USER GUIDE //
LOCKING SYSTEM PA-280
Review 09/19
11
·
All those who modify or have modified, prepared or have prepared medical devices in such way that
they no longer serve the purpose for which they were designed, or no longer provide the desired servi-
ce, must satisfy the valid conditions for the introduction of these in the market.
·
Register and store with these instructions: lot number, place and date of purchase, first date of use,
date of checks, name of operators and any other comments.
·
Be sure to take all necessary precautions to avoid the dangers that may arise as a result of contact with
blood or body fluids.
·
Do not store the device under heavy objects that could cause structural damage.
·
Store in a cool, dry, dark place and do not expose the device directly to the sun.
·
Store and transport the product in its original packaging.
·
The product must not be exposed or come into contact with any source of combustion or flammable
agents.
·
Position and adjust the device being careful not to cause any obstruction to rescuers and/or any other
rescue equipment.
·
When the product is being used, the assistance of qualified personnel must be guaranteed
·
Attention: laboratory tests, post-production tests, instruction manuals cannot always consider all pos-
sible scenarios of use. This means that, in some cases, the performance of the product could have signi-
ficantly different from results to date obtained. Instructions are continually updated and are under the
strict supervision of fully qualified personnel with the appropriate technical formation.
·
In addition, both public and private services are obliged to inform the manufacturer of any measures
that should be adopted in order to take the necessary steps to guarantee the safety and health of pa-
tients and users of any medical device.
·
As a distributor or end users of products manufactured and/or marketed by
Promeba, S.L.
, it is strictly
required that you have a basic knowledge of any legal requirement that applies to the supplied devices,
for the countries in which they will end up (including laws and norms regarding technical specifications
and/or safety requirements) and, therefore, it is also strictly required to have the necessary knowledge
to guarantee all aspects related to the total conformity of the products to the regulations in the corres-
ponding territory.
·
Promptly notify
Promeba, S.L.
with respect to any revision that the manufacturer must carry out in
order to guarantee the conformity of the product to the legal specifications of the territory (including
those resulting from rules and/or norms of other nature).
·
Act, with due care and diligence, and help ensure compliance to general security requirements of all
devices marketed in the territory, providing end users with all the information necessary to perform
periodic checks of their devices, as specified in the instruction manual.
02
WARNINGS
