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, fetal hydrops, placental abnormalities, as well as maternal
hypertension, diabetes, and lupus.
WARNINGS
During the first trimester, you should limit the duration of ultrasound imaging
To prevent injury or misdiagnosis, do not use this system for Percutaneous
CPD or Color images can be used as an adjunctive method, not as a screening tool,
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.
Prostate imaging applications
You can assess the prostate 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 presence or absence of
pathology. You can use the system to provide ultrasound guidance for biopsy and drainage procedures,
vascular line placement, and peripheral nerve blocks.
WARNING
To avoid injury to the patient, use only an Ophthalmic (Oph) exam type when
performing imaging through the eye. The FDA has established lower acoustic
energy limits for ophthalmic use. The system will not exceed these limits only if the
Oph exam type is selected.
Arterial and venous imaging applications
You can assess the carotid arteries, deep veins and arteries in the arms and legs, superficial veins in the arms
and legs, great vessels in the abdomen, and various small vessels feeding organs for the presence or
absence of pathology.
Intended uses (SonoSite SII)
based on MI/TI. For more information, see
Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not
been validated to be proven effective for these two uses.
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)
"Acoustic Output"
on page 1.
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