Gmate VOICE, User Manual

Page 1: ...mate VOICE User Manual Please keep this User Manual in a safe place for reference Thank you for purchasing the Gmate VOICE Blood Glucose Monitoring System Please read the User Manual carefully before use ...

Page 2: ...tting the Meter 14 Testing your Blood Glucose 26 About Alternate Site Testing 35 Reviewing Results 39 Control Solution Testing 41 Replacing the Batteries 46 Caring for the Gmate VOICE 47 Troubleshooting 52 Gmate VOICE Performance Characteristics 55 Gmate VOICE Meter Specifications 59 ...

Page 3: ...e diagnosis or screening of diabetes or for neonatal use Alternative site testing should be done only during steady state times when glucose is not changing rapidly The Gmate VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users The Gmate Blood Glucose Test Strips are for use with the Gmate VOICE Meter for the quantitative measureme...

Page 4: ...lucose sugar in the blood with the reagents in the strip The electric current changes with the amount of glucose in the blood sample The Gmate VOICE Meter measures the current calculates your blood glucose level displays the results and stores it into memory Setting the Time and Date Your Gmate VOICE Monitoring System comes with the date time year and unit of measure pre set All Gmate VOICE Monito...

Page 5: ...1 1 1 1 Meter Meter Box Test Strips Test Strip Insert Control Solution Control Solution Insert Lancets Lancing Device AAA Battery User Manual Quick Reference Guide Log Book Carrying Case Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week www Gmate com System Contents ...

Page 6: ...Meter away and out of reach from children as it contains small parts that may be dangerous if swallowed Do NOT swallow If any parts are swallowed contact your healthcare professional immediately or dial 911 for emergency help To avoid the spread of infectious diseases it is important that you practice good hygiene both before and after using the Gmate VOICE Blood Glucose Monitoring System All part...

Page 7: ...ith CaviWipes towelettes Step 2 With a second CaviWipes towelette disinfect the surfaces of the Gmate VOICE Meter and lancing device to kill blood borne pathogens such as Hepatitis B Hepatitis C or HIV If you are interested in additional information on the importance of disinfection please use the following references 07 ABOUT THE GMATE VOICE MONITORING SYSTEM Call Customer Service Toll Free at 85...

Page 8: ...ing from severe dehydration consult your physician or healthcare professional immediately If your test results fall below 50 mg dL or greater than 250 mg dL repeat the test If you continue to have the same test results follow the treatment advice of your healthcare professional or consult your healthcare professional If you experience symptoms inconsistent with your test results after following th...

Page 9: ...evere shock drop or step on it The Gmate VOICE Meter is NOT waterproof Do NOT wash or touch with wet hands Do NOT wipe the Gmate VOICE Meter with paint thinner or abrasive cleaners Avoid exposing the Gmate VOICE Meter to high temperatures or humidity rain and dust when using or storing your Gmate VOICE Meter If your Gmate VOICE Meter has been exposed to extreme temperatures do NOT use or test unti...

Page 10: ... the meter modes and adjust various other features in the meter such as the date time alarm timer and language settings Please refer to the section in this Gmate VOICE User Manual see page 14 for a complete explanation of how to use and set your Gmate VOICE Meter Insert the end of a Gmate Test Strip into the test strip port to begin a blood glucose test The Gmate VOICE Meter will automatically pow...

Page 11: ...7 days a week www Gmate com Open this cover to replace batteries Data Port Speaker Battery Cover The Gmate VOICE is a speaking meter that will provide an audible output of your test result Use to transfer test results to your personal computer Software and Cable sold separately Side View Back View ...

Page 12: ...12 SYSTEM FUNCTIONS This end of the test strip is inserted into the test strip port of the meter with the electrodes facing up Sample Tip Electrodes Apply blood sample here Gmate Test Strip ...

Page 13: ...t results 3 Set Mode 4 Warning that the battery is low or needs to be replaced 5 Features within the Set Mode Volume Alarm Timer Date and Time Language 6 Displays test results average and error messages 7 Year 8 Indicates control solution test 9 Indicates abnormal temperature warning 10 Measuring Unit 11 Test strip and blood drop 12 Date 13 Time Lancet Carrier Barrel Pocket Clip Release button 1 5...

Page 14: ...e The Gmate VOICE meter is pre set to the English language and Eastern Standard Time USA Power on the meter by pressing either the left or right button To enter the Set mode push both buttons on the left and right side simultaneously and release quickly The Volume Alarm Timer Date Time and Language settings will appear on the screen ...

Page 15: ...s to exit the Set mode Press either side button to scroll through the setting selections Once you have reached your desired setting push both side buttons simultaneously to confirm your setting selection Tip By pressing on either the left or right buttons it will allow you to scroll through the different features within each setting By pressing both the left and right buttons at the same time with...

Page 16: ...will display the date time and the test strip symbol will begin to blink STEP 2 Quickly press and release both left and right buttons together You are now in the Set Mode and the Set symbol appears at the top of the screen with the different settings appearing below The volume is automatically pre set to level 4 for your convenience ...

Page 17: ...is blinking quickly press and release both the left and right buttons together You are now in the volume controls STEP 4 To select your desired volume use the left button to decrease the sound and the right button to increase the sound The sound ranges from 0 4 with 0 no sound to 4 loudest The higher the number the louder the sound Quickly press and release both the left and right buttons when you...

Page 18: ...gin to blink STEP 2 Quickly press and release both left and right buttons together You are now in the Set Mode and the Set symbol appears at the top of the screen with the different settings appearing below STEP 3 Use either the left or right button to scroll through settings Once you see that the Alarm setting is blinking quickly press and release both the left and right buttons together You may ...

Page 19: ...et your 1st Alarm select the hour and minutes be sure to properly select AM or PM by using the left or right buttons Once you have selected the desired hour and minutes quickly press and release both the left and right buttons together and you can proceed to schedule the 2nd Alarm time By following the same process you may enter up to 4 Alarm times STEP 5 If OFF is selected you can quickly press a...

Page 20: ...erent settings appearing below STEP 3 Use either the left or right button to scroll through settings Once you see that the TIMER setting is blinking quickly press and release both the left and right buttons together You are now in the TIMER setting Important Setting the Timer on the meter will set an alarm reminder for you to test For example if you would like the Timer to remind you to test 1 hou...

Page 21: ...re now in the Set Mode and the Set symbol appears at the top of the screen with the different settings appearing below STEP 3 Use either the left or right button to scroll through settings Once you see that the Date Time setting is blinking quickly press and release both the left and right buttons together You are now in the Date Time setting Setting the Date and Time HINT The left button will dec...

Page 22: ...nd right buttons together to confirm your entry and advance to the Month setting STEP 5 Setting the Month The Month will be flashing Use the left or right button to adjust the Month Once the desired month has been selected quickly press and release both left and right buttons together to confirm your entry and advance to the Day setting STEP 6 Setting the Day The Day will be flashing Use the left ...

Page 23: ...een selected quickly press and release both left and right buttons together to confirm your entry and advance to the Clock setting STEP 9 The Gmate Voice System allows you to choose your clock setting to either the 12 hour i e 9 00pm or 24 hour i e 21 00 format Setting the Clock The 12h or 24h will be flashing Use the left or right button to adjust the clock to your preferred setting Once the desi...

Page 24: ... the Set symbol appears at the top of the screen with the different settings appearing below STEP 3 Use either the left or right button to scroll through settings Once you see that the Language setting is blinking quickly press and release both the left and right buttons together You are now in the Language setting STEP 4 The En or ES will be flashing Use the left or right button to adjust the lan...

Page 25: ... test strip vial after use to avoid contamination and damage Store unused test strips only in their original vial DO NOT open the test strip vial until you are ready to perform a test DO NOT return the used test strip to the vial after performing a test DO NOT re use or share a test strip that had blood or control solution applied to it Test strips are for single use only Write the discard date 3 ...

Page 26: ...7 days a week www Gmate com Obtaining a Blood Sample STEP 1 Wash your hands with soap and warm water Dry your hands thoroughly until the finger or designated puncture site is completely dry STEP 2 Take your lancing device Hold the barrel firmly and twist off the device cover by turning it counter clockwise ...

Page 27: ...carrier STEP 4 Twist off the protective cap from the lancet STEP 5 Place the device cover back onto the lancing device STEP 6 Select the desired puncture depth that is suitable for your skin type by turning the adjustable tip 1 2 for delicate skin 3 for normal skin 4 5 for thick or calloused skin ...

Page 28: ...nated puncture site Press and release the top button Remove the lancing device after the puncture is complete STEP 8 After you perform your blood glucose test twist off the device cover and remove the lancet Dispose the lancet in an approved sharps container Replace the lancing device cover Caution Do NOT reuse lancets Lancets are for single use only Do NOT share lancets and the lancing device ...

Page 29: ...mate Customer Service support toll free at 1 855 GO GMATE 1 855 464 6283 STEP 3 STEP 1 Insert the Gmate Test Strip with the electrode end facing up into the test strip port of the Gmate VOICE Meter Make sure that the test strip is inserted all the way The meter will automatically power on and you will hear a chime STEP 2 The screen will display the code date and time A test strip symbol with a blo...

Page 30: ... your finger against the test strip The test strip will automatically draw the blood Continue to keep your finger on the test strip until the meter chimes indicating that the volume of blood is sufficient and the meter will begin calculating your blood glucose level The reading will only take 5 seconds Important The volume of the blood sample must be at least 0 5 microliter Please make sure that th...

Page 31: ...n STEP 6 Discard the used test strip The test result will automatically be stored in memory The meter will power off automatically after one minute of nonuse Caution Used test strips and lancets may be considered a bio hazardous waste in your area Make sure to follow your healthcare provider s recommendation for proper disposal ...

Page 32: ... above 600 mg dL HI will appear on the display screen If your test result is below 20 mg dL Lo will appear on the display screen Immediately contact your physician or healthcare professional if you receive a Lo or HI result If you continue to get unexpected results immediately contact your physician or healthcare professional Repeat the test If your second blood test result is also unusual perform...

Page 33: ...4 Suppl 1 S11 S61 Before eating FPG 100 mg dL Two hours after meals OGTT 140 mg dL Caution for Gmate Test Strips Store the test strips in a cool dry place between 36 F and 90 F 2 C and 32 C Keep away from direct sunlight and heat Do NOT leave the test strip vial open as it may damage the test strips causing inaccurate test results Do NOT use test strips that appear damaged Do NOT press the test st...

Page 34: ...se Monitoring System allows you to test your blood from the Upper Arm Forearm Hand Thigh or Calf Obtaining a blood sample from these alternate sites may be considered less painful than your fingertip The following figure shows the areas where you can test your blood with the Gmate Voice Blood Glucose Monitoring System Upper Arm Forearm Hand Fingertips Thigh Calf ...

Page 35: ...st results It may significantly differ from the alternate site and fingertip samples Alternate site testing should only be used two or more hours after meals physical exercise or any other event that may affect blood glucose levels Testing within those two hours should be obtained through your fingertip Alternate site testing should NOT be used to calibrate continuous blood glucose monitors Altern...

Page 36: ... you are concerned with hypoglycemia insulin reactions such as when operating a vehicle or if you suffer from hypoglycemic unawareness lack of symptoms to indicate an insulin reaction Testing with a fingertip sample may identify a hypoglycemic low blood sugar level sooner than a test with the alternate site sample Routine testing before meals can be done either at the fingertips forearm upper arm ...

Page 37: ...e lancet into the lancing device place the lancing device against the designated puncture site and hold the lancing device continuously for a few seconds Push the release button If there is not enough blood gently massage the area until a sufficient sample has been collected The volume of the blood sample must be at least 0 5 microliter Please make sure that the blood sample completely fills the d...

Page 38: ...er Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week www Gmate com Important If there are no results stored in memory the meter will display STEP 2 Press and release either the left or right button You are now in the Review Mode The memory number and the last glucose test result that was done will automatically be displayed with the date and time To Enter the Review Mode ...

Page 39: ...oth the left and right buttons together To exit the Review or Average Mode press both the left and right buttons together for 2 seconds STEP 4 To Enter the Average Mode To view your glucose test result Averages Press and release both the left and right buttons together Your 7 day average will display Press and release either the left or right button to view your 7 day 14 day and 30 day averages No...

Page 40: ...STEP 2 The screen will display the code date and time A test strip symbol with a blood drop will appear and flash The meter and test strip are now ready to test with the control solution STEP 3 Before you begin make sure the code number displayed on the screen is the same as the code number printed on the test strip vial If the code number is different insert a new test strip If the code number st...

Page 41: ...ontrol Solution tests with the control solution symbol the results will NOT be included in your average results STEP 5 Shake the control solution vial and remove the cap Gently squeeze a drop of the control solution onto a clean flat hard surface Place the tip of the test strip to the control solution until the meter chimes The meter will start calculating the result The reading will only take 5 s...

Page 42: ...ult will be displayed on the screen STEP 7 Compare the control solution test result displayed on the meter to the control solution range printed on the test strip vial If the result is not within the indicated range on the test strip vial the meter and test strips may not be working properly ...

Page 43: ...ormed outside the correct temperature range between 68 F 77 F 20 C 25 C Control solution is too cold or too warm Failure to follow all the instructions for performing a control solution test in this User Manual Control solution is contaminated expired or passed its discard date If you continue to receive the control solution test results outside the range printed on the test strip vial Do NOT use ...

Page 44: ...ld batteries and insert the new AAA batteries into the tray correctly STEP 3 Insert the two hinges into the slots and press the battery cover down until it clicks Dispose of used batteries according to your local environmental regulations Replacing the batteries may require you to reset the date and time It will NOT affect the meter s memory or the other settings Important ...

Page 45: ... control solution vial immediately after use to avoid contamination or damage Store test strips only in their original vial The Gmate Test Strips and Control Solution have expiration dates printed on the vials When you first open the test strip and control solution vials immediately record the discard date 3 months after first opening on the vial labels Caution Do NOT use the test strips or contro...

Page 46: ...s towelettes Wipe the outside of the meter and the lancing device carefully Before you begin squeeze out any excess liquid from the towelette so that it is damp but not dripping wet Take extreme care not to get liquid in the test strip port CaviWipes have been shown to be safe for use with the meter and lancing device 1 First clean the meter and lancing device using CaviWipes towelettes to remove ...

Page 47: ...ter cleaning and or disinfection perform a control solution to make sure the meter was not damaged by the disinfection process Cleaning and disinfecting your Gmate VOICE Blood Glucose Monitoring System is important to prevent the spread of diseases If you are interested in additional information of the importance of disinfection please use the following references 1 FDA Public Health Notification ...

Page 48: ...u notice any change in performance accuracy or appearance of the meter For example testing results outside the control range discoloration of the case or damage to the LCD screen or lancing device as the result of regular cleaning stop using the meter or lancing device immediately and call our Customer Service support line 24 hours a day 7 days a week at 1 855 GO GMATE 1 855 464 6283 for a replace...

Page 49: ...ssistance to the owner of this Gmate VOICE Blood Glucose Monitoring System it is important that you take steps to prevent the spread of diseases while using this product Always clean and disinfect the meter and lancing device following the steps on pages 48 51 before assisting the owner of this Gmate VOICE monitoring system Wash your hands thoroughly both before and after assisting the patient We ...

Page 50: ... Support at 1 885 GO GMATE 1 885 464 6283 or your local distributor Indicates that the environmental temperature is ABOVE or BELOW the system operational range System operational range is 50 F 104 F 10 C 40 C Repeat the test after the meter and test strip have reached the correct temperature range Error Messages Indicates a used test strip has been inserted Re test with a new test strip ...

Page 51: ... can still perform a few more tests Replace the battery soon Battery is too low to perform a test Replace the batteries immediately If the Volume range does not go up to 4 The battery is low The meter will self adjust the volume to range to extend the limited battery life If the battery icon is empty the volume range will adjust only up to 3 ...

Page 52: ...ide up and the electrode end of the strip into the test strip port on the meter Contact Gmate Customer Service support toll free at 1 855 GO GMATE 1 855 464 6283 Contact Gmate Customer Service support toll free at 1 855 GO GMATE 1 855 464 6283 Test does not start after applying the blood sample The battery is installed incorrectly or there is no battery in the meter Test strip inserted upside down...

Page 53: ...ange Hematocrit Operating Temperature Operating Relative Humidity Altitude Power Source Size Weight PG 301 Gmate VOICE Blood Glucose Monitoring System Electrochemical sensor Plasma Whole blood capillary 0 5 μL 5 seconds 5 000 Blood glucose tests 20 600 mg dL 20 60 50 104 F 10 40 C 10 90 Up to 10 000 feet 3 048 meters Two Alkaline AAA 1 5 volt Batteries replaceable 2 44 x 4 52 x 0 51 62 0mm x 114 8...

Page 54: ...hose obtained using an YSI 2300 Glucose Analyzer System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L Regression statistics within 5 mg dL 0 28 mmol L within 10 mg dL 0 56 mmol L within 15 mg dL 0 83 mmol L within 5 within 10 within 15 within 20 R Slope Intercept 2 No of samples Range tested 27 4 15 93 3 14 15 1...

Page 55: ...for immunity to radio frequency interference at the frequency range and test levels specified in IEC 61000 4 3 The Gmate VOICE Meter has been tested for electromagnetic emissions in IEC 61326 Philosys warrants that your Gmate VOICE Meter will be free of defects in materials and workmanship for one 1 year from the date of purchase The warranty extends only to the original purchaser and is not trans...

Page 56: ...ccuracy result for glucose concentrations 75 mg dL 4 2 mmol L 67 63 94 94 88 94 100 94 94 100 94 94 84 79 94 97 91 94 100 94 94 100 94 94 88 7 8 100 8 8 100 8 8 100 8 8 50 4 8 100 8 8 within 5 within 10 within 15 within 20 within 5 within 10 within 15 within 20 within 5 mg dL 0 28 mmol L within 10 mg dL 0 56 mmol L within 15 mg dL 0 83 mmol L within 5 mg dL 0 28 mmol L within 10 mg dL 0 56 mmol L ...

Page 57: ...esults at HAND were compared to test results at YSI 2300 STAT System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L 69 65 94 94 88 94 100 94 94 100 94 94 63 5 8 100 8 8 100 8 8 100 8 8 75 6 8 100 8 8 63 59 94 91 83 94 98 92 94 100 94 94 within 5 within 10 within 15 within 20 within 5 within 10 within 15 within 20...

Page 58: ...300 STAT System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L 76 71 94 98 92 94 100 94 94 100 94 94 75 6 8 88 7 8 100 8 8 63 59 94 93 87 94 98 92 94 100 94 94 100 8 8 38 3 8 100 8 8 within 5 within 10 within 15 within 20 within 5 mg dL 0 28 mmol L within 10 mg dL 0 56 mmol L within 15 mg dL 0 83 mmol L within 5 ...

Page 59: ...together to exit the Timer setting If On is selected to set your timer use the left or right button to adjust the hour The right button will increase the number and the left button will decrease the number Once the desired hour has been selected quickly press and release both left and right buttons together to confirm your entry and advance to the minutes setting STEP 6 The minutes will be flashin...

Page 60: ...contact our Gmate Customer Service Support at 1 855 GO GMATE 1 855 464 6283 or contact your local distributor Do a control solution test To practice the test process instead of using blood When you open a new vial of test strips If you suspect the meter or the test strips are not working properly If you have had repeated unexpected blood glucose results If your meter is damaged Important Use only ...

Page 61: ... Printed in Korea Tel 82 63 453 1421 Fax 82 63 453 1423 E mail help gmate biz 1002R5 Rev Date 2013 01 827 3 Sangpyeong ri Okgu eup Gunsan si Jeollabuk do Korea Address Gmate is a registered trademark of philosys Inc Patents Pending ⓒ2013 philosys Inc All rights reserved Tel 855 GO GMATE 855 464 6283 Fax 800 939 8670 E mail info gmate com www Gmate com New York NY 10010 USA ...