Note
Statement on Fictitious Characters
The faces and names used throughout this User Guide are entirely fictitious. They are not real Residents, and any resemblance to actual individuals, living or deceased, is purely coincidental.
Disclaimer
The individuals depicted in this User Guide are fictional characters created solely for illustrative purposes. The use of fictitious names and images is intended to demonstrate the product features and functionality without compromising the privacy of any real Resident. No personal or identifiable Resident data has been used in this User Guide.
Statement on Non-Clinical, Informational Use only
The PainChek® Portal is intended solely for administrative and informational purposes. The PainChek® Portal functions as a Medical Device Data System (MDDS) and does not provide any clinical interpretation, diagnostic information, treatment guidance, or patient monitoring functions.
The features within the Portal including follow-up assessment reminders, facility-level usage summaries, and trends of historical PainChek® pain assessment results are designed only to support workflow efficiency, record-keeping, and operational oversight.
All displayed graphs, trends, dashboards, reminder alerts, or analytic views are informational representations of past assessment data. They are not intended to inform clinical decisions, evaluate patient status, determine pain severity, or guide clinical management.
Clinical judgment must be made independently of the Portal using validated clinical tools, direct patient assessment, and established clinical protocols.
Any third-party system integrated with PainChek® receives only the same non-clinical, informational data, and integration does not extend or modify the intended use and/or indications for use of the PainChek® device.
PainChek® Adult is intended to be used by medical doctors, registered nurses, licensed practical and vocational nurses, clinical psychologists, physical therapists and occupational therapists to assess pain in non-verbal people (also known as Residents) with moderate to severe dementia in nursing homes
PainChek® Adult is a Pain Assessment software system which is comprised of the following components:
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PainChek® App
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PainChek® Portal
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PainChek® Application Programming Interface (API)
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PainChek® Database
The PainChek® App is a mobile application that uses facial recognition and analysis technology to detect facial features indicative of the presence of pain and then combines these data with non-facial pain features inputted by the User through a series of digital checklists to confirm the presence and intensity of pain. The PainChek® App 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.
The PainChek® Portal is a secure website that allows you to manage your Resident data, PainChek® License, Facilities, Users, installations and edit your PainChek® profile settings. See the "PainChek® Portal User Guide” for the instructions on how to use the PainChek® Portal.
The PainChek® API provides the means for the PainChek® App and PainChek® Portal to access the PainChek® database in a secure, authenticated and controlled manner.
The PainChek® Database stores all of the PainChek® data (e.g. Users, Residents and Assessment details).
PainChek® is an observational pain assessment tool used to assist in the assessment of pain in people who cannot verbalize their pain.
PainChek® Adult is an observational pain assessment software application used to assist healthcare professionals in the assessment of pain in non-verbal Patients who have been diagnosed with moderate to severe dementia and who are living in nursing homes. Specifically, PainChek® Adult is intended to be used by trained medical doctors, nurses, licensed practical and vocational nurses, certified nursing assistants, clinical psychologists, physical therapists and occupational therapists to assess pain in the indicated population.
Note
PainChek® Adult is an observational pain assessment tool intended to assist trained healthcare professionals in assessing pain in non-verbal patients. As such, PainChek® Adult is not a standalone diagnostic tool and its results should be interpreted by qualified healthcare professionals within the context of their broader clinical knowledge and examination of the Patient.
PainChek® is not a substitute for the clinical judgement or assessment by a qualified healthcare professional, who may decide that PainChek® is not appropriate for some Patients.
PainChek® is indicated for use to assess pain in non-verbal Patients with moderate-to-severe dementia in nursing homes.
The automated (video) facial analysis should not be used in patients under the following conditions:
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Subject is unable to partially or completely exhibit any facial expression (e.g., as a result of a facial palsy, facial injuries, stroke, Parkinson’s disease and other pathologies including neuromuscular degenerative diseases such as multiple sclerosis and muscular dystrophy).
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Subject with a significant mental illness such as severe depression, anxiety disorders or schizophrenia, which could lead to altered facial expressions due to the illness or medication.
PainChek® Adult should only be used in subjects who are awake and conscious as were the subjects in the clinical study demonstrating its validity.
The PainChek® Portal is a cloud-hosted Web Application. It can be accessed via the following link:
North American URL: https://prod.na.painchek.com/cloud-portal/
Access is globally available 24/7 to any person with an internet connection and a PainChek® login account.