Chapter 1 Safety Guide; Intended Use/Indications For Use; Safety Precautions - EDAN SD3 Series User Manual

SD3 Series Ultrasonic Pocket Doppler User Manual

Chapter 1 Safety Guide

Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
This user manual is written to cover the maximum configuration. Therefore, your model
may or may not have some of the parameters and functions described, depending on
what you have ordered.

1.1 Intended Use/Indications for Use

The SD3 Series Ultrasonic Pocket Dopplers are intended to be used by health care professionals
including registered nurses, practical nurses, midwives, ultrasound technicians, and physician
assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
The 2 MHz and 3 MHz waterproof probes are indicated for the detection of fetal heart rate from
early gestation thru delivery and as a general indication of fetal well being. Specifically, the 3
MHz probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation.
The 4 MHz, 5 MHz and/or 8 MHz waterproof vascular probes are indicated for the detection of
blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

1.2 Safety Precautions

Safety of Ultrasound
SD3 was designed with physician and patient safety in mind. In early design phases all potential
hazards were eliminated or reduced to As Low As Reasonably Achievable (ALARA) by adhering
to good design practices and industry wide safety standards. Ultrasound procedures should be
performed with the ALARA principle in mind when delivering ultrasound energy into the body.
The following official statements from the American Institute of Ultrasound Medicine (AIUM)
are provided for your general information regarding the safe use of ultrasound.
Clinical Safety (Approved March 1997, October 1982)
Diagnostic ultrasound has been in use since the late 1950s. 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.
There are no confirmed biological effects on patients or instrument operators caused by
exposures from present diagnostic ultrasound instruments. Although the possibility exists that
such biological effects may be identified in the future, current data indicate that the benefits to
CAUTION
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Safety Guide