Operations and Maintenance Manual
75 Pages
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BLADDERSCAN
BVM 9500 Operations & Maintenance Manual
BLADDERSCAN
BVM 9500 Operations & Maintenance Manual Effective: February 23, 2016
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
CONTACT INFORMATION To obtain additional information regarding your BladderScan system, please contact Verathon® Customer Care or visit verathon.com/support.
Verathon Inc. 20001 North Creek Parkway Bothell, WA 98011 U.S.A. 800.331.2313 (US and Canada only) 425.867.1348 Fax: 425.883.2896 verathon.com
Verathon Medical (Europe) B.V. Willem Fenengastraat 13 1096 BL Amsterdam The Netherlands Tel: +31 (0) 20 210 30 91 Fax: +31 (0) 20 210 30 92 verathon.com
0123 Copyright 2009, 2016 Verathon Inc. 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, ScanPoint, and NeuralHarmonics are trademarks or registered trademarks, and Total Reliability Plan is a service mark of Verathon Inc. 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 documentation available at verathon.com/product‑documentation.
TABLE OF CONTENTS IMPORTANT INFORMATION...1 Overview...1 Product Description...1 Notice to All Users...1 Statement of Prescription...2 Statement of Intended Use...2 Safety Information...2 Safety & Performance Summary...2 Biological Safety...2 Contraindications...2 Cautions & Warnings...2 INTRODUCTION...5 Parts & Features...5 Probe Components...6 Console Components...6 Battery Charger/Wireless Hub...7 Components & Accessories...8 Icons & Buttons...9 Battery Status Indicator...9 Instrument Buttons...9 Display Screens... 12 Sleep Mode...29 Memory Optimization During Power Down...30
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SETTING UP...31 Procedure 1.
Unpack the Box & Check the Components... 31
Procedure 2.
Charge the Batteries...32
Procedure 3.
Install a Battery Pack in the Console...32
Procedure 4. Enter the Clinic Name...33 Procedure 5.
Set the Date & Time...35
Procedure 6. Load a Roll of Thermal Paper...36 Procedure 7.
Assemble the Medical Cart (Optional)... 37
Procedure 8. Install the ScanPoint with QuickPrint Software (Optional)...39 Procedure 9.
Watch the Training Video...39
USING THE INSTRUMENT...40 Procedure 1.
Prepare for the Exam...40
Procedure 2.
Measure Bladder Volume & UEBW... 41
Procedure 3.
Record a Voice Annotation...49
Procedure 4. Delete a Saved Exam...50 Procedure 5.
Print an Exam... 51
HISTOGRAM OF COST SAVINGS...52 CLEANING & MAINTENANCE...53 Procedure 1.
Clean the Instrument...53
Procedure 2.
Regular Inspections & Maintenance...54
Procedure 3.
Run a Self‑Test...54
Procedure 4. Calibrate the Instrument...55 Device Repair...55 Unit Disposal...55
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TROUBLESHOOTING...56 Help Resources...56 Icons on the BladderScan Console...57 Diagnosing Problems...57 Instrument Does Not Turn On...57 Printer Problems...58 Factory Reset...59 Procedure 1.
Restore Factory Configuration...59
WARRANTY...60 Disclaimer of Additional Warranties...60 PRODUCT SPECIFICATIONS... 61 Instrument Specifications... 61 Accuracy Specifications...62 Operating Conditions...62 Storage Conditions...62 Battery Charger/Wireless Hub Specifications...63 Storage Conditions...63 Battery Specifications...64 Electromagnetic Effects...64 SYMBOL DIRECTORY...65 GLOSSARY...66
iii Operations & Maintenance Manual: Table of Contents
IMPORTANT INFORMATION OVERVIEW PRODUCT DESCRIPTION The BladderScan BVM 9500 is a portable ultrasound instrument that provides noninvasive measurements of urinary bladder volume, bladder wall thickness and Ultrasound‑Estimated Bladder Weight (UEBW). 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. The BladderScan BVM 9500 is noninvasive and comfortable for the patient. It is quick, accurate, reliable, and easy to use. When the user releases the scan button, within seconds, the BVM 9500 measures ultrasonic reflections on multiple planes inside the body and produces a three‑dimensional image. Based on this image, the BladderScan BVM 9500 calculates and displays the bladder volume, bladder wall thickness and UEBW. A sonographer is not required. NeuralHarmonics® technology in the BVM 9500, sharpens accuracy and accelerates speed of bladder volume 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. If needed, after a scan has been taken, a unique aiming icon guides the operator to optimal probe placement with a comprehensive 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. BladderScan BVM 9500 measurements can be printed via an onboard printer or transmitted using HIPAA‑compliant ScanPoint® image management technology for storage and archiving on Verathon® servers. Stored exams can be accessed at any time from your office's computer or viewing or printing. Note: Use of ScanPoint software is optional.) Exam results may also be transmitted to a 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. A Calibration Targeting System, consisting of a spiral‑shaped calibration target along with a special calibration container, allows the user to easily calibrate the device by scanning a known target. The BladderScan BVM 9500 system also includes a universal battery charger for the custom, user‑replaceable Lithium‑ion battery incorporated in the system. The BladderScan BVM 9500 may be mounted on a wheeled cart which holds the instrument securely and provides a holder for the probe and a bottle of ultrasound gel.
NOTICE TO ALL USERS The system 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 manual prior to using the system. 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.
1 Operations & Maintenance Manual: Important Information
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 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.
SAFETY INFORMATION SAFETY & PERFORMANCE SUMMARY • The BladderScan BVM 9500 computes the volume of the urinary bladder based upon twenty‑four cross‑sectional ultrasound images. • To achieve accurate measurements, have the patient rest quietly in a supine position. • Errors in usage tend to result in the underestimation of bladder volume, except in cases where the probe is moved during scanning. In this case, the measurement may overestimate the patient’s bladder volume. • We recommend that new users measure patients with moderately full bladders rather than initially attempting to locate a bladder with a low urinary volume.
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 system 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 chapter on page 61.
CONTRAINDICATIONS The system is not intended for fetal use or for use on pregnant patients.
CAUTIONS & WARNINGS Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of the device. Cautions indicate that use or misuse of the device may cause a problem, such as a malfunction, failure, or damage to the product. Throughout the manual, pay attention to sections labeled Important, as these contain reminders or summaries of the following cautions as they apply to a specific component or use situation. Please heed the following warnings and cautions. PRECAUTIONS CAUTION If your BladderScan BVM 9500 suffers from a configuration loss and displays the Home screen for a BladderScan BVI 9400 instrument, complete the Restore Factory Configuration procedure on page 59.
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CAUTION 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® representative, or Verathon Customer Care.
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.
CAUTION Hazardous materials present. Ensure 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.
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 BVM 9500 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 instrument and ScanPoint® host computer to an area away from the 2.4 GHz wireless LAN devices (40 meters/44 yards, or more). WARNINGS 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 BVM 9500 is not user‑adjustable and is limited to the minimum level necessary for effective performance. For more information about the acoustic output levels of this device, please refer to the section Instrument Specifications on page 61.
3 Operations & Maintenance Manual: Important Information
WARNING Risk of inaccurate measurements/results. When using the BladderScan BVM 9500 be aware of the following conditions which can affect ultrasound transmission and the accuracy of exam results. • Use care when scanning patients who have had supra‑pubic or pelvic surgery. Scar tissue, surgical incisions, sutures, and staples can affect ultrasound transmission and accuracy. • Do not use the BladderScan BVM 9500 on a patient with open skin or wounds in the suprapubic region or mid‑abdominal area. • 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.
WARNING Ensure proper distance from patient. When transmitting data to or from your computer, make sure the BladderScan BVM 9500, accessories, and computer are outside the patient vicinity (more than six feet [2 meters] from the patient).
WARNING Risk of explosion. If you use the system in the presence of flammable anesthetics, the hazard of potential explosion exists.
WARNING Risk of explosion, fire, or serious injury. The BladderScan BVM 9500 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. 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.
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INTRODUCTION PARTS & FEATURES The BladderScan BVM 9500 has two main components: the console and the probe. The console and probe are linked by a detachable cable. The BladderScan BVM 9500 controls and indicators are illustrated in Figure 1. Figure 1.
BladderScan BVM 9500 Controls and Indicators
Main Display
Console
Battery Status Indicator
Battery Pack
Printer (behind display) Battery Packs Adjust Volume
5 Variable Function Buttons
Adjust Brightness
Power On/Off Battery charger/ wireless hub Probe (Scan button on hand grip) Aiming Display
Microphone (above display)
5 Operations & Maintenance Manual: Introduction
PROBE COMPONENTS The probe transmits and receives ultrasound waves, automatically moving its internal probe 360º to scan 24 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: Table 1.
Probe Components
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 UEBW 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®‑equipped 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: Table 2.
Console Components
PART NAME
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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.
BATTERY CHARGER/WIRELESS HUB The BladderScan BVM 9500 is powered by a Lithium‑ion (Li‑Ion) battery. The battery charger provided with the system can charge two batteries while simultaneously functioning as the wireless hub linking the BVM 9500 to the ScanPoint® host computer. A battery icon on the instrument display is always present, indicating battery status. The user can change the battery whenever necessary. Removing a discharged battery and replacing it with a fresh battery will not erase any saved exams or user settings. To provide power to the batteries, the battery charger/wireless hub must be plugged into a wall outlet using the power cord provided. Use only the battery charger provided with the BVM 9500. Any other battery charger may damage the battery. The battery charger automatically detects whether a Lithium‑ion battery is being charged. To provide wireless communication between the BVM 9500 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 BVM 9500, regardless of barriers such as walls, ceilings, or windows. Note: Use of ScanPoint with QuickPrint software is optional. Figure 2.
Battery Charger/Wireless Hub
Table 3.
Battery Charger/Wireless Hub Components
PART NAME
PURPOSE
Battery charger/ wireless hub
Charges the lithium‑ion batteries and receives and sends information to/from a BVM 9500 instrument within communication range.
Power adapter and power cord
Connects the battery charger/wireless hub to the wall outlet.
USB cable
Connects the battery charger/wireless hub to the ScanPoint host computer.
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COMPONENTS & ACCESSORIES Table 4.
Components & Accessories DESCRIPTION
BVM 9500 console BVM 9500 probe Battery charger/wireless hub Lithium‑ion battery (2 provided) Thermal Paper Roll for the printer BladderScan BVM 9500 Medical Cart (optional) ScanPoint® with QuickPrint user documentation (optional) Calibration Kit (optional-requires ScanPoint with QuickPrint software. Includes Calibration Container, Calibration Target, etc.) Acoustic Coupling Gel, 0.25 liter (optional) Universal Accessory Basket for Medical Cart (optional)
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ICONS & BUTTONS This section describes BladderScan BVM 9500 displays and button functions. The console display presents information that varies depending on the current instrument function. The functions of the five buttons below the display vary according to current instrument mode and function. Button functions are indicated by icons in the display footer, immediately above the each button.
BATTERY STATUS INDICATOR A battery status indicator appears in the header of all BVM 9500 screens. Depending on current level of battery charge, one of the following symbols will be displayed: Indicates a fully charged battery. Indicates a battery 50% to 75% charged. Indicates a battery 25% to 50% charged. Indicates a battery that is nearly discharged and can power only a few more scans. Indicates the battery must be changed.
INSTRUMENT BUTTONS Power On/Off, Brightness (/), and Volume (/) are located on the lower half of the console. Scan (on the probe). The five buttons below the console LCD have variable functions depending on current instrument mode as follows: Table 5.
Instrument Buttons SCREEN/MODE
ACTIVE BUTTONS
Start up screen Appears when the instrument is first turned on. Home Screen Appears when the instrument is turned on.
Power, Volume, Brightness (1) ‑ (5) No function. Power, Scan: opens Aim/Scan screen, (1) Patient Type: toggle between two bladder volume modes: female with uterus, all other patients, (2) Tutorial: opens Tutorial screen, (3) Settings: opens Settings screen (4) Review: opens the Review screen, (5) ScanPoint®: transmits saved exams to ScanPoint.
Scan Screen:
Power: No function
Appears when the operator presses and releases the Scan button.
Scan: Press to take a scan. Buttons (1) ‑ (5): No action.
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SCREEN/MODE
ACTIVE BUTTONS
Power, Scan: opens Aim/Scan screen: Results Screen Appears when the operator releases the SCAN button (after aiming).
Review Screen Review, replay, print, or delete saved exams. Tutorial Screen View the menu of training modules. Video Viewing Screen The video viewing screen.
(1) Record: press to record voice annotation, press Stop to end voice annotation, (2) Print: print to onboard printer, (3) Play: press to play voice annotation; otherwise, no function, (4) Zoom: Image Zoom screen for manual measurement of bladder wall thickness. (5) Home: return to Home screen. Power, Scan, (1) Next: select next exam in memory, (2) Print: print to on‑board printer, (3) Return/Play: On first Review screen, switches to second screen for additional data (UEBW, Bladder Wall Thickness); On second Review screen, plays voice annotation for currently selected exam, (4) Delete: delete currently selected exam, (5) Home: return to Home screen. Power, (1) Skip to next tutorial, (2) Skip to previous tutorial, (3) Select tutorial for viewing (4) No function, (5) Home (return to Home screen). Power, (1) No function, (2) Play/Pause, (3) Return to Tutorial (4) No function, (5) Home (return to Home screen).
Settings Screen Edit clinic name, date & time, general preferences, savings preferences, and self‑test options.
Power, (1) Select next setting in list, (2) Select previous setting in list, (3) Enter (proceed to the selected screen), (4) No action, (5) Home (return to Home screen).
Alpha‑Numeric Screen Displays alpha‑numeric characters for entering information.
Power, (1) Move down, (2) Move right, (3) Add currently selected character, (4) Delete currently selected character, (5) Return to main setup screen.
Date & Time Screen
Power, (1) Move forward to next changeable unit, (2) Move back to previous changeable unit, (3) Add/toggle units as appropriate (hold down to move faster), (4) Decrease/toggle units as appropriate (hold down to move faster), (5) Save current date/time entries and return to main setup screen.
Allows the user to set the date and time
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SCREEN/MODE
ACTIVE BUTTONS
Power, (1) Select next setting in list, (2) Select previous setting in list, (3) Select next option/Enter, (4) Select previous option, (5) Home (return to Home screen). Preferences list and options: General Preferences Screen Set preferences for language, time and date format, time zone, UTI rate and cost, and currency.
Languages: English (default), Chinese Simplified, Chinese Traditional, Czech, Danish, Dutch, Finnish, French, German, Greek, Hungarian, Italian, Japanese, Korean, Norwegian, Portuguese, Spanish, Swedish, Turkish. Date for yy‑mm‑dd Time Format: 12‑hour, 24‑hour Calibration Warning: On (default), Off. When “On” is selected, a calibration warning will appear in the display header when the device is due for calibration. Print Report Type: B‑Mode (default), C‑Mode Print UEBW: On (default). Off UTI Rate: 1–100 % in increments of 1% UTI Cost: $10–100,000 in increments of $1
Saving Preferences Screen
Catheter Cost: $1–1000 in increments of $1 Catheter Volume: 20–100 mL in increments of 20 mL Currency: $ / € / £ / ¥ Savings Calculation: Since new, Since 1/1/2006, Reset Now, Print Since New, Print Recent, Hide Savings.
Self‑Test Screen
(1) to (4): No function; (5) Return to Settings screen
ScanPoint Screen
(Note: Only available when used with ScanPoint with QuickPrint software.) Power, (1) No function, (2) No function, (3) No function, (4) Cancel, (5) No function.
®
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DISPLAY SCREENS HOME SCREEN The Home screen appears when the BVM 9500 is first powered on. The Home screen serves as a starting point for all of the instrument functions. Press the
button to toggle between Male and Female modes.
The Bladder Volume Mode home screen displays: • A list of saved exam results (10 maximum) saved in chronological order. Yellow folders hold saved exams. Gray folders represent empty spaces still available for saving exam results. • A Cost Saving Summary. Displays the savings to your organization from using the BladderScan. BVM 9500 rather than catheterization. The values used to determine the savings are user‑variable and entered from the Savings Preferences Screen (Refer to page 27 for more information about using this screen). Figure 3.
Home Screen: Bladder Volume Mode Battery Status Indicator
Saved exams (yellow) Available memory for 8 more exams (gray)
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Cost Savings Summary
Table 6.
Home Screen Buttons
BUTTON
FUNCTION
Press to toggle between two possible scan options: Take a bladder volume measurement of a female patient who has not had a hysterectomy. (When the female icon is illuminated, the BVM 9500 will assume the patient has a uterus.) Take a bladder volume measurement of a male patient, or a female patient who has had a hysterectomy. Press to view the training video.
Go to the Settings screen (set the time, date, institution name, and user preferences). Press to review a previously saved exam. (This button will be gray (inactive) if there are no previously saved exams to review.) Press to initiate communication with the ScanPoint® host computer. Saved and annotated exams will be automatically uploaded to the host computer. (ScanPoint software must be previously installed and a connection open. Use of the ScanPoint software is optional.)
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SCAN SCREEN The Scan screen (Figure 4) appears and displays a progressively updating image of the bladder outline. When the ultrasound measurement is complete, the Results screen opens automatically. The five buttons below the display do not function during the scan. Figure 4.
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Scan Screen