1
Operations & Maintenance Manual: Important Information
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan BVI 3000 is a B‑mode ultrasonic instrument, portable and battery‑operated, intended for
the noninvasive measurement of urinary bladder volume. A mechanical sector‑scanning transducer provides
cross‑sectional images of the bladder from twelve scan planes. Based on these images, the BladderScan
instrument automatically calculates the estimated bladder volume in milliliters (ml) and displays it on a screen.
STATEMENT OF INTENDED USE
The BladderScan BVI 3000 projects ultrasound energy through the lower abdomen of the nonpregnant patient
to obtain an image of the bladder, which is used to determine bladder volume noninvasively.
ESSENTIAL PERFORMANCE
Essential performance is the system performance necessary to achieve freedom from unacceptable risk. The
essential performance of the BladderScan BVI 3000 system is to produce ultrasonic output energy and display
numerical values for bladder volume. The system has a passively temperature‑controlled transducer assembly.
STATEMENT OF PRESCRIPTION
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
NOTICE TO ALL USERS
The BladderScan BVI 3000 should be used only by individuals who have been trained and authorized by
a physician or the institution providing patient care. All operators should read this manual prior to using the
instrument. Failure to comply with these instructions may compromise the performance of the instrument.
To Next Page
Loading...