Chapter 6: Safety 143
Safety
Gynecology and Infertility Imaging Applications
This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, M Mode, color
power Doppler (CPD), directional color power Doppler (DCPD), Tissue Harmonic Imaging (THI),
and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, ovaries, adnexa, and
surrounding anatomical structures can be assessed for the presence or absence of pathology
transabdominally or transvaginally.
Interventional and Intraoperative Imaging Applications
This system transmits ultrasound energy into the various parts of the body using 2D, color Doppler
(Color), color power Doppler (CPD), directional color power Doppler (DCPD), Tissue Harmonic
Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images that provide guidance
during interventional and intraoperative procedures. This system can be used to provide
ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve
blocks, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance
during abdominal and vascular intraoperative procedures.
Obstetrical Imaging Applications
This system transmits ultrasound energy into the pelvis of pregnant women using 2D, M Mode,
color Doppler (Color), color power Doppler (CPD), directional color power Doppler (DCPD), Tissue
Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The fetal
anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding
anatomical structures can be assessed for the presence or absence of pathology transabdominally or
transvaginally. CPD, color Doppler (Color), and DCPD imaging is 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
This system transmits ultrasound energy into the pediatric or neonatal patients using 2D, M Mode,
color Doppler (Color), color power Doppler (CPD), pulsed wave (PW) Doppler, and continuous
wave (CW) Doppler to obtain ultrasound images. The pediatric abdominal, pelvic and cardiac
anatomy, pediatric hips, neonatal heads, and surrounding anatomical structures can be assessed for
the presence or absence of pathology.
Warning: This system is not intended for use in providing guidance for central nerve blocks,
i.e., the brain and spinal cord, or for ophthalmic applications.
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, DCPD, 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).
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