Processing The Product After Use; Product Return; Product Elimination; Warranty - Sophysa PRESSIO Notice D'utilisation

-20°C/-4.0°F
+60°C/140°F
– Relative humidity:
< 5%
> 95%
– Altitude: between - 500 m and 4.600 m (corresponding to
a flight altitude up to 12.000 m in a pressurized cabin).

11. Processing the product after use

11.1. Product return

Do not use a MRI Support that is damaged.
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 problem that occurs with
the product.
If any issue occurs with the MRI Support while the proper
conditions of use are met, return the faulty MRI Support for
proper investigation. In order to properly assess the returned
product, it must be accompanied by an explanatory Return
to Manufacturer authorization form.

11.2. Product elimination

The used MRI Support should be sent back to Sophysa for
proper elimination.
NOTE
Clean the product carefully. Once cleaned (see Sec-
tion 7. Cleaning the MRI Support (p. 8) ), pull the body
apart from the foot to break the MRI Support before
sending it back to Sophysa.

12. Warranty

The performance and safety of the MRI Support is ensured
only with the Catheter kits and the accessories 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-
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-
Page 10 of 44
tions of maintenance, cleaning, maintenance, storage or
transport.
The MRI Support has an expected lifetime of 1 year in nor-
mal use. However, the results of the visual checks prevail
(see Section 7.4. Inspection (p. 8).) These visual checks will
indicate whether or not the MRI Support can still be used.
Table 1. Date of first use
Date

13. Symbols

Catalog number
Serial number
Manufacturer
Date of manufacture
CE conformity marking
Consult Instructions for Use
Humidity limitation: 5% to 95%
Temperature limits: -20°C (-4° F) to 60°C (140°F)
Align the MRI Support properly behind the patient's
head.
Do not move the MRI Support compared to the pa-
tient's body axis.
Wrong positioning could result in overheating.
Medical Device
Unique Device Identification
MR safe
Keep dry