Stryker 0233–050–064 Manual De Instrucciones página 9

4
R R e e p p r r o o c c e e s s s s i i n n g g
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 cable 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
4.1 Warnings
• This device must be cleaned and sterilized prior to the first use and after every
subsequent use.
• Use only the sterilization cycles and configurations that were validated and are outlined
in this document. Using unspecified sterilization cycles can damage the device or result
in incomplete sterilization.
• Adapters must be removed from the cable prior to cleaning, disinfection, and
sterilization.
• Do not use synthetic detergents or oil-based soaps. These soaps can be absorbed by
the device and leach out, causing a tissue reaction.
• To avoid health risks from aerosol contamination, brush the device only when it is
submerged in liquid.
• Wear appropriate protective equipment: gloves, eye protection, etc.
4.2 Cautions
• Do not sterilize the device outside of the recommended parameters. Doing so will cause
irreversible product damage and will lead to premature replacement of the device.
• Do not use brushes or pads with metal or abrasive tips during manual cleaning, as
permanent scoring or damage could result.
EN- 7