EarlyVue VS30 Instructions for Use 16-21
Radio Regulatory Compliance
European Union
This device complies with the essential requirements of the Radio Equipment Directive:
2014/53/EU. The following test methods have been applied in order to prove
presumption of conformity with the essential requirements of this directive:
• EN 60950-1:2006+A11+A1:2010+A12:2011
Safety of Information Technology Equipment
• EN 300 328 v2.1.1
Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband
Transmission systems; Data transmission equipment operating in the 2.4 GHz ISM
band and using spread spectrum modulation 2014/53/EU.
• EN 301 489-1 v2.2.0
Electromagnetic compatibility and Radio Spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio equipment and services; Part 1: Common
technical requirements
• EN 301 489-17 v3.2.0
Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio equipment and services; Part 17: Specific
conditions for 2,4 GHz wideband transmission systems and 5 GHz high performance
RLAN equipment
• EN 301 893 v2.1.1
Electromagnetic compatibility and Radio spectrum Matters (ERM); Broadband Radio
Access Networks (BRAN); Specific conditions for 5 GHz high performance RLAN
equipment
• EU 2011/65/EU (RoHS)
Declaration of Compliance – EU Directive 2011/65/EU; Reduction of Hazardous
Substances (RoHS)
This device is a 2.4 GHz wideband transmission system (transceiver), intended for use in
all EU member states and EFTA countries, except in France and Italy where restrictive
use applies.
In Italy the end-user should apply for a license at the national spectrum authorities in
order to obtain authorization to use the device for setting up outdoor radio links and/or
for supplying public access to telecommunications and/or network services.
This device may not be used for setting up outdoor radio links in France and in some
areas the RF output power may be limited to 10 mW EIRP in the frequency range of 2454
- 2483.5 MHz. For detailed information the end-user should contact the national
spectrum authority in France.
Philips Medical Systems hereby declares that the EarlyVue VS30 patient monitors are
in compliance with Directive 2014/53/EU, The full text of the Declaration of
Conformity is available on the Philips InCenter website
(https://incenter.medical.philips.com).