Eighteeth Helios 500 - Introduction; Indications for Use; Contraindications; Safety Instructions

3 Introduction
3.1 Indications for Use
The Helios 500 is a digital optical scanning device used to record the
topographic characteristics of teeth or dental impressions in 3D dimensions.
The resulting topographic impressions are intended for use in the computer-
aided design and manufacturing of dental restorative prosthetic devices,
dental implant prosthetic devices, and orthodontic models.
The Helios 500 could be used for both adult and children in clinical practice.
The Helios 500 is designed to acquire 3D models in the followings
 Upper jaw
 Lower jaw
 Bites
3.2 Contraindications
Patients with oral mucosal disease, mental illness, severe respiratory disease,
asthma, Parkinson's disease, hyperactivity disease are forbidden.
Patients with moderate or severe opening limitation should use it with caution.
3.3 Safety Instructions
Scanner
 You MUST read and understand this safety information before using the scanner.
 This device must only be used in hospital environments, clinics or dental offices by qualified
dental personnel and not used in the oxygen-rich environment.
 This scanner shall only be used inside hospitals and other professional healthcare facilities
and MUST NOT be used near high frequency surgical equipment and the RF shielded room
of an ME System for magnetic resonance imaging, where the intensity of electromagnetic
disturbance is high.
 Before using the scanner, check the outer surfaces of the unit and any accessories to ensure
there are no rough surfaces, sharp edges, or protrusions which may cause a safety hazard.
 DO NOT place objects within the field of operation of the unit.
 When the unit is not in use, ensure that the scanner is turned OFF.
 DO NOT use the scanner in conjunction with oxygen-rich environments. This unit is not
intended for use with flammable anesthetics or flammable agents.
 DO NOT pull or twist the cable.
 DO NOT drop the scanner.
 DO NOT sterilize the scanner.
 DO NOT expose the scanner to water spray or submerge it in water or disinfectant.
 DO NOT expose the scanner to high vibrations.
 DO NOT expose the scanner to ultraviolet radiation for a long period.
 DO NOT stare at the LED emission window.
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