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WaveForm A.MENARINI diagnostics GlucoMen Day CGM User Manual

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Summary of Contents for WaveForm A.MENARINI diagnostics GlucoMen Day CGM

  • Page 1 User Guide...
  • Page 2 The Bluetooth word mark and logos are registered trademarks ® owned by Bluetooth SIG, Inc. and any use of such marks by WaveForm Technologies Inc. is under licence. Other trademarks and trade names are those of their respective owners. Apple, the Apple logo, iPhone and iPod touch are trademarks of Apple Inc., registered in the U.S.

  • 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 4.12 Wait for the sensor to stabilise 4.13 How will I know when to replace my sensor? 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...
  • Page 5 / 11 Profile 11.1 Navigating to the Profile screen 11.2 Changing personal information 11.3 Changing your country 11.4 Changing your email 11.5 Changing your password 11.6 Resetting your password 11.7 Email communication settings 11.8 Sharing data with WaveForm 11.9 Analytics...
  • Page 6 Stopping a session 12.1 Automatically stopping a session 12.2 Manually stopping a session Removing a sensor Limitations 14.1 When to use your blood glucose meter for treatment decisions 14.2 Travelling with your GlucoMen Day CGM Troubleshooting 15.1 Continuous glucose reading issues 15.2 Alert issues 15.3...

  • Page 7: Glucomen Day Continuous Glucose Monitoring System

    English GlucoMen Day Continuous Glucose Monitoring System IMPORTANT: Illustrations in this guide are for in- Introduction structional purposes only and are not shown at actual Thank you for choosing the GlucoMen Day Continuous size. Glucose Monitoring (CGM) System. The GlucoMen Day CGM System provides current glucose levels.

  • Page 8: Getting Started

    English rate of change of your glucose. It’s important to un- Limitations derstand where your glucose is and how it’s changing The GlucoMen Day CGM is not safe for use in magne- (trending) rather than focusing only on individual CGM •...

  • Page 9: Parts Of The System

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

  • Page 10: Setting Up The System

    English IMPORTANT: If you do not have an overpatch, you Create an account can use medical tape around the edges of the adhesive patch. Before using the GlucoMen Day CGM App, you need to 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

    Tap LOG IN. CGM App icon to open the app. Review the CONSENT TO DATA PROCESSING BY Passwords must be at least WAVEFORM to decide if you 8 characters. want to consent to sharing NOTA: Tap the ( ) icon to data.

  • Page 12: Connect A Transmitter

    English Connect a transmitter Locate the 6-digit numeric PIN (A) on the bottom of the transmitter. The GlucoMen Day CGM Devices kit includes two transmit- Record the 6-digit numeric PIN, ters so that you can use one while charging the other. which you will need in step 7.
  • Page 13 English When the Bluetooth Pairing Reques t appears, enter the 6-digit On Android devices only: Depending on your device’s per- numeric PIN that you recorded in step 1. mission settings, you may see any Tap PAIR. or all of these messages on the NEW TRANSMITTER screen: Allow this app to access your lo- •...

  • Page 14: Inserting A Sensor And Starting A Session

    English Inserting a sensor Choose a sensor insertion site and starting a session Before you insert the sensor, take a moment to consider where the best insertion site may be. Prepare for sensor insertion Choose a sensor insertion site on your abdomen or lower side that: To start a CGM session, you must insert a sensor.

  • Page 15: Clean The Sensor Insertion Site

    English CAUTION Place the wipe on the insertion • You should only insert the sensor on your abdomen site and wipe in a circular pattern or lower side, roughly between your ribs and beltline. outward, away from that spot. Ask your healthcare professional about the best sensor Continue cleaning until you have insertion site for you.

  • Page 16: Activate The Transmitter

    English Activate the transmitter Set the sensor assembly on a hard, clean surface (such as the inside of the sterile pouch) with the sensor adhesive patch facing down. Although you can connect multiple transmitters to the app, only one transmitter can send CGM readings to the app at a time.

  • Page 17: Prepare The Sensor Insertion Tool

    English Lower the transmitter and steer the arms into the guide slots of Lift this lever up until you hear a the sensor assembly. click, then lower to its starting po- Guide slots: sition. An orange tab indicates that the sensor insertion tool is ready to use.

  • Page 18: Remove The Sensor Adhesive Liner

    English Remove the sensor adhesive liner Hold the sensor insertion tool, with the tab (B) pointing down, perpen- Once you have cleaned the insertion site, you are rea- dicular to the sensor assembly. dy to remove the liner on the sensor adhesive patch. To Align the tab directly above the complete this step, you need the sensor insertion tool opening (A) on the sensor assem-...

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

    English 4.10 Apply the sensor assembly While holding the sensor insertion tool in place, press the release to the insertion site button (3 bumps) until you hear a click. Now that you have removed the liner on the sensor adhe- sive patch, you are ready to apply the patch to your skin.

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

    English Once you have inserted a new sensor, it may take 1-3 4.12 Wait for the sensor to stabilise minutes for the app to detect the sensor. Once you have inserted a new sensor, you must wait ap- NOTE: If the edges of the adhesive patch begin to peel proximately 45 minutes for the sensor to stabilise before up at any time during your session, you may apply the you can calibrate the system.

  • Page 21: Calibrating The System

    English Approximately 24 hours before the session is scheduled Home screen: Transmitters screen: to end, the app provides the following indications: If you have allowed the app to send notifications, you • will receive a notification that the session will end soon. The app displays a message that the session will end •...

  • Page 22: Entering A Calibration Reading

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

  • 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 session, there is a 10-minute data enter your blood glucose reading. collection period during which the system will not display glucose levels.

  • Page 24: Current Status

    English NOTE: You can rotate the Home screen to landscape A. Current CGM glucose reading 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 English C. Low (red) 6.3.2 Trend arrow The current glucose level is The trend arrow indicates below the low glucose line how much your glucose is set in CHART SETTINGS. See changing. There are 7 trend SECTION 6.4.3 for details. arrows, each indicating a different rate of change.
  • Page 26 English IMPORTANT: When using the GlucoMen Day CGM, Trend arrow What it means always carry a blood glucose meter. Your glucose level is rising at a rate of 0.19 mmol/L per minute or greater. You cannot calibrate if this arrow is visible. 6.3.3 Status icons The status icons indicate the current status for calibra-...
  • Page 27 English Transmitter signal icons What the What it means banner says The transmitter The active transmitter signal icons Cannot calibrate You cannot calibrate the system right signal is not detected. indicate the right now now. Tap the banner for details about why you cannot calibrate.

  • Page 28: Trend Chart

    English Home screen Home screen What it means What it means message message After the first calibration of a session, There is no transmitter connected Collecting No transmitter the system needs time to collect to the app. Tap Connect transmitter data…...
  • Page 29 English E. Target range See SECTION 6.4.3 for details. 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 Navigate to CHART SETTINGS to change your settings. NOTE: The settings in CHART SETTINGS only affect the way information is displayed on the HOME screen and do IMPORTANT: Glucose levels below 2.2 mmol/L...

  • 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. The system needs to be calibrated. Estimated glucose After the first calibration: Glucose • Glucose levels levels are estimated if the system is are currently not calibrated within 6 hours of the estimated...

  • 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. See SECTION 7.8 for de- Navigating to the Alerts screen tails. 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 stomise the alert. Most alerts can also be turned on or off. Navigate to the Settings app on Tap NOTIFICATIONS. your device. IMPORTANT: The URGENT LOW and CRITICAL LOW BATTERY alerts cannot be turned off. NOTE: This is outside the Gluco- Men Day App.

  • Page 33: Alert Status Indicators

    English Alert status indicators Tap the alert level to define when the alert will occur. The alert level is dif- The alert status indicators let ferent for each alert. For example, if you know if the GlucoMen Day 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 type When the alert occurs Alert message * Talk to your healthcare professional about what actions Falling Your glucose is decre- Falling glucose to take if you experience high or low glucose. Follow the glucose asing at the selected alert rate of decrease or Your glucose is...

  • Page 35: Devices Alerts

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

  • Page 36: Alert History

    English details (B), a list of available transmitters (C), and a but- Alert history ton to add a new transmitter (D). See SECTION 8.3 for details. Refer to the Comprehensive User Guide. Android: Transmitters Navigating to the Transmitters screen The transmitter is a rechargeable component that sends your continuous glucose data to the app using Blueto- oth wireless technology.
  • Page 37 English 8.3.2 Current session Transmitters screen What it means message The current session details section provides information Connecting The system is connecting to your about the current session. transmitter… transmitter. A. Session status Remove transmitter The system is trying to activate [TRANSMITTER ID] the transmitter indicated by 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 Make sure the computer is turned on. to 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 be fully charged.
  • 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. If you want to use a different transmitter, follow the steps in Tap the row for your transmitter. SECTION 8.6.2 to activate that transmitter.

  • Page 41: Deleting A Transmitter

    English Deleting a transmitter When the confirmation message appears, tap DELETE. Deleting a transmitter will remove the connection betwe- en the transmitter and the app. You will no longer be able to use the transmitter. If you want to use the transmitter again in the future, you will need to go through the steps to connect the transmitter.

  • Page 42: Meters Screen Overview

    English In the app, you can manage your meters on the ME- B. Connected meters list TERS screen. This section lists all of the meters connected to the app. Tap a meter row for details about that meter. In the app, tap the DEVICES but- Tap METERS.
  • Page 43 English Once you connect your meter to the app, the meter will automatically send your blood glucose readings In the app, tap the DEVICES but- Tap METERS. to the app so that you do not have to manually enter ton. If you are unsure about whi- your glucose level when you calibrate.

  • Page 44: Deleting A Meter

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

  • Page 45: Info

    English / 10 Info Tap CREATE REPORT to create a Once the report is displayed, PDF report for the selected date tap the SHARE button. 10.1 Navigating to the Info screen 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

    English 10.4 Sensor insertion instructions 10.9 Customer Service Refer to the Comprehensive User Guide. In the app, tap the INFO button. Tap CUSTOMER SERVICE. 10.5 Sensor removal instructions On Android devices, you may need to tap the BACK ARROW until you see the bottom buttons. Refer to the Comprehensive User Guide.

  • Page 47: Changing Personal Information

    English 11.2 Changing personal information / 11.4 Changing your email Your email address is used to log in to your account, as You can change your name, birth year, gender and type well as for important communications about your CGM. of diabetes.

  • Page 48: Changing Your Password

    English Logging in to your account (SECTION 3.3) / 11.5 Changing your password • Changing your email (SECTION 11.4) • A good password is important to keep your health data Changing your password (SECTION 11.5) • safe. It is good practice to change your password occa- sionally, especially if you believe your password may have been compromised.

  • Page 49: Email Communication Settings

    English / 11.7 Email communication settings Tap the switch next to SHARE DATA WITH WAVEFORM to opt in or out of sharing data. The EMAIL COMMUNICATION settings allow you to opt in or out of certain email communications. Tap READ FULL AGREEMENT to review the entire agreement.

  • Page 50: Stopping A Session

    English / 12 Stopping a session 12.2 Manually stopping a session If you choose to stop a session before the end of the 14 12.1 Automatically stopping a session days, you will need to stop it manually. Reasons you may want to stop a session early: Your GlucoMen Day CGM sensor lasts for 14 days.

  • Page 51: Removing A Sensor

    English Once the session has stopped, you should remove the sensor 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 Lift the transmitter away from the sensor adhesive patch.

  • Page 52: Limitations

    English / 14 Limitations When to use Why you need to use your blood your blood glucose meter glucose meter 14.1 When to use your blood glucose Your CGM is If the CGM is displaying estimated glu- meter for treatment decisions displaying estimated cose values, the quality of CGM glucose glucose values...

  • Page 53: Troubleshooting

    English / 15 Troubleshooting Issue Solution CGM readings The GlucoMen Day CGM measures are significantly glucose levels in the interstitial fluid 15.1 Continuous glucose reading issues different from that surrounds cells in the body, while blood glucose blood glucose meters measure glucose meter readings levels in blood.

  • Page 54: Alert Issues

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

  • Page 55: Sensor Issues

    English 15.4 Sensor issues Issue Solution You have entered a calibration rea- A CALIBRATION Issue Solution ERROR message ding that the system cannot accept appears. because the difference between the Gap between the If there is a gap, the sensor inser- blood glucose meter reading and sensor insertion tool tion tool is not correctly attached...

  • Page 56: Transmitter Issues

    English Issue Solution Issue Solution Cannot start a Once you have inserted a new sensor, Sensor not working If the issue is not resolved after 1 it may take 1-3 minutes for the app after immersing in hour, stop the session, remove the session to detect the sensor.

  • Page 57: Transmitter Charger Issues

    English 15.6 Transmitter charger issues 15.7 Sensor insertion issues Issue Issue Solution Charger light is There is an issue with either charging or There is a gap between the sensor insertion tool and the flashing red pairing the transmitter. sensor assembly. If you are trying to charge the transmitter and the light is flashing red instead of gre- en, the transmitter is not charging.

  • Page 58: Additional Information

    English Issue 16.2 Cleaning your system Edges of the adhesive patch are peeling up. The GlucoMen Day CGM System is for single patient use. Solution Clean in general Follow the next steps to apply the overpatch, if needed. Your CGM system parts should be cleaned only as nee- ded to remove visible dirt and debris.

  • Page 59: System Disposal

    English Transmitter specifications 16.3 System disposal 16.4.2 Consult your local regulations when disposing of the Specification Description sensor insertion tool, the sensor guide, the transmitter, Transmitter battery Non-serviceable, rechargeable and the charger. type thium-ion polymer battery Transmitter battery 14 days of typical use Dispose of the sensor adhesive patch as medical waste.
  • Page 60 English USB charging cable specifications 16.4.6 Specification Description Altitude Up to 3048 metres (10,000 feet) The USB charging cable can be used for powering the transmitter charger. The USB charging cable can be con- Atmospheric 700 hPa - 1060 hPa pressure nected to a PC USB port that can meet the input and connector type specifications listed to the right.

  • Page 61: Labelling Symbols

    English 16.5 Labelling symbols 16.6 Accuracy Summary These symbols may be found on your GlucoMen Day Performance metrics CGM System packaging. Overall accuracy Symbol Description Symbol Description 11.4% Mean ARD% (percentage of average absolute Operating CE Mark error versus reference across all glucose levels) instructions Sterilised using Manufacturer...
  • Page 62 English The GlucoMen Day CGM system complies with the 16.7.1 Guidance and manufacturer’s declaration electromagnetic compatibility immunity requirements — electromagnetic emissions defined in ETSI EN 301 489-1 v2.1.1, ETSI EN 301 489- 17 v3.1.1, and IEC 60601-1-2. The GlucoMen Day CGM system is intended for use in the electromagnetic environment as specified below.

  • Page 63: Warranty

    English CGM transmitter is covered for a period of Two (2) years Immunity test Compliance level from the date of manufacture, your new Sensor Inser- Electrostatic discharge ± 8 kV contact tion Tool is warranted for Two (2) years from its date of (ESD) manufacture, your new CGM Charger is warranted for IEC 61000-4-2...
  • Page 64 English set by the manufacturer. This Hyperglycaemia (high blood presents a security risk. glucose) High levels of glucose in the Do not install the GlucoMen Day blood, also known as high blo- app on a smart device that has od glucose. When left untrea- been jailbroken or rooted.
  • Page 66 www.glucomenday.com 51450 - 03/20...

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