Responsibility - W&H Lyla Instructions For Use Manual

TAMPERING
Do not remove the name plate or labels from
n
the sterilizer.
Repairs, maintenance or service must be
n
carried out by authorized service providers
always using genuine spare parts.
REQUIREMENTS
Use only the power cord set and accessories
n
provided by the manufacturer.
Serious incidents that have occurred in relation
n
to this medical device should be reported to the
manufacturer and competent authority in the
country where the incident occurred.
In case of malfunction of the sterilizer, contact
n
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:
Lyla | Instructions for Use | RIN-210 ENG Rev02 | 15/09/2022 | © W&H Sterilization Srl
the access to the device operating system is not possible (user
n
access to the operating system is disabled);
a firewall is active on the device; all the device network
n
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;
the update/install operations are only possible using signed
n
and encrypted software, provided by W&H;
during the normal use, the operating system and the
n
application (responsible for the device functionalities) are
located in a read-only memory, so to avoid intentional
corruption;
all the sterilization data are secured by means of checksum
n
controls.
In order to minimize the possibility of cyber-attacks, it is user
responsibility to apply the following measures:
software update/install shall be done by authorized and trained
n
personnel only;
it is recommended to activate a firewall on the router/modem
n
used for the internet connection.
Note: further security information is mentioned in the MDS2 document,
which is available on request.

Responsibility

USER RESPONSIBILITY
The user is responsible for the proper installation, the correct
n
use and maintenance of the sterilizer in accordance with these
Safety information
11