bk ultrasound E14CL4b, User Manual

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E14CL4b User Guide (16-01277-EN-02) 5
Introduction
This is the user guide for the E14CL4b transducer, and it must be used together with
the
Care and Cleaning user guide which contains important safety information.
Intended use
The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis
of the human body.
Indications for use
E14CL4b is suitable for transrectal imaging, transvaginal imaging, guidance of
all transperineal interventional procedures including brachytherapy and
cryotherapy treatments. It is also suitable for elastography
1
and contrast imaging
2
.
E14CL4b contains two arrays — a curved array for transverse (T) imaging, and
a linear array for sagittal (S) imaging. Both arrays can be used separately or they
can be used simultaneously. When using the simultaneous biplane feature, you
are able to view two planes at once with a single transducer, and this helps
determine the true position of the needle and its tip during puncture and biopsy.
Patient Population
The patient population is adults.
Imaging Plane
Figure 1. E14CL4b
Physicians
only
Caution Rx-c1
Federal law in North America restricts this device to sale to, or on the order of, a
physician.
1. Elastography on the bk5000 has not been licensed by Health Canada.
2. Contrast imaging on the bk3000/bk5000 has not been licensed by Health Canada. In the USA,
contrast-enhanced ultrasound has not been market cleared by the FDA, with the exception of
only select cardiac imaging applications.
Sagittal Button
Transverse Button