Emc Declaration - Dräger Babyleo TN500 Instructions For Use Manual

Technical data
– Without firewall and antivirus software:
– Data are not protected.
– Device settings are changed.
– The device generates false alarms or no alarms.
– Data are sent incomplete, sent to the wrong device, or not sent at all.
– Patient data are intercepted, falsified, or damaged.
– Data have incorrect time stamps.
– An overload of the device due to very high network loads (e.g., caused by
denial-of-service attacks) can lead to deactivation of the interface. The interface
will only be available again after the device has been restarted. In very rare
cases, a warm boot may take place and may occur repeatedly.
14.8.1.4 Requirements for the electrical characteristics of connected devices and
networks
The LAN interfaces and the serial interfaces are only suitable for the connection of
devices or networks that have a rated voltage of at most 24 V DC on the network
side and that meet the requirements of one of the following standards:
– IEC 60950-1: Ungrounded SELV circuits
– IEC 60601-1 (as of 2nd edition): Touchable secondary circuits
14.9

EMC Declaration

14.9.1 General information
The EMC compliance of the product has been evaluated with the external cables,
transducers, and accessories specified in the list of accessories. Other accessories
which do not affect EMC compliance may be used if no other reasons forbid their
use (see other sections of the instructions for use). The use of noncompliant
accessories can result in increased emissions or decreased immunity of the
medical device.
The medical device may only be used adjacent to or stacked with other devices
when the configuration is approved by Dräger. When use adjacent to or stacked
with other devices is absolutely necessary without the configuration being approved
by Dräger, the correct operation of the device in this configuration must be tested
before the product is used. In any case, strictly observe the instructions for use of
the other devices.
14.9.2 Electromagnetic emissions
When using wireless networking, be aware that the system operates at 2.4 GHz
range. Other equipment, even if compliant with CISPR emission requirements, can
interfere with reception of wireless data. When selecting wireless systems (wireless
communication media, pager systems, etc.) for use in installations where wireless
networking is used, care must always be used to make sure that operating
frequencies are compatible. For example, selecting wireless communication media
that operate at 2.4 GHz will likely cause difficulty with the networking components.
Low-level signals such as ECG signals are particularly susceptible to interference
from electromagnetic energy. Even if the equipment meets the test requirements
196 Instructions for use Babyleo TN500 SW 1.0n