Orascoptic EyeSpy User manual

EyeSpy™Mouth Mirror
Reprocessing Instructions
To re-order, visit orascoptic.com/EyeSpy

Considerations:
•The user/processer should comply with local laws and ordinances in countries where requirements are more stringent than those
detailed in this instruction.
•New and used devices must be processed thoroughly according to these instructions prior to use.
•The devices may be safely and efficiently cleaned using the manual or automated cleaning instructions outlined in this instruction.
•The manufacturer’s methods and instructions for application of the detergents must be followed.
Warnings and Precautions:
•Use only phenol-free and aldehyde-free detergents! Chlorides have a negative effect on these devices!
•Do not use galling solutions or equipment.
•Alkaline detergents are not recommended. Detergents with ph value ≤10.8 can be considered. The operator is responsible for the
conformity of the alkaline detergent with the products. (Long-term effect on the products).
•Do not use hard water. Soft water should be used during initial rinsing of the device. Purified water should be used for final rinsing to
eliminate mineral deposits on devices. Purification may be done by deionization (DI), reverse osmosis (RO) or equivalent.
•Repeated reprocessing has marginal consequences for the device. Normally the end of durability of the product will be determined by
visual degradation.
Cleaning:
Manual/Ultrasonic Cleaning Procedure:
a. Recommended cleaning solution: Enzol®. Prepare cleaning solution per the manufacturer’s recommendations using lukewarm
tap water.
b. Remove devices from storage containers and rinse under tap water to remove all visible residue/soils.
c. Fully immerse devices in the prepared cleaning solution and allow to soak for a minimum of 5 minutes.
d. If necessary, scrub devices with a soft bristle brush, paying particular attention to the crevices.
e. Rinse under running warm tap water until all visible soil is removed.
f. Place devices into a cassette/container/support kit to avoid any contact between instruments to prevent damage during
cleaning/sonication process.
g. Fully immerse devices into the ultrasonic solution and allow to sonicate for a minimum of 10 minutes.
h. Rinse thoroughly with purified water for a minimum of one minute to remove any residual solution.
i. Towel dry the products completely with a clean, soft, lint-free, absorbing cloth. Use of pressurized air is possible.
There is the danger of contamination from the pressurized air! The use of sterile-filtered air is recommended.
Automated Instrument Washer / Thermal Disinfector Cleaning Procedure:
•No chemical disinfection is allowed.
•Use Purified water only.
•Use a Washer-Disinfector compliant with ISO 15883.
a. Place containers/cassettes holding the devices into washer/disinfector in a manner to allow sufficient and adequate contact
for cleaning as well as drainage. Follow the information provided by the equipment manufacturer when selecting the suitable
cleaning solutions taking the following information into consideration:
•The use of powdered detergents is not recommended.
•The use of a neutral ph value enzymatic detergent is recommended and best suited for the durability of the device.
◦Recommendation: “ProCare Dent 10 MA” or “Neodisher MediZym”.
◦Clean at 40- 50°C for approximately 10 minutes.
•The use of mild-alkaline detergents can be considered (ph value ≤10.8).
◦Recommendation: Neodisher MediClean.
◦Clean at 500°C – 600°C for 5 minutes - 10 minutes.
◦Alkaline detergents are not recommended. The operator is responsible for the conformity of the alkaline detergent with
the products. (long-term effect on the products)
b. Neutralization – Is not required. If used, please observe the instruction of the detergent manufacturer.
c. Final Rinsing – It is possible to use “ProCare Dent 40” or “Neodisher MediKlar” as an additive for the final rinsing. Use only
purified water.
d. Disinfection – 5 minutes at >90°C; A0 level = 3000.
e. Drying – 40 minutes at 100°C. In case of residual moisture on the devices final drying must be carried out again. In which case
a reconfirmation of the effectiveness of the process should be done.
INSTRUCTIONS FOR USE
EyeSpy™Mouth Mirror
After Use:
Dry Storage:
•Directly after use, pre-clean with a soft cloth or soft brush. Store in suitable containers or holders. Uncontrolled storage can
cause mechanical damage.
•Keep storage times prior to reprocessing as low as possible, maximum 5 hours.
Wet Storage:
•Wet storage is not recommended for the devices, there is risk of mechanical damage of the devices due to uncontrolled contact and there
is the possibility of negative effects on the materials from long-time contact with detergents.
•If wet storage is used, the operator is responsible for the process qualification/validation. Select a suitable detergent.
Inspection:
•Carefully inspect the devices thoroughly to ensure that all visible contamination/soils have been removed. If not, repeat the
cleaning process.
•Check devices for damage, do not continue use if damage or visual degradation is found.
Packaging:
•If a sterile barrier packaging system will be used, steam sterilization pouches or wraps qualified and/or approved for compliance
with local/country regulations shall be used.
•Choose a size packaging which gives enough space for the devices.
•When using sterilization pouches, we recommend a filling level of not more than 75% with less than 3 cm distance of the
devices to the seals.
Sterilization:
•Steam sterilization only - DO NOT DRY HEAT STERILIZE.
•Steam Sterilizers qualified and/or approved for compliance with applicable local/country regulations shall be used.
•Sterilizer manufacturer recommendations should always be followed when sterilizing more than one set of devices. Do not
exceed manufacturer’s maximum load.
•We recommend the mouth mirrors stay in the cassettes. This helps assure that the packing and devices will not get damaged.
•IMPORTANT: Ensure Mirrors are completely dry prior to sterilization. Failure to dry the mirrors thoroughly may cause marks to be
burned into the glass surface during sterilization or may lead to corrosion.
•Devices should be placed into sterilizers properly:
◦Ensure that devices do not touch any walls of the chamber as this may cause plastic devices to melt/distort.
◦Allowing sufficient room for steam to effectively penetrate and make direct contact with all surfaces.
◦If sterilization pouches are used, ensure that the poly-side of pouch is placed up.
•Sterilization Paramters:
Cycle Type Temperature Exposure Time Dry Time
Recommended parameters in USA Pre-vacuum 132° C | 270° F 4 Minutes 20 Minutes
Recommended parameters in EU Pre-vacuum 134° C | 273° F 3 Minutes 20 Minutes
Where local or national steam sterilization requirements are stricter than those recommended,
they shall be adhered to. Do not steam sterilize the devices above 136° C / 275° F.
Warranty:
Metrex Research LLC, on behalf of its Orascoptic division, provides a 6-month warranty on the EyeSpy mirror. Metrex warrants that
the product will be free of manufacturer’s defects. The warranty does not cover customer abuse or normal wear-and-tear on the product.
INSTRUCTIONS FOR USE
EyeSpy™Mouth Mirror

962070 Rev. A 03/16
LOSER & CO. Benzstr. 1C
D51381 Leverkusen
Germany [phone]
EC REP
The EyeSpy Mouth Mirror is manufactured for Orascoptic by:
Zirc Dental Products, Inc.
3918 Hwy 55 SE
Buffalo, MN 55313, USA
800.328.3899 | www.zirc.com
MANUFACTURER
Technical Support/Customer Service:
800-369-3698
Outside the U.S. Call Your Local Distributor
Rx Only