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IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan Prime instrument provides noninvasive measurement of urinary bladder volume.
The instrument calculates the bladder volume using patented NeuralHarmonics
measurements made with NeuralHarmonics technology are based on a more complex, multifaceted image
of the bladder.
Bladder volume, mode (male, female, and small child), directional aiming with real‑time feedback, battery
status and usage rate indicators are displayed on the touch‑screen display.
The system also includes a battery charger for the custom, user‑replaceable lithium‑ion batteries included
with the system.
Stored exams can be accessed at any time using the console display.
STATEMENT OF INTENDED USE
The BladderScan Prime system is an ultrasound device intended to be used for measuring the urine volume
in the bladder noninvasively.
NOTICE TO ALL USERS
The BladderScan Prime system should be used only by individuals who have been trained and authorized
by a physician or the institution providing patient care. Users should read this entire manual prior to using
the system. Do not attempt to operate this instrument until you thoroughly understand all instructions and
procedures in this manual.
STATEMENT OF PRESCRIPTION
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
ESSENTIAL PERFORMANCE
Essential performance is the system performance necessary to achieve freedom from unacceptable risk.
The essential performance of the BladderScan Prime system is to produce ultrasonic output energy, display
ultrasonic images, and display numerical values for bladder volume. The instrument shall not produce
unintended or excessive probe surface temperature.
Operations & Maintenance Manual: Important Information
technology. Volume
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