BVM 9500 Users Manual and Quick Reference Guide

Bladder Volume Instrument

BVM 9500

Quick Reference Guide

Copyright © 2009, 2010 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. BladderScan, NeuralHarmonics, ScanPoint, Sontac, Vmode, Verathon, the Verathon Torch symbol and Total Reliability Plan are trademarks 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 5,235,985, 6,676,605, 6,884,217 and 6,905,468. The ScanPoint® technology described in this manual is protected by U.S. Patent Number 6,569,097. Other patents pending. Information in this Quick Reference Guide may change at any 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 Quick Reference Guide 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

PN: 0900-2181-02-20

Verathon Medical (Europe) B.V. EC REP Linnaeusweg 11 3401 MS IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512

BVM 9500 Bladder Volume/UEBW Quick Reference NOTE: To measure Ultrasound-Estimated Bladder Weight (UEBW), the patient’s bladder volume must be between 150 ml and 400 ml to ensure an accurate reading. If the bladder volume reading falls within this range, UEBW, bladder wall thickness and bladder surface area will automatically be calculated by the BVM 9500. If the bladder volume is not within this range, UEBW will be shown as “-g”.

Turn on the BladderScan BVM 9500 by pressing the POWER ON/OFF button. Select the exam mode Press the MODE button to toggle between male and female modes: When the female icon is displayed, the BVM 9500 assumes the patient is a female who has not had a hysterectomy. Select to measure bladder volume on male patients, or female patients who have had a hysterectomy.

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 (pubic bone).

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 angling the Probe slightly toward the patient's coccyx (tailbone) so the scan clears the pubic bone.

Press and release the SCAN button Press and release the SCAN button, located on the underside of the Probe. As the scan progresses, sections of the bladder will appear on the Console screen. When you hear the endscan tone, the scan is complete. Scan button

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, the BladderScan symbol, ScanPoint, Verathon and the Verathon Torch symbol are trademarks of Verathon Inc. ©2009, 2010 Verathon Inc. All other brands and product names are trademarks of their respective owners.

BVM 9500 Bladder Volume/UEBW Quick Reference Interpreting scan results If the scan is “on target” the Probe will display eight flashing arrows. On the Console, the bladder will appear in the center of the crosshairs. To measure Ultrasound-Estimated Bladder Weight (UEBW), the patient’s bladder volume must be between 150 ml and 400 ml. Bladder volumes outside this range will return a reading of “--- g” for UEBW. A successful scan of bladder volume and UEBW is shown (Image 1).

Image 1: On-target scan

If the scan is off-target If the scan is “off target” the Probe will show an arrow indicating the direction to move the Probe to be “on target.” On the Console, the bladder will not be centered in the crosshairs, and there will be an arrow pointing in the direction for re-aiming (Image 2). ● If the arrow on the Probe is flashing, you are significantly “off target” ● If the arrow on the Probe is solid, you are slightly “off target”

Right shoulder

Head

Feet

Image 2: Off-target scan

To re-aim ● Adjust the angle of the Probe so the scan head (black tip) moves in the direction of the arrow, or ● Make small movements of the Probe–approximately 0.5 in (1 cm) in the direction of the arrow–until the scan is “on target”

Pubic bone

Please 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 adjust your aim to center the bladder fully in the ultrasound cone.

Image 3: Pubic bone obscuring bladder

Pubic Bone You may also see a display indicating that the pubic bone is inside the ultrasound cone. If this occurs, you should re-aim and re-scan (Image 3). 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. If the bladder volume is greater than 999 ml, the display shows > 999 ml (Image 4).

Image 4: Bladder volume > 999 ml

BVM 9500 Bladder Volume/UEBW Quick Reference e

To make a manual measurement of Bladder Wall Thickness, select the Manual Measurement function on the Results screen and consult the User’s Manual for detailed instructions (Image 5).

Interpreting UEBW Measurement Data A standard deviation value indicating the UEBW measurement confidence is displayed as a +/- range (Image 5). In some cases, the UEBW measurement will be expressed as an approximate value, using a ≈ symbol. This means that the measurement is an approximate result only and you should re-aim and re-scan to get a more accurate reading (Image 6).

Image 5: Measuring UEBW Manual Measurement

The table below provides guidance on interpreting data displayed on the Results screen. Interpreting Results Screen UEBW Measurement Data Aiming Arrow Present?

UEBW measurement symbol

No No

=

No

>

Yes

≈

Yes

>

≈

Recommended Action Accept UEBW measurement Adjust Probe pressure and/ or Probe angle and scan again. Depending on patient anatomy, it may not be possible to get an = sign. Bladder volume is too large for UEBW measurement Angle Probe in direction of arrow on Probe screen, or move Probe no more than 1/2 inch (1 cm) in direction of arrow; scan again Angle Probe in direction of arrow on Probe screen, or move Probe no more than 1/2 inch (1 cm) in direction of arrow; scan again

Additional Scanning Tips When measuring bladder volume and UEBW, it is VERY IMPORTANT to hold the device steady while scanning. Avoid changing position, angle or pressure. Applying too much pressure when scanning may lead to a Greater Than (>) symbol preceding the measurement on the screen. If this happens, apply less pressure and re-scan. To ensure accurate results, make sure that: ● You use a sufficient amount of ultrasound gel and ensure there are no air gaps between the Probe and the patient’s skin. ● You are holding the Probe steady while scanning (avoid changing 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 (for example, detecting a blocked catheter).

Image 6: Approximate UEBW Value

BVM 9500 Bladder Volume/UEBW Quick Reference

9

Save, review and print exam results. 9a

Voice annotate and save exams. ● To save the exam you must record a voice annotation. ● 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. Press the Stop button when you are finished speaking. When the hourglass icon disappears, press the Listen button to replay the annotation. ● To print exam results via the onboard printer, press the Print button.

9b

Review saved exams. ● To review previous exam records, press the Review button. On the Review screens, the user can review all currently saved exams and can print, replay voice annotations, or delete exams. Review Screen 1 shows the bladder volume measurements. Pressing the Return button displays Review Screen 2, which will show:

Listen

Review

Return

Delete

● Bladder Surface Area ● Ultrasound Estimated Bladder Weight (V-Mode) ● Ultrasound Estimated Bladder Wall Thickness (V-Mode) If manual measurements were taken, then two additional measurements will be displayed: ● Bladder Weight (Manual) ● Wall Thickness (Manual) ● To perform another exam, press the Home button.

10

View Next Exam

Review Screen 1

Finish the exam. Once you have completed the scan, wipe the ultrasound gel off the patient and the Probe. For ScanPoint® subscibers, logging onto the ScanPoint application automatically transfers and saves your annotated exams to your Windows® computer.

Review Screen 2

To order additional rolls of paper (0800-0319) or batteries (0400-0066), contact Customer Care at 800.331.2313.

verathon.com https://my.scanpoint.com

0123

For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical representative. Verathon Corporate Headquarters: 20001 North Creek Parkway, Bothell, WA 98011, USA. Phone: +1.425.867.1348 VM Europe B.V.: Linnaeusweg 11, 3401 MS IJsselstein, The Netherlands, Phone:+31.30.68.70.570

0900-2102-03-60

BVI 9000 Series Calibration Quick Reference 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. Note: ScanPoint® with QuickPrint is required to calibrate your BladderScan® instrument online. Online calibration is not supported by ScanPoint® LC.

Prepare for Calibration Set up the calibration tank in a location that is within 10 feet of the Battery Charger/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 spiralshaped target in the container, using the notches to position target correctly. Replace the lid on the calibration container.

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® with QuickPrint From your desktop, open ScanPoint® by double-clicking the ScanPoint® with QuickPrint icon.

Savings Calculation Date Started

Establish BladderScan - QuickPrint connection ®

3/21/2007

Number of Scans

22

Cath Avoided

15

UTI Avoided

0

Savings

$1500

ScanPoint® button

Press the ScanPoint® button on the BladderScan® instrument. On the QuickPrint screen, click the FIND NEW button. When QuickPrint establishes a connection with the BladderScan® instrument, an icon for that device will appear along the left menu.

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 and Verathon are trademarks of Verathon Inc. © 2009 by Verathon Inc.

BVI 9000 Series Calibration Quick Reference

Calibrate instrument From the Tools menu, select Calibrate Instrument. When the Calibration screen opens, click the CALIBRATE button. ScanPoint® then automatically scans and analyzes the calibration target.

Calibrate

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 BladderScan® instrument and the ScanPoint® host computer until all processing is complete.

Successful calibration If ScanPoint® was able to locate the calibration target, 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 To terminate the calibration procedure and end communication with the ScanPoint®, press the CANCEL (X) button on the BladderScan® instrument. Remove the Probe from the calibration chamber lid and dry it with a clean, soft cloth. 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

0123

For more information, call 800.331.2313 (in the U.S. and Canada) or contact your local Verathon Medical representative. Verathon Corporate Headquarters: 20001 North Creek Parkway, Bothell, WA 98011, USA. Phone: +1.425.867.1348 VM Europe B.V.: Linnaeusweg 11, 3401 MS IJsselstein, The Netherlands, Phone:+31.30.68.70.570

0900-1447-05-60

BVM 9500 Information BVIImportant 9600 Important Information

Intended Use Warnings and Cautions: The BladderScan BVM 9500 should be used only by individuals who have been trained and authorized by a physician or the institution providing the patient care. All users must read the entire BladderScan BVM 9500 User’s Manual prior to using the BladderScan BVM 9500. Do not attempt to operate this instrument until you thoroughly understand all instructions and procedures in the User’s 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 > Customer Support links to open a link to this manual and other training materials.

CAUTION

Risk of Fire and Burns. Regarding the battery, do not disassemble, heat above 60° C (140° F), or incinerate. Keep battery out of reach of children and in original package until ready to use. Dispose of used batteries promptly according to local recycling or waste regulations. Use care when scanning patients who have had supra-pubic or pelvic surgery. Scar tissue, surgical incisions, sutures, and staples can affect ultrasound transmission and accuracy. Do not use the BladderScan BVM 9500 on a patient with open skin or wounds in the suprapubic or abdominal regions. Do not use the BladderScan BVM 9500 on a patient with ascites. If you scan a patient with a catheter in his/her bladder, the catheter may affect measurement accuracy. However, the information obtained from the measurement could still be clinically useful for detecting problems such as a blocked catheter.

CAUTION

Use the following procedure to reset your instrument if your BladderScan BVM 9500 suffers from a configuration loss and displays the Home screen for a BladderScan BVI 9400 instrument.

NOTE

Only use this process to restore the factory set configuration. Do NOT use this reset process for any other issue. In very rare instances, your instrument may experience a configuration file error. If a configuration file error occurs, the instrument will lose its factory set configuration and return to its default configuration as a BVI 9400 instrument, meaning it will display a BVI 9400 Home screen. To re-establish the factory configuration specific to your instrument, please follow these steps.

NOTE

Do not press the Power button at any time when the battery is removed. To reset the factory set configuration: 1. Turn the Console OFF.

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BVM 9500 BVIImportant 9600 Important Information Information

2. Turn the Console ON and wait for the Home screen to appear. 3. Remove the battery from the Console. Wait 30 seconds. Do NOT press any buttons on the Console while the battery is removed. 4. Re-insert the battery into the Console. Wait 30 seconds. If the Console does not turn on automatically, turn the Console ON. 5. Confirm that the instrument displays the correct configuration by checking the model number displayed in the upper left corner of the screen.

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 BVM 9500 is not user adjustable and is limited to the minimum level necessary for effective performance. Data on acoustic output levels can be found in the “Instrument Specifications” section of the BladderScan BVM 9500 User’s Manual.

Statement of Prescription United States federal law restricts the BladderScan BVM 9500 to use by, or on the order of, a physician. This statement is required per 21 Code of Federal Regulations (CFR) 801.109.

NOTE

It is standard practice to have medical staff authorize the use of the BladderScan BVM 9500 within its intended use throughout an institution. Individual prescriptions for use are not required.

Statement of Intended Use The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and bladder wall mass noninvasively.

CAUTION

Observe the following precautions in the safe use and care of the BladderScan BVM 9500. Hazardous materials present. Assure proper disposal. The BladderScan BVM 9500 and related devices may contain lead, mineral oils, batteries, and other environmentally hazardous materials. When the BladderScan BVM 9500 has reached the end of its useful service life, return the device, charging cradle, and related accessories to a Verathon® Service Center for proper disposal. Alternatively, follow your local protocols for hazardous waste disposal.

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BVM 9500 BVI Important 9600 Important Information Information

Assure Proper Computer System Configuration When using the BladderScan BVM 9500 with optional ScanPoint® software, your computer must be minimally certified to EN / IEC / CSA / UL 60950 or 60101-1 standards. This configuration ensures that compliance to the EN/IEC 60601-1-1 system standard is maintained. Anyone connecting additional equipment to the BladderScan BVM 9500 signal input port or signal output port configures a medical system, and is therefore responsible for ensuring that the system complies with EN/IEC 60601-1-1. If you need assistance, contact your biomedical staff, Verathon Medical representative, or the Verathon Medical Customer Care Department at 1.800.331.2313.

Assure Proper Distance From Patient When transmitting data to or from your computer, make sure that the BladderScan BVM 9500, 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.

Contraindications The BladderScan BVM 9500 is not intended for fetal use or use on pregnant patients.

Specifications - BVM 9500 BladderScan Bladder Volume Instruments are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. Quality system is Quality System Certified to ISA 13485:2003 standards. US 6,884,217 and other US and Patents Pending. Range: Bladder volume range 0 to 999 ml (150 to 400 ml for UEBW) UEBW range: 20 to 100 g Accuracy: The following accuracy specifications assume usage per instructions and scanning a Verathon® Tissue Equivalent Phantom:

• • •

Bladder volume accuracy: +/- 15%, +/- 15 ml UEBW accuracy: +/- 10%, +/- 3 g Wall Thickness accuracy: +/- 10%, +/- 0.1 mm

Power: 11.1 v Li Battery Pack (2 Supplied). 3.5 hours continuous use on one charge; Battery indicator Display: Color LCD Ultrasound Output Parameters: Maximum ultrasound Isptad during a scan: < 5.0 mW/cm2 Maximum ultrasound Isppad during a scan: < 60.0 W/cm2

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BVM 9500 BVI Important 9600 Important Information Information

Specifications - BVM 9500 Continued Maximum MI (Mechanical Index): .75 max Transducer diameter: 13 mm (0.512 inches) and 5 mm (0.197 inches) Transducer resonant frequency: 3.0 MHz, 1.74 MHz, and 7.37 MHz Transducer bandwidth: 80% at 10 dB Time from 3D scan initiation to result display: < 10 seconds Figure 1. BladderScan BVM 9500 Controls and Indicators Console Battery Status Indicator Main Display

Printer (behind display) Battery Packs

Battery Pack 5 Variable Function Buttons

Adjust Volume

Adjust Brightness

Power On/Off Probe (Scan button on hand grip)

Battery Charger/ Wireless Hub

Microphone (above display)

Aiming Display

To Charge the Batteries

NOTE

1.

Plug the Battery Charger/Wireless Hub unit in to a standard wall outlet.

2.

Remove the protective covering from the battery contacts and insert the battery into the recess in the battery charger.

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.

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BVM 9500 BVI Important 9600 Important Information Information

3.

Check the colored indicator lights on the battery charger to determine battery status:

A. Solid green: Battery is fully charged.

B. Amber: Battery is charging

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).

2.

Slide the door to the right, then lift the printer door up.

3.

Insert the end of a new paper roll with the thermal side down, into the paper slot.

To verify which side is the thermal side, scratch the paper with your finger nail. If a black mark appears, that is the thermal side.

CAUTION NOTE

4.

Extend the end of the paper past the side of the unit.

5.

Rotate the printer door down. Make sure you hear it snap into place.

6.

Slide the printer door to the left.

7.

Tear off any excess paper.

To avoid paper jams, never fold the end of the paper roll or cut it diagonally or to a point. If the paper appears to be stuck in the printer, check the User’s Manual for troubleshooting tips, or contact your authorized BladderScan Service Center, your local BladderScan distributor, or Verathon Medical Customer Care at 1.800.331.2313 for service.

To Record a Voice Annotation After performing an exam, you can record additional information about a patient to be stored with the exam results. The instrument can store ten scans with voice annotations, so you can perform multiple exams on your rounds. If you are using the optional ScanPoint® with QuickPrint software, you can upload saved exams to your PC. (Refer to the ScanPoint with QuickPrint User’s Manual for more information).

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BVM 9500 BVIImportant 9600 Important Information Information

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.

Cleaning and Maintenance To clean the BladderScan BVM 9500:

IMPORTANT!

1.

Use a soft cloth dampened with isopropyl alcohol (or an appropriate hospital cleaning agent) to wipe the Probe until it is thoroughly cleaned.

2.

If you use a detergent solution to clean the instrument, remove all residual detergent. Dry the instrument with a clean, soft cloth.

3.

Alternatively, dampen a soft cloth in any glutaraldehyde-based hospital disinfectant solution such as Cidex® or Cidex 7® from Advanced Sterilization Products, or Sporocidin® from Sporocidin International. Wipe the instrument with the dampened cloth.

4.

To remove all traces of disinfectant solution, wipe the instrument with a clean soft cloth dampened in sterile water or potable tap water. 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.

Failure to heed the following warnings may cause device damage not covered by the BladderScan BVM 9500 warranty.

•

Do not immerse the instrument in disinfectant solution.

•

Do not use CidexPlus® to disinfect the instrument. CidexPlus® will damage the plastic enclosure.

•

Do not subject any part of the instrument to steam sterilization or ethylene oxide sterilization.

Regular Inspections and Maintenance Verathon Medical recommends that the BVM 9500 be certified by an authorized BladderScan Service Center once a year. Certification service includes comprehensive inspection and testing of the instrument to ensure accurate performance in clinical use.

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BVM 9500 BVI Important 9600 Important Information Information

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.

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.

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.

Calibrating the BladderScan BVM 9500 Using the ScanPoint System You must periodically calibrate your BladderScan BVM 9500 to make sure your instrument is providing the most accurate results. Calibration ensures accurate and proper alignment of the instrument’s internal coordinate system. If you do not perform the calibration by the prescribed date, the instrument can still be used to take scans but measurements may be compromised. When calibration is due, a warning appears in the display header.

Device Repair The BladderScan BVM 9500, Probe, and Battery Charger/Wireless Hub are completely sealed. There are no user-serviceable components. Verathon does not make available any type of circuit diagrams, component parts lists, descriptions, or other information that would be required for repairing the device and related accessories. Premium Warranty customers have access to a loaner unit and free shipping options which vary according to plan. If you have any questions, contact your local Verathon Medical representative or the Verathon Medical Customer Care Department at 1.800.331.2313.

Unit Disposal The BladderScan BVM 9500 and related devices may contain lead, mineral oils, batteries, and other environmentally hazardous materials. When the BladderScan BVM 9500 has reached the end of its useful service life, return the device, Battery Charger/Wireless Hub, and related accessories to a Verathon

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BVM 9500 BVIImportant 9600 Important Information Information

Service Center for proper disposal. Alternatively, follow your local protocols for hazardous waste disposal.

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).

Protection Class II equipment, internally powered equipment.

Type BF applied part with EN/IEC-60601-1.

CE marked in accordance with the Medical Device Directive (MDD).

Canadian Standards Association (CSA) mark of certification to United States standards for electromedical equipment.

This unit is powered by a Lithium-Ion battery pack. The Verathon part number for the batter pack is 0400-0066.

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BladderScan® BVM 9500 Bladder Volume and Mass Instrument

User’s Manual CAUTION: In the United States, federal law restricts this device to use by or on the order of a physician.

BladderScan® BVM 9500

Table of Contents

Table of Contents Statement From the CEO...7 Important Information...8 Product Description... 8 Intended Use Warnings and Cautions... 9 Biological Safety...9 Statement of Prescription...9 Statement of Intended Use...9 Contraindications...9 Cautions and Warnings...9 Bluetooth® Wireless Technology...12 Introducing the BladderScan BVM 9500...13 BladderScan Parts and Features...13 Probe Components...14 Console Components...14 Battery Charger/Wireless Hub... 15 Parts and Accessories... 16 Getting Started...17 Unpack the Box and Check the Components...17 Charge the Batteries...17 Install a Battery Pack in the Console...18 Battery Care...18 Enter the Clinic Name...19 Set the Date and Time...20 Setting General Preferences and Savings Preferences...21 Load a Roll of Thermal Paper...22 Assemble the Medical Cart (Optional)...23 Medical Cart Parts List...23 Install the BladderScan BVM 9500 on the Medical Cart (Optional)...25 Install the ScanPoint® with QuickPrint Software (Optional)...26 Watch the Training Video...26 Displays, Controls, and Indicators...27 Console Displays and Button Functions...27 Battery Status Indicator...27

User’s Manual

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Table of Contents

BladderScan® BVM 9500

Home Screen...27 Scan Screen...29 Results Screen...29 Review Screen...31 Tutorial Screen...33 Video Viewing Screen...34 Settings Screen...35 Alpha-Numeric Screen...37 Date & Time Screen...38 General Preferences Screen...39 Savings Preferences Screen...42 Self-Test Screen...43 ScanPoint® Screen...44 Sleep Mode... 44 Memory Optimization During Power Down... 45 Measuring Bladder Volume and Ultrasound Estimated Bladder Weight (UEBW)...46 Preparing for the Exam... 46 Measuring Bladder Volume and UEBW... 47 Additional Scanning Tips... 54 Recording a Voice Annotation... 54 Deleting a Saved Exam... 56 Printing...56 Adding Additional Information...56 Histogram of Cost Savings...57 Cleaning and Maintenance...58 Cleaning the BladderScan BVM 9500...58 Regular Inspections and Maintenance...58 Weekly Inspections...59 Using the Built-in Self-Test Utility...59 Calibrating the BladderScan BVM 9500 Using ScanPoint Technology...59 Self-Calibration...60 Device Repair...60 Unit Disposal...60 Troubleshooting...61 Help Resources...61

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User’s Manual