Fimet F1 - 1.3.1 Quality Standards; 1.4 Terms and Abbreviations; 1.5 Symbols and Markings

6 • User Guide
1.3.1 Quality Standards
Fimet Oy is a responsible dental device manufacturer. The company’s quality manage-
ment system is certified by a notified body according to the following standards:
 ISO 9001:2008 Quality management system - Requirements
 ISO 13485:2003 Medical devices - Quality management system - System require-
ments for regulatory purposes
1.4 Terms and Abbreviations
System: Dental Treatment System, consisting of Dental Unit, Dental Chair,
Operating Light, Foot Control, and Hand Control.
Dental Unit: Part of the System consisting of Cuspidor, Instrument Bridge, Dis-
play, Suction Head, Connection Box, and Tray(s).
Dental Chair: Part of the System consisting of the patient chair, including a seat,
a backrest, a headrest, armrests, a footrest, display and joysticks.
Connection Box: An enclosure consisting of the power supply and connections to
drainage, pressurised air, mains power, suction, and water.
Operating Light: Light source with swivel arms and an optional power supply.
Display: Flat panel display with a swivel arm.
Cuspidor: Main part of the unit consisting of a pneumatic centre, a spittoon
bowl, a clean water bottle, a water heater, filter(s), an amalgam
separator, and water taps for glass filling and bowl flushing.
Instrument Bridge: Device consisting of instrument holders, hoses with whip arms or
hanging hoses, swivel arms, control buttons, and a display. Nor-
mally used by the dentist.
Suction Head: Device consisting of hanging hoses with holders, swivel arms, con-
trol buttons, and a display. Normally used by the assistant.
Tray: Metallic or plastic tray with a supporting arm.
Foot Control: Radio operated control device with batteries or pneumatic remote
control.
Hand Control: Radio operated control device with batteries.
Joystick: Four-way control device for controlling the chair.
1.5 Symbols and Markings
Follow the instructions for use
The information provided is important and must be read.
Note!
The information provided is important and should be read before use.