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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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