Acuson S3000 Ultrasound System; Indications For Use Statement - Siemens Acuson S1000 Instructions For Use Manual

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ACUSON S3000 Ultrasound System

The ACUSON S3000 ultrasound system supports the following applications:
Abdominal (Renal)
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Obstetrics (Fetal Echo)
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Gynecology
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Small Parts (Breast, Testicle, Thyroid)
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Musculoskeletal
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Pediatric (Abdomen, Infant Hip, and Neonatal Cephalic)
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Cardiac
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Vascular (Arterial and Venous)
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Digital
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Urology (Penile, Pelvis, Prostate)
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Indications for Use Statement

Product Indications for Use Statement
ACUSON S3000 The S3000™ ultrasound imaging systems are intended for the following applications: Fetal,
Ultrasound System
Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for
visualization of the ovaries, follicles, uterus, and other pelvic structures), Cardiac, Pelvic,
Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and
Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal,
intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-
esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional),
musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide
information to the clinician that may be used adjunctively with other medical data obtained
by a physician for clinical diagnosis purposes.
syngo Arterial Health The Arterial Health Package (AHP) software provides the physician with the capability to
Package (AHP) measure Intima Media Thickness and the option to reference normative tables that have
been validated and published in peer-reviewed studies. The information is intended to
provide the physician with an easily understood tool for communicating with patients
regarding state of their cardiovascular system.
This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid
Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease
Risk: A Consensus Statement from the American Association of Echocardiography; Carotid
Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging."
ACUSON AcuNav The catheter is intended for intracardiac and intraluminal visualization of cardiac and great
Ultrasound Catheter
vessel anatomy and physiology, as well as visualization of other devices in the heart of
adult and pediatric patients.
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