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3. SYSTEM GENERAL DESCRIPTION
3.1. SYSTEM DESCRIPTION
The Eagle IOS Intraoral Scanner is designed and developed to produce high quality digital
intraoral exams or models for dental restoration or analysis.
The Scanner is light, small, and easy to use, allowing for fast and accurate scanning.
The Eagle IOS must be handled by qualified and properly trained healthcare professionals, it
can be used for the following indications:
3.2. PRINCIPLES OF OPERATION
Eagle IOS is an optical printing system. It is used to record the topographical features of teeth,
dental impressions, or physical models for use in computer-drawn projects (CAD) and assisted by
computerized manufacturing (CAM) of dental restorative prosthetic devices.
Unintentional use of the system can result in physical injury to the patient
and operator and damage to the system.
3.2.1. User Profile
The Eagle IOS Intraoral Scanner can be used by both sexes, with a minimum level of literacy
with the ability to read and understand images, symbols, icons, western characters (Arial font),
alpha numeric characters, and cannot present a degree of visual imperfection. for reading or vision
and average degree of impairment of recent memory, not being in a clear capacity to perform
the activities and functions of the product in a correct way for the profession. The user must be a
qualified and trained health professional to perform the activities, functions frequently used in the
application of the Intraoral Scanner and its primary operations functions.
· Anatomical crowns
· Copings
· Temporary crowns
· Anatomical pontics
· Reduced pontics
· Temporary pontics
· Inlays / Onlays
· Pillars for implants
· 3-unit implant bridges
· Bridges of up to 5 units
· Orthodontic aligners
· “Nightguards”
· Splints
· Retainers
· Bleach trays
· Sleep device
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