80834 REV ED
7
CyberWand Dual Ultrasonic Lithotripsy System • Instructions for Use
EN
EN
Probe Set (Single Use Only)
Physical Dimensions
Outside Diameter
3.75 mm
Working Length
40 cm
Tip Excursion
80 ± 20
μ
m
Material
Probe (Fixed & floating)
300 Series Stainless steel
Free mass ring
Stainless steel
Spring
Stainless steel
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
Electromagnetic Environment
RF emission CISPR 11
Group 1
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.
RF emission CISPR 11
Class A
Harmonic emission
IEC 61000-3-2 and
61000-3-2
Complies
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.
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
± 6 kV contact
± 8 kV air
C
Floors should be wood, concrete or tiled
(ceramic). If the floor is covered with syn-
thetic material, the relative humidity must
be at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
± 2 kV for power supply line
A
Power quality should be that of a typical
commercial or hospital environment
Surge
IEC 6100-4-5
± 1 kV differential
± 2 kV common mode
A
Power quality should be that of a typical
commercial or hospital environment
Voltage dip, short
interruptions and voltage
variations on power sup-
ply input lines
IEC 61000-4-11
<5%
U
T
(>95% dip in
U
T
) for 0.5 cycle
40%
U
T
(60% dip in
U
T
) for 5 cycle
70%
U
T
(30% dip in
U
T
) for 25 cycle
<5%
U
T
(95% dip in
U
T
) for 5 sec
A
Power quality should be that of a typical
commercial or hospital environment. If
the user requires continued operation
during power mains interruptions. It is
recommended that the CyberWand system
be powered from an uninterrupted power
supply.
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
3A/m
A
Magnetic fields in the network frequency
should correspond to the typical
values found in business and hospital
environments.
Note
U
T
is the A.C mains voltage prior to application of test level
