User guide

12 Intended uses
Intended uses
The system is used with a transducer attached and
is powered either by battery or by AC electrical
power. The clinician is positioned beside the patient
and places the transducer onto (or into for invasive
procedures) the patient’s body where needed to
obtain the desired ultrasound image.
The system transmits ultrasound energy into the
patient’s body to obtain ultrasound images as listed
below.
For the intended transducer and imaging modes for
each exam type, see “Imaging modes and exams
available by transducer” on page 33.
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.
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.
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.
WARNING:
The ECG is not used to diagnose
cardiac arrhythmias and is not
designed for long term cardiac
rhythm monitoring.
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.
WARNING:
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).