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BLADDERSCAN

BVI 6100

Operations & Maintenance Manual

Effective: July 31, 2017

Caution: Federal (United States) law restricts this  

device to sale by or on the order of a physician.

Summary of Contents for BVI 6100

Page 1: ...BLADDERSCAN BVI 6100 Operations Maintenance Manual ...

Page 2: ...0900 4830 00 60 ...

Page 3: ...BLADDERSCAN BVI 6100 Operations Maintenance Manual Effective July 31 2017 Caution Federal United States law restricts this device to sale by or on the order of a physician ...

Page 4: ...123 Copyright 2017 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 Verathon the Verathon torch symbol BladderScan the BladderScan symbol Scan Point and Vmode are trademarks or registered trademarks and Total Reliability Plan is a service mark of Verathon Inc All other brand and product names are ...

Page 5: ...ngs 2 INTRODUCTION 7 Product Description 7 BladderScan BVI 6100 7 Scan Point Image Management Technology Optional 7 System Components Accessories 8 Required System Components 8 Optional Components Accessories 9 Buttons Parts Icons 10 Instrument Parts Buttons 10 Screen Icons 11 SETTING UP 13 Procedure 1 Perform Initial Inspection 13 Procedure 2 Charge the Instrument 13 Procedure 3 Activate the Blad...

Page 6: ...derScan Instrument 24 Procedure 1 Calibrate the Instrument 24 Warranty 28 Instrument Repair or Replacement 29 Troubleshooting 30 Frequently Asked Questions 30 Help Resources 31 Device Disposal 31 PRODUCT SPECIFICATIONS 32 Component Specifications 32 Instrument Specifications 32 Charging Cradle Specifications 34 Electromagnetic Compatibility 35 Electromagnetic Emissions 35 Electromagnetic Immunity ...

Page 7: ...e software print and transfer data through an application based interface STATEMENT OF INTENDED USE The BladderScan BVI 6100 instrument is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively ESSENTIAL PERFORMANCE Essential performance is the system performance necessary to achieve freedom from unacceptable risk The essential performance of the Bladd...

Page 8: ...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...

Page 9: ...uipment 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 inc...

Page 10: ...nent is ready for disinfection Failure to properly clean the device could result in a contaminated instrument after completing the disinfection procedure WARNING Ensure that you follow the manufacturer s instructions for handling and disposing of the cleaning and disinfection solutions provided in this manual WARNING When preparing and using one of the approved cleaning disinfection or sterilizati...

Page 11: ...s Pregnant patients Patients with open skin or wounds in the suprapubic region Patients with ascites WARNING To reduce the risk of electric shock or burns do not use the system in conjunction with high 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 instrument and...

Page 12: ...posure 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 BVI 6100 instrument is not user adjustable and is limited to the minimum level necessary for effective performance For more information about acoustic output...

Page 13: ...ly Allows for exam results and images to be downloaded viewed and printed using the optional Scan Point Image Management Technology Is battery operated lightweight and portable SCAN POINT IMAGE MANAGEMENT TECHNOLOGY OPTIONAL You may transmit bladder volume measurements and ultrasound images from your BladderScan instrument to Scan Point image management software Scan Point installs on a Windows ba...

Page 14: ... technicians SYSTEM COMPONENTS ACCESSORIES REQUIRED SYSTEM COMPONENTS Table 1 Required System Components and Accessories PART DESCRIPTION BladderScan BVI 6100 Hand held wireless battery operated ultrasound bladder volume instrument Charging cradle Use the charging cradle to charge the BladderScan instrument s internal battery The charging cradle plugs directly into an electrical wall outlet Before...

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 technology Transmits data from the BladderScan instrument to the Scan Point host computer and simultaneously recharges the instrument battery Calibration kit requires Scan Point with QuickPrint software The ca...

Page 16: ...cally moving its internal transducer 360º 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 BladderScan instrument if the battery becomes completely discharged LCD screen Displays bladder volume measurements and other scan patient and instrument data Infrared IR window Enables the ...

Page 17: ...der imaging in progress Hold instrument steady Solid Indicates that the 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 get an accurate bladder volume measurement you must re aim the probe in the direction of the arrow The patient s actual bladder s...

Page 18: ...tely discharged 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 may only have enough power for few scans Recharge the battery as soon as possible The battery is completely discharged The bladder volume instrument will not work until it is recharged Scrolling segments ...

Page 19: ...representative Procedure 2 CHARGE THE INSTRUMENT In order to maintain electrical safety use only the provided medical grade power adapter battery and battery charger WARNING The charging cradle power adapter and power cords are not intended for patient contact Ensure 2 m 6 ft is maintained between the patient and these components WARNING Before using your BladderScan instrument for the first time ...

Page 20: ...lling segments battery icon 1 Using the tip of the activation tool press the Activation button located just above the Scan button 2 Place the BladderScan instrument in the charging cradle or docking station until the full battery icon is displayed Note When you are not using your instrument Verathon recommends that you store it in the charging cradle in order to ensure that your instrument is alwa...

Page 21: ...sue 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 date exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects However ultrasound should be used prudently and total patient exposure shou...

Page 22: ...e that the battery has sufficient power 4 Wipe the probe gently with a soft cloth soaked in isopropyl alcohol This cleans and disinfects the instrument 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...

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 5 Standing at the patient s right side gently press the probe onto the lower abdomen through the gel The instrument s handle should be oriented at 90 degrees to the sagittal plane of the patient Sagitt...

Page 24: ...flashing arrow is displayed then the scan is off target and the bladder was mostly outside the ultrasound field of view Re aim the probe 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 recommends that you re ...

Page 25: ...ing will lead to a greater than symbol preceding the bladder volume measurement Apply less pressure and re scan Volume reading will be affected by The presence of scar tissue The presence of a catheter Obese patients If you are scanning an obese patient lift as much abdominal adipose tissue out of the way of the instrument as possible Apply more pressure to the BladderScan instrument in order to r...

Page 26: ... 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 instrument The display shows Bladder volume with a symbol No flashing arrow No solid arrow Apply less pressure and rescan Bladder not centered optional rescan The bladder is entirely contained within the ultrasound field of view but not cent...

Page 27: ...bility 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 Failure to properly clean the device could resu...

Page 28: ...king 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 Always wipe in the direction from a clean surface towards a dirty surface Minimize overlap on the wiping pattern If a wipe becomes dry or soiled replace it with a fresh one Do not reuse dry or soiled wipes ...

Page 29: ...isinfectants prior to their expiration 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 s label instructions for the appropriate disinfection level concentration 8 Apply the solution to a soft cloth or wipe for application Do not spray or apply liquid disinf...

Page 30: ... and Scan Point with QuickPrint you can easily and quickly calibrate your own instrument You may also send your instrument to an authorized Verathon service center If you are not using Scan Point with QuickPrint you must send your instrument in to an authorized Verathon service center for calibration To contact Verathon Customer Care about calibration please visit verathon com support Procedure 1 ...

Page 31: ... 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 Scan Point with QuickPrint opens 6 Place the instrument in the Scan Point docking station Scan Point connects to the instrument Note Software may upload to the instrument at this time ...

Page 32: ... Instrument window click the Calibrate button Scan Point prepares the instrument for calibration 9 When the text Make Phantom measurement return to cradle is highlighted and the status says waiting remove the instrument from the Scan Point docking station and place it into the recess in the calibration tank lid Ensure that the tip of the scanhead is submerged in the water ...

Page 33: ...canning is in progress Top Button 11 When the calibration scan is complete four arrows appear on the instrument s LCD screen and the instrument plays a melody 12 Dry the instrument with a clean soft cloth and then return it to the Scan Point docking station The instrument transmits the calibration results to Scan Point Note Do not remove the instrument from the Scan Point docking station while dat...

Page 34: ...int click the link Click Here for Printable Certificate of Calibration The Calibration Report appears WARRANTY Verathon products and software are warranted against defects in material and workmanship according to the Terms and Conditions of Sale This limited warranty applies as long as it is covered by the Scan Point Total ReliabilitySM Plan Warranty coverage applies to the following system compon...

Page 35: ... 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 The BladderScan BVI 6100 instrument is built with a replaceable battery Note Older versions of BladderScan BVI 6100 instruments may not have a battery door If your instrument does not have a battery door t...

Page 36: ... perform bladder volume measurements See Calibrating the BladderScan Instrument WHY DID MY INSTRUMENT BEEP Beeps indicate an alert or completion of a normal instrument function The instrument may beep in the following situations The instrument is turned on The instrument goes into sleep mode in order to conserve battery power The instrument completes a bladder volume or calibration measurement The...

Page 37: ... help resources RESOURCE DESCRIPTION In service CD The CD included with your system provides instructions for using the instrument Clinical studies Scientific papers on BladderScan use Scan Point Online Scan Point Online provides customers The ability to calibrate and certify instruments online anytime you wish Automatic data backup and archiving HIPAA compliant Automatic software upgrades Access ...

Page 38: ... 187 5 mL 150 mL 37 5 mL 112 5 mL Scan time Less than 5 seconds Weight Less than 11 oz 309 grams Power 3 7 v lithium ion rechargeable battery Display Liquid crystal Water resistance Rated at IPX1 indicates drip proof a higher than ordinary level of protection from drips leaks and spills OPERATING STORAGE SPECIFICATIONS Operating Conditions Temperature 10 40 C 50º 104ºF Relative humidity 30 75 non ...

Page 39: ...ed use does not include cephalic 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 provided regarding TIC for any transducer assembly not intended for transcranial or neonatal cephalic uses 3 Information on MI and TI need not be provided if the equipment meet...

Page 40: ...0601 1 requirements and is in compliance with UL and CSA equivalent standards The charging cradle is not intended for direct patient contact It is designed to operate within the specifications and environmental conditions identified in the following table Table 11 Charging Cradle Specifications GENERAL SPECIFICATIONS Input Voltage 90 264 VAC RMS Input Frequency 47 63 Hz Input Current 0 5 Amp max I...

Page 41: ...that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The BladderScan BVI 6100 system uses RF energy only for internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The BladderScan BVI 6100 system is suitable for ...

Page 42: ...wer supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 s In compliance Mains power quality should be that of a typical commercial or hospital environment If the user of the system requires continued operation during power mains interruptions it is recommended that the system be powered from an u...

Page 43: ...ity of equipment 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 situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for r...

Page 44: ...aximum output power not listed 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 in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not ...

Page 45: ...ry to achieve freedom from unacceptable risk ESD Electrostatic discharge GHz Gigahertz HIPAA Health Insurance Portability and Accountability Act Hz Hertz IEC International Electrotechnical Commission Ultrasound field of view Cone shaped area in which the probe transmits ultrasound waves in Inch IP Ingress Protection ISPPA Spatial peak pulse average intensity ISPTA Spatial peak temporal average int...

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