BLADDERSCAN BVI 9400 - SAFETY INFORMATION

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NOTICE TO ALL USERS
The BladderScan BVI9400 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 BladderScan BVI9400. Do not attempt to operate this instrument 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.
STATEMENT OF PRESCRIPTION
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
STATEMENT OF INTENDED USE
The BladderScan BVI9400 projects ultrasound energy through the lower abdomen of the patient to obtain
an image of the bladder, which is used to calculate 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9400 system is to produce ultrasonic output energy, display
ultrasonic images, and display numerical values for bladder volume. The system has a temperature‑controlled
transducer assembly.
SAFETY INFORMATION
BIOLOGICAL SAFETY
To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects. However,
ultrasound should be used only by medical professionals when clinically indicated, using the lowest possible
exposure times indicated by clinical need.
The ultrasound output power of the BladderScan BVI9400 is not user adjustable and is limited to the
minimum level necessary for effective performance. Data on acoustic output levels can be found in the
Product Specifications.
CONTRAINDICATIONS
The BladderScan BVI9400 is not intended for fetal use or for use on pregnant patients.