BLADDERSCAN BVI 3000 Manuale

BLADDERSCAN

BVI 3000

OPERATIONS & MAINTENANCE MANUAL

0900‑0383‑15‑60

BLADDERSCAN

BVI 3000

OPERATIONS & MAINTENANCE MANUAL

Effective: March 6, 2015

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/contact‑us.

Corporate Headquarters:

20001 North Creek Parkway

Bothell, WA 98011 U.S.A.

800.331.2313 (US and Canada only)

425.867.1348

Fax: 425.883.2896

verathon.com

Verathon®Medical (Europe) B.V.

Willem Fenengastraat 13

1096 BL Amsterdam

The Netherlands

+31 (0) 20 210 30 91

Fax: +31 (0) 20 210 30 92

verathon.com

0123

without the express written consent of Verathon Inc.

Verathon, the Verathon torch symbol, BladderScan, and the BladderScan symbol are either trademarks or registered trademarks 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, contact Verathon Customer

Care or your local representative.

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

Statement of Prescription .............................................................................................................................................1

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

SAFETY INFORMATION................................................................................................................................................. 2

Biological Safety............................................................................................................................................................ 2

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

Precautions & Warnings ............................................................................................................................................... 2

INTRODUCTION .................................................................................................................................................................. 6

COMPONENTS & FEATURES .......................................................................................................................................6

Control Unit ................................................................................................................................................................... 7

Scanhead ......................................................................................................................................................................8

Batteries & Battery Charger..........................................................................................................................................8

SYSTEM COMPONENTS & ACCESSORIES................................................................................................................ 9

BUTTONS, ICONS, & CONNECTIONS.......................................................................................................................... 9

Battery Icon ................................................................................................................................................................... 9

Buttons ..........................................................................................................................................................................9

SETTING UP.......................................................................................................................................................................10

ASSEMBLING THE INSTRUMENT ..............................................................................................................................10

Procedure 1. Charge the Batteries .......................................................................................................................10

Procedure 2. Insert or Remove a Battery .............................................................................................................12

Procedure 3. Connect the Scanhead to the Control Unit ..................................................................................... 13

Procedure 4. Load The Thermal Paper Roll......................................................................................................... 14

CONFIGURING USER SETTINGS...............................................................................................................................15

Procedure 1. Program the Name .......................................................................................................................... 15

Procedure 2. Set the Date.....................................................................................................................................17

Procedure 3. Set the Time .................................................................................................................................... 19

Procedure 4. Adjust User Preferences ................................................................................................................. 21

USING THE INSTRUMENT ...............................................................................................................................................24

SCANNING A PATIENT .................................................................................................................................................25

Procedure 1. Measure Bladder Volume................................................................................................................25

Procedure 2. Verify Aim & Accuracy .....................................................................................................................27

Procedure 3. Conrm the Scan Results ............................................................................................................... 29

MANAGING SCAN RESULTS....................................................................................................................................... 31

Procedure 1. Add a Patient ID Number (Optional) ............................................................................................... 31

Procedure 2. Add Notes (Optional)....................................................................................................................... 32

Procedure 3. Print the Scan Result (Optional)......................................................................................................34

Procedure 4. Print a Histogram of Cost Savings (Optional).................................................................................36

CLEANING & DISINFECTING...........................................................................................................................................38

Procedure 1. Clean the Instrument .......................................................................................................................38

Procedure 2. Disinfect the Instrument................................................................................................................... 39

MAINTENANCE & TROUBLESHOOTING.......................................................................................................................40

ANNUAL CERTIFICATION OF CALIBRATION ............................................................................................................40

PERIODIC INSPECTIONS............................................................................................................................................40

Weekly Inspections ..................................................................................................................................................... 40

Monthly Accuracy Check ............................................................................................................................................40

DEVICE REPAIR............................................................................................................................................................ 40

iii

Operations & Maintenance Manual: Table of Contents

TROUBLESHOOTING...................................................................................................................................................41

Procedure 1. Run a Self Test ................................................................................................................................41

Procedure 2. Troubleshoot Power Issues.............................................................................................................42

Procedure 3. Troubleshoot an Error Message...................................................................................................... 42

Procedure 4. Clear a Paper Jam ..........................................................................................................................44

Procedure 5. Test the Printer ................................................................................................................................45

Procedure 6. Verify Instrument Accuracy..............................................................................................................47

DEVICE DISPOSAL....................................................................................................................................................... 47

WARRANTY .......................................................................................................................................................................48

Disclaimer of Additional Warranties............................................................................................................................ 48

PRODUCT SPECIFICATIONS........................................................................................................................................... 49

SAFETY & PERFORMANCE SUMMARY ....................................................................................................................49

ACCURACY RANGE.....................................................................................................................................................49

COMPONENT SPECIFICATIONS ................................................................................................................................50

Control Unit & Scanhead Specications ....................................................................................................................50

Battery Charger Specications...................................................................................................................................52

Battery Specications ................................................................................................................................................. 53

ELECTROMAGNETIC COMPATIBILITY ......................................................................................................................54

Electromagnetic Emissions.........................................................................................................................................54

Electromagnetic Immunity ..........................................................................................................................................55

Recommended Separation Distances........................................................................................................................57

Accessory Conformance to Standards....................................................................................................................... 57

SYMBOL DIRECTORY ...................................................................................................................................................... 58

GLOSSARY ........................................................................................................................................................................ 60

Operations & Maintenance Manual: Important Information

IMPORTANT INFORMATION

OVERVIEW

PRODUCT DESCRIPTION

The BladderScan BVI 3000 is a B‑mode ultrasonic instrument, portable and battery‑operated, intended for

the noninvasive measurement of urinary bladder volume. A mechanical sector‑scanning transducer provides

cross‑sectional images of the bladder from twelve scan planes. Based on these images, the BladderScan

instrument automatically calculates the estimated bladder volume in milliliters (ml) and displays it on a screen.

STATEMENT OF INTENDED USE

The BladderScan BVI 3000 projects ultrasound energy through the lower abdomen of the nonpregnant patient

to obtain an image of the bladder, which is used to determine bladder volume noninvasively.

ESSENTIAL PERFORMANCE

Essential performance is the system performance necessary to achieve freedom from unacceptable risk. The

essential performance of the BladderScan BVI 3000 system is to produce ultrasonic output energy and display

numerical values for bladder volume. The system has a passively temperature‑controlled transducer assembly.

STATEMENT OF PRESCRIPTION

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

NOTICE TO ALL USERS

The BladderScan BVI 3000 should be used only by individuals who have been trained and authorized by

a physician or the institution providing patient care. All operators should read this manual prior to using the

instrument. Failure to comply with these instructions may compromise the performance of the instrument.

SAFETY INFORMATION

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 exposure

times possible commensurate with clinical utility.

The ultrasonic output power of the BladderScan BVI 3000 is not user‑adjustable and is limited to the minimum

level necessary for effective performance. Data on acoustic output levels can be found in the chapter Product

Specications on page 49.

CONTRAINDICATIONS

The BladderScan BVI 3000 instrument is not intended for fetal use or for use on pregnant patients.

PRECAUTIONS & 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 specic component or use situation.

To ensure safe and reliable operation for the user and patient, please heed the following warnings and cautions.

PRECAUTIONS

The BladderScan BVI 3000 and related devices may contain mineral oils, batteries, and other

environmentally hazardous materials. When the instrument and/or accessories have reached the

end of their useful service life, see the section Device Disposal on page 47.

CAUTION

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

CAUTION

Failure to adhere to the following when cleaning the control unit or the scanhead may result in

permanent equipment damage and void the instrument warranty:

• Ensure that you do not immerse either component in water or a cleaning or disinfecting agent.

This may permanently damage the instrument.

• Do not use Cidex®Plus, as it is not recommended for use with Lexan polycarbonate.

• Do not subject any part of the BVI 3000 system to steam sterilization or ethylene oxide

sterilization.

CAUTION

Indice

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