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A.MENARINI GlucoMen Day CGM User Manual

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  • Page 1 User Guide...
  • Page 2 ©2021 WaveForm Technologies Inc. US and International Patents Pending. All rights reserved. All trademarks and copyrights are the property of their respective owners. The Bluetooth word mark and logos are registered trademarks ® owned by Bluetooth SIG, Inc. and any use of such marks by WaveForm Technologies Inc.

  • Page 3: Table Of Contents

    English Table of contents GlucoMen Day Continuous Glucose Monitoring System Introduction Indications for use Getting started Parts of the system System overview Sensor Assembly Setting up the system Download the app Create an account Log into an existing account Connect a transmitter Inserting a sensor and starting a session Prepare for sensor insertion Choose a sensor insertion site...
  • Page 4 Calibrating the system When to calibrate Entering a calibration reading Viewing continuous glucose readings Navigating to the Home screen Home screen overview Current status Trend chart Estimated glucose Alerts Navigating to the Alerts screen Alerts screen overview Allowing notifications Setting up alerts Alert status indicators Glucose alerts Devices alerts...
  • Page 5 / 10 Info 10.1 Navigating to the Info screen 10.2 Glucose overview report 10.3 CSV data report 10.4 Sensor insertion instructions 10.5 Sensor removal instructions 10.6 Icons and colours 10.7 FAQs 10.8 Comprehensive User Guide 10.9 Customer Service 10.10 Technical and medical support 10.11 Legal / 11...
  • Page 6 14.2 Travelling with your GlucoMen Day CGM Troubleshooting 15.1 Continuous glucose reading issues 15.2 Alert issues 15.3 Calibration issues 15.4 Sensor issues 15.5 Transmitter issues 15.6 Transmitter charger issues 15.7 Sensor insertion issues Connected Partners 16.1 Adding a connected partner 16.2...

  • Page 7: Glucomen Day Continuous Glucose Monitoring System

    GlucoMen Day App. The app then displays your glucose levels and The display of the GlucoMen Day CGM App may appear sli- long-term glucose trends. The app also provides alerts if ghtly different depending on the smart device (Android or your glucose is in or projected to be in an unsafe zone.

  • Page 8: Getting Started

    As you use your CGM, remember two important things se monitoring of critically ill patients. about trends: • The GlucoMen Day CGM is not safe for use in magnetic • Trends highlight the direction in which your CGM glucose resonance (MR) environments. Remove the GlucoMen Day...

  • Page 9: Parts Of The System

    CAUTION your diabetes. • Check the expiration date on the pouch before using. • Do not modify any part of the GlucoMen Day CGM or use Parts of the system components other than those specified in this guide. • The GlucoMen Day CGM System contains small parts System overview that may be a choking hazard.

  • Page 10: Setting Up The System

    English Setting up the system Create an account Before using the GlucoMen Day CGM App, you need to Download the app answer a few simple questions and create an account. Your account will be used to store all of your CGM data.

  • Page 11: Log Into An Existing Account

    / 3.3 Log into an existing account characters. NOTE: Tap the ( ) icon to show or hide your password. If you already have an account for the GlucoMen Day CGM App, you can log in to your existing account.

  • Page 12: Connect A Transmitter

    Record the 6-digit numeric PIN, whi- Connect a transmitter ch you will need in step 7. The GlucoMen Day CGM Devices kit includes two transmit- ters so that you can use one while charging the other. Place the transmitter in the charger The transmitters communicate with the GlucoMen Day App and connect to a power source.
  • Page 13 English Open the app: Press the button on the charger. A Tap the DEVICES button. On An- flashing blue light indicates the tran- droid devices you may need to tap smitter is ready to pair. the BACK ARROW until you see the NOTE: Once you press the button on bottom buttons.

  • Page 14: Inserting A Sensor And Starting A Session

    English • Overpatch (optional) GlucoMen Day app (see SECTION 3.1 for instructions to • If this is the first transmitter you have connected, you will see a mes- download the app) sage asking if you want to connect your second transmitter. CAUTION If you tap YES, repeat steps 1-7 •...

  • Page 15: Clean The Sensor Insertion Site

    English Clean the sensor insertion site Clean the chosen insertion site before inserting the sen- sor. Careful cleaning of the insertion site disinfects the skin and helps the sensor adhesive patch to stick tightly to your skin. CAUTION • Do not allow anything to touch the insertion site after Right side Front Left side...

  • Page 16: Select A Transmitter

    English Select a transmitter Remove the sensor assembly from Identify the transmitter you want to use. Make sure the the sterile pouch. transmitter is fully charged by placing it in the charger and checking that the light on the charger is solid green. See SECTION 8.4 for details about charging the transmit- ter.

  • Page 17: Prepare The Sensor Insertion Tool

    English Prepare the sensor insertion tool CAUTION Avoid touching the transmitter contacts, located between Now that you have inserted the transmitter into the sen- the transmitter arms. sor assembly, you can prepare the sensor insertion tool. To complete these steps, you will need the sensor inser- tion tool.

  • Page 18: Remove The Sensor Adhesive Liner

    English Locate the tab (B) on the sensor insertion tool at the end with the The sensor insertion tool and sensor guide should snap together lever (1 bump). without a gap. Check for a gap between the sensor insertion tool and sensor gui- de.

  • Page 19: Apply The Sensor Assembly To The Insertion Site

    English Do not try to adjust the placement of the adhesive Grip the left tab and peel it back to patch after application. remove the second section of the liner. Make sure the adhesive does not fold onto itself before or during applica- tion.

  • Page 20: Remove The Sensor Guide From The Sensor Insertion Tool

    • If you feel resistance when removing the sensor insertion tool your GlucoMen Day CGM. with two separate sensor assemblies, call Customer Service. Once you have inserted a new sensor, it may take 1-3 mi- nutes for the app to detect the sensor.

  • Page 21: How Will I Know When To Replace My Sensor

    • If you have allowed the app to send notifications, you will receive a notification that the session has ended. IMPORTANT: When using the GlucoMen Day CGM, always • The app displays a message that the session has ended. carry a blood glucose meter for calibrating the system.

  • Page 22: Entering A Calibration Reading

    English • Your glucose, according to the BGM, is between 3.9-13.9 IMPORTANT: After the second calibration, you can mmol/L. always calibrate early in order to shift your calibration • Your glucose is changing less than 0.11 mmol/L per mi- schedule to a more convenient time. For example, if the nute.

  • Page 23: Viewing Continuous Glucose Readings

    English On the NEW CALIBRATION screen, If this is the first calibration for the tap the NEW READING field and en- session, there is a 10-minute data ter your blood glucose reading. collection period during which the system will not display glucose le- vels.

  • Page 24: Current Status

    English A. Current CGM glucose reading NOTE: You can rotate the Home screen to landscape orientation to view a larger trend chart. B. Trend arrow C. Status icons D. Calibrate button E. Information banner NOTE: The banner is not always visible. It only appears when there is information to display.
  • Page 25 OR a message explaining what is happening. CAUTION If the app is not displaying a current glucose reading, do not use your GlucoMen Day CGM to make treatment deci- sions. Perform a blood glucose test before making treat- ment decisions.
  • Page 26 You cannot cali- brate if this arrow is visible. CAUTION If the app is not displaying a trend arrow, do not use your GlucoMen Day CGM to make treatment decisions. Perform a blood glucose test before making any treatment deci- sions.
  • Page 27 English Transmitter signal icons What the What it means banner says The transmitter The active transmitter signal is signal icons not detected. Cannot calibrate You cannot calibrate the system right now. Tap right now the banner for details about why you cannot indicate the calibrate.

  • Page 28: Trend Chart

    English Home screen Home screen What it means What it means message message No transmitter Stopping session… There is no transmitter connected to the The session is stopping. app. Tap Connect transmitter to CONNECT A TRANSMITTER. Bluetooth is off Bluetooth is turned off. Bluetooth must be Turn on Bluetooth to turned on, so the transmitter and app can See SECTION 8.5 for details about connecting...
  • Page 29 English 6.4.3 Chart settings CHART SETTINGS lets you choose where to display the high and low glucose lines and the target range on the trend chart. Changing chart settings IMPORTANT: Glucose levels below 2.2 mmol/L are plotted at 2.2 mmol/L. Glucose levels above 22.2 mmol/L Navigate to CHART SETTINGS to change your settings.

  • Page 30: Estimated Glucose

    English Home screen What it means On Android: Tap OK to save your selection. message On iOS: Your selection is automatically saved. Estimated glucose The system needs to be calibrated. Glucose levels are • After the first calibration: Glucose levels are currently estimated estimated if the system is not calibrated within Tap the BACK BUTTON to return to the HOME screen.

  • Page 31: Alerts

    English Alerts B. Alert history The HISTORY tab allows you to see a list of alerts that occurred in the past 14 days. Navigating to the Alerts screen The ALERTS screen allows you to set up alerts to let you know if a certain event is occurring, such as low glucose, that requires your attention.

  • Page 32: Setting Up Alerts

    English IMPORTANT: The URGENT LOW and CRITICAL LOW BATTERY alerts cannot be turned off. Tap NOTIFICATIONS. Navigate to the Settings app on your device. NOTE: This is outside the GlucoMen Day App. In the app, tap the ALERTS button. On Android devices, you may need to tap the BACK ARROW until you see the bottom buttons.

  • Page 33: Alert Status Indicators

    English Alert status indicators Tap the alert level to define when the The alert status indicators let alert will occur. The alert level is dif- you know if the GlucoMen Day ferent for each alert. For example, if you choose 13.9 mmol/L for the high App and the transmitter are glucose alert level, GLUCOSE ABOVE using the same alert settings...
  • Page 34 English CAUTION Alert Alert type When the alert occurs Talk to your healthcare professional about what actions to message * take if you experience high or low glucose. Follow the advice of your healthcare professional to raise or lower your gluco- Falling glucose Falling Your glucose is decreasing at...

  • Page 35: Devices Alerts

    English Alert Alert Alert type When the alert occurs Alert type When the alert occurs message * message Projected high Transmitter Projected If the current trend continues, Signal loss The app cannot detect the high your glucose will be above alert transmitter.

  • Page 36: Transmitters

    English Transmitters Android: Navigating to the Transmitters screen The transmitter is a rechargeable component that sends your continuous glucose data to the app using Bluetooth wireless technology. In the app, you can manage your transmitters on the TRANSMITTERS screen. In the app, tap the DEVICES button. On Android devices, you may need to tap the BACK ARROW until you see the bottom buttons.
  • Page 37 English 8.3.2 Current session Transmitters What it means screen message The current session details section provides information about the current session. Connecting The system is connecting to your transmitter. transmitter… A. Session status Remove transmitter The system is trying to activate the transmitter Status is either STARTED or NOT STARTED.

  • Page 38: Charging A Transmitter

    English 8.3.3 Available transmitters Insert the other end of the USB cable into a computer. This section shows the transmitters that are connected to Make sure the computer is turned on. the app. The active transmitter is marked with an ACTIVE badge.

  • Page 39: Connecting A Transmitter

    English Activating a transmitter Charger light What it means Although you can connect multiple transmitters to the Flashing The transmitter is charging. This app, only one transmitter can send CGM readings to the green light transmitter may take up to 4 hours to app.
  • Page 40 English Now that you have identified the active transmitter, you can use Locate the transmitter in the list of that transmitter to start a session. AVAILABLE TRANSMITTERS. Tap the row for your transmitter. If you want to use a different transmitter, follow the steps in SECTION 8.6.2 to activate that transmitter.

  • Page 41: Deleting A Transmitter

    To activate a different transmitter, tons. see SECTION 8.6. Meters Locate the transmitter in the When using the GlucoMen Day CGM, always carry a blood list of AVAILABLE TRANSMIT- glucose meter for calibrating the system. TERS. Tap the row for your transmit- The calibration can be performed by using the GlucoMen ter.

  • Page 42: Meters Screen Overview

    English In the app, you can manage your meters on the METERS This button lets you add a new meter. See SECTION 9.3 for details about connecting a meter. screen. In the app, tap the DEVICES Tap METERS. button. On Android devices, you may need to tap the BACK ARROW until you see the bottom but- tons.
  • Page 43 English The meter will automatically sync when: You turn on the meter or perform a blood glucose test In the app, tap the DEVICES Tap METERS. and eject the test strip. button. If you are unsure about which The meter and app are within 3 metres (10 feet) of On Android devices, you may meters are compatible with each other and Bluetooth is on.

  • Page 44: Deleting A Meter

    English The top part of the NEW METER screen displays step-by-step in- Locate the meter in the list of meters. structions to connect the meter to the app. After performing each step, swipe left to view the next step. Tap the row for your meter. After following the on-screen instructions, when your meter appe- ars under DETECTED METERS, tap the row for your meter.

  • Page 45: Info

    English / 10 Info Tap CREATE REPORT to create Once the report is displayed, 10.1 Navigating to the Info screen a PDF report for the selected tap the SHARE button. date range. The app includes an INFO section where you can view a Android: glucose overview report, export your raw data, and find helpful information such as sensor insertion instructions...

  • Page 46: Sensor Insertion Instructions

    Technical and medical support The COMPREHENSIVE USER GUIDE section provides a digital The App includes access to 24/7 technical and medical version of the GlucoMen Day CGM system user’s guide. support. NOTE: 24/7 support is not available in all countries.

  • Page 47: Legal

    The LEGAL section provides access to legal documents and need to tap the BACK ARROW able to select this field. agreements related to the GlucoMen Day CGM App. until you see the bottom but- tons. In the app, tap the INFO button.

  • Page 48: Changing Your Email

    English / 11.4 Changing your email In the app, tap the PROFILE button. Your email address is used to log in to your account, as On Android devices, you may need to tap the BACK ARROW until well as for important communications about your CGM. you see the bottom buttons.

  • Page 49: Email Communication Settings

    Tap GET A RESET CODE. not displayed, tap the EMAIL field and enter the email When you create an account to use the GlucoMen Day CGM address associated with your App, your data is stored on AgaMatrix’s secure servers. account.

  • Page 50: Connected Partners

    English / 11.9 Connected Partners IMPORTANT: The GlucoMen Day CGM App stores sen- sitive health-related information on your smart device. We The CONNECTED PARTNERS feature allows you to automa- recommend keeping your device up to date with the latest tically share your data with a trusted healthcare professio- iOS or Android OS version to help ensure the highest level nal or service.

  • Page 51: Stopping A Session

    • Convenience; you may choose to stop the session early if needed. Your GlucoMen Day CGM sensor lasts for 14 days. After 14 days, the CGM session will automatically stop. In the app, tap the DEVICES button. There are other reasons a session may stop automatically: On Android devices, you may need to tap the BACK ARROW until •...

  • Page 52: Removing A Sensor

    English Once the session has stopped, you should remove the sen- sor and place the transmitter in the charger. Pull back on the transmitter release tab. See CHAPTER 13 for details about removing your sensor. / 13 Removing a sensor Once a session stops, you should remove the sensor and Lift the transmitter away from the place the transmitter in the charger.

  • Page 53: Limitations

    Although in banner appears). glucose test to ensure you make the cor- rect treatment decision. most cases you can use your GlucoMen Day CGM to make treatment decisions, it is important to understand situa- 14.2 Travelling with your tions when you do need to perform a blood glucose test before making treatment decisions.

  • Page 54: Troubleshooting

    Issue Solution 15.1 Continuous glucose reading issues CGM readings are signifi- The GlucoMen Day CGM measures glu- cantly different from blood cose levels in the interstitial fluid that glucose meter readings surrounds cells in the body, while blood glucose meters measure glucose levels in blood.

  • Page 55: Alert Issues

    English 15.2 Alert issues Issue Solution Issue Solution SAVE The SAVE button is disabled if: button disabled on the NEW CALIBRATION • You have not manually entered a blo- screen. Not receiving alerts Try the following: od glucose reading. • OR your manually entered blood glu- •...

  • Page 56: Sensor Issues

    English 15.4 Sensor issues Issue Solution Issue Solution A CALIBRATION ERROR You have entered a calibration reading message appears. that the system cannot accept because the difference between the blood glu- If there is a gap, the sensor insertion Gap between the sensor Message: Wait at least one cose meter reading and the CGM rea- tool is not correctly attached to the...

  • Page 57: Transmitter Issues

    English Issue Solution Issue Solution Cannot start a session Once you have inserted a new sensor, it may A SENSOR STATUS message If the sensor is inserted, select YES and take 1-3 minutes for the app to detect the appears. the session will continue.

  • Page 58: Transmitter Charger Issues

    English 15.6 15.7 Transmitter charger issues Sensor insertion issues Issue Issue Solution There is a gap between the sensor insertion tool and the Charger light is There is an issue with either charging or pairing the sensor assembly. flashing red transmitter.

  • Page 59: Connected Partners

    English Issue you see the bottom buttons. Edges of the adhesive patch are peeling up. Tap CONNECTED PARTNERS. On Android: Tap the (+) Solution button. On iOS: Tap ADD A PARTNER. Follow the next steps to apply the overpatch, if needed. NOTE: The overpatch is only needed if you notice that the edges of the adhesive patch are starting to come up.

  • Page 60: Additional Information

    Tap CONNECTED PARTNERS. 17.2 Cleaning your system The GlucoMen Day CGM System is for single patient use. Under YOUR PARTNERS, tap the partner you want to deactivate. Clean in general Tap DEACTIVATE. Your CGM system parts should be cleaned only as needed to remove visible dirt and debris.

  • Page 61: System Disposal

    English 17.4.2 • Be careful and gentle while cleaning the transmitter con- Transmitter specifications tacts. Specification Description Transmitter battery type Non-serviceable, rechargeable lithium-ion 17.3 System disposal polymer battery Transmitter battery 14 days of typical use Consult your local regulations when disposing of the sen- life sor insertion tool, the sensor guide, the transmitter, and the charger.

  • Page 62: Labelling Symbols

    English 17.4.3 Sensor insertion tool specifications The charger can be isolated by unplugging the USB char- ging cable from the PC. Misuse of the USB cable can pre- Specification Description sent electric shock hazards. Life 5 years NOTE: If necessary, the USB charging cable can be used with an AC wall adapter, connected to an AC power outlet 17.4.4 Transmitter charger specifications...

  • Page 63: Accuracy Summary

    GlucoMen Day CGM system when used in a home healthcare environment. These may inter- fere with the proper operation of the GlucoMen Day CGM system. Moving away from or turning off these electronic devices may allow communication.
  • Page 64 GlucoMen Day CGM system, including cables specified by the manufacturer. Otherwise, degradation of The GlucoMen Day CGM system is intended for use in the the performance of this equipment could result. electromagnetic environment specified below. The custo- mer or the user of the GlucoMen Day CGM system should assure that it is used in such an environment.

  • Page 65: Warranty

    English is warranted for Two (2) years from its date of manufactu- Immunity test Nível de conformidade re, your new CGM Charger is warranted for Two (2) years Electrostatic discharge ± 8 kV contact from its date of manufacture and your new CGM Senor is (ESD) warranted up its date of expiration.
  • Page 66 English sional to determine your high A safety statement outlining glucose level. specific situations in which the GlucoMen Day CGM should Hypoglycaemia not be used because it may be (low blood glucose) harmful to you or damage the system. Low levels of glucose in the blo-...
  • Page 68 www.glucomenday.com 51450 - 04/21...

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