BVI 9400 User’s Manual

BladderScan® BVI 9400 Bladder Volume Instrument

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

Copyright © 2008 by Verathon Inc.. All rights reserved. No part of this User’s Manual may be copied or transmitted by any method without the express written consent of Verathon Inc.. ®

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Verathon , Verathon Medical , BladderScan , ScanPoint , Sontac , and NeuralHarmonics™ are either trademarks SM or registered trademarks, and Total Reliability Plan is a service mark of Verathon Inc.. Bluetooth® word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Verathon® is under license. ® Cidex is a registered trademark of Advanced Sterilization Products.

Sporocidin® is a registered trademark of Aporocidin International. All other brand and product names are trademarks or registered trademarks of their respective owners. The BladderScan® technology described in this manual is protected by U.S. Patent Numbers 4,926,871, 5,235,985, 6,676,605, and 6,884,217. The ScanPoint® technology described in this manual is protected by U.S. Patent Number ® 6,569,097. The Sontac ultrasound coupling pad described in this manual is protected by U.S. Patent Number 5,782,767. Other international patents pending. Information in this User’s Manual may change at any time without notice. For the most up-to-date information, see the online manuals at http://www.verathon.com. Examples described or illustrated in this User’s Manual are fictitious and do not in any way represent real patient or exam data.

Corporate Headquarters 20001 North Creek Parkway Bothell, WA 98011 USA 800.331.2313 (US and Canada only) 425.867.1348 Fax: 425.883.2896

Verathon Medical (Europe) B.V. EC REP Boerhaaveweg 1 3401 MN IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512

Verathon Medical (Japan) K.K. Executive Tower Azabudai 7F 1-4-3 Azabudai Minato-ku, Tokyo 106-0041 Japan +81.3.3560.3501 Fax: +81.3.3560.3502

Verathon Medical (France) Postal Address BP 10039 F-67012 Strasbourg Cedex France +33.3.88.60.14.12 Fax: +33.3.88.60.46.87 Office Address: Espace Europeen de l'Entreprise 2 allée d'Oslo 67300 Schiltigheim Verathon Medical (United Kingdom) Ltd. The Granary Manor Farm Courtyard Aston Sandford, Aylesbury Buckinghamshire HP17 8JB United Kingdom +44.1844.299.207 Fax: +44.1844.299.218

PN: 0900-1606-00-60

BladderScan® BVI 9400

User’s Manual

Quick Reference - Use

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Quick Reference - Use

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BladderScan® BVI 9400

User’s Manual

BladderScan® BVI 9400

Quick Reference - Calibration

NOTE: This procedure requires ScanPoint® with QuickPrint Imaging ® Technology Software. If your BladderScan BVI 9400 requires calibration, and you’re not using ScanPoint® with QuickPrint, please ® contact Verathon Technical Support at 1.800.331.2313 (US & Canada) or 425.867.1348 (International).

User’s Manual

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Quick Reference - Calibration

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BladderScan® BVI 9400

User’s Manual

BladderScan® BVI 9400

Table of Contents

Table of Contents Quick Reference... 5 President’s Statement ... 13 Important Information... 14 Product Description ... 14 Intended Use Warnings and Cautions... 14 Biological Safety ... 14 Statement of Prescription... 15 Statement of Intended Use ... 15 Contraindications (U. S. Only) ... 15 Bluetooth® Wireless Technology... 16 Introducing the BladderScan® BVI 9400 ... 17 Product Description ... 17 BladderScan® Parts and Features ... 18 Probe Components ... 19 Console Components ... 19 Battery Charger/Wireless Hub... 20 Parts and Accessories... 21 Getting Started ... 22 Unpack the Box and Check the Components ... 22 Charge the Batteries... 22 Install a Battery Pack in the Console... 23 Battery Care... 23 Enter the Clinic Name... 24 Set the Date and Time... 26 Setting General Preferences and Savings Preferences ... 27 Load a Roll of Thermal Paper ... 27 Assemble the Medical Cart ... 28 Medical Cart Parts List... 28 Install the BladderScan® on the Optional Mobile Cart... 30 Install the ScanPoint® with QuickPrint Software (Optional)... 30 Watch the Training Video ... 31

User’s Manual

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Table of Contents

BladderScan® BVI 9400

Displays, Controls, and Indicators... 32 Console Displays and Button Functions... 32 Home Screen ... 32 Scan Screen ... 34 Results Screen... 34 Review Screen... 36 Tutorial Screen... 37 Video Viewing Screen... 38 Settings Screen... 39 Alpha-Numeric Screen... 40 Date & Time Screen... 41 General Preferences Screen ... 42 Savings Preferences Screen ... 43 Self-Test Screen ... 45 ScanPoint® Screen ... 46 Sleep Mode ... 46 Memory Optimization During Power Down ... 47 Measuring Bladder Volume... 48 Preparing for the Exam... 48 Measuring Bladder Volume ... 49 Additional Scanning Tips ... 52 Recording a Voice Annotation... 52 Deleting a Saved Exam ... 54 Printing... 54 Adding Addition Information... 54 Histogram of Cost Savings ... 55 Cleaning and Maintenance... 56 Cleaning and Disinfecting the BladderScan® BVI 9400 ... 56 Regular Inspections and Maintenance ... 56 Weekly Inspections ... 57 Using the Built-in Self-Test Utility ... 57 Calibrating the BladderScan® BVI 9400 Using the ScanPoint® System ... 57 Self-Calibration ... 58 Device Repair ... 58

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User’s Manual

BladderScan® BVI 9400

Table of Contents

Unit Disposal ... 58 Troubleshooting... 59 Help Resources ... 59 Icons on the BladderScan® Console ... 60 Diagnosing problems... 61 Instrument Does Not Turn On... 61 Printer Problems ... 61 No Paper... 61 Too Hot ... 62 Clearing a Paper Jam ... 62 Warranty... 63 Disclaimer of Additional Warranties ... 63 Contacting Verathon® ...64 Safety and Performance Summary ... 65 Parts and Accessories... 66 BladderScan® BVI 9400 System Components... 66 Product Specifications ... 67 Symbol Directory ... 67 Standards and Regulations Compliance ... 68 Electromagnetic Effects ... 68 BladderScan® BVI 9400 Instrument Specifications ... 69 Ultrasound Output Parameters ... 69 Accuracy Specifications ... 70 BladderScan® BVI 9400 Operating Conditions... 70 BladderScan® BVI 9400 Storage Conditions ... 70 BladderScan® BVI 9400 Displays, Controls, and Indicators ... 71 Instrument Buttons... 71 Instrument Display ... 73 Battery Charger/Wireless Hub Specifications ... 74 Operating Conditions ... 74 Storage Conditions ... 75 Battery Specifications ... 75 Glossary ... 76

User’s Manual

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Table of Figures

BladderScan® BVI 9400

Table of Figures Figure 1. BladderScan® BVI 9400 Controls and Indicators ... 18 Figure 2. Battery Charger/Wireless Hub ... 20 Figure 3. Home Screen ... 24 Figure 4. Settings Screen... 24 Figure 5. Alpha-Numeric Screen... 25 Figure 6. Facility Name in Display Header... 25 Figure 7. Set Up Screen - Date and Time... 26 Figure 8. Date and Time Screen... 26 Figure 9. Medical Cart, PN: 0800-0322 ... 28 Figure 10. Medical Cart Assembly ... 29 Figure 11. Attaching the BVI 9400 to the Medical Cart... 30 Figure 12. Home Screen ... 33 Figure 13. Scan Screen ... 34 Figure 14. Results Screen... 35 Figure 15. Review Screen... 36 Figure 16. Tutorial Screen... 37 Figure 17. Video Viewing Screen... 38 Figure 18. Settings Screen Start Menu... 39 Figure 19. Alpha-Numeric Screen... 40 Figure 20. Date & Time Screen ... 41 Figure 21. General Preferences Screen ... 43 Figure 22. Savings Preference Screen ... 44 Figure 23. Self-Test Screen ... 45 Figure 24. ScanPoint® Screens... 46 Figure 25. Sleep Mode Screen ... 47 Figure 26. Memory Optimization Alert ... 47 Figure 27. Exam Results Printout Using the Onboard Printer ... 54 Figure 28. Calibration Warning ... 58 Figure 29. Printer Out of Paper Screen ... 62

User’s Manual

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BladderScan® BVI 9400

President’s Statement

President’s Statement President’s Statement The team at Verathon® is committed to improving health care delivery by putting healthcare providers and their patients first. Our products support you, the health care provider, by consistently offering accuracy, utility, reliability and excellence. Please contact us directly at 1.800.331.2313 (USA and Canada only) or 1.425.867.1348, if we can improve our service to you. Sincerely,

Gerald McMorrow Gerald McMorrow, CEO, Founder and Chairman of the Board

User’s Manual

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Important Information

BladderScan® BVI 9400

Important Information Important Information Product Description BladderScan® instruments are the gold standard in bladder volume measurement. The BladderScan® BVI 9400, with patented NeuralHarmonics™ technology, is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient’s bladder, and a compact, battery-operated console that provides an array of measurement-related information. BladderScan® is noninvasive and comfortable for the patient. It is accurate, reliable, quick and easy to use. When the user releases the scan button, within seconds, BladderScan® measures ultrasonic reflections on multiple planes inside the body and produces a threedimensional image. Based on this image, the BladderScan® BVI 9400 calculates and displays the bladder volume. A sonographer is not required. Patented NeuralHarmonics™ technology (abbreviated from “neural network harmonics”) in the BVI 9400, sharpens accuracy and accelerates speed of measurement. Volume measurements made with NeuralHarmonics™ technology are more accurate than those from conventional two-dimensional ultrasound, as they are based on a more complex, multifaceted image of the bladder. This technology, applying multi-spectral analysis to a robust data set, helps reduce margin of error and minimize uncertainty in essential measurements of bladder function. BladderScan® BVI 9400 measurements can be printed via an onboard printer or transmitted, using HIPAA-compliant ScanPoint® with QuickPrint Imaging Technology Software (optional), to your office or facility computer for viewing, printing, or archiving.

Intended Use Warnings and Cautions The BladderScan® BVI 9400 should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care. All users must read this entire User’s Manual prior to using the BladderScan® BVI 9400. Do not attempt to operate this instrument until you thoroughly understand all instructions and procedures in this manual. Failure to comply with these instructions may compromise the performance of the device and the reliability of its measurements. For the most current version of the User’s Manual, please visit the Verathon® Web site at: http://www.verathon.com, then select the BladderScan® > Customer Support links to open a link to this manual and other training materials. 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 “Technical Description” section of this manual.

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User’s Manual

BladderScan® BVI 9400

Important Information

Statement of Prescription United States federal law restricts the BladderScan® BVI 9400 to use by, or on the order of, a physician. This statement is required per 21 Code of Federal Regulations (CFR) 801.109. NOTE: It is standard practice to have medical staff authorize the use of the BladderScan® BVI 9400 within its intended use throughout an institution. Individual prescriptions for use are not required. Statement of Intended Use The BladderScan® BVI 9400 projects ultrasound energy through the lower abdomen of the patient to obtain an image of the bladder which is used to calculate bladder volume noninvasively. Contraindications (U. S. Only) The BladderScan® BVI 9400 is not intended for fetal use or for use on pregnant patients. To assure safe and reliable operation for the use and the patient, please read and heed the following warnings and cautions. WARNING! Risk of explosion. If you use the BladderScan® BVI 9400 in the presence of flammable anesthetics, the hazard of potential explosion exists. WARNING! Risk of explosion, fire, or serious injury. The BladderScan® BVI 9400 is provided with two Lithium Ion batteries. Never short circuit the battery pack by either accidentally or intentionally bringing the battery terminals into contact with any other conductive object. This could cause serious injury or fire and could also damage the battery pack and the BladderScan® device. WARNING! Risk of explosion, fire, or serious injury. Never expose the battery pack to abnormal shock, vibration, or pressure. The main battery pack’s internal protective covering could fail, causing it to overheat or ignite, resulting in caustic liquid leakage, or explosion or fire, possibly resulting in serious injury. WARNING! Potential patient hazard. To date, exposure to low-power, pulsed diagnostic ultrasound has not been shown to produce adverse effects. However, medical professionals should use ultrasound only when clinically indicated, using the lowest exposure times possible to obtain accurate measurements. The ultrasonic output of the BladderScan® BVI 9400 is not useradjustable and is limited to the minimum level necessary for effective performance. For more information about the acoustic output levels of this device, please refer to the section in this manual titled BladderScan® BVI 9400 Instrument Specifications on page 69.

CAUTION: Risk of inaccurate measurements/results. When using the BladderScan® BVI 9400 be aware of the following conditions which can affect ultrasound transmission and decrease the accuracy of exam results. Š

User’s Manual

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.

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Important Information

BladderScan® BVI 9400

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Do not use the BladderScan® BVI 9400 on a patient with open skin or wounds in the suprapubic region.

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Do not use the BladderScan® BVI 9400 on a patient with ascites.

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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: Observe the following precautions in the safe use and care of the BladderScan® BVI 9400. Hazardous materials present. Assure proper disposal. The BladderScan® BVI 9400 and related devices may contain lead, mineral oils, batteries, and other environmentally hazardous materials. When the BladderScan® BVI 9400 has reached the end of its useful service life, return the device, charging cradle, and related accessories to a Verathon® Service Center for proper disposal. Alternatively, follow your local protocols for hazardous waste disposal. Assure proper computer system configuration. When using the BladderScan® BVI 9400 with optional ScanPoint® software, your computer must be minimally certified to EN / IEC / CSA / UL 60950 or 60101-1 standards. This configuration ensures that compliance to the EN/IEC 60601-1-1 system standard is maintained. Anyone connecting additional equipment to the BladderScan® BVI 9400 signal input port or signal output port configures a medical system, and is therefore responsible for ensuring that the system complies with EN/IEC 60601-1-1. If you need assistance, contact your biomedical staff, Verathon Medical® representative, or the Verathon Medical® Customer Care Department at 1.800.331.2313. Assure proper distance from patient. When transmitting data to or from you computer, make sure that the BladderScan® BVI 9400, accessories, and computer are outside the patient vicinity (more than six feet (2 meters) from the patient). Refer to UL 2601-1 Clause 2 deviation for the definition of patient vicinity. Bluetooth® Wireless Technology The Bluetooth technology used in the BladderScan® BVI 9400 is compliant with: Š

Bluetooth Specification as defined and approved by The Bluetooth Special Interests Group.

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Logo certification with Bluetooth wireless technology as defined by The Bluetooth Special Interest Group.

CAUTION: 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 loose your network connection. If this happens, you may need to move the BladderScan® and ScanPoint® host computer to an area away from the 2.4 GHz wireless LAN devices (40 meters/44 yards, or more).

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User’s Manual

BladderScan® BVI 9400

Introducing the BladderScan® BVI 9400

Introducing the BladderScan® BVI 9400 Introducing the BladderScan® BVI 9400 Product Description BladderScan® instruments are the gold standard in bladder volume measurement. The BladderScan® BVI 9400, with patented NeuralHarmonics™ technology, is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient’s bladder, and a compact, battery-operated console that provides an array of measurement-related information. BladderScan® is noninvasive and comfortable for the patient. It is accurate, reliable, quick and easy to use. When the user releases the scan button, within seconds, BladderScan® measures ultrasonic reflections on multiple planes inside the body and produces a threedimensional image. Based on this image, the BladderScan® BVI 9400 calculates and displays the bladder volume. A sonographer is not required. Patented NeuralHarmonics™ technology (abbreviated from “neural network harmonics”) in the BVI 9400, sharpens accuracy and accelerates speed of measurement. Volume measurements made with NeuralHarmonics™ technology are more accurate than those from conventional two-dimensional ultrasound, as they are based on a more complex, multifaceted image of the bladder. This technology, applying multi-spectral analysis to a robust data set, helps reduce margin of error and minimize uncertainty in essential measurements of bladder function. BladderScan® BVI 9400 measurements can be printed via an onboard printer or transmitted using HIPAA-compliant ScanPoint® technology for storage and archiving on Verathon® servers. Stored exams can be accessed at any time from your office’s computer for viewing or printing. (NOTE: Use of ScanPoint® software is optional.) If needed, after a scan has been taken, a unique aiming icon guides the operator to optimal probe placement with a comprehensive, three-dimensional display showing the bladder in two cross-sectional images verifying that a complete scan has been achieved. Bladder volume, patient type, directional aiming with real-time feedback, battery status, and usage rate indicators are all displayed on the device’s LCD screen. The BladderScan® BVI 9400 contains an on-board thermal printer that allows the user to print exam results quickly with the press of a button. A Calibration Targeting System, consisting of a spiral-shaped calibration target along with a purpose-designed calibration container, 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 universal battery charger for the custom, user-replaceable Lithium Ion battery incorporated in the system. The BladderScan® BVI 9400 may be mounted on a purpose-designed cart which holds the instrument securely and provides a holder for ultrasound gel and other accessories.

User’s Manual

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Introducing the BladderScan® BVI 9400

BladderScan® BVI 9400

The BladderScan® BVI 9400 is designed for simple, intuitive operation. However, to ensure safe and effective operation, before using the device: Š

Familiarize yourself with the contents of this manual.

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Watch the training video provided on the instrument.

BladderScan® Parts and Features The BladderScan® BVI 9400 has two main components: The Console and the Probe. The Console and Probe are linked by a detachable cable. The BladderScan® BVI 9400 controls and indicators are illustrated in Figure 1. Figure 1. BladderScan® BVI 9400 Controls and Indicators Console Main display

Battery Status Indicator Printer (behind display)

Battery Pack

Battery Packs

Battery Charger/ Wireless Hub

5 Variable Function Buttons Adjust Brightness Power On/Off Adjust Volume Probe (Scan button on hand grip)

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Aiming Display Microphone (above display)

User’s Manual

BladderScan® BVI 9400

Introducing the BladderScan® BVI 9400

Probe Components The Probe transmits and receives ultrasound waves, automatically moving its internal transducer 360º to scan twelve different planes to produce a three-dimensional image of the bladder. The Probe is attached to the Console by a cable. The Probe has three main features: Part Name

Purpose

SCAN button

Press to take a scan.

Aiming Display

The LCD displays directional arrows to assure that the bladder is centered within the scanning cone.

Microphone

Records voice annotations.

Console Components The Console provides all operating controls for the scanning process by means of five variable function buttons. The measured bladder volume and target-shaped aiming icons are clearly displayed on the LCD screen. The Console also provides controls for adjusting brightness and volume, turning the power on/off, interfacing with a ScanPoint® host computer (optional), and adjusting user settings and preferences. The Console also houses the Battery and the Printer. The Console’s controls and features are described in the following table:

User’s Manual

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

Press to adjust volume up/down on voice annotation playback, start up sound, and “scan complete” tone.

Brightness

Press to adjust display brightness dimmer/brighter.

5 Variable Function Buttons

Depending on device mode, the buttons provide access to all instrument functions for scanning, recording annotations, printing, connecting to ScanPoint® (optional), accessing the training video, and setting user preferences.

Printer / Printer Door

Press to release the Printer door.

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Introducing the BladderScan® BVI 9400

BladderScan® BVI 9400

Battery Charger/Wireless Hub The BladderScan® BVI 9400 is powered by a Lithium Ion (Li-Ion) battery pack. The battery charger provided with your BVI 9400 can charge two Li-Ion battery packs while simultaneously functioning as the wireless hub linking your BVI 9400 to the ScanPoint® host computer. NOTE: Use of ScanPoint® with QuickPrint software is optional. Š

To provide power to the battery packs, the Battery Charger/Wireless Hub must be plugged into a wall outlet using the power cord provided.

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To provide wireless communication between the BVI 9400 and the ScanPoint® host computer, plug the Battery Charger/Wireless Hub USB connector into a USB port on the ScanPoint® host computer.

The Battery Charger/Wireless Hub maintains an operating distance of up to 120 feet (36 meters) between the ScanPoint® computer and the BVI 9400, regardless of barriers such as walls, ceilings, or windows. Figure 2. Battery Charger/Wireless Hub Charging bays for two battery packs

Plug into wall outlet to power the battery charger.

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Plug into a USB port on the ® ScanPoint host computer (optional) to enable a wireless connection with the BVI 9400.

User’s Manual

BladderScan® BVI 9400

Introducing the BladderScan® BVI 9400

Parts and Accessories

User’s Manual

Part Number

Description

0570-0190

BVI 9400 Instrument - Console

0570-0188

BVI 9400 Instrument - Probe

0570-0193

Battery Charger/Wireless Hub

0570-0066

Lithium Ion Battery (2 provided)

0900-1606

BVI 9400 User’s Manual (on In-Service CD)

0900-1601

ScanPoint® with QuickPrint User’s Manual (on In-Service CD)

0900-1446

Quick Reference Card - Demo/Use

0900-1447

Quick Reference Card - Calibration

0800-0319

Thermal Paper Roll for the Printer

0900-1500

BladderScan® BVI 9400 In-Service CD (Includes User’s Manuals, Video Tutorial, and Quick Reference Cards)

0800-0322

Mobile Cart (optional)

0900-1238

ScanPoint® with QuickPrint Software Install CD. NOTE: Use of the ScanPoint® software is optional and not required for operation of the BVI 9400.

0620-0340

Calibration Kit (Optional - Requires ScanPoint® with QuickPrint software. Includes Calibration Container, Calibration Target, etc.)

0800-0225

Sontac® Gel Pads, QTY 50

0800-0005

Acoustic Coupling Gel, 0.25 liter (case of 12)

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