Gmate WHeeL System, User Manual

Page 1: ...Guide Thank you for purchasing the Gmate WHeeL System Please read this User s Guide thoroughly before using and ensuring correct operation Please keep this User s Guide in safe place for your future reference ...

Page 2: ... Gmate WHeeL Gmate WHeeL in vitro Gmate WHeeL meter has wheel button to eject the used strip easily and simply The small size with stylish design and ease operation allows you can bring everywhere Shows much useful information Requires very small volume 0 5 L and display the result within 5 seconds Measures glucose level of whole blood by AST Alternate site testing No need to change Code number or...

Page 3: ...lude this USER S GUIDE QUICK Before Starting Symbols SN Caution see instructions for use Single use only Expiration date Serial number Lot number Diagnostic medical device Manufacturer Authorised representative Symbol for temperature limitation Consult instructions for use Biological risks Contains sufficient for n tests Direct current Separate disposal from other household waste In Vitro ...

Page 4: ... to change the glucose unit yourself in order to prevent misinterpretation of the test results The glucose unit has been preset before leaving our factory If you have received a Gmate meter with the glucose unit different from the method you use to measure your glucose Setting the time and date Gmate WHeeL is intended to be for personal self testing to monitoring glucose concentration in fresh who...

Page 5: ...n the battery is low or need to be replaced 4 Display test results and messages 5 Indicate ready to test 6 Indicates abnormal temperature warning 7 Display measuring unit 8 Display current time 9 Indicates alarm 10 Display date and year Display Clear AST cap Adjustable cap Lancet holder Lancet ejector Release button Sliding barrel AvgMemSet mg dL am pm C Clear AST cap is an optional accessory Plea...

Page 6: ...lting your physician in vitro Gmate WHeeL Gmate WHeeL Gmate Gmate Gmate WHeeL Gmate WHeeL Gmate WHeeL Cautions for System Cautions Cautions for Meter Keep the out of children s reach When a children swallowed battery or battery cover accidentally consult with a doctor immediately Do not dispose the battery into fire Do not disassemble or modify the meter Do not attempt to severe shock drop or step...

Page 7: ...t use a test strip that looks damaged and or used Test strips are for single use only Store the test strips in their original container After you take a strip out of the container be sure to use it within three minutes Use test strips within 3 months 90days after opening the container By clean and dried hands you may touch when taking out test strip and or insert to Gmate Obtaining Blood Drop Wash...

Page 8: ...cing depth by rotating the cap 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin Place the lancing device on finger tip While lancing device rest on the finger The harder it is pressed the deeper the lance press the release button to lance Caution To avoid the infection possibility Make sure to wash the lance position with soap and water before sampling Do not share a la...

Page 9: ...ng rapidly such as within two hours of exercise a rapid acting insulin injection or insulin pump bolus or within two hours after a meal When you are testing for hypoglycemia low blood glucose or if you suffer from hypoglycemia unawareness Obtaining a blood sample from alternate sites is different than a fingertips sample collecting After inserting a new sterile lancet put on the clear AST cap to t...

Page 10: ... Compare and ensure the displayed code number is same as printed code on test strip container If displayed code number is different please use another new strip STEP 3 am C AvgMemSet mg dL am pm C Testing Your Blood Glucose Touch the drop to test strip tip and hold until the Gmate WHeeL beeps Blood sample is drawn into test strip The screen shows counting progress during 5 seconds When the measuri...

Page 11: ...dL 13 8mmol L or displays Lo or HI contact your physician or healthcare professional immediately If unexpected results are continued check Gmate WHeeL by control solution See Control Solution Testing page 22 Range of expected results Blood glucose levels will vary depending on food intake medication dosages health condition stress or exercise status Consult your healthcare professional for the tar...

Page 12: ...when the Gmate WHeeL is damaged Insert the test strip while the electrode end facing up into the test strip port until it stops The Gmate WHeeL will turn on automatically STEP 1 After time and date will be displayed for a while code number and strip symbol are displayed A strip symbol with filling blood STEP 2 C Make sure the displayed code number is same as printed code of the test strip containe...

Page 13: ...control solution Please contact the local distributor Out of range results may be caused by when you are not comply the instructions on this USER S GUIDE expired contaminated or watered down control solution expired or damaged test strip control solution test is done out of temperature range 20 C to 25 C or a problem on the Gmate WHeeL STEP 8 mg dL am Reviewing Results STEP 1 During the meter is o...

Page 14: ...result average press and release button while a strip symbol is blinking Pressing and releasing the button allow you to scroll forward to 14 day and 7 day averages Avg mg dL Reviewing Results STEP 5 Press and release the button at the last test result you can see the 30 day average Press and release the button at the 30 day average you can see the last test result STEP 6 Press both and buttons tog...

Page 15: ...et Set During the date is flashing click the and button to select month day or day month format Press and release and buttons together to move to hour setting During the day is flashing press and release the button until the correct day appears Decreasing by button and increasing by button Press and release and buttons together to move to the date format setting STEP 5 Setting the Meter During the...

Page 16: ...ashing press and release the button to select the first alarm on or off Press and release and buttons together to move to the second alarm setting when the first alarm is off Press and release and buttons together to set the time of first alarm when the first alarm is on STEP 10 Setting the Meter STEP 11 Press and release or button to set the first alarm time when the first alarm is on by the same...

Page 17: ...g to your local environmental regulations Error Messages Appears when working temperature is BELOW or ABOVE system operation range The system operation range is 10 40 C 50 104 F Re test after the working temperature reach to the above range C F Appear when inserting a used test strip Re test with a new test strip This error message indicates the Gmate WHeeL has problem Review the instructions and ...

Page 18: ...ip inserted upside down wrong end in or incompletely Insert the test strip with the printed side up and the electrode end into the test strip port Defective meter or test strips Contact your local distributor Blood or foreign objects put into test strip slot Contact your local distributor Probable cause What to do Test does not start after applying the blood sample Blood sample is too small Re tes...

Page 19: ... 100 30 30 within 5 within 10 within 15 within 20 58 99 170 95 162 170 99 169 170 100 170 170 Slope Intercept R No of samples 1 0004 2 1214 mg dL 0 9903 100 Within run precision 100 venous blood tests per glucose level Total precision 100 control solution tests per glucose level Performance Characteristics Standard deviation 1 3 mg dL 0 07 mmol L 2 6 mg dL 0 14 mmol L 2 6 mg dL 0 14 mmol L 3 6 mg ...

Page 20: ...Do not use test strips if the container is damaged broken or left open to air It cause to error or is higher than the actual Test strips and control solution have expiration date which is printed on their containers When open a test strip or control solution vial first time you must write down the opening date on provided label Use all test strips within 3 months after opening Caring for System To...

Page 21: ...ng Temperature Operating Relative Humidity Altitude Power Source Size Specifications The meter has been tested for immunity to electrostatic discharge as specified in IEC 61000 4 2 The meter has been tested for immunity to radio frequency interference at the frequency range and test levels specified in IEC 61000 4 3 The meter has been tested for electromagnetic emissions specified in IEC 61326 Ele...

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Page 23: ...827 3 Sangpyeong ri Okgu eup Gunsan si Jeollabuk do Korea philosys Co Ltd Obelis SA Boulevard Général Wahis 53 1030 Brussels Belgium ...