Publicidad
Idiomas disponibles
Idiomas disponibles
4. HYGIENE
Cross-contamination.
• Do not reuse single use products. Dispose of in accordance with local regulations.
• Reprocess reusable products as described below.
CAUTION
NOTICE
Wrong cleaning or disinfection method.
Damage to the device.
1. Always disassemble Snippers+ catch-tray before final reprocessing.
2. Do not clean or disinfect with aggressive agents (e.g. solutions based on orange oil or acetone).
3. Start reprocessing within 1 hour after use.
For Manual Cleaning and Disinfection
• Discard used gloves according to local regulations.
• Disinfect hands with an appropriate bactericidal, virucidal, and fungicidal hand disinfectant so-
lution according to local regulations. Use according to disinfectant solution manufacturer's In-
structions 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, dis-
Reprocessing
infection, and 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 wash-
Disinfection:
er/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.
• 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 neutraliz-
er, observing concentrations and contact times.
Cleaning and
• As an alternative to automated cleaning and disinfection, the AutoMate®
Disinfection:
III tightening device has to be cleaned by scrubbing with hot water and
Manual
enzymatic detergent solution prepared according to the manufacturer's
instructions, e.g., Resurge® Instrument 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 dis-
infectant solution is compatible with cleaning solution. Pay special atten-
tion 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
Contact
outside the United States, contact your local Dentsply Sirona representa-
tive.
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,
Reprocessing
and sterilization process up to 800 times.
The AutoMatrix® Snippers+ catch-tray can be subjected to the cleaning, dis-
infection, 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:
according to ISO 15883-1.
Automated
1. After opening, place AutoMatrix® Snippers+ and catch-tray in the washer-
disinfector allowing water and detergent to wet all surfaces and to drain
off afterwards during the washer-disinfector-program. Follow washer-dis-
infector'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, Germa-
ny
).
2
Cleaning and
As an alternative to automated cleaning and disinfection, the AutoMatrix®
Disinfection:
Snippers+ and catch-tray can also be manually cleaned and disinfected.
Manual
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%]
3
) containing nonionic surfactants (5-15%), chelating agents
(< 5%) and adjuvants in an aqueous solution, until free of visible contami-
nation. 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, bactericid-
al, tuberculocidal, virucidal and fungicidal disinfection solution (e.g.: Dürr
FD3333) approved according to local regulations and use according to
disinfectant solution manufacturer's Instructions for Use. Make sure dis-
infectant solution is compatible with cleaning solution. Pay special atten-
tion 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.
Packaging
Paper/plastic steam sterilization pouches may be used, but are not required.
Sterilization
After manual cleaning and disinfection or after processing in a washer-dis-
infector, 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.
Drying
Use the drying cycle of the autoclave. Do not exceed 137 °C.
Allow the AutoMatrix® Snippers+ and catch-tray to fully dry before storage.
Maintenance
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+.
Storage
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 un-
wrapped should be used immediately.
Manufacturer
Within the United States, call Dentsply Sirona at 1-302-422-4511. For areas
Contact
outside the United States, contact your local Dentsply Sirona representa-
tive.
Sterilization of matrices pre-use (if desired) may be accomplished (one time) by steam autoclav-
ing, 134 °C, 3 minutes minimum (unwrapped), 12 minutes minimum (wrapped).
5. LOT NUMBER, EXPECTED USEFUL LIFE AND CORRESPONDENCE
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
3. Any serious incident in relation to the product should be reported to the manufacturer and the
competent authority according to local regulations.
© 2023 Dentsply Sirona. All Rights Reserved. 563030 W EB (R 11/21/23)
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.
3
1
Publicidad
