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Operations & Maintenance Manual: Important Information
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan
®
BVI6100 bladder volume instrument is a wireless, battery‑powered, ultrasound instrument
that provides a noninvasive measurement of urinary bladder volume.
During each scan, the instruments employs patented Vmode
®
technology to create a three‑dimensional
image of the bladder, which automatically calculates and displays measurements based upon this image.
Vmode measurements tend to be more accurate than those obtained from conventional two‑dimensional
ultrasound, as they are based on a more complete, multi‑faceted image of the bladder.
Optionally, exam results may be transmitted to a personal computer running ScanPoint
®
with QuickPrint
software via a USB communication cradle. ScanPoint with QuickPrint allows the user to archive data,
calibrate the instrument, update software, print, and transfer data through an application‑based interface.
STATEMENT OF INTENDED USE
The BladderScan BVI 6100 instrument is an ultrasound device intended to be used for measuring the urine
volume in the bladder noninvasively.
ESSENTIAL PERFORMANCE
Essential performance is the system performance necessary to achieve freedom from unacceptable risk.
The essential performance of the BladderScan BVI6100 system is to produce ultrasonic output energy and
display numerical values for bladder volume. The system has a passively temperature‑controlled transducer
assembly.
NOTICE TO ALL USERS
The BladderScan BVI6100 instrument should be used only by individuals who have been trained and
authorized by a physician or the institution providing patient care. All users must read this entire manual
prior to using the instrument. Do not attempt to operate the instrument until you thoroughly understand all
instructions and procedures in this manual. Failure to comply with these instructions may compromise the
performance of the instrument and the reliability of its measurements.
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