User's Manual

Table Of Contents
19
2 enin
 Biological Safety
InnoSight Ultrasound System
P6992-4, EN, 16/12/6
Biological Safety
This product, as with all ultrasound equipment, should be used only for valid reasons and should be
used both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low
As Reasonably Achievable) to produce diagnostically acceptable images The AIUM offers the following
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 Color imaging exams The Thermal
Index (TI) provides a statistical estimate of the potential temperature elevation (in centigrade) of tissue
temperature Two forms of TI are available: TIS, for soft tissue exposures and TIB, for instances when bone
lies near the beam focus
Cavitation
Cavitation 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 cavitation, 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 operators accurately evaluate the likelihood of
cavitation and the related adverse effects
Safe Scanning Guideline
Ultrasound should only be used for medical diagnosis and only by trained medical personnel
Diagnostic ultrasound procedures should be done only by personnel fully trained in the use of
the system, in the interpretation of the results and images, and in the safe use of ultrasound
(including education as to potential hazards)
Operators should understand the likely influence of the machine controls, the operating
mode (eg 2D mode, Color or Spectral Doppler) and the transducer frequency on thermal and
cavitation hazards
Use a low output power default setting for each new patient Output should only be increased during
the examination if penetration is still required to achieve a satisfactory result, and after the Gain control
has been adjusted to its maximum value
Maintain the shortest examination time necessary to produce a useful diagnostic result