PRIME Operations and Maintenance Manual

BLADDERSCAN PRIME OPERATIONS & MAINTENANCE MANUAL Effective: December 14, 2016

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 Copyright © 2016 Verathon, Inc. All rights reserved. BladderScan, the BladderScan symbol, Verathon, the Verathon Torch symbol, and NeuralHarmonics 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.

TABLE OF CONTENTS IMPORTANT INFORMATION...1 OVERVIEW...1 Product Description...1 Statement of Intended Use...1 Notice to All Users...1 Statement of Prescription...1 Essential Performance...1 SAFETY INFORMATION...2 Ultrasound Energy Safety...2 Contraindications...2 Cautions & Warnings...2 INTRODUCTION...7 SYSTEM OVERVIEW...7 Components & Accessories...8 SYSTEM FEATURES...10 Console Features...10 Probe Features... 11 Battery & Battery Charger Features...12 SYSTEM ICONS...13 Console Touch‑Screen Icons...13 Console Battery Level Icons...15 Probe Icons...15

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SETTING UP...16 ASSEMBLING THE INSTRUMENT...16 Procedure 1. Perform the Initial Inspection...16 Procedure 2. Charge the Battery...17 Procedure 3. Attach the Probe to the Console...19 Procedure 4. Attach the Console Base or Printer...20 Procedure 5. Attach the Instrument to the Mobile Cart (Optional)...21 Procedure 6. Install the Port Cover (Optional)...24 Procedure 7. Insert a Battery...25 CONFIGURING SETTINGS...26 Procedure 1. Configure General Settings...26 Procedure 2. Configure Exam Settings...28 Procedure 3. Customize Cost Savings Calculations...29 Procedure 4. Configure Printed Report Settings...31 Procedure 5. Configure Calibration Settings...32 USING THE INSTRUMENT...33 MEASURING BLADDER VOLUME...34 Procedure 1. Start the System...34 Procedure 2. Prepare for the Exam...35 Procedure 3. Input Patient Information or Operator ID (Optional)...36 Procedure 4. Measure Bladder Volume...37 Procedure 5. Review Exam Results...41 Procedure 6. Print, Save, or Exit an Exam...43 Procedure 7. View Cost Savings...44 MANAGING SAVED EXAMS...45 Procedure 1. Recall a Saved Exam...45 Procedure 2. Delete a Saved Exam...46 Procedure 3. Export Saved Exams...47 CLEANING & DISINFECTING...48 Procedure 1. Clean & Disinfect the System...50

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MAINTENANCE & SAFETY...55 REGULAR INSPECTIONS...55 SYSTEM SOFTWARE...55 DEVICE DISPOSAL...55 MAINTENANCE...56 Procedure 1. Load Thermal Paper into the Printer...56 Procedure 2. Run a Self‑Test...58 Procedure 3. Update the Software...59 Procedure 4. Calibrate the Instrument...60 Procedure 5. Test the Probe...62 HELP & TROUBLESHOOTING...63 HELP RESOURCES...63 Procedure 1. Watch the Onboard Tutorial...63 DEVICE REPAIR...64 TROUBLESHOOTING PROCEDURES...65 Procedure 1. Troubleshoot Console Power Issues...65 Procedure 2. Troubleshoot Probe Connection Issues...65 Procedure 3. Troubleshoot Probe Aiming Issues...66 Procedure 4. Restore Factory Defaults...67 Procedure 5. Troubleshoot Printer Power Issues...68 Procedure 6. Troubleshoot Irregular Printouts...70 Procedure 7. Clear a Paper Jam...72 Procedure 8. Replace the Printer Drive Roller...73

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IMPORTANT INFORMATION OVERVIEW PRODUCT DESCRIPTION The BladderScan Prime instrument provides noninvasive measurement of urinary bladder volume. The instrument calculates the bladder volume using patented NeuralHarmonics® technology. Volume measurements made with NeuralHarmonics technology are based on a more complex, multifaceted image of the bladder. Bladder volume, mode (male, female, and small child), directional aiming with real‑time feedback, battery status and usage rate indicators are displayed on the touch‑screen display. The system also includes a battery charger for the custom, user‑replaceable lithium‑ion batteries included with the system. Stored exams can be accessed at any time using the console display.

STATEMENT OF INTENDED USE The BladderScan Prime system is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively.

NOTICE TO ALL USERS The BladderScan Prime 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 prior to using the system. Do not attempt to operate this instrument until you thoroughly understand all instructions and procedures in this manual.

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

ESSENTIAL PERFORMANCE Essential performance is the system performance necessary to achieve freedom from unacceptable risk. The essential performance of the BladderScan Prime system is to produce ultrasonic output energy, display ultrasonic images, and display numerical values for bladder volume. The instrument shall not produce unintended or excessive probe surface temperature.

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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 Prime 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 Product Specifications chapter on page 76.

CONTRAINDICATIONS The BladderScan Prime system 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 The console USB and SD ports are designed to support removable storage media. Use these ports with USB flash drives and SD cards only. Do not attempt to use these ports with other devices. CAUTION To avoid damage to cables and accessories, do not excessively twist or bend cables associated with the system. CAUTION To dispose of the instrument or accessories at the end of their useful service life, see the section Device Disposal on page 55. The system and related devices may contain mineral oils, batteries, and other environmentally hazardous materials.

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CAUTION To maintain electromagnetic interference (EMI) within certified limits, the system must be used with the cables, components, and accessories specified or supplied by Verathon®. For additional information, see the Components & Accessories and Component Specifications sections. The use of accessories and/or cables other than those specified or supplied may result in increased emissions and/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 82. 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. CAUTION Failure to follow these instructions may cause device damage not covered by the warranty: • Do not immerse the instrument in cleaning or disinfectant solution. • Ensure that the console is not exposed to water during the probe cleaning procedure. • Do not subject any part of the instrument to steam, ethylene oxide, radiation, or similar methods of sterilization or autoclaving. • Do not use bleach‑based (sodium hypochlorite) products on the console touchscreen. • Do not use metal or abrasive brushes. These may scratch the instrument, causing permanent device damage.

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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. 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.

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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 result in a contaminated instrument after completing the disinfection procedure. WARNING Availability of cleaning and disinfection 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 Ensure that you follow the manufacturer’s instructions for handling and disposing of the cleaning and disinfection solutions provided in this manual. WARNING To reduce the risk of explosion, do not use the system in the presence of flammable anesthetics. WARNING To reduce the risk of electric shock or burns, do not use the system in conjunction with high‑frequency surgical equipment. WARNING In order to maintain electrical safety, use only the provided power supply, battery, and battery charger. Connect the power cord and power adapter to a properly grounded plug, and ensure the disconnect is easily accessible. Use only the accessories and peripherals recommended by Verathon.

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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 maintain electrical safety, inspect the battery charger for damage prior to 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 No modification of this equipment is allowed.

WARNING The battery charger, power adapter, and power cables are not intended for patient contact. Ensure 2 m (6 ft) are maintained between the patient and these components. WARNING Never use the BladderScan Prime system to display the image of biological features other than the bladder. WARNING This system is not a diagnostic device and is only intended as a measuring tool.

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INTRODUCTION SYSTEM OVERVIEW BladderScan Prime is a 3D ultrasound system that noninvasively measures bladder volume. The core components of the system are a console with a touch‑screen display, an ergonomic probe containing the ultrasound transducer, and a battery charger with rechargeable lithium‑ion batteries. There are several accessories and configuration options available for the system, including a mobile cart, a printer, and external memory solutions. For more information, see Components & Accessories on page 8. Figure 1.

BladderScan Prime System

The BladderScan Prime system includes an onboard tutorial as well as integrated help screens. Scanning is available in a variety of modes that are suited for different patient anatomies: male, female, and small child. In addition, the console features a variety of customizable settings and a saved scans function that allows you to recall, print, or transfer saved exams. The Prime 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, prior to completing the volume measurement scan. This option is disabled by default. For more information about enabling this mode, see Configure Exam Settings on page 28.

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COMPONENTS & ACCESSORIES Table 1.

Included System Components & Accessories INCLUDED SYSTEM COMPONENTS & ACCESSORIES

Console

Battery

8

Probe

Console base

Battery charger

Power adapter

In‑service USB flash drive

Media storage USB flash drive

Power cord Note: Plug may vary by region

Port cover

Media storage SD card

Table 2.

Optional System Components & Accessories OPTIONAL SYSTEM COMPONENTS & ACCESSORIES

Printer

Mobile Cart

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/support.

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SYSTEM FEATURES CONSOLE FEATURES The BladderScan Prime console’s primary feature is a touch‑screen display that allows you to perform scans, manage scan results, and customize settings. The console also provides controls for adjusting brightness and volume and activating the system or putting it in standby mode. A rechargeable battery is inserted into one side of the console, and the other side features 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, attaching the console base, or mounting the console on a mobile cart. Figure 2.

Console Features

Main display

Battery door SD card port USB ports Micro USB port

Standby button

Probe cable port Brightness control Volume control

Table 3.

Console Features

PART NAME

PURPOSE

Main display

Features touch‑screen controls of the system user interface.

Battery door

Opens to access and replace the rechargeable battery.

Standby button

Activates the unit or puts it in standby mode. When the unit is active, an LED next to the Standby button is illuminated.

Volume control

Adjusts volume up or down.

Brightness control

Adjusts the main display to be brighter or dimmer.

Probe cable port

Connects the system probe and console.

USB ports

Provides connection for external, removable storage media.

Micro USB port

Not functional in this version of BladderScan Prime.

SD card port

Provides connection for external, removable storage media.

Note: The console USB and SD ports are designed to support removable storage media. Use these ports with USB flash drives and SD cards only. Do not attempt to use the ports with other devices.

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PROBE FEATURES The probe contacts the patient and transmits and receives ultrasound waves, automatically moving its internal transducer 360º to scan twelve planes to produce a three‑dimensional image of the bladder. The probe is attached to the console by a cable. After a scan, the probe displays bladder volume and targeting. Figure 3.

Probe Features

Probe display

Probe cable

Probe button

Probe dome

Table 4.

Probe Features

PART NAME

PURPOSE

Probe button

Starts aiming or scanning when pressed.

Probe display

Displays ready, in progress, and scan results information.

Probe cable

Connects the probe to the console.

Probe dome

Contacts the patient’s abdomen and transmits ultrasound.

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BATTERY & BATTERY CHARGER FEATURES The BladderScan Prime system is powered by a lithium‑ion battery. The battery charger provided with the system can charge one or two batteries. Removing a discharged battery from the system and replacing it with a fresh battery does not erase any saved exams or system settings. To provide power to the batteries, the battery charger must be connected to a wall outlet using the power adapter and power cord provided. Use only the battery charger provided with the BladderScan Prime system. Any other battery charger may damage the battery. The battery charger automatically detects whether a lithium‑ion battery is being charged. To prevent incorrect insertion of the battery, the console and battery charger have a keyed entry into the battery compartment. Each battery features a test button that allows you to check the charge level of the battery without inserting it into the console. If you press the Test button on the back of the battery, the display next to the test button illuminates to display the approximate charge level: 25%, 50%, 75%, or 100%. Two replaceable batteries ensure the instrument is always available (provided the spare battery is charging when not in use).

Test button

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SYSTEM ICONS CONSOLE TOUCH‑SCREEN ICONS The console touch‑screen displays the interface that controls the BladderScan Prime system. The following icons may appear on the screen, and you may tap them to complete the function associated with the icon. Table 5.

Touch‑Screen Icons

ICON

FUNCTION

Male-Select if you are scanning a male patient. Female-Select if you are scanning a female patient. If you select the Female Patient icon, the instrument asks you if the patient has a uterus. Small Child-Select if you are scanning a child who is shorter than 122 cm (48 in) and lighter than 27 kg (60 lbs). Note: Scanning for this patient type can be disabled on the Exam Settings screen. For more information, see Configure Exam Settings on page 28. Saved Scans-View all scans that are saved to the console. Settings-Open the Settings screen. Orientation-Select whether the system is located on the patient’s right side or left side. Note: The appearance of this icon varies depending on the patient type you selected (male, female, or small child). B‑Mode-View the ultrasound image as pairs of two‑dimensional, orthogonal planes from the three‑dimensional scan. The contours of detected features are overlaid on the image. Note: You may disable the display of the detected contours. For more information, see Configure Exam Settings on page 28. C‑Mode-View the ultrasound image as a cross‑section view of the three‑dimensional scan. The C‑Mode image consists of a circular region with a crosshair overlay. This image displays the bladder shape and, if detected, the shadow of the pubic bone. The probe displays scan results in C‑mode. The console displays scan results in C‑mode by default, and B‑mode may be selected for any scan. Clear-On the Results Screen, clear all scan data within the current exam, but maintain patient information. Delete-On the Saved Scans screens, delete a saved exam that is currently being viewed. Delete-On the Saved Scans screens, delete a saved exam from the exam list.

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ICON

FUNCTION

Help-Start the onboard tutorial or display screen‑sensitive help text. Print-Print the scan, self‑test, or savings calculation results. Note: This function is only available if you have attached the optional printer. Done-On the Results screen, save the scan result with the largest volume and return to the Home screen. Export Exams-On the Saved Scans screen, move exams from the BladderScan Prime system’s internal storage to an external USB drive or SD card. This option is only available if external storage is connected. Configure Savings-Customize the values for calculating the cost savings that result from scanning rather than catheterizing patients. Back-Return to the previous screen or the Home screen. Cancel-On the Results screen, cancel the scan without saving and return to the Home screen. Next-Advance to the next screen. Play-On the onboard tutorial, play the tutorial. Pause-On the onboard tutorial, pause the tutorial. Previous-On the onboard tutorial, move to the previous frame of the tutorial. Next-On the onboard tutorial, move to the next frame of the tutorial.

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