USER GUIDE //
HEAD IMMOBILIZER PA-55
Review 2021/09
8
21. Attention: laboratory testing, post production tests and instruction manuals
cannot always consider every possible scenario for use. This means that in some
cases the performance of the product could be notable different from results to
date obtained. Instructions are continually being updated and are under tight
surveillance of fully qualified staffs with adequate technical formation.
22. Both public and private operators are obliged to report any accident involving
any medical device to the Ministry of Health and the manufacturer as specified and
within the time given by European regulations.
23. Both public and private operators are obliged to inform the manufacturer of the
measures to be taken to guarantee the safety and health of patients and users of
any medical device.
24. As a distributor or end user of the products manufactured and/or distributed by
Promeba, S.L., you are strictly obliged to know the legal provisions in force in the
country of destination of the goods, applicable to the devices to be supplied
(including the regulations relating to technical specifications and/or safety
requirements) and, therefore, understand the necessary requirements to ensure
compliance of the products themselves with all the legal requirements of the
territory.
25. Promptly notify PROMEBA regarding any revisions to be made by
manufacturer in order to guarantee the conformity of the product to the territory
’s
legal specifications (including those resulting from rules and/or norms of other
nature).
26. Act with all due care and diligence, and contribute to ensure conformity to
general safety requirements of all devices marketed in the territory, by providing
final users with all necessary information for carrying out periodical checks on
their devices, as specified in the relevant user manual.
27. Actively contribute to product safety checks on products sold, by
communicating any relevant risk analysis information both to the manufacturer and
to any competent authorities so that the necessary actions can be promptly taken.
28. Be aware that in the event of any failure to conform to the above mentioned
requirements you will be deemed fully responsible for all damages that might
occur. Therefore we expressly disclaim any responsibility and/or liability for your
non-compliance with the present
“Regulatory provisions”.
