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User's Manual

1. ccccescsesesssesesesesteveseseseseeveveeeees 16 Figure 2 ScanPoint Label Writer Parts and Features c cccccccccsscesescscesesesesesesescevevecvecereesevevevacaneesevevereees 18 Figure 3 The ScanPoint Docking Station has a USB Connector c ccccccccceseseseseseseseseseseseseseseseseseseevevens 39 Figure 4 Connecting the ScanPoint Printer to POWeM c ccccccesesesseseseseevecscescevecsceseeveccersevacesevanneereevanes 42 Figure 5 Loading a Roll of Labels on the Spool Spindle ce cccccccccsssseeeeeeeeeeeeseeeeeeeeseaeeeeeeeeeesaeeeeseees 43 Figure 6 Inserting a Label into the Label Feed Slot cccccccssseecccceeseeceeeceeeeeceeeeeeeeeceeseeeeeeessegeeeseessaas 44 Figure 7 ScanPoint Remote Battery ICON cccccccsccsecessesecesescecececescevecseesceveceesevacaeersevacauersevaceereevanereevanes 45 Figure 8 FloSensor Components seccesnxsenadcesates cessonentcncatdiacetinnatntcelseiemesiseedatee deve tendon a iia aE E ATE 56 Figure 9 QuickPrint Window with Status Box and Message ICON ccccceceeeceeeeeeeeeeeeeeeeeaaeeeeeeeeeeaaaaeeees 59 Figure 10 Patient Detail Dialog cccccccscccccesscecceeeeeceesececeeseecseuseeessaeeecseuseeeseaseeessuseseesseeesssaseeessageees 61 Figure 11 New Exams Results WiInd0W cccccccssseeecseseeeceesseccesecesseseeeeeeseeeseaseeecsaueeessegeeesssaeeenssageees 64 Figure 12 New Exam Results Dialog cccccsscccccsseecceeseeecesseec
2. User s Manual page 19 Getting Started FloPoint Elite Uroflow System Getting Started The previous section provided introductory information about the FloPoint Elite Uroflow System This section provides information on how to set up your FloPoint Elite Uroflow System prior to first use Required Equipment In addition to the components included with your FloPoint Elite system see FloPoint Elite Uroflow System Parts and Features beginning on page 16 highly recommended equipment includes Getting Started A Windows computer with a high speed Internet connection Computer hardware software and operating system requirements can be found on page 119 NOTE To use ScanPoint Online a Windows computer with an Internet connection is required Adobe Acrobat Reader for viewing and printing reports see Step 3 Installing Adobe Acrobat Reader on page 25 To assure successful set up and operation of your FloPoint Elite Uroflow System follow these seven steps in the order given Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Unpack the FloPoint Elite components and related accessories Instructions begin on page 21 Attach the Mounting Bracket to the wall and attach the FloCharger to the Mounting Bracket Instructions begin on page 25 Install Adobe Acrobat Reader Instructions begin on page 26 Install ScanPoint with QuickPrint software on y
3. 10 The ScanPoint with QuickPrint software installation is complete ScanPoint with QuickPrint starts automatically and the QuickPrint Preferences Wizard opens C QuickPrint Preferences Wizard QuickPrint eee Welcome to ScanPoint QuickPrint The following windows will help you customize QuickPrint to suit your needs Please read all of the options carefully Using this Wizard you will be able to Specify your User Name and Password for automatic login to ScanPoint severs Customize the default settings for Quick Print prompts Tailor QuickPrint exam reports to your specifications To begin click Next Click NEXT to set your ScanPoint user preferences Step 5 Setting ScanPoint User Preferences Once you have installed ScanPoint with QuickPrint and your FloPoint Elite devices you can use the QuickPrint Preferences Wizard to customize QuickPrint settings The following procedure shows you how to use the Preferences Wizard to set up your initial preferences If at any time you want to change a specific setting go to the Tools menu select PREFERENCES and click on the appropriate tab For information on the Preferences dialog boxes see Changing Your Preferences on page 77 User s Manual page 33 Getting Started FloPoint Elite Uroflow System To set up your user preferences 1 Open ScanPoint with QuickPrint by double clicking the ScanPoint icon in your system tray the
4. After printing the exam results through QuickPrint you can print them again with the same or different printer or report format page 62 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint NOTE You can reprint the most recent exam from QuickPrint Use ScanPoint to print older past exams See Viewing Exam Results in ScanPoint Online beginning on page 66 for more information on printing saved exam results from ScanPoint To Reprint the Most Recent Exam Results 1 Place the Remote used to take the exam in the ScanPoint Docking Station 2 From the QuickPrint File menu select PRINT LAST EXAM 3 The Print Last Exam dialog prompts you for the report type and printer Complete the dialog and click SUBMIT Print Last Exam Exam ID 8804 Date 6 18 2007 Select a Report Type to Prnt PDF Label FloPoint Details 2 labels v Select a Printer to Send to ScanPoint Label Writer 400 v ia l Save As PDF File Sate Cancel Completing a Voice Annotated Exam NOTE If you did not add a voice annotation to the exam refer to Completing an Unannotated Exam on page 60 1 Place the Remote in the ScanPoint Docking Station connected to your computer Exam results are automatically transmitted to ScanPoint As the exams are being transmitted to ScanPoint the Remote display shows the percentage of the data that has been transferred After
5. Voided Volume Voided Volume in ml over Time in seconds page 70 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint Report Type Samples There are two different styles of reports provided by the FloPoint Elite system Asummary report that provides only the peak flow measurement A detailed report that provides all measurements described above Past Exams and Voice Annotated Exams Past exams and voice annotated exams must be printed through the ScanPoint On Line interface Both the summary and the detailed reports have been formatted to fit ona sheet of 8 5 x11 paper in portrait orientation Figure 19 To print a past exam or voice annotated exam 1 After opening the exam results click on either the Summary or the Detail links to open a preview of the printed report 2 Once the preview is open click on the Print This Page link to print the report to your printer Exams Without Voice Annotation Exams without voice annotation may be printed directly through QuickPrint to a sheet of 8 5 x 11 on your local or network printer or to labels available with the ScanPoint Label Writer Figure 24 Your QuickPrint preference settings will let you select which report format you want to print and what printer to use NOTE The Label Report cannot be printed from ScanPoint Online Printing Results from the Last Exam Performed The last exam performed by you
6. P Uroflowmetry Urodynamics 22nd ed London Springer Verlag 1997 pages 20 39 Boone T B and Y H Kim Chapter 4 Uroflowmetry in Nitti V D ed Practical Urodynamics Philadelphia W B Saunders 1998 pages 28 37 Chapple C A and S A MacDiarmid Urodynamics Made Easy Chapter 3 Urodynamic Techniques Flow Rate New York W B Saunders 2000 pages 26 32 Grino P B et al Maximum urinary flow rate by uroflowmetry automatic or visual interpretation J Urol 149 339 341 1993 McLoughlin J et al Symptoms versus flow rates versus urodynamics in the selection of patients for prostatectomy Brit J Urol 66 303 305 1990 Rivas D A and M B Chancellor Chapter 5 Uroflowmetry in Blaivis J and M Chancellor eds Atlas of Urodynamics Baltimore Williams amp Wilkins 1996 Sand P K and D R Ostergard Urodynamics and the Evaluation of Female Incontinence A Practical Guide Chapter 3 Uroflowmetry in the Female London Springer Verlag 1995 page 108 User s Manual FloPoint Elite Uroflow System Parts and Accessories Parts and Accessories FloPoint Elite Uroflow System Components The following components are included with your FloPoint Elite Uroflow System with ScanPoint with QuickPrint system Part and Part Number Name and Description 0570 0175 FloSensor 0800 0337 FloSensor Measures urine volume and flow rate The Handles suspend the Fl
7. The FloCharger LED will begin to alternate orange green to indicate charging Close the clamshell doors Remove and dispose of your gloves User s Manual page 55 Cleaning and Maintenance FloPoint Elite Uroflow System Solid Material Cleaning Procedure lf any solid material enters the FloSensor the top portion of the FloSensor may be disassembled to facilitate cleaning Risk of equipment damage The FloSensor disk is fragile Take care to avoid damaging the disk while the funnel support is separated from the FloSensor Do not drop or bump the FloSensor or lay it on its side while it is disassembled Figure 8 FloSensor Components Funnel Support FloSensor Handle 1 Putona pair of gloves 2 Remove and properly dispose of the funnel Do not flush it down the toilet Check to see if the FloSensor motor is still running If the motor is still running press the button on the Remote twice to stop the motor Verify that the motor has stopped running 4 Remove the funnel support by turning it counter clockwise and lifting it away from the FloSensor disk Risk of personal injury and or equipment damage Unless care is taken to stop the FloSensor motor the FloSensor disk may still be spinning when the funnel support is removed Take care to avoid injury and debris dispersion Do not remove the funnel support if the sensor disk is still spinning 5 Remove the solid material Clean the FloSensor and the fu
8. hazardous waste disposal Assure proper computer system configuration When using the FloPoint Elite Uroflow System with ScanPoint software your computer must be minimally certified to EN IEC CSA UL 60950 or 60101 1 standards This configuration ensures that compliance to the EN IEC 60601 1 1 system standard is maintained Anyone connecting additional equipment to the FloPoint Elite Uroflow System signal input port or signal output port configures a medical system and is therefore responsible for ensuring that the system complies with IEC 60950 or EN IEC 60601 1 1 if in the vicinity of patients If you need assistance contact your biomedical staff Verathon Medical representative or the Verathon Medical Customer Care Department at 1 800 331 2313 Assure proper distance from patient When transmitting data to or from your computer make sure that the FloPoint Elite accessories and computer are outside the patient vicinity more than six feet 2 meters from the patient Refer to EN IEC 60601 1 for the definition of patient vicinity Risk of injury or device damage Keep long hair and loose clothing away from the FloSensor Keep foreign materials such as toilet paper and metal out of the FloSensor Do not flush FloPoint Elite funnels down the toilet Dispose of them as you would other medical waste Service The FloPoint Elite Uroflow System should be serviced by authorized service personnel when The
9. software and ScanPoint Docking Station drivers must already be installed See Step 4 Install ScanPoint with QuickPrint on page 26 for instructions on performing those tasks 1 Make sure the ScanPoint Docking Station is connected to the ScanPoint host computer via its USB connector and that the computer is turned on Set the Remote in the Docking Station The battery icon on the Remote display will scroll from empty to free to indicate that the Remote is charging Leave the Remote in the Docking Station until the battery icon displays a minimum of two segments NOTE Fully charging the battery may take up to 6 hours Figure 7 ScanPoint Remote Battery Icon Remote Battery icon shows a fully LED lights steady charged battery green when the sa Remote oa ScanPoint is fully charged Lo Docking Station Scan Point de teeny aaar Charging the FloSensor Battery i 2 Make sure the FloCharger AC adapter has been plugged into a wall outlet Seat the FloSensor on the FloCharger base The FloCharger LED will alternate orange and green to indicate that the FloSensor battery is charging When the FloCharger LED is solid green the FloSensor battery is fully charged and the FloSensor is ready for use NOTE Fully charging the FloSensor battery may take up to 6 hours User s Manual page 45 Displays Controls and Indicators FloPoint Elite Uroflow System Displays Controls and In
10. you must calibrate the FloSensor every 12 months NOTE If your facility has signed up for the ScanPoint Online Service Plan you will automatically receive the Calibration Fluid 4 pack and a Calibration Quick Reference Card approximately 30 days before your FloSensor requires calibration Figure 26 Figure 26 FloPoint Elite Calibration Fluid and Calibration Quick Reference Card Calibration Fluid Pouch Pouch containing unique fluid for use in calibrating the FloPoint Elite FloPoint Fike Laity ata Mien 0800 0331 FloPoint Elite Calibration Quick Reference Card Provides instructions for the FloPoint Elite calibration procedure 0900 1444 Determining the Number of Days Until Required Calibration 1 Clear the Remote of saved exam data by placing it in the ScanPoint Docking Station and saving the exam data to ScanPoint 2 Remove the Remote from the ScanPoint Docking Station Press and hold down the Start button for at least five seconds The LCD screen displays the setting User s Manual page 81 Calibration FloPoint Elite Uroflow System sun icon and the number of days until the required calibration date 120 in the illustration below ic maan NOTE When the Remote displays i and 000 calibration is required When there are 20 days remaining before the next required calibration a warning message appears in ScanPoint with QuickPrint Figure 27 Figure 27 ScanPoi
11. 48 AM Exam Date amp Tine Example Patent IO Patient Patent Name Operator Operator Physician Physician Peak Flow 20 0ml s Changing Your Preferences 0570 0175 T0602 87893 46 6 7 amp 9 10 Time 8 Yes hamal Vaid for Paliga Standing Position The Preferences dialog box allows you to set your ScanPoint login information QuickPrint prompts default information and print settings and preferred warnings You can also use the Preferences Wizard to set many of your preferences see Step 5 Setting ScanPoint User Preferences on page 33 1 From the Tools menu choose Preferences The Preferences dialog box is displayed Preferences ScanPaoint Login Exam Settinge Report Settings Syetem Settinge Change Your ScanPoint Login User Name jusertest lQuickPrirt uses your ScanPoint Celie User Name and Password to communicate Iwith our servers Please enter your User Name and Password lto the left and click the Connect button WARNING Fyou fail te authenticate to ScanPoint wih the new User Name you will be Unable to use Quick Print until you Jsuccesstully log in When you successfully log in your user preferences wil be changed to match the new Users saved preferences default if none saved previously The preferences For the previous user will be saved User s Manual page 77 Managing Exam Results in ScanPoint with QuickPrint Flo
12. AVERATHON FloPoint Elite Mounting Bracket Template Aids in attaching the Mounting Bracket to the wall 0900 1557 User s Manual page 23 Getting Started FloPoint Elite Uroflow System Part and Part Number Name and Description FloPoint Elite Quick Reference Card Provides a summary of essential user instructions FloPoint Elite Calibration Quick Reference Card Provides instructions for the FloPoint Elite calibration procedure M ner pon datae Maney n De Nate 0900 1444 ScanPoint Label Writer If you ordered a ScanPoint Label Writer the following items are included Part and Part Number Name and Description ScanPoint Label Writer Prints exam results on adhesive label media 0570 0178 USB Cable Connects the ScanPoint Label Writer to the ScanPoint host computer 0600 0233 page 24 User s Manual FloPoint Elite Uroflow System Getting Started Part and Part Number Name and Description Label Writer Power Cord P Connects the Label Writer power adaptor to a wall outlet 0600 0232 Power Supply a gt Connects the power cord to the Label Writer 0275 0002 Roll of Labels i lt Labels in roll format properly sized for the ScanPoint Label Writer 0125 0446 Step 2 Attach the Mounting Bracket to the wall and attach the FloCharger to the Mounting Bracket For an installation of the FloCharger in the patient vicinity
13. Canada 20001 North Creek Parkway Verathon Medical Europe B V Bothell WA 98011 Boerhaaveweg 1 USA 3401 MN lIJsselstein 800 331 2313 Canada and US The Netherlands 425 867 1348 31 30 68 70 570 Fax 425 883 2896 Fax 31 30 68 70 512 Verathon Medical Japan K K Verathon Medical United Kingdom Ltd Executive Tower Azabudai 7F The Granary Manor Farm Courtyard 1 4 3 Azabudai Aston Sandford Aylesbury Minato ku Buckinghamshire HP17 8JB Tokyo Japan 106 0041 United Kingdom 81 03 3560 3501 44 1844 299 207 Fax 81 03 3560 3502 Fax 44 1844 299 218 Verathon Medical France Sarl Office Address Espace Europeen de l Entreprise 2 all e d Oslo 67300 Schiltigheim France 33 03 88 60 14 12 Fax 33 03 88 60 46 87 Postal Address BP 10039 F 67012 Strasbourg Cedex France PN 0900 1442 01 60 FloPoint Elite Uroflow System Setup and Use Quick Reference Note To turn on the ScanPoint Remote when it is in sleep mode press and release the Remote button EEE Remove the FloSensor from the FloCharger Wearing gloves and using the handles remove the FloSensor from the FloCharger Spread the handles and place the FloSensor in the toilet bowl as shown The FloSensor will beep and the motor will start spinning It will take approximately 45 seconds for the FloSensor to warm up Place the Funnel on the FloSensor Press the tabs around the FloSensor handles to secure the Funnel in place T
14. Elite Uroflow System Performing an Exam Performing an Exam Preparing for the Exam Before you begin the exam 1 Make sure you are familiar with the parts of the FloPoint Elite system see FloPoint Elite Uroflow System Parts and Features on page 16 2 Make sure you have performed all the steps in the setup procedure described in the Getting Started which begins on page 20 3 Check the Remote battery icon to make sure the battery has sufficient power NOTE If the battery icon appears less than 25 full return the Remote to the ScanPoint Docking Station until the battery is fully charged Performing an Exam 1 Pick up the Remote from the ScanPoint Docking Station and a funnel and bring both items to the restroom Set both items on the counter while preparing the FloSensor 2 Prepare the FloSensor Put on a pair of gloves and lift the toilet seat Using the handles remove the FloSensor from the FloCharger clamshell The FloSensor will beep and the motor will start spinning 3 Spread the handles and place the FloSensor in the toilet bowl as shown in the photo 4 Place the funnel on top of the FloSensor Place the funnel on top of the FloSensor as shown in the photo Press the tabs on the funnel under the handles to hold the funnel in place Put the seat down or leave it up depending on the preference of the patient Remove and dispose of your gloves User s Manual page 51 Performing
15. Enter a reason for the rejection in the Reason text box not be empty during exam rejection Exam already has exam You have already transmitted the results of the exam data uploaded Please You may conduct a new exam if desired start another exam This field may not be You must make an entry into the appropriate text box It empty cannot remain blank page 90 User s Manual FloPoint Elite Uroflow System Troubleshooting Message Answer You must enter a positive A minus sign cannot be the first character in any number ScanPoint text box Re enter the digits without the minus sign Error Codes Code Meaning Resolution Err 1 FloSensor did not respond to Self Charge the FloSensor Test Request from ScanPoint Remote Err 2 FloSensor did not respond to a stop Reset FloSensor by placing it on exam request from ScanPoint the FloCharger Remote Exam information is complete and a new exam could be Started Err 3 The calibration exchange between the Repeat the calibration If it still FloSensor and the ScanPoint fails upload data to ScanPoint Remote failed and call Verathon Medical Customer Care Err 4 At least 1 second of continuous data Alert on ScanPoint Remote was lost due to a radio indicates loss of radio data communication failure Move ScanPoint Remote closer to the FloSensor during an exam If alert comes after patient has completed voiding there will b
16. Insulation Class II with double insulation to each terminal Testing To EN EN IEC 60601 1 requirements Water Ingress Rated at IPXO not protected against ingress of water Compliance UL and CSA equivalent standards FloSensor Item Specification Sensory Type Spinning Disk Battery type Lithium lon 14 4 V 2200 mAh Battery life A fully charged battery can perform approximately 30 exams within a 24 hour period Charging Method Charge the FloSensor using the FloCharger installed on the Mounting Bracket Charging Time No more than six hours from an empty battery to a full charge Water Ingress Rated at IPX7 Water tight for 30 minutes at a depth of 1 m ScanPoint Remote Item Specification Battery type Lithium lon 4 2 V 700 mAh Battery life A fully charged battery can perform approximately 30 exams within a 24 hour period User s Manual page 117 Specifications FloPoint Elite Uroflow System Item Specification Charging Method Charge the FloSensor using the ScanPoint Docking Station connected to the USB port of a computer compliant with IEC 60950 or IEC 60601 1 Charging Time No more than eight hours from an empty battery to a full charge Water Ingress Rated at IPXO not protected against ingress of water ScanPoint Docking Station Condition Specification Use Indoor Water Ingress Rated at IPXO not protected against ingress of water Computer Regulator
17. R NET Framework p Followed by the ScanPoint with QuickPrint InstallShield Wizard dialog box Click NEXT page 28 User s Manual FloPoint Elite Uroflow System Getting Started i fi ScanPoint QuickPrint InstallShield Wizard Welcome to the InstallShield Wizard for ScanPoint QuickPrint The InstallShield R Wizard will install ScanPoint QuickPrint on vour computer To continue chick Next WARNING This program is protected by copyright law and international treaties 3 The ScanPoint with QuickPrint license agreement is displayed You must accept the agreement to continue with installation Click the ACCEPT THE TERMS IN THE LICENSE AGREEMENT radio button Click NEXT ED ie ScanPoint QuickPrint InstallShield Wizard License Agreement Please read the Following license agreement carefully ScanPoint Consolidated Agreements IMPORTANT PLEASE READ CAREFULLY Ey clicking the I Agree selection you are agreeing to the terms and conditions of e following agreements I ScanPomt End User License Agreement EULA I ScanPoint Total Reliability Plan Agreement PLAN If hii es of ScanPomnt Service E i T not accept the terms in the Ee PEDE InstallShield cect ees coms 4 The Setup Type dialog box is displayed User s Manual page 29 Getting Started FloPoint Elite Uroflow System i ScanPoint QuickPrint inst
18. Voided Volume The total volume of urine measured by the FloSensor in ml page 124 User s Manual M VERATHON MEDICAL FloPoint Elite
19. all the exam data are downloaded the ScanPoint New Exam Results window opens Figure 11 User s Manual page 63 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System Figure 11 New Exams Results Window 8 i Point Bladder Monitor BiadderScan BladderScan UEBW Mobile BiadderS can Pediatric BiadderScan View Exam Resuits New Exams New Exam Results Qick the column heading to sort VERATHON Wednesday June 20 2007 10 09 31 4M Wednesday June 20 2007 10 10 10 AM Wednesday June 20 2007 9 52 51 4M Wednesday June 20 2007 9 44 23 AM BYVI9400 BYVI9400 FloPoint R Elite FloPoint R Elite Enter Details Enter Details Enter Details Enter Details Friday May 25 2007 1 44 00 PM Wednesday June 20 2007 9 41 00 4M Wednesday June 20 2007 9 57 00 4M Wednesday June 20 2007 9 42 00 4M Wednesday June 20 2007 9 35 13 4M Wednesday June 20 2007 9 42 48 AM Wednesday June 20 2007 9 35 00 4M Wednesday June 20 2007 9 36 00 4M Available Available Available Available Available Available Available Available Bladder Mass Bladder Mass Bladder Volume Bladder Volume FloPoint R Elite FloPoint R Elite Pediatric Bladder Volume Pediatric Bladder Volume Operator Operator Operator Operator Operator Operator Operator Operator Example Patient AEE Eaa Example Patient Bladder Monitor Assignment Example Patient Calibration Example Pati
20. area next to your clock in the bottom right corner of your screen If ScanPoint with QuickPrint is not running double click the ScanPoint with QuickPrint icon on your desktop or click the START button and select Programs gt Verathon gt ScanPoint with QuickPrint gt ScanPoint with QuickPrint 2 The first time you run ScanPoint with QuickPrint the Preferences Wizard will start automatically Otherwise from the Tools menu select Preferences Wizard to open the first dialog box E ickPrint Prefe QuickPrint 2 iiPretrences Welcome to ScanPoint Quick Print The following windows will help you customize Quick Print to suit your needs Please read all of the options carefully Using this Wizard you will be able to Specify your User Nane and Password for automatic login to ScanPoint sewers Customize the default settings for Quick Print prompts Tailor Quick Print exam reports to your specifications To begin chek Next 3 Click NEXT to open the Set Your ScanPoint Login dialog 4 Enter the User Name and Password provided to you by Verathon and click CONNECT NOTE If you did not receive a ScanPoint User Name and Password please contact Verathon Medical Customer Care at 1 800 331 2313 In a few moments the status box will indicate that ScanPoint authentication is complete page 34 User s Manual FloPoint Elite Uroflow System Getting Started QuickPront P
21. average urine flow rates are strongly dependent on voided volume and the patient s age and sex NOTE In subsequent FloPoint Elite Report Charts Figure 33 through Figure 42 flow rate is represented by the letter Q User s Manual page 97 Clinical Application FloPoint Elite Uroflow System Figure 33 Measurements Taken From the FloPoint Elite Curve A Measurements of the continuous uroflow curve Average flow rate not shown is calculated by divided total volume voided by flow time B Measurements of flow time and voiding time from an intermittent uroflow curve Flow rate ml sec Peak flow rate ee i Time to peak flow Flow time and voiding time Flow rate Time eee E pe a B a C Laan 1E _ Flow time A B C D e SH Voiding time Table 1 Measurements from the FloPoint Elite Curve see Figure 33 MEASUREMENTS DEFINITION NORMAL RESULTS Peak Flow Rate Maximum measured flow Depends on age sex and rate excluding dribble voided volume Rarely produced or other spikes exceeds 40 ml sec Clinical significance is questionable with irregular flow patterns Average Flow Rate Voided volume divided by Typically is about half of flow time Peak Flow page 98 User s Manual FloPoint Elite Uroflow System Clinical Application MEASUREMENTS Voiding Time Flow Time Time to Peak Flow DEFINITION Total duration of the micturition including interr
22. continuous minutes of non use or charging unsaved exam data is lost If you chose not to be prompted for exam information when you set your user preferences the instrument automatically transmits the exam data When the transmission is complete QuickPrint prints the results according to the user preferences you previously selected NOTE You can view sample report formats at the end of this section or by going to the Help menu and selecting Report Type Samples If you chose to be prompted for information when you specified your user preferences the Exam Details dialog box appears displaying the prompts you requested NOTE Depending on the prompts you requested the dialog box you see may differ from the following illustration Figure 10 Figure 10 Patient Detail Dialog ScanPoint QuickPrint 5 x File Yiew Tools Help To Submit your Exam for Processing please complete the following items Enter Exam Detail required field Patient ID 5 A foe oe Patient Name Patient z Operator Operator Physician Physician Position Gender Normal Void for Patient Yes Select a Report Type to Print Save POF Label FloPomt Details 2 labels Select a Printer ScanPoint Labefwriter 400 z Submit User s Manual page 61 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System 4 Enter the appropriate information according to the followin
23. indicated by a solid border around the status box To communicate with a different instrument click its instrument image in the appropriate status box The Message Indicator This icon indicates the number of ScanPoint messages you have waiting to be viewed To view the messages click the icon If there is more than one message you will be able to move through a scrollable list of message headings The messages are Read Only You cannot create a text reply although you can select YES NO buttons as appropriate Completing an Unannotated Exam Perform the following steps to complete an exam only if you did not enter a voice annotation If you did enter a voice annotation see Completing a Voice Annotated Exam on page 63 NOTE The following procedure assumes that you have performed an exam as described in Performing an Exam beginning on page 51 If You Did Not Enter a Voice Annotation 1 Place your Remote into the ScanPoint Docking Station connected to your computer Exam results are automatically transmitted to ScanPoint As the exams are being transmitted to ScanPoint the Remote display shows the percentage of the data that has been transferred page 60 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint 2 IMPORTANT Unsaved exam data could be lost If the battery is low or the ScanPoint Remote goes into sleep mode after 20
24. information on viewing and printing results in ScanPoint see Viewing Exam Results in ScanPoint Online on page 66 7 When you are finished close the ScanPoint window by clicking the K in the upper right corner of the window User s Manual page 65 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System Viewing Exam Results in ScanPoint Online QuickPrint automatically prints the current exam results from your instrument To view or print previous exam results you must use ScanPoint Online The information in this section explains how to view approve and print exam results in ScanPoint Online You can use any computer with an Internet connection to open ScanPoint Online and view and print exam results However no matter which computer you use you can view only exams performed at your facility and saved in your facility s ScanPoint account Starting ScanPoint Online To start ScanPoint Online choose the appropriate procedure Starting ScanPoint Online Starting ScanPoint Online ScanPoint ScanPoint with QuickPrint is already with QuickPrint is not installed installed 1 Open the QuickPrint window by 1 Open your Internet Explorer browser double clicking the ScanPoint and navigate to the ScanPoint Web icon in the system tray site at http my scanpoint com 2 Start the ScanPoint system by 2 Inthe Sign In dialog box enter the clicking the SCANP
25. nce et oan wee sets se etnias oe nose sees E nee see ee es ee os eee ce 117 ScanPoint Remote cccccccccecssescesecescecececescevecceecevacaceesevacausevevacacersecauevevavavessevacuersevacsuereevacnneneevacaeanen 117 ScanPoint Docking Station c ccccccecesccecssessesececescevececessecaceeseveceueesevacacersevavaversevacversevavaesevacaneneevacseenen 118 POCUN ICY CHIC A OUNS ct seco cindcactans cup fe ecasciara roo sdecacata sige 4vmessesarenaciasvoesdaseseoacie scons sieaseend sc aeoessmpacee cap svedastearct 118 Jerina Condilo n eee eee enter eet eo anne ee ieee mene ee eee eee eee eee eee 119 SOLAS GOIN OIG peresen A E E E EE E 119 Radio SC IMC AI OI S eiir TE A E EEO EE EEE 119 Computer Hardware and Software Requirements ccccccccceeccceeeseeeceeeeeeeseeeeseceeeeseeaeeeeeeeeeesssaaageses 119 Operating System and Software Requirements cccccceesecceeeceeeesseeeeeeeeeeeeeeeeeeeeeessaeaaeeeeeessaaeaeess 120 Label Writer SDS CIC AO INS eas pctsncsinciculosiauinstocssicectaaiacaipvendncmelaa lt asiensusensiecianpeanataieisecastaeuecoecnesanadawetecnnenesadeenumssenter 121 Mounting Bracket and Related Equipment Specifications cccccccssseeccceeeeeeeeeeeeeeeeeeeseeeeseseeeeeesaaas 121 MOS Si Yo scsete cesar E geese esos E E acevo dered E E E 122 page 10 User s Manual FloPoint Elite Uroflow System Table of Figures Table of Figures Figure 1 FloPoint Elite Uroflow System Components and Features
26. note thatif you do not enter exam detaile before pining an exam using QuickPrnt the examwill not be accessible in ScanPont Online If you have chosen to be prompted for the Exam Details you may Default Operator Jane Doe assign a default Operator and Physician in the fields at right to ao eee save time optional Default Physician DOr Smith Frou wa fo continue cusiomizing Quick nint chick Next You may oer Finish at any ime fo close fhe vizand and sef ibe renaming oreferences fo iber desu settings Finish When you finish filling in the dialog box click NEXT to open the Customize Your Report Types dialog Choose whether you want QuickPrint to prompt you to choose a report type each time an exam is performed To view samples of each report type click the VIEW REPORT TYPE SAMPLES link on the right side of the dialog box To have QuickPrint prompt you to choose a report type each time an exam is performed choose the YES WANT QUICKPRINT TO PROMPT ME FOR A REPORT TYPE BEFORE PRINTING radio button If you do not want to be prompted to choose a report type each time you print an exam choose the No DO NOT WANT TO BE PROMPTED FOR A REPORT TYPE radio button Choose the default report type you want to use from the drop down menus Important If you do not enter the Patient ID and Operator before printing an exam you will not be able to access the exam later in ScanPoint page 36 User s Manual FloPoi
27. on recommended security precautions go to the ScanPoint with QuickPrint Help menu and choose SECURITY BEST PRACTICES page 38 User s Manual FloPoint Elite Uroflow System Getting Started If you need to change user profiles or assign new users at any time please contact your Verathon Medical representative or the Verathon Medical Customer Care Department at 1 800 331 2313 Step 6 Installing FloPoint Elite Devices In order for your FloPoint Elite peripheral devices ScanPoint Docking Station and optional Label Writer to function properly they must be installed using the Microsoft Found New Hardware Wizard You will need to complete a separate wizard for each device IMPORTANT The dialog boxes displayed on your computer may differ slightly from those illustrated in the following procedures If so follow the instructions in the dialog boxes displayed on your screen Installing the ScanPoint Docking Station NOTE The ScanPoint Docking Station has a USB connector Figure 3 To make sure that you have the ScanPoint Docking Station check that it has a USB connector and that the label on the bottom says ScanPoint Docking Station Figure 3 The ScanPoint Docking Station has a USB Connector 1 Turn the computer on Plug the ScanPoint Docking Station into any available USB connector on your computer The Found New Hardware Wizard is displayed User s Manual page 39 Get
28. page 102 User s Manual FloPoint Elite Uroflow System Clinical Application Figure 40 Artificial Fluctuating Pattern The patient creates this pattern by repeatedly moving his stream across the commode outlet 50 45 404 35 30 25 imkis 0 5 10 15 20 25 30 35 40 45 Time Figure 41 Artificial Squeezing Pattern The patient creates this pattern by repeatedly obstructing urine flow by squeezing his foreskin or penis 50 45 40 35 30 25 20 15 milfs 10 0 5 10 15 20 25 30 35 40 Time Using Flow Time and Voiding Time to Help Identify the Curve Pattern A long time to peak and a long flow time can help confirm a subjective impression of an obstructive flow pattern Comparing flow time with total voiding time provides a quantitative indication of an interrupted flow pattern s severity the greater the difference between voiding and flow times the more severe the interruption Summary of Diagnostic Significance Table 2 summarizes the diagnostic significance of abnormal FloPoint Elite test results User s Manual page 103 Clinical Application FloPoint Elite Uroflow System Table 2 Diagnostic Significance of FloPoint Elite Results CURVE SHAPE TIME TO VOID TIME CONCLUSION MAXIMUM Continuous Shortened Prolonged Outlet ob NOS Peak flow may obstruction obstructive be difficult to pattern identity Continuous Rounded Variable Normal Detrusor unde
29. prompt you to save the PDF file on your computer for future use Default Save Location C ScanPoint Resuits Browse Click Fimsh io save your settings and exi the QuckFnni Preferences Wizard About User Profiles Your User Name and Password are associated with the User Profile you requested from Verathon when you purchased your FloPoint Elite instrument The ScanPoint features available to you depend on your user profile There are three common types of ScanPoint user profiles Administrative Users have access to all ScanPoint features Administrative users Can prepare new exams upload exam results accept or reject exam results view past exams and calibrate FloPoint Elite instruments Clinical Users can prepare new exams upload exam results accept or reject exam results and view past exams Clinical users cannot calibrate FloPoint Elite instruments Technical Users can calibrate FloPoint Elite instruments but cannot prepare new exams upload exam results accept or reject exam results or view past exams Each time a user logs in to a Windows computer with ScanPoint QuickPrint automatically connects to ScanPoint using the user profile they entered in the Preferences Wizard or Preferences dialog box To prevent unauthorized access to patient data in the ScanPoint system Verathon recommends setting a screen saver password or locking the computer when not in use For more Information
30. the rear of the Remote 3 For more information about charging the Remote see Charging the ScanPoint Remote Battery on page 44 User s Manual page 89 Troubleshooting FloPoint Elite Uroflow System Issue Problem Answer The ScanPoint Remote e Make sure the Remote is seated properly in the isn t working ScanPoint Docking Station Make sure the Remote battery is charged Ifthe Remote is charged but still won t turn on press the Reset button on the back of the Remote using the activation tool provided with you FloPoint Elite system If the Remote is still not functioning properly contact Verathon Medical Customer Care at 1 800 331 2313 The ScanPoint Remote Check the connections between the ScanPoint Docking won t communicate with Station and the USB connector on your computer 4 scanroine If the Remote is still not functioning properly contact Verathon Medical Customer Care at 1 800 331 2313 The ScanPoint Remote It is normal for the Remote to beep when beeped Itis beginning or ending a process Itis entering sleep mode to conserver battery life Press any button to wake up the Remote Battery power is low and the Remote needs to be recharged See Charging the ScanPoint Remote Battery on page 44 Radio contact is weak Move the Remote closer to the ScanPoint Docking Station Error Messages Message Answer User s comments may
31. 20 95 non condensing Radio Specifications The FloSensor and ScanPoint Remote communicate via a radio frequency that operates in the 2 4 GHz ISM Industrial Scientific Medical band with a range of 3 meters 10 feet FloPoint Elite Equipment complies with the specifications contained in FCC Part 15 Parameter Description Condition RF Frequency Range 2 402 2 479 GHz Range Up to 3 meters 10 feet Computer Hardware and Software Requirements To use ScanPoint with QuickPrint your computer must meet the following hardware and software requirements User s Manual page 119 Specifications FloPoint Elite Uroflow System NOTE ScanPoint with QuickPrint works only with Microsoft Internet Explorer 6 0 or later ScanPoint with QuickPrint is not compatible with Apple Macintosh computers Requirement Minimum Recommended Processor PC with 800 MHz PC with 2 0 GHz processor processor Video display Video card and monitor Video card and monitor capable of 800 x 600 capable of 1024 x 768 resolution resolution USB Ports Two USB 1 1 ports Two USB 2 0 ports Hard drive 200 Mb of available space 5 Gb of available space Memory 512 Mb 1024 Mb Internet access 256k DSL 512k DSL cable modem T1 line or other high speed connection Two ports are needed if both the ScanPoint Docking Station and the Label Writer will be used Operating System and Software Requirements Requirement
32. 7040602 Thursday June 21 2007 9 48 43 AM Return to Exam Results Peak Flow Average Flow Time to Peak Flow voided Volurne Flow Tire Pattern Void Time Gender Position Normal Void for Patient 5 Time 5 Time 20 0mi s dls 3 0 1 rl 5 45 Continuous 5 45 Male Standing Yes User s Manual page 73 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System Figure 21 ScanPoint Online Summary Report Preview Exam Date amp Time Patient ID Patient Name Operator Physician Gender Position Normal Void for Patient Peak Flow 50 45 40 39 30 Physician Signature 0570 0175 7040602 857893 Print This Page Return to Exam Results FloPointe Summary Thursday June 21 2007 9 48 43 4M Example Patient Operator Physician Male Standing Yes 20 0 mifs 5 Time 3 page 74 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint Figure 22 QuickPrint Full Page Detail Report Verathor Seankoint Exam Results FloPoint Results Peak Flow 20 0 mis Exam Date amp Time June 21 2007 9 48 AM Average Flow 9 4mis Patient ID Example Time to Peak Flow 3 0s Patient Name Patient Voided Volume 51m Operator Operator Flow Time 5 45 Physician Physician Pattern Continuous Void Time 5 45 Gender Male Position Standing Normal V
33. A A EAE EAEE 76 Figure 25 QuickPrint Summary Label Report sicci a ea i 77 Figure 26 FloPoint Elite Calibration Fluid and Calibration Quick Reference Card 81 Figure 27 ScanPoint Calibration Warning Message cccscsecesesescscesecececeseseecevevecaveceevevevavacerrsevevevareees 82 Figure 28 Instrument Details Dialog ccccseccccsesseeeceeseeeceesecceusececsaeeecseuseeessaseeessaueeeeseueeesseeseeessaneees 83 Foue 29 Calibration REDON rper penen a ET E eae 85 Figure 30 ScanPoint Diagnostics ccccccccsesssesesesessesececesesescevevecacaceceecevavaceceuecevevavavavecersevevavavacaveneneevevanes 87 Figure 31 Application Log REQUEST cccccccssececceeseeecseeeeeeeeeeeeeceeseeessaueeeeseaeeeessaaeeessaceeesseeeeeesseeeesseneees 93 Figure 32 Application Log Dale viivsnvaasieensanceiennesnniveasdvanetdeaidcwadcuanehdaavaarwaddvanelaaitinsnldieinasatsdenaiiceunteoesaava 93 User s Manual page 11 Table of Figures FloPoint Elite Uroflow System Figure 33 Measurements Taken From the FloPoint Elite Curve A Measurements of the continuous uroflow curve Average flow rate not shown is calculated by divided total volume voided by flow time B Measurements of flow time and voiding time from an intermittent UroflOW CUIVe cccccceceeeeeeeeeeeeeeeees 98 Figure 34 Normal Uroflow Curve ccccccccccccccceeeeeesesseeeeeeeeeeeeeeseeeaaaeaeaseeeeeeeeeeeeeeeeeeeesaaaaaaagsaeeeeeeeeeeeeenees 100
34. AC power cord or plug has been damaged Objects have become trapped in the instrument The instrument has been exposed to rain or moisture other than that consistent with use as directed The instrument does not appear to operate normally or exhibits a marked change in performance The instrument has been dropped or the enclosure damaged The FloPoint Elite Uroflow System does not contain any user serviceable components The user should not attempt to service the instrument beyond the procedures provided in this manual unless directed by Verathon service personnel All other servicing should be referred to authorized service personnel If at any time you require assistance with your FloPoint Elite Uroflow System contact Verathon Medical Customer Care at 800 331 2313 Canada and US only or 425 867 1348 User s Manual page 15 Introducing the FloPoint Elite Uroflow System FloPoint Elite Uroflow System Introducing the FloPoint Elite Uroflow System Product Description FloPoint Elite Uroflow System measures and records a patient s pattern of urinary flow allowing physicians to quickly assess the mechanics of flow and to diagnose abnormalities in voiding patterns e g obstructed or restricted flow superflow etc The advanced technology in the FloPoint Elite Uroflow System provides an accurate and convenient method to assess bladder function The FloSensor rapidly and accurately records both t
35. BLE PAGE link A new window appears displaying the exam report as it will print 2 Atthe top of the page click the PRINT THIS PAGE link The Windows Print dialog box will open 3 Select the appropriate options and click OK to send the page to the printer 5 Reviewed Exams are moved to the Past Exams list Once an exam has been viewed a check mark is displayed next to its entry in the last column of the New Exam Results list Figure 16 When you refresh the ScanPoint window any viewed exams disappear from the list Figure 16 New Exam Results New Exam Results A VERATHON Olek the coun beading to ort atient ID xam Dabe xam Type am R e p SSS ESS ee ae Wednesday June 20 2007 10 09 31 AM Wednesday June 20 2007 10 10 10 AM oh Wednesday June 20 2007 9 52 51 AM FloPaint iR Elte Wednesday June 20 2007 9 44 23 AM FloPont R Elte Friday May 25 2007 1 44 00 PM Bladder Mass Wednesday June 20 2007 9 41 00 AM Bladder Mass Wednesday June 20 2007 9 57 00 AM Bladder Volume Wednesday June 20 2007 9 42 00 AM Bladder volume Wednesday June 20 2007 9 35 13 AM FloPoint R Elte Wednesday June 20 2007 9 42 48 4M FloPoint F Elte Wednesday June 20 2007 9 35 00 AM Pedutric Bladder Volume Wednesday June 20 2007 9 36 00 AM Pediatric Bladder volume Viewing Past Exams Once an exam has been viewed in ScanPoint it s automatically moved to the Past Exams list 1 On the ScanPoint menu at the left of the wi
36. C Mara says ceansuoccwavaccorsesnstusperaccaysacaueg te spaveuinaea es eqpcuasteue vent pondarneiesperatsciuatinds EE 13 Intended Use Warnings and Cautions cccccccccccccssssseeceeeeeeeeeeeeceeeeesseeeeeseeeeeeeseueeseeeeesssueaseeeeeeeeeeesaaas 13 Staiement Ol FP VESCIIOUON sssrinin dinnera nE A E 13 Statement of Intended USE rrisin inin ai EAE EAEAN AEA AAA Ea 13 COn aC aO araara EE ee EE N RE 13 Introducing the FloPoint Elite Uroflow SySt M csssssssssesesssescesesesceseeeseseesreceseeseeesencesacencetaveceneesares 16 PROOUCE CSCO NOM eain E E ean dinaaannenesunsicancnauains 16 FloPoint Elite Uroflow System Parts and Features ccccccccceccsesecescecececescececcescevecvensevacerensevrensevacenen 16 ScanPoint Label Writer Optional Printer ccccccccececcececescscecececceesceceececececeecacecercevacecestevavversevacerereaces 17 ScanPoint Online c ccececccccscsecececeececececececcesecevececececsesecevavscacecsesecavaceceusesevavavacaceceucevavavavacenereecsvavsvavereees 18 ScanPoint Premium Warranty Total Customer Care Plan ccccccccsecesscsesecescecscecercevecerercevacereevaceren 19 TENE NC i eae te cite sacar snc cece ae con eset nacre decane ncln ceca da Ren ceca emnMnenees 20 Reguied EoD MEN ee ee ae i a T ae ee E 20 SING LCG PE E AE E E A E E EAE E AE E E 20 Step 1 Unpack the Box and Check the COMPONENMS cccccceeececceeseeceeeceeeeceeeceeeeceeseeeaeeeeeeeeaeeeeeeeas 21 ScanPoint Label Wr
37. Calibrate Instrument screen will open Click the CALIBRATE button on this dialog to begin configuring the Remote for the calibration procedure 3 When the Remote is configured take it along with a paper funnel the pouches containing the Calibration Fluid available from Verathon and the FloCharger with FloSensor inside to the toilet Place the Remote funnel and Calibration Fluid on the counter Place the FloCharger gently on the floor User s Manual page 83 Calibration FloPoint Elite Uroflow System Put on a pair of gloves Remove the FloSensor from the FloCharger and hang it in the toilet bowl just as you would for an exam Place the funnel on top of the FloSensor and push the tabs under the handles to hold it securely in place Pick up the Remote and press the button once to start recording an exam The Remote will play a tune up chirp indicating that the FloSensor is ready to measure the calibration flow Slowly pour the contents of one of the Calibration Fluid Ready to calibrate pouches onto the side of the funnel closet to the front of the toilet The flow rate should not exceed 10ml s as measured by the Remote When the pouch is empty click the Start button once to end the exam Depending on what appears on the Remote display the calibration was either successful go to step 8 or unsuccessful go to step 10 If the Calibration was Successful 8 If the calibration is successful
38. Elite uroflowmetry reimbursement Diagnosis codes for uroflowmetry that are acceptable to regional reimbursement bodies differ by region Therefore specific regions may not authorize uroflowmetry reimbursement for all listed diagnosis Table 3 Diagnosis Codes Used with FloPoint Elite CODE Equina syndrome with neurogenic bladder 344 61 Atony of Bladder 596 4 page 106 User s Manual FloPoint Elite Uroflow System Clinical Application Bladder Neck Obstruction acquired Hypertonicity of bladder Low bladder compliance Paralysis of bladder Neurogenic bladder NOS Detrusor sphincter dyssynergia Other functional bladder disorder Urethral stricture due to unspecified infection Traumatic urethral stricture Postoperative urethral stricture Other specified causes of urethral stricture Urethral stricture unspecified Hypertrophy of prostate BPH Retention of urine unspecified Incomplete bladder emptying Other unspecified retention of urine Urinary incontinence unspecified Urge incontinence Stress incontinence male Mixed incontinence Incontinence w o sensory awareness Post void dribbling Nocturnal enuresis Continuous leakage Other urinary incontinence Urinary frequency micturition Polyuria Nocturia Splitting of urinary stream intermittent Slowing of urinary stream weak User s Manual page 107 Clinical Application FloPoint Elite Uroflow System REFERENCES Abrams
39. Elite In Service CD Includes FloPoint Elite User s Manual and Quick Reference Cards page 110 User s Manual FloPoint Elite Uroflow System Parts and Accessories Part and Part Number Name and Description Box of Paper Funnels Help direct the urine flow toward the FloSensor amp Box contains 40 funnels 0800 0297 Activation Tool Use to press the Reset button on the ScanPoint Remote if ol the Remote needs to be reactivated 0130 0181 Lanyard Attaches to the ScanPoint Remote if desired to assist with placement of the Remote in proximity to the FloSensor FloPoint Elite Setup and Use Quick Reference Card Provides a Summary of essential operator instructions FloPoint Elite Calibration Quick Reference Provides instructions for the FloPoint calibration procedure Sarbon tomers ScarPort Bemcte 0900 1444 User s Manual page 111 Parts and Accessories FloPoint Elite Uroflow System Part and Part Number Name and Description FloPoint Elite Mounting Bracket Template Aids in attaching the Mounting Bracket to the wall 0900 1557 To order any of the above parts contact your authorized Verathon Medical Sales Representative or contact the Verathon Medical Customer Care Department at 1 800 331 2313 Other FloPoint Elite Uroflow System Accessories The following accessories are not included with your FloPoint Elite Uroflow System with ScanPoint wit
40. FOUG 39s SUDEMIOW PALIN cisnna cacyasavesaucceennitctuengesaciasasccavennibeteunciantwsutuas aided betantguaneuentuasavausosninaguantedel 100 Figure 36 Flat Top Obstructive Flow Pattern The peak on the spike at the end of the trace might have been misinterpreted by the uroflowmetry as the peak flOW cccccccseeeeeeeeeeeeeeeeeeeseaeeeeeeaeeeeeeeesaeneeeeeeaas 101 Figure 37 Rounded Top Obstructive Flow Pattern ccccccccccccecceeesssseeeeeeeeeeeeeeeeeeesuaaaaaaaaueeeeeeeeeeeeensees 101 Figure 38 Fluctuating Pattern Caused by Abdominal Straining cscecceeeeeeeeeeeeeesaaaeesseeeeeeeeeeeeees 102 Figure 39 Abnormal Intermittent Pattern Caused By Detrusor Sphincter Dyssynergjia ccccce 102 Figure 40 Artificial Fluctuating Pattern The patient creates this pattern by repeatedly moving his stream ACKOSS th commode OUNC irsissnissitindasnsinanaeannniennsiaisncloaiesieainduladataatnncigunsisaladaissutaiataigubiagusehedadieistaadeysenbenresadateaasouanas 103 Figure 41 Artificial Squeezing Pattern The patient creates this pattern by repeatedly obstructing urine flow DY squeezing Nis TOFESKINOF PENIS vwsssccnucecoadesmnasasecwersa ennventbheatecan Minenc cestaneneenninwndontamennycesuieanatenantedls 103 Figure 42 Artifactual uroflow peak produced by a spike The black arrow identifies an artifactual spike that the uroflowmetry reads as the flow peak The correct peak flow open arrow must be read manuall
41. Figure 30 To access this information from the ScanPoint menu select Tools gt Diagnostics Figure 30 ScanPoint Diagnostics Diagnostics Beginning diagnostics WARNING current ScanPoint URL has been changed from the default URL OKAY Checking application data OKAY Diagnostics complete Close Copy to Clipboard Tum OFF Tracing Resource Description Premium Warranty Total A Verathon insurance plan that provides all the Customer Care Plan benefits of ScanPoint Online preceding paragraph plus Instrument insurance A perpetual warranty against outdated technology with free upgrade replacement when your device is no longer manufactured Free loaner program e Free shipping Phone support In North America call 1 800 331 2313 International customers please refer to the list of Customer Care phone numbers on page 21 User s Manual page 87 Troubleshooting FloPoint Elite Uroflow System Diagnosing Problems ScanPoint Problems Issue Problem Answer How can improve my To view recommended security and privacy practices system s security and from the ScanPoint Help menu and select Security privacy Best Practices When insert the If the installation screen does not automatically open ScanPoint disk into the when you insert the ScanPoint CD you can start CD drive the installation installation this way Bereen ec gt net appre 1 On the Windows
42. FloPoint Elite Uroflow System User s Manual VERATHON Copyright 2008 by Verathon Inc All rights reserved No part of this User s Manual may be copied or transmitted by any method without the express written consent of Verathon Inc FloPoint ScanPoint Sontac VMoDE Verathon and Verathon Medical are registered trademarks and Premium Warranty Total Customer Care Plan is a service mark of Verathon Inc Adobe Acrobat and Reader are registered trademarks of Adobe Systems Incorporated in the United States and or other countries Apple and Macintosh are registered trademarks of Apple Incorporated in the United States and or other countries Microsoft Internet Explorer Windows and NET Framework are registered trademarks of Microsoft Corporation in the United States and or other countries All other brand and product names are trademarks or registered trademarks of their respective owners The ScanPoint technology described in this manual is protected by U S Patent 6 569 097 Other international patents pending Information in this User s Manual may change at any time without notice For the most up to date information you can access an online version of this manual at http www verathon com manuals htm Examples described or illustrated in this User s Manual are fictitious and do not in any way represent real patient or exam data Verathon Inc Corporate HQ US and
43. FloPoint Elite measurements and graphs Cleaning the FloSensor Es Clean the FloSensor thoroughly Leave the FloSensor in the toilet bowl for cleaning Wearing gloves remove the funnel and discard appropriately Flush the toilet to eliminate any urine do not flush funnel Prepare half a gallon of cleaning solution a 10 solution of non abrasive disinfecting cleaner DO NOT use any cleaning products that contain ammonia Slowly pour the solution into the FloSensor if you pour too fast the FloSensor motor may turn off Flush the toilet again Pa Return the FloSensor to the FloCharger To remove the FloSensor from the toilet bowl bring the FloSensor s handles together and lift it from the toilet bowl Dry the FloSensor and place it back in the FloCharger To order additional Funnels 0800 0274 or Calibration Fluid 0800 0331 contact Customer Care at 800 331 2313 www verathon com https my scanpoint com For more information call 800 331 2313 in the U S and Canada or contact your local Verathon Medical representative Verathon Corporate Headquarters 20001 North Creek Parkway Bothell WA 98011 USA Phone 1 425 867 1348 VM Europe B V Boerhaaveweg 1 3401 MN IJsselstein The Netherlands Phone 31 30 68 70 570 0900 1443 01 60 FloPoint Elite Uroflow System Table of Contents Table of Contents IMportan Normal ON Geeemeenemes ete nee en SE sere sisters arin s ase nite sats 13 Frode ISS CMH
44. Minimum Recommended Operating system Microsoft Windows 2000 Microsoft Windows 2000 Professional with Service Professional with Service Pack 2 Pack 4 Windows XP Browser Microsoft Internet Microsoft Internet Explorer Explorer version 6 0 version 7 0 Microsoft NET NET Framework version NET Framework version Framework 2 0 This software is 2 0 with the latest Microsoft installed with ScanPoint updates installed with QuickPrint Adobe Acrobat Reader Adobe Acrobat Reader 6 0 Adobe Acrobat Reader 7 0 Available for free download from www adobe com NOTE For ScanPoint QuickPrint to function properly Microsoft Internet Explorer 6 0 or later must be installed ScanPoint will not function with any other browsers such as Netscape and Firefox ScanPoint QuickPrint is not compatible with Microsoft Windows Vista page 120 User s Manual FloPoint Elite Uroflow System Specifications Label Writer Specifications The ScanPoint Label Writer meets the following specifications Print method Direct thermal Print resolution 300 dots per inch 118 dots per mm Maximum print width 2 25 56 mm Maximum media width 2 44 62 mm Interface USB 2 0 full speed printer class device Average print head life Ei linear inches over 31 miles 50 800 linear meters Printer power requirements 24 VDC 1 75 A Regulatory approvals CE FCC cTUVus GS and C Tick NOTE System configur
45. N Gy sie ces oases a E E e 86 RON FSS OUI CSS ei entearrcansnn ereaiprmtenely E besatenaskatoadianithandientintehnmannccmmenantonis 86 Dagros HoT LODIG NIS ee nee E eee ee E E 88 ScanPoint Problem ccccccccsscesescesececcecececeececevsceccevsceesevevaceesevavaceusecevaceceecevaceuercecaeeevevaveeersevavenenseeees 88 ScanPoint Remote Problems cccccccsesesssesesescevecececececeevevevacacecevevevacaveveresevevavavaveresevevavavavenersevacaees 89 EOF WIGS SAC OS ax cantunesncatnaysaeatontneeananenaddsnnpcauatantan lt iuioiad dunes E E E A 90 Enor O OEC ora E E A 91 POPC On EO e a A E E E E E 92 WANA opaa a EA a S 94 Disclaimer of Additional Warranties ccccccccsseccecseeceeceeeceeceeeceeceeeceeceececseueeeeseaeceeseueeeessaeeessaeeeesaaes 94 Contacting Verathon secessus cen eee eee eee 95 OTERO NN AUN Oso tsetse ss EEEE agus tioned EUERE E EEEE EAEE 96 DS THORS Indications and CUTOUT risens nnan a a a eerie oeeene 96 DENON casen A E E E AE oe Sasa eeawedeeeeees 96 MACIN a E E E E E tobitaianuehiaideccadens 96 Clinical Condition or History Suggestive Of ou ccc cece eeeeeeceeeeeeeaeeeeeeeeeeeeeeaeeeseeeeeeeseaeaeseeeeeesseaaeess 96 Specie SIGNS ANG SY MOONS hearre sninen e a a i 96 FloPoint Elite Output c c ccccesececesesescscececscecesesceveveveceesecevevavacaveceusevavavavaveveuevevevavavaveusevevavaveneneesaneeevens 96 FloPoint Interpretation c cccccccccccsesscecesesescecececesescevevececececeuevevevavaceversusevecav
46. OINT button in User Name and Password assigned the QuickPrint window or by to you by Verathon selecting LAUNCH SCANPOINT from the View menu 3 Click the SIGN IN button to open the initial ScanPoint window Exam results are divided into two categories New and Past New These are exam results that have been transmitted to ScanPoint Online from QuickPrint but not yet viewed Using ScanPoint Online you can review these exams and accept or reject them Once viewed the exams are automatically moved to the Past Exams list New Exams that have an ENTER DETAILS link in the Exam Result column have voice annotations but are missing exam details When viewing these exams you can listen to the voice recording associated with the exam enter exam details and view the results For more information see Completing a Voice Annotated Exam on page 63 Past Exam results that have already been reviewed in ScanPoint and that have been accepted or rejected Viewing Exam Results 1 Click NEW EXAMS On the ScanPoint menu at the left side of the window click NEW EXAMS You page 66 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint may need to expand the View Exam Results menu to see this option The New Exam Results page will open Figure 14 Figure 14 New Exam Results Page Scan Point New Exam Results A VERATHON Bladder Monitor Qick the colum
47. Point Elite Uroflow System 2 Consult the following table for the Preferences you can set up or change When you are finished setting your preferences click the OK button to save your changes and exit the Preferences dialog box or Click the APPLY DEFAULTS button to reset all your Preferences to their default settings Click the SAVE AS ALL USERS button to set the Preferences settings for all users on your computer Click CANCEL to cancel any changes you have made To Do this Log in to ScanPoint or 1 Click the ScanPoint Login tab change from one user profile to another 2 Enter the User Name and Password assigned to you by Verathon 3 Click CONNECT NOTE This ScanPoint User Name and Password will apply every time you log in to Windows using your current user account There is no time out period the User Name and Password you enter will remain active until you change them Change the URL of the NOTE Do not perform this procedure unless ScanPoint Web site instructed to do so by the Verathon Customer Care Department Have QuickPrint prompt 1 Click the Exam Settings tab you for exam details after 2 Indicate which prompts you want displayed for each exam by placing a check mark in the appropriate check boxes each exam 3 If desired in the Default Operator text box enter the name you want to automatically appear in the Operator text box 4 If desired in the Physician tex
48. RNING Possible device damage Failure to heed the following warnings may cause device damage not covered by the FloPoint Elite warranty When cleaning FloPoint Elite components do not use any products that contain ammonia Do not subject any FloPoint Elite device to steam sterilization or ethylene oxide sterilization Cleaning products containing bleach can tarnish the FloSensor handles Tarnish can be readily removed using stainless steel cleaner FloSensor Cleaning Procedures Quick Clean Procedure 1 While a patient is performing an exam prepare two liters of Quick Clean solution a 10 solution of non abrasive disinfecting cleaner After the exam is completed put on a pair of gloves remove and dispose of the paper funnel from the top of the FloSensor and verify that the FloSensor is still running NOTE Do not flush the paper funnel down the toilet Dispose of it as appropriate for medical waste If the FloSensor is not running click the button on the Remote to restart the FloSensor NOTE If the Remote is holding onto an exam first record a voice annotation to save the exam data and then press the button to start the FloSensor Flush the toilet to eliminate any urine After the toilet finishes flushing pour the two liters of Quick Clean solution through the FloSensor Flush the toilet again Remove the FloSensor from the toilet dry it with a clean paper towel and place it back on the FloCharger
49. S MO CIMOUIC eee E E E A E E 106 Reimbursement IMIOMMA NON eserse a E 106 Physician Participation REQUIPFEMENT cccccccseeeeeeeeeeeeecseseeecseeeeseasceessaaeeessaeeeeseaueeessaneeesaaeeeeesaass 106 User s Manual page 9 Table of Contents FloPoint Elite Uroflow System P O odur COOS opn EREE E EEE E E EE EEEE E 106 DIAGMOSIS GOCES SE 106 PREFERENCE sera ase arcs sckeoeiasdecle mend ase eeawatettenet 2a usuauateesuatdeetsacsaceueast2cavsuayatddsndt dea usanssecdenuenbadeseeedoncsceasies 108 Pars and ACCESSOTOS Sean E EE EAE ee eee eee nese ee 109 FloPoint Elite Uroflow System Component cccccccsesscesessecesescevecesescevsceceesevacecesavtervevaceeensevaceneneans 109 FloPoint Elite Uroflow System ACCESSOFICS ccccesessesecesessesesesceveccessevacecesevaceersevatervevaceeensavaneeeneens 110 Other FloPoint Elite Uroflow System ACCESSOLICS ccccccesesessecesescecececescevecscereevacusevecsuereevaceersevaces 112 PECCA NONS oe ag S E R E E AE E E E 114 SV OO DIECO arana E EAN E EE E EE ENE EA E E E A 114 Standards and Regulations Compliance cccceeececccccceceaeeseeeceeeeeeeueeeeeeeesssueaeeeeeeseeseuaaaeeeeeessaaageeeees 115 Elec TOMAS IC ENCIS ceni E E a ssutuseaaeasie 115 Health Insurance Portability and Accountability Act cccccseeceecseeceeseeseeeeeeeeeesaeeeeeseaseeeseeeesnaaeees 116 2 O10 6216 e eee een ee nee ae ee eee E eee eee 117 FO SO SOM gts erg tcc ns versa cares rec E E vs
50. User s Manual FloPoint Elite Uroflow System Contacting Verathon Medical Contacting Verathon The team at Verathon is committed to modernizing healthcare delivery by putting patients first Our products support healthcare professionals by providing the reliability utility and excellence For additional product and company information visit the Verathon Web site at www verathon com If you have any questions or comments about Verathon products and services please contact us at Corporate Headquarters USA Verathon Incorporated 20001 North Creek Parkway Bothell WA 98011 USA Toll free 800 331 2313 US amp Canada Only Tel 425 867 1348 Fax 425 883 2896 Web www verathon com Email customerservice verathon com Verathon Medical B V Europe Boerhaaveweg 1 3401 MN lJsselstein The Netherlands Verathon Medical Sarl France Office Address Espace Europeen de l Entreprise 2 all e d Oslo 67300 Schiltigheim France Tel 31 30 68 70 570 Fax 31 30 68 70 512 Web http www verathon eu Email customerserviceeu verathon nl Postal Address BP 10039 F 67012 Strasbourg Cedex France Tel 33 0 3 88 60 14 02 Fax 33 0 3 88 60 46 87 Email info verathon fr Verathon Medical Ltd United Kingdom The Granary Manor Farm Courtyard Aston Sandford Aylesbury Buckinghamshire HP17 8JB United Kingdom Verathon Medical K K Japan Executive Tower Azabudal 7F 1 4 3 Azabuda
51. again 3 Open an Exam Details page Click the AVAILABLE link to the right of the exam you want to view A new window will open containing the exam results Figure 15 Figure 15 Exam Details Page Scan VERATHON Biria New Exam Results Bladder Monitor Patient information BladderScan BladderScan UEBW Mobile BiadderScan Exam Type FloPoint Elite Pediatric are Example OS S PladderScan Patient ID Example pam View Exam Results Patient Name Patient New Exams Past Exams Operator Operator Biadder Monitor Physician Assignment Physician Calibration Position Standing x verathon com Help Gender Male x Normal Void for Patient Yes v Save and return to Tist Discard this exam 4 Accept or Reject the Exam You can accept reject or print the exam results according to the instructions in the following table User s Manual page 67 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System To Do this Accept the results of Click the CLOSE button at the bottom of the exam result a new exam page Or click the Xl in the upper right corner of the exam result window Reject the results ofa Enter a reason for rejecting the exam in the Reject Reason new exam text box at the bottom of the exam result page Then click REJECT button Print the exam details 1 Atthe bottom of the exam result page click the and scan images PRINTA
52. allshield Wizard Setup Type Choose the setup type that best suits your needs Peace celect a cebup type Complete 2 Al progam features wil be installed Recommercded Choose which program Feabures you want installed and where they vel be retaled If you have a ScanPoint Label Writer Select the COMPLETE radio button If you do not have a ScanPoint Label Writer Select the Custom radio button The next dialog box lists the features that will be installed Clear the check for installing the Label Writer Click NEXT The Destination Folder dialog is displayed You may Accept the default location no action is required Change the location Click the CHANGE button Enter or browse to the desired location and click Ok to return to the Destination Folder dialog Click NEXT ip ScanPointi QuickPrint InstallShield Wizard Destination Folder Click Next to install to this folder or click Change to install to a different folder f Install ScanPoint GQuickPrint to C Program Files verathon QuickPrint MPORTANTI ScanPoint QuickPrint requires Adobe Acrobat Reader 6 0 or higher to print exams Please visit http adobe com for a free download ofthe latest version of Adobe Acrobat immediately following this install cw NOTE ScanPoint with QuickPrint requires Adobe Acrobat Reader 6 0 or higher to print exams Please visit http www adobe com for a free downloa
53. an Exam FloPoint Elite Uroflow System Prepare the ScanPoint Remote Press and release the Start button on the Remote Siar The FloSensor will perform a set of internal self test h NY o ee button to ensure proper functioning If the FloSensor motor is warming up the Remote will display circling arrows for several seconds Next the Remote will display a zero and sound a chirp up to indicate that the FloSensor and Remote are ready to perform an exam i NOTE To indicate that it is ready and waiting the FloSensor will beep every 3 seconds until a flow is detected Advise the patient that the beeping is normal and not a cause for concern NOTE If no flow is detected for 20 minutes the FloSensor motor will shut down to preserve battery life When the Remote button is pushed to start an exam the motor will re start To assure the most accurate measurement instruct the patient to urinate onto the funnel wall closest to the front of the toilet The patient should not urinate directly onto the FloSensor Leave the Remote within 10 feet of the FloSensor for example using the supplied lanyard you can hang the Remote on a hook in the restroom or just outside the restroom door NOTE The Remote will emit a high pitched beep if it begins to lose radio contact with the FloSensor page 52 User s Manual FloPoint Elite Uroflow System Performing an Exam 8 Ending the Exam When the patient
54. as passed Windows Logo testing Lontinue Anyway i f STOP Installation User s Manual page 31 Getting Started FloPoint Elite Uroflow System 7 The Digital Signature dialog is displayed Windows 2000 only Click YES to continue installation Digital Signature Not Found The Microsoft digital signature affirms that software has been tested with Windows and that the sottware has not been altered since it was tested The software you are about to install does not contain 4 Microsoft digital signature Therefore there is na guarantee that this software works corectly with Windows Unknown software package IF you want to search for Microsoft digitally signed software visit the Windows Update Web site at http windowsupdate microsoft com to see if one is available Do you want to continue the installation Installing ScanPoint QuickPrint The program features you selected are being installed Please wait while the InstallShield Wizard installs ScanPoint QuickPrint minutes Instalishield 9 When the installation is complete the InstallShield Wizard Completed dialog box is displayed Click FINISH page 32 User s Manual FloPoint Elite Uroflow System Getting Started ip ScanPoint QuickPrint InstallShield Wizard InstallShield Wizard Completed The InstallShield Wizard has successfully installed ScanPoint QuickPrint Click Finish to exit the wizard
55. ation with accessory Model No 0570 0178 ScanPoint Label Writer was not part of the UL investigation Accessory equipment connected to the analog and digital interfaces must be in compliance with the nationally harmonized IEC standards i e IEC 60950 for data processing equipment IEC 60065 for video equipment IEC 61010 1 for laboratory equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Anybody who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible for ensuring the system complies with the requirements of the system standard IEC 60601 1 1 If in doubt please consult the technical services department or your local representative Mounting Bracket and Related Equipment Specifications Mounting Bracket Description Mounting bracket material 16 guage 304 stainless steel Weight mounting bracket 6 5 Ib 2 95 kg alone Weight mounting bracket 13 Ib 5 9 kg plus funnels charger and sensor User s Manual page 121 Glossary FloPoint Elite Uroflow System Term Meaning Activate When the ScanPoint Remote battery has been completely discharged you may need to activate or reset the Remote before you can use it again The Remote can be reactivated by pressing the recessed Reset button on the back of the unit using the supplied Activation Tool Ac
56. atteries FloSensor The central component of the FloPoint Elite system it contains a rotating disc for measuring urinary flow rate and volume page 122 User s Manual FloPoint Elite Uroflow System Glossary Flow Interval Ends Term Meaning The end of a flow interval is identified by two consecutive samples with a flow rate less that 0 2 ml s Flow Interval Starts The start of a flow interval is identified by two consecutive samples with a flow rate greater than 0 5 ml s The actual start of the interval is selected to be the sample prior to the identifying samples where the flow rate is at least 0 2 ml s Flow Time HIPAA ICS The total amount of time in seconds during which flow is being measured In the case of intermittent flow this value will be smaller than the Void Time as this value does not include the time between intervals where there is no flow Health Insurance Portability and Accountability Act enacted by the US Congress in 1996 Title Il of HIPAA the Administrative Simplification provisions AS requires the establishment of national standards for electronic health care transactions and national identifiers for providers health insurance plans and employers The AS provisions also address the security and privacy of health data The standards are meant to improve the efficiency and effectiveness of the nation s health care system by encouraging the widespread use of elec
57. ceeseeecsaeeecsaueeeessaseessaseeeseuseeessassenessaneees 64 Figure 13 Patient details added to AN exam record cseecccccecseeeeeeeeeaeeeeeeeseaeeeeeeeesaeeeeeessaeeeeesssageeenenaas 65 Figure 14 New Exam Results Page cccccccsseccccesseecceeseeecceseeccssececsaueeecseuseeeseaseeessagseeesegseeessaseeessageees 67 Foure T3 Exam Dotado PAGO esra A a EE E E E E E 67 Fotre T6 NOW Exam Rost Seii S a a E A 68 Figure 17 Patient Exams History screen Search by Patient ID ccc ccccceeeeeeeeeeeeeeeeesaeeeeeeeesaeeeeeeeens 69 Figure 18 Patient Exams History Search Results cccccccssssseecceeeeceaeeseeeeeeeeseeeeeeeeeeessueeseeeeeeeessaaaaeses 69 Figure 19 ScanPoint Online Detail Report ccccccecececesesesesesesesescseseececevevevecevacavavevavevevevesenenenensevevevevevens 72 Figure 20 ScanPoint Online Detail Report Preview ccccccccscesesessseesevevecesececscecececececevevecerenereneevevevevenes 73 Figure 21 ScanPoint Online Summary Report Preview c cccccccececsesesesescesesesseceseseeveceseseevaceersesatereeveees 74 Figure 22 QuickPrint Full Page Detail REDort ccccccccccceceeeeeeceeeeeeseeeeeeeeeeeeeeeeeesesaeeessseseeeeeeeeeeeeeess 75 Figure 23 Quick Print Full Page Summary REPOFt ccccccccccecececcceeeeesseeeeeeeeeeeeeeeeeseesaaeeesseeeceeeeeeeeeeeess 76 Figure 24 QuickPrint Detail Label REDOT icasencdocascncedccecaisanssdenaivesesnsudeacceddnaadangssuincgued RETE
58. d of page 30 User s Manual FloPoint Elite Uroflow System Getting Started the latest version of Adobe Acrobat immediately following the installation of the ScanPoint with QuickPrint software The Ready to Install the Program dialog is displayed Click INSTALL jig ScanPoint QuickPrint InstallShield Wizard Ready to Install the Program The wizard is ready to begin installation Click Install to begin the installation TF you want to review or change any of your installation settings click Back Click Cancel to exit the wizard During installation a Microsoft Warning dialog box is displayed stating that Microsoft has not yet tested this software for compatibility with the Windows XP and Windows 2000 operating systems However Verathon has tested the ScanPoint with QuickPrint software and hardware drivers rigorously and is confident that they are fully compatible with both Windows XP and Windows 2000 Click CONTINUE ANYWAY if this dialog is displayed Software Installation The software you are installing has not passed Windows Logo testng to venty its compatibility with Windows XP Tell me why this testing is important Continuing your installation of this software may impair or destabilize the comect operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the software vendor for software that h
59. d return to list Discard this exam Cancel 5 Fill out the dialog fields according to the information in this table Figure 13 page 64 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint Item Meaning Patient ID The unique code you use to identify this patient If you don t know the Patient ID code press the SEARCH button to display a list of the codes you have assigned to your patients Patient Name The patient s name as it appears in your records Operator The person performing the exam Physician The patient s primary health care provider Gender The patient s gender Position The patient s position during the exam sitting standing Normal Void Ria if the patient feels the void is typical of their normal pattern Figure 13 Patient details added to an exam record Scan VERATHON Point New Exam Results Badder Monitor Patient information Bipdders cant Exam Type FloPoint Elite Patient ID Example Patient Mame atient Operator Physician Position Gender Normal Vaid for Patient 6 To save your entries and return to the New Exam list click the SAVE AND RETURN TO LIST button or the SAVE AND VIEW RESULTS button This exam will remain in the New Exams list until you view the results To delete the exam and return to the New Exams list click the DISCARD THIS EXAM button NOTE For more
60. details Patient ID Patient Name Gender Position Normal Void Operator and Physician before transmitting exam results If you choose to be prompted for exam details you can enter default names for the operator who performed the exam and physician who ordered the exam in the Default Operator and Default Physician text boxes The names you enter will automatically appear in the Operator and Physician text fields after each exam You will be able to overwrite the default names before printing the exam results lf you choose not to be prompted for exam details QuickPrint will automatically print each exam without prompting you for exam details Blank spaces will appear in the printed exam report for you to fill in the Patient ID Patient Name Gender Position Normal Void Operator and Physician NOTE These exams will not be available for future access in ScanPoint User s Manual page 35 Getting Started FloPoint Elite Uroflow System Sp QuickPrint Preferen ces Wiza rd Step 2 of 4 Customize QuickPrint Prompts E Exam Details Indicate below whether you wish to be prompted for Ecam Details A VERATHON Yes want QuickPrint to prompt me for Exam Details Patient ID Operator etc before print an exam Ne donot wish to be prompted for Exam Details before printing an exam report prefer to print the report Immediately without entering patient information IMPORTANT Please
61. dicators ScanPoint Remote Display Icons The following table illustrates and describes the ScanPoint Remote display icons ScanPoint Remote Display Icons O o Meaning Battery power level Four segments The battery is fully charged One segment The battery is nearly depleted and should be charged at once Scrolling segments The battery is charging _ i mj Blank display The Remote is in sleep mode 4a rS gt 4 After clicking the Start button to start an exam a series of rotating arrows indicate that the FloSensor is warming up The warm up period lasts approximately 30 seconds When complete the Remote plays a chirp up and the display shows a zero below The Remote is ready to receive exam data from the FloSensor During an exam the Remote displays the flow rate in ml s le i currently being measured by the FloSensor When an exam is completed either because the Start button on the Remote was clicked or because the FloSensor detected the end of flow the display cycles through four different screens The first screen displays for one second and indicates that the next display will be the volume in ml N c a aa The volume in ml is displayed for two seconds If the voided 5 9C ai i volume is greater than one liter gt 999ml is displayed page 46 User s Manual FloPoint Elite Uroflow System Displays Controls and Indicators Icon Mean
62. dure that was used is specified in EN IEC55011 1991 for Group 1 Class A equipment per EN IEC60601 1 2 36 201 1 7 Verathon declares that this FloPoint Elite uroflow system is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC The declaration of conformity may be consulted at http www verathon com FloPoint_Elite htm This ISM device complies with Canadian ICES 001 Cet appareil ISM est conforme a la norme NMB 001 du Canada NOTE This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur ina particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures User s Manual page 115 Specifications FloPoint Elite Uroflow System e Reorient or relocate the receiving antenna Increase the separation between the equipment and recei
63. e ScanPoint Docking Station The Remote will upload the calibration data to ScanPoint ScanPoint verifies the calibration and assigns a new expiry date to the FloSensor This should take only a minute 13 ScanPoint completes the calibration process by re installing the Remote software so the Remote can perform patient exams 14 If desired select PRINT to print a Calibration Report Figure 29 Figure 29 Calibration Report N Scan VERATHON Point l Calibration Report Calibration Result S uccess Calibration Date Wed Jun 20 12 58 08 PDT 2007 Instrument Model ScanPoint Remote Instrument Serial Number 5310701 Tests Control Functionality PASS Cradle Communication PASS Device Communication PASS Device Flash RAM PASS Device ROM PASS Device DSP PASS Device Self Test PASS Device Application Upload PASS Device Application Execution PASS Upload to Web PASS Image Acquisition PASS Image Intensity PASS Image Alignment PASS All Tests PASSED Customer Name VYerathon Medical Customer Address 21222 30th Drive SE Print This Page User s Manual page 85 Troubleshooting FloPoint Elite Uroflow System Troubleshooting Help Resources Verathon provides an extensive array of customer care resources described in the table below You can obtain copies of this manual Quick Reference Cards and clinical studies and view training videos by accessing the Verathon Web site at www veratho
64. e either to an anatomical abnormality e g prostatic hypertrophy or a neurological abnormality e g detrusor sphincter dyssynergia caused by multiple sclerosis Therefore by itself uroflowmetry cannot determine the cause of a reduced flow rate However many clinicians with uroflowmetry experience contend that uroflowmetry can provide useful clinical information by itself particularly in men For example Boone and Kim state that if a patient complains of a reduced flow of urine but there are no other signs or symptoms of voiding dysfunction and uroflowmetry is normal it is unlikely that further urodynamic testing will reveal an abnormality Chapple and MacDiarmid state Simple uroflowmetry by itself is adequate investigation for uncomplicated prostate mediated bladder outflow obstruction in over 60 of patients McLoughlin et al found that an abnormally reduced maximum urine flow rate is a reliable indicator of obstruction in over 90 percent of men with prostatic symptoms Also Abrams and Sand and Ostergard state that in female patients with urinary incontinence an abnormally high flow rate and short duration void sometimes provides a useful suggestion of detrusor instability and or abnormally reduced outlet resistance Quantitative Measurements Figure 33 diagrams the measurements taken from the FloPoint Elite curve Table 1 summarizes the definitions and normal results of these measurements Flow Rates Both maximum and
65. e has an exam stored in memory press and hold the Start button to record an annotation Check calibration If the Remote does not have exam data stored in memory press and hold the Start button to see how many days are remaining before the required calibration ScanPoint Remote Audio Cues The Remote speaker plays back voice annotations and also emits several different audio cues to indicate the system status as follows Chirp The Remote is ready to measure urine flow page 48 User s Manual FloPoint Elite Uroflow System Displays Controls and Indicators Chirp Down The urine flow has ended and the Remote has stopped receiving data from the FloSensor High pitched Repeating Beep The Remote is not receiving data from the FloSensor This alert is triggered if data transmission from the FloSensor is interrupted for 0 2 seconds This condition is likely due to radio interference and can usually be remedied by moving the Remote closer to the FloSensor The Remote must be used within 3 meters of the FloSensor Siren Chirp During calibration the siren chirp sounds after a successful calibration At this point the Remote must be returned to the ScanPoint Docking Station to complete the calibration process Error Chirp During calibration the error chirp plays after a change in calibration Another calibration must be performed to confirm the change in calibration During exam start up the error chirp will sound
66. e no impact on exam result Err 5 The ScanPoint Remote failed to Repeat the operation Not a write a value to the FloSensor flash function performed by customers Call Verathon Medical Customer Care Err 6 The ScanPoint Remote failed to read Repeat the operation Not a a value from the FloSensor flash function performed by customers Call Verathon Medical Customer Care Err 7 The FloSensor battery has insufficient Charge the FloSensor charge to perform and exam User s Manual page 91 Troubleshooting FloPoint Elite Uroflow System Code Meaning Resolution Err 8 The FloSensor motor is moving too Check the FloSensor for slowly and could no longer be something blocking the motor If controlled necessary remove the funnel retainer and clean the FloSensor see page 56 Re assemble and attempt the exam again If the problem persists contact Verathon Medical Customer Care Err 9 The FloSensor is requiring too much Either the flow rate is too high or current to control the speed there is something preventing the motor from moving Remove the funnel retainer and clean the FloSensor see page 56 Re assemble and attempt the exam again If the problem persists contact Verathon Medical Customer Care Err 10 The FloSensor internal temperature is Let the FloSensor cool off and too high attempt to perform another exam If the problem persists contact Verathon Medical Customer Care A
67. ed with your FloPoint Elite system During an exam data is gathered from the FloSensor by the ScanPoint Remote The Remote in turn downloads this data to the ScanPoint host computer allowing patient record storage further diagnostic analysis and report generation ScanPoint Online is an innovative service that enhances and expands the capabilities of the FloPoint Elite Uroflow System ScanPoint Online allows you to e View exam measurements and graphs from patient exams page 18 User s Manual FloPoint Elite Uroflow System Introducing the FloPoint Elite Uroflow System Print exam results for patient records and for reimbursement if applicable using your choice of report format Save a PDF copy of the exam report that can be imported into other electronic medical record systems Save and store images online allowing you to access patient records from any Internet enabled computer HIPAA compliant e Take advantage of ScanPoint automatic file backup service Ensure the optimum accuracy of your FloPoint Elite system by calibrating online in a matter of minutes and as often as you wish Take advantage of automatic software upgrades ScanPoint Premium Warranty Total Customer Care Plan The Premium Warranty Total Customer Cares Plan includes ScanPoint Online insures your device against damage theft and loss provides free next day loaners and pays all shipping charges
68. eeds the labels stopping at the beginning of the first label If the Label Writer stops without feeding the label make sure the label is fully inserted and then press the form feed button Close the top cover Connect the Label Writer to Your Computer 1 Make sure that The Label Writer is set up and plugged into a power outlet as described in the previous paragraphs Your computer is turned on and the ScanPoint Installation CD is in your computer s CD drive 2 Plug the Label Writer s USB connector into any available USB connector on your computer The Install New Hardware Wizard will start up automatically 3 Follow the on screen directions for installing new hardware as with the ScanPoint Docking Station Step 7 Charge the Batteries The FloSensor and the ScanPoint Remote should come from the factory already charged After the initial charge recharge the batteries whenever they are low or completely drained Charging the ScanPoint Remote Battery Use the ScanPoint Docking Station to charge the ScanPoint Remote The ScanPoint Docking Station is a dual purpose device page 44 User s Manual FloPoint Elite Uroflow System Getting Started It transmits exam data stored in the Remote to the ScanPoint host computer via a USB connection lt charges the Remote battery NOTE To charge the Remote the computer must be turned on To charge the ScanPoint Remote battery NOTE The ScanPoint
69. en to you by Verathon Turn on or turn off specific 1 Click the System Settings tab i a a 2 Place a check mark in the check box es next to the warning s you want to receive Exiting QuickPrint or Hiding the QuickPrint Window You can close the QuickPrint window without exiting the program or you can exit QuickPrint completely Closing the QuickPrint Window without Closing ScanPoint To hide the QuickPrint window do one of the following Click the minimize button in the upper right corner of the QuickPrint window Go to the File menu and select CLOSE The QuickPrint window closes The ScanPoint icon visible in your system tray indicates that the program is still running To Exit QuickPrint Completely Ifa QuickPrint dialog box is currently displayed go to the File menu and select EXIT Ifa QuickPrint dialog box is not currently displayed right click the QuickPrint icon in the system tray and select EXIT A dialog box appears asking you to confirm that you want to exit QuickPrint Click OK page 80 User s Manual FloPoint Elite Uroflow System Calibration Calibration To make sure the FloSensor is providing accurate measurements it must be calibrated at prescribed intervals The entire calibration process takes approximately 15 minutes You can calibrate the FloSensor as often as you like you do not have to wait for the next scheduled calibration date However at a minimum
70. ent verathon com Example Patient Help Example Patient Example Patient Example Patient 2 Inthe ScanPoint New Exam Results window any exams that have not yet been viewed in ScanPoint are displayed By default the exams are arranged in order by Patient ID To arrange the exams in a different order click the appropriate column heading For example to arrange the exams in order by Exam Date click the Exam Date column heading The exams are listed in order from oldest to most recent To reverse the date order click the Exam Date column heading again 3 Inthe Exam Result column exams that display an ENTER DETAILS link have a voice annotation but are missing required exam details To complete exams with missing details Click the ENTER DETAILS link corresponding to the desired exam A blank Patient information dialog will open Figure 12 4 Click the LISTEN button to play the annotation You can replay the annotation as many times as necessary Figure 12 New Exam Results Dialog Scan Point Bladder Mantar Biaoders cant Biaodders canm DEB Mote Badder scan Pediatric Bladder S cami View Exam Resutis New Exams Past Exams Biadder Monitor Assignment New Exam Results VERATHON Eos Patient information FloPoint Elite Exam Type Patient ID Patient Name Operator Physician Position Gender z Normal Void for Patient M Save and view results Save an
71. ent and to not void prior to arriving at the clinic Alternatively the patient might be questioned about the fullness of his bladder upon arriving for his appointment and instructed to drink water immediately if the bladder is empty As noted above voids of more than 600 ml or less than 150 ml should be repeated as the patient s bladder has refilled 2 Instruct the patient to void in a position that he or she is most used to usually standing for a male sitting for a female 3 A male should be instructed to direct the stream to the location marked on the funnel and to maintain constant stream direction throughout the void Reimbursement Information Physician Participation Requirement During the performance of FloPoint Elite uroflowmetry direct physician supervision is required This means that the physician must be present in the office suite not necessarily in the room when the procedure is performed and immediately available to furnish assistance and direction throughout the performance of the procedure Procedure Codes There are only two procedure codes to use for the performance of FloPoint Elite uroflowmetry 51736 Simple uroflowmetry uroflowmetry performed by the use of stop watch flow rate or a mechanical Uroflow System 51741 Complex uroflowmetry uroflowmetry performed using calibrated electronic equipment Diagnosis Codes Table 3 lists diagnosis codes that can be entered into a claim for FloPoint
72. ereesevevavavevevereesevevavnecanenenen 97 Limitations and Specific Clinical Applications w cs2ccssvedasiocacataddnwedicseceuctcehayseiecdewedncdecaeebaetnedaseaeusudentete 97 Quantitative MEASUrEMENTS ccccsscsssssessssessesssesessssessseeseeeseeeseseesseesseeeeseeseeeseeeeeeeeeeeeeeeseeeseeeeeeeees 97 FOV RaO sre wc ahaa tic sic cc lg eg ssc ioe pec nse A cies woes a ese ae lense eee ee eecteaeaees 97 Measurements Related to FloPoint Elite Curve Patterns c cccccccccssessecesesssesesessssesesestevecesersateeereens 99 Continuous Regular Patterns cccccceseccceececaeeeseeceeeeeeaeeseeeeeeeesseeeeeseeeeeesesaeeeeeeeeessaeeaeeeeeeeeeeesaaas 99 PAGCOR FAM CRING siactccscncesnasdunesaqncousvensiainestatentanndiasavcamnimedvoauiaxtuandinsdsendiantuasnibearondieaaendlssauantannd 101 IIa IGM eG oe sec asee a stpesscesee acces EE a dee acetacunessencesoneee o aai 102 Aria aO 0 lt ea E eee ee ee eee E E E ee 102 Using Flow Time and Voiding Time to Help Identify the Curve Pattern ccccseeeeeeesseeeeeeeeeaeees 103 Summary Of Diagnostic Significance ccccccccseesesecceeeeeeeeeseeececeeeeeeeseeeeeeeeessueaseceeeeeseeaaeeeeeeeeeseaaaas 103 AWACS amna Pall seee menin TE e E e EEE E NE ERO ET EEE EENE 104 Spikes or Rapid Fluctuations in the Curve ccccccccssssseseeceeeceeeeeeeeeeeeeeseueeeeeeeeeeeseeeaeeeeeeeeeaaas 104 L w and High Voided VOlUMES ssirssissiris ensenen nain a a Aa EaR 105 TO
73. f interruptions of varying durations between voiding episodes Figure 38 shows an example of a fluctuating flow pattern caused by abdominal straining Figure 39 shows an example of an intermittent flow pattern caused by detrusor sphincter dyssynergia User s Manual page 101 Clinical Application FloPoint Elite Uroflow System Figure 38 Fluctuating Pattern Caused by Abdominal Straining 50 45 40 35 30 25 imis 0 5 10 15 20 25 30 35 40 45 50 55 Time Figure 39 Abnormal Intermittent Pattern Caused By Detrusor Sphincter Dyssynergia 50 45 40d 35 304 254 imis Time Clinical Significance Whether an irregular uroflow pattern or urethral sphincter relaxation are lost causing the detrusor to push intermittently against a contracted urethral sphincter irregular traces can also be caused by fluctuating or poorly sustained detrusor contractions which are generally seen in patients with a neurological abnormality most commonly multiple sclerosis Artifactual Causes As discussed previously irregular traces can be caused by a male patient moving his stream across to the collecting funnel cruising or intermittently squeezing the tip of the penis or foreskin during voiding Figure 40 and Figure 41 show examples of these two types of artifactual irregular patterns Anxiety as might be caused by the unfamiliar laboratory environment can also cause an irregular trace in normals
74. four arrows and 3 3 are displayed The Remote plays a siren chirp indicating that it needs to be placed back in the ScanPoint Docking Station to complete the calibration process When you have performed a successful calibration or when three calibration flows have been attempted return the FloSensor to the FloCharger and flush the toilet Remove your gloves and return the Remote to the ScanPoint Docking Station for re configuration If the Calibration was Unsuccessful 10 The Remote will emit an error beep A maximum of three calibration flows can be conducted during a calibration exam The display shows the current attempt number and the total allowable number of attempts Completing Calibration possible in this case one out of three Return to step 6 to repeat a calibration flow 11 When you have performed a successful calibration or page 84 User s Manual FloPoint Elite Uroflow System Calibration when three calibration flows have been attempted return the FloSensor to the FloCharger and flush the toilet Remove your gloves and return the Remote to the ScanPoint Docking Station for re configuration NOTE If calibration was unsuccessful after three attempts Return to ScanPoint and complete the Calibration Exam You may continue to use your FloPoint Elite or contact Verathon Medical Customer Care for assistance at 1 800 331 2313 12 Return the Remote to th
75. g table IMPORTANT Required fields Fields marked with a red asterisk are required in order for the exam to be available later in ScanPoint Item Meaning Patient ID The unique code you use to identify this patient If you don t know the Patient ID code press the SEARCH button to display a list of the codes you have assigned to your patients Patient Name The patient s name as it appears in your records Operator The person performing the exam Physician The patient s primary health care provider Select Gender The patient s gender Select Position The patient s position during the exam standing or sitting Select Normal Yes if the patient feels that the void was representative of Void his her routine voiding Select a report Click the down arrow at the right of the text box to select the type to print type of report you wish to print NOTE You can view sample report formats starting on page 71 or by going to the Help menu and selecting Report type samples Select a printer Click the down arrow at the right of the text box to select the printer for the report 5 When the dialog is complete click the SUBMIT button The information is transmitted to ScanPoint and the report is printed For more information on viewing and printing past exam results in ScanPoint see Viewing Exam Results in ScanPoint Online beginning on page 66 Reprinting an Exam
76. h QuickPrint system Part and Part Number Name and Description Calibration Fluid Pouches Pouch containing unique fluid for use in calibrating the FloPoint Elite The Calibration Fluid Pouches are shipped with the Calibration Kit amp FloPoine Elre Tatar Pied 0800 0331 ScanPoint Label Writer and Related Components ScanPoint Label Writer optional Prints exam results 0570 0178 page 112 User s Manual FloPoint Elite Uroflow System Parts and Accessories Part and Part Number 0600 0233 0275 0002 0125 0446 0600 0232 Name and Description USB Cable Connects the ScanPoint Label Writer to the ScanPoint host computer Switching Power Adapter Connects the Label Writer to the wall outlet Roll of Labels Labels in roll format properly sized for the ScanPoint Label Writer Power Cord Connects the FloCharger to the wall outlet to charge the FloSensor battery To order any of the above parts contact your authorized Verathon Medical Sales Representative or contact the Verathon Medical Customer Care Department at 1 800 331 2313 User s Manual page 113 Specifications FloPoint Elite Uroflow System Specifications Symbol Directory The following table illustrates and explains the symbols that may appear on the FloPoint Elite Uroflow System components and or packaging These symbols indicate the FloPoint Elite system complia
77. he U S and Canada or contact your local Verathon Medical representative ScanPoint FloPoint Verathon and Verathon Medical are registered trademarks of Verathon Inc in the US and other countries Copyright 2007 by Verathon Inc All rights reserved FloPoint Elite Uroflow System Voice Annotation Quick Reference Important Before proceeding thoroughly read steps 6 and 7 To record patient information press and hold the button on the ScanPoint Remote Hold the ScanPoint Remote close to your mouth when recording an annotation Press and hold the button until you hear a beep Continue holding the button down as you speak into the microphone Be sure to include relevant exam information such as patient name age gender sitting standing name of healthcare professional conducting exam etc You have 10 seconds to record this information Release the button and listen as recording is replayed You have 5 seconds from the end of playback to re record Verify voice annotation To re record press and hold the button again to create a new message To save your recording wait approximately 5 seconds as the ScanPoint Remote automatically stores the recording with the exam results FJ Use ScanPoint to view exam results Place the ScanPoint Remote in the ScanPoint Docking Station to view FloPoint Elite exam results enter the exam type and required data to transmit exam results and then view
78. he flow rate and the total amount of urine discharged by the patient These measurements are transmitted via radio link to a remote handset which in turn interfaces with ScanPoint with QuickPrint allowing data storage diagnostic analysis and report generation The FloPoint Elite Uroflow System has a small footprint making it easy and unobtrusive to use and store The FloSensor the heart of the FloPoint Elite system is lightweight and designed to fit in a standard toilet bowl during an exam Between uses it stows discreetly in the FloCharger which also recharges the FloSensor battery FloPoint Elite Uroflow System Parts and Features The main features of the FloPoint Elite Uroflow System and ScanPoint Remote are illustrated in Figure 1 Figure 1 FloPoint Elite Uroflow System Components and Features Handles Funnel Box Latch a Clamshell FloSensor Microphone LCD display Start button FloPoint Elite Mounting Reset Bracket button Point ScanPoint Remote in the ScanPoint Docking Station FloCharger FloCharger LED page 16 User s Manual FloPoint Elite Uroflow System Introducing the FloPoint Elite Uroflow System The FloSensor fits into a standard toilet bowl and measures a patient s urine flow rate and volume The ScanPoint Remote gathers patient data measured by the FloSensor and transmits it to the ScanPoint host computer allowing further analysis and repor
79. he recording icon is Recording Icon displayed Continue to hold the button until you have finished recording the annotation Start button 2 The microphone is located just above the display Hold the microphone approximately 6 inches 15 cm from your mouth when you are recording the annotation and speak clearly Be sure to include all relevant exam information such as patient ID age gender date and time position sitting or standing whether or not the void was typical for that patient and the name of the person performing the exam A total of 10 seconds of recording time is available If you exceed 10 seconds the Remote will beep to indicate that recording has stopped 3 When you have finished recording the annotation release the Start button The Remote will beep to indicate that recording has stopped 4 The Remote will automatically play back the annotation e If you wish to re record your annotation start over at the first step in the annotation procedure You must begin re recording within 5 seconds after playback has stopped Ifthe annotation is satisfactory the Remote stores the annotation in flash memory 5 At this point the Remote is ready to start the Quick Clean procedure Cleaning procedures are described in detail in the next section of this manual beginning on page 55 page 54 User s Manual FloPoint Elite Uroflow System Cleaning and Maintenance Cleaning and Maintenance WA
80. hten the screw leaving 1 4 of thread exposed on which to hang the bracket 3 Hang the bracket on the 4 screws and tighten the screws The Mounting Bracket should be held securely flush with the wall 4 Measure the distance from the bracket to the outlet On the FloCharger wrap any power cord in excess of that length on the cord wrap recess underneath the FloCharger If necessary use adhesive tape to keep the cord in place 5 Mount the FloCharger on the 4 posts of the Mounting Bracket Start by getting one post into one charger foot then place the other 3 feet on the posts Push the FloCharger down until it is fully seated on the posts 6 Attach the correct prongs into the AC adapter The FloPoint Elite system is compatible with power systems world wide and a set of prongs for various systems are included with the AC adapter The prongs will click into place and be held securely 7 Plug the AC adapter into the socket The FloCharger is now ready to charge The FloSensor and the ScanPoint Remote should come from the factory already charged After the initial charge recharge the batteries whenever they are low or completely drained Step 3 Installing Adobe Acrobat Reader ScanPoint with QuickPrint uses Adobe Acrobat Reader version 6 0 or higher to print labels and patient reports If Acrobat Reader software is not already installed on your computer you can obtain a free copy at the Adobe Web site http www adobe com F
81. i Minato ku Tokyo Japan 106 0041 Tel 44 1844 299 207 Fax 44 1844 299 218 Web www verathon co uk Email customerserviceuk verathon co uk Tel 81 03 3560 3501 Fax 81 03 3560 3502 Email servicejo verathon com page 95 Clinical Application FloPoint Elite Uroflow System Clinical Application Definitions Indications and Output Definitions Uroflowmetry is a diagnostic test in which the patient urinates into a flow sensor connected to a recording device that produces a plot of urine flow rate versus time the uroflow curve Most Uroflow Systems measure urine flow rate by continuously weighing the urine as it fills a catch vessel and calculating the rate of increase in urine weight By contrast the FloPoint Elite FloSensor contains a disk that spins at a constant speed When a flow of urine hits the disk the motor must work harder to maintain the disk spinning at that same speed with the added weight of the urine The FloSensor measures the amount of power needed to maintain the disk s original speed and uses that measurement to calculate the urine flow rate The FloSensor also records the total amount of urine discharged by the patient Indications In general uroflowmetry is used as a screening test to determine which patients with symptoms or clinical conditions involving the lower urinary tract should be referred for further workup e g urodynamics cystography The most common clinical a
82. ials When the FloPoint Elite Uroflow System has reached the end of its useful service life return the device and related accessories toa Verathon Service Center for proper disposal Alternatively follow your local protocols for hazardous waste disposal page 58 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint Managing Exam Results in ScanPoint with QuickPrint Starting ScanPoint with QuickPrint Once ScanPoint with QuickPrint is installed it starts automatically every time you turn on your computer There is no need for you to open it manually You can verify that ScanPoint with QuickPrint is open and running by confirming the presence of the ScanPoint icon in your system tray in the lower right corner of your screen near the clock ScanPoint with QuickPrint stays in the background and becomes active only when you place a FloPoint instrument that is holding exam information into the ScanPoint Docking Station the ScanPoint Docking Station must be connected to the computer s USB port If ScanPoint with QuickPrint i Is running in the background you can open it manually by double clicking the ScanPoint icon in your system tray If ScanPoint with QuickPrint is not running you will not see the ScanPoint icon in the system tray To open it either double click the ScanPoint QuickPrint icon on your desktop or open the Start menu and select P
83. id arrow In situations such as this the clinician must override the computer s interpretation and read the maximum manually from a smooth portion of the uroflow trace open arrow in Figure 42 Figure 42 Artifactual uroflow peak produced by a spike The black arrow identifies an artifactual spike that the uroflowmetry reads as the flow peak The correct peak flow open arrow must be read manually by the interpreter 30 45 40 35 30 25 20 imis oO 0 5 10 15 20 25 30 Time Low and High Voided Volumes When total voided volumes are below 150 ml normal flow rates become so low as to make the test an insensitive indicator of an abnormally low flow rate At voided volumes of over 600 ml the bladder may become decompensated thereby producing an artifactually low flow rate Therefore it is important to avoid voided volumes below 150ml and above 600ml If such volumes are encountered the test should be repeated User s Manual page 105 Clinical Application FloPoint Elite Uroflow System Test Technique Incorporating the following into the FloPoint Elite test procedure will materially enhance both the efficiency with which the test is done and the clinical utility of the test s results 1 The void should be performed with a comfortably full bladder To accomplish this the patient should be instructed to drink approximately 2 pints of fluid two hours before appearing for his or her appointm
84. if the Remote cannot make contact with the FloSensor FloSensor Indicators The FloSensor contains a beeper that communicates device status The FloSensor will sound a beep under following conditions Motor starts Motor stops Every 3 seconds when the FloSensor and the Remote are in radio contact and are ready to measure and record a uroflow exam This can signal to the patient that it s okay to begin voiding NOTE The clinician should advise patients that the FloSensor will beep every 3 seconds to indicate normal operation and is not a cause for concern FloSensor User s Manual page 49 Displays Controls and Indicators FloPoint Elite Uroflow System FloCharger Indicators The FloCharger contains an LED that communicates charging status as follows Solid green The FloSensor is fully charged and ready for use Alternating green and orange The FloSensor is being charged Solid red The FloCharger has stopped charging There is either some foreign metal object in the FloCharger or the FloCharger or FloSensor may be malfunctioning In this case remove the FloSensor from the si charger Make sure there is nothing in either the FloCharger LED charger or in the hole on the sensor and then try charging again If the problem persists call Verathon Medical Customer Care to arrange a replacement No light The FloCharger is unplugged page 50 User s Manual FloPoint
85. ing The third screen indicates that the following screen will display the p F i peak flow rate in ml s Peak flow rate in ml s is displayed for two seconds The Remote is ready to record an annotation a voice recording is in progress icon flashes or the Remote is saving voice annotation data icon flashes ERR followed by a number from 1 10 indicates an error in ER R FloSensor and or Remote function A list of error codes appears in the Troubleshooting section on page 91 When the Remote is placed in the ScanPoint Docking Station it 45 4 automatically downloads saved exam data The display indicates the progress of the download Digits indicate days remaining before the next required calibration 1 9 2 4 NOTE ScanPoint will give you a warning message 20 days before the calibration expires If the calibration has expired the setting sun icon is displayed 0 0 0ra Three flashing zeros provide an additional reminder that the FloSensor calibration has expired When calibrating the FloSensor you have up to three attempts to get a successful calibration Usually a calibration is successful on the first attempt This display shows the current attempt number completed and the total possible number e g one of three After the third calibration attempt or after the first successful calibration the display shows 3 3 to indicate that all necessary attempts are complete If the calibration was succes
86. ink e Rejected exam results will display a Failed Exam due to user rejection link 4 Follow the instructions in the previous table to view or print these results FloPoint Elite Reports in ScanPoint with QuickPrint FloPoint Elite exam results in ScanPoint with QuickPrint Figure 19 are divided into three sections with different kinds of information in each section User s Manual page 69 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System Information Category Description Exam Date and Time The date and time the exam was performed Patient ID The patient s ID as entered into ScanPoint with QuickPrint Patient Name The patient s name as entered into ScanPoint with QuickPrint Operator The instrument operator for this exam as entered into ScanPoint with QuickPrint Physician The supervising physician for this exam as entered into ScanPoint with QuickPrint Gender The patient s gender Position The patient s voiding position sitting or standing Normal Void for Patient Yes No Measurements Measurement Description Peak Flow Measured in ml s Average Flow Measured in ml s Time to Peak Flow Measured in seconds Voided Volume Measured in ml Flow Time Measured in seconds Pattern Intermittent for example Void time Measured in seconds Graphs Flow Rate Flow Rate in ml s over Time in seconds
87. ion Verathon has taken the following measures to ensure the safe delivery and storage of all information that is maintained used and presented by the ScanPoint system All ScanPoint system 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 Web site infrastructure is housed by a Tier 1 Network Service Provider NSP that meets the SAS 70 certification Within the NSP the ScanPoint equipment is located in a locked steel cage structure removing access from even the NSP s personnel e Verathon has enacted all policies and procedures outlined in HIPAA to protect our internal network from unauthorized access Verathon 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 Verathon manages access to PHI refer to the Verathon Business Associate Agreement 0003 0138 page 116 User s Manual FloPoint Elite Uroflow System Specifications FloCharger Input Voltage 100 240 V AC RMS Input Frequency 47 63 Hz Input current 0 8 A max Input connection Employs direct plug in AC prongs for wall outlets
88. is finished pick up the Remote and press the button once to end the exam The Remote play will play a chirp down to signal the end of the exam The FloSensor motor will continue to run for 20 minutes to provide time for cleaning NOTE The exam will end automatically if no flow is detected for 3 minutes After the exam has ended the Remote display will cycle through a series of four informational screens VOL VOL Displays for one second indicating that the following screen will display the total voided volume measured in ml I5en Total volume of urine voided displays for 2 seconds If the total is greater than one liter gt 999 ml is displayed PF PF displays for one second indicating that the following screen will display the peak flow rate measured in ml s ii Peak flow rate measured in ml s displays for 2 seconds 9 Prepare the Quick Clean solution While the patient is performing the exam prepare 2 liters of Quick Clean solution see instructions on page 55 10 Record a voice annotation optional See the following instructions User s Manual page 53 Performing an Exam FloPoint Elite Uroflow System Recording a Voice Annotation After performing an exam you can record additional information about a patient to be stored with the exam results To record a voice annotation 1 Press and hold the Start button until Microphone you hear a beep about three seconds T
89. it is still a good idea to periodically perform some basic interior maintenance You can easily clean your Label Writer printer using the following items Lint free cloth Isopropyl alcohol diluted dishwashing detergent or diluted glass cleaner If you use glass cleaner make sure it does not contain ammonia Small soft brush such as a paint brush Cleaning the Exterior and Interior of Your Printer 1 2 Turn off the printer and disconnect the power cord Use the lint free cloth to wipe the exterior of the printer Remove dirt and smudges with one of the cleaning solutions mentioned above Open the top cover Use a small soft brush cotton swab to whisk away paper dust and other stray particles from the inside of the printer Remove the roll of labels to clean under the roll If you have a Label Writer cleaning card follow the instructions printed on its packaging and feed it through the printer mechanism Reconnect the power cord and turn on the printer Reload the roll of labels and close the top cover User s Manual page 57 Cleaning and Maintenance FloPoint Elite Uroflow System Regular Inspections and Maintenance Verathon recommends that the FloPoint Elite system be calibrated once a year For more information please refer to the Calibration section in this manual and contact Verathon Medical Customer Care at 1 800 331 2313 US and Canada only International custome
90. iter cccccccecccsecsssecerceseceececesceseceecececevaceucevsueesareevaveueevaversavuersaveusevaversateneeeteneees 24 Step 2 Attach the Mounting Bracket to the wall and attach the FloCharger to the Mounting Bracket 25 Step 3 Installing Adobe Acrobat ROACEL cccccccececesescssesecececeecececsvececececeesecevevecececeesevarecacereececsvavereees 26 Step 4 Install ScanPoint with QuickPrint ccccccececescececescscscececcececeecevecececcevaceceucevacecereevacentevacnereeeares 26 Installing ScanPoint with QuickPrint Software c ccsececesessesesescecscesessecececeesevececessevaversevareeeneeveseeen 27 Step 5 Setting ScanPoint User Preferences c c cecccscsesessesescssecerseceececacercevaverserecavaveevarensevaversaveneneaten 33 RADOU US ErP IOCS enn mee ee oe es ete eee Oe eee eee ee 38 Step 6 Installing FloPoint Elite Devices cecccccsececescsecescecscecescececeecevsceceesevavaceucevacaceutevateusevacenereevares 39 Installing the ScanPoint Docking Station c ccccccsccsecesescesesessesecesessevecceevevaceceevevavessevacversevacenersevanes 39 Setting up the ScanPoint Label Writer c cccccecccccceceseccesecescececececcececececcevaceceusevacecervavevensevavenensevaceten 42 Connecting the Label Writer to POW ccccccececccceecceeeeseeceeeeeeeeeeeeeeeeeeeeseaeaaeeeeeessaueaseeeeeeeeessageas 42 MeGa ROIO TA CIS e eacecenesaenaniiesacnnesareco sab ecoes aon enarndeuaaneetecweseaaentescssane 42 Co
91. n com or by contacting your Verathon Medical representative A complete listing of contact information is provided on page 21 Resource Description FloPoint Elite Quick Summary of procedures for using the FloPoint Elite Reference Cards Uroflow System This manual Refer to the troubleshooting suggestions that begin on page 88 for solutions to common problems The Verathon Web site The Verathon Web site www verathon com provides the latest user manuals quick reference cards clinical studies and training videos To find the latest FloPoint Elite information from the Verathon Home page select FloPoint Elite ScanPoint with QuickPrint ScanPoint with QuickPrint software Software Install CD FloPoint Elite In Service CD Includes FloPoint Elite User s Manual and Quick Reference Cards ScanPoint Help From your ScanPoint application select Help from the toolbar at the top of the ScanPoint window ScanPoint Online ScanPoint Online provides e Access to real time troubleshooting from Verathon The ability to calibrate and certify their devices online anytime they wish Automatic software upgrades e Automatic data backup and archiving HIPAA compliant page 86 User s Manual FloPoint Elite Uroflow System Troubleshooting Resource Description ScanPoint Diagnostics This ScanPoint tool checks your system and lets you know of any problems or needed updates
92. n heading to sort Biadderscare LEEW ALO ol EAE Operator Exam Result v BladderScan UEBW Mobile BladderScan Wednesday June 20 2007 10 09 31 4M BYI9400 Enter Details Pediatric Wednesday June 20 2007 10 10 10 AM BYVI9400 Wednesday June 20 2007 9 52 51 4M FloPoint R Elite Wednesday June 20 2007 9 44 23 4M FloPoint R Elite Example Patient Friday May 25 2007 1 44 00 PM Bladder Mass Operator aa tiar Motor Example Patient Wednesday June 20 2007 9 41 00 AM Bladder Mass Operator Assignment Example Patient Wednesday June 20 2007 9 57 00 AM Bladder Volume Operator Calibration Example Patient Wednesday June 20 2007 9 42 00 4M Bladder Volume Operator verathon com Example Patient Wednesday June 20 2007 9 35 13 AM FloPoint R Elite Operator Heip Example Patient Wednesday June 20 2007 9 42 48 4M FloPaoint R Elite Operator Example Patient Wednesday June 20 2007 9 35 00 4M Pediatric Bladder Volume Operator Example Patient Wednesday June 20 2007 9 36 00 4M Pediatric Bladder Volume Operator 2 Sort and review exam data Exam results are sortable By default exam results are displayed in order by the Patient ID number To arrange the exams in a different order click in the appropriate column heading For example to sort the exams by date click the Exam Date column heading By default the exams are listed in order from the oldest at the top to the most recent at the bottom To reverse the date order click the Exam Date heading
93. n this manual Consumable items are not covered in this warranty and should be used in conformance with Verathon product specifications For further details consult your Premium Warranty Total Customer Cares 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 manual 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 This information descriptions recommendations and safety notations in this manual are based upon Verathon experience and judgment with FloPoint Elite as of July 2007 The contents of this manual should not be considered to be all inclusive or to cover all contingencies The physician who directs the use of the FloPoint Elite Uroflow System at the institution where it is in use is responsible for keeping current with clinical research in uroflowmetry Please direct any questions or problems concerning uroflowmetry using the instrument or the interpretation of data to the responsible physician page 94
94. nce with international and national standards and regulations Symbol Meaning lle Underwriters Laboratories mark of certification of the FloPoint Elite uroflow system which consists of the FloSensor the FloCharger cl US with Clamshell the FloPoint Elite Mounting Bracket the ScanPoint Remote and the ScanPoint Docking Station with respect to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 and CAN CSA 22 1 No 601 1 System configuration with accessory Model No 0570 01 78 ScanPoint Label Writer was not part of the UL investigation Accessory equipment connected to the analog and digital interfaces must be in compliance with the nationally harmonized IEC standards i e IEC 60950 for data processing equipment IEC 60065 for video equipment IEC 61010 1 for laboratory equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Anybody who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible for ensuring the system complies with the requirements of the system standard IEC 60601 1 1 If in doubt please consult the technical services department or your local representative IEC 348 symbol indicating Attention consult accompanying documentation Marked in accordance with Directive 2002 96 EC on Waste Electrical and Electronic Equipmen
95. ndow click PAST EXAMS The Patient Exams History screen is displayed Figure 17 page 68 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint Figure 17 Patient Exams History screen Search by Patient ID ah S Pointe Patient Exams History A VERATHON Bladder Monitor Enter Patient iD BiadderScan BiadderScan UEBW Patient ID denotes a required field Mobile BiadderScan ae BiadderScan View Exam Resuits New Exams Past Exams Bladder Monitor Assignment Calibration verathon com Heip Log Off 2 To see a patien s past exams enter the appropriate Patient ID in the Patient ID text box and click SUBMIT Or to choose from a list of IDs used at your institution click the SEARCH button and then click on the appropriate Patient ID A list of viewed exams with the Patient ID you selected will appear Figure 18 Figure 18 Patient Exams History Search Results Scan Die Patient Exams History VERATHON Bladder Monitor 247 7ml 7032702 test20 BladderScan Exam Date amp Time Exam Type Operator Exam Result BladderScan UEBW Sa Mobile BladderScan 3 28 2007 10 44 46 AM FloPoint bc Good Exam Pediatric Bladder Monitor Assignment Calibration verathon com Heip Log Off 3 Toview an exam result click the link in the Exam Result column next to the appropriate exam Accepted exam results will display a Good Exam l
96. nnect the Label Writer to Your COMPUTED ccccccsseeseecceeeeceeeeeeeeeeeecueeseeeeeeeeessaeaseeeeeeeessaaaees 44 Step 7 Charge ihe Bateries au tcc serene ncevnseenicrenennsinrc gan E E 44 Charging the ScanPoint Remote Battery cccccccccccscesssesesesessesesessececescevecacersevaceereeveveneevarseeneeveceen 44 Charging the FloSensor Battery cccccccccccccsssseeeceeeeeeeeeeeeeeeeeeseeeeeseceeeeessesseeeeeeeessaeaaeeseeeeeessaeaaaasess 45 Displays Controls and Indicators wassiertevessessisessdetensestaveesnedeeneueseayeedeededstucusvancewocdabaedendetudiestesespendendaucstans 46 ScanPoint Remote Display ICONS c ccececscsesecescscececescececececcecevaceccecevacersevaceceecevaceteecevacversevacenensevacenen 46 ScanPoint Remote ButtOns c cccecccsecesecsesesceseceececeeceveceesereusecsesevaceucevaveesaveucevatersevaversavenseceneevaversaranen 48 ScanPoint Remote Audio CUES ccccccsesessesesceseceeseceecececeesersecevaceucevaceusarsucarsucevacersevavervaceusevavensereneneaten 48 Flosensor 910 Orc 0 kote nen E cn ee ee ee ee ee ee 49 User s Manual page 7 Table of Contents FloPoint Elite Uroflow System FloCharger MAGIC ALON S uarie Ea EEEE EEE EENET ONIE ued ENESE 50 Pernorming an EXAM sici a a e 51 Fee TO d or Me E All eee E a a aiia 51 Fe POM NIM an Exa erossa i i r EES TET 51 Rocording a VOICE ANMOLAUIOM osasse n a a 54 Cleaning and Maintenance sssssssssrnnnnnnnnnnnnnnnnn
97. nnel support using a disinfecting cleaner 6 Replace the funnel support by carefully seating it on the FloSensor and turning it clockwise to lock Take care not to contact the sensor disk during this process 7 Remove and dispose of your gloves page 56 User s Manual FloPoint Elite Uroflow System Cleaning and Maintenance FloCharger Cleaning Procedure eo Ss eS YS Unplug the FloCharger AC adapter from the mains wall outlet Remove the clamshell from the FloCharger base Dry any liquid remaining in the charging well Using a disinfecting wipe clean all the surfaces of the FloCharger Replace the clamshell on the FloCharger base Plug the FloCharger back into the wall outlet ScanPoint Remote Cleaning Procedure To clean the Remote use a germicidal wipe or a soft cloth dampened with IPA 70 isopropyl alcohol or an appropriate hospital cleaning agent to wipe the surfaces of the Remote until it is thoroughly cleaned Label Writer Cleaning and Maintenance The ScanPoint Label Writer is designed to give you long and trouble free service while requiring very little maintenance You ll get the best possible performance from your Label Writer if you follow the setup instructions that appear on page 39 To keep your Label Writer printer working properly you should clean it from time to time Dusting the outside of the printer occasionally will help keep foreign matter from getting inside the printer However
98. nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nn nnnnnnnn mnn nn nnmnnn mnnn 55 FloSensor Cleaning Procedures cccccccssseeeeccceeeeceeseeeeceeeeeeeaaeeeeeeeeeeseeeesseeeeeeeesesaesseeeeeeeesssaaseeeeeeeeesaaas 55 Quick Clean ProcedUrE seeiis ee ne en Ri 55 Solid Material Cleaning Procedure cccccccccssssseecceeeeseeeseeceeeeeeeeeeeeeceeeeeseueasseeeeeeesssaeaseeeeeesssaaaaaasees 56 FloCharger Cleaning ProCedure ccccccccccssseececceesecececauueeceeecaeueceseceueeeeessuaaeceeessaaaeceesssaeeeeesssagaeeees 57 ScanPoint Remote Cleaning ProC Gure ccccccccesscssssessssssesececesesescecececececescevevavavavecereevevevaseneneevevevaeeees 57 Label Writer Cleaning and Maintenance cccccccsseeeceeeceeeeceeecaeeseceeecaeeeeessaaseeeeessaeeeeeessaaeeeeeseasseeeees 57 Cleaning the Exterior and Interior of Your Printer sa0000nnnnnnnnneannnnnnnnnnnnnnnnosnnnnnnnnrnnnsnnnrnrrnennnrenereee 57 Regular Inspections and Maintenance ccccseeeeecseeeeeeceeseeecaeeeeeeseaeceeseeeeesseeseeessaseeessaeeeessaeeeensageeesens 58 Weekly INSDOCTIONS cccccceseccccesececceseeeceaucecseseecseasececsadeeecsagececseaeeessageeessageeeesaseeessudeeessaueeessageees 58 Repairing FloPoint Elite Devices cccecesssesessesesesesvecscescevecsceccevecaueevavaceusevacacessevavavensevavseertevacsneneesaten 58 Device ISCO SAN sans terncansncin suave tasasnes na tani E a E E E 58 Managing Exam Results in ScanPoint With QuickP
99. nsudipenvataijassnebtulissictiiaemtnudes 66 WIG WARIO FaSt EXAMS eerren earn arei ana ioare d e tata dusesosatinersess 68 FloPoint Elite Reports in ScanPoint with QUICKPYiNt cccececsesesecesescecesecececeseseecevevaceceeseeveraceeenenen 69 Repon Type Sampl ES eee en ee E AE ee eee 71 OnanGging YoUr PrelereriCES rcerassceniirine a a EE AEN EE A 77 Exiting QuickPrint or Hiding the QuickPrint WINKOW ccccccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 80 Closing the QuickPrint Window without Closing ScanPoint 0 c ccccceesesessesesesesesestesessesesteveneneees 80 TO Exit Quick Print Completely seseriai e e E EEEE EEEE E A Aia EE REAA E E AERE 80 CalDTANO oe E 81 Determining the Number of Days Until Required Calibration cccccccccceceeeeesesseeeeeeeeeeaeeeeeeeeeeeaaaeeees 81 page 8 User s Manual FloPoint Elite Uroflow System Table of Contents Calibrating the FloSensor using ScanPoint with QUICKPYiNt c ccccccccscsesesesescevecececeseseeteveveresereesevereeeees 83 If the Calibration was SUCCESSFUL ccccccceeeeeecceceecceeeeeeeeeeeeeeeeesseeeeeeesseeaaseseeeeeeessaeaeeeeessssaaaaaeeeeeeeees 84 If the Calibration Was UNSUCCESSFUL ccecccccceeeccaeeeseeceeeeeeeseeeseecceeeeesaeaeseeeeeeseueaseeeeeeesessuaaseeeseeeees 84 SOMmIDIS HG AMON OM eia goeessesaccanteeccdacecsncteesncudunsaeseatansassncude sondeasacsaauesteeosdevnconaeceen cassausstsacenceeadie 84 TOUS SOO CI
100. nt Calibration Warning Message Message 2 of 3 calibration within 20 days 0570 0154 2006 3 23 0570 0167 Expired 0570 0154 2006 3 24 The following instrument s require To view the date for the next scheduled calibration 1 Place the Remote in the ScanPoint Docking Station 2 In ScanPoint with QuickPrint go to the View menu and select INSTRUMENT DETAILS The Instrument Details dialog will open Figure 28 page 82 User s Manual FloPoint Elite Uroflow System Calibration Figure 28 Instrument Details Dialog D ScanPoint QuickPrint File view Tools Help LO Cradle Details Serial 2677 Instrument Overview Description Sean oveat A Communications Grade nstrument Details Name Part OSALOVES Serial Fay Kernel Version 7 607 Sotware Version 249 OCD Program i enat TAS hrs mrbO e00066I2 Last Calibration S762006 S 27 AM Next Calibration 27a2009 Sz AM The last two lines of information in the dialog provide the date of the last calibration and the date of the next required calibration 3 Click the green RETURN TO INSTRUMENT OVERVIEW button to close the dialog and return to the Instrument Overview Prepare New Exam pane Calibrating the FloSensor using ScanPoint with QuickPrint 1 Place the Remote in the ScanPoint Docking Station When the ScanPoint QuickPrint window opens select the Tools menu and click the Calibrate Instrument menu item 2 The
101. nt Elite Uroflow System Getting Started QuickPrint Preferences Wizard l a xj E Step 3 of 4 Customize Your Report Types s r EA eee A VERATHON C Yes want QuickPrint to prompt me for a Report Type before printing f No do not want to be prompted for a Report Type View Report Type Samples Below is a list of the Exam Types available to you based on the instruments that you own For each Exam Type listed please select the Report Type that you would like as your default BladderScan PDF for Physician s Office Pediatiic BladderScan POF for Physician s Office BladdeScan UEBW POF Stenad o SY Mobile BladderScan PDF for Physician s Office FloPoint Eite FOF Label FloPoint Details 2 labels F pou wish fo confinue customang Quick Pini cick Newt You may cick Fine af any ime fo close the Wizard and sel the remaning preferences fo ther defaui settings Click NEXT to open the last Customize Your Exam Reports dialog 9 If you want QuickPrint to ask you to specify the printer each time you print an exam report click the top radio button Select a default printer from the options in the drop down menu If you want QuickPrint to save the exam report in PDF format opened in Adobe Acrobat Reader each time it prints an exam place a check mark in the bottom check box The PDF can be incorporated into a patient s electronic medical record If you wish enter a default location on your compute
102. o start the exam press and release the button on the ScanPoint Remote Position the Remote within 10 feet of the FloSensor press and release the button on the ScanPoint Remote to start the exam process When you hear a chirp from the Remote see a 0 on the Remote and hear beeps from the FloSensor the device is I ready to perform an exam Instruct the patient Tell the patient that the FloSensor will beep every 3 seconds to indicate normal operation No cause for concern The beeping will stop when the patient begins to urinate Instruct the patient to relax and urinate and only urinate normally into the funnel Ask male patients to aim for the marked location on the side of the funnel Leave the ScanPoint Remote within 10 feet of the FloSensor for example on a hook in the restroom or just outside the restroom door This distance allows the FloSensor and ScanPoint Remote to communicate with each other The Remote will provide real time data throughout the exam Ee To end the exam press and release the button on the ScanPoint Remote When the patient is finished pick up the ScanPoint Remote press and release the button to end the exam The ScanPoint Remote LCD screen displays the final volume the peak flow and a flashing speaker icon to indicate the device is ready for annotation Press and Release www verathon com https my scanpoint com For more information call 800 331 2313 in t
103. oSensor inside the toilet FloCharger with Clamshell Stores the FloSensor recharges the batteries and resets the measuring device to zero FloPoint Elite Mounting Bracket Attaches to the wall securely holding the FloCharger and a funnel box 3 feet 0 914 m or more above the floor User s Manual page 109 Parts and Accessories FloPoint Elite Uroflow System Part and Part Number Name and Description ScanPoint Remote Acts as a remote control to start and stop the FloSensor displays information on flow measurements and device status and records voice annotation 0570 0174 ScanPoint Docking Station PE Transmits data from the ScanPoint Remote to the i P ScanPoint host computer and recharges the Remote batteries sape 0570 0168 To order any of the above parts contact your authorized Verathon Medical Sales Representative or contact the Verathon Medical Customer Care Department at 1 800 331 2313 FloPoint Elite Uroflow System Accessories The following accessories are included with your FloPoint Elite Uroflow System with ScanPoint with QuickPrint system Part and Part Number Name and Description Scan ra ScanPoint with QuickPrint Installation CD sear Produces reports based on the data gathered during an WO exam and submitted by the ScanPoint Remote 0900 1238 FloPoint Elite F Uraia Sytner m N er 0900 1445 FloPoint
104. oid for Patient Yes mb s lume rel Physician Signature 0570 0175 7040602 87893 User s Manual page 75 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System Figure 23 Quick Print Full Page Summary Report Verathon ScanPoint Exam Results FloPoint Results Summary Exam Date amp Time Thursday June 271 2007 9 48 AM Patient ID Example Patient Name Patient Operator Operator Physician Physician Gender Male Position Standing Normal Void for Patient Yes Peak Flow 20 0 mis D mis Physician Signature 0570 0175 7040602 87893 Figure 24 QuickPrint Detail Label Report FloPoint Report 0570 0175 TO40602 27893 June 21 2007 9 48 AM Eram Date amp Time Example Patient iD Patient Patient Name Operator d 3 4 5 6 7 8 9 10 Operator Physician i Physician Standing Yes Positten ormai Ver for Faten Time 2 Peak Flow 20 0mi s Page 1 of 2 page 76 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint FloPoint Report Peak Flow 20 0 mils Time to Peak 3 05 Flow 5 45 Flow Time Pattern Void Time 5 45 Voided Volume 51 mi Continuous 0570 0175 7040602 57653 Average Flow 9 4 mls a a E gt Time 8 Peak Flow 20 0ml s Page 2 of 2 Figure 25 QuickPrint Summary Label Report FloPoint Report June 21 2007 9
105. ollow the links for Acrobat Reader After installing the Acrobat Reader software you must run the program once to accept the End User License Agreement in order to use Acrobat Reader for printing reports Step 4 Install ScanPoint with QuickPrint IMPORTANT You must have Administrator privileges to install ScanPoint with QuickPrint The dialog boxes displayed on your computer may differ slightly from those illustrated in the following procedures If so follow the instructions in the dialog boxes displayed on your screen page 26 User s Manual FloPoint Elite Uroflow System Getting Started To use the ScanPoint Online service you need to install the ScanPoint with QuickPrint software included on the installation CD The software creates links on your Start menu and desktop to ScanPoint with QuickPrint ScanPoint online help the ScanPoint online manual and the Verathon Web site NOTE Review the following information before beginning installation of the ScanPoint with QuickPrint software Verify that your computer meets the minimum requirements for this software installation See Computer Hardware and Software Requirements on page 119 You must have Administrator privileges on your computer to install this software The dialog boxes displayed on your screen may differ slightly from those illustrated in the following steps In this case follow the instructions in the dialog boxes di
106. our PC Instructions begin on page 26 Set your ScanPoint with QuickPrint user preferences Instructions begin on page 33 Install FloPoint devices ScanPoint Docking Station and optional Label Writer using the Windows Install New Hardware Wizard Instructions begin on page 39 Charge the ScanPoint Remote and FloSensor batteries Instructions begin on page 44 NOTE The FloSensor and the Remote should arrive from the factory already charged page 20 User s Manual FloPoint Elite Uroflow System Getting Started Step 1 Unpack the Box and Check the Components Set the shipping container right side up and carefully open the top flaps do not insert anything sharp through the top of the box Remove the contents and verify that you have received everything listed below If anything is missing or damaged notify your authorized Verathon Medical representative or Verathon Medical Customer Care Department at 1 800 331 2313 Part and Part Number Name and Description FloSensor with Handles Measures urine volume and flow rate The Handles suspend the FloSensor inside the toilet 0570 0175 FloCharger with Clamshell Stores the FloSensor and recharges the batteries 0570 0176 FloPoint Elite Mounting Bracket Attaches to the wall securely holding the FloCharger and a funnel box 3 feet 0 914 m or more above the floor 0800 0337 User s Manual page 21 Getting Started FloPoint Eli
107. pplication Log If you are experiencing problems the Customer Care Department at Verathon Medical may send you a message requesting permission to view your application log Figure 31 page 92 User s Manual FloPoint Elite Uroflow System Troubleshooting Message 2 of 2 Figure 31 Application Log Request One of our Customer Service Represertatre staff members has requested that you upload your QuckPoit Representative Date Time log files for analysts CSR 10 20 2005 3 11 PM Do you wish to securely upload your current log file 6 20 2007 1 06 16 PM 6 20 2007 12 54 14 PM 6 20 2007 12 54 13 PM 6 20 2007 12 54 01 PM 6 20 2007 12 54 01 PM 6 20 2007 12 54 01 PM 6 20 2007 12 53 56 PM 6 20 2007 12 53 56 PM 6 20 2007 12 34 22 PM 6 20 2007 12 34 11 PM 6 20 2007 12 34 11 PM 6 20 2007 12 05 21 PM 6 20 2007 12 01 59 PM 6 20 2007 12 01 56 PM 6 20 2007 12 01 56 PM 6 20 2007 12 01 48 PM 6 20 2007 12 01 48 PM 6 20 2007 12 01 48 PM b N 2nn 11 AN AN AM Type Info Dulap Info Info Info Info Info Info Info Info Info Info Info Info Info Dulap Info Info Dulan No Figure 32 Application Log Data Application Log i Date Time ThreadiD Message RETTET Displaying LogFile Cradle found 00002774 ScanPoint A Communicati Opening Socket to Service FUS Assembly Registered Logfile backed up to disk Application Starting Version 1 3 Logfile backed up to disk Logfile backed
108. pplication of uroflowmetry is to provide an objective indication of a low urine flow rate caused by bladder outflow obstruction especially in males with symptoms suggestive of benign prostatic hypertrophy Uroflowmetry is also often included in the workup of females with urinary incontinence Clinical Condition or History Suggestive Of High bladder outlet resistance Examples include prostatism the most common indication lower urinary tract infection and previous lower urinary tract surgery Adecompensated bladder or weak detrusor contraction Neurologic impairment of voiding Examples include multiple sclerosis and spinal cord injury Specific Signs and Symptoms Prolonged or interrupted voiding High residual urine Manually assisted voiding e g by applying pressure to the lower abdomen Excessive straining required to void FloPoint Elite Output The FloPoint Elite Uroflow System plots urine flow rate in ml second versus time in seconds Several measurements are taken from the FloPoint Elite curve either manually by the clinician or automatically by a digital processor page 96 User s Manual FloPoint Elite Uroflow System Clinical Application FloPoint Interpretation Limitations and Specific Clinical Applications A reduced urine flow rate can be caused by either a bladder outlet obstruction or by detrusor hypocontractility In turn bladder outlet obstruction can be du
109. r ivit obstructive pattern Continuous High Peak Shortened Shortened Detrusor short instability and or duration and normal or reduced output superflow resistance pattern Irregular Fluctuating Variable No significance No Voluntary significance abdominal straining Detrusor sphincter dyssynergia Dysfunctional voiding Irregular Interrupted Variable No significance No Same as significance fluctuating pattern Possibly a more severe condition In female rule out stress urinary incontinence and lower urinary tract infection In male rule out cruising variable stream direction and intermittent squeezing of penis or foreskin Artifacts and Pitfalls Following are some events and conditions that can lead to misinterpretation of FloPoint Elite test results Spikes or Rapid Fluctuations in the Curve There are several potential causes of spikes in the FloPoint Elite curve that can lead to misinterpretation The most common of these are 1 mechanical disturbance of the flow sensor and 2 straining either during Figure 42 or at the end Figure 38 of the void The most significant misinterpretation that can be caused by spikes is mistaken identification by an automatic processor of a spike peak as the void maximum page 104 User s Manual FloPoint Elite Uroflow System Clinical Application Figure 42 shows examples of such a computer misinterpretation sol
110. r FloPoint Elite may be re printed through the QuickPrint interface by clicking the PRINT LAST EXAM button QuickPrint reports may be printed to a sheet of 8 5 x 11 on your local or network printer or to labels available with the ScanPoint Label Writer Use QuickPrint preference settings to select the desired report format and printer User s Manual page 71 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System Figure 19 ScanPoint Online Detail Report information images Q mis o Ww Time Volume mil Time 3 Customer comments FloPoint Summary FloPoint Details Exam Date amp Time Wednesday June 20 2007 9 35 13 AM Patient ID Example Patient Name Patient Operator Operator Physician Physician Gender Position Normal Void for Patient Peak Flow 20 0 mi s Average Flow 9 4 milfs Time to Peak Flow 1 3 Voided Volume 38 mil Flow Time 4 0 5 Pattern Continuous Void Time 4 0 S 50 45 40 35 30 25 20 15 10 Result Good Exam page 72 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint Figure 20 ScanPoint Online Detail Report Preview Print This Page FloPoints Details Exam Date amp Time Patient ID Example Patient Name Patient Operator Operator Physician Physician Yolume mil Physician Signature 1570 0175
111. r for saving exams in the Default Save Location text box You will always be able to specify a different location to save a specific exam Sp QuickPrint Preferences Wizard Step 4 of 4 Customize Your Exam Reports Continued ie ean oie A VERATHON I Check here if you wish QuickFrint to prompt you to select a printer each time YOU print an exam report Select a default printer eee eee ae drop esse list 2canPoint Label Writer i Completed Exams are generated by ScanPoint in PDF format Would you like to have GuickPrint prompt you to save the PDF file on your computer for future use Default Save Location C ScanPoint Resuits Browse Click Fimsh to save your settings and exi the QuwckFnni Preferences Wizard Click NExT The Preferences Wizard Complete dialog box is displayed User s Manual page 37 Getting Started FloPoint Elite Uroflow System 10 Click FINISH to exit the Preferences Wizard For more information on Preferences settings see Changing Your Preferences on page 77 QuickPrint Preferences Wizard Step 4 of 4 Customize Your Exam i Continued wy Select your remaining exam options A VERATHON I Check here if you wish QuickPrint to prompt you to select a printer each time you print an exam report Select a defauli printer from the drop ae list SeanPont Label Writer W Completed Exams are generated by ScanPoint in POF format Would you like to have GuickPrint
112. references Wizard Step 1 of 4 Set Your ScanPoint Login VERATHON Quick Print uses your ScenPoint Online User Name and Password to communicate wih the ScanFioint serves Please enter your User Name and NancDos Password to the left and then click the User Name JaneLioe Connect button WARNING H your User Name and Password Password fail to authenticate to ScanPoint check your entres for emors nd cick Connect again You wil be Connect unable to proceed to set your Guck Prt references until you successtully log in Please Enter Your ScanFoint User Name and Password If you cannot ramember your User Name or Password or if you need help logging in call Verathon Medical Customer Care at 800 331 2313 or ScanPoint URL https my scanpoirt com Change Jemma servica iverathon cam Authentication complete 5 Click NEXT to open the Customize QuickPrint Prompts dialog NOTE Do not change the default ScanPoint URL in this dialog unless requested to do so by the Verathon Medical Customer Care Department NOTE This ScanPoint User Name and Password will apply every time you log in to Windows using your current user account There is no time out period the User Name and Password you enter will remain active until you change them For information on changing your ScanPoint user profile see Changing Your Preferences on page 77 6 Indicate whether you want QuickPrint to prompt you for exam
113. rint cccscsssscesesesesseserssescesereesecevaveesevaveseeceveres 59 Starting ScanPoint with QUICKPYiNt ccccccccccesecesesesescssecececesescevevecscecusevevavacaceususevevavacaverensevevevacaventevens 59 ScanPoint with QuickPrint WiINdOWS ICONS ccccssssssesesesesesesesescevevevevevevececacacacacacavevererereneneneneueevevevenees 59 Using Multiple ScanPoint Docking Stations ccccccccccscsesecesesescesececesesescevevevacececeeseveveveueneevevevacanenenen 60 PINS Message MONICA ON serere E E 60 Completing an Unannotated Exam ccccccccccccsssseeeceeeeeeseeeeseeceeeceeeeeseeeceeeeseeaesseeceeeeeesseaaaeeeeeeesesaeanagees 60 If You Did Not Enter a Voice Annotation cccccccccseeceeeeesseeeceeeeeecseeeeessaeeeesseeeeessaeeeeseeeeesseeeessnseees 60 ESAle OEE a EEX GAs E E E E E E E E E T A E AE T TS 62 To Reprint the Most Recent Exam Results ccccceeccecseeeeeeseeeeeeceeeeeeeseeesseeeseseaeeeessegeeessseeeesnageees 63 Completing a Voice Annotated Exam cccccccccssssseeecceeeeeeaeeeeceeeeeeseaeseeceeeeeessaeeseceeeeeesaeeeeeeeeesssaaaaaaesss 63 Viewing Exam Results in ScanPoint Online c ccccccccssesesesesesececesesesesesescscecevevevevevevevevevevavavecenenenenenenen 66 Starting ScamPoint Online cccccccccscsesesesesesecececececececececeecevevevevevevevevavevevavavavavavavevevererereneevevevevevevevens 66 WIG WING E xam TACSUING seers n E nicarsnendl nent cauumenvessiens dndiarasuaicana
114. rinter Insert the power and USB cables through the cable channel and set the printer down 6 Connect USB cable to any available USB port on your computer ONLY when prompted to do so during software installation Installing a Roll of Labels 1 Press the form feed button to eject the labels that protected the Label Writer during shipment 2 Open the top cover and remove any packing material inside the label compartment page 42 User s Manual FloPoint Elite Uroflow System Getting Started 3 Remove the label spool 4 Hold the spool spindle in your left hand and place the label roll on the spindle so that the labels feed from underneath and the left edge of the label roll is flush against the side of the spool Figure 5 Figure 5 Loading a Roll of Labels on the Spool Spindle Spool spindle Spool guide 5 Place the spool guide onto the right side of the spool and press the guide tightly against the label roll leaving no gap between the roll and the spool NOTE The roll of labels must fit snugly against both sides of the label spool with no gaps so that the labels do not become misaligned as they feed through the printer 6 Align the left edge of the label with the left edge of the label feed slot and insert the label into the slot Figure 6 User s Manual page 43 Getting Started FloPoint Elite Uroflow System Figure 6 Inserting a Label into the Label Feed Slot 7 The Label Writer f
115. rograms gt Verathon Medical gt ScanPoint with QuickPrint gt ScanPoint with QuickPrint ScanPoint with QuickPrint Windows Icons The ScanPoint with QuickPrint window displays a status box and if appropriate a message icon Figure 9 Figure 9 QuickPrint Window with Status Box and Message Icon ScanPoint QuickPrint Status Box Status Indicator Instrument name fnsfrumen Delais Park Sno Ae Serial 5310701 l Message Next Calibration 9 12 2008 12 46 58 PM Indicator User s Manual page 59 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System Status Box symbols have the following meanings Item Meaning Status Indicator Possible symbols are Blue exclamation point QuickPrint is waiting for you to input information Green check mark The instrument is ready to use Red stop sign The instrument is performing a process such as transmitting information to ScanPoint Instrument image A picture of the instrument that is currently transmitting data to the computer Instrument name The name assigned to the instrument You can rename the instrument by clicking on the name and entering a new one Using Multiple ScanPoint Docking Stations If you have more than one FloPoint instrument with multiple Remotes and ScanPoint Docking Stations you will see one status box for each available device The currently active instrument is
116. rs please refer to the contact information on page 21 Weekly Inspections Once a week you should inspect the FloPoint Elite for physical faults or cracks Any apparent cracks or faults in the FloSensor FloCharger or ScanPoint Remote must be referred to an authorized FloPoint Elite Service Center or your local FloPoint Elite distributor IMPORTANT If you see any physical faults or cracks in the instrument discontinue use immediately and contact your local Verathon Medical representative or the Verathon Medical Customer Care Department at 1 800 331 2313 Repairing FloPoint Elite Devices The FloPoint Elite Uroflow System components ScanPoint Remote FloSensor and FloCharger and ScanPoint Docking Station are completely sealed There are no user serviceable components Verathon does not make available any type of circuit diagrams component parts lists descriptions or other information that would be required for repairing the device and related accessories Premium Warranty Total Customer Cares Plan customers have access to loaner replacement units and free shipping options which vary according to plan If you have any questions please contact your local Verathon Medical representative or the Verathon Medical Customer Care Department at 1 800 331 2313 Device Disposal The FloPoint Elite Uroflow System and related devices may contain lead batteries and other environmentally hazardous mater
117. ry short flow time A superflow pattern is usually seen in females It suggests decreased outlet resistance and or detrusor instability hence may be associated with urinary incontinence Figure 35 Superflow Pattern imis 30 45 40 35 30 25 Time 8 Obstructive Patterns suggestive of bladder outlet obstruction BOO are characterized by a prolonged flow time during which a large part of the total voided volume is voided at a constant low flow rate Figure 36 and Figure 37 show examples of obstructive flow patterns page 100 User s Manual FloPoint Elite Uroflow System Clinical Application Figure 36 Flat Top Obstructive Flow Pattern The peak on the spike at the end of the trace might have been misinterpreted by the uroflowmetry as the peak flow 30 45 40 35 30 25 miss 0 10 20 30 40 50 60 70 Time Figure 37 Rounded Top Obstructive Flow Pattern 50 45 40 35 304 254 imis 0 5 10 15 20 25 30 35 40 45 50 55 Time Irregular Patterns With the exception of an occasional terminal spurt e g Figure 36 or one or two secondary voids in a normal man irregular flow patterns are always either abnormal or artifactual There are two types of irregular flow patterns a fluctuating flow pattern in which the repeated downward deflections do not fall below a measurable flow rate and an intermittent flow pattern characterized by the occurrence o
118. s Manual page 13 Important Information FloPoint Elite Uroflow System To assure safe and reliable operation for the use and the patient please read and heed the following warnings and cautions WARNINGS and CAUTIONS To assure safe use and accurate results when using the FloPoint Elite Uroflow System be aware of the following conditions Read and understand all procedures prior to use Before using the FloPoint Elite Uroflow System you must read and understand all the instructions and procedures in this User s Manual Failure to comply with the instructions may affect the safety of the patient clinician and or the accuracy of the exam results For the most up to date version of the User s Manual go to http www verathon com manuals htm Clean after every use To ensure the reliability of the FloSensor it is imperative that you clean the FloSensor with a typical disinfecting bathroom cleaner after every use When cleaning FloPoint Elite Uroflow System components do not use any products containing ammonia Sterilization Do not sterilize this instrument Power Supply Only connect the FloPoint Elite AC adapter to power sources consistent with the input specifications shown on the adaptor label Risk of fire and or explosion Do not use the FloPoint Elite Uroflow System in the presence of flammable anesthetics Risk of device damage Do not allow any foreign objects fall onto or into the device Only e
119. s not passed Windows Logo testng to very its compatibility with Windows XP Tell me why this testing is important Continuing your installation of this software may impair or destabilize the comect operation of your system either immediately or in the future Microsoft strongly recommends that you stop this installation now and contact the software vendor for software that has passed Windows Logo testing Continue Anyway i 4 When driver installation is complete a dialog box is displayed to tell you the installation was successful Click FINISH Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software For FTOI FT oUass Device Click Finish to close the wizard User s Manual page 41 Getting Started FloPoint Elite Uroflow System Setting up the ScanPoint Label Writer NOTE This procedure is required only if your order includes the ScanPoint Label Writer Connecting the Label Writer to Power Refer to Figure 4 1 Plug the power cord into the power supply 2 Plug the power supply into the power connector on the bottom of the printer 3 Plug the other end of the power cord into a power outlet near the ScanPoint host computer Figure 4 Connecting the ScanPoint Printer to Power ScanPoint Label Writer Bottom View Power Power A Supply Plug the USB cable into the USB port on the bottom of the p
120. sful all four arrows are displayed User s Manual page 47 Displays Controls and Indicators FloPoint Elite Uroflow System ScanPoint Remote Buttons The ScanPoint Remote has two buttons The Start button below the display controls all the Remote operations and functions The Reset button ina recess on the back of the Remote is used only to reactivate the Remote in case it won t resume Ret i peas normal operation utton gt Button y on back Use the Start button as follows Press and Release the Button Wakes up the Remote when it s sleeping ine If no icons are visible on the display the Remote is sleeping Ifthe Remote is awake and within range of the FloSensor a single press and release will create a radio link between the FloSensor and the Remote The Remote will automatically record any data being transmitted by the FloSensor Ifthe Remote is collecting data from the FloSensor a single click will stop the transmission Pressing the Button Twice Wakes up the Remote when it s sleeping If no icons are visible on the display the Remote is sleeping Ifthe Remote is awake and within range of the FloSensor press the button twice to stop the FloSensor motor To restart the FloSensor either press and release the Start button or place the FloSensor on the FloCharger and then remove it again Press and Hold Record an annotation If the Remot
121. splayed on your screen Do not plug in any new hardware devices Label Writer Docking Station etc before installing ScanPoint with QuickPrint If you have already plugged one in cancel the Add New Hardware dialog box and disconnect the device s before proceeding Important Make sure you have the latest service pack and critical updates for the version of Windows that you are running To find recent security updates visit Windows Update From your Internet Explorer browser window select Tools gt Windows Update Installing ScanPoint with QuickPrint Software 1 To begin place the installation CD into your computer s CD drive The Install Shield Wizard should start automatically NOTE If the Install Shield Wizard does NOT open automatically a Double click the My Computer icon on your desktop b Double click your CD drive icon or name 2 The Preparing to Install screens will open User s Manual page 27 Getting Started FloPoint Elite Uroflow System InstallShield Wizard Preparing to Install ScanPoint QuickPrint Setup is preparing the InstallShield Wizard which will guide you through the program setup process Please wal Checking Operating System Version EE InstallShield Wizard Preparing to Install ScanPoint QuickFrint Setup is preparing the InstallShield Wizard which will guide you through the program setup process Please wai Configuring Microsoft
122. sue Problem Answer A security warning You may be trying to run an outdated version of appeared on my screen ScanPoint or the driver ScanPoint needs is not available If either is true click Yes in the security warning dialog box Why do I get an error A minus sign cannot be the first character in any message saying that ScanPoint text box Re enter the digits without the must enter a positive minus sign number An error message Click the HELP button on any ScanPoint screen and appeared on the follow the directions provided 4 ScanPoint screen If you still have questions contact the Verathon Medical Customer Care Department at 1 800 331 2313 My account has expired Contact Verathon at 1 800 331 2313 to reactivate your account I can t access some menu You can access only the features for which you have options signed up ScanPoint Remote Problems Issue Problem Answer The Remote does not Make sure you are within 3 meters of the FloSensor recognize the FloSensor Or the FloSensor is not communicating with the Remote Make sure the FloSensor battery is charged and the Remote battery is charged The Remote does not turn The Remote battery may need to be charged on 1 Place the Remote in the ScanPoint Docking Station make sure the computer is turned on for up to 8 hours 2 Ifthe scrolling battery icon does not appear after 2 hours press the Reset button on
123. t WEEE solid bar indicates product was put on the market after 13 August 2005 Class Il equipment protected throughout by double insulation or reinforced insulation oj g Type BF applied part with EN IEC 60601 1 page 114 User s Manual FloPoint Elite Uroflow System Specifications Symbol Meaning C CE marked in accordance with the Medical Device Directive MDD Canadian Standards Association CSA mark of certification to SP United States standards for electromedical equipment Cc Standards and Regulations Compliance Verathon certifies that all units are in compliance with all applicable international and national standards and regulations including but not limited to the following Specification Standard Electromagnetic compatibility standards IEC 60601 2 ICES 001 Safety Standard IEC 60601 1 Health Insurance Portability and Accountability Act HIPAA For details on Verathon compliance with privacy rules please refer to the information in the QuickPrint Help menu select Privacy Agreement Electromagnetic Effects There are no restrictions on the use of FloPoint Elite Uroflow System due to its electromagnetic characteristics Both the emissions from FloPoint Elite 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 proce
124. t box enter the name you want to automatically appear in the Physician text box NOTE You can always overwrite these default names for a particular exam 5 Choose a default printer for printing exams NOTE You will be able to change printers for a particular exam only if you place a checkmark in the Prompt for Printer check box Specify default names for 1 Click the Exam Settings tab page 78 User s Manual FloPoint Elite Uroflow System Managing Exam Results in ScanPoint with QuickPrint To the Operator and Physician text boxes in the Exam Details dialog box Do this 2 Place a check mark in the Prompt for Exam Details check box In the Default Operator text box enter the name you want to automatically appear in the Operator text box In the Physician text box enter the name you want to automatically appear in the Physician text box NOTE You can always overwrite these default names for a particular exam Specify a default printer Click the Exam Settings tab Click the down arrow on the right side of the Default Printer check box and choose the printer you want If you do not place a check mark in the Prompt for Printer check box this printer will be used every time you print a new exam Have ScanPoint with QuickPrint prompt you to save a PDF a printable copy of the exam after each exam Click the Exam Settings tab Place a check mark in the Prompt
125. taskbar click Start gt Run The Run dialog will open 2 Type D setup exe where D is the name assigned to the CD drive and click Ok I can t access the Check your Internet connection ScanPoint Web site can t start ScanPoint Exit all open Internet Explorer windows and restart the program I can t log onto You may have mistyped your login name and password ScanPoint Try entering them again making sure that they are spelled correctly and that you are using upper and lower case letters as appropriate If you can t remember your login name or password click Get help with sign in My ScanPoint session Your ScanPoint session has timed out because it was has expired idle for over 12 hours You must log in again Why do some text boxes A red asterisk indicates that the text box cannot be left have red asterisks blank You are required to enter text in any field marked with a red asterisk can t find the exam Make sure the exam was transmitted to your account results I want and not someone else s If it was transmitted to your account but you still can t find it one of the following conditions may apply ScanPoint may not have validated the exam yet Wait a few minutes and try again The exam results may have already been viewed If so go to the Past Exams menu and request the results again page 88 User s Manual FloPoint Elite Uroflow System Troubleshooting Is
126. te Uroflow System Part and Part Number 0900 1238 FloPoint Elite F Ureia Sachem an cin 0900 1445 K 0800 0297 Name and Description ScanPoint Remote Acts as a remote control to start and stop the FloSensor displays information on flow measurements and device status records voice annotations and transmits data to a ScanPoint host computer when placed in the ScanPoint Docking Station below ScanPoint Docking Station Transmits data from the ScanPoint Remote to the ScanPoint host computer and recharges the Remote batteries ScanPoint with QuickPrint Installation CD Produces reports based on the data gathered during an exam and submitted by the ScanPoint Remote FloPoint Elite In Service CD Includes FloPoint Elite User s Manual and Quick Reference Cards Box of Paper Funnels Help direct the urine flow toward the FloSensor Box contains 40 funnels page 22 User s Manual FloPoint Elite Uroflow System Getting Started Part and Part Number Name and Description Activation Tool Use to press the Reset button on the ScanPoint Remote if ag the Remote needs to be reactivated 0130 0181 Lanyard Attaches to the ScanPoint Remote if desired to assist with placement of the Remote in proximity to the FloSensor Ta User s Manual FloPoint Elite FloPoint Elite Uroflow System User s Manual this manual VRA oe User s Manual
127. this instrument until you thoroughly understand all instructions and procedures in this manual Failure to comply with these instructions may compromise the performance of the device and the reliability of its measurements For the most current version of this User s Manual please visit the Verathon web site at htto www verathon com manuals htm Statement of Prescription United States federal law restricts the FloPoint Elite Uroflow System to use by or on the order of a physician This statement is required per 21 Code of Federal Regulations CFR 801 109 NOTE It is standard practice to have medical staff authorize the use of the FloPoint Elite Uroflow System within its intended use throughout an institution Individual prescriptions for use are not required Statement of Intended Use The FloPoint Elite system is intended for uroflowmetry exams the measurement and analysis of urine discharge rate and volume The FloSensor is placed in a toilet bowl with a disposable funnel placed on top which directs the urine flow into the sensor The patient may void into the sensor from either a standing or sitting position Uroflowmetry data gathered by the FloSensor is transmitted to the ScanPoint Remote via wireless radio link When used in conjunction with ScanPoint with QuickPrint software a report containing the ICS values for uroflowmetry may be generated for the patient s medical record Contraindications None User
128. tient records displays flow diagrams Technology from exams downloads software updates and calibrates the FloPoint Elite ScanPoint with ScanPoint with QuickPrint is a software program installed on your QuickPrint computer that communicates with ScanPoint Online to help you quickly and easily download and print FloPoint Elite measurements Sleep mode When the FloSensor and or ScanPoint Remote shuts down to conserve energy Press the ScanPoint Remote button to wake up the device Summary Provides only peak flow measurement and prints on a single label Report or a single sheet of 8 5 x 11 paper The Summary Report contains the date and time of the exam patient ID patient name operator ID physician gender position and indicator for whether or not this was a normal flow for the patient peak flow measurement chart of flow rate vs time part number and serial number of the FloSensor and the ScanPoint exam ID See also Detailed Report Time to Peak Flow The amount of time measured in seconds between the start of the first interval of flow to the maximum measured flow rate Undetermined Pattern There were no flow intervals detected in the exam see also Continuous and Intermittent Void Time The total amount of time in seconds from the start of the first interval to the end of the last interval including all the time between intervals where flow is not measured
129. ting options The Remote also tracks other diagnostic information about the internal functioning of the FloSensor Part Name Purpose Handles Provide a means for carrying the FloSensor suspend the FloSensor in the toilet bowl and support the disposable funnel FloSensor Measures urine volume and flow rate Latch Allows the FloCharger housing to be closed securely Clamshell Protects the FloSensor and FloCharger from dust and contaminants when not in use FloCharger Recharges the FloSensor battery FloPoint Elite Mounting Bracket Attaches to the wall securely holding the FloCharger and a funnel box 3 feet 0 914 m or more above the floor Funnel Box Contains 40 disposable funnels for attachment to FloSensor during uroflow exams ScanPoint Acts as a remote control for starting stopping the FloSensor Its Remote LCD display communicates exam and device status to the user The FloSensor transmits exam data to the Remote via a wireless radio link The Remote in turn downloads this data to a computer with ScanPoint with QuickPrint software Start Stop button LCD display Microphone Starts stops FloSensor functions for exams and calibration Displays measurement data and device status Records voice annotations Reset button A recessed button on the back of the Remote that re activates the Remote when it doesn t self activate Occasionally when the Remote battery has been completel
130. ting Started FloPoint Elite Uroflow System Click NEXT Found New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software Yes this time only O Yes now and every time connect a device Click Next to continue 2 The second New Hardware Wizard screen is displayed Select the INSTALL THE SOFTWARE AUTOMATICALLY radio button and click NEXT to install the drivers for the hardware automatically Faumi Mew Hardware Wirtard This Mian halps pou inslall ofthe for FIG FTIA Device Y li yowm herders came wilh an metallation OI as w Hopp diak insert it maw Wwihal do you man Hee wizard bo do Qik Meal bo conlinue ek ten cence page 40 User s Manual FloPoint Elite Uroflow System Getting Started 3 A warning is displayed stating that Microsoft has not yet tested this software for compatibility with the Windows XP and Windows 2000 operating systems However Verathon Inc has tested the ScanPoint with QuickPrint software and hardware drivers rigorously and is confident that they are fully compatible with both Windows XP and Windows 2000 Click CONTINUE ANYWAY Software Installation The software you are installing ha
131. tivation Tool The small tool used to depress the Reset button on the back of the Remote see Activate above Annotation A brief voice recording made on the ScanPoint Remote providing exam details Average Flow The average flow rate during flow intervals measured in ml s This calculation does not include the time between intervals Calibration Checking the accuracy and function of your FloPoint by comparing it with a known standard ScanPoint The unit that transmits exam data from the Remote to the Docking Station ScanPoint host computer and when the computer is turned on also charges the Remote battery Continuous There was one flow interval detected during the exam Pattern Detailed Report This report contains all ICS values and prints on two labels or a single sheet of 8 5 x 11 paper It contains the date and time of the exam patient ID patient name operator ID physician gender position and indicator for whether or not this was a normal flow for the patient peak flow measurement average flow measurement voided volume flow time measurement void time measurement pattern measurement chart of flow rate vs time chart of cumulative volume vs time part number and serial number of the FloSensor and the ScanPoint exam ID See also Summary Report FloCharger The FloPoint Elite base unit that provides a storage and transportation unit for the FloSensor and also recharges the FloSensor b
132. to Save Exam PDF check box If desired enter a default location for saving exams in the Default Save Location text box You will always be able to override this setting for a specific exam Have ScanPoint with QuickPrint prompt you for a report type View sample report types 1 D Click the Report Settings tab Place a check mark in the Prompt for Report Type check box To specify a default report type for each FloPoint Elite device you have available click the down arrow to the right of the text box and select the appropriate type Click the Report Settings tab Click the View Report Type Samples link You can also view report samples in this manual starting on page 71 page 79 Managing Exam Results in ScanPoint with QuickPrint FloPoint Elite Uroflow System To Do this Specify a default report for 1 Click the Report Settings tab each exam type 2 Click the down arrow to the right of the appropriate instrument text box and select the appropriate report type If you do not place a check mark in the Prompt for Report Type check box these report types will be used every time you print a new exam Change the location for NOTE Do not perform this procedure unless updates to ScanPoint with instructed to do so by an authorized Verathon QuickPrint representative 1 Click the System Settings tab 2 Inthe Update URL text box enter the new Web site location giv
133. to comply with IEC 60601 1 and the National Electric Code in the United States and the Canadian Electric Code in Canada no part of the FloCharger cord must be lower than 3 feet above the floor Use the cord wrap underneath the FloCharger to protect the unused portion of the cord Any other installation method will jeopardize compliance of the FloPoint Elite system with IEC 60601 1 and the NEC or CEC and will therefore void any warranties implied or otherwise offered by Verathon Medical for the instrument WARNING Install the FloCharger Mounting Bracket at a height of at least 3 feet 10 meters above the floor WARNING Use the cord wrap underneath the FloCharger to protect the unused portion of the cord WARNING Installation of a FloCharger that does not use the Mounting Bracket or alternate protection of the cord will not be compliant with the Medical Electrical Safety Standard IEC 60601 1 Alternate protection requires that the cord be 3 feet 10 meters above the floor and not easily accessible by a patient User s Manual page 25 Getting Started FloPoint Elite Uroflow System 1 Attach the Mounting Template to the wall such that the bottom of the template is level and 3 feet 914 cm above the floor 2 At each of the 4 marked locations press the tip of the anchor into the drywall using a 2 Phillips screwdriver Drive anchor clockwise until anchor stops flush with the wall Insert the screw into the anchor Tig
134. tronic data interchange in the U S health care system International Continence Society An international association of medical professionals whose purpose Is to study storage and voiding function of the lower urinary tract its diagnosis and the management of lower urinary tract dysfunction and to encourage research into pathophysiology diagnostic techniques and treatment Intermittent There were two or more flow intervals detected during the exam Pattern see also Continuous and Undetermined LCD screen The LCD liquid crystal display screen on the ScanPoint Remote that displays flow measurements instrument status and other exam settings and information New Flow A new flow interval is identified by a Flow Interval Start that is at Interval Starts least 0 25 seconds after the previous Flow Interval End Peak Flow Peak flow rate measured in ml s The value of the peak flow detected by the FloSensor see also Average Flow QuickPrint The program that process exams and prints the results User s Manual page 123 Glossary FloPoint Elite Uroflow System Term Meaning ScanPoint The remote control unit that receives exam data from the Remote FloSensor via radio contact and transmits the exam data to the ScanPoint host computer via ScanPoint Remote Docking Station ScanPoint The software and online service provided by Verathon that prints Imaging exam results maintains pa
135. up to disk Sending Application to Device Part 570017400 Se Logfile backed up to disk Retrieving Calibration App for DCD Part 570017500 Logfile backed up to disk Removing Cradle Serial 00001 757 Sending Refresh message to Service Processing Refresh Request RAD file received from cradle 00002774 and saved I Beginning Exam Data Download Process for Remote Downloading SRam Scan from DCD Serial 5310701 Cradle found 19NN2774 ScanPnint IR Communica gt The application log is a record of all the actions ScanPoint has performed No patient data is included You can preview your application log by going to the View menu and selecting Application Log Figure 32 shows a typical application log User s Manual page 93 Warranty FloPoint Elite Uroflow System Verathon Medical warrants the FloPoint Elite Uroflow System against defects in material and workmanship as long as it is covered by the Premium Warranty Total Customer Cares Plan This warranty does not cover equipment sold as used Damage or loss insurance is availability as part of the Total Reliability Plan Pursuant to this warranty a service center authorized by Verathon will repair or replace units that prove to be defective during the warranty period This warranty does not apply if the unit was misused or modified by anyone other than a service center authorized by Verathon The unit must be used in accordance with the instructions contained i
136. uptions Total duration of measurable flow Time from flow onset to peak flow Measurements Related to FloPoint Elite Curve Patterns NORMAL RESULTS Averages about 10 seconds with 100 ml voided volume and 25 seconds with 400 ml voided volume No normal limits defined Equal or nearly equal to voiding time A flow time that is significantly shorter than the voiding time indicates an abnormal intermittent FloPoint Elite pattern About 30 percent of voiding time Has no clinical significance with irregular flow pattern Time to peak flow rate flow time and voiding time do not provide the same quantitative normal versus abnormal results as do flow rates However as discussed in the next section these measurements can provide useful indications of the FloPoint Elite curve s shape Continuous Regular Patterns Normal A normal FloPoint Elite pattern is a smooth unbroken bell shaped curve with peak flow occurring relatively early Time to peak flow averages about 30 of total flow time Figure 34 shows an example of a normal uroflow curve User s Manual page 99 Clinical Application FloPoint Elite Uroflow System Figure 34 Normal Uroflow Curve a milfs 50 45 40 35 30 25 Time Superflow Figure 35 shows an example of a superflow pattern This pattern is characterized by a very high flow rate usually greater 40 ml sec and a ve
137. ver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help Modifications to this equipment not expressly approved by Verathon could void the user s authority to operate the equipment FloPoint Elite Uroflow System is suitable for use in industrial scientific and medical ISM environments and in domestic environments under the jurisdiction of a health care professional An indication of adverse electromagnetic effects from FloPoint Elite Uroflow System 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 The FloPoint Elite Uroflow System 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 IEC 60601 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 pressure acceleration or thermal ignition sources Health Insurance Portability and Accountability Act To address the growing concern about the protection and confidentiality of an individual s medical informat
138. xpose the unit to fluids as directed for uroflow measurements and cleaning Do not subject the FloPoint Elite Uroflow System to mechanical vibration dust or shock Do not store or use the FloPoint Elite Uroflow System near heat sources such as radiators Do not operate this device in temperatures below 10 C 50 F or above 35 C 104 F Do not store this device in temperatures below 10 C 14 F or above 35 C 95 F Assure that the FloPoint Elite Uroflow System is situated in an area with proper ventilation To comply with IEC 60601 1 and national electrical codes the FloCharger must be wall mounted as described in this manual Never cover the FloCharger or FloSensor with any cloth or other object that might interfere with proper ventilation Do not store or operate the FloPoint Elite Uroflow System near equipment or devices that generate strong electro magnetic fields Do not place any heavy objects on top of the FloSensor or FloCharger Hazardous materials present Assure proper disposal The FloPoint Elite Uroflow System may contain lead batteries and other environmentally hazardous materials When the FloPoint Elite Uroflow System has page 14 User s Manual FloPoint Elite Uroflow System Important Information reached the end of its useful service life return the device and related accessories to a Verathon Service Center for proper disposal Alternatively follow your local protocols for
139. y Dy Wi TAO US Fs rsrsrs nnie EEE E E E 105 page 12 User s Manual FloPoint Elite Uroflow System Important Information Important Information Product Description The study of urine discharge rate or uroflowmetry is recognized by the medical community to be valuable in the determination of comparative urological function The advanced technology in the FloPoint Elite Uroflow System provides an accurate and convenient method to help assess bladder function The FloSensor contains a disk that spins at a constant speed When a flow of urine hits the disk the motor must work harder to maintain the disk spinning at that same speed with the added weight of the urine The FloSensor measures the amount of power needed to maintain the disk s Original soeed and uses that measurement to calculate the urine flow rate The FloSensor also records the total amount of urine discharged by the patient This data can be analyzed using the ScanPoint with QuickPrint software to determine how quickly or slowly the patient urinated any interruptions or changes in the flow and the total volume of the patient s bladder Intended Use Warnings and Cautions The FloPoint Elite Uroflow System should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care All users must read this entire User s Manual prior to using the FloPoint Elite Uroflow System Do not attempt to operate
140. y The computer must minimally comply with the requirements Compliance of IEC 60950 and preferable with the requirements of IEC 60601 1 Computer Connection USB 1 1 Design Decoupled transformer at 200 mA at 4 2 V 25 kHz Water Ingress IPXO Accuracy Specifications The accuracy specifications assume the instrument is being used according to the instructions provided by Verathon Specification Description Flow rate measurement 3 1 ml s as measured by Verathon accuracy measurement test Volume measurement 3 5 ml s as measured by Verathon accuracy measurement test Maximum Flow Rate 50 ml s Maximum volume measure 2 liters page 118 User s Manual FloPoint Elite Uroflow System Specifications Operating Conditions All components of the FloPoint Elite Uroflow System are designed to function properly within the following specifications Condition Value Use Indoor Ambient Temperature Range 10 35 Celsius 50 95 Fahrenheit Atmospheric pressure range 70 kPa 106 kPa Relative humidity 30 75 non condensing Storage Conditions All components of the FloPoint Elite Uroflow System are designed to withstand the following storage conditions Condition Description Storage Indoor Ambient Temperature Range 10 35 Celsius 14 95 Fahrenheit Atmospheric pressure range 50 kPa 106 kPa Relative humidity
141. y discharged you may need to reset the Remote before it can be used again ScanPoint Label Writer Optional Printer The ScanPoint Label Writer is an optional component of the FloPoint Elite System It prints patient exam data on self adhesive labels approximately 2 5 x 6 that can be attached to a patient record The parts and features of the ScanPoint Label Writer are shown in Figure 2 page 17 Introducing the FloPoint Elite Uroflow System FloPoint Elite Uroflow System Figure 2 ScanPoint Label Writer Parts and Features Bottom View Top Side View Top cover USB Label roll connector DC power connector Platen release Label feed path and tear bar Form feed Cable button and LED bel eject channel Label ejec button The ScanPoint Label Writer is a direct thermal printer and does not use toner ink cartridges or a ribbon Instead it uses heat from a thermal print head to print on specially treated labels The Form feed button on the front of the printer advances a single label The Label eject button is used to remove labels from the printer when changing rolls The LED status light allows you to visually determine the current state of the printer o Solid blue Power is on and the printer is ready o Flashing blue Labels are not loaded properly or label spool is empty ScanPoint Online ScanPoint with QuickPrint software is includ

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