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5.5 Eye safety

WARNING

The scanner emits bright light from its tip during operation .

The scanner complies with EN (IEC) 62471 (Photobiological

safety of lamps and lamp systems) . However, we recommend

caution when handling the scanner .

A brief glimpse of the light into the eye is not dangerous,

but do not stare into the beam or view directly with optical

instruments, and do not aim the beam towards other

people's eyes . In general, viewing bright light sources

(e . g . headlights), which have a high secondary exposure

potential due to their blinding effect, may cause temporary

reduction in visual acuity and afterimages, leading to irri-

tation, annoyance, visual impairment, and even accidents,

depending on the situation .

5.6 Hygiene

WARNING

To maintain a clean work environment and the safety

of the patient, wear clean examination gloves when:

• Handling the scanner tip – changing the tip, setting

the tip for upper/lower scans or handling the mirror .

• Handling the protection tip .

• Handling the color calibration kit .

• Applying TRIOS for scanning patients .

• Touching the TRIOS IOS system .

WARNING

Always clean the scanner unit and its optical window before

attaching the protection tip . Do not allow patient contact

with the protection tip .

WARNING

Always have the scanner tip mounted when you insert

the scanner into the patient's mouth or when the scanner

comes in contact with the patient in any way . Mounting

of the scanner tip is always required for maximal electrical

safety and due to the risk of contamination .

WARNING

Always have a cleaned and sterilized scanner tip mounted

before attaching the color calibration adaptor . Do not

allow patient contact with the color calibration kit .

WARNING

Before each patient, you must:

• disinfect the system,

• apply a new sterilized or high-level disinfected tip to the

scanner .

See the detailed instruction in the chapter below .

System S3P (pod) only

WARNING

Before each patient, make sure any PC connected to the

system and its peripherals are disinfected . It is recom-

mended to use medical-grade peripherals (e . g ., keyboards

and mice) that can be disinfected easily .

5.7 Safety when scanning with TRIOS

CAUTION

The handheld scanner is a highly precise optical instrument

and must be handled carefully . Do not drop, shake or bump

the handheld scanner, as these actions could cause it to break

or malfunction . Follow these guidelines:

• Always return the handheld scanner to its mount when

not in use .

• Do not submerge the handheld scanner in any liquids .

• Do not place the handheld scanner on heated or wet

surfaces .

• Grip the handheld scanner firmly during scanning

and when removing/returning it to its mount .

IMPORTANT NOTICE

The scanner will get warm during use . This is normal

but not part of any patient treatment .

CAUTION

The handheld scanner tip is fragile and contains a delicate

mirror . To avoid damage to the tip and mirror, take care not

to bump the tip onto the patient's teeth or restorations .

CAUTION

When the TRIOS system is used for pediatric patients,

please pay extra attention while scanning the patient .

5.8 Protection from overheating

WARNING

The ventilation openings in the rear of the handheld

scanner must never be blocked or obstructed .

If overheated, the scanner may become uncomfortably

warm and eventually shut down .

System S3A (MOVE/MOVE+ cart) only

WARNING

Ventilation openings must never be blocked or obstructed .

There are openings at the back of the MOVE/MOVE+ cart

(behind the touch screen) and on the top and the bottom

of the base of the MOVE/MOVE+ cart . If overheated, the

system may stop functioning .

6. Cleaning, Disinfection,

and Sterilization

6.1 Cleaning, high-level disinfecting,

and sterilizing the scanner tip

The TRIOS scanner tip is the part of the scanner that is inserted into the

patient's mouth during scanning . The tip can be reused a limited number

of times, but it must be cleaned and sterilized, or cleaned and high-level

disinfected, between patients to avoid cross contamination .