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GlucoRx AiDEX RC2101 User Manual

Continuous glucose monitoring system
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Continuous Glucose Monitoring System
User Guide
GlucoRx Ltd

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Summary of Contents for GlucoRx AiDEX RC2101

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

  • Page 2: Table Of Contents

    Content 1. Important safety information 1.1 Indications for use 1.2 User group 1.3 Contraindications 1.4 Precautions 2. Product description 2.1 Component description 3. User instruction 3.1 Software download and installation...
  • Page 3 3.1.1 Software download 3.1.2 Minimum requirements for software installation 15 3.2 Software registration, login and resetting 3.2.1 Software registration 3.2.2 Software login 3.2.3 Password reset 3.3 Introduction 3.3.1 Bluetooth setting 3.3.2 Notification 3.3.3 Do not disturb 3.3.4 Alerts and warnings setting...
  • Page 4 3.3.5 Low glucose alert setting 3.3.6 High glucose alert setting 3.3.7 Connecting a transmitter 3.4 Application 3.4.1 Pairing a transmitter 3.4.2 Unpairing a transmitter 3.4.3 Applying a sensor 3.4.4 Sensor warm-up 3.4.5 Removing a sensor 3.5 GlucoRx AiDEX™ App functions 3.5.1 Home dashboard...
  • Page 5 3.5.2 History dashboard 3.5.3 Trends dashboard 3.5.4 Blood glucose (BG) dashboard 3.5.5 Events dashboard 3.6 Alerts 3.6.1 Alert settings 3.7 Language 3.8 Others 3.8.1 Terms of service 3.8.2 Privacy policy 3.8.3 Delete account...
  • Page 6 4. Maintenance 4.1 Caring for your Continuous Glucose Monitor System(CGMS) 4.2 Quality control test 5. Data security 6. Troubleshooting 7. Electromagnetic compatibility 88 8. Explanation of symbols...

  • Page 7: Important Safety Information

    1. Important safety information 1.1 Indications for use The GlucoRx AiDEX™ Continuous Glucose Monitoring System (CGMS) is indicated for continuous 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.

  • Page 8: User Group

    The GlucoRx AiDEX™ CGMS also aids in the detection of episodes of hyperglycaemia and hypoglycaemia. Measurements should not be used to make treatment adjustments, but rather as a reminder of when fingertip testing is required.

  • Page 9: Precautions

    m e n t a l d i s o r d e r s ( s u c h a s d e p r e s s i o n , schizophrenia). 2. Are unconscious. 3. Are unable to understand or master the usage of the device.
  • Page 10 diabetes mellitus and should not be used as a basis for clinical diagnosis. • The CGMS should be completely removed before any Magnetic Resonance Imaging (MRI) scan. • The CGMS contains small parts 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 may not be...
  • Page 11 glucose levels rise rapidly, the displayed value could be a lower-than-actual reading. When experiencing symptoms of hypoglycaemia or hyperglycaemia, please take a fingertip blood glucose test and do not rely entirely on the displayed reading on the App. • Severe dehydration or excessive loss of water may result in inaccurate results.
  • Page 12 • While extensive user testing has been done on GlucoRx AiDEX™ CGMS in Type 1 and Type 2 diabetic patients, the study groups did not include women with gestational diabetes. • The performance of the CGMS has not been evaluated when used with another implantable medical device, such as a pacemaker.

  • Page 13: Product Description

    - Please do not use it if you are visually impaired. • Any incident that 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.
  • Page 14 This product uses a GlucoRx AiDEX mobile App, a Transmitter and a Glucose Sensor. The Transmitter package consists of the following components: 1 Transmitter 1 User Guide 1 Quick Guide T h e S e n s o r p a c k a g e c o n s i s t s o f t h e...
  • Page 15 GlucoRx AiDEX™ mobile App. Sensor The glucose sensor package contains a sterilised glucose sensor attached to a sensor base and a sensor applicator. The package is...
  • Page 16 Sensor applicator Glucose sensor Sensor base tape Sensor components Sterile packaging...
  • Page 17 App name: GlucoRx AiDEX™ Continuous glucose monitoring App Model Operating System Unit Release Version RC2101 mg/dL RC2102 mmol/L RC2103 Android mg/dL RC2104 Android mmol/L Release version: V1...
  • Page 18 Blood glucose data measured 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/MicroTech Equivalent Model Numbers...

  • Page 19: User Instruction

    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 download the App, search "GlucoRx AiDEX" in App Store (iOS) or Google Play (Android).
  • Page 20 GlucoRx AiDEX SEARCH...

  • Page 21: Minimum Requirements For Software Installation

    3.1.2 Minimum requirements for software installation Operating System (OS): iOS 10.0 and above Memory: 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: Minimum 200 MB Network: WLAN (Wireless Local Area Network) or cellular...

  • Page 22: Software Registration, Login And Resetting

    After finishing the download, the GlucoRx AiDEX™ App will be installed on your mobile device automatically. 3.2 Software registration, login and resetting 3.2.1 Software registration If you do not have an account, click “Register” button to enter the registration screen. Please input your email address and password.

  • Page 24: Software Login

    3.2.2 Software login Use your registered account email address and password to log in to the GlucoRx AiDEX™ App.

  • Page 26: Password Reset

    3.2.3 Password reset If you forget your password, click “Forgot Password” 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 password reset.

  • Page 28: Introduction

    3.3 Introduction When you log in to the GlucoRx AiDEX™ App for the first time, there will be an introduction guiding you to complete the basic system setups. 3.3.1 Bluetooth Setting You will need Bluetooth connection to pair your CGMS transmitter. Click “Continue” to enable...

  • Page 30: Notification

    3.3.2 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 Settings.

  • Page 32: Do Not Disturb

    3.3.3 Do 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 GlucoRx AiDEX™ App.

  • Page 34: Alerts And Warnings Setting

    3.3.4 Alerts and warnings setting In the “Alerts and Warnings” 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 blood glucose meter and consult your healthcare professional.

  • Page 36: Low Glucose Alert Setting

    3.3.5 Low glucose alert 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. Home > Settings > Alerts Settings.

  • Page 38: High Glucose Alert Setting

    3.3.6 High glucose alert setting After setting your low glucose alert, 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”...

  • Page 40: Connecting A Transmitter

    3.3.7 Connecting a transmitter Click “Continue” to enter 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 scan symbol in the top right hand corner of the screen.
  • Page 42 If you choose to skip the transmitter 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 for detailed operation procedures.

  • Page 43: Application

    3.4 Application 3.4.1 Pairing a transmitter The transmitter sends your continuous glucose data to the GlucoRx AiDEX™ App using Bluetooth 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”.
  • Page 46 2 metres without obstacle. If pairing fails, a notification box will appear. Users may choose to input the serial number again. User may also choose to use the GlucoRx AiDEX™ App without pairing a transmitter by skipping this step.

  • Page 47: Unpairing A Transmitter

    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. If the transmitter is not connected to the App, you may delete the transmitter record permanently by clicking “Delete”.

  • Page 50: Applying A Sensor

    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 52 Rotate your sensor sites regularly to avoid discomfort or skin irritation. Please ensure you have already set up your GlucoRx AiDEX™ App following the instructions in chapter 3.1 to 3.3. of this User Guide . The...
  • Page 53 sensor will expire if you do not pair the sensor- transmitter set with your App within 30 minutes after 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.
  • Page 54 Ta k e o u t t h e s e n s o r applicator by turning it in a n a n t i - c l o c k w i s e direction. Place the applicator on the top of your desired sensor site.
  • Page 55 Remove the applicator. The sensor should be applied successfully. Note Applying a sensor may cause bruising or bleeding. If bleeding does not stop, remove the sensor and apply a new sensor to a diff erent location. Align the transmitter to the sensor base and press the transmitter firmly onto it until it snaps onto the sensor base and attaches to it securely.
  • Page 56 Note If the transmitter is not matching the base as 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.
  • Page 57 2. Place tape over sensor without removing A or B. 3. Peel off section A and stretch gently over 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 1. Gently lift the over patch at the edge. 2. Slowly tug 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...

  • Page 59: Sensor Warm-Up

    Follow the steps described carefully and be sure to only use components that are compatible. Use of unapproved components can result in injury. 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.
  • Page 60 GlucoRx AiDEX™ App is pairing with a new sensor. If the sensor is a used one, please click “A Used One”. If the sensor 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”...

  • Page 62: Removing A Sensor

    3.4.5 Removing a sensor Remove the old sensor when the App indicates that the sensor has expired, or if you feel any site irritation or discomfort. • Carefully pull the tape that holds the sensor to the skin from the edge and slowly uncover it until the entire sensor is removed.

  • Page 63: Glucorx Aidex™ App Functions

    • The sensor is meant for single use only. Dispose the used sensor 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 real- time blood glucose level is displayed (updated every 5 minutes).
  • Page 64 (updated every five minutes). A pop-up notification box will appear two days before your sensor expires. When your sensor expires, the sensor status on the GlucoRx AiDEX™ App will also change to “expired”. Please replace the used sensor.

  • Page 66: History Dashboard

    3.5.2 History dashboard History dashboard displays glucose alert records, events, as well as glucose data in each day. 1. When the sensor blood glucose level is lower/ higher than the pre-set alert value, the App will alert you every 30 minutes about your glucose levels.

  • Page 68: Trends Dashboard

    3.5.3 Trends dashboard The Trends dashboard displays the blood glucose analysis results. In the top section, you can choose to display the analysis results over a certain period ( Last 7 days, Last 14 Days, Last 30 Days or your customised interval).
  • Page 69 glucose range is displayed. The number of hyperglycaemia and hypoglycaemia 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 displayed. Please contact your healthcare professional for interpretations.
  • Page 70 Abbreviation Interpretation Mean Blood Glucose M-value Morbus value SDBG Standard Deviation of Blood Glucose Percentage of Coefficient of Variation J-index An index that perpetuates the inclusion of standard deviation into the measurement of glycaemic variability Inter-Quartile Range AAC100 Area Above Curve 100 AUC100 Area Under Curve 100 LBGI...

  • Page 71: Blood Glucose (Bg) Dashboard

    Note P l e a s e c o n s u l t y o u r h e a l t h c a r e professional for interpretation of the above parameters. 3.5.4 Blood glucose (BG) dashboard In the Blood Glucose (BG) dashboard, you can calibrate the CGMS and record the reference blood glucose level for sensor calibration.
  • Page 72 will be displayed on the Home and History dashboard. 2. If the glucose value measured from other channels is 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.
  • Page 73 Note If you are pairing a new sensor, do not calibrate more than once in the first 6 hours after application. 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.

  • Page 75: Events Dashboard

    Once you have selected the right value, click "Calibrate" to complete 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 “Insulin”, “Carbs”, “Medicine”...
  • Page 76 3. The added events will be 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 your GlucoRx AiDEX™ App account.

  • Page 78: Alerts

    3.6 Alerts 3.6.1 Alert settings In the Alerts dashboard, you can set up alerts. You can set the values for high glucose alerts, low glucose alerts and 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.
  • Page 79 Note 1. Before setting the alerts, please make sure the GlucoRx AiDEX™ App is paired with the sensor and transmitter. 2. When low glucose alerts appear, please take a blood glucose test using a blood glucose meter and test strips. If the test...
  • Page 80 take medicine as advised by your doctor or inject insulin until your 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 average declines more than 0.1 mmol/L per minute, alert notification appears.

  • Page 82: Language

    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 84: Others

    3.8.1 Terms of service Under Home > Settings > Others > Terms of Service, you can check the Terms of Service of the GlucoRx AiDEX™ App. 3.8.2 Privacy policy Under Home > Settings > Others > Privacy Policy, you can check the Privacy Policy of the App.

  • Page 86: Caring For Your Continuous Glucose Monitor System(Cgms)

    4. Maintenance We pledge to continuously improve GlucoRx AiDEX™ App to improve customer experience. User feedback can be submitted to GlucoRx via customer care at info@glucorx.co.uk Tel: 0800 007 5892. 4.1 Caring for your Continuous Glucose Monitor System (CGMS) Cleaning the transmitter •...
  • Page 87 paint thinner to scrub the outer surface. • Keep the transmitter dry. • Do not apply any lubricant to the transmitter. • Keep the connection port area clean. Note Do not immerse the transmitter in water or other liquids. Avoid dust, dirt, blood, chemicals, water and other substances on the transmitter connec- tion port.
  • Page 88 For further information on how to dispose of system components, please contact GlucoRx customer care. Transportation Avoid placing heavy weight 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 area.
  • Page 89 Specifications...

  • Page 90: Quality Control Test

    5. Data security The information stored in this GlucoRx AiDEX™ App includes: - Blood glucose information. - Personal information (e.g., name, gender, date of birth, etc.).
  • Page 91 - Medicine history - Insulin injection history The data collected is stored in a Cloud Service. The data is protected by cloud-based encryption and other security mechanisms offered by the cloud service provider. The data stored in the Cloud can only be interpreted using the decryption algorithm offered by the cloud service provider.

  • Page 92: Troubleshooting

    6. Troubleshooting Data Lost The GlucoRx AiDEX™ App can recover data after restarting. After restarting, the saved App data will be restored automatically. All the saved but not displayed data can be displayed again. If the App fails to display blood glucose data,...
  • Page 93 App. Fail to read data Data reading failure can be caused by signal interference. Users are required to stay away from environments with strong electromagnetic interference, or contact GlucoRx.

  • Page 94: Electromagnetic Compatibility

    7. Electromagnetic compatibility In this chapter, “device” is defined as any com- ponent that requires electricity to function. 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.
  • Page 95 stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the config- uration in which it will be used. Performance Description When the glucose concentration is >4.2mmol/L (75mg/dL), the sensor accuracy deviation does not exceed Measurement accuracy ±20%;...
  • Page 96 IEC60601-1-2 Table 201 Guidance and manufacturer’s declaration – electromag- netic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. Electromagnetic environment - Emissions test Compliance guidance...
  • Page 97 IEC 60601-1-2: Table 202 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. IEC 60601 test Electromagnetic environment Immunity test...
  • Page 98 IEC 60601-1-2: Table 204 Guidance and manufacturer’s declaration – electromag- netic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. Immunity IEC 60601 test Compliance Electromagnetic environment -...
  • Page 99 IEC60601-1-2: Table 206 Recommended separation distances between portable and mobile RF communications equipment and the device These devices are intended for use in an environment in which radiated RF disturbances are controlled. The user of the device can help prevent elec- tromagnetic interference.
  • Page 100 8. Explanation of symbols This section explains the icons used on this CGMS:...
  • Page 103 Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. Customer Careline: Distributor: 0800 007 5892 GlucoRx Ltd. E-mail: info@glucorx.co.uk Unit 1C Henley Business Park Website: www.glucorx.co.uk Pirbright Road, Guildford, Surrey, GU3 2DX, United Kingdom 1016-PMTL-261. V02...

This manual is also suitable for:

Aidex rc2102Aidex rc2103Aidex rc2104

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