Safety Specifications - Gyrus Acmi CyberWand CW-USLS Mode D'emploi

80834 REV ED
Probe Set (Single Use Only)
Physical Dimensions Outside Diameter
Working Length
Tip Excursion
Material Probe (Fixed & floating)
Free mass ring
Spring
Sterilization Steam or Ethylene Oxide
2.2

Safety Specifications

Meets IEC 60601-1, UL60601-1, CSA 22.2 No 601-1.
EN60601-1-2, EN55011.
Electromagnetic Emission Declaration
The CyberWand system is intended for use in the electromagnetic environment specified below. The customer or user of the
CyberWand system should assure that it is used in such an environment
Emission Test Compliance
RF emission CISPR 11 Group 1
RF emission CISPR 11 Class A
Harmonic emission
IEC 61000-3-2 and Complies
61000-3-2
Electromagnetic Immunity Declaration
The CyberWand system is intended for use in the electromagnetic environment specified below. The customer or user of
CyberWand system should ensure that it is used in such an environment
Immunity Test IEC 60601 test level
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst ± 2 kV for power supply line
IEC 61000-4-4
Surge ± 1 kV differential
IEC 6100-4-5 ± 2 kV common mode
Voltage dip, short
interruptions and voltage
<5% U (>95% dip in U
variations on power sup-
T
40% U (60% dip in U
ply input lines
T
70% U (30% dip in U
IEC 61000-4-11
T
<5% U
T
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Note U is the A.C mains voltage prior to application of test level
T
CyberWand Dual Ultrasonic Lithotripsy System • Instructions for Use
3.75 mm
40 cm
80 ± 20 μm
300 Series Stainless steel
Stainless steel
Stainless steel
Electromagnetic Environment
The CyberWand system 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 electric equipment.
The CyberWand system is suitable for use in all establishments, other than
domestic establishments and those directly connected to a low voltage
power supply network that supplies building used for domestic purposes.
Floors should be wood, concrete or tiled
± 6 kV contact (ceramic). If the floor is covered with syn-
C
± 8 kV air thetic material, the relative humidity must
be at least 30%.
Power quality should be that of a typical
A commercial or hospital environment
Power quality should be that of a typical
A
commercial or hospital environment
Power quality should be that of a typical
commercial or hospital environment. If
) for 0.5 cycle
the user requires continued operation
T
) for 5 cycle
A during power mains interruptions. It is
T
) for 25 cycle
recommended that the CyberWand system
T
(95% dip in U ) for 5 sec
be powered from an uninterrupted power
T
supply.
Magnetic fields in the network frequency
should correspond to the typical
3A/m A
values found in business and hospital
environments.
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