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

This guide documents the use of the PainChek Portal.

Intended Audience

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

Glossary

Term	Description
Resident	For the purpose of this user guide and to avoid any ambiguity, the term resident will be applied for anyone on which the app may be used. The term resident encompasses anyone for whom a pain assessment is being carried out. Within an installation of the PainChek app, users may see a different terminology.
Patient	See Resident
Client	See Resident
Consumer	See Resident
Facility	Facilities include hospitals, aged care facilities, primary care centres (e.g. GP practices or outpatient clinics).
App	An application running on a mobile device that enables a user to perform pain assessments and other PainChek functions
Portal	A website that allows a user to perform administration functions of the PainChek system
Device	A supported Apple device running the PainChek app
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 Portal.
License Admin	The user owning the PainChek commercial license. There is only one Super Admin account per PainChek license. The Super Admin can manage licenses, institutions, users and installations. In addition, the Super Admin can view and export patient data or create Admin or User accounts for other team members.
Admin	Admin accounts on commercial licenses can manage institutions, users and installations but cannot modify license information.
User	The person utilising the PainChek app with limited access to the PainChek Portal.
Commercial License	Type of license giving access to all of the functionalities on the Mobile App and the 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 Portal. It excludes creating additional users.
TGA	Therapeutic Goods Administration (https://www.tga.gov.au/tga-basics)

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		Donawa Lifescience Consulting SRL Piazza Albania, 10 00153 Rome Italy
Device Identifier		PainChek Adult
Year of manufacture		2017
CE marking
Serial Number		Refer to the product version number displayed on the Portal home page