Verathon 0900-1606-04-20_BVI-9400-User's-Manual Bladder Volume Instrument BVI 9400 User’s Manual and Quick Reference Guide

Bladder Volume Instrument

BVI 9400

User’s Manual and

Quick Reference Guide

Bladder Volume Instrument

BVI 9400

Quick Reference Guide

BVI 9400 User’s Quick Reference

Turn on the BladderScan® BVI 9400
by pressing the POWER ON/OFF button.

Select scanning mode

The BladderScan® BVI 9400 is designed to scan in three patient­specific modes. Select the proper exam mode to ensure the
accuracy of your scan. Simply press the button repeatedly
until the desired setting appears:

Select to scan a male patient, or a female patient who
has had a hysterectomy

Select to scan a female patient who has not had
a hysterectomy

Select to scan a small child under 48 inches (122cm) tall
and weighing less than 60 lbs (27kg)

Savings Calculation

3/21/2007

ate Started

D

Number of Scans 22

th Avoided 15

Ca

0

UTI Avoided

$1500

Savings

Savings Calculation

Date Started 3/21/2007
Number of Scans 22
Cath Avoided 15
UTI Avoided 0
Savings $1500

Female button

On/Off button

With the patient supine, apply gel

Have the patient lie in t he supine position with abdominal
muscles relaxed.

Palpate the patient's symphysis pubis (pubic bone). Place
an ample quantity of gel (with as few air bubbles as possible)
midline on the patient's abdomen, approximately one inch
(3 cm) above the symphysis pubis.

Aim toward the bladder

Standing at the patient’s right side, place the Probe on the
gel and aim toward the expected location of the bladder.
For most patients, this means tilting the Probe slightly
toward the patient's coccyx (tailbone) so the scan clears
the pubic bone.

Press the SCAN button

Press the SCAN button, located on the underside of the Probe.
As the scan progresses, sections of the bladder will appear on
the console screen. When you hear the end-scan tone, the
scan is complete.

Scan button

verathon.com https://my.scanpoint.com

For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical representative. BladderScan, ScanPoint, and Verathon are
trademarks of Verathon Inc.

©

2008, 2012 Verathon Inc.

BVI 9400 User’s Quick Reference

Verify the scan

If the scan is “on target” all 8 arrows will flash on the Probe
screen, and the bladder will be shown in the center of the
crosshairs on the Console screen. Since no re-aiming is
needed, no arrows will appear on the Console screen.

Re-aiming

If the scan is “off target” the Probe will show an arrow
indicating the direction to move the Probe to be “on target.”
If the arrow is solid, it means you are slightly “off target.”
If the arrow is flashing, it means you are significantly “off
target” and must re-aim and re-scan. On the Console, the
bladder will not be on the crosshairs, and there will be an
arrow pointing in the direction for re-aiming.

To re-aim

To re-aim, note that the small dot at “6 o’clock” on the
Console target represents the feet of the patient. The
“12 o’clock” position represents the head of the patient
and the upper left quadrant (9-12 o’clock) represents the
right shoulder of the patient. This orientation should help
you in re-aiming the Probe to capture the complete bladder
in the ultrasound “cone.”

Right

shoulder

Head

Feet

Pubic Bone

You may also see a screen that indicates the pubic bone is
“inside” the ultrasound cone. If this occurs, you may want
to re-aim and re-scan. Although the bladder may be shown
as centered in the ultrasound cone, and your measurement
could be complete, there is a possibility that the pubic bone
is obscuring some of the bladder. By re-aiming, you can
ensure you have captured the bladder fully inside the
ultrasound cone.

Save, review a nd print exam results

To save the exam, you must annotate it.
To annotate, press and release the RECORD button on the

Console. When you see the RECORD button icon turn to a STOP
button icon, record your patient information by speaking into
the Probe microphone. Press the STOP button on the Console.
When the hourglass icon disappears, press the LISTEN button to
replay the annotation.

To review the images of your scan, press the REVIEW button

(you must first save the exam before you can review it).

To print exam results via on-board printer, press the PRINT

button.

To perform another exam, press the HOME button.

Record Print Listen Review Home

On/Off button

Finish exam

Once you have completed the scan, wipe the ultrasound gel off the patient and the Probe.

®

For ScanPoint

subscribers, logging on to ScanPoint®automatically transfers and saves your annotated exams.

Pubic
bone

0123

To order additional rolls of paper (0800-0319) or batteries (0400-0066), contact Customer Care at 800.331.2313.

verathon.com https://my.scanpoint.com

For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical representative.
Verathon Corporate Headquarters: 20001 North C reek Parkway, Bothell, WA 98011, USA. Phone: [phone]
VM Europe B.V.: Linnaeusweg 11, 3401 MS IJsselstein, The Netherlands, Phone:[phone]

0900-1446-05-60

BVI 9000 Series Calibration Quick Reference

The entire calibration process may take up to 15 minutes. You may calibrate your instrument as often as you like; you do not have
to wait for the next scheduled calibration date. However, at a minimum, you must calibrate the instrument every 12 months.

Note: ScanPoint® with QuickPrint is required to calibrate your BladderScan® instrument online. Online calibration is not supported

®

by ScanPoint

LC.

Prepare for Calibration

Set up the calibration tank in a location that is within
10 feet of the Battery Charger/Wireless Hub.

Place the calibration tank on a flat, nonreflective surface and
remove the lid. Pour clean, room temperature water into the
container, filling to the indicator mark. Make sure the water
contains a minimal amount of bubbles. Place the spiral­shaped target in the container, using the notches to position
target correctly. Replace the lid on the calibration container.

Place the probe

Place the Probe in the cutout in the top of the calibration
tank. Make sure the black tip of the Probe is submerged
in the water.

Open ScanPoint

®

with QuickPrint

From your desktop, open ScanPoint® by double-clicking
the ScanPoint® with QuickPrint icon.

Savings Calculation

Date Started 3/21/2007

Number of Scans 22

Cath Avoided 15

UTI Avoided 0

Establish BladderScan

®

- QuickPrint

connection

ScanPoint

button

®

Savings $1500

Press the ScanPoint® button on the BladderScan®
instrument.

On the QuickPrint screen, click the FIND NEW button.
When QuickPrint establishes a connection with the

®

BladderScan

instrument, an icon for that device will

appear along the left menu.

www.verathon.com https://my.scanpoint.com

For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical representative. BladderScan, ScanPoint and Verathon are
trademarks of Verathon Inc.

©

2009, 2012 by Verathon Inc.

BVI 9000 Series Calibration Quick Reference

Calibrate instrument

From the Tools menu, select Calibrate Instrument. When
the Calibration screen opens, click the CALIBRATE button.
ScanPoint® then automatically scans and analyzes the
calibration target.

IMPORTANT! Do not remove the Probe from the calibration
chamber until four arrows appear on the Probe’s LCD
screen. Do not disconnect the Charger and Wireless Hub
from the computer or otherwise break the connection
between the BladderScan
host computer until all processing is complete.

®

instrument and the ScanPoint

Successful calibration

If ScanPoint® was able to locate the calibration target,
the instrument analyzes the scan data to ensure that it
meets the calibration parameters. If necessary, the
instrument automatically rescans the phantom. When
calibration is complete, a ‘Calibration Successful’ message
is displayed on your computer.

To print a record of the calibration, click: Click Here for
Printable Certificate of Calibration.

Calibrate

®

0123

Failed calibration

If ScanPoint® was unable to locate the calibration target,
it displays an error message and instructs you to ensure
that the calibration chamber has enough water and that
the Probe is seated properly in the calibration system.
You may choose to calibrate again or to quit the
calibration process.

NOTE: If you are unable to calibrate, contact your local
Verathon Medical representative or Verathon Medical
Customer Care at 1.800.331.2313.

End calibration

To terminate the calibration procedure and end
communication with the ScanPoint
CANCEL (X) button on the BladderScan

Remove the Probe from the calibration chamber lid and
dry it with a clean, soft cloth.

To order additional rolls of paper (0800-0319) or batteries (0400-0066), contact Customer Care at 800.331.2313.

www.verathon.com https://my.scanpoint.com

For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical representative.
Verathon Corporate Headquarters: 20001 North Creek Parkway, Bothell, WA 98011, USA. Phone: [phone]
VM Europe B.V.: Linnaeusweg 11, 3401 MS IJsselstein, The Netherlands, Phone:[phone]

®

, press the

®

instrument.

0900-1447-06-60

BVI 9400 Important Information

Intended Use Warnings and Cautions

The BladderScan® BVI 9400 should be used only by individuals who have been
trained and authorized by a physician or the institution providing the patient
care. All users must read the entire BladderScan® BVI 9400 User’s Manual prior
to using the BladderScan® BVI 9400. Do not attempt to operate this instrument
until you thoroughly understand all instructions and procedures in this manual.

Failure to comply with these instructions may compromise the performance of
the device and the reliability of its measurements. For the most current version
of the User’s Manual, please visit the Verathon® Web site at: http://www.
verathon.com, then select the BladderScan® > Customer Support links to open a
link to this manual and other training materials.

Noninvasive, Accurate, Reliable, Easy to Use

CAUTIONS

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.

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® BVI 9400 on a patient with open skin or wounds in
the suprapubic region.

Do not use the BladderScan® BVI 9400 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.

Biological Safety

To date, exposure to pulsed diagnostic ultrasound has not been shown to
produce adverse effects. However, ultrasound should be used only by medical
professionals when clinically indicated, using the lowest possible exposure times
indicated by clinical need. The ultrasound output power of the BladderScan®
BVI 9400 is not user adjustable and is limited to the minimum level necessary
for effective performance. Data on acoustic output levels can be found in the

“Specications” section of the BladderScan® BVI 9400 User’s Manual.

Statement of Prescription

NOTE

0900-2647-02-60

United States federal law restricts the BladderScan® BVI 9400 to use by, or
on the order of, a physician. This statement is required per 21 Code of Federal
Regulations (CFR) 801.109.

It is standard practice to have medical staff authorize the use of the
BladderScan® BVI 9400 within its intended use throughout an institution.
Individual prescriptions for use are not required.

I

BVI 9400 Important Information

Statement of Intended Use

The BladderScan® BVI 9400 projects ultrasound energy through the lower
abdomen of the patient to obtain an image of the bladder which is used to
calculate bladder volume noninvasively.

Noninvasive, Accurate, Reliable, Easy to Use

CAUTION

Observe the following precautions in the safe use and care of the BladderScan®
BVI 9400. Hazardous materials present. Assure proper disposal.
The BladderScan® BVI 9400 and related devices may contain lead, mineral
oils, batteries, and other environmentally hazardous materials. When the
BladderScan® BVI 9400 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.

Assure Proper Computer System Conguration

When using the BladderScan® BVI 9400 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® BVI 9400 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 the Verathon® Customer Care
Department at 1.800.331.2313.

Assure Proper Distance From Patient

The BVI 9400 battery charger/wireless hub and the computer used to access
online ScanPoint™ image archives (if used) must be placed outside the patient
vicinity (more than six feet (2 meters) from the patient). Refer to UL 2601-1

Clause 2 deviation for the denition of patient vicinity.

Contraindications

The BladderScan® BVI 9400 is not intended for fetal use or use on pregnant patients.

Specications - BVI 9400

BladderScan® Bladder Volume Instruments are CE marked in accordance with
the Medical Device Directive, and the Verathon Inc. Quality system is Quality

System Certied to ISA 13485:2003 standards. US 6,884,217 and other US and

International Patents Pending.

Range: Adult bladder volume range: 0 to 999 ml; Small child mode: 0-200 ml

Accuracy: The following accuracy specications assume usage per instructions

and scanning a Verathon® Tissue Equivalent Phantom.

Bladder volume accuracy: +/- 15%, +/- 15 ml

II

BVI 9400 Important Information

Specications - BVI 9400 Continued

Power: 11.1 v Li Battery Pack (2 Supplied). 3.5 hours continuous use on one
charge; Battery indicator

Display: Color LCD

Ultrasound Output Parameters:

• Maximum ultrasound I

• Maximum ultrasound I

• Maximum MI (Mechanical Index): 0.95 max

• Transducer diameter: 13 mm (0.512 inches)

• Transducer resonant frequency: 3.0 MHz and 1.74 MHz

• Transducer bandwidth: 75% at 10 dB

• Time from 3D scan initiation to result display: < 3 seconds

Figure 1. BladderScan® BVI 9400 Controls and Indicators

during a scan: < 5.0 mW/cm

sptad

during a scan: < 60.0 W/cm

sppad

Noninvasive, Accurate, Reliable, Easy to Use

2

2

Main display

Battery
Pack

5 Variable
Function
Buttons

Adjust
Brightness

Console

Power On/Off

Adjust
Volume

Probe (Scan
button on
hand grip)

Battery Status Indicator

Printer (behind display)

Aiming
Display

Microphone
(above display)

Battery Packs

Battery Charger/
Wireless Hub

III

BVI 9400 Important Information

To Charge the Batteries

1. Plug the Battery Charger/Wireless Hub unit into a standard wall outlet.

2. Insert the battery into the recess in the battery charger.

3. Check the colored indicator lights on the battery charger to determine battery
status:

A. Solid green: Battery is fully charged.

B. Amber: Battery is charging.

Noninvasive, Accurate, Reliable, Easy to Use

NOTE

Fully charging the battery may take up to 6 hours.

Batteries may be stored in the charger. There is no danger of overcharging the
batteries.

Time and date settings will be lost if the battery is removed from the instrument

for longer than ve minutes.

Load a Roll of Thermal Paper

To load a new roll of thermal paper:

1. Open the paper compartment door (located on the base of the Console, under
the display).

2. Slide the door to the right, then lift the printer door up.

3. Insert the end of a new paper roll with the thermal side down, into the paper
slot.

To verify which side is the thermal side, scratch the paper with your nger

nail. If a black mark appears, this is the thermal side.

4. Extend the end of the paper past the end of the unit.

5. Rotate the printer door down. Make sure you hear it snap into place.

6. Slide the printer door to the left.

7. Tear the excess paper off.

IV

CAUTION

NOTE

To avoid paper jams, never fold the end of the paper roll or cut it diagonally or to
a point.

If the paper will not advance through the printer, open the printer door on the
back of the Console and clear the paper jam.

BVI 9400 Important Information

To Record a Voice Annotation

After performing an exam, you can record additional information about a patient
to be stored with the exam results.

The instrument can store ten scans with voice annotations, so you can perform
multiple exams on your rounds. If you are using the optional ScanPoint™ with
QuickPrint software, you can upload saved exams to your PC. (Refer to the
ScanPoint™ with QuickPrint User’s Manual for more information).

IMPORTANT!

• If you do not record a voice annotation for a particular exam, that exam will
be lost and the next exam you perform will overwrite the non-annotated one.

• If the instrument battery runs low or the instrument goes into sleep mode,
any non-annotated exam data is lost. However, the instrument does not erase
any annotated exam results when it goes into sleep mode. To make sure you
do not lose any patient data, it is a good idea to add a voice annotation to
every patient exam.

Noninvasive, Accurate, Reliable, Easy to Use

Cleaning the Instrument

To clean the BladderScan® BVI 9400:

1. Use a soft cloth dampened with isopropyl alcohol (or an appropriate hospital
cleaning agent) to wipe the Probe until it is thoroughly cleaned.

2. If you use a detergent solution to clean the instrument, remove all residual
detergent. Dry the instrument with a clean, soft cloth.

3. Alternatively, dampen a soft cloth in any glutaraldehyde-based hospital
disinfectant solution such as Cidex® or Cidex 7® from Advanced Sterilization
Products, or Sporocidin® from Sporocidin International. Wipe the instrument
with the dampened cloth.

4. To remove all traces of disinfectant solution, wipe the instrument with a
clean soft cloth dampened in sterile water or potable tap water. Verathon®
recommends wiping the device three separate times to remove all residual
disinfectant.

5. Thoroughly dry the instrument with a clean, soft cloth before using.

IMPORTANT!

Failure to heed the following warnings may cause device damage not covered by
the BladderScan® BVI 9400 warranty.

• Do not immerse the instrument in disinfectant solution.

• Do not use CidexPlus® to disinfect the instrument. CidexPlus® will damage the

plastic enclosure.

• Do not subject any part of the instrument to steam sterilization or ethylene
oxide sterilization.

V

BVI 9400 Important Information

Regular Inspections and Maintenance

Verathon® recommends that the BladderScan® BVI 9400 be certied by an
authorized BladderScan® Service Center once a year. Certication service
includes comprehensive inspection and testing of the instrument to ensure
accurate performance in clinical use.

For more information, please contact your authorized BladderScan® Service
Center, your local BladderScan® distributor, or Verathon® Customer Care
Department at 1.800.331.2313.

Noninvasive, Accurate, Reliable, Easy to Use

NOTE

ScanPoint™ Online customers can maintain device certication via the Internet
by accessing their ScanPoint™ account. For more information about using
ScanPoint™ Online, please refer to the ScanPoint™ with QuickPrint User’s
Manual.

Weekly Inspections

Once a week, you should inspect the Probe and cable for physical faults or

cracks. Cracks that allow the ingress of uid may affect the performance of the

instrument. Any apparent cracks or faults in the Console, Probe, or the cable that
links the Console and the Probe, must be referred to your authorized

BladderScan® Service Center, your local BladderScan® distributor, your local
Verathon Medical representative, or the Verathon Medical Customer Care
Department.

IMPORTANT!

If you see any physical faults or cracks in the instrument, discontinue use
immediately and contact your local Verathon® representative or the Verathon®
Customer Care Department at 1.800.331.2313.

Calibrating the BladderScan® BVI 9400 Using the ScanPoint™ System

You must periodically calibrate your BladderScan® BVI 9400 to make sure your
instrument is providing the most accurate results. Calibrating ensures accurate
and proper alignment of the instrument’s internal coordinate system. If you do
not perform the calibration by the prescribed date, the instrument can still be
used to take scans but measurements may be compromised. When calibration is
required, a warning appears in the display header.

VI

Device Repair

The BladderScan® BVI 9400, Probe, and Battery Charger/Wireless Hub are
completely sealed. There are no user-serviceable components. Verathon®
does not make available any type of circuit diagrams, component parts lists,
descriptions, or other information that would be required for repairing the device
and related accessories. Premium Warranty customers have access to a loaner
unit, replacement unit, and free shipping options which vary according to plan.
If you have any questions, contact your local Verathon® representative or the
Verathon® Customer Care Department at 1.800.331.2313.

BVI 9400 Important Information

Unit Disposal

The BladderScan® BVI 9400 and related devices may contain lead, mineral
oils, batteries, and other environmentally hazardous materials. When the
BladderScan® BVI 9400 has reached the end of its useful service life, return the
device, Battery Charger/Wireless Hub, and related accessories to a Verathon®
Service Center for proper disposal. Alternatively, follow your local protocols for
hazardous waste disposal.

Symbol Directory

The following table explains the industry symbols used to indicate the
BladderScan® system compliance with international and national standards and
regulations.

Symbol Meaning

Noninvasive, Accurate, Reliable, Easy to Use

Marked in accordance with Directive 2002/96/EC on Waste
Electrical and Electronic Equipment (WEEE) (solid bar
indicates product was put on the market after 13 August

2005).

Protection Class II equipment, internally powered
equipment.

Type BF applied part with EN/IEC-60601-1.

CE marked in accordance with the Medical Device Directive
(MDD).

Canadian Standards Association (CSA) mark of certication

to United States standards for electromedical equipment.

This unit is powered by a Lithium-Ion battery pack. The
Verathon

®

part number for the batter pack is 0400-0066.

VII

No part of this Quick Reference Guide may be copied or transmitted by any method without the express written consent of
Verathon Inc.

BladderScan, NeuralHarmonics, ScanPoint, and Verathon are trademarks of Verathon Inc. © 2009, 2013 Verathon Inc.

Bluetooth® word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Verathon® is under
license.

Cidex® is a registered trademark of Advanced Sterilization Products.

Sporocidin® is a registered trademark of Aporocidin International.

All other brand and product names are trademarks of their respective owners.

The BladderScan® technology described in this manual is protected by U.S. Patent Numbers 5,235,985, 6,676,605,
6,884,217 and 6,905,468. The ScanPoint™ technology described in this manual is protected by U.S. Patent Number
6,569,097. Other patents pending.

Information in this Quick Reference Guide may change at any time without notice. For the most up-to-date information,
see the online manuals at http://www.verathon.com. Examples described or illustrated in this Quick Reference Guide are

ctitious and do not in any way represent real patient or exam data.

Corporate Headquarters

20001 North Creek Parkway
Bothell, WA 98011
USA

800.331.2313 (US and Canada only)

425.867.1348
Fax: [phone]

For contact information for Verathon® subsidiaries please
visit www.verathon.com/ContactUs.htm.

Verathon Medical (Europe) B.V.
EC REP

Linnaeusweg 11
3401 MS IJsselstein
The Netherlands
+31.30.68.70.570
Fax: [phone]

PN: 0900-2861-02-20

BVI 9400

User’s Manual

0900-2864-05-60

No part of this user's manual may be copied or transmitted by any method without the express written
consent of Verathon Inc.

BladderScan, NeuralHarmonics, ScanPoint, and Verathon are trademarks of Verathon Inc.
Verathon Inc.

Bluetooth® word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by
Verathon® is under license.

©

2009, 2013

Cidex® is a registered trademark of Advanced Sterilization Products.

®

Sporocidin

All other brand and product names are trademarks of their respective owners.

The BladderScan
6,676,605, 6,884,217 and 6,905,468. The ScanPoint™ technology described in this manual is protected
by U.S. Patent Number 6,569,097. Other patents pending.

Information in this user's manual may change at any time without notice. For the most up-to-date
information, see the online manuals at http://www.verathon.com. Examples described or illustrated in this

user's manual are ctitious and do not in any way represent real patient or exam data.

The team at Verathon
products support healthcare professionals by providing accuracy, utility, and excellence. For additional
product and company information, visit the Verathon Web site at www.verathon.com. If you have any
questions or comments about Verathon products and services, please contact us at:

is a registered trademark of Aporocidin International.

®

technology described in this manual is protected by U.S. Patent Numbers 5,235,985,

®

is committed to modernizing healthcare delivery by putting patients rst. Our

BladderScan® BVI 9400

Bladder Volume Instrument

User’s Manual

For use with consoles purchased or upgraded after August 2013.

CAUTION: In the United States, federal law restricts this

device to use by or on the order of a physician.

Corporate Headquarters (USA)

Verathon Incorporated
20001 North Creek Parkway
Bothell, WA 98011
USA

P

Verathon Medical B. V. (Europe)
Linnaeusweg 11
3401 MS IJsselstein
The Netherlands

For contact information for Verathon subsidiaries, please visit our website at
www.verathon.com/ContactUs.htm.

C0123

Toll free: 800.331.2313 (US & Canada Only)
Tel: [phone]
Fax: [phone]
Web: www.verathon.com
Email: [e-mail]

Tel: [phone]
Fax: [phone]
Web: http://www.verathon.eu/
Email: [e-mail]

BladderScan® BVI 9400

Table of Contents

Table of Contents

Table of Figures .......................................................................................................................................... 8

Company Statement ................................................................................................................................... 9

Important Information ..............................................................................................................................10

Product Description ..............................................................................................................................10

Intended Use Warnings and Cautions ................................................................................................. 11

Biological Safety .................................................................................................................................. 11

Statement of Prescription .............................................................................................................. 11

Statement of Intended Use ............................................................................................................ 11

Contraindications ........................................................................................................................... 11

Warnings & Cautions ...........................................................................................................................12

Introducing the BladderScan BVI 9400 .................................................................................................14

BladderScan Parts and Features ......................................................................................................... 14

Probe Components ........................................................................................................................15

Console Components .................................................................................................................... 15

Battery Charger/Wireless Hub .............................................................................................................16

Parts and Accessories ......................................................................................................................... 17

Getting Started ..........................................................................................................................................18

Unpack the Box and Check the Components ..................................................................................... 18

Charge the Batteries ........................................................................................................................... 18

Install a Battery Pack in the Console ...................................................................................................19

To Insert the Battery Pack ............................................................................................................. 19

Battery Care ..................................................................................................................................19

Enter the Clinic Name .......................................................................................................................... 19

Set the Date and Time .........................................................................................................................21

Setting General Preferences and Savings Preferences ................................................................ 22

Load a Roll of Thermal Paper ..............................................................................................................23

Assemble the Medical Cart .................................................................................................................. 23

Install the BladderScan on the Optional Medical Cart .........................................................................25

®

Install the ScanPoint

with QuickPrint Software (Optional) ..................................................................26

Watch the Training Video ..................................................................................................................... 26

User's Manual

page 5

Table of Contents

BladderScan® BVI 9400

BladderScan® BVI 9400

Table of Contents

Displays, Controls, and Indicators .........................................................................................................27

Console Displays and Button Functions ..............................................................................................27

Battery Status Indicator .................................................................................................................27

Home Screen .................................................................................................................................27

Scan Screen .................................................................................................................................. 29

Results Screen ..............................................................................................................................30

Review Screen ..............................................................................................................................31

Tutorial Screen ..............................................................................................................................32

Video Viewing Screen ...................................................................................................................33

Settings Screen .............................................................................................................................34

Name Screen .................................................................................................................................35

Date & Time Screen ......................................................................................................................36

General Preferences Screen ......................................................................................................... 37

Savings Preferences Screen ......................................................................................................... 38

Self-Test Screen ............................................................................................................................ 40

®

ScanPoint

Screen .......................................................................................................................41

Device Repair ......................................................................................................................................53

Unit Disposal ........................................................................................................................................ 53

Troubleshooting .......................................................................................................................................54

Help Resources ...................................................................................................................................54

Icons on the BladderScan Console ......................................................................................................55

Diagnosing Problems ........................................................................................................................... 56

Instrument Does Not Turn On ........................................................................................................56

Printer Problems ..................................................................................................................................56

No Paper .......................................................................................................................................56

Too Hot .......................................................................................................................................... 56

Clearing a Paper Jam .................................................................................................................... 56

Warranty ....................................................................................................................................................57

Disclaimer of Additional Warranties .....................................................................................................57

Parts and Accessories ............................................................................................................................. 58

BladderScan BVI 9400 System Components ......................................................................................58

Product Specications.............................................................................................................................59

Sleep Mode ...................................................................................................................................42

Measuring Bladder Volume .....................................................................................................................43

Preparing for the Exam ........................................................................................................................ 43

Measuring Bladder Volume ..................................................................................................................44

Additional Scanning Tips ...................................................................................................................... 47

Recording a Voice Annotation .............................................................................................................. 47

Deleting a Saved Exam .......................................................................................................................49

Printing ................................................................................................................................................. 49

Entering Additional Information ...................................................................................................... 49

Histogram of Cost Savings ......................................................................................................................50

Cost Savings Criteria ..................................................................................................................... 50

Cleaning and Maintenance ...................................................................................................................... 51

Cleaning the BladderScan BVI 9400 ...................................................................................................51

Regular Inspections and Maintenance .................................................................................................51

Weekly Inspections ........................................................................................................................ 51

Using the Built-in Self-Test Utility ......................................................................................................... 52

®

Calibrating the BladderScan BVI 9400 Using the ScanPoint

System ................................................52

Standards and Regulations Compliance ..............................................................................................59

Electromagnetic Effects ................................................................................................................. 59

®

Bluetooth

Wireless Technology .................................................................................................... 59

BladderScan BVI 9400 Instrument Specications ...............................................................................60

Ultrasound Output Parameters ...................................................................................................... 60

Accuracy Specications .................................................................................................................61

BladderScan BVI 9400 Operating Conditions ...............................................................................61

BladderScan BVI 9400 Storage Conditions ...................................................................................61

BladderScan BVI 9400 Displays, Controls, and Indicators .................................................................. 62

Instrument Buttons ........................................................................................................................62

Instrument Display ......................................................................................................................... 64

BladderScan BVI 9400 Icons ............................................................................................................... 65

Battery Charger/Wireless Hub Specications ...................................................................................... 68

Operating Conditions ..................................................................................................................... 68

Storage Conditions ........................................................................................................................ 68

Battery Specications ..........................................................................................................................69

Symbol Directory ..................................................................................................................................70

Self-Calibration .............................................................................................................................. 53

page 6 User's Manual

Glossary .................................................................................................................................................... 72

User's Manual

page 7

Table of Figures

BladderScan® BVI 9400

BladderScan® BVI 9400

Company Statement

Table of Figures

Figure 1. BladderScan BVI 9400 Controls and Indicators .......................................................................... 14

Figure 2. Battery Charger & Wireless Hub ................................................................................................. 16

Figure 3. Home Screen ..............................................................................................................................20

Figure 4. Settings Screen ........................................................................................................................... 20

Figure 5. Name Screen ..............................................................................................................................21

Figure 6. Home Screen ..............................................................................................................................21

Figure 7. Settings Screen - Date & Time ....................................................................................................22

Figure 8. Date & Time Select Screen .........................................................................................................22

Figure 9. Medical Cart PN: 0800-0322 ....................................................................................................... 23

Figure 10. Medical Cart Assembly ..............................................................................................................24

Figure 11. Universal Accessory Basket P/N 0810-0201 (Optional) ............................................................25

Figure 12. Attaching the BVI 9400 to the Medical Cart...............................................................................25

Figure 13. Home Screen ............................................................................................................................28

Figure 14. Scan Screen .............................................................................................................................. 29

Figure 15. Results Screen .......................................................................................................................... 30

Company Statement

The team at Verathon® is committed to improving healthcare delivery by

putting healthcare providers and their patients rst.

Our products support you, the health care provider, by consistently offering
accuracy, utility, reliability, and excellence.

Figure 16. Review Screen .......................................................................................................................... 31

Figure 17. Tutorial Screen .........................................................................................................................32

Figure 18. Video Viewing Screen ...............................................................................................................33

Figure 19. Settings Screen Start Menu ......................................................................................................34

Figure 20. Name Screen ............................................................................................................................35

Figure 21. Date & Time Screen ..................................................................................................................36

Figure 22. B-Mode and C-Mode Print Reports ........................................................................................... 37

Figure 23. General Preferences Screen ..................................................................................................... 38

Figure 24. Savings Preferences Screen ..................................................................................................... 39

Figure 25. Self-Test Screen ........................................................................................................................ 40

Figure 26. ScanPoint® Screens ..................................................................................................................41

Figure 27. Sleep Mode Screen ................................................................................................................... 42

Figure 28. Exam Results Printout Using the Onboard Printer .................................................................... 49

Figure 29. Calibration Warning ................................................................................................................... 53

Figure 30. Printer Out of Paper Screen ...................................................................................................... 56

page 8 User's Manual

User's Manual

page 9

Important Information

BladderScan® BVI 9400

BladderScan® BVI 9400

Important Information

Important Information

Product Description

The BladderScan BVI 9400, with patent-pending NeuralHarmonics® technology,
is a portable ultrasound instrument that provides a noninvasive measurement of
urinary bladder volume. 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.

BladderScan is quick, accurate, reliable, and easy to use. When the user presses the

SCAN button, within seconds, the BVI 9400 measures ultrasonic reections on multiple

planes inside the body and produces a three-dimensional image. Based on this image,
the BVI 9400 calculates and displays the bladder volume. A sonographer is not required.

Patent-pending NeuralHarmonics technology (abbreviated from “neural network
harmonics”) in the BVI 9400 sharpens accuracy and accelerates speed of 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 multispectral
analysis to a robust data set, helps reduce margin of error and minimize uncertainty in
essential measurements of bladder function.

BladderScan BVI 9400 measurements can be printed via an onboard printer or
transmitted, using HIPAA-compliant ScanPoint® image management technology

(optional) to your ofce or facility computer, for viewing, printing, or archiving.

If needed, after a scan has been taken, a unique aiming icon guides the operator to
optimal probe placement with a comprehensive, three-dimensional 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. The BladderScan
BVI 9400 contains an onboard thermal printer that allows the user to print exam results
quickly with the press of a button.

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.

Optionally, exam results may be transmitted to a personal 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.

Intended Use Warnings and Cautions

The BladderScan BVI 9400 should be used only by individuals who have been trained
and authorized by a physician or the institution providing patient care. All users must
read this entire user's manual prior to using the BladderScan BVI 9400. Do not attempt to
operate this instrument until you thoroughly understand all instructions and procedures in
this manual. Failure to comply with these instructions may compromise the performance
of the device and the reliability of its measurements. For the most current version of the
user’s manual, please visit the Verathon® Web site at: http://www.verathon.com, then click
on the "Product Materials" tab on the BladderScan BVI 9400 page to open a link to this
manual and other training materials.

Biological Safety

To date, exposure to pulsed diagnostic ultrasound has not been shown to produce
adverse effects. However, ultrasound should be used only by medical professionals when
clinically indicated, using the lowest possible exposure times indicated by clinical need.

The ultrasound output power of the BladderScan BVI 9400 is not user adjustable and is
limited to the minimum level necessary for effective performance. Data on acoustic output

levels can be found in the BladderScan BVI 9400 Instrument Specications.

Statement of Prescription

United States federal law restricts the BladderScan BVI 9400 to use by, or on the order
of, a physician. This statement is required per 21 Code of Federal Regulations (CFR)

801.109.

NOTE:

It is standard practice to have medical staff authorize the use of the BladderScan BVI
9400 within its intended use throughout an institution. Individual prescriptions for use are
not required.

Statement of Intended Use

The BladderScan BVI 9400 projects ultrasound energy through the lower abdomen of
the patient to obtain an image of the bladder which is used to calculate bladder volume
noninvasively.

Contraindications

The BladderScan BVI 9400 is not intended for fetal use or for use on pregnant patients.

The BladderScan BVI 9400 system also includes a universal battery charger for the
custom, user-replaceable lithium-ion battery incorporated in the system.

The BladderScan BVI 9400 may be mounted on a cart which holds the instrument
securely and provides a holder for ultrasound gel and other accessories.

page 10 User's Manual

User's Manual

page 11

Important Information

BladderScan® BVI 9400

BladderScan® BVI 9400

Important Information

Warnings & Cautions

To assure safe and reliable operation for the user and the patient, please read and heed
the following warnings and cautions:

WARNING! Risk of explosion.

Y
Y

Y

Y

Y

There is a possible risk of explosion if the BladderScan BVI 9400 is used in the presence

of ammable anesthetics.

WARNING! Risk of explosion, re, or serious injury.

The BladderScan BVI 9400 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 re and could

also damage the battery pack and the BladderScan device.

WARNING! Risk of explosion, re, or serious injury.

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 re, possibly resulting in serious injury.

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 BVI 9400 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 BladderScan

BVI 9400 Instrument Specications.

WARNING! Risk of patient injury.
Do not use the BladderScan BVI 9400 on patients with open skin or wounds in the
suprapubic region.

Y

Y

CAUTION! Failure to heed the following cautions may cause device damage not
covered by the BladderScan BVI 9400 warranty.

• Do not immerse the instrument in disinfectant solution.

• Do not use Cidex Plus
plastic enclosure.

• Do not subject any part of the instrument to steam sterilization or ethylene oxide
sterilization.

CAUTION! Observe the following precautions in the safe use and care of the
BladderScan BVI 9400.

Hazardous materials present. Assure proper disposal.

The BladderScan BVI 9400 and related devices may contain lead, mineral oils, batteries,
and other environmentally hazardous materials. When the BladderScan BVI 9400 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.

Assure proper computer system conguration.

When using the BladderScan BVI 9400 with optional ScanPoint® software, your computer

must be minimally certied to EN / IEC / CSA / UL 60950 or 60101-1 standards. This
conguration ensures that compliance to the EN/IEC 60601-1-1 system standard is

maintained. Anyone connecting additional equipment to the BladderScan BVI 9400 signal

input port or signal output port congures 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 the Verathon Customer Care
Department at 1.800.331.2313.

Assure proper distance from patient.

The BVI 9400 battery charger/wireless hub and the computer used to access online
ScanPoint image archives (if used) must be placed outside the patient vicinity (more
than six feet (2 meters) from the patient). Refer to UL 2601-1 Clause 2 deviation for the

denition of patient vicinity.

®

to disinfect the instrument. Cidex Plus will damage the

CAUTION! Risk of inaccurate measurements/results.

Y

page 12 User's Manual

• Accuracy is compromised if the user does not obtain an optimal, repeatable
image.

• The BladderScan BVI 9400 is not intended for use on pregnant patients.

• A catheter in the patient’s bladder may affect the accuracy of the bladder volume
measurement in two ways: 1) by introducing air into the bladder that may block
the ultrasound signal and 2) by having the catheter retaining balloon interfere
with the volume measurement. However, the volume measurement may still be
clinically useful if it is large (detecting a blocked catheter, for example).

When using the BladderScan BVI 9400 be aware of the following conditions which can
affect ultrasound transmission and decrease the accuracy of exam results.

• Previous suprapubic or pelvic surgery with resulting scar tissue, surgical

incisions, sutures, and staples can affect ultrasound transmission and reection.

• Do not use the BladderScan BVI 9400 on a patient with open skin or wounds in
the suprapubic region.

• Do not use the BladderScan BVI 9400 on a patient with ascites.

Y

Y

User's Manual

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 BVI 9400 Bluetooth link and wireless LAN devices
simultaneously, you may experience less than optimal network performance or even lose
your network connection. If this happens, you may need to move the BladderScan and
ScanPoint host computer to an area away from the 2.4 GHz wireless LAN devices (40
meters/44 yards, or more).

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.

page 13

Introducing the BladderScan BVI 9400

Introducing the BladderScan BVI 9400

The BladderScan BVI 9400 is designed for simple, intuitive operation. However, to
ensure safe and effective operation, before using the device:

BladderScan® BVI 9400

BladderScan® BVI 9400

Probe Components

The probe transmits and receives ultrasound waves, automatically moving its internal
transducer 360º to scan twelve 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:

Introducing the BladderScan BVI 9400

• Familiarize yourself with the contents of this manual.

• Watch the training video provided on the instrument.

BladderScan Parts and Features

The BladderScan BVI 9400 has two main components: the console and the probe. The
console and probe are linked by a detachable cable. The BladderScan BVI 9400 controls
and indicators are illustrated in Figure 1.

Figure 1. BladderScan BVI 9400 Controls and Indicators

Part Name Purpose

SCAN Button Press to take a scan.

Aiming Display

The LCD displays directional arrows to ensure that the bladder is
centered within the image cone.

Microphone Records voice annotations.

Console Components

The console provides all operating controls for the scanning process by means of 5
variable function buttons. The measured bladder volume 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

®

host 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:

Part Name Purpose

Main Display

Displays the bladder volume measurement, patient type, settings,
and instrument status.

Power On/Off Toggles main power on/off.

page 14 User's Manual

User's Manual

Volume

Press to adjust volume up/down on voice annotation playback,
start up sound, and “scan complete” tone.

Brightness Press to adjust display brightness dimmer/brighter.

Depending on device mode, the buttons provide access to all
Five Variable
Function Buttons

instrument functions for scanning, recording annotations, printing,

connecting to ScanPoint (optional), accessing the training video,

and setting user preferences.

Printer/Printer Door Slide to release the printer door.

page 15

Introducing the BladderScan BVI 9400

BladderScan® BVI 9400

BladderScan® BVI 9400

Introducing the BladderScan BVI 9400

Battery Charger/Wireless Hub

The BladderScan BVI 9400 is powered by a lithium ion (Li-Ion) battery pack
(Figure 2). The battery charger provided with your BVI 9400 can charge two Li-Ion battery
packs while simultaneously functioning as the wireless hub linking your BVI 9400 to the
ScanPoint® host computer.

NOTE: Use of ScanPoint software is optional.

• To provide power to the battery packs, the battery charger/wireless hub must be
plugged into a wall outlet using the power cord provided.

• To provide wireless communication between the BVI 9400 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 BVI 9400, regardless of barriers such
as walls, ceilings, or windows.

Figure 2. Battery Charger & Wireless Hub

Charging bays for two
battery packs

Parts and Accessories

Part Number Description

0570-0190 BVI 9400 Console

0570-0188 BVI 9400 Probe

0570-0351 BVI 9400 Probe (newer)

0570-0193 Battery Charger/Wireless Hub

0400-0066 Lithium-ion Battery (2 provided)

0900-1606 BVI 9400 User’s Manual (on In-service CD)

0900-1601 ScanPoint

0900-1446 Quick Reference Card - Bladder Volume Measurement

0900-1447 Quick Reference Card - Calibration

0800-0319 Thermal Paper Roll for the Printer

0900-1500

0800-0322 Medical Cart (optional)

0810-0201 Universal Accessory Basket for Medical Cart (optional)

0900-1238

®

with QuickPrint User’s Manual (on CD)

BladderScan BVI 9400 In-service CD (Includes User’s Manuals, Video
Tutorial and Quick Reference Cards)

ScanPoint with QuickPrint Software Install CD.
NOTE: Use of the ScanPoint software is optional and not required for
operation of the BVI 9400.

Plug into wall outlet

to power the battery

charger.

Plug into a USB port on the
ScanPoint host computer
(optional) to enable a wireless
connection with the BVI 9400.

0620-0340

Calibration Kit (Optional - includes Calibration Container, Calibration
Target, etc.)

0800-0005 Acoustic Coupling Gel, 0.25 liter (case of 12)

page 16 User's Manual

User's Manual

page 17

Getting Started

Getting Started

BladderScan® BVI 9400

BladderScan® BVI 9400

3. Check the colored indicator lights on the battery charger to determine battery

Getting Started

status:

The previous section provided basic information about the BVI 9400 parts and features.
This section provides instructions for setting up your BVI 9400 prior to rst use.

To help you get up and running as quickly as possible, the next few pages explain how to:

• Unpack the box and check the components

• Charge and install the batteries

• Customize the display (enter your institution’s name, date, time, and other user
data)

• Assemble the medical cart (optional)

• Install the ScanPoint® with QuickPrint software (optional)

Unpack the Box and Check the Components

Set the shipping container right side up and carefully open the top aps (do not insert

anything sharp through the top of the box). Remove the contents and verify that you
have received everything listed below. If anything is missing or damaged, notify your
authorized Verathon representative or Verathon Customer Care Department.

(1) BladderScan BVI 9400 (console and probe)

(1) Medical cart (optional)

(1) Universal accessory basket for medical cart (optional)

(2) Rechargeable lithium-ion batteries

(1) Battery charger/Wireless hub

(1) In-service CD (includes user's manuals, video tutorial, and quick reference cards)

(1) Training pack

Charge the Batteries

Two lithium-ion batteries are included with the BladderScan BVI 9400. One battery
can be recharged in the battery charger/wireless hub while the other is installed in the
BladderScan instrument. This ensures that there is no instrument downtime. The charger
will bring the batteries to a full charge within 6 hours or less.

• Solid green: Battery fully charged.

• Amber: Battery charging.

Install a Battery Pack in the Console

WARNING! Risk of serious injury.

If the battery pack is leaking or its case is cracked, put on protective gloves to handle

Y

it, and discard it immediately. Always dispose of used battery packs in compliance with
all applicable laws and regulations. Put insulating tape, such as cellophane tape, on the

electrodes during transportation to avoid a possible short circuit, re, or electrical shock.

Failure to do so could result in serious injury.

To insert a battery pack:

Insert the charged battery into the battery well in the Console, slide it under the ledge and
push down gently until the battery clicks into place.

NOTE: The battery pack is designed to prevent incorrect installation. If the battery pack
does not slide into the battery well easily, move the battery and try again. Do not force the
battery into position.

Battery Care

The BladderScan BVI 9400 draws very little power when it is turned off. However, if you
do not plan to use the BladderScan instrument for several weeks, you should remove the
battery to prevent it from discharging.

When batteries are not in use, they should be stored in the Battery Charger so they
remain fully charged.

Enter the Clinic Name

You can customize your BladderScan 9400 by entering your facility’s name and current
date and time. This information will subsequently be included on BladderScan displays
and all printouts of exam results.

NOTE: Before using the BladderScan BVI 9400 for the rst time, you will need to

charge both batteries.

To charge the batteries:

1. Plug the battery charger/wireless hub unit into a standard wall outlet.

2. Insert the battery into the recess in the battery charger.

NOTE: Fully charging the battery may take up to 6 hours.
Batteries may be stored in the charger. There is no danger of overcharging the
batteries.

page 18 User's Manual

User's Manual

NOTE: Use of extended-Latin and/or non-Latin characters: The following instructions
explain how to enter a facility name that uses only standard Latin characters. Extended
Latin characters (tilde, umlaut, accents, circumex, etc.) and/or non-Latin characters can
be entered only by using ScanPoint® with QuickPrint software. To enter a name that uses
extended or non-Latin characters, please refer to the instructions in the ScanPoint with
QuickPrint User’s Manual.

page 19

Getting Started

To enter your clinic’s name:

BladderScan® BVI 9400

BladderScan® BVI 9400

Getting Started

1. Turn the BladderScan BVI 9400 on by pressing the
the console.

2. When the Home screen appears

Figure 3. Home Screen

(Figure 3), press the SETTINGS

button

to open the Settings

screen.

3. On the Settings screen

Figure 4. Settings Screen

(Figure 4), push either the

 or  button until Name is

highlighted (red). Press the
button to open the Name screen.

POWER button on the front of

5. Continue to select and add
characters as needed.

6. When nished, press the

button to return to the Settings
screen. From the Settings screen,
press the HOME button to
return to the Home screen. The
facility name will now appear in the
display header (Figure 6).

Set the Date and Time

To set the date and time:

1. If the BladderScan instrument is turned off, turn the power on by pressing the
button on the front of the console.

SETTINGS

Figure 6. Home Screen

4. On the Name screen (Figure

5), use the  and  buttons to
move to the desired character.
When the desired character
is highlighted (red), press the

 button to add it to your text.

Use the -- button to delete
characters.

 To add a space between

words, press the blank
space below the letter “x”.

 To add a second line of text

use the ¶ character.

Figure 5. Name Screen

2. From the Home screen press the SETTINGS button to open the Settings screen.

3. On the Settings screen

(Figure 7), push either the

button until Date & Time is



highlighted (red). Press the

 or

Figure 7. Settings Screen - Date & Time

button to open the Date & Time

screen.

page 20 User's Manual

User's Manual

page 21

Getting Started

BladderScan® BVI 9400

BladderScan® BVI 9400

Getting Started

4. On the Date & Time Select

Figure 8. Date & Time Select Screen

screen (Figure 8), use the  and

buttons to move to the desired



unit (hours, minutes, month, day,
year).

When the desired unit is highlighted
(red):

• Press the  button to

increase values.

• Press the -- button to

decrease values.

5. When the time and date are set correctly, press the SETTINGS button to return

to the Settings screen. From the Settings screen, push the HOME button

to

return to the Home screen.

NOTES:

• See General Preferences screen for information about setting General Preferences,
Savings Preferences, and Self-Test Options.

• General Preferences, Savings Preferences, and Self-Test Options can be accessed
from the Settings screen.

• General Preferences include options for: Language, Date Format, Time Format, and
Calibration Warning.

• Savings Preferences include: UTI Rate, UTI Cost, Catheterization Cost,
Catheterization Volume, Currency, and Savings Calculation.

6. Slide the printer door to the left.

7. Tear the excess paper off.

To avoid paper jams, never fold the end of the paper roll or cut it

diagonally or to a point.

NOTE:

If the paper appears to be stuck in the printer, open the printer door on the back

of the console and clear the paper jam.

Assemble the Medical Cart

NOTE: If you’re not using the medical cart, please skip to the next section. Install the

ScanPoint® with QuickPrint Software.

The optional medical cart is illustrated in Figure 9.

Medical Cart Parts List

Item
No.

1 1 0142-0276 Tray Assembly
2 1 0810-0140 Bracket and Post
3 1 0810-0141 Medical Cart Base

4 4 0261-0107

5 1 0260-0357 Fluted Knob 3/8-16 x 1.00
6 4 0810-0142 Caster, 3 inch
7 1 0810-0143 Caster, 3 inch with Brake
8 2 0136-0109 Loctite

To assemble the medical cart (Figure 10)

Qty Part Number Description

Screw PH W Lock 25-20
x 1/2

®

680

Figure 9. Medical Cart PN: 0800-0322

Load a Roll of Thermal Paper

To load a new roll of thermal paper:

1. Open the paper compartment door (located on the base of the console, under the
display).

2. Slide the door to the right, then lift the printer door up.

3. Insert the end of a new paper roll with the thermal side down, into the paper slot.

To verify which side is the thermal side, scratch the paper with your ngernail. If a

black mark appears, this is the thermal side.

4. Extend the end of the paper past the end of the unit.

5. Close the door, making sure that you snap it into place, then slide the door to the
left.

page 22 User's Manual

User's Manual

1. Align and press one 3-inch caster with brake (Item 7)
and four 3-inch casters (Item 6) into medical cart base
(Item 3).

2. Align through round hole in bracket and post (Item 2)
bracket to through hole in medical tray (Item 1).

3. Insert bracket and post (Item 2) into square relief in
bottom of medical tray assembly (Item 1).

4. Insert four screws (Item 4) through bracket and post
(Item 2) into molded inserts in medical tray (Item 1);
tighten securely.

5. Place the tray assembly with the bracket and post into
the medical cart base (Item 3).

page 23

Getting Started

BladderScan® BVI 9400

BladderScan® BVI 9400

Getting Started

NOTE: If a permanent attachment of the tray assembly and post to the medical cart

base is required, refer to the Loctite
below before inserting the post into the base.

®

option

Figure 10. Medical Cart Assembly

6. Place device in foot prints on medical tray
(Item 1).

7. Screw the uted knob (Item 5) through

bracket and post (Item 2) bracket round hole
and hand tighten.

Loctite

®

option:

1. Place medical cart base on level oor.

2. Open 2 tubes of Loctite 680 by snapping off
the tips of the tubes.

3. Apply the Loctite 680 all around the tapered
portion of the post. Use all of the contents of
both tubes. Complete coverage of the taper is
not necessary as the Loctite will spread upon
insertion into the base.

4. Slide the post into the hole in the base with a

twisting motion and press down rmly.

5. Wipe off excess Loctite with paper towel and
discard towel as waste.

6. Allow post and base to sit undisturbed for 3
hours.

Figure 11. Universal Accessory Basket P/N 0810-0201 (Optional)

Install the BladderScan on the Optional Medical Cart

Your BladderScan BVI 9400 is completely portable and can be easily moved and
positioned for convenient use. Installing the BVI 9400 on the optional mobile cart
will allow you to move the BladderScan along with related accessories to the patient
examining area or bedside as necessary.

To install the BVI 9400 on the medical cart:

To attach the BVI 9400 to the medical cart, refer to
the instructions on the next page.

A universal accessory basket (P/N 0810-0201) (Figure 11) is available for the medical
cart to provide additional storage capacity.

NOTE: For medical cart assembly instructions and parts list, refer to previous pages in
this section.

Figure 12. Attaching the BVI 9400 to the Medical Cart

BVI 9400

Tray Assembly (Item 1)

Fluted Knob (Item 5)

Bracket and Post (Item 2)

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User's Manual

page 25

Getting Started

To install the BVI 9400 to the medical cart, screw the

uted knob (Item 5) through bracket and post (Item 2)

bracket round hole and tray assembly (Item 1), and into
the mounting hole on the bottom of the device. Hand
tighten (Figure 12).

Install the ScanPoint with QuickPrint Software (Optional)

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Console Displays and Button Functions

The console LCD presents user information and prompts that vary depending on the
current device function.

Displays, Controls, and Indicators

Optional ScanPoint® with QuickPrint software is
designed to mesh seamlessly with your BladderScan
devices. The BVI 9400 automatically downloads exam
data to the ScanPoint host computer via a wireless
connection enabled by the battery charger/wireless hub

- allowing further viewing, analysis, archiving, and report
generation.

To install ScanPoint with QuickPrint, insert the ScanPoint
with QuickPrint install CD into your computer’s CD
drive and follow the on-screen prompts. Please refer
to the separate user’s manual provided with ScanPoint
with QuickPrint for complete installation and operating
instructions.

Watch the Training Video

The training video provides an overview of how to perform an ultrasound scan of the bladder
using the BladderScan BVI 9400. The video is approximately 5 minutes long. The training
video:

• can be found on the In-service CD and at the Verathon
verathon.com/Training%20Videos.htm.

• is available for review anytime on the BladderScan BVI 9400 by pushing the
button from the Home screen

• may also be found at www.verathon.com/BladderScan.htm.

Getting Started

®

Web site: http://www.

The 5 buttons below the display have variable functions according to device mode.
Button functions are indicated by icons in the display footer, immediately above each
button.

Battery Status Indicator

A battery status indicator appears in the header of all BVI 9400 screens. Depending on
the state of the battery, one of the following symbols will be displayed:

Battery is fully charged.

Battery is 50% to 75% charged.

Battery is 25% to 50% charged.

Battery is nearly depleted and can power only a few more scans.

Battery is fully depleted and must be changed.

Home Screen

The Home screen appears when the BVI 9400 is rst powered on. The Home screen

serves as a starting point for all of the main functions of the instrument.

The Home screen displays:

• In the header: Your clinic's name and a battery status indicator.

• In the center panel: A list of saved exam results (10 maximum) saved in
chronological order. Yellow folders hold saved exams. Grey folders represent
empty spaces still available for saving exam results.

A cost saving summary. Displays the savings to your organization due to
using the BladderScan BVI 9400 rather than catheterization. The values used
to calculate the savings are user-variable and are entered from the Savings
Preference screen.

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User's Manual

• In the footer: Five variable-function buttons.

page 27

Displays, Controls, and Indicators

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Figure 13. Home Screen

Home Screen Buttons

Button Function

Single button with three modes. Available when "small child" mode is set
to "on." When performing an exam, press the button repeatedly until the
desired setting appears above the saved exams folders:

• Select the small child icon to scan a patient with height less than

• Select the female icon to scan a female patient who has not had

• Select the BladderScan icon to scan all other patients.

Replaces single button when small child mode is set to "Off." Press
button to toggle between female icon and BladderScan icon.

s

48 inches (122 cm) tall and weight less than 60 lbs (27 kg).

a hysterectomy.

Scan Screen

The Scan screen (Figure 14) appears after you press the SCAN button on the Probe
and displays a progressively updating image of the bladder outline. When the ultrasound
measurement is complete, the Results screen opens automatically.

Four buttons below the display do not function during the scan.

Figure 14. Scan Screen

Results Screen Buttons

Button Function

- No function.

- No function.

- No function.

- No function.

• Select the female icon to scan a female patient who has not had
a hysterectomy.

• Select the BladderScan icon to scan all other patients.

Press to view the training video.

Press to open the Settings screen (set the time, date, institution name,
and user preferences).

Press to review a previously-saved exam. (This button is gray (inactive) if
there are no previously saved exams to review.)

Press to initiate communication with the ScanPoint® host computer.
Saved and annotated exams being held on the BVI 9400 will be
automatically uploaded to the ScanPoint computer. (ScanPoint must be
installed and open. Use of ScanPoint software is optional.)

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User's Manual

HOME: Press to cancel the scan and return to the Home screen.

page 29

Displays, Controls, and Indicators

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Results Screen

The Results screen (Figure 15) appears automatically when an ultrasound scan is
complete.

The display presents the result of the exam: crosshairs, bladder outline, and the
calculated bladder volume. You may choose to print this result to the onboard printer and/
or to record a voice annotation to save the exam. After the annotation is recorded, the
PLAY and REVIEW buttons become active and the newly recorded exam appears on the
main display as an orange folder icon.

Figure 15. Results Screen

Review Screen

The Review screen (Figure 16) opens when you select a saved exam (yellow folder icon)
to review.

The display shows the ultrasound images associated with the selected exam. A green
open-folder icon indicates which exam is being viewed. While reviewing saved exams,
the buttons below the display allow you to print, replay, or delete exam data.

Figure 16. Review Screen

Results Screen Buttons

Button Function

RECORD: Press to record a voice annotation (up to 15 seconds

long). When the (10) folders are full the rst recorderd folder will be

overwritten.

PRINT: Press to print exam results.

PLAY: Press to listen to a previously recorded voice annotation.

REVIEW SCREEN: Press to open the Review screen. This button is
inactive if there are no previously saved exams to review.

HOME: Press to return to the Home screen.

Review Screen Buttons

Button Function

SELECT: Press to select the next exam in the list.

PRINT: Press to print the results for the currently selected exam on the
onboard printer. While printing is in progress an hourglass icon appears
on the display.

PLAY: Press to play a previously recorded voice annotation. The button is
inactive if no voice annotations have been saved.

DELETE: Press to delete the currently selected exam.

HOME: Press to return to the Home screen.

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Displays, Controls, and Indicators

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Tutorial Screen

To open the Tutorial Screen (Figure 17) press the button from the Home screen
(Figure 13).

The Tutorial screen presents a menu of training modules. To select a title, press either

the é or ê button until the desired title is highlighted (red). Press the ENTER button to

go to the Video Viewing screen.

NOTE: The SCAN button (on the probe) is disabled during module playback.

Figure 17. Tutorial Screen

Video Viewing Screen

To view the video press the

button on the Tutorial screen (Figure 17), then the u

button on the Video Viewing screen (Figure 18).

NOTE: The SCAN button is disabled during video playback.

Figure 18. Video Viewing Screen

Tutorial Screen Buttons

Button Function

SELECT NEXT: Press to select the next title.

SELECT PREVIOUS: Press to move back to the previous title.

ENTER: Press to open the Video Viewing screen.

-- No function

HOME: Press to return to the Home screen.

Video Viewing Screen Buttons

Button Function

- No function.

PLAY/PAUSE: Press to start video playback. Press to pause. Press again
to resume playback.

BACK: Return to the Tutorial screen.

- No function.

HOME: Press to return to the Home screen.

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Displays, Controls, and Indicators

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Settings Screen

To open the Settings screen (Figure 19), push the SETTINGS button

on the Home

screen.

The display presents a list of user-congurable settings: Name, Time & Date, General

Preferences, Savings Preferences, and Self-Test. Use the Up/Down arrows to move
through the list of setup options. To select an option, press the ENTER button .

NOTE: When the Settings screens are open, the SCAN button (on the probe) is disabled.

Figure 19. Settings Screen Start Menu

Name Screen

This screen allows you to select the appropriate alpha-numeric characters for entering
your healthcare institution’s name.

Figure 20. Name Screen

Settings Screen Buttons

Button Function

SELECT NEXT: Press to select the next setting in the list.

SELECT PREVIOUS: Press to select the previous setting in the list.

ENTER: Press to select the highlighted setting.

- No function.

HOME: Press to return to the Home screen.

Name Screen Buttons

Button Function

Press to move down in the grid.

Press to move to the right in the grid.

Press to add the highlighted character.

Press to delete one character.

HOME: Press to return to the Home screen.

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Displays, Controls, and Indicators

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Date & Time Screen

This screen allows you to adjust the date and time.

NOTE: If the time display is set to show a 24-hour clock, the hour units are 0 - 23. If the
clock is set to show a 12-hour clock, the hour units are 1 AM - 12 AM Noon and 1 PM - 12
PM Midnight.

Referring to the example shown in Figure 21:

To change the time from 8:17 AM to 11:30 AM:

1. Press the

2. Press the

3. Press the

4. Press the

The time setting is now 11:30 AM.

5. Press the SETTINGS button

Figure 21. Date & Time Screen

ê button until the 8 is highlighted.

 button 3 times until the time digits display 11:17 AM.

ê button until the 17 is highlighted.

 button repeatedly until the minutes display 30.

to save this entry and return to the Setup screen.

General Preferences Screen

This screen displays a list of available settings and their current values.

Available settings:

• Language: English (default), Chinese Simplied, Chinese Traditional, Czech,

Danish, Dutch, Finnish, French, German, Greek, Italian, Hungarian, Japanese,
Korean, Norwegian, Portuguese (European), Spanish, Swedish, Turkish.

• Date Format: mm/dd/yyyy; dd.mm.yyyy; yyyy-mm-dd.

• Time Format: 12-hour or 24-hour.

• Calibration Warning: On (default), Off. When “On” is selected, a calibration

warning will appear in the display header when the device requires calibration.

• Print Report Type: (Figure 22) Toggle between C-mode images (bladder in
crosshairs) and B-mode images (image of bladder and abdominal space below
probe).

Figure 22. B-Mode and C-Mode Print Reports

Date & Time Screen Buttons

Button Function

Press to move back one changeable unit.

Press to move forward to the next changeable unit, in this case: hours,
minutes, AM/PM, month, day, year.

Press to add and/or toggle digits as appropriate (hours, minutes, AM/PM,
month, day, year).

Press to subtract or toggle digits as appropriate.

Press to save the current date & time setting and return to the Setup

page 36 User's Manual

screen.

User's Manual

• Enable ScanPoint: On (default), Off. Select “Off” to disable ScanPoint.

• Enable Small-Child Mode (SCM): On (default), Off. Select “Off” to disable small

child mode.

NOTE: If use of the small child mode is rare in your practice, you may want to
turn that option off.

page 37

Displays, Controls, and Indicators

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Figure 23. General Preferences Screen

General Preferences Screen Buttons

Button Function

SELECT PREVIOUS: Press to select the previous setting in the list.

Savings Preferences Screen

To open the Savings Preferences screen (Figure 24), select Savings Preferences from
the Settings screen menu (Figure 19).

Use this screen to enter base values used to calculate the savings to your organization
from using the BladderScan BVI 9400 rather than catheterization.

Preferences lists and options:

• UTI Rate: 1% to 100% in increments of 1%

• UTI Cost: $10 to $10,000 in increments of $10

• Catheter Cost: $1 to $1000 in increments of $1

• Catheter Volume: 20 ml to 1000 ml in increments of 20 ml

• Currency: $ / € / £ / ¥

• Saving Calculation: Since New, Since 1/1/2006, Reset Now, Print Since New,
Print Recent, Hide Savings

Figure 24. Savings Preferences Screen

SELECT NEXT: Press to select the next setting in the list.

For settings with a list of options, press to select the next option.

For settings with a list of options, press to select the previous option.

Press to save the current options and return to the Setup screen.

Savings Preferences Screen Buttons

Button Function

SELECT PREVIOUS: Press to select the previous setting in the list.

SELECT NEXT: Press to select the next setting in the list.

For settings with a list of options, press to select the next option.

For settings with a list of options, press to select the previous option.

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User's Manual

Press to save the current options and return to the Setup screen.

page 39

Displays, Controls, and Indicators

BladderScan® BVI 9400

BladderScan® BVI 9400

Displays, Controls, and Indicators

Self-Test Screen

To open the Self-Test screen (Figure 25), select Self-Test from the Settings menu
(Figure 19). The Self-Test screen will open and testing begins automatically.

Figure 25. Self-Test Screen

ScanPoint Screen

NOTE: Useful if optional ScanPoint

®

software is installed on a PC.

To open the ScanPoint screen, press from the Home screen (Figure 13). The
ScanPoint screens display information about the status of the link between the
BladderScan instrument and the ScanPoint host computer (Figure 26).

Figure 26. ScanPoint Screens

Searching for ScanPoint

Connected to ScanPoint

Self-Test Screen Buttons

Button Function

-- No function.

-- No function.

-- No function.

-- No function.

Press to return to the Setup screen.

ScanPoint Screen Buttons

Button Function

-- No function.

-- No function.

-- No function.

CANCEL: Cancels the current action and ends communication with the
ScanPoint host computer.

-- No function.

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page 41

Displays, Controls, and Indicators

Sleep Mode

To conserve battery power, the BladderScan BVI 9400 shuts itself down
automatically when not in use (goes into “sleep”).

The sleep mode helps preserve battery power. After four minutes of idle time, a sleep
mode alert message displays for 15 seconds (Figure 27). While the message is
displayed, press any button to keep the console awake and dismiss the message. After
15 seconds, the console goes to sleep. To wake the instrument from sleep, simply press
the power button.

Figure 27. Sleep Mode Screen

BladderScan® BVI 9400

BladderScan® BVI 9400

Measuring Bladder Volume

Preparing for the Exam

Before you begin the exam:

• Make sure you are familiar with the parts of the BladderScan instrument (see
Introducing the BladderScan BVI 9400).

• If you are a new BladderScan instrument user, Verathon® recommends that you

perform your rst exam on a patient with a moderately full bladder, rather than

initially attempting to locate and scan a nearly empty bladder.

• Check the instrument’s battery icon to make sure the battery has sufcient power.

NOTE: If the battery icon is 1/4 or less full, replace the battery with a freshly­charged battery before proceeding. Place the discharged battery in the battery
charger to recharge.

• Clean and disinfect the probe by wiping it gently with a soft cloth soaked in
isopropyl alcohol.

Measuring Bladder Volume

Be aware of the following conditions the patient may have that could affect
ultrasound transmission and the accuracy of your exam:

• A catheter in the patient’s bladder. The presence of a catheter may affect the
accuracy of the bladder volume measurement, but the measurement may still be
clinically useful (detecting a blocked catheter, for example).

• Previous suprapubic or pelvic surgery. Scar tissue, surgical incisions, sutures,
and staples can affect ultrasound transmission and reection.

Do not use the BVI 9400 on:

• Patients with ascites

• Patients with open skin or wounds in the suprapubic region

• Pregnant patients

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Measuring Bladder Volume

BladderScan® BVI 9400

BladderScan® BVI 9400

Measuring Bladder Volume

Measuring Bladder Volume

1. Turn on the BVI 9400.

Turn on the BVI 9400 by pressing
the On/Off button.

2. Select the exam mode.

Select to scan a patient with height
less than 48 inches (122 cm) tall
and weight less than 60 lbs (27 kg).

Select to scan a female patient who
has not had a hysterectomy.

Select to scan all other patients

5b. Aim toward the bladder.

Place the probe on the gel and aim it toward
the expected location of the bladder. For most
patients, this means angling the probe slightly
toward the patient’s coccyx (tail bone) so the
scan clears the pubic bone.

For maximum accuracy, be sure to hold the
Probe motionless while scanning.

6. Press the SCAN button.

Press the SCAN button, located on the
underside of the probe. As the scan progresses,
sections of the bladder will appear on the
console screen. When you hear the end-scan
tone, the scan is complete.

NOTE: Hold the probe steady while scanning.
Movement will impair the accuracy of the
measurement.

Scan button

3. With the patient supine apply gel.

Have the patient lie in the supine position with
the abdominal muscles relaxed.

4. Palpate the patient’s symphysis pubis
(pubic bone).

Place an ample quantity of gel (with as few air
bubbles as possible) midline on the patient’s
abdomen, approximately one inch (3 cm)
above the symphysis pubis (pubic bone).
Make sure that there are as few air bubbles as
possible.

5a. Orient the probe during placement.

Stand to the right of the patient. The probe

handle should point toward you.

7. Verify the scan.

If the scan is “on target” the probe will display
eight arrows. On the console display, the bladder
will appear in the center of the crosshairs.

7a. Re-aiming.

If the scan is “off-target” the probe will show an

arrow (solid or ashing) indicating the direction

to move the probe to be “on target.” If the arrow
is solid, it means you are slightly “off target” and
it is strongly recommended that you re-aim and

re-scan. If the probe shows a single ashing

arrow, you must re-aim and re-scan. In either
case, the bladder will not be in the crosshairs.

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Measuring Bladder Volume

BladderScan® BVI 9400

BladderScan® BVI 9400

Measuring Bladder Volume

7b. To re-aim.

Note that the crosshairs correspond to the anatomy
of the patient as follows:

• The small dot at the base of the crosshairs
represent the feet of the patient.

• The top of the crosshairs represents the
patient’s head.

• The upper left quadrant represents the
patient’s right shoulder.

This orientation should help you in re-aiming the
probe to capture the complete bladder fully in the
image cone.

7c. Pubic bone.

You may also see a display indicating that the
pubic bone is inside the image cone. If this occurs,
you may want to re-aim and re-scan. Although the
bladder may be shown as centered in the image
cone, and your measurement may be complete,
there is a possibility that the pubic bone is obscuring
part of the bladder. By re-aiming and re-scanning
you can ensure you have captured the bladder fully
inside the image cone.

Additional Scanning Tips

Applying too much pressure when scanning will lead to a "greater than" (>) symbol
preceding the measurement. Apply less pressure and re-scan.

Hold the device steady while scanning. Movement will result in an inaccurate reading.

Volume reading will be affected by:

• The presence of scar tissue

• The presence of a catheter

• Overly obese patients

NOTE: The symbol (>) also occurs anytime two sides of the bladder wall are outside
the image cone that is with a relatively large bladder or very full bladder, especially in a
skinny subject (where the scanhead is naturally close to the bladder because there is
so little in between.) So, in many cases there will be no operator error when this symbol
occurs; it's just the result of a big/full bladder that is larger than the ultrasound scan.

With obese patients, lift as much abdominal adipose tissue out of the way of the
instrument as possible. Apply more pressure to the BladderScan BVI 9400 instrument to
reduce the amount of adipose tissue through which the ultrasound must pass.

To ensure accurate results, make sure that:

• There are no air gaps between the probe and the patient’s skin.

• You are holding the instrument steady while scanning (avoid changing its
position, angle, or pressure).

8. Save, review, and print exam results.

• To save the exam you must annotate it.

• To annotate, press and release the RECORD

button on the console. When you see the
RECORD button icon change to a STOP button
icon, record the patient information by speaking
into the probe microphone. When the hourglass
icon disappears, press the LISTEN button to
replay the annotation.

• To review the scan images, press the REVIEW

button. (You must rst save the exam before you

can review it).

• To print exam results via the onboard printer,
press the PRINT button.

• To perform another exam, press the HOME
button.

9. Finish the exam.

Once you have completed the scan, wipe the ultrasound gel off the patient and the probe.
For ScanPoint® subscribers, logging onto ScanPoint automatically transfers and saves your
annotated exams to your Windows® computer.

• You are using enough pressure to maintain good skin contact until the scan is
complete.

• There is not a catheter in the patient’s bladder. The presence of a catheter may
affect the accuracy of the bladder volume measurement, but the measurement
may still be clinically useful (detecting a blocked catheter, for example).

Recording a Voice Annotation

After performing an exam, you can record additional information about a patient to be
stored with the exam results.

The instrument can store ten scans with voice annotations, so you can perform multiple
exams on your rounds. If you are using the optional ScanPoint® with QuickPrint software,
you can upload saved exams to your PC. (Refer to the ScanPoint with QuickPrint user’s
manual for more information).

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Measuring Bladder Volume

BladderScan® BVI 9400

BladderScan® BVI 9400

Measuring Bladder Volume

Record a voice annotation.

1. Press the RECORD button (microphone). A
STOP button is now displayed.

2. The microphone is located just above
the aiming display on the probe. Hold the
microphone approximately 6 inches (15 cm)
from your mouth when you are recording the
annotation, and speak clearly.

Be sure to include all relevant exam
information, including the patient’s name and
the name of the person performing the exam.

3. When you have nished your annotation,

press the STOP button. An hour glass will be
displayed while your annotation and exam
are updated and stored. After the annotation has been saved, to listen to your
annotation, press the LISTEN button.

If you are not satised with the recording, press RECORD again to record a new

annotation.

IMPORTANT!

Deleting a Saved Exam

Saved exams are indicated by yellow folder icons along the left edge of the display. To
delete a saved exam:

1. Open the Review Screen. (From the Home Screen press

2. Press the

3. Press the

Printing

You can use the onboard printer on the BVI 9400 to print the ultrasound images captured
during the scan (Figure 28 is an example).

To print exam results press the PRINT button immediately following the exam.

Entering Additional Information

The label provides elds for Patient ID, Patient Name, Operator, and Physician. This

information must be entered manually.

Figure 28. Exam results printout using the onboard printer

)

button until the desired exam is highlighted (blue).

button to delete the exam.

• If you do not record a voice annotation for a particular exam, that exam will
be lost and the next exam you perform will overwrite the non-annotated
one.

• If the instrument battery runs low or the instrument goes into sleep mode,
any non-annotated exam data is lost. However, the instrument does not
erase any annotated exam results when it goes into sleep mode. To make
sure you do not lose any patient data, it is a good idea to add a voice
annotation to every patient exam.

• You can make a new recording only if the instrument still displays the
bladder volume for that particular exam.

4. When you are satised with your recording, wait while the instrument automatically

accepts and stores the recording with the exam results. The volume displayed
on the LCD screen disappears, and the instrument is ready to perform another
measurement.

5. If you are using the BVI 9400 in conjunction with the optional ScanPoint

®

with
QuickPrint software, you can view exam results and annotations on your PC.
Please refer to the ScanPoint with QuickPrint user’s manual for more information.

NOTE: If the facility name, date, and time have not been set, those lines will be skipped
on the printout.

The BVI 9400 prints on thermal paper, which fades over time. For maximum storage life,
Verathon® recommends that you photocopy the printout.

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page 49

Histogram of Cost Savings

BladderScan® BVI 9400

BladderScan® BVI 9400

Cleaning and Maintenance

Histogram of Cost Savings

Each volume measurement from a completed scanning procedure is stored in the
memory of the BladderScan BVI 9400 in one of eleven volume ranges (each with a
100 ml increment). This data is analyzed and can be displayed on the BVI 9400 at any
time. The Cost Savings screen lists: Date Started, Number of Scans, Cath Avoided, UTI
Avoided, Savings.

Cost savings criteria

Cost savings are based on the following criteria:

• Catheterizations avoided: Urinary catheterization is deemed unnecessary.
Thus, by using the BVI 9400, these catheterizations are avoided. The default
setting (for volume below which catheterization is unnecessary) is 200 ml.

• UTIs avoided: Studies indicate that a certain percentage of catheterizations lead
to urinary tract infections (UTIs).

By avoiding unnecessary catheterizations, the resulting UTIs are thereby
avoided. The default setting (for percent of catheterizations leading to UTIs) is
3%.

• Associated UTI costs: Literature suggests that the additional costs associated
with treating UTIs amounts to $1875.00 per patient infection. The default setting
is $1870.00.

• Cost of catheter kits: The default setting is $3.00 per kit.

• Total cost savings from using the BVI 9400 =

(Catheterizations avoided x catheter costs) + (UTIs avoided x UTI costs)

Cleaning and Maintenance

Cleaning the BladderScan BVI 9400

1. Use a soft cloth dampened with isopropyl alcohol (or an appropriate hospital
cleaning agent) to wipe the probe until it is thoroughly cleaned.

2. If you use a detergent solution to clean the instrument, remove all residual
detergent. Dry the instrument with a clean, soft cloth.

3. Alternatively, dampen a soft cloth in any glutaraldehyde-based hospital disinfectant
solution such as Cidex
Sporocidin

®

from Sporocidin International. Wipe the instrument with the dampened

cloth.

4. To remove all traces of disinfectant solution, wipe the instrument with a clean, soft
cloth dampened in sterile water or cleaning solution. Verathon
the device three separate times to remove all residual disinfectant.

5. Thoroughly dry the instrument with a clean, soft cloth before using.

Regular Inspections and Maintenance

Verathon recommends that the BVI 9400 be certied by an authorized BladderScan
Service Center once a year. Certication service includes comprehensive inspection

and testing of the instrument to ensure accurate performance in clinical use. For more
information, please contact your authorized BladderScan Service Center, your local
BladderScan distributor, or Verathon Customer Care Department. Please refer to the
contact information at the beginning of this manual.

®

or Cidex 7® from Advanced Sterilization Products, or

®

recommends wiping

NOTE: The default settings can be customized to reect the rates and costs at

your facility by selecting from the Home screen:

(SETTINGS) > SAVINGS
PREFERENCES. See Savings Preferences Screen for more information on customizing
savings preferences.

page 50 User's Manual

User's Manual

NOTE: ScanPoint® Online customers can maintain device certication via the Internet by
accessing their ScanPoint® account. For more information about using ScanPoint Online,
please refer to the ScanPoint with QuickPrint user's manual.

Weekly inspections

Once a week, you should inspect the probe and cable for physical faults or cracks.

Cracks that allow the ingress of uid may affect the performance of the instrument. Any

apparent cracks or faults in the console, probe, or the cable that links the console and
the probe, must be referred to your authorized BladderScan Service Center, your local
BladderScan distributor, your local Verathon representative, or the Verathon Customer
Care Department.

IMPORTANT! If you see any physical faults or cracks in the instrument, discontinue
use immediately and contact your local Verathon representative or the Verathon
Customer Care Department at 1.800.331.2313.

page 51

Cleaning and Maintenance

BladderScan® BVI 9400

BladderScan® BVI 9400

Cleaning and Maintenance

Using the Built-in Self-Test Utility

The BVI 9400 can perform a number of self-diagnostic tests. To access the
Self-Test utility:

1. From the Home screen, press the SETTINGS button:

2. When the Settings screen opens, press the

highlighted (red), then press

3. When the Self-Test screen opens, testing begins automatically with the display
providing status and results.

4. When the test is complete, press the SETTINGS button

Settings screen, then press the HOME button

5. If any test results were failed or abnormal, contact your authorized BladderScan
representative, or contact the Verathon Customer Care Department.

to open the Self-Test screen.

é or ê buttons until SELF TEST is

to return to the Home screen.

to return to the

Calibrating the BladderScan BVI 9400 Using the ScanPoint System

You must periodically calibrate your BladderScan BVI 9400 to make sure your instrument
is providing the most accurate results. Calibrating ensures accurate and proper alignment
of the instrument's internal coordinate system. If you do not perform the calibration by the
prescribed date, the instrument can still be used to take scans but measurements may be
compromised.

When calibration is required, a warning appears in the display header (Figure 29).

Figure 29. Calibration Warning

If you do not have ScanPoint® with QuickPrint, you must send your instrument to an
authorized Verathon® service center for calibration. Contact your Verathon Customer
Care Center for more information. For contact information, please see the front of this
manual.

Self-calibration

Self-calibration requires the ScanPoint with QuickPrint system and a calibration kit for the
BVI 9400 (P/N 0620-0340). For instructions on software requirements and installation,
please refer to the ScanPoint with QuickPrint User's Manual.

The entire calibration process takes approximately 15 minutes. ScanPoint Online plans
allow for calibration of the instrument as often as you like. You do not need to wait until
the next scheduled calibration date. However, at a minimum, you must calibrate the
instrument once every 12 months.

page 52 User's Manual

Device Repair

Unit Disposal

User's Manual

The BladderScan BVI 9400, probe, and battery charger/wireless hub are completely
sealed. There are no user-serviceable components. Verathon does not make available
any type of circuit diagrams, component parts lists, descriptions, or other information that
would be required for repairing the device and related accessories.

Premium warranty customers have access to a loaner unit and free shipping options
which vary according to plan.

If you have any questions, contact your local Verathon representative or the Verathon
Customer Care Department.

The BladderScan BVI 9400 and related devices may contain lead, mineral oils, batteries,
and other environmentally hazardous materials. When the BladderScan BVI 9400 has
reached the end of its useful service life, return the device, battery charger/wireless hub,
and related accessories to a Verathon Service Center for proper disposal. Alternatively,
follow your local protocols for hazardous waste disposal.

page 53

Troubleshooting

BladderScan® BVI 9400

BladderScan® BVI 9400

Troubleshooting

Troubleshooting

Help Resources

Verathon® provides an extensive array of customer service resources, described
in the table below.

You can obtain copies of this manual, quick reference cards, and clinical studies by
visiting the Verathon Web site at www.verathon.com or by contacting your Verathon
representative.

Resource Description

BladderScan BVI 9400
In-service CD

Onboard training
modules

BladderScan BVI 9400
Quick Reference Cards

Clinical Studies Scientic papers on BladderScan use.

ScanPoint

CD included with your BVI 9400 that shows how to use the
BladderScan.

Training modules installed on your BladderScan are
available by pressing the button from the Home Screen.
Available titles include: Using the BladderScan BVI 9400 and
NeuralHarmonics

Summary of procedures for using the BladderScan system.

®

Online ScanPoint Online provides customers:

• The ability to calibrate and certify devices
online anytime you wish .

• Automatic data backup and archiving

• Provides customers a HIPAA compliant solution for
data storage.

• Automatic software upgrades.

• Access to real-time troubleshooting from Verathon.

®

Technology.

Icons on the BladderScan Console

The following icons may appear on the instrument’s LCD screen.

Symbol Meaning

ç

Battery power level:

Indicates a fully-charged battery.

Indicates a battery 50% to 75% charged.

Indicates a battery 25% to 50% charged.

Almost depleted. Can power a few more scans.

Replace immediately.

(Green Solid arrow) The bladder is contained within the
image cone (cone-shaped area in which the probe transmits
ultrasound waves), but not centered. You may be able to
obtain a more accurate measurement by re-aiming the probe
in the direction indicated by the arrow.

(Red Solid arrow) If the condole shows a red arrow you must
re-aim and re-scan.

The patient is a small child with height less than 48 inches
(122 cm) tall and weight less than 60 lbs (27 kg).

The patient is a female patient who has not had a
hysterectomy.

Select to scan all other patients.

Premium Warranty A Verathon device warranty plan that

provides all the benets of ScanPoint
Online (preceding paragraph) and also:

• All repairs performed free of charge.

• Instrument insurance: A perpetual warranty against
outdated technology with free
upgrade/ replacement when your device
is no longer manufactured.

• Free loaner program.

• Free shipping.

Verathon Web site www.verathon.com includes many in-service training

resources. From the Verathon Home page, select
“BladderScan.” On the BladderScan page, select the
appropriate model (BVI 9400) and then click on the "Product
Materials" tab.

Phone support In North America, call: 1.800.331.2313. International

customers, please refer to the list of Customer Care
resources found at www.verathon.com/ContactUs.htm.

page 54 User's Manual

User's Manual

>

The bladder is too large to be contained within the image
cone, or the bladder contains more than 999 ml of urine.

page 55

Troubleshooting

BladderScan® BVI 9400

BladderScan® BVI 9400

Warranty

Diagnosing Problems

Instrument Does Not Turn On

If the instrument does not turn on, this is usually due to a dead or discharged battery and
can be remedied by replacing the dead battery with a charged battery. Check the battery
icon in the upper right corner of the LCD display. If the battery icon does not display any
power segments, 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 device displays the following message:

bAttErY chArgE LEvEL iS too Low for inStrUmEnt oPErAtion. rEchArgE bEforE nExt USE

In this case, the battery must be recharged or replaced with a charged one.

Printer Problems

No paper

The BladderScan BVI 9400 senses the presence of paper and automatically
displays this image when the printer is out of paper (Figure 30).

Figure 30. Printer Out of Paper Screen

Warranty

Verathon Inc. warrants the BladderScan BVI 9400 against defects in material and
workmanship as long as it is covered by the Premium Warranty.

Pursuant to this warranty, a service center authorized by Verathon® will repair or replace
units that prove to be defective during the warranty period.

This warranty does not apply if the unit was misused or modied by anyone other than a

service center authorized by Verathon.

The unit must be used in accordance with the instructions contained in this manual.
Consumable items are not covered in this warranty and should be used in conformance

with Verathon product specications.

For further details, consult your Premium Warranty. Warranty conditions may differ in
some countries outside the United States. Contact your local distributor for warranty
terms.

Disclaimer of Additional Warranties

There are no understandings, agreements, representations of warranties expressed or

implied (including warranties of merchantability or tness for a particular purpose) other

than those set forth in the preceding Warranty section. The contents of this manual do not
constitute a warranty.

For instructions on loading paper, review the onboard training module or refer to the
section in this manual titled, Load a Roll of Thermal Paper.

Too hot

The BVI 9400 displays the message TOO HOT if the print head overheats. In this case,
turn off the BVI 9400 immediately. This condition may be the result of a paper jam.

Clearing a paper jam

If the paper will not advance through the printer, open the printer door on the back of the
console and clear the paper jam.

Certain regional authorities disallow certain limitations on applied or implied warranties.
The purchaser, user, and patient should consult applicable law if there is a question
regarding this disclaimer. This information, descriptions, recommendations, and safety
notations in this manual are based upon Verathon experience and judgment with
BladderScan instruments as of July 2013. The contents of this manual should not be
considered to be all-inclusive, or to cover all contingencies.

The physician who directs the use of the BladderScan BVI 9400 at the institution where
it is in use is responsible for keeping current with clinical research in bladder volume
measurements.

Please direct any questions or problems concerning bladder volume measurement, using
the instrument, or the interpretation of data to the responsible physician.

page 56 User's Manual

User's Manual

page 57

Parts and Accessories

BladderScan® BVI 9400

BladderScan® BVI 9400

Product Specications

Parts and Accessories

BladderScan BVI 9400 System Components

The following components are included with your BladderScan BVI 9400 system.

Part Number Description

0570-0190 Console - Controls the transmission and reception of ultrasound to

measure a patient’s bladder volume

0570-0188

0570-0351

0570-0193 Battery Charger/Wireless Hub

0400-0066 Rechargeable Batteries (2 included)

0800-0319 Roll of Thermal Paper: Properly-sized paper for the onboard Printer.

0620-0340

Probe - Transmits and receives ultrasound to measure a patient’s
bladder volume

Probe (newer) - Transmits and receives ultrasound to measure a
patient’s bladder volume

Calibration Kit (optional - requires ScanPoint
software)

®

with QuickPrint

Product Specications

Standards and Regulations Compliance

Verathon® certies that all units are in compliance with all applicable international and
national standards and regulations, including but not limited to the following:

Specication Standard

International Electrotechnical
Commission

Canadian Standards Association

Underwriters Laboratories, Inc. UL 60601-1

Health Insurance Portability and Accountability Act (HIPAA)*

*For details on Verathon compliance with privacy rules, please refer to the information in
the ScanPoint

Electromagnetic Effects

®

with QuickPrint Help menu (select PRIVACY AGREEMENT).

EN/IEC 60601-1 Amendments 1 and 2 and EN/
IEC 60601-1-2 (EMC)

C22.2 No. 601.1-M90 (Master Contract No.

177198)

0800-0322 Medical Cart (optional)

0810-0201 Universal Accessory Basket for Medical Cart (optional)

0900-1606 BladderScan BVI 9400 User’s Manual (on In-service CD)

0900-1500

BladderScan BVI 9400 In-service CD (with user's manuals, video
tutorial, and quick reference cards)

0900-1601 ScanPoint with QuickPrint User's Manual (on In-service CD)

0900-1446 Quick Reference Cards - Demo/Use

0900-1447 Quick Reference Cards - Calibration

To order any of the above parts, contact your authorized Verathon sales representative or
contact the Verathon Customer Care Department at 1.800.331.2313.

There are no restrictions on the use of BladderScan BVI 9400 due to its electromagnetic
characteristics. Both the emissions from the BladderScan instrument and the
susceptibility of this instrument to interference from other sources are within prescribed
limits of all applicable standards at the date of manufacture. The emissions test

procedure that was used is specied in EN 55011:2009 for Group 1, Class A equipment

(per EN/IEC60601-1-2, 36.201.1.7).

BladderScan

BVI 9400 is suitable for use in industrial, scientic, and medical (ISM)

environments, and in domestic environments under the jurisdiction of a healthcare
professional. An indication of adverse electromagnetic effects from BladderScan BVI
9400 on another electronic device would be a degradation of performance in the other
device when the devices are operated simultaneously. If such interference is suspected,
separate the two devices as much as possible, or discontinue simultaneous operation, if
practical, and contact Verathon.

BladderScan BVI 9400 will operate normally in the proximity of other potential

interference sources, and has demonstrated immunity at a eld strength of 3 V/m (per

EN/IEC 60601-1- 2, 36.202.2.1). You do not need to take any other precautions regarding

exposure in reasonably foreseeable environmental conditions to magnetic elds,

pressure, or variations in pressure, acceleration, or thermal ignition sources.

Bluetooth

®

wireless technology

The Bluetooth technology used in the BladderScan BVI 9400 is compliant with:

• Bluetooth Specication as dened and approved by The Bluetooth Special
Interests Group.

• Logo certication with Bluetooth wireless technology as dened by The
Bluetooth Special Interest Group.

page 58 User's Manual

User's Manual

page 59

Product Specications

BladderScan® BVI 9400

BladderScan® BVI 9400

Product Specications

BladderScan BVI 9400 Instrument Specications

For technical performance assessment in an acoustic laboratory, the probe cannot be
immersed in water.

Item Specication

Input Lithium-ion battery pack. Verathon

Output No load to full load at rated voltage. Refer to unit label.

Insulation The power supply is Class I with basic insulation to

each terminal.

Transient overvoltage Category II

Weight 5.2 lb (2.36 kg) (with battery)

Display 13.36cm W x 10.13cm H (5.26” W x 3.99” H)

(640 x 480 pixels, 120 dpi)

Integrated printer Thermal label printer

Language English, Chinese Simplied, Chinese Traditional,

Czech, Danish, Dutch, Finnish, French, German,
Greek, Italian, Hungarian, Japanese, Korean,
Norwegian, Portuguese (European), Spanish,
Swedish, Turkish

®

P/N 0400-0066.

Accuracy Specications

The accuracy specications assume the instrument is being used according to the

instructions provided by Verathon

®

, scanning a tissue-equivalent phantom.

Specication Description

Bladder volume accuracy

± 15%, ± 15 ml (on a Verathon tissue-equivalent
phantom)

Bladder volume range 0 - 999 ml (0-200ml in small child scan mode)

BladderScan BVI 9400 Operating Conditions

The BladderScan BVI 9400 is designed to function properly within the following

specications:

Condition Description

Use Indoor

Ambient temperature range +10 - +40º Celsius (+50 - +104º Fahrenheit)

Atmospheric pressure range 700 hPa - 1060 hPa

Relative humidity 30% - 75% non-condensing

Ultrasound Output Parameters

Item Specication

Maximum ultrasound I
Temporal Average derated) during a scan

Maximum ultrasound I
Average derated) range during a scan

(Spatial Peak

spta

(Spatial Peak Pulse

sppa

≤ 5.0 m W/cm2

≤ 60.0 W/cm2

Maximum MI (Mechanical Index) 0.95 max

TIS/TIB/TIC range 0.0 - 4.0

Transducer diameter 13 mm (0.512 inches)

Transducer resonant frequency 3.0 MHz and 1.74 MHz

Transducer bandwidth 75% at 10 dB

Time from 3D scan initiation to result display < 3 seconds

Penetration depth (in normal North American
patient)

≥ 15 cm

Water resistance Rated at IPX1 (indicates DRIP-PROOF, a higher than

ORDINARY level of protection from drips, leaks, and
spills)

BladderScan BVI 9400 Storage Conditions

The BladderScan BVI 9400 is designed for storage under the following conditions:

Condition Description

Storage Indoor

Ambient temperature range -20 - +60º Celsius (-4 - +140º Fahrenheit)

Atmospheric pressure range 500 hPa - 1060 hPa

Relative humidity 20% - 95% non-condensing

page 60 User's Manual

User's Manual

page 61

Product Specications

BladderScan® BVI 9400

BladderScan® BVI 9400

Product Specications

BladderScan BVI 9400 Displays, Controls, and Indicators

The BladderScan BVI 9400 provides the following controls, connectors, and features:

Instrument Buttons

POWER ON/OFF, BRIGHTNESS (▲/▼), VOLUME (▲/▼). SCAN and RECORD

buttons are on the probe. Five buttons below the console LCD vary depending on current
instrument mode as follows:

Screen/Mode Active Buttons

Splash Screen

Screen(s) that display
during boot-up to show
boot-up process is
proceeding properly.

Home Screen

Appears when the

instrument is rst turned

on.

Scan Screen

Appears when the
operator presses and
holds the SCAN button.

Results Screen

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.

None.

POWER, SCAN: opens Aim/Scan screen, (1) PATIENT
TYPE: toggle between three modes: small child, female
with uterus, all other patients, (2) TUTORIAL: opens
tutorial screen, (3) SETUP: opens Setup screen, (4)
REVIEW: opens the review screen, (5) ScanPoint
transmits saved exams to ScanPoint.

POWER: No function
SCAN: Press to take a scan.
Buttons (1) - (5): No action.

POWER, SCAN: opens Aim/Scan screen, (1) RECORD:
press to record, release to replay, (2) PRINT: print to
onboard label printer, (3) PLAY: press to play voice
annotations, otherwise, no function, (4) REVIEW: opens
review screen if a voice annotation has been recorded.
Otherwise, no function, (5) HOME: return to Home screen.

POWER, SCAN, (1) NEXT: select next exam in memory,
(2) PRINT: print to onboard printer, (3) PLAY: replay voice
annotation for currently selected exam, (4) DELETE:
delete currently selected exam, (5) HOME: return to Home
screen.

POWER, (1) Skip back one chapter, (2) Play/Pause, (3)
Skip forward one chapter, (4) No function, (5) Home (return
to Home screen).

POWER, (1) No function, (2) Play/Pause, (3) Return to
Tutorial screen, (4) No function, (5) Home (return to Home
screen).

Screen/Mode Active Buttons

Settings Screen

Start screen for editing
clinic name, date & time,
general preferences,
savings preferences, and

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).
Settings: Name, Date/Time, General Preferences, Savings
Preferences, Self-Test.

self-test options.

Name Screen

Displays alpha-numeric
characters for entering

POWER, (1) Move down, (2) Move right, (3) Add currently
selected character, (4) Delete currently selected character,
(5) Return to main setup screen.

information.

Date & Time Screen

Allows the user to set the
date and time

POWER, (1) Move forward to next changeable unit,
(2) Move back to previous changeable unit, (3) Add/
toggle units as appropriate, (4) Decrease/toggle units as
appropriate, (5) Save current date/time entries and return
to main setup screen.

General Preferences
Screen

®

:

Set preferences for
language, time and date
format, time zone

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:

Languages: English (default), Chinese Simplied, Chinese
Traditional, Czech, Danish, Dutch, Finnish, French,
German, Greek, Italian, Hungarian, Japanese, Korean,
Norwegian, Portuguese (European), Spanish, Swedish,
Turkish.
Date format: mm/dd/yyyy, dd.mm.yyyy, yyyy-mm-dd
Time: 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 requires calibration.
Enable ScanPoint: On (default), Off. Select “Off” to disable
ScanPoint.
Enable Small Child Mode (SCM): On (default), Off. Select
"Off" to disable small child mode.
Print Report Type: Print Recent, Print Since New

Savings Preferences
Screen

Set preferences for UTI
Cost Savings Tracking

UTI Rate: 1% - 100% in increments of 1%
UTI Cost: $10 - $100,000 in increments of $10
Catheter Volume: 20 ml - 1,000 ml in increments of 20 ml
Currency: $ / € / £ / ¥
Catheter Cost: $1 to $1000 in increments of $1
Savings Calculation: Since New, Since 1/1/2006, Reset
Now, Print Since New, Print Recent, Hide Savings.

Self-Test Screen POWER, (1) Scroll down, (2) Scroll up, (3) No function, (4)

No function, (5) SETUP (Go back to setup screen).

ScanPoint

(NOTE: Available only

®

Screen

POWER, (1) No function, (2) No function, (3) No function,
(4) CANCEL, (5) No function.

when ScanPoint is
installed on instrument.)

page 62 User's Manual

User's Manual

page 63

Product Specications

BladderScan® BVI 9400

BladderScan® BVI 9400

Product Specications

Instrument Display

The instrument display is divided into three horizontal panes:

• The center pane is the main display area. The user interface for the center pane
varies depending on device mode.

• The header pane displays the institution name, date, time, and a battery status
icon.

• The footer pane displays icons that indicate button functions (described in the
preceding table).

Screen/Mode Display

Splash Screen

Screen(s) that display during boot-up to show boot-up
process is proceeding properly.

Home Screen Memory indicator, correct scanning technique graphic table.

Appears when the operator presses the SCAN button.

Scan Screen

As bladder volume is calculated, the display refreshes and
updates until the scan is complete.

Appears when a scan is complete. Prominently displays

Results Screen

calculated bladder volume, patient type, available memory,
and animated print icon (if print is pressed).

BladderScan BVI 9400 Icons

The BladderScan BVI 9400 uses the following icons:

Instrument Icons

Icon Description

Empty Exam Folder

Current Exam Folder

Saved Exam Folder

Tutorial Video

Device Setup Options

Review Saved Exams

Review currently saved exams. Saved exam folders on left

Review Screen

(currently selected folder is yellow) and ultrasound images
associated with selected exam.

Tutorial Screen Access to the tutorial video.

Setup Screen Lists available setting screens.

Name Screen A grid of alpha-numeric characters.

Date & Time Screen The date and time.

Preferences Screen List of available settings and their current values.

Self-Test Screen Displays test progress and results.

When ScanPoint with QuickPrint is installed on the

ScanPoint

®

Screen

instrument: Displays status information about the ScanPoint
communication. For example, when uploading an exam it
displays a progress bar.

Enable ScanPoint Connection

Start Recording Voice Annotation

Stop Recording Voice Annotation

Print Results

Play Voice Annotation

Return to Home Screen

Move Down

page 64 User's Manual

User's Manual

Delete or Cancel

page 65

Product Specications

BladderScan® BVI 9400

BladderScan® BVI 9400

Product Specications

Instrument Icons (cont'd)

Icon Description

Move Up

Select / Enter Current Item in List

Move Right

Play Video

Pause Video

Add or Increase the Current Item

Mode Icons

The current acquisition mode is indicated by one of the icons shown in the following table.

Icon Description

Male/Female (no uterus)

Female

Small Child

Delete or Decrease the Current Item

Button Not Available

Mode Selection

Orientation Icons

Orientation markers are displayed in the B-mode images displayed in review and on the printed
results.

Icon Description

Sagittal

Transverse

page 66 User's Manual

User's Manual

page 67

Product Specications

BladderScan® BVI 9400

BladderScan® BVI 9400

Product Specications

Battery Charger/Wireless Hub Specications

The battery charger/wireless hub is powered from a standard wall outlet (adaptable
to international power standards). The battery charger/wireless hub can charge two
batteries simultaneously.

Operating Conditions

The following are proper operating conditions for the battery charger/wireless hub:

Specication Description

Use Indoor

Ambient temperature range +5 - +40º Celsius (+41 - +104º Fahrenheit)

Atmospheric pressure range 700 hPa - 106o hPa

Relative humidity 30% - 75% non-condensing

Water resistance

Computer connection USB 2.0

Charger Powered by a desktop DC power supply.

Input voltage 100 - 240 VAC RMS

Input frequency 50 - 60 Hz

Input current 1 Amp max

Input connection 2 wire IEC 60320 C7

Output 9v at 1 Amp

Insulation Class II with double insulation

Rated at IPX 0 (ordinary equipment without
protection against ingress of water)

Battery Specications

The BladderScan BVI 9400 is provided with two lithium-ion batteries. A battery icon on
the instrument display is always present indicating how much power remains and when
the battery needs to be changed. The user can change the battery whenever necessary.
Removing a discharged battery and replacing with a fresh battery should not erase
any saved exams or user settings. In the event any user settings change, reset them
by following the instructions in the Getting Started section of this manual. Use only the
battery charger provided with the BVI 9400. Any other battery charger may damage the
battery pack.

The batteries meet the following specications:

Condition Description

Battery type Lithium-ion

Battery life

Charging time

Rated capacity 5200 mAh

Normal voltage 11.1 V

Max charging voltage 12.6 V

Max weight 350 g

Width 3.11 in (79 mm)

Length 4.65 in (118 mm)

Thickness 0.91 in (23 mm)

A fully charged battery can provide approximately 30 exams
within a 24-hour period.

Charging time ofine will take no more than six hours from an

empty battery to a full charge.

Fuses 250 VAC, 2A, quick acting

Testing CSA 60950-1-03/UL 60950-1

Storage Conditions

Condition Description

Storage Indoor

Ambient temperature range -20 - +60º Celsius (-4 - +140º Fahrenheit)

Atmospheric pressure range 500 hPa - 1060 hPa

Relative humidity 20% - 95% non-condensing

page 68 User's Manual

User's Manual

page 69

C0123

C U

S

BladderScan® BVI 9400

BladderScan® BVI 9400

C0123

Symbol Directory

The following table explains the industry symbols used to indicate the BladderScan
system compliance with international and national standards and regulations.

Symbol Meaning

Marked in accordance with Directive 2002/96/EC on Waste
Electrical and Electronic Equipment (WEEE) (solid bar
indicates product was put on the market after 13 August

2005).

Class II electrical equipment

Type BF applied part with EN/IEC-60601-1.

CE marked in accordance with the Medical Device Directive

C0123

(MDD). Number refers to Notied Body.

Canadian Standards Association (CSA) mark of certication

to United States standards for electromedical equipment.

Symbol Meaning

Energy Efciency Level V

Connector Polarity Mark

TUV - Safety approval mark for components or
subassemblies

GS - German safety approval showing conformity with the
German Equipment Safety Law

Danger of electric shock

Power

USB

Lithium-ion batteries in shipping package

Flammable

P

Y

M
N

f

+60:

l

-20:

Tested to Federal Communications Commission
Requirements

European Representative

This unit is powered by a lithium-ion battery pack.

Warning or Caution - consult accompanying documents.
Read instructions before connecting or operating. Pay
special attention.

Manufacturer of the Product

Manufactured date

Serial #

Temperature range -20º C to +60º C

Fragile

Limited power source

Eljintek - Manufacturer of the switching power supply.

Symbols assigned to GMN for CSA inspector audits.

page 70 User's Manual

User's Manual

page 71

Glossary

BladderScan® BVI 9400

BladderScan® BVI 9400

Glossary

Glossary

Term Meaning

Aiming Arrows Arrows that appear on the LCD screen to indicate the location of

the bladder relative to the probe. Eight arrows displayed (aiming
in different directions) means that you are on target.

Battery Charger/
Wireless Hub

The unit that charges the lithium-ion batteries that power the
BladderScan instrument. It simultaneously receives and sends
information from/to a BVI 9400 instrument within communication
range.

BladderScan The BladderScan

instrument transmits ultrasound energy to
produce an image of the patient’s bladder and determine bladder
volume.

Calibration Kit Tools for calibrating your BladderScan instrument. The calibration

container has a spiral-shaped target which provides a known
reference shape. The calibration of the instrument to this known
reference assures the accuracy of volume measurements.

Console The main BladderScan device that provides operating controls

and communicates with the user via images and text displays on
an LCD screen.

Coupling Medium A substance, such as ultrasound gel, that enhances the

transmission of ultrasound waves.

Term Meaning

SCAN Button Located on the underside of the BladderScan probe, this button is

used to initiate the measurement.

ScanPoint
Imaging
Technology

®

The software and online service provided by Verathon® that prints
exam results, maintains patient records, displays ultrasound
images from exams, downloads software updates, and calibrates
the BladderScan instrument.

ScanPoint with
QuickPrint

ScanPoint with QuickPrint is a software program installed on your
computer that communicates with ScanPoint Online to help you
quickly and easily download and print exams results.

Sleep Mode When the BladderScan instrument shuts down to conserve

energy. Press any button to turn on the instrument.

Solid Aiming
Arrow

Indicates the bladder is inside the image cone but is not
completely centered. The arrow shows the direction to move
or tilt the probe to improve the measurement. Re-aiming is
recommended but not required.

Supine Position Refers to the patient laying on his/her back with their face upward.

Suprapubic The area above the pubic bone.

Symphysis Pubis The front of the pelvis where the pubic bones meet.

Ultrasonic Involving ultrasound. Ultrasound is sound at frequencies above

the range that can be heard by the human ear.

Flashing Aiming
Arrows on the
Probe

Indicate the bladder is not inside the image cone and the probe
needs to be redirected. The arrow shows the direction to move or
tilt the probe to improve the measurement. Re-aiming is required.

HIPAA Health Insurance Portability and Accountability Act, enacted by

the US Congress in 1996.

Image Cone During a bladder volume measurement, this is the cone-shaped

area in which the probe transmits ultrasound waves.

Instrument In this manual, refers to the BladderScan BVI 9400. The

BladderScan instrument transmits ultrasound energy to produce
an image of the patient’s bladder and determine bladder volume.

LCD Screen The LCD (liquid crystal display) screen on the BladderScan

console that displays the bladder volume measurement,
instrument status, and other exam settings and information.

NeuralHarmonics
Technology

®

A patent-pending ultrasound technology that sharpens accuracy
and accelerates speed of three-dimensional ultrasound bladder
volume measurements.

Probe The handheld part of the BladderScan instrument that transmits

ultrasound energy to the patient.

page 72 User's Manual

User's Manual

page 73

BladderScan® BVI 9400

Bladder Volume Instrument

User’s Manual Addendum

IMPORTANT! The present User's Manual (BladderScan® BVI 9400 User’s Manual - PN:

0900-2864-04-60) has the following changes as of July 28, 2013:

• Page 17: "Parts and Accessories"

Add new part: 0570-0351, Probe.

• Page 19: "Caution! Possible device damage! DO NOT remove the battery for any reason
while the BVI 9400 is on. Doing so will damage the instrument. Always turn off the BVI
9400 before removing the battery."

This caution no longer applies. Due to a software change, the battery may be
removed while the unit is on; however, the unit will lose power and if a scan
was in progress it will be lost.

• Page 21: "Set the Date and Time The clock can hold the current time and date setting for

up to ve minutes after the battery is removed. Time and date settings will be lost if the
battery is removed from the instrument for longer than ve minutes."

This statement no longer applies as the clock is now backed up by a long­lasting lithium Ion battery.

• Page 42: "Memory Optimization During Power Down"

This section no longer applies.

• Page 43: "Before You Begin the Exam: Note: Time and date settings will be lost if the

battery is removed from the instrument for longer than ve minutes."

This statement no longer applies as the clock is now backed up by a long­lasting lithium Ion battery.

• Page 47: "Note The BVI 9400 is able to scan rapidly and repeatedly throughout the day.
If however scans are taken quickly, in rapid succession, over a 30 minute period, some
slowing in performance may be noticed. While this may occur rarely, it is normal for the
instrument."

Due to a software change, the performance of the instrument as described
above no longer applies.

• Page 57: "Disclaimer of Additional Warranties"

Date of "December 2007" should be amended to July 2013.

• Page 60: "BladderScan BVI 9400 System Components"

0900-4343-00-60

Add new part: 0570-0351, Probe.

BladderScan BVI 9400

User’s Manual Addendum

Scan Counter Feature

BladderScan BVI 9600

AortaScan AMI 9700

Important! This addendum is effective as of November 1, 2013.

BladderScan® BVI 9000 Series instruments and AortaScan® AMI 9700 Aortic Measurement Instruments are
equipped with a scan counter feature that counts all scan button pushes that are captured by the console.
The scan count can be viewed on the Self Test screen. It is designed to enable clinical users or service
technicians to determine the number of scans the device has performed over its lifetime. It counts all scans
taken with the instrument, including air scans and practice scans. The counter advances automatically after
each scan.

To ensure reliability, a backup copy of the scan count is stored in device memory. If both the scan
counter and its backup copy are corrupted, the scan counter will automatically reset to a zero value. If
one of the storage locations fails, the text “EEPROM Failed” will be added to the DSP status line of the
self-test function. In the event of an EEPROM failure, the counter will continue to work but will not have
a backup copy stored in the instrument. To restore the scan counter function with backup storage,
please contact your Verathon® service representative or Verathon Customer Care at 800.331.2313 or
+1.425.867.1348.

0900-4394-00-60

0900-1606-04-20