OCULUS Myopia Master Basic, Instruction Manual

Page: 87 / 90

22 Annex
82 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
22.5 Notes for integration into an IT-Network
The device, in conjunction with the connected computer and the device
software running on it, forms a programmable electrical medical system
(PEMS) according to IEC 60601-1.
It is essential that you follow the cybersecurity instructions section of
“Safety Instructions” in the device instruction manual.
Please note the following information for implementing an integration of
the PEMS into an IT-Network:
The purpose of integrating the PEMS into an IT-Network can be:

Licensing by local license server

Storage and retrieval of the examination data on a local network
drive

Printing

Data export
Required characteristics of the IT-Network into which the PEMS is to
be integrated:

Prefer wired LAN connection

IPv4 network

Fast-Ethernet (100 Mbit/s minimum)
Required configuration of the IT-Network into which the PEMS is to
be integrated:

Licensing: required opened ports: 3968 TCP; 51371 - 51372 UDP

Storage, printing, data export: File and Printer Sharing for Microsoft
Networks (SMB 3.0 or higher - required opened port: 445]
Technical specifications of the network connection with the PEMS,
including the specifications of data security:

Refer to the cybersecurity section of “Safety Instructions” in the
device instruction manual.

Refer to the “Floating License Key - License management for
software options” instruction manual (if applicable)
The intended flow of information between PEMS, the IT-Network and
other devices in the IT-Network and the intended routing through the
IT-Network

License handling from local license server to PEMS and vice versa

Storage and data export to local network storage and loading from
local network storage

Printout to local printer
List of hazard situations that result from the IT-Network being unable
to provide the features that are required to fulfill the purpose of
integrating the PEMS into to meet the IT-Network:

Loss of data

unsuitable data exchange

Data corruption

unsuitable temporal data allocation