Caution: Federal (United States) law restricts this
device to sale by or on the order of a physician.
CONTACT INFORMATION
To obtain additional information regarding your BladderScan system,
please contact Verathon® Customer Care or visit verathon.com/support.
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011 U.S.A.
800.331.2313 (US and Canada only)
425.867.13 48
Fax: 425.883.2896
verathon.com
Verathon Medical (Europe) B.V.
Willem Fenengastraat 13
1096 BL Amsterdam
The Netherlands
Tel: +31 (0) 20 210 30 91
Fax: +31 (0) 20 210 30 92
verathon.com
0123
Copyright 2009, 2016 Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without
the express written consent of Verathon Inc.
Verathon, the Verathon torch symbol, BladderScan, the BladderScan symbol, ScanPoint, and NeuralHarmonics are trademarks or
registered trademarks, and Total Reliability Plan is a service mark of Verathon Inc. All other brand and product names are trademarks or
registered trademarks of their respective owners.
Information in this manual may change at any time without notice. For the most up‑to‑date information, see the documentation
available at verathon.com/product‑documentation.
TABLE OF CONTENTS
IMPORTANT INFORMATION .................................................................................................................................1
Notice to All Users ...........................................................................................................................................1
Statement of Prescription .................................................................................................................................2
Statement of Intended Use ..............................................................................................................................2
Safety Information ..............................................................................................................................................2
Parts & Features .................................................................................................................................................. 5
Battery Status Indicator .................................................................................................................................... 9
Memory Optimization During Power Down .......................................................................................................30
Operations & Maintenance Manual: Table of Contents
i
SETTING UP ......................................................................................................................................................... 31
Procedure 1. Unpack the Box & Check the Components ........................................................................... 31
Procedure 2. Charge the Batteries ............................................................................................................32
Procedure 3. Install a Battery Pack in the Console .....................................................................................32
Procedure 4. Enter the Clinic Name ..........................................................................................................33
Procedure 5. Set the Date & Time .............................................................................................................35
Procedure 6. Load a Roll of Thermal Paper ...............................................................................................36
Procedure 7. Assemble the Medical Cart (Optional) ..................................................................................37
Procedure 8. Install the ScanPoint with QuickPrint Software (Optional) .....................................................39
Procedure 9. Watch the Training Video ..................................................................................................... 39
USING THE INSTRUMENT ...................................................................................................................................40
Procedure 1. Prepare for the Exam ...........................................................................................................40
Unit Disposal ....................................................................................................................................................55
Help Resources .................................................................................................................................................56
Icons on the BladderScan Console ..................................................................................................................... 57
SYMBOL DIRECTORY ..........................................................................................................................................65
Operations & Maintenance Manual: Table of Contents
iii
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan BVM9500 is a portable ultrasound instrument that provides noninvasive measurements of
urinary bladder volume, bladder wall thickness and Ultrasound‑Estimated Bladder Weight (UEBW). The device
consists of an ultrasound probe that scans the patient’s bladder and a compact, battery‑operated console
that provides an array of measurement‑related information.
The BladderScan BVM9500 is noninvasive and comfortable for the patient. It is quick, accurate, reliable, and
easy to use. When the user releases the scan button, within seconds, the BVM9500 measures ultrasonic
reflections on multiple planes inside the body and produces a three‑dimensional image. Based on this image,
the BladderScan BVM9500 calculates and displays the bladder volume, bladder wall thickness and UEBW. A
sonographer is not required.
NeuralHarmonics® technology in the BVM9500, sharpens accuracy and accelerates speed of bladder volume
measurement. Volume measurements made with NeuralHarmonics technology are more accurate than those
from conventional two‑dimensional ultrasound, as they are based on a more complex, multifaceted image
of the bladder. This technology, applying multi‑spectral analysis to a robust data set, helps reduce margin of
error and minimize uncertainty in essential measurements of bladder function.
If needed, after a scan has been taken, a unique aiming icon guides the operator to optimal probe placement
with a comprehensive display showing the bladder in two cross sectional images verifying that a complete
scan has been achieved. Bladder volume, patient type, directional aiming with real‑time feedback, battery
status, and usage rate indicators are all displayed on the device’s LCD screen.
BladderScan BVM9500 measurements can be printed via an onboard printer or transmitted using
HIPAA‑compliant ScanPoint® image management technology for storage and archiving on Verathon® servers.
Stored exams can be accessed at any time from your office's computer or viewing or printing. Note: Use of
ScanPoint software is optional.)
Exam results may also be transmitted to a computer running ScanPoint with QuickPrint software via a
proprietary wireless connection. ScanPoint with QuickPrint allows the user to archive data, calibrate the
device, update software, print, and transfer data through a Web‑based interface.
A Calibration Targeting System, consisting of a spiral‑shaped calibration target along with a special calibration
container, allows the user to easily calibrate the device by scanning a known target.
The BladderScan BVM9500 system also includes a universal battery charger for the custom, user‑replaceable
Lithium‑ion battery incorporated in the system. The BladderScan BVM9500 may be mounted on a wheeled
cart which holds the instrument securely and provides a holder for the probe and a bottle of ultrasound gel.
NOTICE TO ALL USERS
The system 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 system. 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.
Operations & Maintenance Manual: Important Information
1
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 BVM9500 is intended to project ultrasound energy through the lower abdomen to obtain
an image of the bladder and measure urinary bladder volume and bladder wall mass noninvasively.
SAFETY INFORMATION
SAFETY & PERFORMANCE SUMMARY
• The BladderScan BVM9500 computes the volume of the urinary bladder based upon twenty‑four
cross‑sectional ultrasound images.
• To achieve accurate measurements, have the patient rest quietly in a supine position.
• Errors in usage tend to result in the underestimation of bladder volume, except in cases where the
probe is moved during scanning. In this case, the measurement may overestimate the patient’s
bladder volume.
• We recommend that new users measure patients with moderately full bladders rather than initially
attempting to locate a bladder with a low urinary volume.
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 system 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 Instrument
Specifications chapter on page61.
CONTRAINDICATIONS
The system is not intended for fetal use or for use on pregnant patients.
CAUTIONS & WARNINGS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of
the device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction,
failure, or damage to the product. Throughout the manual, pay attention to sections labeled Important, as
these contain reminders or summaries of the following cautions as they apply to a specific component or
usesituation. Please heed the following warnings and cautions.
PRECAUTIONS
CAUTION
If your BladderScan BVM9500 suffers from a configuration loss and displays the Home screen
for a BladderScan BVI9400 instrument, complete the Restore Factory Configuration procedure
on page59.
2
CAUTION
When using the BladderScan BVM9500 with optional ScanPoint® software, your computer
must be minimally certified to EN / IEC / CSA / UL 60950 or 60101‑1 standards. This
configuration ensures that compliance to the EN/IEC 60601‑1‑1 system standard is maintained.
Anyone connecting additional equipment to the BladderScan BVM9500 signal input port or
signal output port configures a medical system, and is therefore responsible for ensuring that
the system complies with EN/IEC 60601‑1‑1. If you need assistance, contact your biomedical
staff, Verathon
®
representative, or Verathon Customer Care.
CAUTION
Risk of Fire and Burns. Regarding the battery, do not disassemble, heat above 60° C (140° F),
or incinerate. Keep battery out of reach of children and in original package until ready to use.
Dispose of used batteries promptly according to local recycling or waste regulations.
CAUTION
Hazardous materials present. Ensure proper disposal. The BladderScan BVM9500 and
related devices may contain lead, mineral oils, batteries, and other environmentally hazardous
materials. When the BladderScan BVM9500 has reached the end of its useful service life, return
the device, charging cradle, and related accessories to a Verathon
®
Service Center for proper
disposal. Alternatively, follow your local protocols for hazardous waste disposal.
WARNINGS
CAUTION
Bluetooth and Wireless LAN devices operate within the same radio frequency range and
may interfere with one another. If you are using the BladderScan BVM9500 Bluetooth link
and Wireless LAN devices simultaneously, you may experience less than optimal network
performance or even loose your network connection. If this happens, you may need to move
the BladderScan instrument and ScanPoint
®
host computer to an area away from the 2.4 GHz
wireless LAN devices (40 meters/44 yards, or more).
WARNING
Potential patient hazard. To date, exposure to low‑power, pulsed diagnostic ultrasound has not
been shown to produce adverse effects. However, medical professionals should use ultrasound only
when clinically indicated, using the lowest exposure times possible to obtain accurate measurements.
The ultrasonic output of the BladderScan BVM9500 is not user‑adjustable and is limited to the
minimum level necessary for effective performance. For more information about the acoustic output
levels of this device, please refer to the section Instrument Specifications on page61.
Operations & Maintenance Manual: Important Information
3
WARNING
Risk of inaccurate measurements/results. When using the BladderScan BVM9500 be aware
of the following conditions which can affect ultrasound transmission and the accuracy of exam
results.
• Use care when scanning patients who have had supra‑pubic or pelvic surgery. Scar tissue,
surgical incisions, sutures, and staples can affect ultrasound transmission and accuracy.
• Do not use the BladderScan BVM9500 on a patient with open skin or wounds in the
suprapubic region or mid‑abdominal area.
• Do not use the BladderScan BVM9500 on a patient with ascites.
• If you scan a patient with a catheter in his/her bladder, the catheter may affect measurement
accuracy. However, the information obtained from the measurement could still be clinically
useful for detecting problems such as a blocked catheter.
WARNING
Ensure proper distance from patient. When transmitting data to or from your computer,
make sure the BladderScan BVM9500, accessories, and computer are outside the patient
vicinity (more than six feet [2 meters] from the patient).
WARNING
Risk of explosion. If you use the system in the presence of flammable anesthetics, the hazard of
potential explosion exists.
WARNING
Risk of explosion, fire, or serious injury. The BladderScan BVM9500 is provided with two
Lithium‑ion batteries. Never short circuit the battery pack by either accidentally or intentionally
bringing the battery terminals into contact with any other conductive object. This could cause serious
injury or fire and could also damage the battery pack and the BladderScan device.
Never expose the battery pack to abnormal shock, vibration, or pressure. The main battery pack’s
internal protective covering could fail, causing it to overheat or ignite, resulting in caustic liquid
leakage, or explosion or fire, possibly resulting in serious injury.
4
INTRODUCTION
PARTS & FEATURES
The BladderScan BVM9500 has two main components: the console and the probe. The console and probe
are linked by a detachable cable. The BladderScan BVM9500 controls and indicators are illustrated in
Figure 1.
Figure 1. BladderScan BVM9500 Controls and Indicators
Main Display
Battery
Pack
5 Variable
Function Buttons
Adjust
Brightness
Probe
(Scan button
on hand grip)
Console
Aiming Display
Battery Status Indicator
Printer (behind display)
Battery Packs
Adjust
Volume
Power On/Off
Battery charger/
wireless hub
Microphone
(above display)
Operations & Maintenance Manual: Introduction
5
PROBE COMPONENTS
The probe transmits and receives ultrasound waves, automatically moving its internal probe 360º to scan 24
different planes to produce a three‑dimensional image of the bladder. The probe is attached to the console
by a cable. The probe has three main features:
Table 1. Probe Components
PART NAMEPURPOSE
Scan buttonPress to take a scan.
Aiming Display
MicrophoneRecords voice annotations.
The LCD displays directional arrows to assure that the bladder is centered within the
scanning cone.
CONSOLE COMPONENTS
The console provides all operating controls for the scanning process by means of five variable function
buttons. The measured bladder volume and UEBW and target‑shaped aiming icons are clearly displayed
on the LCD screen. The console also provides controls for adjusting brightness and volume, turning the
power on/off, interfacing with a ScanPoint®‑equipped computer (optional), and adjusting user settings and
preferences. The console also houses the battery and the printer. The console’s controls and features are
described in the following table:
Table 2. Console Components
PART NAMEPURPOSE
Main Display
Power on/offToggles main power on/off
Volume
BrightnessPress to adjust display brightness dimmer/brighter.
5 Variable Function
Buttons
Printer/Printer DoorPress to release the printer door.
Displays the bladder volume measurement, patient type, settings, and instrument
status.
Press to adjust volume up/down on voice annotation playback, start up sound,
and “scan complete” tone.
Depending on device mode, the buttons provide access to all instrument
functions for scanning, recording annotations, printing, connecting to ScanPoint
(optional), accessing the training video, and setting user preferences.
6
BATTERY CHARGER/WIRELESS HUB
The BladderScan BVM9500 is powered by a Lithium‑ion (Li‑Ion) battery. The battery charger provided
with the system can charge two batteries while simultaneously functioning as the wireless hub linking the
BVM9500 to the ScanPoint® host computer. A battery icon on the instrument display is always present,
indicating battery status. The user can change the battery whenever necessary. Removing a discharged
battery and replacing it with a fresh battery will not erase any saved exams or user settings.
To provide power to the batteries, the battery charger/wireless hub must be plugged into a wall outlet using
the power cord provided. Use only the battery charger provided with the BVM9500. Any other battery
charger may damage the battery. The battery charger automatically detects whether a Lithium‑ion battery is
being charged.
To provide wireless communication between the BVM9500 and the ScanPoint host computer, plug the
battery charger/wireless hub USB connector into a USB port on the ScanPoint host computer. The battery
charger/wireless hub maintains an operating distance of up to 120 feet (36 meters) between the ScanPoint
computer and the BVM9500, regardless of barriers such as walls, ceilings, or windows.
Note: Use of ScanPoint with QuickPrint software is optional.
Figure 2. Battery Charger/Wireless Hub
Table 3. Battery Charger/Wireless Hub Components
PART NAMEPURPOSE
Battery charger/
wireless hub
Power adapter and
power cord
USBcableConnects the battery charger/wireless hub to the ScanPoint host computer.
Operations & Maintenance Manual: Introduction
Charges the lithium‑ion batteries and receives and sends information to/from a
BVM9500 instrument within communication range.
Connects the battery charger/wireless hub to the wall outlet.
7
COMPONENTS & ACCESSORIES
Table 4. Components & Accessories
BVM9500 console
BVM9500 probe
Battery charger/wireless hub
Lithium‑ion battery (2 provided)
Thermal Paper Roll for the printer
BladderScan BVM9500 Medical Cart (optional)
ScanPoint® with QuickPrint user documentation (optional)
Calibration Kit (optional—requires ScanPoint with QuickPrint software. Includes Calibration Container,
Calibration Target, etc.)
Acoustic Coupling Gel, 0.25 liter (optional)
Universal Accessory Basket for Medical Cart (optional)
DESCRIPTION
8
ICONS & BUTTONS
This section describes BladderScan BVM9500 displays and button functions.
The console display presents information that varies depending on the current instrument function.
The functions of the five buttons below the display vary according to current instrument mode and function.
Button functions are indicated by icons in the display footer, immediately above the each button.
BATTERY STATUS INDICATOR
A battery status indicator appears in the header of all BVM9500 screens. Depending on current level of
battery charge, one of the following symbols will be displayed:
Indicates a fully charged battery.
Indicates a battery 50% to 75% charged.
Indicates a battery 25% to 50% charged.
Indicates a battery that is nearly discharged and can power only a few more scans.
Indicates the battery must be changed.
INSTRUMENT BUTTONS
Power On/Off, Brightness (/), and Volume (/) are located on the lower half of the console. Scan (on the
probe). The five buttons below the console LCD have variable functions depending on current instrument
mode as follows:
Table 5. Instrument Buttons
SCREEN/MODEACTIVE BUTTONS
Start up screen
Appears when the
instrument is first turned
on.
Home Screen
Appears when the
instrument is turned on.
Scan Screen:
Appears when the operator
presses and releases the
Scan button.
Power, Volume, Brightness
(1) ‑ (5) No function.
Power, Scan: opens Aim/Scan screen, (1) PatientType: toggle between
two bladder volume modes: female with uterus, all other patients, (2)
Appears when the operator
releases the SCAN button
(after aiming).
Review Screen
Review, replay, print, or
delete saved exams.
Tutorial Screen
View the menu of training
modules.
Video Viewing Screen
The video viewing screen.
Settings Screen
Edit clinic name, date &
time, general preferences,
savings preferences, and
self‑test options.
Power, Scan: opens Aim/Scan screen:
(1) Record:press to record voice annotation, press Stop to end voice
annotation, (2) Print:print to onboard printer, (3) Play:press to play voice
annotation; otherwise, no function, (4) Zoom:Image Zoom screen for
manual measurement of bladder wall thickness. (5) Home:return to Home
screen.
Power, Scan, (1) Next: select next exam in memory, (2)Print: print to
on‑board printer, (3) Return/Play: On first Review screen, switches to
second screen for additional data (UEBW, Bladder Wall Thickness); On
second Review screen, plays voice annotation for currently selected exam, (4)
Delete: delete currently selected exam, (5) Home: return to Home screen.
Power, (1) Skip to next tutorial, (2) Skip to previous tutorial, (3) Select tutorial for viewing (4) No function, (5)Home (return to Home screen).
Power, (1) No function, (2) Play/Pause, (3) Return to Tutorial (4) No function, (5)Home (return to Home screen).
Power, (1)Select next setting in list, (2)Select previous setting in list,
(3)Enter (proceed to the selected screen), (4)No action, (5)Home (return to
Home screen).
Alpha‑Numeric Screen
Displays alpha‑numeric
characters for entering
information.
Date & Time Screen
Allows the user to set the
date and time
Power, (1)Move down, (2)Move right, (3)Add currently selected character,
(4)Delete currently selected character, (5)Return to main setup screen.
Power, (1)Move forward to next changeable unit, (2)Move back to previous
changeable unit, (3)Add/toggle units as appropriate (hold down to move
faster), (4)Decrease/toggle units as appropriate (hold down to move faster),
(5)Save current date/time entries and return to main setup screen.
10
SCREEN/MODEACTIVE BUTTONS
Power, (1)Select next setting in list, (2)Select previous setting in list,
(3)Select next option/Enter, (4)Select previous option, (5)Home (return to
Home screen).
Preferences list and options:
General Preferences
Screen
Set preferences for
language, time and date
format, time zone, UTI rate
and cost, and currency.
Languages: English (default), Chinese Simplified, Chinese Traditional, Czech,
Danish, Dutch, Finnish, French, German, Greek, Hungarian, Italian, Japanese,
Korean, Norwegian, Portuguese, Spanish, Swedish, Turkish.
Date for yy‑mm‑dd
Time Format: 12‑hour, 24‑hour
Calibration Warning: On (default), Off. When “On” is selected, a calibration
warning will appear in the display header when the device is due for
calibration.
Print Report Type: B‑Mode (default), C‑Mode
Print UEBW: On (default). Off
UTI Rate: 1–100 % in increments of 1%
UTI Cost: $10–100,000 in increments of $1
Catheter Cost: $1–1000 in increments of $1
Saving Preferences
Screen
Catheter Volume: 20–100mL in increments of 20mL
Currency: $ / € / £ / ¥
Savings Calculation: Since new, Since 1/1/2006, Reset Now, Print Since New,
Print Recent, Hide Savings.
Self‑Test Screen(1) to (4): No function; (5) Return to Settings screen
(Note: Only available when used with ScanPoint with QuickPrint software.)
The Home screen appears when the BVM9500 is first powered on. The Home screen serves as a starting
point for all of the instrument functions.
Press the button to toggle between Male and Female modes.
The Bladder Volume Mode home screen displays:
• A list of saved exam results (10maximum) saved in chronological order. Yellow folders hold saved
exams. Gray folders represent empty spaces still available for saving exam results.
• A Cost Saving Summary. Displays the savings to your organization from using the BladderScan.
BVM9500 rather than catheterization. The values used to determine the savings are user‑variable and
entered from the Savings Preferences Screen (Refer to page27 for more information about using
this screen).
Figure 3. Home Screen: Bladder Volume Mode
Saved exams
(yellow)
Battery Status Indicator
Available memory
for 8 more exams
(gray)
Cost Savings
Summary
12
Table 6. Home Screen Buttons
BUTTONFUNCTION
Press to toggle between two possible scan options:
Take a bladder volume measurement of a female patient who has not had a hysterectomy.
(When the female icon is illuminated, the BVM9500 will assume the patient has a uterus.)
Take a bladder volume measurement of a male patient, or a female patient who has had a
hysterectomy.
Press to view the training video.
Go to the Settings screen (set the time, date, institution name, and user preferences).
Press to review a previously saved exam. (This button will be gray (inactive) if there are no
previously saved exams to review.)
Press to initiate communication with the ScanPoint® host computer. Saved and annotated
exams will be automatically uploaded to the host computer. (ScanPoint software must be
previously installed and a connection open. Use of the ScanPoint software is optional.)
Operations & Maintenance Manual: Introduction
13
SCAN SCREEN
The Scan screen (Figure 4) appears and displays a progressively updating image of the bladder outline. When
the ultrasound measurement is complete, the Results screen opens automatically.
The five buttons below the display do not function during the scan.
Figure 4. Scan Screen
14
RESULTS SCREEN
The Results screen (Figure 5) appears automatically when a scan is complete. The Results screen displays the
bladder outline, the calculated bladder volume and the ultrasound‑estimated bladder weight (UEBW).
Figure 5. Results Screen
In Figure 5, a standard deviation value indicating the UEBW measurement confidence is displayed as a +/‑
range.
In some cases, the UEBW measurement will be expressed as an approximate value, using a ≈ symbol
(Figure 6). This means that the measurement is an approximate result only and you should re‑aim and re‑scan
to get a more accurate reading. The table below provides guidance on interpreting data displayed on the
Results Screen.
Figure 6. Results Screen with Approximate UEBW value
Operations & Maintenance Manual: Introduction
15
Table 7. Interpreting Results Screen UEBW Measurement Data
AIMING
ARROW
PRESENT?
UEBW
MEASUREMENT
SYMBOL
RECOMMENDED ACTION
No=Accept UEBW measurement
No≈
Adjust probe pressure and/or probe angle and scan again. Depending on
patient anatomy, it may not be possible to get an = sign.
No>Bladder volume is too large for UEBW measurement
Yes≈
Yes>
Angle probe in direction of arrow on probe screen, or move probe no more
than 0.5in (1cm) in direction of arrow; scan again
Angle probe in direction of arrow on probe screen, or move probe no more
than 0.5in (1cm) in direction of arrow; scan again
Table 8. Results Screen Buttons
BUTTONFUNCTION
Press to record a voice annotation (up to 10seconds long).
Press to print exam results
Press to play a previously recorded voice annotation (blue). If no voice annotations are
recorded, this button is disabled (gray).
Press to go to the Image Zoom screen.
Press to return to the Home screen.
16
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