Dentsply Sirona Purevac Indicaciones De Uso página 2

ENGLISH
Indications for Use
The Purevac® High Volume Evacuation Mirror Tip
allows for evacuation, visualization, retraction
and illumination during dental procedures. The
mirror tip is intended to be used by trained dental
professionals only.
Contraindications
None known.
Warnings
The mirror tip must be sterilized before first use and
between patients to prevent cross-contamination.
Follow validated reprocessing instructions
provided.
Precautions
The mirror tip is designed to last up to 100 uses. Ensure
the mirror tip is secured in the valve before use. Do not
use brushes for cleaning which may scratch the mirror
or plastic. Take precaution during use with other dental
instruments to avoid damage to the mirror and plastic.
Be sure to dry the mirror surfaces thoroughly prior to
sterilization. Dispose of the mirror tip in accordance
with government agency regulations.
Adverse Reactions
None known.
Residual Risks
Use of the device beyond its useful life may
cause damage and increase risk of patient cross-
contamination.
Failure to follow the validated reprocessing
instructions provided may result in exposing
the patient to cytotoxic residuals and/or cross-
contamination.
Step by Step Instructions
Always sterilize the mirror tip before first use and
between patients. Insert the mirror tip directly into
high volume evacuation valve. The mirror tip is
compatible with standard 15 mm systems per ISO
10637:1999. Ensure the mirror tip is secured in the
valve before use.
Reprocessing Instructions
There are two possible cleaning and disinfection
procedures recommended between patient use
to prevent cross-contamination: (1) Ultrasonic
Cleaning and Disinfection or (2) Automated
Cleaning and Disinfection. It is only required to
follow one of these two methods as part of the
overall reprocessing procedure
Point of Use: Turn suction off and remove mirror tip
from valve.
Ultrasonic Cleaning and Disinfection: Remove visible
soil by rinsing the interior and exterior of the mirror
tip under tap water of at least drinking quality for
a minimum of 30 seconds. Prepare instrument
cleaning or cleaning/disinfection solution per the
manufacturer's recommendation. Immerse the mirror
tip in an ultrasonic bath containing the prepared
solution for the contact time specified by the
solution manufacturer. The recommended solutions
are PracticeProtect™ Instrument Disinfection &
Cleaning Liquid and Resurge® Instrument Cleaning
Solution. Rinse the mirror tip under tap water of at
least drinking quality for a minimum of 30 seconds.
Allow the mirror tip to dry. Visually inspect the
mirror tip for visible soil, and repeat the cleaning and
disinfection procedure if necessary.
Automated Cleaning and Disinfection: A thermal
disinfector that complies with ISO 15883 may
be used for automatic cleaning and disinfection.
Follow the manufacturer's instructions to select
the solutions and programs.
Sterilization: Ensure that the mirror tip, particularly
the mirror, is completely dry before sterilization.
A lint-free, disposable cloth may be used to
dry the mirror tip. Enclose the mirror tip into an
appropriately sized sterilization pouch intended for
steam sterilization. The mirror tip must be sterilized
using a steam sterilizer. A pre-vacuum sterilizer
may be used at 135°C for 3 minutes or 121°C for
15 minutes. A positive steam flush pressure pulse
sterilizer may be used at 134°C for 3.5 minutes.
A gravity displacement steam sterilizer may be used
at 135°C for 10 minutes. Do not remove the mirror
tip from the sterilization pouch until ready for use to
prevent device contamination.
Any serious incident that has occurred in relation to
this device should be reported to the manufacturer
and the Competent Authority of the Member State.