Verathon BladderScan i10 Manual

Operations & Maintenance Manual

0900‑5005 REV‑00

0900‑5005 REV‑00
Operations & Maintenance Manual
Effective: March 12, 2021
Caution: Federal (United States) law restricts this
system to sale by or on the order of a physician.

0900‑5005 REV‑00
CONTACT INFORMATION
To obtain additional information regarding your BladderScan system,
contact Verathon CustomerCare or visit verathon.com/global‑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 © 2021 Verathon, Inc. All rights reserved.
BladderScan, the BladderScan symbol, BladderScan i10, BladderTraq, CaliScan, ImageSense, VMODE, Verathon, and the Verathon Torch
symbol are 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, see the documentation
available at verathon.com/product‑documentation.

i
Operations & Maintenance Manual: Table of Contents
0900‑5005 REV‑00
TABLE OF CONTENTS
IMPORTANT INFORMATION ................................................................................................................................1
OVERVIEW........................................................................................................................................................1
Product Description......................................................................................................................................1
Statement of Intended Use..........................................................................................................................1
Notice to All Users ........................................................................................................................................1
Essential Performance ..................................................................................................................................1
Environments of Intended Use ....................................................................................................................1
HIPAA Privacy................................................................................................................................................2
SAFETY INFORMATION....................................................................................................................................2
Ultrasound Energy Safety ............................................................................................................................2
Contraindications..........................................................................................................................................2
Warnings & Cautions ....................................................................................................................................2
INTRODUCTION ....................................................................................................................................................9
SYSTEM OVERVIEW .........................................................................................................................................9
Components & Accessories.........................................................................................................................10
SYSTEM FEATURES.........................................................................................................................................12
Console Features......................................................................................................................................... 12
Probe Features ............................................................................................................................................14
Battery Features..........................................................................................................................................15
SYSTEM ICONS ............................................................................................................................................... 15
Console Touchscreen Icons.........................................................................................................................15
Console Information Icons .........................................................................................................................18
Battery Indicator LED Colors...................................................................................................................... 19
Console Battery Level Icons .......................................................................................................................20

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SETTING UP.........................................................................................................................................................21
ASSEMBLING THE SYSTEM ............................................................................................................................21
Procedure 1. Perform the Initial Inspection ..........................................................................................21
Procedure 2. Assemble the Workstation and Attach the System........................................................22
Procedure 3. Insert a Battery .................................................................................................................23
Procedure 4. Charge the Battery ...........................................................................................................25
Procedure 5. Install the Printer (Optional) ............................................................................................27
CONFIGURING SETTINGS ...............................................................................................................................28
Procedure 1. Configure General Settings..............................................................................................28
Procedure 2. Configure Administrative Settings ..................................................................................30
Procedure 3. Configure Exam Settings ..................................................................................................32
Procedure 4. Configure Printed and PDF Report Settings ...................................................................33
Procedure 5. Customize Cost Savings Calculations ...............................................................................34
Procedure 6. Configure a PIN for Saved Exams.....................................................................................35
Procedure 7. Configure a PIN for System Settings................................................................................36
USING THE SYSTEM............................................................................................................................................37
MEASURING BLADDER VOLUME ..................................................................................................................37
Procedure 1. Prepare for the Exam........................................................................................................37
Procedure 2. Input Patient Information or Operator ID (Optional) ....................................................38
Procedure 3. Measure Bladder Volume.................................................................................................39
Procedure 4. Review Exam Results.........................................................................................................41
Procedure 5. Generate a Barcode containing an Exam Result.............................................................45
Procedure 6. Print, Save, or Exit an Active Exam ..................................................................................46
Procedure 7. View Cost Savings .............................................................................................................46
MANAGING SAVED EXAMS ..........................................................................................................................47
Procedure 1. Recall a Saved Exam..........................................................................................................47
Procedure 2. Delete a Saved Exam ........................................................................................................48
Procedure 3. Export Saved Exams..........................................................................................................49

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Operations & Maintenance Manual: Table of Contents
0900‑5005 REV‑00
REPROCESSING ...................................................................................................................................................50
CLEANERS & DISINFECTANTS ........................................................................................................................50
Disinfection Efficacy ...................................................................................................................................50
Compatibility...............................................................................................................................................51
BEST PRACTICES & INSTRUCTIONS ...............................................................................................................52
Procedure 1. Clean & Disinfect the Console, Probe, & Cable...............................................................52
Procedure 2. Clean the Printer (Optional).............................................................................................53
MAINTENANCE & SAFETY .................................................................................................................................54
REGULAR INSPECTIONS .................................................................................................................................54
CALIBRATION .................................................................................................................................................54
SYSTEM SOFTWARE.......................................................................................................................................55
DEVICE DISPOSAL ..........................................................................................................................................55
WARRANTY....................................................................................................................................................55
MAINTENANCE PROCEDURES .......................................................................................................................56
Procedure 1. Load Thermal Paper into the Printer (Optional).............................................................56
Procedure 2. Run a Self‑Test...................................................................................................................57
Procedure 3. Update the Software........................................................................................................58
Procedure 4. Complete a CaliScan Test..................................................................................................59
Procedure 5. Turn the System Off..........................................................................................................60
Procedure 6. Perform an Unconditional Shutdown .............................................................................61
Procedure 7. Copy the System’s Configuration to Other Systems .......................................................62
Procedure 8. Turn Off the USB Ports .....................................................................................................63
HELP & TROUBLESHOOTING..............................................................................................................................64
HELP RESOURCES ...........................................................................................................................................64
Procedure 1. Watch the Onboard Tutorial............................................................................................64

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DEVICE REPAIR ...............................................................................................................................................65
TROUBLESHOOTING PROCEDURES ...............................................................................................................65
Procedure 1. Troubleshoot Console Battery Issues ...............................................................................65
Procedure 2. Troubleshoot Probe Connection Issues............................................................................66
Procedure 3. Troubleshoot Probe Aiming Issues...................................................................................66
Procedure 4. Restore Factory Defaults ..................................................................................................68
Procedure 5. Troubleshoot Irregular Printouts (Optional) ...................................................................69
Procedure 6. Clear a Paper Jam (Optional) ...........................................................................................71
Procedure 7. Replace the Printer Drive Roller (Optional).....................................................................72
Procedure 8. Evaluate Console Error Messages.....................................................................................73
PRODUCT SPECIFICATIONS ................................................................................................................................ 74
SYSTEM SPECIFICATIONS ............................................................................................................................... 74
COMPONENT SPECIFICATIONS......................................................................................................................77
ELECTROMAGNETIC COMPATIBILITY ...........................................................................................................81
ACCESSORY CONFORMANCE TO STANDARDS.............................................................................................84
GLOSSARY...........................................................................................................................................................85

1
Operations & Maintenance Manual: Important Information
0900‑5005 REV‑00
IMPORTANT INFORMATION
OVERVIEW
PRODUCT DESCRIPTION
The BladderScan i10 system provides noninvasive measurement of urinary bladder volume. The system
calculates the bladder volume using ImageSense™, a proprietary Verathon artificial intelligence algorithm
that draws on real‑world data to create a consistent evaluation of the bladder’s location, size, and shape.
The primary components of the system are a console and a probe. The console’s touchscreen displays
critical information such as bladder volume, directional aiming with real‑time feedback, configuration and
administrative settings, and indicators for battery level and charging status. The touchscreen also provides
most of the system’s controls, both during exams and between them. A clinician with appropriate access
permission can use the touchscreen to retrieve stored exams at any time.
The console includes a bay for a rechargeable lithium‑ion battery. When the console is connected to external
power, it charges the battery.
STATEMENT OF INTENDED USE
The BladderScan i10 system is an ultrasound device intended to be used for measuring the urine volume in
the bladder noninvasively.
NOTICE TO ALL USERS
The BladderScan i10 system should be used only by individuals who have been trained and authorized
by a physician or the institution providing patient care. Users should read this entire manual before using
the system. Do not attempt to operate the system until you thoroughly understand all instructions and
procedures in this manual.
ESSENTIAL PERFORMANCE
Essential performance is the system performance necessary to avoid unacceptable risk. The essential
performance of the BladderScan i10 system is to produce ultrasonic output energy, display ultrasonic images,
and display numerical values for bladder volume. The system shall not produce unintended or excessive probe
surface temperature.
ENVIRONMENTS OF INTENDED USE
The BladderScan i10 system is intended to be used in professional healthcare environments such as hospitals,
clinics, and doctors’ offices.

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HIPAA PRIVACY
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) regulations require our customers
to monitor and limit the ways in which patients’ confidential information is accessed, used, stored,
transmitted, and disposed of. Our customers are ultimately responsible for ensuring all electronic health
information contained within the system is protected. In the course of providing services to customers,
Verathon will remove any electronic protected health information from the system, if such information is still
present.
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, refer to the American Institute of Ultrasound in Medicine
publication, Medical Ultrasound Safety.
The ultrasound output power of the BladderScan i10 system is not user adjustable and is limited to the
minimum level necessary for effective performance. For more information about acoustic output levels, see
the chapter “Product Specifications” on page74.
CONTRAINDICATIONS
The BladderScan i10 system is not intended for fetal use or for use on fetal patients, pregnant patients,
patients with open skin or wounds in the suprapubic region, or patients with ascites.
WARNINGS & CAUTIONS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of the
system. Cautions indicate that use or misuse of the system 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. When using the system, heed the following warnings and cautions.
WARNINGS
Do not use the system on:
•Fetal patients.
•Pregnant patients.
•Patients with open skin or wounds in the suprapubic region.
•Patients with ascites.
WARNING