Home

BVI 9400 User`s Manual - Frank`s Hospital Workshop

1. 45 ScanPoint Screen ccccccsecessecescecescsccescececesvececevaceusevaceesavaucevvervaceusevauesvavetervaceevevsservasnnesvanensaseneeess 46 SS esse x 46 Memory Optimization During Power Down ssssessssssesseeeeee nennen menn nnne nnn n anni nnns 47 Measuring Bladder V fo Du c 48 mius 5 drole TNS E RET TEE 48 Measuring Bladder Volume uu vetus pron cda esau ia sius e dic pene dad aita nva iari Ried ics Io Rd vata a Rau MuR NE icu DV dud 49 Additional Scanning TIPS c 52 Recording a Voice Annotation ccccceccceceeeeeseeeeseeeeeseeeecaeeeeseaeeeseeeeeseeeeeseeeeseaeeeseeeeseueessaesessageeeseneessees 02 Deleting a Saved m PR T 54 xutupormccc 54 Adding Addition TORN an RE Oo LOEO 54 Histogram of COST SAVINGS soisiu a E EEE a a 55 Cle aning and Maintenance usse vines uuu uvicva cu aaa a aaaea a aia a a a a a a 56 Cleaning and Disinfecting the BladderScan BVI 9400 o cceeccecssesessecesessececeresseveceresvevaveversecenersevenenen 56 Regular Inspections and Maintenance ccccccccseceeceeeeeeeeeeeseeee
2. suctacaausabennenaeiiadepeatiussnoduiuacenacsauemeandicdeaabep hosed 75 cin T n O YX 76 User s Manual page 11 Table of Figures BladderScan BVI 9400 Table of Figures Figure 1 BladderScan BVI 9400 Controls and Indicators enn 18 Figure 2 Battery Charger Wireless Hub ccccccsssceccseseeeceenseecceuseeeseaeeeseaseeeseaseeessageeecsaaseesauseeesssageees 20 19416 3 ROME elec DNE TE TEE OO TOTO 24 POUCAS SEDIS T O cesta idniatubum eu BUE bu EEen oda I du MEM Oc ata pM UMEN EU d US IUD E NEUEM REED 24 Figure 5 Alpha Numeric 660 0 0 25 Figure 6 Facility Name in Display Hea del cccccccccceeeeceeeeeseeeeeaeeesaeeeeeeeeeeeeeeeseueeeseneessueesseeeeseneeesanees 25 Figure 7 Set Up Screen Date and Time esses eene nennen nnne nnne nnns nnn nnns 26 Foure o Date and TIME CrO MR DE Uo m m 26 Figure 9 Medical Cart PN 0800 0322 28 Figure 10 Medical Cart ASSemlbly aai oneri bte pa c
3. Press to save the current date date time setting and return to the Setup screen Self Test Screen To open the Self Test screen select Self Test from the Setup menu Figure 18 page 39 The Self Test screen will open and testing begins automatically Figure 23 Self Test Screen BVI 9400 Bladder Volume Instrument Self Test Serial Number 8 Versions U I 2 0 132 DSP 4 0 Disk Space 11534KB Available Microphone Passed DSP Present and Functional Battery 10096 9796 ref 48 mAh Cap Cells 5 23 25mV Internal Temperature 409C Probe Calibration Expires in 212 Days Printer appears functional Self Test Screen Buttons Button Function No function No function No function No function Press to return to the Setup screen page 45 Displays Controls and Indicators BladderScan BVI 9400 ScanPoint Screen NOTE Only available if optional ScanPoint software is installed on a PC To open the ScanPoint screen press e from the Home screen Figure 12 page 18 The ScanPoint screens display information about the status of the link between the BladderScan instrument and the ScanPoint host computer Figure 24 Figure 24 ScanPoint Screens Searching for ScanPoint Connected to ScanPoint BVI9400 Smee i BVI 9400 Bladder Vvealume Instmurmment Proba Calbraten Epiat ii D Days Bladder Valurmue Instmrment Probe Calbeatin Epiat
4. 66 BladderScan BVI 9400 System Components seen treten 66 Product SCC piedi o p MERE 67 sese M 67 Standards and Regulations Compliance sees eene nennen nennen nnne nnn nns 68 mieigenepiedme 68 BladderScan BVI 9400 Instrument Specifications cccccccesecescesescesersesesscersreevreesersrersenersenenenreeten 69 Ultrasound Output Parameters ccc cccccsecccceececceeeeceeeeeceeeecseeeeseeeeeceueeeseaeessaueessaeessaeeessaeeessneeessaees 69 PREC UN ACY SCI CA US ese cnc fep post ndepbsentinc dementis tanien e ANTEE dme a om rem ERE mands 70 BladderScan BVI 9400 Operating Conditions 70 BladderScan BVI 9400 Storage Conditions eene 70 BladderScan BVI 9400 Displays Controls and Indicators iecit o dee hoop poder deep esae doe epis mis 71 Instrument mI IPIE E m 71 Mstrument MNS FO a 9 73 Battery Charger Wireless Hub Specifications cccccccccccseeceeeaeeeeeceeeeeeseeeeeeeaeeeeeeseeeeesueeesseneeesaaeseees 74 Si Ut AS ONGOING E S 74 Storage COPA INS cat sw sc ak wetted cit dato std Ri Se cain cade dasa om thon aided daae ae ata 75 Batten SC Ci CANONS 000
5. Class Il equipment protected throughout by double or reinforced insulation Canadian Standards Association CSA mark of certification to United States standards for electromedical equipment cH un User s Manual page 67 Product Specifications BladderScan BVI 9400 Standards and Regulations Compliance Verathon certifies that all units are in compliance with all applicable international and national standards and regulations including but not limited to the following Specification Standard 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 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 BVI 9400 due to its electromagnetic characteristics Both the emissions from BladderScan and the susceptibility of this instrument to interference from other sources are within prescribed limits of all applicable standards at the date of manufacture The emissions test procedure that was used is specified in EN IEC
6. page 42 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 Enable Small Child Mode SCM On default Off Select Off to disable Small Child Mode NOTE If use of the small child mode is rare in your practice you may want to turn that option off User s Manual BladderScan BVI 9400 Displays Controls and Indicators Figure 21 General Preferences Screen BVI 9400 iar noas Bladder Volume Instrument Language English Date Format mm dd yyyy Time Format 24H Calibration Warning Enable Small Child Mode General Preferences Screen Buttons Button Function 4 k SELECT PREVIOUS Press to select the previous setting in the list 4 SELECT NEXT Press to select the next setting in the list For settings with a list of options press to select the next option i For settings with a list of options press to select the previous option oe Press and hold to move through options more quickly EO Press to return to the Setup screen AB Savings Preferences Screen To open the Savings Preferences screen select S
7. Saved exams are indicated by yellow folder icons along the left edge of the display To delete a saved exam m 1 Open the Review Screen From the Home Screen press B 2 Press the button until the desired exam is highlighted blue 3 Press the X button to delete the exam You can use the BVI 9400 onboard Printer to print the ultrasound images captured during the scan Figure 27 is an example To print exam results press the PRINT button immediately following the exam Adding Addition Information The label provides fields for Patient ID Patient Name Operator and Physician This information must be entered manually Figure 27 Exam Results Printout Using the Onboard Printer BladderScan Results 12 19 2007 20659 Eram Tiene And Date NOTE If the facility name date and time have not been set those lines will be skipped on the printout The BVI 9400 prints on thermal paper which fades over time For maximum storage life Verathon recommends that you photocopy the printout User s Manual BladderScan BVI 9400 Histogram of Cost Savings Histogram of Cost Savings Each volume measurement from a completed scanning procedure is stored in the BVI 9400 memory in one of eleven volume ranges each with a 100 ml increment This data is analyzed and can be displayed on the BVI 9400 at any time The cost savings screen lists Date Started Number of Scans Cath Avoided UTI Avoided Savings Cost Sav
8. Y 22 Unpack the Box and Check the Components ccccccccecceceeeeeeeeeeeaeececaeeeeceeeeeseeeeseeeesseeeessaeeesaeeesaees 22 03196 th BAU CTC NOTTE 22 Install a Battery Pack in the Console oaa inta dn rti tin aha timi kat iennnavebedecastundeniialdeciarnenedcowenaess 23 sua HR 23 ENFIN Bal 10111 e 24 Set the Date and 11006 0 00 00 26 Setting General Preferences and Savings Preferences 27 030 aRt Thermal AD wensen doe donee sae cteeeonssaee DOTEM 27 Assemble the Medical Cart 0 28 Medical Cart du cH m enren 28 Install the BladderScan on the Optional Mobile Cart sese 30 Install the ScanPoint with QuickPrint Software Optional eee 30 Watch the Training Video ssssssssssssseseseeenneee nennen nnnm nnn nnne nnne n nnne nnns a
9. BladderScarv Bladder Volume Instrument BVI 9400 User s Manual N A VERATHON BladderScan BVI 9400 Bladder Volume Instrument User s Manual CAUTION In the United States federal law restricts this device to use by or on the order of a physician Copyright 2008 by Verathon Inc All rights reserved No part of this User s Manual may be copied or transmitted by any method without the express written consent of Verathon Inc Verathon Verathon Medical BladderScan ScanPoint Sontac and NeuralHarmonics are either trademarks or registered trademarks and Total Reliability Plan is a service mark of Verathon Inc Bluetooth word mark and logos are owned by the Bluetooth SIG Inc and any use of such marks by Verathon is under license Cidex is a registered trademark of Advanced Sterilization Products Sporocidin is a registered trademark of Aporocidin International All other brand and product names are trademarks or registered trademarks of their respective owners The BladderScan technology described in this manual is protected by U S Patent Numbers 4 926 871 5 235 985 6 676 605 and 6 884 217 The ScanPoint technology described in this manual is protected by U S Patent Number 6 569 097 The Sontac ultrasound coupling pad described in this manual is protected by U S Patent Number 5 782 767 Other international patents pending Information in this User s Manual may change at any
10. 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 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 LU Indicates the battery must be changed tall and weight less than 60 Ibs 27 kg r The patient is a small child with height less than 48 inches 122 cm page 60 User s Manual BladderScan BVI 9400 Troubleshooting Symbol Meaning The patient is a female patient who has not had a hysterectomy Select to scan all other patients The bladder is too large to be contained within the scan cone or the gt bladder contains more than 999 ml of urine 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 BEFO
11. 14 FOGG ED CSCO MOM NEN HTH 14 Intended Use Warnings and Cautions ccccccccccceeeeeeceeeeeesaeeeeeseeeeeeseeeeeesseeeeesseeeeeeseeseesaeeeeesseeeeeeeseaes 14 BOCCA O er 14 Statement of Prescription sessiun oein Ee a Aa EA E E T aa AE A 15 Statement of Intended Use cc eecccccsececcceseeccesseecceseeessaeeecseececsauseeecsgeeessaueeecsageeeesegseesssaseesssageees 15 Contraindications U S Only 2 0 15 Bluetooth Wireless Technology tenerent ertet tnter treten 16 Introducing the BladderScan BVI 9400 eere nennen tnr entes nasse teta spans ana nnas 17 Product DESONDUON MENTEM TTKI 17 BladderScan Parts and Features c ccccccccscsesssesescececescececcesesvevscersevaveveevevaveueevevavaversevaverersevacenereevenen 18 OC OOS NS NRI 19 CORSE Oo ag ele FEN TTC T eee LOTO EM 19 Battery Charger Wireless 20 Parts and CCS SONS cee esse 21 GENDO SC sas C
12. 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 0322 Medical Cart optional 0900 1606 BladderScan BVI 9400 User s Manual on In Service CD 0900 1500 BladderScan BVI 9400 In Service CD with User Manuals Video Tutorial and Quick Reference Cards 0900 1601 ScanPoint with QuickPrint User s Manual on In Service CD 0900 1446 Quick Reference Cards Demo Use 0900 1447 Quick Reference Cards Calibration To order any of the above parts contact your authorized Verathon Medical sales representative or contact the Verathon Medical Customer Care Department at 1 800 331 2313 page 66 User s Manual BladderScan BVI 9400 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 Type BF applied part with EN IEC 60601 1 This unit is powered by a Lithium lon battery pack The Verathon part number for the battery pack is 0400 0066 0400 0066 CE marked in accordance with the Medical Device Directive MDD
13. 31 30 68 70 570 Fax 31 30 68 70 512 Web http www verathon eu Email customerserviceeu verathon nl Postal Address BP 10039 F 67012 Strasbourg Cedex France Tel 33 0 3 88 60 14 02 Fax 33 0 3 88 60 46 87 Email info verathon fr Verathon Medical Ltd United Kingdom The Granary Manor Farm Courtyard Aston Sandford Aylesbury Buckinghamshire HP17 8JB United Kingdom Verathon Medical K K Japan Executive Tower Azabudai 7F 1 4 3 Azabudai Minato ku Tokyo Japan 106 0041 Tel 44 1844 299 207 Fax 44 1844 299 218 Web http www verathon co uk Email customerserviceuk verathon co uk Tel 81 03 3560 3501 Fax 81 03 3560 3502 Email servicejp verathon com User s Manual BladderScan BVI 9400 Safety and Performance Summary Safety and Performance Summary The BladderScan BVI 9400 computes the volume of the urinary bladder based upon twelve cross sectional ultrasound images For maximum accuracy be sure to hold the Probe motionless while scanning The most accurate measurements are obtained when the patient rests 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 BVI 9400 to measure patients with moderately full bladders rather than
14. Displays status information about the ScanPoint communication For example when uploading an exams displays a progress bar 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 5 40 Celsius 41 104 Fahrenheit Atmospheric pressure range 70 kPa 106 kPa Relative humidity 30 75 non condensing Water resistance Rated at IPX 0 ordinary equipment without protection 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 current 1 Amp max Input connection 2 wire IEC 60320 C7 Output 9v at 1 Amp Insulation Class II with double insulation page 74 User s Manual BladderScan BVI 9400 Product Specifications Specification Description Fuses 250 VAC 2A quick acting Testing CSA 60950 1 03 UL 60950 1 Storage Conditions Condition Description Use Indoor Ambient Temperature Range 5 40 Celsius 41 104 Fahrenheit Atmospheric pressure range 70 kPa 106 kPa Rel
15. 2313 in the U S and Canada or contact your local Verathon Medical representative Verathon Corporate Headquarters 20001 North Creek Parkway Bothell WA 98011 USA Phone 1 425 867 1348 VM Europe B W Boerhaaveweg 1 3401 MN IJsselstein The Netherlands Phone 31 30 68 70 570 0900 1446 02 60 page 6 User s Manual BladderScan BVI 9400 Quick Reference Calibration NOTE This procedure requires ScanPoint with QuickPrint Imaging Technology Software If your BladderScan BV 9400 requires calibration and you re not using ScanPoint with QuickPrint please HI dd S contact Verathon Technical Support at 1 800 331 2313 US amp a er Car Canada or 425 867 1348 International Bladder Volume Instruments BVI 9400 Calibration Quick Reference Noninvasive Accurate Reliable Easy to Use The entire calibration process may take up to 15 minutes You may calibrate your instrument as often as you like you do not have to wait for the next scheduled calibration date However at a minimum you must calibrate the instrument every 12 months Ce Prepare for Calibration Set up the calibration tank in a location that is within 10 feet of Charger and Wireless Hub Place the calibration tank on a flat nonreflective surface and remove the lid Pour clean room temperature water into the container filling to the indicator mark Make sure the water contains a minimal amount of bubbles Place the spiral shaped target i
16. F ENTER Press to begin module playback While the module is playing ql press to pause Press again to resume play No function H HOME Press to return to the Home screen User s Manual page 37 Displays Controls and Indicators BladderScan BVI 9400 Video Viewing Screen The Video Viewing Figure 17 screen is activated by pushing the button on the Tutorial screen Figure 16 NOTE The SCAN button is disabled during video playback Figure 17 Video Viewing Screen BVI 9400 General Hospital Bladder Volume Instrument U rology Associates N VERATHON Video Viewing Screen Buttons Button Function No function PLAY PAUSE Press to start video playback Press to pause Press again to resume play d BACK Return to the training titles screen No function HOME Press to return to the Home screen page 38 User s Manual BladderScan BVI 9400 Displays Controls and Indicators Settings Screen To open the Settings screen Figure 18 push the SETTINGS button as on the Home screen The display presents a list of user configurable settings Name Time amp Date General Preferences Savings Preferences and Self Test Use the Up Down arrows to move through the list of setup options To select an option press the U turn arrow NOTE When the Settings screens are open the SCAN button on the Probe is disabled Figure 18 Settings Screen Start Menu BVI 9400 222 Bladder Volum
17. Hub while the other is installed in the BladderScan instrument This ensures 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 BVI 9400 for the first time you will need to charge both batteries prior to first use page 22 User s Manual BladderScan BVI 9400 Getting Started To charge the batteries 1 Plug the Battery Charger Wireless Hub unit in to 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 charge
18. The BVI 9400 can perform a number of self diagnostic tests To access the Self Test utility 1 From the Home screen press the SETTINGS button Bo 2 When the Settings screen opens press the V or ff buttons until SELF TEST is highlighted red then press q 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 e to return to the Settings screen then press the HOME button 2 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 BVI 9400 Using the ScanPoint System You must periodically calibrate your BladderScan BVI 9400 to make sure your 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 required a warning appears in the display header Figure 28 User s Manual page 57 Cleaning and Maintenance BladderScan BVI 9400 Figure 28 Calibration Warning General Hospital BV 940 0 Urology Associates Bladder Volume Instrument Please run Calibrati
19. To terminate the calibration procedure and end communication with the ScanPoint press the CANCEL X button on the BVI 9400 Remove the Probe from the calibration chamber lid and dry it with a clean soft cloth a Progress i 06009 updated carson valeam MyEVISMDO Pefomng Calbation exam please mal Poussin alis ahon rendi data Tiaras Calbrahon daa io Scan onr Chck hore Por Printatibe C gria gue of Calibradorn Calibration Successfull xj erp nier puee e Aen exa or o Lalibiation Tank before To order additional rolls of paper 0800 0319 or batteries 0400 0066 contact Customer Care at 800 331 2313 www verathon com https my scanpoint com For more information call 800 331 2313 in the U S and Canada or contact your local Verathon Medical representative Verathon Corporate Headquarters 20001 North Creek Parkway Bothell WA 98011 USA Phone 41 425 867 1348 VM Europe B V Boerhaaveweg 1 3401 MN Lsselstein The Netherlands Phone 31 30 68 70 570 0900 1447 01 60 page 8 User s Manual BladderScan BVI 9400 Table of Contents Table of Contents QUICK Helerel6e oec docui gen nnensdinveteesdseseoususemuedecectaseueueiavedseseaccesonteedeuendassuneviuesgseseaccqsosteudioe dave 5 Presidents SIalelnelll souci oea Seticersnesmeiceaweioeice ters cusan ei A ene ee ensign es aie NN AEAEE EEEREN NEN KNEE 13 Jas efolutziaudlejfelugnrzidTo o cem S
20. employers The AS provisions also address the security and privacy of health data The standards are meant to improve the efficiency and page 76 User s Manual BladderScan BVI 9400 Glossary User s Manual Meaning 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 bladder volume measurement this is the cone shaped area in which the Probe transmits ultrasound waves Instrument In this manual refers to the BladderScan BVI 9400 The BladderScan instrument transmits ultrasound energy to produce an image of the patient s bladder and determine bladder volume LCD screen NeuralHarmonics The LCD liquid crystal display screen on the BladderScan Console that displays the bladder volume measurement instrument status and other exam settings and information A patented BladderScan technology that sharpens accuracy Technology and accelerates speed of three dimensional ultrasound bladder volume measurements Probe The handheld part of the BladderScan instrument that transmits ultrasound energy to the patient SCAN button ScanPoint bladder imaging technology Located on the underside of the BladderScan hand grip this button is used to initiate the measurement The software and online service provided by Verathon that prints exam results maintains patient re
21. female with uterus all other patients 2 TUTORIAL opens tutorial screen 3 SETUP opens Setup screen 4 REVIEW opens Appears when the instrument is first tumed on the review screen 5 SCANPOINT transmits saved exams to ScanPoint Scan Screen POWER No function SCAN Press to take a scan Appears when the Buttons 1 5 No action operator presses and holds the SCAN button Results Screen POWER SCAN opens Aim Scan screen 1 RECORD press to record release to replay 2 PRINT print to on board label printer 3 PLAY press to play voice annotations otherwise no function 4 REVIEW opens review screen if a voice annotation has been recorded Otherwise no function 5 HOME return to Home screen Appears when the operator releases the SCAN button after aiming Review Screen POWER SCAN 1 NEXT select next exam in memory 2 PRINT print to on board printer 3 PLAY replay voice annotation for currently selected exam 4 DELETE delete currently selected exam 5 HOME return to Home screen Review replay print or delete saved exams Training Title Screen POWER 1 Skip back one chapter 2 Play Pause 3 Skip Forward one chapter 4 No function 5 Home return to View the menu of H ome screen training modules Video Viewing Screen POWER 1 No function 2 Play Pause 3 Return to Training Title Screen 4 No function 5 Home return to The video v
22. indicating that the pubic bone is inside the ultrasound cone If this occurs you may want to re aim and re scan Although the bladder may be shown 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 Save review and print exam results To save the exam you must 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 review the scan images press the REVIEW button You must first save the exam before you can review it To print exam results via the on board printer press the PRINT button To perform another exam press the HOME button General Hospital Urology Associates BVI 9400 Bladder Volume Instrument Volume gt 128ml General Hospital Urology Associates BVI 9400 Bladder Volume Instrument Volume 130ml 150ml e 6 m O Record Print Listen Review Home e On Off button re E a Sma m f f page 51 Measuring Bladder Volume BladderScan BVI 9400 8 Finish the exam Once
23. initially attempting to locate a bladder with a low urinary volume To conserve battery power the BladderScan BVI 9400 shuts itself down automatically when not in use goes into sleep WARNING Risk of explosion There is a possible risk of explosion if the BladderScan BVI 9400 is used in the presence of flammable anesthetics WARNING Risk of patient injury Do not use the BladderScan BVI 9400 on patients with open skin or wounds in the suprapubic region CAUTION Risk of inaccurate measurements Accuracy is compromised if the user does not obtain an optimal repeatable image The BladderScan BVI 9400 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 User s Manual page 65 Parts and Accessories BladderScan BVI 9400 Parts and Accessories BladderScan BVI 9400 System Components The following components are included with your BladderScan BVI 9400 system 0570 0190 BVI 9400 system Console and Probe Transmits and receives 0570 0188 ultrasound to measure a patient s bladder volume 0570 0193 Battery Charger Wireless Hub 0400 0066 Rechargeable batteries
24. 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 Chinese Traditional Czech Danish Dutch Finnish French German Greek Italian Hungarian Japanese Korean Norwegian Portuguese European Spanish Swedish Turkish Ultrasound Output Parameters Item Specification Maximum ultrasound lspta during a scan lt 5 0 m W cm Maximum ultrasound lsppa during a scan lt 60 0 W cm Maximum MI Mechanical Index 95 max Transducer diameter 13 mm 0 512 inches Transducer resonant frequency 3 0 MHz and 1 74 MHz Transducer bandwidth 75 at 10 dB Time from 3D scan initiation to result lt 3 seconds display Penetration depth in normal North 215cm American patient page 69 Product Specifications BladderScan BVI 9400 page 70 Accuracy Specifications 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 Description 15 15 ml on a Verathon tissue equivalent phantom Bladder volume range 0 999 ml 0 200ml in small child scan mode BladderScan BVI 9400 Operating Conditions The Bladd
25. 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 Additional Scanning Tips Applying too much pressure when scanning will lead to a Greater Than symbol gt preceding the measurement Apply less pressure and re scan Hold the device steady while scanning Movement will result in an inaccurate reading 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 Apply more pressure to the BladderScan BVI 9400 instrument to reduce the amount of adipose tissue through which the ultrasound must pass To ensure accurate results make sure that There are no air gaps between the Probe and the patient s skin The gel pad is intact not broken or cracked There are no air bubbles under the gel pad You are holding the instrument steady while scanning avoid changing its position angle or pressure 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 blocke
26. 30 AM 1 Press the button until the 8 is highlighted 2 Press the button 3 times until the time digits display 11 17 AM Alternatively press and hold the button to move more rapidly through the digits Press the button until the 17 is highlighted 4 Press the button repeatedly until the minutes display 30 Alternatively press and hold the button to move more rapidly through the digits The time setting is now 11 30 AM 5 Press the SETTINGS button e to save this entry and return to the Setup screen Figure 20 Date amp Time Screen BVI 9400 Bladder Volume Instrument 4 j 10 2007 User s Manual page 41 Displays Controls and Indicators BladderScan BVI 9400 Date amp Time Screen Buttons Button Function V 4 Press to move forward to the next changeable unit in this case hours Move back one changeable unit minutes AM PM month day year Press to add and or toggle digits as appropriate hours minutes uds AM PM months day years Press and hold the button to move through options more quickly Press 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 date time setting and return to the Setup EQ screen ABC General Preferences Screen This screen displays a list of available settings and their current values Available settings
27. 55011 1991 for Group 1 Class A equipment per EN IEC60601 1 2 36 201 1 7 BladderScan BVI 9400 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 BVI 9400 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 BVI 9400 will operate normally in the proximity of other potential interference sources and has demonstrated immunity at a field strength of 3 V m per EN IEC 60601 1 2 36 202 2 1 You do not need to take any other precautions regarding exposure in reasonably foreseeable environmental conditions to magnetic fields pressure or variations in pressure acceleration or thermal ignition sources page 68 User s Manual BladderScan BVI 9400 Product Specifications BladderScan BVI 9400 Instrument Specifications User s Manual 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
28. 9400 Instrument Specifications on page 69 07 Y a3 6 H Risk of inaccurate measurements results When using the BladderScan BVI 9400 be aware of the following conditions which can affect ultrasound transmission and decrease the accuracy of exam results Use care when scanning patients who have had supra pubic or pelvic surgery Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and accuracy page 15 Important Information BladderScan BVI 9400 page 16 Do not use the BladderScan BVI 9400 on a patient with open skin or wounds in the suprapubic region Do not use the BladderScan BVI 9400 on a patient with ascites f 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 e7 Y aa 67 H Observe the following precautions in the safe use and care of the BladderScan BVI 9400 Hazardous materials present Assure proper disposal The BladderScan BVI 9400 and related devices may contain lead mineral oils batteries and other environmentally hazardous materials When the BladderScan BVI 9400 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
29. ES C3 C EI cy C 3 C C Review Screen Buttons Button Function 4 1 SELECT Press to select the next exam in the list a 1 PRINT Press to print the results for the currently selected exam to the onboard label printer While printing is in progress a flashing print icon appears on the display The buttons are disabled except SELECT and PLAY a N PLAY Press to play a previously recorded voice annotation If no voice annotations are recorded this button is disabled x DELETE Press to delete the currently selected exam e HOME Press to return to the Home screen User s Manual BladderScan BVI 9400 Displays Controls and Indicators Tutorial Screen To open the Tutorial Screen Figure 16 press the te button from the Home screen Figure 12 page 33 The Tutorial screen presents a menu of training modules To select a title press either the or button until the desired title is highlighted red Press the ex button to go to the Video Viewing screen NOTE The SCAN button on the Probe is disabled during module playback Figure 16 Tutorial Screen BVI 9400 one Bladder Volume Instrument Using the BladderScan BVI 9400 NeuralHarmonics Technology Tutorial Screen Buttons Button Function SELECT NEXT Press to move down one title or to skip back one 4 chapter in the training module SELECT PREVIOUS Press to move up one title or to skip forward one t module
30. IBRATE button ScanPoint then automatically scans and analyzes the calibration target IMPORTANT Do not remove the Probe from the calibration chamber until four arrows appear on the Probe s LCD screen Do not disconnect the Charger and Wireless Hub from the computer or otherwise break the connection between the BVI 9400 and the ScanPoint host computer until all processing is complete a Calibrate he anf int A Qik Print Cahibrate Insirumenf n Vrirtrarmesni Hana E Successful calibration oap remm mee binumi Senet 47 If ScanPoint was able to locate the calibration target AN the instrument analyzes the scan data to ensure that it meets the calibration parameters If necessary the instrument automatically rescans the phantom When calibration is complete a Calibration Successful message is displayed on your computer To print a record of the calibration click Click Here for Printable Certificate of Calibration Failed calibration If ScanPoint was unable to locate the calibration target it displays an error message and instructs you to ensure that the calibration chamber has enough water and that the Probe is seated properly in the calibration system You may choose to calibrate again or to quit the calibration process NOTE If you are unable to calibrate contact your local Verathon Medical representative or Verathon Medical Customer Care at 1 800 331 2313 End calibration
31. Languages 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 24 hour Time Zone scroll through available time zones Calibration Warning On default Off When On is selected a calibration warning will appear in the display header when the device requires calibration Enable Small Child Mode SCM On default Off Select Off to disable Small Child Mode UTI Rate 1 100 in increments of 1 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 X savings Calculation Since new Since 1 1 2006 Reset Now Print Since New Print Recent Hide Savings User s Manual BladderScan BVI 9400 Product Specifications Screen Mode Active Buttons Self Test Screen POWER 1 Scroll down 2 Scroll up 3 No function 4 No function 5 SETUP Go back to setup 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 Instrument Display The instrument display is divided into three horizontal panes The center pane is the main display area The user int
32. Manual on In Service CD ScanPoint with QuickPrint User s Manual on In Service CD Quick Reference Card Calibration 0620 0340 Calibration Kit optional 0800 0005 Acoustic Coupling Gel x VERATHON MEDICAL Corporate Headquarters 20001 North Creek Parkway Bothell WA 98011 8218 USA 425 867 1348 800 331 2313 425 883 2896 Fax verathon com 0900 2484 01 60
33. RE NEXT USE In this case the battery must be recharged or replaced with a charged one Printer Problems No Paper The BladderScan BVI 9400 senses the presence of paper and automatically displays this image when the printer is out of paper Figure 29 User s Manual page 61 Troubleshooting BladderScan BVI 9400 Figure 29 Printer Out of Paper Screen General Hospital BV 9 4 0 0 Urology Associates Bladder Volume Instrument The printer is open or out of paper Press any button to continue e C3 ma 3 o o m For instructions on loading paper review the on board training module or refer to the section in this manual titled Load a Roll of Thermal Paper beginning on page 27 Too Hot The BVI 9400 displays the message Too HOT if the print head overheats In this case turn off the BVI 9400 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 gently pull the paper jam backward while moving the thumb wheel counterclockwise i7 Ye Possible device damage If the paper jam is inaccessible do not try to disassemble the printer Contact you authorized Verathon Service Center or your local Verathon distributor for service page 62 User s Manual BladderScan BVI 9400 Warranty Verathon Inc warrants the BladderScan BVI 9400 against defects in material and
34. User s Manual page 21 Getting Started BladderScan BVI 9400 Getting Started The previous section provided basic information about the BVI 9400 parts and features This section provides instructions for setting up your BVI 9400 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 BVI 9400 and related accessories Charge and install the batteries Customize the display enter your institution s name date time and other user data Assemble the mobile 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 BVI 9400 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 1 Training Pack Charge the Batteries Two Lithium lon batteries are included with the BladderScan BVI 9400 One battery can be recharged in the Battery Charger Wireless
35. afety To date exposure to pulsed diagnostic ultrasound has not been shown to produce adverse 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 BVI 9400 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 Technical Description section of this manual User s Manual BladderScan BVI 9400 Important Information User s Manual Statement of Prescription United States federal law restricts the BladderScan BVI 9400 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 BVI 9400 within its intended use throughout an institution Individual prescriptions for use are not required Statement of Intended Use The BladderScan BVI 9400 projects ultrasound energy through the lower abdomen of the patient to obtain an image of the bladder which is used to calculate bladder volume noninvasively Contraindications U S Only The BladderScan BVI 9400 is not intended for fetal use or for use on pregnant patients To assure safe and reliable operation for the use and the patient please read and heed the following w
36. arnings and cautions WARNING Risk of explosion If you use the BladderScan BVI 9400 in the presence of flammable anesthetics the hazard of potential explosion exists WARNING Risk of explosion fire or serious injury The BladderScan BVI 9400 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 WARNING Risk of explosion fire or serious injury 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 BVI 9400 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 BVI
37. arpens accuracy and accelerates speed of 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 BladderScan BVI 9400 measurements can be printed via an onboard printer or transmitted using HIPAA compliant ScanPoint with QuickPrint Imaging Technology Software optional to your office or facility computer for viewing printing or archiving Intended Use Warnings and Cautions page 14 The BladderScan BVI 9400 should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care All users must read this entire User s Manual prior to using the BladderScan BVI 9400 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 then select the BladderScan gt Customer Support links to open a link to this manual and other training materials Biological S
38. ation 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 If the instrument battery runs low or the instrument goes into sleep mode any non annotated exam 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 anew recording only if the instrument still displays the bladder volume for that particular exam 5 When you are satisfied with your recording wait while the instrument automatically accepts and stores the recording with the exam results The volume displayed on the LCD screen disappears and the instrument is ready to perform another measurement 6 If you are using the BVI 9400 in conjunction with the optional ScanPoint with QuickPrint software you can view exam results and annotations on your Windows PC Please refer to the ScanPoint with QuickPrint User s Manual for more information User s Manual page 53 Measuring Bladder Volume BladderScan BVI 9400 Deleting a Saved Exam Printing page 54
39. ative humidity 30 75 non condensing Water resistance Rated at IPX 0 ordinary equipment without protection against ingress of water Battery Specifications User s Manual The BladderScan BVI 9400 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 BVI 9400 Any other battery charger may damage the battery pack The batteries meet the following specifications Condition Description Battery type Lithium lon Battery life A fully charged battery can provide approximately 30 exams within a 24 hour period Charging time Charging time offline will take no more than six hours from an empty battery to a full charge page 75 Glossary BladderScan BVI 9400 Term Meaning Aiming arrows Arrows that appear on the LCD screen to indicate the location of the bladder relative to the Probe A solid aiming arrow means re aiming is optional Battery The unit that charges the Lithium lon batteries that power the Charger Wireless BladderScan and simultaneously receives and sends Hub information from to a BVI 9400 instrument within communication range BladderScan The Bla
40. avings Preferences from the Setup ocreen Figure 18 page 39 Use this screen to enter base values used to calculate the savings to your organization from using the BladderScan BVI 9400 rather than catheterization User s Manual page 43 Displays Controls and Indicators BladderScan BVI 9400 page 44 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 X Saving Calculation Since New Since 1 1 2006 Reset Now Print Since New Print Recent Hide Savings Figure 22 Savings Preferences Screen BVI 9400 Bladder Volume Instrument UTI Rate 3 UTI Cost 20 Cath Cost 10 Cath Volume 180 ml Currency Savings Calculation Since New Savings Preferences Screen Buttons Button Function 4 1 SELECT PREVIOUS Press to select the previous setting in the list 4 SELECT NEXT Press to select the next setting in the list For settings with a list of options press to select the next option Press cw 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 User s Manual BladderScan BVI 9400 Displays Controls and Indicators User s Manual Button Function
41. cal are registered trademarks of Verathon Inc in the US and other countries Copyright 2008 by Verathon Inc All rights reserved User s Manual page 5 Quick Reference Use BladderScan BVI 9400 BladderScan Bladder Volume Instruments BVI 9400 User s Quick Reference Noninvasive Accurate Reliable Easy to Use Verify the scan BVI9400 aoz If the scan is on target all 8 arrows will flash on the Probe screen and the bladder will be shown in the center of the crosshairs on the Console screen Since no re aiming is needed no arrows will appear on the Console screen 6a Re aiming If the scan is off target the Probe will show an arrow indicating the direction to move the Probe to be on target If the arrow is solid it means you are slightly off target If the arrow is flashing it means you are significantly off target and must re aim and re scan On the Console the bladder will not be on the crosshairs and there will be an arrow pointing in the direction for re aiming 6b To re aim To re aim note that the small dot at 6 o clock on the Console target represents the feet of the patient The 12 o clock position represents the head of the patient and the upper left quadrant 9 12 o clock represents the right shoulder of the patient This orientation should help you in re aiming the Probe to capture the complete bladder in the ultrasound cone Gener d Pong 6c Pubic Bone Sweet You may al
42. computer and the BVI 9400 regardless of barriers such as walls ceilings or windows Figure 2 Battery Charger Wireless Hub Charging bays for two battery packs Plug into wall outlet to power the battery charger Plug into a USB port on the ScanPoint host computer optional to enable a wireless connection with the BVI 9400 User s Manual BladderScan BVI 9400 Introducing the BladderScan BVI 9400 Parts and Accessories 0570 0190 BVI 9400 Instrument Console 0570 0188 BVI 9400 Instrument Probe 0570 0193 Battery Charger Wireless Hub 0570 0066 Lithium lon Battery 2 provided 0900 1606 BVI 9400 User s Manual on In Service CD 0900 1601 ScanPoint with QuickPrint User s Manual on In Service CD 0900 1446 Quick Reference Card Demo Use 0900 1447 Quick Reference Card Calibration 0800 0319 Thermal Paper Roll for the Printer 0900 1500 BladderScan BVI 9400 In Service CD Includes User s Manuals Video Tutorial and Quick Reference Cards 0800 0322 Mobile 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 BVI 9400 0620 0340 Calibration Kit Optional Requires ScanPoint with QuickPrint software Includes Calibration Container Calibration Target etc 0800 0225 Sontac Gel Pads QTY 50 0800 0005 Acoustic Coupling Gel 0 25 liter case of 12
43. cords displays ultrasound images from exams downloads software updates and calibrates the BladderScan 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 BladderScan results Sleep mode When the BladderScan shuts down to conserve energy Press any button to turn on the instrument Solid aiming arrow Indicates the bladder is inside the scan cone but is not completely centered The arrow shows the direction to move or tilt the BladderScan to improve the measurement Re aiming is optional but not required Supine position Refers to the patient laying on their back with their face upward Suprapubic The area above the pubic bone Symphysis pubis The front of the pelvis where the pubic bones meet Ultrasonic Involving ultrasound Ultrasound is sound at frequencies above the range that can be heard by the human ear page 77 N i VERATHON For more information call 800 331 2313 in the U S and Canada or contact your local Verathon Medical representative BladderScan ScanPoint Verathon and Verathon Medical are registered trademarks of Verathon Inc in the United States and or other countries Copyright 2008 All rights reserved BladderScan BVI 9400 Parts List Lithium lon Battery 2 provided 0900 1606 BVI 9400 User s
44. d 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 designed to prevent incorrect installation NOTE 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 Battery Care The BladderScan BVI 9400 draws very little power when it is turned off However if you do not plan to use the BladderScan 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 User s Manual page 23 Getting Started BladderScan BVI 9400 Enter the Clinic Name You can customize your BladderScan 9400 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 enter your clinic
45. d catheter for example NOTE The BVI 9400 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 page 52 After performing an exam you can record additional information about a patient to be stored with the exam results The instrument can store ten scans with voice annotations so you can perform multiple exams on your rounds If you are using the optional ScanPoint with QuickPrint software User s Manual BladderScan BVI 9400 Measuring Bladder Volume you can upload saved exams to your PC Refer to the ScanPoint with QuickPrint User s Manual for more information To record a voice annotation p 1 Press the RECORD button microphone A STOP button is now displayed LISTEN 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 RECORD Be sure to include all relevant exam information including the patient s name and the name of the person performing the exam When you have finished your annotation press the RECORD button again When you have finished your annotation press the SToP button An hour glass will be displayed while your annot
46. dderScan instrument transmits ultrasound energy to produce an image of the patient s bladder and determine bladder volume Calibration Checking the accuracy and function of your BladderScan by comparing it with a known standard Calibration Kit Tools for calibrating your BladderScan 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 volume 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 or a gel pad 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 d ii or tilt the BladderScan to improve the measurement Re sh aiming is required Gel pad Sontac Gel Pad A disc shaped gel filled pad that enhances the transmission of ultrasound waves 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
47. 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 User s Manual BladderScan BVI 9400 Getting Started separate User s Manual provided with ScanPoint with QuickPrint for complete installation and operating instructions Watch the Training Video The training video provides an overview of how to perform an ultrasound scan of the bladder using the BladderScan BVI 9400 The video is approximately 5 minutes long The training video is available at the Verathon Web site http www verathon com Training 20Videos htm A training tutorial is available for review anytime on the BladderScan BVI 9400 by pushing the tz button from the Home screen User s Manual page 31 Displays Controls and Indicators BladderScan BVI 9400 Displays Controls and Indicators Console Displays and Button Functions page 32 The Console LCD display presents user information and prompts that vary depending on the current device function The five buttons below the display have variable functions according to device mode Button functions are indicated by icons in the display footer immediately above each butto
48. e instrunmsnt Name Date amp Time General Preferences Savings Preferences Self Test Settings Screen Buttons Button Function 4 SELECT NEXT Press to select the next setting in the list 4 SELECT PREVIOUS Press to select the previous setting in the list ENTER Press to select the highlighted setting No function HOME Press to return to the Home screen User s Manual page 39 Displays Controls and Indicators BladderScan BVI 9400 Alpha Numeric Screen This screen allows you to select the appropriate alpha numeric characters for entering your health care institution s name Figure 19 Alpha Numeric Screen BVI9400 moe Bladder Volurne Instrument General Hospital Urology Associ Alpha Numeric Screen Buttons Button Function E Press to move down in the grid Press to move to the right in the grid Press to add the highlighted character to the name Press to delete one character from the name EO Press to return to the Setup screen ABC page 40 User s Manual BladderScan BVI 9400 Displays Controls and Indicators 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 20 To change the time from 8 17 AM to 11
49. ecific modes Select the proper exam mode to ensure the accuracy of your scan Simply press the button repeatedly until the desired setting appears Select to scan a male patient or a female patient who has had a hysterectomy Select to scan a female patient who has not had a hysterectomy Y Select to scan a small child under 48 inches 122cm tall and weighing less than 60 Ibs 27kg EX With the patient supine apply gel Have the patient lie in the supine position with 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 Rw Aim toward the bladder Standing at the patient s right side place the Probe on the gel and aim toward the expected location of the bladder For most patients this means tilting the Probe slightly toward the patient s coccyx tailbone so the scan clears the pubic bone EXE Press the SCAN button Press 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 www verathon com https my scanpoint com For more information call 800 331 2313 in the U S and Canada or contact your local Verathon Medical representative BladderScan ScanPoint Verathon and Verathon Medi
50. er If you are using the BladderScan BVI 9400 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 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 BVI 9400 Introducing the BladderScan BVI 9400 Introducing the BladderScan BVI 9400 Product Description User s Manual BladderScan instruments are the gold standard in bladder volume measurement The BladderScan BVI 9400 with patented NeuralHarmonics technology is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume 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 BladderScan is noninvasive and comfortable for the patient It is accurate reliable quick and easy to use When the user releases the scan button within seconds BladderScan measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image Based on this image the BladderScan BVI 9400 calculates and displays the bladder volume A sonographer is not required Patented NeuralHarmonics technology abbreviated from neural network harmonics in
51. erScan BVI 9400 is designed to function properly within the following specifications Condition Use Description Indoor Ambient Temperature Range 10 40 Celsius 50 104 Fahrenheit Atmospheric pressure range 700 hPa 1060 hPa Relative humidity 30 75 non condensing Water resistance Rated at IPX1 indicates DRIP PROOF a higher than ORDINARY level of protection from drips leaks and spills BladderScan BVI 9400 Storage Conditions The BladderScan BVI 9400 is designed for storage under the following conditions Condition Storage Description Indoor Ambient Temperature Range 20 60 Celsius 4 140 Fahrenheit Atmospheric pressure range 500 hPa 1060 hPa Relative humidity 20 95 non condensing User s Manual BladderScan BVI 9400 Product Specifications BladderScan BVI 9400 Displays Controls and Indicators The BladderScan BVI 9400 provides the following controls connectors and features Instrument Buttons Power ON OFF Brightness Volume 4 SCAN and RECORD buttons are on the Probe Five buttons below the Console LCD vary depending on current instrument mode as follows Start up screen POWER VOLUME BRIGHTNESS Appears when the 1 5 No function instrument is turned on Home Screen POWER SCAN opens Aim Scan screen 1 PATIENT TYPE toggle between three modes small child
52. erface for the center pane varies depending on device mode The header pane displays the institution name date time and a battery status icon The footer pane displays icons that indicate button functions described in the preceding table Screen Mode Display Start Up Screen Displays BladderScan and a progress bar appears when the instrument is turned on Home Screen Memory indicator Correct scanning technique graphic 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 scan is complete Prominently displays calculated bladder volume patient type available memory and animated Print icon if Print is pressed Review Screen Review currently save exams Saved exam folders on left currently selected folder is yellow and ultrasound images associated with selected exam Tutorial Screen The tutorial video Setup Screen Lists available setting screens Name Screen A grid of alpha numeric characters User s Manual page 73 Product Specifications BladderScan BVI 9400 Screen Mode Display Date amp Time Screen The date and time 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
53. ery 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 3 3 L3 L3 User s Manual page 47 Measuring Bladder Volume BladderScan BVI 9400 Measuring Bladder Volume 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 BVI 9400 on page 17 f you are a new BladderScan 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 Check the instrument s 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 battery in the Battery Charger to recharge Clean and disinfect the Probe by wiping it gently with a soft cloth soaked in isopropyl alcohol 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 Pre
54. es comprehensive inspection and testing of the instrument to ensure accurate performance i in clinical use For more information please contact your authorized BladderScan 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 64 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 with QuickPrint User s Manual page 56 User s Manual BladderScan BVI 9400 Cleaning and Maintenance 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
55. for hazardous waste disposal Assure proper computer system configuration When using the BladderScan BVI 9400 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 the EN IEC 60601 1 1 system standard is maintained Anyone connecting additional equipment to the BladderScan BVI 9400 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 When transmitting data to or from you computer make sure that the BladderScan BVI 9400 accessories and computer are 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 Bluetooth Wireless Technology The Bluetooth technology used in the BladderScan BVI 9400 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 opecial Interest Group 1 Bluetooth and Wireless LAN devices operate within the same radio frequency cee and may interfere with one anoth
56. h 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 Founder and Chairman of the Board page 13 Important Information BladderScan BVI 9400 Important Information Product Description BladderScan instruments are the gold standard in bladder volume measurement The BladderScan BVI 9400 with patented NeuralHarmonics technology is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume 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 BladderScan is noninvasive and comfortable for the patient It is accurate reliable quick and easy to use When the user releases the scan button within seconds BladderScan measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image Based on this image the BladderScan BVI 9400 calculates and displays the bladder volume A sonographer is not required Patented NeuralHarmonics technology abbreviated from neural network harmonics in the BVI 9400 sh
57. iD Dar ScanPoint Screen Buttons Button Function No function No function No function CANCEL Cancels the current action and ends communication with X ScanPoint No function Sleep Mode The Sleep mode helps preserve battery power After four minutes of idle time a Sleep mode alert message displays for 15 seconds Figure 25 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 page 46 User s Manual BladderScan BVI 9400 Displays Controls and Indicators Figure 25 Sleep Mode Screen BVI 9400 Bladder Volume Instrument Savings Calculation 12 27 2007 Entering Sleep to save power or Press any button to continue EX 4 A LE UTI Avoided Savings DOBBaBGBBBES Memory Optimization During Power Down When the power is turned off the BVI 9400 begins 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 26 Figure 26 Memory Optimization Alert General Hospital 0 Urology Associates Bladder Volume Instrument Please wait while I optimize memory Do not remove battery xL UTI Avoided 0 Savings 1700 Wi o NOTE DO NOT replace the batt
58. iewing Home screen screen User s Manual page 71 Product Specifications BladderScan BVI 9400 page 72 Screen Mode Settings Screen Start screen for editing clinic name date amp time general preferences savings preferences and self test options Active Buttons POWER 1 Select next setting in list 2 Select previous setting in list 3 Enter proceed to the selected screen 4 No action 5 Home return to Home screen Settings Name Date Time Preferences Self Test Alpha Numeric Screen Displays alpha numeric characters for entering information POWER 1 Move down 2 Move right 3 Add currently selected character 4 Delete currently selected character 5 Return to main setup screen Date amp Time Screen Allows the user to set the date and time 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 Preferences Screen Set preferences for language time and date format time zone UTI rate and cost and currency POWER 1 Select next setting in list 2 Select previous setting in list 3 Select next option Enter 4 Select previous option 5 Home return to Home screen Preferences list and options
59. ight less than 48 inches 122 cm tall and weight less than 60 Ibs 27 kg Select the female icon to scan a female patient who has not had a hysterectomy Select the BladderScan icon to scan all other patients Press to view the training video Go to the Settings screen set the time date institution name and user preferences i Press to review a previously saved exam User s Manual page 33 Displays Controls and Indicators BladderScan BVI 9400 page 34 Button Function Press to initiate communication with the ScanPoint host computer Saved and annotated exams will be automatically uploaded to the host i computer ScanPoint software must be previously installed and the computer connected to the wireless hub Use of the ScanPoint software is optional Scan Screen The Scan screen Figure 13 appears after you press the SCAN button on the probe 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 13 Scan Screen BVI 9400 Bladder Volume Instrument L3 L3 L3 3 m 3 Results Screen The Results screen Figure 14 appears automatically when an ultrasound scan is complete The display presents the result of the exam crosshairs bladder outline and the calcu
60. ings Criteria Cost savings are based on the following criteria Catheterizations avoided Urinary catheterization is deemed unnecessary Thus by using the BVI 9400 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 catheterizations lead 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 3 Associated UTI costs Literature suggests that the additional costs associated with treating UTIs amounts to 680 00 per patient infection The default setting is 680 00 Cost of catheter kits The default setting is 3 00 per kit Total Cost Savings from Using the BVI 9400 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 gt SAVINGS PREFERENCES See page 43 Savings Preferences Screen for more information on customizing Savings Preferences User s Manual page 55 Cleaning and Maintenance BladderScan BVI 9400 Cleaning and Maintenance Cleaning and Disinfecting the BladderScan BVI 9400 To Clean and disinfect the BladderScan BVI 9400 1 Use a soft cloth dampened with isopropyl a
61. ks Battery Charger Wireless Hub Brightness Power On Off r l Aiming Display Adjust Volume bcd above displa Probe play Scan button on hand grip page 18 User s Manual BladderScan BVI 9400 Introducing the BladderScan BVI 9400 Probe Components The Probe transmits and receives ultrasound waves automatically moving its internal transducer 360 to scan twelve 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 Part Name Purpose 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 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 host 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 Part Name Purpose Main Display Displays the bladder volume measurement patient type settings and instrument status Powe
62. lated bladder volume You may choose to print this result to the onboard printer and or to record a voice annotation to save the exam After the annotation is recorded the PLAY and REVIEW buttons become active and the newly recorded exam appears on the main display as an yellow folder icon User s Manual BladderScan BVI 9400 Displays Controls and Indicators Figure 14 Results Screen BVI 9400 Bladder Volume Instrument LC El Cc LC LJ m o o Results Screen Buttons Button Function UN Press to record a voice annotation up to 10 seconds long we ah Press to print exam results to the onboard label printer Press to play a previously recorded voice annotation If no voice a c annotations are recorded this button is disabled Press to go to the review screen If no voice annotations are recorded A this button is disabled Press to return to the Home screen User s Manual page 35 Displays Controls and Indicators BladderScan BVI 9400 page 36 Review Screen The Review screen Figure 15 opens when you select a saved exam yellow 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 15 Review Screen BVI 9400 Bladder Volume Instrument E
63. lcohol or an appropriate hospital cleaning agent to wipe the Probe until it is thoroughly cleaned 2 If you use a detergent solution to clean the instrument remove all residual detergent Dry the instrument with a clean soft cloth 3 Ifthe instrument needs to be disinfected dampen a soft cloth In any glutaraldehyde based hospital disinfectant solution such as Cidex or Cidex 7 from Advanced Sterilization Products or Sporocidin from Sporocidin International Wipe the instrument with a dampened cloth 4 Toremove all traces of disinfectant solution and 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 BVI 9400 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 Changing gel pads between patients is strongly recommended Regular Inspections and Maintenance Verathon Medical recommends that the BVI 9400 be certified by an authorized BladderScan Service Center once a year Certification service includ
64. n The following tables illustrate and describe the BladderScan BVI 9400 displays and button functions Home Screen The Home screen Figure 12 page 33 appears when the BladderScan is first powered on The Home screen serves as a starting point for all of the main functions of the BladderScan The Home screen displays Alist of saved exam results 10 maximum saved in chronological order Yellow folders hold saved exams Grey folders represent empty spaces still available for saving exam results A battery status indicator Indicates a fully charged battery Indicates a battery 50 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 an Indicates the battery must be changed User s Manual BladderScan BVI 9400 Displays Controls and Indicators Figure 12 Home Screen BVI 9400 iar noors 3 j Battery Bladder Volume Instrument Saved Indicator exams yellow Savings Calculation C3 C Date Started 12 27 2007 m Number Of Scans Cost Available savings memory 3 udo 006 calculator for 8 more mA UTI Avoided exams Sayings gray C m Home Screen Buttons Button Function Single button with three modes When performing an exam press the button repeatedly until the desired setting appears above the saved exams folders ns x Select the small child icon to scan a patient with he
65. n Reference Cards system Clinical Studies Scientific papers on BladderScan use ScanPoint Online ScanPoint Online provides customers 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 User s Manual page 59 Troubleshooting BladderScan BVI 9400 Resource Description Premium Warranty 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 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 the list of Customer Care Department phone numbers on page 64 Icons on the BladderScan Console The following icons may appear on the instrument s LCD screen Symbol Meaning Solid arrow The bladder is contained within the image cone cone cm shaped area in which the Probe transmits ultrasound waves
66. n the container using the notches to position target correctly Replace the lid on the calibration container ENXENNE Place the probe Place the Probe in the cutout in the top of the calibration tank Make sure the black tip of the Probe is submerged in the water Open ScanPoint QuickPrint From your desktop open QuickPrint by double clicking the QuickPrint icon BVI9400 Ww Establish BVI 9400 QuickPrint ScanPointe connection button Press the ScanPoint button on the BVI 9400 On the QuickPrint screen click the FIND NEW button qure When QuickPrint establishes a connection with the T ee or BVI 9400 an icon will appear along the left menu 4 net Po maet Ls Freira Combe stm recul doa 11 ib kon dig th rand rn bis i www verathon com https my scanpoint com For more information call 800 331 2313 in the U S and Canada or contact your local Verathon Medical representative ScanPoint BladderScan Verathon and Verathon Medical are registered trademarks of Verathon Inc in the US and other countries Copyright 2007 by Verathon Inc All rights reserved User s Manual page 7 Quick Reference Calibration BladderScan BVI 9400 BladderScarv Bladder Volume Instruments Noninvasive Accurate Reliable Easy to Use BVI 9400 Calibration Quick Reference EXE Calibrate instrument From the Tools menu select Calibrate Instrument When the Calibration screen opens click the CAL
67. nnia nnne nnns 31 User s Manual page 9 Table of Contents BladderScan BVI 9400 Displays Controls and INGICAIONS issiusti E a 32 Console Displays and Button 411000115 0 02 32 FOMO OGI MR MTM MH 32 SCAM EO we T 34 a meli em I T renne 34 REVIGW SCICCN MEME 36 UO ES ee g TT 37 video VIC WING SCP CC Maire TIE 38 OY RIO ele zl eee en E a ne eee een eee 39 Alpha Numeric SONS Set 0 40 Date Se TINE o Cl CMe ec seiceriaeo ante DR 41 General Preferences Screen ccccccseccccseseeccceseeecceuseeeceaueeecsaeeecsaaseeesaueeessageeessageeeesegeeesssaseeeessgeees 42 SAVINGS Preferences Screen 43 Self Test Screen RR
68. on fom ScanPoint Savings Calculation Date Started 12 27 2007 Number Of Scans 107 Cath Avoided UTI Avoided Savings 3 o m i 3 3 If you do not have ScanPoint with QuickPrint you must send your instrument 10 to an 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 64 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 with QuickPrint User s Manual The entire calibration process takes approximately 15 minutes ScanPoint Online 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 BVI 9400 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 replacement unit and free shipping options which vary according to plan If
69. ote REFER iE Uere Akana edu es rug r Esa ku Pep ht pA IAS D orina 29 Figure 11 Attaching the BVI 9400 to the Medical Cart eeseeesssseeeesseeeeennenm enne 30 Fig rs PAM eup melek T m t mmm 33 UUM 13 Scan SSNS CN PON RR ERN 34 FOES 14 Res lts Sh SSM a MRPNITE ER eE AEE 35 Figure T5 ISeVIGW SCHOOL saraswat diamo che detorisudta tuac eco Rud cen nese cant eres C mM Eaa EE aD D E M TUE 36 mie Iz 16 EU Or Perez EHE 37 Fouro 17 VIGGO VICWING SOUS GC cc 38 Figure 18 Settings Screen Start MON ccccccccccceeeceeceeeeeeseeeeeeseeeeeeeseeeeeeseeeeeessaueeesseeeeeseseeesaaseeeessaeeees 39 Figure 19 Alpha Numeric 660 0 00000 40 Figure 20 Date amp Time SOLO gc seisticeiarcisuceidsnschicatatsdinscedletaedtecdaniactehadiealnatssint oduatenudivenaitdlabicuedjassdameddabcheinet altdamaentdaunedabisinn 41 Figure 21 General Preferences Screen ccccccccssssceccseseeeceeeecsesececseueeecseaseeeseaseeessageeeesageeessuseseessageees 43 Figure 22 Savings Preference Screen 44 Fig
70. play header Figure 6 User s Manual page 25 Getting Started BladderScan BVI 9400 Set the Date and Time The clock has its own Lithium battery and maintains the correct date and time for at least ten years To set the date and time 1 page 26 If the BladderScan instrument is turned off turn the power on by pressing the o button on the front of the Console From the Home screen Figure 3 press the SETTINGS button Eo to open the Settings screen On the Settings screen push either the or arrow until Date amp Time is highlighted red Figure 7 Press the button to open the Time amp Date screen On the Date amp Time screen Figure 8 use the and buttons to move to the desired unit hours minutes month day year When the desired unit is highlighted red Press the button to increase values Press the button to decrease values When the time and date are set correctly press the SETTINGS button asc to return to the Settings screen From the Settings screen push the HOME button to return to the Home screen Figure 7 Set Up Screen Date and Time BVI 9400 sry scone Bladder Volume instrument Name Date amp Time General Preferences Savings Preferences Self Test Figure 8 Date and Time Screen BVI 9400 222 Bladder Volume Instrument s 2 4 10 2007 User s Manual BladderScan BVI 9400 Getting Started Set
71. r on off Toggles main power on off Volume Press to adjust volume up down on voice annotation 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 all Buttons 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 User s Manual page 19 Introducing the BladderScan BVI 9400 BladderScan BVI 9400 Battery Charger Wireless Hub page 20 The BladderScan BVI 9400 is powered by a Lithium lon Li Ion battery pack The battery charger provided with your BVI 9400 can charge two Li lon battery packs while simultaneously functioning as the wireless hub linking your BVI 9400 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 BVI 9400 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 86 meters between the ScanPoint
72. re 23 SCM Test Screen 000 i n ianuadth beoenti de usascles bdsm depadieece yaad devsdechb Dess 45 Figure 24 ScanPoint Screens entere entere tete teretes rrr srt tend 46 Figure 25 Sleep Mode Screen c ccccccccsesceccceseeecceuseeccuseeecsageeecseueeeecsageeecseeesssuseeessugeeeesagseessssuseesssageees 47 Figure 26 Memory Optimization Alert 47 Figure 27 Exam Results Printout Using the Onboard Printer 1 54 Figure 28 Calibration Warning 58 Figure 29 Printer Out of Paper Screen 62 User s Manual page 12 BladderScan BVI 9400 President s Statement President s Statement User s Manual The team at Verathon is committed to improving healt
73. rew the Fluted Knob Item 5 Figure 10 Medical Cart Assembly through Bracket and Post Item 2 bracket round hole and hand tighten To attach the BVI 9400 to the Medical Cart refer to the instructions on page 30 User s Manual page 29 Getting Started BladderScan BVI 9400 Install the BladderScan on the Optional Mobile Cart Your BladderScan BVI 9400 is completely portable and can be easily moved and positioned for convenient use Installing the BVI 9400 on the optional mobile cart will allow you to move the BladderScan along with related accessories spare battery Sontac Gel Pads or ultrasound gel and an extra roll of paper to the patient examining area or bedside as necessary To install the BladderScan BVI 9400 on the Mobile Cart NOTE For cart assembly instructions and parts list refer to page 28 To install the BVI 9400 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 11 Figure 11 Attaching the BVI 9400 to the Medical Cart BVI 9400 ge Tray Assembly A Item 1 F7 w Fluted Knob lt Bracket and Post Item 2 Install the ScanPoint with QuickPrint Software Optional page 30 Optional ScanPoint with QuickPrint software is designed to mesh seamlessly with your BladderScan devices The BVI 9400 automatically
74. s name 1 Turn the BladderScan BVI 9400 on by pressing the POWER button D on top of the Console Figure 3 Home Screen 2 When the Home screen appears B 400 Figure 3 press the SETTINGS pests Vena ere button ae screen to open the Settings Savings Calculation Figure 4 Settings Screen 3 On the Settings screen Figure 4 push either the or button until BVI 9400 Name is highlighted red Press the 4l button to open the Alpha name Numeric screen Date amp Time General Preferences Savings Preferences Self Test page 24 User s Manual BladderScan BVI 9400 Getting Started Figure 5 Alpha Numeric Screen 4 On the Alpha Numeric screen General Hospital Figure 5 use the 3 and BVI 9400 eae eae buttons to move to the desired ears character When the desired Urology sein 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 adda second line of text use the J character 5 Continue to select and add characters as needed BVI 9400 6 When finished press the SETTINGS Savings Calculation Date Started 12 27 2007 button F o to return to the Settings 0001 Cath Avoided screen From the Settings screen A UTI Avoided press the HOME button 2 to return to the Home screen The facility name will now appear in the dis
75. s of December 2007 The contents of this manual should not be considered to be all inclusive or to cover all contingencies The physician who directs the use of the BladderScan BVI 9400 at the institution where itis in use is responsible for keeping current with clinical research in bladder volume measurements Please direct any questions or problems concerning bladder volume measurement using the instrument or the interpretation of data to the responsible physician User s Manual page 63 Contacting Verathon BladderScan BVI 9400 Contacting Verathon 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 Verathon Incorporated 20001 North Creek Parkway Bothell WA 98011 USA Toll free 800 331 2313 US amp Canada Only Tel 425 867 1348 Fax 425 883 2896 Web http www verathon com Email customerservice verathon com Verathon Medical B V Europe Boerhaaveweg 1 3401 MN lJsselstein The Netherlands Verathon Medical Sarl France Office Address Espace Europeen de l Entreprise 2 all e d Oslo 67300 Schiltigheim France Tel
76. s the user to easily calibrate the device by scanning a known target Optionally exam results may be transmitted to a personal computer running ScanPoint with QuickPrint software via a proprietary wireless connection ScanPoint with QuickPrint allows the user to archive data calibrate the device update software print and transfer data through a Web based interface The BladderScan BVI 9400 system also includes a universal battery charger for the custom user replaceable Lithium lon battery incorporated in the system The BladderScan BVI 9400 may be mounted on a purpose designed cart which holds the instrument securely and provides a holder for ultrasound gel and other accessories page 17 Introducing the BladderScan BVI 9400 BladderScan BVI 9400 The BladderScan BVI 9400 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 video provided on the instrument BladderScan Parts and Features The BladderScan BVI 9400 has two main components The Console and the Probe The Console and Probe are linked by a detachable cable The BladderScan BVI 9400 controls and indicators are illustrated in Figure 1 Figure 1 BladderScan BVI 9400 Controls and Indicators Console Main display Battery Status Indicator Printer behind display Battery Pack Battery Pac
77. service User s Manual page 27 Getting Started BladderScan BVI 9400 Assemble the Medical Cart NOTE If you re not using the medical cart please skip to the next section Install the ScanPoint with QuickPrint Software on page 30 The optional Medical Cart is illustrated in Figure 9 Figure 9 Medical Cart PN 0800 0322 Medical Cart Parts List Quantity Part Number Description 1 1 0142 0276 Tray Assembly 2 1 0810 0140 Bracket and Post 3 1 0810 0141 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 page 28 User s Manual BladderScan BVI 9400 Getting Started To assemble the cart While following the assemble procedure refer to Figure 10 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 2 Align through round hole in Bracket and Post Item 2 bracket to through hole in Medical Tray Item 1 3 Insert Bracket and Post Item 2 into square relief in bottom of Medical Tray Assembly Item 1 4 Insert four Screws Item 4 through Bracket and Post Item 2 into molded inserts in Medical Tray Item 1 tighten securely 5 Place Medical Tray Assembly with Bracket and Post into Medical Cart Base Item 3 6 Place device in foot prints on Medical Tray Item 1 7 Sc
78. so see a screen that indicates the pubic bone is inside the ultrasound cone If this occurs you may want to re aim and re scan Although the bladder may be shown as centered in the ultrasound cone and your measurement could be complete there is a possibility that the pubic bone is obscuring some of the bladder By re aiming you can ensure you have captured the bladder fully inside the ultrasound cone Save review and print exam results To save the exam you must annotate it To annotate press and release the RECORD button on the Console When you see the RECORD button icon turn to a STOP button icon record your patient information by speaking into the Probe microphone Press the STOP button on the Console When the hourglass icon disappears press the LISTEN button to replay the annotation To review the images of your scan press the REVIEW button you must first save the exam before you can review it To print exam results via on board printer press the PRINT button To perform another exam press the HOME button KNEE Finish exam Once you have completed the scan wipe the ultrasound gel off the patient and the Probe For ScanPoint subscribers logging on to ScanPoint automatically transfers and saves your annotated exams To order additional rolls of paper 0800 0319 or batteries 0400 0066 contact Customer Care at 800 331 2313 www verathon com https my scanpoint com For more information call 800 331
79. sseeeeeeeeesaeeeeseeeeeseeeessaeeesseeesaeeesanseessees o6 We ekly AAS CC ONG MEMO EC I 57 Using the Buillin Self Test Ut 57 Calibrating the BladderScan BVI 9400 Using the ScanPoint System eee 57 SSC ANNO AL OI P 58 POVES 202 91210 RE ROTRRIT 9 58 page 10 User s Manual BladderScan BVI 9400 Table of Contents 1111 21801 ERROR HH 58 TROUDISS OO UNG sete ss tm 59 PODRO SUC CS oee 59 Icons on the BladderScan Console c ccccsecessssesesescssecscescevececeevacscescevavaceusevacacersevavversevaceeereevenersevenenen 60 DIAG MOSWIG PONIO AS NR T T 61 InSuUMeNt Does Not Turn OMA P 61 FFG dele gr NR TERI UL T 61 NOP ODG MN o e 61 Bison seerne e E E E 62 TSAI a Paper 48111 asiassaan mm 62 Warr AIAN esea a E a e E e 63 Disclaimer of Additional Warranties ccccccecccecseeeeeeeeeeeeceeeceeeseeeeeeeeeeeeeeeueeesaeeeessaeeesseeeeeseaeeesaaeeees 63 Contacting Verathon Soenosesdstunareete MEME E D E 64 Safety and Performance Summary i auus s ves ecc inuus suse eat cus acus ur rkau c spa c euin Rr Fav E avSu crea p vRy C cuxE s MUrR nnmnnn 65 Pans and RG COS SONS cise t
80. the BVI 9400 sharpens accuracy and accelerates speed of 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 BladderScan BVI 9400 measurements can be printed via an onboard printer or transmitted using HIPAA compliant ScanPoint 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 If needed after a scan has been taken a unique aiming icon guides the operator to optimal probe placement with a comprehensive three dimensional 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 The BladderScan BVI 9400 contains an on board thermal printer that allows the user to print exam results quickly with the press of a button A Calibration Targeting System consisting of a spiral shaped calibration target along with a purpose designed calibration container allow
81. time without notice For the most up to date information see the online manuals at http www verathon com Examples described or illustrated in this User s Manual are fictitious and do not in any way represent real patient or exam data Corporate Headquarters 20001 North Creek Parkway Bothell WA 98011 USA 800 331 2313 US and Canada only 425 867 1348 Fax 425 883 2896 Verathon Medical Japan K K Executive Tower Azabudai 7F 1 4 3 Azabudai Minato ku Tokyo 106 0041 Japan 81 3 3560 3501 Fax 81 3 3560 3502 C 60123 Verathon Medical Europe B V EC REP Boerhaaveweg 1 3401 MN IJsselstein The Netherlands 31 30 68 70 570 Fax 31 30 68 70 512 Verathon Medical France Postal Address BP 10039 F 67012 Strasbourg Cedex France 33 3 88 60 14 12 Fax 33 3 88 60 46 87 Office Address Espace Europeen de l Entreprise 2 all e d Oslo 67300 Schiltigheim Verathon Medical United Kingdom Ltd The Granary Manor Farm Courtyard Aston Sandford Aylesbury Buckinghamshire HP17 8JB United Kingdom 44 1844 299 207 Fax 44 1844 299 218 PN 0900 1606 00 60 BladderScan BVI 9400 Quick Reference Use BladderScar r Bladder Volume Instruments BVI 9400 User s Quick Reference Noninvasive Accurate Reliable Easy to Use Turn on the BladderScan BVI 9400 by pressing the POWER ON OFF button Select scanning mode The BladderScan BVI 9400 is designed to scan in three patient sp
82. ting General Preferences and Savings Preferences NOTE See page 42 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 Time Zone and Calibration Warning Savings Preferences include UTI Rate UTI Cost Catheterization Cost Catheterization Volume Currency and Savings Calculation 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 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 Rotate the printer door down Make sure you hear it snap into place Slide the printer door to the left 0 XL os Tear the excess paper off eZ uae 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 contact your authorized BladderScan Service Center your local BladderScan distributor or Verathon Medical Customer Care at 1 800 331 2313 for
83. tton Press the SCAN button located on the underside of the Probe As the scan progress sections of the bladder will appear on the Console screen When you hear the end scan tone the scan is complete Scan button 6 Verify the scan VI 9400 Gener Hosp If the scan is on target the Probe will Wadder Volume instrument display eight arrows On the Console display the bladder will be appear in the center of the crosshairs anpnnonBBBB Eu 6a Re aiming If the scan is off target the Probe will show an arrow indicating the direction to move the Probe to be on target If the arrow is solid it means you are slightly C Volume gt 128ml off target and must re aim and re scan On the Console the bladder will not be in the crosshairs and there will be an arrow pointing in the direction for re aiming BVI 9400 sous ume Instrument page 50 User s Manual BladderScan BVI 9400 Measuring Bladder Volume 6b To re aim 6c User s Manual Note that the crosshairs correspond to the anatomy of the patient as follows The small dot at the base of the crosshairs 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 Pubic Bone You may also see a display
84. vious suprapubic or pelvic surgery Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and reflection Do not use the BVI 9400 on Patients with ascites Patients with open skin or wounds in the suprapubic region Pregnant patients page 48 User s Manual BladderScan BVI 9400 Measuring Bladder Volume Measuring Bladder Volume 1 Turn on the BVI 9400 Turn on the BVI 9400 by pressing the ON OFF button 2 Select the exam mode Select to scan a patient with height less than 48 inches 122 cm tall and weight less than 60 Ibs 27 kg 4 Select to scan a female patient who has not had a hysterectomy e Select to scan all other patients 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 49 Measuring Bladder Volume BladderScan BVI 9400 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 5 Press the SCAN bu
85. workmanship as long as it is covered by the Premium Warranty Damage or loss insurance is available as part of the Total ReliabilityS Plan Pursuant to this warranty a service center authorized by Verathon will repair or replace units that prove to be defective during the warranty period This warranty does not apply if the unit was misused or modified by anyone other than a service center authorized by Verathon The unit must be used in accordance with the instructions contained 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 a
86. 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 58 The BladderScan BVI 9400 and related devices may contain lead mineral oils batteries and other environmentally hazardous materials When the BladderScan BVI 9400 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 BVI 9400 Troubleshooting Troubleshooting Help Resources 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 A complete listing of contact information is provided on page 64 BladderScan BVI 9400 CD included with your BVI 9400 that shows how to In Service CD use the BladderScan Onboard training modules Training modules installed on your BladderScan are available by pressing the me button from the Home Screen Available titles include Using the BladderScan BVI 9400 and NeuralHarmonics Technology BladderScan BVI 9400 Quick Summary of procedures for using the BladderSca

BVI 9400 User`s Manual - Frank`s Hospital Workshop

Contents

Download Pdf Manuals

Related Search

Related Contents