Reveal AURA - SECTION 2 Safety; 2.2 Electrical and Mechanical Safety Features of the System

Operator Manual
This chapter describes general safety issues regarding the use of the AURA™ system, with special
emphasis on optical and electrical safety. With proper operation and maintenance, trained and
qualied medical practitioners can use the AURA™ system safely. The supervising physician and all
other personnel operating or maintaining the AURA™ must be familiar with the safety information
provided in this chapter. The primary consideration should be for the safety of the patient, the
physician and other personnel. Patient safety is mainly assured with a well-trained sta and a well
laid-out treatment room. Patient education is also important, including information about the nature
of the treatment.
2.1 Introduction
SECTION 2
Safety
The following precautions, cautions and warnings must be observed for the safe use of the
AURA™ system.
1.
Physicians and clinicians should read this manual thoroughly before attempting to operate
the AURA™ system.
2.
The system weighs approximately (20 kg) and may cause injury if proper care is not
used when moving it. The system is well balanced and is designed to be moved, but
should always be moved carefully and slowly. Never pull the system by the module or its
umbilical cable.
3.
An audible tone indicates energy activation.
4.
During activation, the system performs a self-test of the hardware.
5.
The hardware is tested every 10ms to ensure proper operation of electrical circuit.
2.2 Electrical and Mechanical Safety
Features of the System
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