BIONIME GM550 User manual

150x70mm
GM550
GM550
Manufacturer: BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan
http: //www.bionime.com E-mail: [email protected]
Made in Taiwan / Hecho en Taiwan
USA Service Center: BIONIME USA CORPORATION
1450 E. Spruce Street, Bldg. #B, Ontario, CA 91761
Tel: [phone] Fax: [phone]
(Monday through Friday 8:00 AM to 5:00 PM PST)
USER’S MANUAL
Manual del Usuario
(BIONIME Rightest Blood Glucose Monitoring System Model GM550)
101-3GM550-0C5 EN+ES(US)
Blood Glucose Monitoring System
Sistema de Monitoreo de Glucosa en Sangre

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Preface Preface
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.
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Thank you for selecting the Blood Glucose Monitoring System GM550. 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.
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Through the assistance of Blood Glucose Monitoring system GM550, which provides considerate design and
accurate results, your diabetes management can become more reliable and ease-to-use.
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The Blood Glucose Monitoring System GM550 is intended for in vitro diagnostic use ( For self-testing &
professional use ) 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.
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The Blood Glucose Monitoring System GM550 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 toll free at 1 [phone] (Monday
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Precaution Precaution
- Before using the Rightest Blood Glucose Monitoring System GM550 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 GM550 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 GM550 is intended for self-testing. It should not be used to diagnose
diabetes mellitus.
- Rightest Blood Glucose Monitoring System GM550 has not been validated for use on neonates. Therefore, it's not
intended for use of neonates.
- Rightest Blood Glucose Monitoring System GM550 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.
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Please take a minimum of 1.0µL to do the test on Rightest Blood Glucose Monitoring System GM550. 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.
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PRECAUTOIN
The Rightest Blood Glucose Meter GM550 will be set to mg/dL by default when sold in the United States.
When your display shows " mmol/L " during setting or test, please contact customer service. Use of the wrong
unit of measure may cause you to incorrect treatment.
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Sample Size Example
- Not to be exposed dripping or splashing.
- The minimum blood sample size of Rightest Blood Glucose Monitoring System GM550 is 1.0µL : ( )
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1.0µL 1.5µL 2.0µL 3.0µL 4.0µL

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Table of Contents Table of Contents
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About Rightest System
The Rightest Blood Glucose Monitoring System GM550
The Rightest Blood Glucose Meter GM550
The Rightest Blood Glucose Test Strip GS550
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 GS550
Testing Procedure
Getting Ready for Testing
Performing a Blood Test
View Window Appearance
Comprehending Test Results and Messages
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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

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The Rightest Blood Glucose Monitoring System GM550
®The Rightest Blood Glucose Monitoring System GM550
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Package of System Kit
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Your Blood Glucose Monitoring System GM550 consists of several items. Please identify each item of your
system and learn what they're called and how they're used.
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These items are included in your Blood Glucose Monitoring System GM550 :
1. Getting Started Guide
2. User's Manual ( includes Log Book, Warranty Card, Emergency Card )
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3. Blood Glucose Test Strip GS550 Package Insert ＊
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4. Control Solution Package Insert ＊
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5. Blood Glucose Meter GM550 ( with 2 CR2032 batteries installed )
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6. Blood Glucose Test Strip GS550 ( 0/10/25 pcs )＊
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7. Control Solution ＊
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8. Lancing Device GD500 ＊
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.)
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GM550
GM550
GM550

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Left Button ( )
For operating the meter, please
check details in following sections.
Main Button ( )
For operating the meter, please check details
in following sections.
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
GM5 50
The Rightest Blood Glucose Meter GM550
®The Rightest Blood Glucose Meter GM550
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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
The Rightest Blood Glucose Meter GM550
®The Rightest Blood Glucose Meter GM550
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The Rightest Blood Glucose Test Strip GS550
®The Rightest Blood Glucose Test Strip GS550
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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.
Sample Entry
µL
Apply a drop of blood or control solution here.
The test request is only 1.0 of blood.
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 GM550 can only be used with the Rightest Blood Glucose Test Strip GS550.
The application of other Test Strips or control solutions can lead to incorrect results.
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PRECAUTION
- Re-cap the Blood Glucose Test Strip GS550 vial immediately after taking out a test strip.
- Do not reuse Blood Glucose Test Strip GS550.
- Do not use expired Blood Glucose Test Strip GS550.
- Record the date of opening a new Blood Glucose Test Strip GS550 vial for the first time. Discard the
vial of test strips after 3 month from opening.
- Store the Blood Glucose Test Strip GS550 in a cool (39-86℉ or 4-30℃) and dry location (< 90%
relative humidity). Do not expose to direct sunlight or heat.
- For detailed information, please refer to the Blood Glucose Test Strip GS550 Package Insert.
- If the Blood Glucose Meter GM550 and Test Strips GS550 are exposed to a high temperature
difference, please wait 30 minutes before measurement.
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Meter activation and Battery change Meter activation and Battery Change
1. Turn the
GM550 over. Press and push battery
cover to open.
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PRECAUTION
- Please follow the local regulation and discard a used battery properly.
4. The Blood Glucose Meter GM550 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.
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3. Slide the battery cover back until it
snaps into place.
2. Install the batteries. Be sure to put
battery in correct direction.
Your Blood Glucose Meter GM550 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.
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NOTE
- When Blood Glucose Meter GM550 backlight has no function, you cannot see the backlight, please
change your backlight battery.
- When the backlight battery is running out of power, your Blood Glucose Meter GM550 still works
properly but without backlight function.
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Setting Up Your Meter- Setting the Time, Volume and Date Setting Up Your Meter- Setting the Time, Volume and Date
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 Blood Glucose Meter GM550 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 Blood Glucose Meter GM550. 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.
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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. 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 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.
1)
2)
3)
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.

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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) 7)
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.
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 finish the settings.
NOTE
- When you do not do any settings of meter for over 2 minutes, the Blood Glucose Meter GM550 will
leave setting mode and power off automatically.
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Turning On/Off the Meter Turning on/off the Backlight
1. How to turn on the Blood Glucose Meter GM550
Press the Main button or insert a test strip.
2. Manual Power off
If you want to turn off the Blood Glucose Meter GM550, please keep pressing the Main button for 4 seconds.
3. Auto Power off
The Blood Glucose Meter GM550 will power off automatically if you don't operate it over 2 minutes.
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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 Blood Glucose Meter GM550 backlight will turn off automatically if you don’t operate it over 10 seconds.Rightest®

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Easily Handling the Rightest Test Strip GS550
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Easily Handling the Rightest Test Strip GS550
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How to easily handle the Rightest Blood Glucose Test Strip GS550?
Inserting the Rightest Blood Glucose Test Strip GS550:
1. Hold the Rightest Blood Glucose Test Strip GS550 between thumb and middle finger with
indication symbol " " facing up.
2. Put forefinger on the side of strip as shown.
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NOTE
This is the easiest way to insert the strip.
3. Insert the Rightest Blood Glucose Test Strip GS550 into test strip port until it snaps and firmly
stops.
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Removing the Rightest Blood Glucose Test Strip GS550:
1. Hold the Rightest Blood Glucose Test Strip GS550 same as insert it.
2. Rotate the Rightest Blood Glucose Test Strip GS550 counterclockwise and pull up at the same time.
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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 GS550 out of test strip port totally.
Please follow the local regulation and discard used strip properly.
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NOTE
Test Strip Port will not be contaminated by blood, if you follow the step correctly.

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Getting Ready for Testing Performing a Blood Test
Before performing a blood glucose test, you have to
prepare the items below :
- Rightest Blood Glucose Meter GM550
- Rightest Blood Glucose Test Strips GS550
( Please check the expired date on the vial. Don’t use the expired test
strip )
- Rightest Lancing device GD500
- Sterile lancet
- Alcohol swab ( optional )
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PlungerHubLancet carrier
Release button
Safe switch
Depth adjustable cap
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. 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.
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Performing a Blood Test 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 Blood Glucose Test Strip GS550 from the vial. Re-cap the vial cap
immediately.
10. Insert the strip into the strip port of the Blood Glucose Meter GM550 with
the indication symbol facing up. The meter confirms the insertion of the strip with a
beep (if volume is turned on).
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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.
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NOTE
The Blood Glucose Meter GM550 will automatically detect Code
number on strip. You don't have to check the Code number on the meter display
and strip vial.
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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 Blood Glucose Test Strip GS550.
14. You will see the countdown mode on the screen. After 5 seconds, the test result
appears.
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Performing a Blood Test Performing a Test in Order
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.
PRECAUTION
- Do not apply your blood drop to the sample entry on the strip until you see the " " appear. The
Blood Glucose Meter GM550 is performing an internal test and will display " " and " " if
you apply blood too soon. Please repeat the test with a new Blood Glucose Test Strip GS550.
- Record the date of opening a new Blood Glucose Test Strip GS550 vial for the first time. Discard
the vial of test strips after 3 months from opening.
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Test Strips
2013.10.01
Alternative site testing-palm or forearm blood sampling
- 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.
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Pressing for
a few seconds
Releasing
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Performing a Test in Order View Window Appearance
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.
Make sure your blood sample covers the whole area of the
View Window to get an accurate test result. An insufficient
blood sample will result in an error message ("Er4"). If this
occurs, 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 Rightest
Blood Glucose Test Strip GS550.
- Use each Rightest Blood Glucose Test Strip GS550 immediately after taking it out from the vial.
- Do not reuse Rightest Blood Glucose Test Strip GS550.
- Do the test at least 30 minutes after while entering another site with different ambient temperature.
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Insufficient blood sample Enough blood sample

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Comprehending Test Results and Messages Comprehending Test Results and Messages
Blood glucose test results are shown on the Rightest Blood Glucose Meter GM550 as mg/dL.
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 GS550. You can also run a QUALITY CONTROL TEST with your Rightest Control
Solutions to check your Rightest Blood Glucose Meter GM550 and Test Strip GS550 ( 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.
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The Rightest Blood Glucose Meter GM550 displays results between 20 and 600 mg/dL. If your test
result is below 20 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.
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Quality Control Test Quality Control Test
Test St rips
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.
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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 GS550 has expired.
- You left the cap of the Rightest Blood Glucose Test Strip GS550 vial opened or the Rightest Control Solution off for a long time.
- You didn't perform the test procedure correctly.
- Malfunction of the Rightest Blood Glucose Meter GM550 or Test Strip GS550.
If Control Solution results are out of range, your Rightest Blood Glucose Monitoring System GM550 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 GM550 to test your blood glucose and contact your Bionime Customer service.
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Please use normal or high level Control Solutions tested with Blood Glucose Monitoring System
GM550 under Control Solution Mode. If the test result is within the Control Solution Range printed on the strip vial label,
the Blood Glucose Monitoring System GM550 passes Quality Control Test. That means your Blood
Glucose Monitoring System GM550 is working correctly.
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Example of Control Solution Range
printed on your test strip vial label.
Control Solution Range mg/dL
Normal: 83-113
High: 237-321
Control Solution Range:
When should a Quality Control Test be performed ?
- To ensure that your Blood Glucose Meter GM550 and Test Strip GS550 are working together properly.
- To confirm that you are following the correct procedure.
- To prepare for your initial blood glucose test.
- To check the Blood Glucose Test Strip GS550 when you open a new vial of strips.
- To check your Blood Glucose Meter GM550 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.
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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.
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