Intended Uses - FujiFilm SonoSite M-Turbo User Manual

Intended uses

This system transmits ultrasound energy into
various parts of the patient's body to obtain
ultrasound images, as follows.
For the intended transducer and imaging modes
for each exam type, see "Imaging modes and
exams available by transducer" on page 34.
Abdominal Imaging Applications You can assess
the liver, kidneys, pancreas, spleen, gallbladder,
bile ducts, transplanted organs, abdominal
vessels, and surrounding anatomical structures
for the presence or absence of pathology
transabdominally.
Cardiac Imaging Applications You can assess the
heart, cardiac valves, great vessels, surrounding
anatomical structures, overall cardiac
performance, and heart size for the presence or
absence of pathology.
In addition, you can identify the presence and
location of fluid around the heart and lungs, use
to assist in pericardiocentesis and thoracentesis
procedures, visualize blood flow through cardiac
valves, and detect normal lung motion for the
presence or absence of pathology.
You can obtain the patient's electrocardiogram
(ECG). The ECG is used for timing of cardiac
events.
WARNING: The ECG is not used to diagnose
cardiac arrhythmias and is not
designed for long term cardiac
rhythm monitoring.
Gynecology and Infertility Imaging Applications
You can assess the uterus, ovaries, adnexa, and
surrounding anatomical structures for the
presence or absence of pathology
transabdominally or transvaginally.
Interventional Imaging Applications You can use
the system for ultrasound guidance in biopsy and
drainage procedures, vascular line placement,
peripheral nerve blocks, spinal nerve blocks and
taps, ova harvesting, amniocentesis and other
obstetrical procedures, and provide assistance
during abdominal, breast, and neurological
surgery.
Obstetrical Imaging Applications You can assess
the fetal anatomy, viability, estimated fetal
weight, gestational age, amniotic fluid, and
surrounding anatomical structures for the
presence or absence of pathology
transabdominally or transvaginally. CPD and
Color imaging are intended for high‐risk
pregnant women. High‐risk pregnancy
indications include, but are not limited to,
multiple pregnancy, fetal hydrops, placental
abnormalities, as well as maternal hypertension,
diabetes, and lupus.
WARNING: To prevent injury or misdiagnosis,
do not use this system for
Percutaneous Umbilical Blood
Sampling (PUBS) or in vitro
Fertilization (IVF) The system has
not been validated to be proven
effective for these two uses.
CPD or Color images can be used as
an adjunctive method, not as a
screening tool, for the detection of
structural anomalies of the fetal
heart and as an adjunctive method,
not as a screening tool for the
diagnosis of Intrauterine Growth
Retardation (IUGR).
Pediatric and Neonatal Imaging Applications
You can assess the pediatric and neonatal
abdominal, pelvic and cardiac anatomy, pediatric
hips, neonatal head, and surrounding anatomical
structures for the presence or absence of
pathology.
Superficial Imaging Applications You can assess
the breast, thyroid, testicle, lymph nodes,
hernias, musculoskeletal structures, soft tissue
structures, ophthalmic structures, and
surrounding anatomical structures for the
Chapter 1: Getting Started 13