Apps Activ8rlives4 Health+Wellness App User Guide

June 3, 2024
APPs

Apps Activ8rlives4 Health+Wellness App

Apps-Activ8rlives4-Health-Wellness-App-Product-Image

The Activ8rlives family of medical devices connects wirelessly and uploads data to Activ8rlives4 Health+Wellness, Asthma+me or Active+me REMOTE Apps. Works with: Bluetooth Smart Ready device (typically Bluetooth 4.0+), iOS 12+ and Android 10+. Apple Health App compatible.Apps-Activ8rlives4-Health-
Wellness-App-Fig-01

We are a healthcare company. Our mission is to empower you to take care of your health and that of your family by self-care through self-monitoring.
From tracking levels of physical activity, weight, food intake, cardiovascular and lung function, to a new generation of at-home testing for long-term lung disease, we provide the devices and web-based tools to help you be active, eat well and stay healthy. Learn more at www.activ8rlives.com

Activ8rlives4 Health+Wellness App is a Class I medical device designed for use with persons 5-80+ years-old, and 5-12-years-old with adult supervision, who have a health condition for which the App can be used at home for their self- care.
The Self-Care mobile application and cloud services, is intended to deliver a comprehensive home self-care platform (remote monitoring from connected medical and non-medical devices, track medication use, peer-to-peer support, food diary, adventures, record other events such as cardiac or respiratory symptoms or exacerbations, for effective health self-management. The user can also share their data via sharing functions. Activ8rlives4 Health+Wellness App is a stand-alone software product, which can be installed on Apple and Android platforms from their respective App stores. It can be accessed also via the Activ8rlives web portal.
Activ8rlives4 Health+Wellness App is a free service.
Included in the Activ8rlives4 Health+Wellness App (UDI-DI 5060293170946) is:

  • Wireless connectivity to the Activ8rlives branded self-monitoring devices: Connect PUFFClicker smart inhaler trackers, Peak Flow/FEV1 monitor, Spirometer @Home,
  • Pulse Oximeters, Blood Pressure Monitors, BuddyBand2 Activity Tracker, Body Analyser Smart Scales to monitor key physiological signs.
  • Medication: Record medication prescribed and taken, track doses and use of batches of the prescription (e.g. antibiotics, steroids, antihistamines, beta blocker, ACE inhibitors, statins etc).
  • Charts and Reports: Generate custom charts to identify trends. Create pre-configured report as a PDF which can be printed or emailed to a patient’s Doctor.
  • Behaviour Change: Encouraging adherence to their Care Plan and medication routine can be a challenge for all. Activ8rlives4 Health+Wellness App includes a configurable rewards capability to work towards, earning points for every action completed each day to motivate and encourage behaviour change.
  • Adventures: Different adventure walking routes, that can be used individually or as a Group.
  • Support Groups: Provide encouragement and tips to help you on your health and wellness journey.
  • Food Diary: Can enter photographs of your meals or add ingredients, whole meals or carb counting for diabetics.

If in any doubt about your health, please consult your medical team first and follow their advice closely.

Intended Use
Activ8rlives⁴ Health+Wellness is a Class I medical device 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, for effective health self-management. The user can share their data via sharing functions.
Intended Population
The Activ8rlives⁴ Health+Wellness App is intended for use by 5-80+ years-old, with adult supervision for 5-12- years-old.

Contraindications

Activ8rlives⁴ Health+Wellness App is not intended to monitor vital physiological parameters where variation could result in immediate danger.

  • Not intended for diagnosis or treatment of disease.
  • Not for use by children under 5-years-old.
  • Not a substitute for expert clinical advice.
  • You should not rely solely on the Reminder capabilities of the Activ8rlives⁴ Health+Wellness App to take your prescribed medication as directed by your medical team.
  • Not an alternative to your clinically prescribed Care Plan.

Warnings
Long-term health conditions (LTHC) can be life-threatening.

Always take your medication and follow your Care Plan as prescribed.
If you experience any 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, chest pain or discomfort; heart palpitations; rapid or irregular heartbeats; unexplained wheezing; shortness of breath; fainting or near fainting; lightheadedness or dizziness; refer to your Care Plan and follow the instructions carefully. If you continue to have symptoms, consult your medical team.

Disclaimer
It remains your responsibility at all times to seek expert clinical advice in the event of an emergency or worsening symptoms. The functionality of the Activ8rlives4 Health+Wellness App should never be used as an alternative to medical advice from your doctor or another healthcare provider.
If you experience any serious incident that occurs in relation to the Activ8rlives4 Health+Wellness App, please report this to Aseptika Limited (Activ8rlives) and the competent authority of the Country in which you are based.

The Asthma+me App is a mobile application intended for use in the home to assist children and young people to receive and review information from connected medical and non-medical devices, track medication use and recording other events such as asthma attacks, for effective health self-management. The user can also share the data via sharing functions. The Asthma+me App is designed for use with children and young people 6-18-years-old with moderate to severe asthma.
The Asthma+me App is a stand-alone software product, which can be installed on Apple and Android platforms from their respective App stores. The Asthma+me App is a subscription service with a monthly charge.
Included in the Asthma+me App (UDI-DI 5060293170939) is:

  • Clinician-approved education syllabus on Asthma management: series of 50+ simple lessons delivered daily, provided training and instruction for the family. Included at the end of each lesson is a simple quiz to confirm understanding.
  • Wireless connectivity to the Activ8rlives branded self-monitoring devices: Connect PUFFClicker smart inhaler trackers, Peak Flow/FEV1 monitor, Spirometer @Home, BuddyBand2 Activity Tracker, Body Analyser Smart Scales to monitor key physiological signs.
  • Medication: Record the medication prescribed for each family member and track doses and use of batches of the prescription (e.g. inhaler in the bag, at home, at school, in the car etc.). Include noninhaler medications, such as antibiotics, steroids, antihistamines etc.
  • 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 App.
  • Motivation: Encouraging children and young people to adhere to their Care Plan or PAAP and medication routine can be a challenge for all family members or carers. Asthma+me App includes a configurable rewards capability for the children and young people to work towards, earning points for every action completed each day to motivate and encourage.
  • Care Plan: Asthma+me App brings together all of your CYP’s information in one, easy-to-read and printable or emailable Care Plan or PAAP. Everyone with asthma should have a written care plan.
  • Print and give to school, college, friends, family, carers, GP and Hospitals to give clear instructions in the event of an asthma attack.

Intended Use
The Asthma+me App is a Class I medical device mobile application intended for use in the home to assist children and young 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 can share their data via sharing functions.

Intended Population
Asthma+me App has been designed for use with children and young people 6-18-years with moderate to severe or difficult to treat asthma.

Contraindications
The Asthma+me App is not intended to monitor vital physiological parameters where variation could result in immediate danger.

  • Not intended for diagnosis or treatment of asthma.
  • Not for use by children under 13 years-old without supervision of a responsible adult.
  • Not for use with children younger than 5 years-old.
  • Not a substitute for expert clinical advice.
  • You should not rely solely on the Reminder capabilities of the Asthma+me App to take your prescribed medication as directed by your medical team.

Warnings

  • 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 or 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 or PAAP and follow the instructions carefully. If you continue to have symptoms consult with your medical team.

Disclaimer
It remains your responsibility at all times to seek expert clinical advice in the event of an emergency or worsening of symptoms. The functionality and content within the Asthma+me App should never be used as an alternative to medical advice from your doctor or other healthcare providers.
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 Country in which you are based.

Active+me REMOTE App is a Class I medical device designed for use with adults which, have had a cardiac or respiratory exacerbation or procedure, where they have been referred to the Self-Care mobile application and cloud services, intended to deliver a comprehensive home recovery system (live exercise classes, exercise videos, remote monitoring from connected medical and non- medical devices, track medication use, education, peer-to-peer support, dietary advice, record other events, such as cardiac or respiratory symptoms or exacerbations) for effective health self-management. The user can also share their data via sharing functions.
Active+me REMOTE App is a stand-alone software product, which can be installed on Apple and Android platforms from their respective App stores. The Active+me REMOTE App is a subscription service with a monthly charge.
Included in the Active+me REMOTE App (UDI-DI 5060293171004) is:

  • Clinician-approved education syllabus on Cardiac or Pulmonary disease management: series of 60+ simple lessons delivered daily, provided training and instruction for the patient and carer. Included at the end of each lesson is a simple quiz to confirm understanding.
  • Wireless connectivity to the Activ8rlives branded self-monitoring devices: Connect PUFFClicker smart inhaler trackers, Peak Flow/FEV1 monitor, Spirometer @Home, Pulse Oximeters, Blood Pressure Monitors, BuddyBand2 Activity Tracker, Body Analyser Smart Scales to monitor key physiological signs.
  • Medication: Record the medication prescribed, track doses and use of batches of the prescription (e.g. antibiotics, steroids, antihistamines, beta blocker, ACE inhibitors, statins etc).
  • 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 Active+me REMOTE App.
  • Behavior Change: Encouraging adherence to their Care Plan and medication routine can be a challenge for all. Active+me REMOTE App includes a configurable rewards capability to work towards, earning points for every action completed each day to motivate and encourage behaviour change.
  • Care Plan: Active+me REMOTE App brings together all of your information in one, easy-to-read and printable or emailable Care Plan. Everyone with a long-term health condition should have a written care plan. Print and give to work, friends, family, carers, GP and Hospitals to give clear instructions in the event of an exacerbation, cardiovascular incident or worsening symptoms.
  • Exercise: Includes live exercise classes via Starleaf, Teams, Zoom or other platform and embeds exercise videos within the Active+me REMOTE App.

Intended Use
Active+me REMOTE App is a Class I medical device mobile application and cloud services intended to deliver a comprehensive home recovery system (live exercise classes, exercise videos, step counting, remote monitoring from connected medical and non-medical devices, track medication use, education, peer-to-peer support, dietary advice, record other events such as cardiac or respiratory symptoms or exacerbations) for effective health selfmanagement. The user can share their data via sharing functions.

Intended Population
The user target group are adults over the age of 18 years that have had a cardiac or pulmonary exacerbation or procedure for their use at home in their recovery.

Contraindications
Active+me REMOTE App is not intended to monitor vital physiological parameters where variation could result in immediate danger.

  • Not intended for diagnosis or treatment of cardiac or pulmonary disease.
  • Not for use by those under 18-years-old.
  • Not a substitute for expert clinical advice.
    You should not rely solely on the Reminder capabilities of the Active+me REMOTE App to take your prescribed medication as directed by your medical team.

Warnings
Cardiac or pulmonary events can be life-threatening.
Always take your medication and follow your Care Plan as prescribed.
If you experience any pulmonary-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.
If you experience any cardiac-related symptoms of chest pain or discomfort; heart palpitations; rapid or irregular heartbeats; unexplained wheezing; shortness of breath; fainting or near fainting; lightheadedness or dizziness; refer to your Care Plan and follow the instructions carefully. If you continue to have symptoms, consult your medical team.

Disclaimer
It remains your responsibility at all times to seek expert clinical advice in the event of an emergency or worsening symptoms. The functionality of the Active+me REMOTE App should never be used as an alternative to medical advice from your doctor or other healthcare providers.
If you experience any serious incident that occurs in relation to the Active+me REMOTE App, please report this to Aseptika Limited (Activ8rlives) and the competent authority of the Country in which you are based.

Let’s get started with the Set-up and Connect to one of our Apps

The Activ8rlives branded medical devices are programmed by and uploads information directly to and from your account each time your Bluetooth Smartphone or Tablet is connected to it (not included).
This guide will show you how to:

  • Install the free Activ8rlives4Health+Wellness or the paid subscription Apps Asthma+me and Active+me REMOTE to your iOS or Android Smartphone or Tablet.

Aseptika Limited, Suite 5, SiTwo (formerly LDH House), Parsons Green, St Ives, Cambridgeshire, PE27 4AA, United Kingdom.
European Healthcare & Device Solutions (Ireland) Ltd. (AER-EU), Stratton House, Bishopstown Road, Bishopstown, Cork, Ireland.

Read instructions before use. https://www.activ8rlives.com/support/

Medical Device| Manufacture Date

| Version
---|---|---
Activ8rlives 4 Health+Wellness App| 08.2021| 4.10.0 series
Asthma +me App| 07.2022| 3.1.0 series
Active +me REMOTE App| 07.2022| 1.4.0 series

Installing an Activ8rlives’ App on Your Smartphone or Tablet

Note: Bluetooth 4.0 Enabled Devices are required to use the Activ8rlives medical devices.
Download one of our Apps from the App Store appropriate to your device. Search for Activ8rlives in the search bar of your App Store that is appropriate for your smart device (iOS or Android) or scan the corresponding QR code below and it will take you to the appropriate App Store for your device.

Activ8rlives4 Health+Wellness App (Free)
Apps-Activ8rlives4-Health-Wellness-App-Fig-10

Asthma+me App (Subscription)
Apps-Activ8rlives4-Health-Wellness-App-Fig-11
Apps-Activ8rlives4-Health-Wellness-App-Fig-09
Active+me REMOTE App (Subscription)

Apple devices running iOS 12+.
Android devices running 10+.

NOTE: Please adjust the screen lock function on your Smartphone or Tablet to be longer than 2 minutes to allow the Activ8rlives branded medical device time to sync with your device.
Short times of less than 2 minutes cause frequent loss of connectivity.

Our Apps Developed Around Six Pillars of Self-Care

Our Apps are based around the six pillars of successful self-care, evidence- based from a meta-review of 270 studies of supporting self-management of asthma in adults (Hilary Pinnock, et al. 2017). The six pillars for patient self-care include: a care plan, management of triggers, medication adherence, technology for measuring physiological signs, education and behaviour change techniques where there is active involvement of the participants in reducing unscheduled healthcare visits and admissions.

Apps-Activ8rlives4-Health-Wellness-App-Fig-13

Trouble Shooting

Help Menu?
Help can be found on nearly all pages of our Apps in the top right-hand corner.
Touch ? to expand the page and scroll down through the Help information, including viewing the Help Videos.
This symbol also provides helpful hints, when found within each of the Apps.

Will Not Connect via Bluetooth?
Requires Bluetooth Smart Ready devices (typically Bluetooth 4.0+), iOS 12+ and Android 10+.
If the Activ8rlives branded medical device will not connect to Bluetooth, first check that your Smartphone or Tablet is connected to the Internet and has Bluetooth turned on. Then touch the On/Off Button on the Activ8rlives medical device to wake it up.
If your device is still not seeing the Activ8rlives branded medical device, you may need to go back to Upload
Devices and the first screen, choose Change and the next screen you can choose between several Activ8rlives branded medical device models.
Lastly, try rebooting your Smartphone or Tablet and reopening the App.

On/Off Button Does Not Respond
Ensure that you depress the On/Off Button completely to turn on the Activ8rlives branded medical device to wake it up. Also the batteries may be depleted or incorrectly orientated in the battery department. Reinsert or replace the batteries or charge the device where is has an integrated battery and then try to pair again with one of the Activ8rlives’ Apps.

App Crashes
Close other Apps open on your Smartphone or Tablet, as these may be using too much memory to allow the Apps to function fully.

Help Videos in App, follow this ?

Website www.Activ8rlives.com
YouTube http://bit.ly/Activ8rlives

Still Need Help
We are here to help you 7-days-a-week, so please call us to help you set-up your device on UK 01480 352821 between 09:00-20:00.

Aseptika Limited

Suite 5, SiTwo {formerly LDH House) Parsons Green St Ives Cambridgeshire PE27 4AA

United Kingdom

tel: +44 {0)1480 352 821

email: support@aseptika.com

website: www.activ8rlives.com

**** © Copyright Aseptika 2022. All rights reserved.

ASL TF-002_010_017 MAN/IFU18 Activ8rlives Apps (V4.0)

Last updated 23.08.2022

References

Read User Manual Online (PDF format)

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