GlucoRx Nexus Voice TD-4280 Page 36 Owner'S Manual Download

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In vitro

diagnostic medical device

Consult instructions for use

Temperature limitation

Use by

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Manufacturer

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EC/REP

Authorised representative in the

European Community

Biological Risks

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Summary of Contents for Nexus Voice TD-4280

Page 1: ...Version 1 0 2012 10 311 4280100 003 MANUAL OWNER S BLOOD GLUCOSE MONITORING SYSTEM TD 4280 Voice ...

Page 2: ... contents thoroughly and carefully Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes Due to its compact size and easy operation you can use the GlucoRx Nexus Voice TD 4280 Blood Glucose Monitoring System to easily monitor your blood glucose levels by yourself anywhere any time If you have other questions regarding this product please ...

Page 3: ...tions thoroughly and practice the test Carry out all the quality control checks as directed 8 Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lan cets and vial caps are choking hazards 9 Use of this instrument in a dry environment especially if synthetic materials are present synthetic clothing carpets etc may give damaging...

Page 4: ...DES 17 BEFORE TESTING 18 Control Solution Testing 18 Performing a Control Solution Test 18 TESTING WITH BLOOD SAMPLE 21 Preparing the Lancing Device for Blood Testing 21 Preparing the Puncture Site 21 Alternative Site Testing 26 METER MEMORY 27 Reviewing Test Results 27 Reviewing Blood Glucose Day Average Results 28 DOWNLOADING RESULTS ONTO A COMPUTER 29 MAINTENANCE 30 Battery 30 Caring for Your M...

Page 5: ...or Your Test Strips 32 Important Control Solution Information 33 SYSTEM TROUBLESHOOTING 34 Result Readings 34 Error Messages 34 Troubleshooting 36 DETAILED INFORMATION 37 SYMBOL INFORMATION 38 SPECIFICATIONS 39 ...

Page 6: ... symptoms that are inconsistent with your blood glucose test results and you have followed all the instruc tions given in this owner s manual contact your healthcare profes sional We do not recommend using this product on severely hypotensive individuals or patients in shock Readings which are lower than actual values may occur for individuals experiencing a hypergly caemic hyperosmolar state with...

Page 7: ...ld not be used for the diagnosis of diabetes or testing on newborns Professionals may test with capillary and venous whole blood home use is limited to capillary whole blood testing Test Principle Your system measures the amount of sugar glucose in whole blood The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip Th...

Page 8: ...T STRIP EJECTOR Eject the used strip by pushing up this button DISPLAY SCREEN DATA PORT Download test results with a cable connection M BUTTON Enter the meter memory and silence a reminder alarm SET BUTTON Enter and confirm the meter settings BATTERY COMPARTMENT Front Left Side Back Right Side ...

Page 9: ... Blood Drop Symbol Test Strip Symbol Low Battery Symbol Test Result Measurement Unit Day Average Time Alarm Symbol Measuring Modes Date Memory Mode Symbol Control Solution Mode Error Message Ketone Warning Volume Symbol ...

Page 10: ...e test strip Contact Bars Insert this end of the test strip into the meter Push it in firmly until it will go no further Test Strip Handle Hold this part to insert the test strip into the slot Confirmation Window This is where you confirm if enough blood has been applied to the absorbent hole of the test strip Absorbent Hole Apply a drop of blood here The blood will be automati cally absorbed Talk...

Page 11: ...ve your desired settings saved Entering the setting mode Start with the meter off no test strip inserted Press SET to turn on the meter 1 Setting the date With the year flashing press to select the correct year Press SET With the month flashing press to select the correct month Press SET With the day flashing press to select the correct day Press SET SETTING THE METER ...

Page 12: ...nute flashing press to select the cor rect minute Press SET 4 Setting the audio volume There are seven 7 volume options to choose from Press to select the desired volume To confirm your selection press SET Volume 0 indicates that the talking function is turned off and will not display during testing Volume 1 to 7 indicates audio volume from low to high and will be displayed throughout the testing ...

Page 13: ...5 Setting the reminder alarm You may set up any or all of the reminder alarms 1 4 The meter displays On or OFF and press to turn on or turn off to set the first reminder alarm Press to select On then press SET to set the hour When the hour is flashing press to add an hour Press SET to confirm and go to minutes press to add one minute Press SET to confirm and go to the next alarm setting ...

Page 14: ...testing If you do not press the meter will beep for 2 minutes then switch off If you do not want to test at this time press to switch off the meter Congratulations You have completed all settings These parameters can ONLY be changed in the setting mode If the meter is idle for 3 minutes during the setting mode it will switch off automatically NOTE ...

Page 15: ...after a meal QC testing with the control solution You can switch between each mode by 1 Start with the meter switched off Insert a test strip to turn on the meter The screen will display a flashing blood drop and Gen Voice Guide Thank you for using this product Today s date is Friday 8 October 2010 The time is 10 00 Please apply blood onto the test strip Voice Guide You are now in testing mode Thi...

Page 16: ...or if you think the results are not accurate practicing the testing process or you have dropped or think you may have damaged the meter Test strips control solution or sterile lancets may not be included in the kit please check the contents of your carry case They can be obtained separately Please make sure you have those items needed for a blood glucose test beforehand Performing a Control Soluti...

Page 17: ...ip of the vial cap Hold the meter to move the absorbent hole of the test strip to touch the drop Once the confirmation window fills completely the meter will begin counting down Voice Guide You are now in control solution mode When doing the control solution test you have to mark it so that the test result will NOT mix with the blood glucose TEST RESULTS stored in the memory Failure to do so will ...

Page 18: ...ange for your blood glucose level See the MAINTENANCE section for important information about your control solution NOTE 4 Read and compare the result After counting down to 0 the control solution test result will appear on the display Compare this result with the range printed on your test strip vial and it should fall within this range If not please read the instructions again and repeat the con...

Page 19: ...has a significant influence on the glucose value obtained Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger When the puncture site is rubbed prior to blood extraction the difference is significantly reduced Please follow the suggestions below before obtaining a drop of blood Wash and dry your hands before starting Select the...

Page 20: ...d avoid lancing the areas with obvious veins because of excessive bleeding Choose a different spot each time you test Repeated punc tures at the same spot may cause soreness and calluses Please consult your health care professional before you begin AST It is recommended to discard the first drop of blood as it might contain tissue fluid which may affect the test result NOTE Clean the puncture site...

Page 21: ...lood with a clean cotton swab Gently squeeze the punctured area to obtain another drop of blood Be careful NOT to smear the blood sample The volume of blood sample must be at least 0 5 microliter μL of volume actual size Voice Guide Thank you for using this product Today s date is Friday 8 October 2010 The time is 10 00 Please apply blood onto the test strip Voice Guide You are now in testing mode...

Page 22: ... NEVER try to add more blood to the test strip after the drop of blood has moved away Discard the used test strip and retest with a new one If you have trouble filling the confirmation window please contact your health care professional or local customer service for assistance NOTE 4 Apply the sample Gently apply the drop of blood to the absorbent hole of the test strip at a tilted 45 degree angle...

Page 23: ...ardous Please discard them carefully according to your local regulations WARNING 6 Eject the used test strip Eject the test strip by pushing the eject but ton on the side Use a sharps bin to dispose of used test strips The meter will switch itself off automatically Always follow the instructions in the lancing device insert when removing the lancet Voice Guide Now testing Your blood glucose is 5 1...

Page 24: ... sites Thus when testing blood glucose during or immediately after a meal physical exercise or any other event take a blood sample from your finger only We strongly recommend that you perform AST ONLY at the following times In a pre meal or fasting state more than 2 hours since the last meal Two hours or more after taking insulin Two hours or more after exercise Do NOT use AST if You think your bl...

Page 25: ... Results The meter stores 450 of the most recent blood glucose test results along with respective dates and times in its memory To enter the meter memory start with the meter switched off Voice Guide Thank you for using this product Today s date is Friday 8 October 2010 The time is 10 00 Press M key for memory recall mode Memory Record for 8 October 2010 10 00 Your blood glucose was 5 1 millimole ...

Page 26: ...Exit the meter memory Keep pressing and the meter will turn off after displaying the last test result Any time you wish to exit the memory keep pressing for 5 seconds or leave it without any action for 3 minutes The meter will switch off automatically Control solution results are NOT included in the day average If using the meter for the first time displays when you recall the test results or revi...

Page 27: ... System please visit www glucorx co uk 2 Connecting to a personal computer Connect the cable to a RS232 port on your computer With the meter switched off connect the other end of the interface cable to the meter data port PC will appear on the meter display indicating that the meter is in communication mode 3 Data transmission To transmit data follow the instructions provided with the software Res...

Page 28: ...ugh to do a test Please change the battery immediately Low Battery Signal The meter will display one of the messages below to alert you when the meter power is getting low Replacing the Battery To replace the batteries make sure that the meter is turned off 1 Press the edge of the battery cover and lift it up to remove 2 Remove the old batteries and replace with two 1 5V AAA size alkaline batterie...

Page 29: ...be kept away from small children If swallowed promptly seek medical assistance Batteries may leak chemicals if unused for a long time Re move the batteries if you are not going to use the device for an extended period i e 3 months or more Properly dispose of the batteries according to your local envi ronmental regulations NOTE ...

Page 30: ... Avoid dropping and heavy impact Avoid direct sunlight and high humidity Meter Disposal The used meter should be treated as contaminated and may carry a risk of infection during measurement The batteries in this used meter should be removed and the meter should be disposed in ac cordance with local regulations The meter falls outside the scope of the European Directive 2002 96 EC Directive on wast...

Page 31: ... to ensure a pure sample and an ac curate result Store the control solution tightly closed at temperatures between 2 C and 30 C 35 6 F and 86 F Do NOT freeze After removing a test strip from the vial immediately close the vial cap tightly Touch the test strip with clean and dry hands Use each test strip immediately after removing it from the vial Write the date on the vial label when you first ope...

Page 32: ... never try to disassemble the meter under any circumstances Result Readings MESSAGE WHAT IT MEANS 1 1 mmol L 20 mg dL 15 mmol L 270 mg dL 33 3 mmol L 600 mg dL MESSAGE WHAT DOES METER SAY WHAT IT MEANS WHAT TO DO Beep Appears when the batteries are too low Replace the batteries immediately The test strip has been used Please replace Appears when a used test strip is inserted Repeat with a new test...

Page 33: ...s out of range Thus unable to measure Appears when ambient temperature is above or below system operation range System operation range is 10 C to 40 C 50 F to 104 F Repeat the test after the meter and test strip are in the above temperature range Beep Problem with the meter Repeat the test with a new test strip If the meter still does not work please contact your customer service for assistance No...

Page 34: ...utes after last user action Repeat the test with a new test strip Apply sample only when flashing appears on the display Defective meter Please contact customer services POSSIBLE CAUSE WHAT TO DO Error in performing the test Read instructions thoroughly and repeat the test again Control solution vial was poorly shaken Shake the control solution vigor ously and repeat the test again Expired or cont...

Page 35: ...mal blood glucose range for people with diabetes Fasting and before meal 4 7 mmol L 72 126 mg dL 2 hours after meals Less than 9 mmol L 162 mg dL Source Diabetes UK Blood glucose target Balance No 234 2010 April P 69 Please consult your doctor to determine a target range that works best for you ...

Page 36: ...vitro diagnostic medical device Consult instructions for use Temperature limitation Use by Batch code Manufacturer Serial number EC REP Authorised representative in the European Community Biological Risks SYMBOL INFORMATION ...

Page 37: ...down Auto switch off after 3 minutes without action Temperature Warning Operating Condition 10 C to 40 C below 85 relative humidity non condensing Meter Storage Transportation Conditions 20 C to 60 C 4 F to 140 F below 95 R H Strip Storage Transportation Conditions 2 C to 32 C 35 6 F to 89 6 F below 85 R H Measurement Units mmol L Measurement Range 1 1 to 33 3 mmol L 20 to 600mg dL This device has...

Page 38: ...nlea Monument Way West Woking Surrey GU21 5EN UK Website www glucorx co uk Call centre number 01483 755133 TaiDoc Technology Corporation 3F 5F No 127 Wugong 2nd Road 24888 Wugu Dist New Taipei City Taiwan www taidoc com For self testing ...

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