NOTICE No. 1 - REVITIVE MEDIC COACH CONNECTED PRODUCT

Pre-contractual information pursuant to Article 3(2) of Regulation (EU) 2023/2854 (hereinafter the "Data Act")

The Revitive Circulation Booster (hereinafter the "Connected Product") is a connected medical device that generates, stores and transmits data relating to its use and its environment through its embedded sensors and communication modules. The device only transmits data when securely connected to the Revitive iOS or Android Mobile Application.

This notice constitutes the pre-contractual information required by Article 3(2) of the Data Act for connected products. It covers exclusively the data generated by the Connected Product itself (product data) and does not address the information obligations relating to any related service within the meaning of Article 3(3) of the Data Act, which is the subject of a separate notice. It is made available to any user, whether consumer or professional, including resellers, prior to the conclusion of any contract for the purchase, rental or provision of services relating to the Connected Product.

Revitive products qualify as "connected products" within the meaning of the Data Act. As such, the Connected Product collects and transmits usage and environmental data as described below.

 

1 Types and formats of data generated by the Connected Product

The Connected Product generates the following categories of data, in the estimated volumes indicated below. These data comprise both raw data produced directly by the sensors without further processing and pre-processed data converted into comprehensible values (e.g. translation of an electrical signal into a physical measurement):

• Device Usage Data: session start times, session duration, therapy day, stimulation programme used, average intensity, rocking duration, hydration measurements, body pad and thigh pad connection status.
• Minute-Level Device Telemetry: per-minute waveform data including waveform type, average intensity, rocking duration and rocking thresholds.
• Device and Application Metadata: firmware version, device identifiers (RIN), pairing information.
• Environmental and Physical Measurement Data: physical quantities measured by the sensors of the Connected Product during use, including but not limited to electrical muscle stimulation parameters, hydration levels and any other sensor-derived measurements relating to the user's physical environment or physiological response.

The Connected Product does not generate any data when it is switched off or in standby mode. The data described in this notice are generated exclusively during active use of the Connected Product.

These data are generated in machine-readable technical formats: relational database records, numeric and Boolean values, date and time values, enumerated values, JSON-formatted records and structured arrays. By way of example, the data include hydration measurement arrays, waveform data. Users may request to download their data in a structured, commonly used and machine-readable format, subject to the conditions in Section 5 below.

In terms of estimated volume per category of data:

• Device Usage Data: each 15 minute session generates one session record, estimated at approximately 34 B
• Minute-Level Device Telemetry: one telemetry record per minute of use, estimated at approximately 38 B per minute, potentially reaching 2.2 KB for longer sessions;
• Device and Application Metadata: a fixed and limited volume, generated primarily during pairing and device updates, estimated at approximately 82B per event

 

2 Continuous and real-time data generation

During use, the Connected Product generates data continuously and in real time. The frequency of data generation and transmission to the CIRRUS cloud platform varies by category:

• Device Usage Data: generated at the start and completion of each therapy session, and transmitted at completion of each session;
• Minute-Level Device Telemetry: generated continuously at a frequency of one record per minute during active therapy sessions, and transmitted approximately every 15 minutes;
• Device and Application Metadata: generated during pairing transmitted immediately following the relevant event;

 

3 Data storage

Data may be stored locally on the Connected Product or transmitted to the CIRRUS cloud platform, hosted on Amazon Web Services (AWS) infrastructure located in Ireland, European Union.

The retention period for each category of data depends on its nature and the purpose of its processing:

• Device Usage Data: retained for the lifetime of the user's account, or anonymized if users account is deleted to aid research;
• Minute-Level Device Telemetry: retained for the lifetime of the user's account, or anonymized if users account is deleted to aid research;
• Device and Application Metadata: retained for the lifetime of the user's account, or anonymized if users account is deleted to aid research;

Data are deleted at the expiry of the applicable retention period, provided no legal retention obligation requires their continued storage. Anonymous and aggregated datasets may be retained for research, statistical analysis and product improvement purposes were permitted by applicable law.

 

4 Personal data qualification

Certain data generated by the Connected Product constitute personal data within the meaning of Regulation (EU) 2016/679 (General Data Protection Regulation, hereinafter "GDPR"), where they can be linked, directly or indirectly, to an identified or identifiable natural person. This concerns notably:

• Device Usage Data, insofar as session data can be associated with an individual user account;
• Minute-Level Device Telemetry, where linked with an individual user account;
• Environmental and Physical Measurement Data, including hydration measurements, which may constitute health-related data within the meaning of Article 9 of the GDPR;
• Device and Application Metadata, insofar as device identifiers and pairing information can be linked to an individual user account;.

The processing of such personal data is governed by the GDPR and by Actegy's Privacy Policy, available in the Revitive mobile application.

 

5 Access, retrieval and deletion of data

Users can access relevant therapy and service information through the Revitive mobile application, under the “Me” section.

Data not available within the application may be requested through Actegy Customer Services at the following address: [email protected]

Users may request deletion of their personal data and account information through the application or through Customer Services. Following a valid account deletion request, personal data is deleted in accordance with Actegy's Privacy Policy and applicable legal obligations.

To initiate a data access request, please contact Actegy Customer Services at the following address: [email protected]

For further information, please refer to Actegy's Privacy Policy and Terms of Use available in the Revitive mobile application and at the following address:

https://www.revitive.com/privacy-policy

https://doc-ios-2-8-1-20240318.app.revitive.com/EU/en/terms_of_use_app.html

 

6 Data classification upon transfer or end of life of the Connected Product

Before transferring the Connected Product to a third party, users should (i) perform a factory reset of the Connected Product in accordance with the user manual.