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70

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 Special Interest 

Group.

ELECTROMAGNETIC COMPATIBILITY

The BladderScan BVI 9400 system is designed to be in compliance with IEC 60601‑1‑2:2007, which contains 
electromagnetic compatibility (EMC) requirements for medical electrical equipment. The limits for emissions 
and immunity specified in this standard are designed to provide reasonable protection against harmful 
interference in a typical medical installation.

The BladderScan BVI 9400 system complies with the applicable essential performance requirements specified 
in IEC 60601‑1 and IEC 60601‑2‑37. Results of immunity testing show that the essential performance of 
the system is not affected under the test conditions described in the following tables. For more information 
about the essential performance of the BladderScan BVI 9400 system, see 

Essential Performance

 on 

page 2.

ELECTROMAGNETIC EMISSIONS

Table 29.  Guidance and Manufacturer’s Declaration—Electromagnetic Emissions

The system is intended for use in the electromagnetic environment specified below. The customer or the user 
of the system should ensure that it is used in such an environment.

EMISSIONS TEST

COMPLIANCE

ELECTROMAGNETIC ENVIRONMENT – GUIDANCE

RF emissions 
CISPR 11

Group 1

The BladderScan BVI 9400 system uses RF energy only for its 
internal function. Therefore, its RF emissions are very low and are 
not likely to cause any interference in nearby electronic equipment.

RF emissions 
CISPR 11

Class A

The BladderScan BVI 9400 system is suitable for use in all 
establishments other than domestic and those directly connected 
to the public low‑voltage power supply network that supplies 
buildings used for domestic purposes.

Harmonic emissions 
IEC 61000‑3‑2

Class A

Voltage fluctuations/
flicker emissions 
IEC 61000‑3‑3

Complies

Summary of Contents for BVI 9400

Page 1: ...BLADDERSCAN BVI 9400 Operations Maintenance Manual ...

Page 2: ...0900 4412 06 60 ...

Page 3: ...BLADDERSCAN BVI 9400 Operations Maintenance Manual Effective September 29 2017 Caution Federal United States law restricts this device to sale by or on the order of a physician ...

Page 4: ...f this manual may be copied or transmitted by any method without the express written consent of Verathon Inc Verathon the Verathon torch symbol BladderScan the BladderScan symbol Scan Point and NeuralHarmonics are 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 mark...

Page 5: ...rmance 2 Safety Information 2 Biological Safety 2 Contraindications 2 Cautions Warnings 3 INTRODUCTION 7 Components Features 7 Probe Components 8 Console Components 9 Battery Charger Wireless Hub Components 10 System Components Accessories 11 Icons Buttons 12 Console Display Icons 12 Variable Button Functions 13 Button Functions for Each Display Screen 14 Display Screens 17 Sleep Mode 33 Histogram...

Page 6: ...cedure 8 Install Scan Point with QuickPrint Optional 44 Procedure 9 Watch the Onboard Tutorial 44 USING THE DEVICE 45 Procedure 1 Prepare for the Exam 46 Procedure 2 Measure Bladder Volume 47 Procedure 3 Save Review Print Exam Results 50 Procedure 4 Delete a Saved Exam 51 CLEANING MAINTENANCE 52 Procedure 1 Clean Disinfect the Instrument 53 Regular Inspections 54 Maintenance 55 Procedure 1 Run a S...

Page 7: ...64 Procedure 3 Instrument Too Hot 64 Procedure 4 Clear a Paper Jam 64 PRODUCT SPECIFICATIONS 65 Component Specifications 65 Console Probe Specifications 65 Battery Specifications 68 Battery Charger Wireless Hub Specifications 69 Bluetooth Wireless Technology 70 Electromagnetic Compatibility 70 Electromagnetic Emissions 70 Electromagnetic Immunity 71 Recommended Separation Distances 73 Accessory Co...

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Page 9: ...surements can be printed via an onboard printer or transmitted using HIPAA compliant Scan Point image management technology optional to your office or facility computer for viewing printing or archiving After a scan has been taken a unique aiming icon guides the operator to optimal probe placement with a comprehensive three dimensional display which shows the bladder in two cross sectional images ...

Page 10: ...e bladder volume noninvasively ESSENTIAL PERFORMANCE Essential performance is the system performance necessary to achieve freedom from unacceptable risk The essential performance of the BladderScan BVI 9400 system is to produce ultrasonic output energy display ultrasonic images and display numerical values for bladder volume The system has a temperature controlled transducer assembly SAFETY INFORM...

Page 11: ...0 m 44 yd or more CAUTION Use of the following cleaning methods or solutions may cause device damage not covered by the BladderScan BVI 9400 warranty Do not immerse the instrument in disinfectant solution Do not use Cidex Plus to disinfect the instrument Cidex Plus will damage the plastic enclosure Do not subject any part of the instrument to steam sterilization or ethylene oxide sterilization CAU...

Page 12: ...ely to cause harmful interference with other devices in the vicinity There is no guarantee that interference will not occur in a particular installation Evidence of interference may include degradation of performance in this device or other devices when operated simultaneously If this occurs try to correct the interference by using the following measures Turn devices on and off in the vicinity to ...

Page 13: ...put on protective gloves to handle it and discard it immediately Always dispose of used batteries in compliance with all applicable laws and regulations Put insulating tape such as cellophane tape on the electrodes during transportation in order to avoid a possible short circuit fire or electrical shock WARNING Risk of patient injury and inaccurate measurements results When using the instrument be...

Page 14: ...on page 65 WARNING This product may only be cleaned and disinfected by using the approved processes provided in this manual Cleaning and disinfection methods listed are recommended by Verathon based on compatibility with component materials WARNING Availability of cleaning and disinfection products varies by country and Verathon is unable to test products in every market For more information pleas...

Page 15: ...e operation do the following before using the device Familiarize yourself with the contents of this manual Watch the onboard tutorial provided on the instrument The BladderScan BVI 9400 has two main components the console and the probe The console and probe are linked by a detachable cable Figure 1 BladderScan BVI 9400 Components Console Probe Battery charger wireless hub Battery ...

Page 16: ... bladder The probe is attached to the console by a cable The probe has three main features Figure 2 Probe Components Scan button Aiming display Microphone Table 1 Probe Components PART NAME PURPOSE Scan button Takes a scan when pressed Aiming display Displays directional arrows to ensure the bladder is centered within the ultrasound field of view Microphone Records voice annotations ...

Page 17: ...nsole Components Battery status indicator Main display Battery Brightness button Power button Printer Volume button Five variable function buttons Table 2 Console Components PART NAME PURPOSE Main display Displays the bladder volume measurement patient type settings and instrument status Power on off Toggles main power on off Volume Adjusts volume up down on voice annotation playback start up soun...

Page 18: ...detects whether a lithium ion battery is being charged To provide wireless communication between the BVI 9400 and the Scan Point host computer plug the battery charger wireless hub USB connector into a USB port on the Scan Point host computer and ensure that the battery charger wireless hub is also plugged into a wall outlet The battery charger wireless hub maintains an operating distance of up to...

Page 19: ...9400 In Service CD or USB containing the operations maintenance manual Thermal paper roll for the printer Ultrasound gel Mobile cart Optional Universal accessory basket Optional Scan Point with QuickPrint software install CD Optional Scan Point user documentation Optional Calibration kit Includes calibration tank and calibration target Optional To order any of the above parts or accessories contac...

Page 20: ...emale and have not had a hysterectomy Scan mode for small patients less than 122 cm 48 in tall and weighing less than 27 kg 60 lbs Scan mode for all other patients A grey outlined folder indicates an empty exam An open blue folder indicates the currently displayed exam An orange folder indicates a saved exam The bladder is too large to be contained within the ultrasound field of view cone shaped a...

Page 21: ...eview screen If there are no saved exams this button is disabled Initiate communication with the Scan Point host computer Once communication is established saved exams will automatically upload to the host computer Note Scan Point software must be previously installed on host computer and connected to the wireless hub Use of the Scan Point software is optional Record a voice annotation Play a prev...

Page 22: ...S Splash screen Displays during boot up to show the process is proceeding properly None Home screen Appears when the instrument is turned on 1 Patient mode Toggle between three modes small child female with uterus all other patients 2 Tutorial Opens Tutorial screen 3 Settings Opens Settings screen 4 Review Opens the Review screen 5 Scan Point Opens the Scan Point screen and searches for a connecti...

Page 23: ...ed exam 4 Delete Delete selected exam 5 Home Return to the Home screen Tutorial screen View the training video menu 1 Down Arrow Move down one title 2 Up Arrow Move up one title 3 Select Open the Video Viewing screen for highlighted video 4 No function 5 Home Return to the Home screen Video Viewing screen Plays the selected tutorial video 1 No function 2 Play Plays selected video changes to a paus...

Page 24: ...o previous option 5 Settings Save the settings and return to main Settings screen Savings Preferences screen Set preferences for UTI cost savings tracking 1 Down Arrow Select next setting in list 2 Up Arrow Select previous setting in list 3 Plus Sign Change selected setting to next option 4 Minus Sign Change selected setting previous option 5 Settings Save the settings and return to main Settings ...

Page 25: ...er Orange folders hold saved exams Grey outlined folders show spaces available to save an exam In the center panel right side A cost saving summary Displays the savings to your organization due to using the BladderScan BVI 9400 rather than catheterization The values used to calculate the savings are user variable and are entered from the Savings Preferences screen In the footer Five variable funct...

Page 26: ...set the time date facility name and user preferences Review a previously saved exam Initiate communication with the Scan Point host computer Saved and annotated exams will be automatically uploaded to the host computer once connected Note Scan Point software must be previously installed and the computer connected to the wireless hub Use of the Scan Point software is optional SCAN SCREEN The Scan s...

Page 27: ...save the exam After the annotation is recorded the Listen and Review buttons become active and the newly recorded exam appears on the main display as an open blue folder icon Table 7 Results Screen Button Functions BUTTON FUNCTION Record a voice annotation up to 10 seconds long Print exam results to the onboard printer Listen to a previously recorded voice annotation If no voice annotations are re...

Page 28: ... next exam in the list Print the results for the currently selected exam to the onboard printer While printing is in progress an hourglass icon appears on the display and all buttons are disabled except Select and Listen Play a previously recorded voice annotation If no voice annotations are recorded this button is disabled Delete the currently selected exam Return to the Home screen Table 9 Ultra...

Page 29: ... Home screen The Tutorial screen presents a menu of training modules Note When this screen is open the Scan button on the probe is disabled Table 10 Tutorial Screen Button Functions BUTTON FUNCTION Move down one title Move up one title Open the Video Viewing screen for highlighted video No function Return to the Home screen ...

Page 30: ...Play button to begin the desired tutorial Note When this screen is open the Scan button on the probe is disabled Table 11 Video Viewing Screen Button Functions BUTTON FUNCTION No function Plays selected video changes to a pause button when video is playing Return to the Tutorial screen No function Return to the Home screen ...

Page 31: ... of user configurable settings Name Date Time General Preferences Savings Preferences and Self Test Note When this screen is open the Scan button on the probe is disabled Table 12 Settings Screen Button Functions BUTTON FUNCTION Move down one setting in the list Move up one setting in the list Select the highlighted setting No function Return to the Home screen ...

Page 32: ...or more information see the procedure Program the Facility Name on page 38 Table 13 Name Screen Button Functions BUTTON FUNCTION Move to the character below Move to the character to the right Add the highlighted character to the name Delete the last character from the name Save the settings and return to main Settings screen ...

Page 33: ... 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 12 followed by AM or PM Table 14 Date Time Screen Button Functions BUTTON FUNCTION Move forward to the next changeable unit Move back to the previous changeable unit Increase the selected value by one Decrease the selected value by one Save the settings and return to main Settin...

Page 34: ...fault Off When On is selected a calibration warning will appear in the display header when the device requires calibration Print Report Type Toggle between C mode images bladder in crosshairs and B mode images image of bladder and abdominal space below probe Enable Scan Point On default Off Select Off to disable Scan Point Enable Small Child Mode On default Off Select Off to disable Small Child Mo...

Page 35: ...nces Screen Button Functions BUTTON FUNCTION Move down a setting in the list Move up a setting in the list Select the next option Press and hold to move through options more quickly Select the previous option Press and hold to move through options more quickly Save the settings and return to main Settings screen ...

Page 36: ...of 1 UTI Cost 10 to 10 000 in increments of 10 Cath Cost 1 to 1000 in increments of 1 Cath Volume 20 mL to 1000 mL in increments of 20 mL Currency Savings Calculation Since New Since XX XX 20XX indicates the last reset date Reset Now Print Since New Print Recent Hide Savings Table 16 Savings Preferences Screen Button Functions BUTTON FUNCTION Move down a setting in the list Move up a setting in th...

Page 37: ... enable clinical users or service technicians to determine the number of scans the device has performed over its lifetime It counts all scans taken with the instrument including air scans and practice scans The counter advances automatically after each scan Please note that the scan counter feature is available only with software version 3 1 0 0 or higher Some BladderScan consoles cannot be upgrad...

Page 38: ...counter feature is designed so that the value cannot be manually reset or modified by the clinical user or service partner VIEWING THE SCAN COUNTER The scan counter can be viewed on the Self Test screen PRINTING THE SCAN COUNT FROM THE SELF TEST SCREEN Once the Self Test screen is accessed data on the screen is printed automatically using the instrument s onboard printer Figure 6 Printout of Self ...

Page 39: ... in multiple locations in the instrument s internal memory If one of the storage locations fails the text EEPROM Failed will be added to the DSP status line In the event of an EEPROM failure the counter will continue to work but will not have a backup copy stored in the instrument Figure 7 Self Test Screen and Printout when EEPROM Has Failed ...

Page 40: ... Scan Point host computer Note The Scan Pointscreen connected is only available if the optional Scan Point software is installed on a PC Figure 8 Scan Point Screen Searching Figure 9 Scan Point Screen Connected Table 18 Scan Point Screen Button Functions BUTTON FUNCTION No function No function No function Cancels the current action and ends communication with Scan Point No function ...

Page 41: ...ns Cath Avoided UTI urinary tract infection Avoided Savings COST SAVINGS 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 percent...

Page 42: ...dure 1 PERFORM THE INITIAL INSPECTION When you receive the system Verathon recommends that an operator familiar with the instrument perform a full visual inspection of the system for any obvious physical damage that may have occurred during shipment 1 Carefully open the top of the shipping box Do not insert anything sharp through the box 2 Remove the contents and verify that you have received the ...

Page 43: ...o avoid a possible short circuit fire or electrical shock WARNING Ensure proper distance from patient When transmitting data to or from your computer make sure the BladderScan BVI 9400 accessories and computer are outside the patient vicinity more than 2 m 6 ft from the patient WARNING Two lithium ion batteries are included with the BladderScan BVI 9400 One battery can be recharged in the battery ...

Page 44: ...nto the battery well easily remove the battery reorient it and try again Do not attempt to force the battery into position 5 While the console is powered on the battery status indicator remains in the top right corner of the screen and indicates the charge level of the battery Table 19 Battery Power Level BATTERY ICON POWER LEVEL Indicates a fully charged battery Indicates a battery 50 to 75 charg...

Page 45: ...arrow on the probe cable connector ring to the top of the cable port Arrow on cable connector 3 Gently push the connector into the port until the connector ring clicks into place and is secure The cable can remain attached to the console in between uses Note To remove the cable pull the connector ring back until the cable disconnects Do not pull on the cable ...

Page 46: ...d on BladderScan displays and all printouts of exam results 1 Turn on the instrument by pressing the Power button 2 On the Home screen press the Settings button to open the Settings screen 3 On the Settings screen push either the Up Arrow button or Down Arrow button until Name is highlighted in red Press the Enter button to open the Name screen ...

Page 47: ...en words use the blank space below the letter x To add a second line of text use the character 5 When finished press the Settings button to return to the Settings screen From the Settings screen press the Home button to return to the Home screen The facility name will now appear in the display header Note Extended Latin characters tilde umlaut accents circumflex etc and non Latin characters can be...

Page 48: ...he Up Arrow button and Down Arrow button to move to the desired unit hours minutes month day year When the desired unit is highlighted in red press the Plus button to increase values and the Minus button to decrease values 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 12 followed by AM or PM 5 When t...

Page 49: ...door on the base of the console behind the display 2 Slide the door out then lift up 3 If there is an empty paper roll remove it 4 In the paper well insert the end of a new paper roll with the thermal side down 5 Extend the end of the paper past the side of the unit 6 Snap the door completely closed then slide the door back into the console 7 Tear off any paper extending from the side of the conso...

Page 50: ...CAL CART 1 Insert the post into the square relief on the underside of the medical tray 2 Insert the four screws through the bracket on the top of the post into the molded inserts in the medical tray and tighten securely 3 If you want to permanently attach the post to the wheeled base refer to Step 5 through Step 10 If you want the ability to disassemble the medical cart at a later date place the t...

Page 51: ... a twisting motion and press down firmly 9 Wipe off any excess Loctite with a paper towel and then discard the towel 10 Allow the post and base to sit undisturbed for 3 hours ATTACH THE UNIVERSAL ACCESSORY BASKET OPTIONAL A universal accessory basket is available for the medical cart to provide additional storage capacity 11 Follow the manufacturer s instructions for attaching the accessory basket...

Page 52: ...an Point with QuickPrint software insert the Scan Point with QuickPrint install CD into your computer s CD drive and follow the on screen prompts For complete installation and operating instructions please refer to Scan Point user documentation Procedure 9 WATCH THE ONBOARD TUTORIAL The onboard tutorial provides an overview of how to perform an ultrasound scan of the bladder using the BladderScan ...

Page 53: ...ect ultrasound transmission and decrease the accuracy of exam results Use care when scanning patients who have had suprapubic or pelvic surgery Scar tissue surgical incisions sutures and staples can affect ultrasound transmission and accuracy A catheter in the patient s bladder may affect the accuracy of the bladder volume measurement in two ways 1 by introducing air into the bladder that may bloc...

Page 54: ...eeding Place the discharged battery in the battery charger 4 Ensure that the instrument has been properly cleaned according to the instructions in the chapter Cleaning Maintenance on page 52 5 Be aware of the following conditions that may affect ultrasound transmission and the accuracy of the exam A catheter in the patient s bladder The presence of a catheter may affect the accuracy of the bladder...

Page 55: ...ct to scan all other patients 3 With the patient lying in a supine position and with the abdominal muscles relaxed palpate the patient s pubic bone 4 Place an ample quantity of ultrasound gel with as few air bubbles as possible midline on the patient s abdomen approximately 3 cm 1 in above the pubic bone 5 Standing at the patient s right side gently press the probe onto the lower abdomen through t...

Page 56: ...ultrasound must pass 8 Ensure that there are no air gaps between the probe and the patient s skin and that you are applying enough pressure to maintain adequate skin contact until the scan is complete 9 Press and release the Scan button located on the underside of the probe Hold the probe steady while scanning avoid changing its position angle or pressure As the scan progresses sections of the bla...

Page 57: ...ther case the bladder will not be centered in the crosshairs Large Bladder A large bladder is indicated when more than one bladder wall falls outside the ultrasound field of view The scan results may show a symbol even though the probe indicates a successful scan See successful entry in this table When this happens try one of the following Apply less pressure with the probe and re scan Re aim and ...

Page 58: ...bout using Scan Point with QuickPrint please refer to Scan Point user documentation contact your local Verathon representative or contact Verathon Customer Care Note 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 a...

Page 59: ...f another exam on the patient is required press the Home button and repeat the procedures within this chapter 8 Once you have completed the scan wipe the ultrasound gel off of the patient and the probe For complete cleaning instructions see the Cleaning Maintenance chapter on page 52 Procedure 4 DELETE A SAVED EXAM Saved exams are indicated by orange folder icons along the left edge of the display...

Page 60: ...y clean the device could result in a contaminated instrument after completing the disinfection procedure WARNING Cleaning and disinfecting the instrument is an important part of using and maintaining the device Prior to each use ensure the instrument has been cleaned and disinfected according to the following procedures BEST PRACTICES Cleaning is the removal of all visible soil or contaminants fro...

Page 61: ...Sol Spray Clorox Germicidal Wipes Sani Cloth Bleach Wipes Sani Cloth Germicidal Wipes Sani Cloth Plus Germicical Wipes Sporicidin Disinfecting Towelettes T Spray II Procedure 1 CLEAN DISINFECT THE INSTRUMENT Failure to heed the following may cause device damage not covered by the warranty Do not immerse the instrument in the disinfectant solution Do not subject any part of the instrument to steam ...

Page 62: ...r Verathon recommends wiping the instrument three separate times to remove all residual disinfectant 11 Allow the instrument to air dry or towel dry with a clean dry cloth REGULAR INSPECTIONS Verathon recommends that the BVI 9400 be certified by an authorized BladderScan service center once a year Certification service includes comprehensive inspection and testing of the instrument to ensure accur...

Page 63: ...ins automatically The display provides the status and results When the test is complete the printer prints the results Note For the self test results to print the printer must be loaded with paper prior to running the self test For instructions on loading the thermal paper see the procedure Load the Thermal Paper on page 41 3 If the screen indicates any failed tests or abnormal results contact Ver...

Page 64: ...ble click the Scan Point with QuickPrint icon Scan Point opens 3 On the computer in the Scan Point QuickPrint window click Find New QuickPrint establishes a connection with the instrument and an icon for the device appears in the left pane On the console two arrows appear confirming that the console is connected to Scan Point ...

Page 65: ...utton 5 If any updates are available the device downloads and installs them The console displays a progress bar and automatically restarts when the installation is complete If no updates are available nothing happens 6 If you would like to view the current software version and verify that the newest software is installed complete the procedure Run a Self Test on page 55 The results screen displays...

Page 66: ...performed 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 14 Calibration Warning 1 Within 3 m 10 ft of the Battery Charger Wireless Hub place the calibration tank on a flat nonreflective surface and then remove the lid 2 Pour clean room temperature water into the ta...

Page 67: ...obe is submerged in the water 6 On the computer double click the Scan Point with QuickPrint icon Scan Point opens 7 On the instrument from the Home screen press the Scan Point button 8 On the computer in the Scan Point QuickPrint window click Find New QuickPrint establishes a connection with the instrument and an icon for the device appears in the left pane On the console two arrows appear confirm...

Page 68: ...rial number on the screen matches the serial number on the bottom of console and then click the calibration tank icon 10 Click the Calibrate button Scan Point begins to scan and analyze the data in order to ensure that it meets the calibration parameters ...

Page 69: ...es occur contact Verathon Customer Care 12 On the console click the Exit button This terminates the calibration procedure and ends communication with Scan Point 13 Remove the probe from the tank lid and then dry the probe with a clean soft cloth DEVICE DISPOSAL The BladderScan BVI 9400 and related devices may contain mineral oils batteries and other environmentally hazardous materials When the ins...

Page 70: ...ormation that would be required for repairing the device and related accessories Premium warranty customers have access to a loaner unit and free shipping options that vary according to the service plan If you have any questions please contact your local Verathon representative or Verathon Customer Care WARRANTY Verathon products and software are warranted against defects in material and workmansh...

Page 71: ...New button Repeat this step up to 3 times If the console does not connect continue to the next step 3 Turn the console off turn the console on and then press the Scan Point button On the PC in Scan Point click Find New If the console does not connect continue to the next step 4 While the instrument is attempting to connect to Scan Point remove the battery 5 Reinsert the battery allow the instrumen...

Page 72: ...rged one If the instrument has stopped responding even with a new battery perform a full reset by removing and reinserting the battery If the instrument still does not respond contact Verathon Customer Care Procedure 3 INSTRUMENT 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 j...

Page 73: ...s FDA Format Values in this table are the maximum readings obtained from three test results ACOUSTIC OUTPUT MI ISPTA 3 mW cm2 ISPPA 3 W cm2 Global Maximum Value 0 519 0 632 9 35 Associated Acoustic Parameter pr 3 MPa 0 684 Wo mW 1 55 1 44 fc MHz 1 74 1 74 2 63 1 74 zsp cm 1 90 1 90 Beam dimensions x 6 cm 0 321 y 6 cm 0 334 PD µsec 2 93 2 93 PRF Hz 400 400 EDS Az cm 7 40 7 38 Ele cm 7 40 7 38 TIS T...

Page 74: ... pulse is 1 cycle at 2 95 MHz and the second pulse is 5 cycles at 1 74 MHz Intended use does not include cephalic uses so TIC is not computed Data for each pulse is provided and seporated by a comma No data reported Notes 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode 2 Information need not be provided regarding TIC for any transdu...

Page 75: ...lows 160 mL 15 24 mL 22 5 mL 15 mL 39 mL 150 mL 39 mL 111 189 mL The accuracy specifications assume the instrument is being used according to the instructions provided by Verathon while scanning a tissue equivalent phantom Table 25 Operating Storage Conditions SPECIFICATION DESCRIPTION Operating Conditions Ambient temperature range 10 40ºC 50 104ºF Atmospheric pressure range 700 1060 hPa Relative ...

Page 76: ...he event any user settings change reset them by following the instructions in the Setting Up section of this manual Use only the battery charger provided with the BVI 9400 Any other battery charger may damage the battery Table 26 Battery Specifications CONDITION DESCRIPTION Battery type Lithium ion Battery life A fully charged battery can provide approximately 30 exams within a 24 hour period Char...

Page 77: ...omputer connection USB 2 0 Charger Powered by a desktop DC power supply Input voltage 18 V DC Insulation Class II with double insulation Testing IEC 60950 1 Storage Conditions Storage Indoor Ambient temperature range 20 60ºC 4 140ºF Atmospheric pressure range 500 1060 hPa Relative humidity 20 95 non condensing Table 28 Power Adapter Specifications CONDITION DESCRIPTION Input voltage 100 240 V AC R...

Page 78: ...not affected under the test conditions described in the following tables For more information about the essential performance of the BladderScan BVI 9400 system see Essential Performance on page 2 ELECTROMAGNETIC EMISSIONS Table 29 Guidance and Manufacturer s Declaration Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified below The customer or the ...

Page 79: ...typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 s In compliance Mains power quality should be that of a typical commercial or hospital environment If the user of the BladderScan BVI 940...

Page 80: ...is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios a...

Page 81: ...t power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all...

Page 82: ...eve freedom from unacceptable risk ESD Electrostatic discharge F Fahrenheit g Gram GHz Gigahertz HIPAA Health Insurance Portability and Accountability Act hPa Hectopascal Hz Hertz IEC International Electrotechnical Commission in Inch ISM Industrial scientific and medical ISPPA Spatial peak pulse average intensity ISPTA Spatial peak temporal average intensity kV Kilovolt LAN Local area network LCD ...

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