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Section 2.0 General Description and Intended Use
The Gyrus ACMI CyberWand Ultrasonic Lithotripsy System is an electromechanical device capable of
fragmenting calculi and aspirating stone debris. It is classified as Class 1 equipment with a Type BF
applied part, per IEC 60601-1. This product conforms to EU Council Directive 93142/EEC for medical
devices.
The CyberWand Ultrasonic Lithotripsy System is intended to be used to fragment urinary tract calculi
in the kidney, ureter, and bladder.
The following items are included in the CyberWand System:
REF
Description
CW-USLS
CyberWand Dual Ultrasonic Lithotripsy System: Includes Generator, Transducer, Footswitch,
Power Cord, 2 Renal/Bladder probe sets, Wrench and Cleaning Stylet (Cleaning rod)
CW-USLG
Generator (100 ~ 240 VAC)
CW-USLT
Transducer (Hand piece)
CW- USLRBP
Renal/Bladder Probe Sets (2) 3.8 mm
CW-USLFS
Footswitch
CW-USLPC
Power Cord
CW-USLW
Wrench
CW-USLCS
Cleaning Stylet
NOTE: The above items can also be ordered separately from Gyrus ACMI.
2.1 Specifications
Generator
Power supply
Voltage
100 ~ 240 VAC
Frequency
50/60 Hz
Physical
Dimensions
31x 12x 28 cm W x H x D
Weight
6 kg
Classification (Electro-Medical)
Protection against electric shock
Class I
Type of applied part
Type BF
Ultrasonic Energy
Frequency
21 kHz±1 kHz
Maximum output
100 W
Footswitch
Physical Specifications
Dimension
20 x 4 x 15 cm W x H x D
Weight
3.18 kg, 7lbs
Length of Cord
3 m
Classification
Degree of water resistance
IPX8 watertight type
(except plug)
Transducer
Housing Dimensions
Diameter
4 cm
Length
17 cm
Weight
300 g
Cable
Length
3 m
Sterilization
Steam or Ethylene Oxide