Regulatory Information; Technical Description; Device Classification; Safety And Identification Markings - Marus Nustar 1700 SII Series Owner's Manual

REGULATORY INFORMATION

Technical Description

The dental chair is used to position the patient so that the oral cavity is in the desired position for the dentist to
perform various dental procedures. Dental chairs can be either hydraulically or electromechanically operated.
There are two dynamic functions: the base (up/down) and the back (forward/back). These functions are
activated by use of either a foot switch or a hand-operated touch pad.
The dental chairs have the provision to mount additional dental equipment including over-the-patient delivery
systems. For this purpose the chair must provide a stable foundation for both the patient and the additional
equipment.
Power to the chair is either 115 or 230 volts. The power is delivered to a microprocessor controlled printed circuit
board. Software in the microprocessor controls the movement of the chair. The dentist can program some chair
models to preset positions.

Device Classification

The dental chair is classified as Class 1 device under rule FDA CFR 21, Class I device
under Health Canada guidelines, and a Class I device under rule 11 of the MDD 93/42/
EEC of Annex IX.

Safety and Identification Markings

This dental chair can be identified by its product label, located inside or underneath the chair seat. This label
states the chair model and serial number, electrical specifications, manufacture date and safety classification.
Note the SAMPLE labels shown below.
4
Safety Labels
RISK OF EXPLOSION IF USED
IN THE PRESENCE OF
FLAMMABLE ANESTHETICS.
ELECTRIC SHOCK HAZARD.
DO NOT REMOVE COVER.
REFER SERVICING TO
QUALIFIED SERVICE
PERSONNEL.
WARNING:
THIS DEVICE SHOULD ONLY BE CONNECTED TO HOSPITAL
GRADE OUTLETS. FAILURE TO DO SO MAY RESULT IN
ELECTRICAL SHOCK DUE TO IMPROPER GROUNDING.
ATTENTION!
CET APPAREIL DOIT ETRE BRANCHÉ A UNE PRISE DE
TERRE ADEQUATE.
¡ADVERTENCIA!
ESTE DISPOSITIVO DEBE CONECTARSE ÚNICAMENTE A
TOMACORRIENTES DE GRADO HOSPITALARIO. SI NO SE HACE
ASÍ, PUEDE PRODUCIRSE UN CHOQUE ELÉCTRICO A CAUSA
DE UNA PUESTA A TIERRA INADECUADA.
31064 R00
70-047R024 R8
70-22090 • Rev. 5 • 1/11