BIONIME GM550, User Manual

Page 1: ... Renhua Road Dali Dist Taichung City 412 Taiwan Tel 886 4 24951268 Fax 886 4 24952568 http www bionime com E mail info bionime com 101 3GM550 231 EN BIONIME GmbH Tramstrasse 16 9442 Berneck Switzerland GM550 Blood Glucose Monitoring System 0197 ...

Page 2: ...ufactured and supported by Bionime Corporation If you have any question or concern please contact your local Bionime Customer Service or call us at 886 4 24951268 GMT 08 00 08 30 17 30 TM Rightest TM TM Rightest Blood Glucose Meter GM550 Rightest Blood Glucose Test Strip GS550 TM TM Rightest Rightest GM550 TM TM TM Rightest Rightest GM550 Rightest TM Rightest TM Rightest GM550 BGMS TM Rightest GM5...

Page 3: ...etting the Time Volume and Date Turning On Off the Metert Turning on off the Backlight Testing Procedure Performing a Blood Test Alternative Site Testing AST View window appearance 24 28 30 Quality Control Test 32 Quality Control Lo and Hi readings Error Messages and Trouble Shooting Specification Limitations Accuracy Customer Service Warranty Main Parts 40 47 49 50 51 44 46 Review Your Test Memor...

Page 4: ...550 TM Rightest GM550 TM Rightest GS550 TM Rightest GD500 7 Clear Cap 8 Disposable Sterile Lancets 10 pcs 9 Instructions for the lancing device TM 10 Rightest Control Solution TM 11 Rightest Control Solution Package Insert not shown 12 Warranty Card not shown 13 Carrying Case not shown 1 Meter with 2 CR2032 batteries installed 2 Test Strips 0 10 25 pcs 3 Getting Started Guide 4 User Manual 5 Test ...

Page 5: ...test GM550 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 TM Rightest GM550 Meter GM550 Meter Battery Backlight Battery ...

Page 6: ...ry 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 ...

Page 7: ... a different location with significant change in temperature TM Rightest TM TM Rightest Rightest S TM Rightest TM Rightest TM Rightest GM550 TM Rightest GM550 TM Rightest GM550 13 12 Precaution Precaution Dispose of used batteries properly Please note the System kit contains small parts like test strips which could result in a choking hazard for children Prevent water from entering the meter Never...

Page 8: ...Control Solution The application of other Test Strips or control solutions can lead to incorrect results PRECAUTION Re cap the test strip vial immediately after taking out a test strip Do not reuse test strips Do not use expired test strips Record the date of opening a new test strip vial for the first time Discard the vial of test strips after 3 month from opening Store the test strips in a cool ...

Page 9: ...still stored in the memory 3 Slide the battery cover back until it snaps into place 2 Install the batteries 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 ...

Page 10: ...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 Setti...

Page 11: ...measurement of unit 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 Your Meter default is set according to your local preference TM Rightest GM550 Setting Up Your Meter Setting the Time Volume and Date Setting Up Your Meter Setting the Time Volume and Date 9 Ending setting After settings for confirmation you wil...

Page 12: ...o 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 ...

Page 13: ...and 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 ...

Page 14: ...ective 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...

Page 15: ...or hypoglycemia Low blood glucose Fingertip samples can show the rapid change of glucose faster than palm or forearm samples As the blood flow taken from forearm is slower than fingertip or palm we recommend using the GD500 lancing device with Clear Cap for testing sites other than fingertip Fingertip test only Two hours or less after eating After exercising If you are sick If you think your blood...

Page 16: ...od 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 to check your meter and test strip 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 yo...

Page 17: ...perform the test proce Quality Control Test Please use Control Solution tested with GM550 BGMS under Control Solution Mode If the test result is within the Control Solution Range printed on the strip vial label the BGMS passes Quality Control Test That means your BGMS is working correctly TM Rightest TM Rightest GM550 TM Rightest GM550 Example of Control Solution Range printed on your test strip v...

Page 18: ...n the top of the cap Performing a Quality Control Test OPEN 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 1 2 5 6 7 9 GM550 PRECAUTION Your Control Solution results will not be calculated for average reading but still can be recalled The Control Solution Test result will be shown with symbol on the screen Our sugge...

Page 19: ... 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 Note The right button is for reviewing the tests with sequence number increasing and the left button is for re...

Page 20: ...eeping 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 ...

Page 21: ...creen still appears contact your local Bionime Customer Service Battery Error 1 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 2 The and symbols are blinking when the battery is too low Meter can not do the strip test Please change the battery immediately meter 1a 1b 2 Error messages and Trouble shooting NOTE When m...

Page 22: ...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 10 40 or 50 104 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 ...

Page 23: ...0 4 30 39 86 90 relative humidity Memory Capacity 10 40 50 104 10 90 Turn off automatically 2 minutes after last user action Press the button for 4 seconds Measurement Technology Measurement Calibration Sample Minimum Sample Volume Measuring Range Test Time 1 0 microliters 5 seconds 10 600 mg dL 0 6 33 3 mmol L Oxidase Electrochemical Sensor Plasma Capillary whole blood Operating Temperature Opera...

Page 24: ...ted by comparing whole blood plasma equivalent glucose values on the Rightest meter with plasma glucose values on a lab instrument A total of 114 patients were enrolled Each patient collected and tested their own blood samples from the fingertip using the Rightest Another blood sample was collected within 5 minutes and got the plasma Rightest Rightest Rightest palm and forearm System Analyze the p...

Page 25: ...pus value and the Rightest meter value Within 5 Within 10 Within 15 Within 20 The percent and number of samples for which the difference between the Rightest meter value and the Olympus value were within the difference range shown in the side row Table 2 represents samples for glucose results greater than 75 mg dL Acceptance criteria in ISO15197 are that 95 of all differences in glucose values sho...

Page 26: ... The manufacturer warrants that your Meter will be free from defects in materials and workmanship for five years from the date of purchase This warranty does not apply to the performance of a Meter that has been altered misused tampered with or abused in any way This warranty applies only to the original purchaser of the meter Please complete and return the enclosed warranty card to your local Bio...