The PainChek® Infant 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® Infant App should be used, charged, maintained and disposed of according to the standard instructions provided their manufacturer.
Intended Use
PainChek® is a software system which is comprised of the following components:
a) PainChek® Infant App
b) PainChek® Portal
PainChek Infant is intended to be used to assess and monitor procedural pain in infants (i.e., 1 to 12 months old) by both trained health professionals and lay persons.file settings.
Indications for Use
Procedural pain assessment where procedural pain is defined as short-lived acute pain associated with medical investigations and treatments conducted for the purpose of health care.
Procedures range from minor procedures such as intravenous cannulation, venepuncture, finger and heel pricks, immunisations, suturing and dressing changes to more invasive procedures, such as lumbar punctures, fracture reductions and bone marrow biopsies; and may occur in a variety of settings, including but not limited to, hospitals, day surgery centres, ambulatory care clinics, general practice, dental clinics and including in the home of infants and their primary caregiver.
PainChek® Infant is not intended to specify or recommend any treatment or clinical interventions. The user, as a health professional or as a layperson under the advice or prescription from a health professional, makes any clinical decisions.
Contraindications
PainChek® Infant is advised to be used with caution on infants born with craniofacial birth defects, including but not limited to the below, considering that each will have varying degrees of clinical presentation:
Cleft lip and cleft palate
Facial palsy
Vascular birthmarks and haemangiomas
Hairy nevus
Product Description
The PainChek® Infant App has an intelligent pain assessment feature which provides a point-of-care application that uses a smart-device camera to capture images of the infant’s face over a period of time. These images are then analysed in real-time using facial recognition and analysis technology to detect muscle movements which are indicative of the presence of pain, resulting in an automatic calculation of a pain score. The PainChek® Infant App has a graphing function which allows monitoring the infant’s pain over time.
The PainChek® Portal is a secure website that allows users to manage infant data, PainChek license, facilities, users, installations and customise PainChek® profile settings.
Software
The PainChek® Infant App is a software application that assists trained healthcare professionals and lay persons in assessing the levels of pain in infants. The PainChek® Infant App uses automated, real-time facial analysis which can detect pain related facial micro-expressions to indicate pain intensity.
The software can be downloaded and supported by most iOS mobile devices, including smartphones and tablets.
Hardware
PainChek Ltd may supply hardware devices to a user – for example a tablet that is capable of running the PainChek® Infant App. These are supplied to the user in the original manufacturers packaging and the PainChek® Infant App (nor any other third-party software for that matter) is not installed by PainChek Ltd. PainChek Ltd typically arranges for direct delivery of the devices from a distributor to the user. It is the responsibility of the user to manage the devices according to the hardware manufactures’ instructions and to install the PainChek® Infant App as per the instructions provided by PainChek Ltd.
Users
All users must thoroughly read and comprehend this user guide.
If any aspect of this user guide is unclear or you have any questions about the use or suitability of the PainChek® Infant App, seek assistance from the support team (via support.painchek.com) before using the application.
Supported Devices
iOS Devices
The PainChek® Infant App is supported on all devices that can run iOS 14 or later. Apple publishes a list of supported devices with each version of iOS/iPadOS - for version 14, the current version at the time of writing, see the list here).
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 can validate the device to determine its suitability.
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 was 14, meaning the PainChek® Infant App is currently supported on iOS versions 12, 13 and 14.
Patches and Updates
PainChek Ltd. recommends that you keep your device up to date with the latest available firmware and operating system that are provided by your manufacturer.
License Settings
It's possible for a PainChek® administrator to change settings that impact the labelling and available features of the PainChek® Infant App.
These PainChek® features can be turned on or off:
Quick Sign In - this allows you to sign in to the PainChek® Infant App using a 4 digit PIN instead of a username/password
Site Segregation - restrict which facilities users have access to
When features are switched off, the PainChek® Infant App will grey out or remove the options that are not enabled.
PainChek® administrators can also change the following labels:
Infant - used to label the individual being assessed: "infant", "patient" 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 PainChek® Infant App is designed to be used indoors, in areas with good lighting. As the PainChek® Infant App relies on using the camera of the device, sufficient lighting is essential to ensure correct assessment results .
Internet Connectivity
The PainChek® Infant 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 PainChek® Infant 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 PainChek® , but you do when you are:
Downloading the PainChek® Infant App from the Apple App Store
Setting up the PainChek® Infant 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® Infant App up is kept up-to-date. If a new version is released onto the Apple App Store, your device will notify you automatically. You should download the new version as soon as is practical.
Warnings and Cautions
Automated Facial Assessments
The PainChek® Infant App requires the child's face be unobstructed and the child to be as still as practical in order to capture 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 child's face not being clearly visible
The child is moving too much
Suboptimal lighting conditions
In these instances attempt to remediate lighting conditions (increase lighting if dull, remove excessive glaze, use a dark background for contrast for babies with pale skin, minimise or remove environmental stimulation or console the infant to minimise head movement.