Device Combinations; Connections To It-Networks - Dräger Primus SW 4.5n Instructions For Use Manual

Device combinations

This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying docu-
ments for the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional state of the individual
devices can be compromised. The operating or-
ganization must ensure that the device combination
complies with the applicable editions of the relevant
standards for medical devices.
Device combinations approved by Dräger meet the
requirements of the following standards:

Connections to IT-networks

Data can be exchanged across an IT-network by
using hard-wired and wireless technologies. An
IT-network can be any data interface (e.g., RS232,
LAN, USB, printer interface) that is described in
standards and conventions.
During operation, this device can exchange infor-
mation with other devices and support the following
functions by means of IT-networks:
– Display of waveforms and parameter data
– Signaling of alarms
– Transfer of device settings and patient data
Connecting this device to a network that incorpo-
rates other devices or making subsequent changes
to that network can lead to new risks for patients,
users, and third parties. Before the device is con-
nected to the network or the network is changed,
these risks must be identified, analyzed, and eval-
uated, and appropriate measures taken.
Examples of subsequent changes to the network:
– Changing the network configuration
Instructions for use Primus SW 4.5n
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, software-con-
trolled functions)
– IEC 60601-1-2 (electromagnetic compatibil-
ity)
– IEC 60601-1-8 (alarm systems)
Or:
– IEC 60601-1, 2nd edition (general require-
ments for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic compatibil-
ity)
– IEC 60601-1-4 (software-controlled func-
tions)
– IEC 60601-1-8 (alarm systems)
– Removing devices from the network
– Adding new devices to the network
– Performing upgrades or updates on devices
that are connected to the network
Technical Data
267