USER’S MANUAL
5
Product description
The Accuro is a pocket-sized and
battery operated ultrasound
instrument. The device is a single
self-contained unit consisting of
an ultrasound system, ultrasound
probe, and rotatable touchscreen
display. The instrument provides
LUMBAR and THORACIC presets
to facilitate epidural and spinal
anesthesia imaging guidance
with real-time 3D navigation of
the lumbar or thoracic spine. The
LUMBAR and THORACIC presets
use proprietary technology, called
SpineNav3D, to automate spinal
bone landmark detection and depth
measurements and to assess real-
time scan plane orientation in 3D.
Accuro ultrasound scans and
measurements can be saved in an
examination file on the device and
exported to a computer for storage
or printing.
Principles of operation
Medical ultrasound imaging uses
an ultrasound transducer, which
transmits and receives high
frequency mechanical waves. The
transmitted ultrasound waves
reflect off of structures in the body
that exhibit changes in acoustic
impedance. A portion of the
reflected ultrasound energy returns
to the ultrasound transducer and
is converted back into an electrical
signal, which is then amplified,
digitized, and processed through a
series of filters. The digital signal is
transformed into an image that can
be saved in memory and displayed
to the display screen in real-time.
The SpineNav3D feature has only
been clinically validated in the
lumbar and thoracic spine analysis
of obese and non-obese patients
and not in any other areas of the
spine or in case of spinal deformities,
significant spinal degeneration,
previous spinal surgeries, etc.
The Accuro LUMBAR and THORACIC
presets use ultrasonic reflections
acquired from multiple scan planes
to obtain 3D volume scans of the
lumbar and thoracic spine. The
SpineNav3D technology facilitates
image interpretation of individual 2D
lumbar and thoracic spine scans by
automating spinal bone landmark
detection and depth measurements
and providing a real-time
assessment of scan plane orientation
in 3D. SpineNav3D technology
makes image interpretation and
measurements of the lumbar and
thoracic spine anatomy simple,
quick, and easy. A sonographer is
not required to use the LUMBAR or
THORACIC presets.
Real-time 2D scans from either
LUMBAR, THORACIC, or BONE
presets are formed using proprietary
BoneEnhance technology. The
BoneEnhance technology provides
images of bone anatomy at greater
bone-to-tissue contrast compared
with conventional ultrasound image
reconstructions.
Indications for use
The Accuro ultrasound scanner is
intended for diagnostic ultrasound
imaging of the human body in the
following clinical applications:
USA only
•
Abdominal
•
Cardiac
•
Musculoskeletal (Conventional)
•
Musculoskeletal (Superficial)
•
Pediatric
•
Small Organ
•
Peripheral vessel
Non-USA only
•
Abdominal
•
Cardiac
•
Musculoskeletal (Conventional)
•
Musculoskeletal (Superficial)
•
Peripheral vessel
Essential performance
The essential performance of the
Accuro consists of ultrasonic image
display of the dimension and
location of spinal anatomy, display
of ultrasound indexes pertaining
to safety related indications,
and prevention of unintended
or excessive ultrasound output
and transducer assembly surface
temperature.
Contraindications
The Accuro ultrasound instrument is
not intended for ophthalmic use or
any use causing the acoustic beam
to pass through the eye.
Statement of prescription
United States law restricts this device
to sale or use by, or on the order of,
a physician.
Warnings and cautions
The Accuro should only be used by
trained individuals who have been
authorized by a physician. All users
must read the entire User’s Manual
prior to using the Accuro. To prevent
damage of the equipment or injury
to yourself or others, carefully
read the following warnings and
cautions before using the Accuro.
Rivanna Medical, LLC disclaims all
responsibility and liability for the
operating safety, reliability, and
performance of the Accuro if the
warnings and cautions disclosed in
this User’s Manual are disregarded in
any way.
The Accuro has not been evaluated
for use with high frequency (HF)
surgical equipment.
A typical examination using the
Accuro is guidance of neuraxial
anesthesia.
Important Information