General Instructions for Using the App

The PainChek® App is a mobile application that is downloaded from the Apple App Store or the Google Play Store and it is generally used in much the same way as any other App.

Devices running the PainChek App should be used, charged, maintained and disposed of according to the standard instructions provided its manufacturer.

Intended Use

PainChek is a software system which is comprised of the following components:

a)    PainChek App

b)    PainChek Portal

PainChek is intended to be used to assess and monitor pain in people who cannot verbalise such as people with dementia or communication difficulties.

The PainChek App is a point-of-care application which uses a smart-device camera to capture a short video of a person’s face, this is then analysed in real-time using facial recognition technology to detect nine muscle movements - these are indicative of the presence of pain. This data is then combined with non-facial pain cues including movements, behaviours and vocalisations and inputted into the App to allow the automatic calculation of a pain severity score. The App has a graphing function which allows monitoring the person’s pain over time.  

The App also includes an (optional) self-reporting Numeric Rating Scale (NRS) feature for documenting the pain reported by people who are able to articulate and self-report the extent of their pain.

PainChek assessments should be conducted by a person that is trained on how to use the App.

Users

All users must thoroughly read and comprehend this user manual.

If any aspect of this user guide is unclear or you have any questions about the use or suitability of the App, seek assistance from the support team (via support.painchek.com) before using the application.

Supported Devices

Apple Devices

PainChek is designed to run on Apple devices meeting these minimum requirements:

• Apple A9 SoC (Apple A10 SoC recommended)

• 2GB RAM (3GB Recommended)

• 5GB of available storage (10GB recommended)

• 1.2MP selfie/front camera (5MP recommended)

• 5MP main/rear camera (8MP recommended)

• Minimum screen resolution (width x height) of 750 x 1134 pixels (1080 x 1920 recommended)

• Minimum diagonal screen size of 4.7 inches (5.4 inches recommended)

• A supported version of iOS/iPadOS (see below)

 

PainChek has been verified on these Apple devices:

• iPhone models: 6S, 6S+, 7, 7+, 8, 8+, X, XR, XS, XS Max, 11, 11 Pro, 11 Pro Max, 12
• iPad (5th generation), iPad (6th generation)
• iPad Mini (5th generation)
• iPad Air (3rd generation, iPad Air (4th generation)
• iPad Air 2
• iPad Pro: 10.5" and 12.9" (2nd Generation)

PainChek should work on devices that are not listed above, provided that they meet the minimum requirements for Apple devices. Please contact support@painchek.com if you plan to run PainChek on a device that is not listed above and we'll confirm the suitability of your chosen device.

iOS/iPadOS versions

Apple devices must be running the latest publicly released version of iOS or iPadOS, or one of the two prior versions. At the time of writing, the current iOS/iPadOS version is 14, meaning PainChek is currently supported on iOS versions 12, 13 and 14.

Android Devices

PainChek is designed to run on devices meeting these minimum requirements:

• Quad-core 1.3GHz processor (1.5GHz recommended)
• 2GB RAM (3GB Recommended)
• 5GB of available storage (10GB recommended)
• 2MP selfie/front camera (5MP recommended)
• 8MP main/rear camera
• Minimum screen resolution (width x height) of 768 x 1024 pixels (1080 x 1920 recommended)
• Minimum diagonal screen size of 4.5 inches (5 inches recommended)
• A supported version of Android (see below)

PainChek has been verified on these Android devices:

Android Versions

Android devices must be running the latest publicly released version of Android, or one of the three prior versions.  At the time of writing, the current Android version was 10, meaning PainChek is currently supported on versions 7, 8, 9 and 10.

Patches and Updates

PainChek recommends that you keep your device up to date with the latest available firmware and operating system that are provided by your manufacture.

License Settings

It's possible for a PainChek administrator to change settings that impact the labelling and available features of the PainChek app.

These PainChek features can be turned on or off:

• Medications - the ability to record medication and pain relief administered to Residents)
• Quick Sign In - this allows you to sign in to the app using a 4 digit PIN instead of a username/password
• Site Segregation - restrict which facilities users have access to
• Resident Sharing  - share a resident with a third party

When features are switched off, the app will grey out or remove the options that are not enabled.

PainChek administrators can also change the following labels:

• Resident - used to label the person being assessed:  "resident", "patient", "people", "consumer" or "client"can be selected
• Site - used to label a location: "site",  "facility", "location" or "institution" can be selected

Appropriate menu items, descriptions and buttons will reflect the selected labels.

Contact PainChek Support by emailing support@painchek.com to make changes.

Operating Environment

The App is designed to be used indoors, in areas with good lighting. As the PainChek App relies on using the camera of the device, good lighting (such as you would find in an office) is essential to ensure consistent results.

Internet Connectivity

The App relies on internet connectivity in order to synchronise the data collected on the App with the data stored in the PainChek cloud database. The App can use WiFi and/or mobile (cellular) data connections. Please follow the standard instructions from the manufacturer or from your organisation in order to set-up internet connectivity on your device.

You do not need to be continuously connected to the internet in order to use the App, but you do when you are:

• Downloading the App from the App Store
• Setting up the App for the first time
• Logging onto a device using a username and password (NB: quick sign-in can be used offline)
• Synchronising data between your device and the PainChek cloud database

Updating the PainChek App

It is recommended that the PainChek App up is kept up-to-date. If a new version is released onto the Apple App Store or Google Play Store, your device will notify you automatically. You should download the new version as soon as is practical.

Warnings and Cautions

Automated and Manual Facial Assessments:

The App requires that residents be reasonably still and co-operative in order to record a video of sufficient duration to allow for an automated facial assessment.

It might not be possible to perform an automated facial assessment due to:

• The residents face not being clearly visible
• The resident moving too much
• Lighting being of poor quality
• The resident preferring that they are not recorded

 In any of these circumstances, a manual assessment should instead be performed.