User's Manual

Table Of Contents
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics
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These mechanisms are discussed later.
Benefits & Risks
Ultrasound is widely used because it provides many clinical benefits to the patient and has an
outstanding safety record. In more than three decades of use, there has been no known long-
term negative side-effects associated to this technology.
More questions of safety are being discussed because more applications are being discovered,
and the industry is producing technically sophisticated scanners that provide more diagnostic
information. Dialogue among the medical community, manufacturers, and the FDA has
resulted in a standard that allows higher outputs for greater diagnostic capability.
Ultrasound benefits:
• Multiple diagnostic uses
• Immediate results with high-quality information
• Replacement or complimentary or used with other procedures
• Cost-effectiveness
• Portability
• Patient acceptance
Safety record
Ultrasound risks:
The potential for adverse bioeffects caused by heating or cavitation.
… the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if
any, that may be present.” -- AIUM
Safety Topics
Use the Clarius Ultrasound Scanner only if you have read and understood all the information in
this section. Operating the system without proper safety awareness could lead to fatal or
serious personal injury.
This section covers general safety information. Safety information applicable to specific tasks
are noted in the procedure. The Clarius Ultrasound Scanner is intended for use by a trained
medical professional, or by the direction and supervision of a licensed physician qualified to
instruct its usage.