Lot Number, Expiration Date And Correspondence - Dentsply Sirona Capsule Extruder 2 Instructions For Use Manual

Drying
Maintenance,
Inspection and Testing
Storage
Additional Information
Manufacturer Contact
The instructions provided above have been validated by Dentsply Sirona as being capable of preparing
a medical device for re-use. It remains the responsibility of the processor to ensure that the processing
is actually performed using equipment, materials and traineda personnel in the processing facility to
achieve the desired result. This requires validation and routine monitoring of the process. Likewise, any
deviation by the processor from the instructions provided should be properly evaluated for effectiveness
and potential adverse consequences. Use of other reprocessing procedures/methods is at the discre-
tion and sole responsibility of the practitioner.
4.2 Disposal
Dispose of in accordance with local regulations.
5 Lot number (
1. Do not use after expiration date.
ISO standard is used: "YYYY-MM" or "YYYY-MM-DD".
2. The following numbers should be quoted in all correspondence:
• Reorder number
• Lot number
• Expiration date
3. Any serious incident in relation to the product should be reported to the manufacturer and the
competent authority according to local regulations.
© Dentsply Sirona 2020-03-08
[These Instructions for Use are based on Master Version 01]
• Use the drying cycle of the autoclave, minimum 30 minutes.
• Allow the Capsule Extruder 2 to fully air dry before storage.
• Immediately before use, visually inspect to ensure that all contamina-
tion has been removed. If the device is discolored, damaged, worn, or
distorted it should be discarded.
• Regularly apply dental instrument lubricant.
• Ensure moving parts operate smoothly.
• Store the processed Capsule Extruder 2 at room temperature, away
from moisture or excessive humidity.
• 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.
Do not use Capsule Extruder 2 which has become damaged, worn, or
distorted.
Within the United States, call Dentsply Sirona at 1-302-422-4511. For
areas outside the United States, contact your local Dentsply Sirona
representative.
), expiration date ( ) and correspondence
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