The use of alea is permitted only within its intended purpose and the limitations of use defined in these Instructions for Use.
Correct Use of Compatible Continence Products
alea may only be used with approved compatible absorbent continence products or with sensor strips correctly applied to approved product lines in accordance with these Instructions for Use.
The use of non-approved product combinations or incorrect application may impair system performance and result in incorrect status indicators or notifications.
Technical Requirements
The proper functioning of the system requires that:
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only approved system components are used,
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all components are correctly installed and operational,
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the required network and power supply are available, and
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mobile devices, workstations and web browsers meet the approved system requirements.
Limitations of System Performance
The functionality of the system may be limited, in particular:
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when non-approved product combinations are used,
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when sensor strips are applied incorrectly,
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when system components are damaged or not operational,
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when network or power supply is limited,
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when environmental conditions are outside the specified operating conditions, or
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when unsupported operating systems or web browsers are used.
Medical Limitations
alea:
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does not establish diagnoses,
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does not make therapeutic decisions,
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does not assess individual risks of disease or injury,
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does not assess the risk of pressure injuries,
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does not detect or confirm fall events,
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does not provide an alarm or emergency function, and
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does not perform positioning or GPS location tracking.
Function-Specific Limitations
Individual functions may only be used within their intended purpose.
This applies in particular to:
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Continence Monitoring exclusively for displaying the fill level of compatible absorbent continence products.
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Repositioning Monitoring exclusively for displaying body position, the duration of the respective position and providing reminders for configured repositioning intervals.
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Fall Suspicion Notification exclusively as a notification of unusual abrupt movements or changes in body position.
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Area Exit Notification exclusively as a notification that a predefined area has been left.
General Information
The information, status indicators, notifications and reminders provided by alea must always be assessed within the overall care context.
The professional assessment, decision-making and provision of care always remain the responsibility of the responsible care professionals.