SonoSite S-Cath - Page 20

10 Intended uses
obstetricalproceduresandto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,fetal
hydrops,placentalabnormalities,aswellas
maternalhypertension,diabetes,andlupus.
Pediatric and Neonatal Imaging ApplicationsYou
canassessthepediatricabdominalandpelvic
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
presenceorabsenceofpathology.Youcanusethe
systemtoprovideultrasoundguidancefor
biopsyanddrainageprocedures,vascularline
placement,peripheralnerveblocks,andspinal
nerveblocksandtaps.
Vascular 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.
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 following:
• Detection of structural anomalies
of the fetal heart
• Diagnosis of Intrauterine Growth
Retardation (IUGR)
To avoid errors in fetal growth
estimation, do not use the system
as a fetal growth screening tool. The
system does not provide fetal
growth data.
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.