Symbols; Electromagnetic Compatibility - Sophysa PRESSIO Notice D'utilisation

the Catheter and the patient bedside monitor) designed, tes-
ted 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-
tions of maintenance, cleaning, maintenance, storage or
transport.
The cables have an expected lifetime of 2 years in normal
use (disconnecting and reconnecting between each monitor-
ing). However, the results of the visual checks prevail (see
Section 6. Maintenance of the cables (p. 9)).
These visual checks will indicate whether or not the cables
can still be used.
Table 2. Date of first use
Date

10. Symbols

Catalog number
Lot number
Manufacturer
Date of manufacture
CE conformity marking
Consult Instructions for Use
Page 10 of 36
Humidity limitation: 15% to 95%
Temperature limits: -20°C (-4° F) to 60°C (140°F)
The Catheter Extension Cable is not protected
against the effects of a cardiac defibrillator.
MR unsafe
The cables are not suitable for use in an MRI envi-
ronment. Do not use during an MRI examination.
Medical Device
Unique Device Identification
Keep dry
Keep away from sunlight
By prescription only
Discarding this type of product with other waste is
prohibited.

11. Electromagnetic compatibility

In case of electrostatic discharge or electromagnetic disturb-
ance, find below the behavior that the Monitor, the cables or
the sensor might have:
– If a strong electrostatic discharge occurs on the Monitor,
the cables or the sensor:
– the mean ICP or ICT value can be temporarily affected,
– the ICP curve can show temporary peaks of high ampli-
tude.
– If an electromagnetic disturbance occurs on the Monitor,
the cables or the sensor:
– the mean ICP or ICT value can be affected,
– the ICP curve can show abnormal ripples.