This guide documents the use of the PainChek® Infant App, which is an application running on mobile devices. The PainChek® Infant system assists healthcare workers and carers in assessing and monitoring the levels of pain in infants.
Intended Audience
This document is intended for use by any person using the PainChek® Infant App and applies to iOS version 2.0 or newer.
PainChek® Infant is intended to be used to assess and monitor pain in infants (i.e., 1 to 12 months old) by both trained health professionals and laypersons.
NB: See the "PainChek® Portal User Guide” for the instructions on how to use the corresponding PainChek® Portal website.
Glossary
Term | Description |
|---|---|
Infant | An Infant for the purposes of using the PainChek® Infant App, specifically refers to an infant the age of 1 month old from the date of birth to 12 months old on the infant’s 1st Birthday |
Admin | Admin accounts are only available for PainChek commercial licenses. Admins have access to all of the functionalities on the PainChek® Infant App |
Facility | A Facility is not limited to but generally refers to that of Hospitals, Medical Centres or other Heath Care Setting |
Layperson | Refers to a User of the PainChek® Infant App without a professional or medically trained healthcare background. For example Parents and Care Givers of infants unsupervised in a Healthcare setting |
User | The person utilising the PainChek® Infant App to assess infants. User accounts are only available for PainChek commercial licenses. |
License | A license provides access for an Organisation or Individual to the PainChek® Infants App and the PainChek® Portal. |
App, Infants App, PainChek App, PainChek Infants App | An iOS app that runs on a device that enables a user to perform pain assessments and other PainChek® Infant App functions |
PainChek Portal | A website that allows a user to perform administration functions of the PainChek Infant system |
Device | A supported Apple device running the PainChek® Infant App |
TGA | Therapeutic Goods Administration (https://www.tga.gov.au/tga-basics) |
PainChek® Infant | A system intended to be used to assess and monitor pain in infants who cannot verbalise their pain. The major components are the PainChek® Infant App and the PainChek® Portal |
PainChek® System | See PainChek® Infant |
App Store | The Apple app store used to download and install apps on iOS devices |
Compliance Information
PainChek® Infant 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 AUSTRALIA |
Authorised European Representative |
| Donawa Lifescience Consulting SRL Piazza Albania, 10 ITALY |
Authorised New Zealand Representative | ACRA Regulatory Services Limited 182 Teasdale Street, NEW ZEALAND | |
Device Identifier |
| PainChek Infant |
Year of manufacture |
| 2021 |
CE marking |
| |
Serial Number |  | Refer to the product version number displayed on the app login page |
