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USER'S GUIDE

1. Urology Suite User s Guide 47 10 In the Patient Profile section of the screen review the patient information for accuracy and completeness including e Target Volume e Return Date If the information is correct click the Submit button to accept the Patient Profile update the information in the database and reprogram the instrument If changes are required for example the parameters for the target volume make the necessary changes and then click the Submit button Important Before you send the instrument home with the patient in order for the instrument to function properly you must verify and update the patient information so that it is accurate and complete 1f you do not verify the patient information the instrument will not perform exams or operate properly for the patient After you click the Submit button confirm that the status box displays the following message Preparing device for exam percent transmitted Transmission will take a few minutes so please be patient When the transmission is complete confirm that ScanPoint displays the following message Device is ready to perform exam You have successfully verified patient information for the Bladder Monitor Viewing and Printing Bladder Monitor Exam Results Once BVI 6300 exam data has been transmitted to ScanPoint ScanPoint analyzes the data and makes the exam results available to you for viewing and printing This section descr
2. 1 Place the calibration container on a flat non reflective surface and carefully remove the lid Using clean room temperature water pour the water gently into the container until it reaches the fill level indicator mark located on the inside of the container Before continuing ensure that the water in the tank contains a minimal amount of bubbles n p Container If you have filled the container with the correct amount of a Lid water only the black tip of the scanhead will be submerged E when you make the calibration measurement 2 Place the spiral shaped target in the container using the notches to position the target correctly 3 Replace the lid on the calibration container and place the container on a flat surface Spiral Shaped Target Water Filled Container Urology Suite User s Guide 87 Step 2 Calibrating the Scanning Unit 1 Place the scanning unit in the communication cradle which is connected to your computer 2 Go to ScanPoint by double clicking the ScanPoint icon on your Windows desktop or by opening Internet Explorer and typing https my scanpoint com in the browser s address bar 3 To log on to ScanPoint type your Login Name and Password on the Sign in screen and then click the Sign in button 4 On the ScanPoint menu click Calibration ScanPoint displays the Calibration screen and Instrument Information Paint Calibration Cabbration Interval Cakbration Charge pati
3. 14 To return to the Exam Results window click Return to Exam Results 15 To accept the exam results click the Close button To reject the exam results In the Reason field type a brief description of why you want to reject the results and ESELS then clickthe Reject button You will no OC eE TASA 3 longer be able to view or print exam results after you reject them 16 To refresh the list on the New Exam Results screen so that you can see which results have not been reviewed click the Refresh button Note After you accept the exam results and refresh the New Exam Results screen the results you just viewed no longer appear in the list of new exams If you want to view these exam results again use the Past Exams option on the ScanPoint menu Urology Suite User s Guide 71 Viewing and Printing New Exam Results Using ScanPoint you can view and print saved exam records at any time from any computer with an Internet connection Simply log on to ScanPoint and choose the View Exam Results menu option The results for an exam are typically available within minutes after you transmit the exam data to ScanPoint When viewing and printing exam results you do not need to place the scanning unit in the communication cradle You will be able to view the results only for exams performed at your institution and saved in your institution s ScanPoint account Note Exams are saved on ScanPoint as New Exams or Past Exams
4. 25 Determining Bladder Volume and Wall Mass u cz 25 Chapter 4 Assigning the Bladder Monitor BVI 6300 29 About Bladder Monitor BVI 6300 Technology E EE 30 Symbol Directory cdecesectaverauvbies N N y kewen d ye Ee K Min ea eee K d k Assigning and Reassigning the Bladder Monitor Assigning the Bladder Monitor to a New Patienit 31 Reassigning the Bladder Monitor to a New Patient 35 Editing and Verifying Patient Information for the Bladder Monit r iismasidil nu a ate la nayan nes l aia yana aw kana n 37 Measuring Bladder Fullness yii ilk kara belas bnn neiii nan n G Turning On the Scanning Unit Applying a Gel Pad ss a da enwn a menaa nalaebana si Performing a Measurement Transmitting Exam Data to ScanPoint Verifying Bladder Monitor Patient Information at Return WVisit 46 Viewing and Printing Bladder Monitor Exam Results EEEE EEE 48 Viewing and Printing New Bladder Monitor Exam Results 48 Viewing and Printing Past Bladder Monitor Exam Results 52 Viewing a Bladder Monitor Assignment List cee eee 56 Chapters Using Scan Point ooien enoaan TITEN ONENE OANA 59 Using SCaMPomit sins Aa e ca a a NEN K nE ANENA 60 About ScanPoint Applications suis yiy sixalnay yak nn aka n l Anay weda s leyakn 60 Understan
5. Chapter 2 Introduction to BladderScan in this Urology Suite User s Guide You need to calibrate the scanning unit In this case the LCD screen displays zero as the number of days remaining until calibration and you must calibrate the scanning unit before you can continue to perform bladder volume measurements See Chapter 6 Inspecting and Maintaining BladderScan for instructions on displaying the days remaining until calibration and calibrating the scanning unit Note This does not apply for the BV 6300 The scanning unit beeps The scanning unit may beep in the following situations You turn on the scanning unit The scanning unit goes into sleep mode to conserve battery power The battery power is low and the battery requires recharging In this case the battery icon will show no power segments Place the scanning unit in the charging cradle or communication cradle to recharge the battery You need to calibrate the scanning unit In this case when you press and hold down the Top Gender button for five seconds the LCD screen will display zero as the number of days remaining until calibration For more information about calibrating the scanning unit see Chapter 6 Inspecting and Maintaining BladderS can in this Urology Suite User s Guide Note This does not apply for the BV 6300 The scanning unit performs and completes a bladder volume or calibration measurement The scanning unit has begun or fi
6. The username that Verathon Corporation assigned to you for logging onto ScanPoint e Password The password that Verathon Corporation assigned to you for logging onto ScanPoint Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window On the ScanPoint menu click Bladder Monitor ScanPoint displays the Bladder Monitor Patient Information screen with empty data fields If the data fields are not empty and contain information the scanning unit that you are assigning was previously assigned to another patient You may overwrite this information if needed Bladder Monitor Eum Tye renmen Senal Number Parant Category O tum vet Please enter ndormation and then press the amet button E Please enter patient information Preparing device for scan Chapter 4 Assigning the Bladder Monitor BVI 6300 Field Description Serial Number Exam Type Displays the instrument serial number and the type of scanning unit Patient Category Patient ID Patient First Name Patient Last Name Physician Name Examined B y Gender Target Volume Return Date No return visit Status Box Select the exam type that meets one of the following criteria e Adult height gt 49 in weight gt 61 Ibs e Pediatric height lt 48 in weight lt 60 Ibs Type the Patient ID Type the patient
7. Your login has expired Please log in again Please restart calibration process This field may not be empty This instrument s usage has expired Please perform calibration before proceeding Unable to initialize duLAP ActiveX control Unable to open COM User s comments may not be empty during exam rejection Your credit card will expire soon Please contact customer service to update your credit card information You have already accepted or rejected the results for the exam you are viewing On the New Exam Results screen click the Refresh button to refresh the list of exam results so that the screen shows only the exams that you have not yet viewed or rejected You typed an incorrect Login Name or Password For help logging in click Get help with sign in You cannot type a minus sign as the first character in any ScanPoint field Delete the minus sign and submit the information again You have typed an invalid Patient ID Type a different Patient ID or click the Lookup button to locate a patient A ScanPoint problem has occurred that requires assistance from customer support Please contact a customer support representative at Verathon Corporation or your local representative Your ScanPoint session has timed out You must log in again ScanPoint cannot match the transmitted calibration data to the assigned calibration ID Please start the calibration process again You must enter a value in all
8. return to Client or destroy all PHI received from or created or received by DU on behalf of Client that DU still maintains in any form and retain no copies or b if return or destruction is not feasible extend the protections of this Business Associate Agreement to the PHI and limit further uses and disclosures to those purposes that make return or destruction infeasible Obligations of Client Relating to DU s Use of Client s PHI Client shall provide DU with a copy of the notice of privacy practices that Client produces in accordance with 45 CFR 164 520 as well as any changes to such notice Client shall provide DU with any changes in or revocation of permission by any Individual to use or disclose PHI if such changes affect DU s permitted or required uses and disclosures Client shall notify DU of any restriction to the use or disclosure of PHI that Client has agreed to in accordance with 45 CFR 164 522 Client shall not request DU to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rules if done by Client except as provided by Sections 2 2 and 2 5 of this Agreement Term and Termination The Term of this Agreement shall begin on the Effective Date and shall terminate when all of the PHI provided by Client to DU or created or received by DU on behalf of Client is destroyed or returned to Client or if it is infeasible to return or destroy PHI protections are ex
9. s Urology Suite Written for instrument operators this guide provides comprehensive information about operating and maintaining Verathon s bladder imaging technology Included in this guide is information regarding BladderScan BVI 6100 Measures bladder volume Pediatric BladderScan BVI 6200 Measures pediatric bladder volume Bladder Monitor BVI 6300 Prosthetic bladder management device Mobile BladderScan BVI 6400 Stores multiple voice annotated bladder volume exams BladderScan BVM 6500 Measures bladder volume and bladder wall mass ScanPoint s online imaging and calibration service Collectively this technology is referred to throughout this guide as BladderScan and ScanPoint Organized by subject this guide contains the following chapters Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Appendix A Glossary Getting Started Provides set up information for BladderScan and ScanPoint including instructions for charging the scanning unit installing ScanPoint software and connecting the communication cradle to your computer Introduction to BladderScan Introduces BladderScan describes its components in detail and provides the information needed before using the instrument Measuring Bladder Volume and Bladder Wall Mass Expands upon the information in the Quick Start Guide providing detailed step by step
10. Bladder Volume L ee 12 Bladd rscan Components gt J days os nan nye d z na nei GUN ane S KA 12 Scanning Unit y n Hadi a seas bak AWA A i wa Ra TE wah seve A V k na va cea ay MAA DA RAAR 13 Chareine Cradle i s sya i ke at HA Ki k na N Wa ive kU nA Vin tents 4 RAA aA RA BA k 14 CommuniCation Cradle says n Aniye na vine nsen ea W Ayn Eni NTA 15 Calibration Targeting System siisasiissiieaiiiia asaidie 15 Inteprating With ScanPomt siisii kelay EEE Hud kk NEE RE ene 15 Intended Use Warnings and CatitionS ii kull i kek 16 Symbol Directory for the Scanning Unit LCD Screen Ei ee 17 Chapter 3 Measuring Bladder Volume and Bladder Wall Mase 19 Measuring a Patient s Bladder Volume ccccssesseeseeeeeeeeeeeceeeeeeeeeeeees 20 Turning On the Scanning Unit cerisier bS alayan E Aa R 20 Selecting Gender uan na n xan casa na Raa AWIRA N N SNAN kelka 20 Applying Gel Pad siyanma menehn ye ineinal aniya ekana yol a ina neda 21 Scannine o Patient eniin ads ilies dls tuct chs hs esaud ens claus te ene 21 Recording a Voice Annotation BVI 6400 Onl 24 Measuring Bladder Wall Mass siener e AEAEE 24 Using the Bladder Wall Mass Application J EL EL EEE 24 Turning On the Scamming Unit siisii ieaie aa 29 Downloading the Bladder Wall Mass Application from ScanPoint
11. Monitor BVI 6300 10 When the transmission is completed confirm that ScanPoint displays the following screen and message Device is ready to perform exam 11 To assign a new scanning unit to another patient click Click here to assign device and then repeat the previous steps Bladder Monitor Point Dastre Maret or Rotur Date BT DB B koret n wn Smoter a reqarek tet Please enter ndormation an then gress the Yate button BERR Device is ready to perform exam Click here to assign device You have successfully assigned the Bladder Monitor to a patient and can now send the scanning unit home with this patient Reassigning the Bladder Monitor to a New Patient When ScanPoint displays the Bladder Monitor Patient Information screen for a scanning unit that has been previously assigned to and used by a patient the information for the previous patient automatically populates the page The following procedure describes how to reassign a scanning unit from a previous patient to a new patient Important Before you send the instrument home with the patient in order for the instrument to function properly you must verify that you have updated the patient information so that it is accurate and complete If you do not review and edit the relevant patient information the instrument will not perform exams or operate properly for the patient To reassign the Bladder Monitor to a new patient 1
12. Place the scanning unit in the communication cradle which must be connected to your computer ScanPoint software must also be installed 2 Ifyou did not install the ScanPoint software from the ScanPoint CD ROM ScanPoint prompts you to install it now To install the ScanPoint software click Yes Note If you do not install the ScanPoint software your scanning unit cannot communicate with ScanPoint and you will not be able to configure the Bladder Monitor for patient use Urology Suite User s Guide 35 3 Goto the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop ScanPoint displays the Sign In screen DIAGNOSTIC Welcome to ScanPoint ULTRASOUND April 29 2004 EEE EEE Newsflash Diagnostic Ultrasound introduces the SA BladderScan BVI 6300 Password For Individual Bladder Volume Signin Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BYI 6300 can restore a more natural volume directed voiding pattern The BYI 6300 is available by prescription allowing individuals to monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service Click here to learn more about the BVI 6300 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoint Password Type the secure password that Verathon Co
13. Results window and return to the list of exam results click the Close button 78 Chapter 5 Using ScanPoint Viewing Your Account Information Using ScanPoint you can review current account charges or billing statements for previous months In order to review account charges you will need to log on with Administrative or Purchasing privileges Viewing the Charges for the Current Month To view charges accrued for the current month simply log on to ScanPoint and click Your Account To view the charges for the current month 1 Go to the ScanPoint website at https my scanpoint com and log on 2 On the ScanPoint menu click Your Account and then click Current Charges ScanPoint displays the Current Charges screen including an itemized list of usage charges and charge details for the current month and identifies how you are paying your account e g credit card monthly billing or pre payment If you have more than one credit card to which the charges are being billed separate lists will appear for each credit card account number Current Charges u Customer ID 211104 DU Marketing Departement u 00030151 Information Description Part Number The part number for your ScanPoint service plan Date The date of the charges or the first day of the next month the charges are due Description Your specific ScanPoint service plan which identifies how Verathon Corporation charges your account and the serial number of
14. SE Suite 120 Bothell WA 98021 800 331 2313 US and Canada only 425 867 1348 Fax 425 883 2896 EU Representative Europe B V Lage Dijk Noord 14 3401 VA IJsselstein The Netherlands 31 30 68 70 570 Fax 31 30 68 70 512 apan K K Executive Tower Azabudai 7F 1 4 3 Azabudai Minato ku Tokyo Japan 106 0041 81 03 3560 3501 Fax 81 03 3560 3502 United Kingdom Ltd The Granary Manor Farm Courtyard Aston Sandford Aylesbury Buckinghamshire HP17 8JB United Kingdom 44 1844 299 207 Fax 44 1844 299 218 France Sarl 4 Place Arnold F 67000 Strasbourg France 33 03 88 60 14 12 Fax 33 03 88 60 46 87 For additional contact information please visit our corporate website at www dxu com C o123 0900 0787 08 60 CONTENTS WV CLC ONG a ction rrr dg gd 1 Guide CONnVentOnss sie yeye w eee o k ence ers SS Ke E ee ye nn ere ts 2 Chapter 1 Getting Started 3i 5 4443443454344 45334y3 Xak 0 R a Hl P M k eka 3 Getting Started with BladderScan 2 00 0 n KN A NAN o ee 4 mSlallin SCan Pol ya mi an n bee Nan Sed hn an de Pa ee a Da ek 4 Connecting the Communication Cradle yk cuda nand yana ea n n nad 8 Removing the ScanPoiit Sottwateyie sick ieee 8 Chapter 2 Introduction to BladderScan kk 11 About BladderScan Techilol xEl ke a en aut cae n 12 About Measuring Bladder Wall Mass K kk K k k e 12 About Measuring Pediatric
15. Scan button located on the underside of the scanning unit s handgrip Note To ensure accurate imaging make sure the scanning unit is in contact with the gel pad and be sure to hold the scanning unit steady avoid changing its position angle or pressure until the scan is complete and the instrument beeps each scan lasts several seconds Chapter 4 Assigning the Bladder Monitor BVI 6300 Important The accuracy of your measurement depends on properly aiming the scanning unit Errors in usage typically result in the underestimation of bladder volume except when the scanning unit is moved during the scan In this case the measurement may overestimate the actual bladder volume The presence of a catheter in the patient s bladder can also affect the accuracy of scan results by overestimating bladder volume 6 After a scan confirm that the LCD screen displays the following information e Measured bladder fullness The level of bladder fullness will be represented by the bladder icon in the center of the screen Bladder Fullness Level Symbols Meaning Description Empty 0 10 of Target Volume 0 volume segments will be displayed 7 lt 3 lt j Low 11 35 of Target Volume 1 volume segment will be displayed Medium 36 60 of Target Volume 2 volume segments will be displayed Medium High 61 85 of Target Volume 3 volume segments will be displayed TUAANA High 86 110 of Target Volume 4 volume segments will be disp
16. To date exposure to low power pulsed Verathon has not been shown to produce adverse effects However medical professionals should use ultrasound only when clinically indicated using the lowest exposure times possible commensurate with Clinical utility The ultrasonic output power of BladderScan is not user adjustable and is limited to the minimum level necessary for effective performance For more information about acoustic output levels see Chapter 9 Product Specifications in this User s Guide When using BladderScan be aware of the following conditions which can affect ultrasound transmission and decrease the accuracy of exam results Use care when scanning patients who have had supra pubic or pelvic surgery Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and reflection Do not use the scanning unit on a patient with open skin or wounds in the supra pubic region Ifyou scan a patient with a catheter in his or her bladder the catheter may affect measurement accuracy however the information so obtained has clinical utility e g detection of a blocked catheter 16 Chapter 2 Introduction to BladderScan Symbol Directory for the Scanning Unit LCD Screen BVI 6100 BVI 6200 BVI 6400 BVM 6500 The symbols shown in the table may appear on the scanning unit s LCD screen for the following instruments BVI6100 BVI 6200 BVI 6400 BVM 6500 Note For a sym
17. Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 42 Chapter 4 Assigning the Bladder Monitor BVI 6300 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging on to ScanPoint e Password The password that Verathon Corporation assigned to you for logging on to ScanPoint Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window On the ScanPoint menu click Bladder Monitor ScanPoint displays the Bladder Monitor page with the message Ready to Transmit Exam Bladder Monitor KIZ eee In the Patient Profile section of the screen review the information that corresponds to this patient and assigned instrument including the Instrument Serial Number and Exam Type To submit your exam data into the database click Click here to transmit exam located at the bottom of the screen The status box displays the following message Transmitting exam percent transmitted Transmission will take a few minutes so please be patient When the transmission is completed confirm that ScanPoint displays the following screen including the message Exam received success
18. affect the operation of the instrument Caution If you see any physical faults or cracks in the scanning unit discontinue use immediately and contact customer service or your local BladderScan distributor Calibrating the Scanning Unit Using ScanPoint Your ScanPoint warranty allows you to calibrate your scanning unit as often as you like At minimum Verathon Corporation requires that you calibrate the instrument every 6 12 months depending on your Total Reliability Plan Calibrating your scanning unit on a regular basis ensures the maximum accuracy of bladder imaging The calibration process takes approximately 15 minutes Displaying the Days Remaining Until Calibration The scanning unit itself tracks the number of days remaining until calibration is necessary When zero days remain until calibration the scanning unit is disabled and you will have to calibrate the instrument before using it again You will know your scanning unit is disabled when 000 and the sun symbol are displayed on the LCD screen 86 Chapter 6 Inspecting and Maintaining BladderScan To display the number of days remaining until calibration for the BVI 6100 BVI 6200 and BVM 6500 1 Remove the scanning unit from the charging or communication cradle 2 Press and hold down the Top Gender button located on the back of the scanning unit s handgrip below the LCD screen When the Top Gender button is held down for five seconds the number of d
19. fields marked with a red asterisk If you have questions about a specific field click the Help option on the ScanPoint menu Your scanning unit must be successfully calibrated before you can resume exams Close all browser windows and attempt to log on again Your communication connection with ScanPoint is faulty Check the cradle s cable connection and your COM port settings Before you click the Reject button to reject exam results you must type a rejection reason in the Reason field Contact Verathon Corporation and provide new credit card information for billing Otherwise when your current credit card expires your account will become inactive and you will not be able to use ScanPoint Urology Suite User s Guide 97 98 Chapter 7 Troubleshooting CHAPTER 8 CONTACTING This chapter contains contact information for Verathon Corporation and information about additional resources In This Chapter Contacting Verathon Corporation Additional Resources Urology Suite User s Guide 99 Contacting Corporation The team at Verathon Corporation is committed to modernizing healthcare delivery by putting patients first Our products support healthcare professionals by providing the highest level of accuracy utility and excellence For additional product and company information visit the Verathon Corporation website at http verathon com If you have any questions or comments about Verathon s produ
20. laboratory may require partial immersion of the scanning unit Immerse the scanning unit s rounded head no further than the point at which it connects to the body of the scanning unit Accuracy Specification Given the tremendous variation in healthy and compromised human anatomy a guaranteed accuracy specification for the instrument used on humans would be difficult For this reason the following accuracy specification assumes usage per instructions scanning a Verathon Corporation tissue equivalent phantom Condition Description Use Indoor Ambient temperature 10 to 40 degrees Celsius Atmospheric pressure 70 kPa to 106 kPa Relative humidity Maximum is 80 for temperatures up to 31 degrees Celsius decreasing linearly to 50 relative humidity at 40 degrees Celsius Water ingress Rated at IPX1 BladderScan BVI 6100 Bladder volume range 0 to 999 ml Bladder volume accuracy 15 15 ml BladderScan BVI 6200 Bladder volume range 0 to 200 ml Bladder volume accuracy 15 15 ml BladderScan BVI 6300 Bladder volume range 0 to 999 ml Bladder volume accuracy 15 15 ml BladderScan BVI 6400 Bladder volume range 0 to 999 ml Bladder volume accuracy 15 15 ml Urology Suite User s Guide 105 BladderScan BVM 6500 Bladder volume range 0 to 999 ml Bladder volume accuracy 15 15 ml Bladder wall mass range 10 to 150 grams Bladder wall mass accuracy 10 grams Specifications for the Communication Cradl
21. obtain an accurate measurement you must first select the appropriate gender Gender selection allows the scanning unit to take into account the presence or absence of a uterus when calculating bladder volume To select the patient s gender 1 Press the Top Gender button located below the LCD screen e Select the female option if the patient is a female who has NOT undergone a hysterectomy The female option allows BladderScan to exclude the uterus which may resemble the bladder Urology Suite User s Guide 25 ultrasonically When the female option is selected a female icon will appear on the scanning unit s LCD screen e Ifthe patient is a male or a female who has undergone a hysterectomy press the Top Gender button to toggle between options until the gender icon no longer appears on the LCD screen Applying a Gel Pad To apply a gel pad and scan the patient 1 pa Clean and disinfect the scanhead of the scanning unit by wiping it gently with a germicidal wipe or a soft cloth soaked in isopropyl alcohol For more information about cleaning and disinfecting BladderScan see Chapter 6 Inspecting and Maintaining BladderScan Prepare to apply a Sontac Ultrasound gel pad by peeling back the foil lid of the individual Sontac packaging to expose the gel pad To avoid patient cross contamination use a new gel pad for each patient With the patient resting quietly in the supine position palpate the symphysis pub
22. other than as permitted by this Agreement DU will report to Client any impermissible use or disclosure of PHI of which it becomes aware DU will require its agents or subcontractors if any to whom it provides PHI to agree to the same conditions that are applicable to DU s use or disclosure of PHI under this Agreement DU will do the following in accordance with the HIPAA Privacy Rules Make PHI about an individual available to that individual on request Make PHI available for amendment and incorporate any amendments on request Document such disclosures of PHI and information related to such disclosures as would be required for Client to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 CFR 164 528 Provide to Client in the time and manner reasonably requested by Client and subject to any applicable extra charge information collected in accordance with Section 3 4 3 of 3 4 5 3 4 6 4 1 4 2 4 3 4 4 5 1 this Agreement to permit Client to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 CFR 164 528 Make its internal practices books and records relating to the use and disclosure of PHI available to Client or at Client s request to the U S Department of Health and Human Services for purposes of determining compliance At the termination of the Service Agreement DU will a if feasible
23. patient information so that it is accurate and complete If you do not review and edit the relevant patient information the instrument will not perform exams or operate properly for the patient 8 When completed to submit your information and reassign the scanning unit click the Submit button The status box displays the following message Preparing device for exam percent transmitted Transmission will take a few minutes so please be patient 9 When the transmission is completed confirm that ScanPoint displays the following message Device is ready to perform exam You have successfully reassigned the Bladder Monitor to a new patient Editing and Verifying Patient Information for the Bladder Monitor When ScanPoint displays the Bladder Monitor Patient Information screen for a scanning unit that has been previously assigned to and used by a patient you should review the patient information for accuracy and completeness If changes and updates need to be made to the information contained on the Bladder Monitor Patient Information you can use ScanPoint to make those updates Important Before you send the instrument home with the patient in order for the instrument to function properly you must verify that you have updated the patient information so that it is accurate and complete If you do not review and edit the relevant patient information the instrument will not perform exams or operate properly for the patient
24. ready for your review Errors The exam failed and no results are available for review 72 Chapter 5 Using ScanPoint Note The information above is included with your exam results if it was entered at the time of the exam 3 To view the results for a specific exam in the Exam Result column click the result status for that exam ScanPoint opens a new window displaying the results for the selected exam including multiple views of the ultrasound images If the exam failed an error message will describe the failure IB Exam Results Microsoft Internet Explorer Exam Date amp Time Wednesday Agel 21 2004 8 gt 44 00 AM Putsent 10 Phantom Scan Patent amer Operator C brko Physician Note The orientation of the images relative to the BladderScan is depicted by an icon in the upper left corner of each image 4 To print the exam results scroll to the bottom of the Exam Results window and click one of the following print options e Printable Page Prints the exam and patient identification information and six ultrasound images from the exam e Printable Page for Physicians Offices Prints the exam and patient identification information a checklist that allows the physician to identify the patient s medical conditions and history and six ultrasound images from the exam e Printable Page for ECF SNF Prints the exam and patient identification information a checklist that allows the healthcare facility to ide
25. s first name Type the patient s last name Type the name of the physician who has prescribed the instrument Type the name of the person who will perform the exams Select the appropriate gender from the drop down list Specify the target volume that corresponds to the patient being assigned the instrument The target volume is the volume at which the patient should void or perform catheterization Select the date that the patient should return for a follow up consultation Select the check box if no return visit is scheduled or planned Click here to submit the data and finalize the assignment of the unit to the patient Review additional messages instructions and the status of your actions here 7 Inthe Patient Profile section of the screen type values for each of the following fields Note You must type information in all fields marked with a red asterisk e Patient Category Use the drop down menu to select one of the following exam types Adult height gt 49 in weight gt 61 Ibs Pediatric height lt 48 in weight lt 60 Ibs e Patient ID Type the identification value which can be any combination of numbers letters or other characters that you have assigned to the patient in ScanPoint If you cannot remember the Patient ID for an existing patient click the Lookup button located to the right of the Patient ID field e Patient First Name Type the patient s first name e Patient Last Name Type
26. screen Aiming arrows Located in the bottom center of the screen these arrows identify the location of the bladder relative to the scanhead Ifthe scanning unit was aimed properly so that the bladder was centered within the image cone the aiming arrows will either not appear or will not flash If the aiming arrows are flashing you must re aim the scanning unit and perform the exam again Aim the scanning unit in the direction indicated by the arrows and press the Scan button again For example if the LCD screen gt 3 5 Si displays a flashing arrow pointing to the left the bladder is located to the left 2 of the scanhead Without lifting the scanning unit tilt it so it projects ultrasound further to the left Repeat this step until the arrows no longer flash Note If solid aiming arrows appear then re aiming is not required A solid arrow indicates that the bladder is not completely centered in the image cone but the measurement is still clinically useful If desired re aim the scanning unit and re scan the patient as described above For patients with bladders that are oblong or extremely large a solid arrow may accompany good measurements To secure the highest degree of accuracy Verathon Corporation recommends that you scan the patient s bladder at least three times per exam to ensure the repeatability of your measurements Repeat Steps 1 3 to scan the bladder again Note Repeatability refers to your ability to cente
27. selected Patient ID Type the name of the person who performed the exam Type the name of the patient s physician the physician who requested the exam Click the Submit button to submit the patient data and transmit the exam to ScanPoint 64 Chapter 5 Using ScanPoint To transmit the exam click the Submit button The status box displays the following message Transmitting exam percent transmitted The data for the patient exam is transmitted from your scanning unit to ScanPoint and ScanPoint analyzes the exam data BladderScan Transmitting exam Please do not remove device from cradle or click any ScanPoint link until transmission is complete When the transmission is completed confirm that the following message displays Exam received successfully BladderScan to perform another exam press the New Exam button VAJ Exam received successfully Your exam is being analyzed Results will be available shortly Note If you did not perform the exam before entering the patient information on the Exam Information screen ScanPoint prompts you to do so now Perform the exam and return the instrument to the communication cradle At the bottom of the screen click Click here when you have completed the exam and then click Click here and verify patient information or click the Submit button If you want to start a new patient exam click the New Exam button and enter the required i
28. to install it now To install the ScanPoint software click Yes Note If you do not install the ScanPoint software your scanning unit cannot communicate with ScanPoint and you will not be able to configure the Bladder Monitor for patient use 3 Goto the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop ScanPoint displays the Sign In screen DIAGNOSTIC Welcome to ScanPoint ULTRASOUND April 29 2004 EEE TEEN Newsflash Diagnostic Ultrasound em introduces the ED 77 agin Name BladderScan BVI 6300 Password For Individual Bladder Volume ia Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BYI 6300 can restore a more natural volume directed voiding pattern The BVI 6300 is available by prescription allowing individuals to monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service Urology Suite User s Guide 31 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoint Password Type the secure password that Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 4 X 32 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name
29. unit Access Verathon s corporate website at http verathon com Note In accordance with the User Account email that you received from your instrument has been set up with the initial user profiles that you selected If you need to edit or assign new users please contact Corporation or your local representative Logging On and Off To log on and off 1 To go to the ScanPoint website open Internet Explorer and in the browser s address bar type https my scanpoint com If you installed the desktop icons from the ScanPoint CD ROM you can also double click the ScanPoint icon on your Windows desktop Urology Suite User s Guide 61 Your system displays the Sign In screen with the username that you last typed in the Login Name field AGNOSTIC DI ULTRASOUND Welcome to ScanPoint April 29 2004 EEE TE EEE Newsflash Diagnostic Ultrasound aa introduces the ogn Name BladderScan BVI 6300 Password For Individual Bladder Volume Signin Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BVI 6300 can restore a more natural volume directed voiding pattern The BVI 6300 is available by prescription allowing individuals to monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service Click here to learn more about the BVI 6300 Field Action Login Name Type the Username that Verath
30. will beep and automatically begin to transmit the calibration measurement data to ScanPoint To indicate that the scanning unit is in the process of transmitting data to ScanPoint a down arrow appears along with a number indicating the percentage of data remaining to be transmitted Wait while the scanning unit transmits the calibration results to ScanPoint ScanPoint then removes the calibration program from your device and prepares the instrument to perform patient exams Do not remove the scanning unit from the communication cradle until this process is complete Important Do not remove the scanning unit from the communication cradle until transmission of the calibration measurement data is complete and a green light appears in the ScanPoint status box When calibration is complete the scanning unit beeps and ScanPoint displays the message Calibration successful as shown below Calibration When you see the Calibration Successful message remove the scanning unit from the communication cradle It is now ready to measure bladder volume Chapter 6 Inspecting and Maintaining BladderScan You will be given the option to print a certificate of calibration If you wish to print this certificate click the message Click here for Printable Certificate of Calibration 13 Empty the water from the calibration container and dry the container Always fill the calibration container with clean room temperature water wh
31. A New Exam is an exam record that you have transmitted to ScanPoint but have not yet viewed Once you view an exam record it becomes a Past Exam To view and print new not previously viewed exam results 1 Go to the ScanPoint website at https my scanpoint com and log on to ScanPoint 2 On the ScanPoint menu click View Exam Results and then click New Exams The New Exam Results screen displays a list of new exam results New Exam Results Ck the coke haading t9 wert oa SDN fxhard White Wed aag 3 1 01 05 FOT 5 pen Teran Tarte 18020001 5 Margaret Wec renidin Aeri 20 2004 208 56 aM x n Grbes Statens Thursday aori 29 2004 12 55 00 PM X n White Wed Aug 3 1 05 00 FOT S harien hemla Wed ag 2 19 06 06 9011 S Wec rendi tert 20 2004 2104 AM Bt rron Wec reydir aori 20 2004 10 53 AM Mca Smeh Wechat sgri 20 2004 6 56 27 ame Richard Jackson Wad Aug 3 120808 POT 5 Barbara Hs Wed Aug 3 18 09 07 FOT S Point Information Description Patient ID Patient ID numbers include any combination of numbers letters or other characters that you assigned to the patient in ScanPoint Patient Name The patient s first and last names Exam Date amp Time The date month day and year the exam was performed Exam Type The type of exam that was performed Operator The name of the person who performed the exam Exam Result Possible exam results include Available ScanPoint has analyzed the exam data and the results are
32. Name and Password on the Sign In screen and then click the Sign In button If you did not install the ScanPoint driver from the ScanPoint CD ROM or a newer version of the ActiveX plug in is available a Security Warning dialog box prompts you to install it now If prompted to install the driver click Yes If not prompted or if you have already previously installed the driver continue to the next step ScanPoint automatically downloads the Mobile BladderScan exams The message Transmitting Exam appears above the status box in the lower left corner of ScanPoint Polat New Exam Results ck tect hezir t vt m S L lt Achad wito t ar nn nat Taio a er prm itu CHETID Ed Caren more waca Sm n 2 MOSM Rhard Jackson Wed Aug 3 18 08 08 SOT 5 Padiatr Backer Volume Catoia HARRIBO113 Babra Hans Wed Aug 3 18 09 07 POT S Padat Baddo vaure pra Trareunitting exam 2 Note You may click other ScanPoint options while exams are being transmitted however you should not remove the Mobile BladderScan from the communication cradle until transmission of the exams is complete and a green light appears in the status box located in the lower left corner of the ScanPoint screen To view the Mobile BladderScan exam results and enter patient information 6 68 After transmission is complete on the ScanPoint menu click Exam Results gt New Exams to display a list of the new exam results saved on your accoun
33. Password The password that Verathon Corporation assigned to you for logging on to ScanPoint Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window Chapter 4 Assigning the Bladder Monitor BVI 6300 4 On the ScanPoint menu click View Exam Results and then click Past Exams ScanPoint displays the Enter Patient ID section of the Patient Exams History screen Patient Exams History Point ET TT YEE NEKE Tairt D a Field Action Patient ID Type the Patient ID that corresponds to the past exams that you wish to view Click here to search the database of patient IDs a Click here to search for a customer 5 Inthe Patient ID text box type the patient ID for past exams that you wish to view If you cannot remember the Patient ID for an existing patient click the Lookup button located to the right of the Patient ID field Urology Suite User s Guide 53 ScanPoinf displays the Patient Exams History screen including an archived list of previous exams that are cross referenced to a corresponding patient Patient Exams History Richard Wrete 53497628 Point SANOA 1 24 00 PM Sj4j2004 121900 PM 6 To view the past exam results in the Exam Result column click the result that corresponds to the relevant patient and exam date ScanPoint displays the Choose Exam Date Ra
34. Results Exam Date amp Time Wednesday Apri 28 2004 1 56 26 PM Patent ID Patient Name a Urine Volume 248 m Operator Prisar Zprature Bam 77676 13 To print click Print This Page Your system displays a Windows Print dialog box 14 In the Windows Print dialog box select the appropriate print options and click the Print button 15 To return to the Exam Results window click Return to Exam Results 16 In the Exam Results window to accept the exam results click the Close button To reject the exam results In the Reason field type a brief description of why you want to reject the results and then click the Reject button You will no longer be able to view or print exam results after you reject them Note For more information about using ScanPoint see the ScanPoint Online Help which you can access by clicking the Help button on any ScanPoint screen Urology Suite User s Guide 67 Transmitting Mobile BladderScan Exam Data to ScanPoint To transmit Mobile BladderScan exam data to ScanPoint Note For step by step instructions that describe how to perform patient examinations see Chapter 3 Measuring Bladder Volume and Bladder Wall Mass 1 2 Place your scanning unit in the communication cradle connected to your computer Go to the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop To log on to ScanPoint type your Login
35. SSOCIATE AGREEMENT this Agreement is made and entered into as of the Effective Date by and between DU and Client RECITALS Contemporaneously with this Business Associate Agreement DU and Client have entered into a ScanPoint Total Reliability Plan Agreement of even date herewith the Service Agreement as a consequence of which the parties expect and intend that DU will be a business associate of Client under the Social Security Act and applicable regulations relating to Protected Health Information collectively the HIPAA Privacy Rules Consequently this Agreement applies when DU acquires any information in the course of its duties under the Service Agreement that is Protected Health Information PHI received from or created or received by DU on behalf of Client under the HIPAA Privacy Rules In consideration of the promises and of the mutual agreements and covenants hereinafter set forth and other valuable consideration receipt and sufficiency of which each of the parties hereby acknowledges the parties agree as follows 1 Definitions Capitalized terms used but not defined in this Agreement shall have the same meaning as in 45 CFR 160 103 and 164 501 Capitalized terms used herein but not defined herein or in 45 CFR 160 103 and 164 501 shall have the meanings given them in the Service Agreement Unless otherwise stated a reference to a Section is to a section of this Agreement All defini
36. THE SCANPOINT UROLOGY SUITE USER S GUIDE A Comprehensive Guide to Using Verathon Corporation s Bladder Imaging Technology VERATHON MEDICAL THE SCANPOINT UROLOGY SUITE USER S GUIDE FOR THE BVI 6100 BVI 6200 BVI 6300 BVI 6400 amp BVM 6500 b J VERATHON MEDICAL Copyright 2004 by Verathon Corporation All rights reserved No part of this User s Guide may be copied or transmitted by any method without the express written consent of Verathon Corporation BladderScan ScanPoint Sontac and V MopE are registered trademarks and Total Reliability Plan is a service mark of Verathon Corporation Other products and companies named in this User s Guide may be trademarks of their respective companies The BladderScan instruments documented in this manual are protected by U S Patent Numbers 4 926 871 and 5 235 985 Other international patents pending The ScanPoint technology documented in this manual is protected by U S Patent Number 6 569 097 The Sontac ultrasound coupling pad documented in this manual is protected by U S Patent Number 5 782 767 Other international patents pending This User s Guide is Verathon Corporation Part No 0900 0787 Information in this User s Guide may change at any time without notice Examples described or illustrated in this User s Guide are fictitious and do not in any way represent real patient or exam data Corporate Headquarters 21222 30th Drive
37. Urology Suite User s Guide 37 To edit patient information for the Bladder Monitor Place the scanning unit in the communication cradle which must be connected to your computer ScanPoint software must also be installed If you did not install the ScanPoint software from the ScanPoint CD ROM ScanPoint prompts you to install it now To install the ScanPoint software click Yes Note Jf you do not install the ScanPoint software your scanning unit cannot communicate with ScanPoint and you will not be able to configure the Bladder Monitor for patient use Go to the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop ScanPoint displays the Sign In screen DIAGNOSTIC ULTRASOUND Welcome to ScanPoint April 29 2004 EEE YERE Newsflash Diagnostic Ultrasound i introduces the H rane BladderScan BVI 6300 Password For Individual Bladder Volume Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BVI 6300 can restore a more natural volume directed voiding pattern The BYI 6300 is available by prescription allowing individuals to monitor their bladder volumes on an ongoing basis Get help with sian in Customer Service D Click here to learn more about the BVI 6300 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoin
38. User s Guide 55 Viewing a Bladder Monitor Assignment List Using ScanPoint you can gain access to the ScanPoint database to view the assignment list for a specific scanning unit and view the cross referenced information associated with the instrument including patient ID and name assigned date time and return date To view a Bladder Monitor assignment list 1 Place the scanning unit in the communication cradle which must be connected to your computer Your computer must also have the ScanPoint software installed 2 Ifyou did not install the ScanPoint software from the ScanPoint CD ROM ScanPoint prompts you to install it now To install the ScanPoint software click Yes Note If you do not install the ScanPoint software your scanning unit cannot communicate with ScanPoint and you will not be able to configure the BVI 6300 for patient use 3 Goto the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop ScanPoint displays the Sign In screen DIAGNOSTIC Welcome to ScanPoint ULTRASOUND April 29 2004 PSignin O O Newsflash Diagnostic Ultrasound ae introduces the E agn Name BladderScan BVI 6300 Password For Individual Bladder Volume sinn Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BYI 6300 can restore a more natural volume directed voiding pattern The BYI 6300 is available by p
39. When this icon begins to scroll the scanning unit must be calibrated within 30 days in order to maintain functionality NEWE 2 When this icon begins to flash the scanning unit must be calibrated before another scan can be 4N completed When this icon is solid i e not flashing or scrolling bladder imaging is in progress 30 Chapter 4 Assigning the Bladder Monitor BVI 6300 Assigning and Reassigning the Bladder Monitor Healthcare providers may use ScanPoint to personalize the Bladder Monitor ScanPoint enables the specification of gender target bladder volume whether the patient is pediatric or adult and the date that a patient should return to have his exam data analyzed optional This section describes how to Assign a Bladder Monitor to a patient Reassign a Bladder Monitor to a new patient Edit and verify patient information Assigning the Bladder Monitor to a New Patient When ScanPoint displays the Bladder Monitor Patient Information screen all of the data fields are empty until you enter the relevant information and assign the unit The following procedure describes how to assign a new scanning unit to a new patient To assign the Bladder Monitor to a new patient 1 Place the scanning unit in the communication cradle which must be connected to your computer ScanPoint software must also be installed 2 Ifyou did not install the ScanPoint software from the ScanPoint CD ROM ScanPoint prompts you
40. adderScan About ScanPoint Applications Without ScanPoint all BladderScan instruments measure bladder volume or fullness For a list of the additional applications available to your instrument model when used in conjunction with ScanPoint see the following table Pediatric Bladder Mobile Bladder Wall ScanPoint BladderScan piadderScan Monitor BladderScan Mass Application BVI 6100 BVI 6200 BladderScan BVI 6400 BladderScan BVI 6300 BVM 6500 View Save and Print Exam Results Calibrate Instrument Program for Individual User Record Voice Annotation Measure Bladder Wall Mass View Your Account Information o d rae pot of tf 60 Chapter 5 Using ScanPoint Understanding User Profiles The ScanPoint features available to you depend on the user profile that you requested from Verathon when you purchased your instrument Your user name and password are associated with this profile The following table describes the features available based on your user profile Administrative Clinical Technical Purchasing User User User User Exam Type Submit patient information create a new exam record and transmit the exam data to ScanPoint View Exam Results View and print the results for new exams and past exams for specific patients Menu Option Description Your Account View account charges for the current month or billing statements for past months Calibration Calibrate your scanning
41. an accurate and proper alignment of the scanner s internal spherical coordinate system and thus measurement accuracy Electromagnetic Effects There are no restrictions on the use of BladderScan due to its electromagnetic characteristics Both the emissions from BladderScan and the susceptibility of this instrument to interference from other sources are within prescribed limits of all applicable standards at the date of manufacture The emissions test procedure that was used is specified in EN IEC55011 1991 for Group 1 Class A equipment per EN IEC60601 1 2 36 201 1 7 BladderScan is suitable for use in industrial scientific and medical ISM environments and in domestic environments under the jurisdiction of a healthcare professional An indication of adverse electromagnetic effects from BladderScan on another electronic device would be a degradation of performance in the other device when the devices are operated simultaneously If such interference is suspected separate the two devices as much as possible or discontinue simultaneous operation if practical and contact Verathon Corporation BladderScan will operate normally in the proximity of other potential interference sources and has demonstrated immunity at a field strength of 3 V m per EN IEC60601 1 2 36 202 2 1 You do not need to take any other precautions regarding exposure in reasonably foreseeable environmental conditions to magnetic fields pressure or variations in pr
42. anguage user_language Time Zone user_tzone User account added Ms J ane Doe Your role_name login has been created Login user_login User account added password Ms J ane Doe Your role_name login has been created Password user_password Monthly Statement monthly statement is enclosed transmitted Urology Suite User s Guide 83 Online Help The ScanPoint online Help system includes detailed information for all ScanPoint menu options screens and error messages To access the ScanPoint online Help system 1 Go to the ScanPoint website at https my scanpoint com and log on to ScanPoint For more information about logging on see Logging On and Off in this chapter 2 On the ScanPoint menu click Help 84 Chapter 5 Using ScanPoint CHAPTER 6 INSPECTING AND MAINTAINING BLADDERSCAN This chapter describes how to care for your BladderScan with regular cleaning weekly inspections and calibration You will also find information about replacing your instrument should the need arise In This Chapter e Cleaning and Disinfecting BladderScan e Performing Weekly Inspections e Calibrating the Scanning Unit Using ScanPoint e Replacing BladderScan Urology Suite User s Guide 85 Cleaning and Disinfecting BladderScan To clean and disinfect BladderScan 1 Use a germicidal wipe or a soft cloth dampened with isopropyl alcohol or an appropriate hospital cleaning agent to wipe
43. any PHI provided that such use or disclosure is made in accordance with the terms of this Agreement Miscellaneous Provisions Forum Selection ANY LITIGATION BETWEEN THE PARTIES ARISING OUT OF OR RELATING TO THIS AGREEMENT MUST BE BROUGHT EXCLUSIVELY IN THE STATE OR FEDERAL COURTS LOCATED IN THE STATE OF WASHINGTON THE PARTIES HEREBY WAIVE ANY AND ALL OBJECTIONS TO THE EXERCISE BY THE COURTS OF THE STATE OF WASHINGTON OF PERSONAL JURISDICTION OVER THEM AND TO THE VENUE OF THE COURTS OF THE STATE OF WASHINGTON Urology Suite User s Guide 113 7 2 7 3 7 4 1 5 7 6 114 Successors and Assigns This Agreement and all rights and powers granted hereby will bind and inure to the benefit of the parties hereto and their respective successors and assigns For purposes of this Section assignment by operation of law in connection with a merger acquisition asset sale or other corporate reorganization shall be deemed an assignment In the event of any assignment the assignor shall remain liable and responsible for the performance of the obligations under this Agreement and the assignee shall expressly a agree to be bound by the terms of this Agreement and b grant the other party enforcement rights against the assignee Notices Any notices permitted or required by this Agreement will be deemed given when personally delivered or upon deposit in the United States mail postage fully prepaid certified return r
44. ays remaining until calibration is displayed on the scanning unit s LCD screen Note The actions described in this step do not apply to the BVI 6300 or BVI 6400 scanning unit To display the number of days remaining until calibration for the BVI 6400 1 Place the scanning unit in the charging or communication cradle 2 Press and hold down the Top Gender button located on the back of the scanning unit s handgrip below the LCD screen When the Top Gender button is held down for three seconds the number of days remaining until calibration is displayed on the scanning unit s LCD screen Note The BVI 6400 must be in the charging or communication cradle and the cradle must be powered on for the days remaining until calibration to be displayed Using ScanPoint for Calibration In order to calibrate your scanning unit you must log in with either Administrative or Technical User privileges for ScanPoint There are two steps in the calibration procedure Step 1 Preparing the Calibration Targeting System Step 2 Using the prepared calibration targeting system and ScanPoint to calibrate the scanning unit Caution The calibration download procedure and any procedure involving your personal computer should be performed outside the Patient Vicinity i e more than 6 feet away from the patient See UL 2601 1 Clause 2 deviation for an exact definition of Patient Vicinity Step 1 Preparing the Calibration Targeting System
45. bol directory for the BVI 6300 refer to Chapter 4 Assigning the Bladder Monitor BVI 6300 Symbol Description Indicates days remaining until calibration Battery power level Female option selected Bladder imaging in progress BVI 6100 BVI 6200 BVI 6400 BVM 6500 Flashing arrows indicate you must re aim the scanning unit in the direction of the arrows after the scan attempt If the arrow is solid re aiming is optional Indicates that true bladder volume is greater than displayed volume BVI 6400 only Indicates that voice annotation is being recorded and stored A V w ue gt um i Urology Suite User s Guide 17 18 Chapter 2 Introduction to BladderScan CHAPTER 3 MEASURING BLADDER VOLUME AND BLADDER WALL MASS This chapter provides detailed step by step instructions for measuring bladder volume and bladder wall mass In This Chapter Measuring a Patient s Bladder Volume Adult Pediatric Measuring a Patient s Bladder Wall Mass Urology Suite User s Guide 19 Measuring a Patient s Bladder Volume The following section describes how to measure a patient s bladder volume with BladderScan Before you begin the exam make sure that you clean and disinfect the scanning unit to minimize the risk of infection If you are a new instrument operator Verathon recommends that you use BladderScan on a patient with a moderately full bladder rather than initially attempting to locate an
46. butor or Verathon Corporation To obtain contact information for Verathon Corporation s Customer Service Center see Chapter 8 Contacting Common Problems Problem Description Resolution The scanning unit does not This problem is usually caused by a dead or discharged battery Charge the scanning unit turn on for a minimum of six hours When your computer is turned on you can also charge the instrument using the communication cradle If the scrolling battery icon does not appear after two hours you will need to activate the scanning unit using the activation tool Press the activation button with the activation tool Once activated replace the scanning unit in its cradle to continue charging For more information about charging the battery and activating the scanning unit see Chapter 2 Introduction to BladderS can in this Urology Suite User s Guide The scanning unit is If the scanning unit does not measure bladder volume when you press the Scan button charged but will not scan but the battery icon on the scanning unit s LCD screen indicates that the battery has some power remaining one of the following conditions may apply The battery has some power remaining but not enough to perform bladder imaging In this case the battery icon will show only one power segment Simply place the scanning unit in the charging cradle or communication cradle to recharge the battery For more information about charging the battery see
47. button UEBW Ultrasonic 118 Glossary Caused or affected by the nervous system The process of repeating a scan multiple times in order to get more accurate exam results The button located on the underside of the scanning unit s handgrip which initiates the bladder volume measurement The portion of the scanning unit attached above the handgrip through which ultrasound energy is transmitted to the patient The handheld instrument including the scanhead and handgrip which transmits ultrasound energy to produce an image of the patient s bladder and determine bladder volume Online service provided by The Verathon Corporation Allows BladderScan operators to print exam results maintain patient records view ultrasound images from exams download software updates and calibrate the scanning unit The scanning unit appears to be off Press any button to re activate Asolid arrow indicates an aiming suggestion The solid arrow appears on the scanning unit s LCD screen below the bladder volume measurement when the instrument senses that the bladder was not completely centered in its field of vision In this case re aiming is optional but not required Lying on the back with the face upward Situated above the pubic bone The part of the human body where the pubic bones meet in the front of the pelvis The button located below the scanning unit s LCD screen This button allows the user to select various settings and perfo
48. ce center authorized by Verathon Corporation The instrument must be used in accordance with the instructions contained in this Urology Suite User s Guide Consumable items should be used in conformance with Verathon Corporation product specifications Consumable items are not covered under this warranty For further details consult your ScanPoint Total Reliability Plan Warranty conditions may differ in some countries outside the United States Contact your local distributor for warranty terms Disclaimer of Additional Warranties There are no understandings agreements representations of warranties expressed or implied including warranties of merchantability or fitness for a particular purpose other than those set forth in the preceding Warranty section The contents of this User s Guide do not constitute a warranty Some states disallow certain limitations on applied warranties The purchaser user and patient should consult state law if there is a question regarding this disclaimer The information descriptions recommendations and safety notations in this handbook are based upon Verathon Corporation s experience and judgment as of May 2004 with respect to BladderScan This is a new product involving a relatively new area of medical technology The contents of this handbook should not be considered to be all inclusive or to cover all contingencies The physician who directs the use of BladderScan at your institution is responsib
49. charge it for six hours Reading the Battery Power Status The battery icon is located in the lower right corner of the scanning unit s LCD screen When the scanning unit is not charging this icon indicates the power level of the battery At a minimum you should recharge the scanning unit whenever you see a single power segment remaining in the battery icon While charging the battery icon displays scrolling power segments The following table describes how to read the battery icon Battery Icon Status Description 100 Four power segments indicate that the battery is fully charged and ready for use mo m om 75 Three power segments indicate a partially discharged battery 50 Two power segments indicate a partially discharged battery 25 One power segment indicates that the battery is nearly discharged You will be able to perform a few more scans but should recharge the battery soon a 0 An empty battery icon no power segments indicates that the battery is completely discharged The scanning unit will not work Scrolling Indicates that the instrument is being charged oy 14 Chapter 2 Introduction to BladderScan Communication Cradle Use the communication cradle to transmit calibration and exam data to ScanPoint The cradle s cable plugs directly into a Universal Serial Bus USB port on your personal computer You can also charge your scanning unit in the communication cradl
50. ciated with the selected Patient ID Examined By Type the name of the person who performed the exam Physician Type the name of the patient s physician the physician who requested the exam Click the Save and view results button to save the patient information and view the bladder volume measurement and ultrasound images from the exam Urology Suite User s Guide 69 Field Description Click the Save and return to list button to save the patient information and exam data for r avaa later viewing The exam results will be available on the New Exams page when you wish to review it Click the Cancel button to return to the New Exams list The exam will remain on the New Exams list until you enter the Patient Information and click one of the Save options Click the Discard this exam button to delete the exam 10 To save and view the exam click the Save and View Results button ScanPoint opens a new window displaying the results for the selected exam including multiple views of the ultrasound images If the exam failed an error message will describe the failure Note The orientation of the images relative to the BladderScan is depicted by an icon in the upper left corner of each image zos Note If you do not want to view the exam Exat Date amp Tame Wednesday Aor 21 2004 4400 A4 results at this time click the Save and Return Patent 10 Phantom Scan Pata Name to List button ScanPoint re
51. click Next The installation program copies the relevant files from the CD ROM onto your computer s hard drive When copying and installation is completed the installation program displays an InstallShield Wizard Complete dialog box To finalize your ScanPoint installation click Finish Remove the ScanPoint CD from your computer s CD ROM drive InstallShield Wizard Scan InstallShield Wizard Completed Po i n t The wizard was interrupted before Diagnostic Ultrasound ScanPoint could be completely installed The system has not been modified To install this program at a later time run the installation again Click Finish to exit the wizard You have successfully installed ScanPoint onto your computer Urology Suite User s Guide 7 Connecting the Communication Cradle If your BladderScan came with a communication cradle connect this cradle to a USB port on your computer and use it to transmit data to ScanPoint When your computer is turned on you may also use the communication cradle to charge the scanning unit Note If you shut down the computer connected to your communication cradle no power will be transmitted to the scanning unit via the communication cradle and the instrument will not continue to charge Note You must install the ScanPoint software before connecting the communication cradle to your computer To connect the communication cradle 1 Turn your computer off 2 Plug the comm
52. ction and enables the scanning unit to communicate with the computer This cradle can also be used to recharge the battery of the scanning unit when the connected computer is turned on Asubstance such as ultrasound gel that facilitates the transmission of ultrasound waves A flashing arrow may appear on the scanning unit s LCD screen when part of the bladder is outside the scanning unit s field of vision A flashing arrow indicates that you must re aim the instrument and re scan the patient to obtain the highest degree of accuracy A disc shaped gel filled pad that facilitates the transmission of ultrasound waves The cone shaped range within which ultrasound waves are transmitted by the scanhead when scanning the bladder The window located at the base of the handgrip which enables the scanning unit to connect with your computer via the communication cradle The square label located below the Scan button on the scanning unit that provides important product information including the name product and serial numbers and instrument classifications The LCD liquid crystal display screen on the scanning unit that displays the bladder volume measurement and other scan patient and instrument data Urology Suite User s Guide 117 Term Description Neurogenic Repeatability Scan button Scanhead Scanning unit ScanPoint Sleep mode Solid aiming arrow Supine position Supra pubic Symphysis pubis Top Gender
53. cts and services please contact us at Corporate Headquarters 21222 30th Drive SE Suite 120 Bothell WA 98021 800 331 2313 US and Canada only 425 867 1348 Fax 425 883 2896 E mail cservice dxu com Verathon Europe B V Lage Dijk Noord 14 3401 VA IJsselstein The Netherlands 31 30 68 70 570 Fax 31 30 68 70 512 Email service dxu nl Verathon J apan K K Executive Tower Azabudai 7F 1 4 3 Azabudai Minato ku Tokyo Japan 106 0041 81 03 3560 3501 Fax 81 03 3560 3502 Email service japan dxu com Verathon United Kingdom Ltd The Granary Manor Farm Courtyard Aston Sandford Aylesbury Buckinghamshire HP17 8JB United Kingdom 44 1844 299 207 Fax 44 1844 299 218 Email customerservice dxuuk co uk Verathon France Sarl 4 Place Arnold F 67000 Strasbourg France 33 03 88 60 14 12 Fax 33 03 88 60 46 87 Email service dxu nl 100 Chapter 8 Contacting Additional Resources Verathon Corporation provides additional print video and online resources to supplement the Urology Suite User s Guide These resources contain more information about using the BladderScan in conjunction with ScanPoint Additional resources to supplement this User s Guide include ScanPoint Online Help Comprehensive online information organized by topic to guide you easily through ScanPoint menus and screens ScanPoint Urology Suite Training CD ROM This CD ROM contains the ScanPoint User s Guide and
54. d on your computer For details refer to Chapter 1 Getting Started If you did not install the ScanPoint software form the ScanPoint CD ROM ScanPoint prompts you to install it now 2 Ifyou are prompted to install the ScanPoint software to install the software click Yes If your ScanPoint software is already installed continue to the next step Note If you do not install the ScanPoint software your scanning unit cannot communicate with ScanPoint and you will not be able to transmit exam data to ScanPoint 3 Goto the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop ScanPoint displays the Sign In screen DIAGNOSTIC ULTRASOUND Welcome to ScanPoint April 29 2004 a TEEN Newsflash Diagnostic Ultrasound a introduces the Aoo agin Name BladderScan BVI 6300 Password For Individual Bladder Volume Signin Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BYI 6300 can restore a more natural volume directed voiding pattern The BYI 6300 is available by prescription allowing individuals to monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service Click here to learn more about the BVI 6300 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoint Password Type the secure password that
55. d scan a nearly empty bladder Turning On the Scanning Unit If you have stored your scanning unit in the charging cradle or the communication cradle the power will be on when you remove it from the cradle If the scanning unit is not stored in the cradle it goes into sleep mode when not in use and you must turn it on before measuring bladder volume To turn on the scanning unit 1 Ifthe scanning unit is in sleep mode press and release any button When the scanning unit chirps it is ready to scan Note If it does not turn on the battery may be completely discharged For more information see Chapter 2 Introduction to BladderScan 2 Check the battery icon to verify that the battery is sufficiently charged for patient exams If the battery icon shows no power segments return the scanning unit to the charging cradle and recharge it before attempting to perform exams If the battery icon shows only one power segment you can perform a few more scans but you will need to recharge your instrument soon For more information about charging the scanning unit see Chapter 1 Getting Started in this User s Guide Selecting Gender In order to obtain an accurate bladder volume measurement you must first select the appropriate gender Gender selection allows the scanning unit to take into account the presence or absence of a uterus when calculating bladder volume To select the patient s gender ha r Gender ico
56. d upon this image to provide the greatest ease of use V MoDE measurements tend to be more accurate than those obtained from conventional two dimensional ultrasound as they are based on a more complete multi faceted image About Measuring Bladder Wall Mass Users who have purchased the BladderScan BVM 6500 can calculate both bladder wall mass and bladder volume With the BVM 6500 and ScanPoint bladder wall mass can be measured quickly and noninvasively About Measuring Pediatric Bladder Volume Intended for use on children up to 48 inches tall and weighing 60 pounds or less Pediatric BladderScan measures bladder volumes within the range of 0 200 ml Instructions and information about measuring bladder volume in this User s Guide apply to both the BladderScan and Pediatric BladderScan instruments BladderScan Components Your BladderScan may include some or all of the following components Scanning unit Charging cradle Communication cradle Calibration targeting system You ll find more information about each of these components on the following pages 12 Chapter 2 Introduction to BladderScan Scanning Unit Use the handheld scanning unit to measure a patient s bladder volume or bladder wall mass The scanning unit produces an ultrasound image of the bladder and determines bladder volume and or mass based on that image The features of the scanning unit include Microphone BVI 6400 LCD Screen Top Gender B
57. descending order with the most recent exam at the top of the list Patient Exams History Richard Whete 52497628 Bae Dat amp Tae SAROHA 1 24 00 PM SARO 12 19 00 PM Information Description Exam Date amp Time The date month day and year the exam was performed Patient ID Type the identification value that you assigned to the patient in ScanPoint Exam Type The type of exam that was performed Operator The name of the person who performed the exam Exam Result Possible exam results include Good Exam ScanPoint has successfully analyzed the exam results and the results have been accepted Failed exam due to user rejection ScanPoint has successfully analyzed the exam results but the results have been rejected Failed exam due to a ScanPoint server error ScanPoint has experienced a server error therefore no results are available for review 76 Chapter 5 Using ScanPoint To view the results for a specific exam in the Exam Result column click the result status ScanPoint opens a new window and displays the results for the selected exam including multiple views of the ultrasound images If the exam failed an error message describes the failure BB Exam Results Microsoft Internet Explorer Exam Date amp Time Wednesday Apri 21 2004 8 gt 54 00 AM Patent ID Phantom sean Note The orientation of the images relative to the BladderScan is depicted by an icon in the upper left corner of eac
58. ding User Profiles 61 LO Sine ON dnd OFF yyy xox yaya year aya d ao yana qar ao Adi 61 Transmitting Exam Data to ScanPoint 6100 6200 amp 6500 63 Transmitting Mobile BladderScan Exam Data to ScanPoint 68 Viewing and Printing New Exam Results oscene 72 Viewing and Printing the Exam Results for a Specific Patient 75 Viewing Your Account Information Receiving Email Notificaions Online Help sis cates sezaees sheds Nan lesa ni kan n Visa Vian tees riiete na ih nk x l AWAR Chapter 6 Inspecting and Maintaining BladderScan EE 85 Cleaning and Disinfecting BladderScant Gund le 86 Performing Weekly Inspections siopimrgiiicarorime cani 86 Calibrating the Scanning Unit Using ScanPoint u diyne alayek 86 Displaying the Days Remaining Until Calibration 86 Using ScanPoint for Calibration Replacing BladderScan i i k Ec kS Chapter 7 Troubleshooting L Erkek keke k r kek ke 93 Troubleshooting Common Pr D TAS i nk kel el e Ked kin n 94 ScanPoint Etror MESSAGES sl s lsyn caylan daye da kl ba a eyl a nad reda KE E del eki wal 96 Chapter 8 Contacting Aslluskk sk kanen ae dakakaa e k ke b ra en kaz dak e rade bk ke dd a a he kak 99 Contacting Verathon Corporation isss kl ny l346 150000550 3c 49y 3n key Ml sAAA 100 Ad
59. ditonal Resouces 2s sey E k ne ken ban ser n n ke len n ni 1950e Qe Ye e teases 101 Chapter 9 Product Specifications LE keke kk k ke 103 BladderScan Technical Specifications s His as nk l n 3 RN i HERWA 104 Compliance With Standards isiii y a y n n letek sadan nalan an l 104 Specifications for the Scanning Unit 4 uLCuLu cucccuccececa 104 Accuracy SPECIPICALION i ii arvincssvervancecestassqeciseuvaniecdestaarsesees 105 Specifications for the Communication Cradle 106 Specifications for the Charging Cradle iicccccccccccsseeeseeeseeeneeeeneeens 106 ScanPoint Hardware and Software Requirements 107 Specifications for the Calibration Targeting System 108 Electromagnetic Effects siiwurvaccrainrsanaicdinmaminei ain aves 108 Parts Information 108 WAEA Y seis N etait ene ha fates tea anteaters 109 Symbol Directory A cd cae nene E We Goan n sa k 110 Appendix A ScanPoint Legal Information A E 111 Verathon HIPAA Business Associate Agreement uE ereke 112 Health Insurance Portability and Accountability Act HIPA A 115 GLOSSAE Y ie n esa cena ce eve anc derana dar b KE RN unc ers SER NEN WNN K HRRK MEN WSE ea A RAN A cee de E EE 117 WELCOME Welcome to the User s Guide for Verathon Corporation
60. e The communication cradle plugs into any personal computer through a standard USB version 1 1 connection This connection provides both DC power and communications to external devices The cradle charges the scanning unit using a decoupled transformer design at 200 mA at 4 2 volts 25 kHz Condition Description Use Indoor Ambient temperature 5 to 40 degrees Celsius Atmospheric pressure 70 kPa to 106 kPa Relative humidity Maximum is 80 for temperatures up to 31 degrees Celsius decreasing linearly to 50 relative humidity at 40 degrees Celsius Water ingress Rated at IPXO ordinary equipment without protection against ingress of water Computer connection USB 1 1 Specifications for the Charging Cradle The charging cradle is tested to EN EN IEC 60601 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 tables Specification Description Input voltage 90 264 V AC RMS Input frequency 47 63 Hz Input current 2A max Input connection Employs direct plug in AC prongs for wall plug in units Insulation Class II with double insulation to each terminal Condition Use Indoor Ambient temperature 5 to 40 degrees Celsius Atmospheric pressure 700 hPa to 1060 hPa Relative humidity Maximum is 80 for temperatures up to 31 degrees Celsius decreasin
61. e Complete dialog box InstallShield Wizard E Maintenance Complete PONE insatorieu Wad has fished performing maintenance operations on ScanPoint 6 To finalize the uninstall click Finish The InstallShield Wizard removes the ScanPoint software from your system 10 Chapter 1 Getting Started CHAPTER 2 INTRODUCTION TO BLADDERSCAN This chapter provides an overview of Verathon Corporation s bladder imaging technology Read this section to learn about the intended use and components of BladderScan and how the instrument integrates with ScanPoint Before operating BladderScan you should also read the important safety notices contained in this chapter In This Chapter About BladderScan Technology About Measuring Bladder Wall Mass About Measuring Pediatric Bladder Volume BladderScan Components Integrating with ScanPoint Intended Use Warnings and Cautions Symbol Directory for the Scanning Unit LCD Screen Urology Suite User s Guide 11 About BladderScan Technology BladderScan is a portable battery operated V mope ultrasonic instrument that is intended for the noninvasive measurement of urinary bladder volume and bladder wall mass on an intermittent basis During each scan BladderScan employs patented V mopE technology to obtain multiple consecutive B mode images and create a three dimensional image of the bladder BladderScan automatically calculates and displays measurements base
62. e counterpart Health Insurance Portability and Accountability Act HIPAA Compliance Statement To address the growing concern about the protection and confidentiality of an individual s medical information The Verathon Corporation has taken the following measures to insure the safe delivery and storage of all information that is maintained used and presented by the ScanPoint system e All ScanPoint communications across the Internet are transmitted using the Secure Socket Layer SSL protocol and the 128 bit Data Encryption Standard DES All Patient Health Information PHI specific data stored within the ScanPoint database is encrypted The ScanPoint website infrastructure is housed by a Tier 1 Network Service Provider NSP that meets the SAS 70 certification e Within the NSP the ScanPoint equipment is located in a locked steel cage structure removing access from even the NSP s personnel The Verathon Corporation has enacted all policies and procedures outlined in HIPAA to protect our internal network from unauthorized access The Verathon Corporation has taken these actions to meet HIPAA s Privacy and Security requirements and shall continue to monitor any changes in these laws to insure all precautions are taken to protect PHI For further information on how The Verathon manages access to PHI refer to the Verathon Business Associates Agreement 0003 0138 Urology Suite User s Guide 115 116 Append
63. e terms of the agreement click Yes If you choose not to accept the terms you cannot finish installation ScanPoint displays the Select Features dialog box InstallShield Wizard xl Select Features S can Choose the features Setup will install Po i nt Select the features you want to install clear the features you do not want to install ScanPoint Manual ScanPoint Help File ScanPoint Shortcuts Point Cradle S Destination Folder C Program Files Diagnostic Ultrasound ScanPoint Space Required on C 28128 K Space Available on C 2125132 K Disk Space InstallShield Erzan Cancel Select the components you want to install If you do not want to save the ScanPoint files to the specified default location to choose a different location click the Browse button When completed to continue click Next Note The required ScanPoint software components are automatically selected by the Setup Wizard and cannot be deselected Optional components include Help files and desktop icons To conserve space on your computer s hard drive you can choose to view ScanPoint Help files directly from the ScanPoint CD ROM and you can choose not to install the desktop icons Chapter 1 Getting Started ScanPoint displays the Start Copying Files dialog box in i j InstallShield Wizard Ji Start Copying Files Review settings before copying files To begin copying the ScanPoint files
64. e while transmitting data to and from ScanPoint Calibration Targeting System Use the calibration targeting system in conjunction with ScanPoint to calibrate your instrument for maximum accuracy The calibration targeting system consists of a spiral shaped calibration target located within a specially designed calibration container For more information about calibration see Chapter 6 Inspecting and Maintaining BladderScan in this User s Guide Integrating with ScanPoint Verathon s ScanPoint is an online service that enhances and expands the capabilities of BladderScan ScanPoint is included as part of your Total Reliability Plan You can use ScanPoint to Save exam data View ultrasound images from exams Print exam results Determine bladder wall mass measurements with the BVM 6500 Assign the BVI 6300 scanning unit to a patient and view exam data Calibrate your BladderScan instrument Access your account and payment information Note ScanPoint meets all the patient data privacy requirements of HIPAA ScanPoint uses the Secure Sockets Layer SSL protocol to insure the confidentiality of exam records as they are transmitted over the Internet Health Insurance Portability and Accountability Act Note To use ScanPoint you must have Windows 2000 and Microsoft Internet Explorer version 6 0 or later installed on your computer For more detailed information about using ScanPoint see Chapter 5 Usin
65. eceipt requested addressed to the address specified on the Sales Agreement Compliance with the Laws The parties understand and intend that the terms of this Agreement and their relationship comply with all applicable laws ordinances and regulations Further during the term of and with respect to their performance under this Agreement each party will remain in compliance with all applicable laws ordinances and regulations Integration and Priority The ScanPoint Agreements collectively constitute the entire agreement between the parties as to their subject matter There are no promises terms conditions or obligations between the parties other than those contained in the ScanPoint Agreements The ScanPoint Agreements supersede all prior communications representations and agreements oral or written of the parties with respect to their subject matter In the event of a conflict among the ScanPoint Agreements the terms of the Service Agreement shall be controlling followed by the Terms and Conditions of Sale followed by this Agreement followed by the EULA No modification of this Agreement will be valid unless in writing and signed by both parties Modification No modification of this Agreement will be valid unless in writing and signed by both parties The Parties agree to amend this Agreement from time to time as is Appendix A ScanPoint Legal Information 7 1 7 8 1 3 7 10 7 41 necessary for C
66. elp 2 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging on to ScanPoint e Password The password that Verathon Corporation assigned to you for logging on to ScanPoint 3 Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window 4 On the ScanPoint menu click View Exam Results and then click New Exams Urology Suite User s Guide 49 ScanPoinf displays the New Exam Results screen including an archived list of new exams cross referenced to a corresponding patient New Exam Results Ck the cokers h ading t9 wert se2 Wed Muz 3 1801 05 FOT 5 600341 Tarr Wed A 3 102 00 FOT S 41414 Wec rendir Acri 20 2004 306566 aM 0 Wacaan Aeri 20 2004 20009 AM Watain Aeri 20 2004 209 32 AM Traridiy aori 29 2004 12 55 00 PM Wed Aug 2 10500 FOT S Wed M 2 18060901 S Wec reytiy Ar 20 2004 3 19 04 AM Wacheni acri 20 2004 3 19 5 AM Wacheni Agri 20 2004 6 56 27 aM Wed Aug 3 120608 FOT 5 Wed Aug 3 18 09 07 FOT 5 5 To view exam results in the Exam Result column click the result that corresponds to the relevant patient ScanPoint displays the Choose Exam Date Range dialog box including Exam ID and Exam Date F roose Exam Date Range NETOS BVI 6200 E
67. en calibrating the scanning unit You have successfully calibrated your scanning unit Replacing BladderScan Verathon Corporation provides full coverage warranty services for BladderScan through your Total Reliability Plan If you are unable to calibrate or scan contact Verathon Corporation s Customer Service department and we will send you a replacement according to the terms of your Total Reliability Plan General warranty information is contained in Chapter 9 Product Specifications in this Urology Suite User s Guide For details see your Total Reliability Plan or talk to your local Verathon representative For information about how to contact customer service see Chapter 8 Contacting Urology Suite User s Guide 91 92 Chapter 6 Inspecting and Maintaining BladderScan CHAPTER 7 TROUBLESHOOTING This chapter provides information to help you identify and resolve minor technical problems that may interfere with the normal operation of BladderScan and ScanPoint It includes a basic troubleshooting guide and descriptions of common problems In This Chapter e Troubleshooting Common Problems e ScanPoint Error Messages Urology Suite User s Guide 93 Troubleshooting If you are having problems operating BladderScan or ScanPoint review this list of common problems If you do not find a solution here contact your authorized BladderScan service center your local BladderScan distri
68. ent contact Device ready for calibration please press the Calibration bution to begn Information Description Instrument Serial Number Unique serial number assigned to the instrument Instrument Model Model type Software Version Software version currently installed on the device Remaining Usage Time Date and time when the device will require calibration Calibration Interval How often the device requires calibration Calibration Charge Amount that your account is charged for the calibration process and the currency used to calculate that amount Calibratic Click here to begin the calibration process 5 To verify that ScanPoint has successfully initialized the connection with your scanning unit locate and review the status box which contains red and green lights and is located in the lower left corner of the Calibration screen If an error message e g Could not find device is displayed below the status box verify that you positioned the scanning unit correctly in the communication cradle 88 Chapter 6 Inspecting and Maintaining BladderScan Click the Calibration button ScanPoint displays the Calibrate Instrument screen creates a calibration record in the ScanPoint database and transmits the calibration program to the scanning unit An up arrow appears on the scanning unit s LCD screen indicating that ScanPoint is transmitting data to the unit The speed of your Internet connection determines how quickl
69. es the names of publications such as this Urology Suite User s Guide and highlights terms that are defined in the glossary Italics will also indicate instructions throughout the manual as when instructing the reader To charge the scanning unit 2 Welcome CHAPTER 1 GETTING STARTED This chapter describes the set up procedures necessary before using BladderScan It is important that you read and follow these instructions carefully before using your BladderScan instrument In This Chapter Getting Started with BladderScan e Installing ScanPoint e Connecting the Communication Cradle e Removing the ScanPoint Software Urology Suite User s Guide 3 Getting Started with BladderScan Before using your BladderScan for the first time and subsequently if your instrument becomes completely discharged you must charge your scanning unit for six hours or until it is fully charged To charge the scanning unit 1 Plug the charging cradle into an electrical wall outlet 2 Place the BladderScan in the charging cradle The battery icon will begin scrolling indicating that the instrument is charging If the battery icon does not appear then your scanning unit was completely discharged and may need to charge for up to six hours The battery icon will appear when the scanning unit is charged sufficiently for operation Note If the battery icon with scrolling power segments does not appear after the instrument has been
70. escription allowing individuals ito monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service Glick here to learn more about the BVI 6300 46 Chapter 4 Assigning the Bladder Monitor BVI 6300 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoint Password Type the secure password that Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 4 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging on to ScanPoint e Password The password that Verathon Corporation assigned to you for logging on to ScanPoint 5 Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window 6 On the ScanPoint menu click Bladder Monitor ScanPoint displays the Bladder Monitor Patient Information screen including the information for the patient whose information you are reviewing and verifying Bladder Monitor Point Target vore Rotum Date Groten eq ae tekl Piene mter information and then press the YAd mt button Please enter patient information Preparing device for scan
71. essure acceleration or thermal ignition sources Parts Information You can use the part numbers in the following table to order parts and documentation from Verathon Part Number Description 0270 0234 Charging Cradle 0270 0235 Communication Cradle 0620 0225 Calibration Targeting System 0900 0813 ScanPoint Urology Suite Training CD ROM 0900 0972 ScanPoint Install CD ROM 0130 0181 Activation Tool BladderScan is a completely sealed unit As such the BladderScan scanning unit cannot be repaired by the customer or end user Therefore Verathon Corporation will not make available any type of circuit diagrams component parts lists descriptions or other information that would be required for repairing BladderScan If you have any questions please contact your Technical Service Representative 108 Chapter 9 Product Specifications Warranty Verathon Corporation warrants BladderScan against defects in material and workmanship as long as it is covered by the ScanPoint Total Reliability Plan This warranty does not cover equipment sold as used Damage or loss insurance is available as part of the Total Reliability Plan Pursuant to this warranty a service center authorized by Verathon Corporation will repair or replace products that prove to be defective during the warranty period This warranty does not apply if the product has been damaged by misuse or as the result of service or modification by anyone other than a servi
72. etting Started ScanPoint displays a Choose Language Setup dialog box Choose Setup Language x 1a Select the language for this installation from the choices below 2 From the dropdown list select your preferred language To continue click OK ScanPoint starts the InstallShield Wizard and displays the Welcome screen InstallShield Wizard xi Scan Welcome to the InstallShield Wizard for P fe i n t Diagnostic Ultrasound ScanPoint The InstallShield Wizard will install Diagnostic Ultrasound ScanPoint on your computer To continue click Next Note If you do not see the ScanPoint InstallShield installation screen double click the My Computer icon on your Microsoft Windows desktop and then double click the icon for your CD ROM drive 3 To continue and begin the installation click Next Urology Suite User s Guide 5 6 ScanPoint displays the License Agreement dialog box InstallShield Wizard xi License Agreement S can Please read the following license agreement carefully Po i nt Press the PAGE DOWN key to see the rest of the agreement CAN POINT SOFTWARE END USER LICENSE AGREEMENT Do you accept all the terms of the preceding License Agreement If you choose No the setup will close To install Diagnostic Ultrasound ScanPoint you must accept this agreement InstallShield oe ET we Review the contents of the License Agreement To continue with the installation and accept th
73. formation see Chapter 2 Introduction to BladderScan 2 Check the battery icon to verify that the battery is sufficiently charged for patient exams If the battery icon shows no power segments return the scanning unit to the charging cradle and recharge it before attempting to scan a patient If the battery icon shows only one power segment you can perform a few more scans but you will need to recharge your instrument soon For more information about charging the scanning unit see Chapter 1 Getting Started in this User s Guide Downloading the Bladder Wall Mass Application from ScanPoint Before taking a measurement you will need to download the Bladder Wall Mass application from ScanPoint To download the Bladder Wall Mass application from ScanPoint 1 Place the scanning unit in the communication cradle which should be connected to your computer 2 Go to the ScanPoint website by double clicking the ScanPoint icon on your Windows desktop or by opening Internet Explorer and typing https my scanpoint com in the browser s address bar 3 Log on to ScanPoint by typing your Login Name and Password on the Sign in screen and then clicking the Sign in button 4 Follow the steps in ScanPoint for downloading the Bladder Wall Mass application Determining Bladder Volume and Wall Mass Note Bladder volume must be between 200 and 400 ml to obtain an accurate bladder wall mass measurement Selecting Gender In order to
74. fully Urology Suite User s Guide 43 10 To view exam results click the following hyperlink located at the bottom of the screen Click here to view your exam results Bladder Monitor sen tO Exam Type Blacker Morstor 1 rstrument Sena Number 4452 To askon device press the ew Exam button LETS Exam received successfully Click here to view your exam results ScanPoint displays the Choose Exam Date Range dialog box including Exam ID and Exam Date Field Action Exam Date The period between the date the device was assigned to the patient and the date the patient exam data was transmitted to ScanPoint Start Date In the drop down menus select a start date range for the exam results that you wish to view End Date In the drop down menus select an end date range for the exam results that you wish to view OK Click here to view the exam results based on the date range you specified Cancel Click here to cancel your actions and return to the previous screen Note To view an exam the Start Date and End Date you select must fall within the Exam Date range shown under Bladder Monitor Exam Information 11 In the Select Scatter Plot Date Range section of the dialog box use the drop down menus to select a date range for the exam results that you wish to view 44 Chapter 4 Assigning the Bladder Monitor BVI 6300 12 When finished to view a scatter plot of the exam results from the date range you spec
75. g ScanPoint in this User s Guide Urology Suite User s Guide 15 Intended Use Warnings and Cautions BladderScan should be used only by individuals who have been trained and authorized by a physician or by the institution providing care for the patient All operators must read this entire Urology Suite User s Guide prior to using BladderScan Do not attempt to operate the instrument until you thoroughly understand all instructions and procedures in this User s Guide Failure to comply with instructions may compromise the performance of the instrument Statement of Prescription Statement of Intended Use Contraindication Warning Warning Caution United States Federal law restricts BladderScan to use by or on the order of a physician This statement is required per 21 Code of Federal Regulations CFR 801 109 Note Itis standard practice to have medical staff authorize the use of medical equipment to be used within its intended use throughout the institution Individual prescriptions for use are not required BladderScan projects ultrasound energy through the lower abdomen of the non pregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume and or bladder wall mass noninvasively BladderScan is contraindicated for fetal use and for use on pregnant patients If you use BladderScan in the presence of flammable anesthetics the hazard of potential explosion exists
76. g linearly to 50 relative humidity at 40 degrees Celsius Water ingress Rated at IPXO ordinary equipment without protection against ingress of water 106 Chapter 9 Product Specifications ScanPoint Hardware and Software Requirements To use ScanPoint your computer must meet the hardware and software requirements identified in the following tables Requirement Minimum Recommended Hardware Video display Video card and monitor capable of Video card and monitor capable of 800x600 resolution 1024x768 resolution Port USB 1 1 port USB 1 1 port Hard drive 50 MB of available space 50 MB of available space Memory 128 MB 256 MB Internet access 56K dial up modem connection to the Internet Digital subscriber line DSL cable modem T1 Faster connection strongly recommended line or other high speed connection Software Operating System Microsoft Windows 2000 Professional Microsoft Windows 2000 Professional with Service Pack 2 Service with Pack 3 or Windows XP and latest service pack Browser Microsoft Internet Explorer version 6 0 Microsoft Internet Explorer version 6 0 or later Note Make sure that your computer meets the following important requirements e ScanPoint only works with Internet Explorer version 6 0 or later Jn order for ScanPoint to interface with your scanning instrument you must also set the Internet Explorer security option Run ActiveX controls and Plug ins to Enable For more information about setting thi
77. h image To print the exam results scroll to the bottom of the Exam Results window and click one of the following print options e Printable Page Prints the exam and patient identification information and six ultrasound images from the exam e Printable Page for Physicians Offices Prints the exam and patient identification information a checklist that allows the physician to identify the patient s medical conditions and history and six ultrasound images from the exam e Printable Page for ECF SNF Prints the exam and patient identification information a checklist that allows the healthcare facility to identify the patient s medical conditions and history and six ultrasound images from the exam Urology Suite User s Guide 77 After you click one of the print option buttons ScanPoint displays the printable Results window Beam Resets Merosoft Internet Explorer BladderScan Results Exam Date amp Time Wednesday Ag ri 28 2004 1 56 26 PM Patent ID Patent Name a Urine Volume 248 m Operator Note The orientation of the images relative to the BladderScan is depicted by an icon in the upper left corner of each image 6 To print click Print This Page Your system displays a Windows Print dialog box 7 Inthe Windows Print dialog box select the appropriate print options and click the Print button 8 To return to the Exam Results window click Return to Exam Results 9 To close the Exam
78. hing you must re aim the scanning unit and perform the exam again Aim the scanning unit in the direction indicated by the arrows and press the Scan button again For example if the LCD screen displays a flashing arrow pointing to the left the bladder is located to the left of the scanhead Without lifting the scanning unit tilt it so it projects ultrasound further to the left Repeat this step until the arrows no longer flash Chapter 3 Measuring Bladder Volume and Bladder Wall Mass Note If solid aiming arrows appear then re aiming is not required A solid arrow indicates that the bladder is not completely centered in the image cone but the measurement is still clinically useful If desired re aim the scanning unit and re scan the patient as described above For patients with bladders that are oblong or extremely large a solid arrow may accompany good measurements 4 To secure the highest degree of accuracy Verathon Corporation recommends that you scan the patient s bladder at least three times to ensure the repeatability of your measurements Repeat Steps 1 3 to scan the bladder again Note 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 Volume measurements should be close but need not be identical If you cannot obtain an optimal repeatable measurement the accuracy of the result is compromised When you are
79. iance with Standards Verathon Corporation certifies that BladderScan and accessories are in compliance with all applicable international and national standards and regulations including but not limited to the following a International Electrotechnical Commission EN IEC 60601 1 Amendments 1 and 2 and EN IEC 60601 1 2 EMC Medical Device Directive MDD 93 42 EEC Annex 1 Canadian Standards Association C22 2 No 601 1 M90 Master Contract No 177198 Underwriters Laboratories Inc UL STD No 2601 1 Per the MDD BladderScan is a Class Ia device Standard Classification ol Protection Class Il internally powered equipment Type BF suitable for continuous use Specifications for the Scanning Unit The following table identifies the specifications for the scanning unit Item Specification Power Weight Display Power 3 8 v Li lon rechargeable battery Power level indicator 100 consecutive scans on a full charge Weight Less than 11 oz 309 grams Display Liquid crystal Ultrasound Output Parameters Intensity SPTA Spatial Temporal Average Power 1 04 mW cm maximum Intensity SPPA Spatial Peak Pulse Average Power 65 0 W cm maximum Mechanical Index MI 0 925 maximum Transducer Dimension 10 mm diameter Working Frequency Mode 3 7 MHz V mon multiple aligned B mode images Scan Angle 120 degrees 104 Chapter 9 Product Specifications Note Technical performance assessment for example in an acoustic
80. ibes how to view and print exam results including Viewing and Printing New Exam Results from the BVI 6300 Viewing and Printing Past Exam Results from the BVI 6300 Viewing and Printing New Bladder Monitor Exam Results To view and print new exam results from the Bladder Monitor 1 48 Go to the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop Chapter 4 Assigning the Bladder Monitor BVI 6300 ScanPoint displays the Sign In screen DIAGNOSTIC ULTRASOUND Welcome to ScanPoint April 29 2004 OOOO o simin O Newsflash Diagnostic Ultrasound introduces the jin N 4 S BladderScan BVI 6300 Password For Individual Bladder Volume ia Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BYI 6300 can restore a more natural volume directed voiding pattern The BYI 6300 is available by prescription allowing individuals SZ to monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service Click here to learn more about the BVI 6300 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoint Password Type the secure password that Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get h
81. ified click OK ScanPoint displays the Exam Results in a scatter plot 10 11 2003 ante fot 10712 2003 51 27 PM Volume in ml 13 To print the exam results scatter plot click Print This Page Your system displays a Windows Print dialog box 14 In the Windows Print dialog box select the appropriate print options and click the Print button 15 To close the window and return to the Bladder Monitor Patient Information screen click the Close button 16 To prepare the scanning unit for patient exams click New Exam and then verify the patient information as described in the following section titled Verifying Bladder Monitor Patient Information at Return Visit Important You must verify the patient information before returning the instrument to the patient if you fail to do so the instrument will not function properly Note If desired you also have the option to assign the instrument to a new patient at this time See the section in this chapter titled Reassigning the Bladder Monitor to a New Patient for details Urology Suite User s Guide 45 Verifying Bladder Monitor Patient Information at Return Visit After you transmit a patient s exam data you must review the Patient Profile and update the following information Target volume Return date if applicable Important Before you send the instrument home with the patient in order for the instrument to function properly you must verify tha
82. in the cradle for two hours you need to activate your instrument before continuing to charge The activation button is located in the opening on the underside of the instrument s handgrip just above the scan button Use the tip of the activation tool to press this button and activate your BladderScan Your instrument is now ready to charge Note When you are not using your scanning unit Corporation recommends that you store it in the charging cradle to ensure that your instrument is always sufficiently charged The charging cradle cannot overcharge the battery Installing ScanPoint Before using the ScanPoint online service you must install the required components from the ScanPoint CD ROM Your ScanPoint CD ROM includes ScanPoint software required Allows your scanning unit to communicate with ScanPoint Shortcuts and desktop icons optional Provide links for your Windows Start menu and desktop that allow you to quickly access ScanPoint ScanPoint Online Help and Verathon s home page ScanPoint Online Help optional Describes how to use ScanPoint menus and screens Note For information about the technical requirements for using ScanPoint please refer to Chapter 9 Product Specifications To install ScanPoint Note You must install the ScanPoint software before connecting the communication cradle to your computer 1 Insert the ScanPoint CD ROM into your computer s CD ROM drive 4 Chapter 1 G
83. ing conditions which may affect ultrasound transmission and the accuracy of your exam results When scanning a patient with a catheter in his or her bladder the catheter may affect the accuracy of the resulting bladder volume measurement however measurements so obtained are still clinically useful i e detecting a blocked catheter Do not use the scanning unit on a patient with open skin or wounds in the supra pubic region Use care when you scan patients who have had supra pubic or pelvic surgery Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and reflection To scan the patient 1 Place the scanhead on the gel pad aimed slightly downward toward the expected location of the bladder For most patients this means aiming the tip of the scanhead toward the patient s coccyx tailbone Note We recommend that you place the scanning unit so that the right hand side of the LCD screen is oriented toward the patient s feet This will ensure that when you view ultrasound images on ScanPoint the orientation of the images will be properly identified Press and release the Scan button located on the underside of the scanning unit s handgrip After a scan the LCD screen displays some or all of the following information Urology Suite User s Guide 21 22 Measured bladder volume The volume measurement in milliliters ml appears in large type in the top half of the
84. instructions for measuring the patient s bladder volume and bladder wall mass Assigning the Bladder Monitor BVI 6300 Provides instructions for using the BVI 6300 including information about personalizing the instrument and maintaining patient information Using ScanPoint Offers detailed instructions for using ScanPoint Inspecting and Maintaining BladderScan Provides step by step instructions for inspecting and maintaining BladderScan including how to perform weekly inspections and calibrate the instrument Troubleshooting Answers frequently asked questions and provides solutions to common problems Contacting Provides comprehensive contact information forVerathon Corporation and lists additional resources Product Specifications Lists the technical specifications of BladderScan Also includes the product warranty and ordering information ScanPoint Legal Information Contains legal documentation for ScanPoint Defines important terminology presented in this User s Guide Urology Suite User s Guide 1 Guide Conventions This User s Guide uses the formatting conventions identified in the following table Convention Meaning Bold Identifies specific buttons screens and user options you will encounter when using the products For example a procedure may instruct you to Plug the communication cradle s cable into a USB port on your computer and press the instrument s Scan button Italic Identifi
85. int The BVI 6400 holds ten or more patient exams at once so the operator can download multiple exams to ScanPoint in one sitting The voice annotation associated with each exam ensures that important patient and exam data is retained To record a voice annotation 1 Follow the instructions for measuring bladder volume above 2 Press and hold the Top button until you hear a tone approx 3 seconds 3 Record your message Speak into the microphone located above the instrument s LCD screen Note Continue holding the top button while recording your voice annotation Be sure to include all relevant exam information including the patient s name and your name name of the person performing the exam 4 Release the top button and listen as your voice annotation is replayed If you are not satisfied with the annotation press and hold the top button to record a new message return to step 1 above If you are satisfied with the annotation do not press any buttons After several seconds the instrument automatically accepts and stores the annotation with the exam The microphone icon on the LCD screen flashes while the exam and voice annotation are being saved 5 You may now begin a new patient exam if desired Measuring Bladder Wall Mass When used in conjunction with ScanPoint the BladderScan BVM 6500 measures both bladder volume and bladder wall mass Please note that the measurement displayed on your scanning unit will be a bladde
86. is Place the gel pad midline on the patient s abdomen approximately 1 inch 3 cm above the symphysis pubis Scanning a Patient Note Bladder volume must be between 200 and 400 ml to obtain an accurate bladder wall mass measurement 1 Place the scanhead on the gel pad angled slightly downward toward the expected location of the bladder For most patients this means aiming the tip of the scanhead towards the coccyx tailbone Note We recommend that you place the scanning unit so that the right hand side of the LCD screen is oriented toward the patient s feet This will ensure that when you view ultrasound images on ScanPoint the orientation of the images will be properly identified Press and release the Scan button located on the underside of the scanning unit s handgrip To help ensure accurate imaging hold the scanning unit steady until the scan is complete Avoid changing its position angle or pressure After a scan your scanning unit s LCD screen displays some or all of the following information 26 Measured bladder volume The volume measurement in milliliters ml appears in large type in the top half of the screen Aiming arrows Located in the bottom center of the screen these arrows identify the location of the bladder relative to the scanhead If the scanning unit was aimed properly so that the bladder was centered within the image cone the aiming arrows will not flash Ifthe aiming arrows are flas
87. ix A ScanPoint Legal Information Activate Activation tool Aiming arrows Calibration Calibration targeting system Charging cradle Communication cradle Coupling medium Flashing aiming arrow Gel pad Image cone IR Window Labeling LCD screen GLOSSARY Term Description The act of turning on your instrument by placing the activation tool in the opening just above the Scan button When your instrument has been completely discharged sometimes activation will be necessary The small metal tool used to activate your instrument Arrows located in the center of the scanning unit s LCD screen below the bladder volume measurement which identify the location of the bladder relative to the scanhead A flashing aiming arrow means re aiming is required A solid aiming arrow means re aiming is optional The act of checking the accuracy and system functionality of a measuring instrument by comparing it with a known standard A system used for calibration purposes consisting of a calibration container holding a spiral shaped calibration target The calibration system provides a known reference ina spherical coordinate system which in normal operation allows the device to provide accurate volume measurements The cradle that is used to charge the battery of the scanning unit this cradle plugs directly into an electrical wall outlet The cradle that plugs into any personal computer through a standard USB conne
88. layed wal 6 Flashing Greater than 110 of Target Volume aN Aiming arrows Located on all four sides of the screen these arrows identify the location v of the bladder relative to the scanhead If the scanning unit was aimed properly so that the bladder was contained within the image cone the aiming arrows either will not appear or will not flash Note The image cone is the cone shaped range within which ultrasound waves are transmitted by the scanhead during a scan 7 Ifthe aiming arrows are flashing you must re aim the scanning unit and perform the exam again Aim the scanning unit in the direction indicated by the arrows and press the Scan button again Repeat this step until the arrows no longer flash Important The accuracy of a measurement depends on properly aiming the scanning unit Errors in usage typically result in the underestimation of bladder volume however if the scanning unit was not held still during the scan the measurement may overestimate the actual bladder fullness Urology Suite User s Guide 41 Transmitting Exam Data to ScanPoint After a Bladder Monitor is personalized and an exam is performed you can upload the data into the ScanPoint database and use ScanPoint to view and print the final exam results To transmit Bladder Monitor exam results 1 Place the scanning unit in the communication cradle which must be connected to your computer You must also have the ScanPoint software installe
89. le for keeping current with developments in the literature on bladder volume Please direct any questions or problems concerning bladder volume the use of this instrument or the interpretation of data to the responsible physician Disposal of Device At the end of equipment useful service life the user should return the device to The Verathon Corporation Urology Suite User s Guide 109 Symbol Directory The following table identifies the industry symbols used to classify BladderScan Symbol Description m gt B 0123 e ce 7 60C oe 20C 06 50 jS Class II equipment Type BF applied part used to identify a type BF applied part with EN IEC 60601 1 CE marked in accordance to the MDD CSA symbol Attention consult accompanying documents Ambient temperature storage conditions Atmospheric pressure storage conditions Relative humidity storage conditions 110 Chapter 9 Product Specifications APPENDIX A SCANPOINT LEGAL INFORMATION This appendix contains legal documents that apply to the ScanPoint service For the latest versions of these legal documents see the Verathon Corporation website at In This Appendix The Verathon Corporation HIPAA Business Associate Agreement e Health Insurance Portability and Accountability Act HIPAA Compliance Statement Urology Suite User s Guide 111 The Verathon HIPAA Business Associate Agreement This BUSINESS A
90. lient to comply with the requirements of the HIPAA Privacy Rules and Public Law 104 191 Interpretation The section and paragraph headings of this Agreement are for the convenience of the reader only and are not intended to act as a limitation of the scope or meaning of the sections and paragraphs themselves This Agreement will not be construed against the drafting party Any ambiguity in this Agreement shall be resolved in favor of a meaning that permits Client to comply with the HIPAA Privacy Rules Severability and Waiver The invalidity of any term or provision of this Agreement will not affect the validity of any other provision Waiver by any party of strict performances of any provision of this Agreement will not be a waiver of or prejudice any party s right to require strict performance of the same provision in the future or of any other provision of this Agreement Governing Law This Agreement will be interpreted and enforced according to the laws of the State of Washington and the United States of America No Third Party Beneficiaries This Agreement creates no third party rights or obligations between DU and any other person It is understood and agreed that the parties do not intend that any third party should be a beneficiary of this Agreement Counterparts This Agreement may be executed in multiple counterparts all of which together will constitute one agreement even though all parties do not sign the sam
91. me measurement then the bladder is too large to be fully contained within the image cone In such cases the true volume is greater than the measurement displayed and re aiming the instrument will not help This situation occurs almost exclusively in patients with extremely high bladder volumes At these high volumes measurements are clinically useful even though they underestimate the actual bladder volume When you connect to ScanPoint to use its calibration or exam services an error message may occasionally appear on your computer screen For information about resolving connectivity problems and other ScanPoint related issues see ScanPoint Online Help which you can view by clicking the Help button on any ScanPoint screen You may also contact Verathon s Customer Service support team See Chapter 8 Contacting Verathon for contact information If you attempt to access the ScanPoint website and receive a browser error message your Internet connection may not be working properly Attempt to view another website to verify that you have Internet access If you attempt to log on to ScanPoint and receive an error message that states Invalid login name or password Please try again your username or password may be invalid Attempt to log on again If you cannot remember your Login Name or Password or you need help logging on click Get help with sign in The ScanPoint features that you can use depend on the logon profile that yo
92. menu 74 Chapter 5 Using ScanPoint Viewing and Printing the Exam Results for a Specific Patient Patient Exams History Point To view exam results for a specific patient simply log on to ScanPoint and choose the View Exam Results menu option ScanPoint will display a list of all the exam results associated with a selected Patient ID To view and print exam results for a specific patient 1 Go to the ScanPoint website at https my scanpoint com and log on 2 On the ScanPoint menu click View Exam Results and then click Past Exams ScanPoint displays the Enter Patient ID section of the Patient Exam History screen Information Description Patient ID Type the identification value that you assigned to the patient in ScanPoint If you don t remember the Patient ID click here to look it up Click here to submit the Patient ID and obtain a record of the patient s exam results 3 On the Patient Exam History screen enter the Patient ID and then click the Submit button Note If you cannot remember the Patient ID for an existing patient then click the Search button located to the right of the Patient ID field A Patient List will appear Click the Patient ID that you want and wait while ScanPoint compiles a list of all past exam results for that patient Urology Suite User s Guide 75 ScanPoinf displays the Patient Exam History screen including all past exam results for that patient Exams are sorted by date in
93. n t imi m amp attery icon 1 Press the Top Gender button located below the LCD screen Select the female option if the patient is a female who has not undergone a hysterectomy The female option allows BladderScan to exclude the uterus which may resemble the bladder ultrasonically When the female option is selected a female icon will appear on the scanning unit s LCD screen If the patient is a male or a female who has undergone a hysterectomy press the Top Gender button to toggle between options until the gender icon no longer appears on the LCD screen 20 Chapter 3 Measuring Bladder Volume and Bladder Wall Mass Applying a Gel Pad To apply a gel pad and scan the patient 1 Clean and disinfect the scanhead of the scanning unit by wiping it gently with a germicidal wipe or a soft cloth soaked in isopropyl alcohol For more information about cleaning and disinfecting BladderScan see Chapter 6 Inspecting and Maintaining BladderScan Prepare to apply a Sontac ultrasound gel pad by peeling back the foil lid of the individual Sontac packaging to expose the gel pad To avoid patient cross contamination use a new gel pad for each patient With the patient resting quietly in the supine position palpate the symphysis pubis Place the gel pad midline on the patient s abdomen approximately inch 3 cm above the symphysis pubis Scanning a Patient When using BladderScan be aware of the follow
94. n when you log on Contact Verathon Corporation to reactivate your account If the credit card for your account expires within 30 days ScanPoint will prompt you to contact Verathon Corporation and update your credit card information Transmitting Exam Data to ScanPoint For BladderScan Pediatric BladderScan and Bladder Wall Mass exams Note For instructions on transmitting Mobile BladderScan exams see the section titled Transmitting Mobile BladderScan Exam Data to ScanPoint below To transmit exam data to ScanPoint Note For step by step instructions that describe how to perform patient examinations see Chapter 3 Measuring Bladder Volume and Bladder Wall Mass 1 2 Place your scanning unit in the communication cradle connected to your computer Go to the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop To log on to ScanPoint type your Login Name and Password on the Sign In screen and then click the Sign In button On the ScanPoint menu click the appropriate Exam type i e BladderScan Pediatric BladderScan etc If you did not install the ScanPoint driver from the ScanPoint CD ROM or a newer version of the ActiveX plug in is available a Security Warning dialog box prompts you to install it now If prompted to install the driver click Yes If not prompted or if you have already previously installed the driver continue to the next ste
95. nformation Urology Suite User s Guide 65 To view and print the exam results 10 After the exam data has been successfully transmitted and ScanPoint has analyzed the data confirm 11 12 66 that ScanPoint displays the following screen BladderScan aed fek ote To perform another exam press the wew Exam button BDN Exam received successfully Click here to view your exam results y To view your exam results click the Click here to view your exam results link This link appears within approximately 1 2 minutes after ScanPoint has completed the exam analysis ScanPoint displays the Exam Results window PESSE including the patient information and _ tzpa t ter werma sot 2 zot 04490004 ultrasound images from the exam Note The images have the orientation shown relative to the BladderScan depicted by an icon in the upper left corner of each image To print the exam results scroll to the bottom of the Exam Results window and then choose one of the available print options e Printable Page e Printable Page for Physicians Offices e Printable Page for ECF SNF Chapter 5 Using ScanPoint After you click one of the print option buttons ScanPoint displays the printable Results window Note The orientation of the images relative to the BladderScan is depicted by an icon in the upper left corner of each image Bh Exam Rests Microsoft Internet Explorer BladderScan
96. nge dialog box including Exam ID and Exam Date Field Action Exam Date The period between the date the device was assigned to the patient and the date the patient exam data was transmitted to ScanPoint Start Date In the drop down menus select a start date range for the exam results that you wish to view End Date In the drop down menus select an end date range for the exam results that you wish to view OK Click here to view the exam results based on the date range you specified Cancel Click here to cancel your actions and return to the previous screen Note The Start Date and End Date you select must fall within the Exam Date range shown under BVI 6300 Exam Information 54 Chapter 4 Assigning the Bladder Monitor BVI 6300 10 11 In the Select Scatter Plot Date Range section of the dialog box use the drop down menus to select a date range for the exam results that you wish to view exam results will be graphed on a scatter plot Click OK to view a scatter plot for the exam results covering the date range you specified ScanPoint displays the Exam Results in a scatter plot Volume in ml To print the exam results scatter plot click Print This Page Your system displays a Windows Print dialog box In the Windows Print dialog box select the appropriate print options and click the Print button To close the window and return to the Patient Exams History screen click the Close button Urology Suite
97. ning unit to the charging cradle or communication cradle within 20 minutes of completing the exam the scanning unit will go into sleep mode to conserve battery power Unless saved by using ScanPoint or by recording a voice annotation BVI 6400 bladder imaging data will be lost when the scanning unit goes into sleep mode Chapter 3 Measuring Bladder Volume and Bladder Wall Mass Bladder Optimal Scan of Patient s Bladder Bladder is contained 7 j Bladder is contained NS Bladder volume is greater than 999 ml Bladder is partially contained EN Bladder volume is too high to be CAN fully contained within scan cone Optional Rescan G Bladder is partially contained aT ca Cl within scan cones Rescan Patient s Bladder U Bladder partially contained Example Display BIETJIE Volume displayed No gt symbol No arrow or solid arrow Volume displayed is 999 ml gt symbol Volume is displayed gt symbol Flashing arrow or no arrow Volume displayed Solid arrow in direction of optional rescan Volume displayed Flashing arrow in direction to rescan Urology Suite User s Guide 23 Recording a Voice Annotation BVI 6400 Only When you complete a bladder volume exam with the Mobile BladderScan BVI 6400 you can record a voice annotation to be saved with the exam The voice annotation is replayed when the exam is viewed on ScanPo
98. nished transmitting data to ScanPoint The calibration procedure was successfully completed You select or deselect the female option You select the pre void or post void option 94 Chapter 7 Troubleshooting Problem Description Resolution Flashing aiming arrows appear on the LCD screen A solid aiming arrow appears on the LCD screen A gt symbol appears before the volume measurement An error message appears on the ScanPoint screen You cannot access the ScanPoint website You cannot log on to ScanPoint Some menu options are not available If flashing aiming arrows appear on the scanning unit s LCD screen after a scan the bladder was not fully within the image cone You should adjust your aim in the direction indicated by the arrow and rescan the patient Repeat this process until no flashing arrows appear When the scanning unit is aimed properly either a solid arrow or no arrow appears with the bladder volume measurement For more information about using the aiming arrows see Chapter 3 Measuring Bladder Volume and Bladder Wall Mass in this Urology Suite User s Guide Asolid arrow indicates an aiming suggestion The solid aiming arrow appears on the scanning unit s LCD screen when the bladder was not completely centered in the scanning unit s field of vision In this case the measurement is good and re aiming is optional If a greater than symbol gt appears before the bladder volu
99. ntify the patient s medical conditions and history and six ultrasound images from the exam Urology Suite User s Guide 73 ScanPoinf displays the printable Results window eam Rents Microsoft Intenet Explorer BladderScan Results Exam Date amp Time Wednesday Apri 28 2004 1 56 26 PM Patent ID SMIIDISE2 Patient Name Jessica Smith Urine Volume 248 m Operator Physician Note The orientation of the images relative to the BladderScan is depicted by an icon in the upper left corner of each image 5 To print click Print This Page Your system displays a Windows Print dialog box 6 In the Windows Print dialog box select the appropriate print options and click the Print button 7 To return to the Exam Results window click Return to Exam Results 8 To accept the exam results click the Close button To reject the exam results In the Reason field type a brief description of why you want to reject the results and then clickthe Reject button You will no longer be able to view or print exam results after you reject them 9 To refresh the list on the New Exam Results screen so that you can see which results have not been reviewed click the Refresh button Note After you accept the exam results and refresh the New Exam Results screen the results you just viewed no longer appear in the list of new exams If you want to view these exam results again use the Past Exams option on the ScanPoint
100. on Corporation assigned to you for logging on to ScanPoint Password Type the secure Password that Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 2 62 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging onto ScanPoint e Password The password that Verathon Corporation assigned to you for logging onto ScanPoint Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window To log off at any time click Log Off on the ScanPoint menu Chapter 5 Using ScanPoint Notes If either your Login Name or Password is invalid ScanPoint displays the following error message Invalid login name or password Please try again Attempt to log on again If you cannot remember your Login Name or Password or if you need help logging on click Get help with sign in If you are logged on to ScanPoint for a period of time without any activity ScanPoint logs you off automatically When you attempt to use ScanPoint after a session has timed out the Sign In screen will appear and you will have to log on again If your account has expired ScanPoint displays the Account Expired scree
101. ons For any given month Verathon Corporation charges the total monthly fees to your credit card on the first day of the following month The Credit Card Transactions section contains information about these charges including the following Information Description Date The date month day and year that the credit card was charged for the specified month s fees Card Type The type of card e g MasterCard or VISA Card Number The credit card number For security purposes only the last four digits of the card number are shown DB CR Whether it is a debit DB or credit CR transaction Amount The exact amount being charged to the credit card Currency The currency used to calculate the amount e g USD indicates that the amount is specified in U S Dollars 4 To print a copy of the statment scroll to the bottom of the statement and click Print Your system displays a Windows Print dialog box 5 Inthe Windows Print dialog box select the appropriate print options and click the Print button Viewing the Billing Statement for Any Past Month To view billing statements from any past month simply log on to ScanPoint and click on Your Account To view the billing statement for any past month 1 Go to the ScanPoint website at https my scanpoint com and log on to ScanPoint 2 On the ScanPoint menu click Your Account and then click Past Statements ScanPoint displays the Past Statements screen Past Statements Poin
102. ose button Urology Suite User s Guide 51 Viewing and Printing Past Bladder Monitor Exam Results To view and print past exam results from the Bladder Monitor 1 Go to the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop ScanPoint displays the Sign In screen DIAGNOSTIC Welcome to ScanPoint METRASCUND April 29 2004 EEE TEEN Newsflash Diagnostic Ultrasound introduces the H ee BladderScan BVI 6300 Password For Individual Bladder Volume i Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BYI 6300 can restore a more natural volume directed voiding pattern The BVI 6300 is available by X prescription allowing individuals SAE to monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service Click here to learn more about the BVI 6300 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoint Password Type the secure password that Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 52 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging on to ScanPoint e
103. p Urology Suite User s Guide 63 ScanPoint displays the Patient Information screen Point BladderScan Gan Type Patient iD Parant Name Treet Oy Ptyanin deroten reared ttt Please enter information arat then press the ater baton BED Please enter patient information Device is holding new scan 6 Enter the patient information in the fields provided You must type information in all fields marked with a red asterisk Field Description Exam Type Patient ID Patient Name Examined By Physician Displays the type of exam that your instrument is holding Type the identification value that you assigned to the patient in ScanPoint For a new patient type a unique Patient ID and ScanPoint creates a new patient record Note The identification value can be any combination of numbers letters or other characters that you have assigned to the patient in ScanP oint If you cannot remember the Patient ID for an existing patient click the Lookup button located to the right of the Patient ID field A Patient List displays all the patients in your account Click the appropriate patientname and his or her information will appear on the Perform Exam screen Click the Lookup button to search for an existing Patient ID Type the patient s first and last names Note If you used the Lookup feature to locate the Patient ID ScanP oint automatically displays the correct patient name associated with the
104. quick reference cards and training videos for the instruments in Verathon s Urology Suite BVI 6100 BVI 6200 BVI 6300 BVI 6400 and BVM 6500 Some of these items may have been included in the box with your BladderScan To order additional resources please contact your local BladderScan distributor or Verathon Corporation Additional resources including training videos quick reference cards and documentation about BladderScan technology as well as clinical trials and applications are available at the Verathon Corporation website http verathon com The Verathon website presents a comprehensive bibliography of clinical papers with links to summaries of these studies and describes the benefits and applications of the BladderScan in private practice acute care and extended care Success stories reimbursement information and online ordering service are also provided at http verathon com Urology Suite User s Guide 101 102 Chapter 8 Contacting CHAPTER 9 PRODUCT SPECIFICATIONS This chapter describes the technical specifications of BladderScan and contains information about instrument parts and the product warranty In This Chapter e BladderScan Technical Specifications e Parts Information e Warranty e Symbol Directory Urology Suite User s Guide 103 BladderScan Technical Specifications The following sections describe the compliance and technical specifications of BladderScan components Compl
105. r volume measurement ScanPoint will generate your bladder wall mass measurement after you have uploaded your exam information You can view the bladder wall mass measurement in ScanPoint on the Bladder Wall Mass Exam Results page The following section describes how to measure a patient s bladder wall mass with the BladderScan BVM 6500 Before you begin the exam make sure that you clean and disinfect the scanning unit to minimize the risk of infection Using the Bladder Wall Mass Application There are three main parts to the bladder wall mass procedure e Download the bladder wall mass application from ScanPoint e Scan the patient and determine if bladder volume is sufficient for a bladder wall mass exam bladder volume must be between 200 and 400 ml e Use ScanPoint to view the bladder wall mass measurement 24 Chapter 3 Measuring Bladder Volume and Bladder Wall Mass Turning On the Scanning Unit If you have stored your scanning unit in the charging cradle or communication cradle the power will be on when you remove it from the cradle If the scanning unit is not stored in the cradle it goes into sleep mode when not in use and you must turn it on before measuring bladder volume To turn on the scanning unit 1 Ifthe scanning unit is in sleep mode press and release any button When the scanning unit chirps it is ready to scan Note If the scanning unit does not turn on the battery may be completely discharged For more in
106. r the bladder during each measurement not your ability to obtain exactly the same bladder volume measurement each time Volume measurements should be close but need not be identical If you cannot obtain an optimal repeatable measurement the accuracy of the result is compromised Important The accuracy of your measurement depends on properly aiming the scanning unit Errors in usage typically result in the underestimation of bladder volume except when the scanning unit is moved during the scan In this case the measurement may overestimate the actual bladder volume The presence of a catheter in the patient s bladder can also affect the accuracy of scan results by overestimating bladder volume When you are satisfied that the scanning unit was aimed properly and the scan result is accurate note the bladder volume measurement displayed on the LCD screen Note If you are using the BladderScan models BVI 6100 BVI 6200 or BVM 6500 to determine bladder volume you may want to chart this measurement because the scanning unit will not save it after you begin a new exam If desired you can also view save and print exam results using ScanPoint See Chapter 5 Using ScanPoint for more information If you are using the BVI 6400 you can save the measurement in the scanner s memory by recording a voice annotation See the following section titled Recording a Voice Annotation for details Important If you do not return the scan
107. ram information TM Exam ID Eram Date May 4 2004 To May 4 2004 KA KAR neme Field Action Exam Date The period between the date the device was assigned to the patient and the date the patient exam data was transmitted to ScanPoint Start Date In the drop down menus select a start date range for the exam results that you wish to view End Date In the drop down menus select an end date range for the exam results that you wish to view OK Click here to view the exam results based on the date range you specified Cancel Click here to cancel your actions and return to the previous screen Note The Start Date and End Date you select must fall within the Exam Date range shown under BVI 6300 Exam Information 50 Chapter 4 Assigning the Bladder Monitor BVI 6300 10 In the Select Scatter Plot Date Range section of the dialog box use the drop down menus to select a date range for the exam results that you wish to view exam results will be graphed on a scatter plot Click OK to view a scatter plot for the exam results within the date range you specified ScanPoint displays the Exam Results in a scatter plot Es 3 a To print the exam results scatter plot click Print This Page Your system displays a Windows Print dialog box In the Windows Print dialog box select the appropriate print options and click the Print button To close the window and return to the New Exam Results screen click the Cl
108. rescription allowing individuals to monitor their bladder volumes on an ongoing basis Get help with sign in Customer Service D Click here to learn more about the BVI 6300 Field Action Login Name Type the Username that Verathon Corporation assigned to you for logging on to ScanPoint Password Type the secure password that Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 56 Chapter 4 Assigning the Bladder Monitor BVI 6300 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging on to ScanPoint Password The password that Verathon Corporation assigned to you for logging on to ScanPoint Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window On the ScanPoint menu click Your Account and then click Bladder Monitor Assignment ScanPoint displays the Bladder Monitor Assignment List screen Bladder Monitor Assignment List Note The annotation N A refers to an instrument that is not currently assigned ScanPoint displays the following information on the Bladder Monitor Assignment List screen Instrument Serial Number Patient ID Pa
109. rm different functions depending on the device model For example it is used to select or deselect the female setting when measuring bladder volume with the BVI 6100 BVI 6200 BVI 6400 and BVM 6500 to select the pre void or post void option when using the BVI 6300 to record a voice annotation with the BVI 6400 to initiate a calibration measurement and to display the days remaining until calibration Ultrasound estimated bladder weight Metric indicating bladder wall thickness used to diagnose bladder hypertrophy Involving ultrasound ultrasound refers to acoustic frequencies above the range that can be heard by the human ear Urology Suite User s Guide 119 Ave RATHON MEDICAL www dxu com
110. rporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 4 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging on to ScanPoint e Password The password that Verathon Corporation assigned to you for logging on to ScanPoint 5 Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window 6 On the ScanPoint menu click Bladder Monitor 36 Chapter 4 Assigning the Bladder Monitor BVI 6300 ScanPoint displays the Bladder Monitor Patient Information screen including the information for the previous patient that was assigned to this particular scanning unit Bladder Monitor Baer a Point Bladder morstor for E demoten areare Set Peseta ernatin ae then pes the att ato ES Please enter patient information Preparing device for scan 7 Inthe Patient Profile section of the screen enter the relevant information for the new patient to whom you will be assigning this particular scanning unit replacing the previous patient s data Important Before you send the instrument home with the patient in order for the instrument to function properly you must verify that you have updated the
111. s security option see your Microsoft Internet Explorer documentation or the browser s online Help Note All procedures involving your personal computer in which a BladderScan scanning unit is placed in the communication cradle should be performed outside the Patient Vicinity more than 6 feet from the patient See UL 2601 1 Clause 2 deviation for definition of Patient Vicinity Important It is necessary that the computer connected to the USB communication cradle connection be an approved computer certified to minimally EN IEC 60950 CSA 950 UL 1950 or EN IEC 60601 1 CSA 601 1 UL 2601 1 standards This configuration ensures that compliance to the EN IEC 60601 1 1 system standard is maintained Any person who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard EN IEC 60601 1 1 If in doubt consult your biomedical staff s customer service department or your local representative Urology Suite User s Guide 107 Specifications for the Calibration Targeting System The specially designed calibration container is intended to hold a spiral shaped calibration target and 4 2 liters of water In locating the scanning unit in a known and repeatable location with respect to the spiral target the calibration container is used with a calibration application to periodically ensure
112. sage Resolution Account expired Contact a customer support representative at Verathon Corporation to reactivate your account Commentis too long The comment you typed in the rejection Reason field is too long Type a shorter comment Instrument is not ScanPoint cannot communicate with your scanning unit Make sure that your scanning responding unit is positioned properly in the communication cradle If this error occurred while transmitting data to ScanPoint click the Submit button to restart the transmission Instrument is not Your scanning unit needs to be returned for repair Please contact a customer support working representative at Verathon Corporation for a replacement instrument Instrument with given serial You are using a scanning unit that is not registered with ScanPoint Contact a customer and part numbers does not support representative at Verathon Corporation or your local representative exist Please contact to resolve this problem customer support at 800 331 2313 Exam already has exam You have already transmitted the exam results associated with the current exam record data uploaded Please start You can begin another exam now another exam 96 Chapter 7 Troubleshooting Error Message Resolution Exam already has result code set Invalid login name or password Please try again Negative values are not allowed No patient was found with given ID Please contact customer support at 800 331 2313
113. satisfied that the scanning unit was aimed properly and the scan result is accurate note the bladder volume measurement displayed on the LCD screen Important If you do not return the scanning unit to the charging cradle or communication cradle within 20 minutes of completing the exam the scanning unit will go into sleep mode to conserve battery power Measurement data will be lost when the scanning unit goes into sleep mode Verify that the bladder volume measurement is sufficient for a bladder wall mass exam In order to obtain an accurate bladder wall mass measurement the measured bladder volume must be between 200 and 400 milliliters Use ScanPoint to view bladder wall mass results e Place the scanning unit in the communication cradle and log on to ScanPoint e Click Bladder Wall Mass e Verify Patient Information e Click Transmit Exam Note ScanPoint uploads and analyzes your exam data This can take several minutes At the bottom of the page click the option Click Here to View Your Exam Results Your exam results will appear including scan and patient information bladder volume and wall mass measurements and ultrasound images If desired you may print the exam results and ultrasound images Urology Suite User s Guide 27 28 Chapter 3 Measuring Bladder Volume and Bladder Wall Mass CHAPTER 4 ASSIGNING THE BLADDER MONITOR BVI 6300 Intended for use on adult or pediatric patients with neurogenic or overacti
114. t Urology Suite User s Guide 81 Information Description Month Select a month Year Select a year Click here to view the billing statement for the selected month and year 3 From the drop down menus select the desired Month and Year and then click the Search button 82 ScanPoint displays the Past Statements screen including an itemized list of usage charges charge details and credit card transactions for the selected month If charges are being billed to more than one credit card the charges will be listed separately for each card ScanPoint Monthly Statement Point Part Nhe 0090161 00030151 Note For information about the billing information displayed on the Past Statements screen see the previous section on viewing account charges To print a copy of the statment scroll to the bottom of the statement and click Print Your system displays a Windows Print dialog box In the Windows Print dialog box select the appropriate print options and click the Print button Chapter 5 Using ScanPoint Receiving Email Notifications This section outlines the automated email messages that are transmitted from ScanPoint For a description of the ScanPoint transmitted email messages that you may receive refer to the following table Description Message Body User account edited ScanP oint user J ohnDoe account information has changed User Role user_role Name user_name Title user title L
115. t Chapter 5 Using ScanPoint 7 Find the Mobile BladderScan exam you wish to view and click Enter Details in the Exam Result column ScanPoint displays the Patient Information page New Exam Results Point Patient information Ezim Te Paent ID Parme Name Kamek Oy Pran 8 Click the Listen button to hear the voice annotation associated with the exam 9 Enter the patient information in the fields provided You must type information in all fields marked with a red asterisk Field Description Exam Type Displays the type of exam that your instrument is holding Patient ID Type the identification value that you assigned to the patient in ScanPoint For a new patient type a unique Patient ID and ScanPoint creates a new patient record Note The identification value can be any combination of numbers letters or other characters that you have assigned to the patientin ScanP oint If you cannot remember the Patient ID for an existing patient click the Lookup button located to the right of the Patient ID field A Patient List displays all the patients in your account Click the appropriate patient name and his or her information will appear on the Perform Exam screen Click the Lookup button to search for an existing Patient ID Patient Name Type the patient s first and last names Note If you used the Lookup feature to locate the Patient ID ScanPoint automatically displays the correct patient name asso
116. t Password Type the secure password that Verathon Corporation assigned to you for logging on to ScanPoint Sign In Click here to log on to ScanPoint Get help with signin Click here to get help 38 To log on to ScanPoint on the Sign In screen type values for the following fields Login Name The username that Verathon Corporation assigned to you for logging on to ScanPoint Password The password that Verathon Corporation assigned to you for logging on to ScanPoint Chapter 4 Assigning the Bladder Monitor BVI 6300 Click the Sign in button ScanPoint validates your username and password and starts a secure session identified by the yellow padlock symbol at the lower right hand corner of the browser window On the ScanPoint menu click BVI 6300 ScanPoint displays the Bladder Monitor Patient Information screen including the information for the previous patient that was assigned this particular scanning unit Bladder Monitor Pcie enter ermaton a then ees the at baton ES Please enter patient information Preparing device for scan To update or change the patient information in the Patient Profile section of the screen enter the updated information Important Before you send the instrument home with the patient in order for the instrument to function properly you must verify that you have updated the patient information so that it is accurate and complete If you do not review and edit the relevant pa
117. t you have updated the patient information so that it is accurate and complete If you do not review and verify the relevant patient information the instrument will not perform exams or operate properly for the patient Note The following procedure assumes you have already transmitted exam data for the patient to ScanPoint To review and verify Bladder Monitor patient information 1 Place the scanning unit in the communication cradle which must be connected to your computer ScanPoint software must also be installed 2 Ifyou did not install the ScanPoint software from the ScanPoint CD ROM ScanPoint prompts you to install it now To install the ScanPoint software click Yes Note If you do not install the ScanPoint software your scanning unit cannot communicate with ScanPoint and you will not be able to configure the Bladder Monitor for patient use 3 Goto the ScanPoint website at https my scanpoint com or double click the ScanPoint icon installed on your desktop ScanPoint displays the Sign In screen DIAGNOSTIC Welcome to ScanPoint Meee April 29 2004 EEE TEEN Newsflash Diagnostic Ultrasound B introduces the D 77 ogn Name BladderScan BVI 6300 Password For Individual Bladder Volume a Monitoring For individuals with neurogenic bladders due to spinal cord injury or other conditions the BYI 6300 can restore a more natural volume directed voiding pattern The BYI 6300 is available by pr
118. tended to such information in accordance with the termination provisions in this Section 5 3 5 4 Upon Client s knowledge of a material breach by DU Client shall provide an opportunity for DU to cure the breach or end the violation within thirty 30 days and may terminate this Agreement and the Service Agreement if DU does not cure the breach or end the violation within the time permitted Except as provided in Section 5 4 upon termination of this Agreement for any reason DU shall return or destroy all PHI received from Client or created or received by DU on behalf of Client This provision shall also apply to PHI that is in the possession of subcontractors or agents of DU DU shall retain no copies of the PHI except as provided in Section 5 4 In the event that DU determines that returning or destroying the PHI is infeasible DU shall provide to Client notification of the conditions that make return or destruction infeasible Upon mutual agreement of the Parties that return or destruction of PHI is infeasible DU shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible for so long as DU maintains such PHI Indemnity Client agrees to indemnify defend and hold DU harmless from and against any and all claims or causes of action arising out of or in any way pertaining to the use or disclosure by DU of
119. the instrument assigned to your service plan Amount The total amount of the charges for each month Urology Suite User s Guide 79 Note Current charges do not include applicable sales tax or per use charges If no charges were made in the current month the statement No records will appear 4 To print a copy of your current charges scroll to the bottom of the statement and click Print Your system displays a Windows Print dialog box 5 In the Windows Print dialog box select the appropriate print options and click the Print button Viewing the Previous Month s Billing Statement To view the previous month s charges simply log on to ScanPoint and click Your Account To view the billing statement for the previous month 1 Go to the ScanPoint website at https my scanpoint com and log on 2 On the ScanPoint menu click Your Account and then click Last Statement ScanPoint displays the Monthly Statement screen and an itemized list of usage charges charge details and credit card transactions for the previous month If charges are being billed to more than one credit card the charges will be listed separately for each card ScanPoint Monthly Statement Customer ID 211104 DU Marketing Department ou Bothell WA 90260 Attn Jesca MeMorrow Currency U Dolar Note Ifno charges were made that month the statement No records will appear 80 Chapter 5 Using ScanPoint Credit Card Transacti
120. the patient s last name If you used the Lookup feature to locate the Patient ID ScanPoint automatically displays the correct patient name and his or her information will appear in the Patient Profile section of the screen Urology Suite User s Guide 33 e Physician Name Type the name of the physician who has prescribed the instrument Examined By Type the name of the person who will perform the exams e Gender In the drop down list select male or female Note For female patients who have had a hysterectomy select Male Target Volume Type the numerical value in ml for the patient s target volume which is the volume at which the patient should void or perform catheterization e Return Date Use the drop down menu to specify the date that the patient should return for a follow up consultation If no return visit is scheduled or planned select the no return visit check box Note Indicates a required field 8 When finished review your information for accuracy and completeness 9 To submit your information into the database and program the scanning unit click the Submit button The status box displays the following message Preparing device for exam percent transmitted Transmission will take a few minutes so please be patient Bladder Monitor Please weiter niiormation arut then pews the att baaton IR Preparing device for exam Exam id 77740 34 Chapter 4 Assigning the Bladder
121. the scanhead until it is thoroughly cleaned Cleaning removes any debris mucous or other substances that may interfere with the performance of the scanning unit 2 If you use a detergent solution to clean the scanning unit remove all residual detergent Dry the instrument with a clean cloth 3 Ifthe scanning unit needs to be disinfected dampen a soft cloth in any glutaraldehyde based hospital disinfectant solution such as Cidex or Cidex 7 from Advanced Sterilization Products or Sporicidin from Sporicidin International Wipe the scanning unit with the dampened cloth Warning Do not immerse the instrument in disinfectant solution u Do not use CidexPlus to disinfect the instrument CidexPlus is not recommended for use with low density polyethylene LDPE plastic Do not subject any part of BladderScan to steam sterilization or ethylene oxidesterilization Failure to heed these warnings may cause damage to a BladderScan that is not covered under warranty 4 To remove all traces of disinfectant solution wipe the scanning unit with a soft cloth dampened in sterile water or cleaning solution Verathon Corporation recommends wiping the unit three separate times to remove all residual disinfectant 5 Thoroughly dry BladderScan with a soft clean cloth prior to use Performing Weekly Inspections Once a week you should inspect the scanning unit for physical faults or cracks Cracks that allow the leakage or ingress of fluid may
122. tient Name Assigned Date Time Return Date Urology Suite User s Guide 57 58 Chapter 4 Assigning the Bladder Monitor BVI 6300 CHAPTER 5 USING SCANPOINT This chapter explains how you can use ScanPoint to enhance and expand the capabilities of your scanning unit In This Chapter e Using ScanPoint e Understanding User Profiles e Logging On and Off Transmitting Exam Data to ScanPoint BVI 6100 BVI 6200 BVM 6500 Transmitting Mobile BladderScan Exam Data to ScanPoint BVI 6400 e Viewing and Printing New Exam Results e Viewing and Printing Exam Results for a Specific Patient e Viewing Your Account Information e Receiving Email Notifications e Online Help Urology Suite User s Guide 59 Using ScanPoint ScanPoint is an online service that integrates with other Verathon Corporation technologies to provide additional features and capabilities For example you can use ScanPoint to view save and print detailed reports of exam results to view your account information and to calibrate your scanning unit Note For instructions on Installing and Removing the ScanPoint software see Chapter 1 Getting Started in this Urology Suite User s Guide For information about using ScanPoint in conjunction with the BVI 6300 see Chapter 4 Assigning the Bladder Monitor BVI 6300 For information about using ScanPoint to calibrate your instrument see Chapter 6 Inspecting and Maintaining Bl
123. tient information the instrument will not perform exams or operate properly for the patient When completed to submit your revised information and update the database click the Submit button The status box displays the following message Preparing device for exam percent transmitted Transmission will take a few minutes so please be patient When the transmission is completed confirm that ScanPoint displays the following message Device is ready to perform exam You have successfully edited existing patient information on the Bladder Monitor Patient Information page Urology Suite User s Guide 39 Measuring Bladder Fullness After personalizing the Bladder Monitor BladderScan BVI 6300 for a patient healthcare providers should instruct patients on how to measure bladder fullness This chapter provides instructions for using the Bladder Monitor and training patients to use the instrument Turning On the Scanning Unit To turn on the scanning unit 1 Ifthe scanning unit is in sleep mode press and release any button When the scanning unit chirps it is ready to scan 2 Check the battery icon to verify that the battery is sufficiently charged for performing exams If the battery icon shows no power segments return the scanning unit to the charging cradle and recharge it before attempting to perform a scan If the battery icon shows only one power segment you can perform a few more scans but you will need
124. tions are equally applicable to plural and singular defined terms A reference in this Agreement to a section in the HIPAA Privacy Rules means the section as in effect or as amended 2 Permitted Use or Disclosure of PHI by DU DU may not use or disclose PHI except as follows 2 1 Except as otherwise limited in this Agreement DU may use or disclose PHI to perform functions activities or services for or on behalf of Client as specified in the Service Agreement provided that such use or disclosure would not violate the HIPAA Privacy Rules if made by Client 112 Appendix A ScanPoint Legal Information 2 2 2 3 2 4 3 2 3 3 3 4 3 4 1 3 4 2 3 4 3 3 4 4 DU may use PHI as necessary for the proper management and administration of its business or to carry out its legal responsibilities DU may disclose PHI if disclosure is required by law DU may disclose PHI if DU obtains reasonable assurances that the PHI will be held confidentially and used or further disclosed only as required by law or for the purpose for which it was disclosed and any person to whom the PHI is disclosed notifies DU of any instances of which it is aware in which the confidentiality of the information has been breached DU may provide Data Aggregation services to Client as permitted by 42 CFR 164 504 e 2 i B Obligations of DU Relating to Client s PHI DU will use appropriate safeguards to prevent use or disclosure of PHI
125. to recharge your instrument soon Note If the scanning unit does not turn on the battery may be completely discharged The scanning unit must be charged for six hours before it will be ready for use Applying a Gel Pad To apply a gel pad 1 Clean and disinfect the scanhead of the scanning unit by wiping it gently with a germicidal wipe or a soft cloth soaked in isopropyl alcohol 2 Prepare to apply a Sontac ultrasound gel pad by peeling back the foil lid of the individual Sontac packaging to expose the gel pad 3 Patient should lie down or recline as fully as possible and find his or her pubic bone by pressing gently on the lower abdomen 4 Place the gel pad midline on the abdomen approximately 1 inch 3 cm above the pubic bone Performing a Measurement Patients will be able to take both pre and post void measurements Specific instructions should be based on the care plan you provided 1 40 To conduct a pre void measurement Press and release the Top Gender button until the beaker in the upper right hand corner of the LCD screen appears to be full To conduct a post void measurement Press and release the Top Gender button until the beaker icon appears empty When the display is correct proceed with the scan Place the scanhead on the gel pad aimed slightly downward toward the expected location of the bladder For most people this means aiming the scanhead toward the coccyx tailbone Press and release the
126. to set the required return exam date when the patient should return to have his patient information analyzed and updated The Bladder Monitor looks like other BladderScan instruments but it can be used by both healthcare providers and patients This section was written to help the healthcare provider instruct patients in self use of the Bladder Monitor BVI 6300 Symbol Directory Symbols on the Bladder Monitor LCD screen differ from the symbols on other BladderScan scanning units The following symbols may appear on the Bladder Monitor LCD screen Symbol Description i Displays level of bladder fullness Located on all four sides of the screen these arrows identify the location of the bladder relative to the scanhead If the scanning unit was aimed properly so that the bladder was contained within the image cone the aiming arrows will either not appear or will not flash v Flashing arrows mean you must re aim the scanning unit in the direction indicated by the arrows or If the arrow is not flashing re aiming is optional Pre void measurement Post void measurement Patient is reminded that a visit is due with their healthcare provider After patient exam data is uploaded to ScanPoint for review the healthcare provider must verify that the patient profile is accurate If the profile is not verified and uploaded to the instrument this symbol will flash and the Bladder Monitor will not perform exams
127. turns to the New Operator C brko Exams list and the exam is saved on the New Exams page for later viewing Demo 77735 5 renet 70 Chapter 5 Using ScanPoint 11 To print the exam results scroll to the bottom of the Exam Results window and click one of the following print options e Printable Page Prints the exam and patient identification information and six ultrasound images from the exam e Printable Page for Physicians Offices Prints the exam and patient identification information a checklist that allows the physician to identify the patient s medical conditions and history and six ultrasound images from the exam e Printable Page for ECF SNF Prints the exam and patient identification information a checklist that allows the healthcare facility to identify the patient s medical conditions and history and six ultrasound images from the exam ScanPoint displays the printable Results window d bam Rents Merosof Intemet Explorer zax Note The orientation of the images relative to the BladderScan is depicted by an icon in the upper left corner of each image BladderScan Results Exam Date amp Tine Wednesday Agri 29 2004 136 26 PM 12 To print click Print This Page Patt Name devara Sth Urine Volume 248 sei De Doxtor Your system displays a Windows Print dialog box 13 Inthe Windows Print dialog box select the appropriate print options and click the Print button
128. u were assigned by Verathon Corporation Your user name and password are associated with your profile You will only have access to menu options that are related to your user profile Urology Suite User s Guide 95 Problem Description Resolution You cannot find the exam results When you log on to ScanPoint you can view results for any exams that have that you are looking for been transmitted to ScanPoint within your customer account If you cannot locate the exam that you want to view you may be attempting to view results for an exam that was not transmitted to ScanPoint within your account If this is not the case one of the following conditions may apply u ScanPoint may not have validated the exam yet Wait several minutes and then attempt to view the exam results again You may be attempting to view a past exam If you are looking in the New Exams menu and the exam results have already been viewed you will find the results in the Past Exams menu A Security Warning dialog box If you attempt to run ScanPoint on a computer that has an outdated version of appears the ScanPoint driver or no driver installed a Security Warning dialog box will eventually prompt you to install it Click Yes The ScanPoint driver will be installed from the ScanPoint server ScanPoint Error Messages The following table describes ScanPoint error messages and how to resolve them The error messages are listed in alphabetical order Error Mes
129. unication cradle s cable into a USB port on your computer 3 Turn your computer back on If the communication cradle is connected to your computer correctly the green power light on the cradle lights up 4 Place the scanning unit in the cradle fitting the notch into the base of the scanning unit onto the matching peg on the communication cradle 5 Ifyou did not install the ScanPoint software from the ScanPoint CD ROM ScanPoint prompts you to install it now To install the ScanPoint software click Yes and follow the instructions in the Installing ScanPoint section of this manual Note If you do not install the ScanPoint software your scanning unit cannot communicate with ScanPoint Important Your computer must be minimally certified to EN IEC CSA UL 950 or 60101 1 standards This configuration ensures that compliance to the EN IEC 60601 1 1 system standard is maintained Any person who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard EN JIEC 60601 1 1 If you need assistance contact s Customer Service department or your local representative Removing the ScanPoint Software If necessary you can remove the ScanPoint software If you choose to remove the software you must reinstall it before you can transmit exam data to ScanPoint and calibrate the scanning
130. unit To remove ScanPoint in a Microsoft Windows operating system 1 Click the Start button and then open Control Panel 2 Locate and double click the Add Remove Programs icon 8 Chapter 1 Getting Started ScanPoint displays the Add Remove Programs dialog box aree og ane inizi C ra nadet Hak wives 2 Digest Unraseund scanat aj Cet here tor pasar nirmaboo bata de tre mua O angejfereve Doarea nuan seeman de l 2z In the Currently Installed Programs list locate and select ScanPoint and then click the Change Remove button ScanPoint displays the InstallShield Wizard dialog box InstallShield Wizard xj Welcome Scan Modify repair or remove the program Point Welcome to the ScanPoint Setup Maintenance program This program lets you modify the current installation Click one of the options below Modify ma Select new program features to add or select currently installed features to remove C Repair F Reinstall all program features installed by the previous setup eae v Remove all installed features InstallShield Click the Remove option button To continue click Next ScanPoint displays a Confirm Uninstall dialog box Confirm Uninstall xi Do you want to completely remove the selected application and all of its Features Urology Suite User s Guide 9 5 To confirm and continue the uninstall program click OK ScanPoint displays the Maintenanc
131. utton y Infrared Window Scan Button Labeling Activation Button Scanhead Component Description Scanhead Rounded dome is the surface through which ultrasound waves are transmitted LCD liquid crystal display screen Displays the bladder volume measurement and other scan patient and instrument data For more information see the symbol directory at the end of this chapter Top Gender button Located just below the LCD screen Scan button To begin bladder imaging press this button located on the underside of the handgrip Activation button Located in the small opening on the underside of the scanning unit s handgrip above the Scan button use the activation tool to press this button to reactivate your scanning unit when the battery is completely discharged Infrared IR window Located at the base of the handgrip this window enables the scanning unit to communicate with your computer via the communication cradle Labeling Located below the Scan button you ll find the label with your instrument s name product and serial numbers and classifications Microphone Located above the LCD screen on the BVI 6400 instrument only Speak into the microphone to record a voice annotation following patient exams Urology Suite User s Guide 13 Charging Cradle Use the charging cradle to charge the scanning unit s battery The charging cradle plugs directly into an electrical wall outlet Before using your scanning unit you must
132. ve bladders the Bladder Monitor BVI 6300 enables healthcare providers to prescribe BladderScan for individual use allowing patients to monitor their own bladder volume levels The Bladder Monitor looks like other BladderScan instruments but can be used by both healthcare providers and patients Healthcare providers can program the Bladder Monitor for the patient specifying gender target bladder volume and whether the patient is pediatric or adult If desired the healthcare provider can also specify the date that a patient should return to have their exam data analyzed and patient information updated This chapter describes the procedures that the healthcare provider can use when instructing patients in self use of the Bladder Monitor In This Chapter e About Bladder Monitor Technology e Symbol Directory e Assigning and Reassigning the Bladder Monitor e Measuring Bladder Fullness e Transmitting Exam Data e Verifying Bladder Monitor Patient Information at Return Visit e Viewing and Printing Bladder Monitor Exam Results e Viewing a Bladder Monitor Assignment List Urology Suite User s Guide 29 About Bladder Monitor BVI 6300 Technology The Bladder Monitor BVI 6300 allows healthcare providers to personalize BladderScan so patients can monitor their own bladder volume levels Using the Bladder Monitor you may specify gender target bladder volume and whether the patient is pediatric or adult and you have the option
133. y ScanPoint transmits this data When completed the status box reads Go make phantom measurement and return device to cradle waiting This indicates that you should now begin calibration Calibration Remove the scanning unit from the communication cradle and place it in the top of the calibration container Position the scanhead in the circular cutout so that the black tip of the scanhead is submerged in water Important The scanhead must make contact with the water otherwise the phantom measurement will not be valid Press and release the Top Gender button located on the top of the scanning unit below the LCD screen Top Gender button Urology Suite User s Guide 89 10 11 12 90 Wait while the instrument scans the phantom and calibrates The instrument beeps once when the scan is complete and then proceeds to analyze the scan data to ensure that it meets the calibration parameters the instrument may automatically rescan the phantom if necessary When calibration is complete the instrument chirps and four arrows appear on the LCD screen Important Do not remove the instrument from the phantom until four arrows appear on the LCD screen Remove the scanning unit from the calibration container wipe it gently with a clean towel or cloth to remove any water and place it back in the communication cradle When the scanning unit is placed back in the communication cradle the scanning unit

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