1.5.2 | Restrictions on use (limitations)

Correct use of incontinence products see also section 1.4.2
General note: The use of alea can only work with alea-compatible incontinence material (e.g. Seni Smart brand) or ICP equipped with the alea sensor strip.
Correct attachment: The functionality of alea as a digital care assistance system can only be guaranteed if the incontinence material used is correctly applied to the body of the care recipient. The respective manufacturer's instructions for the correct activation of the ICP must be observed.
Suitable suction strength: The ICP used must always correspond to the required suction strength depending on the severity of the incontinence in order to guarantee adequate care for the care recipient regardless of the use of the digital care assistance system.
Correct fit: The fit of the ICP must correspond to the physical requirements of the care recipient in order to ensure optimum care and to be able to use all the functions of alea according to the indication.
Change in good time: alea measures the fill level in the (alea-compatible) ICP. The ICP should be changed on the care recipient as soon as the skin of the person wearing the ICP comes into permanent contact with wetness caused by urine (usually when the maximum permitted amount has been reached, depending on the suction strength). In this regard, please always observe the manufacturer's instructions for use of the smart ICP.
Notes on restrictions when using alea
Faulty function due to moisture: The alea clip must always be dry. During use, especially when attaching to the ICP and when charging, the alea clip must be dry and free from moisture.
General restriction of use: alea provides support for care-related events such as incontinence detection, movement detection, fall detection and zone management. It is not a substitute for professional medical advice, diagnosis or treatment or general care.
Accuracy of the data: Although alea provides real-time monitoring and alerts, it should not be used as the sole basis for nursing and medical diagnoses or care and treatment plans.
Environmental conditions: alea is calibrated for use under certain ambient conditions (e.g. temperature, humidity), which are specified in these instructions for use. Use under these conditions may lead to inaccurate readings.
Device malfunctions: alea may not function as intended if it is located near other electronic devices or in areas with strong electromagnetic interference. It is therefore recommended to place the alea dock at least 30 cm away from other electronic devices.
Battery life: The operation of alea depends on the service life of the battery. Timely and regular recharging in the alea dock is required for optimum functionality of the alea clip.
Ensure network connection: The system hardware consisting of alea-Clip and alea-Dock require a stable Bluetooth or LTE connection for the functions to work optimally. Make sure that the alea clip is connected according to the LED status indicators (green) (see section 3.1).
Note material wear: The system hardware has a limited service life and may require spare parts or a complete replacement after a certain time or in the event of signs of wear, which can only be carried out by the manufacturer.
Responsibility of the user: Carers and those responsible for the system are responsible for regularly checking the functionality of alea and complying with the guidelines contained in the instructions for use to ensure optimum performance and safety.
Do not use alea at extreme temperatures (e.g. sauna)
No immersion of alea or external components in liquids especially absorbent articles
No application in the context of high voltage, z. e.g. internal or external application of electric shocks, e.g. with defibrillators
Notes on restrictions of use with regard to contraindications
Incontinence detection function should not be used for people without a diagnosis of incontinence according to ICD-10; the function should also not be used for monitoring constipation or diarrhoea or for collecting information for diagnosis and treatment.
Zone management function should not be used for care recipients who do not exhibit any risk behaviour, such as wandering or wandering tendencies (e.g. in the context of dementia).
Fall detection function should not be used for people in need of care who have no risk or tendency to fall.
Function of the movement monitoring should not be used for immobile patients with automated pressure mattresses.
General information on alea-compatible ICP: alea does not apply if there is no indication for the use of ICP in general or a corresponding ICP-related contraindication. Please consult the manufacturer of your alea-compatible ICP.

Correct use of incontinence products

Notes on restrictions when using alea

Faulty function due to moisture:

The alea clip must always be dry. During use, especially when attaching to the ICP and when charging, the alea clip must be dry and free from moisture.

General restriction of use:

alea provides support for care-related events such as incontinence detection, movement detection, fall detection and zone management. It is not a substitute for professional medical advice, diagnosis or treatment or general care.

Accuracy of the data:

Although alea provides real-time monitoring and alerts, it should not be used as the sole basis for nursing and medical diagnoses or care and treatment plans.

Environmental conditions:

alea is calibrated for use under certain ambient conditions (e.g. temperature, humidity), which are specified in these instructions for use. Use under these conditions may lead to inaccurate readings.

Device malfunctions:

alea may not function as intended if it is located near other electronic devices or in areas with strong electromagnetic interference. It is therefore recommended to place the alea dock at least 30 cm away from other electronic devices.

Battery life:

The operation of alea depends on the service life of the battery. Timely and regular recharging in the alea dock is required for optimum functionality of the alea clip.

Ensure network connection:

The system hardware consisting of alea-Clip and alea-Dock require a stable Bluetooth or LTE connection for the functions to work optimally.
Make sure that the alea clip is connected according to the LED status indicators (green) (see section 3.1).

Note material wear:

The system hardware has a limited service life and may require spare parts or a complete replacement after a certain time or in the event of signs of wear, which can only be carried out by the manufacturer.

Responsibility of the user:

Carers and those responsible for the system are responsible for regularly checking the functionality of alea and complying with the guidelines contained in the instructions for use to ensure optimum performance and safety.

Do not use alea at extreme temperatures

(e.g. sauna)

No immersion of alea or external components in liquids

especially absorbent articles

No application in the context of high voltage,

z. e.g. internal or external application of electric shocks, e.g. with defibrillators

Notes on restrictions of use with regard to contraindications

Incontinence detection function

should not be used for people without a diagnosis of incontinence according to ICD-10; the function should also not be used for monitoring constipation or diarrhoea or for collecting information for diagnosis and treatment.

Zone management function

should not be used for care recipients who do not exhibit any risk behaviour, such as wandering or wandering tendencies (e.g. in the context of dementia).

Fall detection function

should not be used for people in need of care who have no risk or tendency to fall.

Function of the movement monitoring

should not be used for immobile patients with automated pressure mattresses.

General information on alea-compatible ICP:

alea does not apply if there is no indication for the use of ICP in general or a corresponding ICP-related contraindication. Please consult the manufacturer of your alea-compatible ICP.