Byron LySonix 3000 User manual

Byron Medical’s
LySonix 3000
®
with PulseSelect
™
Operation
Manual
3000G

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 2 of 43 Rev B
TABLE OF CONTENTS
1. SAFETY
Summary of Safety Notices (Warnings and Precautions) 5
2. GENERAL INFORMATION
2.1 Description of the System 8
2.2 Concept and Principles of Operation 8
2.3 Functional Components of the System 9
2.4 Controls and Indicators 11
2.5 Indications for Use 18
2.6 Device Specifications 18
3. UNPACKING INSTRUCTIONS
3.1 Reusables (Non-Sterile) 20
4. SYSTEM ASSEMBLY AND SET-UP
4.1 System Components Preparation 21
4.2 System Assembly 22
5. SYSTEM TEST 24
6. INSTRUCTIONS FOR PulseSelect
™
6.1 Explanation of Front Panel with PulseSelect Feature 26
6.2 Set-up 26
6.3 System Test 26
6.4 Selection of Pulse Duration 27
6.5 Pulse Setting 28
7. SYSTEM TROUBLESHOOTING
7.1 Troubleshooting Guide 29
7.2 Mechanical Limit 30
7.3 Electrical Fault 30
8. SYSTEM DISASSEMBLY AND MAINTENANCE
8.1 Cleaning and Sterilization 31
8.2 Reuse Life of Components 33
8.3 Deviations form Cleaning and Sterilization Instructions 33
8.4 Technical Assistance 34
9. SERVICE, REPAIR, AND TECHNICAL CORRESPONDENCE
9.1 Fuse Replacement 35
9.2 Repair Service and Replacement Parts 35

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 3 of 43 Rev B
TABLE OF CONTENTS
9. SERVICE, REPAIR, AND TECHNICAL CORRESPONDENCE (continued)
9.3 Modifications 36
9.4 Damage or Loss In Shipment 36
9.5 Incorrect Items Shipped by Byron Medical 36
9.6 Policy On Returned Goods 36
Figure 1 PRINCIPLES OF OPERATION 12
Figure 2 HANDPIECE PROBE ASSEMBLY 13
Figure 3 FRONT PANEL 14
Figure 4 REAR PANEL 15
Figure 5 EXPLANATION OF SYMBOLS 16
Figure 6 FUSE REPLACEMENT PROCEDURE 17
 2003 by Byron Medical
Byron Medical reserves all rights to this document. No part of this manual may be reproduced, stored,
or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, etc.)
without prior written permission of Byron Medical. Requests for permission to reproduce or distribute
this document should be addressed to:
Byron Medical, Inc.,
602 West Rillito Street,
Tucson, Arizona 85705

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 4 of 43 Rev B
GENERAL SAFETY STATEMENTS
THE LySonix 3000
® with PulseSelect ™
SHOULD ONLY BE USED BY QUALIFIED MEDICAL
PERSONNEL.
THE LySonix 3000
® with PulseSelect ™
IS AN ELECTRO-MECHANICAL DEVICE THAT, UNDER
CERTAIN CIRCUMSTANCES, COULD PRESENT AN ELECTRICAL SHOCK HAZARD TO THE
OPERATOR AND/OR PATIENT. PLEASE READ MANUAL THOROUGHLY AND FOLLOW
DIRECTIONS STATED HEREIN TO ASSURE MAXIMUM SAFETY DURING OPERATION.
SINCE THE LySonix 3000
® with PulseSelect ™
IS INTENDED TO BE USED IN VARIOUS TYPES
OF INVASIVE SURGERY PROCEDURES, THERE MAY BE INDIRECT DANGER TO THE
PATIENT SHOULD THE UNIT FAIL DURING THE PROCEDURE. THEREFORE, IT IS
RECOMMENDED THAT A COMPLETE SPARE SYSTEM BE AVAILABLE FOR USE AS A
BACKUP.
FCC STATEMENTS
The LySonix 3000
® with PulseSelect ™
is designed and tested to comply with FCC regulations for
conducted and radiated emissions under 21CFR Subchapter J. It also has been designed and tested to
comply with EN 60601-1-2:2001 standards for Electrical Emissions and Electrical Immunity.
SAFETY STATEMENTS
The LySonix 3000
® with PulseSelect ™
has been designed and tested to comply with UL 2601-1 and EN
60601-1 Medical Device Standards with respect to Electrical Shock, Fire and Mechanical Hazards.
Made in the USA
The LySonix 3000
® with PulseSelect ™
is manufactured wholly in the United States of America.

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 5 of 43 Rev B
1. SUMMARY OF SAFETY NOTICES
Please read this section of the manual carefully. It contains a summary of all PRECAUTION,
WARNING and CAUTION statements contained in the manual. However, the user is advised to read
the entire manual and operate the LySonix 3000
® with PulseSelect ™
only in accordance with all of the
instructions contained herein.
Servicing of the device should only be performed by qualified technicians. Please contact Byron
Medical, Inc. There are no service controls accessible to the user.
CAUTION: ALL REUSABLE COMPONENTS OF THE DEVICE MUST BE CLEANED
AND STERILIZED AND ALL DISPOSABLE COMPONENTS REPLACED
BEFORE USING THE DEVICE SYSTEM ON ANOTHER PATIENT.
CAUTION: USE OF CONTROLS OR ADJUSTMENTS OR PERFORMANCE OF
PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN MAY RESULT
IN HAZARDOUS EXPOSURE TO ULTRASONIC ENERGY.
WARNING: TO AVOID ELECTRIC SHOCK, DO NOT REMOVE THE CASE COVER
FROM THE GENERATOR, HANDPIECE, IRRIGATION, OR ASPIRATION
PUMP UNIT. THERE ARE NO USER SERVICEABLE PARTS INSIDE ANY
OF THESE DEVICES.
WARNING: DO NOT ENCLOSE THE ENTIRE GENERATOR HOUSING, IRRIGATION
UNIT HOUSING OR ASPIRATION UNIT HOUSING IN A BAG, OR DRAPE
WHILE THEY ARE IN OPERATION. AIRFLOW MUST CIRCULATE
THROUGH UNITS DURING USE FOR PROPER COOLING OF ELECTRONIC
COMPONENTS.
WARNING: CARE MUST BE TAKEN NOT TO DAMAGE THE PROBE. DO NOT GOUGE,
KNICK, SCRATCH, BEND OR KINK PROBES DURING USE OR
CLEANING/STERILIZING. DISCARD ANY PROBES WHICH SHOW SIGNS
OF SUCH DAMAGE.
WARNING: WHEN ULTRASOUND OUTPUT POWER IS ON, DO NOT TOUCH THE
PROBE. DOING SO MAY RESULT IN INJURY. PLACE PROBE IN WATER
BEFORE ACTIVATING. DO NOT ALLOW PROBE TO RUN UNLESS
IMMERSED IN WATER.
WARNING: IF ELECTRICAL FAULT INDICATOR ILLUMINATES AND/OR AN
ELECTRICAL FAULT AUDIBLE ALARM SOUNDS, IMMEDIATELY
SUSPEND OPERATION. TURN MAIN POWER SWITCH (REAR PANEL OF
GENERATOR) TO THE OFF POSITION AND REMOVE PROBE FROM
SURGICAL SITE. DO NOT TOUCH METALLIC PARTS OF HANDPIECE,
PROBE OR GENERATOR WHILE FAULT IS INDICATED.

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 6 of 43 Rev B
WARNING: IF THE PROBE HAS BEEN USED IN A SURGICAL SITE DO NOT ACTIVATE
THE ULTRASONICS WITH THE PROBE IN OPEN AIR WITHOUT FIRST
WIPING THE PROBE LENGTH WITH A STERILE WIPE TO REMOVE BODY
FLUIDS.
CAUTION:
THE DISPOSABLE ITEMS ARE INTENDED FOR ONE PROCEDURE ONLY.
DO NOT ATTEMPT TO REUSE OR RESTERILIZE.
CAUTION: ALL PROBES, HANDPIECES, HANDPIECE CABLES, WRENCHES AND
ACCESSORIES ARE SUPPLIED INDUSTRIALLY CLEANED, BUT
NONSTERILE. ALL ITEMS INTENDED FOR USE IN THE STERILE FIELD
MUST BE CLEANED AND STERILIZED BEFORE FIRST USE AND BEFORE
EVERY SUBSEQUENT USE.
CAUTION: DO NOT IMMERSE GENERATOR, IRRIGATION UNIT (IF SUPPLIED) OR
THE ASPIRATION UNIT (IF SUPPLIED). THESE UNITS ARE NOT SEALED
AGAINST LIQUIDS AND DAMAGE TO EQUIPMENT MAY RESULT.
CAUTION: ENSURE ALL CONNECTIONS AND MATING SURFACES ARE CLEAN AND
DRY BEFORE ASSEMBLY.
CAUTION: DO NOT USE THE PROBE OR REDUCED-DIAMETER SECTION OF THE
HANDPIECE AS A HAND GRIP. IT IS NOT MADE FOR THIS PURPOSE AND
MAY BREAK. HOLD THE MAIN BODY OF THE HANDPIECE ONLY.
CAUTION: THE GENERATOR SHOULD NOT BE TURNED ON UNTIL THE CABLE HAS
BEEN CONNECTED TO BOTH THE GENERATOR AND HANDPIECE.
OTHERWISE, DAMAGE TO THE GENERATOR CAN RESULT.
CAUTION: DO NOT APPLY EXCESSIVE PHYSICAL FORCE WHEN MANIPULATING
THE HANDPIECE PROBE ASSEMBLY IN THE TISSUE. DO NOT FORCE
THE PROBE THROUGH THE ANATOMIC AREA.
WARNING: IF AFTER FUSE REPLACEMENT THE FUSE FAILS WHEN THE
GENERATOR IS REACTIVATED, DISCONTINUE USE OF THE DEVICE
AND CONTACT BYRON MEDICAL INC, IMMEDIATELY. (800-777-
3434 or
520-573-0857)
CAUTION: USE ONLY GENUINE REPLACEMENT PARTS FURNISHED BY BYRON
MEDICAL INC. USE OF PARTS FURNISHED BY OTHER SOURCES MAY
RESULT IN DANGER OR FAILURE AND WILL VOID ANY WARRANTY
THAT MAY APPLY.

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 7 of 43 Rev B
WARNING: PLUGGING GENERATOR UNIT INTO SOCKET WHICH SUPPLIES
IMPROPER VOLTAGE MAY CAUSE GENERATOR TO MALFUNCTION OR
CREATE A SHOCK OR FIRE HAZARD. BE CERTAIN LINE INPUT
VOLTAGE SELECTOR SWITCH IS PROPERLY ADJUSTED.
WARNING: PROPER SYSTEM GROUNDING CANNOT BE INSURED UNLESS UNIT IS
CONNECTED TO A PROPERLY WIRED HOSPITAL GRADE OUTLET.
CAUTION: DO NOT PLACE GENERATOR ON TOWEL, FOAM OR OTHER SOFT
SURFACE SINCE THE MATERIAL MAY BLOCK AIR VENTS LOCATED ON
THE BOTTOM OF THE GENERATOR. BLOCKING THESE VENTS MAY
CAUSE GENERATOR TO OVERHEAT AND MALFUNCTION OR CREATE A
SHOCK HAZARD.
CAUTION: SYSTEM TEST SHOULD ALWAYS BE DONE IN ADVANCE OF PREPPING
PATIENT FOR SURGERY TO MINIMIZE RISK TO PATIENT IN CASE OF
SYSTEM MALFUNCTION.
WARNING: IF PROBE IS CRACKED, DAMAGED, OR IN NEED OF REPLACEMENT,
SURFACE TEMPERATURE CAN BECOME VERY HOT, SO THAT PROBE
MAY PRESENT A BURN HAZARD TO PATIENT OR CLINICIAN, IF
TOUCHED. EXERCISE CARE IN TESTING AND HANDLING OF PROBES
AT ALL TIMES. PROBES SHOULD BE TESTED FOR TEMPERATURE RISE
AT VARIOUS INTERVALS DURING PROCEDURE TO PREVENT BURNING
OF PATIENT DUE TO DAMAGED OR CRACKED PROBE. DO NOT TOUCH
PROBE WHILE IT IS ACTIVATED.
WARNING: DO NOT HOLD PROBE TIP UP TO EAR. THE OPERATING FREQUENCY
OF THE SYSTEM IS ABOVE THE RANGE OF HUMAN HEARING, BUT
DOES EMIT ACOUSTIC ENERGY. DO NOT ACTIVATE THE PROBE IN
OPEN AIR WITHIN 2 FEET OF THE EARS OF OPERATING ROOM STAFF
OR PATIENT.
CAUTION: DURING CLEANING BE CERTAIN TO CLEAR DEBRIS FROM ALL
HOLLOW PROBE AND HANDPIECE INTERNAL PASSAGES BY BRUSHING.
FAILURE TO DO SO MAY HINDER STERILIZATION OF UNITS DURING
AUTOCLAVING.
CAUTION: DO NOT USE ULTRASONIC CLEANERS TO CLEAN HANDPIECE CABLES
OR PROBES. USE MANUAL CLEANING TECHNIQUES ONLY.

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 8 of 43 Rev B
CAUTION: BEFORE USING LOOSE PACKING MATERIALS, SUCH AS FOAM
PELLETS, SHREDDED PAPER, OR EXCELSIOR, BE SURE TO WRAP THE
COMPONENT(S) SEPARATELY IN PLASTIC BAGS OR FILM OR OTHER
PROTECTIVE WRAPPING.
Electromagnetic Compatibility Guidance (in accordance with EN/IEC 60601-1-2:2001)
CAUTION: THE LYSONIX 3000® WITH PULSESELECT™IS CONSIDERED MEDICAL
ELECTRICAL EQUIPMENT. MEDICAL ELECTRICAL EQUIPMENT NEEDS
SPECIAL PRECAUTIONS REGARDING ELECTROMAGNETIC
COMPATIBILITY (EMC) AND NEEDS TO BE INSTALLED AND PUT INTO
SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THIS
OPERATOR’S MANUAL.
CAUTION: PORTABLE AND MOBILE RF COMMUNICATION EQUIPMENT CAN
EFFECT MEDICAL ELECTRICAL EQUIPMENT.
WARNING THE USE OF ACCESSORIES, TRANSDUCERS AND CABLES OTHER THAN
THOSE SPECIFIED, WITH THE EXCEPTION OF TRANSDUCERS AND
CABLES SOLD BY THE MANUFACTURER OF THE LYSONIX 3000® WITH
PULSESELECT™AS REPLACEMENT PARTS FOR INTERNAL
COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR
DECREASED IMMUNITY OF THE LYSONIX 3000® WITH PULSESELECT™.
WARNING:
THE LYSONIX 3000® WITH PULSESELECT™SHOULD NOT BE USED
ADJACENT TO OR STACKED WITH OTHER EQUIPMENT AND THAT IF
ADJACENT OR STACKED USE IS NECESSARY, THE LYSONIX 3000®
WITH PULSESELECT™ SHOULD BE OBSERVED TO VERIFY NORMAL
OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED.
List of cables, transducers and accessories:
Item Cable
Length Type
Ultrasonic Transducer NA NA
Transducer cable 3.8m shielded 4-conductor
AC Main Power cord 3.6m unshielded 3-conducter
Foot Switch Cable 4.4m unshielded 2-conductor
Pump Umbilical Cable 1.5m unshielded 2-conductor

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 9 of 43 Rev B
Guidance and manufacturer’s declaration – electromagnetic emissions
(Table 201)
The LySonix 3000® with PulseSelect™ is intended for use in the electromagnetic environment specified
below. The customer or the user of the LySonix 3000® with PulseSelect™ should assure that it is used in
such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1 The LySonix 3000® with PulseSelect™ 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 electronic equipment.
RF emissions
CISPR 11 Class A
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3 Complies
The LySonix 3000® with PulseSelect™ is suitable for
use in all establishments other than domestic and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
(Table 202)
The LySonix 3000® with PulseSelect™ is intended for use in the electromagnetic environment specified below.
The customer or the user of the LySonix 3000® with PulseSelect™ should assure that it is used in such an
environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power
supply lines
±1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
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 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
<5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the LySonix
3000® with PulseSelect™ requires
continued operation during power
mains interruptions, it is recommended
that the LySonix 3000® with
PulseSelect™be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 10 of 43 Rev B
Guidance and manufacturer’s declaration – electromagnetic immunity
(Table 204)
The LySonix 3000® with PulseSelect™ is intended for use in the electromagnetic environment specified below. The
customer or the user of LySonix 3000® with PulseSelect™ should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the LySonix
3000® with PulseSelect™, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Pd 2.1=
Pd 2.1=
80 MHz to 800 MHz
Pd 3.2=
800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey,
a
should be
less than the compliance level in each frequency
range.
b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the LySonix 3000® with
PulseSelect™is used exceeds the applicable RF compliance level above, the LySonix 3000® with
PulseSelect™should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the LySonix 3000® with PulseSelect™.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.