Verathon BladderScan BVI 9400 User Manual
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Verathon BladderScan BVI 9400 User Manual

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Summary of Contents for Verathon BladderScan BVI 9400

  • Page 1 Bladder Volume Instrument BVI 9400 User’s Manual...
  • Page 3 ® BladderScan BVI 9400 Bladder Volume Instrument User’s Manual CAUTION: In the United States, federal law restricts this device to use by or on the order of a physician.
  • Page 4 Copyright © 2008 by Verathon Inc.. All rights reserved. No part of this User’s Manual may be copied or transmitted by any method without the express written consent of Verathon Inc.. ® ® ® ® ® Verathon , Verathon Medical...

  • Page 5: Quick Reference

    ® BladderScan BVI 9400 Quick Reference - Use User’s Manual page 5...
  • Page 6 ® Quick Reference - Use BladderScan BVI 9400 page 6 User’s Manual...
  • Page 7 NOTE: This procedure requires ScanPoint with QuickPrint Imaging ® Technology Software. If your BladderScan BVI 9400 requires ® calibration, and you’re not using ScanPoint with QuickPrint, please ® contact Verathon Technical Support at 1.800.331.2313 (US & Canada) or 425.867.1348 (International). User’s Manual page 7...
  • Page 8 ® Quick Reference - Calibration BladderScan BVI 9400 page 8 User’s Manual...

  • Page 9: Table Of Contents

    ® BladderScan BVI 9400 Table of Contents Table of Contents Quick Reference............................5 President’s Statement ..........................13 Important Information..........................14 Product Description ..........................14 Intended Use Warnings and Cautions..................... 14 Biological Safety ..........................14 Statement of Prescription........................15 Statement of Intended Use ........................15 Contraindications (U.
  • Page 10 ® Table of Contents BladderScan BVI 9400 Displays, Controls, and Indicators......................32 Console Displays and Button Functions....................32 Home Screen ............................32 Scan Screen ............................34 Results Screen............................. 34 Review Screen............................. 36 Tutorial Screen............................. 37 Video Viewing Screen.......................... 38 Settings Screen............................ 39 Alpha-Numeric Screen.........................
  • Page 11 No Paper.............................. 61 Too Hot ..............................62 Clearing a Paper Jam .......................... 62 Warranty..............................63 Disclaimer of Additional Warranties ......................63 ® Contacting Verathon ..........................64 Safety and Performance Summary ......................65 Parts and Accessories..........................66 ® BladderScan BVI 9400 System Components..................66 Product Specifications ..........................
  • Page 12 ® Table of Figures BladderScan BVI 9400 Table of Figures ® Figure 1. BladderScan BVI 9400 Controls and Indicators ................ 18 Figure 2. Battery Charger/Wireless Hub ..................... 20 Figure 3. Home Screen ..........................24 Figure 4. Settings Screen..........................24 Figure 5. Alpha-Numeric Screen......................... 25 Figure 6.

  • Page 13: President's Statement

    President’s Statement President’s Statement President’s Statement ® The team at Verathon is committed to improving health care delivery by putting healthcare providers and their patients first. Our products support you, the health care provider, by consistently offering accuracy, utility, reliability and excellence.

  • Page 14: Important Information

    Failure to comply with these instructions may compromise the performance of the device and the reliability of its measurements. For the most current version of the ® User’s Manual, please visit the Verathon Web site at: http://www.verathon.com, then ®...

  • Page 15: Statement Of Prescription

    ® BladderScan BVI 9400 Important Information Statement of Prescription ® United States federal law restricts the BladderScan BVI 9400 to use by, or on the order of, a physician. This statement is required per 21 Code of Federal Regulations (CFR) 801.109.

  • Page 16: Bluetooth ® Wireless Technology

    BVI 9400 signal input port or signal output port configures a medical system, and is therefore responsible for ensuring that the system complies with EN/IEC 60601-1-1. If ® you need assistance, contact your biomedical staff, Verathon Medical representative, or ®...

  • Page 17: Introducing The Bladderscan Bvi 9400

    BVI 9400 measurements can be printed via an onboard printer or ® transmitted using HIPAA-compliant ScanPoint technology for storage and archiving on ® Verathon servers. Stored exams can be accessed at any time from your office’s ® computer for viewing or printing. (NOTE: Use of ScanPoint software is optional.)

  • Page 18: Bladderscan ® Parts And Features

    ® ® Introducing the BladderScan BVI 9400 BladderScan BVI 9400 ® The BladderScan BVI 9400 is designed for simple, intuitive operation. However, to ensure safe and effective operation, before using the device: Familiarize yourself with the contents of this manual. Watch the training video provided on the instrument.

  • Page 19: Probe Components

    ® ® BladderScan BVI 9400 Introducing the BladderScan BVI 9400 Probe Components The Probe transmits and receives ultrasound waves, automatically moving its internal transducer 360º to scan twelve different planes to produce a three-dimensional image of the bladder. The Probe is attached to the Console by a cable. The Probe has three main features: Part Name Purpose...

  • Page 20: Battery Charger/Wireless Hub

    ® ® Introducing the BladderScan BVI 9400 BladderScan BVI 9400 Battery Charger/Wireless Hub ® The BladderScan BVI 9400 is powered by a Lithium Ion (Li-Ion) battery pack. The battery charger provided with your BVI 9400 can charge two Li-Ion battery packs while ®...

  • Page 21: Parts And Accessories

    ® ® BladderScan BVI 9400 Introducing the BladderScan BVI 9400 Parts and Accessories Part Number Description BVI 9400 Instrument - Console 0570-0190 BVI 9400 Instrument - Probe 0570-0188 Battery Charger/Wireless Hub 0570-0193 Lithium Ion Battery (2 provided) 0570-0066 BVI 9400 User’s Manual (on In-Service CD) 0900-1606 ®...

  • Page 22: Getting Started

    Remove the contents and verify that you have received everything listed below. If anything is missing or damaged, notify your ® ® authorized Verathon Medical representative or Verathon Medical Customer Care Department at 1.800.331.2313. ® (1) BladderScan...

  • Page 23: Install A Battery Pack In The Console

    ® BladderScan BVI 9400 Getting Started To charge the batteries: 1. Plug the Battery Charger/Wireless Hub unit in to a standard wall outlet. 2. Remove the label covering the battery contacts and insert the battery into the recess in the battery charger NOTE: Fully charging the battery may take up to 6 hours.

  • Page 24: Enter The Clinic Name

    ® Getting Started BladderScan BVI 9400 Enter the Clinic Name ® You can customize your BladderScan 9400 by entering your facility’s name and current ® date and time. This information will subsequently be included on BladderScan displays and all printouts of exam results. NOTE: Use of extended-Latin and/or non-Latin characters: The following instructions explain how to enter a facility name that uses only standard Latin characters.

  • Page 25: Figure 5. Alpha-Numeric Screen

    ® BladderScan BVI 9400 Getting Started Figure 5. Alpha-Numeric Screen On the Alpha-Numeric screen (Figure 5), use the buttons to move to the desired character. When the desired character is highlighted (red), press button to add it to your text. Use the button to delete characters.

  • Page 26: Set The Date And Time

    ® Getting Started BladderScan BVI 9400 Set the Date and Time The clock has its own Lithium battery and maintains the correct date and time for at least ten years. To set the date and time: ® 1. If the BladderScan instrument is turned off, turn the power on by pressing the button on the front of the Console.

  • Page 27: Setting General Preferences And Savings Preferences

    NOTE: If the paper appears to be stuck in the printer, contact your authorized ® ® ® BladderScan Service Center, your local BladderScan distributor, or Verathon Medical Customer Care at 1.800.331.2313 for service. User’s Manual page 27...

  • Page 28: Assemble The Medical Cart

    ® Getting Started BladderScan BVI 9400 Assemble the Medical Cart NOTE: If you’re not using the medical cart, please skip to the next section, Install the ® ScanPoint with QuickPrint Software, on page 30. The optional Medical Cart is illustrated in Figure 9. Figure 9.

  • Page 29: Figure 10. Medical Cart Assembly

    ® BladderScan BVI 9400 Getting Started To assemble the cart: While following the assemble procedure, refer to Figure 10 1. Align and press one 3-inch Caster with Brake (Item 7) and four 3-inch Casters (Item 6) into Medical Cart Base (Item 3). 2.

  • Page 30: Install The Bladderscan ® On The Optional Mobile Cart

    ® Getting Started BladderScan BVI 9400 ® Install the BladderScan on the Optional Mobile Cart ® Your BladderScan BVI 9400 is completely portable and can be easily moved and positioned for convenient use. Installing the BVI 9400 on the optional mobile cart will allow you to ®...

  • Page 31: Watch The Training Video

    The training video provides an overview of how to perform an ultrasound scan of the ® bladder using the BladderScan BVI 9400. The video is approximately 5 minutes long. ® The training video is available at the Verathon Web site: http://www.verathon.com/Training%20Videos.htm. ® A training tutorial is available for review anytime on the BladderScan...

  • Page 32: Displays, Controls, And Indicators

    ® Displays, Controls, and Indicators BladderScan BVI 9400 Displays, Controls, and Indicators Displays, Controls, and Indicators Console Displays and Button Functions The Console LCD display presents user information and prompts that vary depending on the current device function. The five buttons below the display have variable functions according to device mode. Button functions are indicated by icons in the display footer, immediately above each button.

  • Page 33: Figure 12. Home Screen

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Figure 12. Home Screen Battery Status Indicator Saved exams (yellow) Cost Available savings memory calculator for 8 more exams (gray) Home Screen Buttons Button Function Single button with three modes. When performing an exam, press the button repeatedly until the desired setting appears above the saved exams folders: Select the “small child”...

  • Page 34: Scan Screen

    ® Displays, Controls, and Indicators BladderScan BVI 9400 Button Function ® Press to initiate communication with the ScanPoint host computer. Saved and annotated exams will be automatically uploaded to the host ® computer. (ScanPoint software must be previously installed and the ®...

  • Page 35: Figure 14. Results Screen

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Figure 14. Results Screen Results Screen Buttons Button Function Press to record a voice annotation (up to 10 seconds long). Press to print exam results to the onboard label printer. Press to play a previously recorded voice annotation. If no voice annotations are recorded, this button is disabled.

  • Page 36: Review Screen

    ® Displays, Controls, and Indicators BladderScan BVI 9400 Review Screen The Review screen (Figure 15) opens when you select a saved exam (yellow folder icon) to review. The displays shows the ultrasound images associated with the selected exam. A green open-folder icon indicates which exam is being viewed.

  • Page 37: Tutorial Screen

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Tutorial Screen To open the Tutorial Screen (Figure 16) press the button from the Home screen (Figure 12, page 33). The Tutorial screen presents a menu of training modules. To select a title, press either button until the desired title is highlighted (red).

  • Page 38: Video Viewing Screen

    ® Displays, Controls, and Indicators BladderScan BVI 9400 Video Viewing Screen The Video Viewing (Figure 17) screen is activated by pushing the button on the Tutorial screen (Figure 16). NOTE: The button is disabled during video playback. SCAN Figure 17. Video Viewing Screen Video Viewing Screen Buttons Button Function...

  • Page 39: Settings Screen

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Settings Screen To open the Settings screen (Figure 18), push the button on the Home SETTINGS screen. The display presents a list of user-configurable settings: Name, Time & Date, General Preferences, Savings Preferences, and Self-Test. Use the Up/Down arrows to move through the list of setup options.

  • Page 40: Alpha-Numeric Screen

    ® Displays, Controls, and Indicators BladderScan BVI 9400 Alpha-Numeric Screen This screen allows you to select the appropriate alpha-numeric characters for entering your health care institution’s name. Figure 19. Alpha-Numeric Screen Alpha-Numeric Screen Buttons Button Function Press to move down in the grid. Press to move to the right in the grid.

  • Page 41: Date & Time Screen

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Date & Time Screen This screen allows you to adjust the date and time. NOTE: If the time display is set to show a 24-hour clock, the hour units are 0 - 23. If the clock is set to show a 12-hour clock, the hour units are 1 AM - 12 AM and 1 PM - 12 PM.

  • Page 42: General Preferences Screen

    ® Displays, Controls, and Indicators BladderScan BVI 9400 Date & Time Screen Buttons Button Function Move back one changeable unit. Press to move forward to the next changeable unit (in this case, hours, minutes, AM/PM, month, day, year). Press to add and/or toggle digits as appropriate (hours, minutes, AM/PM, months, day, years).

  • Page 43: Savings Preferences Screen

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Figure 21. General Preferences Screen General Preferences Screen Buttons Button Function SELECT PREVIOUS: Press to select the previous setting in the list. SELECT NEXT: Press to select the next setting in the list. For settings with a list of options, press to select the next option.

  • Page 44: Figure 22. Savings Preference Screen

    ® Displays, Controls, and Indicators BladderScan BVI 9400 Preferences lists and options: UTI Rate: 1% to 100% in increments of 1% UTI Cost: $10 to $10,000 in increments of $10 Catheter Cost: $1 to $1000 in increments of $1 Catheter Volume: 20 ml to 1000 ml in increments of 20 ml Currency: $ / €...

  • Page 45: Self-Test Screen

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Button Function Press to save the current date date/time setting and return to the Setup screen. Self-Test Screen To open the Self-Test screen, select Self-Test from the Setup menu (Figure 18, page 39). The Self-Test screen will open and testing begins automatically.

  • Page 46: Scanpoint ® Screen

    ® Displays, Controls, and Indicators BladderScan BVI 9400 ® ScanPoint Screen ® NOTE: Only available if optional ScanPoint software is installed on a PC. ® To open the ScanPoint screen, press from the Home screen (Figure 12, page 18). ® The ScanPoint screens display information about the status of the link between the ®...

  • Page 47: Memory Optimization During Power Down

    ® BladderScan BVI 9400 Displays, Controls, and Indicators Figure 25. Sleep Mode Screen Memory Optimization During Power Down When the power is turned off, the BVI 9400 begins an internal process of memory optimization. This process takes several minutes. When complete, the device will shut down.

  • Page 48: Measuring Bladder Volume

    BVI 9400 on page 17). ® ® If you are a new BladderScan user, Verathon recommends that you perform your first exam on a patient with a moderately full bladder, rather than initially attempting to locate and scan a nearly empty bladder.

  • Page 49: Measuring Bladder Volume

    ® BladderScan BVI 9400 Measuring Bladder Volume Measuring Bladder Volume 1. Turn on the BVI 9400. Turn on the BVI 9400 by pressing the button. 2. Select the exam mode. Select to scan a patient with height less than 48 inches (122 cm) tall and weight less than 60 lbs (27 kg).
  • Page 50 ® Measuring Bladder Volume BladderScan BVI 9400 4. Aim toward the bladder. Standing at the patient’s right side, place the Probe on the gel and aim it toward the expected location of the bladder. For most patients, this means angling the Probe slightly toward the patient's coccyx (tail bone) so the scan clears the pubic bone.
  • Page 51 ® BladderScan BVI 9400 Measuring Bladder Volume 6b. To re-aim: Note that the crosshairs correspond to the anatomy of the patient as follows: The small dot at the base of the crosshairs represents the feet of the patient. The top of the crosshairs represents the patient’s head.

  • Page 52: Additional Scanning Tips

    ® Measuring Bladder Volume BladderScan BVI 9400 8. Finish the exam. Once you have completed the scan, wipe the ultrasound gel off the patient and the ® ® Probe. For ScanPoint subscribers, logging onto ScanPoint automatically transfers and ® saves your annotated exams to your Windows computer.
  • Page 53 ® BladderScan BVI 9400 Measuring Bladder Volume ® you can upload saved exams to your PC. (Refer to the ScanPoint with QuickPrint User’s Manual for more information.) To record a voice annotation: 1. Press the button RECORD (microphone). A S button is now displayed.

  • Page 54: Deleting A Saved Exam

    NOTE: If the facility name, date, and time have not been set, those lines will be skipped on the printout. The BVI 9400 prints on thermal paper, which fades over time. For maximum storage life, ® Verathon recommends that you photocopy the printout. page 54 User’s Manual...

  • Page 55: Histogram Of Cost Savings

    ® BladderScan BVI 9400 Histogram of Cost Savings Histogram of Cost Savings Histogram of Cost Savings Each volume measurement from a completed scanning procedure is stored in the BVI 9400 memory in one of eleven volume ranges (each with a 100 ml increment). This data is analyzed and can be displayed on the BVI 9400 at any time.

  • Page 56: Cleaning And Maintenance

    4. To remove all traces of disinfectant solution and wipe the instrument with a clean soft ® cloth dampened in sterile water or cleaning solution. Verathon recommends wiping the device three separate times to remove all residual disinfectant.

  • Page 57: Weekly Inspections

    ® Medical Customer Care Department. IMPORTANT! If you see any physical faults or cracks in the instrument, discontinue use ® immediately and contact your local Verathon Medical representative or the Verathon ® Medical Customer Care Department at 1.800.331.2313. Using the Built-in Self-Test Utility The BVI 9400 can perform a number of self-diagnostic tests.

  • Page 58: Self-Calibration

    Premium Warranty customers have access to a loaner replacement unit and free shipping options which vary according to plan. ® If you have any questions, contact your local Verathon Medical representative or the ® Verathon Medical Customer Care Department at 1.800.331.2313.

  • Page 59: Troubleshooting

    You can obtain copies of this manual, Quick Reference Cards, and clinical studies by ® visiting the Verathon Web site at http://www.verathon.com or by contacting your ® Verathon Medical representative. A complete listing of contact information is provided on page 64.

  • Page 60: Icons On The Bladderscan ® Console

    / replacement when your device is no longer manufactured. Free loaner program. Free shipping. ® Verathon Web site http://www.verathon.com includes many in-service ® training resources. From the Verathon Home page, ® ® select “BladderScan .” On the BladderScan page, select “Customer Service.” Phone support In North America, call: 1.800.331.2313.

  • Page 61: Diagnosing Problems

    ® BladderScan BVI 9400 Troubleshooting Symbol Meaning The patient is a female patient who has not had a hysterectomy. Select to scan all other patients. The bladder is too large to be contained within the scan cone, or the > bladder contains more than 999 ml of urine.

  • Page 62: Too Hot

    CAUTION! Possible device damage. If the paper jam is inaccessible, do not try to disassemble the printer. Contact you ® ® authorized Verathon Service Center or your local Verathon distributor for service. page 62 User’s Manual...

  • Page 63: Warranty

    Damage or loss insurance is available as part of the Total Reliability Plan. Pursuant to ® this warranty, a service center authorized by Verathon will repair or replace units that prove to be defective during the warranty period. This warranty does not apply if the unit was misused or modified by anyone other than a ®...

  • Page 64: Contacting Verathon

    ® and excellence. For additional product and company information, visit the Verathon ® site at http://www.verathon.com. If you have any questions or comments about Verathon products and services, please contact us at: Toll free: 800.331.2313 (US & Canada Only) Corporate Headquarters (USA) Verathon Incorporated Tel: 425.867.1348...

  • Page 65: Safety And Performance Summary

    ® BladderScan BVI 9400 Safety and Performance Summary Safety and Performance Summary Safety and Performance Summary ® The BladderScan BVI 9400 computes the volume of the urinary bladder based upon twelve cross-sectional ultrasound images. For maximum accuracy, be sure to hold the Probe motionless while scanning. The most accurate measurements are obtained when the patient rests quietly in a supine position.

  • Page 66: Parts And Accessories

    0900-1601 Quick Reference Cards - Demo/Use 0900-1446 Quick Reference Cards - Calibration 0900-1447 ® To order any of the above parts, contact your authorized Verathon Medical sales ® representative or contact the Verathon Medical Customer Care Department at 1.800.331.2313. page 66...

  • Page 67: Product Specifications

    CE marked in accordance with the Medical Device Directive (MDD). Canadian Standards Association (CSA) mark of certification to United States standards for electromedical equipment. This unit is powered by a Lithium-Ion battery pack. The ® Verathon part number for the battery pack is 0400-0066. User’s Manual page 67...

  • Page 68: Standards And Regulations Compliance

    C22.2 No. 601.1-M90 (Master Contract No. 177198) Underwriters Laboratories, Inc. UL 60601-1 Health Insurance Portability and Accountability Act (HIPAA)* ® *For details on Verathon compliance with privacy rules, please refer to the information in the QuickPrint Help menu (select P RIVACY GREEMENT Electromagnetic Effects ®...

  • Page 69: Bladderscan ® Bvi 9400 Instrument Specifications

    For technical performance assessment in an acoustic laboratory, the Probe cannot be immersed in water. Item Specification Input Lithium Ion Battery Pack. Verathon P/N 0400-0066. Output No load to full load at rated voltage. Refer to unit label. Insulation The power supply is Class I with basic insulation to each terminal.

  • Page 70: Accuracy Specifications

    Verathon , scanning a tissue-equivalent phantom. Specification Description ® Bladder volume accuracy ± 15%, ± 15 ml (on a Verathon tissue-equivalent phantom) Bladder volume range 0 - 999 ml (0-200ml in small child scan mode) ® BladderScan BVI 9400 Operating Conditions ®...

  • Page 71: Bladderscan ® Bvi 9400 Displays, Controls, And Indicators

    ® BladderScan BVI 9400 Product Specifications ® BladderScan BVI 9400 Displays, Controls, and Indicators ® The BladderScan BVI 9400 provides the following controls, connectors, and features: Instrument Buttons Power O , Brightness ( / ), Volume ( / ). S and R buttons are on the ECORD...
  • Page 72 ® Product Specifications BladderScan BVI 9400 Screen/Mode Active Buttons POWER, (1) Select next setting in list, (2) Select previous Settings Screen setting in list, (3) Enter (proceed to the selected screen), Start screen for editing (4) No action, (5) Home (return to Home screen). clinic name, date &...

  • Page 73: Instrument Display

    ® BladderScan BVI 9400 Product Specifications Screen/Mode Active Buttons POWER, (1) Scroll down, (2) Scroll up, (3) No function, Self-Test Screen (4) No function, (5) SETUP (Go back to setup screen). ® ® (NOTE: Only available when used with ScanPoint with ScanPoint Screen...

  • Page 74: Battery Charger/Wireless Hub Specifications

    ® Product Specifications BladderScan BVI 9400 Screen/Mode Display The date and time. Date & Time Screen List of available settings and their current values. Preferences Screen Displays test progress and results. Self-Test Screen ® ® When ScanPoint with QuickPrint is installed: Displays ScanPoint Screen ®...

  • Page 75: Storage Conditions

    ® BladderScan BVI 9400 Product Specifications Specification Description Fuses 250 VAC, 2A, quick acting Testing CSA 60950-1-03/UL 60950-1 Storage Conditions Condition Description Indoor Ambient Temperature Range +5 - +40º Celsius (+41 - +104º Fahrenheit) Atmospheric pressure range 70 kPa - 106 kPa Relative humidity 30% - 75% non-condensing Water resistance...

  • Page 76: Glossary

    ® Glossary BladderScan BVI 9400 Glossary Glossary Term Meaning Arrows that appear on the LCD screen to indicate the location Aiming arrows of the bladder relative to the Probe. A solid aiming arrow means re-aiming is optional. The unit that charges the Lithium Ion batteries that power the Battery ®...
  • Page 77 Located on the underside of the BladderScan hand grip, this button button is used to initiate the measurement. ® ® The software and online service provided by Verathon that ScanPoint bladder prints exam results, maintains patient records, displays imaging ultrasound images from exams, downloads software updates, technology ®...
  • Page 79 For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical® representative. BladderScan®, ScanPoint®, Verathon® and Verathon Medical® are registered trademarks of Verathon Inc. in the United States and/or other countries. Copyright ©2008. All rights reserved.

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