Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 9 of 73
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
(Table 204)
Ultrasonic surgical suction system Expected to use in the following electromagnetic environment, buyers or users should ensure
that it uses in the electromagnetic environment:
Immunity test IEC 60601 Test level In line with levels
Electromagnetic environment —
Guide
Electrostatic discharge
GB/T 17626.2
±6 kV Contact discharge
±8 kV Air discharge
±6 kV Contact discharge
±8 kV Air discharge
Floors should be wood,
concrete or ceramic tiles, if the
ground covered with synthetic
material, the relative humidity
should be at least 30%
Electrical fast
transient/burst
GB/T 17626.4
±2 kV On the power supply
line
±1 kV On the input / Output
lines
±2 kV On the power supply
line
±1 kV On the input / Output
lines
Net power supply should be
used in a typical commercial or
hospital environment quality
Surge
GB/T 17626.5
±1 kV Wire to wire
±2 kV Line to ground
±1 kV Wire to wire
±2 kV Line to ground
Net power supply should be
used in a typical commercial or
hospital environment quality
Power supply input voltage
dips, short interruptions
and voltage variations
GB/T 17626.11
< 5% U
T
, Continued 0.5 Cycle
(In the U
T
Shang, > 95% SAG)
40% U
T
, Continued 5 Cycle
(In the U
T
Shang, 60% SAG)
70% U
T
, Continued 25 Cycle
(In the U
T
Shang, 30% SAG)
< 5% U
T
, Continued 5s
(In the U
T
Shang, > 95% SAG)
< 5% U
T
, Continued 0.5 Cycle
(In the U
T
Shang, > 95% SAG)
40% U
T
, Continued 5 Cycle
(In the U
T
Shang, 60% SAG)
70% U
T
, Continued 25 Cycle
(In the U
T
Shang, 30% SAG)
< 5% U
T
, Continued 5s
(In the U
T
Shang, > 95% SAG)
Mains should have a typical
commercial or hospital
environment with quality.
Ultrasonic surgical suction system
user requires continuous
operation during power
interruption, it is recommended
to Ultrasonic surgical suction
system using an uninterruptible
power supply or battery powered
Power frequency magnetic
field ( 50 Hz/60 Hz )
GB/T 17626.8
3 A/m 3 A/m
Power frequency magnetic
fields should have in a typical
commercial or hospital
environment, level of power
frequency magnetic field
characteristics of typical sites
Note: U
T
Before the test voltage applied AC voltage.
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