SD3 Series Ultrasonic Pocket Doppler User Manual Safety Guide
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patients of the prudent use of diagnostic ultrasound outweigh the risks, if any that may be present.
Prudent Use (Approved May 1999)
The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly
discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The
use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus,
obtain a picture of the fetus or determine the fetal gender without a medical indication is
inappropriate and contrary to responsible medical practice. Although there are no confirmed
biological effects on patients caused by exposures from present diagnostic ultrasound instruments,
the possibility exists that such biological effects may be identified in the future. Thus ultrasound
should be used in a prudent manner to provide medical benefit to the patient.
Safety in Training and Research (Approved March 1997, March 1983)
Diagnostic ultrasound has been in use since the late 1950s. There are no confirmed adverse
biological effects on patients resulting from this usage. Although no hazard has been identified
that would preclude the prudent and conservative use of diagnostic ultrasound in education and
research, experience from normal diagnostic practice may or may not be relevant to extended
exposure times and altered exposure conditions. It is therefore considered appropriate to make the
following recommendation:
In those special situations in which examinations are to be carried out for purposes other than
direct medical benefit to the individual being examined, the subject should be informed of the
anticipated exposure conditions, and of how these compare with conditions for normal diagnostic
practice.
This unit is internally powered equipment, and it is an IEC/EN 60601-1 Type B applied
part. Type B protection means that the connection between the equipment and personnel
complies with permitted leakage currents and dielectric strength of IEC/EN 60601-1.
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the device.
WARNING
1 The Doppler is a tool to aid the healthcare professional and should not be used in
place of normal fetal monitoring. It is not intended for treatment.
2 Placement of the ultrasound transducer on the abdomen is critical to obtaining the
fetal heart beat as opposed to maternal heart beat or other abdominal noise. The
user should be trained in proper placement techniques either through acceptable
Ob/Gyn training and individual state accreditation, or as being prescribed by such a
trained clinician and trained in device placement.
3 This device is not explosion-proof and can not be used in the presence of flammable
anaesthetics.
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