Konica Minolta SONIMAGE HS2 - 1.1 Intended Use

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The Ultrasound System SONIMAGE HS2 is a portable
ultrasound system for general purposes.
This system provides ultrasound images in all its
modes of B-mode, M-mode, Color Flow-mode,
Doppler-mode, and Elastography-mode. The system
provides ultrasound imaging information such as used
for the purpose of diagnosing the human body, which
visually represents the internal geometry, characteris-
tics and dynamics of the human body, and transmits /
receives ultrasound waves to obtain image data of the
visual representation.
This system conforms to Real Time Display of Thermal
and Mechanical Output Indices on Diagnostic Ultra-
sound Equipment (Track 3). Transducers have their
own characteristic applications, and are brought into
contact with the body surface. For the transducers that
can be used with this system and their applications,
refer to "1.6.7 Connectable Transducers and Biopsy
Brackets". The ultrasound images displayed by this
system can also be used for real-time observation dur-
ing biopsy procedures.
There is panoramic view as a reference display.
Intended Patient Population
a) Age group: any patient age
b) Weight range: any patient weight
DANGER
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• Do not use this system for an eyeball examination
or any other examination that may require the pas-
sage of an ultrasound beam through an eyeball.
This system is not designed to be applied to eye-
balls.
• Do not use ammable or explosive gases near this
system, or use this system in a high-oxygen envi-
ronment. This system is not explosion-proof.
• Do not use it together with a debrillator. Doing so
may cause performance degradation or failure of
the system.
• Do not use this system for intracardiac use or di-
rect cardiac contact. It may injure patients.
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1.1 Intended Use
IMPORTANT
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• The system should not be used by persons other
than fully qualied and certied medical personnel.
• The system should be used under the supervision
of an operator.
• The method of applying or using the system is
shown in "Chapter 3 Starting Examination" and
"Chapter 4 Diagnosis Mode" of this operation man-
ual.
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1.1.1 Indication for Use State-
ments
The Ultrasound System SONIMAGE HS2 and its trans-
ducers are products designed to collect ultrasonic im-
age data of the human body for diagnostic purposes.
The system employs the ultrasonic pulse-echo method
to visualize the anatomic structures, characteristics,
and dynamics of the human body, and using an image
display, Doppler display and / or Doppler sound, o󰀨ers
a procedure applied to the human body for medical di-
agnosis or examination. The range of intended clinical
applications is same as other conventional ultrasound
imaging systems for general purpose, such as small
parts, abdomen, obstetrics, gynecology, musculoskel-
etal (soft tissue), peripheral vascular, and Cardiac.
1.1.2 Contraindication
This system is contraindicated for an eyeball examina-
tion or any other examination that may require the pas-
sage of an ultrasound beam through an eyeball.
This system is NOT designed for use in direct contact
to central nerves and cardiac systems.