System GM260 is working correctly.

A Quality Control Test should be performed:

• To ensure that your Rightest Blood Glucose Meter GM260 and Test Strip GS260 are working together properly.
• To confirm that you are following the correct procedure.
• To prepare for your initial blood glucose test.
• To check the Rightest Blood Glucose Test Strip GS260 when you open a new vial of strips.
• To check your BIONING GM260 Blood Glucose Meter GM260 after it has been dropped, damaged or exposed to liquids.
• When you suspect that your test results are inaccurate, or if your test results are not consistent with the way you feel.

The possible reasons your Control Solution results are out of the range:

• Your Rightest Control Solution has expired or has been opened 3 months ago.
• Your Rightest Blood Glucose Test Strip GS260 has expired.
• You left the cap of the Rightest Blood Glucose Test Strip GS260 vial opened or the Rightest Control Solution off for a long time.
• You didn’t perform the test procedure correctly.
• Malfunction of the BIONING GM260 Blood Glucose Meter GM260 or Test Strip GS260.

If Control Solution results are out of range, your Rightest Blood Glucose Monitoring System GM260 may not be working properly. Repeat the Quality Control Test. If your Control Solution results outside the range still exist, do not use the Blood Glucose Monitoring System GM260 to test your blood glucose and contact your Bionime Customer service.

The BIONING GM260 Blood Glucose Meter GM260 is able to store 500 test results with time and date automatically. If your meter has stored 500 results, which is the maximum memory of the meter, the newest test result will replace the oldest one. To recall your test memory, start the meter without test strip inserted.

1. Press the Main button to switch from the Time mode to the Memory mode. First you will see the “MEM” symbol on the up per left corner of the display. When you press the right button, the latest result will be displayed. By pressing the right button sequentially former test results will be shown in historical order. You will see the sequence number on the lower right corner and the year on the lower left corner of the display followed by date and time of the measurement.

The Right button is for reviewing the tests with sequence number increasing, and the Left button is for reviewing tests with sequence number decreasing. The sequence no “1” is the latest result while sequence no “500” is the oldest test result.

2. To finish reviewing memory tests, press Main button again, and you will enter the Average screen. By pressing the Right button, the display shows “AVG” on the upper right corner of the display and the average value for the actual day. By sequentially pressing the Right or Left button you will get to the 1-day, 14-day, 30-day and 90-day average of your blood glucose values. You will see the number of the calculated days on the lower left corner and the number of the calculated readings on the lower right corner.

You may select the unwanted or doubtful test results, to exclude them from the average calculation, after your every test. After you finished your test in the test mode, you can exclude the unwanted result. Keep pressing the Right button until you see the symbol “NO AVG” in the top right cornetr of the screen. By keeping the Right button pressed and pressing the main button simultaneously to confirm the value as “Non average”.

Now this value is flagged by the symbol “NO AVG” in the up per right corner of the screen.

If you want to cancel this non-averaging setting, you have to stay in the test mode. First keep pressing the Right button until the “NO AVG” symbol changes to “AVG” in the up per right corner of the screen. To confirm this original status you again simultaneously press the Main button to confirm the “AVG” status. Now the value will be stored as a regular value and included in the average values.

The average function is related to the time setting. You must set the time right and have enough time intervals on the basis of current inquiry time, to make sure that the average test results will show. Use the 14-day average for example; if your current inquiry time is 2010/1/30, then that you must check that you have tested blood glucose in the past 14 days before 1/30, including today. If not, the 14-day average will show no figure.

The Non-averaging/re-averaging function only works in the test mode and when you get the value. In the MEM mode, you can not perform this action.

If you want to see all values automatically displayed in sequence, first enter the memory mode. Then keep pressing the Right or Left button for 2 seconds. (Right button is for searching the tests the latest value to the oldest one; by using the Left button you can scroll from the oldest to the latest one). Anytime you want to stop just release the pressed button. It will stop and display the current displayed value. You can use this way to find a particular reading you want to check.

If you just finish the test, press the Main button to enter the MEM (memory) screen and review the latest test result.

You have to set the time and date to activate the average function.

The “Lo”, “Hi” results, the Control Solution results and the test result made out of normal temperature range <50°F (10°C), >104°F (40°C) are not calculated in the average.

Your Control Solution results will be automatically non-averaged without selecting, but still can be recalled. The Control Solution Test results will show with “CS” symbol under memory screen.

Keep your BIONING GM260 Blood Glucose Meter GM260 and Test Strip GS260 free of dust, water or any other liquid. Store the meter in the carrying case when not in use. If meter is dropped or damaged, perform a quality control test with the control solution before doing a blood glucose test.

Clean the outside of the BIONING GM260 Blood Glucose Meter GM260 with a damp cloth and mild soap/detergent. Keep the test strip port from getting wet.

If your Test Strip Port is stained with blood, control solution or any liquid, please use a dry tissue or alcohol swab to clean it up immediately. Do not use any thing wet to clean it. Perform a quality control test to ensure the BIONING GM260 Blood Glucose Meter GM260 is working properly.

Er1 means the inserted test strip has been used or damaged. Please use a new test strip from vial.

Er2 means the meter has malfunctioned. Do the Quality Control Test or reinstall the battery to check if the meter works properly.

Er3 means signal transmission is disrupted. Repeat the test.

Er4 means applied blood volume is insufficient. Repeat the test with a new test strip.

Er5 means an issue calibrating the Meter has occurred. Please follow the steps below:

1. Remove the test strip from the meter.

2. Turn off the meter(press and hold the Main button for 3 seconds).

3. Press the main button to turn ON the meter.

If after turning on the Meter, you do not see Er5, your meter is functioning properly and able to perform a test.

The “” symbol is blinking when the battery power is low. Please change the meter battery as soon as you can. You can still do the test.

The “” and “Error” symbols are blinking when the battery is too low. Meter is unable to perform a normal test. Please change the battery immediately.

When the test strip is inserted incorrectly, the meter will beep 4 times while the ” ” symbol flashes. Do not apply a sample on the test strip. Please re-insert the unused test strip correctly (refer to “Handling the Rightest GS260 Blood Glucose Test Strip” on P.23 for more information).

If, after performing the required steps, the ” ” and flashing “Error” symbols appear on the screen, it means the Rightest GS260 Test strip has been inserted incorrectly more than twice. Please, re-insert the unused test strip again after reviewing the steps on how to insert a test strip correctly on P.23 or call Customer Service for support. This error message can also indicate that you may have used the wrong test strips. Please check the test strip vial to ensure you are using the Rightest GS260 Test strips.

In order to get accurate test result, perform a test between 50~104°F (10~40°C).

1. When the ambient temperature is 32~49°F (0~9°C) or 105~122°F (41~50°C) the “” warning symbol will be blinking (1a), you still can do the test but the test result is only for reference, because the test result under these ranges of temperature might not be correct. In the memory screen this value will be flagged with “” symbol (1b). Repeat the test at an area with temperature between operating range (50~104°F or 10~40°C).

2. When you move from the area with temperature outside the operating range of test strip to another area with temperature inside operating range of test strip, please wait for 30 minutes before you do the test.

3. When the temperature is below 32°F (0°C) or over 122°F (50°C), Rightest Blood Glucose Meter GM260 can not do the test and the “Error” symbol will blink with thermograph symbol displaying on screen in this condition. Please move the meter to environment with temperature between 50~104°F (10~40°C) and repeat the test after 30 minutes.

Please don’t apply the blood drop to the sample entry of the strip before the BIONING GM260 Blood Glucose Meter GM260 displays””. If you do so, the meter will display” Error ” and ” ” accompanied by beeps (if volume is turned on). Please discard the test strip and repeat the test with a new Rightest Blood Glucose Test Strip GS260.

A blood sample should ONLY be applied to the test strip after the test strip has been inserted correctly and the Meter’s screen is showing the image of the test strip and a blood drop flashing symbol. If the blood drop flashing symbol is NOT showing on the screen, do not apply a sample to the test strip. Please re-insert the unused test strip correctly. The screen MUST show the image of the test strip accompanied by the blood drop symbol flashing (this symbol take 3 seconds to show after correctly inserting the test strip) in order for a sample to be applied. Please consult your User Manual and/or contact Customer Service for support on how to correctly insert a Rightest GS260 Test strip.

If the BIONING GM260 Blood Glucose Meter GM260 can not be started, please follow the steps below:

1. Open the battery cover, remove the battery.

2. Wait for 5 minutes and insert the battery as described “Meter activation and Battery change” on P.16~17.

The BIONING GM260 Blood Glucose Meter GM260 should be working normally after finishing above steps. If not, please contact your local Bionime customer service.

• Store the Rightest Blood Glucose Test Strips GS260 in the original capped vial at temperatures between 39°F to 86°F (4°C to 30°C) and relative humidity below 90%. Do not freeze.
• Rightest Blood Glucose Test Strips GS260 are designed for using with capillary whole blood samples. Do not use serum or plasma samples.
• Inaccurate test results may be obtained at high altitude more than about 10000 feet (3048 meters) above sea level.
• Hematocrit below 30% may cause higher results, and hematocrit above 60% may cause lower results.
• Severe dehydration and excessive water loss may cause inaccurately low results.
• Rightest Blood Glucose Monitoring System GM260 has not been validated for use on neonates.
• The glucose test may be interfered under abnormal concentration of Uric acid≥ 16.0 mg/dL (≥ 0.96 mmol/L)

NOTE

• Acetaminophen, Ascorbic acid (Vitamin C), Dopamin, Ibuprofen, Methyldopa, L-Dopa, Salicylic Acid, Tetracycline, Tolbutamide, Bilirubin-unconjugated, Cholesterol, Creatinine, Triglyceride, Maltose, Xylose, Galactose and Lactose (when occurring in normal blood or normal therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurate results.
• Sodium Fluoride/Potassium Oxalate at low glucose levels may result in inaccurate blood glucose reading. Sodium Fluoride/Potassium Oxalate should not be used as an anticoagulant with this device.

The main parts of the BIONING GM260 Blood Glucose Meter GM260 include:

• Test Strip Port: Insert test strip here until you hear a click.
• Display Window: Show your test result, messages and relative information.
• Main Button ( ): For operating the meter, please check details in following sections.
• Left Button ( ): For operating the meter, please check details in following sections.
• Right Button ( ): For operating the meter, please check details in following sections.
• Battery Cover: Slide cover to change batterry.
• Product name.
• Meter Serial Number.
• Meter Battery.