The user has the option to obtain a paper version of the instructions for use. The manufacturer ensures the operation of a paper-based instructions distribution system at no additional cost to the user.

The paper version of the instructions is provided upon the user’s request, following prior contact with the manufacturer, within a timeframe determined by the risk assessment performed, but no later than seven (7) calendar days from the date of receipt of the request. If the request is submitted simultaneously with a product order, the instructions shall be delivered no later than on the day of product delivery.

Archived versions of the instructions for use (eIFU) are available upon the user’s request, following prior contact with the manufacturer, within a timeframe determined by the risk assessment performed, but no later than seven (7) calendar days from the date of receipt of the request. If the request is submitted simultaneously with a product order, the instructions shall be delivered no later than on the day of product delivery.