Verathon BLADDERSCAN BVI 6400 Manual

BLADDERSCAN
BVI6400
Operations & Maintenance Manual

0900‑4831‑02‑60

BLADDERSCAN
BVI6400
Operations & Maintenance Manual
Effective: November 1, 2018
Caution: Federal (United States) law restricts this
device to sale by or on the order of a physician.

CONTACT INFORMATION
To obtain additional information regarding your BladderScan system,
please contact Verathon®Customer Care or visit verathon.com/support.
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011 U.S.A.
Tel: [phone] (US and Canada only)
Tel: [phone]
Fax: [phone]
verathon.com
Verathon Medical (Europe) B.V.
Willem Fenengastraat 13
1096 BL Amsterdam
The Netherlands
Tel: [phone]
Fax: [phone]
Verathon Medical (Australia) Pty Limited
Unit 9, 39 Herbert Street
St Leonards NSW 2065
Australia
Within Australia: 1800 613 603 Tel / 1800 657 970 Fax
International: [phone] Tel / [phone] Fax
0123
Copyright 2018 Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the
express written consent of Verathon Inc.
Verathon, the Verathon torch symbol, BladderScan, the BladderScan symbol, ScanPoint, and Vmode are trademarks or registered
trademarks, and Total Reliability Plan is a service mark of Verathon Inc. All other brand and product names are trademarks or registered
trademarks of their respective owners.
Information in this manual may change at any time without notice. For the most up‑to‑date information, see the documentation
available at verathon.com/product‑documentation.

i
Operations & Maintenance Manual: Table of Contents
TABLE OF CONTENTS
IMPORTANT INFORMATION.................................................................................................................................1
Overview ............................................................................................................................................................1
Product Description .........................................................................................................................................1
Statement of Intended Use ..............................................................................................................................1
Essential Performance ......................................................................................................................................1
Environments of Intended Use .........................................................................................................................1
Notice to All Users ...........................................................................................................................................1
Safety Information ..............................................................................................................................................2
Ultrasound Energy Safety.................................................................................................................................2
Contraindications.............................................................................................................................................2
Cautions & Warnings .......................................................................................................................................2
INTRODUCTION ....................................................................................................................................................7
System Overview ................................................................................................................................................7
BladderScan BVI6400 .....................................................................................................................................7
ScanPoint Image Management Technology (Optional) .....................................................................................7
System Components & Accessories .....................................................................................................................8
Required System Components .........................................................................................................................8
Optional Components & Accessories................................................................................................................9
Buttons, Parts, & Icons ......................................................................................................................................10
Buttons & Parts..............................................................................................................................................10
Screen Icons .................................................................................................................................................. 11
SETTING UP ......................................................................................................................................................... 13
Procedure 1. Perform Initial Inspection ..................................................................................................... 13
Procedure 2. Charge the Device ............................................................................................................... 13
Procedure 3. Activate the Device (Optional) .............................................................................................. 14
Procedure 4. Install ScanPoint Software (Optional)................................................................................... 14

ii
MEASURING BLADDER VOLUME.......................................................................................................................15
Performing Scans.............................................................................................................................................. 15
Procedure 1. Prepare for the Exam ........................................................................................................... 16
Procedure 2. Measure Bladder Volume ..................................................................................................... 16
Scanning Tips....................................................................................................................................................20
CLEANING & DISINFECTING ...............................................................................................................................22
Procedure 1. Clean & Disinfect the Device ................................................................................................24
MAINTENANCE & TROUBLESHOOTING.............................................................................................................25
Regular Inspections ..........................................................................................................................................25
Calibrating the Device.......................................................................................................................................25
Procedure 1. Calibrate the Device.............................................................................................................25
Warranty ..........................................................................................................................................................29
Device Repair or Replacement ...........................................................................................................................30
Troubleshooting................................................................................................................................................31
Frequently Asked Questions...........................................................................................................................31
Help Resources ..............................................................................................................................................32
Device Disposal.................................................................................................................................................32
PRODUCT SPECIFICATIONS.................................................................................................................................33
Component Specifications ................................................................................................................................33
Device Specifications......................................................................................................................................33
Charging Cradle Specifications.......................................................................................................................35
Electromagnetic Compatibility...........................................................................................................................36
Electromagnetic Emissions .............................................................................................................................36
Electromagnetic Immunity .............................................................................................................................36
Recommended Separation Distances..............................................................................................................39
Accessory Conformance to Standards.............................................................................................................39
GLOSSARY ...........................................................................................................................................................40

1
Operations & Maintenance Manual: Important Information
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan®BVI6400 bladder volume instrument is a wireless, battery‑powered, ultrasound device that
provides a noninvasive measurement of urinary bladder volume.
During each scan, the device employs patented Vmode®technology to create a three‑dimensional image
of the bladder, which automatically calculates and displays measurements based upon this image. Vmode
measurements tend to be more accurate than those obtained from conventional two‑dimensional
ultrasound, as they are based on a more complete, multi‑faceted image of the bladder.
Optionally, exam results may be transmitted to a personal computer running ScanPoint®with QuickPrint
software via a USB communication cradle. ScanPoint with QuickPrint allows the user to archive data,
calibrate the device, update software, print, and transfer data through an application‑based interface.
STATEMENT OF INTENDED USE
The BladderScan BVI6400 is an ultrasound device intended to be used for measuring the urine volume in the
bladder noninvasively.
ESSENTIAL PERFORMANCE
Essential performance is the system performance necessary to achieve freedom from unacceptable risk.
The essential performance of the BladderScan BVI6400 system is to produce ultrasonic output energy and
display numerical values for bladder volume. The system has a passively temperature‑controlled transducer
assembly.
ENVIRONMENTS OF INTENDED USE
The BladderScan BVI 6400 system is intended to be used in professional healthcare environments such as
hospitals, clinics, and doctors’ offices.
NOTICE TO ALL USERS
This device should be used only by individuals who have been trained and authorized by a physician or the
institution providing patient care. All users must read this entire manual prior to using the device. Do not
attempt to operate the device 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.

2
SAFETY INFORMATION
ULTRASOUND ENERGY SAFETY
To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects. However,
ultrasound should be used prudently, and total patient exposure should be kept as low as reasonably achievable
(ALARA). Following the ALARA principle, ultrasound should only be used by medical professionals when
clinically indicated, using the lowest possible exposure times necessary to obtain clinically useful information.
For more information on ALARA, please refer to the American Institute of Ultrasound in Medicine publication,
Medical Ultrasound Safety.
The ultrasound output power of this device is not user adjustable and is limited to the minimum level
necessary for effective performance. For more information about acoustic output levels, see the Product
Specifications chapter on page33
CONTRAINDICATIONS
This device is not intended for fetal use or for use on pregnant patients, patients with open skin or wounds in
the suprapubic region, or patients with ascites.
CAUTIONS & WARNINGS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of
the device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction,
failure, or damage to the product. Throughout the manual, pay attention to sections labeled Important, as
these contain reminders or summaries of the following cautions as they apply to a specific component or
usesituation. Please heed the following warnings and cautions.
PRECAUTIONS
When using the system with optional ScanPoint®software, your computer must be minimally
certified to EN/IEC/CSA/UL 60950‑1 or 60601‑1 standards. This configuration ensures that
compliance to the EN/IEC60601‑1 system standard is maintained. Anyone connecting additional
equipment to the 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. If you need
assistance, contact your biomedical staff, local representative, or Verathon®Customer Care.
CAUTION
Failure to follow these instructions may cause device damage not covered by the warranty:
• Do not immerse the device in cleaning or disinfectant solution or other liquids.
• Do not subject any part of the device to steam, ethylene oxide, radiation, or similar methods
of sterilization or autoclaving.
• Do not use metal or abrasive brushes. These may scratch the device, causing permanent damage.
• Do not use CIDEXPLUS®to disinfect the device. CIDEXPLUS will damage the plastic enclosure.
CAUTION

3
Operations & Maintenance Manual: Important Information
Statement of Prescription: Federal (United States) law restricts this device to sale by or on the
order of a physician.
CAUTION
Medical electrical equipment requires special precautions regarding electromagnetic
compatibility (EMC) and must be installed and operated according to the instructions in this
manual. For more information, see the Electromagnetic Compatibility section on page36.
This device can radiate radio frequency energy and is very unlikely to cause harmful interference
with other devices in the vicinity. There is no guarantee that interference will not occur in a
particular installation. Evidence of interference may include degradation of performance in this
device or other devices when operated simultaneously. To correct interference, use the following
measures:
• Turn devices on and off in the vicinity to determine the source of interference
• Reorient or relocate this device or other devices
• Increase the separation between devices
• Connect the device to an outlet on a circuit different than the other device(s)
• Eliminate or reduce EMI with technical solutions (such as shielding)
• Purchase medical devices that comply with IEC60601‑1‑2 EMC Standards
Be aware that portable and mobile radio frequency communications equipment (cellular phones,
etc.) may affect medical electrical equipment; take appropriate precautions during operation.
CAUTION

4
WARNINGS
This system may only be cleaned and disinfected by using the approved processes provided in
this manual. Cleaning and disinfection methods listed are recommended by Verathon®based on
compatibility with component materials.
WARNING
Availability of cleaning, disinfection, and sterilization products varies by country, and Verathon is
unable to test products in every market. For more information, please contact Verathon Customer
Care or your local representative. For contact information, visit verathon.com/support.
WARNING
Cleaning is critical to ensuring the component is ready for disinfection. Failure to properly clean
the device could result in a contaminated device after completing the disinfection procedure.
WARNING
Ensure that you follow the manufacturer’s instructions for handling and disposing of the
cleaning and disinfection solutions provided in this manual.
WARNING
When preparing and using one of the approved cleaning, disinfection, or sterilization solutions,
follow the instructions of the solution manufacturer. Pay close attention to the proper dilution
and immersion times.
WARNING
In order to maintain electrical safety, use only the provided power adapter, battery, and battery
charger.
WARNING
To reduce the risk of electric shock, use only the accessories and peripherals recommended by
Verathon.
WARNING

5
Operations & Maintenance Manual: Important Information
The docking station, charging cradle, power adapter, and power cords are not intended for
patient contact. Ensure 2m (6ft) is maintained between the patient and these components.
WARNING
Ensure proper distance from patient. When transmitting data to or from your computer, make sure
the device, accessories, and computer are outside the patient vicinity (more than 2m (6ft) from
the patient).
WARNING
Do not use the system on:
• Fetal patients.
• Pregnant patients.
• Patients with open skin or wounds in the suprapubic region.
• Patients with ascites.
WARNING
To reduce the risk of electric shock or burns, do not use the system in conjunction with
high‑frequency surgical equipment.
WARNING
To reduce the risk of electrical shock, do not attempt to open the system components. This may
cause serious injury to the operator or damage to the device and will void the warranty. Contact
Verathon®Customer Care or your local representative for all servicing needs.
WARNING
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and cause improper operation.
WARNING
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30cm (12inches) to any part of the
BladderScan BVI 6400 system, including cables specified by Verathon. Otherwise, degradation
of performance of this equipment could result.
WARNING

6
To reduce the risk of explosion, do not use the system in the presence of flammable anesthetics.
WARNING
No modification of this equipment is allowed.
WARNING
Be aware of the following conditions that can affect ultrasound transmission:
• Catheterization—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).
• Abdominal Surgery—Scar tissue, surgical incisions, sutures, and staples can affect ultrasound
transmission. Use care when scanning patients who have had abdominal surgery.
WARNING
Accuracy is compromised if you do not obtain an optimal, repeatable image.
WARNING
To reduce the risk of leakage, explosion, fire, or serious injury, note the following when handling
the lithium‑ion battery included in the system:
• Never short‑circuit the battery by bringing the battery terminals into contact with any other
conductive object.
• Never expose the battery to abnormal shock, vibration, or pressure.
• Do not disassemble, heat above 60°C (140°F), or incinerate the battery.
• 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.
• If the battery is leaking or its case is cracked, put on protective gloves to handle it, and
discard it immediately.
• Put insulating tape, such as cellophane tape, on the electrodes during transportation.
WARNING

7
Operations & Maintenance Manual: Introduction
INTRODUCTION
SYSTEM OVERVIEW
The BladderScan BVI6400 is a portable, hand‑held ultrasound device that scans the patient’s bladder. It is
battery‑powered with an ergonomic design. Using patented Vmode®technology, it provides a noninvasive
measurement of urinary bladder volume. The display provides aiming assistance and provides an array of
bladder measurement information.
The device measures ultrasonic reflections on multiple planes inside the body, producing a three‑dimensional
image. Based on this image, the device calculates and displays the bladder volume. A sonographer is not
required.
Volume measurements made with Vmode ultrasound are more accurate than those from conventional
ultrasound, as they are based on a more complex, three‑dimensional image of the bladder.
The device includes an integrated microphone for recording voice annotations. Voice annotation allows up to
10 exams to be stored on the device.
BLADDERSCAN BVI6400
This hand‑held, portable device:
• Measures bladder volume noninvasively.
• Takes scans quickly, providing test results in a matter of seconds.
• Is easy to operate: staff members can easily learn to scan patients quickly
and accurately.
• Provides the capability to voice annotate each exam (10seconds to record
patient ID and relevant exam information), ensuring that valuable patient
and exam data is retained.
• Stores voice‑annotated data for up to ten exams.
• Improves efficiency of healthcare professionals who examine multiple
patients on their rounds.
• Allows for exam results and images to be downloaded, viewed and
printed using the optional ScanPoint®Image Management Technology.
• Is battery‑operated, lightweight, and portable.
SCANPOINT IMAGE MANAGEMENT TECHNOLOGY (OPTIONAL)
You may transmit bladder volume measurements and ultrasound images from your BladderScan device to
ScanPoint image management software. ScanPoint installs on a Windows®‑based computer and allows
viewing, printing, and archiving of patient exam results, including ultrasound images for patient records and
reimbursement (when applicable). Exam data and ultrasound images may be printed in a variety of report
formats from adhesive labels that may be affixed to patient charts, to full, letter‑size formats.
ScanPoint can also be used to calibrate your device. The ScanPoint image management technology
(ScanPoint software, license, and accessories) is available with the purchase of many BladderScan systems.
Comprehensive service and warranty are provided under the ScanPoint Total ReliabilitySM Plan.

8
Note: Plan availability and conditions may differ depending on your location. For more information about
terms and availability, contact Verathon®Customer Care or your local representative.
ScanPoint Local Client (LC) is a stand‑alone, non‑networked version of the software. It is available for use
with this device.
ScanPoint with QuickPrint is a network‑based version of the application. Archived patient data is
stored securely on HIPAA‑compliant, Verathon‑maintained servers. Users can access records from any
Internet‑enabled, Windows‑based PC. ScanPoint with QuickPrint allows users to maintain the most recent
software for their devices, to calibrate their devices themselves without having to send them in for service,
and also enables remote diagnostics and troubleshooting by Verathon service technicians.
SYSTEM COMPONENTS & ACCESSORIES
REQUIRED SYSTEM COMPONENTS
Table 1. Required System Components and Accessories
PART DESCRIPTION
BladderScan BVI6400
Hand‑held, wireless, battery‑operated, ultrasound bladder volume instrument.
Charging cradle
Use the charging cradle to charge the device’s internal battery. The
charging cradle plugs directly into an electrical wall outlet. Before using
your device, you must charge it for a minimum of 6hours.
BladderScan BVI6000 series in‑service CD
Includes the electronic version of this operations and maintenance manual.
Activation tool
If needed, use this tool in order to press the Activation button on the device.

9
Operations & Maintenance Manual: Introduction
OPTIONAL COMPONENTS & ACCESSORIES
The following optional items are available to enhance the capabilities of your device. Please contact
Verathon®Customer Care or your local representative for more information on any of the following Verathon
products.
Table 2. Optional Components and Accessories
PART DESCRIPTION
Local Client
Local Client
Scan Point, Verat hon and the Verathon Torch are
trademar ks of Verathon Inc. ©2017 Verathon Inc.
Verathon Inc.
20001 North Creek Parkway
Bothell, WA 98011, USA
Tel: [phone] (USA & Canada only)
Tel: [phone] Fax: [phone]
Verathon Medical (Europe) B.V.
Willem Fenengastraat 13
1096 BL Amsterdam, The Netherlands
Tel: [phone]
Fax: [phone]
verathon.com
0900-1009
0900-1025-04-40
ScanPoint®LC Software install CD
Installs ScanPoint Image Management System on a stand‑alone
(non‑networked) Windows®PC. For more information, see ScanPoint
Image Management Technology (Optional).
ScanPoint with QuickPrint Install CD
Installs ScanPoint with QuickPrint software on a network‑enabled
Windows PC. For more information, see ScanPoint Image
Management Technology (Optional).
ScanPoint docking station
Used with ScanPoint image management technology. Transmits data
from the BladderScan device to the ScanPoint host computer and
simultaneously recharges the battery.
Calibration kit (requires ScanPoint with QuickPrint software)
The calibration tank base holds a spiral‑shaped calibration target and
4.2liters of water. The indentation in the tank lid places the device
in a known and repeatable location with respect to the spiral target.
Self‑calibration takes about 15 minutes.
ScanPoint label writer
Prints exam results on adhesive label media. Requires installation
of ScanPoint software on a Windows®PC. The following items are
related to the ScanPoint label writer:
• USB Cable—Connects the ScanPoint label writer to the ScanPoint
host computer.
• Power Cord—Connects the ScanPoint label writer power adapter
to a wall outlet.
• Power Adapter—Connects the power cord to the label writer.
• Roll of Labels—Labels in roll format properly sized for the
ScanPoint label writer.
Battery replacement kit
Contains a replacement lithium‑ion battery and instructions for
installing it.

10
BUTTONS, PARTS, & ICONS
BUTTONS & PARTS
Figure 1. Buttons and Parts
Display
Scanhead
Activation
button
Infrared window
Top button
Scan button
Handle
Table 3. Buttons and Parts
PART PURPOSE
Scan button Press to take a scan.
Scanhead
The scanhead transmits and receives ultrasound waves, automatically moving its
internal transducer 360º in order to scan twelve different planes, producing a
three‑dimensional image of the bladder.
Top button Press to select gender.
Activation button Press to reactivate the device if the battery becomes completely discharged.
Display Displays bladder volume measurements and other scan, patient, and device data.
Infrared (IR) window Enables the device to communicate with a ScanPoint®‑equipped PC via the
ScanPoint docking station.
Microphone Speak into the microphone to record voice annotations.

11
Operations & Maintenance Manual: Introduction
SCREEN ICONS
The following icons may appear on the display.
Table 4. Display icons
ICON MEANING
Battery power level.
Female gender option is selected. Select this option only for women who have not
had a hysterectomy. Deselect for all others, male or female.
Bladder imaging in progress. Hold device steady.
Solid: Indicates that the bladder was not centered within the ultrasound field of view.
However, the bladder volume measurement is still accurate. Re‑aiming is optional.
Flashing: Indicates that the aim was “off target.” In order to get an accurate bladder
volume measurement, you must re‑aim in the direction of the arrow.
The patient’s actual bladder size is larger than the ultrasound field of view.
Solid: Indicates that a voice annotation is being recorded.
Flashing: Indicates that the recorded voice annotation is being stored
Indicates the number of days remaining until the next required calibration.

12
BATTERY ICON
The battery icon is located in the lower‑right corner of the display and indicates the power level of the
battery. The device can be charged at any time, but if the battery is completely discharged, it must be
recharged before use.
Table 5. Battery status icons
BATTERY ICON DESCRIPTION
Battery is fully charged and ready for use.
Battery is 50–75% charged.
Battery is 25–50% charged.
Battery is nearly discharged and may only have enough power for a few scans.
Recharge the battery as soon as possible.
The battery is completely discharged. The device will not work until it is recharged.
Scrolling segments indicate that the battery is charging.

13
Operations & Maintenance Manual: Setting up
SETTING UP
To help you get up and running as quickly as possible, the next few pages explain how to:
1. Perform Initial Inspection
2. Charge the Device
3. Activate the Device (Optional)
4. Install ScanPoint Software (Optional)
PROCEdURE 1. PERFORM INITIAL INSPECTION
When you receive the device, Verathon®recommends that there is a full visual inspection of the system for
any obvious physical damage that may have occurred during shipment.
1. Verify that you have received the appropriate components for your system by referring to System
Components & Accessories.
2. Inspect the components for damage.
3. If any of the components are missing or damaged, notify the carrier and Verathon Customer Care or your
local representative.
PROCEdURE 2. CHARGE THE dEVICE
In order to maintain electrical safety, use only the provided power adapter, battery, and battery
charger.
WARNING
The charging cradle, power adapter, and power cords are not intended for patient contact.
Ensure 2m (6ft) is maintained between the patient and these components.
WARNING
Before using your device for the first time, or when the battery becomes completely discharged, you must
charge your device battery for approximately 6 hours or until it is fully charged. In this procedure, you set up
the charging cradle and use it to charge thebattery.
Note: If you have already installed ScanPoint®on your computer and installed the docking station, then you
can use the docking station to charge the device.
When you are not using your device, Verathon recommends that you store it in the charging cradle in order
to ensure that the device is always sufficiently charged. The charging cradle cannot overcharge the battery.

14
1. Plug the charging cradle into an electrical wall outlet.
2. Place the device in the charging cradle. The scrolling‑segments battery icon displays, indicating that the
device is charging.
If the battery icon does not appear, then the device was completely discharged. Allow the battery to
charge for 2hours. If the scrolling‑segments battery icon does not appear after 2hours, reactivate the
device according to the following procedure.
PROCEdURE 3. ACTIVATE THE dEVICE (OPTIONAL)
Complete this procedure if the battery is completely discharged, or if after 2hours in the charging cradle the
device does not show the scrolling‑segments battery icon.
1. Using the tip of the activation tool, press the Activation button located just above the Scan button.
2. Place the device in the charging cradle or docking station until the “full battery” icon is displayed.
Note: When you are not using your device, Verathon®recommends that you store it in the charging cradle
in order to ensure that your device is always sufficiently charged. The charging cradle cannot overcharge the
battery.
PROCEdURE 4. INSTALL SCANPOINT SOFTWARE (OPTIONAL)
If you are using ScanPoint®Image Management Technology, install it according to the instructions in the
ScanPoint user’s manual. Refer to the manual for further instructions on how to use ScanPoint or how
to set up and install the ScanPoint label writer. For more information, see the section ScanPoint Image
Management Technology (Optional).