Intended Use; Safety Overview Of Intended Use; Intended Use Of The Cypress System Ultrasound Imaging System - Siemens ACUSON Cypress Operator's Manual

Intended Use

Safety Overview of Intended Use

For well over 25 years diagnostic ultrasound has been accepted as a safe and
very effective diagnostic technique. Diagnostic ultrasound images are obtained
with a minimal risk to the patient, especially when compared to other imaging
techniques. Diagnostic ultrasound does not use ionizing radiation. According to
the published literature, there are no known, immediate or delayed or long-term
risks from diagnostic ultrasound imaging using accepted acoustic output levels
and conventional examination techniques.
Intended Use of the Cypress System Ultrasound Imaging
System
Diagnostic ultrasound is useful for diagnosing several different disease states.
The Cypress ultrasound system is intended for cardiac, abdominal, peripheral
vascular, fetal, neonatal cephalic, pediatric, and intraoperative cardiac applica-
tions, as defined in
FDA
with the system include adults, children, and neonates. The system can be used
with or without legally marketed ultrasound contrast agents.
All scanning modes may be applied for each application. The Cypress system
contains three measurement and analysis applications:
General
Cardiac
Vascular
WARNING The Cypress system is not intended for use as an
for diagnostic
triggering only.
ACUSON Cypress™ Operator's Manual
guidance documents. The patients who may be imaged
. Signals displayed are for reference or
ECG
Intended Use
monitor or
ECG
10-3