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: I according to 93/42/EEC directive
12.3 Symbols
Symbols Meaning
On/off button
Programme selection button
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
Do not use the medical device if the patient or practitioner are fitted with
an implantable device
Do not use the medical device if the patient is wearing a medical device for
deep brain stimulation
Do not use the medical device if the patient is wearing a medical device for
vagus nerve stimulation
Biohazard
User Manual | Mini LED™ | J02541|V8|(07)| 01/2017|NG13EN010H - Page 29/38
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