iTero Element Operation Manual page 8

ENGLISH
SAFETY INSTRUCTIONS
Before beginning to work with the system, all users are required to read these safety instructions.
Power Supply
• Power is supplied to the system via an internal medical grade power supply.
Electric
• Electric shock hazard!! Only authorized Align Technology technicians can remove
Warning
external panels and covers. There are no user-serviceable parts inside.
• To avoid risk of electric shock, iTero Element must only be connected to a supply
mains with protective grounding.
• Only Align Technology approved Web Camera or DOK should be connected to
the USB socket on the back side of the System.
Wireless LAN
• The system comes equipped with a Wireless LAN unit.
Safety
• Type of protection against electrical shock: Class 1.
Classifications
• Degree of protection against electrical shock: Type B.
• Degree of protection against harmful ingress of water: Ordinary.
• Equipment not suitable for use in presence of flammable anesthetic mixtures.
• Mode of operation: Continuous.
Prescription
• The system serves as a prescription medical device and should be operated by
Health Device
qualified health-care providers only.
Scanner
• The scanner emits red laser light (680nm Class 1) as well as white LED emissions. Normal
Warnings
usage of the scanner does not present any danger to the human eye. However, doctors
should refrain from shining the scanner directly into the patient's eyes.
• Avoid twisting cable, knotting cable, pulling on cable, stepping on cable.
• When the system is not in use, the scanning unit should be placed inside the holder with
the probe facing to the rear side of the touchscreen so there will be no eye contact with
the laser beam in any case.
Cleaning &
• To avoid cross contamination, it is mandatory that after each patient session the
Disinfection
disposable plastic sleeve be replaced and the scanning unit be disinfected.
• Dispose of scanner sleeves according to standard operating procedures or local
regulations for the disposal of contaminated medical waste.
Unpacking &
• The system should be unpacked and installed following Align Technology's instructions.
Installing
Work
• The system should be moved between rooms with utmost care to avoid damage.
Environment
• Do not block the air vents on the Scanning Unit and Base Unit.
• System is intended for indoor use only. It should not be exposed to direct sunlight,
excessive heat or humidity.
Electro
• WARNING: This device has been tested and found to comply with the requirements for
Magnetic
medical devices according to standard EN60601-1-2. This standard is designed to
Interference
provide reasonable protection against harmful interference in a typical medical
installation. However, because of the proliferation of radio-frequency transmitting
equipment and other sources of electrical noise in the healthcare environments
(e.g., cellular phones, mobile two-way radios, electrical appliances), it is possible that
high levels of such interference due to close proximity or strength of source, may result
in disruption of performance of this device.
General
• WARNING: No modification of this equipment is allowed.
• WARNING: The touchscreen always needs to be in a stand while in operation!
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2017 Align Technology, Inc. Publication 109797
iTero ® Element Operation Manual
™