Intended Use Of Sterilization Trays; Product Description; Warnings; Cautions - Stryker 0242000112 Manual De Instrucciones

Intended Use of Sterilization trays

Sterilization trays are plastic and/or metal containers used to hold and protect surgical devices during the sterilization
process.

Product Description

The sterilization tray consists of an interlocking tray and lid, which are both perforated to allow the passage of
sterilizing agent from outside the tray to the devices placed inside.
Sterilization trays typically feature a silicone finger mat or group of device holders that secure devices during the
sterilization process. Some models feature stacking internal trays to allow the segregation of devices.
The sterilization tray has been validated with a load that consists of various metallic instruments, some with close-mated
parts, mechanical locking mechanisms, grooves/notches, and lumens up to a length of 340mm and minimum internal
diameter of 1.4mm. The maximum load is 6.6 kg (14.6 lbs), which is distributed equally within the tray.

Warnings

• These instructions are validated only for sterilization of the tray and device(s) identified herein. Using
combinations or parameters not described in this manual may result in incomplete sterilization.
• These instructions are validated only when internal trays are arranged as prescribed. Any other combinations
could result in incomplete sterilization.
• These instructions do not replace the cleaning instructions provided with individual devices. Prior to
sterilization, clean all devices as specified in their respective user manuals.
• Wear appropriate protective equipment (gloves, eye protection, etc.) when reprocessing any medical device.
• Both the device and the tray must be cleaned prior to sterilization, or incomplete sterilization may result.
• The sterilization tray, its lid, and any internal components have been designed and validated for use as a
single system. Do not separate components from the system, for use individually or in combination with other
components, or incomplete sterilization may result.
• Inspect the tray and its components for visible damage, such as cracking or chipping, prior to use. Do not use
the tray if it is damaged.
• Do not load the tray with more than 6.6 kg (14.6 lbs). Overloading may result in incomplete sterilization.

Cautions

• Before lifting the tray assembly, verify that the latches connecting the lid to the tray are secure.
• The tray is not designed for use as a shipping container. To avoid damage, remove all devices and pack them
separately.
• Do not use highly alkaline solutions when reprocessing the tray. Alkaline solutions can react with aluminium
components and cause permanent damage.
• Do not use metallic brushes, scrub pads, or other abrasive cleaning aids when reprocessing the tray. These can
cause permanent damage.
• Do not use harsh chemicals (such as chlorine or caustic soda) or organic or ammoniated acids or solvents (such
as acetone) when reprocessing the tray. These can cause permanent damage.
• The sterilization tray should only be used with devices/instruments listed in this IFU.
• Caution: Federal law (USA) restricts this device to sale by or on order of a physician.
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