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BladderScan® BVM 9500 User's Manual

1. Power On Off Battery Charger Wireless Hub Probe 1 Scan button ta IN on hand grip i li crophone Aiming Display above display User s Manual page 13 Introducing the BladderScan BVM 9500 BladderScan BVM 9500 Probe Components The Probe transmits and receives ultrasound waves automatically moving its internal Probe 360 to scan 24 different planes to produce a three dimensional image of the bladder The Probe is attached to the Console by a cable The Probe has three main features SCAN button Press to take a scan Aiming Display The LCD displays directional arrows to assure that the bladder is centered within the scanning cone Microphone Records voice annotations Console Components The Console provides all operating controls for the scanning process by means of five variable function buttons The measured bladder volume and UEBW and target shaped aiming icons are clearly displayed on the LCD screen The Console also provides controls for adjusting brightness and volume turning the power on off interfacing with a ScanPoint equipped computer optional and adjusting user settings and preferences The Console also houses the battery and the printer The Console s controls and features are described in the following table Main Display Displays the bladder volume measurement patient type settings and instrument status Power ON OFF Toggles main power on off Volume Press to adjust volume up down on voice annotat
2. Savings ES E m NOTE DO NOT remove the battery until the device shuts down completely Replacing the battery while memory is being optimized might disable the instrument as program and exam files might not be rewritten properly User s Manual page 45 Measuring Bladder Volume and UEBW BladderScan BVM 9500 Measuring Bladder Volume and UEBW Preparing for the Exam Before You Begin the Exam Make sure you are familiar with the parts of the BladderScan instrument see Introducing the BladderScan BVM 9500 on page 13 If you are a new BladderScan instrument user Verathon recommends that you perform your first exam on a patient with a moderately full bladder rather than initially attempting to locate and scan a nearly empty bladder To measure Ultrasound Estimated Bladder Weight UEBW verify that the measured bladder volume is sufficient for a successful exam The patient s bladder volume must be between 150 ml and 400 ml to ensure an accurate reading UEBW will be shown as g when the bladder volume is above or below the recommended range of 150 to 400 ml UEBW will also be shown this way if the bladder is not centered in the ultrasound cone Check the instruments battery icon to make sure the battery has sufficient power NOTE If the battery icon is 1 4 or less full replace the battery with a freshly charged battery before proceeding Place the discharged batter
3. User s Manual BladderScan BVM 9500 Statement From the CEO Statement From the CEO The team at Verathon is committed to improving health care delivery by putting healthcare providers and their patients first Our products support you the health care provider by consistently offering accuracy utility reliability and excellence Please contact us directly at 1 800 331 2313 USA and Canada only or 1 425 867 1348 if we can improve our service to you Sincerely Gerald McMorrow Gerald McMorrow CEO and Founder User s Manual page 7 Important Information BladderScan BVM 9500 Important Information Product Description page 8 The BladderScan BVM 9500 is a portable ultrasound instrument that provides noninvasive measurements of urinary bladder volume bladder wall thickness and Ultrasound Estimated Bladder Weight UEBW The device consists of an ultrasound Probe that scans the patient s bladder and a compact battery operated Console that provides an array of measurement related information The BladderScan BVM 9500 is noninvasive and comfortable for the patient It is quick accurate reliable and easy to use When the user releases the scan button within seconds the BVM 9500 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image Based on this image the BladderScan BVM 9500 calculates and displays the bladder volume bladder wall thickness and UEBW A son
4. 4 To remove all traces of disinfectant solution wipe the instrument with a clean soft cloth dampened in sterile water or cleaning solution Verathon recommends wiping the device three separate times to remove all residual disinfectant 5 Thoroughly dry the instrument with a clean soft cloth before using IMPORTANT Failure to heed the following warnings may cause device damage not covered by the BladderScan BVM 9500 warranty Do not immerse the instrument in disinfectant solution Do not use CidexPlus to disinfect the instrument CidexPlus will damage the plastic enclosure Do not subject any part of the instrument to steam sterilization or ethylene oxide sterilization NOTE Ultrasound probes that are non critical devices only need to be cleaned and low level disinfected between patient uses Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Appendix D Cleaning Disinfection and Sterilization Accessed at www fda gov MedicalDevices DeviceRegulationandGuidance GuidanceDocuments ucm098001 htm Regular Inspections and Maintenance Verathon Medical recommends that the BVM 9500 be certified by an authorized BladderScan Service Center once a year Certification service includes comprehensive inspection and testing of the instrument to ensure accurate performance in clinical use For more information please contact your authorized Bl
5. Date and Time Screen highlighted red READE VM 9500 BVM 9500 Press the button to ee ee increase values Press the button to 11 22 decrease values 026 2008 6 When the time and date are set correctly press the SETTINGS button asc to return to the Settings screen From the a screen push the HOME button to return to the Home screen Setting General Preferences and Savings Preferences NOTE See page 39 for information about setting General Preferences Savings Preferences and Self Test Options General Preferences Savings Preferences and Self Test Options can be accessed from the Settings screen General preferences include options for Language Date Format Time Format Calibration Warning Print Report Type Print UEBW and Manual Wall Thickness Mode Savings Preferences include UTI Rate UTI Cost Catheterization Cost Catheterization Volume Currency and Savings Calculation User s Manual page 21 Load a Roll of Thermal Paper To load a new roll of thermal paper 1 Open the paper compartment door located on the base of the Console under the display Slide the door to the right then lift the printer door up 3 Insert the end of a new paper roll with the thermal side down into the paper slot To verify which side is the thermal side scratch the paper with your finger nail If a black mark appears this is the thermal side Extend the end of the paper past the end of the unit Ro
6. Take a bladder volume measurement of a female patient who has J not had a hysterectomy When the female icon is illuminated the BVM 9500 will assume the patient has a uterus Take a bladder volume measurement of a male patient or a ae E female patient who has had a hysterectomy Press to view the training video Go to the Settings screen set the time date institution name and user preferences 20 gt o A Press to review a previously saved exam This button will be gray inactive if there are no previously saved exams to review e Press to initiate communication with the ScanPoint host computer Saved and annotated exams will be automatically uploaded to the host computer ScanPoint software must be previously installed and a connection open Use of the ScanPoint software is optional 6 sg page 28 User s Manual BladderScan BVM 9500 Displays Controls and Indicators Scan Screen The Scan screen Figure 14 appears and displays a progressively updating image of the bladder outline When the ultrasound measurement is complete the Results screen opens automatically The five buttons below the display do not function during the scan Figure 14 Scan Screen BVM 9500 BVM 9800 Bladder Volume and Mass Instrument CCCCCOCOCOCOOO e le Results Screen The Results screen Figure 15 appears automatically when a scan is complete The Results screen displays the bladder outline
7. The ability to calibrate and certify devices online anytime you wish Automatic data backup and archiving HIPAA compliant Automatic software upgrades Access to real time troubleshooting from Verathon A Verathon device warranty plan that provides all the benefits of ScanPoint Online preceding paragraph and also All repairs performed free of charge Instrument insurance A perpetual warranty against outdated technology with free upgrade replacement when your device is no longer manufactured Free loaner program Free shipping page 61 Troubleshooting BladderScan BVM 9500 Resource Description Verathon Web site http www verathon com includes many in service training resources From the Verathon Home page select BladderScan On the BladderScan page select Customer Service Phone support In North America call 1 800 331 2313 International customers please refer to contact information on page 66 Icons on the BladderScan Console The following icons may appear on the instrument s LCD screen Symbol Meaning m Solid arrow The bladder is contained within the image cone cone shaped area in which the Probe transmits ultrasound waves but not centered You may be able to obtain a more accurate measurement by re aiming the Probe in the direction indicated by the arrow Battery power level Indicates a fully charged battery Indicates a battery 50
8. to 75 charged Indicates a battery 25 to 50 charged Indicates a battery that is nearly discharged and can power only a few more scans ul Indicates the battery must be changed The patient is a female patient who has not had a hysterectomy The patient is male or a female who has had a hysterectomy gt The bladder is too large to be contained within the scan cone or the bladder contains more than 999 ml of urine page 62 User s Manual BladderScan BVM 9500 Troubleshooting Diagnosing Problems Instrument Does Not Turn On If the instrument does not turn on this is usually due to a dead or discharged battery and can be remedied by replacing the dead battery with a charged battery Check the battery icon in the upper right corner of the LCD display If the battery icon does not display any power segments replace the battery When the battery charge is too low to allow normal operation but not too low to permit operation of the internal circuitry the device displays the following message BATTERY CHARGE LEVEL IS TOO LOW FOR INSTRUMENT OPERATION RECHARGE BEFORE NEXT USE In this case the battery must be recharged or replaced with a charged one UEBW displayed as g To measure Ultrasound Estimated Bladder Weight UEBW the patient s bladder volume must be between 150 400 ml to ensure an accurate reading Above or below this range UEBW is shown as g UEBW may also show a
9. 0 95 max TIS TIB TIC Range 0 0 4 0 Transducer diameter 13 mm 0 512 inches Transducer resonant frequency 1 74 MHz 3 0 MHz and 7 37 MHz Transducer bandwidth 80 at 10 dB Time from 3D scan initiation to result lt 10 seconds display User s Manual page 71 Product Specifications page 72 Accuracy Specifications BladderScan BVM 9500 The accuracy specifications assume the instrument is being used according to the instructions provided by Verathon scanning a tissue equivalent phantom Specification Bladder volume accuracy Bladder volume range UEBW accuracy UEBW range Wall thickness accuracy Description 15 15 ml on a Verathon tissue equivalent phantom 0 999 ml 10 39 on a Verathon tissue equivalent phantom 20 100g 1096 1 mm on a Verathon tissue equivalent phantom BladderScan BVM 9500 Operating Conditions The BladderScan BVM 9500 is designed to function properly within the following specifications Condition Description Use Ambient temperature range Atmospheric pressure range Relative humidity Water resistance Indoor 10 40 Celsius 50 104 Fahrenheit 700 hPa 1060 hPa 30 75 non condensing Rated at IPX1 indicates DRIP PROOF a higher than ORDINARY level of protection from drips leaks and spills BladderScan BVM 9500 Storage Conditions The BladderScan BVM 9500 is designed for storage under the following conditions Condi
10. 3 m 6d Pubic Bone seen You may also see a display indicating BVM 9500 GVM 8500 ajaa that the pubic bone is inside the ultrasound cone If this occurs you should re aim and re scan Volume 280ml Although the bladder may be shown pl as centered in the ultrasound cone and your measurement may be complete there is a possibility that the pubic bone is obscuring part of the bladder By re aiming and re scanning you can ensure you have captured the bladder fully inside the ultrasound cone DOOOOOCOCEE 0 6e If the bladder volume is greater than TETTE 999 ml the display shows gt 999 ml BVM 9500 ae Bladder Volume and Mass Instrum 10 2 2008 Volume 999ml UEBW g page 50 User s Manual BladderScan BVM 9500 Measuring Bladder Volume and UEBW 7 Manual Measurement of Bladder Wall Thickness Optional BVM 9500 xcu 133 2 4 2010 To make a manual measurement of Bladder Wall Thickness please select the MANUAL MEASUREMENT function Volume 197ml on the Results screen and follow the UEBW 43g 2 1g process below lf a manual measurement is not desired please skip to Step 8 Manual Measurement Selecting the MANUAL MEASUREMENT i button displays one of two bladder BVM 9500 BVM 9500 aama wall images available for manual measurement The BVM 9500 Volume 197ml automatically selects the two best ac 2 4mm bladder wall images from the 24 scan planes measure
11. EE RA ANENE AARS 27 Ca OO EE EEE T E A E E 29 Results EN 29 FN EN 31 HW elite oero Mm eee eee ee eee eee eee 33 video Viewing CVG EEE EE EEE bd em anta RU ME dE 34 AE EN 35 Alpha Numeric Screen iussa ient ento edikt dpi el atus dd Latio on bes Lab i doemuxEdsliues sisi dM ce tmeR ude demetsakedant ST BELE S TMe SCS EE EE mr 38 erf PENN EN 39 SAVINGS Preferences SCION ccccsccccssscccceecccsesscccnseccsuseecsageecsgeeeceueeessueeecsaeeecseeeeessueeessaeeessaeesssass 42 AT EN 43 PN NNN 44 TAN 44 Memory Optimization During Power DOWN iisssiexcosececisaccnidasensagsancedsis csvaunnedatndectaennsuensadeawiveeendsosowerdetantien 45 Measuring Bladder Volume and Ultrasound Estimated Bladder Weight UEBW 46 miss eripere TS EP NL 46 Measuring Bladder Volume and UEBW rrrnnnrrnnnronnnnonnnnernnnennnnennnnennnnennnnnnnnnnnnnnnennnnennnnnnnnnennnnennnnnnnnnnen 47 Additional Scanning MIO RETE mm 54 Recording a VOICE AMMOAU OM Met desi oaraiiiei o4 Deleting a Saved Exam EEE EE EEE e aaa e eaaa 56 PAUNO EEE EE AE HP 56 POCINGAGCIMO ge Aae AU OM EEE EEE EE EE bn nca dU uU 56 Histogram OF COST Savings Jaaa vu Dag ENS cR UE EAR Ga RWV sU ROB a aa ERO i AE Eu REV aD D EUU dua nd Ud 57 cleaning and MEN ENGE Vase RIRARATWSC RN endre OD DR DA NER PERI EH 58 Cleaning the Bladderscan BVM 9500 uuu meretu tt nirc rot Riera paso R19 IPod XE Toe x e Rx EY YE Bo tac
12. FAC CSS GOSS MM OP 16 SO CHING SAIC EE EEE SE E 17 Unpack the Box and Check the Components c cccccssscceeeeceeeeecneeeceeeeceeeeseueesaueesausesausesaueessaeessaeeees 17 C arde TNS BS EEE M i RIP EUN LS d E 17 WIS Vee Battery Pack inthe Console MEM FR m 18 BA LEE 18 Enter tne NIG IN 1 MR RE 19 DEE NE Date and TIME Em omm 20 Setting General Preferences and Savings Preferences esee eene nennen 21 Load a FROM OT Thermal PAPE HEU eee ese 22 Assemble the Medical Cart Optional ccccccsscecceeeeeceeeeecseeeeecseeecseueeesageeessueeeseuseesseseeeseueeessaseeess 23 Medicali Gart Parts LIST ONERE mm 23 Install the BladderScan BVM 9500 on the Medical Cart Optional cccccesseeeeeeeeeeeeeeeeeseeeeeseeeeeens 25 Install the ScanPoint with QuickPrint Software Optional ccccccccssssecccceceeseeeeeeeeeeeeeeeesseeeaseeeeesees 26 MV Aten me TANINO de c 26 Displays Controls and Indicators oou sticsicericsd eretontpiwverucecatenersctesticetandessvenssticosuncuotaeusueiesnbes sveveuncawases 27 Console Displays nd Button FUHCLUOFIS cuneos mr planam a lima Fabi smidde m de Glad dette Pad wo Edd tu ds 2f Battery Status MAGIC 0 T E 2 User s Manual page 3 Home SOGI EE ened EE EEEE SEA NEE SERRATA EATE
13. Pressing the RETURN button displays Review Screen 2 which will display Bladder Surface Area Ultrasound Estimated Bladder Weight V Mode Ultrasound Estimated Bladder Wall Thickness V Mode If manual measurements were taken then two additional measurements will be displayed Bladder Weight Manual Wall Thickness Manual To perform another exam press the HOME button Finish the exam UEBW 23g Record Print Listen Zoom Home P TTL 2 BVM 9500 we Ee Bladder Volume and Mass Instrument 2 4 2010 BVM 9500 E MOSQ BVM 9500 Bladder Volume and Mass Instrument Surface Area 177cm 2 4 2010 13 31 Bladder Weight ode 43g Wall Thickness Mode 2 4mm Mode Bladder Weight mE 43g Wall Thickness ul 2 4mm ppnnnmnnna f T3 ER x Review Screen 2 UEBW and Manual Measurements Once you have completed the scan wipe the ultrasound gel off the patient and the Probe For ScanPoint subscribers logging onto ScanPoint automatically transfers and saves your annotated exams to your Windows computer page 53 BladderScan BVM 9500 Additional Scanning Tips NOTE When measuring bladder volume and or UEBW and bladder wall thickness with the BladderScan BVM 9500 it is VERY IMPORTANT to hold the device steady while scanning Avoid changing position angle or pressure Applying too much pressure when scanning may lead to a Greater Than gt symbol preceding the m
14. ScanPoint with QuickPrint for complete installation and operating instructions Watch the Training Video A training video provides an overview of how to perform an ultrasound scan of the bladder using the BladderScan BVM 9500 The video is approximately 5 minutes long The Measuring Bladder Volume and UEBW training video is available for review any time on the BladderScan BVM 9500 by pushing the m button on the Home screen The training video is also available for viewing on the BladderScan BVM 9500 In Service CD The training video may also be found at www verathon com page 26 User s Manual BladderScan BVM 9500 Displays Controls and Indicators Displays Controls and Indicators Console Displays and Button Functions This section describes BladderScan BVM 9500 displays and button functions The Console display presents information that varies depending on the current instrument function The functions of the five buttons below the display vary according to current instrument mode and function Button functions are indicated by icons in the display footer immediately above the each button Battery Status Indicator A battery status indicator appears in the header of all BVM 9500 screens Depending on current level of battery charge one of the following symbols will be displayed EEE indicates a fully charged battery ENNENNNEE indicates a battery 50 to 75 charged ENSE indicates a battery 25 to 50 char
15. Surface Area 199cm Wall Thickness 1 2mm Ultrasound Estimated Bladder Weight mode 249 User s Manual page 41 Displays Controls and Indicators BladderScan BVM 9500 Savings Preferences Screen To open the Savings Preferences screen select Savings Preferences from the Settings Screen Figure 21 page 36 Use this screen to enter base values used to calculate the savings to your organization from using the BladderScan BVM 9500 rather than catheterization Preferences lists and options UTI Rate 1 to 100 in increments of 1 UTI Cost 10 to 10 000 in increments of 10 Catheter Cost 1 to 1000 in increments of 1 Catheter Volume 20 ml to 1000 ml in increments of 20 ml Currency Saving Calculation Since New Since 1 1 2006 Reset Now Print Since New Print Recent Hide Savings o Select Reset Now to clear all savings preferences o Selecting Print Since New or Print Recent and then asc prints the Savings Calculation data Figure 26 Savings Preferences Screen BVM 9500 guts UTI Rate UTI Cost Cath Cost Cath Volume Currency Savings Calculation Since New page 42 User s Manual BladderScan BVM 9500 Displays Controls and Indicators Savings Preferences Screen Buttons Button Function SELECT PREVIOUS Press to select the previous setting in the list SELECT NEXT Press to select the next setting in the list For settings with a
16. To achieve accurate measurements have the patient rest quietly in a supine position Errors in usage tend to result in the underestimation of bladder volume except in cases where the Probe is moved during scanning In this case the measurement may overestimate the patient s bladder volume We recommend that new users use the BladderScan BVM 9500 to measure patients with moderately full bladders rather than initially attempting to locate a bladder with a low urinary volume To conserve battery power the BladderScan BVM 9500 powers down automatically when not in use goes into sleep mode WARNING Risk of explosion There is a possible risk of explosion if the BladderScan BVM 9500 is used in the presence of flammable anesthetics WARNING Risk of patient injury Do not use the BladderScan BVM 9500 on patients with open skin or wounds in the suprapubic region er Yasre H Risk of inaccurate measurements Accuracy is compromised if the user does not obtain an optimal repeatable image The BladderScan BVM 9500 is not intended for use on pregnant patients The patient being scanned should not have a catheter in his her bladder This could create microbubbles in the bladder which will compromise the accuracy of the measurement Use care when scanning suprapubic and pelvic surgery patients Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and reflection Risk o
17. any questions or problems concerning bladder volume measurement using the instrument or the interpretation of data to the responsible physician User s Manual page 65 Contacting Verathon BladderScan BVM 9500 Contacting Verathon page 66 The team at Verathon is committed to modernizing healthcare delivery by putting patients first Our products support healthcare professionals by providing accuracy utility and excellence For additional product and company information visit the Verathon Web site at http www verathon com If you have any questions or comments about Verathon products and services please contact us at Corporate Headquarters USA Toll free 800 331 2313 US amp Canada Only Verathon Incorporated Tel 425 867 1348 20001 North Creek Parkway Fax 425 883 2896 Bothell WA 98011 Web http www verathon com USA Email customerservice verathon com EC Rep Verathon Medical B V Europe Tel 31 30 68 70 570 Linnaeusweg 11 Fax 31 30 68 70 512 3401 MS IJsselstein Web http www verathon eu The Netherlands Email customerserviceeu verathon nl For contact information for Verathon subsidiaries please visit our web site at www verathon com ContactUs htm User s Manual BladderScan BVM 9500 Safety and Performance Summary Safety and Performance Summary The BladderScan BVM 9500 computes the volume of the urinary bladder based upon twenty four cross sectional ultrasound images
18. authorized Verathon service center for calibration Contact your Verathon Medical Customer Care Center for more information For contact information please see Contacting Verathon on page 66 Self Calibration Self calibration requires the ScanPoint with QuickPrint System and a Calibration Kit P N 0620 0340 For instructions on software requirements and installation please refer to the ScanPoint User s Manual The entire calibration process takes approximately 15 minutes ScanPoint plans allow for calibration of the instrument as often as you like You do not need to wait until the next scheduled calibration date However at a minimum you must calibrate the instrument once every 12 months Device Repair The BladderScan BVM 9500 Console Probe and battery charger wireless hub 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 customers have access to a loaner unit and free shipping options which vary according to plan If you have any questions contact your local Verathon Medical representative or the Verathon Medical Customer Care Department at 1 800 331 2313 Unit Disposal page 60 The BladderScan BVM 9500 and related devices may contain lead mineral oils batteries and other environmentally hazard
19. go to the Video Viewing screen NOTE The SCAN button on the Probe is disabled during module playback Figure 19 Tutorial Screen BVM 9500 eel Bladder Volume and Mass Instrument Measuring Bladder Volume and UEBW page 33 Displays Controls and Indicators BladderScan BVM 9500 Tutorial Screen Buttons Button Function SELECT NEXT Press to move to next title O SELECT PREVIOUS Press to move back to previous title ENTER Press to begin module playback While the module is playing press to pause Press again to resume play i gt No function f j Y bh e HOME Press to return to the Home screen Video Viewing Screen The Video Viewing screen Figure 20 is activated by pushing the button on the Tutorial screen Figure 19 NOTE The SCAN button is disabled during video playback Figure 20 Video Viewing Screen BVM 9500 mes Bladder Volume and Mass Instrument BladderScan BVM 9500 Bladder Volume Instrument page 34 User s Manual BladderScan BVM 9500 Displays Controls and Indicators Video Viewing Screen Buttons Button Function No function PLAY PAUSE Press to start video playback Press to pause Press again to resume play O BACK Return to the training titles screen No function e HOME Press to return to the Home screen Settings Screen To open the Settings screen Figure 21 push the SETTINGS button T on the Home screen The display p
20. list of options press to select the next option Press and hold to move through options more quickly For settings with a list of options press to select the previous option Press and hold to move through options more quickly Press to save the current date time setting and return to the Settings screen 04 Me gt o A Self Test Screen To open the Self Test screen select Self Test from the Settings menu Figure 21 page 36 The Self Test screen will open and testing begins automatically Press asc to return to the Settings menu Figure 27 Self Test Screen BVM 9500 Vhon Meta Bladder Volume and Mass Instrument Self Test Serial Number 0001 Versions U I 2 2 79 DSP 2 0 BVM9500 Disk Space 19751KB Available Microphone Passed DSP Present and Functional Battery 94 90 ref 250 mAh Cap Cells 179 204 203mV Internal Temperature 31 259C Probe Calibration Expires in 352 Days Printer appears functional User s Manual page 43 Displays Controls and Indicators BladderScan BVM 9500 Sleep Mode page 44 ScanPoint Screen NOTE Only available if optional ScanPoint software is installed on a PC To open the ScanPoint screen press Sp from the Home screen The ScanPoint screens display information about the status of the link between the BladderScan instrument and the ScanPoint host computer Figure 28 Press x to terminate communication with ScanPoint Figure 28 ScanPoint S
21. ml and 400 ml to ensure an accurate reading Bladder volumes above or below this range will return a reading of g for UEBW A successful scan of bladder volume and UEBW is shown Note that the bladder volume falls within the desired range of 150 400 ml The standard deviation value indicating the UEBW measurement confidence is displayed as a range BVM 9500 co Me ETE Bladder Volume and Mass Instrument 2 4 2010 Volume 197ml UEBW 43g 2 1g CJ o m m ma o User s Manual BladderScan BVM 9500 Measuring Bladder Volume and UEBW User s Manual 6a Re aiming BVM 9500 wes em If the scan is significantly off target the Bladder Volume and Mas Instrument PS image on the Console screen will show that the bladder is not centered in the crosshairs and there will be a red arrow pointing in the direction for re aiming Volume 203ml UEBW gt 26 2 1g The Probe will show an arrow indicating the direction to move the scan head black tip of the Probe to be on target o e Ifthe arrow on the Probe is flashing then you are significantly off target e Ifthe arrow on the Probe is solid it means you are slightly off target To adjust your aim e Adjust the angle of the Probe so the scan head moves in the direction of the arrow or e Make small movements of the Probe approximately one half inch 1 cm in the direction of the arrow
22. more than six hours from an empty battery to a full charge 4800 mAh 11 1 V 12 6 V 350 g 3 11 in 79 mm 4 65 in 118 mm 0 91 in 23 mm page 77 he BIBIBOESCSRDNMUSUD Term Meaning Aiming display Ultrasound image showing the bladder on a white field with blue crosshairs the Aiming Display shows the location of the bladder within the ultrasound cone radiating from the Probe Also referred to as C Mode B Mode Ultrasound images showing an abdominal cross section with the bladder shown as a dark circle Also referred to as the Results display Battery Charger The unit that charges the Lithium lon batteries that power Wireless Hub the BladderScan BVM 9500 and simultaneously receives and sends information from to a BVM 9500 instrument within communication range BladderScan The BladderScan instrument transmits ultrasound energy to produce an image of the patient s bladder and determine bladder volume and UEBW C Mode Ultrasound image showing the bladder found within the ultrasound cone Also referred to as the Aiming display Calibration Checking the accuracy and function of your BladderScan instrument by comparing it with a Known standard Calibration Kit Tools for calibrating your BladderScan instrument The calibration container has a spiral shaped target which provides a known reference in a spherical coordinate system The calibration of the instrument to this known reference increases the accuracy of volum
23. ubdauo Hivo eneste 58 Regular Inspections ANG MANNEN TG ia taiurdansuntevadarancdrsrseautserbnnoutescunsshanemanauidendusadbeatusiwsammasactoenian 58 Weekly Inspections Lauvsnes numhjueusmeijan Cua a cox Linien e x CD T drake 59 Using the Built in Self Test Utility uacua tado tidem dende duae os Y aen Fat bl uma hU bsitu ta edmmbF anis on detiRes 59 Calibrating the BladderScan BVM 9500 Using ScanPoint TeChnolog ccccseeeeeseeeeeeeeeeesaeeeeeseeees 59 vixi T 60 PE IS COU MN mmm 60 BADE se EE IMMINENTE sae 60 et Vo IO O GUNG EN EEE EN EEE 61 NRS G1 page 4 User s Manual BladderScan BVM 9500 Table of Contents Icons on the BladderScan Console cccccccssscccceececcencecceueeccseeecseuseeeeueeessueeecsseeeeseeeeeseseeesageeessueeeess 62 Diagnosing eoo PR MEE E OO LL STU 63 feritguissis qii DOCS Not TUNT ON tot cece cree cd xa 63 UEBW displayed as OY a uasd cuucennainanpusctmangiapntenahinntiendsesxteiseaaianndesrnaienledienasidnanspnataimammadaingwsiiaxdinmearaabnauns 63 PAN 8 9 9 gt NN Eea 63 NF M ere E ane E eee ene ee ee Cee ne eee 63 Po 64 EP TN 64 ET ala EEE EE EE KN 65 Disclaimer or Additional Warranties eus iencics estt eiat o reso adv Mis guq oi Xx po rendeusysenpiiedwanenndeny ceaddacessuaniosetscoaccseeys 65 Contacting VATN Ne 66 Safety and Performance Summary sivsisieisceseecavesncenencesnsnecadvamsrardcewensavisarssne
24. until the scan is on target The small dot at the base of the crosshairs on the Console screen represents the feet of the patient The top of the crosshairs represents the patient s head The upper left quadrant represents the patient s right shoulder This orientation should help you in re aiming the Probe to capture the complete bladder fully in the ultrasound cone 6b Intepreting Results Screen UEBW Measurement Data Aiming UEBW Arrow measurement Present symbol Recommended Action No Accept UEBW measurement No Adjust Probe pressure and or Probe angle and scan again Depending on patient anatomy it may not be possible to get an sign No gt Bladder volume is too large for UEBW measurement Yes Move Probe scan head no more than 1 2 inch 1 cm in direction of arrow scan again Yes gt Move Probe scan head no more than 1 2 inch 1 cm in direction of arrow scan again page 49 Measuring Bladder Volume and UEBW BladderScan BVM 9500 6c Volume Outside Scan BVM 9500 In cases where an arrow appears and OVNI JIUV oan 2 4 2010 the UEBW is given as an approximate value the bladder was not captured within the ultrasound cone Volume gt 156ml UEBW 31 1 8 If this occurs move the scan head the black tip of the Probe in the direction of the arrow on the Probe no more than 1 2 inch and re scan Continue adjusting your aim until an accurate scan is achieved e mt Ba A m
25. 77 BAe Rees ellen S ENE m TT ET EEE qr T 78 User s Manual page 5 Table of F igures BladderScan BVM 9500 Table of Figures Figure 1 BladderScan BVM 9500 Controls and Indicators rrrrarrrrrnnrrrrnnnrernnnrrrnnnnrrrnnnrrrnnerrvnnnrrnvnnennnnnn 13 Figure 2 Battery Charger Wireless Hub rrrrarnrannrnvannrrvnnnrnnnnnnvnnnnnrnnnnnrnnnnnsnnnnnnrnnnnnsnnnnnsnnnnnennnnnnnnnnnsnnnnnee 15 Figure 3 Home STN 19 Figure 4 Settings TEN 19 Figure 5 Alpha Numeric Screen Tt TO TTE 20 Figure o Facility Name in Display Header iieniissiccswatacatcarndvavdinssndatoucseesdassvanendiacisubentibidsuandlasicewandysadaiuvmanntes 20 Figure 7 Set Up Screen Date and Time sees nennen nennen nennen nnns nn nnne nnns 21 mit PB N leME Eee i e m s 21 Figure 9 Medical Cart PN 0800 0347 ecgecscontcsceccosksdgudenendiedicasunhstaizcanedsciceuundasdtswennaiaeneeameisensscusssacesniendaien 23 Figure 10 Medical Cart FEN m E 24 Figure 11 Universal Accessory Basket P N 0810 0201 Optional rrrrrnnnrnrnnnrnrnnnrrnrnnrrnrnnrrnnnnnrennnnennnn 25 Figure 12 Attaching the BVM 9500 to the Medical Cart rrnnnnnnnnnrnnnnnrnnnnnnvnvannrnnnnnrnnnnnnrnnnnnennnnnrnnnnnnennnn 25 Figure 13 Home Np 28 HUE gt Er 29 Figure 15 Results Screen ERROREM 29 Figure 16 Results Screen with Approximate UEBW Value rarrrrararnonrrrnnrrrnnnrvnnnrnnnnenranenrnnenrnnennnnnnnnnnennn 30 Figure 17 Review Screen Leed 31 Figure 18 Revi
26. BladderScan BVM 9500 Bladder Volume and Mass Instrument User s Manual CAUTION In the United States federal law restricts this device to use by or on the order of a physician BladderScan BVM 9500 Table of Contents Table of Contents Statement FLOM Ne CEO sissien Eara ENEE EEEa VEE Fen Ew eieren 7 Veg efelg ts hake bg Ke ANON EEE EE TUI 8 Prod ct De 59 EEE EEE ER 8 Intended Use Warnings and Cautions diano auo aac atico nma indo mdus de do ruin unus d dain ccmebdeddauunse d 9 melee es NR ERE mmm 9 Statement of Prescription aaret ma Sn UES 9 Statement of Intended 1UJS6 eoninorait corr tarevvs ao trad Vae rire i et dotes co pd koh uda dens dea nei dude ua dua kde die acd dun eddie us 9 Gro 911211 011 11 19 TE EEE EE 9 Caunes ana VVSbIFI SEE EE REE ENE 9 Bluetooth Wireless TECHnOlOQ ssscccccccccceseesseeecceececeeeeaeessssceeeceseeeeeeessseeeeeesssseauaeseeeeeeeeeseeaaes 12 Introducing the BladderScan BVM 9500 rrnnnvrnnnnnvrnnnnennnnnevnnnnnennnnnenennnennnnnnnnnnnnnnnnnnennnnnernnnnnennnnnennnnnern 13 BladderScan Parts and FEAMES x ccccnscsmedncscuccancdssennedancodesemndenstneqstuintedanteadanieeeenncuadapladaadesncswncaesbeusoneeer 13 Probe CGI OMS NS TERT A 14 Console ComponeNiS ME EEE EE ane 14 Battery Charger Wireless Hub css saccsisccastastncncusnanadaonse dui oc EUER Ch etat a SE viu dol on eoe s deiner d en Dnus c a pncdeacntebenspaeeen 15 Parts and
27. BladderScan BVM 9500 in the presence of flammable anesthetics the hazard of potential explosion exists WARNING Risk of explosion fire or serious injury The BladderScan BVM 9500 is provided with two Lithium lon batteries Never short circuit the battery pack by either accidentally or intentionally bringing the battery terminals into contact with any other conductive object This could cause serious injury or fire and could also damage the battery pack and the BladderScan device Never expose the battery pack to abnormal shock vibration or pressure The main battery pack s internal protective covering could fail causing it to overheat or ignite resulting in caustic liquid leakage or explosion or fire possibly resulting in serious injury WARNING Potential patient hazard To date exposure to low power pulsed diagnostic ultrasound has not been shown to produce adverse effects However medical professionals should use ultrasound only when clinically indicated using the lowest exposure times possible to obtain accurate measurements The ultrasonic output of the BladderScan BVM 9500 is not user adjustable and is limited to the minimum level necessary for effective performance For more information about the acoustic output levels of this device please refer to the section in this manual titled BladderScan BVM 9500 Instrument Specifications on page 0 ez Y ade H Risk of inaccurate measurements results When using the Bladder
28. Buttons Alpha Numeric Screen POWER 1 Move down 2 Move right 3 Add currently selected character 4 Delete currently selected EE NE character 5 Return to main setup screen characters for entering information Date amp Time Screen POWER 1 Move forward to next changeable unit 2 Move back to previous changeable unit 3 Add toggle units as appropriate hold down to move faster 4 Decrease toggle units as appropriate hold down to move faster 5 Save current date time entries and return to main setup screen General Preferences POWER 1 Select next setting in list 2 Select previous Screen setting in list 3 Select next option Enter 4 Select previous option 5 Home return to Home screen Allows the user to set the date and time Set preferences for language time and date Preferences list and options format time zone UTI rate and cost and currency Languages English default Chinese Simplified Chinese Traditional Czech Danish Dutch Finnish French German Greek Hungarian Italian Japanese Korean Norwegian Portuguese Spanish Swedish Turkish Date format mm dd yyyy dd mm yyyy yyyy mm dd Time Format 12 hour 24 hour Calibration Warning On default Off When On is selected a calibration warning will appear in the display header when the device is due for calibration Print Report Type B Mode default C Mode Print UEBW On default Off Saving Preferenc
29. MDD 93 42 EEC Annex 1 Canadian Standards Association C22 2 No 601 1 M90 Master Contract No 177198 Underwriters Laboratories Inc UL 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 BladderScan BVM 9500 due to its electromagnetic characteristics Both the emissions from the BladderScan BVM 9500 and the susceptibility of this instrument to interference from other sources are within prescribed limits of all applicable standards at the date of manufacture The emissions test procedure that was used is specified in EN IEC55011 1991 for Group 1 Class A equipment per EN IEC60601 1 2 36 201 1 7 BladderScan BVM 9500 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 BladderScan BVM 9500 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 BladderScan BVM 9500 will operate normally in the proximity of other potential in
30. QuickPrint allows the user to archive data calibrate the device update software print and transfer data through a Web based interface A Calibration Targeting System consisting of a spiral shaped calibration target along with a special calibration container allows the user to easily calibrate the device by scanning a known target The BladderScan BVM 9500 system also includes a universal battery charger for the custom user replaceable Lithium lon battery incorporated in the system The BladderScan BVM 9500 may be mounted on a wheeled cart which holds the instrument securely and provides a holder for the Probe and a bottle of ultrasound gel User s Manual BladderScan BVM 9500 Important Information Intended Use Warnings and Cautions The BladderScan BVM 9500 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 User s Manual prior to using the BladderScan BVM 9500 Do not attempt to operate 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 the User s Manual please visit the Verathon Web site at http www verathon com Biological Safety To date exposure to pulsed diagnostic ultrasound has not been shown to produce adve
31. SELF TEST is highlighted red then press to open the Self Test screen 3 When the Self Test screen opens testing begins automatically with the display providing status and results 4 When test is complete press the SETTINGS button t to return to the Settings screen then press the HOME button Q5 to return to the Home screen 5 If any test results were failed or abnormal contact your authorized BladderScan representative or contact the Verathon Medical Customer Care Department at 1 800 331 2313 Calibrating the BladderScan BVM 9500 Using ScanPoint User s Manual The BladderScan BVM 9500 must be periodically calibrated to ensure that the instrument is providing the most accurate results Calibrating ensures accurate and proper alignment of the instrument s internal coordinate system If you do not perform the calibration by the prescribed date the instrument can still be used to take scans but measurements may be compromised When calibration is due a warning appears in the display header Figure 32 page 59 Figure 32 Calibration Warning BVM 9 5 0 0 EE EE Bladder Volume and Mass Instrument Please run Calibration fom ScanPaint 9 30 2008 Savings Calculation BladderScar Date Started 1 1 2006 Number Of Scans 0 1 Cath Avoided 0 UTI Avoided 0 NeuralHarmonics Savings 0 L3 o m o L3 m If you do not have ScanPoint with QuickPrint you must send your instrument in to an
32. Scan BVM 9500 be aware of the following conditions which can affect ultrasound transmission and the accuracy of exam results e Use care when scanning patients who have had supra pubic or pelvic surgery Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and accuracy Do not use the BladderScan BVM 9500 on a patient with open skin or wounds in the suprapubic region or mid abdominal area Do not use the BladderScan BVM 9500 on a patient with ascites If you scan a patient with a catheter in his her bladder the catheter may affect measurement accuracy However the information obtained from the measurement could still be clinically useful for detecting problems such as a blocked catheter ee Use the following procedure to reset your instrument if your BladderScan BVM 9500 suffers from a configuration loss and displays the Home screen for a BladderScan BVI 9400 instrument NOTE Only use this process to restore the factory set configuration Do NOT use this reset process for any other issue n very rare instances your instrument may experience a configuration file error User s Manual BladderScan BVM 9500 Important Information If a configuration file error occurs the instrument will lose its factory set configuration and return to its default configuration as a BVI 9400 instrument meaning it will display a BVI 9400 Home screen To re establish the factory configuration specif
33. ad to urinary tract infections UTIs By avoiding unnecessary catheterizations the resulting UTIs are thereby avoided The default setting for percent of catheterizations leading to UTIs is UO Associated UTI costs Literature suggests that the additional costs associated with treating UTIs amounts to 1875 00 per patient infection The default setting is 1870 00 Cost of catheter kits The default setting is 3 00 per kit Total Cost Savings from Using the BVM 9500 Catheterizations avoided x catheter costs UTIs avoided x UTI costs NOTE The default settings can be changed to reflect the rates and costs at your facility by selecting from the Home screen Eo SETTINGS SAVINGS PREFERENCES See page 42 Savings Preferences Screen for more information on customizing Savings Preferences page 57 BladderScan BVM 9500 Cleaning and Maintenance Cleaning the BladderScan BVM 9500 1 Use a soft cloth dampened with isopropyl alcohol or an appropriate hospital cleaning agent to wipe the Probe until it is thoroughly cleaned 2 Ifyou use a detergent solution to clean the instrument remove all residual detergent Dry the instrument with a clean soft cloth 3 Alternatively dampen a soft cloth in any glutaraldehyde based hospital disinfectant solution such as Cidex or Cidex 7 from Advanced Sterilization Products or Sporocidin from Sporocidin International Wipe the instrument with the dampened cloth
34. adderScan Service Center your local BladderScan distributor or Verathon Medical Customer Care Department at 1 800 331 2313 North America only International customers please refer to the contact information on page 66 page 58 User s Manual BladderScan BVM 9500 NOTE ScanPoint Online customers can maintain device certification via the Internet by accessing their ScanPoint account For more information about using ScanPoint Online please refer to the ScanPoint User s Manual Weekly Inspections Once a week you should inspect the Probe and cable for physical faults or cracks Cracks that allow the ingress of fluid may affect the performance of the instrument Any apparent cracks or faults in the Console Probe or the cable that links the Console and the Probe must be referred to your authorized BladderScan Service Center your local BladderScan distributor your local Verathon Medical representative or the Verathon Medical Customer Care Department 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 Using the Built in Self Test Utility The BVM 9500 can perform a number of self diagnostic tests To access the Self Test utility 1 From the Home screen press the SETTINGS button asc 2 When the Settings screen opens press the V or buttons until
35. annotation press releases the SCAN button STOP to end voice annotation 2 PRINT print to after aiming onboard printer 3 PLAY press to play voice annotation otherwise no function 4 ZOOM Image Zoom screen for manual measurement of bladder wall thickness 5 HOME return to Home screen Review Screen POWER SCAN 1 NEXT select next exam in memory 2 PRINT print to on board printer 3 RETURN PLAY On first Review screen switches to second screen for additional data UEBW Bladder Wall Thickness On second Review screen plays voice annotation for currently selected exam 4 DELETE delete currently selected exam 5 HOME return to Home screen Tutorial Screen POWER 1 Skip to next tutorial 2 Skip to previous tutorial 3 Select tutorial for viewing 4 No function 5 Home return to Home screen Review replay print or delete saved exams View the menu of training modules Video Viewing Screen POWER 1 No function 2 Play Pause 3 Return o to Tutorial 4 No function 5 Home return to Home The video viewing screen screen Settings Screen POWER 1 Select next setting in list 2 Select previous setting in list 3 Enter proceed to the selected screen Edit clinic name date amp 4 No action 5 Home return to Home screen time general preferences savings preferences and self test options page 73 Product Specifications BladderScan BVM 9500 Screen Mode Active
36. ans with voice annotations so you can perform multiple exams on your rounds If you are using the optional ScanPoint with QuickPrint software you can upload saved exams to your PC Refer to the ScanPoint with QuickPrint User s Manual for more information page 54 User s Manual BladderScan BVM 9500 To record a voice annotation 1 Press the RECORD button Recording begins and the RECORD button becomes a STOP button 3 UEBW 239 A s d Record Print Listen Zoom Home ecc e es ver i 2 The microphone is located just above the aiming display on the Probe 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 including the patient s ID and the name of the person performing the exam 3 When you have finished your annotation press the STOP button An hourglass icon will be displayed while your annotation and exam are updated and stored After the annotation has been saved to listen to your annotation press the LISTEN button If you are not satisfied with the recording press RECORD again to record a new annotation IMPORTANT If you do not record a voice annotation for a particular exam that exam will be lost and the next exam you perform will overwrite the non annotated one Ifthe instrument battery runs low or the instrument goes into sleep mode any non annotated exa
37. ble memory and Aiming display Review Screen Displays either the Aiming display or the Image display along with calculated bladder volume Tutorial Screen Lists available video tutorials Settings Screen Lists options for setting name date and time general and savings preferences and self text Name Screen A grid of alpha numeric characters Date amp Time Screen Options for setting date time and display formats Preferences Screen List of available settings and their current values Self Test Screen Displays test progress and results ScanPoint Screen When ScanPoint with QuickPrint is installed Displays status information about the ScanPoint communication User s Manual page 75 Product Specifications BladderScan BVM 9500 Battery Charger Wireless Hub Specifications The battery charger wireless hub is powered from a standard wall outlet adaptable to international power standards The battery charger wireless hub can charge two batteries simultaneously Operating Conditions The following are proper operating conditions for the battery charger wireless hub Specification Description Use Indoor Ambient temperature range 41 104 F 5 40 C Atmospheric pressure range 70 kPa 106 kPa Relative humidity 30 75 non condensing against ingress of water Computer connection USB 2 0 Charger Powered by a desktop DC power supply Input voltage 100 240 VAC RMS Input frequency 50 60 Hz Input c
38. creens Searching for ScanPoint Connected to ScanPoint BVM 9500 amean mene BVM 9500 ess BVM 9500 Bladder Volume and Mass Instrument Bladder Volume and Mass Instrument et O e The Sleep Mode helps preserve battery power After four minutes of idle time a Sleep Mode alert message displays for 15 seconds Figure 29 While the message is displayed press any button to keep the Console awake and dismiss the message After 15 seconds the Console goes to sleep To wake the instrument from sleep simply press the Power button Figure 29 Sleep Mode Screen BVM 9500 Cus Bladder Volume and Mass Instrument BladderScar Entering Sleep to save power or Press any button to continue k a NU UTI Avoided NeuralHarmonics Savings 3 m a 3 User s Manual BladderScan BVM 9500 Displays Controls and Indicators Memory Optimization During Power Down When the power is turned off the BladderScan BVM 9500 may begin an internal process of memory optimization This process takes several minutes When complete the device will shut down An alert appears on the display during the memory optimization process Figure 30 Figure 30 Memory Optimization Alert BVM 9500 SET Bladder Volume and Mass Instrument Savings Calculation RladrarSran Please wait while I optimize memory Do not remove battery NU UTI Avoided NeuralHarmonics 1 1 2006
39. d The Scan Plane Select Icon allows the user to select between the two best bladder wall images The Scan Plane 13 Bladder Wall Image number in the upper left corner of the ultrasound image identifies the scan plane Scan planes 10 and 13 are used in BVM 9500 NNNM this example but the set of scan plane EDVIN JJUV END 2 4 2010 images will vary with each scan Once the user selects the best pese scan image for making a manual z measurement scan plan 10 is selected in this example the and buttons allow the user to Widen the image of the bladder wall to a maximum size of 8 5 x 11 5 cm as shown here Narrow the image to obtain a Scan Plane 10 Bladder Wall Image close up of the bladder wall with image dimensions of 2 25 x 2 75 cm User s Manual page 51 Measuring Bladder Volume and UEBW BladderScan BVM 9500 Note that Scan Plane 10 Magnified Image has image dimensions of 4 5 BVM 9500 BVM 9500 x 5 75 cm which allows for more accurate placement of the cursors for Volume 197ml taking a manual measurement HB aeo 2 4mm To take a manual measurement of bladder wall thickness please select the CURSOR button Scan Plane 10 Magnified Image Use the Axis Select icon to select tete ms either the Up Down or Left BVM 9500 BVM 9500 sion Right axis of movement for the Bladder Volume and Mass Instrument highlighted cursor Volume 197ml UEBW 43
40. designed to prevent incorrect installation If the battery pack does not slide into the battery well easily move the battery and try again Do not force the battery into position NOTE Do NOT remove the battery for any reason while the BVM 9500 is on Doing so will damage the instrument Always turn off the BVM 9500 before removing the battery Battery Care The BladderScan BVM 9500 draws very little power when it is turned off However if you do not plan to use the BladderScan instrument for several weeks you should remove the battery to prevent it from discharging When batteries are not in use they should be stored in the battery charger so they remain fully charged page 18 User s Manual BladderScan BVM 9500 Getting Started Enter the Clinic Name You can customize your BladderScan BVM 9500 by entering your facility s name and current date and time This information will subsequently be included on BladderScan displays and all printouts of exam results NOTE Use of extended Latin and or non Latin characters The following instructions explain how to enter a facility name that uses only standard Latin characters Extended Latin characters tilde umlaut accents circumflex etc and or non Latin characters can be entered only by using ScanPoint with QuickPrint software To enter a name that uses extended or non Latin characters please refer to the instructions in the ScanPoint with QuickPrint User s Manual To ent
41. e measurements Console The main BladderScan device that provides operating controls and communicates with the user via images and text displays on an LCD screen Coupling medium A substance such as ultrasound gel that enhances the transmission of ultrasound waves Flashing Aiming Indicate the bladder is not inside the scan cone and the Probe Arrows needs to be redirected The arrow shows the direction to move or tilt the Probe to improve the measurement Re aiming is required page 78 User s Manual Term Meaning HIPAA 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 electronic data interchange in the US health care system Image cone During a measurement this is the cone shaped area in which the Probe transmits ultrasound waves Instrument In this manual refers to the BladderScan BVM 9500 The BladderScan instrument transmits ultrasound energy to produce an image of the patient s bladder and determine bladder volume and UEBW LCD screen T
42. easurement on the screen If this happens apply less pressure and re scan Volume reading will be affected by The presence of scar tissue The presence of a catheter Overly obese patients with obese patients lift as much abdominal adipose tissue out of the way of the instrument as possible You can also apply more pressure to the Probe to reduce the amount of adipose tissue through which the ultrasound must pass To ensure accurate results make sure that You use sufficient gel and make sure there are no air gaps between the Probe and the patient s skin You are holding the instrument steady while scanning avoid changing its position angle or pressure e You are using enough pressure to maintain good skin contact until the scan is complete There is not a catheter in the patient s bladder The presence of a catheter may affect the accuracy of the bladder volume measurement but the measurement may still be clinically useful detecting a blocked catheter for example NOTE The BVM 9500 is able to scan rapidly and repeatedly throughout the day If however scans are taken quickly in rapid succession over a 30 minute period some slowing in performance may be noticed While this may occur rarely it is normal for the instrument Recording a Voice Annotation After performing an exam you can record additional information about a patient to be stored with the exam results The instrument can store ten sc
43. ed Figure 11 Universal Accessory Basket P N 0810 0201 Optional Install the BladderScan BVM 9500 on the Medical Cart Optional Your BladderScan BVM 9500 is completely portable and can be easily moved and positioned for convenient use Installing the BVM 9500 on the optional Medical Cart will allow you to move the BladderScan instrument along with related accessories ultrasound gel or an extra roll of paper to the patient examining area or bedside as necessary To install the BladderScan BVM 9500 on the Medical Cart To install the BVM 9500 to the Medical Cart screw the Fluted Knob Item 5 through Bracket and Post Item 2 bracket round hole and Tray Assembly Item 1 and into the mounting hole on the bottom of the device Hand tighten Figure 12 Figure 12 Attaching the BVM 9500 to the Medical Cart Bracket and Post Item 2 User s Manual page 25 Install the ScanPoint with QuickPrint Software Optional Optional ScanPoint with QuickPrint software is designed to mesh seamlessly with your BladderScan devices The BVM 9500 downloads exam data to the ScanPoint host computer via a wireless connection enabled by the battery charger wireless hub allowing further viewing analysis archiving and report generation To install ScanPoint with QuickPrint insert the ScanPoint with QuickPrint Install CD into your computer s CD drive and follow the on screen prompts Please refer to the separate User s Manual provided with
44. ed manual mode allows measurement of the thickness of the detrusor muscle only page 39 Displays Controls and Indicators BladderScan BVM 9500 Figure 24 General Preferences Screen BVM 9500 um Bladder Volume and Mass Instrument Language English Date Format mm dd yyyy Time Format 24H Calibration Warning On Print Report Type B mode Print UEBW On Manual Wall Thickness Mode Normal General Preferences Screen Buttons Button Function y SELECT PREVIOUS Press to select the previous setting in the list SELECT NEXT Press to select the next setting in the list For settings with a list of options press to select the next option For settings with a list of options press to select the previous option Press and hold to move through options more quickly Press to return to the Settings screen JA page 40 User s Manual BladderScan BVM 9500 Displays Controls and Indicators Figure 25 Print Report Samples BladderScan Results Verathon Medical BVM 9500 ee e C Mode eee UEBW 24 Patientib Print Report PUNE Surface Area 199cm Sample Operator ID All Thickness a 1 2mm Physician Procecure Code Urine Volume 186ml BladderScan Results Verathon Medical BVM 9500 10 8 2008 10 48 i Exam Time And Date e e B M ode Pa entD Print Report Patient Name Sample Operator ID Physician Procedure Code BladderScan Results UEBW l Print Report Urine Volume 86ml Sample
45. eeneseeiencsensamoensvewbineaeadanseccwerwees 67 Parts and ACCeSSOLTIBS cuiii ndisse cu N scu pu EbRNUoN p Du BUS S M DHaNVNCUA Dar EMF E P UDURN SERRE DS EN IDA MAIN EREDMNU PR DR RNEGE NS 68 BladderScan BVM 9500 System Components cccccssseeceeseeceeseeceeeeeceaseecsensecseusecceseessageessageessees 68 Product SPENN de 69 urere See EEE EE A 69 Standards and Regulations COMPpliance ccccccssecccceeececseececceseecceueeecsueeesseeeecaueeeseueeessuseesseneessagees 70 IEC IONAMIN TC gt eg EN NE EE EE 70 BladderScan BVM 9500 Instrument Specifications ccccccescccceseeeceeseeceeseessegeeeeeeeeseageessageeeseaeeenes 71 Ultrasound Output Parameters Acoustic Output LIMItS cece eececeeeee ee eeeseeeeseeeeseeeeseeeeseeeeeees 71 PROCUNACY SCCM Ca ONS ER EN NN 72 BladderScan BVM 9500 Operating Conditions rannrnnnnnrnrnnnnrnrnnnrnrnnnrnnnnnrenrnnnennnanrnnnnnsennnsnennnnnsennnnne 2 BladderScan BVM 9500 Storage Conditions 2 1241 HU KIRKE TK BDRM EL ens 72 BladderScan BVM 9500 Displays Controls and Indicators rrrrrnnrrrnanenvnnrrvnnrrrnnnnrnnnrnnnnennnnennanennnnenn 73 lg Ev pp IS ITOWNS RE peitoantiansusdneteneidaotanessitanwinanudumuueebducunanoiadatunens 73 MASERU CHIT DSD RR 75 Battery Charger Wireless Hub Specifications rrrnrrrrnnnnnrvnnnnrvnnnnrnrnnnnnvnnnnnnnnnnnnvnnnrnnnnnennnnnsnnnnnnrnnnnnsnn 76 Operating COM CNOA EEE EE 76 orage CONAIS EE NE EE EE
46. er your clinic s name 1 Turn the BladderScan BVM 9500 on by pressing the POWER button on top of the Console 2 When the Home screen Figure 3 Home Screen appears Figure 3 press the BVM 9500 Veratnon Media SETTINGS button asc to open Pai cA Do M Ras the Settings screen Savings Calculation BladderScan Date Started 1 1 2006 Number Of Scans 61 1 Cath Avoided 16 UTI Avoided 0 NeuralHarmonics Savings O000000000 6 3 On the Settings screen Figure 4 Settings Screen Figure 4 push either the 4 or V ey button until Name is highlighted BVM 9500 BVM 9500 red Press the button to open the Alpha Numeric screen Name Date amp Time General Preferences Savings Preferences Self Test User s Manual page 19 Getting Started 4 On the Alpha Numeric screen Figure 5 use the gt and buttons to move to the desired character When the desired character is highlighted red press the button to add it to your text Use the button to delete characters To add a space between words press the blank space below the letter x To add a second line of text use the f character 5 Continue to select and add characters as needed 6 When finished press the SETTINGS button S to return to the Settings screen From the Settings screen press the HOME button A to return to the Home screen The facility name will now appear in the display header Figure 6 S
47. es UTI Rate 1 96 100 96 in increments of 196 Seren UTI Cost 10 100 000 in increments of 1 Catheter Cost 1 to 1000 in increments of 1 Catheter Volume 20 ml 100 ml in increments of 20 ml Currency Savings Calculation Since new Since 1 1 2006 Reset Now Print Since New Print Recent Hide Savings Self Test Screen 1 to 4 No function 5 Return to Settings screen ScanPoint Screen NOTE Only available when used with ScanPoint with QuickPrint software POWER 1 No function 2 No function 3 No function 4 CANCEL 5 No function page 74 User s Manual BladderScan BVM 9500 Product Specifications Instrument Display The instrument display is divided into three horizontal panes The header pane displays the instrument mode Male or Female mode the institution name date time and a battery status icon The center pane is the main display area The information displayed in the center pane varies depending on the device mode The footer pane displays icons that indicate button functions as described in the preceding table Home Screen Mode indicator Memory indicator Savings Calculation table Scan Screen Appears when the operator presses the SCAN button As bladder volume is calculated the display refreshes and updates until the scan is complete Results Screen Appears when a bladder volume scan is complete Displays calculated bladder volume UEBW patient type availa
48. et the Date and Time BVM 9500 Bladder Volume and Mass Instrument BVM 9500 O00000086808 Volume and Mass Instrument BladderScan iS NeuralHarmonics BladderScan BVM 9500 Figure 5 Alpha Numeric Screen Verathon Medical BVM 9500 Verathon Medical BYM 9500 Savings Calculation Date Started 8 14 2008 Number Of Scans 76 Cath Avoided UTI Avoided Savings The clock can hold the current time and date setting for up to five minutes after the battery is removed Time and date settings will be lost if the battery is removed from the instrument for longer than five minutes To set the date and time 1 If the BladderScan instrument is turned off turn the power on by pressing the button on the front of the Console 2 From the Home screen Figure 3 press the SETTINGS button ED to open the Settings screen page 20 User s Manual BladderScan BVM 9500 Getting Started 3 On the Settings screen push Figure 7 Set Up Screen Date and Time BVM 9500 amao Bladder Volume and Mass Instrument either the or Y button until Date amp Time is highlighted red Figure 7 Press the button to open the Date amp Time screen Name 4 Onthe Date amp Time screen Date amp Time Figure 8 use the gt and y General Preferences buttons to move to the desired unit Savings Preferences hours minutes month day year Self Test 5 When the desired unit is Figure 8
49. ew Screen Lnr bedere 32 Figure 19 Tutorial Screen hr 33 Figure 20 Video Viewing Screen ccccccssecccsesecceencecceueecceaeeecseueecseueeessueeecsaueeesueeesaueeessueeessuaeeesegeeessaes 34 Figure 21 Settings Screen Leik nd 36 Figure 22 Alpha Numeric Screen ccccsescccseseccceseecceeeccsaeeecsaueecseueeessueeecsueeeeeaueeessueeecsueeessuseeesesseessass 37 Figure 23 Date amp Time Screen NETTE 38 Figure 24 General Preferences SCreen cccccscccsssscccesecccseseccceneecceeeecseeeecseueeeseueesssaeeeesaueeeseneessegeeessaes 40 Figure 25 Prnt Report Samples uero eect vinci reor pain nei nese dino Gere deen ceusledeutsdemsandelaaendasesis 41 Figure 26 Savings Preferences SCreen cccccscccssseccceseeccsencccseneccceueecseesecseueecsaueeessaeeessaueeeseeeeesesseessaes 42 Figure 27 Self Test Screen eda PENA UM renne 43 Figure 28 ScanPoint SCl CRIT 44 Figure 29 Sleep Mode Screen Ham usvnestkumensnimd mbeiitie denectvnssscedanwsdndeeaaviassciediuedeiaweseeatd ene 44 Figure 30 Memory Optimization Alert rrrnnrrrrnnnnrnrnnnrrrnnnrrnrnnnrnvnnnrnrnnnrnnnnnsrnnnnnrnnnnnsnnnnnssnnannrnnnnnsnnnnnsennnn 45 Figure 31 Exam Results Printout Using the Onboard Printer rrrrrnnnnnnnvnnnnrvnnnnrvrnnnnnrnnnrnnnnnrnnnnnnrnnnnennnnn 56 Figure 32 Calibration Ante TOT US 60 Figure 33 Printer Out of Paper SCIeGli aus ierunt icit name hn ansanseidavinsdscneanwstSenecseuehisscaduestedecienebiaeas 63 page 6
50. f Fire and Burns Do not disassemble heat above 60 C 140 F or incinerate battery Keep battery out of reach of children and in original package until ready to use Dispose of used batteries promptly according to local recycling or waste regulations User s Manual page 67 Parts and Accessories Parts and Accessories BladderScan BVM 9500 BladderScan BVM 9500 System Components The following components are included with your BladderScan BVM 9500 system Part Number Description 0570 0208 BVM 9500 Probe 0570 0207 BVM 9500 Console 0570 0193 Battery Charger Wireless Hub 0400 0067 Desktop Power Supply 0400 0066 Rechargeable batteries 2 included 0800 0319 Roll of Thermal Paper Properly sized paper for the on board printer 0620 0340 Calibration Kit Optional requires ScanPoint with QuickPrint software 0800 0347 BladderScan BVM 9500 Medical Cart optional 0900 1596 BladderScan BVM 9500 User s Manual on In Service CD 0900 2103 BladderScan BVM 9500 In Service CD with User s Manuals Video Tutorials and Quick Reference Cards 0900 1601 ScanPoint User s Manual on In Service CD 0900 2102 Quick Reference Card BladderScan BVM 9500 Bladder Volume and UEBW Measurement 0900 1447 Quick Reference Card Calibration 0810 0201 Universal Accessory Basket for Medical Cart optional To order any of the above parts contact your authorized Verathon Medical sales representative or contact the Verathon Medica
51. g 177cm 2 4mm o ep d Move the highlighted cursor to the edge of the bladder wall 2 Select the second cursor using the Cursor Select icon Scan Plane 10 Select Second Cursor BVM 9500 Sus ee Bladder Volume and Mass Instrument 2 4 2010 Q Move the second cursor on to the opposite edge of the bladder wall Volume 197m 177cm 2 4mm Press the Return icon to save the measurement and exit Manual Measurement mode D a Th Press the Return icon again to return to the Results screen Scan Plane 10 Move Second Cursor page 52 User s Manual BladderScan BVM 9500 User s Manual 8 Save review and print exam results To save the exam you must voice annotate it To annotate press and release the RECORD button on the Console When you see the RECORD button icon change to a STOP button icon record the patient information by speaking into the Probe microphone When the hourglass icon disappears press the LISTEN button to replay the annotation To print exam results via the onboard printer press the PRINT button To review previous scan images press the REVIEW button You must first save the exam before you can review it On the review screen the user can review all currently saved exams and can print replay voice annotations or delete exams The Review Screen consists of two screens Review Screen 1 shows the bladder volume measurements
52. g Started The previous section provided basic information about the BladderScan BVM 9500 parts and features This section provides instructions for setting up your BVM 9500 prior to first use To help you get up and running as quickly as possible the next few pages explain how to Unpack the BladderScan BVM 9500 and related accessories Charge and install the batteries Customize the display enter your institution s name date time and other user data e Assemble the Medical Cart optional Install the ScanPoint with QuickPrint software optional 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 1 BladderScan BVM 9500 Console and Probe 1 Medical Cart optional 2 Rechargeable Lithium lon batteries 1 Battery Charger Wireless Hub 1 In Service CD includes User Manuals Video Tutorial and Quick Reference Cards Charge the Batteries Two Lithium lon batteries are included with the BladderScan BVM 9500 One battery can be recharged in the battery charger wireless hub while the other is installed in the BladderScan instrument This ensure
53. ged ENS Indicates a battery that is nearly discharged and can power only a few more scans Indicates the battery must be changed Home Screen The Home screen appears when the BVM 9500 is first powered on The Home screen serves as a Starting point for all of the instrument functions e Press the MODE button to toggle between Male and Female modes The Bladder Volume Mode home screen displays Alist of saved exam results 10 maximum saved in chronological order Yellow folders hold saved exams Gray folders represent empty spaces still available for saving exam results ACost Saving Summary Displays the savings to your organization from using the BladderScan BVM 9500 rather than catheterization The values used to determine the savings are user variable and entered from the Savings Preferences Screen Refer to page 42 for more information about using this screen User s Manual page 27 Displays Controls and Indicators BladderScan BVM 9500 Figure 13 Home Screen Bladder Volume Mode noe Battery BVM 9500 uua Status Bladder Volume and Mass Instrument Ind icator Saved islam Savings Calculation yellow E s o eee OME stated 0 goo par Available EI Number Of Scans 76 Savings memory lt i gt Cath Avoided 68 Summary for 8 more ES UTI Avoided 2 exams E NeuralHarmonics g ray Savings C Home Screen Buttons Button Function Press to toggle between two possible scan options F
54. he EN IEC 60601 1 1 system standard is maintained Anyone connecting additional equipment to the BladderScan BVM 9500 signal input port or signal output port configures a medical system and is therefore responsible for ensuring that the system complies with EN IEC 60601 1 1 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 The BVM 9500 battery charger wireless hub and the computer used to access online ScanPoint image archives if used must be placed outside the patient vicinity more than six feet 2 meters from the patient Refer to UL 2601 1 Clause 2 deviation for the definition of patient vicinity User s Manual page 11 Important Information BladderScan BVM 9500 page 12 Bluetooth Wireless Technology NOTE This feature is used only with the optional ScanPoint software The Bluetooth technology used in the BladderScan BVM 9500 is compliant with Bluetooth Specification as defined and approved by The Bluetooth Special Interests Group Logo certification with Bluetooth wireless technology as defined by The Bluetooth Special Interest Group i7 Yade H Risk of Fire and Burns Regarding the battery do not disassemble heat above 60 C 140 F or incinerate Keep battery out of reach of children and in original package until ready to use Dispose of used batteries promptl
55. he LCD liquid crystal display screen on the BladderScan Console that displays measurement information instrument status and other exam settings and information NeuralHarmonics A patent pending technology that sharpens accuracy and Technology accelerates speed of three dimensional ultrasound bladder volume measurements Probe The handheld part of the BladderScan instrument that transmits ultrasound energy to the patient Results display Ultrasound image showing an abdominal cross section with the bladder shown as a dark circle on a field of speckled gray Also referred to as B Mode SCAN button Located on the underside of the BladderScan Probe this button is used to initiate the measurement ScanPoint The software and online service provided by Verathon image management that prints exam results maintains patient records displays technology ultrasound images from exams downloads software updates and calibrates the BladderScan instrument ScanPoint with ScanPoint with QuickPrint is a software program installed on QuickPrint your computer that communicates with ScanPoint Online to help you quickly and easily download and print download and print exam reports Sleep Mode When the BladderScan instrument powers down to conserve energy Press the POWER button to turn on the instrument Term Meaning Solid aiming arrow Indicates the bladder is inside the scan cone but is not completely centered The arrow shows the directio
56. ic to your instrument please follow these steps NOTE Do not press the Power button at any time when the battery is removed To reset the factory set configuration 1 Turn the Console OFF 2 Turn the Console ON and wait for the Home screen to appear 3 Remove the battery from the Console Wait 30 seconds Do NOT press any buttons on the Console while the battery is removed 4 Re insert the battery into the Console Wait 30 seconds If the Console does not turn on automatically turn the Console ON 5 Confirm that the instrument displays the correct configuration by checking the model number displayed in the upper left corner of the screen e7 ade H Observe the following precautions in the safe use and care of the BladderScan BVM 9500 Hazardous materials present Assure proper disposal The BladderScan BVM 9500 and related devices may contain lead mineral oils batteries and other environmentally hazardous materials When the BladderScan BVM 9500 has reached the end of its useful service life return the device charging cradle and related accessories to a Verathon Service Center for proper disposal Alternatively follow your local protocols for hazardous waste disposal Assure proper computer system configuration When using the BladderScan BVM 9500 with optional ScanPoint software your computer must be minimally certified to EN IEC CSA UL 60950 or 60101 1 standards This configuration ensures that compliance to t
57. ion playback start up sound and scan complete tone Brightness Press to adjust display brightness dimmer brighter 5 Variable Function Depending on device mode the buttons provide access to Buttons all instrument functions for scanning recording annotations printing connecting to ScanPoint optional accessing the training video and setting user preferences Printer Printer Door Press to release the printer door page 14 User s Manual BladderScan BVM 9500 Introducing the BladderScan BVM 9500 Battery Charger Wireless Hub The BladderScan BVM 9500 is powered by a Lithium lon Li lon battery pack The battery charger provided with your BVM 9500 can charge two Li lon battery packs while simultaneously functioning as the wireless hub linking your BVM 9500 to the ScanPoint host computer NOTE Use of ScanPoint with QuickPrint software is optional To provide power to the battery packs the battery charger wireless hub must be plugged into a wall outlet using the power cord provided To provide wireless communication between the BVM 9500 and the ScanPoint host computer plug the battery charger wireless hub USB connector into a USB port on the ScanPoint host computer The battery charger wireless hub maintains an operating distance of up to 120 feet 36 meters between the ScanPoint host computer and the BVM 9500 regardless of barriers such as walls ceilings or windows Figure 2 Battery Charger Wire
58. l Customer Care Department at 1 800 331 2313 page 68 User s Manual BladderScan BVM 9500 Product Specifications Product Specifications Symbol Directory The following table explains the industry symbols used to indicate the BladderScan system compliance with international and national standards and regulations Symbol Meaning Marked in accordance with Directive 2002 96 EC on Waste Electrical and Electronic Equipment WEEE solid bar indicates product was put on the market after 13 August 2005 Class ll equipment protected throughout by double or reinforced insulation Type BF applied part with EN IEC 60601 1 C CE marked in accordance with the Medical Device Directive MDD Canadian Standards Association CSA mark of certification to P United States standards for electromedical equipment C US m This unit is powered by a Lithium lon battery pack The Verathon part number for the battery pack is 0400 0066 0400 0066 User s Manual page 69 Product Specifications BladderScan BVM 9500 Standards and Regulations Compliance page 70 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 International Electrotechnical EN IEC 60601 1 Amendments 1 and 2 and Commission EN IEC 60601 1 2 EMC Safety Standard EN IEC 60601 2 Medical Device Directive
59. less Hub Charging bays for two battery packs Plug into wall outlet to ev power the battery charger Plug into a USB port on the User s Manual ScanPoint host computer optional to enable a wireless connection with the BVM 9500 page 15 Introducing the BladderScan BVM 9500 BladderScan BVM 9500 Parts and Accessories Part Number Description 0570 0207 BVM 9500 Console 0570 0208 BVM 9500 Probe 0570 0193 Battery Charger Wireless Hub 0400 0066 Lithium lon battery 2 provided 0900 1596 BVM 9500 User s Manual on In Service CD 0900 1601 ScanPoint with QuickPrint User s Manual on In Service CD 0900 2102 Quick Reference Card BladderScan BVM 9500 Bladder Volume and UEBW Measurement 0900 1447 Quick Reference Card Calibration 0800 0319 Thermal Paper Roll for the printer 0900 2103 BladderScan BVM 9500 In Service CD Includes User s Manuals Video Tutorials and Quick Reference Cards 0800 0347 BladderScan BVM 9500 Medical Cart optional 0900 1238 ScanPoint with QuickPrint Software Install CD NOTE Use of the ScanPoint software is optional and not required for operation of the BVM 9500 0620 0340 Calibration Kit Optional Requires ScanPoint with QuickPrint software Includes Calibration Container Calibration Target etc 0800 0005 Acoustic Coupling Gel 0 25 liter 0810 0201 Universal Accessory Basket for Medical Cart optional User s Manual BladderScan BVM 9500 Getting Started Gettin
60. m data is lost However the instrument does not erase any annotated exam results when it goes into sleep mode To make sure you do not lose any patient data it is a good idea to add a voice annotation to every patient exam You can make a new recording only if the instrument still displays the bladder volume for that particular exam 4 When you are satisfied with your recording press the HOME button to perform another measurement 5 If you are using the BVM 9500 in conjunction with ScanPoint software you can User s Manual view exam results and annotations on your PC Please refer to the ScanPoint User s Manual for more information page 55 BladderScan BVM 9500 Deleting a Saved Exam Saved exams are indicated by yellow folder icons along the left edge of the display To delete a saved exam 1 Open the Review Screen From the Home Screen press 2 Press the button until the desired exam is highlighted blue 3 Press the X button to delete the exam Printing You can use the BladderScan BVM 9500 onboard printer to print the ultrasound images captured during the scan Figure 31 is an example To print exam results you must first record a voice annotation as described previously When this is complete press the PRINT button Adding Additional Information The label provides fields for Patient ID Patient Name Operator and Physician This information must be entered manually Figure 31 Exam Resul
61. n to move or tilt the BladderScan instrument to improve the measurement Re aiming is optional but not required Supine position Refers to the patient laying on their back Suprapubic The area above the pubic bone Symphysis pubis The front of the pelvis where the pubic bones meet UEBW Ultrasound estimated bladder weight a measurement of bladder wall mass to help identify bladder outlet obstruction BOO Ultrasonic Involving ultrasound Ultrasound is sound at frequencies above the range that can be heard by the human ear
62. ographer is not required Patent pending NeuralHarmonics technology abbreviated from neural network harmonics in the BVM 9500 sharpens accuracy and accelerates speed of bladder volume measurement Volume measurements made with NeuralHarmonics technology are more accurate than those from conventional two dimensional ultrasound as they are based on a more complex multifaceted image of the bladder This technology applying multi spectral analysis to a robust data set helps reduce margin of error and minimize uncertainty in essential measurements of bladder function If needed after a scan has been taken a unique aiming icon guides the operator to optimal Probe placement with a comprehensive display showing the bladder in two cross sectional images verifying that a complete scan has been achieved Bladder volume patient type directional aiming with real time feedback battery status and usage rate indicators are all displayed on the device s LCD screen BladderScan BVM 9500 measurements can be printed via an onboard printer or transmitted using HIPAA compliant ScanPoint image management technology for storage and archiving on Verathon servers Stored exams can be accessed at any time from your office s computer for viewing or printing NOTE Use of ScanPoint software is optional Exam results may also be transmitted to a computer running ScanPoint with QuickPrint software via a proprietary wireless connection ScanPoint with
63. on appears on the display Press to view review additional data including bladder surface area UEBW and bladder wall thickness Review Screen 2 Press to delete the currently selected exam Press to return to the Home screen e o5 do ap e Select the RETURN button on Review Screen 1 to view Review Screen 2 with bladder wall images Figure 18 Figure 18 Review Screen 2 i pm BVM 9500 wo Bladder Volume and Mass Instrument 2 4 2010 Surface Area 177cm2 2 4 2010 13 31 Bladder Weight mode 43g DE 2 Bladder Weight manual 43g Wall Thickness wana 2 4mm F e o L3 o page 32 User s Manual BladderScan BVM 9500 Displays Controls and Indicators User s Manual Review Screen 2 Buttons Button Function Press to select the next exam in the list Press to print the results for the currently selected exam on the onboard printer While printing is in progress an hourglass icon appears on the display Press to view review additional data including bladder surface area UEBW and bladder wall thickness Review Screen 2 Press to delete the currently selected exam Press to return to the Home screen CARE IK Tutorial Screen To open the Tutorial Screen Figure 19 press the mm button from the Home screen The Tutorial screen presents a menu of training modules To select a title press either the A4 or Y button until the desired title is highlighted red Press the button to
64. ous materials When the BladderScan BVM 9500 has reached the end of its useful service life return the device battery charger wireless hub and related accessories to a Verathon Service Center for proper disposal Alternatively follow your local protocols for hazardous waste disposal User s Manual BladderScan BVM 9500 Troubleshooting Help Resources User s Manual Troubleshooting Verathon provides an extensive array of customer service resources described in the table below You can obtain copies of this manual Quick Reference Cards and clinical studies by visiting the Verathon Web site at http www verathon com or by contacting your Verathon Medical representative For contact information please see page 66 Resource BladderScan BVM 9500 In Service CD Training modules BladderScan BVM 9500 Quick Reference Cards Clinical Studies ScanPoint Online Premium Warranty Description CD included with the BVM 9500 that provides information on how to use the instrument Includes user manual quick reference cards and training videos Training modules explaining how to take bladder volume and UEBW measurements can be found on the In Service CD The tutorials are also installed on the instrument and can be accessed by pressing the button from the Home Screen Summary of procedures for using the BladderScan system Scientific papers on BladderScan use ScanPoint Online provides customers
65. resents a list of user configurable settings e Name see page 37 Time amp Date see page 38 e General Preferences see page 39 e Savings Preferences see page 42 e Self Test see page 43 Use the Up Down arrows to move through the list of options To select an option press the ENTER button NOTE When any Settings screen is open the SCAN button on the Probe is disabled User s Manual page 35 Displays Controls and Indicators BladderScan BVM 9500 Figure 21 Settings Screen Start Menu BVM 9500 x Bladder Volume and Mass Instrument Name Date amp Time General Preferences Savings Preferences Self Test Settings Screen Buttons Button Function co SELECT NEXT Press to select the next setting in the list O SELECT PREVIOUS Press to select the previous setting in the list ENTER Press to select the highlighted setting ii No function e HOME Press to return to the Home screen page 36 User s Manual BladderScan BVM 9500 Displays Controls and Indicators Alpha Numeric Screen This screen allows you to select the appropriate alpha numeric characters for entering your health care institution s name Figure 22 Alpha Numeric Screen BVM 9500 zu Bladder Volume and Mass Instrument Verathon Medical BVM 9500 Alpha Numeric Screen Buttons Button Function Press to move down in the grid Press to move to the right in the grid Press to add the highlighted character to
66. rse effects However ultrasound should be used only by medical professionals when clinically indicated using the lowest possible exposure times indicated by clinical need The ultrasound output power of the BladderScan BVM 9500 is not user adjustable and is limited to the minimum level necessary for effective performance Data on acoustic output levels can be found in the BladderScan BVM 9500 Instrument Specifications section of this manual on page 70 Statement of Prescription United States federal law restricts the BladderScan BVM 9500 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 BladderScan BVM 9500 within its intended use throughout an institution Individual prescriptions for use are not required Statement of Intended Use The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively Contraindications The BladderScan BVM 9500 is not intended for fetal use or for use on pregnant patients Cautions and Warnings To assure safe and reliable operation for the use and the patient please read and heed the following warnings and cautions User s Manual page 9 Important Information BladderScan BVM 9500 page 10 WARNING Risk of explosion If you use the
67. s g when the bladder is not centered in the ultrasound cone Printer Problems No Paper The BladderScan BVM 9500 senses the presence of paper and automatically displays this image when the printer is out of paper Figure 33 Figure 33 Printer Out of Paper Screen Verathon Medical BVM 9500 BVM 9500 Bladder Volume and Mass Instrument The printer is open or out of paper Press any button to continue e 3 3 o 3 L3 o User s Manual page 63 Warranty page 64 BladderScan BVM 9500 For instructions on loading paper please refer to the section in this manual titled Load a Roll of Thermal Paper beginning on page 22 Too Hot The BVM 9500 displays the message Too hot if the print head overheats In this case turn off the BVM 9500 immediately This condition may be the result of a paper jam To clear the paper jam see the following paragraph Clearing a Paper Jam If the paper will not advance through the printer open the printer door on the back of the Console and clear the paper jam User s Manual BladderScan BVM 9500 Warranty Verathon Inc warrants the BladderScan BVM 9500 against defects in material and workmanship as long as it is covered by the Premium Warranty 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 uni
68. s that there is no instrument downtime The charger will bring the batteries to a full charge within 6 hours or less NOTE Before using the BladderScan BVM 9500 for the first time you will need to charge both batteries User s Manual page 17 To charge the batteries 1 Plug the battery charger wireless hub unit into a standard wall outlet 2 Remove the label covering the battery contacts and insert the battery into the recess in the battery charger NOTE Fully charging the battery may take up to 6 hours Batteries may be stored in the charger There is no danger of overcharging the batteries 3 Check the colored indicator lights on the battery charger to determine battery status Solid green Battery fully charged Amber Battery charging Install a Battery Pack in the Console Warning Risk of serious injury If the battery pack is leaking or its case is cracked put on protective gloves to handle it and discard it immediately Always dispose of used battery packs in compliance with all applicable laws and regulations Put insulating tape such as cellophane tape on the electrodes during transportation to avoid a possible short circuit fire or electrical shock Failure to do so could result in serious injury To insert a battery pack Insert the charged battery into the battery well in the Console slide it under the ledge and push down gently until the battery clicks into place NOTE The battery pack is
69. s to subtract or toggle digits as appropriate same as above Press and hold the button to move through options more quickly Press to save the current date time setting and return to the Settings screen General Preferences Screen This screen displays a list of available settings and their current values Available settings User s Manual Language English default Chinese Traditional Czech Danish Dutch Finnish French German Greek Italian Hungarian Japanese Korean Norwegian Portuguese European Spanish Swedish Turkish Date Format mm dd yyyy dd mm yyyy yyyy mm dd Time Format 12 hour or 24 hour Calibration Warning On default Off When On is selected a calibration warning will appear in the display header when the device requires calibration Print Report Type Toggle between C Mode images bladder in crosshairs and B Mode images image of bladder and abdominal space below Probe Figure 25 shows examples of C Mode and B Mode print reports respectively Print UEBW Toggle between On Off When On is selected any printout will include both Bladder Volume and UEBW measurements When Off is selected only Bladder Volume measurements will be printed Figure 25 shows an example of the UEBW print report Manual Wall Thickness Mode Normal default Detrusor When Normal is selected manual wall thickness mode allows measurement of the entire bladder wall When Detrusor is select
70. sumes the patient is a female who has not had a hysterectomy Select to measure bladder volume on male patients 3 or female patients who have had a hysterectomy 3 With the patient supine apply gel Have the patient lie in the supine position with the abdominal muscles relaxed Palpate the patient s symphysis pubis pubic bone Place an ample quantity of gel with as few air bubbles as possible midline on the patient s abdomen approximately one inch 3 cm above the symphysis pubis pubic bone User s Manual page 47 Measuring Bladder Volume and UEBW BladderScan BVM 9500 page 48 4 Aim toward the bladder Standing at the patient s right side place the Probe on the gel and aim it toward the expected location of the bladder For most patients this means angling the Probe slightly toward the patient s coccyx tail bone so the scan clears the pubic bone Press and release the SCAN button Press and release the SCAN button located on the underside of the Probe As the scan progresses sections of the bladder will appear on the Console screen When you hear the end scan tone the scan is complete Scan button Verify the scan If the scan is on target the Probe will display eight arrows On the Console display the bladder cavity will be appear in the center of the crosshairs To measure Ultrasound Estimated Bladder Weight UEBW the patient s bladder volume must be between 150
71. t 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 in 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 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 BladderScan instruments as of September 2010 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 BladderScan BVM 9500 at the institution where it is in use is responsible for keeping current with clinical research in bladder volume measurements Please direct
72. tate the printer door down Make sure you hear it snap into place Slide the printer door to the left DX Ue QV ge Tear the excess paper off SALSA To avoid paper jams never fold the end of the paper roll or cut it diagonally or to a point NOTE If the paper appears to be stuck in the printer open the printer door on the back of the Console and clear the paper jam page 22 User s Manual BladderScan BVM 9500 Getting Started User s Manual Assemble the Medical Cart Optional NOTE The Medical Cart Figure 9 is an optional accessory If you re not using the Medical Cart please skip to the next section Install the ScanPoint with QuickPrint Software on page 26 Figure 9 Medical Cart PN 0800 0347 Medical Cart Parts List Item No Quantity Part Number Description 1 1 0142 0289 Tray Assembly 2 1 0810 0140 Bracket and Post 3 1 0810 0002 Medical Cart Base 4 4 0261 0107 Screw PH W Lock 25 20 x 1 2 5 1 0260 0357 Fluted Knob 3 8 16 x 1 00 6 4 0810 0142 Caster 3 inch 7 1 0810 0143 Caster 3 inch with Brake 8 2 0136 0109 Loctite 680 page 23 To assemble the cart Please refer to Figure 10 during assembly process 1 Align and press one 3 inch Caster with Brake Item 7 and four 3 inch Casters Item 6 into Medical Cart Base Item 3 Align through round hole in Bracket and Post Item 2 bracket to through hole in Tray Assembly Item 1 Figure 10 Medical Cart Assembly Insert
73. terference 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 User s Manual BladderScan BVM 9500 Product Specifications BladderScan BVM 9500 Instrument Specifications For technical performance assessment in an acoustic laboratory the Probe cannot be immersed in water Item Specification Input Lithium lon Battery Pack Verathon P N 0400 0066 Output No load to full load at rated voltage Refer to unit label Insulation The power supply is Class with basic insulation to each terminal Transient Overvoltage Category Il Weight 5 2 Ib 2 36 kg with battery Display 13 36cm W x 10 13cm H 5 26 W x 3 99 H 640 x 480 pixels 120 dpi Integrated Printer Thermal label printer Languages English default Chinese Simplified Chinese Traditional Czech Danish Dutch Finnish French German Greek Hungarian Italian Japanese Korean Norwegian Portuguese Spanish Swedish Turkish Ultrasound Output Parameters Acoustic Output Limits Item Specification Maximum ultrasound l Intensity lt 5 0 mW cm Spatial Peak Temporal Average derated Long Intensity Spatial Peak Pulse lt 60 0 W cm Average derated Range Maximum MI Mechanical Index
74. the Bracket and Post Item 2 into the square relief in bottom of the Tray Assembly Item 1 Insert four Screws Item 4 through the Bracket and Post Item 2 into the molded inserts in the Tray Assembly Item 1 tighten securely Place the Tray Assembly with the Bracket and Post into the Medical Cart Base Item 3 NOTE If permanent attachment of the Tray Assembly and Post to the Medical Cart base is required refer to the Loctite Option below before inserting the post into the base Place the BVM 9500 into the foot prints on top of the Tray Assembly Item 1 Screw the Fluted Knob Item 5 through the Bracket and Post Item 2 bracket round hole and hand tighten Loctite Option 1 Place the medical cart base on a level floor Open 2 tubes of Loctite 680 by snapping off the tip of the tube Apply the Loctite 680 all around the tapered portion of the post Use all of the contents of both tubes Complete coverage of the taper is not necessary as the Loctite will spread upon insertion into the base Slide the post into the hole in the base with a twisting motion and press down firmly Wipe off excess any Loctite with a paper towel and discard towel as waste Allow the post and base to sit undisturbed for 3 hours A universal accessory basket P N 0810 0201 is available for the Medical Cart to add additional storage capacity Figure 11 page 24 User s Manual BladderScan BVM 9500 Getting Start
75. the calculated bladder volume and the ultrasound estimated bladder weight UEBW Figure 15 Results Screen BVM 9 5 0 0 Es Bladder Volume and Mass Instrument 2 4 20 10 Volume 197ml UEBW 43g 2 1g r3 o o o o o o User s Manual page 29 Displays Controls and Indicators BladderScan BVM 9500 page 30 In Figure 15 a standard deviation value indicating the UEBW measurement confidence is displayed as a range In some cases the UEBW measurement will be expressed as an approximate value using a symbol Figure 16 This means that the measurement is an approximate result only and you should re aim and re scan to get a more accurate reading The table below provides guidance on interpreting data displayed on the Results Screen Figure 16 Results Screen with Approximate UEBW value BVM 9500 ahonMedcal MMMSS Bladder Volume and Mass Instrument noc0000000 9 2 4 2010 Volume gt 156ml UEBW 31 1 8g Interpreting Results Screen UEBW Measurement Data Aiming Arrow Present No No No Yes Yes UEBW measurement symbol Recommended Action Accept UEBW measurement Adjust Probe pressure and or Probe angle and scan again Depending on patient anatomy it may not be possible to get an sign gt Bladder volume is too large for UEBW measurement Angle Probe in direction of arrow on Probe screen or move Probe no more than 1 2 inch 1 cm in direction of arro
76. the name Press to delete one character from the name Press to return to the Settings screen User s Manual page 37 Displays Controls and Indicators BladderScan BVM 9500 Date amp Time Screen This screen allows you to adjust the date and time NOTE If the time display is set to show a 24 hour clock the hour units are 0 23 If the clock is set to show a 12 hour clock the hour units are 1 AM 12 AM and 1 PM 12 PM Referring to the example shown in Figure 23 To change the time from 20 42 AM to 23 30 11 30 PM 1 Press the button until the 20 is highlighted red 2 Press the button 3 times until the time digits display 23 30 3 Press the V button until the 42 is highlighted 4 Press the button repeatedly until the minutes display 30 The time setting is now 23 30 5 Press the SETTINGS button EO to save this entry and return to the Settings screen Figure 23 Date amp Time Screen BVM 9500 verti TIEN Bladder Volume and Mass Instrument Pl 5 77 267 2008 page 38 User s Manual BladderScan BVM 9500 Date amp T Displays Controls and Indicators ime Screen Buttons UJ le EI 80 Move forward one changeable unit e g hours minutes AM PM etc Press to move back one changeable unit Press to add and or toggle digits as appropriate hours minutes AM PM months day years Press and hold the button to move through options more quickly Pres
77. tion Description Storage Ambient temperature range Atmospheric pressure range Relative humidity Indoor 20 60 Celsius 4 140 Fahrenheit 500 hPa 1060 hPa 20 95 non condensing User s Manual BladderScan BVM 9500 Product Specifications BladderScan BVM 9500 Displays Controls and Indicators User s Manual The BladderScan BVM 9500 provides the following controls connectors and features Instrument Buttons POWER ON OFF BRIGHTNESS 4 and VOLUME 4 v are located on the lower half of the Console SCAN on the Probe The five buttons below the Console LCD have variable functions depending on current instrument mode as follows Screen Mode Active Buttons Start up screen POWER VOLUME BRIGHTNESS Appears when the 1 5 No function instrument is first turned on Home Screen POWER SCAN opens Aim Scan screen 1 PATIENT TYPE toggle between two bladder volume modes female with uterus all other patients 2 TUTORIAL opens Tutorial screen 3 SETTINGS opens Settings screen 4 REVIEW opens the Review screen 5 SCANPOINT transmits saved exams to ScanPoint Scan Screen POWER No function SCAN Press to take a scan Buttons 1 5 No action Appears when the instrument is turned on Appears when the operator presses and releases the SCAN button Results Screen POWER SCAN opens Aim Scan screen Appears when the operator 1 RECORD press to record voice
78. ts Printout Using the Onboard Printer BladderScan Results 10 8 2008 10 48 Exam Time And Date Patient ID Patient Name Opera tor ID Physician Procedure Code Urine Volume 86ml BladderScan Results Verathon Medical BVM 9500 Urine Volume 86mi Surface Area 199cm Wall Thickness 1 2mm Ultrasound Estimated Bladder Weight nose 249 NOTE If the facility name date and time have not been set those lines will be skipped on the printout The BVM 9500 prints on thermal paper which fades over time For maximum storage life Verathon recommends that you photocopy the printout page 56 User s Manual BladderScan BVM 9500 Histogram of Cost Savings User s Manual Each volume measurement from a completed scanning procedure is stored in the memory of the BladderScan BVM 9500 in one of eleven volume ranges each with a 100 ml increment This data is analyzed and can be displayed on the BVM 9500 at any time The cost savings screen lists Date Started Number of Scans Cath Avoided UTI Avoided Savings Cost Savings Criteria Cost savings are based on the following criteria Catheterizations avoided Urinary catheterization may be unnecessary Thus by using the BVM 9500 these catheterizations are avoided The default setting for volume below which catheterization is unnecessary is 200 ml UTIs avoided Studies indicate that a certain percentage of unnecessary catheterizations le
79. urrent 1 Amp max Input connection 2 wire IEC 60320 C7 Output 9v at 1 Amp Insulation Class ll with double insulation Fuses 250 VAC 2A quick acting Testing CSA 60950 1 03 UL 60950 1 page 76 User s Manual BladderScan BVM 9500 Storage Conditions Condition Glossary Description Use Indoor Ambient Temperature Range Atmospheric pressure range 41 104 F 5 40 C 70 kPa 106 kPa Relative humidity 30 75 non condensing Water resistance Battery Specifications Rated at IPX 0 ordinary equipment without protection against ingress of water The BladderScan BVM 9500 is provided with two Lithium lon batteries A battery icon on the instrument display is always present indicating how much power remains and when the battery needs to be changed The user can change the battery whenever necessary Removing a discharged battery and replacing with a fresh battery will not erase any saved exams or user settings Use only the battery charger provided with the BVM 9500 Any other battery charger may damage the battery pack The batteries meet the following specifications Condition Battery type Battery life Charging time Rated capacity Normal voltage Max charging voltage Max weight Width Length Thickness User s Manual Description Lithium lon A fully charged battery can provide approximately 30 exams within a 24 hour period Charging time offline will take no
80. w scan again gt Angle Probe in direction of arrow on Probe screen or move Probe no more than 1 2 inch 1 cm in direction of arrow scan again User s Manual BladderScan BVM 9500 Displays Controls and Indicators User s Manual Results Screen Buttons Press to record a voice annotation up to 10 seconds long UJ lo Press to print exam results nD Press to play a previously recorded voice annotation blue If no C voice annotations are recorded this button is disabled gray ccu Press to go to the Image Zoom screen Press to return to the Home screen Review Screen The Review screens Figures 17 and 18 open when you select a saved exam blue folder icon to review The displays shows the ultrasound images associated with the selected exam A green open folder icon indicates which exam is being viewed While reviewing saved exams the buttons below the display allow you to print replay or delete exam data Figure 17 Review Screen 1 BVM 9500 then Medical MESS Bladder Volume and Mass Instrument 2 4 2010 2 4 2010 13 31 Urine Yolume 19 7mi e r3 o o L3 o 3 page 31 Displays Controls and Indicators BladderScan BVM 9500 Review Screen 1 Buttons Press to select the next exam in the list UJ e Press to print the results for the currently selected exam on the onboard printer While printing is in progress an hourglass ic
81. y according to local recycling or waste regulations Bluetooth and Wireless LAN devices operate within the same radio frequency range and may interfere with one another If you are using the BladderScan BVM 9500 Bluetooth link and Wireless LAN devices simultaneously you may experience less than optimal network performance or even loose your network connection If this happens you may need to move the BladderScan instrument and ScanPoint host computer to an area away from the 2 4 GHz wireless LAN devices 40 meters 44 yards or more User s Manual BladderScan BVM 9500 Introducing the BladderScan BVM 9500 Introducing the BladderScan BVM 9500 The BladderScan BVM 9500 is designed for simple intuitive operation However to ensure safe and effective operation before using the device Familiarize yourself with the contents of this manual Watch the training videos provided on the instrument and on the In Service CD BladderScan BVM 9500 Parts and Features The BladderScan BVM 9500 has two main components The Console and the Probe The Console and Probe are linked by a detachable cable The BladderScan BVM 9500 controls and indicators are illustrated in Figure 1 Figure 1 BladderScan BVM 9500 Controls and Indicators Console Main Display Battery Status Indicator Battery Pack e Printer behind display dabei Battery Packs m Adjust Volume 5 Variable Function Buttons Adjust Brightness
82. y in the battery charger to recharge Clean the Probe by wiping it gently with a soft cloth soaked in isopropyl alcohol NOTE When measuring bladder volume and or UEBW and bladder wall thickness with the BladderScan BVM 9500 it is VERY IMPORTANT to hold the device steady while scanning Be aware of the following conditions the patient may have that could affect ultrasound transmission and the accuracy of your exam Acatheter in the patient s bladder The presence of a catheter may affect the accuracy of the bladder volume measurement but the measurement may still be clinically useful detecting a blocked catheter for example Previous suprapubic or pelvic surgery Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and reflection Do not use the BVM 9500 on Patients with ascites Patients with open skin or wounds in the suprapubic region Pregnant patients page 46 User s Manual BladderScan BVM 9500 Measuring Bladder Volume and UEBW Measuring Bladder Volume and UEBW 1 Turn on the BladderScan BVM 9500 Turn on the instrument by pressing the ON OFF button em meson On Off button 2 Select the exam mode BVM 9500 AHE Savings Calculation Press the MODE button 4 X repeatedly to toggle between male and female modes Date Started 6 14 2008 Number Of Scans 76 When the female icon is displayed the BVM 9500 as

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