Dentsply Sirona Palodent V3 Instrucciones De Uso página 2

4. HYGIENE
Cross-contamination
• Do not reuse single use products. Dispose of in accordance with local regulations. During
incineration, Wedges and WedgeGuards may produce irritating and highly toxic gasses.
CAUTION
• Reprocess reusable products as described below.
Instructions for Disinfecting/Sterilizing the Palodent
retaining rings
Warnings • High level disinfection by itself is not appropriate for the Palodent
forceps, pin tweezers and retaining rings.
• It is not recommended to submerse Palodent
and retaining rings into disinfection solutions.
• Do not allow the device to exceed 134°C.
• The Palodent V3 sectional matrix band, Wedges and WedgeGuards are intended
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for single use only. Do not attempt to reprocess and/or re-use. Properly dispose
used Wedges, WedgeGuards and matrices with other contaminated sharps.
• Properly dispose of the used and/or contaminated matrices Wedges or
WedgeGuards in accordance with local regulations. During incineration, Wedges
and WedgeGuards may produce irritating and highly toxic gasses.
• Ensure that phosphoric acid etchants are removed from the retaining ring tines
prior to steam sterilization.
Limitations on • The Palodent V3 placement forceps, pin tweezers and retaining rings can be
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subjected to the cleaning and Reprocessing automated disinfection up to 500
times, and sterilization process up to 1000 times. Repeated processing has
minimal effect on the Palodent
rings.
• Cold liquid disinfection/sterilization, chemical vapor sterilization, and dry heat
sterilization methods have not been tested or validated for efficacy and are not
recommended for use.
Point of Use • Remove excess soil with disposable cloth/paper wipe.
• Most ultrasonic cleaning solutions will not affect the Palodent
chemicals in some cleaners may cause tine discoloration. The discoloration is only
cosmetic, but if that is a concern put the rings in a beaker with a water/detergent
solution and place that in the ultrasonic cleaner to prevent contact with chemicals.
• It is recommended that the Palodent
retaining rings are reprocessed as soon as is reasonably practical following use.
Containment & • No particular requirements.
Transportation
Cleaning & Disinfection: • Use only a properly maintained, inspected, calibrated, and approved washer/
disinfector (according to ISO 15883).
Automated: • Perform a cleaning program cycle (the following cycle is recommended):
– 1 minute pre-wash/rinse in cold tap water.
– 5 minutes wash with enzymatic detergent at 55°C.
– 6 minute enzymatic neutralization.
– 1 minute rinse in deionized water.
– Thermal disinfection with minimum A0 of 3000 (e.g. 5 minutes at 90°C).
– 30 minutes drying at 60°C.
• Follow manufacturer's recommendation for use of detergent and neutralizer,
observing concentrations and contact times.
Cleaning & Disinfection: • As an alternative to automated cleaning and disinfection, the Palodent
placement forceps, pin tweezers and
Manual: retaining rings have to be cleaned by scrubbing with hot water and soap or
detergent.
– Use a new clean pair of examination gloves
– After cleaning thoroughly wipe all device surfaces with a single-use cloth
in combination with an alcohol-based, bactericidal, virucidal and fungicidal
disinfection solution approved according to local regulations and use according
to disinfectant solution manufacturer's Instructions for Use. Make sure
disinfectant solution is compatible with cleaning solution. Pay special attention to
device seams and insertions.
– Remove disinfectant solution residue with a cloth soaked with water.
– Discard gloves according to local regulations and disinfect hands with an
appropriate bactericidal, virucidal, and fungicidal hand disinfectant solution
according to local regulations. Use according to disinfectant solution
manufacturer's Instructions for Use.
– Dry device with a lint-free single-use cloth.
Packaging • Paper/plastic steam sterilization pouches may be used, but are not required.
Sterilization • Use a steam autoclave. Do not exceed 134°C.
• Steam autoclaving – Full cycle: wrapped or unwrapped at 134°C, 2 bar/273°F, 29
psi for 3 minutes.
Drying • Use the drying cycle of the autoclave. Do not exceed 134°C.
• Allow the Palodent
dry before storage.
• Avoid leaving the Palodent
in an autoclave overnight or for long periods, as this may cause staining from the
autoclave itself.
Maintenance • If the Palodent V3 placement forceps, pin tweezers or retaining rings are damaged,
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worn, or distorted they should be discarded. Before use, visually inspect the tines
for damage, such as cracking or pitting.
• The Palodent V3 forceps and pin tweezers require no additional maintenance and
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should not be oiled or greased.
• If a Palodent V3 retaining ring is deformed by over stretching during placement or
removal, the ring should be
Storage • Store the Palodent
temperature, away from moisture or excessive humidity. Palodent
forceps, pin tweezers and retaining rings should be disinfected/sterilized and dried
prior to storage.
• Sterilization of new matrices, Wedges and WedgeGuards pre-use (if desired) may
be accomplished (one time) by steam autoclaving, 134°C, 3 minutes minimum prior
to storage and/or use.
Manufacturer • Within the United States, call Dentsply Sirona at 1-302-422-4511. For areas outside
the United States, contact Contact
Sirona representative.
V3 placement forceps, pin tweezers and
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V3 placement forceps, pin tweezers
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V3 placement forceps, pin tweezers and retaining
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V3 placement forceps, pin tweezers and
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V3 placement forceps, pin tweezers and retaining rings to fully
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V3 placement forceps, pin tweezers and retaining rings
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discarded.
V3 placement forceps, pin tweezers and retaining rings at room
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your local Dentsply
5. LOT NUMBER AND EXPECTED USEFUL LIFE
1. The following numbers should be quoted in all correspondence:
• Reorder Number
• Lot number on the package
• Copy of proof of purchase
V3 placement
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V3 rings, although
V3
®
V3 placement
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Manufactured by
Dentsply Caulk
38 West Clarke Avenue
Milford, DE 19963 USA
1-302-422-4511
www.dentsplysirona.com
Distributed by
DENTSPLY Canada
Dentsply DeTrey GmbH
161 Vinyl Court
De-Trey-Strasse 1
Woodbridge, Ontario
78467 Konstanz
Germany L4L 4A3 Canada
49-7531-583-0
559702v WEB (R 10/5/17)
www.dentsplysirona.com