Emc Declaration; General Information - Dräger Primus Infinity Empowered Instructions For Use Manual

IEC 60601-1-8
ISO 80601-2-13
Medical electrical equipment
ISO 80601-2-55

EMC declaration

General information

The EMC compliance of the product has been eval-
uated 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 instruc-
tions for use). The use of noncompliant accessories
can result in increased emissions or decreased im-
munity of the medical device.
The medical device may only be used adjacent to
or stacked with other devices when the configura-
tion is approved by Dräger. When use adjacent to
or stacked with other devices is absolutely neces-
sary 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.
Instructions for use Primus Infinity Empowered SW 4.5n
Part 1-8:
General requirements for safety including essential perform-
ance characteristics
Collateral standard: Alarm systems; General requirements,
tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
Part 2-13:
Particular requirements for basic safety and essential per-
formance of an anaesthetic workstation
Part 2-55:
Particular requirements for the basic safety and essential
performance of respiratory gas monitors
Technical data
271