TELEMED ClarUs User Guide, REV 4.0 2013.12.04
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APPENDIX
1. Guidelines for the safe use of diagnostic ultrasound
A. Recommendations
General
The use of diagnostic ultrasound to obtain information about functions or
structures in human beings should be restricted to situations in which the
medical benefit that may accrue from the diagnostic data outweighs any
foreseeable risk. Most such situations are limited to clinical examinations of
the ill or potentially ill patient or pregnant women.
Situations such as training, demonstrations or research may also provide a
medical benefit from diagnostic data and one that outweighs any foreseeable
risk. Here, information is obtained for people who are not necessarily in the
categories of Recommendation (1), above. During all training, demonstration
or research situations, if either the Thermal Index or the Mechanical Index
exceeds 1, then a subject should be informed of the anticipated exposure
condition and how it compares regarding safety with conditions for normal
diagnostic practice.
Ultrasound should not be used for any of the following:
o
obtaining pictures of the fetus solely for
non-medical
reasons;
o
learning the sex of the fetus solely for
non-medical
reasons;
o
for commercial purposes, such as trade shows, or producing
pictures or videos of the fetus.
Thermal Effects
The M-mode is a valuable clinical tool and, despite any potential risks, is not
contraindicated. Operators however should be careful to limit exposure to only
vital structures and utilize the exposure information provided by the
manufacturer.
In particular, users should employ exposures which are
As Low As
Reasonably Achievable (ALARA)
1
because of the potential for
ultrasonic
heating
of tissues during M-mode imaging and, normally to a significantly
greater extent, Doppler ultrasound blood flow examinations. Exposure can be
reduced by either reducing the
Thermal Index
using the output controls or by
reducing the
dwell time
which is the amount of time that the transducer
remains in any one place.
Mechanical Effects
Users should employ exposures, regardless of the mode used, which are
As Low As Reasonably Achievable (ALARA)
because of the potential for:
o
ultrasonically induced capillary hemorrhaging in lung tissues if it is
exposed
during
pediatric
diagnostic
ultrasound
examinations,
