Safety Information > Cleaning and Disinfection
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CAUTION:
You MUST cover the panoramic bite blocks with FDA-cleared or CE mark protective sheaths that are available from distributors to use them between each patient. We recommend that you cover the TMJ nose rest and the 3D bite block with FDA-cleared or CE mark protective sheaths that are available from distributors to use them between each patient. |
The following accessories must first be cleaned and then steam-sterilized between each patient use:
TMJ nose rest
Panoramic standard bite block
Bite block for edentulous patient
Frankfort guide bite block for panoramic
3D bite blocks
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Note: It is recommended that you repeat the process as soon as it is reasonably practical after use. |
To clean the accessories that have contact with the mucous membranes, follow these steps:
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CAUTION:
You must use medical autoclaving equipment cleared by the FDA in the USA or that is recognized by your Local Authority. You must always follow the operating parameters recommended by the manufacturer of the autoclaving equipment. Use FDA cleared or CE mark standard packaging material. |
To steam autoclave the accessory, once cleaning is complete, follow these steps:
Wrap the cleaned accessory using a standard packaging material for autoclaving.
Steam autoclave at 132°C (270°F) for 4 minutes in the USA or depending on your local regulation you can steam autoclave at 134°C (273°F) for 18 minutes.
Visually inspect the accessory for signs of deterioration. If any damage is noted, do not use the accessory and contact your representative.
Once sterilized, the accessory can be used immediately or stored dry and dust-free in its sterilization wrapping under temperature specified in section “CS 9600 Environmental Requirements” of the present guide.
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CAUTION: You must cover ear cones with FDA-cleared or CE mark protective sheaths that are available from distributors and use them between each patient. After use, remove and discard the protective sheath. You must clean and disinfect the ear cones between each patient use with an EPA-registered, or CE-mark, intermediate-level disinfectant with labels claims of tuberculocidal activity. |
To clean the ear cones, follow these steps:
Remove and discard the protective sheath from the accessory.
Remove all visible soil with disposable cloth or paper wipe.
Dampen (not soak) a lint-free cloth with soap and running water.
Thoroughly clean manually the ear cones with the dampened lint-free cloth.
Rinse thoroughly with lint-free cloth with running water.
Dry the accessory with hygienic disposable cloth.
Visually inspect the accessory for residual soil. If soil is visible, either repeat steps 2 to 6, or safely dispose of the accessory.
To disinfect the ear cones, follow these steps:
Use an intermediate-level disinfectant with tuberculocidal activity as identified above and as recommended by the manufacturer of the disinfectant.
Allow to dry in open air.
The following accessories must first be cleaned and then disinfected between each patient use:
Panoramic and sinus chin rest
3D frontal head rest
Wrist support (optional accessory)
Facial scanner support (optional accessory)
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Note: It is recommended that you repeat the process as soon as it is reasonably practical after use. |
To manually clean the components or accessories that have contact with the skin, follow these steps:
Remove all visible soil with a disposable cloth or paper wipe.
Rinse at least 1 minute under running water to thoroughly clean the component/accessory from any excess soil.
Using a soft brush, apply medical enzyme detergent solutions (basically with a multi-enzymatic formula) to all surfaces of the component/accessory. Detergent manufacturer’s directions must be strictly adhered to.
Rinse thoroughly under running water for at least 1 minute to remove detergent residue.
Dry the component/accessory with compressed air or hygiene disposable cloth.
Visually inspect the component/accessory for residual soil. If soil is visible, either repeat steps 1 to 4, or safely dispose of the accessory.
Disinfect the accessory by using an EPA-registered hospital disinfectant for low-level activity or low-level disinfectant that is recognized by your Local Authority (for example, quaternary ammonium compounds and some phenolics). You must follow the disinfectant’s manufacturer instructions for use, especially with respect to contact time.
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CAUTION: If there is a visible contamination with blood, you must clean the accessory with an EPA-registered hospital disinfectant for intermediate-level disinfectant or intermediate-level disinfectant that is recognized by your Local Authority that has claim for activity against hepatitis B after cleaning. The disinfectant’s manufacturer instructions for use must always be followed, especially with respect to contact time. |