A.MENARINI GlucoMen Day CGM, User Manual

Page 1: ...User Guide ...

Page 2: ... 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 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 and other countries App Store is a service mark of...

Page 3: ...nsor insertion 4 2 Choose a sensor insertion site 4 3 Clean the sensor insertion site 4 4 Select a transmitter 4 5 Activate the transmitter 4 6 Place the transmitter into the sensor assembly 4 7 Prepare the sensor insertion tool 4 8 Attach the sensor insertion tool to the sensor assembly 4 9 Remove the sensor adhesive liner 4 10 Apply the sensor assembly to the insertion site 4 11 Remove the senso...

Page 4: ...ions 7 4 Setting up alerts 7 5 Alert status indicators 7 6 Glucose alerts 7 7 Devices alerts 8 Transmitters 8 1 Navigating to the Transmitters screen 8 2 Transmitters screen overview 8 3 Transmitters screen details 8 4 Charging a transmitter 8 5 Connecting a transmitter 8 6 Activating a transmitter 8 7 Deleting a transmitter 9 Meters 9 1 Navigating to the Meters screen 9 2 Meters screen overview 9...

Page 5: ...ing 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 AgaMatrix 11 9 Connected Partners 11 10 Analytics 11 11 Customer Service Access 12 Stopping a session 12 1 Automatically stopping a session 12 2 Manually stopping a session 13 Removing a sensor 14 Limitations ...

Page 6: ...sor insertion issues 16 Connected Partners 16 1 Adding a connected partner 16 2 Deactivating a connected partner 17 Additional information 17 1 Customer Service information 17 2 Cleaning your system 17 3 System disposal 17 4 Product specifications 17 5 Labelling symbols 17 6 Accuracy Summary 17 7 Electromagnetic compatibility 17 8 Warranty 18 Glossary of terms 51 52 52 53 53 54 55 56 56 57 57 57 5...

Page 7: ...ing the GlucoMen Day CGM always carry a blo od glucose meter There may be situations when you need to perform a blood glucose test before making treatment decisions See SECTION 14 1 for details CAUTION Please read all the instructions provided in this user guide before using the system IMPORTANT Illustrations in this guide are for instructio nal purposes only and are not shown at actual size The d...

Page 8: ...nds a glucose reading once per mi nute and provides a trend arrow that shows the direction and rate of change of your glucose It s important to under stand where your glucose is and how it s changing tren ding rather than focusing only on individual CGM readin gs As you use your CGM remember two important things about trends Trends highlight the direction in which your CGM glucose levels are headi...

Page 9: ...ucoMen Day CGM or use components other than those specified in this guide The GlucoMen Day CGM System contains small parts that may be a choking hazard 2 2 Sensor Assembly CAUTION Do not use the sensor assembly if the sterile pouch is open or damaged Do not handle the sensor assembly un til you are ready to insert the sensor because the sensor can become contaminated Do not wear the sensor in a ho...

Page 10: ...ostics com IMPORTANT The app stores sensitive health related information on your smart device It is recommended to keep your smart device up to date with the latest security software For details on updating your smart device and keeping your information safe contact the manufacturer of your smart device Review the GlucoMen Day CGM App s operating system compatibility before updating the operating ...

Page 11: ...Last Name and tap the icon Select your Birth year and tap the icon Select your Gender and tap the icon Select Type of diabetes and tap the icon 8 Read the explanation of why notifications are important and tap the icon Enter your email and create a password 9 Choose your email communication settings On iOS If you see a message asking for permission to send notifications or critical alerts tap ALLO...

Page 12: ...f you connect the transmitter to a second smart device it will no longer be connected to the first smart device IMPORTANT If this is the first time you have connected a transmitter the app will di splay hints to point out the next step and highlight impor tant features When you are done reading the hints tap OK 1 Locate the 6 digit numeric PIN A on the bottom of the transmitter Record the 6 digit ...

Page 13: ...ar tap the message and follow the prompts to enable permissions CAUTION All of these permissions must be enabled to connect to a transmitter 3 Open the app 1 Tap the DEVICES button On An droid devices you may need to tap the BACK ARROW until you see the bottom buttons 2 Tap TRANSMITTERS 3 On Android Tap the button On iOS Tap ADD A NEW TRANSMIT TER 5 Press the button on the charger A flashing blue ...

Page 14: ... active Only the active transmitter can be used for a session See SECTION 8 6 for details about activating a transmitter Overpatch optional GlucoMen Day app see SECTION 3 1 for instructions to download the app CAUTION Check the expiration date on the sensor assembly pou ch If the sensor has expired do not use it Using an expi red sensor may result in inaccurate glucose readings Follow the sensor i...

Page 15: ... seat belts may rub and irritate In areas on which you frequently sleep 2 Place the wipe on the insertion site and wipe in a circular pattern outward away from that spot Continue cleaning until you have cle aned the area about 15 20 cm 6 8 inches across without returning to any areas you already cleaned 3 Allow the cleaned area to dry completely for two minutes CAUTION Keep clothing from touching ...

Page 16: ... transmitter for any visible defects such as cracks Do not use the transmitter if you see any defects 4 5 Activate the transmitter Although you can connect multiple transmitters to the app only one transmitter can send CGM readings to the app at a time That transmitter is referred to as the active transmitter See SECTION 8 6 how to activate a transmitter 4 6 Place the transmitter into the sensor a...

Page 17: ...he sensor insertion tool Now that you have inserted the transmitter into the sen sor assembly you can prepare the sensor insertion tool To complete these steps you will need the sensor inser tion tool 1 Place the sensor insertion tool on a hard clean surface Locate the plastic lever with 1 bump A on the sensor insertion tool 2 Lift this lever up until you hear a click then lower to its starting po...

Page 18: ...back to remove the first section of the liner A B A B 2 Locate the tab B on the sensor insertion tool at the end with the lever 1 bump B B 3 Hold the sensor insertion tool with the tab B pointing down perpendi cular to the sensor assembly Align the tab directly above the ope ning A on the sensor assembly NOTE The sensor assembly opening A is for alignment and positioning of sensor insertion tool t...

Page 19: ... 4 10 Apply the sensor assembly to the insertion site Now that you have removed the liner on the sensor adhe sive patch you are ready to apply the patch to your skin CAUTION Failure to follow insertion instructions carefully may cau se the sensor to slide along the skin instead of inserting into the skin If this occurs the session may not start or the sensor will provide low quality data which wil...

Page 20: ...or assembly is attached to you If you feel resistance when removing the sensor insertion tool 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 NOTE If the edges of the adhesive patch begin to peel up at any time during your session you may apply the overpatch See SECTION 15 7 for instructions on ...

Page 21: ... app provides the following indications If you have allowed the app to send notifications you will receive a notification that the session has ended The app displays a message that the session has ended The HOME screen and TRANSMITTERS screen show in structions indicating that a session is not in progress You can also replace the sensor sooner if You have pain tenderness or swelling at the sensor ...

Page 22: ...libration alert you will receive a notifica tion when it is time to calibrate 5 1 1 What happens without calibration If you do not enter a calibration reading the CGM will con tinue to display glucose levels for a period of time but they will appear with an ESTIMATED GLUCOSE banner to indicate that the data quality may be lower than usual Estimated glucose levels appear as light grey points on the...

Page 23: ...into two sections the current status top and the trend chart bottom Current status top The current status section displays the most recent gluco se level and glucose trend See SECTION 6 3 for details 6 If this is the first calibration for the session there is a 10 minute data collection period during which the system will not display glucose le vels At the end of the data collection period the app...

Page 24: ...level is between the high and low glu cose lines set in CHART SET TINGS See SECTION 6 4 3 for details Trend chart bottom The trend chart displays recent glucose readings See SECTION 6 4 for details A Chart area B Chart display options Tap to choose the amount of data to show on the trend chart C Chart settings Tap to adjust the high and low glucose lines and the target range A Current CGM glucose ...

Page 25: ...RT SETTINGS See SECTION 6 4 3 for details D No glucose grey A grey background appears if the app is not receiving glucose readings from the transmitter or if there is a temporary sensor issue preventing glucose from being displayed The screen will either show instead of a glucose level OR a message explaining what is happening CAUTION If the app is not displaying a current glucose reading do not u...

Page 26: ...w is visible Your glucose level is rising at 0 14 0 19 mmol L per minute You cannot calibrate if this arrow is visible Your glucose level is rising at 0 08 0 14 mmol L per minute Your glucose level is changing less than 0 08 mmol L per minute Your glucose level is falling at 0 08 0 14 mmol L per minute Yourglucoselevelisfallingat0 14 0 19mmol L per minute You cannot calibrate if this arrow is visi...

Page 27: ...mitter signal is detected What the banner says What it means Sensor insertion instructions A session is not currently in progress Tap to view instructions for inserting a sensor and starting a new session Time to calibrate It is time to calibrate Tap the banner or the CALIBRATE button to enter a blood glucose reading from a meter What the banner says What it means Cannot calibrate right now You ca...

Page 28: ...rtion instructions It may take 1 3 minutes to detect the sensor A transmitter is connected but a session has not been started See CHAPTER 4 for details about starting a session Starting session The session is starting A progress bar indica tes the amount of time remaining before the session has started Waiting for cali bration Add a blood glucose meter reading The system is ready to be calibrated ...

Page 29: ...splay the last 1 3 6 12 or 24 hours of glucose data The right side of the chart always starts with the current time and past readings are plotted to the left 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 ...

Page 30: ... The system needs to be calibrated After the first calibration Glucose levels are estimated if the system is not calibrated within 6 hours of the session start After the second calibration Glucose levels are estimated if the system is not calibrated within 24 hours of the session start After all other calibrations Glucose levels are estimated if the system is not calibrated within 26 hours of the ...

Page 31: ...tabs allow you to set up your alerts Tap GLUCOSE for alerts related to current and future glucose levels See SECTION 7 6 for details Tap DEVICES for alerts related to the transmitter or your smart device See SECTION 7 7 for details See SECTION 7 4 for details about setting up alerts 7 3 Allowing notifications If you want alerts to appear as notifications on your smart device you need to give the G...

Page 32: ... options you can set to cu stomise the alert Most alerts can also be turned on or off 2 Select the type of alert you want to set Tap GLUCOSE for alerts related to current and future glucose levels See SECTION 7 6 for details Tap DEVICES for alerts related to the transmitter or your smart device See SECTION 7 7 for details 3 Tap the alert you want to set up Each alert has a title A and a cur rent s...

Page 33: ...lert settings there may be a delay be fore you receive alerts based on the new settings During this delay alerts will be based on the previous settings See SECTION 7 5 for details 7 5 Alert status indicators The alert status indicators let you know if the GlucoMen Day App and the transmitter are using the same alert settings and if your notification settings could prevent alerts from beha ving as ...

Page 34: ...alert to 6 7 19 4 mmol L You can customise the RE PEAT setting for this alert See SECTION 7 4 for details High glucose alert Your glucose is 14 3 mmol L Alert type When the alert occurs Alert message Falling glucose Your glucose is decreasing at the selected rate of decrease or faster You can set the rate of decrease to 0 1 or 0 2 mmol L per minute You can customise the RE PEAT setting for this al...

Page 35: ...ou can customise the REPEAT setting for this alert See SECTION 7 4 for details Time to calibrate Enter a blood glucose reading from your meter Alert type When the alert occurs Alert message Signal loss The app cannot detect the transmitter The transmitter may be too far from the app or something may be blocking the transmitter signal You can choose how long the signal must be lost before you are a...

Page 36: ...s You can also manually stop a session from this screen The TRANSMITTERS screen has four main sections a message area A this section only appears when there is relevant information to display current session details B a list of available transmitters C and a button to add a new transmitter D See SECTION 8 3 for details Android iOS 8 3 Transmitters screen details 8 3 1 Message area When a message a...

Page 37: ...ITTER ID from the charger to activate Activating transmitter The system is trying to activate the transmitter indicated by TRANSMITTER ID You must remove the transmitter from the charger in order to activate it See SECTION 8 6 for details about activating a transmitter NEXT STEP Follow sensor insertion instructions It may take 1 3 minutes to detect the sensor A transmitter is connected but a sessi...

Page 38: ...er is turned on NOTE If necessary you can use an AC wall adapter that complies with the specifications in SECTION 17 4 5 The light on the charger indicates the status of the tran smitter See SECTION 8 4 1 for details about the charger light This transmitter may take up to 4 hours to be fully char ged CAUTION If you want to use a computer to charge the transmitter a USB port supporting a minimum ch...

Page 39: ...o pair with the app This light appears when you press the button on the charger See SECTION 3 3 for details about connecting a transmitter to the app Solid blue light The transmitter is successfully paired with the app After 60 seconds this light will turn green flashing or solid to indicate that the transmitter is charging or charged Flashing red light Lasting up to 5 seconds The transmitter has ...

Page 40: ...ntified the active transmitter you can use that transmitter to start a session If you want to use a different transmitter follow the steps in SECTION 8 6 2 to activate that transmitter 8 6 2 Activating a different transmitter If you want to use a transmitter other than the one that is currently active you must activate that transmitter 1 Identify the transmitter you want to activate See SECTION 8 ...

Page 41: ...hanumeric ID A on the top of the tran smitter 4 Tap DELETE 5 When the confirmation message appears tap DELETE 6 If the deleted transmitter was the active transmitter a message indica tes which transmitter is now active Tap OK To activate a different transmitter see SECTION 8 6 9 Meters When using the GlucoMen Day CGM always carry a blood glucose meter for calibrating the system The calibration can...

Page 42: ...s about that meter C Add meter button On Android Tap the button On iOS Tap ADD A NEW METER This button lets you add a new meter See SECTION 9 3 for details about connecting a meter 9 3 Connecting a meter The app is compatible with the GlucoMen Day METER sy stem which communicates with the app using Bluetooth wireless technology and must be connected to the app before it can transfer readings to th...

Page 43: ...turned on to continue NOTE The app will update the time on the meter each time it syncs 3 On Android Tap the but ton On iOS Tap ADD A NEW ME TER 4 On Android devices only Depending on your device s permission settings you may see any or all of these messa ges on the NEW METER scre en Allow this app to access your location Turn on location Allow Bluetooth If any of these messages ap pear tap the me...

Page 44: ...splayed on the meter Tap PAIR 9 4 Deleting a meter Deleting a meter will remove the connection between the meter and the app You will no longer be able to transfer readings from the meter to the app If you want to transfer readings from the meter to the app again in the future you will need to go through the steps to connect the meter 1 In the app tap the DEVICES button On Android devices you may ...

Page 45: ... 3 Select the date range for whi ch you want to create a report 4 Tap CREATE REPORT to create a PDF report for the selected date range 5 Once the report is displayed tap the SHARE button Android iOS 6 Select an option to email or save the report Sharing options may vary based on your smart device 10 3 CSV data report The CSV data export allows you to export a comma sepa rated values CSV file conta...

Page 46: ...guages Select the language you want to view 10 9 Customer Service 1 In the app tap the INFO but ton On Android devices you may need to tap the BACK ARROW until you see the bottom but tons 2 Tap CUSTOMER SERVICE 3 Customer Service information is listed by country Locate the Cu stomer Service contact information for your country 10 10 Technical and medical support The App includes access to 24 7 tec...

Page 47: ...the PROFILE determines the glu cose units used throughout the app mg dL or mmol L IMPORTANT Your phone must allow outgoing phone calls to access medical support 10 11 Legal The LEGAL section provides access to legal documents and agreements related to the GlucoMen Day CGM App 1 In the app tap the INFO button On Android devices you may need to tap the BACK ARROW until you see the bottom buttons 2 T...

Page 48: ...assword 11 6 Resetting your password If you have forgotten your password you can reset it and create a new password 1 Tap FORGOT PASSWORD The FORGOT PASSWORD button appears when Logging in to your account SECTION 3 3 Changing your email SECTION 11 4 Changing your password SECTION 11 5 11 4 Changing your email Your email address is used to log in to your account as well as for important communicati...

Page 49: ...UNICATION section tap the switch next to each option to opt in or out 11 8 Sharing data with AgaMatrix When you create an account to use the GlucoMen Day CGM App your data is stored on AgaMatrix s secure servers If you prefer to use the app without sharing your data you have that option In that case your data is stored locally on your smart device only and cannot be retrieved from the server if so...

Page 50: ...a you need an access code to provide to Customer Service The access code will appear under CUSTOMER SERVICE ACCESS after you have agreed to the DATA ACCESS AGREEMENT The permission allows Customer Service to view the last 60 days of your anonymised CGM readings alerts and 11 9 Connected Partners The CONNECTED PARTNERS feature allows you to automa tically share your data with a trusted healthcare p...

Page 51: ...bleshooting This access will expire 30 days after it is enabled or when you turn off this setting whichever occurs first If you need assistance from Customer Service in the futu re you may need to turn on this feature again 12 Stopping a session 12 1 Automatically stopping a session Your GlucoMen Day CGM sensor lasts for 14 days After 14 days the CGM session will automatically stop There are other...

Page 52: ...you should remove the sen sor and place the transmitter in the charger See CHAPTER 13 for details about removing your sensor 13 Removing a sensor Once a session stops you should remove the sensor and place the transmitter in the charger CAUTION The sensor is for single use only up to 14 days Do not reuse the sensor or use it beyond 14 days Do not remove the transmitter while the sensor assem bly i...

Page 53: ... blood glucose test to ensure you make the correct treatment deci sion Your CGM does not display a current glucose level If the CGM does not display a glucose level the only way to know your cur rent glucose level is to perform a blood glucose test with your meter Your CGM does not display a trend arrow If the CGM does not display a trend arrow the CGM does not have enou gh information to provide ...

Page 54: ...he app are deter mined by the country selected under PROFILE See SECTION 11 2 for details about changing your country Issue Solution CGM readings are not di splayed on the HOME screen If the HOME screen shows a messa ge instead of a glucose reading see SECTION 6 3 6 for details about the message If the HOME screen shows instead of a glucose level You may need to calibrate Tap CA LIBRATE or the TIM...

Page 55: ...isabled on the NEW CALIBRATION screen The SAVE button is disabled if You have not manually entered a blo od glucose reading OR your manually entered blood glu cose reading is outside the range of 3 9 13 9 mmol L If you haven t entered a blood glucose reading enter one If your blood glucose is outside of 3 9 13 9 mmol L wait until your blood glu cose is within 3 9 13 9 mmol L before trying to calib...

Page 56: ...tions occur get treatment advice from your healthcare professional Sensor not working after immersing in water If the issue is not resolved after 1 hour stop the session remove the sensor and insert a new sensor to start a new session Issue Solution A CALIBRATION ERROR message appears Message Wait at least one hour before trying again You have entered a calibration reading that the system cannot a...

Page 57: ...or it may take 1 3 minutes for the app to detect the sensor Reasons a session may not be able to start There is a problem with the sensor Follow the instructions in CHAPTER 13 to remove the sensor The session ended early The session will end early if There is an issue with the sensor that can not be corrected OR the system detects that the sensor may have been removed and when prompted you confirm...

Page 58: ...ed instead of green the transmitter is not charging Try the following options to correct the issue Removethetransmitterandplaceitbackinthecharger RemovetheUSBcableandreinsertitintotheUSBport If the charger is plugged into a computer make sure the computer is on If the charger is plugged into a wall adapter unplug the adapter and plug it in again If the issue is not resolved contact Customer Servi ...

Page 59: ...atch 16 Connected Partners 16 1 Adding a connected partner In order to add a connected partner you need an activa tion code from the partner with whom you want to share If you have not received a code contact the partner to request one 1 In the app tap the PROFILE button On Android devices you may need to tap the BACK ARROW until you see the bottom buttons 2 Tap CONNECTED PARTNERS 3 On Android Tap...

Page 60: ...r and sensor assembly are considered bioha zardous and can potentially transmit infectious diseases even after you have performed cleaning Do not clean the transmitter charger as cleaning solu tions may cause USB port connection issues or corrosion of electrical contacts Do not clean the transmitter while it is in use or placed in the charger 17 Additional information 17 1 Customer Service informa...

Page 61: ...4 2 Transmitter specifications Specification Description Transmitter battery type Non serviceable rechargeable lithium ion polymer battery Transmitter battery life 14 days of typical use Transmitter life 5 years of average continuous use Transmitter data storage 14 days of calculated glucose data sampled once per minute Transmitter dimensions Length 33 0 mm width 24 0 mm thickness 9 0 mm Transmitt...

Page 62: ...ale Length 1 metre 3 feet 17 5 Labelling symbols These symbols may be found on your GlucoMen Day CGM System packaging 17 4 3 Sensor insertion tool specifications 17 4 4 Transmitter charger specifications 17 4 5 AC wall adapter specifications NOTE the AC wall adapter is not included 17 4 6 USB charging cable specifications The USB charging cable can be used for powering the transmitter charger The ...

Page 63: ... complete text of the declaration of EU conformity is available at www red menarinidiagnostics com The Transmitter meets the essential data transmission requirements for operating in the 2 4 GHz ISM band per ETSI EN 300 328 v2 1 1 Due to the continuous nature of the CGM system s wireless communication the user should not enter or discontinue use in locations where mobile phones and other radio tra...

Page 64: ...an ge applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people If interference does occur and the following device beha viour is observed Loss or incorrect CGM measurements Loss of transmitter charging capabilities The user can mitigate the situation by following the solu tions recommended ...

Page 65: ...ied altered or misused Under this war ranty we will replace free of charge any CGM component that is defective in material or workmanship In order to have Your CGM replaced under this warranty please call Customer Service No other warranties express or im plied are made We will not be liable for any incidental or consequential damages you may incur This warranty gi ves You specific legal rights an...

Page 66: ...to a smart device s operating sy stem by removing restrictions set by the manufacturer This presents a security risk Do not install the GlucoMen Day app on a smart device that has been jailbroken or rooted Ketones Chemicals that the body crea tes when breaking down fats for energy If ketones build up in the blood they can lead to serious complications Limitations A safety statement outlining speci...

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