User's Manual

NaviCam Small Bowel Capsule Endoscopy System
User Manual P a g e |
91
ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1
10.5.2 Capsule
Guidance and manufacturer’s declaration - electronicemissions
The Capsules are intended for use in the electromagneticenvironment specified below.
The user of the Capsules should assure that it is used insuch an environment.
Emissions test Compliance Electromagnetic environment - guidance
Radiated
emissions
CISPR 11
Group 1 The Capsules 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.
Conducted
emissions
CISPR 11
Class B
Harmonic
Emissions IEC
61000-3-2
N/A
The Capsules are 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.
Voltage
fluctuations
and flicker
emissions
IEC 61000-3-3
N/A
Guidance and manufacturer’s declaration - electromagneticimmunity
The Capsules are intended for use in the electromagneticenvironment specified below.
The user of the Capsules should assure that it is used insuch an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic
environment -
guidance
Electrostatic
discharge
IEC 61000-4-2
±8 kV
contact
discharge
±2~15 kV air
discharge
±8 kV
Horizontal
Coupling
±8 kV Vertical
Coupling
±8 kV
contact
discharge
±2~15 kV air
discharge
±8 kV
Horizontal
Coupling
±8 kV Vertical
Coupling
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.