Lexa | Instructions for Use | MN-111 Med ENG Rev14 | 03/04/2023 | © W&H Sterilization Srl
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Safety information
TAMPERING
n
Do not remove the name plate or labels from
the sterilizer.
n
Repairs, maintenance or service must be
carried out by authorized service providers
always using genuine spare parts.
REQUIREMENTS
n
All accessories connected to the sterilizer shall
be FDA cleared.
n
Use only the power cord set and accessories
provided by the manufacturer.
n
Serious incidents that have occurred in relation
to this medical device should be reported to the
manufacturer and competent authority in the
country where the incident occurred.
n
In case of malfunction of the sterilizer, contact
an authorized technician or the manufacturer.
CYBER SECURITY
The device is designed in such a way that a cyber-attack or software
failure does not compromise the safety in relation to the intended
use. A successful cyber-attack cannot result in direct patient harm:
in fact, the device is not in contact with patients.
The device does not share any data (sensible and not sensible)
related to patients.
To further protect the device and minimize successful cyber-attacks,
the following precautions have been taken:
n
the access to the device operating system is not possible (user
access to the operating system is disabled);
n
a firewall is active on the device; all the device network
connections (to and from the external world) are managed by
the firewall which, following specific rules, filters them and
blocks everything that is not strictly necessary for the device;
n
the update/install operations are only possible using signed
and encrypted software, provided by W&H;
n
during the normal use, the operating system and the
application (responsible for the device functionalities) are
located in a read- only memory, so to avoid intentional
corruption;
n
all the sterilization data are secured by means of checksum
controls.
In order to minimize the possibility of cyber- attacks, it is user
responsibility to apply the following measures:
n
software update/install shall be done by authorized and trained
personnel only;
n
it is recommended to activate a firewall on the router/modem
used for the internet connection.
Note
: further security information is mentioned in the MDS2 document,
which is available on request.
Summary of Contents for MN-111
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