Regulations - Satelec ACteon i-Surge+ User Manual

XV – REGULATIONS
This medical device is classified as class IIa according to European directive 93/42/EEC. This equipment
is manufactured in compliance with the current IEC 60601-1 standard. This equipment has been designed
and manufactured according to an ISO 13485-certified quality assurance system.
XVI – SYMBOLS
This Operating and Maintenance Instruction Manual provides instructions on I-SURGE +. The text,
graphics and icons are used to facilitate understanding of the functions and operations by the final user.
Target Group: Dentists and office personnel.
It is very important to keep this manual with the device, for easy reference at any time in the future. In
the event of sale or transfer to another final user, be sure to attach this Operating and Maintenance
Instruction Manual. Transferring this manual will ensure, the new final user will have all the necessary
information to understand the functionality and proper use of the unit. These instructions are intended
to ensure the safe use of this equipment and should be read carefully before installation and use of the
device.
Description of safety instruction
Important information, explanation or integration for users.
Have a direct impact on the functionality of this product or warns of possible misuse
and/or harm to the product or the user.
Three hazard levels are used in this document for avoiding personal and property damage:
Indicates a hazardous situation that can cause damage to property, or mild or moderate
physical harm. (*)
Indicates a hazardous situation that can cause death or serious injury. (*)
Indicates the maximum hazard level. Indicates a directly hazardous situation that can
cause death or serious injury. (*)
(*) The optional step covers necessary measures for avoiding hazards.
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