Specifications Safety and Regulatory Requirements
158 Lumify Ultrasound System
Philips Healthcare 4535 618 58571_A/795 * MAY 2016
Safety and Regulatory Requirements
Classification
• Device with transducers: Class II/internally powered ME equipment. Transducers: Type BF
applied parts, IP47
• Ordinary Equipment/Continuous Operation
• Non-AP/APG
Electromechanical Safety Standards Met
The transducers and software comply with the requirements of IEC 60601-1 Medical Electrical
Equipment, General Requirements for Safety, including all applicable collateral and particular
standards, as well as all applicable deviations. System users are responsible for ensuring that
the chosen device is compliant with the law in the jurisdiction in which the product is used.
Compliance
Philips products comply with relevant international and national standards and laws.
Information on compliance will be supplied by your local Philips representative, or the
manufacturer, on request.
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