Verathon BladderScan BVI 3000 User manual

BladderScan® BVI 3000
Bladder Volume Instrument
Operator’s Manual

BladderScan® BVI 3000
Bladder Volume Instrument
Operator’s Manual

Copyright © 2007, 2010 by Verathon Inc
All rights reserved. No part of this Operator’s Manual may be copied or transmitted by any method without the express written
consent of Verathon Inc.
BladderScan, Sontac, and Verathon are trademarks of Verathon Inc.
Other products and companies named in this Operator’s Manual may be trademarks of their respective companies.
The BladderScan instrument documented in this manual is protected by U.S. Patent Number 5,235,985. Other international
patents pending.
This Operator’s Manual is Verathon Part No. 0900-0383.
Information in this Operator’s Manual may change at any time without notice. Examples described or illustrated in this User’s
Guide are ctitious and do not in any way represent real patient or exam data.
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011 USA
800.331.2313 (US and Canada only)
425.867.1348
Fax: [phone]
Verathon Medical (Europe) B.V.
Linnaeusweg 11
3401 MS IJsselstein
The Netherlands
+31.30.68.70.570
Fax: [phone]
For additional contact information, please visit our web site at www.verathon.com.
0900-0383-11-60

Page 5BVI 3000 Operator’s Manual
Table of Contents
Important Information .................................................................................................................6
BladderScan® BVI 3000 Components ........................................................................................7
Description of the BladderScan® BVI 3000 ...............................................................................8
Preparation For Use ....................................................................................................................8
Customizing the BladderScan® BVI 3000 ................................................................................11
Operating the BladderScan® BVI 3000 .....................................................................................13
Verifying Aim ..............................................................................................................................15
Printing Results .........................................................................................................................17
Histogram of Cost Savings .......................................................................................................18
Adding a Patient ID and Notes .................................................................................................19
Print Options ..............................................................................................................................20
Adjusting Preferences ..............................................................................................................21
Additional Features ...................................................................................................................23
Regular Inspections and Maintenance ....................................................................................24
Troubleshooting ........................................................................................................................25
Warranty and Disclaimer Information ......................................................................................26
Contacting Verathon® ................................................................................................................27
Safety and Performance Summary ..........................................................................................28
Parts and Accessories ..............................................................................................................29
Technical Description ...............................................................................................................29
Technical Description: Battery Charger ..................................................................................31
Symbol Directory .......................................................................................................................33

Page 6 BVI 3000 Operator’s Manual
Important Information
Product Description The BladderScan® BVI 3000 is a B-mode ultrasonic instrument, portable
and battery operated, intended for the noninvasive measurement of
urinary bladder volume. A mechanical sector scanning transducer
provides cross-sectional images of the bladder from twelve scan planes.
Based on these images, the BladderScan automatically calculates the
estimated bladder volume in milliliters and displays it on a screen.
Notice to All
Operators
The BladderScan BVI 3000 should be used only by individuals who have
been trained and authorized by a physician or the institution providing
patient care. All operators should read this manual prior to using the BVI
3000. Failure to comply with these instructions may compromise the
performance of the instrument.
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
exposure times possible commensurate with clinical utility.
The ultrasonic output power of the BladderScan BVI 3000 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 section
titled “Technical Description,” beginning on page 29.
Statement of
Prescription
Caution: United States Federal law restricts this instrument to use by or
on the order of a physician.
Statement of
Intended Use
The BladderScan BVI 3000 projects ultrasound energy through the lower
abdomen of the nonpregnant patient to obtain an image of the bladder,
which is used to determine bladder volume noninvasively.
Warning: Not intended for fetal use.
Warning: Not intended for use on pregnant patients.
Warning: There is the hazard of possible explosion if the BVI 3000
instrument is used in the presence of ammable anesthetics.
Cautions The BVI 3000 should not be used on a patient with open skin or wounds
in the suprapubic region.
The patient should not have a catheter in his/her bladder. This could
affect the accuracy of the instrument.
Use care with suprapubic/pelvic surgery patients. Scar tissue, incisions,
sutures and staples affect ultrasound transmission and reection.
Accuracy may be affected for patients with ascites or free oating uid
in the peritoneum.

Page 7BVI 3000 Operator’s Manual
BladderScan® BVI 3000 Components

Page 8 BVI 3000 Operator’s Manual
Scanhead
The scanhead transmits and receives
ultrasound, automatically moving its internal
transducer 360º to scan twelve planes and
produce a three-dimensional image of the
urinary bladder. The scanhead is connected to
the control unit by means of a cable.
Control Unit
The control unit provides all operating controls
for the scanning procedure by means of six
soft keys. The measured bladder volume and a
target-shaped aiming icon are clearly displayed
on the LCD screen, helping the operator to
achieve accurate measurement results.
Batteries & Charger
Two NiMH rechargeable batteries are included with the BladderScan BVI 3000. One battery can be
recharged in the battery charger while the other is being used to power the BVI 3000. This ensures that
there is no instrument downtime. The charger brings the battery to a full charge in 6 hours or less.
(See picture and instructions for charging the battery on the following page.)
The BladderScan BVI 3000 consists of 4 main components: The Scanhead, Control Unit, Rechargeable
Battery, and the Battery Charger.
Description of the BladderScan® BVI 3000
Connecting the
Scanhead
Connect the scanhead to the input socket at the back of the instrument
by aligning the tabs on the scanhead plug with the matching slots on the
instrument socket. Press the plug straight in until you hear a click.
To remove the plug, grasp the black plastic ring and pull straight out. Do
not twist.
Preparation For Use

Page 9BVI 3000 Operator’s Manual
Preparation For Use
Charging the
Batteries
To charge a battery, plug the charger into an electrical outlet. Remove the
label covering the battery contacts and slip the battery into the recess on
the top of the charger Fully charging the battery may take up to 6 hours.
Batteries may be stored in the charger. There is no danger of
overcharging the battery.
Rechargeable Battery and Battery Charger
Check the color indicator lights on top of the battery charger to determine
the battery’s power status while charging.
Solid Green: When the battery is low on charge, charging begins in the
fast charge mode. During fast charge mode, the green light is solid. For a
fully discharged battery, fast charge mode lasts about two to three hours.
Quickly Blinking Green: When the battery reaches 80% of its charge
level, the charger starts to “top off” the charge and the green light
blinks quickly. At this point, you can use the battery in the BVI 3000
instrument.
Amber Light: In some cases the charger displays an amber light.
The amber light means the battery temperature is stabilizing before
recharging can begin. This may occur when the battery is taken from a
very cold or warm environment, or if the battery is defective. If the light
remains amber for over an hour, the battery is defective and must be
replaced.
Slowly Blinking Green Light: If the green light blinks slowly upon
inserting a battery, then the battery level is too low for fast charging. The
charger trickle charges the battery until the power level is high enough to
begin fast charging. At this point, fast charging begins automatically.
Installing a Battery
When the battery has been properly charged, install it in the BVI 3000 as
demonstrated in the illustration below.
Note: Battery life is extended
if you wait for about three
hours until the battery is fully
charged. Verathon recommends
that you store your spare
battery in the charger to
prevent instrument downtime
due to discharged batteries.
Note: Plugging and
unplugging the charger while
a battery is inserted causes no
damage. There is no danger
when the charger is plugged in
without the battery inserted.

Page 10 BVI 3000 Operator’s Manual
Preparation For Use
Battery release button. To remove the battery,
press the battery release button.
Battery Icon The battery icon, located in the upper right corner of the LCD screen,
indicates the power status of the battery currently installed in your
instrument. Read the battery icon as follows:
100%
A fully darkened battery icon indicates that the battery is
fully charged and ready for use.
75%
A battery icon that is almost full indicates a partially
discharged battery.
50%
When the battery icon is half-darkened, the battery is
partially discharged. This is the most common display,
shown during the majority of the battery’s charge life.
25%
An almost empty battery icon indicates that the battery
is nearly discharged. While a few more scans can still be
performed, the battery should be replaced at this point.
0%
When the battery is fully discharged, the battery icon is
completely clear and the BVI 3000 does not work. The
discharged battery must be replaced with a charged one.
Battery Care The BladderScan® BVI 3000 draws very little power when it is turned
off; however, if you do not plan to use your instrument for several weeks,
you should remove the battery to prevent it from becoming discharged.
The battery that is not in use should be stored in the charger so it remains
fully charged.

Page 11BVI 3000 Operator’s Manual
Customizing the BladderScan® BVI 3000
Programming the
Facility Name
You can customize the BladderScan BVI 3000 instrument by entering
your facility name and the current date and time. This information will
subsequently be included on all printouts of exam results. To customize
the BVI 3000:
• Turn the BVI 3000 on by pressing the on/off button
• On the Main Menu screen, press the ALT button to display the
Alternate Menu screen, illustrated below.
Important: If your BVI 3000 came with the PIN code option enabled, you must
enter your PIN code before you can access the Alternate Menu. The default PIN
code is “0000.” For information about how to personalize the PIN code, see the
section titled, “Adjusting Preferences,” on page 21.
Note: You may use any
combination of up to 27
characters when entering the
facility name. For example,
you can enter the name of the
hospital, clinic, or physician
supervising use of the
BVI 3000.
Note: You can use the empty
character as a space to
separate words.
Note: When the arrow buttons
are held down, the cursor
moves one character a second.
When the cursor reaches the
end or bottom of the grid of
characters, it wraps around to
the rst character again.
• Press the NAME button. The Name Preset screen, with a 4 x 13
grid containing alphabetic, numeric, and punctuation characters, is
displayed.
• Use the “arrow right” à and “arrow down” â buttons to highlight the
rst character you want to enter.
• When the desired character is highlighted, press the SEL button to
select it. The character(s) you have selected are displayed below the
character grid.
• Continue to use the “arrow right,” “arrow down,” and SEL buttons to
enter all the characters in your facility’s name. If you make a mistake,
use the ERASE button to delete the last character entered.
• When you are nished, press DONE to return to the Main Menu. The
programmed facility name will now be displayed on the Main Menu
screen.
Note: Diagnostic Ultrasound
Corp. is now called
Verathon Inc.

Page 12 BVI 3000 Operator’s Manual
Setting the Date • On the Main Menu screen, press the ALT button to access the
Alternate Menu (if prompted, enter your PIN number). Then press the
DATE button.
• The Date Preset screen displays the current setting for the date, in
U.S. format (two digits each for the month, day, and year).
Note: Once set, the BVI 3000
clock recognizes the number of
days in each month, including
February during leap years. It
has its own lithium battery and
maintains the correct date and
time for at least ten years, even
if the rechargeable battery is
removed.
• Press the MM button until the correct month is displayed. Only values
from 01 to 12 are allowed (12 is followed by 01).
• Press the DD button until the correct day is displayed. Only values
from 01 to 31 are allowed (31 is followed by 01).
• Press the YY button until the correct year is displayed. Only values
from 97 to 19 (for 1997 to 2019) are allowed.
• Press âá to toggle between the following options: 1) values are
increased, or 2) values are decreased, when the month, day, and year
buttons are pressed.
• When the date is set, press DONE to return to the Main Menu screen.
Setting the Time • On the Main Menu screen, press the ALT button (and then enter
your PIN code, if required) to access the Alternate menu. Next, press
the TIME button. The Time Preset screen displays the time that is
currently set.
Note: Enter the time in 24-
hour format (“military time”).
To convert standard clock time
to 24-hour format, after 12-
noon add 12 hours to the clock
time (Example: 3:00 pm + 12
hours = 15:00 hours).
• Press the HH â or HH á to set the hour.
• Press the MM â or MM á buttons to set the minutes.
• When the time is set, press DONE to return to the Main Menu screen.
Customizing the BladderScan® BVI 3000

Page 13BVI 3000 Operator’s Manual
Operating the BladderScan® BVI 3000
Turning On the
BVI 3000
Note to First Time Users: Verathon® advises new operators to use the
BladderScan BVI 3000 on patients with moderately full bladders, rather
than initially attempting to locate nearly empty bladders. An in-service
training video has been supplied with your BVI 3000. We recommend
that you view the video to supplement the information in this manual with
an actual demonstration of BVI 3000 use.
• Turn the BVI 3000 on by pressing the on/off button
• The Main Menu screen is displayed.
• From the Main Menu, press the SCAN button to go to the Scanning
screen.
Note: The Scanning screen
may also be selected by
pressing the scan button on the
scanhead. This is especially
practical when the scanhead
is already positioned on the
patient’s abdomen.
Selecting Gender
• Press the Male/Female button to select the patient gender. The LCD
screen shows a male or a female icon to indicate the gender that is
selected. Use the female option ONLY for women who have NOT
undergone a hysterectomy (the “Female” option allows the instrument
to exclude the uterus from the measurement, which may resemble the
bladder ultrasonically). For all other patients, use the “Male” option.
Preparing the
Scanhead
• Clean the rounded end of the scanhead by wiping it gently with a
cleaning pad dampened in isopropyl alcohol or a hospital disinfectant
solution.
Note: If the calibration
due date for your BVI 3000
has passed, the message
“Calibration Due” will
appear every time you turn
on the instrument. You can
still measure bladder volume;
however, this message will
continue to appear until
an authorized Verathon
Service Center calibrates
the instrument. Press OK to
continue.

Page 14 BVI 3000 Operator’s Manual
Measuring Bladder
Volume
• Locate the patient icon on the scanhead and make sure the head
of the icon will point toward the head of the patient when you place
the scanhead on the patient’s abdomen.
• Place the scanhead on the gel on the patient’s abdomen.
Have the patient lie in the supine
position with abdominal muscles
relaxed. Palpate the patient’s
symphysis pubis (pubic bone). Place
an ample amount of gel midline on
the patient’s abdomen approximately
one inch (3 cm) above the symphysis
pubis.
Applying Ultrasound
Gel
• Aim the scanhead so that the ultrasound is projected toward the
expected location of the bladder. For most patients, this means aiming
the tip of the scanhead toward the patient’s coccyx.
• Press and release the scan button located on the scanhead.
• Hold the scanhead steady throughout the scan. The scanhead
clicks once at each scan plane. When the scanhead beeps, the scan is
complete. The Aiming screen is then displayed.
Note: While scanning, avoid
making any changes in the
position, angle or pressure of
the scanhead.
Operating the BladderScan® BVI 3000
View from patient’s right side View from the patient’s feet

Page 15BVI 3000 Operator’s Manual
Verifying Aim
Aiming Screen
The greatest measured bladder volume is displayed in large type in the
upper left-hand corner of the Aiming screen. Also displayed are the
target-shaped Aiming Icon, the instrument status (READY TO SCAN),
and the current volume measurement.
Largest Volume and
Current Volume
The BVI 3000 always displays two volumes; the largest volume
measured and the current volume.
Verathon® recommends that you take several measurements to ensure
maximum accuracy. The BVI 3000 assumes that the largest volume
measured is the true bladder volume, because in most cases the largest
volume is the most accurate. Exceptions occur when the operator moves
the probe during the scan, or fails to select the female gender when
required. In these situations, the largest volume measurement may be
higher than the actual bladder volume, and the operator should clear the
aiming screen before rescanning the patient.
Clearing the Screen
To clear the scan results screen, press the clear button, which is labeled
with an “X” on the LCD screen. If your instrument does not have a clear
button, clear the screen by pressing the DONE button and then pressing
the SCAN button to start over. Then rescan your patient. In the following
section, we explain how to ensure maximum accuracy by adjusting your
aim.
The Aiming Icon
The light area inside the target-shaped Aiming Icon represents the
position of the bladder relative to the scanhead. Accurate results are
obtained when the bladder image is centered on the crosshairs of the
Aiming Icon. If the bladder is not centered, re-aim the scanhead and
rescan the patient. Repeat until the image is properly centered
(see Figure 1).
Adjusting Aim
The Aiming Icon displays the bladder as viewed when looking down on
the patient’s abdomen. To adjust your aim, slightly move or angle the
scanhead toward the direction of the bladder image on the Aiming Icon
(target). For example, if the bladder image is located on the right side of
the icon, aim the scanhead so the ultrasound will be projected further to
the right.

Page 16 BVI 3000 Operator’s Manual
Verifying Aim
In Figure 1, the bladder image is centered on the crosshairs of the Aiming
Icon. This indicates that the scanhead was properly aimed and the
bladder volume measurement is accurate.
In Figure 2, the bladder image is not centered on the crosshairs; the
bladder overlaps one side of the Aiming Icon. This indicates that the
scanhead was not properly aimed and part of the bladder was outside its
eld of vision. In such cases, the measured volume is lower than the true
bladder volume. The BVI 3000 recognizes this condition and displays
a > (greater than) symbol before the bladder volume measurement.
To achieve an accurate measurement, the operator should re-aim the
scanhead toward the bladder image and repeat the scan.
In Figure 3, the bladder overlaps two sides of the Aiming Icon. This
indicates that the bladder is too large to be fully contained within the
scanhead’s eld of vision. The BVI 3000 recognizes this condition
and displays a > (greater than) symbol before the bladder volume
measurement. In such cases, repositioning or re-aiming the scanhead
will do little to improve accuracy; however, this situation arises almost
exclusively in patients with very large bladder volumes. At these high
volumes, measurements are clinically useful even if they underestimate
the true bladder volume.
The Scan Results
Screen
The Scan Results Screen displays the longitudinal and horizontal scan
planes from the largest image taken during the exam. The light areas
represent the bladder. The dark, triangular surfaces, called scan planes,
represent the scanhead’s eld of vision. The volume measurement is
accurate when the light colored bladder images are completely contained
within the dark, triangular scan planes.
If the light surface in either scan plane is overlapping the edge of the
black area, or appears to be cut off, then part of the bladder was not
contained in the scanhead’s eld of vision and the measurement may
underestimate the patient’s bladder volume. Press the SCAN button
to clear the results of the last scan and return to the Scanning screen.
Reposition the scanhead and repeat the scanning procedure.
Note: The longitudinal scan
plane is marked by a gender
icon bisected by a vertical
line. The horizontal scan plane
is marked by a gender icon
bisected by a horizontal line.
When the bladder images are completely contained in both scan planes,
the measurement results are accurate. Pressing either the PRINT
or MAIN button completes the scanning procedure and stores the
measurement results in the instrument’s memory.

Page 17BVI 3000 Operator’s Manual
Printing Results
Printing Results
To print the scan results, press the PRINT button to open the Print Menu
shown below.
Press PRINT to obtain a printout of the most recent exam. Printing takes
about one minute. See Figure 4 for an illustration of the printout. Note: If the facility name, date,
and time have not been set,
those lines will be skipped on
the printout. The BVI 3000
prints on thermal paper. Over
time, the thermal printout will
fade. For maximum storage
life, Verathon® recommends
that you photocopy the
printout.
More information about printing can be found in the “Print Options”
section on page 20.
To stop a print in progress, press the ABORT PRINT button.
Figure 4

Page 18 BVI 3000 Operator’s Manual
Histogram of Cost Savings
Each volume measurement from a completed scanning procedure is
stored in the instrument’s memory. Measurement data is stored in one
of eleven volume ranges (each with a 100 ml increment). This data is
analyzed and can be printed at any time in a Histogram of Cost Savings
(see Figure 5).
Cost savings are calculated based on the following criteria:
• Catheterizations Avoided - Urinary catheterization below a certain
volume is deemed unnecessary. Thus, by using the BVI 3000, these
catheterizations are avoided. The default setting (for volume below
which catheterization is unnecessary) is 200 ml.
• UTI’s Avoided - Studies indicate that a certain percentage of
catheterizations lead to urinary tract infections (UTI’s). By
avoiding unnecessary catheterizations, the resulting UTI’s may
be prevented. The default setting (for percent of catheterizations
leading to UTI’s) is 3%.
Associated Costs:
• Cost of UTI’s Avoided - Literature suggests that the additional
costs associated with treating UTI amount to $680.00 per patient
infection. The default setting is $680.00.
• Cost of Catheter Kits - The default setting is $3.00 (per kit).
Total Cost Savings as a Result of Using the BVI 3000:
• (Caths Avoided x Catheter Costs) + (UTI’s Avoided x UTI Costs)
Note: The default settings can
be changed in the Preference
screen to reect the rates
and costs at your facility.
For more information, see
the section titled, “Adjusting
Preferences,” beginning on
page 21.
Note: For reference articles
on UTI Rate and UTI Costs,
please visit our web site at
www.verathon.com.
Figure 5
HISTOGRAM
Volume
000-099
100-199
200-299
300-399
400-499
500-599
600-699
700-799
800-899
900-999
>1000
# of Scans
870
1,219
589
488
252
176
154
87
69
5
4
Catheterizations
Avoided: 2089
UTIs Avoided 63
Savings $49,107

Page 19BVI 3000 Operator’s Manual
Adding a Patient ID and Notes
Adding a Patient ID
Number
A patient ID number (maximum 10 digits) can be added to the scan
result and will be included on the printout. To add a patient ID number,
press the # button on the Scan Results screen. The screen displays
0000000000.
• Use the ß (arrow left) and à (arrow right) buttons to select the digit
you want to change (the selected digit is underlined).
• Use the + (plus) or -- (minus) buttons to select the correct number.
• Continue to use the ß (arrow left) and à (arrow right) buttons and the
+ (plus) or -- (minus) buttons to enter all the digits of the patient ID
number.
• When the patient ID number has been entered, press the DONE button
to return to the Scan Results screen.
The patient ID number will now be included on the printout of the scan.
Note: Only press the button
marked # when a patient ID
number is required. If the #
button is used and no patient
ID number is entered, the BVI
3000 will assume a patient
ID number was entered and
0000000000 will be printed on
the printout.
After a scanning procedure has been completed, it is possible to annotate
the measurement results. Press the button marked NOTES on the Scan
Results screen. When the Notes option is selected, notes appear on the
printout of the exam data.
The operator can change the following settings to annotate the exam:
Exam Type
Default settings:
• If the measured bladder volume is less than 100 ml, the BVI 3000
assumes the measurement was taken after patient voiding and
“POSTVOID” is displayed on the screen.
• If the measured bladder volume is between 100 ml and 400 ml,
the BVI 3000 assumes the measurement was taken prior to patient
voiding and “PREVOID” is displayed on the screen.
• If the measured bladder volume is greater than 400 ml, the BVI 3000
assumes the measurement was taken prior to patient voiding and the
bladder was lled to maximum capacity. “CAPACITY” is displayed
on the screen.
• If the default does not apply, the Exam Type setting can be changed
by pressing the EXAM TYPE button to toggle between options. The
selected exam type will appear on the right side of the LCD screen.
Adding Notes

Page 20 BVI 3000 Operator’s Manual
Adding a Patient ID and Notes
The Print screen can be accessed by selecting PRINT, either from
the Main Menu screen or from the Scan Results screen after a scan is
completed. The following table describes the different print options.
From the Print screen, use the SEL button to select a print option. An X
appears in front of the option selected.
Option Description
Last
Image
This option prints the most recent measurement data on the
built-in thermal printer. Different types of images can be
selected from the Preference screen, using the “Printout”
option. (The default is B-mode grayscale images with
highlighted bladder walls).
Cost
Savings
This option is used to print a Histogram of Cost Savings
based on the volume history of the instrument. Cost savings
are calculated based on the catheter and UTI costs avoided
due to BVI 3000 use. For details, see the section titled,
“Histogram of Cost Savings,” in this manual. Histogram
settings can be changed in the Preference Menu (for
instructions, see the section titled, “Adjusting Preferences,”
in this manual).
Test
Print
Select this option to test if the built-in thermal printer works.
Alphanumeric characters and a simple grayscale test pattern
are printed out.
Action Taken
Using the SEL â button, you can also note the action taken as a result of
the current bladder volume measurement. Possible selections are:
No Action: The default selection
Patient Voided: The patient was able to void
Patient
Catheterized:
The patient’s bladder was emptied
using a urinary catheter
Allowed to Fill: The patient’s bladder was not as
full as desired and voiding was
postponed
Adjusting Volume Approximation
The instrument assumes that the amount of urine voided or catheterized
is equal to the volume measured by the BVI 3000 (rounded to the nearest
10 ml). This value can be adjusted up or down using the + and -- buttons.
Adding Notes
(continued)
Print Options