BIONIME rightest GM260 User manual

101-3GM260-032 EN
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
http: //www.bionime.com
E-mail: [email protected]
BIONIME GmbH
Tramstrasse 16, 9442 Berneck
Switzerland
E-mail: [email protected] 0197
USER’S MANUAL
GM260
Blood Glucose Monitoring System
GM260
Rev. Date: 2017-08

We will make every effort to provide assistance and solutions for you.
Healthcare professional should be contacted when the authorized representatives are not available.
Please forward your warranty card to Bionime authorized representative to activate your warranty
coverage.
Thank you for selecting the Blood Glucose Monitoring System GM260. Please read this
manual thoroughly before you start testing. It provides all the information you need to use the
product. You will get a correct test result by the following instruction of this manual.
It is quite important for you to monitor blood glucose regularly. A derived complication can thus be
effectively reduced. Through the assistance of Rightest™ Blood Glucose Monitoring system GM260,
which provides considerate design and accurate results, your diabetes management can become
more reliable and ease-to-use.
The Rightest™ Blood Glucose Monitoring System GM260 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. You may consult your
healthcare professional for instructions on how to use the system correctly. Our Customer Support
staff is available to assist you as well.
The Rightest™ Blood Glucose Monitoring System GM260 was manufactured and supported by
Bionime Corporation and its authorized representative. If you have any questions or concerns, please
contact your Bionime authorized representative or email to [email protected].
Rightest™
Preface
32
Preface

Precaution
54
Precaution
- Before using the Rightest™ Blood Glucose Monitoring System GM260 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 Rightest™ 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 Rightest™ 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 Rightest™ 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.
Please take a minimum of 0.75µL to do the test on Rightest™ 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.
Sample Size Example
- Not to be exposed dripping or splashing.
- The minimum blood sample size of Rightest™ Blood Glucose Monitoring System GM260 is 0.75µL
( )
0.75 .0µL .0µLµL 1.0µL µL 1.5 2 3

Table of Contents
76
Table of Contents
About Rightest™ System
The Rightest™ Blood Glucose Monitoring System GM260
The Rightest™ Blood Glucose Meter GM260
The Rightest™ Blood Glucose GS260Test Strip
Being Ready for Test
Meter activation and Battery change
Setting Up Your Meter - Setting the Time, Volume and Date
Turning On/Off the Meter
Handling the Rightest™ Test Strip GS260
Testing Procedure
Getting Ready for Testing
Performing a Blood Test
View Window Appearance
Comprehending Test Results and Messages
8
10
14
16
18
22
23
25
26
32
33
Quality Control
Quality Control Test
Performing a Quality Control Test
Review Your Test Memory
Recalling Test Result and Average
Caring for Your Meter
Error Messages and Trouble Shooting
Limitations
Specification
Customer Service
Warranty
Main Parts
35
37
39
42
43
48
49
51
52
53

9
10＊
53 ＊2
6 ＊
1
8
4 ＊
7 ＊
8 ＊
9 ＊
The Rightest™ Blood Glucose Monitoring System GM260
GM260
Package of System Kit
Your Blood Glucose Monitoring System GM260 consists of several items. Please identify
each item of your system and learn what they're called and how they're used.
These items are included in your Rightest™ Blood Glucose Monitoring System GM260 :
1. Getting Started Guide
2. User's Manual ( includes Log Book, Warranty Card, Emergency Card )
3. Rightest™ Blood Glucose Test Strip GS260 Package Insert ＊
4. Rightest™ Control Solution Package Insert ＊
5. Rightest™ Blood Glucose Meter GM260 ( with 1 CR2032 battery installed )
6. Rightest™ Blood Glucose Test Strip GS260 ( 10/25 pcs )＊
7. Rightest™ Control Solution ＊
8. ＊
9. Clear Cap ＊
10. Disposable Sterile Lancets ( 10 pcs ) ＊
11. Carrying Case ( not shown )＊
12. Instruction for the lancing device ( not shown )＊
( Different packages have different bundled items. Some of packages might not include ＊ items.)
Rightest™
Rightest™ Lancing Device GD500
The Rightest™ Blood Glucose Monitoring System GM260

1110
Left Button ( )
For operating the meter, please
check details in following sections.
Main Button ( )
For operating the meter, please
check details in following sections.
GM260
Display Window
Show your test result, messages
and relative information.
Test Strip Port
Insert test strip here until you hear a
click.
Right Button ( )
For operating the meter, please
check details in following sections.
Product name
Meter Serial Number
Meter Battery
Battery Cover
Slide cover to change
batterry.
TM
The Rightest Blood Glucose Meter GM260 TM The Rightest Blood Glucose Meter GM260

1312
Indicates a test result stored in memory
Indicates a test result, not joining into the Average
function of this meter
Indicates with the average result
Indicates a control solution test result
Unit of test result
Test result
Warns when the battery is low or must be replaced
Tell when to apply the blood sample
Current date under time mode or Testing date
under memory mode
Indicates if the environmental temperature is
exceeded during testing
Indicates the time in 12H format
Current time or Testing time
under memory mode
under time mode
Manufacturing use only
TM
The Rightest Blood Glucose Meter GM260 TM The Rightest Blood Glucose Meter GM260
Appears after you insert test strip into meter
Appears when an error occurs

1514
View Window
This window is yellow before applying
blood sample. It gradually turns red
when filled with blood.
Hand Bar
Grip here to insert
test strip into meter.
Electrode Contacts
Sensing signal output terminals.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with indication symbol
up and toward meter.
The Rightest™ Blood Glucose Meter GM260 can only be used with the Rightest™ Blood Glucose
Test Strips GS260.
The application of other Test Strips or control solutions can lead to incorrect results.
TM
The Rightest Blood Glucose Test Strip GS260
Sample Entry
µL
Apply a drop of blood or control solution here.
The test request is only 0.75 of blood.
TM
The Rightest Blood Glucose Test Strip GS260
PRECAUTION
TM
- Re-cap the Rightest Blood Glucose Test Strip GS260 vial immediately after taking out a
test strip.
TM
- Do not reuse Rightest Blood Glucose Test Strip GS260.
TM
- Do not use expired Rightest Blood Glucose Test Strip GS260.
TM
- 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 month from opening.
TM
- Store the Rightest Blood Glucose Test Strip GS260 in a cool (39-86℉ or 4-30℃) and
dry location (< 90% relative humidity). Do not expose to direct sunlight or heat.
TM
- For detailed information, please refer to the Rightest Blood Glucose Test Strip GS260
Package Insert.
TM
- If the Rightest Blood Glucose Meter GM260 and Test Strips GS260 are exposed to a
high temperature difference, please wait 30 minutes before measurement.

1716
Meter activation and Battery Change
Meter activation and Battery change
Your Rightest™ Blood Glucose Meter GM260 comes with one CR2032, 3volt, battery installed. One
new battery will provide power to perform about 1000 tests under normal use. You can press the
main button or insert a strip to activate your meter.
1. Turn the
Glucose Meter
cover
to open.
Rightest™ Blood
GM260
Press and push battery
over.
PRECAUTION
- Please follow the local regulation and discard a used battery properly.
4. The Rightest™ Blood Glucose Meter performs a self test.
5. Press any button to exit the self-test and enter Setting Mode.
6. Set the time and date when the batteries are replaced. See Chapter "Setting up your meter -
setting the time, volume and date". Test results are still stored in the memory.
GM260
3. Slide the battery cover
back until it snaps into
place.
2. Install the battery. Be sure to
put battery in correct direction.

1918
You can enter Setting Mode by the following two ways.
1. Reload battery
After removing the battery, please press the main button for several times until no signal on screen,
then follow the battery installation steps to load . The Rightest™ Blood Glucose Meter
GM260 will do self test. Press the main button to exit the self test and enter Setting Mode.
2. Press the Main button
Press the main button to turn on the Rightest™ Blood Glucose Meter hen press and
hold the main button for 7 seconds until you hear a beep
battery
GM260. T
, indicating you have successfully entered
Setting Mode. The display screen will show setting data.
Setting Up Your Meter- Setting the Time, Volume and Date Setting Up Your Meter- Setting the Time, Volume and Date
1)
2)
3)
NOTE
- When you keep pressing the main button for 3 seconds, the display on screen will turn off.
Please don't care it. Keep pressing the main button till entering setting data.
- Quick press the main button allows you to change setting. However, if you want to return to
the time mode, you need to go through all the settings first by pressing quickly the main
button.
1. Year setting
2. Month setting
With the month blinking, press the Left or Right button until the current month
appears. Then press the Main button to confirm it and move to Day setting.
3. Day setting
With the day blinking, press the Left or Right button until the current day
appears. Then press the Main button to confirm it and move to Time format
setting.
With the year format blinking, press the Left or Right button to adjust it. Then
press the Main button to confirm it. Then it will move to Month setting.

2120
Setting Up Your Meter- Setting the Time, Volume and Date Setting Up Your Meter- Setting the Time, Volume and Date
4a) 4b)
5) 6)
7a) 7b)
4. Time format 12/24H selection
With the time format blinking, press the Left or Right button
to adjust it. Then press the Main button to confirm it and
move to hour setting.
8. Setting the Unit of Measurement
With milligrams per deciliter(mg/dL) or per
(mmol/L) blinking, press the Left or Right button to
switch. Then press the main button to confirm it and finish
the settings.
millimoles
liter
5. Hour setting
With the hour blinking, press the Left or Right button until
the current hour appears. Then press the Main button to
confirm it and move to minute setting.
6. Minute setting
With the minute blinking, press the Left or Right button to
adjust it. Then press the Main button to confirm it. Then it
will move to volume setting.
7. Volume setting
With the volume blinking, press the Left or Right button to
turn it on or off. Then press the Main button to confirm and
move to measurement of unit setting.
NOTE
- When you do not do any settings of meter for over 2 minutes, the Rightest™ Blood Glucose
Meter ll leave setting mode and power off automatically.
- Your Meter GM260 is ready to use at the first time. The meter default is set
according to your local preference.
GM260 wi
Rightest™
9. Ending setting
After measurement of unit settings, for confirmation you will hear a beep (if
volume is turned on). All the settings are saved and completed and will return
to time screen. (If Volume is turned off, the display will directly return to time
screen without a sound of “beep”.)

2322
Turning On/Off the Meter Handling the Rightest™ Test Strip GS260
1. How to turn on the Rightest™ Blood Glucose Meter GM260
Press the Main button or insert a test strip.
2. Manual Power off
If you want to turn off the Rightest™ Blood Glucose Meter GM260, please keep pressing the Main
button for 3 seconds.
3. Auto Power off
The Rightest™ Blood Glucose Meter GM260 will power off automatically if you don't operate it
over 2 minutes.
How to handle the Rightest™ Blood Glucose Test Strip GS260?
Inserting the Rightest™ Blood Glucose Test Strip GS260:
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.
NOTE
This is the easiest way to insert the strip.
3. Insert the Rightest™ Blood Glucose Test Strip GS260 into test strip port until
it snaps and firmly stops.

25
24
Handling the Rightest™ Test Strip GS260 Getting Ready for Testing
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 )
PlungerHubLancet carrier
Release button
Safe switch
Depth adjustable cap
GM260
Removing the Rightest™ Blood Glucose Test Strip GS260:
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.
NOTE
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.
NOTE
Test Strip Port will not be contaminated by blood, if you follow the step
correctly.

27
26
Performing a Blood Test
2. Pull off the depth adjustable cap.
3. Insert a new disposable lancet firmly into lancet carrier.
Twist off and set aside the protective cover of the
disposable lancet.
5. Replace the depth adjustable cap.
4.
1
2 3
4 5
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.
Performing a Blood Test
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.
8. Wash your hands with warm soapy water and dry thoroughly.
9. Take one Rightest™ Blood Glucose Test Strip GS260 from
the vial. Re-cap the vial cap immediately.
10. Insert the strip into the strip port of the Rightest™ 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).
6
7
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.
8
NOTE
The Rightest™ Blood Glucose Meter will
automatically detect Code number on strip. You don't
have to check the Code number on the meter display
and strip vial.
GM260
10
10
9

Test Strips
2010.09.0 1
29
28
11. 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.
12. Place the lancing device against your fingertip and press
the release button.
13. 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
14. You will see the countdown mode on the screen. After 5
seconds, the test result appears.
GS260.
12
11
14
Performing a Blood Test
15. Pull off the depth adjustable cap. Without touching the used
disposable lancet, stick the lancet tip into the protective
cover.
16. 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.
17. Discard the used disposable lancet into an appropriate
puncture-proof or biohazard container.
18. Replace the depth adjustable cap after finishing the test.
17
15
1
2
16
18
Performing a Blood Test
PRECAUTION
- Do not apply your blood drop to the sample entry on the strip until you see the
" appear. The Rightest™ Blood Glucose Meter
vial
for the first time. Discard the vial of test strips after 3 months from opening.
"GM260 is performing an
internal test and will display " " and " " 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
13a
13c

31
30
Alternative site testing-palm or forearm blood sampling
- To do the alternative site testing, please install the 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 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.
clear cap
clear cap
Performing a Test in Order
PRECAUTION
- 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.
Performing a Test in Order
Palm
Forearm
Pressing for
a few seconds
Releasing
button

33
32
View Window Appearance
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.
Insufficient blood sample Enough blood sample
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 Rightest™ 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.
Comprehending Test Results and Messages
PRECAUTION
- Check the expiration date printed on the package every time you use the strip. Do not use
expired Rightest™ Blood Glucose Test Strip GS260.
- Use each Rightest™ Blood Glucose Test Strip GS260 immediately after taking it out from
the vial.
- Do not reuse Rightest™ Blood Glucose Test Strip GS260.
- Do the test at least 30 minutes after while entering another site with different ambient
temperature.

Test St rips
35
34
Comprehending Test Results and Messages
The Rightest™ Blood Glucose Meter GM260 displays results between 10
and 600 mg/dL. If your test result is below 10 mg/dL, " " will appear on
the screen. Please repeat your test again by a new strip.
If you still get " " 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 ), " " will appear on the screen. Please repeat your test again by a
new strip. If you still get " " result, you should immediately contact your
healthcare professional.
Quality Control Test
Please use tested with Blood Glucose Monitoring System
GM260 under Control Solution Mode. If the test result is within the Control Solution Range printed on
TM
the strip vial label, the Rightest Blood Glucose Monitoring System GM260 passes Quality Control
TM
Test. That means your Rightest Blood Glucose Monitoring System GM260 is working correctly.
TM
Rightest Control Solution TM Rightest
Example of Control Solution Range
printed on your test strip vial label.
Control Solution Range:
When should a Quality Control Test be performed ?
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.
TM
- To check the Rightest Blood Glucose Test Strip GS260 when you open a new vial of strips.
TM
- To check your Rightest Blood Glucose Meter GM260 af
TM
- To ensure that your Rightest Blood Glucose
ter 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.
Control Solution Range:
83-113 mg/dL
4.6-6.3 mmol/L

36 37
Quality Control Test
Example of Expiration Date:
Exp. Date 2015-06
Performing a Quality Control Test
OPEN
5
6
12
The your Control Solution results are out of the range :
Y
possible reasons
TM
- our Rightest Control Solution has expired or has been opened 3 months ago.
TM
- Your Rightest Blood Glucose Test Strip GS260 has expired.
TM TM
- 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.
TM
- Malfunction of the Rightest Blood Glucose Meter GM260 or Test Strip GS260.
TM
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.
NOTE
TM
- If you want to purchase new Rightest Control Solution, please contact your authorized
Bionime representative.
PRECAUTION
Each time you open a new bottle of
Control Solution is good for 3 months after opening the
bottle, or until the expiration date printed on the label,
whichever comes first.
TM
Rightest Control
TM
Solution, write the discard date on the label. Rightest
1. Take one
ith 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 " " symbol appears.
4. You will see blinking " " symbol and " " symbol on the screen,
prompting you to apply
Control
Solution on the top of the cap.
TM
Rightest Blood Glucose Test Strip GS260 from vial and
re-cap the vial cap immediately.
TM
2. Insert the Rightest Blood Glucose Test Strip GS260 w
TM
Rightest Control Solution.
TM
5. Shake the bottle of Rightest Control Solution well before opening
the cap. Then open the bottle and put the cap on the table.
TM
6. Drip a drop of Rightest Control Solution on the top of the cap.
TM
7. Gently touch sample entry of the strip with the Rightest
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.
7
4