Basic Safety; Essential Performance - GE Versana Essential Technical Publication

Basic Safety

Essential performance

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Versana Essential
5759238-100 English Rev. 2
1. The creepage distances and air clearance should meet the
requirements.
2. The protective earthing should meet the requirements.
3. The leakage current should meet the requirements.
The essential performance of the ultrasound unit is:
1. The ability to display physiological images as input for
diagnosis by trained physician.
2. The ability to display physiological traces as aid for
diagnosis by trained physician.
3. The ability to display quantified data as input for diagnosis
by trained physician.
4. No component failures.
5. No changes in programmable parameters.
6. No reset to factory defaults (manufacturer's presets).
7. No change of operating mode.
User Guide
Safety Precautions
4-29