Verathon BLADDERSCAN BVI 6400 Operation & Maintenance Manual Download Page 2

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0900‑4831‑02‑60

Summary of Contents for BLADDERSCAN BVI 6400

Page 1: ...BLADDERSCAN BVI 6400 Operations Maintenance Manual...

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: ...hin Australia 1800 613 603 Tel 1800 657 970 Fax 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 transmi...

Page 5: ...ntraindications 2 Cautions Warnings 2 INTRODUCTION 7 System Overview 7 BladderScan BVI 6400 7 Scan Point Image Management Technology Optional 7 System Components Accessories 8 Required System Componen...

Page 6: ...ng the Device 25 Procedure 1 Calibrate the Device 25 Warranty 29 Device Repair or Replacement 30 Troubleshooting 31 Frequently Asked Questions 31 Help Resources 32 Device Disposal 32 PRODUCT SPECIFICA...

Page 7: ...face STATEMENT OF INTENDED USE The BladderScan BVI 6400 is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively ESSENTIAL PERFORMANCE Essential performa...

Page 8: ...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 summ...

Page 9: ...ference 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...

Page 10: ...e component is ready for disinfection Failure to properly clean the device could result in a contaminated device after completing the disinfection procedure WARNING Ensure that you follow the manufact...

Page 11: ...frequency surgical equipment 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 device and will...

Page 12: ...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 expl...

Page 13: ...scan patients quickly and accurately Provides the capability to voice annotate each exam 10 seconds to record patient ID and relevant exam information ensuring that valuable patient and exam data is...

Page 14: ...ir 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 SYSTEM COMPONENTS AC...

Page 15: ...QuickPrint software on a network enabled Windows PC For more information see Scan Point Image Management Technology Optional Scan Point docking station Used with Scan Point image management technolog...

Page 16: ...ernal transducer 360 in order to scan twelve different planes producing a three dimensional image of the bladder Top button Press to select gender Activation button Press to reactivate the device if t...

Page 17: ...bladder was not centered within the ultrasound field of view However the bladder volume measurement is still accurate Re aiming is optional Flashing Indicates that the aim was off target In order to...

Page 18: ...echarged before use Table 5 Battery status icons BATTERY ICON DESCRIPTION Battery is fully charged and ready for use Battery is 50 75 charged Battery is 25 50 charged Battery is nearly discharged and...

Page 19: ...tative Procedure 2 CHARGE THE DEVICE In order to maintain electrical safety use only the provided power adapter battery and battery charger WARNING The charging cradle power adapter and power cords ar...

Page 20: ...s battery icon 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...

Page 21: ...n 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 t...

Page 22: ...r Cleaning Disinfecting on page 22 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...

Page 23: ...relaxed palpate the patient s pubic bone 4 Place an ample quantity of ultrasound gel with as few air bubbles as possible midline on the patient s abdomen approximately 3 cm 1 in above the pubic bone...

Page 24: ...a flashing arrow is displayed then the scan is off target and the bladder was mostly outside the ultrasound field of view Re aim in the direction indicated by the flashing arrow and perform the scan a...

Page 25: ...approximately 3 seconds and then continue to hold the top button 13 Hold the microphone approximately 15 cm 6 in from your mouth and speak clearly Be sure to include all relevant exam information suc...

Page 26: ...ply more pressure with the device in order to reduce the amount of adipose tissue through which the ultrasound must pass To ensure accurate results make sure that There are no air gaps between the sca...

Page 27: ...too large to be fully contained within the ultrasound field of view Either the bladder is too large to be contained by the ultrasound field of view or the user is pressing too hard with the device The...

Page 28: ...ity with component materials WARNING Availability of cleaning disinfection and sterilization products varies by country and Verathon is unable to test products in every market For more information ple...

Page 29: ...ed making removal more difficult Change gloves as directed in the procedure or if gloves become soiled When using a wipe cleaning or disinfection method please adhere to the following best practices A...

Page 30: ...piration date 6 Remove the gloves used in the cleaning portion of the procedure and then put on new gloves 7 If using a liquid disinfectant mix the disinfection solution according to the manufacturer...

Page 31: ...ration kit and Scan Point with QuickPrint you can easily and quickly calibrate your own device You may also send your device to an authorized Verathon Service Center If you are not using Scan Point wi...

Page 32: ...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 Scan Point with QuickPrint opens 6 Place the...

Page 33: ...tank icon 8 In the Calibrate Instrument window click the Calibrate button Scan Point prepares the device for calibration 9 When the text Make Phantom measurement return to cradle is highlighted and th...

Page 34: ...ss Top Button 11 When the calibration scan is complete four arrows appear on the display and the device plays a melody 12 Dry the device with a clean soft cloth and then return it to the Scan Point do...

Page 35: ...libration in Scan Point click the link Click Here for Printable Certificate of Calibration The Calibration Report appears WARRANTY Verathon products and software are warranted against defects in mater...

Page 36: ...se visit verathon com support BATTERY REPLACEMENT This device is built with a replaceable battery Note Older versions of the device may not have a battery door If your device does not have a battery d...

Page 37: ...te the device before you can continue scanning See Calibrating the Device WHY DID MY DEVICE BEEP Beeps indicate an alert or the completion of a normal function The device may beep in the following sit...

Page 38: ...TION In service CD The CD included with your system provides instructions for using the device Clinical studies Scientific papers on BladderScan use Scan Point Online Scan Point Online provides custom...

Page 39: ...mL 121 199 mL Scan time Less than 5 seconds Voice annotation interval 10 seconds Weight Less than 11 oz 309 grams Power 3 7 v lithium ion rechargeable battery Display Liquid crystal Water resistance...

Page 40: ...ic uses so TIC is not computed No data reported Notes 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode 2 Information need not be provid...

Page 41: ...The charging cradle is tested to applicable IEC 60601 1 requirements but it is not intended for direct patient contact It is designed to operate within the specifications and environmental conditions...

Page 42: ...or the user of the system should ensure that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The system uses RF energy o...

Page 43: ...ply input lines IEC 61000 4 11 0 UT 0 5 Cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single Phase at 0 Not applicable Mains power quality should be that of a typical ho...

Page 44: ...marked with the following symbol Note Ut is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all...

Page 45: ...above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter...

Page 46: ...acceptable risk ESD Electrostatic discharge GHz Gigahertz HIPAA Health Insurance Portability and Accountability Act Hz Hertz IEC International Electrotechnical Commission Ultrasound field of view Cone...

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