FujiFilm SonoSite X-Porte User Manual page 36

Color Power Doppler (CPD) and Color Velocity Doppler (CVD) imaging tools are intended to evaluate the
blood flow of the fetus, placenta, umbilical cord, and surrounding maternal structures in all cases, including
high-risk pregnancies. High-risk pregnancy indications include, but are not limited to, multiple pregnancies,
fetal hydrops, placental abnormalities, maternal hypertension, diabetes, and lupus. CPD and Color imaging
tools are not intended as a sole means of diagnosis nor as a sole method of high-risk pregnancy screening.
WARNINGS
Pediatric and Neonatal Imaging Applications
You can assess the neonatal abdominal, pelvic and cardiac anatomy, neonatal head, and surrounding
anatomical structures for the presence or absence of pathology.
Transcranial Imaging Applications
You can assess the anatomical structures and vascular anatomy of the brain for the presence or absence of
pathology. You can use imaging temporally, transoccipitally, or transorbitally.
WARNING
Small parts, breast, musculoskeletal, nerve, superficial, and lung 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 detect normal lung motion for the presence or absence of pathology. You can
demonstrate blood flow in superficial anatomical structures.
You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement,
and peripheral nerve blocks.
Contraindications
The SonoSite X-Porte ultrasound system has no known contraindications.
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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).
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.
To avoid injury to the patient, use only an Orbital (Orb) or 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 Orb or Oph exam type is selected.
Getting started