1.3.1 | Incontinence monitoring

General information

The alea incontinence monitoring function supports incontinence management by providing real-time digital data that informs carers about the fill level or status of the ICP attached to a care recipient. Urine detection with fill level indicator is available.

Note regarding updates

This function currently relates to urine detection and fill level. Should new functions be added, we will inform users and customers in advance via an update and add the relevant information to the application notes in the instruction manual.

Objectives of the function

• Ideally, incontinence-related complications such as skin irritation, skin infections, bedsores and urinary tract infections should be prevented, as should bacterial growth, dermatitis, eczema and other health problems.

• When used by the person responsible for care, continuous monitoring of all relevant events during care should lead to the ideal time for changing being determined. Micturition logs are automatically created and transferred to the care documentation in an appropriate form.

• A secondary goal that saves time and materials is to reduce and prevent leaks.

• In terms of care organisation, the aim is to optimise changing intervals and changing routines in general in order to use time and materials more efficiently.

• The goal for care recipients is to have no or fewer symptoms and to suffer from fewer secondary diseases.

Indication

The prerequisite for using alea at all for certain care recipients is a diagnosis of incontinence, i.e. persons with mild, moderate and severe incontinence (stress incontinence, urge incontinence (motor and/or sensory), mixed urinary incontinence, reflex incontinence, overflow incontinence, extraurethral forms of urinary incontinence, faecal incontinence.

Information on possible risks of use

Digital incontinence management should be viewed as a digital care assistance system and does not replace existing quality and action standards in care.

When used and attached correctly, the alea hardware does not come into direct contact with the care recipient or their skin. Private and professional carers should nevertheless ensure that the clip is attached to the side of the ICP that is not the lying side of the home or inpatient care bed.

Additional information regarding medical application parameters for incontinence monitoring

Intended medical use of the incontinence monitoring function:

Digital incontinence monitoring that provides caregivers with real-time information about the fill level or status of an absorbent product (e.g. incontinence pad as a medical device) worn by an adult care recipient with urinary and/or faecal incontinence,

• in order to minimise and prevent incontinence-related comorbidities such as skin irritation, skin infections, urinary tract infections (supporting the medical purpose),

• to help reduce bacterial growth, dermatitis, eczema and other damage,

• to further ensure the medical use of an absorbent article (adult ICP as a medical device) to further ensure

• optimise and support ICP change intervals,

• avoid long periods of time with full ICPs on the body, reduce the risk of skin damage from prolonged contact with urine or faeces, and

• prevent leakage from an ICP.

Indications for use

Individuals with mild, moderate and severe incontinence (stress incontinence, urge incontinence (motor and/or urge incontinence (motor and/or sensory), mixed urinary incontinence, reflex incontinence, overflow incontinence, extraurethral forms of urinary incontinence, faecal incontinence.

Medical condition that needs to be diagnosed, treated or monitored

Need for care (ICD-10 Z.74.-)

Urinary or faecal incontinence (ICD-10 F45.9, F98.0, N31, N39.3, N39.4, R32.0, R15, F98.0, F98.1)

Duration of use

The digital assistance system for digital incontinence monitoring can be used in the short, medium and long term.

Contraindications

There are currently no known contraindications for this medical device. In order to continuously validate this status, further studies, investigations and observations are being integrated into product development to identify possible contraindications.