Simpli Series System Instructions for Use
8
01-5034-00 R1
Ultrasound Probes
Device Description
The Interson USB Ultrasound Probe System is a self-contained, portable, multiple-mode, and multiple-
application diagnostic ultrasound system. The system contains an ultrasound generator/receiver, analog
to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full
complement of conventional operating modes, software-based parameter controls, and recording. The
selection of probes offered with the system permits a wide range of clinical applications including fetal
heart, abdomen, OB/GYN, vascular, extremity, pediatric, cardiac, neonatal cephalic, urology, and
ophthalmology. With these general areas of intended use, the various probes adapt the system for the
specific imaging tasks.
Different models of the USB Ultrasound Probe System are available. The initial operational settings for
each USB Ultrasound Probe System are preprogrammed in the system. User-customized parameter
settings for each USB Ultrasound Probe System may be inserted by the operator and stored for recall as
needed via the system control panel. Customization includes transmit power, images controls selection,
and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the
Cine function.
The Interson USB Ultrasound Probe System supports B-Mode mode scanning, providing high resolution
and high penetration performance. The probes can be used in applications such as fetal heart,
abdomen, OB/GYN, vascular, extremity, pediatric, neonatal cephalic, cardiac, and urology. The Interson
USB Ultrasound Probe System can measure distances and calculate areas, circumferences and volumes.
A Color Flow Mapping (CFM) mode provides a qualitative indication of fluid flow and direction. The
Interson USB Ultrasound Probe System supports the Cine function (capable of storing up to 32 to 1024
sequential images). Management of patient history is possible by image-storage function.
The expected service life of Interson probes is at least five (5) years.
Refer to
Appendix B
for more information on Interson Probe System. Refer to
Appendix D
for more
information on Interson probes.
Indications for Use
Please refer to
Appendix G
.
The system is intended for use by healthcare professionals.
Contraindications
The Interson Simpli Series GP-C01 and SP-L01 ultrasound probes are not indicated for ophthalmic use or
any application that causes the acoustic beam to pass through the eye.
Acoustic Energy and Surface Temperatures
The effects of acoustic energy on human tissue are currently under investigation. Therefore, it is
recommended that diagnostic ultrasound output power be set to the lowest possible levels in
accordance with the principle of ALARA (As Low As Reasonably Achievable).
See
Appendix E
of this manual for Acoustic measurements and
Appendix F
for guidance on how to best
implement ALARA.
