1.0.4 | alea components

alea (digital assistance system for care for incontinence and movement monitoring) consists of:

Component

Description

alea Software

Medical device software of the alea digital care assistance system. It comprises the alea App and the alea Cockpit. The alea Software monitors, calculates and displays the fill level of compatible absorbent continence products as well as the body position and the duration of the respective position. It provides status indicators, notifications and reminders.

alea Clip

Hardware accessory to the alea Software for acquiring and transmitting sensor data. The alea Clip does not independently evaluate data and does not make medical or nursing-related decisions.

alea Dock

Hardware accessory to the alea Software for transmitting sensor data. The alea Dock does not independently evaluate data and does not make medical or nursing-related decisions.

alea Router

Network infrastructure component supporting data transmission within the system where required for the respective care setting. The alea Router is not part of the alea medical device software.

Compatible absorbent continence products

Approved compatible third-party products for use with alea. They are not part of the alea system.

Sensor Strip (optional)

Optional sensor strip for use with designated compatible absorbent continence products. The sensor strip is applied to a designated continence product in accordance with these Instructions for Use and enables its use with the alea system. Sensor strips are intended exclusively for compatible continence products approved by AssistMe.

Software and System Requirements

Depending on the respective care setting, the following components are additionally required for the use of alea:

  • Mobile device (smartphone or tablet)

  • Desktop computer or workstation (for using the alea Cockpit)

  • Network and/or Internet connection

  • Supported web browser

  • Approved power supplies and charging cables

Notes on Use

All components may only be used in accordance with their intended purpose.

This applies in particular to:

  • the use of approved compatible absorbent continence products and sensor strips only,

  • the use of compatible mobile devices and supported web browsers,

  • the use of approved hardware and accessory components only, and

  • use within the care settings described in these Instructions for Use.