1.5.1 | Application and safety instructions

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Before installation and use by intended users, all information provided in this section must be read and understood. As part of initial and supplementary training sessions, AssistMe will place particular emphasis on the importance of the safety information provided herein. In addition, FAQs, videos, and tutorials based on these Instructions for Use are made available to all users in digital and personal formats and are accessible through this Helpdesk.

General Safety Information

Read these Instructions for Use completely before installation and operation.

User training is conducted according to the requirements of the respective organization. Additional training materials and support information are available from the manufacturer if required.

Pay particular attention to the following general safety rules:

  • Check after configuration changes:
    After changes in the alea Cockpit, alea App, or hardware components, verify the correct assignment and functionality of the affected components (e.g., status displays and information shown in the App). Inform affected users of relevant changes.

  • Observe status indicators:
    Regularly check the status indicators of the respective components (e.g., LED indicators). In the event of deviations or error indications, follow the troubleshooting instructions.

  • Updates:
    Software updates may be performed automatically. Ensure that devices are connected to a power source and have an active data connection. During updates, information display may be temporarily limited.

  • Moisture:
    Do not expose alea hardware to excessive moisture. Do not use in washing systems, dishwashers, or outside the approved cleaning and disinfection procedures.

  • Sunlight / Heat:
    Protect the system from direct sunlight and heat sources.

  • Accessories / Components:
    Use only approved or compatible components and accessories specified in these Instructions for Use. Do not modify hardware components.

  • Repairs:
    Do not open or repair devices yourself. In the event of a defect, contact the manufacturer or an authorized service provider.

  • Limitations of Use:
    The system supports care processes but does not replace professional care assessment. Do not use the system as the sole basis for decisions in situations where delays in care could result in harm.

  • Electromagnetic Compatibility (EMC):
    The product complies with applicable electromagnetic compatibility requirements and standards.

Technical Safety Information

Power Supply and Cables

  • Use only undamaged and approved power adapters and cables.

  • The alea Dock may only be operated using the designated power adapter.

  • Cables must not be crushed, pinched, or routed over sharp edges.

  • Whenever possible, use fixed wall outlets instead of portable power strips.

  • Damaged cables may only be replaced with authorized replacement parts.

Hardware Operation

  • Never open or repair hardware components yourself.

  • The alea Dock and alea Clip contain sensitive electronic components.

  • Operation is permitted only with original components and approved accessories.

  • Where possible, maintain distance from other electronic devices to minimize interference.

Installation and Environmental Conditions

  • The alea Dock is intended for indoor use only.

  • Protect from rain, frost, direct sunlight, and heat sources.

  • Do not clean in a dishwasher.

  • Disconnect the power supply before cleaning.

  • Clean only with a slightly damp cloth and avoid prolonged exposure to splashing water.

MRI / CT

  • The alea Clip must be removed from the incontinence product before MRI or CT examinations.

Service Life

  • The intended service life of the alea Dock and alea Router is defined in the technical documentation.

Safe Use of the alea App and alea Cockpit

  • Changes to notifications, user assignments, and basic settings should only be made in coordination with the responsible organization.

  • Relevant changes must be documented and communicated to affected users.

  • Push notifications are displayed only on the most recently authenticated authorized device.

  • Password changes should be communicated promptly to authorized users.

Error Prevention and Operational Safety

Malfunctions may occur in particular due to:

  • Damaged hardware

  • Faulty cable connections

  • Power interruptions

  • Loss of internet connectivity

  • Incorrect installation of components

  • Unintentional removal of the incontinence product or Clip

  • Local network failures

  • Outdated software versions

If signs of damage, burning odors, or unusual device behavior are observed, immediately remove the affected device from service and contact the manufacturer or service provider.

Repair and Service

  • Repairs may only be performed by the manufacturer or authorized service partners.

  • Unauthorized repairs invalidate safety assumptions and warranty coverage.

  • Defective devices must be returned for inspection.

Safety in Care Applications

  • alea is intended as a digital care assistance system.

  • The system does not replace established care quality standards or care procedures and must not be used as the sole basis for decision-making in safety-critical situations.