OCULUS Keratograph 5M - Instructions for Integration into an IT-Network

27 Appendices
104 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
27.5 Instructions 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
(“Cybersecurity Instructions” on page 17) of “Safety Instructions”
(page 12) 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
 DICOM workflow
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 Micro-
soft Networks (SMB 3.0 or higher - required opened port: 445]
 DICOM Storage Service Class = PACS
 DICOM Worklist Management Service Class (Modality Worklist
Server)
Technical specifications of the network connection with the PEMS,
including the specifications of data security:
 Refer to the cybersecurity section (page 17) of “Safety Instructions”
(page 12) in the device instruction manual.
 Refer to the “Floating License Key - License management for soft-
ware options” instruction manual (if applicable)
 Refer to device specific DICOM interface description (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