Verathon
or registered trademarks, and Total Reliability
, Verathon Medical®, BladderScan®, ScanPoint®, Sontac®, and NeuralHarmonics™ are either trademarks
SM
Plan is a service mark of 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.
®
is a registered trademark of Advanced Sterilization Products.
Cidex
Sporocidin
®
is a registered trademark of Aporocidin International.
All other brand and product names are trademarks or registered trademarks of their respective owners.
The BladderScan
6,676,605, and 6,884,217. The ScanPoint
6,569,097. The Sontac
®
technology described in this manual is protected by U.S. Patent Numbers 4,926,871, 5,235,985,
®
ultrasound coupling pad described in this manual is protected by U.S. Patent Number
®
technology described in this manual is protected by U.S. Patent Number
5,782,767. Other international 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 fictitious 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: 425.883.2896
Verathon Medical (Japan) K.K.
Executive Tower Azabudai 7F
1-4-3 Azabudai
Minato-ku, Tokyo 106-0041
Japan
+81.3.3560.3501
Fax: +81.3.3560.3502
Verathon Medical (Europe) B.V.
EC REP
Boerhaaveweg 1
3401 MN IJsselstein
The Netherlands
+31.30.68.70.570
Fax: +31.30.68.70.512
Verathon Medical (France)
Postal Address
BP 10039
F-67012 Strasbourg Cedex
France
+33.3.88.60.14.12
Fax: +33.3.88.60.46.87
NOTE: This procedure requires ScanPoint® with QuickPrint Imaging
Technology Software. If your BladderScan
calibration, and you’re not using ScanPoint
contact Verathon
Parts and Accessories.............................................................................................................................21
Getting Started ..........................................................................................................................................22
Unpack the Box and Check the Components .........................................................................................22
Charge the Batteries................................................................................................................................22
Install a Battery Pack in the Console....................................................................................................... 23
Unit Disposal ...........................................................................................................................................58
Help Resources .......................................................................................................................................59
No Paper.............................................................................................................................................. 61
Too Hot ................................................................................................................................................62
Clearing a Paper Jam .......................................................................................................................... 62
Symbol Directory ..................................................................................................................................... 67
Standards and Regulations Compliance ................................................................................................. 68
Figure 3. Home Screen............................................................................................................................... 24
Figure 29. Printer Out of Paper Screen ......................................................................................................62
User’s Manual page 12
BladderScan® BVI 9400 President’s Statement
President’s Statement
President’s Statement
The team at Verathon® is committed to improving health care delivery by
putting healthcare providers and their patients first.
Our products support you, the health care provider, by consistently
offering accuracy, utility, reliability and excellence.
Please contact us directly at 1.800.331.2313 (USA and Canada only) or
1.425.867.1348, if we can improve our service to you.
Sincerely,
Gerald McMorrow
Gerald McMorrow, CEO, Founder and Chairman of the Board
User’s Manual page 13
Important Information BladderScan® BVI 9400
Important Information
Important Information
Product Description
BladderScan® instruments are the gold standard in bladder volume measurement.
The BladderScan
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
and easy to use. When the user releases the scan button, within seconds, BladderScan
measures ultrasonic reflections on multiple planes inside the body and produces a threedimensional image. Based on this image, the BladderScan
displays the bladder volume. A sonographer is not required.
Patented NeuralHarmonics™
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 multi-spectral analysis to a
robust data set, helps reduce margin of error and minimize uncertainty in essential
measurements of bladder function.
BladderScan
transmitted, using HIPAA-compliant ScanPoint
Software (optional), to your office or facility computer for viewing, printing, or archiving.
®
is noninvasive and comfortable for the patient. It is accurate, reliable, quick
®
BVI 9400 measurements can be printed via an onboard printer or
®
BVI 9400, with patented NeuralHarmonics™ technology, is a portable
®
BVI 9400 calculates and
technology (abbreviated from “neural network harmonics”)
®
with QuickPrint Imaging Technology
®
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
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
select the BladderScan
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
limited to the minimum level necessary for effective performance. Data on acoustic output
levels can be found in the “Technical Description” section of this manual.
®
> Customer Support links to open a link to this manual and other
®
BVI 9400. Do not attempt to
®
Web site at: http://www.verathon.com, then
®
BVI 9400 is not user adjustable and is
page 14 User’s Manual
BladderScan® BVI 9400 Important Information
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 (U. S. Only)
The BladderScan
®
BVI 9400 is not intended for fetal use or for use on pregnant patients.
To assure safe and reliable operation for the use and the patient, please read and heed
the following warnings and cautions.
WARNING! Risk of explosion.
If you use the BladderScan® BVI 9400 in the presence of flammable anesthetics, the
hazard of potential explosion exists.
WARNING! Risk of explosion, fire, 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 fire and could
also damage the battery pack and the BladderScan® device.
WARNING! Risk of explosion, fire, 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 fire, 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 useradjustable and is limited to the minimum level necessary for effective performance. For
more information about the acoustic output levels of this device, please refer to the
section in this manual titled BladderScan® BVI 9400 Instrument Specifications on
page 69.
CAUTION: Risk of inaccurate measurements/results.
When using the BladderScan® BVI 9400 be aware of the following conditions which can
affect ultrasound transmission and decrease the accuracy of exam results.
Use care when scanning patients who have had supra-pubic or pelvic surgery.
Scar tissue, surgical incisions, sutures, and staples can affect ultrasound
transmission and accuracy.
User’s Manual page 15
Important Information BladderScan® BVI 9400
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.
CAUTION: Observe the following precautions in the safe use and care of the
The BladderScan
batteries, and other environmentally hazardous materials. When the BladderScan
9400 has reached the end of its useful service life, return the device, charging cradle, and
related accessories to a Verathon
®
BVI 9400 and related devices may contain lead, mineral oils,
®
Service Center for proper disposal. Alternatively,
®
BVI
follow your local protocols for hazardous waste disposal.
Assure proper computer system configuration.
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 Medical
the Verathon Medical
®
Customer Care Department at 1.800.331.2313.
Assure proper distance from patient.
When transmitting data to or from you computer, make sure that the BladderScan
®
representative, or
®
BVI
9400, accessories, and computer are outside the patient vicinity (more than six feet (2
meters) from the patient). Refer to UL 2601-1 Clause 2 deviation for the definition of
patient vicinity.
Bluetooth
The Bluetooth technology used in the BladderScan
®
Wireless Technology
®
BVI 9400 is compliant with:
Bluetooth Specification as defined and approved by The Bluetooth Special
Interests Group.
Logo certification with Bluetooth wireless technology as defined by The Bluetooth
Special Interest Group.
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 loose 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).
page 16 User’s Manual
BladderScan® BVI 9400 Introducing the BladderScan® BVI 9400
Introducing the BladderScan® BVI 9400
Introducing the BladderScan
Product Description
BladderScan® instruments are the gold standard in bladder volume measurement.
The BladderScan
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
and easy to use. When the user releases the scan button, within seconds, BladderScan
measures ultrasonic reflections on multiple planes inside the body and produces a threedimensional image. Based on this image, the BladderScan
displays the bladder volume. A sonographer is not required.
Patented 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 multi-spectral analysis to a
robust data set, helps reduce margin of error and minimize uncertainty in essential
measurements of bladder function.
BladderScan
transmitted using HIPAA-compliant ScanPoint
Verathon
computer for viewing or printing. (NOTE: Use of ScanPoint
®
is noninvasive and comfortable for the patient. It is accurate, reliable, quick
®
BVI 9400 measurements can be printed via an onboard printer or
®
servers. Stored exams can be accessed at any time from your office’s
®
BVI 9400
®
BVI 9400, with patented NeuralHarmonics™ technology, is a portable
®
BVI 9400 calculates and
®
technology for storage and archiving on
®
software is optional.)
®
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 on-board 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 purpose-designed 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.
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 purpose-designed cart which holds
the instrument securely and provides a holder for ultrasound gel and other accessories.
User’s Manual page 17
Introducing the BladderScan® BVI 9400 BladderScan® BVI 9400
The BladderScan® BVI 9400 is designed for simple, intuitive operation. However, to
ensure safe and effective operation, before using the device:
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
Console
Main display
Battery
Pack
5 Variable
Function
Buttons
Adjust
Brightness
Battery Status Indicator
Printer (behind display)
Battery Packs
Battery Charger/
Wireless Hub
Power On/Off
Adjust
Volume
Probe
(Scan button
on hand grip)
Aiming Display
Microphone
(above display)
page 18 User’s Manual
BladderScan® BVI 9400 Introducing the 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:
Part Name Purpose
SCAN button
Aiming Display
Press to take a scan.
The LCD displays directional arrows to assure that the bladder
is centered within the scanning cone.
Microphone
Records voice annotations.
Console Components
The Console provides all operating controls for the scanning process by means of five
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
Volume
Press to adjust volume up/down on voice annotation
playback, start up sound, and “scan complete” tone.
Brightness
5 Variable Function
Buttons
Press to adjust display brightness dimmer/brighter.
Depending on device mode, the buttons provide access to all
instrument functions for scanning, recording annotations,
printing, connecting to ScanPoint
®
(optional), accessing the
training video, and setting user preferences.
Printer / Printer Door
Press to release the Printer door.
User’s Manual page 19
Introducing the BladderScan® BVI 9400 BladderScan® BVI 9400
Battery Charger/Wireless Hub
The BladderScan® BVI 9400 is powered by a Lithium Ion (Li-Ion) battery pack. 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
®
with QuickPrint 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
Plug into wall outlet
to power the
battery charger.
Plug into a USB port on the
ScanPoint
(optional) to enable a wireless
connection with the BVI 9400.
®
host computer
page 20 User’s Manual
BladderScan® BVI 9400 Introducing the BladderScan® BVI 9400
Parts and Accessories
Part Number Description
0570-0190
0570-0188
0570-0193
0570-0066
0900-1606
0900-1601
0900-1446
0900-1447
0800-0319
0900-1500
0800-0322
0900-1238
BVI 9400 Instrument - Console
BVI 9400 Instrument - Probe
Battery Charger/Wireless Hub
Lithium Ion Battery (2 provided)
BVI 9400 User’s Manual (on In-Service CD)
ScanPoint
®
with QuickPrint User’s Manual (on In-Service CD)
Quick Reference Card - Demo/Use
Quick Reference Card - Calibration
Thermal Paper Roll for the Printer
BladderScan
®
BVI 9400 In-Service CD (Includes User’s Manuals,
Video Tutorial, and Quick Reference Cards)
Mobile Cart (optional)
ScanPoint
ScanPoint
®
with QuickPrint Software Install CD. NOTE: Use of the
®
software is optional and not required for operation of the
BVI 9400.
0620-0340
0800-0225
0800-0005
Calibration Kit (Optional - Requires ScanPoint
®
with QuickPrint
software. Includes Calibration Container, Calibration Target, etc.)
Sontac
®
Gel Pads, QTY 50
Acoustic Coupling Gel, 0.25 liter (case of 12)
User’s Manual page 21
Getting Started BladderScan® BVI 9400
Getting Started
Getting Started
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 first use.
To help you get up and running as quickly as possible, the next few pages explain how
to:
Unpack the BladderScan
Charge and install the batteries
Customize the display (enter your institution’s name, date, time, and other user
data)
Assemble the mobile cart (optional)
Install the ScanPoint
Unpack the Box and Check the Components
Set the shipping container right side up and carefully open the top flaps (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 Medical
Department at 1.800.331.2313.
(1) BladderScan
®
BVI 9400 (Console and Probe)
®
BVI 9400 and related accessories
®
with QuickPrint software (optional)
®
representative or Verathon Medical® Customer Care
(1) Medical Cart (optional)
(2) Rechargeable Lithium Ion batteries
(1) Battery Charger/Wireless Hub
(1) In Service CD (includes User 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
charger will bring the batteries to a full charge within 6 hours or less.
NOTE: Before using the BladderScan
both batteries prior to first use.
®
instrument. This ensures that there is no instrument downtime. The
®
BVI 9400 for the first time, you will need to charge
page 22 User’s Manual
BladderScan® BVI 9400 Getting Started
To charge the batteries:
1. Plug the Battery Charger/Wireless Hub unit in to a standard wall outlet.
2. Remove the label covering the battery contacts and 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.
3. Check the colored indicator lights on the battery charger to determine battery
status:
If the battery pack is leaking or its case is cracked, put on protective gloves to handle 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, fire, 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.
NOTE: 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
do not plan to use the BladderScan
®
BVI 9400 draws very little power when it is turned off. However, if you
®
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.
User’s Manual page 23
Getting Started BladderScan® BVI 9400
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: 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, circumflex, etc.) and/or non-Latin characters can
be entered only by using ScanPoint
extended or non-Latin characters, please refer to the instructions in the ScanPoint
®
with QuickPrint software. To enter a name that uses
®
with
QuickPrint User’s Manual.
To enter your clinic’s name:
1. Turn the BladderScan
®
BVI 9400 on by pressing the POWER button on top of the
Console.
Figure 3. Home Screen
2. When the Home screen appears
(Figure 3), press the S
button
to open the Settings
ETTINGS
screen.
Figure 4. Settings Screen
3. On the Settings screen (Figure 4),
push either the Å or Æ button until
Name is highlighted (red). Press
the
button to open the Alpha-
Numeric screen.
page 24 User’s Manual
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