MediSono P11 EXP, User Manual

Page: 15 / 151

P11 EXP
Portable Digital Color Doppler Ultrasound System
1-5
time when the transducer is not used. This system, as a basic imaging system with the
Doppler and Color Doppler feature generates acoustic power that is below pre-enactment
levels, which are generally considered to be safe for the respective applications.
1.5 Biological Safety
This product, as with all diagnostic 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 oper-
ators 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: TIS, for soft tissue
exposures; TIB, for instances when bone lies near the beam focus; and TIC, for the heating
of bone situated close to the transducer.
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 users accurately evaluate the likelihood of cavitation and the related
adverse effects.
1.6 Scanning Patients and Education
The Track-3 or IEC60601-2-37 output display standard allows users to share the respon-
sibility for the safe use of this ultrasound system. Follow these usage guidelines for safe
operation:
• In order to maintain proper cleanliness of the transducers, always clean them between
patients.
• Always use a new disinfected sheath on all EV/ER probes during every exam.