Table 3 Declaration – electromagnetic immunity
The PlayMakar
®
Therapeutic Wearable System™ is intended for use in the electromagnetic environment
specified below. The customer or the user should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 5%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output lines
±2 kV for power sup-
ply lines
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential
mode
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Voltage dips,
short interrup-
tions and volt-
age variations
on power sup-
ply input lines
IEC 61000-4-11
0 % U
T
; 0 , 5 cycle
At 0o , 45o , 90o , 135o ,
180o , 225o , 270o and 315o
0 % U
T
; 1 cycle
and
70 % U
T
; 25/30 cycle
Single phase: at 0o
0 % U
T
; 0 , 5 cycle
At 0o , 45o , 90o , 135o
, 180o , 225o , 270o
and 315o
0 % U
T
; 1 cycle
and
70 % U
T
; 25/30 cycle
Single phase: at 0o
Mains power quality should be that of a
typical commercial or hospital environ-
ment. If the user of the EQUIPMENT or
SYSTEM requires continued operation
during power mains interruptions, it is
recommended that the EQUIPMENT or
SYSTEM be powered from an uninter-
ruptible power supply or a battery.
36
www.iReliev.com
Содержание PlayMakar
Страница 18: ...18 www iReliev com ...
Страница 41: ...41 www iReliev com ...
Страница 42: ......
Страница 43: ......