Bvi 9400 Bladder Scanner Manual Full Pdf

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All rights reserved. No part of 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.Data on acoustic output levels can be found in the Product Specifications. WARNING Risk of electric shock or burns. Do not use the BladderScan instrument in conjunction with HF surgical equipment. WARNING Risk of explosion, fire, or serious injury.The ultrasonic output of the BladderScan BVI 9400 is not user adjustable and is limited to the minimum level necessary for effective performance. For. The BladderScan BVI 9400 has two main components: the console and the probe. The console and probe are linked by a detachable cable. The probe is attached to the console by a cable. The probe has three main features: Figure 2. Button functions are indicated by icons in the display footer, immediately above each button. CONSOLE DISPLAY ICONS The following icons may appear on the console main display. Go to the Home screen. Go to the Tutorial screen. Go to the Settings screen. Play video playback. Pause video playback. Add, increase, or toggle characters, as appropriate. Remove, decrease, or toggle characters, as appropriate. No function. BUTTON FUNCTIONS FOR EACH DISPLAY SCREEN The Power, Brightness, and Volume buttons are constant buttons on the body of the console and can be pressed at any time. Changes to a stop button during recording. Results screen (2) Print—Print to onboard printer. Appears when a scan is complete. (3) Listen—Press to listen to the voice annotations, otherwise, Prominently displays calculated bladder no function. Allows the user to set the date and time. (4) Minus Sign—Decrease or toggle the selected value.
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Displays the savings to your organization due to using the BladderScan BVI 9400 rather than catheterization.View the onboard tutorial. Go to the Settings screen (set the time, date, facility name, and user preferences). The display presents the result of the exam: crosshairs, bladder outline, and the calculated bladder volume. You may choose to print this result to the onboard printer and also record a voice annotation to 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. The display shows the ultrasound images associated with the selected exam. While reviewing saved exams, the buttons below the display allow you to print, listen to, or delete exam data. 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. Press the Play button to begin the desired tutorial. Note: When this screen is open, the Scan button on the probe is disabled. Table 11. Note: When this screen is open, the Scan button on the probe is disabled. Table 12. For 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. For more information, see the procedure Set the Date and Time on page 40.General Preferences 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. The default settings can be customized to reflect the rates and costs at your facility. For more information on cost savings, see Histogram of Cost Savings on page 33 Preferences lists and options:. It counts all Scan button pushes captured by the console.
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It is designed to enable clinical users or service technicians to determine the number of scans the device has performed over its lifetime. If both the scan counter and its backup copy are corrupted, the scan counter will automatically reset to a zero value. The scan counter feature is designed so that the value cannot be manually reset or modified by the clinical user or service partner. 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. Note: The Scan Point screen (connected) is only available if the optional Scan Point software is installed on a PC. Figure 8. This data is analyzed and can be displayed on the BVI 9400 at any time. The Savings Preferences screen lists: Date Started, Number of Scans, Cath Avoided, UTI (urinary tract infection) Avoided, Savings. The BladderScan BVI 9400 draws very little power when it is turned off. However, if you do not plan to use the BladderScan instrument for several weeks, you should remove the battery to prevent it from discharging. Note: The battery is designed to prevent incorrect installation. If the battery does not slide into the battery well easily, remove the battery, reorient it, and try again. Arrow on cable connector 3. This information is included on BladderScan displays and all printouts of exam results. 1. Turn on the instrument by pressing the Power button 2. When the desired character is highlighted in red, press the Plus button to add it to your text. Use the Minus button to delete characters. Installing the instrument on the optional mobile cart will allow you to move it, along with related accessories, to the patient examining area or bedside. If you use the BladderScan BVI 9400 in the presence of flammable anesthetics, the hazard of potential explosion exists. WARNING Potential patient hazard.
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However, medical professionals should use ultrasound only when clinically indicated, using the lowest exposure times possible to obtain accurate measurements. Select to scan a patient less than 122 cm (48 in) tall and weighing less than 27 kg (60 lbs). Select to scan a female patient who has not had a hysterectomy. Select to scan all other patients 3. For most patients, this means angling the probe slightly toward the patient’s tail bone (coccyx) so the scan clears the pubic bone. 7. If you are scanning an obese patient, lift as much abdominal adipose tissue out of the way of the instrument as possible. This information must be written on the printout. Note: If the facility name, date, and time have not been set, those lines will be skipped on the printout. Note: The BVI 9400 prints on thermal paper, which fades over time. WARNING Availability of cleaning and disinfection products varies by country, and Verathon is unable to test products in every market. Certification service includes comprehensive inspection and testing of the instrument to ensure accurate performance in clinical use. QuickPrint establishes a connection with the instrument, and an icon for the device appears in the left pane. The console displays a progress bar and automatically restarts when the installation is complete. Ensure that the opening for the scanhead is directly above the spiral target. 5. Place the probe into the cutout in the lid. Ensure that the tip of the probe is submerged in the water. 6. DEVICE DISPOSAL The BladderScan BVI 9400 and related devices may contain mineral oils, batteries, and other environmentally hazardous materials.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. Repeat this step up to 3 times. If the console does not connect, continue to the next step.
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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. A battery icon on the instrument display is always present indicating how much power remains and when the battery needs to be changed. You can change the battery whenever necessary. Verathon recommends that you replace your batteries every two years. The limits for emissions and immunity specified in this standard are designed to provide reasonable protection against harmful interference in a typical medical installation. If the measured field strength in the location in which the BladderScan BVI 9400 system is used exceeds the applicable RF compliance level above, the BladderScan BVI 9400 system should be observed to verify normal operation. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the system The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment. Replace the Printer Door Disassemble the Console Ba. Replace the DSP PCBA Replace the Handle, Printe. Disassemble the Console Di. Replace the Keypad PCBA or. Replace the Console Hinges Replace the LCD and LCD Fl. Replace the Inverter Flex. Replace the Display Housin. Reassemble the Console Dis. Reassemble the Console Bas. Replace the Console Label Disassemble the Probe Replace the Probe LCD Flex. Replace the Probe Top Cove. Remove the Probe Bottom Co. Install the DCM into a New. Reassemble the Probe Replace the Probe Serial N. Scan a Tissue-Equivalent P. Load Thermal Paper All rights reserved.

Verathon, the Verathon torch symbol, BladderScan, the BladderScan symbol, and Scan Point are either trademarks or registered trademarks of Verathon Inc. As you complete these procedures, you may identify a service issue or required repair.UDI COMPLIANCE Depending on its date of manufacture, a Verathon product may or may not conform to the Unique Device Identification (UDI) standard. For items manufactured before the standard went into effect, the identity of the product line and the individual device are shown on the product’s labels and packaging as plain text. Please heed the following warnings.When servicing an instrument, it is necessary to verify that the device is functioning properly.Verathon Service Partner Manual: Annual Certification. 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 software version that the console is currently running, complete the procedure Run a Self Test on page 110. Ensure that the water is as free of bubbles as possible. Note: The tank may need to sit for 24 hours until the water has degassed. Verathon Service Partner Manual: Annual Certification. Ensure that the tip of the probe is submerged in the water. 6. Verathon Service Partner Manual: Annual Certification. If necessary, the instrument automatically rescans the tank. 13. If calibration is successful, a “Calibration Successful” confirmation is displayed on the computer.This terminates the calibration procedure and ends communication with Scan Point. 16. Remove the probe from the tank lid, and then dry it with a clean, soft cloth. Verathon Service Partner Manual: Annual Certification. Complete this procedure in order to verify that the system is in good working order.Certification service is performed in compliance with Verathon Inc.Verathon recommends that certification of calibration be performed once a year.
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On the Home screen, press the Scan Point button.Ensure there is a roll of thermal paper in the console. 22. On the Home screen, press the Settings button 23. Press the Down button until Self Test is highlighted, and then press the Enter button. Verathon Service Partner Manual: Annual Certification. Complete this procedure in order to determine the location. Continue to the following section, Repair Guide on page 24.If damaged or faulty, replace the probe PCBA in Reassemble the Probe Inaccurate scan Replace the probe cable in Reassemble the Probe result (Example: Probe zero bladder Optionally, repair the DCM bottom cover assembly in. If the console does not connect, repeat Step 1 (up to 3 times), and then refer to Table 1 on page 24.The volume measurement is inaccurate, and the instrument does not display aiming arrows. Potential cause: The patient may be obese. Adipose tissue may be obscuring the scan. Suggested adjustment: Rescan the patient, lift as much abdominal tissue out of the way of the probe as possible, and apply more pressure with the probe. The volume measurement may not be accurate. No aiming arrows are displayed. Potential cause: The uterus may contain fluid that interferes with the accuracy of the volume measurement. Suggested adjustment: Ensure that the scan mode is set to female patient. Ensuring that you do not touch the LCD, grip the display housing lens by the exposed top and sides, and then lift the lens up and out. This creates a gap between the front and back panels of the display. 16. If the battery contacts are dirty, it may prevent the console from drawing battery power. Figure 7. Dirty Battery Contacts Figure 8. If cleaning the print head does not solve the service issue, then replace the printer according to the procedure Replace the Handle, Printer, or Top Cover Assembly on page 52. Replace The Printer Door Disassemble The Console Base Housing Power Cable Connector Speaker Cable Connector 10.
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Inspect the DSP PCBA for damaged L14 and Q13 components. Damage to these components is caused by a shorted circuit in connector pins 1 and 2 in the probe cable. Replace The Dsp Pcba Replace The Handle, Printer, Or Top Cover Assembly If the printer is producing irregular printouts, these procedures may resolve the issue. Disassemble The Console Display Otherwise, skip to the procedure Reassemble the Console Base Housing on page 86. If you need to replace the display housing lens, it is not necessary to disassemble the console display. For more information, see the procedure Replace the Display Housing Lens on page 33. Note: A T5 star screwdriver may be needed for older consoles. If necessary, use a magnet to remove the screws from the bosses. Replace The Keypad Pcba Or Keypad Flex Cable Replace The Console Hinges Replace The Lcd And Lcd Flex Cable Do not attempt to remove the power inverter until it is disconnected from the LCD. Note: If necessary, separate the inverter from the display housing bottom using tweezers. 6. Pull any excess flex cable through the frame, and then press the remaining edges of the PCBA into place.Complete any additional repairs to the console display, and then reassemble the console according to the procedure Reassemble the Console Display on page 78.Replace The Inverter Flex Cable If you are updating the LCD as well, refer to Replace the LCD and LCD Flex Cable on page 67. Replace The Display Housing Bottom This provides space for you to access the LCD power cable connector. Note: If necessary, use tweezers in order to leverage the inverter away from the display housing bottom.Set the LCD and flex cable aside. 15. Remove the Kapton tape that secures the inverter flex cable to the display housing bottom. 16. Reassemble The Console Display If any of the console display housing components require replacement, replace those components during this reassembly procedure. If you did not remove these items, skip to Step 8. 6.

Place the inverter and inverter flex cable onto the display housing bottom, ensuring that the inverter fits correctly onto the posts of the bottom housing. If you are using a new top cover assembly, peel the protective backing off of the housing vent membrane, and then install the membrane into the top cover assembly as shown in the following figure. 15. Reassemble The Console Base Housing Replace The Console Label If the probe has a serial number that starts with a 00 or PA and the probe has a black dome, then it must be replaced. Disassemble The Probe If replacing a part or component requires additional disassembly, that information is detailed in the corresponding part replacement procedure.Replace The Probe Lcd Flex Cable Replace The Probe Top Cover Assembly Or Housing Remove The Probe Bottom Cover Install The Dcm Into A New Bottom Cover Note: Do not apply RTV adhesive at any notch or alignment feature. In the following figure, the oil filler tube is omitted for clarity. 8. Reassemble The Probe If the DCM is malfunctioning or if the clips or bosses are damaged, replace the DCM bottom cover assembly: 4. If needed, press the probe against a hard surface.Note: These screws are delicate. It is recommended that you replace these screws instead of reusing them. Replace The Probe Serial Number Label. If the label is damaged or missing, contact Verathon Customer Care for assistance.RuN A SeLF TeST No parts are required in order to run this test. Use the self test and this procedure in order to receive basic diagnostics about the instrument, including the software version, available storage capacity, DSP version, and other helpful information. Scan A Tissue-Equivalent Phantom For additional information about reading ultrasound results, see Troubleshoot by Using Ultrasound Images page 28. Table 3. Verifying Accuracy of Scan Results BLADDER RESULT SAMPLE DISPLAY DESCRIPTION. Load Thermal Paper Ensure that the door clicks into place. 7.
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Tear off any excess paper protruding from the printer. Verathon Service Partner Manual: Reference Documentation. Sign in Forgot Password. My Bench Close Sign In Not A Member. Sign Up Join MedWrench OK name type Receive Summary Emails. With one click, the BVI 9400 captures ultrasound images in multiple planes inside the body and produces a three-dimensional dataset of the bladder. Based on this data, the BVI 9400 calculates and displays the bladder volume. No sonographer is required.By continuing to browse the site you are agreeing to our use of cookies. Please review our Privacy Policy for more details. All Rights Reserved. Turn on the BladderScan BVI 9400. Calculation. SavingsNumbeCath AvoideUTI AvoideSavingThe BladderScan BVI 9400 is designed to scan in three patientspecific modes. Select the proper exam mode to ensure theSimply press the button repeatedlySelect to scan a male patient, or a female patient whoSelect to scan a female patient who has not hadSavings Calculation. Date Started. Number of ScansFemale button. Select to scan a small child under 48 inches (122cm) tallWith the patient supine, apply gel. Have the patient lie in the supine position with abdominalPalpate the patient's symphysis pubis (pubic bone). PlaceAim toward the bladder. Standing at the patient’s right side, place the Probe on theFor most patients, this means tilting the Probe slightlyPress the SCAN button. Press the SCAN button, located on the underside of the Probe. As the scan progresses, sections of the bladder will appear onScan buttonAll rights reserved. BVI 9400 User ’s Quick Reference. Verify the scan. If the scan is “on target” all 8 arrows will flash on the ProbeSince no re-aiming isRe-aiming. If the scan is “off target” the Probe will show an arrowIf the arrow is solid, it means you are slightly “off target.”. If the arrow is flashing, it means you are significantly “offOn the Console, theHead. RightTo re-aim. To re-aim, note that the small dot at “6 o’clock” on the.

Console target represents the feet of the patient. TheThis orientation should helpFeet. Pubic Bone. You may also see a screen that indicates the pubic bone isIf this occurs, you may wantAlthough the bladder may be shownBy re-aiming, you canPubicSave, 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 STOPPress the STOP button on the Console. When the hourglass icon disappears, press the LISTEN button toRecord. Print. Listen. Review. Home. To review the images of your scan, press the REVIEW buttonTo print exam results via on-board printer, press the PRINTTo perform another exam, press the HOME button. Finish exam. Once you have completed the scan, wipe the ultrasound gel off the patient and the Probe. To order additional rolls of paper (0800-0319) or batteries (0400-0066), contact Customer Care at 800.331.2313. Verathon, the Verathon torch symbol, BladderScan, the BladderScan symbol, ScanPoint, 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.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. Information in this manual may change at any time without notice. For the most up to date information, see the online manuals at verathon.com. 0123 The device consists of an ultrasound probe that scans the patient s bladder and a compact, battery operated console that provides measurement related information. BladderScan instruments are quick, accurate, reliable, and easy to use.

When the user presses the Scan button, within seconds the BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on this image, the BVI 9400 calculates and displays the bladder volume. A sonographer is not required. NeuralHarmonics technology in 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 multispectral 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 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 verifying 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 onboard thermal printer that allows the user to print exam results quickly with the press of a button. A calibration targeting system, consisting of a calibration target and a calibration container, allows 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 battery charger for the custom, user replaceable lithium ion battery used in the system. The BladderScan BVI 9400 may be mounted on a cart, holding the instrument securely, and providing optional storage for ultrasound gel and other accessories.All users must read this entire manual prior to using the BladderScan BVI 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. STATEMENT OF PRESCRIPTION Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. 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. 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 INFORMATION BIOLOGICAL SAFETY 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 Product Specifications.

CONTRAINDICATIONS The BladderScan BVI 9400 is not intended for fetal use or for use on pregnant patients. 2. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction, failure, or damage to the product. To ensure safe and reliable operation for the user and the patient, please heed the following warnings and cautions. PRECAUTIONS CAUTION Potential Device Interference. Bluetooth and wireless LAN devices operate within the same radio frequency range and may interfere with one another. 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 lose your network connection. 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. CAUTION The BladderScan BVI 9400 and related devices may contain mineral oils, batteries, and other environmentally hazardous materials.For more information, see the Electromagnetic Compatibility section on page 70. To maintain electromagnetic interference (EMI) within certified limits, the BladderScan BVI 9400 system must be used with the cables, components, and accessories specified or supplied by Verathon. The BladderScan BVI 9400 system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used. This device can radiate radio frequency energy and is very unlikely 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 determine the source of interference Reorient or relocate this device or other devices Increase the separation between devices Connect the device to an outlet on a circuit different than the other device(s) Eliminate or reduce EMI with technical solutions (such as shielding) Purchase medical devices that comply with IEC EMC Standards Be aware that portable and mobile radio frequency communications equipment (cellular phones, etc.) may affect medical electrical equipment; take appropriate precautions during operation. 4 If you use the BladderScan BVI 9400 in the presence of flammable anesthetics, the hazard of potential explosion exists. WARNING Risk of electric shock or burns. Do not use the BladderScan instrument in conjunction with HF surgical equipment. WARNING Ensure proper distance from patient. WARNING Risk of explosion, fire, or serious injury. The BladderScan BVI 9400 is powered by a lithium-ion battery. Failure to note the following when handling the battery may result in serious injury: Never short-circuit the battery 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 and the BladderScan device. Never expose the battery to abnormal shock, vibration, or pressure. The battery s internal protective covering could fail, causing it to overheat or ignite, resulting in caustic liquid leakage, explosion, or fire. Do not disassemble, heat above 60 C (140 F), or incinerate the battery. Keep battery out of reach of children and in original package until ready to use. Dispose of used batteries promptly according to local recycling or waste regulations.