Restrictions For Use; Emissions And Immunity; Guidance And Manufacturer's Declaration - Philips SureSigns VS1 Manuel D'utilisation

Restrictions for Use

Artifact on physiological waveforms caused by electromagnetic interference should be evaluated by a
physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or
treatment.

Emissions and Immunity

The VS1 monitor is designed and evaluated to comply with the emissions and immunity requirements of
international and national EMC standards. See Tables 1 through 4 for detailed information regarding
declaration and guidance.
The EMC standards state that manufacturers of patient-coupled equipment must specify immunity levels
for their systems. See Tables 2 and 3 for this detailed immunity information. See Table 4 for recommended
minimum separation distances between portable and mobile communications equipment and the VS1
monitor.
Immunity is defined in the standard as the ability of a system to perform without degradation in the
presence of an electromagnetic disturbance. Degradation in system performance is a qualitative assessment
which can be subjective.
Caution should, therefore, be taken in comparing immunity levels of different devices. The criteria used for
degradation is not specified by the standard and can vary with the manufacturer.

Guidance and Manufacturer's Declaration

The VS1 monitor is intended for use in the electromagnetic environment specified in the following tables.
The customer or the user of the monitor should assure that it is used in such an environment.
Emissions Test
Radio Frequency (RF)
emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
A-2
Electromagnetic Compatibility
Table A-1. Electromagnetic Emissions
Compliance Electromagnetic Environment Guidance
Group 1 The VS1 monitor uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and not likely to cause any interference
in nearby electronic equipment.
Class B
Class B The VS1 monitor is suitable for use in all
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Complies