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Type BF equipment (Standard IEC 60601-1).
Medical Device
Consult electronic instructions for use (Standard ISO 7000-1641).
Attention, consult accompanying documents (Standard IEC 60601-1).
The use of accessory equipment not complying with the equivalent
requirements of this equipment may lead to a reduced level of safety of
the resulting system. Consideration relating to the choice shall include:
•
use of the accessory in the Patient Vicinity
•
evidence that the safety certification of the accessory has been
performed in accordance to appropriate IEC60601 and/or IEC60601-1-1
harmonized national standard.
Planmeca ProSensor is ETL classified and conforms to ANSI/AAMI
ES60601-1 and is certified to CAN/CSA C22.2 No. 60601.1.
Separate collection for electrical and electronic equipment according to
Directive 2002/96/EC (WEEE)
3143029
ETL CLASSIFIED
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2 KaVo ProXam iS
Instructions for use