Control Pedal; Environmental Characteristics; Environmental Restrictions; Main Performance Characteristics - Ultradent Products ultrawave XS Manuel D'utilisation

8.6 Control pedal

Width (in mm)
Height (in mm)
Depth (in mm)
Weight (in g)
Ingress protection rating

8.7 Environmental characteristics

Operating temperature
Storage temperature
Operating humidity
Storage humidity
Atmospheric pressure
Altitude

8.8 Environmental restrictions

Usage premises
Use in gas-filled
atmosphere
Immersion

8.9 Main performance characteristics

Ultrasonic vibrations of the tip or file fitted to the end of the conventional dental ultrasonic handpiece.
• Vibration frequency ≥ 28 kHz.
• Tip amplitude ≤ 200 µm.

9 Regulations and standards

9.1 Official Texts

This medical device complies with the essential requirements of European Directive 93/42/EEC. This
equipment is designed and developed in compliance with Electrical Safety standard IEC60601-1 in force. It was
designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system.

9.2 Medical class of the device

This medical device is a class IIa device according to European Directive 93/42/EEC.
14
Can be used at all medical premises. The medical device must not be used
in an operating theater, or outside.
The medical device is not designed for use in a type AP or APG gas-filled
atmosphere or in the presence of anesthetic gases.
The handpiece must not be immersed.
J58109 • V1 • (14) • 03/2014 • NB79US010B
70
30
95
150
IPX1
+10°C to +30°C
-0°C to +60°C
30% to 75%
10% to 70%, including condensation
Between 800 hPa and 1060 hPa
Less than or equal to 2000 meters