requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances
- Requirements and tests:
•
IEC 62471, Photobiological safety of lamps and lamp systems
1.5
Regulatory
The EzScan is manufactured and marketed in accordance with US FDA
Regulations and EU Medical Device Regulation 2017/745.
1.6
Intended Use
The EzScan is an optical impression system. It is used to record the
topographical characteristics of teeth, dental impressions, or stone models
for use in the computer-aided design (CAD) and computer-aided
manufacturing (CAM) of dental restorative prosthetic devices.
1.7
Classifications
The EzScan system has the following classifications
•
Protection against electrical shock: Type B Applied Part
•
Protection against harmful ingress of water: Ordinary equipment
(IPX0)
•
Safety of application in the presence of a flammable anesthetic
material with air or with oxygen or nitrous oxide: Equipment not
suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
CAUTION
: Rx only - Federal law restricts this device to be sold by or on the
order of a Dentist.
WARNING
: Unintended use of the system can result in physical injury to the
patient and operator, and damage to the system.
