Symbol Identification; Classifications; Disposal Of Unit; Electro-Magnetic Compatibility Precautions - Dentsply Sirona Cavitron 300 Series Instructions For Use Manual

14. Symbol Identification

AC POWER
AC Power
TYPE B APPLIED PART EQUIPMENT
TYPE B APPLIED
PART EQUIPMENT
PROTECTIVE EARTH (GROUND)
PROTECTIVE EARTH
(GROUND)
Footswitch not for operating theatres
IPX1
Protection Class- IPX1
IPX1 Classification of ingress of water
Consult Instructions for Use
Consult Instructions
for Use
O/I
AC Power Switch (0 = Off, | = On)
Footswitch
Foot Switch
This symbol is a mandatory marking for devices entering the European market to indicate conformity with the
essential health and safety requirements set out in European Directives. The symbol may be accompanied by a
four-digit identification number of the notified body.
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
MEDICAL EQUIPMENT
UL 60601-1
CAN/CSA-C22.2 No. 601.1
ANSI/AAMI ES60601-1 AMD 1 (2012)
CAN/CSA-C22.2 No. 60601-1 (2014)
This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received, including interference that may cause undesired operation.
FCC ID:TFB-BT2
IC: 5969A-BT2
Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/EC of the
European Parliament and the Council of the European Union
This is a wireless device.

15. Classifications

Type of protection against electric shock:
Degree of protection against electric shock:
Degree of protection against the harmful ingress of water:
Mode of operation:
Degree of safety of application in the presence of a flammable
anaesthetic mixture with air or with oxygen or nitrous oxide:
According to medical device directive:

16. Disposal of Unit

U.S. - Dispose of the system components in accordance with state and local laws.

17. Electro-Magnetic Compatibility Precautions

Document can be viewed on the Dentsply Sirona website https://www.dentsplysirona.com under the Cavitron
Scaling System Resources.
Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the Competent Authority of
the Member State.
English - 17
Class 1
Type B
Ordinary
Continuous
Equipment not suitable for use in the presence of flammable
anaesthetic or oxygen.
IIA (rule 9)
300 Series Ultrasonic
®
English - 18