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Instructions for use – Infinity Acute Care System – Monitoring Applications VG6.n
507
IT applications (options)
Connecting to the network
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, ISB 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 (for example, 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, users, and third
parties. These risks must be identified, analyzed,
evaluated, and controlled before placing the
medical device into the IT network. Before a device
can be in service on the Infinity Network, a valid and
unique IP address must be entered.
EC 60601-1:2005 and 60601-1:2012
clause 14.13 compliance
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 (for example, biomedical or
network engineers) 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
medical 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 instruction
for use documentation.
– The specifications of the LAN connection for
Dräger medical devices to the IT-Network are
outlined in the IEEE 802.3 wired and IEEE
802.11(b, g, n) wireless Ethernet standards.
Port settings for layer 2 and layer 3 switches are
defined on a product-specific basis. These
settings are available from your DrägerService
representative. Dräger provides products for
initial set-up with pre-loaded IP addresses.