Asthma+me

Asthma+me App is a Class 1 medical device Self-Care solution for children and young people aged 5-18 years old with asthma, in which parents and family members can support and monitor the wellbeing of all the children and young people under their care. This is a family-focused service, developed in collaboration with a leading NHS Paediatric Hospital in the UK.

Use of Asthma+me requires a subscription, which is handled by the App Store and will auto renew unless cancelled. You will be charged 24 hours before your renewal date. If you do not cancel 24 hours before your renewal you may be charged. If you purchase a subscription during your free trial period then any unused portion of your free trial will be forfeited. You can manage your subscription and auto-renewal settings through your iTunes Account Settings. Terms of sale can be found here: https://www.activ8rlives.com/support/

Asthma+me includes:

1.	Clinician-approved Education syllabus on Asthma management: 56 simple lessons and quizzes delivered daily, provides training and instruction for the family.
2.	Wireless connectivity to self-monitoring devices: Connect PUFFClicker inhaler trackers, Peak Flow/FEV1 monitor, BuddyBand2 Activity Tracker, Body Analyser Smart Scales to monitor key physiological signs.
3.	Medication: record medication prescribed for each family member. Track doses and use of batches of the prescription (eg inhaler in the bag, at home, etc). Include non-inhaler medications such as antibiotics, steroids, antihistamines etc.
4.	Charts and Reports: Generate custom charts to identify trends. Create pre-configured report as a PDF which can be printed, emailed or exported to clinical centres using Asthma+me.
5.	Motivation: encourage children and young people to adhere to their Care Plan and medication routine. Asthma+me includes a rewards module for the child(ren) to work towards, earning points for every action completed each day to motivate and encourage.
6.	Care Plan: Asthma+me brings together all of your child(ren)’s information in one, easy-to-read and printable or emailable Care Plan. EVERYONE with asthma should have a written care plan. Print and give to schools, friends, family, carers, GP and Hospitals to give clear instructions in the event of an asthma attack. 


Medical device

The Asthma+me App is classified as a Class 1 medical device under MEDDEV  2. 4/1 Rev. 9 June 2010 as per the requirements set out in Annex IX of Directive 93/42/EEC as amended 2007/47/EC.

Intended Use: 
Asthma+me is a mobile application intended for use in the home to assist people to receive and review information from connected medical and non-medical devices, track medication use and record other events such as asthma attacks, for effective health self-management. The user also can share the data via sharing functions. 

Health and Safety Notices:
Asthma+me App is not intended to monitor vital physiological parameters where variation could result in immediate danger.

Asthma can be a life-threatening condition. Always take the medication as prescribed. If you experience any asthma-related symptoms of shortness of breath that does not get better after using your Reliever inhaler; trouble walking and talking because of shortness of breath; blue lips or fingernails; severe wheezing; or a peak flow reading of less than 50% of your personal best, refer to your Care Plan and follow the instructions carefully. If you continue to have symptoms, consult your medical team. 

Do not rely on the Asthma+me App to diagnose or treat your Asthma.

Only recommended for children 5 years of age and over and only under adult supervision. 
Do not rely solely on the Reminder capabilities of the Asthma+me App to take your prescribed medication as directed by your medical team.

If you experience any serious incident that occurs in relation to the Asthma+me App, please report this to Aseptika Limited (Activ8rlives) and the competent authority of the Member State in which you are based.