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.

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Operations & Maintenance Manual: Table of Contents
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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
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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

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Operations & Maintenance Manual: Important Information
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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
Anatomical features surrounding the bladder can interfere with accurate scanning. When aiming
the probe, ensure that the entire bladder is in view and centered.
WARNING
Do not use water or surgical lubricants as a substitute for ultrasound gel. Substituting these or
other materials can cause incorrect scan results.
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
Cleaning is critical to ensuring the component is ready for disinfection. Failure to properly clean
the device could cause contamination to remain after the disinfection procedure is complete.
WARNING
Ensure that you follow the manufacturer’s instructions for handling and disposing of the
cleaning and disinfection solutions provided in this manual.
WARNING

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To reduce the risk of explosion, do not use the system in the presence of anesthetic substances
that can catch fire if exposed to an existing fire or an electrical spark.
WARNING
To reduce the risk of electric shock or burns, do not use the system in conjunction with
high‑frequency surgical equipment.
WARNING
Do not use accessories, transducers, or cables other than those specified or provided by
Verathon. Use of other such devices may cause this system to emit excessive electromagnetic
energy or to pick up unwanted electromagnetic signals or noise from its surroundings. These
malfunctions may cause improper operation, procedure delays, or both.
WARNING
Portable radio frequency communications equipment (including peripherals such as antenna
cables and external antennas) may not be used within 30 cm (12 inches) of any part of the
BladderScan system, including cables that Verathon specifies or provides for use with the
system. If this distance is not maintained, performance of the system may be degraded and
image display may be compromised.
WARNING
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
WARNING

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Operations & Maintenance Manual: Important Information
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To reduce the risk of leakage, explosion, fire, or serious injury, note the following when handling
the lithium‑ion battery included in the system:
•Remove the battery from the console if it is out of use for an extended period of time.
•Do not use the optional battery charger to charge the battery within 1.83 m (6 ft) of any
patient, including the furniture containing the patient (such as a bed or exam table).
•Do not charge the battery in any area where oxygen is administered.
•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.
•Use a general‑purpose cleaner, such as an all‑purpose spray cleaner or a cloth moistened
with soap and water, to clean the battery. Do not clean or disinfect the battery using any of the
cleaning or disinfection materials described in the Reprocessing chapter of this manual.
•Do not disassemble the battery, heat it above 60°C (140°F), or incinerate it.
•Keep the battery out of reach of children and in its original package until you are ready to
use it.
•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
To maintain electrical safety, use only the battery, power adapter, and power cord supplied
with the system. Use only Verathon‑recommended accessories and peripherals, including the
accessory battery charger.
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 system and will void the warranty.
Contact Verathon CustomerCare or your local representative for all servicing needs.
WARNING
To maintain electrical safety, inspect the power adapter for damage before each use. Do not use
a power adapter with cracks, broken wiring insulation, or other damage. If the power adapter is
damaged, contact Verathon CustomerCare or your local representative.
WARNING

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To maintain electrical safety, if you are using the accessory battery charger, inspect the charger
for damage before each use. Do not use a battery charger with cracks or other damage. If the
battery charger is damaged, contact Verathon CustomerCare or your local representative.
WARNING
If the battery is overheating or drawing excessive current, turn the system off and disconnect
external power immediately. Allowing overheating or excess current draw to continue can
start a fire or cause an electrical injury. For help with battery malfunctions, contact Verathon
Customer Care.
WARNING
No modification of this equipment is allowed.
WARNING
To avoid the risk of injury, when the printer door is open:
•Do not touch the printer mechanism or print head, which may be hot from recent printing.
•Do not touch the edge of the paper cutter.
WARNING
Never use the BladderScan i10 system to display the image of anatomical features other than the
bladder.
WARNING
This system is intended as a measuring tool only. It is not a diagnostic device.
WARNING
Use only a passive‑type USB flash drive. Do not use USB drives powered by another external
source.
WARNING

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Operations & Maintenance Manual: Important Information
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CAUTIONS
Statement of Prescription: Federal (United States) law restricts this device to sale by or on the
order of a physician.
CAUTION
Before scanning a patient, make sure that a battery is installed and properly charged. The
system cannot scan while connected to external power.
CAUTION
To avoid damage to cables and accessories, do not excessively twist or bend cables associated
with the system.
CAUTION
To dispose of the system or accessories at the end of their useful service life, see the section
“Device Disposal”. The system and related devices may contain mineral oils, batteries, and other
environmentally hazardous materials.
CAUTION
Before you perform any system upgrade, self‑test, or maintenance procedure, make sure that
a battery is installed and charged to a level of at least 20%. Disconnect external power before
performing a system upgrade.
CAUTION

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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.
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 the IEC60601‑1‑2standard.
•Be aware that portable and mobile radio frequency communications equipment (cellular
phones, etc.) may affect medical electrical equipment; take appropriate precautions during
operation.
CAUTION
Failure to follow these instructions may cause device damage not covered by the warranty:
•Do not immerse any system component in cleaning or disinfectant solution or other liquids.
•Do not subject any system component to steam, ethylene oxide, radiation, or similar methods
of sterilization or autoclaving.
•Do not use metal or abrasive brushes. These may scratch a component of the system, causing
permanent damage.
CAUTION

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Operations & Maintenance Manual: Introduction
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INTRODUCTION
SYSTEM OVERVIEW
BladderScan i10 is a 3D ultrasound system that measures bladder volume noninvasively. The core components
of the system are a console with a touchscreen display and a probe containing the ultrasound transducer. The
system also includes a rechargeable battery. Available accessories and configuration options for the system
include a mobile workstation, a printer, an external battery charger, and extra rechargeable batteries. For
more information, see “Components & Accessories” on page10.
Figure 1. BladderScan i10 System (Showing Accessory Printer and Workstation)
The system includes an onboard tutorial as well as integrated help screens. The console features a variety of
customizable settings and a Saved Exams function that allows you to recall, print, or transfer saved exams.
The console also features an optional live imaging pre‑scan mode that enables you to locate the bladder by
displaying a B‑mode view of the abdomen in real time, before completing the volume measurement scan.

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COMPONENTS & ACCESSORIES
Table 1. Included System Components & Accessories
INCLUDED SYSTEM COMPONENTS & ACCESSORIES
Console Probe
Battery In‑service USB flashdrive
Power adapter Power cord
Note: Plug may vary by region

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Operations & Maintenance Manual: Introduction
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Table 2. Optional System Components & Accessories
OPTIONAL SYSTEM COMPONENTS & ACCESSORIES
Battery Charger
Extra Battery
Mobile Workstation Printer
Calibration Kit Thermal Paper
Additionally, quick reference materials and ultrasound gel may be available for order in your
region. For more information, contact Verathon CustomerCare or your local representative or visit
verathon.com/global‑support.

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SYSTEM FEATURES
CONSOLE FEATURES
Read the “Warnings & Cautions” section before using the system.
The console’s primary feature is a touchscreen display that allows you to perform scans, manage scan results,
and customize settings. A rechargeable battery is inserted into one side of the console, and the bottom surface
includes a selection of ports for connecting system components and accessories such as external, removable
media storage devices. You may also customize your console by adding an optional printer.
Figure 2. Console Features
Battery door
On/Off button
Main display
Probe cable portUSB ports
USB‑C portPower port
Battery indicator LED