Dräger Infinity M300 series - Clause 14.13

Instructions for use – Infinity
®
M300 and M300+ series – VG3.0 265
IFU CONTENT TO COMPLY WITH IEC 60601-1:2005 and with IEC 60601-1:2012 CLAUSE 14.13
IFU CONTENT TO COMPLY WITH IEC 60601-1:2005 and with
IEC 60601-1:2012 CLAUSE 14.13
Dräger provides patient monitoring, therapy, and IT products that may exchange information electronically
with each other in the clinical environment, as well as other non-Dräger devices, over information
technology networks (IT networks). Each data interface is an IT network in terms of the relevant
communications standard (e.g. printer interface, USB interface, etc.).
Transmission of patient and device data across the IT Network enables patient data and equipment data
to be monitored, stored, transferred, printed, or shared through the use of direct wired, as well as wireless
technologies, facilitating the following operations:
 Waveform and Parameter Data Display
 Alarm Notification
 Network Recordings and printing
 Remote Control (e.g. Alarm Management)
 Remote BedView
 Patient Archive Data Review (Trends, Events, Charting Information)
 Equipment setting and patient data transfer
 Service access (device and component status data; log file access
Connecting Dräger devices to a shared IT network with other devices, or subsequent changes to the
shared IT network, can lead to previously unidentified risks for patients, operators, and third parties. These
risks must be identified, analyzed, evaluated, and controlled before placing the medical device into the IT
network.
Subsequent changes to the IT network can include, among other things:
– IT network configuration changes
– Adding or removing additional devices to/from the IT network
– Upgrading and/or updating network equipment connected to the IT network
Hospital personnel (e.g. Biomed, Network Engineering) should read the accompanying documents of the
Dräger equipment carefully before connecting the device to an IT network. Additionally, attention should
be given to the network interface description and network-relevant alarms. Installation personnel should
also refer to IEC 80001-1 for guidance before connecting the Dräger equipment to IT-networks.
The following summary provides additional disclosure on the connection of Dräger medical devices to IT
Networks:
– The most commonly-required configuration of the LAN-based IT-Network incorporating Dräger medi-
cal devices is a star topology that connects monitoring units and groups of monitoring units (“care
units”) via layered network switches and the segmentation from other IT-Network traffic via separately
designated Virtual LANs. Required device interface configurations are described in the respective
product Instructions for Use documentation.