USER GUIDE // EVACUATION SEDAN CHAIR PS-350
Review 2021/07
8
01 INTRODUCTION
14. The device must not in any way be tampered with (modication, adjustment, addition, replacement).
In such cases all responsibility will be denied for any malfunctions or injuries caused by the appliance itself;
moreover CE certication and product warranty will be considered void.
15. Those who modify or have modied, prepare or have prepared medical appliances in such a way that
they no longer serve the purpose for which they were intended, or no longer supply the intended service,
must satisfy the valid conditions for the introduction onto the market.
16. Handle with care.
17. Ensure that all the necessary precautions are taken in order to avoid the hazards that can arise as the
result of contact with blood or body uids.
18. Register and store with these instructions: lot number, place and date of purchase, rst date of use, date
of checks, name of users, any comments.
19. When the device is being used, the assistance of qualied sta must be guaranteed.
20. Do not store the device underneath any heavy objects which could cause structural damage.
21. Store in a cool, dry, dark place and do not expose to direct sun.
22. Store and transport device in its original packaging.
23. The device must not be exposed or come into contact with any source of combustion or inammable
agents.
24. Position and adjust the device taking care not to cause any obstruction to rescuers and or any other
rescue equipment.
25. 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 dierent from results to date obtained. Instructions are continually being updated and are under
tight surveillance of fully qualied stas with adequate technical formation.
26. Both public and private operators are obliged to report any accident involving any medical device to the
Ministry of Health and the manufacturer as specied and within the time given by European regulations.
27. 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.
28. 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 specications and/or safety re-
quirements) and, therefore, understand the necessary requirements to ensure compliance of the products
themselves with all the legal requirements of the territory.
29. 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 specications (including those resulting from rules
and/or norms of other nature).
30. 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 nal users with all necessary information for carrying
out periodical checks on their devices, as specied in the relevant user manual.
31. 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 ac-
tions can be promptly taken.
