BIONIME GM550 User manual

USER’S MANUAL
(BIONIME Rightest Blood Glucose Monitoring System Model GM550)
GM550
101-3GM550-0U2 EN+FR(CA)
GM550
Blood Glucose Monitoring System
Le système de lecture de glycémie
Distribution and Customer Service in Canada by/
Distribution et service a la clientele au Canada:
Auto Control Medical
www.autocontrol.com
6695 Millcreek Drive, unit 6
Mississauga, On L5N 5R8
Toll-free/Sans frais: 1-800-964-8434
0197
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]
Klaus Ellensohn
Tschuetschgasse 8, 6833
Klaus / Vlbg., Austria

The Blood Glucose Monitoring System 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 call us by
Rightest™
toll free at 1 [phone] (Monday through
Friday 8:00 AM to 5:00 PM PST). 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 Rightest™ Blood Glucose Monitoring System. 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, which
provides considerate design and accurate results, your diabetes management can become more
reliable and ease-to-use.
The Rightest™ Blood Glucose Monitoring System is intended for in vitro diagnostic use and for sel-
testing only (do not share your meter and lancing device with other users). It's for checking on
glucose levels in capillary whole blood (CB) from the fingertip, palm and forearm. 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 is not intended for the diagnosis of or screening
for diabetes mellitus or for use with neonatal or arterial blood.
Preface
32
Preface

- Before using the Rightest™ System to test your blood glucose, please read all the instructions and
practice the tests including quality control test. ( Refer to page 36.)
- Please do the quality control test regularly to make sure the test results are accurate .
- The Rightest™ Blood Glucose Meter GM550 can only be used with the Rightest™ Blood Glucose
Test Strips GS550. 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 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 is intended for self-testing. It should not be used
to diagnose diabetes mellitus.
- Rightest™ Blood Glucose Monitoring System has not been validated for use on neonates.
Therefore, it's not intended for use of neonates.
- Rightest™ Blood Glucose Meter 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.
Precaution
54
Precaution
Please take a minimum of 1.0µl to do the test on glucose monitoring system. Blood sample size
above 3.0µl might contaminate the test strip port and the meter.
Blood sample size below 1.0µl 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™ Glucose Monitoring System is 1.0µl :( )
1.0µL 1.5µL 2.0µL 3.0µL 4.0µL
PRECAUTOIN
- The meter will be set to mmol/L by default when sold in the Canada. When your display
shows " mg/dL " during setting or test, please contact customer service. Use of the wrong
unit of measure may lead to incorrect treatment.
- The meter and lancing device are for single patient use. Do not share them with anyone
including other family members. Do not use on multiple patients!!
User should wash hands thoroughly with soap and water after handling the meter, lancing
device, used lancets and/or tested strips.

Table of Contents
76
Table of Contents
About Rightest™ System
The Rightest™ Blood Glucose Monitoring System
The Rightest™ Meter
The Rightest™ Test 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
Turning On/Off the Backlight
Easily Handling the Rightest™ Test Strip
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
24
26
27
33
34
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
Warranty
Customer Service
Expected glucose values without diabetes
Parts of Critical Component
Log Book
Warranty Card
Emergency Card
36
38
40
43
44
48
49
51
52
53
54
55
66
69

9
10＊
53 ＊2
6 ＊
1
8
Package of System Kit
Your Blood Glucose Monitoring System 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 Blood Glucose Monitoring System :
1. Getting Started Guide
2. User's Manual ( includes Log Book, Warranty Card, Emergency Card )
3. Blood Glucose Test Strip Package Insert ＊
4. Control Solution Package Insert ＊
5. Meter ( with 2 CR2032 batteries installed )
6. Test strips ( 0/10/25 pcs )＊
7. Control Solution ＊
8. GD500 Lancing Device ＊
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™
Rightest™
Rightest™
Rightest™
Rightest™
Rightest™
4 ＊
7 ＊
8 ＊
9 ＊
The Rightest™ Blood Glucose Monitoring System The Rightest™ Blood Glucose Monitoring System
GM550
GM550
GM550

Manufacturer:
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.
TM
The Rightest Meter
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
Battery Cover
Slide cover to change
batteries.
Meter Serial Number
Meter Battery
Backlight Battery
TM
The Rightest Meter
GM550

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
Test strip
Warns when using the strip, not suitable for your
region test, or strip error
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 Meter TM The Rightest Meter

1716
Meter activation and Battery Change
1. Turn the meter over. Press and
push batteries cover to open.
PRECAUTION
- Please follow the local regulation and discard a used battery properly.
4. The 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.
3. Slide the battery cover
back until it snaps into
place.
2. Install the battery. Be sure to
put battery in correct direction.
Meter activation and Battery change
Your meter comes with two CR2032, 3volt, batteries installed. Two new batteries 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.
NOTE
- When meter backlight has no function, you cannot see the backlight, please change your
backlight battery.
- When the backlight battery is running out of power, your meter still works properly but
without backlight function.

1918
NOTE
- When you keep pressing the main button for 2 seconds, the display on screen will show
backlight. Keep pressing the main button till display is off.
- When you keep pressing the main button for 4 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.
You can enter Setting Mode by below 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 batteries. The meter will do self test. Press the
main button to exit the self test and enter Setting Mode.
2. With Battery inserted
Press the main button first to turn on the meter. Then press and hold the main button for 7 seconds
(the meter will first show backlight, then be turned off during this period, please keep pressing)
until you hear a beep, 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. Year setting
With the year format blinking, press the Left or Right button to adjust it. Then
press the Main button to confirm it. Meantime, it will shift to next digit for
setting. Repeat the above action until the year setting is completed. Then it
will move to Month 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 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.
1)
2)
3)

2120
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.
Meantime, it will shift to next digit for setting. Repeat the
above action until the minute setting is completed. 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
finish the settings.
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 hours setting.
NOTE
- When you do not do any settings of meter for over 2 minutes, the meter will leave setting
mode and power off automatically.
Setting Up Your Meter- Setting the Time, Volume and Date Setting Up Your Meter- Setting the Time, Volume and Date
8. Ending setting
After volume 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”.)
4a) 4b)
5) 6)
7a) 7b)

2322
Turning on /off the Backlight
1. How to turn on the Meter
Press the Main button or Insert a test strip.
2. Manual Power off
If you want to turn off the meter, please keep pressing the Main button for 4 seconds.
3. Auto Power off
The meter will power off automatically if you don't operate it over 2 minutes.
Turning On/Off the Meter
1. How to turn on the Backlight
Keep pressing the Main button for 2 seconds.
2. Manual Backlight off
If you want to turn off the backlight, please keep pressing the Main button for another 2 seconds.
3. Auto Backlight off
The meter backlight will turn off automatically if you don’t operate it over 10 seconds.

25
24
How to easily handle the Rightest™ test strip ?
Inserting the test strip:
1. Hold the test strip between thumb and middle finger with indication symbol
" " facing up.
2. Put on the side of strip as shown. forefinger
NOTE
This is the easiest way to insert the strip.
3. Insert the test strip into test strip port until it snaps and firmly stops.
Removing the test strip:
1. Hold the test strip same as insert it.
2. Rotate the test strip 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 test strip 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.
Easily Handling the Rightest™ Test Strip Easily Handling the Rightest™ Test Strip

27
26
Getting Ready for Testing
Before performing a blood glucose test,
you have to prepare the items below :
- Rightest™ Blood Glucose Meter
- Rightest™ Blood Glucose Test Strips
( Please check the expired date on the vial. Don’t
use the expired test strip )
- Lancing device
- Sterile lancet
- Alcohol swab ( optional )
PlungerHubLancet carrier
Release button
Safe switch
Depth adjustable cap
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.
PRECAUTION
- The GD500 Lancing device is for single patient use
only. Do not share them with anyone including other
family members. Do not use on multiple patients!

29
28
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 strip from the vial. Re-cap the vial cap immediately.
10. Insert the strip into the strip port of the meter 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
9
NOTE
- The meter will automatically detect Code number on
strip. You don't have to check the Code number on
the meter display and strip vial.
10
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
test strip.
14. You will see the countdown mode on the screen. After 5
seconds, the test result appears.
12
14
11
13c
Performing a Blood Test
GM5 50
13a 13b

31
30
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 I (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
PRECAUTION
- Do not apply your blood drop to the sample entry on the strip until you see
the " appear. The meter is performing an internal test and will display
" " and " if you apply blood too soon. Please repeat the test with a
new test strip.
- Record the date of opening a new test strip vial for the first time. Discard the
vial of test strips after 3 months from opening.
"
"
18
Test Strip s
2009 .10 .0 1
Performing a Blood Test
Alternative site testing-palm or forearm blood sampling
- To do the alternative site testing, please install the for your lancing device.
( For detailed information of lancing device, please check the instruction manual
for the lancing device. )
- 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
Pressing for
a few seconds
Releasing
button

33
32
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.
- The GD500 Lancing device is for single patient use only. Do not share them with anyone
including other family members. Do not use on multiple patients!
Performing a Test in Order 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.
PRECAUTION
- Check the expiration date printed on the package every time you use the strip. Do not use
expired test strips.
- Use each test strip immediately after taking it out from the vial.
- Do not reuse test strips.
- Do the test at least 30 minutes after while entering another site with different ambient
temperature.
Insufficient blood sample Enough blood sample

35
34
Comprehending Test Results and Messages
Blood glucose test results are shown on the meter as mmol/L.
If your blood glucose result is unusually high or low, or if you question your testing results, repeat
the test with a new test strip. You can also run a QUALITY CONTROL TEST with your Rightest™
Control Solutions to check your meter and strip. ( Refer to page 36. ) 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
The Rightest™ Meter displays results between 1.1 and 33.3 mmol/L. If your test
result is below 1.1 mmol/L, " " 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 ( 33.3
mmol/L ), " " 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.

36 37
Test St rips
Quality Control Test
PRECAUTION
- Each time you open a new bottle of Control Solution, write
the discard date on the label. Control Solution is good for
3 months after opening the bottle, or until the expiration
date printed on the label, whichever comes first.
The your Control Solution results are out of the range :
Y
dure correctly.
Malfunction of the meter or the test strip.
possible reasons
- our Control Solution has expired or has been opened 3 months ago.
TM
If Control Solution results are out of range, your Rightest Blood Glucose Monitoring System 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 to test your blood glucose and
contact your Bionime Customer service.
- Your test strip has expired.
- You left the cap of the tst strip vial opened or the control solution off for a long time.
- You didn't perform the test proce
-
Quality Control Test
Please use normal or high level control solutions tested with Blood Glucose Monitoring
System 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 passes Quality Control Test. That
TM
means your Rightest Blood Glucose Monitoring System is working correctly.
TM
Rightest
Example of Control Solution Range
printed on your test strip vial label.
Control Solution Range mmol/L
Normal: 4,6-6,3
High: 13,2-17,8
Control Solution Range:
When should a Quality Control Test be performed ?
- To ensure that your meter and test strips are working together properly.
- To confirm that you are following the correct procedure.
- To prepare for your initial blood glucose test.
- To check the test strips when you open a new vial of strips.
- To check your meter 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.
Example of Expiration Date:
Exp. Date 2014-06
NOTE
- If you want to purchase new normal or high level control solutions, please contact your
authorized Bionime representative.