AutoSonix™ Ultrasonic Generator System Operator’s Manual

AutoSonix

™

Ultrasonic Surgical System Operator’s Manual

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

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.

1

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

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 CISPR 11 RF emissions

Compliance

Electromagnetic environment – guidance

Group 1

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.

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

4

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.

5

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.

7

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

8

*

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

9

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

10

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.

11

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.

13

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.

14

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.

15

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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