System Classification - Profound Sonalleve MR-HIFU Instructions For Use Manual

1. Introduction to Sonalleve MR-HIFU > 1.9. System classification

1.9. System classification

According to the classification in the international/European standard IEC/EN 60601-1:
Tab. 2: Equipment classification.
EQUIPMENT CLASSIFICATION
Classification according to IEC 60601-1, Medical electrical equipment
Protection against electrical shock
Protection against harmful ingress of
water or particulate matter
Methods of sterilization or
disinfection
Mode of operation
Instructions for Use
109745C2 / 02-2022
System: Class 1 Medical Electrical Equipment.
Applied parts: type BF.
Ordinary equipment (enclosed equipment without
protection against ingress of water, IPX0).
Not intended to be sterilized. Use of liquid surface
disinfectants only.
Continuous operation.
11 (192)