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Dentsply Sirona SmartLite Pro EndoActivator Manual De Instrucciones página 14

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4.1 Activator Tip
Processing Instructions for Activator Tip
Warnings
• Follow proper infection prevention activities, such as proper hand washing and donning
new gloves at pertinent steps.
• Use only the recommended validated processing procedure.
• Do not autoclave prior use. Autoclaving may increase risk of activator tip fracture.
Limitations on
• Activator Tips are not validated for use in automated washer disinfectors.
reprocessing
• Intended for single-use only.
• Use of the device beyond its useful life may cause damage to the device and increases
the risk of patient cross-contamination.
• Use of autoclave or steam sterilization is not recommended.
• Chemical vapor sterilization and dry heat sterilization methods have not been tested or
validated for e cacy and are not recommended for use.
Initial treatment
Imediately after use, it is recommended that the activator tips be removed from the
at the point
attachment and discarded according to local regulations.
of use
Preparation
Wear clean gloves prior to handling and disinfecting.
before
cleaning/
disinfection
Cleaning:
Activator tips are not validated for ultrasonic cleaning.
Mechanical
Cleaning and
Cleaning
Disinfection:
• Cleaning is not needed prior use.
Manual
Disinfection by Immersion and Wiping
• The recommended disinfectant solution is 5.25% Sodium Hypochlorite solution (bleach)
and wiping with 70% Isopropyl Alcohol (IPA).
• Disinfect the activator tips by fully immersing in a bath of 5.25% Sodium Hypochlorite
solution for one minute. Gently wipe the activator tips with a sterile gauze moistened by
70% Isopropyl Alcohol. Air dry the activator tips until completely free from moisture.
Do not use disinfecting solutions containing Phenol or any products which are not
compatible with the treated filling material.
Cleaning and
Activator tips are not validated for automated immersion disinfection.
Disinfection:
Automated
Drying
The drying instructions are incorporated in the disinfection section above.
Maintenance,
Visually inspect the device for any damage prior processing. If the device is fractured,
Inspection and
cracked, distorted, etc., discard and do not use.
Testing
Packaging
Ensure that the blister packaging for the individual activator tips is not damaged
before use.
Sterilization
Do not subject to steam sterilization.
/ Steam
Material cannot tolerate autoclaving and may result in degradation.
autoclaving
Storage
• Store at room temperature, away from moisture or excessive humidity.
• Keep away from sunlight and heat.
• Use the product at room temperature.
• To prevent contamination, store processed device in covered storage such as a drawer
or cabinet until use.
Additional
Prior to use, inspect the device. Discard any device which has become damaged
Information
or compromised.
Manufacturer
Within the United States, call Dentsply Sirona at 1-844-848-0137. For areas outside the
Contact
United States, contact your local Dentsply Sirona representative.
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