1.1.5 | Intended use

Intended Purpose

Software

Within the care context, the software calculates and visualizes:

• The saturation level or status of a compatible incontinence product

• Body position by determining the respective repositioning position

The software is not intended to provide diagnoses or make therapeutic decisions.

alea Clip

• The alea Clip is an accessory to the alea medical device software.

• It is attached to a compatible incontinence product and is intended to receive signals from a sensor strip integrated into the incontinence product and securely transmit these signals to the alea software for analysis and display.

alea Dock

• The alea Dock is an accessory to the alea medical device software.

• It is intended to receive and forward technical data from alea Clips to the alea backend infrastructure and to charge the alea Clips.

• The alea Dock does not perform any medical evaluation of data.

alea Router

• The alea Router is a network component of the alea system.

• It is exclusively intended to extend and stabilize wireless data transmission between alea Clips, alea Docks, and the alea backend infrastructure within a care facility.

• The alea Router has no direct function in the active use of the medical device and is not intended for the diagnosis, monitoring, or treatment of care recipients.

• It is therefore neither classified as a medical device nor as an accessory to a medical device.

Medical Purposes

Digital Incontinence Management

• By providing real-time information on the saturation level or status of a compatible incontinence product, alea supports timely and needs-based product changes.

• This can help prevent unnecessarily prolonged use of saturated products, reduce moisture-associated skin exposure resulting from prolonged contact with urine, and decrease leakage events.

Repositioning Support

• By providing information on body position and relevant position changes, alea supports repositioning-related care processes.

• This includes, in particular, the detection of relevant position changes and the elapsed time since the last relevant repositioning event in order to support timely repositioning decisions and reduce prolonged pressure on vulnerable areas of the body.

Non-Medical Purposes

Area Management

• Supports awareness of whether care recipients are located within areas defined by care staff based on movement- and position-related data.

Suspected Fall Notification

• Analysis of movement and position changes to provide notifications of abrupt position changes.

• This function is not intended for fall diagnosis, emergency detection, or as the sole basis for safety-critical decisions.

Additional Information

Intended Users and User Groups

• Professional care staff in residential, outpatient, and clinical care settings

• Family caregivers in home care environments

• Care managers and supervisory personnel

• Caregivers within the intended care context

Care recipients are the individuals receiving care within the respective setting and intended use environment.

Target Population and Care Context

The system is intended for supportive use in home care and home-like care environments.

The application is intended for adult care recipients with urinary incontinence who use absorbent incontinence products as part of their care.

The notifications, status information, and alerts provided by the system are intended solely to support care and care-related workflows, particularly for the assessment of situations related to the incontinence product in use and selected repositioning-related or safety-related events.

The system is intended for use by:

• Professional care staff

• Family caregivers

• Other authorized caregivers

The information provided by the system supports the organization and prioritization of care activities but does not replace individual professional judgment, medical diagnosis, therapeutic decision-making, or the professional assessment of care personnel.

Exclusions

alea is not intended for use:

• Outside defined care and care delivery contexts

• With non-approved incontinence products or accessories

• As a medical emergency, alarm, or diagnostic system

• As the sole basis for care-related or medical decisions

• Outside the user groups described in these Instructions for Use

User Needs

alea supports safe, transparent, and needs-based care processes through:

• Prioritized notifications

• Status-based overviews

• Support for incontinence care

• Support for repositioning-related care processes

• Improved planning of care interventions

Social Care Classification of the Care Context (§ 40 SGB XI)

In addition to the medical and care-organizational intended purpose described in these Instructions for Use, the alea system may contribute to facilitating care within the meaning of Section 40 SGB XI in the intended care environment.

This applies in particular through support of needs-based and transparent care processes by means of:

• Prioritized and needs-based monitoring notifications instead of routine checks

• Improved planning of care activities through status displays and notifications

• Reduction of unnecessary checks, walking distances, and monitoring routines in home care and residential care settings

• Structured handovers and improved visibility of care-relevant status information

• Support for informal and professional caregivers during recurring care activities

This classification does not constitute an independent medical intended purpose but describes the additional care-related benefits provided within the intended care environment.