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BreatheSuite MDI Device User Manual

Copyright 2021 - BreatheSuite Inc (v1.1) 47

Electromagnetic Compatibility

Medical electrical equipment needs special
precautions regarding electromagnetic compatibility
(EMC) and needs to be installed and put into service
according to the information provided in this user
manual.

Portable and mobile radio frequency (RF)
communications equipment can affect medical
electrical equipment. The following table provides
recommended separation distances between
portable and mobile RF communications equipment
and the BreatheSuite Bluetooth-enabled MDI Device.

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Summary of Contents for BreatheSuiteMDIV1

Page 1: ...BreatheSuiteMDIV1 v1 1 User Manual BreatheSuite Metered Dose Inhaler MDI Device...

Page 2: ...ual Copyright 2021 BreatheSuite Inc v1 1 2 Table of Contents Indications for Use 4 How it Works 7 Getting Started 10 Sign Up 10 Assigning a device to a prescription 13 Taking a puff and syncing a dose...

Page 3: ...atheSuite MDI Device User Manual Copyright 2021 BreatheSuite Inc v1 1 3 Product Description 22 Frequently Asked Questions 24 Precautions 33 Warnings 38 Contraindications 40 Troubleshooting 41 Appendix...

Page 4: ...and monitoring the actuations and technique of prescribed metered dose inhaler MDI usage The BreatheSuite System is composed of the disposable battery powered portable BreatheSuite MDI Device and a m...

Page 5: ...arameters of MDI use and records them for review by the patient The BreatheSuite application records stores and transmits usage events from the BreatheSuite MDI Device to a remote storage system Furth...

Page 6: ...aining in an MDI The BreatheSuite MDI Device is not intended to replace a physician s advice or inhaler labels patients are expected to always follow their doctor s advice and inhaler labels The Breat...

Page 7: ...t Works The BreatheSuite MDI Device collects information on how you use your inhaler It measures how long you shake your inhaler It senses if the inhaler mouthpiece is horizontal It measures how long...

Page 8: ...the date and time of each inhaler use This information is sent to the BreatheSuite app on your smartphone using a Bluetooth connection The BreatheSuite app assists the user in recording and monitorin...

Page 9: ...he BreatheSuite MDI Device and app provide feedback on inhaler usage but the communication of data can be delayed You know your health best never wait to call a doctor if you are not feeling well If y...

Page 10: ...Getting Started For detailed instruction on how to use the BreatheSuite MDI Device and app including how to videos and in app screenshots visit www breathesuite com help gettingstarted Sign Up 1 Down...

Page 11: ...al Copyright 2021 BreatheSuite Inc v1 1 11 2 Create an account in the BreatheSuite app by pressing the Sign Up button and then entering your email and creating a password 3 Verify your account using t...

Page 12: ...ht 2021 BreatheSuite Inc v1 1 12 email 4 You re done You re now ready to assign your device to a prescription If you need any help setting up your BreatheSuite MDI Device send an email to help breathe...

Page 13: ...opyright 2021 BreatheSuite Inc v1 1 13 Assigning a device to a prescription 1 Take the BreatheSuite MDI Device out of the packaging 2 Hold down on the BreatheSuite MDI Device to begin setup a flashing...

Page 14: ...escription Setup page will appear in the app Select your a Medication Type Controller or Rescue b Medication Name c Medication Dosage d Number of AM puffs Controller Only e Number of PM puffs Controll...

Page 15: ...15 4 Attach the BreatheSuite MDI Device to the top of the canister of your inhaler by gently pressing it down until it stops You re now ready to use BreatheSuite Taking a puff and syncing a dose When...

Page 16: ...opyright 2021 BreatheSuite Inc v1 1 16 1 Make sure your BreatheSuite MDI device is attached to the top of the canister of your inhaler 2 Shake your inhaler and the BreatheSuite MDI Device to mix your...

Page 17: ...te Inc v1 1 17 3 Take a puff from your inhaler as prescribed pressing down on the top of the BreatheSuite MDI Device similar to how you d press on the top of the inhaler canister 4 Open the BreatheSui...

Page 18: ...Copyright 2021 BreatheSuite Inc v1 1 18 internet and that Bluetooth is enabled 5 The dose will be automatically synced in the app If the dose does not appear shake the device and press the button in...

Page 19: ...y using your inhaler to ensure your BreatheSuite MDI Device is attached Bluetooth Pairing Syncing After the initial pairing the BreatheSuite MDI Device will automatically connect to the BreatheSuite a...

Page 20: ...right 2021 BreatheSuite Inc v1 1 20 To sync your BreatheSuite MDI Device 1 Shake the BreatheSuite MDI Device and wait for the blinking blue light to appear 2 Ensure that Bluetooth is enabled on your s...

Page 21: ...r Manual Copyright 2021 BreatheSuite Inc v1 1 21 3 Wait for the app to retrieve the data from the BreatheSuite MDI Device If the dose does not appear shake the device and press the button in the app t...

Page 22: ...reatheSuite Inc v1 1 22 Product Description The BreatheSuite MDI Device will help you record and monitor your inhaler medication use and technique When you take your medication the BreatheSuite MDI De...

Page 23: ...inhaler It senses if the inhaler mouthpiece is horizontal It measures how long you inhale It senses if you push down on your inhaler as you start to breathe in It records the date and time of each inh...

Page 24: ...f metered dose inhalers Check www breathesuite com help compatible inhalers for details on which inhalers are compatible with the BreatheSuite MDI Device Frequently Asked Questions A comprehensive lis...

Page 25: ...ch dose How long you shook the inhaler seconds The angle of the inhaler mouthpiece compared to the horizontal degrees How long you inhaled seconds The time between pushing down on your inhaler and whe...

Page 26: ...reatheSuite MDI Device 1 Shake the BreatheSuite MDI Device and wait for the blinking blue light 2 Open the BreatheSuite app on your smartphone and ensure Bluetooth is enabled 3 Wait for the app to ret...

Page 27: ...es show that correct inhaler usage results in less frequent rescue inhaler usage Will the BreatheSuite MDI Device work if I m not in close proximity to my smartphone The BreatheSuite MDI Device will k...

Page 28: ...luetooth off in your smartphone settings Do not Swipe Close the BreatheSuite app on your smartphone Will the BreatheSuite app work if I am offline No the BreatheSuite app requires a stable internet co...

Page 29: ...eSuite app Can I clean my BreatheSuite MDI Device Do not put your Device under water or in a dishwasher or sterilizer This could damage your Device Remove the Device from your inhaler before cleaning...

Page 30: ...atheSuite MDI Device has a lifespan of 1 5 years Why is my dose missing If you Swipe Close the app during dose sending this could result in your dose not being recorded in the app Ensure that while yo...

Page 31: ...the BreatheSuite MDI Device does not have adequate charge To guarantee that your dose is recorded in the BreatheSuite app ensure that The BreatheSuite MDI Device and your smartphone are in close proxi...

Page 32: ...ck the dose and mark it as taken in the BreatheSuite app Instructions on how to manually mark a dose as taken can be found in the Help Center 1 Open the BreatheSuite app 2 Click on the Settings page 3...

Page 33: ...having an asthma attack or a medical emergency call your doctor right away Device information can be delayed and your doctor circle of care may not be aware of your condition The BreatheSuite MDI Dev...

Page 34: ...Device immediately Send an email at help breathesuite com or call 1 855 667 8931 to report your BreatheSuite MDI Device interfering with inhaler usage Never delay using your inhaler in order to attach...

Page 35: ...heSuite MDI Device may not be immersed in liquid Do not place the Device underwater or put it in a dishwasher or a sterilizer It could damage the BreatheSuite MDI Device and cause it to not function p...

Page 36: ...nc v1 1 36 Device or think your battery does not have an adequate charge please email help breathesuite com or call 1 855 667 8931 Changes and or modifications not expressly approved by BreatheSuite c...

Page 37: ...much medication reaches your lungs The BreatheSuite MDI Device is meant to track the way you use your inhaler BreatheSuite assists in recording and monitoring of inhaler usage and does not replace yo...

Page 38: ...owed WARNING Choking hazard keep away from pets and small children WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper funct...

Page 39: ...d result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in malfunctioning WARNING Portable RF communications equipment including peripherals...

Page 40: ...agnosis provided by a licensed physician The BreatheSuite system is not intended for use as an MDI medication dose counter nor is it intended to indicate the quantity of medication remaining in an MDI...

Page 41: ...ngs page and clicking on the Help Center Turning on your BreatheSuite MDI Device Turn on your BreatheSuite MDI Device by shaking it Shake your inhaler with the BreatheSuite MDI Device attached to ensu...

Page 42: ...BreatheSuite MDI Device User Manual Copyright 2021 BreatheSuite Inc v1 1 42 3 Click on Help Center for a list of topics...

Page 43: ...rial Number Product should not be disposed of in a landfill Date of manufacture YYYY MM DD Name of manufacturer Protected from safety risks due to dripping water when Device is tilted up to 15 degrees...

Page 44: ...r Manual Copyright 2021 BreatheSuite Inc v1 1 44 TUV SUD Safety Operating and Storage Conditions Operating temperature 20 to 40 C Storage temperature 25 to 70 C Relative Humidity 5 to 95 non condensin...

Page 45: ...may not be functioning as intended as a result of electromagnetic interference Blue light no longer lighting up after shaking Device unable to connect to BreatheSuite app via Bluetooth If your Breathe...

Page 46: ...Suite MDI Device has been selected to last for 1 5 years of service without maintenance The main functionality of the BreatheSuite MDI Device is an inhaler add on If you think at any time that there i...

Page 47: ...atibility EMC and needs to be installed and put into service according to the information provided in this user manual Portable and mobile radio frequency RF communications equipment can affect medica...

Page 48: ...The user and or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radio frequency communications equipment emitters and...

Page 49: ...ing the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and...

Page 50: ...netic emissions Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group1 Class B The BreatheSuite MDI uses RF energy only for its internal function Therefore its RF...

Page 51: ...charge 2 4 6 and 8kV contact discharge 2 4 6 8 and 15kV air discharge IEC 61000 4 3 Radiated RF EM fields 10 V m 80 MHz 2 7 Ghz 80 AM at 1 kHz IEC 61000 4 3 Proximity fields from RF wireless communica...

Page 52: ...opyright 2021 BreatheSuite Inc v1 1 52 RF Transmission Technical Specification Value Radio Frequency 2 4 GHz Modulation GFSK Channels 40 channels 2MHz channel FHSS Protocol Bluetooth Low Energy Power...

Page 53: ...Manual Copyright 2021 BreatheSuite Inc v1 1 53 If you have any questions please contact us 1 855 667 8931 help breathesuite com User Manual Information Copyright BreatheSuite Inc Model BreatheSuiteMD...

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