Acteon Piezotome Cube - 12 Regulations and standards; 12.1 Applicable standards and regulations; 12.2 Medical class of the device; 12.3 Symbols

12 Regulations and standards
12.1 Applicable standards and regulations
This medical device complies with the essential requirements of European Directive 93/42/EEC. It was designed and
manufactured in accordance with an EN ISO 13485-certified quality assurance system.
12.2 Medical class of the device
Class of medical device: IIa according to 93/42/EEC directive
12.3 Symbols
Symbol Meaning
Footswitch
O Switching off (OFF)
I Switching on (ON)
Always wear safety goggles
Always wear protective gloves
Refer to the supporting documentation
Consult the User Manual
The accompanying documentation is available in electronic format
Pressure limit
Temperature limit
Humidity limit
User Manual | Piezotome Cube | J50101 | V4 | (17) | 03/2018 | NO37EN010D - Page 31/39