Emissions And Immunity Information - Welch Allyn RetinaVue 100 Imager Pro Directions For Use Manual

64 General compliance and standards
• However, it is good practice to avoid using the 901103 Imager in extremely close
proximity to other equipment.
• It is not safe to operate the 901103 Imager in the presence of high-frequency
surgical equipment.

Emissions and immunity information

The 901103 is intended for use in the electromagnetic environment specified below. The customer or user of the 901103
should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
a
The 901103 contains a 5-GHz orthogonal frequency-division multiplexing transmitter or a 2.4-GHz frequency hopping
spread-spectrum transmitter for the purpose of wireless communication. The radio is operated according to the
requirements of various agencies, including FCC 47 CFR 15.247 and R&TTE Directive (1995/5/EC). The transmitter is
excluded from the EMC requirements of 60601-1-2, but should be considered when addressing possible interference
issues between this and other devices.
The 901103 is intended for use in the electromagnetic environment specified below. The customer or the user of the
901103 should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
Electromagnetic emissions
Compliance Electromagnetic environment - guidance
Group 1 The 901103 uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
Class B
The 901103 is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage
power supply network that supplies buildings used for domestic
purposes.
Class A
Complies
Electromagnetic immunity
IEC 60601 test level Compliance level
±8 kV contact ±8 kV contact
±15 kV air ±15 kV air
±2 kV for power supply ±2 kV for power supply
lines lines
±1 kV for input/output ±1 kV for input/output
lines lines
± 1 kV differential ± 1 kV differential
mode mode
Welch Allyn RetinaVue™ 100 Imager Pro
WARNING This equipment/system is intended for
use by healthcare professionals only. This
equipment/ system may cause radio interference or
may disrupt the operation of nearby equipment
may be necessary to take mitigation measures, such
as re-orienting or relocating the 901103 or shielding
the location.
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
a
. It