Emission Of High-Frequency Energy - Dräger Oxylog VE300 Instructions For Use Manual

Technical data
Immunity against
Voltage dips and short interruptions on
AC mains input lines (IEC 61000-4-11)
Radiated high-frequency disturbances
(IEC 61000-4-3)
Conducted radio frequency
(IEC 61000-4-6)
Electromagnetic fields in the vicinity of
wireless communication devices
15.11.3 Recommended separation distances from wireless
communication devices
To ensure that the functional integrity of this device is maintained, there must be a
separation distance of at least 1.0 m (3.3 ft) between this device and wireless
communication devices.
15.12

Emission of high-frequency energy

15.12.1 Bluetooth
This medical device is equipped with a Bluetooth module for wireless
communication. Changes or modifications to the Bluetooth module may only be
carried out by experts.
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 such as IEC 60601-1-2 and
standards for radio equipment such as EN 300328, and have been defined by
regulatory authorities.
The Bluetooth module of this medical device complies with Part 15 of the FCC
regulations and Industry Canada license-exempt RSS standards. Operation is
subject to the following 2 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.
Changes or modifications that are not expressly approved by Dräger may void the
user's authority to operate the device.
Dräger hereby declares that this medical device and the radio equipment is in
compliance with Directive 2014/53/EU.
The complete EU Declaration of Conformity can be viewed at the following web
address: http://www.draeger.com/doc-radio
122
Test level and required electromag-
netic environment
Voltage dips of 30 % to 100 %, 8.3 ms to
5 s, different phase angles
80 MHz to 2.5 GHz: 30 V/m
2.5 GHz to 2.7 GHz: 10 V/m
The CO sensor with RI ≤15 has a lower
2
compliance level (20 V/m) but will fail in
safe mode.
150 kHz to 80 MHz: 3 V,
ISM bands: 10 V
Diverse frequencies from 380 MHz to
5800 MHz: 9 V/m to 28 V/m
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Instructions for use Oxylog VE300 SW 1.n