Symmetry Surgical FlashPak 9020 Instrucciones De Uso

®
INSTRUCTIONS FOR USE
Description
The FlashPak Sterilization Container System consists of a family of rigid reusable containers that provide an effective sterilization packaging
method for surgical instruments requiring immediate-use (flash) steam sterilization. Each FlashPak system is comprised of an upper lid that
seals by means of a silicone gasket and latches to a lower base creating a totally enclosed environment. A stainless steel wire basket is utilized
inside the container to facilitate handling of sterilized items. The lid and base incorporate pressure actuated valves that open to allow sterilant to
enter the container during the pressurization portion of the sterilization cycle and then close to seal the container once the cycle is over so the
container and its contents can be removed from the sterilizer and immediately transported to the point of use without the risk of recontamination.
Intended Use
FlashPak is a reusable rigid container system to be used during flash sterilization by hospitals and healthcare facilities. It is intended to
enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is
compatible with gravity-displacement flash sterilization using a 10 minute cycle at 132
cycle at 132 C. FlashPak is recommended for surface sterilization of stainless steel instruments and for lumens with the following limits: gravity-
o
displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1 mm inner diameter or larger and up to 203mm in
length).
WARNINGS AND PRECAUTIONS
Warnings
• Read these instructions completely before using the device.
• FlashPak is designed and intended for immediate-use (flash) steam sterilization only.
• Care should be taken when removing FlashPak after sterilization because it will be hot.
Precautions
• This product is packaged and shipped non-sterile. It must be cleaned with a neutral pH detergent prior to use.
• Do not use a FlashPak container that is chipped, cracked or has a damaged lid gasket, valve seal or vent button.
• Do not stack the FlashPak containers in the sterilizer as this may inhibit sterilant access.
• FlashPak is recommended for use with an approved multi-parameter chemical integrator (CI). Always verify proper multi-parameter
chemical integrator (CI) exposure after every sterilization cycle.
• After sterilization the valves must seat against silicone seals to prevent possible recontamination. Always visually verify full seal contact
after every sterilization cycle.
• Immediate-use (flash) steam sterilization does not include dry times so condensation in the container is expected. Care should be taken
when transporting the container and when removing the container lid and contents.
• Unless otherwise recommended by the device manufacturer's instructions, do not use FlashPak for sterilization of batteries, motorized,
electric or electronic devices.
• The FlashPak valves and pressure balancing element (i.e. metal microfilter) must be periodically replaced in order to ensure continued
effectiveness. Replacement of parts should only be performed by trained personnel.
CLEANING
Manual Cleaning
1. Wash all surfaces (inside and outside) using a neutral 6.0 - 8.0 pH detergent solution. FlashPak may be immersed for cleaning. Soft sponges
or cloth wipes are recommended for cleaning.
2. Rinse thoroughly with warm water.
3. Dry the FlashPak thoroughly using lint free absorbent towels or clean pressurized air.
Automated Cleaning
1. FlashPak may be cleaned with automated washing equipment using a low-sudsing neutral 6.0 - 8.0 pH detergent solution. Follow the washer
manufacturers recommended directions for this activity and ensure the container is dry before using or storing it.
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sterilization solutions
FLASHPAK STERILIZATION CONTAINER SYSTEM
®
sterilization solutions
®
o C and with pre-vacuum flash sterilization using a 4 minute
IFU-1000789 Rev 4