User's Manual

12 Intended uses
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.
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.
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
forultrasoundguidanceinbiopsyand
drainageprocedures,vascularlineplacement,
peripheralnerveblocks,andspinalnerveblocks
andtaps.
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.
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).