Verathon BladderScan BVI 3000 User manual

0900-0383-04-60 BVI 3000 Operators Manual 3
Your Local
BladderScan®
Distributor is:
Operator's Manual
BladderScan® BVI 3000
Noninvasive Bladder Volu e Instru ent

BladderScan BVI 3000
Noninvasive Bladder Volu e Instru ent
Operator's Manual
Caution: In the United States federal law restricts this device
to use by or on the order of a physician.
®

Copyright © 2006 by Verathon Inc.
All rights reserved. No part of this Users Guide may be copied or transmitted by any method without the express
written consent of Verathon Inc.
BladderScan® and Sontac® are registered trademarks of Verathon Inc.
Other products and companies named in this Users Guide may be trademarks of their respective companies.
The BladderScan® instrument documented in this manual is protected by U.S. Patent Numbers 4 926 871 and
5 235 985. The Sontac® ultrasound coupling pad described in this manual is protected by U.S. Patent Number
5 782 767. Other international patents pending.
This Users Guide is VerathonTM Part No. 0900-0383.
Information in this Users Guide may change at any time without notice. Examples described or illustrated in this
Users Guide are fictitious and do not in any way represent real patient or exam data.
Verathon Inc.
21222 30th Drive SE Suite 120
Bothell WA 98021
800.331.2313 (US and Canada only)
425.867.1348
Fax: [phone]
Verathon Medical (Europe) B.V.
Boerhaaveweg 1
3401 MN IJsselstein
The Netherlands
+31.30.68.70.570
Fax: [phone]
Verathon Medical (Japan) K.K.
Executive Tower Azabudai 7F
1-4-3 Azabudai
Minato-ku
Tokyo Japan 106-0041
+81.03.3560.3501
Fax: [phone]
Verathon Medical (United Kingdom) Ltd.
The Granary Manor Farm Courtyard
Aston Sandford Aylesbury
Buckinghamshire HP17 8JB
United Kingdom
+44.1844.299.207
Fax: [phone]
Verathon Medical ( rance) Sarl
BP 10039
F-67012 Strasbourg Cedex
France
+33.03.88.60.14.12
Fax: [phone]
For additional contact information please visit our website at www.verathon.com.
0900-0383-09-60
BVI 3000 Operators Manual 31

BVI 3000 Operators Manual 3
Table of Contents
I portant Infor ation .................................................4
BladderScan® BVI 3000 Co ponents................................5
Description of the BladderScan® BVI 3000 .........................6
Preparations for Use ..................................................... 7
Custo izing the BladderScan® BVI 3000 ........................9
Operating the BladderScan® BVI 3000.......................11
Verifying Ai ................................................................... 13
Printing Results ............................................................. 15
Histogra of Cost Savings ........................................ 16
Adding a Patient ID Nu ber and Notes ...............17
Print Options ..............................................................18
Adjusting Preferences...................................................19
Additional Features ......................................................... 21
Regular Inspection and Maintenance ..............................22
Trouble Shooting ............................................................. 23
Warranty and Disclai er Infor ation............................24
Contacting Verathon Inc. ...........................................25
Safety and Perfor ance Su ary .................................. 26
Parts and Accessories .................................................. 27
Technical Description....................................................... 27
Technical Description: Battery Charger ........................... 29
Sy bol Directory ............................................................. 30
30 BVI 3000 Operators Manual
The power supply is designed to operate with free air convection.
The earth terminal provided in this unit is a functional earth terminal as
indicated by the ground symbol on the unit. It is not utilized in the power
supply to provide earth protection. Various ground options are available upon
request.
The fuses used in the power supply are rated at 250V AC 2A quick acting.
No cleaning is needed. If desired a dry or slightly damp cloth may be used to
clean the surface of the power supply while it is disconnected from the AC
source. In no instance should water be allowed to enter the unit.
Earth Ter inal
Fuses
Cleaning
Ventilation
Sy bol Directory
Class II Equipment
Type B applied part. To identify a type B applied part
with IEC-60601-1
Canadian CSA Symbol
CE mark in accordance to the Medical Device Directive
Attention, consult accompanying documents
Battery Pack Reference Part Number
Ambient Temperature, storage conditions
Atmospheric Pressure, storage conditions
Ground Symbol, Earth Terminal
#400-0039
Relative Humidity, storage conditions
Technical Description: Battery Charger (continued)

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.
I portant Infor ation
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.
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  in this manual.
Caution: United States Federal law restricts this instrument to use by or on
the order of a physician.
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 B I 3000 instrument
is used in the presence of flammable anesthetics.
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 reflection.
Accuracy may be affected for patients with ascites or free floating fluid in the
peritoneum.
State ent of
Prescription
Biological Safety
Notice To All
Operators
Product Description
State ent of
Intended Use
Cautions
BVI 3000 Operators Manual 29
4 BVI 3000 Operators Manual
Technical
Docu entation
Certification
Technical Description: Battery Charger
Environ ental
Conditions For Use
Technical
Specifications
Verathon Inc. upon written request will make available circuit diagrams and
other technical documentation which will assist the user's appropriately qualified
technical personnel to repair this equipment. This information is deemed
confidential and proprietary and its use is limited solely to such repair
applications. Repair should be performed only by VerathonTM or a VerathonTM
authorized service organization.
The battery charger used with the BVI 3000 is tested to IEC 601-1 requirements
and is in compliance with UL and CSA equivalent standards.
The power supply is not intended for direct patient contact. The batteries used
in the BVI 3000 are charged separate from the control unit and not during
patient use.
The BladderScan® power supply is designed to operate under the following
conditions:
Input Voltage: 100-120V AC/North American (LZA-) units 200-250V
AC/European (LZE-) units 100-250VAC/Universal (LZU-) units.
Input frequency: 50-60Hz.
Input Current: 0.39A/North American (LZA-) units. 0.25/European (LZE-) units.
0.38A/Universal (LZU-) units.
Output: No load to full load at rated voltage. Refer to unit label.
Input Connection: The power supply employs a direct plug in AC prongs for
wall plug in units.
Insulation: The power supply is Class I with basic insulation to each terminal.
 Indoor use
 Temperature from +10 to +40 degrees Celsius
 Transient overvoltage: Category II
 Pollution degree II
 Atmospheric pressure 70 hPa to 106 hPa
 Relative humidity 30% to 75% non-condensed
Battery Charger
The battery charger (Verathon Part No. 400-0036) can be used with an input
of 100-250V~ sat 47 to 63 Hz. Its output is 9v at 1Amp.
Use only the battery charger supplied. Use of any other charger may damage
the battery pack.

Given the tremendous variation of healthy and compromised human anatomy
a guaranteed accuracy specification for the instrument used on humans would
be difficult. For this reason the following accuracy specification assumes
usage per instructions scanning a VerathonTM Tissue Equivalent Phantom:
Bladder Volume Range: 0 to 999 ml
Accuracy: 0 to 699 ml ± 20% ± 20 ml
700 to 999 ml ± 25% ± 25 ml
BVI 3000 Operators Manual 5
BladderScan® BVI 3000 Co ponents
Battery
Eject Button
Battery
On/off
Switch
Buttons
Back Light
Sensor
Scanhead
Input Socket
Manual
Paper Roller
Printer/Paper
Print Head
Release Lever
Scan
Button
Scanhead
28 BVI 3000 Operators Manual
Avoiding or
Identifying and
Resolving Adverse
Electro agnetic
Effects
Clock/Calendar
Scanning Accuracy
Environ ental
Conditions for
Storage
Environ ental
Conditions for Use
Ambient temperature from -20 to +60 degrees Celsius
Relative humidity of 20% to 95% non-condensing
Atmospheric pressure from 500 hPa to 1060 hPa
Ambient temperature from +10 to +40 degrees Celsius
Relative humidity of 30% to 75% non-condensing
Atmospheric pressure from 700 hPa to 1060 hPa
The internal clock is accurate to better than one minute per month at 25 degrees
Celsius. It will operate for at least 10 years from an internal lithium battery. It
knows the number of days in each month and will correctly handle February
in a leap year.
There are no restrictions for the use of the BladderScan® BVI 3000 due to its
electromagnetic characteristics. Both the emissions from the BVI 3000 and
the susceptibility of the BVI 3000 to interference from other sources are within
prescribed limits of all applicable standards at the date of manufacture. The
emissions test procedure used is that specified in EN55011: 1991 for Group 1
Class A equipment (per EN60601-1-2 36.201.1.7). The BVI 3000 is suitable
for use in ISM (industrial scientific and medical) environments and in domestic
environments under the jurisdiction of a health care professional. An indication
of adverse electromagnetic effects from the BVI 3000 on another electronic
device would be a degradation of performance in that other device when the
BVI 3000 is operated simultaneously. If such interference is suspected separate
the two devices as much as possible or discontinue simultaneous operation
if practical and contact VerathonTM.
The BVI 3000 will operate normally in the proximity of other potential
interference sources and has demonstrated immunity at a field strength of 3
V/m (per EN60601-1-2 36.202.2.1). In addition the BVI 3000 detects outside
interference and will display RESCAN instead of a volume measurement if
detected interference is of sufficient magnitude to possibly compromise
measurement accuracy. If this RESCAN display occurs repeatedly attempt
to locate and disable or remove the interference source or use the BVI 3000
away from the interference source. If these efforts do not restore normal
operation contact the distributor.
No other precautions need be taken regarding exposure in reasonably foreseeable
environmental conditions to magnetic fields pressure or variations in pressure
acceleration or thermal ignition sources.
Note: The accuracy that an
individual achieves using the
B I 3000 depends on properly
aiming the scanhead so that the
bladder falls entirely within the
measurement cone.
Technical Description (continued)

The ultrasound output parameters of the BVI 3000 are as follows:
Temporal Average Power: 1 mW maximum
Focal 20 dB Beam-Area: 1.4 cm2
Transducer Dimension: 3 mm diameter
Working Frequency: 2 MHz
Peak Instantaneous Intensity: 14 W/cm maximum
Pulse Repetition Frequency: 180 pulses/second
Technical performance assessment (for example in an acoustic laboratory) may
require partial immersion of the scanhead. Immerse the black plastic dome no
further than the point at which it connects to the black body.
VerathonTM certifies that the BladderScan® BVI 3000 is in compliance with all applicable
international and national standards and regulations including but not limited to IEC-
601-1 (EN60601-1) and EN 60601-1-2; MDD 93/42/EEC Annex 1 CSA22.2 No. 125
(Risk class 2) (LR 76129-1) and UL544. Per the provisions of IEC-601-1 this device
is classified as:
Protection Class II, INTERNALLY POWERED EQUIPMENT
TYPE B , suitable for CONTINUOUS USE
Per the MDD the BladderScan® BVI 3000 is a Class IIa device.
2
Technical Description
Co pliance with
Standards
Scanning
Specifications
Description of the BladderScan® BVI 3000
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.
The BladderScan® BVI 3000 consists of 4 main components: The Scanhead
Control Unit Rechargeable Battery and Battery Charger.
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
BladderScan®. 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 page 7).
BVI 3000 Operators Manual 27
6 BVI 3000 Operators Manual
Parts and Accessories
Part Number Description
0570-0090 BVI 3000 Instrument
0570-0091 Dome Scanhead Assembly
0400-0036 Battery Charger
0400-0039 Battery 7.2V
0800-0166 Carrying Case
0800-0167 Rolling Cart
0800-0005 Acoustic Coupling Gel 0.25 liter
0800-0042 Printer Paper (5 rolls)
0800-0225 Sontac Gel Pad Qty. 50
®
0900-0383 Operator's Manual
0900-0396 Training Video

Preparations For Use
Connecting the
Scanhead
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.
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 there is a click. To remove
the plug grasp the black plastic ring and pull straight out. Do not twist.
Charging
Batteries
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 BladderScan® 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.
Note: The battery life is
extended if you wait for about
three hours until the battery is
fully charged. VerathonTM
recommends that you store
your spare battery in the
charger to prevent instrument
downtime due to discharged
batteries.
BVI 3000 Operators Manual 7
26 BVI 3000 Operators Manual
 The BVI 3000 computes the volume of the urinary bladder based upon twelve
cross-sectional ultrasound images. For maximum accuracy be sure to hold the
scanhead motionless while scanning.
 The most accurate measurements are obtained when the patient rests quietly in
the supine position.
 Accuracy is compromised if the user does not obtain an optimal repeatable image.
 Errors in usage tend to result in the underestimation of bladder volume except
in cases where the scanhead is moved during scanning. In this case the
measurement may overestimate the patients bladder volume.
 The BladderScan® BVI 3000 is not intended for use on pregnant patients.
 The patient being scanned should not have a catheter in his or her bladder. This
could create micro bubbles in the bladder which affect the accuracy of the
measurement.
 Do not use the BVI 3000 on patients with open skin or wounds in the suprapubic
region.
 Use care when scanning suprapubic and pelvic surgery patients. Scar tissue
surgical incisions sutures and staples can affect ultrasound transmission and
reflection.
 To conserve power the BladderScan® BVI 3000 turns off automatically when
not in use.
 We recommend that new operators first use the BVI 3000 on patients with
moderately full bladders rather than initially attempting to locate a bladder with
a low volume.
Warning: There is the possible hazard of explosion if the B I 3000 is used in
the presence of flammable anesthetics.
Safety and Perfor ance Su ary
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.

The team at Verathon Inc. is committed to modernizing healthcare delivery by putting patients first. Our products support
healthcare professionals by providing the highest level of accuracy utility and excellence. For additional product and
company information visit the VerathonTM web site at www.verathon.com. If you have any questions or comments about
VerathonTM products and services please contact us at:
Verathon Inc. E-mail:
21222 30th Drive SE, Suite 120 [email protected]
Bothell, WA 98021
800.331.2313 US and Canada only)
425.867.1348
Fax: [phone]
Verathon Medical (Europe) B.V. E-mail:
Boerhaaveweg 1 [email protected]
3401 MN IJsselstein
The Netherlands
+31.30.68.70.570
Fax: [phone]
Verathon Medical (Japan) K.K. E-mail:
Executive Tower Azabudai 7F [email protected]
1-4-3 Azabudai
Minato-ku
Tokyo, Japan 106-0041
+81.03.3560.3501
Fax: [phone]
Verathon Medical (United Kingdom) Ltd. E-mail:
The Granary Manor Farm Courtyard [email protected]
Aston Sandford, Aylesbury
Buckinghamshire, HP17 8JB
United Kingdom
+44.1844.299.207
Fax: [phone]
Verathon Medical ( rance) Sarl E-mail:
BP 10039 [email protected]
F-67012 Strasbourg Cedex
France
+33.03.88.60.14.12
Fax: [phone]
The battery icon located in the upper-right corner of the BladderScan® LCD
screen indicates the power status of the battery currently installed in your
instrument. Read the battery icon as follows:
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.
Battery Icon
Battery Care
When the battery has been properly charged install it in the BVI 3000 as
demonstrated in the illustration below.
Installing a Battery
Battery release button
To re ove the battery, push the battery release button.
Preparations For Use (Continued)
BVI 3000 Operators Manual 25
8 BVI 3000 Operators Manual
Contacting Verathon Inc.
A fully darkened battery icon indicates that the
battery is fully charged and ready for use.
A battery icon that is almost full indicates a
partially discharged battery.
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.
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.
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.
0%
25%
50%
75%
100%

 Use the arrow right and arrow down buttons to highlight the first
character you want to enter. (To move horizontally press the arrow right
button. To move vertically press the arrow down button).
 When you have highlighted the desired character 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 finished press DONE to return to the Main Menu. The
programmed facility name will now be displayed on the Main Menu screen.
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 follow
these steps:
 Turn the BVI 3000 on by pressing the button marked:
VerathonTM warrants the BladderScan® BVI 3000 against defects in material
and workmanship for one (1) year from the date of purchase from Verathon
Inc. This warranty is given only to the original purchaser of the BladderScan®
instrument.
Pursuant to this warranty a service center authorized by Verathon Inc. will
repair or replace products which prove to be defective during the warranty
period.
This warranty does not cover equipment sold as used.
This warranty does not apply if the product has been damaged by misuse or
as the result of service or modification by anyone other than a service center
authorized by VerathonTM. The instrument shall be used in accordance to the
instructions contained in this Operators Manual.
Consumable items shall be used in conformance with VerathonTM product
specifications. Consumable items are not covered under this warranty.
Warranty conditions may differ in some countries. Contact your local distributor
for warranty terms.
Warranty extensions are available. For more information please talk to your
local Verathon MedicalTM representative or contact the Verathon MedicalTM
Customer Care department using the contact information on page 25.
Progra ing the
Facility Na e
Custo izing the BladderScan® BVI 3000
.
There are no understandings agreements representations of warranties expressed
or implied (including warranties of merchantability or fitness for a particular
purpose) other than those set forth in the preceding Warranty section. The
contents of this Operator's Manual do not constitute a warranty.
Some states disallow certain limitations on applied warranties. The purchaser
user and patient should consult state law if there is a question regarding this
disclaimer.
The information descriptions recommendations and safety notations in this
Operator's Manual are based upon VerathonTM experience and judgment as of
August 2006 with respect to the BladderScan® BVI 3000 instrument. This
product involves a relatively new area of medical technology. The contents of
this Operator's Manual should not be considered to be all inclusive or covering
all contingencies.
The physician(s) at your institution directing the use of the BVI 3000 instrument
is responsible for keeping current with developments in the literature on bladder
volume. Please direct any questions or problems concerning bladder volume
the use of the instrument or interpretation of data to the responsible physician(s).
Warranty
Disclai er of
Additional Warranties
Warranty and Disclai er Infor ation
BVI 3000 Operators Manual 9
24 BVI 3000 Operators Manual
 On the Main Menu screen press the ALT button to display the Alternate
Menu screen illustrated below.*
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 B I
3000.
Note: You can use the empty
character as a space to
separate words.
 Press the NAME button. The Name Preset screen with a 4 x 13 grid containing
alphabetic numberic and punctuation characters is displayed.
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 first character again.
Erase Sel Done
# $ ( ) - ; : . ,  /
A B C D E F G H I J K L M
N O P Q R S T U V W X Y Z
1 2 3 4 5 6 7 8 9
Note: Diagnostic Ultrasound Corp.
is now called erathon Inc.
*Important: If your B I 3000 came with the PIN code option enabled, you
must enter your PIN code before you can access the Alternate Menu. The
default PIN is 0000. For information about how to personalize the PIN
code, see the section titled, Adjusting Preferences, in this manual.
SELECT ITEM TO PRESET
Copyright 2002 by
Diagnostic Ultrasound Corp.
Na e Date Ti e Pref Self Test
Ver: x.xxx
Box ID: nnnnnnn

 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 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.
 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 B I 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.
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: 3:00pm + 12
hours = 15:00 hours).
Setting the Ti e
MM DD YY DONE
MM / DD / YY
Setting the Date
Custo izing the BVI 3000 (Continued)
Disengaged Print
Head
Too Hot
Clearing Paper Ja
If the instrument does not turn on this is usually due to a dead or discharged
battery and can be fixed simply by replacing the dead battery with a charged
one. Check the battery icon in the upper-right corner of the LCD screen. If the
battery icon is clear (empty) replace the battery.
When the battery charge is too low to allow normal operation (but not too low
to permit operation of the internal circuitry) the BVI 3000 displays the following
message: BATTERY CHARGE LEVEL IS TOO LOW FOR INSTRUMENT
OPERATION. RECHARGE BEFORE NEXT USE. In this event the battery
must be recharged or replaced with a charged one.
The BVI 3000 detects the presence of a scanhead.
If no scanhead is connected when a scan is
attempted the instrument displays this image:
 When the scanhead is connected this image disappears and you can proceed
to perform a scan.
The BVI 3000 senses the presence of paper and automatically
displays this image when the printer is out of paper:
 For instructions on how to load the paper see the section titled Loading
Paper  in this manual.
The BVI 3000 senses when the print head is disengaged and
displays the following image until the print head release lever
is positioned up as far as it can go:
The BVI 3000 displays the message TOO HOT if the print head overheats.
When this message appears turn off the BVI 3000. This condition may be the
result of a paper jam (see the following section for more information).
If the paper will not advance through the printer lower the print head release
lever (located adjacent to the paper advance thumb wheel). Gently pull the
paper backward while moving the thumb wheel counterclockwise to clear the
paper jam.
Caution: If the paper jam is inaccessible, do not try to disassemble the printer.
Contact your authorized erathonTM Service Center or your local erathonTM
distributor for service.
Instru ent Does
Not Turn On
Battery Recharge
Message
No Scanhead
Message
No Paper
Trouble Shooting
BladderScan
BVI 3000 Operators Manual 23
10 BVI 3000 Operators Manual
 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.
HH HH MM MM Done
16:45
 Press the HH or HH to set the hour.
 Press the MM or MM buttons to set the minutes.
 When the time is set press DONE to return to the Main Menu screen.
You have now customized your BladderScan® B I 3000 instrument.

Monthly Accuracy
Check
VerathonTM recommends that the BVI 3000 be certified by an authorized
VerathonTM Service Center once a year. Certification service includes a
comprehensive inspection and testing of the instrument to ensure accurate
measurement performance. For more information please contact your VerathonTM
Service Center or your local VerathonTM distributor.
Once a week you should inspect the scanhead and cable for physical faults or
cracks. Cracks that allow the leakage or ingress of fluid may affect the performance
of the instrument. Any apparent faults or cracks must be referred to your authorized
VerathonTM Service Center or your local VerathonTM distributor.
Each month or whenever accuracy assessment is desired the accuracy of the
BVI 3000 should be tested using the following procedure:
 Take a pre-void measurement of bladder volume.
 Void or catheterize into a measurement beaker.
 Take a post-void measurement of bladder volume to check for post-void
residual (PVR).
 Subtract the post-void measurement from the pre-void measurement and
compare to the voided volume.
 The measured volume should be within a range of ± 20% ± 20ml of the
voided volume for volumes less than 699ml or ± 25% ± 25ml for volumes
larger than 699ml.
The BVI 3000 instrument may be cleaned with a soft cloth dampened in
isopropyl alcohol.
The round black plastic dome of the scanhead can be disinfected with any
liquid disinfecting agent suitable for use with LEXAN polycarbonate. In the
United States Cidex and Cidex 7 are FDA-cleared for this purpose. Follow the
instructions provided by the manufacturer of the disinfecting agent.
Do not immerse any part of the scanhead or the control unit in a cleaning or
disinfecting solution.
Do not use Cidex Plus as it is not recommended for use with LEXAN
polycarbonate.
Do not subject any part of the BVI 3000 instrument to steam sterilization or
ethylene oxide sterilization.
Changing gel pads between patients is strongly recommended.
Caution: In the event of
changes in the performance of
the instrument, discontinue use
and contact your authorized
erathonTM Service Center or
your local erathonTM
distributor.
Regular Inspections and Maintenance
Weekly Inspections
Care, Cleaning
and Disinfecting
22 BVI 3000 Operators Manual
irst Time Users: We advise 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 BladderScan® use.
 Turn on the BVI 3000 by pressing the button marked:
The Main Menu screen is displayed.
Operating the BladderScan® BVI 3000
 From the Main Menu press the SCAN button to go to the Scanning screen.
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
BVI 3000 Operators Manual 11
Turning On
 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 B I
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
erathonTM Service Center
calibrates the insturment.
Press OK to continue.
Done Scan
READY TO SCAN
BVI 3000
NOT INTENDED FOR FETAL USE
Facility Name
02 11 00 14:47
Scan Alt Print Notes
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.
M F

Additional Features
To perform an instrument test go to the Main Menu and press the ALT button
(then enter PIN code if required) to access the Alternate Menu. From the
Alternate Menu press the SELF TEST button. The instrument then performs
the following tests:
ROM TEST - Program Memory
BUS TEST - Microprocessor Bus
NVRAM TEST - Non-Volatile Battery Backed Memory
SRAM TEST - Main Memory
FLASH TEST - Flash Memory
Self-Test
BVI 3000 Operators Manual 21
Measuring Bladder
Volu e
The Sontac® Ultrasound Gel Pad is a convenient and easy-to-use coupling
medium designed for use with the BladderScan®. To apply the Sontac®
Ultrasound Gel Pad peel back the foil lid of the individual gel pad package
exposing the gel pad. Palpate the patients symphysis pubis (pubic bone)
and place the Sontac® Gel Pad immediately superior to the patients symphysis
pubis as shown in the images below.
.
®
Sometimes it may be necessary to use liquid ultrasound transmission gel
(for example on obese patients or patients with excessive amounts of body
hair). When using liquid ultrasound transmission gel apply a generous
amount on the round dome of the scanhead. Smooth the gel out and remove
any air bubbles which may block ultrasound transmission.
 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.
 Palpate the patients symphysis pubis and place the scanhead midline on
the patients abdomen approximately 1.5 inches (4 cm) superior to the
symphysis pubis (see illustrations below). Or if using Sontac® Gel Pads
simply place the scanhead on the gel pad.
 Aim the scanhead so 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 scanplane. When you hear a beep the scan is complete. The Aiming
screen is then displayed.
Applying the
Sontac
Ultrasound Gel
Pad
Operating the BVI 3000 (Continued)
Note: While scanning, avoid
making any changes in the
position, angle or pressure of
the scanhead.
Figure 1 Figure 2 Figure 3
Using Ultrasound Gel
12 BVI 3000 Operators Manual
Scanhead
Patients
Feet
Patients
Head
Scanline Scanline
Bladder
View fro the
Patients Right Side
Sy physis
Pubis
Patients
Right
Scanline Scanline
Scanhead
Bladder
View fro the
Patients Feet
Icon
Scan
Button

BVI 3000 Operators Manual 13
The Ai ing Icon
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.
Ai ing Screen
Verifying Ai
The BVI 3000 always displays two volumes; the largest volume measured
and the current volume.
We recommend 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.
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).
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.
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.
Largest Volu e and
Current Volu e
Adjusting Ai
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.
Parameter
ADD_WALLS (default)
UTI_cost
Printout
RAW_ONLY
WALLS_ONLY .
UTI_rate 0-100 (default=3%)
Cath_cost 0-20 (default=$3)
Cath_vol
lash ON (default)
OFF
Contrast Adjust 30-63 (default=57)
NO_IMAGES
ADD_WALLS = Print grayscale B-mode images with bladder
walls highlighted.
NO_IMAGES = Do not print any B-mode images.
RAW_ONLY = Print grayscale B-mode images without identifying
bladder walls.
WALLS_ONLY = Bladder outline only.
Percentage of catheterizations which result in UTI; used in cost
savings calculations.
Cost of a catheter; used in cost savings calculations.
0-1000ml (default=300ml) Bladder volume below which catheterization is unnecessary; used
in cost savings calculations.
ON = Flash memory is enabled and scans are saved even if power
is removed.
OFF = Scan information is not retained if unit is turned off; however
processing time is slightly faster.
Adjust display contrast ratio; the higher the value the darker the
background.
Note: An immediate effect is seen only when adjusting the contrast
value up. Adjusting contrast down is not visible until the instrument
is turned off and then on again.
0-2000 (default=$680) Cost to treat a UTI; used in cost savings calculations.
Figure 1
175 ml
READY TO SCAN
CURRENT=175ml
Done Scan X
20 BVI 3000 Operators Manual
12_PLANES 12 PLANE = All 12 scan planes printed as in the ADD_WALLS
mode.
Time Zone GMT ± 0-12
Currency $  £ ¥ (default=blank)
This function currently not used.
Set the currency for calculating cost savings. Choose US dollars
Euros Pounds or Yen. When a different currency is selected
calculations are not affected.
Scan Count
Screen
# of scans performed Selecting this option allows the user to monitor instrument usage.
There are two scan counters; one is resettable and one is not. Press
Clear Count to reset the resettable counter to zero. Only a
qualified VerathonTM Service Center can reset the non-resettable
counter to zero.
Reset Histogram
Change PIN Selecting this option takes the user to a separate screen to personalize
or change the PIN code. The current PIN is displayed. Enter a new
PIN and then press DONE.
Important: Remember your PIN code. If your existing PIN is
forgotten, only a qualified erathonTM Service Center can reset the
PIN code.
Allows the user to reset the histogram to begin a new analysis of
cost savings.
Range & Values Description

The Scan
Results Screen
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 field 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 field
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.
When you are satisfied that the scanhead was aimed properly and the measured
bladder volume is accurate press the DONE button. A Scan Results screen is
then displayed.
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
field 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 field 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.
Verifying Ai (Continued)
Adjusting Ai
(Continued)
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.
14 BVI 3000 Operators Manual
Various BVI 3000 operating parameters can be customized for individual use
via the preference screen. To access the Preference screen and adjust your
instrument settings go to the Main Menu and then press ALT to access the
Alternate Menu. (If required enter your PIN code to access the Alternate Menu.
See the section below titled The PIN Code Option  for more information.)
Then press the PREF button.
On the Preference screen a list of adjustable parameters is displayed. Use the
SEL and SEL buttons to select a parameter. Use the + and - buttons
to adjust the parameter value. Press DONE to save the new setting. For a
description of the adjustable parameters see the table below.
BVI 3000 Operators Manual 19
Adjusting Preferences
Adjusting
Preferences
If the PIN code option is enabled users must enter a PIN code in order to
access the Alternate Menu and change instrument settings. This prevents
unauthorized users from changing the instrument settings. The default PIN
code is 0000. Enter this default code the first time you access the Alternate
Menu.
To personalize your PIN code select the change PIN option on the Preference
screen. The current PIN is displayed. Enter a new PIN and then press DONE.
Important: Remember your PIN code. If your existing PIN code is forgotten,
only a qualified erathonTM Service Center can reset the PIN code.
Parameter
Backlight AUTO (default)
ON
OFF OFF = Backlight always off.
ON = Backlight always on.
AUTO = Backlight turns on and off automatically depending on
ambient light conditions.
Beep Volume 0-9 (default=5) Allows user to adjust sound volume (lower values are quieter).
PORTUGUESE
ITALIAN
FRENCH
GERMAN
Language
SPANISH
SWEDISH
NORWEGIAN
TURKISH
ENGLISH (default)
DANISH
DUTCH
Specifies the language which will be used on the display and local
printout.
Date MM/DD/YY (default)
DD/MM/YY
YY/MM/DD
Allows the format in which the date is displayed (order of month
day and year) to be adjusted.
Figure 2
Figure 3
22 cm224 cm2
175 ml
Print Scan Notes Main
Note: If your B I 3000
came with the PIN code
option enabled, you must
enter your PIN code before
you can access the Alternate
Menu.
The PIN Code
Option
FINNISH
(continued on next page)
Range & Values Description
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.
Personalizing
the PIN Code

BVI 3000 Operators Manual 15
Note: If the facility name,
date, and time have not been
set, those lines will be skipped
on the printout. The B I 3000
prints on thermal paper. Over
time, the thermal printout will
fade. For maximum storage
life, we recommend that you
photocopy the printout.
If a printout of the scan result is desired press the PRINT button to open the
Print Menu. The Print Menu is 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.
More information about printing can be found in the Print Options section
of this manual. During printing the message Printing in Progress  is displayed.
If you need to stop a print in progress press the ABORT PRINT button.
Printing Results
TEAR TO BACK
The BVI 3000 has an automatic paper loading mechanism. To load a new roll
of paper open the paper well door at the top of the instrument and insert the
end of a new paper roll with the thermal side down into the paper input slot.
The BVI 3000 senses the presence of the paper and feeds automatically (paper
is forwarded through the paper eject slot in the top of the instrument).
It is important that you feed a straight edge into the paper feed mechanism.
Cut off the first inch of a new paper roll before loading the paper.
Caution: To avoid paper jams, never fold the end of the paper roll or cut it
diagonally or to a point.
Caution: If the paper does not advance, or it appears to be stuck in the printer,
turn off the instrument. Lower the printhead release lever, located adjacent to
the paper advance thumb wheel. Gently pull the paper backward while moving
the thumb wheel counterclockwise. If the paper jam is inaccessible, contact
your authorized erathonTM Service Center or local erathonTM distributor for
service.
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.
Print Options
Tip: To verify that you are
loading the paper with the
thermal side down, flick your
nail over the paper. If a black
mark appears, this is the thermal
side.
Loading Paper
18 BVI 3000 Operators Manual
Option
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.
Last Image
Test Print
Cost Savings
Print Sel Done
igure 4
BladderScan®
User Name (27 Chars Max)
MM-DD-YY
HH:MM
Bladder Volume = XXXml
Male/Female Patient Name:
Patient ID:
Procedure Code:
Signature:
Longitudinal Axis Area
L = XX cm2
Horizontal Axis
Area H = XXcm2
Description

16 BVI 3000 Operators Manual
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 100ml 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 200ml.
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)
Histogra of Cost Savings
Note: The default settings
can be changed in the
Preference screen to reflect
the rates and costs at your
facility. For more
information, see the section
titled, Adjusting
Preferences, in this manual.
Note: For reference articles
on UTI Rate and UTI Costs,
see the section titled, For
Further Information, in
this manual.
igure 5 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 100ml 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 100ml and 400ml 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 400ml the BVI 3000 assumes
the measurement was taken prior to patient voiding and the bladder was filled 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.
Action Taken
Using the SEL 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
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 10ml). This
value can be adjusted up or down using the buttons labeled + and -.
Adding Notes
BVI 3000 Operators Manual 17
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 marked
with a # symbol on the Scan Results screen. The screen displays 0000000000.
 Use the (arrow left) and (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 (arrow left) and (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 be included on the printout of the scan.
Adding a Patient
ID Nu ber
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
B I 3000 will assume a
patient ID number was
entered and 0000000000
will be printed on the
printout.
Adding a Patient ID Nu ber and Notes
Scans
HISTOGRAM
Volume # of
000-099 870
100-199 1 219
200-299 589
300-399 488
400-499 252
500-599 176
600-699 154
700-799 87
800-899 69
900-999 5
>1000 4
Catheterizations
Avoided: 2089
UTIs Avoided: 63
Savings: $49 107