The “AssistMe Digital Assistance System” alea consists of medical device software and the hardware accessories listed in this Declaration of Conformity.
The intended medical purpose of alea is to
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support the prevention of incontinence related diseases and bed sores related diseases
For this purpose, the alea software
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monitors, calculates and displays the fill status of a compatible absorbent incontinence product
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monitors and displays the care recipient’s body position and the duration of the respective position
The alea software provides visual status indications and push notifications when defined fill-status criteria are met and provides reminders when repositioning intervals configured by the caregiver are reached.
The information, visual status indications, notifications and reminders provided by alea are intended to support caregivers in organizing, planning and prioritizing continence care and repositioning activities.
alea does not assess an individual risk of disease or injury and does not diagnose medical conditions.
The alea Clip and alea Dock are accessories to the alea medical device software. They transmit data to the alea software and do not independently evaluate data or make medical or care-related decisions.
The system is intended to be used in homecare, outpatient care, and institutional care.