7
STERILIZATION:
• Place the Heat Plugger/Hot Pulp Test Tip in a sterilization pouch suitable for steam sterilization.
• For Heat Plugger/Hot Pulp Test Tip operate Gravity Displacement Sterilization Cycle at 121 °C (250
°F) for 30 minutes followed by 30 minutes of drying time or Pre-Vacuum sterilization cycle 132
°C (270 °F) for 4 minutes, followed by 20 minutes of drying time as noted in the table titled:
Recommended Sterilization Parameters.
EXTRUDER AND SYSTEM B SHIELDS
The Extruder and System B shields must be cleaned and sterilized after each use.
CLEANING:
• The shields must be removed from the handpieces for cleaning and sterilization.
• Note: Do not remove the Silicone Boot from either handpiece shield.
• The Extruder and System B shields should be wiped down with a cloth moistened with any of
the common nonabrasive, mild, cleaning liquids containing alcohol. SybronEndo recommends
CaviCide.
• Use a cotton swab or a small, soft brush moistened with CaviCide to remove any soil that may
have accumulated in crevices (e.g., between the silicone boot and the body of the shield)
• Repeat with additional wipes until no soil is visible on the cloth. After cleaning soil, the shields
should be rinsed with clean running water for a minimum of 30 seconds to remove residues
of cleaning agents.
• Visually inspect the Extruder and System B Shields to ensure cleanliness and for any damage or
contamination. If any contamination is visible, repeat the cleaning steps.
• Dry with a clean, lint free cloth until there is no visible moisture.
STERILIZATION:
• Place the handpiece shields in a sterilization pouch suitable for steam sterilization. For
handpiece shields, operate Gravity Displacement Sterilization Cycle at 121 °C (250 °F) for
30 minutes followed by 30 minutes of drying time or Pre-Vacuum sterilization cycle 132 °C
(270 °F) for 4 minutes, followed by 20 minutes of drying time as noted in the table titled:
Recommended Sterilization Parameters.
CARTRIDGE NEEDLE BENDER
The Cartridge Needle Bender must be cleaned and sterilized after each use.
CLEANING:
• Prepare an ultrasonic bath with an enzymatic cleaning solution at the concentration and
temperature specified by the manufacturer of the enzymatic solution.
• Place Cartridge Needle B Hender in the ultrasonic bath for 10 minutes.
• Remove the Cartridge Needle Bender from the bath and rinse with clean running water for a
minimum of 30 seconds
• Visually inspect for cleanliness and for any damage or contamination.
• If any contamination is visible, repeat the cleaning steps until there is no visible contamination.
• Dry with a clean, lint free cloth until there is no visible moisture.
STERILIZATION:
• Place the Cartridge Needle Bender in a sterilization pouch suitable for steam sterilization. For
Cartridge Needle Bender operate Gravity Displacement Sterilization Cycle at 121 °C (250 °F) for
30 minutes followed by 30 minutes of drying time or Pre-Vacuum sterilization cycle 132 °C
(270 °F) for 4 minutes, followed by 20 minutes of drying time as noted in the table titled:
Recommended Sterilization Parameters.
Recommended Sterilization Parameters
Moist Heat Sterilization
Cycle Gravity Displacement* Pre-Vacuum
Temperature (°C) 121 °C (250 °F) 132 °C (270 °F)
Exposure Time (minutes) 30 minutes 4 minutes
Drying Time (minutes) 30 minutes 20 minutes
*The sterilization process of the Shields and Needle Benders were validated within fully loaded
chamber using steam gravity displacement sterilization cycle.
STORAGE:
• After sterilization, place the FDA-cleared sterilization pouches containing the devices in a dry
and dark place such as a closed cupboard or a drawer.
• Follow the instructions provided by the FDA-cleared sterilization pouches' manufacturer
regarding storage conditions and maximum allowed time in storage.
SYMBOLS
Serial Number
Manufacturer
Date of Manufacture
This way up
Fragile, handle with care
Fragile, handle with care
Keep dry
Temperature limits for storage and transportation
Humidity Limitation
Atmospheric pressure Limitation
Do not throw into trash
CSA mark with «C/US» indicator for certified products
Warning or Precautions
Consult instructions for use
Type B applied part
Class II Medical Electrical Equipment
Do not autoclave
Part Number
121°C
(250°F)
Gravity Displacement
Sterilizable in a steam sterilizer (autoclave) at 121 °C (250 °F).
132°C
(270°F)
Pre-Vacuum
Sterilizable in a steam sterilizer (autoclave) at 132 °C (270 °F).
CAUTION: USA federal law restricts this device to sale by or on the order of a dentist.
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