Acteon ImplantCenter M+, Руководство пользователя

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12 Regulations and standards
12.1 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 the Electrical Safety standard IEC60601-1 in force. It
was designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system.
This documentation complies with European regulation No.207/2012.
12.2 Medical class of the device
Class of medical device: IIb according to 92/42/EEC directive
12.3 Standardised symbols
Symbols Meaning
Authorised humidity range
Authorised temperature range
Authorised pressure range
Quantity (1)
Keep away from humidity
Fragile
Not to be used on patients with implantable medical devices
Refer to the accompanying documentation
Consult the User Manual
User Manual • ImplantCenter™ M+ • J27251 • V1 • (13) • 09/2013 • NO25EN010A - Page
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