Stryker 1588 AIM Manual Del Usuario página 34

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These reprocessing instructions are provided in accordance with ISO 17664, AAMI TIR12,
AAMI TIR30, AAMI ST79, and AAMI ST81. While they have been validated by Stryker as being
capable of preparing the device for re-use, it remains the responsibility of the processor to
ensure that the reprocessing, as actually performed (using equipment, materials, and
personnel in the reprocessing facility), achieves the desired result. This normally requires
routine monitoring and validation of the facility's reprocessing procedures. Stryker
recommends users observe these standards when reprocessing medical devices.
O O v v e e r r v v i i e e w w
Reprocessing the device involves manual or automated cleaning with two different detergents,
optional disinfection, and sterilization.
• S S t t e e p p 1 1 (required): Cleaning with Enzymatic Detergent
• S S t t e e p p 2 2 (required): Cleaning with Non-Enzymatic Detergent
• S S t t e e p p 3 3 (optional): Disinfection
• S S t t e e p p 4 4 (required): Sterilization
W W a a r r n n i i n n g g s s
• This device must be cleaned and sterilized prior to the first use and after every subsequent
use.
• Separate the camera head, coupler (1588-210-105 and 1588-710-105 only), and scope prior
to cleaning, disinfection, or sterilization. Failure to follow this instruction will render the devices
non-sterile. (Refer to the coupler and scope product manuals for reprocessing instructions for
those devices.)
• Wear appropriate protective equipment: gloves, eye protection, etc.
• To avoid health risks from aerosol contamination, brush the device only when it is submerged
in liquid.
• Use only the sterilization cycles outlined in this document. Using unspecified sterilization
cycles may damage the device or result in incomplete sterilization.
• Sterilize only one camera head per tray, or incomplete sterilization may result. Follow any
instructions provided with the sterilization tray or system regarding tray setup and other
devices that may be sterilized within the same tray.
C C a a u u t t i i o o n n s s
• Always install the soaking cap prior to processing the camera. Failure to properly tighten the
soaking cap will corrode the connector pins and void the warranty. Refer to the Installing the
Soaking Cap section for more detail about installing the cap.
• Inspect the camera cable for cuts and breaks before soaking in any fluid. Return any damaged
camera to Stryker for service.
• Never soak the camera in the same tray with sharp instruments.
• Do not use brushes or pads with metal or abrasive tips during manual cleaning, as permanent
scoring or damage could result.
EN 32 P29924F