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Verathon BLADDERSCAN BVI 6400 Operation & Maintenance Manual

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BLADDERSCAN
BVI 6400
Operations & Maintenance Manual

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Summary of Contents for Verathon BLADDERSCAN BVI 6400

  • Page 1 BLADDERSCAN BVI 6400 Operations & Maintenance Manual...
  • Page 2 0900‑4831‑02‑60...
  • Page 3 BLADDERSCAN BVI 6400 Operations & Maintenance Manual Effective: November 1, 2018 Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
  • Page 4 International: +61 2 9431 2000 Tel / +61 2 9475 1201 Fax 0123 Copyright 2018 Verathon Inc. All rights reserved. No part of this manual may be copied or transmitted by any method without the express written consent of Verathon Inc.

  • Page 5: Table Of Contents

    TABLE OF CONTENTS IMPORTANT INFORMATION ..........................1 Overview ................................1 Product Description ............................1 Statement of Intended Use ..........................1 Essential Performance ............................1 Environments of Intended Use .........................1 Notice to All Users ............................1 Safety Information ..............................2 Ultrasound Energy Safety ..........................2 Contraindications .............................2 Cautions & Warnings ............................2 INTRODUCTION ..............................7 System Overview ..............................7 BladderScan BVI 6400 .............................7...
  • Page 6 MEASURING BLADDER VOLUME ........................15 Performing Scans .............................. 15 Procedure 1. Prepare for the Exam ......................16 Procedure 2. Measure Bladder Volume ..................... 16 Scanning Tips..............................20 CLEANING & DISINFECTING ..........................22 Procedure 1. Clean & Disinfect the Device ....................24 MAINTENANCE & TROUBLESHOOTING ......................25 Regular Inspections ............................25 Calibrating the Device ............................25 Procedure 1.

  • Page 7: Important Information

    The system has a passively temperature‑controlled transducer assembly. ENVIRONMENTS OF INTENDED USE The BladderScan BVI 6400 system is intended to be used in professional healthcare environments such as hospitals, clinics, and doctors’ offices. NOTICE TO ALL USERS This device should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care.

  • Page 8: Safety Information

    EN/IEC 60601‑1. If you need assistance, contact your biomedical staff, local representative, or Verathon Customer Care.
  • Page 9 CAUTION Statement of Prescription: Federal (United States) law restricts this device to sale by or on the order of a physician. CAUTION Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and operated according to the instructions in this manual.
  • Page 10 WARNING Availability of cleaning, disinfection, and sterilization 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 Cleaning is critical to ensuring the component is ready for disinfection.
  • Page 11 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12inches) to any part of the BladderScan BVI 6400 system, including cables specified by Verathon. Otherwise, degradation of performance of this equipment could result.
  • Page 12 WARNING To reduce the risk of explosion, do not use the system in the presence of flammable anesthetics. WARNING No modification of this equipment is allowed. 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.

  • Page 13: Introduction

    INTRODUCTION SYSTEM OVERVIEW The BladderScan BVI 6400 is a portable, hand‑held ultrasound device that scans the patient’s bladder. It is battery‑powered with an ergonomic design. Using patented V ® technology, it provides a noninvasive mode measurement of urinary bladder volume. The display provides aiming assistance and provides an array of bladder measurement information.

  • Page 14: System Components & Accessories

    Scan Point with QuickPrint is a network‑based version of the application. Archived patient data is stored securely on HIPAA‑compliant, Verathon‑maintained servers. Users can access records from any Internet‑enabled, Windows‑based PC. Scan Point with QuickPrint allows users to maintain the most recent software for their devices, to calibrate their devices themselves without having to send them in for service, and also enables remote diagnostics and troubleshooting by Verathon service technicians.

  • Page 15: Optional Components & Accessories

    OPTIONAL COMPONENTS & ACCESSORIES The following optional items are available to enhance the capabilities of your device. Please contact Verathon Customer Care or your local representative for more information on any of the following Verathon ® products. Table 2. Optional Components and Accessories...

  • Page 16: Buttons, Parts, & Icons

    BUTTONS, PARTS, & ICONS BUTTONS & PARTS Figure 1. Buttons and Parts Display Scanhead Top button Activation button Scan button Handle Infrared window Table 3. Buttons and Parts PART PURPOSE Scan button Press to take a scan. The scanhead transmits and receives ultrasound waves, automatically moving its Scanhead internal transducer 360º...

  • Page 17: Screen Icons

    SCREEN ICONS The following icons may appear on the display. Table 4. Display icons ICON MEANING Battery power level. Female gender option is selected. Select this option only for women who have not had a hysterectomy. Deselect for all others, male or female. Bladder imaging in progress.
  • Page 18 BATTERY ICON The battery icon is located in the lower‑right corner of the display and indicates the power level of the battery. The device can be charged at any time, but if the battery is completely discharged, it must be recharged before use.

  • Page 19: Setting Up

    1. Verify that you have received the appropriate components for your system by referring to System Components & Accessories. 2. Inspect the components for damage. 3. If any of the components are missing or damaged, notify the carrier and Verathon Customer Care or your local representative. PROCEdURE 2. CHARGE THE dEVICE...

  • Page 20: Procedure 3. Activate The Device (Optional)

    1. Using the tip of the activation tool, press the Activation button located just above the Scan button. 2. Place the device in the charging cradle or docking station until the “full battery” icon is displayed. Note: When you are not using your device, Verathon recommends that you store it in the charging cradle ®...

  • Page 21: Measuring Bladder Volume

    MEASURING BLADDER VOLUME PERFORMING SCANS 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 To reduce the risk of explosion, do not use the system in the presence of flammable anesthetics. WARNING Be aware of the following conditions that can affect ultrasound transmission: •...

  • Page 22: Procedure 1. Prepare For The Exam

    PROCEdURE 2. MEASURE BLAddER VOLUME To ensure the highest degree of accuracy, Verathon recommends that you scan the patient’s bladder at least three times per exam, in order to ensure the repeatability of your measurements. Repeatability refers to your ability to center the bladder during each measurement, not your ability to obtain exactly the same bladder volume measurement each time.
  • Page 23 2. If the patient is a female who has not had a hysterectomy, press the top button until the gender icon is displayed. If the patient is a male, or a female who has had a hysterectomy, press the top button until the gender icon is cleared.
  • Page 24 Re‑aim in the direction indicated by the flashing arrow and perform the scan again. If a solid arrow is displayed, then the bladder was mostly inside the ultrasound field of view. The results are satisfactory, but in order to ensure accuracy, Verathon ®...
  • Page 25 10. If you would like to ensure the highest degree of accuracy, repeat Step 5–Step 9 in order to complete three scans, and then compare the results. It is not necessary that the three exam results be identical, but they should be similar. 11.

  • Page 26: Scanning Tips

    SCANNING TIPS IMPORTANT Hold the device steady while scanning. Movement will result in an inaccurate reading. Applying too much pressure when scanning will lead to a “greater than” symbol (>) preceding the bladder volume measurement. Apply less pressure and re‑scan. Volume reading will be affected by: •...
  • Page 27 The following table illustrates typical scanning scenarios and corresponding bladder volume information that may appear on the display. Table 6. Typical scanning scenarios and displays SCANNING SCENARIO EXAMPLE DISPLAY DESCRIPTION In an optimal scan, the bladder is entirely contained Optimal scan within the ultrasound field of view.

  • Page 28: Cleaning & Disinfecting

    WARNING Availability of cleaning, disinfection, and sterilization 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 Cleaning is critical to ensuring the component is ready for disinfection.
  • Page 29 Cleaning and disinfecting this device is an important part of using and maintaining it. Prior to each use, ensure the device has been cleaned and disinfected according to the following procedures. Remove the device from the docking station or charging cradle to clean and disinfect it. BEST PRACTICES Cleaning is the removal of all visible soil or contaminants from the exterior surfaces of the device, and disinfection is the process of destroying pathogenic organisms or rendering them inert.

  • Page 30: Procedure 1. Clean & Disinfect The Device

    Follow the manufacturer’s instructions for the appropriate disinfection level contact duration. 10. If rinsing or removal of the disinfectant solution from the device is required by the disinfectant manufacturer’s instructions, wipe the device with a clean soft cloth dampened in sterile water. Verathon ®...

  • Page 31: Maintenance & Troubleshooting

    ® device. You may also send your device to an authorized Verathon Service Center. If you are not using Scan Point with QuickPrint, you must send your device in to an authorized Verathon Service Center for calibration. To contact Verathon Customer Care about calibration, please visit verathon.com/support.
  • Page 32 3. Using the notches to position the spiral‑shaped target correctly, place the target in the tank base. 4. Replace the tank lid on the tank base. Ensure that the opening for the scanhead is directly above the spiral target. 5. On the computer, double‑click the Scan Point QuickPrint icon.
  • Page 33 7. In Scan Point , select the device, verify that the serial number matches the device you are calibrating, and ® then click the calibration tank icon. 8. In the Calibrate Instrument window, click the Calibrate button. Scan Point prepares the device for calibration.
  • Page 34 10. On the device, press the top button. The device begins to scan the calibration tank. Note: Do not remove the device from the calibration tank while scanning is in progress. Top Button 11. When the calibration scan is complete, four arrows appear on the display, and the device plays a melody. 12.

  • Page 35: Warranty

    Consumable items are not covered under this warranty. For more information about your warranty or to purchase a Scan Point Total Reliability Plan that extends the limited warranty on your system, please contact Verathon Customer Care or your local representative. Operations & Maintenance Manual: Maintenance & Troubleshooting...

  • Page 36: Device Repair Or Replacement

    ® descriptions, or other information that would be required for repairing the device and related accessories. For additional information or to request service or repairs, contact Verathon Customer Care or your local representative. For contact information, please visit verathon.com/support. BATTERY REPLACEMENT This device is built with a replaceable battery.

  • Page 37: Troubleshooting

    TROUBLESHOOTING FREQUENTLY ASKED QUESTIONS If you are encountering issues when operating your device, review this list of common questions. If you do not find a solution here, contact Verathon Customer Care or your local representative. For contact ® information, see verathon.com/support.

  • Page 38: Help Resources

    Verathon ® provides an extensive array of customer service resources, described in the table below. You may obtain copies of this manual, quick reference cards, and clinical studies by visiting the Verathon Web site at verathon.com or by contacting your local representative. To obtain contact information, see verathon.com/support.

  • Page 39: Product Specifications

    BladderScan Device Specifications GENERAL SPECIFICATIONS Bladder volume range: 0–999 mL The following accuracy specification assumes usage per instructions, scanning a Verathon ® tissue equivalent phantom: Bladder Volume: ± (15% + 15 mL) Accuracy: Example for a scanned volume of 160 mL: 160 mL ×...
  • Page 40 Table 9. Ultrasound Acoustic Output Parameters (IEC Standard) INDEX LABEL NON‑SCAN NON‑ SCAN SCAN ≤1 cm² >1 cm² APRT APRT Maximum index value 0.251 1.42E‑3 — — — (MPa) 0.470 (mW) 0.331 — — † min of [P ), I )] (mW) —...

  • Page 41: Charging Cradle Specifications

    Table 10. Ultrasound Acoustic Output Parameters (FDA Standard) Values in this table are the maximum readings obtained from three test results SPTA.3 SPPA.3 ACOUSTIC OUTPUT (mW/cm (W/cm Global Maximum Value 0.268* 0.0977 8.06 (MPa) 0.501 (mW) 0.339 0.339 (MHz) 3.54 3.54 3.54 (cm)

  • Page 42: Electromagnetic Compatibility

    ELECTROMAGNETIC COMPATIBILITY The system is designed to be in compliance with IEC 60601‑1‑2, which contains electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions and immunity specified in this standard are designed to provide reasonable protection against harmful interference in a typical medical installation.
  • Page 43 Table 13. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC ENVIRONMENT IMMUNITY TESTS IEC 60601 TEST LEVEL LEVEL...
  • Page 44 Table 13. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC ENVIRONMENT IMMUNITY TESTS IEC 60601 TEST LEVEL LEVEL...

  • Page 45: Recommended Separation Distances

    ACCESSORY CONFORMANCE TO STANDARDS To maintain electromagnetic interference (EMI) within certified limits, the system must be used with the cords, components, and accessories specified or supplied by Verathon . For additional information, see ®...

  • Page 46: Glossary

    GLOSSARY The following table provides definitions for specialized terms used in this manual or on the product itself. For a full list of caution, warning, and informational symbols used on this and other Verathon products, please ® refer to the Verathon Symbol Directory at verathon.com/symbols.

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