Verathon BladderScan i10, Operation & Maintenance Manual

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Operations & Maintenance Manual: Important Information
0900‑5005 REV‑00
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan i10 system provides noninvasive measurement of urinary bladder volume. The system
calculates the bladder volume using ImageSense™, a proprietary Verathon artificial intelligence algorithm
that draws on real‑world data to create a consistent evaluation of the bladder’s location, size, and shape.
The primary components of the system are a console and a probe. The console’s touchscreen displays
critical information such as bladder volume, directional aiming with real‑time feedback, configuration and
administrative settings, and indicators for battery level and charging status. The touchscreen also provides
most of the system’s controls, both during exams and between them. A clinician with appropriate access
permission can use the touchscreen to retrieve stored exams at any time.
The console includes a bay for a rechargeable lithium‑ion battery. When the console is connected to external
power, it charges the battery.
STATEMENT OF INTENDED USE
The BladderScan i10 system is an ultrasound device intended to be used for measuring the urine volume in
the bladder noninvasively.
NOTICE TO ALL USERS
The BladderScan i10 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 before using
the system. Do not attempt to operate the system until you thoroughly understand all instructions and
procedures in this manual.
ESSENTIAL PERFORMANCE
Essential performance is the system performance necessary to avoid unacceptable risk. The essential
performance of the BladderScan i10 system is to produce ultrasonic output energy, display ultrasonic images,
and display numerical values for bladder volume. The system shall not produce unintended or excessive probe
surface temperature.
ENVIRONMENTS OF INTENDED USE
The BladderScan i10 system is intended to be used in professional healthcare environments such as hospitals,
clinics, and doctors’ offices.