Storage; Processing Of The Products After Use; Products Return; Products Elimination - Sophysa POLARIS Gebrauchsanweisung

11. Storage

CAUTION
Due to the power of its magnetic field, the Magnet must
be stored in its shielded case when it is not being used.
CAUTION
Do not expose the adjustment kit to temperatures high-
er than 50°C (122°F). The function of the Magnet could
be adversly altered.
CAUTION
Do not store the adjustment kit close to a source of
magnetic fields to preserve the ability of the magnet to
function properly.
Keep all the components of the adjustment kit together in
their original shielded case after use, or when stored.
Store the shielded case in a cool, dry place away from light.
The products are designed to withstand a storage tempera-
ture up to 50 °C (122 °F).

12. Processing of the products after use

12.1. Products return

To return a faulty product, contact a Sophysa representative
to obtain the explanatory return form to be provided.
Do not do anything to the product so that its condition dur-
ing analysis is as representative as possible.
Return all the components of the adjustment kit in its original
shielded case.

12.2. Products elimination

CAUTION
The Magnet contains components that must be dis-
posed of properly. Failure to do so may lead to environ-
mental pollution.
Clean the product carefully (see Section 7. Cleaning and dis-
infection procedure (p. 11)) and send the product back to
Sophysa for proper elimination, in its original shielded case.

13. Monitoring of the product safety

As part of its continual improvement program, Sophysa asks
its customers to inform it and the legal authority of the coun-
try of any unexpected and serious problems that occur with
the product.

14. Warranty

The performance and safety of the adjustment kit is ensured
only with the Polaris range of valves, designed, tested and
manufactured by Sophysa.
Sophysa warrants the performance and safety of this medi-
cal device under the normal conditions of the intended use
of the device, adapted to its intended purpose and use, and
in accordance with these Instructions for Use.
The medical device must be stored and transported in an en-
vironment and under conditions that also comply with the in-
Page 18 of 82
formation in these Instructions for Use. These storage and
transport conditions have been tested and validated by So-
physa. Thus, Sophysa does not grant any other express or
implicit guarantee as for the good conservation and the safe-
ty of the product in other premises than its own which would
not respect these conditions. Likewise, no express or implicit
guarantee is granted by Sophysa as to the suitability of the
product for the use which will be made of it, or its adaptation
to a particular use, except within the indications and the in-
tended purpose of the product, or when it has been trans-
formed, modified or repaired except within the instructions of
Sophysa.
Under no circumstances, Sophysa can be held responsible
in case of damages, for any incident and/or complication, re-
sulting from damage or prejudice arising directly or indirectly
from the unsuitable use of the device and/or a use of the de-
vice which fail to conform or the non-respect of its condi-
tions of maintenance, cleaning, maintenance, storage or
transport.

15. Symbols

Catalogue number
Serial number
Medical Device
Unique Device Identification
Manufacturer
Date of manufacture
Consult Instructions for Use
Do not sterilize
Keep dry
Keep away from sunlight
Upper limit of temperature: up to 50 °C (122 °F)
Powerful magnet