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1. Gmate VOICE User Manual Thank you for purchasing the Gmate VOICE Blood Glucose Monitoring System Please read the User Manual carefully before use S ELU TABLE OF CONTENTS About the Gmate VOICE Monitoring System System Functions Setting the Meter Testing your Blood Glucose About Alternate Site Testing Reviewing Results Control Solution Testing Replacing the Batteries Caring for the Gmate VOICE Troubleshooting Gmate VOICE Performance Characteristics Gmate VOICE Meter Specifications 03 10 14 26 35 39 41 46 47 52 55 59 ABOUT THE VOICE MONITORING SYSTEM 03 Intended Use E The Gmate VOICE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose sugar in fresh capillary whole blood samples drawn from the fingertips hand upper arm forearm calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by individuals with diabetes The Gmate VOICE Blood Glucose Monitoring System is intended to be used by a single user and should not be shared with any other person Gmate VOICE Blood Glucose Monitoring System is for self testing outside the body in vitro diagnostic use only by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The Gmate VOICE Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal us
2. Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week ABOUT ALTERNATE SITE TESTING 38 Obtaining a blood sample from alternate sites is different than getting a sample from the fingertips After inserting the sterile 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 designated area of the Gmate Test Strip Refer to page 26 for Obtaining a Blood Sample and Testing your Blood Glucose REVIEWING RESULTS 39 a ON ag E 25 Ahia i paa 00d mg dL cote 25 YYZ pm D STEP 1 If the meter is off press and release either button to power the meter on The screen will display the date time and the test strip symbol will begin to blink STEP 2 To Enter the Review Mode 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 Important If there are no results stored in memory the meter will display www Gmate com Call Customer
3. Toll Free at 855 GO GMATE 855 6283 24 hours a day 7 days a week SYSTEM FUNCTIONS 12 Sample Tip Apply blood sample here a E g Electrodes This end of the test strip is inserted into the test strip port of the meter with Gmate Test Strip the electrodes facing up SYSTEM FUNCTIONS 13 RAO RSE ad O K O FN Volume Alam _ Timer _Dateatime n iat XDK AVERAGE in ee a am i pm al Display Lancing Device Cover Adjustable Tip Ore B ON E Review Mode Displays the number of test results Set Mode Warning that the battery is low or needs to be replaced Features within the Set Mode Volume Alarm Timer Date and Time Language Displays test results average and error messages Year Indicates control solution test Indicates abnormal temperature warning Measuring Unit Test strip and blood drop Date Time Lancet Carrier Barrel Pocket Clip Release button eu 1 Lancing Device www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week SETTING THE METER 14 The Gmate VOICE Blood Glucose Monitoring System has five user settings Volume Alarm Timer Date amp Time and Language The Gmate VOICE meter is pre set to the English language and Eastern Standard Time USA x Power on th
4. adjust the Day Once the desired day has been selected quickly press and release both left and right buttons together to confirm your entry and advance to the Hour setting www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week SETTING THE METER 24 om Q ae 1 252 B om STEP 7 Setting the Hour The Hour will be flashing Use the left or right button to adjust the Hour 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 When setting the hour be sure to propertly select AM or PM STEP 8 Setting the Minutes The Minutes will be flashing Use the left or right button to adjust the Minutes Once the desired minutes have been 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 desired clock setting has been selected quickly press and release both left and right buttons together to confirm your entry STEP 10 You have now completed the Date amp Time settings To exit
5. code number printed on the test strip vial If the code number is different insert a new test strip If the code number still does not match call Gmate Customer Service support toll free at 1 855 GO GMATE 1 855 464 6283 TESTING YOUR BLOOD GLUCOSE 31 STEP 4 Using the lancing device to obtain the blood sample place the blood from your finger to the tip of the Gmate Test Strip Do NOT press 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 the blood sample completely fills the designated area of the Gmate Test Strip P oF 32 www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week TESTING YOUR BLOOD GLUCOSE 32 aie o amp m 25 42pm yi M Xi agi Z 25 442 pm STEP 5 When the test is complete your blood glucose test result will be displayed on the LCD screen 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 Used test strips and lancets may
6. or storing your Gmate VOICE Meter If your Gmate VOICE Meter has been exposed to extreme temperatures do NOT use or test until you have kept the Gmate VOICE Meter at room temperature for a minimum of 20 minutes www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week SYSTEM FUNCTIONS 10 Front View Test Strip Port 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 power on when you insert the test strip Buttons The two side buttons power the Gmate VOICE Meter on off recall the stored test results in memory change 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 Display Screen Large LCD screen displays test results and other information SYSTEM FUNCTIONS 11 Data Port Use to transfer test results to your personal computer Software and Cable sold separately Speaker The Gmate VOICE is a speaking meter that will provide an audible output of your test result Battery Cover Side View Back View Open this cover to replace batteries www Gmate com Call Customer Service
7. stored in memory www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 6283 24 hours a day 7 days a week REPLACING THE BATTERIES 46 STEP 1 Your Gmate VOICE meter requires two 1 5 volt AAA alkaline batteries N To remove the battery cover squeeze the tab and lift STEP 2 Remove the old 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 A Important 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 CARING FOR THE GMATE VOICE 47 Storing Your System Store your meter strips and control solution in your carrying case after each use Store each item in a cool dry place below 90 F 32 C Do NOT refrigerate Keep all items away from direct sunlight and heat Tightly close the cap on the test strip vial and or control solution vial immediately after use to avoid contamination or damage Store test strips only in their original vial Checking the Expiration of Strips and Control Solution 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 dis
8. to measure the reaction of glucose 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 Monitoring Systems sold in the United States are set to English Eastern Standard Time EST and the measuring unit mg dL Before using your Gmate VOICE Monitoring System for the first time or when you change the batteries check and set the time and date as necessary See page 14 Setting the Meter to set the meter properly ABOUT THE VOICE MONITORING SYSTEM 05 System Contents Meter 1 1 Meter Box 1 1 Test Strips 10 Test Strip Insert 1 Control Solution q Control Solution Insert 1 Lancets 10 Lancing Device 1 AAA Battery 2 2 User Manual 1 1 Quick Reference Guide 1 d Log Book 1 1 Carrying Case 1 1 www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week ABOUT THE VOICE MONITORING SYSTEM 06 Important Safety Information About the Gmate VOICE System The Gmate VOICE Blood Glucose Monitoring System is intended for use outside the body in vitro diagnost
9. together for 2 seconds Note To exit the Alarm setting at any time press both the left and right buttons together for 2 seconds www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week SETTING THE METER 20 Setting the Timer Important m 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 hour and 30 minutes after a meal set the Timer to 1 30 tie son The Timer has to be pre set before you test your glucose level irks ue The Timer will only ring when the meter is turned off x bar STEP 1 If the meter is off press and release either button to power the meter on The screen will display the date time and the test strip symbol with begin to blink STEP 2 os Quickly press and release both left and right buttons together You are now eWwon in the Set Mode and the Set symbol appears at the top of the screen with x E the different settings appearing below STEP 3 Use either the left or right button to scroll through settings Once you see that ea the TIMER setting is blinking quickly press and release both the left and right n HSD buttons together You are now in the TIMER setting SETTING THE METER 22 BA 25 gpm Setting the Date and Time HINT The left button will decrease the number and the right button will
10. 4 within 15 98 92 94 within 20 100 94 94 SETTING THE METER 21 STEP 4 To turn the timer On or OFF use the left or right button to make your selection then quickly press and release both left and right buttons together STEP 5 If OFF is selected you can quickly press and release both the left and right buttons 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 flashing Use the left or right button to adjust the minutes Once the desired minutes are selected quickly press and release both left and right buttons together to confirm your entry STEP 7 You have now completed the Timer setting To exit the Timer at any time press both the left and right buttons together for 2 seconds Note When you test your blood glucose after the Timer is set to On the Timer will ring after the selected hour and minute you have selected www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week CONTROL SOLUTION TESTING 41 Gmate Control Solution c
11. ONITORING SYSTEM 07 m Keep your Gmate VOICE Blood Glucose Monitoring System clean Clean and disinfect your Gmate VOICE Blood Glucose Monitoring System at least once per week by following the instructions on page 48 of this User Manual Wash your hands thoroughly with soap and warm water both before and after using the Gmate VOICE Blood Glucose Monitoring System m Cleaning and disinfecting your Gmate VOICE Blood Glucose Monitoring System is important to prevent the spread of diseases Cleaning and disinfecting your Gmate VOICE Blood Glucose Monitoring System should be completed in two steps Step 1 Clean the surfaces of the Gmate VOICE Meter and lancing device of any blood dirt or any visible residue with 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 m If you are interested in additional information on the importance of disinfection please use the following references 1 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm 2 CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk or Transmitting Bloodborne Pathogens 2010 http www cdc g
12. Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week REVIEWING RESULTS 40 D gt z STEP 3 D ws To view older test results press the right button on the meter To go back and view your current test results press the left button on the meter The most current test result will always be stored in memory Review as 1 The older the ani Hes test result the higher the memory Review number The Gmate VOICE Meter 1 25 ggm stores up to 5 000 test results 9 STEP 4 _ To Enter the Average Mode tb 4 l 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 AVERAGE ual either the left or right button to view your 7 day 14 day and 30 day averages Note The Average function will only display the average test result stored in id memory within the recent 7 day 14 day and 30 day J Be gt STEP 5 rT Y To switch between Review Mode and Average Mode press and release both the left and right buttons together To exit the Review or Average Mode press both the left and right buttons together for 2 seconds mg dL edie hes weg To scroll quickly press and hold either the left or right button SETTING THE METER 42 How to test with the Control Solution STEP 1 Insert the Gmate Test Strip with the electrode end facing up into the test strip port of the Gmate
13. 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 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 still does not match call Gmate Customer Service support toll free at 1 855 GO GMATE 1 855 464 6283 SETTING THE METER 43 STEP 4 Make sure to mark the test as a control solution test Press and release either the left or right button once The control solution symbol will be displayed Note If you mark the Control 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 seconds E F l Please make sure that the control solution completely fills the designated area of the Gmate Test Strip www Gmate com Call Customer Service Toll Fre
14. be considered a bio hazardous waste in your area Make sure to follow your healthcare provider s recommendation for proper disposal TESTING YOUR BLOOD GLUCOSE 33 be l J ene Ges 442 om 1 ae ba of patted eels HH pm Unexpected Results m If your test result is 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 Repeat the test If your test result is below 50 mg dL or above 250 mg dL m f your second blood test result is also unusual perform acontrol solution test to ensure that your meter is working properly see Control Solution testing in this User Manual on page 41 Retest your blood If you continue to get unexpected results immediately contact your physician or healthcare professional Range of Unexpected Results Blood glucose levels will vary depending on food intake medication dosages health stress or exercise Consult your physician or healthcare professional for the target value that is appropriate for you www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 283 24 hours a day 7 days a week TESTING YOUR BLOOD GLUCOSE 34 The American Diabetes Association suggests the following targets for most normal adults Before eati
15. card date 3 months after first opening on the vial labels m Do NOT use the test strips or control solution after the expiration date discard date date first opened plus 3 months whichever comes first or your results may be inaccurate m Do NOT use test strips if the vial is damaged or left open to air This could lead to inaccurate test results and error messages www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week CARING FOR THE GMATE VOICE 48 Cleaning and Disinfection of the Gmate VOICE Blood Glucose Monitoring System For safe accurate and dependable use of the Gmate VOICE Blood Glucose Monitoring System and to prevent the spread of infectious diseases the meter should be properly maintained Your Gmate VOICE meter should be cleaned and disinfected when blood dirt or any visible residue is on the meter and lancing device Cleaning and disinfecting of the Gmate VOICE is a two step process and should be done once a week 1 First clean the meter and lancing device using CaviWipes towelettes to remove visible dirt blood or other substances 2 After cleaning disinfect the meter and lancing device using a second CaviWipes towelette to kill the germs that may spread infection Cleaning Clean the meter and lancing device by wiping both devices with CaviWipes towelettes Wipe the outside of the meter and the lancing device caref
16. d 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 replacement The cleaning and disinfecting performance testing on the Gmate VOICE meter was done using CaviWipes with the EPA registration number of 46781 8 manufactured by Metrex CaviWipes are widely available through healthcare supply stores and on the internet from companies like Amazon com If you have difficulty finding CaviWipes near you please call Metrex toll free at 1 888 678 6392 or our Gmate Customer Service support line 24 hours a day 7 days a week at 1 855 GO GMATE 1 855 464 6283 CARING FOR THE GMATE VOICE 51 Place the parts of the Gmate VOICE meter in the carrying case and store it in a cool and dry place Keep out of reach of children Do not refrigerate Avoid exposure to the sun Do NOT soak the meter and strips in water or liquid Do NOT place the meter and sirips in fire or microwave ovens Do NOT subject the meter and test strips to excessive heat Special Note to Caregivers If you are a home health aide family member or other caregiver providing assistance 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 sy
17. e Alternative site testing should be done only during steady state times when glucose is not changing rapidly m The Gmate VOICE Blood Glucose Monitoring System includes a speaking feature that provides audible test results for diabetic users m The Gmate Blood Glucose Test Strips are for use with the Gmate VOICE Meter for the quantitative measurement of glucose sugar in fresh capillary whole blood samples drawn from the fingertips hand upper arm forearm calf or thigh E The Gmate Control Solution is for use with the Gmate VOICE Blood Glucose Monitoring System and is intended as a quality control measure to verify the accuracy of your blood glucose test results and to ensure that the Gmate VOICE Meter and Gmate Test Strips are working properly The Gmate Control Solution is intended for use by people with diabetes at home ABOUT THE VOICE MONITORING SYSTEM 04 Before you Begin Before using the Gmate VOICE Blood Glucose Monitoring System carefully read this User Manual and the inserts that come with the Gmate Test Strips and the Gmate Control Solution Take note of the Important and Caution areas throughout the User Manual Note It may be helpful to practice the test with the control solution before testing with blood for the first time See Control Solution Testing and the Control Solution Insert Test Principle The Gmate VOICE Monitoring System uses small electric currents
18. e at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week ___ CONTROL SOLUTION TESTING 44 w JZ ct ania 1 25 442 om _ Control Test Range 80 120mg dL STEP 6 When the test is complete your control solution test result 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 NTROL SOLUTION TESTIN 45 Results outside the expected range may indicate 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 Test strip is damaged expired or passed its discard date Control solution test was performed outside the correct temperature range between 68 F 77 F 20 C 25 C Control solution is too cold or too warm If you continue to receive the control solution test results outside the range printed on the test strip vial Do NOT use the meter test strips or control solution Call your local distributor or Gmate Customer Service Support toll free at 1 855 GO GMATE 1 855 464 6283 24 hours a day 7 days a week STEP 8 Discard the used test strip The control solution test result will automatically be
19. e 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 www Gmate com Call Cust Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week TROUBLESHOOTING 54 Meter does not enter the test mode after inserting test strip Probable Cause What to do The battery is dead Replace the battery The battery is installed incorrectly or there is no Check that the battery is installed correctly battery in the meter See page 46 Test strip inserted upside down wrong end in or not completely inserted into the meter Insert the test strip with the printed side up and the electrode end of the strip into the test strip port on the meter Defective meter or test strips Contact Gmate Customer Service support toll free at 1 855 GO GMATE 1 855 464 6283 Blood or foreign objects put into the test strip port 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 Probable Cause Blood sample is too small What to do Repeat the test with a new test strip and a larger blood sample Defective meter or test strips Repeat the test with a new test strip If the same problem persists contac
20. e meter by pressing either the left or right button via DE s 25 aaa To enter the Set mode push both buttons on the left and right side He aon simultaneously and release quickly The Volume Alarm Timer D Date amp Time and Language settings will appear on the screen SETTING THE METER 15 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 Important Press and release left or right button to make your setting selection m Simultaneously press and release both buttons left and right at the same time to confirm your setting selection Press and release both buttons left and right at the same time for 2 seconds to exit the Set mode 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 a quick release this will confirm your entry or desired feature Within each feature the left button will scroll the numbers down Within each feature the right button will scroll the numbers up www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week SETTING THE METER 16 Setting the Volume The volume is automatically pre s
21. ea jL philosys Distributed by philosys Inc Address New York NY 10010 USA Tel 855 GO GMATE 855 464 6283 Fax 800 939 8670 E mail info gmate com www Gmate com Gmate is a registered trademark of philosys Inc Patents Pending 2013 philosys Inc All rights reserved www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week
22. et to level 4 for your convenience 3 STEP 1 If the meter is off press and release either button to power the meter on The screen will display the date time and the test strip symbol will begin to blink sla 202 lt 25 WH an STEP 2 ie HOM Quickly press and release both left and right buttons together You are x D 4 now in the Set Mode and the Set symbol appears at the top of the screen with the different settings appearing below SETTING THE METER 17 ofn STEP 3 4 I Use either the left or right button to scroll through settings Once you see s i o that the Volume setting is blinking quickly press and release both the left Ee gt ag and right buttons together You are now in the volume controls 1 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 have reached your desired volume www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week SETTING THE METER 18 Setting the Alarm The Alarm will only ring when the meter is turned off STEP 1 If the meter is off press and release either button to power the meter on The screen will display the date ti
23. ic use only The Gmate VOICE Blood Glucose Monitoring System should only be used to test your blood glucose level with fresh capillary whole blood Do NOT use the Gmate VOICE Meter for any other purpose Before using the Gmate VOICE Blood Glucose Monitoring System read all the instructions in this User Manual carefully to practice for safe and accurate testing Consult your physician or healthcare professional for the proper use of this meter and daily management of your diabetes The Gmate VOICE Meter should only be used with the Gmate Test Strip and Gmate Control Solution m Keep the Gmate VOICE 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 parts of the blood glucose monitoring system may be considered a biohazard and can potentially transmit infectious diseases Please follow all regulations regarding proper disposal of system components including lancets and test strips If you are a caregiver or helper to the owner of this blood glucose monitoring system please refer to page 51 for a special message to avoid the transmission of diseases ABOUT THE VOICE M
24. increase the number STEP 1 If the meter is off press and release either button to power the meter on The screen 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 STEP 3 Use either the left or right button to scroll through settings Once you see that the Date amp Time setting is blinking quickly press and release both the left and right buttons together You are now in the Date amp Time setting SETTING THE METER 23 i A STEP 4 Setting the Year The Year will be flashing Use the left or right button to adjust the Year The left button will decrease the number and the right a button will increase the number Once the desired year has been selected n A quickly press and release both left and right buttons together to confirm f5 BL om your entry and advance to the Month setting OD 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 ante g 05 tao pm OM STEP 6 Setting the Day The Day will be flashing Use the left or right button to
25. me and the test strip symbol will begin 0 BOT IOLA to blink x 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 QI STEP 3 gainon Use either the left or right button to scroll through settings Once you see x 6 that the Alarm setting is blinking quickly press and release both the left and right buttons together You may now set your Alarm You may have up to 4 Alarms mn mamam SETTING THE METER 19 toe al an Sart ne 2 geo STEP 4 To turn the alarm On or OFF use the left or right button to make your selection then quickly press and release both left and right buttons together If On is selected to set your 1 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 2 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 and release both the left and right buttons together to advance to the next alarm and so forth up to 4 Alarm times To quickly exit the Alarm setting press both the left and right buttons
26. mg dL 0 83 mmol L 100 15 15 System accuracy result for glucose concentrations gt 75 mg dL 4 2 mmol L within 5 59 50 85 within 10 95 81 85 within 15 100 85 85 within 20 100 85 85 Regression statistics Slope 0 9978 Intercept 2 1025 mg dL R 0 9905 No of samples 100 Range tested 32 7 442 mg dL www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 rs a day 7 days a week VOICE METER SPECIFICATIONS 60 Electrical and Safety Standards The Gmate VOICE Meter has been tested for immunity to electrostatic discharge as specified in IEC 61000 4 2 The Gmate VOICE Meter has been tested 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 Warranty 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 transferable VOICE PERFORMANCE CHARACTERISTICS Alternate site Alternate site test results were compared to glucose test results at YSI 2300 STAT Test results at FINGERTIPS were compared to test results at YSI 2300 STAT System accuracy result for glucose concentrations lt 75 mg dL 4 2
27. mmol L within 5 mg dL 0 28 mmol L 88 7 8 within 10 mg dL 0 56 mmol L 100 8 8 within 15 mg dL 0 83 mmol L 100 8 8 System accuracy result for glucose concentrations gt 75 mg dL 4 2 mmol L within 5 67 63 94 within 10 94 88 94 within 15 100 94 94 within 20 100 94 94 Test results at UPPER ARM were compared to test results at YSI 2300 STAT System accuracy result for glucose concentrations lt 75 mg dL 4 2 mmol L within 5 mg dL 0 28 mmol L 50 4 8 within 10 mg dL 0 56 mmol L 100 8 8 within 15 mg dL 0 83 mmol L 100 8 8 System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L within 5 84 79 94 within 10 97 91 94 within 15 100 94 94 within 20 100 94 94 VOICE PERFORMANCE CHARACTERISTICS 57 Test results at FOREARM were compared to test results at YSI 2300 STAT System accuracy result for glucose concentrations lt 75 mg dL 4 2 mmol L within 5 mg dL 0 28 mmol L 63 5 8 within 10 mg dL 0 56 mmol L 100 8 8 within 15 mg dL 0 83 mmol L 100 8 8 System accuracy result for glucose concentrations gt 75 mg dL 4 2 mmol L within 5 69 65 94 within 10 94 88 94 within 15 100 94 94 within 20 100 94 94 Test results at HAND were compared to test results at YSI 2300 STAT System accuracy resul
28. ng FPG lt 100 mg dL Two hours after meals OGTT lt 140 mg dL More or less stringent glycemic goals may be appropriate for each individual Reference 1 American Diabetes Association 2011 Standards of Medical Care in Diabetes 2011 Diabetes Care 34 Suppl 1 S11 S61 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 strip against your finger Do NOT bend cut or alter the test strips Do NOT swallow Keep away from children ABOUT ALTERNATE SITE TESTING 35 The Gmate VOICE Blood Glucose 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 www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 283 24 hours a day 7 days a week ABOUT ALTERNATE SITE TESTING 36 Important Information About Using Alternate Site Blood Samples Consult you
29. ontains a known amount of glucose and is used to verify that the meter and test strips are working properly Level 2 Control Solution is included in the Starter Kit The Gmate Control Solution are available in three levels Level 1 Level 2 and Level 3 and are available separately To receive the level of control solution that you desire please contact our Gmate Customer Service Support at 1 855 GO GMATE 1 855 464 6283 or contact your local distributor Important Use only Gmate Control Solution with your Gmate VOICE Meter Control Solution test must be done at room temperature 68 F 77 F 20 C 25 C Make sure the meter test strips and control solution are at room temperature before testing Write the discard date 3 months after first opening on the control solution label Do acontrol solution test To practice the test process instead of using blood When you open a new vial of test strips f you suspect the meter or the test strips are not working properly f you have had repeated unexpected blood glucose results f your meter is damaged www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week 61 Manufactured by philosys Co Ltd Address 827 3 Sangpyeong ri Okgu eup Gunsan si Jeollabuk do Korea Tel 82 63 453 1421 Fax 82 63 453 1423 E mail help gmate biz 1002R5 Rev Date 2013 01 Printed in Kor
30. ov injectionsafety Fingerstick DevicesBGM html www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week ABOUT THE VOICE MONITORING SYSTEM 08 m Do NOT use the Gmate VOICE Blood Glucose Monitoring System if the user is critically ill in shock dehydrated or hyper osmolar m Severe dehydration or excessive water loss may cause inaccurate test results If you believe you are suffering from severe dehydration consult your physician or healthcare professional immediately m f 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 m f you experience symptoms inconsistent with your test results after following the instructions in this User Manual contact your physician or healthcare professional ABOUT THE VOICE MONITORING SYSTEM 09 m Do NOT disassemble or modify the Gmate VOICE Meter m Do NOT throw the batteries into fire m Do NOT subject the Gmate VOICE meter to severe shock drop or step on it m The Gmate VOICE Meter is NOT waterproof Do NOT wash or touch with wet hands a Do NOT wipe the Gmate VOICE Meter with paint thinner or abrasive cleaners m Avoid exposing the Gmate VOICE Meter to high temperatures or humidity rain and dust when using
31. r Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm 2 CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk or Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week CARING FOR THE GMATE VOICE 50 Your Gmate VOICE blood glucose monitoring system has an expected life of five 5 years and should withstand the cleaning and disinfecting recommended in this User Manual We tested the Gmate VOICE Meter and re usable lancing device with the CaviWipes disinfection towelettes representing weekly cleaning and disinfecting two separate steps please see page 48 for five 6 years and did not observe any change in performance accuracy or appearance The test was performed once per week for five years 52 weeks x 5 years x 1 cleaning and disinfecting cycle 2 wipings for a total of 260 times 520 wipings for the meter and reusable lancing device However should you 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 an
32. r physician or healthcare professional before you begin using alternate sites for testing Avoid moles veins bones and tendons Testing during or after a meal physical exercise or any other event that will impact glucose levels can alter your blood glucose test 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 Alternate site testing should NOT be used to make insulin dosing calculations Alternate site testing is NOT recommended for people with a history of recurrent hypoglycemia ABOUT ALTERNATE SITE TESTING 37 Alternate site testing may fail to detect hypoglycemia Use fingertip samples when 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 hand thigh or calf www Gmate com Call Customer Service Toll
33. stem Wash your hands thoroughly both before and after assisting the patient We also recommend that you wear gloves while assisting another person with their meter Parts of the system particularly the test strips and lancets after being exposed to blood are potential biohazards and can spread diseases such as HIV hepatitis B and hepatitis C For more information please contact your local department of health or the toll free help line at 1 855 GO GMATE 1 855 464 6283 www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week TROUBLESHOOTING 52 Error Messages ri Indicates a used test strip has been inserted Re test with a new test strip gt Loe z 1 Indicates that there may be a possible meter malfunction Review the instructions and re test with a new test strip If this message appears ag Y again contact Customer Service Support at 1 885 GO GMATE 1 885 464 6283 or your local distributor ba Wt al Indicates that the environmental temperature is ABOVE or BELOW the system operational range System operational range is 50 F 104 F ri D 10 C 40 C Repeat the test after the meter and test strip have reached the correct temperature range TROUBLESHOOTING 53 D 3 Battery is low You can still perform a few more tests Replace the battery aa ONA Toa pi ie 25 UM pm Battery is too low to perform a test Replace th
34. t Gmate Customer Service Support toll free at 1 855 GO GMATE 1 855 464 6283 Blood sample is applied after meter times out and turns off meter will power off if no activity after 90 seconds Repeat the test using a new test strip VOICE METER SPECIFICATIONS 59 Model PG 301 Gmate VOICE Blood Glucose Monitoring System Test Method Electrochemical sensor Calibration Method Plasma Sample Whole blood capillary Sample Size 0 5 uL Test Time 5 seconds Memory 5 000 Blood glucose tests Result Range 20 600 mg dL Hematocrit 20 60 Operating Temperature 50 104 F 10 40 C Operating Relative 10 90 Humidity Altitude Up to 10 000 feet 3 048 meters Power Source Two Alkaline AAA 1 5 volt Batteries replaceable Size 2 44 x 4 52 x 0 51 62 0mm x 114 8mm x 13 0mm Weight 2 820z 80g www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 6283 24 hours a day 7 days a week GMATE VOICE PERFORMANCE CHARACTERISTICS 55 Clinical accuracy The accuracy of the Gmate VOICE System was assessed by comparing the blood glucose test results obtained from patients with those obtained using an YSI 2300 Glucose Analyzer System accuracy result for glucose concentrations lt 75 mg dL 4 2 mmol L within 5 mg dL 0 28 mmol L 27 4 15 within 10 mg dL 0 56 mmol L 93 3 14 15 within 15
35. t for glucose concentrations lt 75 mg dL 4 2 mmol L within 5 mg dL 0 28 mmol L 75 6 8 within 10 mg dL 0 56 mmol L 100 8 8 within 15 mg dL 0 83 mmol L 100 8 8 System accuracy result for glucose concentrations gt 75 mg dL 4 2 mmol L within 5 63 59 94 within 10 91 83 94 within 15 98 92 94 within 20 100 94 94 www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 rs a day 7 days a weel VOICE PERFORMANCE CHARACTERISTICS Test results at THIGH were compared to test results at YSI 2300 STAT System accuracy result for glucose concentrations lt 75 mg dL 4 2 mmol L within 5 mg dL 0 28 mmol L 75 6 8 within 10 mg dL 0 56 mmol L 88 7 8 within 15 mg dL 0 83 mmol L 100 8 8 System accuracy result for glucose concentrations gt 75 mg dL 4 2 mmol L within 5 76 71 94 within 10 98 92 94 within 15 100 94 94 within 20 100 94 94 Test results at CALF were compared to test results at YSI 2300 STAT System accuracy result for glucose concentrations lt 75 mg dL 4 2 mmol L within 5 mg dL 0 28 mmol L 38 3 8 within 10 mg dL 0 56 mmol L 100 8 8 within 15 mg dL 0 83 mmol L 100 8 8 System accuracy result for glucose concentrations gt 75 mg dL 4 2 mmol L within 5 63 69 94 within 10 93 87 9
36. te with soap and water before sampling Make sure the Gmate VOICE meter and test strips are about the same temperature room temperature is best before you test Immediately close the 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 months after first opening on the test strip label Keep your meter and lancing device clean by following the cleaning and disinfection protocol in this User Manual see page 48 TESTING YOUR BLOOD GLUCOSE 27 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 www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week TESTING YOUR BLOOD GLUCOSE 28 STEP 3 Insert a new sterile lancet into the bottom of the lancet carrier STEP 4 Twist off the protective cap from the lancet STEP 5 Place the device cover back on
37. the Date amp Time setting at any time press both the left and right buttons together for 2 seconds SETTING THE METER 25 m Hanen Setting the Language STEP 1 If the meter is off press and release either button to power the meter on The screen 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 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 language that you prefer Once the desired language has been selected quickly press and release both left and right buttons together to confirm your entry En English ES Spanish www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week TESTING YOUR BLOOD GLUCOSE Preparing for a Test Be sure to have these items ready when you test Gmate VOICE Meter Lancing Device Gmate Test Strips Sterile Lancets Important Use only Gmate Test Strips Make sure to wash the puncture si
38. to 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 TESTING YOUR BLOOD GLUCOSE 29 STEP 7 Place the end of the lancing device against the designated 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 Do NOT reuse lancets Lancets are for single use only Do NOT share lancets and the lancing device www Gmate com Call Customer Service Toll Free at 855 GO GMATE 855 464 6283 24 hours a day 7 days a week TESTING YOUR BLOOD GLUCOSE 30 Testing with a fingertip sample 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 blood drop will appear and flash The meter and test strip are now ready to test your blood sample STEP 3 Before you begin make sure the code number displayed on the screen is the same as the
39. ully 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 Disinfecting Disinfecting can be accomplished by wiping the meter and the reusable lancing device with CaviWipes disinfecting towelettes It is very important that the meter and lancing device remain wet for two 2 minutes CARING FOR THE GMATE VOICE 49 Wipe the outside of the meter and the re usable lancing device carefully using CaviWipes disinfecting towelettes If the towelette is dripping wet excess liquid should be squeezed out Take extreme care to avoid getting liquid in test strip port To achieve disinfection of all the stated efficacy kill claims let the solution sit on the meter or lancing device for at least 2 minutes Allow the meter and lancing device to dry completely before use After 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 Use of Fingerstick Devices on More than One PersonPoses Risk fo

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