Instructions for use: Champions of the Shengha Pro app

 It is designed for use by young people ('users') aged 9-18 years who want to / can benefit from learning emotional self-regulation skills to better deal with stress, anxiety and frustration.

Champions of the Shengha is based on good existing evidence about the effectiveness of using regulated diaphragmatic breathing as a means of dealing with stress and pressure. It trains users in diaphragmatic breathing to teach them the skills they need to manage their emotions effectively, in an engaging, age-appropriate, culturally relevant way.

Diaphragmatic breathing has been promoted in connection with stress reduction by institutions such as Mind, Bupa and the NHS. These recommendations are supported by substantial evidence that regulating the physical movement and speed of the breath can directly reduce physical stress reactions in the body. Building emotional responsiveness into the game trains players in emotional control, improving their capacity to deal with stress, anxiety and frustration.

When connected to the internet, the app will send usage data to the secure VitaMind Hub which is only accessed by the professional person who is responsible for providing game access to the user.

Software Installation, Upgrade and Configuration

Internet is needed to use the app. This app works on mobile devices on both Android and iOS platforms.

The app must be downloaded on a mobile device that the young person will have access to from the Apple store or the Google Play store. 

Once downloaded, users will need to input the game key provided to them by a professional - this will unlock the game.

New version updates will get installed (automatically or manually depending on device settings chosen by the user).

Step by Step Instructions

Once the user (young person) has downloaded the app and has received a game pack with a heart rate sensor provided by BFB Labs, the user will need to unlock the app with the game key provided to them.

Bluetooth must be turned on the user’s mobile device.

Internet is needed to use the app.

USERS MUST NOT USE THE APP WITH ANY HEART RATE SENSORS NOT SUPPLIED BY BFB LABS.

Troubleshooting

What if I forget my user key?

• If you forget your user key contact your Game Pack distributor or BfB Labs at support@bfb-labs.com 

What if the game stops working?

• If you have any technical issues with the game, contact BfB Labs at support@bfb-labs.com 

FINDING EXTRA SUPPORT

• If you are concerned about any aspect of the user’s mental health, then discuss this with your GP.

Technical Specifications

The product Champions of the Shengha is a piece of software in the form of an application that works on both Android and iOS platforms. It includes a piece of hardware - this app must be used alongside a tested ‘heart rate sensor’ provided only by BFB Labs in the official game pack.

Regulatory Information

Champions of the Shengha is software is a medical device Class 1 (as per the MHRA guidelines) and is compliant with the following regulations and standards:

• Medical Devices Directive 93/42/EEC (MDD)

• Medical Devices Regulation (EU) 2017/745 (MDR)

• General Data Protection Regulation (EU) 2016/679 (GDPR)

• Applicable national data protection and health legislation 

• ISO 13485:2016 for medical device quality management (part application)

• ISO 14971:2012 for medical device risk management

• ISO 15233-1:2016 for medical device symbols

• IEC 62304:2006 + Amd 1:2015 for medical device software development lifecycle

• Any configuration of the software is carried out pursuant to the NHS Health IT Safety Standard DCB0129.

Previous Labels

May 2020 - May 2024