Scope
These instructions are applicable to the ET Flex™ family of products. They are applicable before initial use and after each subsequent use. ET Flex™
products are provided mechanically clean, but are not sterile. Therefore, ET Flex™ products should be sterilized before first use.
Warnings
1. Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel and plastics and must not be used. Cleaning agents
with neutral pH are recommended.
2. Do not use dry heat.
Reprocessing Limitations
The end of life is determined by wear and damage in use and the ET Flex™ should be inspected for defects during the cleaning process.
Point of Use
Delay in reprocessing must be kept to a minimum to avoid contaminants drying thereby making cleaning more difficult.
Containment/Transportation
The ET Flex™ can be transported wet or dry and should be protected from damage. If transported wet there is an increased chance of staining or corrosion.
Prolonged storage in disinfectant solutions may result in degradation of the product and must be avoided.
Manual Cleaning Procedure
1. If hand cleaning is the only available option, the ET Flex™ should be cleaned in a sink reserved for the purpose.
2. Rinse the ET Flex™ under running cold water and, keeping it immersed, brush thoroughly away from the body using a neutral cleaning or cleaning/
disinfecting agent validated for use on stainless steel dental instruments. Follow the agent manufacturers' instructions.
3. Special care should be taken to clean crevices, blind holds and other hard-to-reach areas thoroughly.
4. Visually inspect to confirm the removal of debris. Repeat the cycle if needed.
5. Perform a final thorough rinse of the device.
6. Dry the device using a non-shedding wipe or clean compressed air.
Automated Cleaning Procedure
1. Rinse the ET Flex™ under running cold water and, keeping it immersed, brush thoroughly away from the body using a neutral cleaning or cleaning/
disinfecting agent validated for use on stainless steel dental instruments. Follow the agent manufacturers' instructions. Care should be taken to avoid
spreading contaminants by spraying or splashing during the brushing process.
2. Special care should be taken to clean crevices, blind holds and other hard-to-reach areas thoroughly.
3. Prepare a neutral cleaning solution and place in a sonication unit. Follow the agent manufacturers' instructions for correct concentration, exposure
time, temperature and water quality. Completely submerge the device in the cleaning solution and sonicate for at least 15 minutes.
4. Visually inspect to confirm the removal of debris. Repeat the cycle if needed.
5. Perform a final thorough rinse of the device.
6. Dry the device using a non-shedding wipe or clean compressed air.
Inspection Testing
1. Carefully inspect each device to ensure that all debris has been removed.
2. Visually inspect the device for damage/ wear that would prevent proper operation.
a. Do not use if the plastic surfaces show excessive crazing, cracking or delamination.
b. Do not use if the diamond-coated stainless steel strip (where applicable) is showing wear.
c. Do not use if the serrated stainless steel strip (where applicable) has broken teeth.
d. Do not use if the stainless steel strip exhibits signs of rust.
Packaging
Singly: Pack the device in pouches validated for sterilization.
In Sets: Place the devices in the dedicated instrument block.
Sterilization
Use the following cycle for steam sterilization:
DENTAL INSTRUMENTATION
B-3468
-06.11-25M-TT
©2011 Brasseler USA. All rights reserved. Printed in the U.S.
Patent # US 7,455,521 B2
Manufactured for:
One Brasseler Boulevard
Savannah, GA 31419
800-841-4522
Cycle Type
Min.Sterilization Exposure Time (Minutes)
Min. Sterilization Exposure Temperature
Min. Dry Time
Gravity
15
121°C (250°F)
15 minutes
Ensure that the sterilizer manufacturer’s maximum load is not exceeded.
Storage
The device should be stored in the sterilization pouch (or instrument block) until required.
Additional Information
These processes have been validated as being capable of preparing ET Flex™ products for reuse. Any deviation from these instructions should be properly
validated for effectiveness and potential adverse results.
