autosonix_ultrasonic_generator_system_operators_man.pdf
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AutoSonix
™
Ultrasonic Surgical System
Operator’s Manual
Système Chirurgical Ultrasonique
Manuel de l’opérateur
Ultraschallsystem Für Die Chirurgie
Bedienungsanleitung
Sistema Chirurgico A Ultrasuoni
Manuale dell’utente
Sistema Quirúrgico Ultrasónico
Manual del operador
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AutoSonix
™
Ultrasonic Surgical System
Operator’s Manual
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Table of Contents
1 Summary of Safety Notices.....................................................................................................................1
2 General Information...................................................................................................................................7
3 Indications and Adverse Effects.............................................................................................................11
4 Operating Instructions..............................................................................................................................13
5 System Test....................................................................................................................................................15
6 System Troubleshooting..........................................................................................................................17
7 Maintenance.................................................................................................................................................19
8 Fuse replacement........................................................................................................................................21
9 Warranty and Limitation of Liability.....................................................................................................23
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1 Summary of Safety Notices
General Safety Statements
The AutoSonix™ System is an electro-mechanical device which, under certain circumstances, could present an electrical shock hazard to the
operator and/or patient. Please read the manual thoroughly and follow the directions stated herein to assure maximum safety during operation.
Since the AutoSonix™ System is intended to be used in various types of invasive surgical 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.
Ultrasonic Radiation Safety Statement
The AutoSonix™ System. complies with 21 CFR Subchapter J - Radiological Health.
Electrical Safety Statement
The AutoSonix™ System complies with the following international and national recognized standards:
EN 60601-1:1990 with Amd1, Amd2, Amd13 - Medical electrical equipment Part 1: General requirements for safety.
(IEC 60601-1:1998 with Amd1, Amd2 - Medical electrical equipment Part 1: General requirements for safety.)
- Equipment classification - Class 1, Type CF applied part.
IEC 60601-1-2:2001 - Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic
compatibility - Requirements and test.
UL 2601-1:1997 - Medical Electrical Equipment, Part 1: General Requirements for Safety.
CAN/CSA C22.2 No. 601-1 - Medical Electrical Equipment, Part 1: General Requirements for Safety.
ANSI/AAMI ES-1 - Safe Current Limits for Electrical Apparatus 3rd Edition.
IEC 529 - Degrees of Protection provided by enclosures (IP code). Footswitch IPX rating: IPX 68.
Warnings and Cautions
Please read this section of the manual carefully. It contains a summary of all warning and caution statements contained in the manual.
However, the user is advised to read the entire manual and operate the AutoSonix™ System only in accordance with all of the instructions
contained herein.
Servicing of the device should only be performed by qualified technicians authorized by United States Surgical. There are no service controls
accessible to the user.
Safety Recommendations for Use of the Device
CAUTION: Use only genuine replacement parts manufactured for United States Surgical. Use of parts furnished by other sources may
result in danger or failure and may void any warranty that may apply.
CAUTION: The AutoSonix™ ULTRA SHEARS™ instruments, Ball Probe and Hook Probe single use instruments are provided STERILE and
are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.
WARNING: DO NOT ENCLOSE THE GENERATOR HOUSING IN A BAG, OR DRAPE COVERING OVER it WHILE IN OPERATION. AIRFLOW
MUST CIRCULATE THROUGH UNIT DURING USE IN ORDER FOR PROPER COOLING OF ELECTRONIC COMPONENTS.
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.
WARNING: PLUGGING GENERATOR UNIT INTO SOCKET WHICH SUPPLIES IMPROPER VOLTAGE MAY CAUSE GENERATOR TO
MALFUNCTION OR TO CREATE A SHOCK OR FIRE HAZARD. BE CERTAIN LINE INPUT VOLTAGE SELECTOR SWITCH IS
PROPERLY ADJUSTED.
WARNING: PROPER SYSTEM GROUNDING CANNOT BE ENSURED UNLESS UNIT IS CONNECTED TO PROPERLY WIRED HOSPITAL
GRADE OUTLET.
CAUTION: The generator should not be turned on until the patient cable has been connected to both the generator and transducer.
Otherwise, damage to the generator may result.
CAUTION: Ensure all connections and mating surfaces are clean and dry before assembly.
WARNING: CARE MUST BE TAKEN NOT TO DAMAGE THE PROBE. DO NOT GOUGE, NICK, SCRATCH, BEND OR KINK PROBES DURING
USE. DISCARD ANY PROBES WHICH SHOW SIGNS OF SUCH DAMAGE.
CAUTION: Do not hold the probe tightly while the power is on. Clamping the probe restricts the longitudinal motion, causing the probe
to heat at that point. Prolonged restriction may cause the probe to break. Restriction may also cause a mechanical limit
condition, causing ultrasonic energy to be inhibited. Undue bending of the probe may do the same. If both these conditions
are relieved, the mechanical limit condition will be cleared.
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CAUTION: System test should always be done in advance of prepping patient for surgery to minimize the risk to patient in case of system
malfunction.
WARNING: WHEN ULTRASOUND OUTPUT POWER IS ON, DO NOT TOUCH THE PROBE. DOING SO MAY RESULT IN INJURY.
WARNING: IF PROBE IS CRACKED OR DAMAGED, SURFACE TEMPERATURE CAN BECOME VERY HOT, AND 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.
WARNING: DO NOT TOUCH PROBE WHILE IT IS ACTIVATED.
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 any fluids.
WARNING: TO AVOID ELECTRIC SHOCK, DO NOT REMOVE THE CASE COVER FROM THE GENERATOR OR THE transducer. THERE ARE
NO USER-SERVICEABLE PARTS INSIDE ANY OF THESE components.
CAUTION: Ultrasonic energy is inhibited if excessive physical force is applied to the probe; use only enough force to guide the probe to
the removal site and to advance the probe through the tissue. Do not force the probe; allow the ultrasonic action to
do all tissue cutting or coagulation.
WARNING: IF ELECTRICAL FAULT INDICATOR ILLUMINATES and/or electrical fault alarm sounds, IMMEDIATELY turn power
switch (rear panel of generator) to the off position. REMOVE PROBE FROM surgical site. DO NOT TOUCH
METALLIC PARTS OF transducer, PROBE OR GENERATOR while fault is indicated.
CAUTION: Be certain to clear debris from all surfaces by brushing. Failure to do so may hinder sterilization of units.
CAUTION: Do not use ultrasonic cleaners to clean transducer or probes. Use manual cleaning techniques only.
Warning: Examine the transducer and patient cable for obvious signs of damage (cracks, gouges, cuts in cable,
etc.). Remove any items which show signs of damage from service after cleaning and sterilizing. Mark
damaged items clearly to prevent future use before disposal.
CAUTION: Do not immerse the generator. The unit is not sealed against liquids and damage to equipment may result.
WARNING: IF AFTER FUSE REPLACEMENT THE FUSE FAILS WHEN THE GENERATOR IS REACTIVATED, DISCONTINUE USE OF THE
DEVICE AND CONTACT UNITED STATES SURGICAL.
CAUTION: Before using loose packing materials, such as foam pellets, shredded paper, or excelsior, be sure to wrap the components(s)
separately in plastic bags or film or other protective wrapping.
Electromagnetic Compatibility Guidance (in accordance with IEC 60601-1-2:2001)
CAUTION: The AutoSonix™ Ultrasonic Surgical System 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 AutoSonix™ Ultrasonic Surgical System
as replacement parts for internal components, may result in increased emissions or decreased
immunity of the AutoSonix™ Ultrasonic Surgical System.
WARNING: The AutoSonix™ Ultrasonic Surgical System should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the AutoSonix™ Ultrasonic Surgical System
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
Ultrasonic Transducer
NA
NA
Transducer cable
4.2m
shielded multiconductor
AC Main Power cord
3.0m
unshielded 3-conducter
Foot Pedal cable
4.8m
unshielded multiconductor
Thumb Switch cable
3.0m
unshielded multiconductor
2
Type
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Guidance and manufacturer’s declaration – electromagnetic emissions
(Table 201)
The AutoSonix™ Ultrasonic Surgical System is intended for use in the electromagnetic environment specified below. The customer or the
user of the AutoSonix™ Ultrasonic Surgical System should assure that it is used in such an environment.
Emissions test
RF emissions
Compliance
Group 1
CISPR 11
RF emissions
Electromagnetic environment – guidance
The AutoSonix™ Ultrasonic Surgical 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 electronic equipment.
Class A
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Class A
The AutoSonix™ Ultrasonic Surgical System 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.
Complies
IEC 61000-3-3
Guidance and manufacturer’s declaration – electromagnetic immunity
(Table 202)
The AutoSonix™ Ultrasonic Surgical System is intended for use in the electromagnetic environment specified below. The customer or the
user of the AutoSonix™ Ultrasonic Surgical System should assure that it is used in such an environment.
IEC 60601
test level
Immunity test
Compliance level
Electromagnetic environment
– guidance
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Electrostatic discharge (ESD)
±6 kV contact
±6 kV contact
IEC 61000-4-2
±8 kV air
±8 kV air
Electrical fast transient/burst
±2 kV for power supply lines
IEC 61000-4-4
±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
±1 kV differential mode
IEC 61000-4-5
±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.
<5 % UT
(>95 % dip in UT ) for 0,5 cycle
<5 % UT
(>95 % dip in UT ) for 0,5 cycle
40 % UT
(60 % dip in UT ) for 5 cycles
40 % UT
(60 % dip in UT ) for 5 cycles
70 % UT
(30 % dip in UT ) for 25 cycles
70 % UT
(30 % dip in UT ) for 25 cycles
<5 % UT
(>95 % dip in UT ) for 5 sec
<5 % UT
(>95 % dip in UT ) for 5 sec
3 A/m
3 A/m
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the AutoSonix™ Ultrasonic
Surgical System requires continued
operation during power mains
interruptions, it is recommended
that the AutoSonix™ Ultrasonic
Surgical System be powered from
an uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
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Guidance and manufacturer’s declaration – electromagnetic immunity
(Table 204)
The AutoSonix™ Ultrasonic Surgical System is intended for use in the electromagnetic environment specified below. The customer or the
user of the AutoSonix™ Ultrasonic Surgical System should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the AutoSonix™ Ultrasonic Surgical System,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.2√P
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
d = 1.2√P 80 MHz to 800 MHz
3V
d = 2.3√P 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).
3 V/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
b
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 AutoSonix™ Ultrasonic Surgical System is used exceeds the applicable RF compliance level above, the AutoSonix™
Ultrasonic Surgical System should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the AutoSonix™ Ultrasonic Surgical System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the AutoSonix™ Ultrasonic Surgical System
(Table 206)
The AutoSonix™ Ultrasonic Surgical System is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the AutoSonix™ Ultrasonic Surgical System can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AutoSonix™
Ultrasonic Surgical System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = 1.2√P
d = 1.2√P
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.37
1
1.2
1.2
2.3
10
3.7
3.7
7.4
100
12
12
23
W
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For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
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2 General Information
System Overview
Description of the System (refer to Figure 1)
The AutoSonix™ System is a system of electromechanical components designed to ultrasonically transect and coagulate a broad range of soft
tissue. The system includes a Generator that produces a 55.5 kHz electrical signal and feeds that signal via the patient cable to a piezoelectric
crystal stack mounted in the autoclavable transducer. The crystal stack converts the electrical signal to mechanical vibration at that same
frequency. This ultrasonic vibration is amplified as it traverses the length of the titanium probe within the disposable instrument to levels
which will permit tissue ablation, cauterization or cutting.
Concept and Principles of Operation (refer to Figure 2)
The AutoSonix™ System uses ultrasound, or sound waves, for fragmentation of soft tissues. Unlike standard cutting or electrosurgical
systems, the AutoSonix™ System offers precise control of tissue ablation due to the controlled ultrasonic field generated. This precise control
allows the surgeon to perform traumatic transection and coagulation with minimal disturbance to surrounding tissue structure.
The Generator unit (Power Supply) feeds a 55.5 kHz (55,500 cycles per second) electrical signal to piezoelectric crystals mounted in the
transducer. The active elements of the transducer then vibrate at that same 55.5 kHz frequency. When placed in a liquid, the vibrating ball tip
causes microscopic bubbles to grow and then collapse with great energy intensity, thus causing the tissue directly in front of the Probe to
be liquefied or fragmented. The blade tip allows cutting and coagulation of tissue by causing shearing forces to be developed in the tissue.
These shearing forces separate tissue and heat the surrounding tissue to a level which permits coagulation and sealing of blood vessels,
without the burning associated with electrocautery.
Functional Components of the System (refer to Figures 1 and 2)
Generator (refer to Figure 1)
The Generator supplies a 55.5 kHz electrical signal to the transducer. A feedback circuit tracks frequency changes in the Probe caused by load
and temperature changes, and maintains maximum electrical efficiency at all times.
In addition, the Generator incorporates an automatic gain control which maintains the amplitude selected by the user. As the Probe contacts
an obstruction, the Generator will automatically supply greater power (wattage) to the transducer, thereby keeping the amplitude constant.
Amplitude, which is the distance the Probe moves out from rest and back in each cycle, determines the extent of tissue disruption. The
Generator has a self-limiting feature which prevents damaging overload.
Main power is controlled by the Main Power switch at the back panel of the Generator. Amplitude is controlled by the Amplitude Control
Knob on the front panel of the Generator (with a setting range from 0-5). A Digital Display is provided to allow the clinician to see the
amplitude set from a distance.
A Mechanical Limit Detector detects breakage along the Probe, Transducer failure, or system overload. These faults will activate an indicator
light and an audible alarm.
An Electrical Fault Detector detects a disconnected transducer cable and a short or break in an output circuit. These faults will activate an
indicator light as well as an audible alarm. Both fault alarms will deactivate the ultrasonic output of the generator.
Foot Switch (refer to Figure 1)
Ultrasonic power is controlled by the Ready/Standby switch on the front panel and by a dual Footswitch connected to the rear panel of
the generator. The left Footswitch pedal control turns on the Ultrasonic output to the level set by the front panel control described above.
The right Footswitch pedal turns on the Ultrasonic Output to maximum. This feature allows the clinician to choose rapidly from a cutting or
sealing mode to coagulation mode.
Transducer (refer to Figure 3)
The handle section of the Transducer houses the piezoelectric crystals which transform the electrical energy from the Generator into
mechanical vibration. The Front Driver transmits and amplifies the vibration out of the transducer casing. A Probe is attached to the Front
Driver by an integral mounting stud. This Probe amplifies the motion and provides the debriding surface of the device. As applications
require, various Probe configurations will be used to extend the working length, to provide increased amplification of vibration, or to provide
a cutting surface for fast removal of tissue. The Transducer is attached to the Generator by a 12 foot (3.66 meters) autoclavable patient cable.
Transducer Cable (refer to Figure 1)
The transducer is attached to the generator by a 12 ft (3.66 meters) autoclavable cable. The cable is supplied with the transducer, and utilizes
keyed connectors at both ends. Either end will fit into the transducer or generator. The transducer cable should be replaced at the same
intervals as the transducer.
Cart
An optional rolling cart is available for storage and transport of the AutoSonix™ generator. The cart is supplied fully assembled.
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The AutoSonix™ ULTRA SHEARS™ 5mm instruments are available in 3 different sizes:
• The STANDARD size is 5 mm in diameter, has a working length of approximately 30 cm, and is intended for introduction and use
through a properly-sized trocar sleeve.
• The SHORT size is 5 mm in diameter, has a working length of approximately 15.7 cm.
• The LONG size is 5 mm in diameter, has a working length of approximately 38 cm, and is intended for introduction and use through a
properly-sized trocar sleeve.
The AutoSonix™ Hook Probes are available in 2 different sizes:
• The SHORT size is 5 mm in diameter, has a working length of approximately 13 cm.
• The LONG size is 5 mm in diameter, has a working length of approximately 35 cm, and is intended for introduction and use through a
properly-sized trocar sleeve.
The AutoSonix™ Ball Probe is available in 1 size:
• The LONG size is 5 mm in diameter, has a working length of approximately 34 cm, and is intended for introduction and use through a
properly-sized trocar sleeve.
• The scallop dial on the ULTRA SHEARS™ instruments rotates the shaft and transducer 360°. The rate of coagulation and dissection can
be controlled manually by selecting the level on the Generator Box and by controlling the tension or pressure on the tissue.
Controls and Indicators
The controls and indicators available to the operator of the AutoSonix™ System are as follows:
Generator: Main Power ON/OFF Switch (on rear panel)
Power On Indicator (LED)
Line Input Voltage Selector Switch (on rear panel)
Ready/Standby Switch
Amplitude Control Knob
Output Level Indicator (digital)
Ultrasound On Indicator Light
Mechanical Limit Indicator Light
Electrical Fault Indicator Light
Footswitch(es): Dual Level Control - Low Voltage Finger Trigger (optional)-Single Level Control
Figure 1: Autosonix™ System
"
%
M
#
(
$
&
'
)
A) BALL PROBE
D) AutoSonix™ ULTRASONIC GENERATOR
G)FINGER TRIGGER
B) HOOK PROBE
E) TRANSDUCER CABLE
H) ADAPTER BOX
C) LIGATOR
F) FOOTSWITCH
I) BACK OF GENERATOR
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*
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Figure 2: System Principle of Operations
A) AMPLITUDE
B) TIP MOTION
Figure 3: Transducer Probe Assembly
"
#
%
$
"
%
PROBE ASSEMBLY
1) ALIGN TORQUE WRENCH (A) WITH TRANSDUCER (B). SCREW CLOCKWISE INTO PROBE HANDLE (C).
2) WHILE HOLDING SCALLOPED PORTION (D) TURN TORQUE WRENCH CLOCKWISE UNTIL IT CLICKS ONCE. DO NOT OVERTIGHTEN. REMOVE
TORQUE WRENCH.
PROBE DISASSEMBLY
3) WHILE HOLDING SCALLOPED PORTION (D), TURN TORQUE WRENCH (A) COUNTERCLOCKWISE AND UNSCREW TRANSDUCER FROM PROBE
HANDLE.
Figure 4: Front / Rear Elevation
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Figure 5: Explanation of Symbols
SYMBOL
SYMBOL
TYPE-CF EQUIPMENT
TEST GROUNDS
DANGEROUS VOLTAGE (CAUTION)
EARTH GROUND POINT
OFF-POWER (DISCONNECTION FROM MAINS)
UNIT ON STANDBY (ULTRASOUND DISABLED)
ON-POWER (CONNECTIONS FROM MAINS)
UNIT READY (ULTRASOUND ENABLED)
SEE INSTRUCTIONS
SEPARATE COLLECTION REQUIRED
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3 Indications and Adverse Effects
Indications
The AutoSonix™ hand instruments have application in abdominal, pediatric, gynecologic and other open and endoscopic procedures for the
transection, dissection and coagulation of tissue(s).
Adverse Effects
Certain parts and accessories to be used in conjunction with the AutoSonix™ System are intended for repeated use on different patients.
Such parts and accessories are clearly defined in this manual and MUST BE PROPERLY DECONTAMINATED AND STERILIZED BEFORE EACH USE
AS PER INSTRUCTIONS CONTAINED IN THIS MANUAL. FAILURE TO DO SO MAY LEAD TO ADVERSE EFFECTS SUCH AS, BUT NOT LIMITED TO,
INFECTIONS AND TRANSMISSION OF DISEASES SUCH AS HEPATITIS.
Device Specifications
Ultrasonic Generator
Equipment Type: Class 1 Type CF
Power Input: 110-130VAC 60Hz /200-240V AC 50Hz 250 VA
Operating Frequency: 55.5 kHz ± 500 Hz
Ground Leakage Current: 150 µ A maximum
Mode of Operation: Continuous Wave
Features:
• Main Power ON/OFF Switch (on rear panel)
• Power On Indicator (LED)
• Line Input Voltage Selector Switch (on rear panel)
• Ready/Standby Switch
• Amplitude Control Knob
• Output Amplitude Level Indicator (digital)
• Ultrasound On Indicator Light
• Mechanical Limit Indicator Light
• Electrical Fault Indicator Light
Operating Conditions: Temperature 55° F - 95° F (12.7° C - 35° C), Relative Humidity 20-90% (non-condensing)
Dimensions: 7 1/2” W x 19” D x 11” H (19 cm W x 48.3 cm D x 27.9 cm H)
Weight: 19 lbs. (8.6 Kg)
Transducer
Operating Frequency: 55.5 kHz ± 150 Hz
Power Capability: 80 Watts (max)
Operating Conditions: Temperature 55° F - 95° F (12.7° C - 35° C)
Dimensions: 5 1/2” L x 1 1/2” Dia. (14.0 cm L x 3.81 cm Dia.)
Unpacking Instructions
Carefully inspect shipping container before opening. After visual inspection of container, carefully unpack all components and place on
a table or cart. Visually inspect all components for obvious shipping damage. Retain the shipping container and immediately notify the
shipping carrier of any damage.
The following components are included:
(1) Generator Box
(1) Footswitch
CAUTION: Use only genuine replacement parts manufactured for United States Surgical. Use of parts furnished by other sources may
result in danger or failure and may void any warranty that may apply.
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4 Operating Instructions
System Components Preparation
CAUTION: The AutoSonix™ ULTRA SHEARS™ instruments, Ball Probe and Hook Probe single use instruments are provided STERILE and
are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.
NOTE: The AutoSonix™ transducer and single use instruments together are compatible with generators that produce a continuous wave,
series resonance at a frequency between 55kHz and 60kHz, and utilize phase lock loop / VCO frequency control.
The following reusable items must be cleaned and sterilized prior to the procedure in accordance with appropriate protocols as suggested
herein or such other guidelines as may be directed.
Transducer
The transducer and patient cable can be steam sterilized. It is also possible to cover the transducer and patient cable with a sterile plastic bag
during the procedure rather than sterilizing beforehand.
The front panels of the Generator may also be covered with clear sterile plastic covers during the procedure.
WARNING: DO NOT ENCLOSE THE GENERATOR HOUSING IN A BAG, OR DRAPE COVERING OVER it WHILE IN OPERATION. AIRFLOW
MUST CIRCULATE THROUGH UNIT DURING USE IN ORDER FOR PROPER COOLING OF ELECTRONIC COMPONENTS.
Cleaning and Sterilization
Refer to Section 7, Maintenance, for cleaning and sterilization instructions.
System Assembly
Refer to Section 2, General Information, Figures 1 and 3
NOTE: It is recommended that the Generator be positioned on a cart or table outside the sterile field of the Operating Theater. The Generator
must be placed on a smooth, hard surface.
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.
Verify Settings
Verify that the Main Power Switch on the rear panel of the Generator and the Ready/Standby Switch on the front panel of the Generator are
in the OFF position and that the Amplitude Control Knob on the front panel is set at zero (0). Verify that the Line Input Voltage Selector on
rear panel of generator is set to the proper setting for the line voltage to be supplied by the outlet. Plug the female end of the line cord into
the rear of the Generator. Plug other end of line cord into Hospital grade socket receptacle.
WARNING: PLUGGING GENERATOR UNIT INTO SOCKET WHICH SUPPLIES IMPROPER VOLTAGE MAY CAUSE GENERATOR TO MALFUNCTION
OR TO CREATE A SHOCK OR FIRE HAZARD. BE CERTAIN LINE INPUT VOLTAGE SELECTOR SWITCH IS PROPERLY ADJUSTED.
WARNING: PROPER SYSTEM GROUNDING CANNOT BE eNSURED UNLESS UNIT IS CONNECTED TO PROPERLY WIRED HOSPITAL
GRADE OUTLET.
CAUTION: The generator should not be turned on until the patient cable has been connected to both the generator and transducer.
Otherwise, damage to the generator may result.
Footswitch
Attach the plug from the Footswitch into the connector on the rear panel of the Generator. Make certain that connector is fully inserted. Turn
the collar fully clockwise. Position Footswitch on floor in area easily accessible during procedure.
Transducer and Disposables
Transducer and disposables should be assembled on a table top covered with a sterile drape. Only persons authorized to be in sterile field
should assemble these components.
Probe Threads
Thread the distal end of the Transducer onto the stud in the proximal end of the Transducer. Turn clockwise until snug. Use the Torque
Wrench supplied and fit it into the ridges on the rear of the Transducer for final tightening. Turn the Torque Wrench clockwise until a click is
heard. DO NOT OVERTIGHTEN. Remove Torque Wrench from rear of Transducer.
CAUTION: Ensure all connections and mating surfaces are clean and dry before assembly.
WARNING: CARE MUST BE TAKEN NOT TO DAMAGE THE PROBE. DO NOT GOUGE, NICK,
SCRATCH, BEND OR KINK PROBES DURING USE. DISCARD ANY PROBES WHICH SHOW SIGNS OF SUCH DAMAGE.
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High Frequency Patient Cable
Attach one end of high frequency patient cable to output connector on Generator front panel. Line up the dot on the cable connector with
the corresponding dot on the front panel connector. Push the cable connector into place. Assure that the connection snaps into place.
Patient Cable and Transducer
Connect other end of patient cable to the connector at rear of Transducer, using the same procedure as above. Assure that the connection
snaps into place.
CAUTION: Do not hold the probe tightly while the power is on. Clamping the probe restricts the longitudinal motion, causing the probe
to heat at that point. Prolonged restriction may cause the probe to break. Restriction may also cause a mechanical
limit condition, causing ultrasonic energy to be inhibited. Undue bending of the probe may do the same. If both
these conditions are relieved, the mechanical limit condition will be cleared.
The AutoSonix™ System is now ready for system test.
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5 System Test
CAUTION: System test should always be done in advance of prepping patient for surgery to minimize the risk to patient in case of
system malfunction.
Power On/Off
Turn the Main Power On/Off Switch (rear panel) to the ON position. Fan should start and the Power LED Display should illuminate.
WARNING: WHEN ULTRASOUND OUTPUT POWER IS ON, DO NOT TOUCH THE PROBE. DOING SO MAY RESULT IN INJURY.
Ready/Standby
Place the Ready/Standby Switch (front panel) in the READY position. Turn the Amplitude Control Knob to setting ‘3’. Depress the Left
Footswitch. The Ultrasound ON Light should illuminate. A bell type sound should be heard for 1 second upon pressing of the Footswitch.
Placing the distal end of the Probe in sterile liquid should result in an audible hiss or noise and bubbles of liquid should appear below the
distal end of the Probe in the liquid.
Release Footswitch
Release the Footswitch. The Ultrasound output should be disabled.
System Run Test
Depress Pedal to turn on Ultrasound Output Power. Hold distal end of Probe in air and run system for 15 seconds. Unit should run normally
with no visual or audible alarms activated. Running unit for 15 seconds checks Probe for defects and confirms all electrical and mechanical
connections.
Temperature Test
Release Pedal. Gently feel tip of Probe. Probe temperature should not be significantly above ambient temperature, regardless of how long it
was operating. If Probe feels hot at the junction of the Transducer and Probe, retighten with wrenches supplied and retest. If Probe feels hot
at any point along its length, replace Probe and retest.
WARNING: IF PROBE IS CRACKED OR DAMAGED, SURFACE TEMPERATURE CAN BECOME VERY HOT, AND 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.
WARNING: DO NOT TOUCH PROBE WHILE IT IS ACTIVATED.
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 any fluids.
AutoSonix™ System is now ready for use.
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6 System Troubleshooting
WARNING: TO AVOID ELECTRIC SHOCK, DO NOT REMOVE THE CASE COVER FROM THE GENERATOR OR THE transducer. THERE ARE
NO USER-SERVICEABLE PARTS INSIDE ANY OF THESE components.
Mechanical Limit
Mechanical limit light illuminated and pulsing audible alarm activated.
Causes
Possible causes are: Loose Probe to Transducer connection, Cracked or Damaged Probes, Defective Transducer or Overload condition at
Probe tip.
Reset
To reset Mechanical Limit Alarm, release Footswitch. Depress Footswitch again. If Mechanical Limit Light and Audible Alarm sounds, refer to
Troubleshooting Chart.
CAUTION: Ultrasonic energy is inhibited if excessive physical force is applied to the probe; use only enough force to guide the probe to
the removal site and to advance the probe through the tissue. Do not force the probe; allow the ultrasonic action to
do all tissue cutting or coagulation.
Electrical Fault
Electrical fault light illuminated and steady audible alarm activated.
Causes
Possible causes are: Patient Cable or Transducer disconnected, Faulty Transducer, Cable or Generator, or overheated Probe.
WARNING: IF ELECTRICAL FAULT INDICATOR ILLUMINATES and/or electrical fault alarm sounds, IMMEDIATELY turn power
switch (rear panel of generator) to the off position. REMOVE PROBE FROM surgical site. DO NOT TOUCH
METALLIC PARTS OF Transducer, PROBE OR GENERATOR while fault is indicated.
Reset
To reset Electrical Fault Alarm, switch Ready/Standby switch to STANDBY. Turn Main Power On/Off switch to OFF. Refer to Troubleshooting
Chart and go through ALL steps given. Switch Main Power On/Off switch to ON and Ready/Standby switch to READY. Depress Right
Footswitch. If Electrical Fault Alarm activates again, DISCONTINUE USE, REPLACE ENTIRE SYSTEM WITH BACKUP, SET UP AND TEST BACKUP
and continue operation. Call United States Surgical for repair.
Trouble shooting chart
SYMPTOM
POSSIBLE CAUSES
REMEDIAL ACTION
SYSTEM DOES NOT TURN ON
POWER CORD NOT CONNECTED
CHECK POWER CORD
POWER OUTLET OFF
CHECK WALL SOCKET FOR VOLTAGE
FUSE(S)
BLOWN LINE FUSE(S)
REPLACE FUSE(S)
MECHANICAL LIMIT INDICATOR
LOOSE PROBE
RETIGHTEN PROBE TO TRANSDUCER
BROKEN PROBE
REPLACE PROBE INSTRUMENT
POWER OVERLOAD
RELEASE PRESSURE ON PROBE
OVERHEATED PROBE
COOL PROBE. RETEST. IF PROBE HEATS, REPLACE.
ELECTRICAL FAULT INDICATOR
TRANSDUCER AND/OR CABLE DISCONNECTED
CHECK ALL ELECTRICAL CONNECTIONS
OVERHEATED PROBE
COOL PROBE. RETEST. IF PROBE HEATS, REPLACE.
FAULTY CABLE OR TRANSDUCER
REPLACE CABLE OR TRANSDUCER
FAULTY GENERATOR
REPLACE GENERATOR
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7 Maintenance
Sterilization
CAUTION: The AutoSonix™ ULTRA SHEARS™ instruments, Ball Probe and Hook Probe single use instruments are provided STERILE and
are intended for use in a SINGLE procedure only. DISCARD AFTER USE DO NOT RESTERILIZE.
Follow ANSI/AAMI ST35, Good Hospital Practice: Handling and Biological Decontamination of Reusable Medical Devices (1996), or such other
guidelines as may be directed by Hospital or Clinic GHP’s.
Disassemble Components
Disassemble all components of system in reverse order of assembly (refer to Figure 1). Unplug all power cords. Use wrenches supplied and
rotate wrenches as shown in Figure 3 to untighten Probe from Transducer. Separate Probe from Transducer.
Disposal of Contaminated Waste
Dispose of all contaminated or opened disposables in accordance with standard hospital procedures for disposal of contaminated biological
wastes.
Cycle Parameters for Transducer and Cable Sterilization
In general, the operator should follow the manufacturer’s instruction for cycle parameters for sterilization. It is recommended that the
AutoSonix™ Transducer and Cable be sterilized in accordance with the following sterilization times and temperatures:
Prevacuum Cycle
Temperature: 270° F - 275° F (132° C - 135° C)
Time: 4 minute cycle (wrapped)
Gravity Cycle
Temperature: 250° F - 255° F (121° C - 124° C)
Time: 30 minute cycle (wrapped)
ETO Cycle
130° F (54° C) 600mg/L, 2 Hours, 40 - 60% RH (wrapped)
Steris
122° F (50° C) Peracetic acid standard Steris cycle (12 minutes)
Formaldehyde
140° F (60° C) for 60 Minutes (wrapped)
Cleaning
Cleaning Transducer and Cable
Brushing should be done with antimicrobial and antiviral soap and warm running water. A standard soft bristle cleaning brush may be used
to scrub exterior surfaces of transducer and cable. Rinse all soap residue from interior and exterior of unit under warm running water for a
minimum of 1 minute. Care must be taken to ensure connections are dry prior to use.
CAUTION: Be certain to clear debris from all surfaces by brushing. Failure to do so may hinder sterilization of units.
CAUTION: Do not use ultrasonic cleaners to clean Transducer or probes. Use manual cleaning techniques only.
Drying Components
Dry all components with absorbent towel or paper. Dispose of cloth or paper in accordance with Hospital or Clinic practices for contaminated
wastes.
Cleaning the Generator
With a cloth or absorbent paper moistened with an antimicrobial and antiviral cleaning agent, wipe down the Generator. Clean all surfaces of
bloodstains and obvious signs of contamination. Dispose of cloth or paper with contaminated wastes.
Warning: Examine the transducer and patient cable for obvious signs of damage (cracks, gouges, cuts in cable,
etc.). Remove any items which show signs of damage from service after cleaning and sterilizing. Mark
damaged items clearly to prevent future use before disposal.
CAUTION: Do not immerse the generator. The unit is not sealed against liquids and damage to equipment may result.
NOTE: The reuse life given takes into account wear and tear due to cleaning and sterilization only.
Damage or wear caused by actual use in surgery will affect life of components.
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Deviations from Cleaning and Sterilization Instructions
It is highly recommended that the procedures given in this manual for cleaning and sterilizing the AutoSonix™ System and related
accessories be followed. It is the responsibility of the user of this device, or any accessories used with it, to validate procedures for cleaning
and/or sterilization if they differ from the procedures as outlined in this manual.
Technical Assistance
Should the user wish further information or instructions regarding any aspect of cleaning or sterilizing procedures, please contact:
United States Surgical, a division of Tyco Healthcare Group LP,
150 Glover Avenue, Norwalk, Connecticut 06856
Telephone: 1-800-722-8772 Fax: 1-800-544-USSC
CAUTION: Before using loose packing materials, such as foam pellets, shredded paper, or excelsior, be sure to wrap the components(s)
separately in plastic bags or film or other protective wrapping.
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8 Fuse replacement
WARNING: TO AVOID ELECTRIC SHOCK DO NOT REMOVE THE CASE COVER FROM THE GENERATOR OR THE Transducer. THERE ARE
NO USER-SERVICEABLE PARTS INSIDE ANY OF THESE COMPONENTS.
Figure 5: Fuse Replacement
1
1- .5
UT A
7
"
A
2
L
AL
#
.
$
A) SNAP CONNECTOR
B) FUSE HOLDER
C) FUSES
FUSE REPLACEMENT NOTES:
1. Turn off and remove power cord from both wall outlet and the generator.
2. Use a small screwdriver or thumb nail to remove the fuse holder below the power cord connector by releasing the spring loaded snap
clips.
3. Pull out fuse holder.
4. Remove and replace with new fuses of the same type. There is no required orientation of the fuses. Be sure to replace both fuses.
5. Reinsert the fuse holder by pressing it into the power connector until it snaps into place.
WARNING: IF AFTER FUSE REPLACEMENT THE FUSE FAILS WHEN THE GENERATOR IS REACTIVATED, DISCONTINUE USE OF THE
DEVICE AND CONTACT UNITED STATES SURGICAL.
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