Huntleigh Healthcare Limited Huntleigh Diagnostic Products Division SF1US 사용자 설명서

Diagnostic ultrasound has been in use for over 35 years with no confi rmed 
adverse effects on patients or instrument operators at the intensities typical 
of present diagnostic instruments. However, available data are not wholly 
conclusive, and the possibility remains that biological effects may be identifi ed 
in the future.
Because fetal tissue could be more sensitive to biological effects by reason 
of rapid cell division, it is particularly desirable that ultrasound exposure of 
pregnant subjects be kept to a minimum.
Medical and scientifi c authorities therefore recommend that ultrasound 
procedures be performed in accordance with the “ALARA” principle, which 
states that the energy delivered to the patient should always be kept As Low As 
Reasonably Achievable.
The transmitted acoustic power of the Sonicaid Freedom Ultrasound transducer 
is fi xed and cannot be adjusted by the operator. Therefore, the user can best 
observe the ALARA principle by ensuring that each examination is medically 
indicated and by limiting the duration of the study to the extent appropriate for 
the clinical objectives.
Acoustic output data for the transducers is summarized in the following tables.

The Sonicaid Freedom’s ultrasound transducer, which is used with Sonicaid 
FM800 Encore series fetal monitors, has a single mode of operation, with fi xed 
acoustic output parameters that are not user adjustable.  Refer to Table 1 for 
the Acoustic Output Reporting Table used for ultrasound devices following FDA 
Track 1.