194 Instructions for use Babyleo TN500 SW 1.0n
Technical data
14.7 Device combinations
This device can be operated in combination with other Dräger devices or with
devices from other manufacturers. Observe the accompanying documents of the
individual devices.
If a device combination is not approved by Dräger, the safety and the functional
integrity of the individual devices can be compromised. The operating organization
must make sure 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 (general requirements for safety)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-8 (alarm systems)
14.8 Connections to IT networks
In an IT network, data can be exchanged by means of wired or 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 by
means of IT networks and supports the following functions:
– Display of parameter data
– Signaling of alarms
– Transfer of device settings and patient data
– Service mode, access to logbooks
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 taken.
Examples of subsequent changes to the network:
– Changing the network configuration
– Removing devices from the network
– Adding new devices to the network
– Performing upgrades or updates on devices that are connected to the network
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