Warnings Concerning Connection To An It Network; Warnings Associated To External Factors, Electromagnetic Fields - Smeg BPW1260 User Manual

5.2.1 WARNINGS CONCERNING CONNECTION TO AN IT NETWORK

The device can only be connected to an IT network with installation of optional accessory BPW-
LANI, code 905561.
The communication protocol is proprietary and the device can only be connected to an IT network
using the application supplied by the manufacturer and accessed on the network via the
passwords, differentiated by level.
Differentiated passwords for authorised engineers only enable safer management of the
device's operating parameters.
The IT security of devices overall also implies correct behaviour on the part of staff who
interface with them and appropriate control of accesses, in line with the provisions of the MDCG
guidelines (especially Ref. MDCG 2019-16).
PC used for connection, minimum requirements: RJ45 port, Microsoft Windows 32 or 64bit
operating system, Windows 7 or higher with Framework 4.0 or higher installed and updated.
Health operators should adopt a risk management process in line with IT security best
practices in order to maintain overall security:
- physical security to prevent unauthorised physical access to medical devices or network access
points;
- access control measures (e.g. role-related) to guarantee that only authorised, identified
personnel can access network devices, stored data, services and applications;
- network access controls, such as segmentation, to restrict the communication of medical
devices;
- Malware protection to prevent the execution of unauthorised code;
- Training to raise awareness of security.
- ability to reliably establish who has made which changes to the system.

5.2.2 WARNINGS ASSOCIATED TO EXTERNAL FACTORS, ELECTROMAGNETIC FIELDS

[This point responds to requirement MDR 23.4 s concerning warnings regarding electromagnetic interference].
The device has been tested for electromagnetic compatibility in accordance with the EN IEC
61326-1 standard (which is also mentioned in the declaration of conformity) and complies with
the required levels in terms of both immunity and emissions.
The device is suitable for operation in the health facility premises assigned for the reprocessing
of excrement containers: the aforesaid standard 61326-1 is directly referred to in the
performance standards for "Washer-disinfectors" (EN ISO 15883-1).
Health facility managers are specifically required to ensure appropriate management of
equipment, in terms to the installation environments and the correct segmentation of electricity
supplies, with differentiation of devices with special requirements, such as diagnostic or therapy
equipment.
Equipment used for diagnostic or therapy purposes and particularly sensitive to electromagnetic
interference should not be installed in the immediate vicinity of this device.
User Manual 193909105 rev.02 BPW1260 Page 27 – 93