Align Technology iTero Element 5D User Manual page 8

Wireless LAN
Safety
classifications
Prescription
health device
Scanner
precautions
Cleaning &
disinfection
Unpacking &
installing
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iTero Element 5D and iTero Element 5D Plus imaging systems User manual
The system comes equipped with a wireless LAN unit.
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When using the product, maintain a separation distance of at least 20cm between the
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computing unit and all persons' bodies to ensure compliance with RF exposure
requirements.
Type of protection against electrical shock: Class 1.
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Degree of protection against electrical shock: Type BF.
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Degree of protection against harmful ingress of water: Ordinary.
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Equipment not suitable for use in the presence of flammable anesthetic mixtures.
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Mode of operation: Continuous.
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The system serves as a prescription medical device and should be operated by qualified
health-care providers only.
The wand emits red laser light (680nm Class 1) as well as white LED emissions and 850nm
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LED emissions. Normal usage of the wand does not present any danger to the human eye.
Avoid shining the wand directly into the patient's eyes.
Avoid twisting, knotting, pulling, and stepping on the wand cable and the power cable.
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When the system is not in use, the wand should be placed in the cradle with the optical
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surface facing the touch screen, in order to avoid eye contact with the laser beam, flickering
white LED emission, and 850nm LED emission. Eye contact could cause damage to the
eyes.
Avoid activating the wand while the tip of the wand is outside the patient's mouth, in order to
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prevent eye damage.
Avoid placing the wand in the cradle while the scanning operation is still active, in order to
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prevent eye damage.
Do not use the equipment if a scanner malfunction occurs or if physical damage is
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observed, in order to avoid electrical shock or physical injury. Call Customer Support.
To avoid cross-contamination, it is mandatory to:
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o Clean and disinfect the wand, as described in
replace the wand sleeve, as described in
session.
o Remove and replace gloves after each patient session.
o Discard torn, contaminated, or removed gloves.
o Replace the wand sleeve between each patient. Failing to replace the wand sleeve
between patients may cause the inadvertent transfer of microorganisms and other
contaminants from one patient to another.
o Dispose of wand sleeves according to standard operating procedures or local
regulations for the disposal of contaminated medical waste.
The system should be unpacked and installed following Align Technology's instructions,
described in Assembly instructions.
Note: Contact Customer Support if the scanner box is damaged or if the ShockDot indicator
on the box has been activated.
Cleaning and disinfecting the
Applying a wand sleeve, before each patient
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