Specifications
306 Instructions for Use Apollo SW 4.5n
Part Number: 9053586, 3rd edition
Device combinations
This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying
documents 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
organization 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:
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, software-
controlled functions)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-8 (alarm systems)
Or:
– IEC 60601-1, 2nd edition (general requirements
for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-4 (software-controlled functions)
– IEC 60601-1-8 (alarm systems)
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
information 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 incorporates
other devices or making subsequent changes to that
network can lead to new risks for patients, users, and
third parties. Before the device is connected to the
network or the network is changed, these risks must
be identified, analyzed, and evaluated, and
appropriate measures must be taken.
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