Gyrus Acmi CyberWand CW-USLS User manual

EN
EN
REF CW-USLS
CyberWand™ Dual Ultrasonic Lithotripsy System
Instructions for Use
Products and information available from
Gyrus ACMI, Inc. • 136 Turnpike Road • Southborough, MA 01772-2104 • USA
1-888-524-7266 or 1-763-416-3000 • www.gyrusacmi.com
CyberWand is manufactured by
Cybersonics Inc. • Erie, PA 16510 • USA
:
MediTech Strategic Consultants B.V. • Maastrichterlaan 127-129 • 6291 EN Vaals • The Netherlands • Tel: [phone] • Fax: [phone]
CAUTION: Federal (US) Law restricts this device to sale by or on order of a physician.
80834 REV ED 2010-09
DE
DE
IT
IT
FR
FR
ES
ES
SV
SV
Système de lithotritie ultrasonique à double sonde CyberWand Mode d’emploi
CyberWand Dual-Ultraschall-Lithotripsiesystem Gebrauchsanweisung
Systema ultrasonico a doppia sonda CyberWand per litotripsia Istruzioni per l’uso
Sistema dual de litotricia ultrasónica CyberWand Instrucciones de uso
CyberWands dubbla ultraljudslithotripsi-system Bruksanvisning
NL
NL CyberWand dubbel ultrasoon lithotripsiesysteem Gebruiksaanwijzing

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Table of Contents
Return/Repair/Warranty .................................................................................................. 3
WARNINGS AND CAUTIONS............................................................................................. 3
Section 1.0 Unpacking and Initial Inspection ................................................................ 5
Section 2.0 General Description and Intended Use....................................................... 6
2.1 Specifications .................................................................................................. 6
2.2 Safety Specifications ....................................................................................... 7
2.3 Front Panel....................................................................................................... 8
2.4 Back Panel ....................................................................................................... 8
2.5 Footswitch (REF CW-USLFS) ............................................................................. 8
2.6 Transducer (REF CW-USLT) .............................................................................. 9
2.7 Probe Set (REF CW-USLRBP and CW-RBPBX)................................................... 9
2.8 Cleaning Stylet (REF CW-USLCS) and Wrench (REF CW-USLW)......................... 9
2.9 Symbol Identifications on labeling and unit .................................................. 10
Section 3.0 Assembling the Unit ................................................................................. 10
3.1 Probe/System Tuning .................................................................................... 11
Section 4.0 Operating Instructions.............................................................................. 11
Section 5.0 Cleaning, Disinfection and Sterilization.................................................... 12
5.1 Generator....................................................................................................... 12
5.2 Probes ........................................................................................................... 12
5.3 Transducers ................................................................................................... 12
5.4 Steam Sterilization......................................................................................... 13
5.5 Ethylene Oxide Sterilization............................................................................ 13
5.6 STERRAD™ Sterilization ................................................................................ 13
5.7 Caution........................................................................................................... 13
Section 6.0 Operating and storage environment......................................................... 14
Section 7.0 Preventive Maintenance........................................................................... 14
7.1 General Checks .............................................................................................. 14
7.2 Periodic Safety Checks .................................................................................. 14
Section 8.0 Troubleshooting........................................................................................ 14
8.1 Troubleshooting ............................................................................................. 14
8.2 Fuse Replacement.......................................................................................... 14
Section 9.0 Disposal of Waste Electrical Equipment................................................... 15
Section 10.0 Repair ...................................................................................................... 15
© 2010 Gyrus ACMI, Inc. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of
Gyrus ACMI, Inc.
Gyrus ACMI is a registered trademark of Gyrus ACMI, Inc. and/or its affiliated entities, in the U.S. and/or other countries.
CyberWand is a trademark of Cybersonics, Inc.
STERRAD is a trademark of Johnson & Johnson Medical, Inc.

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Return/Repair/Warranty
Return/Repair
All returns must have prior authorization. To comply with OSHA Bloodborne Pathogen Standard 29
CFR 1910.1030 regulations and U.S. Postal and Transportation law, all used medical devices returned
for repair or replacement must be properly cleaned and decontaminated with a chemical germicide that
has been cleared for use as a “Hospital Disinfectant.” To ensure that the product has been properly
decontaminated, a signed Decontamination Certificate should be enclosed in the package.
All medical devices returned to Gyrus ACMI for any reason must be shipped in accordance with Gyrus
ACMI’s return procedures (available upon request) and all applicable regulations. To obtain a return
authorization number (RMA), return address, and instructions, please call Gyrus ACMI Customer Service
at 1-888-524-7266 or 1-763-416-3000.
Please provide the product part number and lot/serial number. Product should be returned in its original
packaging (when possible) and marked with the RMA number on the exterior of the package.
Limited Express Warranty
SHOULD THE PRODUCT BECOME INOPERABLE DURING NORMAL AND PROPER USE IN ACCORDANCE
WITH APPLICABLE INSTRUCTIONS AND WITHIN THE TIME FRAME SPECIFIED BELOW FROM THE DATE
OF SHIPMENT, GYRUS ACMI WILL REPAIR OR REPLACE THE PRODUCT, AT ITS SOLE OPTION, AT NO
CHARGE. GYRUS ACMI MAKES NO OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND
EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AS TO MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER MATTER. IN NO EVENT SHALL GYRUS ACMI BE
LIABLE FOR ANY CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL GYRUS ACMI BE LIABLE FOR ANY
BREACH OF WARRANTY IN ANY AMOUNT EXCEEDING THE PURCHASE PRICE OF THE PRODUCT.
This warranty applies only to the original purchaser and will be voided if the product(s) are serviced or
repaired by anyone other than Gyrus ACMI or an organization duly authorized by Gyrus ACMI for such
purpose.
Ultrasonic Lithotripters ..................................................................1 year
Accessories ............................................................................... 90 days
WARNINGS AND CAUTIONS
The following warnings and cautions apply to the use, care, and/or maintenance of the Gyrus ACMI®
CyberWand Ultrasonic Lithotripsy System.
Warnings
(Indicate that danger to life or health can result from misusing the equipment)
1. This device should be operated only by or under the direct supervision of a physician
experienced in ultrasonic lithotripter procedures. The user should be thoroughly familiar with the
operation of this device prior to use.
2. This device is designed to function with single-use ultrasonic lithotripsy probes designed
specifically for the CW-USLS generator. Probes are single-use should not be reprocessed for
reuse.
3. Perform the prescribed inspections and operational tests prior to first use and regularly thereafter
to ensure continued satisfactory performance. Do not use a CyberWand Ultrasonic Lithotripter
that fails to meet the criteria stated in the labeling or that has been damaged. Otherwise, injury to
patient, personnel and/or an adverse effect on the procedure could result.
4. When used in an environment containing flammable gasses and high oxygen concentrations, be
aware of the potential for a flammable event. Take routine cautions to prevent this kind of event.
The product is not explosion proof.
5. A potential shock hazard exists when the instrument cabinet is opened. Refer all repairs to
authorized service personnel.
6. Do not adjust electronic circuitry. Contact your local Gyrus ACMI representative or call Gyrus
ACMI customer service at 1-888-524-7266 or 1-763-416-3000.

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7. A continuous outflow of irrigation from the body cavity (operative site) is necessary to prevent
excessive pressure buildup.
8. Never attempt to service the device when it is connected to a power source. Hazardous voltages
inside the device may cause severe electrical shock. Disconnect the power cord before servicing.
9. As a Type BF applied part, this instrument must never be applied directly to the heart and must
not be used in procedures involving cardiac observation or surgery. Do not use electrically active
devices, such as electrosurgical units, on the patient during lithotripsy.
10. The housing of the generator must be properly grounded to ensure safe operation. To reduce the
risk of electric shock, be sure to connect the power cord to a properly grounded 3-pin receptacle.
Do not use a 3-pin /2-pin adapter.
11. The receptacle to which this product is connected should have enough power capacity to fulfill
the total power requirements of all equipment connected to it. If the capacity is insufficient,
the circuit breaker of the medical facility may be tripped, cutting off the power supply to all
equipment connected to the same power source.
12. To minimize the risk of electric shock and generator damage, keep all liquids away from the
generator. If liquid is spilled into this product, immediately stop the procedure and contact Gyrus
ACMI. If the power cord gets wet, fully dry it before use. Otherwise the user may receive an
electric shock.
13. This product is provided with air vents for heat release on the rear panel and bottom. Do not
block the air vents.
14. This product is a precision device; handle it with care. Avoid rough or violent handling, which
may cause equipment damage.
15. If you suspect any abnormality while using this product, immediately stop the procedure, and if
the trouble persists, contact Gyrus ACMI.
16. Keep the tip of probe in the field of view at all times when the CyberWand system is being used.
17. This equipment has been tested and found to comply with the EMC limits for the Medical Device
(EN55011 Class A and EN 60601-1-2 2004). The limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. The equipment generates
and can radiate radio frequency energy and, if not installed and used in accordance with these
instructions, may cause harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference with another device, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
methods:
a. Reorient or relocate the receiving device.
b. Increase the separation between instruments.
c. Connect the equipment into an outlet on a circuit different from that to which the other
devices are connected.
d. Consult the manufacturer or field service technician for help.
18. As with any lithotripter device, adverse events may occur, such as, bleeding and/or damage in
the kidney, and other potential events associated with endoscopy.
19. If a probe breaks during a procedure, use a grasping device to remove it. Always maintain a
spare probe set to finish the procedure.

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CyberWand Dual Ultrasonic Lithotripsy System • Instructions for Use
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Cautions
(Indicate that equipment or other property may be damaged or may malfunction by misuse)
1. Damage (mechanical and electrical) may result if the unit is dropped or struck against another
object.
2. Thoroughly inspect all electrical cables and probes before each use. Do not use if there is any
evidence of deterioration. Replace if any damage or excessive wear is observed.
3. Using the wrench provided, ensure that the probe is tightened on to the transducer before
operation. Before attaching, be sure probe and transducer threads are clean.
4. Do not allow fluids to enter the cabinet. Damage can result.
5. Continuous irrigation and suction must be applied to prevent overheating of the transducer and
probe. Clogs within the probe or transducer must be cleared immediately.
6. Do not allow the probe to press against the scope during the procedure. Pressure on the probe
may stall the transducer and heat the probe within the scope’s working channel.
Section 1.0 Unpacking and Initial Inspection
Proper care and maintenance are critical for safe and effective operation of sophisticated medical
equipment. We recommend careful inspection of all equipment upon receipt and prior to each use as a
safeguard against possible injury to patient or operator.
1. To avoid inadvertent damage, study this manual thoroughly before handling assembling, testing,
using or cleaning the CyberWand unit.
2. Examine the shipping carton and instrument for signs of damage. Any breakage or other
apparent damage should be noted, the evidence retained, and the carrier or shipping agency
notified.
3. Verify that the shipping carton contains the items listed below:
a. CW-USLG Generator
b. CW-USLT Transducer
c. CW-USLPC Power cord
d. CW-USLFS Foot switch
e. CW-USLRBP Renal/bladder probe sets (2) (non-sterile)*
* CW-RBPBX 3-pack, Sterile Renal/Bladder Probes sold separately
f. CW-USLW Wrench
g. CW-USLCS Cleaning Stylet
h. 80834 Instructions for Use
4. Notify Gyrus ACMI Customer Service immediately if any damage or discrepancies are noted.

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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

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Probe Set (Single Use Only)
Physical Dimensions Outside Diameter 3.75 mm
Working Length 40 cm
Tip Excursion 80 ± 20 μm
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 APower 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% UT(>95% dip in UT) for 0.5 cycle
40% UT(60% dip in UT) for 5 cycle
70% UT(30% dip in UT) for 25 cycle
<5% UT(95% dip in UT) 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 UTis the A.C mains voltage prior to application of test level

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General Description of CyberWand Unit and accessories
23
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2.3 Front Panel
1. Power Indicator
Power LED is illuminated when power is applied to the system.
Iindicates power is “ON,” Oindicates power is “OFF.”
2. Tune Indicator
Tune LED, flashing when power is applied, indicates that the
CyberWand system is not tuned and is not ready for use.
3. Ready Indicator
When Ready LED is steady on, the system is tuned and ready for
use.
4. Fault Indicator
Fault LED is illuminated when either the footswitch or the
transducer is disconnected.
5. Footswitch Receptacle
Align the white dots to connect the footswitch to the generator
6. Transducer Receptacle
Align the red dots to connect the transducer to the generator.
2.4 Back Panel
1. Cooling Fans (2) with finger guard
2. Power Receptacle
UL Listed 3-prong hospital grade plug
3. Fuse Holder
CAUTION: Do not block fan during operation; unit will overheat.
1
2.5 Footswitch (REF CW-USLFS)
1. LARGE Pedal Mode (gray)
Depressing LARGE pedal causes the CyberWand system to produce maximum pulse energy to
fragment large stones into smaller stone pieces.
2. SMALL Pedal mode (green)
Depressing SMALL pedal causes the CyberWand system to produce a pulse energy level that
keeps the probe in contact with the smaller stone fragments allowing greater fragmentation.
Small stones are repulsed less when the SMALL pedal is used.
3. Connector plug
4. Cable
2
1
3
4
6
5

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2.6 Transducer (REF CW-USLT)
1. Transducer cover (Nose Cone)
2. Transducer housing contains crystals that produce the piezo-electric ultrasonic energy.
3. Suction Outlet
4. Cable
5. Connector plug
2.7 Probe Set (REF CW-USLRBP and CW-RBPBX)
5
1. Fixed (Inner) Probe
2. Free Mass Ring
3. Floating (outer) Probe
4. Return Spring
2.8 Cleaning Stylet (REF CW-USLCS) and Wrench (REF CW-USLW)
NOTE: these are very important for each case.
34 2
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2

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2.9 Symbol Identifications on labeling and unit
1234
2X T5A 250V
5 6 7
SN
8
9 10 11
#
12
Rx Only
13
Distributed
by
14 15
IO~1. Type BF applied part
2. Power ON
3. Power OFF
4. Alternating current
5. Fuse
6. Footswitch
7. Transducer output
8. Serial Number
9. Instructions for Use
10. Caution, Consult Accompanying Documents.
11. Tested by TUV Product Service to UL60601-1: 2003,
CSA 22.2 No. 601.1-M90
12. Quantity symbol: Numeral in symbol (in place of #)
indicates the quantity of units in package.
13. Caution: Federal (US) Law restricts this device to sale
by or on the order of a physician.
14 Distributed by
15. Reference Directive 2002/96/EC.
(O-Ring)
4
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Section 3.0 Assembling the Unit
1. Disinfect and sterilize transducer, probe, cleaning stylet, and wrench according to the instructions
in Sections 5.2, 5.3, and 5.4. Note: The stylet must be removed from within the probe prior to
disinfection and sterilization.
2. Disconnect the transducer cover (nose cone) from transducer body to expose the probe
attachment screw threads
3. Firmly wipe the threads in the transducer and the mating screw end of the probe with a sterile
4” x 4” gauze pad to remove any moisture and to permit a firm seating.
4. Check to ensure that the Probe set parts are in the correct order before attaching probe to
transducer.
1. Floating (outer) Probe
2. Return Spring
3. Fixed (Inner) Probe
4. Free Mass Ring
First, finger-tighten the Fixed (inner) Probe to the Transducer. Then use the wrench to be sure that
the Fixed Probe is screwed tightly onto the Transducer.
CAUTION: Probe must be secured tightly in transducer to assure good coupling. Loosening of
the probe during operation will decrease or halt lithotripsy action of the probe and may cause
damage.
Caution: If the probe is not properly assembled, seated or tightened into the transducer, it
will not perform properly. Check to ensure that the probe is assembled and seated correctly
prior to use. If the probe does not appear to work effectively, use a cleaning stylet to make sure it
is not obstructed by debris.
Do not use a damaged probe. Probes (REF CW-USLRBP) are supplied non-sterile* and must
be sterilized prior to use. CyberWand probes are designed as single use devices. DO NOT
REUSE. BREAKAGE MAY OCCUR.
* Sterile 3-pack Probe Sets (REF CW-RBPBX) are available, sold separately.

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5. Remove the connector cap covering pins on the transducer cable and connect the transducer to
the generator by aligning the red dots on the transducer connector with those on the transducer
receptacle on the front panel (see photo at left). Push straight in. Check condition of cord and
transducer body. Should repair be necessary, contact Gyrus ACMI Customer Service.
6. Connect aspiration tubing (OD 9mm, ID 6mm) to the port at the rear of the transducer and
connect the other end of the tubing to an appropriate suction source.
7. Connect the footswitch to the generator by aligning the white indicators on the footswitch
connector with those on the footswitch receptacle on the front panel (see photo at left). Push
straight in.
NOTE: It is recommended that the footswitch be protected from contamination by containing it in
a plastic bag.
8. Turn the CyberWand system power ON and verify that the green POWER and TUNE LEDs on the
front panel are illuminated. The TUNE LED should be flashing, indicating that the system is not
tuned.
9. Verify that both fans in the back of the generator are running and that nothing is blocking/
interfering with air intake.
3.1 Probe/System Tuning
Depress either the LARGE or SMALL pedal on the footswitch for approximately 2 seconds or until the
tuning cycle begins, then take foot off the pedal and allow the tuning cycle to run until complete. The
probe vibrates in response to the generator computer tuning program. After pressing the footswitch,
the flashing LED will become solid for the duration of the tuning cycle. Once tuned, the Ready LED will
illuminate, the CyberWand system is then tuned and ready for use.
NOTE: During auto tuning, the tuning sound keeps changing. At the end of tuning, the sound should
be strong. If the sound is weak, it means it is not tuned. Retighten or change the probe set if
needed and retune again. In order to re-tune, it is necesary to turn the generator power off and
then back on. If the problem persists, change the transducer and re-tune.
5
7
Section 4.0 Operating Instructions
This section is intended to provide the operator with instructions on the use of the CyberWand system,
not on how to perform ultrasonic lithotripsy. Be sure a backup probe and backup transducer are
sterilized and available before beginning any ultrasonic lithotripsy procedure.
1. The tip of the probe should be visible at all times while in use.
2. The probe tip should be in contact with the stone while activated.
Note: Position the probe gently against the stone for best fragmentation.
3. Do not contact tissue with the tip or sides of the probe; tissue damage could result.
4. Depending on the stone size, select LARGE stone mode or SMALL stone mode by depressing
right or left foot pedal, respectively.
Notes:
LARGE Stone Mode: Depressing LARGE pedal (gray) causes the CyberWand system to produce
maximum pulse energy to fragment large stones into smaller stone pieces.
SMALL Stone Mode: Depressing SMALL pedal (green) causes the CyberWand system to
produce a pulse energy level that keeps the probe in contact with the smaller stone fragments
allowing greater fragmentation. Small stones are repulsed less when the SMALL pedal is used.
5. Cleaning stylets are provided to clear the probe should obstructions occur. Should the ultrasonic
action lessen during use, remove the suction tubing from the transducer. Pass the cleaning stylet
through the transducer to the probe tip to dislodge any obstruction.
6. Continuous irrigation and suction should be used to avoid overheating the probe and transducer.
Note: Normal physiological saline is the recommended irrigation for ultrasonic lithotripsy.

12 80834 REV ED
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7. Continue fragmentation and suctioning of stone debris until remaining pieces are deemed small
enough to pass, or patient is stone free.
Note: if the performance is weak, or after long periods of running, the system generator should
be turned off and then back on and re-tuned as described in Section 3.1 above.
Warning:
• The tip of the probe must be kept visible at all times when the transducer is activated.
• Do not contact mucosal tissue with the tip of the probe as tissue damage may occur.
Caution
• A back-up transducer and probe set should be sterilized and available prior to beginning a
procedure.
• Continuous irrigation and suction is necessary for proper operation of the CyberWand system.
Section 5.0 Cleaning, Disinfection and Sterilization
The following cleaning, disinfection, and sterilization procedures are recommended by Gyrus ACMI.
Use of any procedures not expressly recommended by Gyrus ACMI may adversely affect or damage
Gyrus ACMI devices and may void Gyrus ACMI’s Limited Express Warranty.
Follow all applicable bloodborne pathogen procedures as indicated by OSHA and/or your hospital
requirements when cleaning, disinfecting, and/or sterilizing instruments and accessories.
5.1 Generator
1. Turn off power to the unit and remove the power cord before cleaning.
2. Wipe generator cabinet, front panel, power cord, and footswitch with a sponge (or towel) lightly
moistened with a mild soap solution. Follow with a sponge (or towel) lightly moistened with clear
tap water. Dry completely.
3. Avoid using chemical or abrasive cleaning agents, which can damage the finish.
4. Wipe the transducer cable with a gauze pad (or towel) dampened with a mild soap solution.
Remove the soap solution with a gauze pad (or towel) lightly moistened with clear tap water. Dry
completely.
5.2 Probes
CyberWand probes are intended for single use. Discard after each procedure. Reuse may result in
breakage of the probe.
5.3 Transducers
After each use or prior to placing in a disinfectant or sterilizer, carefully inspect transducer and cable
for tears, cracks or other signs of damage. Do not use damaged equipment.
1. Remove the transducer connector from the generator and place the connector cap over pins.
2. Remove the cover (nose cone) of the transducer (REF CW-USLT) by unscrewing
counterclockwise.
3. Fully immerse both the transducer and its cover (nose cone) in an enzymatic cleaning solution
that is formulated to dissolve proteinaceous material. Follow the manufacturer’s written
instructions for dilution, temperature, and time. Warm water (100–120°F or 38–49°C) should
be used; water above these temperatures can make proteins difficult to remove from the
instruments. Do not use dishwashing detergents, skin cleansers, or any other cleaning agent not
designed to dissolve protein. Avoid using chemical or abrasive cleaners that could damage the
finish.
4. Scrub instrument with a soft brush.
5. Rinse all components thoroughly in warm tap water to remove all traces of cleaning solution;
then towel dry.

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5.4 Steam Sterilization
Thoroughly clean, rinse, and dry transducers, probes, cleaning stylet, and wrench prior to sterilization.
CyberWand components may be sterilized in a steam sterilizer controlled within the following
parameters:
Probe Sets
Prevacuum Transducer Prevacuum
(polypropylene double wrapped)
Temp: °F 270 270
°C 132 132
Vacuum 20-28 in Hg 20-28 in Hg
Pressure 25-28 psig 25-28 psig
Exposure (minimum) 4 minutes 60 minutes
5.4.1 Caution
Never rinse the CyberWand components with cooled water for speedy cooling after sterilization.
Sudden changes in temperature may damage the components.
NOTE:
• Both sterile (REF CW-RBPBX) and non-sterile (REF CW-USLRBP) probes are identical.
• All sterile and non-sterile probes are single-use.
• Sterile probes can be steam sterilized with the same method as non-sterile probes if opened and
unused.
• See the Instructions for Use for the sterile probes for more details.
5.5 Ethylene Oxide Sterilization
The transducer, probe, cleaning stylet, and wrench can be sterilized in an ethylene oxide (EO) sterilizer.
1. Thoroughly clean, rinse, and dry prior to sterilization.
2. The devices can be placed in an ethylene oxide (EO) sterilizer controlled within the following
parameters:
EO (100%)
Temp °F (°C): 131 (55)
Rel. Humidity: > 35%
Vacuum: 2–3 psia (0.14 – 0.20 bar)
Preconditioning Time: ≥30 minutes
Gas Conc.: 725–750 mg/l
Exposure: ≥60 minutes
3. After EO exposure, aerate for a minimum of 12 hours at 131°F (55°C) in a mechanical aerator.
5.6 STERRAD™ Sterilization
DO NOT USE STERRAD TO STERILIZE TRANSDUCER. STERRAD sterilization has not been tested for,
submitted to, or cleared by the FDA for transducer, probe, or component sterilization.
5.7 Caution
CyberWand transducer components can be processed until they exhibit evidence of deterioration, such
as cracking on the transducer or broken insulation on the cable. At such time they must be removed
from use and discarded. Please refer your facility’s procedure for medical waste disposal. Check
carefully for cracking and broken cable after each sterilization.

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Section 6.0 Operating and storage environment
Operating environment Ambient temperature 10 – 40°C
Relative humidity 30% – 70%
Air Pressure 70 – 106 kPa
Storage environment Ambient temperature -25 – +55°C
Relative humidity 10% – 85%
Air Pressure 70 – 106 kPa
Section 7.0 Preventive Maintenance
7.1 General Checks
The operator should ensure the generator and all cables and all components on transducer are
undamaged prior to beginning any procedure.
7.2 Periodic Safety Checks
The safety checks should be performed at least every 24 months. The inspection can only be
performed by a person who has adequate training. knowledge, and practical experience. All the
equipment used in safety check must be calibrated. Gyrus ACMI recommends returning the unit for
safety inspection or contact your local representative for information about maintenance contracts.
Section 8.0 Troubleshooting
8.1 Troubleshooting
Irregular Description Possible cause Solution
Power indicator LED is not
illuminated.
The power cord is not securely
plugged into a receptacle
Connect power cord into receptacle.
Note: Ensure the power switch is at OFF
position before plugging in.
The power cord is not securely
plugged into generator
Connect power cord into generator.
Note: Ensure the power switch is at OFF
position before plugging in.
Power switch is not turned ON Turn the switch ON.
The fuse has blown Replace fuse as described in 8.2 Fuse
Replacement below.
Fault Indicator light is
illuminated.
Footswitch is not plugged into
generator
Plug footswitch into generator.
Note: Ensure the power switch is at OFF
position before plugging in.
Transducer is not plugged into
generator
Plug transducer into generator.
Note: Ensure the power switch is at OFF
position before plugging in.
Poor performance or low
power
• Mis-tuned probe
• Loose Probe
• Re-tune system (Section 3.1).
• Retighten probe and re-tune system.
8.2 Fuse Replacement
Warning:
Ensure that the power cord is disconnected from the instrument before opening the fuse holder.
1. Remove the fuse holder with a flat screwdriver, to expose fuse
2. Replace the blown fuse with a new fuse (TYPE T 250V 5A).
3. Replace the fuse holder securely into the generator.

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Section 9.0 Disposal of Waste Electrical Equipment
It is the sole responsibility of the user/user facility to properly dispose of equipment in a safe manner
consistent with all compliance guidelines, applicable policies and procedures, statutes, and regulations
that govern waste electrical equipment discarded by their facility in conjunction with all applicable
local, city, county, town, state, or country specific codes for waste management.
The safe disposal of waste electrical equipment should be undertaken only at the end of the
equipment’s useful life (i.e., the device is nonfunctional & nonrepairable), and should be undertaken in
an environmentally conscious manner minimizing environmental impact.
It is the sole responsibility of the user/user facility to determine whether waste electrical equipment
should be collected and disposed separately from or together with unsorted municipal waste.
Public or private solid waste collection and disposal facilities that offer various forms of recovery
(dismantling, reuse, and recycling, where possible) should be selected reducing the amount of waste
being discarded and providing the highest level of protection for human health and the environment.
It is the sole responsibility of the user/user facility to determine the conditions under which the waste
electrical equipment is to be collected, noting that items contaminated by the user may require
confirmed decontamination by means of the best available treatment options.
Section 10.0 Repair
This product does not contain any user serviceable parts. Do not disassemble, modify or attempt to
repair it; patient or user injury and/or equipment damage can result.
Some problems that appear to be malfunctions may be correctable by referring to Section 8.0
Troubleshooting.
A technical manual is available upon request for Biomedical Technicians.
NOTE: Do not open transducer or generator systems. A technical manual is to help in troubleshooting
the problems or to help in the diagnosis if the part or system is returned for repairs.

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Mode d’emploi
REF CW-USLS
Système de lithotritie ultrasonique à double sonde CyberWand
Produits et informations disponibles auprès de :
Gyrus ACMI, Inc. • 136 Turnpike Road • Southborough, MA 01772-2104 • USA
1-888-524-7266 ou 1-763-416-3000 • www.gyrusacmi.com
CyberWand est fabriqué par :
Cybersonics Inc. • Erie, PA 16510 • USA
:
MediTech Strategic Consultants B.V. • Maastrichterlaan 127-129 • 6291 EN Vaals • Pays-Bas • Tél. : [phone] • Fax : [phone]
80834 REV ED 2010-09

2 80834 REV ED
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Table des Matières
Retour/Réparation/Garantie.............................................................................................3
AVERTISSEMENTS...........................................................................................................3
Section 1.0 Ouverture de l’emballage et inspection initiale..........................................5
Section 2.0 Description générale et utilisation prévue..................................................6
2.1 Spécifications.............................................................................................6
2.2 Normes de sécurité....................................................................................7
2.3 Panneau de devant.....................................................................................8
2.4 Panneau arrière .........................................................................................8
2.5 Pédale de commande (REF CW-USLFS) ......................................................8
2.6 Transducteur (REF CW-USLT) ......................................................................9
2.7 Jeu de sondes (REF CW-USLRBP et CW-RBPBX).........................................9
2.8 Stylet de nettoyage (REF CW-USLCS) et clé (REF CW-USLW).......................9
2.9 Identification des symboles sur l’étiquetage et l’unité .............................10
Section 3.0 Montage de l’unité....................................................................................10
3.1 Réglage de la sonde/du système..............................................................11
Section 4.0 Instructions d’utilisation...........................................................................11
Section 5.0 Nettoyage, désinfection et stérilisation ....................................................12
5.1 Générateur ...............................................................................................12
5.2 Sondes .....................................................................................................12
5.3 Transducteurs...........................................................................................12
5.4 Stérilisation à la vapeur ..........................................................................13
5.5 Stérilisation à l’oxyde d’éthylène .............................................................13
5.6 Stérilisation par le système STERRAD .....................................................13
Section 6.0 Cadre d’utilisation et de rangement .........................................................14
Section 7.0 Maintenance préventive...........................................................................14
7.1 Vérifications générales ............................................................................14
7.2 Vérifications de sécurité ponctuelles .......................................................14
Section 8.0 Dépannage...............................................................................................14
8.1 Dépannage...............................................................................................14
8.2 Remplacement des fusibles .....................................................................14
Section 9.0 Élimination des déchets électriques.........................................................15
Section 10.0 Réparation................................................................................................15

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Système de lithotritie ultrasonique à double sonde CyberWand • Mode d’emploi
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Retour/Réparation/Garantie
Retour/réparation
Tous les retours doivent avoir obtenu une autorisation préalable. Pour satisfaire aux règlements de la norme sur les
pathogènes à diffusion hématogène 29 CFR 1910.1030 de l’OSHA et à la législation américaine sur les transports et
les envois postaux, tous les dispositifs médicaux déjà utilisés et retournés pour réparation ou échange doivent avoir
été soigneusement nettoyés et décontaminés avec un germicide chimique agréé pour utilisation comme « désinfectant
hospitalier ». Pour assurer que le produit a été correctement décontaminé, un certificat de décontamination signé doit être
inclus dans le colis.
Tous les dispositifs médicaux retournés à Gyrus ACMI, quelle qu’en soit la raison, doivent être envoyés conformément
aux procédures de retour de Gyrus ACMI (disponibles sur demande) et aux réglementations en vigueur. Pour obtenir un
numéro d’autorisation de retour, l’adresse du retour et les instructions applicables, appeler le service clientèle de Gyrus
ACMI au 1-888-524-7266 ou 1-763-416-3000.
Fournir la référence et le numéro de lot ou de série du produit. Les produits retournés doivent être envoyés dans leur emballage
d’origine (lorsque cela est possible) et marqués du numéro d’autorisation de retour sur l’extérieur de l’emballage.
Garantie expresse limitée
SI LE PRODUIT DEVIENT INUTILISABLE PENDANT SON USAGE NORMAL ET CORRECT, SELON LES INSTRUCTIONS
APPLICABLES ET DANS LE DÉLAI SPECIFIE CI-DESSOUS COMPTE À PARTIR DE LA DATE D’EXPÉDITION, GYRUS ACMI
REPARERA OU REMPLACERA, AU CHOIX, LE PRODUIT GRATUITEMENT. GYRUS ACMI N’OFFRE AUCUNE AUTRE GARANTIE
SUR LES PRODUITS ET DENIE EXPRESSEMENT TOUTE AUTRE GARANTIE, EXPRESSE OU IMPLICITE, CONCERNANT
LA VALEUR MARCHANDE, L’ADAPTATION A UN USAGE PARTICULIER OU TOUTE AUTRE CONSIDERATION. EN AUCUNE
CIRCONSTANCE GYRUS ACMI N’ASSUMERA DE RESPONSABILITE POUR TOUT DOMMAGE INDIRECT. GYRUS ACMI NE
SERA EN AUCUN CAS TENU RESPONSABLE D’UNE RUPTURE DE LA GARANTIE POUR TOUT MONTANT DÉPASSANT LE
PRIX D’ACHAT DU PRODUIT.
Cette garantie s’applique seulement à l’utilisateur d’origine et peut être annulée si la maintenance ou la réparation du ou
des produits est effectuée par quiconque autre que Gyrus ACMI ou qu’une organisation dûment autorisée à cet effet par
Gyrus ACMI.
Lithotriteurs ultrasoniques ...................................................................... 1 an
Accessoires ......................................................................................90 jours
AVERTISSEMENTS
Les mises en garde et avertissements suivants concernent l’utilisation, l’entretien et/ou la maintenance du
système de lithotritie ultrasonique CyberWand Gyrus ACMI.
Mises en garde
(Indiquent qu’une mauvaise utilisation de l’équipement peut présenter un danger.)
1. L’appareil ne doit être utilisé que par ou sous la supervision directe d’un médecin expérimenté
au niveau des procédures de lithotritie ultrasonique. L’utilisateur doit être bien familiarisé avec le
fonctionnement de l’appareil avant de l’utiliser.
2. Cet appareil est conçu pour fonctionner avec des sondes de lithotritie ultrasoniques à usage
unique, spécifiquement destinées à être utilisées avec le générateur CW-USLS. Les sondes sont
à usage unique et ne peuvent pas être traitées afin d’être réutilisées.
3. Effectuez les inspections prescrites et les tests opérationnels avant la première utilisation, puis
régulièrement, afin de garantir que les résultats sont toujours satisfaisants. Ne pas utiliser de
lithotriteur ultrasonique CyberWand ne répondant pas aux critères spécifiés sur l’étiquetage
ou ayant été endommagé. Sinon, cela peut blesser les patients, le personnel et/ou avoir des
conséquences préjudiciables sur la procédure.
4. En cas d’utilisation dans un environnement contenant des gaz inflammables et des
concentrations élevées en oxygène, il faut être attentif au risque de flammes. Prenez les
précautions habituelles pour éviter ce type d’incident Ce produit n’est pas antidéflagrant.
5. Il existe un risque potentiel de choc lorsque le boîtier de l’instrument est ouvert. Il est nécessaire
de soumettre toute réparation au personnel de maintenance.
6. Ne pas ajuster les circuits électroniques. Contacter votre représentant Gyrus ACMI local ou
appeler le service à la clientèle Gyrus ACMI au 1-888-524-7266 ou 1-763-416-3000.

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7. Un débit continu d’irrigation de la cavité corporelle (champ opératoire) est nécessaire pour
prévenir l’accumulation de pression excessive.
8. Ne jamais essayer de réparer l’appareil lorsqu’il est branché sur une source d’alimentation
électrique. Des tensions internes dangereuses risquent de provoquer des décharges électriques
graves. Débrancher le cordon d’alimentation électrique avant de le réparer.
9. En tant que pièce appliquée de type BF, cet instrument ne doit jamais être appliqué directement
sur le cœur ni être utilisé au cours de procédures impliquant une intervention chirurgicale ou une
observation cardiaque. Ne pas utiliser d’instruments actifs électroniquement, comme des unités
électro chirurgicales, sur le patient au cours d’une lithotritie.
10. Le boîtier du générateur doit être correctement mis à terre pour garantir un fonctionnement sans
risque. Pour réduire le risque de choc électrique, veiller à connecter le cordon d’alimentation à
une prise à 3 broches correctement mis à terre. Ne pas utiliser d’adaptateur à 3 broches / 2
broches.
11. La prise dans laquelle est branché ce produit doit avoir une puissance suffisante pour remplir
l’ensemble des exigences de puissance de tout l’équipement qui lui est relié. Si la capacité
est insuffisante, le coupe-circuit de l’installation médicale peut être déclenché, coupant ainsi
l’alimentation électrique pour tout l’équipement relié à la même source d’énergie.
12. Pour limiter le risque de choc électrique et de dommages au générateur, laisser tous les liquides
à l’écart de ce dernier. Si un liquide se renverse dans ce produit, il faut immédiatement arrêter
la procédure et contacter Gyrus ACMI. Si le cordon d’alimentation est mouillé, le sécher
complètement avant utilisation. Sinon, l’utilisateur peut recevoir un choc électrique.
13. Ce produit est fourni avec des évents sur les panneaux arrière et en bas, pour permettre a la
chaleur de s’échapper, Ne pas obstruer les évents.
14. Ce produit est un instrument de précision ; le manipuler avec soin. Eviter toute manipulation
brusque ou violente pouvant endommager l’équipement.
15. En cas de suspicion d’anomalie lors de l’utilisation de ce produit, arrêtez immédiatement la
procédure et, si le problème persiste, contacter Gyrus ACMI.
16. Laissez toujours l’extrémité de la sonde dans le champ de vision lorsque le système CyberWand
est en cours d’utilisation.
17. Cet équipement a été testé et jugé conforme aux limites de compatibilité électromagnétique
(CEM) pour les instruments médicaux (EN55011 Classe A et EN 60601-1-2 2004). Ces limites
sont conçues pour fournir une protection raisonnable contre les interférences dangereuses dans
une installation médicale conventionnelle. Cet appareil génère et diffuse de l’énergie de radio
fréquence qui peut créer des interférences nuisibles pour d’autres appareils installés à proximité
s’il n’est pas installé et utilisé conformément aux instructions. Cependant, il est impossible
de garantir qu’aucune interférence ne se produira dans une installation particulière. Si cet
équipement produit des interférences dangereuses avec un autre instrument, ce qui peut être
déterminé en fermant l’équipement puis en le rallumant, l’utilisateur est encouragé à essayer de
corriger l’interférence grâce à une ou plusieurs des méthodes suivantes :
a. Réorienter ou déplacer l’appareil de réception.
b. Augmenter la distance entre les instruments.
c. Brancher l’équipement dans une prise de circuit différente de celle à laquelle l’autre appareil
est relié.
d. Consulter le fabriquant ou le technicien de maintenance pour obtenir de l’aide.
18. Comme avec tout instrument de lithotritie, des événements indésirables peuvent se produire,
comme un saignement et/ou un dommage aux reins ou d’autres événements potentiels liés à
l’endoscopie.
19. Si une sonde se rompt au cours d’une procédure, utiliser un instrument de préhension pour la
retirer. Gardez toujours un jeu de sondes de rechange pour terminer la procédure.