CareFusion Snowden-Pencer Tebbetts Mode D'emploi page 6

Sterilization for Outside United States Market
STANDARD 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
STANDARD GRAVITY STEAM STERILIZATION CYCLES
Gravity Steam Sterilization Cycle (Outside U.S. Market)
• Temperature: 132°C (270°F) - 135°C (275°F)
• Exposure Time: 15 – 30 minutes
• Dry Time: 45 minutes
• Sterilization Configuration: 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 every surgical device
bearing the Snowden-Pencer brand name (unless otherwise
noted) to be free of functional defects in workmanship and
materials when used normally for its intended surgical purpose.
Any Snowden-Pencer device proving to be defective will be
replaced or repaired at no charge.
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