GlucoRx AiDEX RC2101, User Manual

Page 1: ...Continuous Glucose Monitoring System User Guide GlucoRx Ltd...

Page 2: ...afety information 1 1 1 Indications for use 1 1 2 User group 2 1 3 Contraindications 2 1 4 Precautions 3 2 Product description 7 2 1 Component description 7 3 User instruction 13 3 1 Software download...

Page 3: ...tallation 15 3 2 Software registration login and resetting 16 3 2 1 Software registration 16 3 2 2 Software login 18 3 2 3 Password reset 20 3 3 Introduction 22 3 3 1 Bluetooth setting 22 3 3 2 Notifi...

Page 4: ...tting 32 3 3 7 Connecting a transmitter 34 3 4 Application 37 3 4 1 Pairing a transmitter 37 3 4 2 Unpairing a transmitter 41 3 4 3 Applying a sensor 44 3 4 4 Sensor warm up 53 3 4 5 Removing a sensor...

Page 5: ...5 3 Trends dashboard 62 3 5 4 Blood glucose BG dashboard 65 3 5 5 Events dashboard 69 3 6 Alerts 72 3 6 1 Alert settings 72 3 7 Language 76 3 8 Others 78 3 8 1 Terms of service 78 3 8 2 Privacy polic...

Page 6: ...ntenance 80 4 1 Caring for your Continuous Glucose Monitor System CGMS 80 4 2 Quality control test 84 5 Data security 84 6 Troubleshooting 86 7 Electromagnetic compatibility 88 8 Explanation of symbol...

Page 7: ...tinuous or regular monitoring of glucose levels in subcutaneous tissue and is used for daily detection and self management of blood glucose levels in people 14 years or older It is intended for use by...

Page 8: ...d hypoglycaemia Measurements should not be used to make treatment adjustments but rather as a reminder of when fingertip testing is required 1 2 User group This CGMS is suitable for people with diabet...

Page 9: ...ave severe hearing or vision impairment 5 Are below the age of 14 or are not capable of administering diabetes therapy themselves or who always need to use CGMS under strict supervision of parents or...

Page 10: ...that can be dangerous if swallowed Should there be rapid changes in blood glucose value displayed by the App more than 0 1 mmol L per minute or 1 8 mg dL per minute the displayed blood glucose levels...

Page 11: ...irely on the displayed reading on the App Severe dehydration or excessive loss of water may result in inaccurate results When you suspect you are dehydrated consult a healthcare professional immediate...

Page 12: ...een evaluated when used with another implantable medical device such as a pacemaker Only compatible consumables should be used with the CGMS If the product is not working properly or has been damaged...

Page 13: ...t is related to the App should be reported to GlucoRx All pictures shown in this guide are for illustration purpose only Actual product may vary due to product enhancement 2 Product description 2 1 Co...

Page 14: ...wing components 1 Transmitter 1 User Guide 1 Quick Guide The Sensor package consists of the following components 1 Continuous Glucose Monitoring Sensor Applicator with built in sensor set 1 User Guide...

Page 15: ...s glucose readings as well as transmitting the readings to the GlucoRx AiDEX mobile App Sensor The glucose sensor package contains a sterilised glucose sensor attached to a sensor base and a sensor ap...

Page 16: ...10 Sensor applicator Sensor base tape Glucose sensor Sterile packaging Sensor components...

Page 17: ...name GlucoRx AiDEX Continuous glucose monitoring App Model No Operating System Unit Release Version RC2101 iOS mg dL V1 RC2102 iOS mmol L V1 RC2103 Android mg dL V1 RC2104 Android mmol L V1 Release v...

Page 18: ...ed by the CGMS is updated every 5 minutes The App synchronises the sensor glucose data every 5 minutes The GlucoRx AiDEX App is compatible with the following devices GlucoRx AiDEX CGMS GlucoRx MicroTe...

Page 19: ...ware download You can download the GlucoRx AiDEX App from App Store iOS or Google Play Android Please check the Operating System OS on your phone to make sure you get the correct App version To downlo...

Page 20: ...14 SEARCH GlucoRx AiDEX...

Page 21: ...ry 2GB RAM Storage Minimum 200 MB Network WLAN Wireless Local Area Network or cellular network as well as Bluetooth function Android Operating System OS Android 8 0 and above Memory 3GB RAM Storage Mi...

Page 22: ...not have an account click Register button to enter the registration screen Please input your email address and password Read the Terms of Use and Privacy Policy before ticking the box By ticking the...

Page 23: ...17...

Page 24: ...18 3 2 2 Software login Use your registered account email address and password to log in to the GlucoRx AiDEX App...

Page 25: ...19...

Page 26: ...to enter the password Reset screen Type in your email address and your new Password then click Continue You will receive a verification email Follow the instruction in the email to complete your pass...

Page 27: ...21...

Page 28: ...etups 3 3 1 Bluetooth Setting You will need Bluetooth connection to pair your CGMS transmitter Click Continue to enable the Bluetooth connection between your CGMS and the App or enable the Bluetooth i...

Page 29: ...23...

Page 30: ...Notification In the Receiving CGMS Alerts screen choose Continue to enable the alert notification If you do not wish to receive alerts you can disable the alert setting in Settings Home Settings Alert...

Page 31: ...25...

Page 32: ...not disturb In the Do Not Disturb screen reminder to check your Do Not Disturb Mode in your phone is displayed Ensure that your have turned off Do Not Disturb Mode in your phone before using the Gluco...

Page 33: ...27...

Page 34: ...gs screen there are tips for blood glucose management when alerts appear If your glucose alerts and sensor glucose readings do not match your symptoms or expectations take a blood glucose test with a...

Page 35: ...29...

Page 36: ...setting Set your lower glucose threshold in the low glucose alert setting screen You can also change the alert threshold by clicking the Settings icon on the upper right corner of the Home screen Hom...

Page 37: ...31...

Page 38: ...click Continue to enter the high glucose alert setting screen Set your upper glucose limit in the high glucose alert setting screen You can also change the alert value by clicking the Settings icon on...

Page 39: ...33...

Page 40: ...ter the Transmitter setting screen Input the SN Serial number code on your transmitter package manually or scan the QR code on the transmitter package to complete the pairing automatically using the s...

Page 41: ...35...

Page 42: ...mitter setting you can also click the Settings icon on the upper right corner of the Home screen and choose Transmitter to connect the transmitter Home Settings Transmitter Please refer to chapter 3 4...

Page 43: ...tooth wireless technology You can manage your transmitter in the Home dashboard Home Settings Transmitter Click the Settings icon on the top right hand corner then click Transmitter Input the SN code...

Page 44: ...38...

Page 45: ...39...

Page 46: ...lease enable the Bluetooth function in your mobile device The communication radius of your transmitter is 2 metres without obstacle If pairing fails a notification box will appear Users may choose to...

Page 47: ...ansmitter 3 Click the Unpair button If unpairing fails you can choose to delete the transmitter permanently Note Please make sure the GlucoRx AiDEX App is paired with the transmitter before unpairing...

Page 48: ...42...

Page 49: ...43...

Page 50: ...44 3 4 3 Applying a sensor Use the sensor applicator of your CGMS to insert the GlucoRx AiDEX CGMS sensor Please ensure the selected skin area is hair free for best user experience...

Page 51: ...45...

Page 52: ...ich may weaken the sensor and its adhesive tape It is strongly recommended to put the sensor on your abdomen rather than the arms or other areas Rotate your sensor sites regularly to avoid discomfort...

Page 53: ...application Before application use alcohol pads to disinfect your selected skin area and wait for a minute to let the skin dry Open the sensor package Ensure the sensor has not expired by checking its...

Page 54: ...k w i s e direction Place the applicator on the top of your desired sensor site Press it firmly against your skin and press the button to launch the sensor After inserting the sensor wait a few secon...

Page 55: ...g a sensor may cause bruising or bleeding If bleeding does not stop remove the sensor and apply a new sensor to a different location Align the transmitter to the sensor base and press the transmitter...

Page 56: ...s the picture shown above the transmitter cannot func tion properly Note Please use an over patch to reinforce th e adhe siveness if you think it is necessary Over patch To apply 1 Clean skin area wit...

Page 57: ...sensor Smooth down on skin 4 Remove section B and stretch gently over the rest of the sensor Smooth down on skin Tips Wait at least 20 minutes before swimming or athletic activities after application...

Page 58: ...g away the patch from the sensor For more support contact UK customer care info glucorx co uk Tel 0800 007 5892 The recyclable applicator is meant for single use only Discard the used sensor package a...

Page 59: ...y 3 4 4 Sensor warm up When you have successfully paired the transmitter you need to wait for one hour for your sensor to warm up You will see the real time glucose readings updated every 5 minutes on...

Page 60: ...sor is a used one you may skip the warm up The real time glucose readings updated every 5 minutes will be displayed on the Home screen directly In addition please do not suspend or cancel the sensor w...

Page 61: ...55...

Page 62: ...ly pull the tape that holds the sensor to the skin from the edge and slowly uncover it until the entire sensor is removed You can use warm soapy water to remove any remaining sticky residue Press the...

Page 63: ...r according to your local regulations 3 5 GlucoRx AiDEX App functions 3 5 1 Home dashboard Home dashboard displays the overview of your blood glucose levels In the upper section of the dashboard the r...

Page 64: ...hours or 24 hours Scroll the plot to view blood glucose levels over different periods The data point gives you the blood glucose value and the time of measurement updated every five minutes A pop up n...

Page 65: ...59...

Page 66: ...lert value the App will alert you every 30 minutes about your glucose levels The alert and the time it took place is displayed in the History dashboard 2 The events added on the Home screen will be di...

Page 67: ...61...

Page 68: ...n choose to display the analysis results over a certain period Last 7 days Last 14 Days Last 30 Days or your customised interval In the Average Glucose Level section your average sensor glucose level...

Page 69: ...emia events and their corresponding durations are also displayed In the Daily Trends section your blood glucose level recorded each day is displayed In the Expand section the analysis parameters are d...

Page 70: ...variability IQR Inter Quartile Range AAC100 Area Above Curve 100 AUC100 Area Under Curve 100 LBGI Low Blood Glucose Index HBGI High Blood Glucose Index ADRR Average Daily Risk Range GRADE Glycaemic R...

Page 71: ...Blood Glucose BG dashboard you can calibrate the CGMS and record the reference blood glucose level for sensor calibration In the Blood Glucose dashboard there are two functions for Calibration and Re...

Page 72: ...s different from the sensor glucose level displayed in the Home dashboard percentage difference greater than 20 you can manually input the calibration glucose level to calibrate the sensor Alternative...

Page 73: ...ation Do not calibrate the system frequently afterwards Please calibrate only when your glucose value is stable Do not calibrate while your blood glucose is rising or falling rapidly The glucose value...

Page 74: ...68...

Page 75: ...mplete the calibration 3 5 5 Events dashboard The GlucoRx AiDEX CGMS allows you to log and track events that may affect you blood glucose level 1 You can note down different types of events including...

Page 76: ...displayed in the History dashboard 4 You can pre set up to 9 events for quick recording 5 The recorded events are uploaded to the Cloud Services You can access the event history on the Cloud by using...

Page 77: ...71...

Page 78: ...urgent low alerts High glucose alerts and low glucose alerts will appear as pop up notifications The records of high glucose alerts and low glucose alerts will also be displayed in History dashboard 1...

Page 79: ...a blood glucose meter and test strips If the test result is not consistent with the blood glucose level displayed on the App please contact your healthcare professional for advice 3 When high glucose...

Page 80: ...blood glucose level returns to normal glucose range 4 When the sensor glucose level on average rises more than 0 1 mmol L per minute alert notification appears 5 When the sensor glucose level on aver...

Page 81: ...75...

Page 82: ...76 3 7 Language Click the Settings icon in the top right hand corner then click Language to select the GlucoRx AiDEX App display language...

Page 83: ...77...

Page 84: ...lucoRx AiDEX App 3 8 2 Privacy policy Under Home Settings Others Privacy Policy you can check the Privacy Policy of the App 3 8 3 Delete account Click Delete account to permanently delete your account...

Page 85: ...79...

Page 86: ...ia customer care at info glucorx co uk Tel 0800 007 5892 4 1 Caring for your Continuous Glucose Monitor System CGMS Cleaning the transmitter Clean the outer surface of the transmitter using a mild det...

Page 87: ...the transmitter in water or other liquids Avoid dust dirt blood chemicals water and other substances on the transmitter connec tion port Disposal Dispose transmitters and sensors that you do not use a...

Page 88: ...ight on top of the transmitter Avoid direct sunlight and rain Storage If you are temporarily not using the transmitter or sensor system store the components in a cool dry clean and well ventilated are...

Page 89: ...83 Specifications...

Page 90: ...r and or test strips are not working properly or if you suspect that your test results are inaccurate or inconsistent with how you feel 5 Data security The information stored in this GlucoRx AiDEX App...

Page 91: ...d service provider The data stored in the Cloud can only be interpreted using the decryption algorithm offered by the cloud service provider User information can be protected You can clear your data s...

Page 92: ...ll the saved but not displayed data can be displayed again If the App fails to display blood glucose data please restart the Bluetooth and re pair the App and the corresponding transmitter or contact...

Page 93: ...lucose data is temporarily stored in the transmitter during signal loss When connection between the App and the transmitter is restored all relevant data will be transmitted to the App Fail to read da...

Page 94: ...on Transmitters and sensors devices are intend ed for use in the electromagnetic environment specified below The user of the device should ensure that the device is used in such an envi ronment Portab...

Page 95: ...y normal operation in the config uration in which it will be used Performance Description Measurement accuracy When the glucose concentration is 4 2mmol L 75mg dL the sensor accuracy deviation does no...

Page 96: ...l function Therefore its RF emissions are very low and are not likely to cause any interference in near by electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all esta...

Page 97: ...line to GND 2KV line to GND 1KV line to GND 2KV line to GND Mains power quality should be that of a typical commer cial or hospital environment Voltage dips short interruptions and voltage variations...

Page 98: ...V m Portable and mobile RF communica tions equipment should be used no closer to any part of the device includ ing cables than the recommended separation distance calculated from the equation applicab...

Page 99: ...paration distance according to frequency of transmitter m 150kHz 80MHz d 1 2 P 80MHz 800MHz d 1 2 P 800MHz 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12...

Page 100: ...94 8 Explanation of symbols This section explains the icons used on this CGMS...

Page 101: ...95...

Page 102: ......

Page 103: ...1C Henley Business Park Pirbright Road Guildford Surrey GU3 2DX United Kingdom Customer Careline 0800 007 5892 E mail info glucorx co uk Website www glucorx co uk EC REP Lotus NL B V Koningin Juliana...