CareFusion V.Mueller Mode D'emploi page 5

Inspection/Maintenance
Proper care and handling is essential for satisfactory performance
of any surgical device. The previous cautions should be taken to
ensure long and trouble-free service from all your surgical devices.
Inspect devices before each use for broken, cracked, tarnished
surfaces, movement of hinges, and chipped or worn parts. If any
of these conditions appear, do not use the device. Return devices
to an authorized repair service center for repair or replacement.
Before sterilizing, lubricate the device with instrument milk or a
steam permeable/ water soluble lubricant, following the
lubricant manufacturer's instructions.
Let devices drip dry for three (3) minutes before packaging for
sterilization.
Non-Stick Bipolar Forceps
The polished tips are made from precious metal and may
tarnish, similar to silver. This does not impair the functionality
of the instrument. The original gloss can be established by
polishing with a silver cleaning cloth.
Bipolar forceps with Irrigation
The enclosed stylet should always be inserted in the respective
irrigation channel, except during use and cleaning, to prevent
clogging of the channel. The irrigation channel must be
thoroughly flushed during cleaning. After cleaning, the
transmissibility of the channel has to be verified.
Packaging
Devices can be loaded into dedicated packaging systems.
Sterilization wrap material must be cleared for the applicable
sterilization modality by your country's regulatory body. Use in
accordance with packaging manufacturer's sterilization instructions
being sure to protect jaws and cutting edges from damage.
Sterilization
All devices must be processed in the completely open position
(i.e. flushports, jaws, etc.) to allow sterilant contact of all
surfaces. Note that applicable device disassembly should not
require any mechanical tooling (i.e. screwdriver, pliers etc.)
unless otherwise indicated.
All devices with concave surfaces shall be configured so that
water pooling does not occur.
Sterilization for United States Market
STANDARD PREVACUUM STEAM STERILIZATION CYCLES
Prevacuum Steam Sterilization Cycle
(U.S. "FDA Compliant – WRAPPED")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Dry Time: 30 minutes
• Sterilization Configuration: FDA Cleared Sterilization
Wrap (2 layer-1 ply, or 1 layer -2 ply – examples:
cellulose, polypropylene, muslin)
Prevacuum Steam Sterilization Cycle – Immediate Use
Steam Sterilization (U.S. "FDA Compliant – WRAPPED")
• Conditioning Pulses: 3
• Exposure Temperature: 132°C (270°F)
• Exposure Time: 4 minutes
• Sterilization Configuration: FDA Cleared 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. Refer to ANSI/AAMI ST79 for
requirements on when to perform and how to control
immediate use steam sterilization.
Reference: ANSI/AAMI ST79: (current revision)
Comprehensive guide to steam sterilization and sterility
assurance in health care facilities.
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