Manual Cleaning - Bowa LOTUS Serie Instrucciones De Uso

LIMITATIONS ON REPROCESSING
• Transducers can be autoclaved a maximum of 50 times.
• End of life is generally determined by wear or damage in surgical case.
• Carefully inspect instruments between uses to verify proper functioning.
• Damaged instruments should be replaced to prevent potential patient injury
and loss of metal fragments into the surgical site.
IMMEDIATELY AFTER USE
• Immediately after use, wipe down all components and remove any surplus body
fluids and debris.
• Fit the attached end cap over the free end of the Transducer cable. Push the cap
until it clicks into place.

MANUAL CLEANING

• Prepare enzymatic cleaning solution (e.g. Gigazyme Plus) to manufacturer's
instructions.
• Soak soiled instruments in enzymatic solution for 5 minutes.
• When cleaning, fully submerge the instruments in the cleaning solution. Brush
with a soft nonmetallic bristle brush or cloth to remove all traces of blood and
debris, concentrating on any crevices, seams or other surface discontinuities.
Clean holes and recesses using an appropriate brush, ensuring that the full
depth of the feature is reached. Ensure instruments are visibly clean before
progressing to the next step.
• Rinse instruments thoroughly with clean running water for 2 minutes. Ensure
that blind holes and recesses are repeatedly filled and emptied with running
water.
• Dry instruments immediately after final rinse. Do not exceed 285 ºF (140 ºC)
AUTOMATED CLEANING
• Instruments may require manual cleaning prior to automated cleaning to
improve the removal of adherent soil. Brush with a non-metallic bristle brush in
enzymatic cleaning solution.
• Load instruments such that crevices, seams, surface discontinuities, holes and
recesses can drain.
• Clean using the "Instruments" cycle in a validated washer disinfector and a pH
neutral cleaning agent intended for use in automatic cleaning (e.g. Getinge En-
zymatic Detergent). The cleaning cycle should incorporate pre-rinse (minimum
3 minutes), wash (minimum 14 minutes), rinse (minimum 7 minutes), thermal
rinse (minimum 1 minute at 200 ºF / 93 ºC), and drying steps – do not exceed
285 ºF (140 ºC).
• An alkaline cleaning solution such as, for example, Serchem pH Plus Detergent,
with a pH up to 13.2 may be used instead of, or in addition to, an enzymatic
solution.
CLEANING INSPECTION
• Inspect all instruments prior to sterilization or storage to ensure the complete
removal of soiled surfaces.
• Visually inspect instruments. If soil is still present, clean instruments again.
• Inspect cables for wear and damage, ensuring that no cracks, tears or other
damage is found.
• Check to see that waveguides are free of scratches.
• Report any damage found to the LOTUS representative.
WRAPPING
• Double wrap in accordance with local procedures, using standard wrapping
techniques such as those described in ANSI / AAMI ST46-1993.
• Label contents of wrapped tray using indelible marker or other sterilization
compatible label system.
STERILIZATION
• Transducers can be autoclaved a maximum of 50 times.
• Sterilization is best achieved on the day preceding the surgery, but must be at
least one hour prior to use to allow the equipment to cool and stabilize.
• Transducers are NOT to be submerged in water to expedite cooling.
• Do NOT sterilize the generator.
• These components have been validated for sterilization by the following
method in a vacuum autoclave. The parameters for this being 270º – 277 ºF
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