Dentsply Sirona AutoMatrix Instrucciones De Uso página 2

For Manual Cleaning and Disinfection
• Discard used gloves according to local regulations.
• 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.
• Use a new clean pair of examination gloves.
Instructions for Disinfecting / Sterilizing the Automate® III Tightening Device
Warnings • High level disinfection by itself is not appropriate for the AutoMate® III tightening device.
• Steam autoclaving sterilization is appropriate for the Automate® III Tightening device.
• It is not recommended to submerse AutoMate® III tightening device into disinfection
solutions.
• Do not allow the device to exceed 137° C.
• The AutoMatrix® Retainerless Matrix System matrix band is intended for single use only. Do
not attempt to reprocess and/or re-use.
Limitations on The AutoMate® III tightening device can be subjected to the cleaning, disinfection, and
Reprocessing sterilization process up to 1000 times. Repeated processing has minimal effect on the
AutoMate® III tightening device.
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.
It is recommended that the AutoMate® III tightening device is reprocessed as soon as is
reasonably practical following use.
Containment and No particular requirements.
Transportation
Cleaning and Use only a properly maintained, inspected, calibrated, and approved washer / disinfector
Disinfection: (according to ISO 15883).
Perform a cleaning program cycle (the following cycle is recommended):
Automated
• 1 minute pre-wash / rinse in cold tap water.
• 5 minutes wash with enzymatic detergent at 55° C.
• 1 minute enzymatic neutralization in cold tap water.
• 1 minute rinse in cold tap water.
• Thermal disinfection with minimum A0 of 3000 (e.g. 5 minutes at 90° C).
• 20 minutes drying at 100° C.
Follow manufacturer's recommendation for use of detergent and neutralizer, observing
concentrations and contact times.
Cleaning and
• As an alternative to automated cleaning and disinfection, the AutoMate® III tightening
Disinfection: device has to be cleaned by scrubbing with hot water and enzymatic detergent solution
prepared according to the manufacturer's instructions, e.g., Resurge® Instrument
Manual Cleaning Solution. 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.
• 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 137° 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 137° C.
Allow the Automate® III Tightening Device to fully dry before storage.
Maintenance If the AutoMate® III tightening device is damaged, worn, or distorted it should be discarded.
If the knurled barrel of the AutoMate® III tightening device does not turn freely, add one
drop of mineral oil to the ball bearing above the knurling and rotate the barrel to distribute
the oil.
Storage Store the AutoMate® III tightening device at room temperature, away from moisture or
excessive humidity. Tightening device should be disinfected/sterilized and dried prior to
storage.
Instruments steam autoclaved bagged should remain bagged until ready for use. Prior to
subsequent re-use, inspect the sterilization pouch and the device. If the integrity of the
sterilization pouch has been compromised, the device must be reprocessed prior to use.
Instruments steam autoclaved unwrapped should be used immediately.
Manufacturer Within the United States, call Dentsply Sirona at 1-302-422-4511. For areas outside the
Contact United States, contact your local Dentsply Sirona representative
Instructions for Disinfecting / Sterilizing the AutoMatrix® Snippers+ and catch-tray
Warnings • High level disinfection by itself is not appropriate for the AutoMatrix® Snippers+ and
catch-tray.
• Steam autoclaving sterilization is appropriate for the AutoMatrix® Snippers+ and catch-
tray.
• Do not allow the device to exceed 137° C.
• The AutoMatrix® Retainerless Matrix System matrix band is intended for single use only.
Do not attempt to reprocess and/or re-use.
Limitations on The AutoMatrix® Snippers+ can be subjected to the cleaning, disinfection, and sterilization
Reprocessing process up to 800 times.
The AutoMatrix® Snippers+ catch-tray can be subjected to the cleaning, disinfection, and
sterilization process up to 80 times.
Point of Use 1. For loosening of Catch-Tray, open AutoMatrix® Snippers+ as widely as possible.
2. Pull off Catch-Tray from the AutoMatrix® Snippers+.
3. Clean the devices using a soft brush and running cold water.
Containment and No particular requirements.
Transportation
Cleaning and Use only properly maintained, calibrated, and approved washer-disinfector
Disinfection: ISO 15883-1.
1. After opening, place AutoMatrix® Snippers+ and catch-tray in the washer-disinfector
Automated
allowing water and detergent to wet all surfaces and to drain off afterwards during the
washer-disinfector-program. Follow washer-disinfector's Instructions for Use.
2. Run washer-disinfection program with A0 value ≥ 3000 (e.g. 5 min at ≥ 90°C), using
appropriate detergents (e.g.: neodisher® MediClean [0.5%] (alkaline detergent) and
neodisher® Z [0.1%] (acid neutralization and cleaning detergent); both detergents from Dr.
Weigert, Hamburg, Germany ).
2
Cleaning and
Disinfection:
Manual
Packaging
Sterilization
Drying
Maintenance
Storage
Manufacturer
Contact
Sterilization of matrices pre-use (if desired) may be accomplished (one time) by steam autoclaving,
134°C, 3 minutes minimum (unwrapped), 12 minutes minimum (wrapped).
5. LOT NUMBER AND EXPECTED USEFUL LIFE
1. AutoMatrix ® system accessories are warranted for one year from date of purchase.
2. The following should be quoted in all correspondences:
• Reorder number
• Lot number on the package
• Copy of proof of purchase
Manufactured by
Dentsply Caulk
38 West Clarke Avenue
Milford, DE 19963 USA
Tel.: 1-302-422-4511
www.dentsplysirona.com
according to
1
1. For example Miele Washer-Disinfector G7835 CD using program vario TD.
2 .Not registered trademarks of Dentsply Sirona, Inc.
3. Not registered trademarks of Dentsply Sirona, Inc.
©2017 Dentsply Sirona. All Rights Reserved.
As an alternative to automated cleaning and disinfection, the AutoMatrix® Snippers+ and
catch-tray can also be manually cleaned and disinfected.
1. Clean AutoMatrix® Snippers+ and catch-tray with a soft brush, cold tap water, and an
appropriate cleaning solution (e.g.: alkaline solution: Dürr FD370 [2%]
nonionic surfactants (5 - 15 %), chelating agents (< 5 %) and adjuvants in an aqueous
solution, until free of visible contamination. Pay special attention to AutoMatrix®
Snippers+ and catch-tray seams and insertions.
2. Remove cleaning solution residue with a cloth soaked with water.
3. Dry AutoMatrix® Snippers+ and catch-tray with a lint-free, single-use cloth.
4. After cleaning thoroughly wipe all surfaces with a single-use cloth in combination
with an undiluted, aldehyde-free, alcohol-based, bactericidal, tuberculocidal, virucidal
and fungicidal disinfection solution (e.g.: Dürr FD333
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 devices seams and insertions.
5. After 2 minutes remove disinfectant solution residue with a cloth soaked with water.
6. Dry AutoMatrix® Snippers+ and catch-tray with a lint-free single-use cloth.
Paper / plastic steam sterilization pouches may be used, but are not required.
After manual cleaning and disinfection or after processing in a washer-disinfector, the
AutoMatrix® Snippers+ and catch-tray can also be autoclaved.
1. Steam autoclave device unwrapped at 134 °C/ 2 bar = 273 °F/ 29 psi for 3 minutes 30
seconds. Do not exceed 137° C.
Use the drying cycle of the autoclave. Do not exceed 137° C.
Allow the AutoMatrix® Snippers+ and catch-tray to fully dry before storage.
If the AutoMatrix® Snippers+ or catch-tray is damaged, worn, or distorted it should be
discarded.
Regularly apply medical white oil to the AutoMatrix® Snippers+.
Store the AutoMatrix® Snippers+ and catch-tray at room temperature, away from moisture
or excessive humidity. AutoMatrix® Snippers+ and catch-tray should be disinfected/
sterilized and dried prior to storage.
Instruments steam autoclaved bagged should remain bagged until ready for use. Prior to
subsequent re-use, inspect the sterilization pouch and the device. If the integrity of the
sterilization pouch has been compromised, the device must be reprocessed prior to use.
Instruments steam autoclaved unwrapped should be used immediately.
Within the United States, call Dentsply Sirona at 1-302-422-4511. For areas outside the
United States, contact your local Dentsply Sirona representative
Dentsply DeT GmbH
rey
De-Trey-Str. 1
78467 Konstanz
Germany
Tel.: 49-7531-583-0
www.dentsplysirona.com
563030 WEB (R 11/3/17)
) containing
3
) approved according to local
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Distributed by
Dentsply Canada
161 Vinyl Court
Woodbridge, Ontario
L4L 4A3 Canada