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PM110-CE0-2105_Gmate On_user guide_20170621.indd 4

2017-08-03 �� 9:41:30

Introduction

Welcome to

Gmate™ On Blood Glucose

Monitoring System

Thank you for purchasing the

Gmate™ On Blood

Glucose Monitoring System. Please read this User

Guide thoroughly before operating the system as it

provides important information on the proper use of

the system. It is recommended you keep this User

Guide in a safe place for your future reference. The
Gmate™ On Blood Glucose Monitoring System
combined with your Android device is used to

measuring your blood glucose level anytime,

anywhere in a convenient manner. Compatible with
your Android mobile device, Gmate™ On Blood
Glucose Monitoring System is very easy and sim-

ple to use. The automatic coding of

Gmate™ On

Blood Glucose Monitoring System returns accurate

test results. The

Gmate™ On Blood Glucose

Monitoring System should not be used for

diagnosis of diabetes.

Summary of Contents for Gmate On

Page 1: ...ard Général Wahis 53 1030 Brussels Belgium Tel 32 2 732 59 54 Fax 32 2 732 60 03 email mail obelis net philosys Co Ltd 28 5 Gwangwol gil Okgu eup Gunsan si Jeollabuk do 54172 Korea Tel 82 63 453 1421 Fax 82 63 453 1423 email help philosys com PM110 CE0 2105 Date 2017 06 Printed in Korea ...

Page 2: ...PM110 CE0 2105_Gmate On_user guide_20170621 indd 3 2017 08 03 9 41 30 User Guide ...

Page 3: ...PM110 CE0 2105_Gmate On_user guide_20170621 indd 4 2017 08 03 9 41 30 ...

Page 4: ...4 Precautionary Information 8 What s Inside 10 Identifying Partsand Functions 12 Running the App 16 Performing the Test 17 Alternate Site Testing 26 Control Solution Testing 29 Reviewing Past Results 34 Troubleshooting 36 Care and Maintenance 38 System Specifications 40 Meaning of Symbols 43 3 ...

Page 5: ... recommended you keep this User Guide in a safe place for your future reference The Gmate On Blood Glucose Monitoring System combined with your Android device is used to measuring your blood glucose level anytime anywhere in a convenient manner Compatible with your Android mobile device Gmate On Blood Glucose Monitoring System is very easy and sim ple to use The automatic coding of Gmate On Blood ...

Page 6: ...ransportable anywhere with your mobile device 3 The meter does not require batteries nor prior settings 4 The app is easy and intuitive use 5 Sound support provides clear instructions and readings 6 All test results automatically saved into your mobile device 7 Only requires a small volume 0 5μL ofyour blood 8 Displays your results in just fiveseconds 9 Approved for alternate sitetesting AST 5 ...

Page 7: ...rtips forearms upperarms hands thighs and calves as an aid in monitoring the effectiveness of diabetes management at home by patients with diabetes A single patient only and should not be shared with any other persons Self testing outside the body in vitro diagnostic use by people with diabetes at home as an aid to monitoring for effective diabetes control Alternative site testing should be done o...

Page 8: ...or screening of diabetes The Gmate On Blood Glucose Monitoring System should not be used for neonates The Gmate Blood Glucose Test Strips are intended for use with Gmate On Blood Glucose Monitoring System only for the purpose of quantitative measurement of blood glucose in fresh capillary whole blood samples The Gmate Blood Glucose Control Solutions are intended for use with Gmate On Blood Glucose...

Page 9: ... System for any purposes other than testing your blood glucose level with fresh capillary whole blood Before using the Gmate On Blood Glucose Monitoring System read all instructions in this User Guide and the test strip insert found in the test strip box carefully and then practice the procedure for safe and accurate testing Keep the Gmate On Blood Glucose Monitoring System out of reach from child...

Page 10: ...g infectious diseases even after the cleansing procedures Please follow all regulations concerning proper disposal of system components including lancets and test strips There are two types of glucose units mg dL and mmol L Your Gmate On meter does not allow you to change the glucose unit yourself in order to prevent misinterpretation of the test results The glucose unit has been preset before lea...

Page 11: ..._20170621 indd 10 2017 08 03 9 41 30 What s Inside Contained in your package 1 Gmate On Meter 2 Gmate Lancing Device 3 Gmate Lancets 4 Gmate Blood Glucose Test Strips 5 Carrying Case Documents in your package include this User Guide 10 ...

Page 12: ...n Control Solutions are available separately Mobile devices are not included Gmate On Meter is compatible with Android 4 0 or higher version platform based mobile devices Samsung Galaxy S2 Galaxy S3 Galaxy S4 Galaxy S5 Galaxy Note Galaxy Note 2 and Galaxy Note 3 Galaxy is a trademark of Samsung Electronics Co Ltd and Android is a trademark of Google Inc 11 ...

Page 13: ...7 08 03 9 41 30 Identifying Parts Functions Gmate On meter Test Strip Port Insert the end of a Gmate Test Strip here Power Indicator Insert the test strip when the light flashes here Micro USB Connector Plug this end to the USB jack of your mobile device 12 ...

Page 14: ...0 Identifying Parts Functions Gmate Test Strip Test Strip Port Apply your blood sample on the edge of the absorbent Hold the test strip with your fingers here Electrodes The end of the test strip is inserted into the test strip port of the meter with the end facing up 13 ...

Page 15: ... 14 2017 08 03 9 41 30 Identifying Parts Functions Lancing Device Adjustable cap Lancet holder Clear AST cap Lancet ejector Release button Sliding barrel Clear AST cap is an optional accessory Please contact your local distributor for availability 14 ...

Page 16: ...ancing Device are subject to change without notice Test Principle Performing a test using Gmate On Blood Glucose Monitoring System involves the measurement of electrical currents caused by the reaction of glucose with the reagent of the test strip This current is converted to the amount of glucose in the blood sample which is then displayed as a result on your mobile device 15 ...

Page 17: ...p 2 Installing the app Follow the instructions through the installation process After the installation is complete run the app by either tapping Open option at the end or tapping the newly downloaded Gmate On app Step 3 Starting up the app Tap Start button then proceed to the main start upscreen Plug your Gmate On Meter to the USB jack If your device recognizes the meter the power indicator will f...

Page 18: ...ng the Test Step 1 Preparing the app and the meter Start the app and plug your meter to the USB jack of your mobile device When the meter s power indicator is on insert the test strip into the test strip port of the meter Make sure the Gmate logo of the test strip is facing up 17 ...

Page 19: ...17 08 03 9 41 31 Performing the Test Step 2 Preparing the lancing device Wash your hands thoroughly with warm water to increase blood circulation into the fingers Then dry your hands completely including your puncture site Unscrew the lancing device cap 18 ...

Page 20: ... Performing the Test Insert a new sterile lancet into the lancet holder and fix it in firmly Hold the lancet in one hand and twist off the protective cap with the other hand Place the cap back on the lancing device Cock the lancing device by drawing the sliding barrel 19 ...

Page 21: ...uncture will be deeper as the number increases The smaller numbers are for shallower puncture that is more suitable for softer skin and deeper puncture is more suitable for thick er or calloused skin Step 3 Obtaining a blood sample Hold the lancing device against the finger you have chosen to lance Then press the release button to collect a blood sample 20 ...

Page 22: ... 03 9 41 31 Performing the Test Step 4 Applying blood to the test strip Touch the end of the yellow absorbent gently to the edge of your blood drop The yellow absorbent will automatically draw your blood IMPORTANT 21 The blood sample volume must be at least 0 5 ...

Page 23: ...nnounced as it appears on the screen along with the date and time All your test results will be automatically saved in your mobile device CAUTION Step 6 Saving the test result You can customize your results by selecting a rele vant icon Premeal Postmeal Exercise Medication and Stress from the icon bar at the bottom You may also type in additional comments 22 The screen will display HIGH if your te...

Page 24: ...est result Step 7 Removing and discarding used test strip and lancet Remove the test strip from the meter and the lancet from the lancing device Dispose of them in accordance with your local regulations CAUTION 23 Used test strips and lancets may be considered biohazardous waste in your area Be sure to conform to your local regulations for proper disposal ...

Page 25: ...dL 2 8mmol L Above 250mg dL 13 9mmol L LOW HIGH If you continue to get unusual test results call your healthcare professional Check your system with control solution if you have purchased it with the system See Control Solution Testing for details page 29 Call your healthcare profession al without delay if your control solution result is within range printed on the test strip vial 24 ...

Page 26: ...ed blood glucose level for a non pregnant patient with diabetes After fasting Less than 110mg dL 6 0mmol L Two hours after a meal Less than 140mg dL 7 8mmol L Fasting means not having anything to eat or drink except water for at least eight hours References 1 Self Monitoring of Blood Glucose in Non Insulin Treated Type2 Diabetes 2009 Interna tional Diabetes Federation Online Available https www id...

Page 27: ... upper arm thigh and calf The purpose of this alternate site testing is to use your fingertips less to avoid calluses and pain from repeated lancing in the same spot Sampling from alternate sites may also cause less pain The following are the body parts you can choose to perform as alternate site testing Be sure to consult your healthcare professional before you perform an AST Upper Arm Forearm Ha...

Page 28: ...od glucose levels two hours after a rapid acting insulin injection or insulin pump bolus Avoid an AST under following situations during or within two hours after a meal physi cal exercises or other activities that may affect blood glucose levels when intending to calibrate continuous blood glucose results when making insulin dosing calculations when testing for hypoglycemia or for those with a his...

Page 29: ... ster ile lancet firmly into the lancet carrier place the clear AST cap on top Hold the lancing device against the site you have chosen to lance Avoid moles veins bones and tendons Press and hold the lancing device on the spot for a few seconds Then press the release button to collect a blood sample Observe through the clear cap to see if sufficient amount of blood sample is taken If there is not ...

Page 30: ...l replace the role of your blood sample Control solutions are available to purchase separately Perform a control test in the following instances to check the test process without sampling blood every time you open a new vial of test strips you get repeated unexpected blood glucose results you suspect the meter or test strips are not working properly you have dropped or damaged the meter your test ...

Page 31: ...pow er indicator is on insert the test strip into the test strip port of the meter Make sure the Gmate logo of the test strip is facing up Step 2 Applying control solution The app will instruct you to ap ply blood Slide over to Control Solution display to the right The animation of applying control solution will be displayed Shake the control solution vial remove the cap then squeeze to release a ...

Page 32: ...tion Testing Step 3 Reading control solution test result Along with the recognition sound the display of your mobile device will show the progress bar for about five seconds Then the control solution result will be announced as it appears on the screen along with the date and time 31 ...

Page 33: ...lt Compare the result with the control solution range printed on the test strip vial If the result is within range your meter and test strips are proven to work properly If not within range repeat the control solution test If out of range result occurs again contact your local distributor 32 Control Test Range 80 120mg dL ...

Page 34: ... steps not used the control solution level you intended expired or contaminated control solution expired or damaged test strip defective meter the test not performed within temperature range of 20 C to 25 C 68 F to 77 F If you continue to get control solution results that do not fall within the range printed on the test strip vial withdraw use and call your local distributor 33 ...

Page 35: ...your results from the app without connecting the meter to your mobile device The test results are displayed as a list with the most recent result displayed on the top Tap on each re sult to view details You can transfer the test results by SMS and e mail by using the Message icon and Mail icon respectively IMPORTANT 34 For security reasons use of cellular data networks instead of Wi Fi is recommen...

Page 36: ...110 CE0 2105_Gmate On_user guide_20170621 indd 35 2017 08 03 9 41 32 Reviewing Past Results Above you can see how your test results will be listed and what will show when you tap on one of the results 35 ...

Page 37: ... port Remove visible foreign ob jects on the surface gently with a dry cloth Contact your local distributor if it still does not work 36 There is no response after you connect the meter to your mobile device Probable cause To do The meter is not properly connected to the mobile device Connect the meter again properly Contact your local distributor if recognition fails again The meter will not conn...

Page 38: ...08 03 9 41 32 Troubleshooting 37 There is no response after the blood sam ple is applied to the test strip Probable cause To do The meter or test strips are Redo the test with a new defective test strip Contact your local distributor if it still does not work ...

Page 39: ...e between 2 and 32ºC 36 and 90ºF If your meter has been exposed to extreme temperatures perform the test after you have kept it in room temperature for at least 20 minutes Do not subject the meter to severe shock Do not leave the vial cap open for a long time as it may cause inaccurate test results Leave the vial cap closed immediately after each use Use all test strips and control solution within...

Page 40: ...an is essential for avoiding malfunction such as foreign objects contaminating the meter causing it to fail and spreading of infection Use soft cloth dampened with mild soap and water to wipe the exterior of your meter lancing device and clear AST cap Do not use alcohol or other solvents to clean Do not immerse your meter and lancing device in liquid 39 ...

Page 41: ...ned by patients with those obtained using a YSI 2300 Glucose Analyzer System accuracy result for glucose concentrations 100 mg dL 5 5 mmol L System accuracy result for glucose concentrations 100 mg dL 5 5 mmol L within 5 90 9 374 411 within 10 100 411 411 within 15 100 411 411 Regression statistics Slope 0 9857 Intercept 2 9141 mg dL R 0 9976 No of samples 600 Range tested 34 2 447 mg dL 1 9 24 8 ...

Page 42: ...oefficient of variation 48 mg dL 2 7 mmol L 2 0 mg dL 0 1 mmol L 4 1 108 mg dL 6 0 mmol L 4 2 mg dL 0 2 mmol L 3 9 355mg dL 19 7 mmol L 9 3 mg dL 0 5 mmol L 2 6 41 Mean glucose Standard deviation Coefficient of variation 48 mg dL 2 7 mmol L 2 0 mg dL 0 1 mmol L 4 1 93 mg dL 5 2 mmol L 3 4 mg dL 0 2 mmol L 3 6 137 mg dL 7 6 mmol L 4 4 mg dL 0 2 mmol L 3 2 240 mg dL 13 3 mmol L 6 4 mg dL 0 4 mmol L ...

Page 43: ...ocrit Level Operating Temperature Operating Relative Humidity Altitude PG 110 Gmate On Blood Glucose Monitoring System Electrochemical sensor Plasma equivalent Whole blood capillary 0 5 µL 5 seconds No limit 10 600 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 Power Source Size Weight From the smart phone 41 5mm x 33 6mm x 9 0mm 1 63 x 1 32 x 0 35 5 9g 0 21oz 4...

Page 44: ...gle use only Expiration date Serial number Lot number In Vitro Diagnostic medical device Manufacturer Authorised representative of European Community Symbol for temperature limitation Consult instructions for use Biological risks Contains sufficient for n tests Direct current Separate disposal from other house hold waste Catalogue number 43 REF ...

Page 45: ...ecified as requirements in IEC 61010 1 Additionally it meets the requirements of electromagnetic compatibility EMC as specified in IEC 61326 1 and IEC 61326 2 6 Warranty Philosys warrants that the Gmate On Meter alone should be free of defects in materials and workmanship under regular use without damage for a period of five years since the date of purchase This warranty pertains only to the origi...

Page 46: ...PM110 CE0 2105_Gmate On_user guide_20170621 indd 45 2017 08 03 9 41 33 ...

Page 47: ...PM110 CE0 2105_Gmate On_user guide_20170621 indd 46 2017 08 03 9 41 33 Gmate On User guide size 65x115mm 펼침면130x115mm 총4도 CMYK 무선제본 표지 아트지150 속지 모조지 미색 70 코팅 없음 연구개발본부 정은지 2017 06 20 ...

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