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101-3GM750-

XXX

BIONIME CORPORATION

No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
http: //www.bionime.com
E-mail: [email protected]

Made in Taiwan

User’s Manual

GT200

Rev

. Da

te: 2019-10

Blood Glucose Monitoring System

143x100mm

BIONIME GmbH

Tramstrasse 16

9442 Berneck

Switzerland

E-mail: [email protected]

0197

Summary of Contents for GT200

Page 1: ...ng City 40242 Taiwan Tel 886 4 2369 2388 Fax 886 4 2261 7586 http www bionime com E mail info bionime com Made in Taiwan User s Manual GT200 Rev Date 2019 10 Blood Glucose Monitoring System 143x100mm BIONIME GmbH Tramstrasse 16 9442 Berneck Switzerland E mail info bionime ch 0197 ...

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Page 3: ...regularly monitor blood glucose levels to effectively reduce complications from the disease The easy to use Blood Glucose RIGHTEST GT200 Monitoring System provides accurate reliable test results to help you better manage your diabetes RIGHTEST GT200 in vitro Blood Glucose Monitoring System is designed for diagnostic use only for self testing by a single user outside the body Testing requires only ...

Page 4: ...e test strips control solution or vial cap away from children They may cause a choking hazard If a test strip or vial cap is swallowed contact your physician immediately Prevent water from entering the meter Never immerse the meter or hold it under running water A drop of blood is required to perform a blood glucose test Capillary blood can be used while venous neonatal or arterial blood may also ...

Page 5: ...erforming a Blood Glucose Test Alternative Site Testing View Window Appearance Understanding Test Results and Messages Quality Control About Quality Control Testing Performing a Quality Control Test Understanding Control Test Results Test Memory Recalling Test Results Recalling Average Test Results Maintain the Products Error Messages and Troubleshooting Limitations Specifications Warranty Custome...

Page 6: ...kage Insert RIGHTEST Control Solution GC700 5 Blood Glucose Meter with 2 CR2032 batteries installed RIGHTEST GT200 6 Blood Glucose Test strips 10 25 pcs RIGHTEST GT200 7 Level 2 is provided in your starter kit RIGHTEST Control Solution GC700 8 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 package...

Page 7: ...11 10 RIGHTEST Blood Glucose Meter RIGHTEST Blood Glucose Meter Left Button Main Button Display Window Test Strip Port Right Button Battery Cover Meter Label Backlight Battery Meter Battery ...

Page 8: ... batteries are low or must be replaced Indicates when to apply the blood sample test strip Appears when an error occurs Current date under time mode or testing date under memory mode Warns when the operational temperature limit is exceeded during testing Indicates the time in 12H format Displays current time under time mode or testing time under memory mode Manufacturing use only RIGHTEST Blood Gl...

Page 9: ...d control solution here Noble Metal Electrodes Electrochemical sensor View Window Electrode Contacts RIGHTEST Blood Glucose Test Strip PRECAUTION Close the RIGHTEST Blood Glucose Test Strip vial immediately after removing a test strip Do not reuse RIGHTEST Blood Glucose Test Strips Do not use expired RIGHTEST Blood Glucose Test Strips Use each test strip immediately after removing from the vial Fo...

Page 10: ...1000 tests under normal use Press the main button or insert a strip to activate your meter PRECAUTION Please follow the local regulation to properly discard a used battery 4 RIGHTEST Blood Glucose Meter will enter Self Testing Mode automatically when replacing the battery all symbols will appear on the screen 5 Press any button to exit the self test and enter Setting Mode 6 You must set the time a...

Page 11: ...he Day Setting will appear 3 Day setting With the day blinking press the Left or Right button until you see the current day Press the Main button to confirm Once the day is confirmed the Time Setting will appear 1 2 3 You can enter the Setting Mode two ways 1 Replace the Battery After removing the battery press the main button several times until there is no signal on screen then follow the batter...

Page 12: ...the Volume Setting will appear 5 6 4a 4b NOTE If you do no change any settings during Meter Set up for over 2 minutes RIGHTEST Blood Glucose Meter will leave setting mode and power off automatically 7 Volume Setting With the volume blinking press the Left or Right button to turn the volume on or off Press the Main button to confirm and finish the settings 8 Setting the Unit of Measurement With mil...

Page 13: ...will power off automatically after 2 minutes if no buttons are pressed or no strip is inserted Turning On Off the Meter Turning On Off the Backlight 1 Turn on the backlight Press and hold the Main button for 2 seconds 2 Manually turn off the backlight With the backlight on press and hold the Main button for another 2 seconds 3 Auto shutoff RIGHTEST Blood Glucose Meter backlight will turn off autom...

Page 14: ...trip as shown 3 Insert RIGHTEST Blood Glucose Test Strip into test strip port until it clicks and firmly stops Handling RIGHTEST Blood Glucose Test Strip Removing the RIGHTEST Blood Glucose Test Strip 1 Hold the RIGHTEST Blood Glucose Test Strip as shown 2 Rotate the RIGHTEST Blood Glucose Test Strip counterclockwise and pull up simultaneously 3 Take the RIGHTEST Blood Glucose Test Strip out of th...

Page 15: ...djustable cap in one hand and hold the hub in the other hand Bend the cap towards the down side until a gap appears between the cap and hub 2 Pull the cap and hub off in opposite directions remove the 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 penetrat...

Page 16: ...will begin on the display window After 5 seconds your test result will appear 7 Hold the base in one hand and pull on the plunger with the other hand The device will be cocked Release the plunger and 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 from the vial Close the vi...

Page 17: ...ood drop to the sample port on the strip until you see the appear The screen will display and if you apply blood too soon If this occurs please use a new test strip to test Record the opening date of a new test strip vial Discard the vial of test strips 12 months after opening Always keep the metal contacts of the test strip port clean If any dust or impurities are present please clean with a smal...

Page 18: ...ically compare the test system to a laboratory test system that is known to be well maintained and monitored by a healthcare provider Alternative site testing palm or forearm blood sampling To perform alternative site testing install the clear cap for your RIGHTEST Lancing Device For detailed information refer to the instruction for the RIGHTEST Lancing Device To increase the blood flow massage th...

Page 19: ...p Doing this might contaminate the meter or cause damages and is not recommended Blood glucose test results are shown on Blood Glucose Meter as mg dL or mmol L RIGHTEST If your blood glucose result is unusually high or low or if you question your test results repeat the test with a new Blood Glucose Test Strip RIGHTEST You can also run a Quality Control Test with the to check your RIGHTEST Control...

Page 20: ...ng function it is necessary to regularly perform a quality control test Use one of the RIGHTEST Control Solutions when testing your RIGHTEST Blood Glucose Monitoring System in the Control Solution Mode If the test result is within the Control Solution Range printed on the strip vial label RIGHTEST Blood Glucose Monitoring System passes the Quality Control Test and your RIGHTEST Blood Glucose Monit...

Page 21: ...istent with the way you feel To practice testing Required Items for Quality Control Tests To perform a quality control test prepare the items below RIGHTEST Blood Glucose Meter RIGHTEST Blood Glucose Test Strips RIGHTEST Control Solution CAUTION Each time you open a new bottle of control solution write the expiration date on the label RIGHTEST Control Solution GC700 is good for 3 months after open...

Page 22: ... on 1 2 9 OPEN 6 7 3 10 Tightly replace the cap on the Control Solution bottle 11 The control solution result will appear Compare your Quality Control Test result to the Control Solution Range printed on RIGHTEST Blood Glucose Test Strip vial label CLOSE 10 CAUTION Your Control Solution Test results will not be included in the average calculations however they can still can be recalled and viewed ...

Page 23: ...onitoring System may not be working properly Repeat the Quality Control Test If your control solution results are still out of range do not use RIGHTEST Blood Glucose Meter to test your blood glucose Please contact customer service RIGHTEST Blood Glucose Meter is able to automatically store a maximum of 1 000 test results with time and date If your meter has stored 1 000 results the newest test re...

Page 24: ...hile simultaneously pressing the Main button until AVG appears The test result is now included into the average calculation 5 Quick Searching To view test results in sequential order automatically enter the Memory Mode Press the Right or Left button for 2 seconds The Right button is for viewing from the most current to the oldest test results The Left button is for viewing from the oldest to the m...

Page 25: ... second person NOTE the cleaning procedure can only remove visible contaminates from surfaces Only the disinfecting procedure can eliminate non visible pathogens The following disinfecting wipe has been tested and may be used to clean and disinfect the meter and lancing device CAVIWIPES DISINFECTING TOWELETTES manufacturer Metrex It is with Isopropanol as the active ingredient have been shown to b...

Page 26: ...ting cycles The testing simulates high frequency of cleaning and disinfecting cycles around 5 years 2 1 3 Allow to remain wet for 2 minute 1 2 3 Allow to remain wet for 2 minute To clean the lancing device 1 Throughly wipe the entire surface of the lancing device with disinfecting wipes listed above to clean any possible dirt dust blood and other body fluids To disinfect the lancing device 2 Take ...

Page 27: ...ease button or depth adjustable cap You are unable to enter meter settings function modes or recall your testing results If you have any questions or concerns please contact your RIGHTEST Blood Glucose Monitoring System authorized representative or contact your local Bionime distributor or email to rightest bionime com Error Messages and Troubleshooting Temperature Error 1 In order to get accurate...

Page 28: ...sting purposes until the and symbols appear as described above Er1 The inserted test strip has been used or damaged Please use a new test strip Er2 The meter has malfunctioned Do a Quality Control Test or reinstall the batteries to check if the meter works properly Er3 The signal transmission is disrupted Repeat the test using a new test strip Er4 The blood sample volume is insufficient Repeat the...

Page 29: ...0 mg dL 1 33 mmol L Not for screening or diagnosis of diabetes mellitus Regarding potential electromagnetic or other interference keep meter out of electromagnetic radiation sources Measurement Technology Measuring Range Test Time Memory Capacity Power Saving Operating Temperature Operating Relative Humidity Power Supply Battery Life Dehydrogenase Electrochemical Sensor 10 600 mg dL 0 6 33 3 mmol ...

Page 30: ...Please complete and return the enclosed warranty card Different models have different specifications This warranty applies only to the RIGHTEST Blood Glucose Monitoring System other models are not covered with this warranty card NOTE During blood glucose measurement the RIGHTEST Blood Glucose Meter itself may come into contact with blood All parts of the RIGHTEST Blood Glucose Monitoring System ar...

Page 31: ...al risks References 1 Diabetes Information American Association for Clinical Chemistry AACC Electronic Version Retrieved Aug 21 2015 form www labtestsonline org understanding analytes glucose test html 1 Expected values Fasting Blood Glucose GLUCOSE LEVEL From 70 to 99 mg dL 3 9 to 5 5 mmol L From 100 to 125 mg dL 5 6 to 6 9 mmol L 126 mg dL 7 0 mmol L and above on more than one testing occasion I...

Page 32: ... Diagnostic Medical Device Directive 98 79 EC CE0197 EC Rep Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland Lancing Device Manufacturer Bionime Corporation No 100 Sec 2 Daqing St South Dist Taichung City 40242 Taiwan Product complies with Medical Device Directive 93 42 EEC EC Rep Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland Disposable Sterile Lancets Manufacture information is as pack...

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