BladderScan i10 Operations and Maintenance Manual Rev 06

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BladderScan i10™ Operations & Maintenance Manual Effective: September 6, 2023

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

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Contact Information To obtain additional information regarding your BladderScan system, contact Verathon Customer Care or visit verathon.com/service‑and‑support.

Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011 U.S.A. Tel: +1 800 331 2313 (US and Canada only) Tel: +1 425 867 1348 Fax: +1 425 883 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

EU

MDSS CH GmbH Laurenzenvorstadt 61 5000 Aarau Switzerland

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: +61 2 9431 2000 Tel / +61 2 9475 1201 Fax

CH

Anandic Medical Systems AG Stadtweg 24 8245 Feuerthalen Switzerland

0123 Copyright © 2023 Verathon, Inc. All rights reserved. BladderScan, BladderScan i10, BladderScan Prime, BladderScan Prime Plus, BladderTraq, CaliScan, ImageSense, VMODE, Verathon, and associated symbols are trademarks of Verathon Inc. All other brand and product names are trademarks or registered trademarks of their respective owners. Not all Verathon Inc. products shown or described in this manual are available for commercial sale in all countries. 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/service‑and‑support.

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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...24 Procedure 4. Charge the Battery...26 Procedure 5. Install the Printer (Optional)...28 CONFIGURING SETTINGS...29 Procedure 1. Configure General Settings...29 Procedure 2. Configure Administrative Settings...31 Procedure 3. Configure Exam Settings...33 Procedure 4. Configure Printed and PDF Report Settings...34 Procedure 5. Customize Cost Savings Calculations...35 Procedure 6. Configure a PIN for Saved Exams...36 Procedure 7. Configure a PIN for System Settings...37 USING THE SYSTEM...38 MEASURING BLADDER VOLUME...38 Procedure 1. Prepare for the Exam...38 Procedure 2. Input Patient Information or Operator ID (Optional)...39 Procedure 3. Use a Barcode Scanner to Enter a Patient or Operator ID (Optional)...40 Procedure 4. Measure Bladder Volume...41 Procedure 5. Review Exam Results...43 Procedure 6. Generate a Barcode containing an Exam Result...47 Procedure 7. Print, Save, or Exit an Active Exam...48 Procedure 8. View Cost Savings...48 MANAGING SAVED EXAMS...49 Procedure 1. Recall a Saved Exam...49 Procedure 2. Delete a Saved Exam...50 Procedure 3. Export Saved Exams...51

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REPROCESSING...52 CLEANERS & DISINFECTANTS...52 Disinfection Efficacy...52 Compatibility...53 BEST PRACTICES & INSTRUCTIONS...54 Procedure 1. Clean & Disinfect the Console, Probe, & Cable...54 Procedure 2. Clean the Printer (Optional)...55 MAINTENANCE & SAFETY...56 REGULAR INSPECTIONS...56 SYSTEM SECURITY INFORMATION...57 CALIBRATION...57 SYSTEM SOFTWARE...58 DEVICE DISPOSAL...58 WARRANTY...58 MAINTENANCE PROCEDURES...59 Procedure 1. Load Thermal Paper into the Printer (Optional)...59 Procedure 2. Run a Self‑Test...60 Procedure 3. Update the Software...61 Procedure 4. Complete a CaliScan Test...62 Procedure 5. Turn the System Off...63 Procedure 6. Perform an Unconditional Shutdown...64 Procedure 7. Copy the System’s Configuration to Other Systems...65 Procedure 8. Turn the USB Ports On or Off...67 HELP & TROUBLESHOOTING...68 HELP RESOURCES...68 Procedure 1. Watch the Onboard Tutorial...68 Procedure 2. Watch the Onboard Training Video...69 Customer Services Resources...69

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DEVICE REPAIR...69 TROUBLESHOOTING PROCEDURES...70 Procedure 1. Troubleshoot Console Battery Issues...70 Procedure 2. Troubleshoot Probe Connection Issues...71 Procedure 3. Troubleshoot Probe Aiming Issues...71 Procedure 4. Restore Factory Defaults...73 Procedure 5. Troubleshoot Irregular Printouts (Optional)...74 Procedure 6. Clear a Paper Jam (Optional)...76 Procedure 7. Replace the Printer Drive Roller (Optional)...77 Procedure 8. Evaluate Console Error Messages...78 PRODUCT SPECIFICATIONS...80 SYSTEM SPECIFICATIONS...80 COMPONENT SPECIFICATIONS...83 ELECTROMAGNETIC COMPATIBILITY...88 ACCESSORY CONFORMANCE TO STANDARDS...91 GLOSSARY...92

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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 80.

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 WARNING Do not use the system on: •   Fetal patients. •   Pregnant patients. •   Patients with open skin or wounds in the suprapubic region. •   Patients with ascites.

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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 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 When handling or disposing of the cleaning and disinfection products listed in this manual, be sure to follow the handling and disposal instructions provided by the manufacturers of those products.

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WARNING 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.

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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: •   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.

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WARNING 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 Apart from settings that can be configured through the system’s software menus, no mechanical, electrical, or acoustic 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.

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CAUTIONS CAUTION 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.

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CAUTION Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and operated according to the instructions in this manual. For more information, see the “Electromagnetic Compatibility” section. 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.

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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

Ultrasound gel packets

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Table 2.

Optional System Components & Accessories OPTIONAL SYSTEM COMPONENTS & ACCESSORIES

Battery Charger

Extra Battery

Mobile Workstation

Calibration Kit

Printer

Barcode Scanner

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/service‑and‑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

Main display

On/Off button Battery indicator LED

USB ports

Probe cable port Power port

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USB‑C port