5
Safety
Do not dispose of batteries in fi re as this can cause them to
explode.
Do not attempt to recharge normal dry-cell batteries. They may
leak, cause a fi re or even explode.
This product contains sensitive electronics, therefore, strong
radio frequency fi elds could possibly interfere with it. This
will be indicated by unusual sounds from the loudspeaker. We
recommend that the source of interference is identifi ed and
eliminated.
Any equipment connected to RS232 interface must be
compliant with IEC60601-1:2005.
Connect headphones only to the headphone socket.
Dopplex Dopplers are screening tools to aid the healthcare
professional and should not be used in place of normal
vascular or fetal monitoring. If there is doubt as to vascularity
or fetal well-being after using the unit, further investigations
should be undertaken immediately using alternative
techniques.
1.2 Patient Applied Parts
As defi ned in IEC60601-1:2005, the patient applied parts of the Dopplex
Dopplers are the ultrasound probes.
1.3 Acoustic Safety
Continuous wave Doppler ultrasound instruments such as the MD2/SD2 have
been used extensively for medical diagnosis in the United States for over 25
years. Throughout this period, there have been no reports of adverse effects to
patients or instrument operators at the acoustic intensities recommended for
diagnostic use. Despite this highly favorable safety experience, available data
are not conclusive and the possibility remains that unwanted biological effects
might be identifi ed in the future. 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. With the MD2/SD2, the transmitted
acoustic power 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.
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