WaveForm A.MENARINI diagnostics GlucoMen Day CGM, User Manual

Page 1: ...User Guide...

Page 2: ...ark 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 respectiv...

Page 3: ...existing account 3 4 Connect a transmitter 4 Inserting a sensor and starting a session 4 1 Prepare for sensor insertion 4 2 Choose a sensor insertion site 4 3 Clean the sensor insertion site 4 4 Sele...

Page 4: ...Home screen 6 2 Home screen overview 6 3 Current status 6 4 Trend chart 6 5 Estimated glucose 7 Alerts 7 1 Navigating to the Alerts screen 7 2 Alerts screen overview 7 3 Allowing notifications 7 4 Se...

Page 5: ...e 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 Le...

Page 6: ...ng with your GlucoMen Day CGM 15 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 is...

Page 7: ...the instructions provided in this user gui de before using the system IMPORTANT Illustrations in this guide are for in structional purposes only and are not shown at actual size The display of the Gl...

Page 8: ...ake treatment decisions it is important to understand how you can use the information from your CGM Your current glucose le vel current glucose trend and your past readings can all be used to make inf...

Page 9: ...mall parts that may be a choking hazard IMPORTANT If you do not have SKIN PREPTM wipes you can use an alcohol wipe IMPORTANT The transmitter and sensor adhesive patch can be worn while bathing and sho...

Page 10: ...Doing so may com promise the security and functionality of the app 3 2 Create an account Before using the GlucoMen Day CGM App you need to answer a few simple questions and create an account Your acco...

Page 11: ...icon to show or hide your password 8 Read and agree to the PRIVACY POLICY and tap SIGN UP 9 Review the CONSENT TO DATA PROCESSING BY WAVEFORM to decide if you want to consent to sharing data On iOS If...

Page 12: ...e in pairing mode for 60 seconds If you are unable to successfully pair the tran smitter during this time you will need to restart the pai ring process CAUTION You can only connect a transmitter to on...

Page 13: ...se permissions must be enabled to connect to a transmitter 5 Press the button on the charger A flashing blue light indicates the transmitter is ready to pair NOTE Once you press the button on the char...

Page 14: ...sor insertion tool 4 2 Choose a sensor insertion site Before you insert the sensor take a moment to consider where the best insertion site may be Choose a sensor insertion site on your abdomen or lowe...

Page 15: ...sensor use If any of these conditions occur get treat ment advice from your healthcare professional You should choose a new insertion site every time you insert a new sensor Using the same site may c...

Page 16: ...CGM readings to the app at a time That transmitter is referred to as the acti ve transmitter See SECTION 8 6 how to activate a transmitter 4 6 Place the transmitter into the sensor assembly To complet...

Page 17: ...til you hear a click then lower to its starting po sition An orange tab indicates that the sensor insertion tool is ready to use 4 8 Attach the sensor insertion tool to the sensor assembly Next attach...

Page 18: ...l downward to meet the sensor assembly until you hear a click 6 The sensor insertion tool and sensor guide should snap together without a gap Check for a gap between the sensor insertion tool and sens...

Page 19: ...a straight outward motion If you feel resistance repeat steps 4 5 IMPORTANT The sensor guide remains connected to the sensor insertion tool leaving only the transmitter sensor and adhesive patch on yo...

Page 20: ...itters screen Once you have inserted a new sensor it may take 1 3 minutes 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...

Page 21: ...irst six hours IMPORTANT WhenusingtheGlucoMenDayCGM always carry a blood glucose meter for calibrating the system Approximately 24 hours before the session is scheduled to end the app provides the fol...

Page 22: ...2 Tap TRANSMITTERS 3 Tap CALIBRATE 5 1 1 What happens without calibration If you do not enter a calibration reading the CGM will continue to display glucose levels for a period of time but they will...

Page 23: ...d into two sections the current status top and the trend chart bottom Current status top The current status section displays the most recent glu cose level and glucose trend See SECTION 6 3 for detail...

Page 24: ...amount of data to show on the trend chart C Chart settings Tap to adjust the high and low glucose lines and the tar get range A Current CGM glucose reading B Trend arrow C Status icons D Calibrate but...

Page 25: ...CHART 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 pre v...

Page 26: ...t 0 08 0 14 mmol L per minute 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 treat ment...

Page 27: ...stem is saving the calibration reading Cannot calibrate right now Saving calibration Glucose levels are currently estimated Tap the banner for details about why glucose levels are estimated See SECTIO...

Page 28: ...ted See CHAPTER 5 for details about calibration Starting session Waiting for calibration Add a blood glucose meter reading Home screen message What it means After the first calibration of a session th...

Page 29: ...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 plot ted to the left 6 4 3 Chart settings CHART SETTINGS lets you choose wher...

Page 30: ...ystem 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 oth...

Page 31: ...ap 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 SE...

Page 32: ...g up alerts The GlucoMen Day App includes a variety of alerts you can set up to notify you if something occurs that requires your attention Each alert has options you can set to cu IMPORTANT The URGEN...

Page 33: ...he alert settings there may be a delay before you receive alerts based on the new settings Du ring this delay alerts will be based on the previous set tings See SECTION 7 5 for details 7 5 Alert statu...

Page 34: ...gh glucose alert Your glucose is 14 3 mmol L Alert type When the alert occurs Alert message Falling glucose Your glucose is decre asing at the selected rate of decrease or faster You can set the rate...

Page 35: ...u 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...

Page 36: ...s where you manage your transmitters 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 relev...

Page 37: ...Time to calibrate Enter a blood glucose reading See CHAPTER 5 for details about calibrating Saving calibration The system is saving the calibration reading Collecting data After the first calibration...

Page 38: ...uter is turned on NOTE If necessary you can use an AC wall adapter that complies with the specifications in SECTION 16 4 5 The light on the charger indicates the status of the tran smitter See SECTION...

Page 39: ...ssfully pair with the app See SECTION 15 6 for details about charger errors 8 5 Connecting a transmitter Please refer to SECTION 3 3 for Connecting a transmit ter instructions 8 6 Activating a transmi...

Page 40: ...y charging remove the transmitter from the charger The transmitter cannot be activated while in the charger 3 In the app tap the DEVICES but ton On Android devices you may need to tap the BACK ARROW u...

Page 41: ...hanumeric ID A on the top of the transmitter 4 Tap DELETE 5 When the confirmation message appears tap DELETE 6 If the deleted transmitter was the active transmitter a messa ge indicates which transmit...

Page 42: ...B Connected meters list This section lists all of the meters connected to the app Tap a meter row for details about that meter C Add meter button On Android Tap the button On iOS Tap ADD A NEW METER...

Page 43: ...time on the meter each time it syncs IMPORTANT Your GlucoMen Day METER communi cates with the app using Bluetooth wireless technolo gy Your smart device must have Bluetooth turned on to continue 3 On...

Page 44: ...layed on the meter Tap PAIR 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...

Page 45: ...OVERVIEW 3 Select the date range for which 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 Andro...

Page 46: ...network connection to view Guides listed under AVAILABLE GUIDES require a network con nection to download and view 10 9 Customer Service 1 In the app tap the INFO button On Android devices you may ne...

Page 47: ...units of the selected country mg dL or mmol L 11 2 Changing personal information You can change your name birth year gender and type of diabetes 11 3 Changing your country The country selected in the...

Page 48: ...our password A good password is important to keep your health data safe It is good practice to change your password occa sionally especially if you believe your password may have been compromised 1 In...

Page 49: ...nless you turn on SHARE DATA WITH WAVEFORM 1 In the app tap the PROFILE button 2 Tap the switch next to SHARE DATA WITH WAVEFORM to opt in or out of sharing data Tap READ FULL AGREEMENT to review the...

Page 50: ...has ended Tap SENSOR REMOVAL INSTRUCTIONS for information about removing the sensor OR Tap OK 12 Stopping a session 12 1 Automatically stopping a session Your GlucoMen Day CGM sensor lasts for 14 days...

Page 51: ...itter while the sensor assem bly is attached to you 1 Remove the sensor adhesive patch starting at the end closest to the flat back side of the transmitter Peel the patch away from your body 2 After r...

Page 52: ...device has Bluetooth turned on with your smart device in ae roplane mode 14 Limitations 14 1 When to use your blood glucose meter for treatment decisions You can use your GlucoMen Day CGM to make tre...

Page 53: ...e communication is re stored the gap may be filled in if the transmitter was collecting data during that time Issue Solution CGM readings are significantly different from blood glucose meter readings...

Page 54: ...ollow instructions from your heal thcare professional to raise or lower your blood glucose level as needed A CALIBRATION ERROR message appears Message Make sure your hands are clean and dry and retest...

Page 55: ...u may need to wait for your glucose to stabilise before you can calibrate 15 4 Sensor issues Issue Solution Gap between the sensor insertion tool and sensor assembly If there is a gap the sensor inser...

Page 56: ...with the sensor that cannot be corrected OR the system detects that the sensor may have been removed and when prompted you confirm that the sensor is no longer inserted Follow the instructions in CHAP...

Page 57: ...and app are within 3 metres 10 feet of each other and Bluetooth is on If the charger light is solid red for more than 10 seconds try the following to correct the issue 1 Leave the transmitter in the c...

Page 58: ...ing your system The GlucoMen Day CGM System is for single patient use Clean in general Your CGM system parts should be cleaned only as nee ded to remove visible dirt and debris This does not re duce t...

Page 59: ...16 4 2 Transmitter specifications Specification Description Transmitter battery type Non serviceable rechargeable li thium ion polymer battery Transmitter battery life 14 days of typical use Transmit...

Page 60: ...tions The USB charging cable can be used for powering the transmitter charger The USB charging cable can be con nected to a PC USB port that can meet the input and connector type specifications listed...

Page 61: ...ransmission and electromagnetic compatibility requirements defined in 2014 53 EU The complete text of the declaration of EU conformity is available at www red menarinidiagnostics com The Transmitter m...

Page 62: ...munity The GlucoMen Day CGM system is intended for use in the electromagnetic environment specified below The custo mer or the user of the GlucoMen Day CGM system should assure that it is used in such...

Page 63: ...rements to check adjust or set to a standard provides the necessary information to ensu re that the GlucoMen Day App accurately displays your gluco se levels Continuous glucose monitor CGM A CGM uses...

Page 64: ...does not produce insulin Interstitial fluid The fluid that surrounds all the cells of the body Jailbroken or rooted Gaining unauthorised access to a smart device s operating sy stem by removing restri...

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