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The BladderScan® PRIME PLUS system is an ultrasound device intended to be used for measuring urine volume of the bladder non-invasively.

The BladderScan" PRIME PLUS system provides non-invasive measurement of urinary bladder volume. The system calculates the bladder volume using patented neural network technology. Volume measurements made with this technology are based on a more complex, multifaceted image of the bladder. Bladder volume, directional aiming with real-time feedback, battery status and usage rate indicators are displayed on the LCD display. The system operates using a battery which includes a charging cradle.

The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine in the bladder non-invasively.

The BladderScan" Prime system instrument provides noninvasive measurement of urinary bladder volume. The instrument calculates the bladder volume using patented NeuralHarmonics technology, which is easy to use and comfortable for the patient. Volume measurements made with NeuralHarmonics are accurate than those from conventional two-dimensional ultrasound as they are based on a more complex, three-dimensional 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 LCD display. The system also includes a battery charger for custom, user-replaceable lithium-ion batteries included with the system,

- Abdomen, B-Mode, per Indications for Use Ultrasound Form . - The BladderScan® BVM 9500 is intended to project ultrasound energy through . the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass non-invasively. - Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Other (Bladder)

The BladderScan® BVM 9500 is a B-mode ultrasonic instrument, portable and battery operated, intended for the noninvasive measurement of urinary bladder volume and bladder mass. The BladderScan® BVM 9500 calculates the bladder volume and mass using patented Vmode® technology. Vmode ultrasound is easy to use and comfortable for the patient. When you release the scan button, within seconds, the Vmode technology measures ultrasonic reflections on multiple planes inside the body and produces a 3-dimensional image. Based on this image, the BladderScan® calculates and displays the bladder volume and bladder mass. Volume measurements made with Vmode ultrasound are more accurate than those from conventional 2-dimensional ultrasound, as they are based on a more complex, 3-D image of the bladder. Bladder volume and mass, mode (uterus detection or standard BladderScan), directional aiming with real-time feedback, battery status, and usage rate indicators are all displayed on the BladderScan® BVM 9500 LCD display. The instrument contains a thermal printer that will allow the user to print exams with a single button click.

The Verathon Inc. BladderScan® BVI 9600 with AortaScan® Mode is a user selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorfa for aorlic diameter measurement. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: General (Track I only), Specific (Tracks I & III) Specific: Abdominal, Other (Abdominal Aorta Measurement), Other (Bladder) Mode of Operation: B (for Abdominal), N (for Abdominal Aorta Measurement), P (for Bladder)

The BVI9600, with AortaScan®, is a B-mode ultrasonic instrument that is portable and battery operated. The BVI 9600 has two user controlled modes of operation; (1) - Bladder Volume Measurement and (2)- Abdominal Aortic Measurement, both noninvasive. Either bladder volume or aortic diameter measurement functions can be chosen by a button press. When the scan button is pressed the BVI9600 uses patented Vmode® technology to measure ultrasonic reflections on multiple planes inside the body to produce a 3dimensional image. Based on these images and the mode of operation chosen, the BV19600 either calculates and displays the bladder volume (BladderScan® mode) or calculates and displays the abdominal aortic diameter (AortaScan® mode). The measurements made with Vmode ultrasound are more accurate than those from conventional 2-dimensional ultrasound, as they are based on a more complex. 3-D image. Bladder volume (in BladderScan® mode), aortic diameter (in AortaScan® mode), mode selection, directional aiming, battery status, and usage rate indicators are all displayed on the BV19600 LCD display. The instrument contains a thermal printer that allows the user to print exams with a single button click. New device: The Verathon Inc. BladderScan® BVI 9600 with AortaScan® is a user selectable dual function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume or the mid abdomen to obtain an image of the abdominal aorta for aortic diameter measurement. The Verathon Inc. BladderScan® BVI 9600, with AortaScan®, and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume (in BladderScan® Mode) or abdominal aortic diameter (in AortaScan® Mode). The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume (in BladderScan® Mode), aortic diameter (in AortaScan® Mode), patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9600 Ultrasound System scanner. The ultrasonic power transmitted from the system is not user adjustable. The portable Verathon Inc. BladderScan® BVI 9600 Ultrasound System with AortaScan® is applied to the patient's abdomen along with Sontac Ultrasound Coupling Gel to obtain aortic measurement. The BladderScan® BVI 9600 Ultrasound System transducer collects cross- sectional images of the bladder or aorta from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9600 Ultrasound System constructs a finite element model of the bladder (in BladderScan® Mode) or aorta (in AortaScan® Mode) and automatically computes the volume of urine via volumetric integration (for the bladder measurement) or the diameter of the aorta (for aortic measurement), depending on the mode of operation chosen (AortaScan® or BladderScan®).

The BladderScan® BVI 9400 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume and bladder wall mass noninvasively. Contraindications: - The BladderScan® BV19400 is contraindicated for fetal use and for use on pregnant patients. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Other (Bladder) Mode of Operation: N Clinical Application: Abdominal Mode of Operation: P

The Verathon Inc. BladderScan® BVI 9400 Ultrasound System is a portable, battery powered, software controlled ultrasound system used to acquire and display real time B-mode images of the bladder. The system is intended to non invasively monitor bladder volume on an intermittent basis. The system is an effective, low cost, simple to use option for use in a clinical hospital or nursing home setting or for home use under medical supervision. The Verathon Inc. BladderScan® BVI 9400 Ultrasound System and its integrated 3.0 MHz mechanical sector transducer operate only in B-mode to locate and automatically measure bladder volume. The same transducer is driven at 1.74 MHz to obtain a second harmonic for enhanced bladder wall detection. Bladder volume, patient gender, non optimal directional aiming, battery status, and usage rate indicators are all displayed on the Verathon Inc. BladderScan® BVI 9400 Ultrasound System scanner. The ultrasonic power transmitted the system is not user adjustable. The portable Verathon Inc. BladderScan® BVI 9400 Ultrasound System is applied to the patient's abdomen with a single patient use Sontac® hydrogel pad, manufactured by Verathon Inc. BladderScan® BVI 9400 Ultrasound System. The transducer collects cross-sectional images of the bladder from twelve (12) scan planes. From this information, the Verathon Inc. BladderScan® BVI 9400 Ultrasound System constructs a finite element model of the bladder and automatically computes the volume of urine via volumetric integration.