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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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