Electronic Instructions for Use

This document contains information about the proper and safe use of the software and concerns the Aether Digital Platform 1.17.0 web application (ADP).

• –Read this document carefully before using the software. Keep it available for reference; a paper copy is available free of charge on request.
• –The Aether Digital Platform is compatible only with the Zeus hand. All required functions are available within the application; there is nothing to download from a website to launch the program.
• –The application must be accessed via Google Chrome (version 131 or higher) or Microsoft Edge (version 131 or higher), on Windows 11 or higher or macOS 14 or higher, with an internet connection.
• –Bluetooth Low Energy 4.0 or higher is required to connect to the Zeus hand.
• –The platform lets clinicians set up accounts, invite other medical professionals and patients, render usage data, and adjust settings and parameters of the Zeus hand remotely. It also allows clinicians to connect with the patient through the patient mobile application (M‑ADP).

The Aether Digital Platform is intended to monitor the Zeus device (prosthetic hand, a class I device) and to remotely connect with the patient. It is designed to be used solely by clinicians certified by Aether Biomedical; patients do not have access to this web-based software, but have access to the mobile application. The software is designed exclusively for the Zeus hand.

The platform lets a clinician log in or set up an account with two-factor authentication; set up a patient profile and invite the patient to the mobile app; assign a Zeus hand to the patient and configure its settings; and run local, remote or asynchronous sessions to change Zeus hand parameters. Previous settings can be restored by loading a previously saved configuration from the history logs.

The clinician can view the patient's EMG muscle contractions in real-time graphs and adjust thresholds, and can invite a fellow medical professional via 'Invite a new Medical Professional'. The integrated Zeus Configurator defines input options, sites, control strategy, grip changes and grip-switching modes.

3.1  BLE connection

The Zeus hand uses Bluetooth Low Energy to communicate with the Zeus Configurator. Bluetooth on the computer must be enabled to start configuring.

Open the Aether Digital Platform at https://zeushand.com in Google Chrome or Microsoft Edge. From the landing page the clinician can sign in, create an account, or reset a forgotten password.

4.1  Login or set up account

• –Sign in if you already have an account. Logging in is secured with two-factor authentication: after entering your credentials you complete a second verification step.
• –To create an account, complete the registration form and set up two-factor authentication when prompted.
• –To reset your password, use the reset link on the landing page and follow the instructions sent to your email.

5.1  Clinician dashboard

Once the account is created the clinician receives a confirmation email. In the Clinician Dashboard you have a list of patients, an inbox for messages, and a left sidebar for navigating the application.

5.1.1  Account settings

From Account settings you can manage your profile and credentials.

5.2  Connect to Zeus

To connect the Zeus hand, click the blue button in the center. A Bluetooth pairing window shows available devices; select Zeus Hand and click Pair to establish the connection.

5.3  Patients

Create a new patient account from the Patients area and invite the patient to the mobile app. You can set goals for a patient (grips, switches and exercises) and monitor progress.

5.4  Devices

Assign a Zeus hand to a patient from the Devices area.

5.5  Medical professionals

View the list of medical professionals and invite a new medical professional via 'Invite new Medical Professional'.

The Zeus Configurator communicates with and accesses the Zeus hand through three session types: Local, Asynchronous and Remote. A Local session is opened with the 'Connect to Zeus' button in the top-right of the dashboard; the Configurator can also be launched from the patient card via 'Configure Zeus'. Allied Health access depends on the permission granted by the clinician.

6.1  Changing Zeus hand settings

Within the Configurator you adjust the hand settings across dedicated tabs. Changes are sent to the hand through the active session.

6.2  EMG settings

The EMG settings tab shows the patient's muscle signals in real-time graphs and lets you set activation levels and thresholds for opening, closing and speed.

6.3  Grips and prosthesis settings

The Grips configuration and Choose grips tabs let you set the available grips and their order, including custom grips. The Prosthesis settings tab covers input options and sites, speed control strategy, grip-switching settings, Soft-Grip, finger-speed calibration, ignore-EMG-spikes, EMG freeze mode and the audio and vibration signal guide.

Device Usage Monitoring provides information on the patient's day-to-day use of the prosthesis. It consists of graphs showing the number of grips and grip switches performed, with an hourly breakdown.

Modes are different configurations saved in the device, for example for sports, vocation or recreation. After the clinician creates mode profiles they are sent to the patient's hand, and the patient switches between them in the mobile app. Each mode's settings are separate, with a maximum of three modes per device. Choose the mode you are editing from the panel on the right in the Configurator.

Allied Health users can use the same functionalities as clinicians once access is granted, covering remote, local and asynchronous sessions, config templates, modes, goals and history log. Access to selected patients and functionality depends on the permission granted by the clinician.

9.1  Allied Health – My patients

Allied Health users see and work with only the patients assigned to them.

For support, email support@aetherbiomedical.com. Describe the question or problem, ideally what led to it, what is happening and your desired outcome; screenshots can be attached.

10.1  Troubleshooting

The Aether Digital Platform supports Zeus V1 and Zeus V2 hands, and Aether MyoSense electrodes. Compatible models:

Any serious incident that has occurred in relation to the device should be reported to Aether Biomedical Sp. z o.o. via support@aetherbiomedical.com and to the competent regulatory authority of the country in which the user is resident.

Operate the application from a secure device with a firewall enabled and anti-malware software installed. Check the certificate of the web page before logging in. Close the application when you are not using it or are away from the computer.

• –Aether Biomedical declares that it meets the appropriate European standards for the design, manufacture and supply of prosthetic products and user software under the CE mark. Continued compliance is monitored by internal and external audits.
• –All individual products are marked to indicate compliance with Medical Device Regulation 2017/745.