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Gmate Gmate Mini, User Manual

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Gmate Gmate Mini User Manual Download Page 39

39

Specifications

Electrical and safety standards

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.

Warranty

Philosys warrants that your Gmate™ meter will be free of defects in
materials and workmanship for 5 years, valid from the date of
purchase. The warranty extends only to the original purchaser and is
not transferable.

Summary of Contents for Gmate Mini

Page 1: ...User sGuide Thank you for purchasing the Gmate System Please read this User s Guide carefully before using to ensure correct use Please keep this User s Guide for your future reference ...

Page 2: ...ith use at home and in clinical settings It should not be used for the diagnosis of diabetes or the testing of newborn Gmate meter has only one button to navigate all functions easily with simple operation It is small size stylish design and ease of use allows you to take it everywhere It can show all information variously It requires very small volume 0 5uL and display the result in 5 seconds It ...

Page 3: ...ions 10 Obtaining Blood Drop 13 About Alternate Site Testing 16 Testing Your Blood Glucose 18 Control Solution Testing 22 Reviewing Results 25 Setting the Meter 27 Replacing the Battery 30 Error Messages 31 Troubleshooting 33 Performance Characteristics 34 Caring for System 36 Specifications 38 ...

Page 4: ...4 About GmateTM System Gmate System includes ...

Page 5: ...ation date Serial number Lot number In Vitro 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 ...

Page 6: ...strip This current changes with the amount of glucose in the blood sample The glucose concentration in the sample is calculated based on the electrical current and displayed on the meter Setting the time and date Your Gmate meter comes with the time date year and unit of measure pre set Before using your meter for the first time or if you change the meter battery you should check and set the time ...

Page 7: ...just the parameters in set up mode You can turn the meter off by pressing and holding the M button for 2 seconds Test Strip Port Insert the end of a Gmate test strip here The meter will turn on when you insert the test strip Electrodes The end of the test strip is inserted into the test strip port of the meter with this end facing up Sample Tip The end of the test strip where the blood sample is d...

Page 8: ... of the Parts Side View Back View Strap Hole It is for hand strap or neck strap Battery Cover Slide cover off to replace batteries SET Button Used to enter the set up mode for changing the date and time and unit of measure ...

Page 9: ... or must be replaced Display test results measuring status error messages and other informations Results are displayed along with the units of measure Clear AST cap Lancet ejector Sliding barrel Adjustable cap Lancet holder Release button Clear AST cap is an optional accessory Please contact your local distributor ...

Page 10: ...on Do not use the Gmate System for the diagnosis of diabetes testing on newborns and testing of arterial blood The Gmate System contains small parts that may be dangerous if swallowed Check the package before starting the measurement Be sure to read user s guide and the test strip insert found in the test strip box carefully before testing Do not make any decision of medical relevance without firs...

Page 11: ...re Do not disassemble or modify the meter Do not subject the meter to severe shock drop or step on meter The meter is not waterproof Do not wash it or touch it with wet hands Do not wipe the meter with thinner or abrasive cleaners Avoid the meter being exposed to high temperature high humidity rain and or dust when using or storing the meter Do not test glucose instantly when the meter move to a p...

Page 12: ... directly Do not press the test strip against your finger This may affect inaccurate aspiration of blood Do not use a test strip that appears damaged or has been used Test strips are for single use only Store test strips in their original vial After you take a test strip out of the vial be sure to use it within three minutes Always use test strips within 3 months 90days after first opening With cl...

Page 13: ...lly with warm water to increase the circulation of the blood into the fingers Dry hands thoroughly until the finger to be pricked is completely dry STEP 2 Unscrew the cap of the lancing device by turning it counter clockwise while holding the base firmly ...

Page 14: ...rile lancet into the bottom of lancet carrier STEP 4 Twist the cap of the lancet off STEP 5 Put the cap of the lancing device back on and turn it clockwise STEP 6 Hold the tip firmly in one hand then pull out the sliding barrel with the other hand This will cock the lancing device ...

Page 15: ...ng device firmly against the side of the finger with the cap resting on the finger The harder it is pressed the deeper the puncture Press the release button to take a sample Caution To reduce the chance of infection Make sure to wash the puncture site with soap and water before sampling Do not share a lancet or a lancing device with anyone Always use a new lancet lancets are for single use only Ke...

Page 16: ...aining a drop of blood from these alternate site testing may be less painful than a fingertip sample Following figure shows the areas where you can test with the Gmate System Avoid moles veins bones and tendons Consult to your healthcare professional before using alternate site testing Upper Arm Forearm Hand Fingertips Thigh Calf ...

Page 17: ...reness Obtaining a blood sample from alternate sites is different than getting a sample from fingertips After inserting a new sterile lancet into the bottom of lancet carrier put the clear AST cap to the lancing device Place the lancing device on the skin in the chosen site press and hold the lancing device continuously for a few seconds then push the release button to take a sample watch through ...

Page 18: ... turn on STEP 2 Time will be displayed for a moment Then Code number and strip symbol will be displayed A strip symbol with filling blood will appear letting you know the meter is ready to test STEP 3 Make sure the code number showed on the screen is same as the code number printed on the test strip vial If the code number on the screen is different from the code number printed on the strip vial t...

Page 19: ...er beeps Blood is automatically pulled into the test strip STEP 5 The Meter will now show counting progress during 5 seconds STEP 6 The test result is complete when you hear beeps Your blood glucose test result is shown on the display screen Important The volume of blood sample must be at least 0 5 microliter real size ...

Page 20: ...nt The meter turns off automatically after one minute of nonuse When this happens test results are still saved in memory Caution Used test strips and lancets may be considered biohazardous waste in your area Be sure to follow your local regulations for proper disposal STEP 7 To turn your Meter off simply remove the used test strip The Meter turns off automatically Your test result will automatical...

Page 21: ... results check your system with control solution See Control Solution Testing page 22 Range of expected results Blood glucose levels will vary depending on food intake medication dosages health stress or exercise Consult your healthcare professional for the target value that is appropriate for you Expected blood glucose levels for non pregnant people without diabetes Fasting Less than 100 mg dL 5 ...

Page 22: ...u suspect the meter or the test strips are not working properly if you have had repeated unexpected blood glucose results or if your meter is damaged STEP 1 Hold the test strip with the electrode end facing up Insert the electrode end into the test strip port on the meter Insert a new test strip into the meter until it stops The meter will turn on STEP 2 Time will be displayed for a moment Then Co...

Page 23: ...al If the code number on the screen is different from the code number printed on the strip vial try to insert new strip STEP 4 Shake the control solution vial and remove the cap Gently touch a drop of control solution to the tip of the test strip Hold until the meter beeps STEP 5 The meter will now show counting progress during 5 seconds ...

Page 24: ...n this range the meter and strips may not be working properly Repeat the control solution test Out of range results may be caused by not following the instructions on this USER S GUIDE expired contaminated or watered down control solution expired or damaged test strip control solution test done outside 20 C to 25 C 68 F to 77 F or a problem with the meter If you continue to get control solution re...

Page 25: ... be displayed If you set the date of average result 0 day the meter will show most recent test result instead of average If you press M button again while the average is showing then most recent result should be displayed STEP 2 To enter review mode In the average mode press and hold the M button The number of last glucose result will be displayed Release the M button The first glucose result will...

Page 26: ...l be displayed Each time you press and release the M button the meter will display the next result up to the last 500 test results STEP 4 The Meter is off if you press and hold M button for 2 seconds Important If there is no result the meter will display The meter will display time date and the result alternatively after no pressing M button for 3 seconds ...

Page 27: ... correct year appears Press the SET button to move to the date format setting STEP 4 With m d or d m flashing press the M button to select month day or day month format Press the SET button to move to the month setting STEP 2 Then press the SET button located in the battery compartment The meter is now in the setting mode You can start setting up the meter ...

Page 28: ...tton until the correct day appears Press the SET button to move to the hour setting STEP 7 With the hour flashing press the M button until the correct hour appears The meter displays only the 24 hour time format Press the SET button to move to the minute setting STEP 8 With the minute flashing press the M button until the correct minute appears Press the SET button to move to the unit setting ...

Page 29: ...e to the average day setting STEP 10 For the average day setting press M button then the period of date will change 0 7 14 and 30 If you set the period of date to 0 then no average would be displayed in reviewing results Press the SET button to complete meter set up and turn off the meter Setting the Meter ...

Page 30: ...place the new one in the tray with the side facing up STEP 3 Slide the battery cover back into place and close firmly Caution Dispose of battery according to your local environmental regulations Important If you do not replace the new battery within one minute of taking the old one out you have to reset the date and time Removing the battery does not affect the meter s memory or user settings ...

Page 31: ...st after the meter and test strip have reached the above temperature range Appears when environmental temperature is ABOVE system operation range System operation range is 10 40 C 50 104 F Repeat the test after the meter and test strip have reached the above temperature range Appear when inserting a used test strip Re test with a new test strip ...

Page 32: ...eat the test with a new test strip This error message indicates the meter has problem Review the instructions and re test with a new test strip If this messages appears again contact the local dealer Battery is low but you can still perform a few tests Replace the battery as soon as possible Battery is too low to perform a test Replace the battery immediately ...

Page 33: ...led correctly with the positive sign facing upward Insert the test strip with the printed side up and the electrode end of the strip into the test strip port on the meter Contact your local distributor Contact your local distributor Test does not start after applying the blood sample Probable cause Blood sample is too small Defective meter or test strips Sample applied after meter times out one mi...

Page 34: ...5 mg dL 4 2 mmol L within 5 mg dL 0 28 mmol L within 10 mg dL 0 56 mmol L within 15 mg dL 0 83 mmol L GmateTM mini System 87 26 30 100 30 30 100 30 30 System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L within 5 within 10 within 15 GmateTM mini System 72 120 170 94 160 170 99 169 170 within 20 100 170 170 Regression statistics Slope Intercept R2 GmateTM mini System 0 9995 1 9724 ...

Page 35: ... 102 mg dL 5 7 mmol L 147 mg dL 8 2 mmol L 237 mg dL 13 2 mmol L 394 mg dL 21 9 mmol L 1 2 2 3 3 7 4 7 8 6 2 8 2 3 2 5 2 0 2 2 GmateTM mini System Total precision 100 control solution tests per glucose level Mean glucose Standard deviation mg dL Coefficient of variation 40 mg dL 2 2 mmol L 106 mg dL 5 9 mmol L 322 mg dL 17 9 mmol L 0 9 2 3 6 4 2 2 2 2 2 0 GmateTM mini System ...

Page 36: ...ial Checking for expiration to strips and control solution Test strips and control solution have expiration dates printed on their vials When you first open a test strip or control solution vial you must record the opening date in the space provided on the label Use all test strips within 3 months after the first opening Caution Do not use the strips or control solution after the expiration date p...

Page 37: ...t to clean your meter Do not get any liquids dirt dust blood or control solution inside the meter through the test port Cleaning your lancing device and clear AST cap Clean and wipe the outside of the lancing device with a soft cloth dampened with mild soap and water Wash the adjustable cap and clear AST cap with mild soap Do not immerse the lancing device in any liquid ...

Page 38: ...00 mg dL 0 6 33 3 mmol L 20 60 10 40 C 50 104 F 10 90 Up to 3 048 meters 10 000 feets One CR2032 3 volt lithium battery replaceable 36 7mm x 61 7mm x 15 8mm 1 44 x 2 43 x 0 62 24g 0 85oz Model Test Method Calibration Method Sample Sample Size Test Time Memory Result Range Hematocrit Operating Temperature Operating Relative Humidity Altitude Power Source Size Weight ...

Page 39: ...io 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 Warranty Philosys warrants that your Gmate meter will be free of defects in materials and workmanship for 5 years valid from the date of purchase The warranty extends only to the original purchaser and is not transferable ...

Page 40: ... B 1040 Brussels Belgium Tel 32 2 732 59 54 Fax 32 2 732 60 03 philosys Co Ltd 827 3 Sangpyeong ri Okgu eup Gunsan si Jeollabuk do Korea Tel 82 63 453 1421 Fax 82 63 453 1423 Email help gmate biz 0102R0 Rev Date 2011 03 Printed in Korea ...

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