Principles of The AutoSonix™ System
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. 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 atraumatic 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 shear 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.
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).
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Frequently Asked Questions
What is “Shear Logic™ Technology ”?
Shear Logic™ Technology refers to the ability of the AutoSonix™ Generator to sense resistance to the motion of the cutting blade. This resistance triggers an increase in power delivered to the shear, to maintain consistent amplitude and cutting speed. Current AutoSonix™ users will see the incidence of “mechanical faults” decreased dramatically. Shear Logic™ Technology can easily be described as the same logic that tells the cruise control in a car to deliver more power when climbing a hill. The car maintains consistent speed despite increased resistance, and doesn’t slow down or stall.
What maintenance is required?
Periodic Calibration may be required on the Generator, especially if Electrical or Mechanical faults become frequent. This calibration is done by the service personal in your area.
What do I do if an AutoSonix™ system breaks?
Call the incident in to the service personal in your area.
Will the AutoSonix™ Transducer and Instruments work with the Ethicon Generator?
The AutoSonix™ Transducer and Instruments are compatible with some of the older generations of the Harmonic Scalpel generator, although the performance has been reported to be less than optimal as compared to using the AutoSonix™ generator. They are not compatible with the most recent Harmonic generators (300 series).
How does the Finger Trigger work?
Use of the Finger Trigger requires the Finger Trigger Adapter. The Finger Trigger Adapter plugs into the Foot Pedal receptacle on the back of the generator, and the Foot Pedal and Finger Trigger then plug into the Adapter. The Finger Trigger operates the AutoSonix™ at the Variable Power setting selected on the front dial.
What does the Mechanical Fault indication mean, why does it occur, and how do I reset the Generator when it occurs?
The Mechanical Fault functionality of the generator is a safety feature that activates when the system is not running within a predetermined set of parameters. The initiation of a Mechanical Fault indicates a problem with the disposable Instrument, i.e. the ULTRA SHEARS™, Hook Probe, or Ball Probe. The problem could be as simple as the Transducer not being attached properly, or too much tissue being grasped between the jaw and the active blade. It could also indicate a more severe instrument problem, such as a broken tip or small crack resulting in a frequency shift. Mechanical Faults can also occur when the tip of the ULTRA SHEARS™ Instrument is clogged with fluid or tissue. The Jaws and Tip of the Instrument should be kept as clean as possible by periodically wiping or activating the Instrument in a container of saline for a few seconds. To reset the Generator when a Mechanical Fault occurs, simply deactivate the Footswitch or Finger Trigger. It is recommended that the user release any tissue being grasped by the ULTRA SHEARS™ and take a new bite once the fault has been resolved.
What does the Electrical Fault Indicator mean, why does it occur, and how do I reset the Generator after it occurs?
The Electrical Fault functionality of the AutoSonix™ Generator is a safety feature that activates when the generator encounters problems involving electrical current flow. If the Transducer Cable is not attached to either the Generator or the Transducer, the fault will activate. This is because the circuit is not complete. A damaged cable or cable connector can also be the cause of an Electrical Fault. Additionally, if the System senses more current coming into the Generator than the Generator is putting out, it will activate the Electrical Fault. This prevents the System from becoming a ground during the use of electrosurgical devices and potentially harming the patient. If the Electrical Fault is tripped, simply turn the System Power off using the Power Switch on the back of the Generator. After 3-5 seconds, turn the power switch back on and continue with the case.
What is the difference between “Standby” and “Ready”?
“Standby” is the position the Generator should be kept in after turning it on and before the user is ready to activate the Instrument in the case. Once the user is prepared to begin activating the Instruments, the Generator should be put in the “Ready” position.
How many different power settings does the Generator have?
The AutoSonix™ Generator has 10 power settings ranging from 0.5 to 5 in .5 increments. The lower power settings will result in slower cutting speeds and higher degrees of hemostasis achieved during use. A higher power setting will result in faster cutting speed and a lower degree of hemostasis.
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Features and Benefits
AutoSonix™ Generator with Shear Logic™ circuitry :
Ensures fast cutting and coagulation in variable tissue types and thickness.
10 individual power settings :
Allows for individual preference and greater flexibility for various tissue types and effects
Electrical Fault Indicator :
Helps protect the patient from stray current and audibly indicates a system problem to the user before complications can occur.
AutoSonix™ Trigger Switch & Adapter :
Allows for hand activation of the Variable Power Level to reduce fatigue from Footswitch use.
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INSTRUCTIONS FOR USE
Inspecting and attaching transducer to instrument
1. If transducer is not brand new, inspect the front face of the metal horn for contamination and/or pitting. If black residue is present, wipe face with a piece of sterile gauze wetted with alcohol. Be sure to dry the surface prior to use. If residue and severe pitting are present and cannot be cleaned, discard transducer and cable and replace with a new set.
2. Attach the transducer to the instrument as follows: Thread the distal end of the transducer onto the stud in the proximal end of the instrument. Turn clockwise until gently snug. While holding the scalloped dial of the instrument, apply torque wrench (supplied) to the proximal end of the transducer. Turn clockwise until torque wrench clicks once. DO NOT OVERTIGHTEN AS DAMAGE TO TRANSDUCER AND/OR HANDPIECE MAY OCCUR.
Inspecting and attaching cable to transducer & generator
3. Check the black connectors on both ends of the cable to ensure that they function properly and are not damaged. The 7 pins in each connector should be present and unbent. The collar with the white arrows and “PULL HERE” should be able to move freely when pulled.
4. Insert one end of the transducer cable into the receptacle on the proximal end of the transducer by lining up the white key on the cable connector with the white arrow on the proximal end of the transducer.
5. Insert the opposite end of the transducer cable into the receptacle located on the front display of the generator box by lining up the white key on the cable connector with the white arrow on the female connector on the generator box.
Generator activation & instrument use
6. Turn the generator box on. Refer to the AutoSonix™ Operator’s Manual for proper instructions regarding operation of the generator box. It is recommended that the generator be allowed to run in the Standby position for at least 5 minutes to reach equilibrium temperature prior to use in a procedure.
7. Place the tip (or jaw) of the instrument on the tissue to be transected and/or coagulated. Depress the foot pedal to energize the instrument. Be sure to avoid all contact with metal surfaces, i.e. clips or instruments as this can result in damage to the instrument and Mechanical Limit alarms thus significantly reducing its useful life.
8. It is highly recommended that the tip of the instrument be wiped and cleaned periodically during the procedure when the instrument is not in use. This should be done with a moist gauze or towel to prevent damage to the instrument. For extended use or long procedures it is also recommended that the tip of the instrument be submerged in approximately 1 inch of sterile saline solution and the instrument be activated for 4 seconds by depressing the FULL foot pedal. This should remove most gross contamination and prolong the useful life of the instrument. Do Not use metal forceps to remove contamination around the tip of the instrument. Do not use commercial cautery cleaning pads or metallic instruments to clean the tip as this may damage the probe and render the instrument inoperable.
NOTE: Do not activate instrument when tip (or jaw) is not in contact with tissue or submerged in saline solution. Failure to heed this caution may result in damage to the instrument.
9. Upon completion of the procedure, turn the generator box off. Remove the transducer cable from the generator box by gently pulling on the black collar on the cable connector. This collar is marked with a double arrow symbol and the text “PULL HERE”. Failure to remove the cable in this manner may result in damage to the cable and/or the generator box. Remove the cable from the transducer in the same manner.
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PRECAUTIONS
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.
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.
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.
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REPROCESSING INSTRUCTIONS
Autosuture™ reusable devices are supplied non-sterile. They must be cleaned and sterilized prior to use.
Repeated processing at the listed parameters has minimal effect on Autosuture™ reusable devices. Wear and damage due to use normally determine the end of instrument life.
CAUTION: Autosuture™ reusable devices must be carefully inspected prior to and after each use, as any damage may affect the safe operation of the device. Failure to lubricate the device prior to sterilization may cause malfunctions such as jamming, difficult operation, or unacceptable staple formation.
Devices with moving parts should be evaluated for proper function prior to application. If damage is suspected, contact your local representative for replacement or repair by the manufacturer.
Point of Use:
Remove excess soil with disposable wipes.
Containment and Transportation:
It is recommended that reusable instruments be reprocessed as soon as possible following use. They should be covered with a moist towel if reprocessing cannot be performed immediately.
Preparation for Cleaning:
Autosuture™ reusable devices are supplied non-sterile. Prior to use, they must be cleaned and sterilized. After each use, they must be disassembled (if applicable) and any single use components discarded.
CAUTION: Detergents and solutions for reusable devices should have a pH between 7.0 and 9.5.
Sterilization temperature should not exceed 275° F (135° C).
Manual Cleaning:
Reusable instruments should be cleaned thoroughly immediately after each use to remove all traces of blood and debris. Pay particular attention to crevices and hard-to-reach areas while scrubbing instruments with a soft bristle brush in warm water (20-25° C) with a mild detergent/enzymatic cleaner (such as Alconox® or TERG-A-ZYME® solution).
Lubrication:
Prior to sterilization, devices with moving parts must be lubricated with a water soluble lubricant such as Tomac® solution to help insure proper operation.
Automatic Cleaning:
Autosuture™ reusable devices may be placed in an automatic dishwasher at 194° F (90° C).
Disinfection:
See above (automatic cleaning)
Sterilization:
Autosuture™ reusable devices are provided non-sterile and are designed for reuse. They may be sterilized in accordance with the following process parameters:
Prevacuum Steam Cycle
Temperature: 270-275° F (132-135° C)
Time: 4 minutes minimum of exposure, wrapped
Gravity Cycle
Temperature: 250-255° F (121-124° C)
Time: 15 minutes minimum of exposure, wrapped
ETO Cycle
130° F (54° C), 600-650 mg/L, 40-60% RH, 2 hours exposure minimum, wrapped
100° F (38° C), 650-700 mg/L, 40-60% RH, 6 hours exposure minimum, wrapped
Maintenance:
Visually inspect the instruments for damage or wear and check for proper function prior to each use.
Repeated autoclaving may tarnish or discolor instrument surfaces.
Packaging:
Items may be placed in a Polyethylene/Tyvek® pouch or standard hospital wrap.
Storage:
Store at room temperature.
Additional Information:
When sterilizing multiple instruments in one autoclave cycle ensure that the sterilizer manufacturer’s stated maximum load is not exceeded.
