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A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y
MyLab
- G E T T I N G S T A R T E D 2 - 15
GETTI
NG STARTED
In current clinical practice, using commercially available equipment, it is
unlikely that such thermal exposure would occur at a specific fetal anatomic
site.
Transducer self-heating is a significant component of the temperature rise of
tissues close to the transducer. This may be of significance in transvaginal
scanning, but no data for the fetal temperature rise are available.
The TI should not be interpreted as an actual degree Celsius temperature rise
in the region of interest. Its use should be limited to a relative indication of
the maximum temperature rise. Although the TI is not ideal, it should be used
to assess the potential thermal risk in conjunction with the dwell time.
Scans should be minimized as possible and exposure should be ALARA to
answer the diagnostic question. If it is ever clinically indicated in the first
trimester, spectral Doppler examination of the fetus should be used with
caution.
The application of SWE in human fetuses was not approved so far due to the
potential risk concerns of SWE to the developing fetuses and the lack of
literature reporting an ascertaining risk in this field.
Biocompatibility and Infection Control
Probes and electrodes intended to be used on intact skin have very limited
probabilities to propagate infections; basic procedures as described in the “Probes
and Consumables” manual are sufficient for infection control.
Endocavity and transesophageal probes require specific cleaning and disinfecting
procedures. See the “Probes and Consumables” manual for complete details on
these procedures.
Before each exam properly clean the probes. Refer to the “Probes and
Consumables” manual for further details on cleaning and disinfecting probes, kits
and electrodes.
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.