Intended use
The "AssistMe Digital Assistance System" alea consists of medical device software and the associated hardware accessories, which are intended for both medical and non-medical purposes.
The intended medical purpose of alea is to support the prevention of illness and injury in patients and to improve work processes in the health and care sector.
In this care area
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the software calculates and visualises the fill level of the incontinence product
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calculates and visualises the position of the body by determining the patient's body position
The software is therefore not intended to make diagnoses or therapeutic decisions.
It also includes support for non-medical use cases in care, such as fall detection and zone management, which improve the safety and efficiency of care processes.
Functions of the individual accessories/components
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The IKP sensor strip and the clip work together to provide data for continuous monitoring of the nappy fill level (fill level).
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The clip fulfils its function by recording and transmitting movement data and information on the fill level of the nappy.
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The clip, dock, router and software together form a technical system that ensures seamless management, data capture, transfer, processing and communication via the user interface.
Medical purposes
Digital incontinence management (= prevention of diseases caused by urine coming into contact with the skin):
By optimising nappy change intervals based on real-time fill level data, alea helps to prevent infections (e.g. urinary tract infections), dermatitis, eczema and other moisture-related skin damage, including conditions caused by prolonged exposure to moisture such as pressure ulcers (bedsores) and other complications of incontinence.
Help with repositioning (= prevention of diseases caused by lack of exercise):
By tracking movement and position, the technical system supports carers in preventing pressure ulcers by recommending repositioning in good time.
Non-medical purposes
Zone management:
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Monitoring of zones defined by carers using movement and position data to ensure that patients remain in safe areas.
Fall detection:
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Analysis of changes in movement and position to alert carers to possible falls.
Prerequisite for use: Declaration of consent
Before integrating and using alea in your home, make sure that you have obtained the consent of each care recipient or the responsible carer (or carers if applicable). It is also not recommended or advisable to use alea without the consent of the relevant carers.
Exclusions
A person in need of care in the intended user group suffers from incontinence, but the person in need of care or the professional or private carers or caregivers have not given their consent to use alea.
Intended main user group (care recipients)
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Age: Adults (from 18 years)
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Health status: See information in the chapter 1.3 ff.
Intended users or user groups
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Carers within a professional medical, care environment or care setting (e.g. in residential long-term care or hospital).
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Carers in a private or domestic context, generally lay carers and those responsible for care such as family members, friends, neighbours, etc.
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Care recipients in the sense of care recipients or people in need of care in all care settings (home, private environment, assisted living or other care settings such as inpatient long-term care, clinics or social facilities with a care focus).
User needs
Simple (= usable), safe and effective device (system) that supports your medical or care workflows and independent living.