Safety
2.11 Manufacturer
Responsibility
The manufacturer, assembler, importer or installer considers himself/herself responsible regarding
safety, reliability and performance of the instrument under the following conditions:
- when assembling the system, when adding options, when new settings or modifications or repairs
were performed by personnel authorized by him/her,
- also that the local electric installation complies to the national regulations,
and that the equipment is only used according to the User Manual.
2.12 Service
Documents
The Service Manual supplies block diagrams, lists of spare parts, descriptions, adjustment instructions
or similar information which help adequately qualified technical personnel in repairing those parts of
the instrument which have been defined repairable by the manufacturer.
2.13 Basic
Interaction
between Ultrasound and Matter
2.13.1 Bioeffects
"Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized
efficacy for medical diagnosis, including use during human pregnancy, the American Institute of
Ultrasound in Medicine herein addresses the clinical safety of such use:
No confirmed biological effects on patients or instrument operators caused by exposure at intensities
typical of present diagnostic ultrasound instruments have ever been reported. Although they indicate
that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any, that
may be present."
Reference:
Bioeffects considerations for the safety of Diagnostic Ultrasound - Journal of
Ultrasound in Medicine, Vol.7, Number 9 (supplement) - American Institute of
Ultrasound in Medicine, Bioeffects Committee.
Please note:
Prudent use means that the ultrasound machine is to be used by the operator in
accordance with the ALARA principle, i.e. keep the power levels and the exposure
time
A
S
L
OW
A
S
R
EASONABLY
A
CHIEVABLE.
An ultrasound bioeffect is any biological mechanism or process, that is produced, triggered or
catalyzed by exposure to ultrasound.
One can differentiate two known mechanisms for the development of bioeffects when humans are
exposed to ultrasound: the
thermal
effect of ultrasound and the
cavitation
.
With humans no harmful bioeffects due to exposure to diagnostic ultrasound have been noticed.
Voluson
®
730Pro - Basic User Manual
105831 Rev. 0
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