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9. Product disposal > 9.1. Introduction
9.1. Introduction
Profound Medical is concerned to help protect the natural environment, and to help ensure
continued safe and effective use of this product, through proper support, maintenance and training.
Therefore, Profound Medical products are designed and manufactured to comply with relevant
guidelines for environmental protection. As long as the product is properly operated and
maintained, it presents no environmental risks. However, the product may contain materials, which
could be harmful to the environment if disposed of incorrectly. Use of such materials is essential to
performing the functions of the product, and to meeting statutory and other requirements.
This section of this Instructions for Use is directed mainly at the user / owner of the product.
9.2. Passing the product on to another user
If this product passes to another user, it must be in its complete state, including all product support
documentation. Make the new user aware of the support services that Profound Medical provides
for installing, commissioning and maintaining the product.
Before passing on the product or taking it out of service, all patient data must be (backed up
elsewhere if necessary, and) unrecoverably deleted from the product.
It must be remembered by all existing users that passing on medical electrical products to new
users may create serious technical, medical and legal (e.g., on privacy) risks. Such risks can arise
even if the product is given away. Existing users are strongly advised to seek advice from their
local Profound Medical representative before committing themselves to passing on any product.
Alternatively, contact the manufacturer.
Once the product has been passed on to a new user, a previous user may still receive important
safety-related information, such as bulletins and field change orders. In many jurisdictions, there is
a clear duty on the previous user to communicate such safety-related information to new users.
Previous users who are not able or prepared to do this should inform Profound Medical about the
new user, so that Profound Medical can provide the new user with safety-related information.
9.3. Final disposal of the product
Final disposal is when the user disposes of the product in such a way that it can no longer be used
for its intended purpose.
Profound Medical supports users in:
Recovering reusable parts
Recycling of useful materials by competent disposal companies
Safe and effective disposal of the product
For advice and information, contact your Profound Medical service organization first, or otherwise
the manufacturer.
NOTICE
The product contains privacy sensitive information which should be properly removed. It is
advisable to contact your Profound Medical service organization before disposing of the product.
Instructions for Use
109745C2 / 02-2022
9. Product disposal
155 (192)
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