Verathon BLADDERSCAN BVI 6400, Руководство по эксплуатации и техническому обслуживанию

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Operations & Maintenance Manual: Important Information
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan ® BVI 6400 bladder volume instrument is a wireless, battery‑powered, ultrasound device that
provides a noninvasive measurement of urinary bladder volume.
During each scan, the device employs patented V
mode
®
technology to create a three‑dimensional image
of the bladder, which automatically calculates and displays measurements based upon this image. V
mode
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 Scan Point ® with QuickPrint
software via a USB communication cradle. Scan Point with QuickPrint allows the user to archive data,
calibrate the device, update software, print, and transfer data through an application‑based interface.
STATEMENT OF INTENDED USE
The BladderScan BVI 6400 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 BVI 6400 system is to produce ultrasonic output energy and
display numerical values for bladder volume. The system has a passively temperature‑controlled transducer
assembly.
ENVIRONMENTS OF INTENDED USE
The BladderScan BVI 6400 system is intended to be used in professional healthcare environments such as
hospitals, clinics, and doctors’ offices.
NOTICE TO ALL USERS
This device 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 device. Do not
attempt to operate the device until you thoroughly understand all instructions and procedures in this manual.
Failure to comply with these instructions may compromise the performance of the device and the reliability of
its measurements.