CareFusion V.Mueller Manual Del Usuario página 6

Prevacuum Steam Sterilization Cycle (U.S. "FDA
Compliant WRAPPED Sterilization Tray or Case")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Dry Time: 40 minutes in chamber, 15 minutes in-chamber
post sterilization chamber door cracked, 60 minutes on
drying rack.
• Sterilization Configuration: Sterilization Tray or Case
enclosed in FDA Cleared Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Sterilization for outside United States Market
PREVACUUM STEAM STERILIZATION CYCLES
Prevacuum Steam Sterilization Cycle (Outside U.S. Market)
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F) - 135°C (275°F)
• Exposure Time: 3-18 minutes
• Dry Time: 30 minutes
• Sterilization Configuration: Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Prevacuum Steam Sterilization Cycle – Immediate Use
Steam Sterilization (Outside U.S. Market)
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F) - 135°C (275°F)
• Exposure Time: 3-18 minutes
• Sterilization Configuration: Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Note: Devices must be used immediately and cannot be
stored for later use.
Immediate Use Steam sterilization is not recommended as
a routine practice. In order to control steam sterilization
please refer to ISO 17665-1 or ANSI/AAMI ST79. To
control immediate use steam sterilization, please refer to
ANSI/AAMI ST79.
References ISO 17655-1 (current revision) : Sterilization of
health care products - Moist heat - Part 1: Requirements
for the development, validation and routine control of a
sterilization process for medical devices - ANSI/AAMI ST79
(current revision): Comprehensive guide to steam
sterilization and sterility assurance in health care facilities.
Prevacuum Steam Sterilization Cycle
(Outside U.S. Market "WRAPPED Sterilization Tray or
Case")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F) - 135°C (275°F)
• Exposure Time: 3-18 minutes
• Dry Time: 60 minutes in chamber, 15 minutes
in-chamber post sterilization chamber door is cracked,
60 minutes on drying rack.
• Sterilization Configuration: Sterilization Tray or Case
enclosed in Sterilization Wrap
(2 layer-1 ply, or 1 layer -2 ply – examples: cellulose,
polypropylene, muslin)
Storage
After sterilization, devices must remain in sterilization
packaging and be stored in a clean, dry environment.
Warranty
CareFusion offers a lifetime guarantee on every surgical device
bearing the V. Mueller brand name (unless otherwise noted) to
be free of functional defects in workmanship and materials
when used normally for its intended surgical purpose. Any V.
Mueller device proving to be defective will be replaced or
repaired at no charge.
5