User's Manual
NaviCam Small Bowel Capsule Endoscopy System
User Manual P a g e |
89
ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1
Guidance and manufacturer’s declaration - electromagneticimmunity
The Data Recorder is intended for use in the electromagnetic environment specifiedbelow.
The user of the Data Recorder should assure that it is used in such anenvironment.
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
d
ischarge
±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%.
Electrical fast
transient/burst
IEC
61000-4-4
±2 kV for power supply
Lines
±1 kV for input/output
Lines
±2 kV for power supply Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge IEC/EN
61000-4-5
±0.5 kV, ±1 kV line(s) to
line(s)
±0.5 kV, ±1 kV, ±2 kV
line(s) to earth
±0.5 kV, ±1 kV, ±2 kV
line(s) to earth
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power
supply input
Lines
IEC 61000-4-11
Voltage dips：
0% U
T
; 0.5
cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° ,315°
0% U
T
; 1 cycle
and
70%
U
T
; 25/30 cycles
Single phase: at 0°
Voltage dips：
0% U
T
; 0.5
cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° ,315°
0% U
T
; 1 cycle
and
70%
U
T
; 25/30 cycles
Single phase: at 0°
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the Data Recorder requires
continued operation during
power mains interruptions, it
is recommended that the
Data Recorder be powered
from an un-interruptible
power supply or a battery.
Voltage
interruptions
0% U
T
; 250/300
cycle
Voltage interruptions
0%
U
T
; 250/300
cycle
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.