Introduction

The PainChek Mobile Application assists healthcare workers and carers in assessing the levels of pain in non-communicative patients with cognitive impairment, especially those with dementia.

PainChek uses facial recognition technology to detect facial cues indicative of the presence of pain and then combines these with non-facial pain cues to assess a pain severity score.

This guide documents the use of the PainChek App.

Intended Audience

This document is intended for use by any person using the PainChek Mobile app.

NB: See the "WAP User Guide” for the instructions on how to use the corresponding Web Administration Portal web site.

Glossary

Term

Description

Patient

For the purpose of this user guide and to avoid any ambiguity, the term patient will be applied for anyone on which the app may be used. The term patient encompasses residents and clients or anyone for whom a pain assessment is being carried out. Within an installation of the PainChek app users can select what terminology they would like to use, patient, resident or client.

Resident

See Patient

Client

See Patient

Admin

Admin accounts are only available for PainChek commercial licenses. Admins have access to all of the functionalities on the Mobile App.

Institution

Institutions include hospitals, aged care facilities, primary care centres (e.g. GP practices or outpatient clinics).

User

The person utilising the PainChek Mobile App to assess patients, residents or clients. User accounts are only available for PainChek commercial licenses. Users have access to all of the functionalities on the Mobile App

Commercial License

Type of license giving access to all of the functionalities on the Mobile App and the Web Admin Portal including creating users with specific roles.

Private License

Type of license giving access to all of the functionalities on the Mobile App with restricted uses of the Web Admin Portal. It excludes creating additional users.

App

An iOS app that runs on a device that enables a user to perform pain assessments and other PainChek Adult functions

Web Admin Portal

A website that allows a user to perform administration functions of the PainChek system

WAP

See Web Admin Portal

Device

A supported Apple device running the PainChek app

TGA

Therapeutic Goods Administration (https://www.tga.gov.au/tga-basics)

PainChek

Means PainChek Adult

PainChek Adult

A system intended to be used to assess and monitor pain in people who cannot verbalise such as people with dementia or communication difficulties. The major components are the App and the Web Admin Portal

App Store

The Apple app store used to download and install apps on iOS devices

Manual Facial Assessment

An assessment of a patient where the user evaluates if the 9 items in the “facial domain” are present or absent without the use of the in-app facial recognition

Automated Facial Assessment

Assessment of a patient where the PainChek app evaluates if the 9 items in the “facial domain” are present or absent using the in-app facial recognition

Domain

One of 6 areas that the PainChek app assesses for a patient – the 6 domains are being: “The Face”, “The Voice”, “The Movement”, “The Behaviour”, “The Activity”, “The Body”

Compliance Information

PainChek Adult is a certified Class I medical device, with CE Marking and TGA Australian Register of Therapeutic Goods (ARTG) inclusion 

Item

Symbol

Details

Manufacturer and Australian Sponsor

PainChek Ltd
Suite 401, 35 Lime Street

Sydney NSW 2000,

AUSTRALIA

Authorised European Representative

Priory Analysts Ltd

The Pinnacle

160 Midsummer Boulevard

Milton Keynes

MK9 1FF

United Kingdom

Device Identifier

PainChek Adult

Year of manufacture

2017

CE marking


Serial Number

Refer to the product version number displayed on the iOS app login page