M y L a b
–
S A F E T Y A N D S T A N D A R D
2-3
Items in Contact with Patient
ESAOTE probes and electrodes materials that are in contact with the patient have
been proved to comply with EN ISO 10993 “Biocompatibility Tests
Requirements”, according to their intended use. No negative reactions to these
materials have been reported.
Latex Sensitive Patient
The USA Food and Drug Administration (FDA) has issued an alert on products
composed of latex, because of reports of severe allergic reactions.
Note
ESAOTE probes and electrodes do NOT contain latex.
The transducer protective covers used during the patient exam are usually
composed of latex. Carefully read the protective cover package labeling to verify
the material used. Be certain to identify latex sensitive patients prior to the exam.
Serious allergic reactions to latex have been reported and the user should be ready
to react accordingly.
Ultrasound Safety
Introduction
ESAOTE has adopted the more recent requirements and recommendations
established by the USA Food and Drug Administration and by the American
Institute of Medicine and Biology.
MyLab
is equipped with the
Acoustic Output
Display
feature to provide the user with real-time, on-line information on the
actual power of the system. The following sections describe the rationale of this
methodology. ESAOTE recommends the use of the
ALARA
principle (see
below), which is extensively covered in this manual.
Clinical Safety
In the USA, in more than three decades of use, there has been no report of injury
to patients or operators from medical ultrasound equipment.
American Institute for Ultrasound in Medicine (AIUM)
Statement on Clinical Safety: October 1982, Revised March
1983, October 1983 and March 1997.
Diagnostic ultrasound has been in use for over 25 years. 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:
W A R N I N G
MyLab
“Operator
Manual CD”
provides data about
the acoustic power
levels.
Refer to the glossary
at the end of this
chapter for specific
terms.
