Device Combinations; Emission Of High-Frequency Energy - Dräger Perseus A500 Instructions For Use Manual

Emission of high-frequency energy

This medical device is equipped with an RFID
system for wireless communication with Infinity ID
accessories.
This medical device has been designed and
manufactured so that emission limit values for
high-frequency energy are not exceeded. These
limit values are incorporated in international safety
standards like IEC 60601-1-2 which have been
defined by regulation authorities, such as the
Federal Communications Commission (FCC
Rules), Industry Canada (Radio Standards
Specifications), and the European
Telecommunications Standards Institute (ETSI
standards).
The RFID system of this medical device complies
with Part 15 of the FCC regulations and its
operation is subject to the following conditions:
1 This medical device does not cause any
harmful interference.
2 The medical device will not suffer damage
when receiving interference, including
interference causing undesired operating
conditions.

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 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-
Instructions for use Perseus A500 SW 1.1n
Dräger hereby declares that the RFID components
comply with the basic requirements and the other
pertinent regulations of Directive 1999/5/EC.
A copy of the declaration of compliance can be
obtained through the local distribution company.
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)
Technical data
233