Verathon BVI 6000 User manual

BLADDERSCAN

BVI6100

Operations & Maintenance Manual

0900‑4830‑00‑60

BLADDERSCAN

BVI6100

Operations & Maintenance Manual

Effective: July 31, 2017

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: 800.331.2313 (US and Canada only)

Tel: 425.867.1348

Fax: 425.883.2896

verathon.com

Verathon Medical (Europe) B.V.

Willem Fenengastraat 13

1096 BL Amsterdam

The Netherlands

Tel: +31 (0) 20 210 30 91

Fax: +31 (0) 20 210 30 92

0123

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.

TABLE OF CONTENTS

IMPORTANT INFORMATION .................................................................................................................................1

Overview ............................................................................................................................................................1

Product Description .........................................................................................................................................1

Statement of Intended Use ..............................................................................................................................1

Essential Performance ......................................................................................................................................1

Notice to All Users ...........................................................................................................................................1

Safety Information ..............................................................................................................................................2

Ultrasound Energy Safety ................................................................................................................................. 2

Contraindications .............................................................................................................................................2

Cautions & Warnings ....................................................................................................................................... 2

INTRODUCTION ....................................................................................................................................................7

Product Description ............................................................................................................................................7

BladderScan BVI6100 ......................................................................................................................................7

ScanPoint Image Management Technology (Optional) .....................................................................................7

System Components & Accessories .....................................................................................................................8

Required System Components .........................................................................................................................8

Optional Components & Accessories ................................................................................................................ 9

Buttons, Parts, & Icons ...................................................................................................................................... 10

Instrument Parts & Buttons ............................................................................................................................ 10

Screen Icons .................................................................................................................................................. 11

SETTING UP ......................................................................................................................................................... 13

Procedure 1. Perform Initial Inspection ..................................................................................................... 13

Procedure 2. Charge the Instrument ......................................................................................................... 13

Procedure 3. Activate the BladderScan Instrument (Optional) .................................................................... 14

Procedure 4. Install ScanPoint Software (Optional) ................................................................................... 14

Operations & Maintenance Manual: Table of Contents

MEASURING BLADDER VOLUME ....................................................................................................................... 15

Performing Scans .............................................................................................................................................. 15

Procedure 1. Prepare for the Exam ........................................................................................................... 16

Procedure 2. Measure Bladder Volume ..................................................................................................... 16

Scanning Tips....................................................................................................................................................19

CLEANING & DISINFECTING ...............................................................................................................................21

Procedure 1. Clean & Disinfect the Instrument .......................................................................................... 22

MAINTENANCE & TROUBLESHOOTING .............................................................................................................24

Regular Inspections .......................................................................................................................................... 24

Calibrating the BladderScan Instrument .............................................................................................................24

Procedure 1. Calibrate the Instrument ......................................................................................................24

Warranty ..........................................................................................................................................................28

Instrument Repair or Replacement .....................................................................................................................29

Troubleshooting ................................................................................................................................................ 30

Frequently Asked Questions ...........................................................................................................................30

Help Resources ..............................................................................................................................................31

Device Disposal ................................................................................................................................................. 31

PRODUCT SPECIFICATIONS ................................................................................................................................. 32

Component Speciﬁcations ................................................................................................................................32

Instrument Speciﬁcations ............................................................................................................................... 32

Charging Cradle Speciﬁcations .......................................................................................................................34

Electromagnetic Compatibility ........................................................................................................................... 35

Electromagnetic Emissions .............................................................................................................................35

Electromagnetic Immunity .............................................................................................................................35

Recommended Separation Distances ..............................................................................................................38

Accessory Conformance to Standards.............................................................................................................38

GLOSSARY ...........................................................................................................................................................39

IMPORTANT INFORMATION

OVERVIEW

PRODUCT DESCRIPTION

The BladderScan® BVI6100 bladder volume instrument is a wireless, battery‑powered, ultrasound instrument that provides a noninvasive measurement of urinary bladder volume.

During each scan, the instruments 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 instrument, update software, print, and transfer data through an application‑based interface.

STATEMENT OF INTENDED USE

The BladderScan BVI 6100 instrument 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6100 system is to produce ultrasonic output energy and display numerical values for bladder volume. The system has a passively temperature‑controlled transducer assembly.

NOTICE TO ALL USERS

The BladderScan BVI6100 instrument 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 instrument. Do not attempt to operate the instrument until you thoroughly understand all instructions and procedures in this manual. Failure to comply with these instructions may compromise the performance of the instrument and the reliability of its measurements.

Operations & Maintenance Manual: Important Information

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 the BladderScan BVI6100 instrument 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32.

CONTRAINDICATIONS

The BladderScan BVI 6100 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

CAUTION

When using the system with optional ScanPoint® software, your computer must be minimally certiﬁed to EN/IEC/CSA/UL 60950‑1 or 60101‑1 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

CAUTION

Use of the following cleaning methods or solutions may cause device damage not covered by the BladderScan BVI 6100 warranty:

• Do not immerse the instrument in disinfectant solution.

• Do not use Cidex Plus

• Do not subject the instrument to any method of sterilization.

Customer Care.

to disinfect the instrument. Cidex Plus will damage the plastic enclosure.

CAUTION

Statement of Prescription: Federal (United States) law restricts this device to sale by or on the order of a physician.

CAUTION

To maintain electromagnetic interference (EMI) within certiﬁed limits, the system must be used with the cords, components, and accessories speciﬁed or supplied by Verathon

. For additional information, see the System Components & Accessories and Component Speciﬁcations sections. The use of accessories or cords other than those speciﬁed or supplied may result in increased emissions or decreased immunity of the system.

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35.

The system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the conﬁguration in which it will be used.

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.

Operations & Maintenance Manual: Important Information

WARNINGS

WARNING

This product 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 instrument 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, medical‑grade power adapter, battery, and battery charger.

WARNING

To reduce the risk of electric shock, use only the accessories and peripherals recommended by Verathon.

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

Ensure proper distance from patient. When transmitting data to or from your computer, make sure the instrument, 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 instrument and will void the warranty. Contact Verathon

Customer Care or your local representative for all servicing needs.

WARNING

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.

Operations & Maintenance Manual: Important Information

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:

• Do not store the battery in the console for an extended period of time.

• 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.

INTRODUCTION

PRODUCT DESCRIPTION

The BladderScan BVI6100 device is a portable ultrasound instrument. Using patented Vmode® technology, it provides a noninvasive measurement of urinary bladder volume.

The instrument consists of an ergonomic, battery‑powered, hand‑held probe that scans the patient’s bladder. The LCD screen provides aiming assistance and displays an array of bladder measurement information.

BladderScan instruments are quick and easy to use. A sonographer is not required. The instrument measures ultrasonic reﬂections on multiple planes inside the body, producing a three‑dimensional image. Based on this image, the instrument calculates and displays the bladder volume.

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.

BLADDERSCAN BVI6100

The hand‑held, portable BladderScan BVI6100:

• 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

• Allows for exam results and images to be downloaded, viewed and

• Is battery‑operated, lightweight, and portable.

and accurately.

printed using the optional ScanPoint® Image Management Technology.

SCANPOINT IMAGE MANAGEMENT TECHNOLOGY (OPTIONAL)

You may transmit bladder volume measurements and ultrasound images from your BladderScan instrument 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 instrument. The ScanPoint image management technology (ScanPoint software, license, and accessories) is available with the purchase of many BladderScan instruments. Comprehensive service and warranty are provided under the ScanPoint Total ReliabilitySM Plan.

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 the BladderScan BVI6100 instrument.

Operations & Maintenance Manual: Introduction

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 instruments, to calibrate their instruments 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6100

Hand‑held, wireless, battery‑operated, ultrasound bladder volume instrument.

Charging cradle

Use the charging cradle to charge the BladderScan instrument’s internal battery. The charging cradle plugs directly into an electrical wall outlet. Before using your BladderScan instrument, 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 instrument.

OPTIONAL COMPONENTS & ACCESSORIES

Local Client

The following optional items are available to enhance the capabilities of your BladderScan instrument. 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

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

Local Client

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 instrument to the ScanPoint host computer and simultaneously recharges the instrument 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 instrument 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.

Operations & Maintenance Manual: Introduction

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