iTero Element 5D Configuration Operation Manual page 8

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.
Battery power
• Charging – Battery will be fully charged after being plugged into a
power source for 2 hours.
• With a fully charged battery, the user can scan up to 30 minutes
with the iTero Element 5D scanner, without having to plug in
for power.
Electric warning
• Electric shock hazard! Only authorized Align Technology
technicians can remove external panels and covers. There are no
user-serviceable parts inside.
• To avoid risk of electric shock, iTero Element 5D 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 classifications
• Type of protection against electrical shock: Class 1.
• Degree of protection against electrical shock: Type BF.
• 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 health device
• The system serves as a prescription medical device and should
be operated by qualified health-care providers only.
Scanner warnings
• The scanner emits red laser light (680nm Class 1) as well as
white LED emissions, and 850nm LED emissions. Normal 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 cradle with the probe facing towards the cart's
post and rear side of the touch screen so there will be no eye
contact with the laser beam or the flickering white LED emission,
and 850nm LED emissions in any case.
• The doctor should activate scanning operation only while the
scanner's probe is inside the patient's mouth.
• Doctors should avoid placing the scanner in the cradle while
scanning operation is still active.
• If scanner malfunction occurs, stop scanning and call service support.
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iTero Element 5D operation manual
Cleaning & disinfection
• To avoid cross contamination, it is mandatory that after each
patient session the disposable plastic sleeve be replaced and the
scanning unit be disinfected.
• To avoid cross contamination, it is mandatory that after each
patient session the gloves shall be removed and replaced.
• To avoid cross contamination, discard gloves when torn,
contaminated, or removed for any reason.
• Dispose of scanner sleeves according to standard operating
procedures or local regulations for the disposal of contaminated
medical waste.
Unpacking & installing
• The system should be unpacked and installed following Align
Technology's instructions.
Work environment
• The system should be moved between rooms with utmost care to
avoid damage.
• WARNING: Do not block the air vents on the Scanning Unit and
Base Unit.
• WARNING: System is intended for indoor use only. It should not
be exposed to direct sunlight, excessive heat or humidity.
Electro magnetic interference
• WARNING: This device has been tested and found to comply
with the requirements for medical devices according to standard
IEC60601-1-2. This standard is designed to 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.
ESD may cause an interference during scanning. In case of ESD
interference the system will stop scanning / displaying proper
viewfinder image. If the failure occurs within scan, the user may
be required to press the wand scan button to restart the scan.
The viewfinder will always recover automatically.
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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