Cleaning And Sterilization - Stryker Formula Manual Del Usuario

Cleaning and Sterilization

These reprocessing instructions are provided in accordance with AAMI ST79,
AAMI ST81, AAMI TIR12, AAMI TIR30, ISO 15883, ISO 17664, and ISO 17665.
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 validation and routine monitoring of the process. Stryker recommends
users observe these standards when reprocessing medical devices.
Warning
Cautions
• For Formula® handpieces, always install the soaking cap prior to
cleaning or sterilization. If moisture reaches the connection pins of the
cable connector, it could damage the connector.
• Never immerse the handpiece in a liquid to help it cool after sterilization,
or product damage may result. Cool the handpiece by wrapping it in a
sterilized damp sponge or cloth.
• Do not cross-sterilize the handpiece. Alternating between different
methods of sterilization may cause undue wear on the handpiece.
Product longevity is extended by the consistent use of a single
sterilization method.
• Do not leave the handpiece in solutions longer than necessary. This may
accelerate normal product aging.
Limits on Reprocessing
• Proper processing has a minimal effect on the handpiece. End of life is
normally determined by wear and damage due to use.
• Using multiple sterilization methods may significantly reduce the
performance of the device and is not recommended.
• Damage incurred by improper processing will not be covered by the
warranty.
• To minimize the risk of infection, clean and sterilize the
handpiece prior to the first use and every use thereafter.
• Ensure the suction lever is completely in the on position
during sterilization.
• Drying time depends on several variables, including:
altitude, humidity, type of wrap, preconditioning, size of
chamber, mass of load, material of load, and placement
in chamber. Users must verify that drying time set in their
autoclave yields dry surgical equipment.
EN-17