This data notice (the “Data Notice”), issued in accordance with Regulation (EU) 2023/2854 (EU Data Act), describes the product data generated by the Avance Solo Pump and Avance Solo Adapt Pump. These products are battery powered pumps with an embedded software designed to support wound therapy treatment (hereinafter referred to as the “connected product” or “connected products”), which is configured with a canister and a compatible dressing.

This Data Notice provides information about the product data generated when using the connected product, and your rights under the EU Data Act. 

The Data Notice is intended for individuals that use our connected products (referred to as “you” or “user”). Mölnlycke Health Care AB, as the data holder and manufacturer of the connected products, is referred to as “MHC”, “we”, “us” or “our”.

We regularly improve our products, so this notice may change over time. The date at the top shows when the Data Notice was last updated.

The specific product data generated may vary depending on product use conditions and clinical application. Product data will only become readily available to us if the connected product is physically returned for investigation, and extraction of product data is deemed necessary in accordance with applicable MDR requirements (EU Regulation 2017/745).  

The following product data may be generated during operation of the connected product: 

• Types of product data 
• Type of alarms (e.g., error messages); 
• When the alarm happened, based on how long the device had been turned on; 
• Battery energy levels; 
• Instances when the device was paused and restarted;  
• The duration of device operation; 
• How long specific components inside the device have been active.  
• Temperature of the device during operation  

The connected products generate data periodically as well as when certain events are triggered (e.g., alarms or button presses). 

The product data is stored in a memory chip inside the connected product until it is disposed. If extracted by Mölnlycke, the product data is stored in accordance with applicable MDR requirements (EU Regulation 2017/745).

Product data is only accessible if the connected product can be identified and is returned to us for complaint investigations as required under the MDR.  

Data can be made available even after the product has been used for its intended single-use purpose. The device (incl. the pump) can be fully reactivated for specific purposes through proprietary MHC commands.  

You, or a third party of your choice, can request access to readily available data using this form. Note that your rights to access data are not absolute. For example, there are limitations in regard to highly processed/enriched data. Additionally, we must be able to verify that you are a user before giving you access. If we cannot confirm that you are a user and which connected product belongs to you, we may not be able to provide access. If we cannot fully meet your request, we will explain why. 

You also have the right to contact your local supervisory authority if you have concerns about how we handle your data. You are also welcome to contact us using this information.