ECO Series VET Digital Color Doppler Ultrasound System
9
guidelines:
Clinical Safety Quoted from AIUM
Approved March 26, 1997
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:
There are no confirmed biological effects on patients or instrument operators caused by exposures from
present diagnostic ultrasound instruments. Although the possibility exists that such biological effects may be
identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic
ultrasound outweigh the risks, if any that may be present.
Heating: Elevating tissue temperature during obstetrical examinations creates medical concerns. At the embryo
development stage, the rise in temperature and the length of time exposed to heat combine to determine
potential detrimental effects. Exercise caution particularly during Doppler/Color exams. The Thermal Index
(TI) provides a statistical estimate of the potential temperature elevation (in centigrade) of tissue temperature.
Three forms of TI are available: Soft Tissue Thermal Index (TIS), Bone Thermal Index (TIB) and Cranial
Bone Thermal Index (TIC).
Soft Tissue Thermal Index (TIS). Used when imaging soft tissue only, it provides an estimate of potential
temperature increase in soft tissue.
Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB
examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue.
Cranial Bone Thermal Index (TIC). Used when bone is near the skin surface as in transcranial examination, it
provides an estimate of potential temperature increase in the bone or adjacent soft tissue.
Cavitations: Cavitations may occur when sound passes through an area that contains a cavity, such as a gas
bubble or air pocket (in the lung or intestine, for example). During the process of cavitations, the sound wave
may cause the bubble to contract or resonate. This oscillation may cause the bubbles to explode and damage
the tissue. The Mechanical Index (MI) has been created to help users accurately evaluate the likelihood of
cavitations and the related adverse effects.
MI recognizes the importance of non-thermal processes, cavitations in particular, and the Index is an attempt to
indicate the probability that they might occur within the tissue.
2.6
Scanning Patients and Education
The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe use
of this ultrasound system. Follow these usage guidelines for safe operation:
In order to maintain proper cleanliness of the probes, always clean them between patients.
Always use a disinfected sheath on all EV/ER probes during every exam.
Continuously move the probe, rather than staying in a single spot, to avoid elevated temperatures in one part
of the patient’s body.
Move probe away from the patient when not actively scanning.
Summary of Contents for ECO 1VET
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