BladderScan® Bladder Volume Instruments
User’s Manual
For:
BladderScan BVI 6100 Bladder Volume Instrument
BladderScan BVI 6400 Bladder Volume Instrument
CAUTION: In the United States, federal law restricts this device to use by or on the order of a physician.
User’s Manual |
page 1 |
Copyright © 2008, 2011 by Verathon Inc. No part of this User’s Manual may be copied or transmitted by any method without the express written consent of Verathon Inc.
BladderScan, the BladderScan symbol, ScanPoint, Sontac, Vmode, Verathon, the Verathon Torch Symbol, and Total Reliability Plan are trademarks of Verathon Inc.
Cidex® is a registered trademark of Advanced Sterilization Products. Sporocidin® is a registered trademark of Sporocidin International.
Microsoft® and Windows® are registered trademarks of Microsoft Corporation in the United States and/or other countries.
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 and 6,884,217. The ScanPoint® technology described in this manual is protected by U.S. Patent Number 6,569,097. Other 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 verathon.com. Examples described or illustrated in the User’s Manual are fictitious and do not in any way represent real patient or exam data.
Corporate Headquarters |
Verathon Medical (Europe) B.V. |
||
20001 North Creek Parkway |
EC |
REP |
|
Bothell, WA 98011 |
Linnaeusweg 11 |
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USA |
3401 MS IJsselstein |
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800.331.2313 (US and Canada only) |
The Netherlands |
||
425.867.1348 |
+31.30.68.70.570 |
||
Fax: 425.883.2896 |
Fax: +31.30.68.70.512 |
||
PN: 0900-1236-02-60
page 2 |
User’s Manual |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Table of Contents |
Table of Contents |
|
Table of Figures........................................................................................................................................... |
5 |
Statement from the CEO............................................................................................................................. |
6 |
Important Information................................................................................................................................. |
7 |
Product Description....................................................................................................................................... |
7 |
Intended Use Warnings and Cautions.......................................................................................................... |
7 |
Biological Safety............................................................................................................................................ |
7 |
Statement of Prescription....................................................................................................................... |
7 |
Statement of Intended Use.................................................................................................................... |
8 |
Contraindications................................................................................................................................... |
8 |
Introducing the BladderScan® BVI 6000 Series Instruments................................................................ |
10 |
Product Description................................................................................................................................. |
10 |
BladderScan Bladder Volume Instruments.............................................................................................. |
11 |
Optional ScanPoint® Image Management Technology............................................................................ |
12 |
Getting Started.......................................................................................................................................... |
14 |
Unpack the Box and Check the Components.......................................................................................... |
14 |
Optional Accessories............................................................................................................................... |
16 |
BladderScan Controls and Features....................................................................................................... |
17 |
Charging the BladderScan Instrument.................................................................................................... |
19 |
Battery Power Status Icons.................................................................................................................. |
19 |
Battery Charging Notes........................................................................................................................ |
20 |
Installing ScanPoint Image Management Technology............................................................................. |
20 |
Measuring Bladder Volume...................................................................................................................... |
21 |
Preparing for the Exam............................................................................................................................ |
21 |
Measuring Bladder Volume..................................................................................................................... |
22 |
Additional Scanning Tips......................................................................................................................... |
26 |
User’s Manual |
page 3 |
Table of Contents |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Cleaning and Maintenance....................................................................................................................... |
28 |
Cleaning and Disinfecting the BladderScan® Instrument......................................................................... |
28 |
Regular Inspections and Maintenance.................................................................................................... |
28 |
Calibrating the BladderScan Instrument.................................................................................................. |
29 |
Displaying the Days Remaining Until Calibration................................................................................. |
29 |
Device Repair and/or Replacement......................................................................................................... |
30 |
Battery Replacement............................................................................................................................... |
30 |
Unit Disposal........................................................................................................................................... |
31 |
Troubleshooting........................................................................................................................................ |
32 |
Help Resources....................................................................................................................................... |
32 |
Common Problems.................................................................................................................................. |
33 |
Warranty..................................................................................................................................................... |
35 |
Disclaimer of Additional Warranties......................................................................................................... |
35 |
Contacting Verathon®............................................................................................................................... |
36 |
Safety and Performance Summary.......................................................................................................... |
37 |
Parts and Accessories.............................................................................................................................. |
38 |
BladderScan System Components (BVI 6100 and BVI 6400)................................................................. |
38 |
Product Specifications............................................................................................................................. |
40 |
Symbol Directory..................................................................................................................................... |
40 |
Standards and Regulations Compliance................................................................................................. |
41 |
Electromagnetic Effects....................................................................................................................... |
41 |
BladderScan Instrument Specifications................................................................................................... |
42 |
Storage Conditions.................................................................................................................................. |
43 |
Charging Cradle Specifications............................................................................................................... |
43 |
Glossary..................................................................................................................................................... |
44 |
page 4 |
User’s Manual |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Table of Figures |
Table of Figures |
|
Figure 1. BladderScan® Report for a Physician’s Office............................................................................. |
12 |
Figure 2. BladderScan Instrument Parts..................................................................................................... |
17 |
Figure 3. Calibration Required Display....................................................................................................... |
29 |
Figure 4. BVI 6000 series instrument with replaceable battery................................................................... |
30 |
Table of Tables |
|
Table 1. BladderScan Controls and Features............................................................................................. |
17 |
Table 2. Display Icons................................................................................................................................. |
18 |
Table 3. Battery Status Icons...................................................................................................................... |
19 |
Table 4. Typical Scanning Scenarios and Displays..................................................................................... |
27 |
Table 5. Troubleshooting Help Resources.................................................................................................. |
32 |
Table 6. Common Problems and Solutions................................................................................................. |
33 |
Table 7. Contacting Verathon®.................................................................................................................... |
36 |
Table 8. Included Items............................................................................................................................... |
38 |
Table 9. Optional Items............................................................................................................................... |
38 |
Table 10. Symbol Directory......................................................................................................................... |
40 |
Table 11. Standards and Regulations Compliance..................................................................................... |
41 |
Table 12. BladderScan Instrument Specifications....................................................................................... |
42 |
Table 13. BladderScan BVI 6000 Series Storage Conditions..................................................................... |
43 |
Table 14. Charging Cradle Specifications................................................................................................... |
43 |
Table 15. Charging Cradle Storage Conditions........................................................................................... |
43 |
Table 16. Glossary...................................................................................................................................... |
44 |
User’s Manual |
page 5 |
Statement from the CEO |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Statement from the CEO
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 and Founder
page 6 |
User’s Manual |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Important Information |
Important Information
Product Description
BladderScan® BVI 6000 series bladder volume instruments are wireless, battery-powered, ultrasound instruments that provide a noninvasive measurement of urinary bladder volume.
During each scan, BladderScan instruments employ patented Vmode® technology to create a three-dimensional image of the bladder. BladderScan instruments automatically calculate and display measurements based upon this image. Vmode measurements tend to be more accurate than those obtained from conventional two-dimensional ultrasound, as they are based on a more complete, multi-faceted image of the bladder.
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.
Intended Use Warnings and Cautions
All users must read this entire User’s Manual prior to using the BladderScan instrument. 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 verathon.com.
BladderScan instruments should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care.
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 BladderScan BVI 6000 series instruments is not user adjustable and is limited to the minimum level necessary for effective performance. Data on acoustic output levels can be found in Product Specifications beginning on page 40 of this manual.
Statement of Prescription
United States federal law restricts BladderScan BVI 6000 series instruments 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 a BladderScan instrument within its intended use throughout an institution. Individual prescriptions for use are not required.
User’s Manual |
page 7 |
Important Information |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Statement of Intended Use
BladderScan® bladder volume instruments project ultrasound energy through the lower abdomen of the patient to obtain an image of the bladder which is used to noninvasively measure urinary bladder volume.
Contraindications
BladderScan instruments are not intended for fetal use or for use on pregnant patients.
Cautions and Warnings
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 instrument in the presence of flammable anesthetics, the hazard of potential explosion exists.
Warning! Risk of explosion, fire, or serious injury.
The BladderScan BVI 6100/6400 is provided with an internal lithium-ion battery. 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, 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 instrument 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
BladderScan Instrument Specifications beginning on page 42 of this manual.
CAUTION: Items Affecting Accuracy of Results.
When using the BladderScan BVI 6100/6400 be aware of the following conditions which can affect ultrasound transmission and decrease 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 BVI 6100/6400 on patients with open skin or wounds in the suprapubic region.
Do not use the BVI 6100/6400 on patients 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.
page 8 |
User’s Manual |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Important Information |
CAUTION: Observe the following precautions in the safe use and care of the BladderScan® instrument.
Hazardous materials present. Assure proper disposal.
The BladderScan instrument and related devices may contain lead, mineral oils, batteries, and other environmentally hazardous materials. When the BladderScan instrument 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 instrument with optional ScanPoint® image management technology, 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 instrument 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.
The BladderScan instrument, accessories, and computer used to access online ScanPoint image archive (if needed) must be placed 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.
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.
User’s Manual |
page 9 |
Introducing the BladderScan Bladder Volume Instruments
Introducing the BladderScan Bladder Volume Instruments
Product Description
The BladderScan® BVI 6100/6400 are portable ultrasound instruments that measure bladder volume. Using patented Vmode® technology, BladderScan BVI 6000 series instruments provide a noninvasive measurement of urinary bladder volume.
The BVI 6100/6400 consists of an ergonomic, battery-powered, handheld probe that scans the patient’s bladder. The LCD display provides aiming assistance and displays an array of bladder measurement information.
BladderScan instruments are quick, accurate, reliable, and easy to use. When the user releases the scan button, within seconds, the BladderScan instrument measures ultrasonic reflections on multiple planes inside the body and produces a threedimensional image. Based on this image, the BladderScan instrument calculates and displays the bladder volume. A sonographer is not required.
Volume measurements made with Vmode ultrasound are more accurate than those from conventional ultrasound, as they are based on a more complex, 3D image of the bladder.
The BladderScan BVI 6400 includes an integrated microphone for recording voice annotations.Voice annotation allows up to 10 exams to be stored on the instrument.
page 10 |
User’s Manual |
Introducing the BladderScan Bladder Volume Instruments
BladderScan Bladder Volume Instruments
BladderScan BVI 6100
PN: 0570-0154
The handheld, portable BladderScan® BVI 6100:
Measures bladder volume noninvasively.
Provides fast, accurate and reliable results.
Takes scans quickly providing test results in a matter of seconds.
Is easy to operate: staff members can easily learn to scan patients quickly and accurately.
Allows for exam results and images to be downloaded, viewed and printed using the optional ScanPoint® image management technology.
Is battery-operated, lightweight, and portable.
BladderScan BVI 6400
PN: 0570-0167
The handheld, portable BladderScan BVI 6400:
Measures bladder volume noninvasively.
Provides fast, accurate, and reliable results.
Takes scans quickly providing test results in a matter of seconds.
Is easy to operate: staff members can easily learn to scan patients quickly and accurately.
Provides the capability to voice annotate each exam (10 seconds to record patient ID and relevant exam information) ensuring that valuable patient and exam data is retained.
Stores voice annotated data for up to ten exams.
Improves efficiency of healthcare professionals who examine multiple patients on their rounds.
Allows for exam results and images to be downloaded, viewed, and printed using the optional ScanPoint technology.
Is battery-operated and easy to use.
User’s Manual |
page 11 |
Introducing the BladderScan Bladder Volume Instruments
Optional ScanPoint Image Management Technology
Bladder volume measurements and ultrasound images may be transmitted from your device to ScanPoint® image management software. ScanPoint software installs on a Windows®-based computer and allows viewing, printing, and archiving of patient exam results including ultrasound images for patient records and reimbursement (when applicable). Exam data and ultrasound images may be printed in a variety of report formats from adhesive labels that may be affixed to patient charts, to full letter-size formats. Figure 1 shows an example of a ScanPoint report.
Figure 1. BladderScan Report for a Physician’s Office
CAUTION:
ScanPoint can also be used to calibrate your BladderScan instrument. The ScanPoint image management technology (ScanPoint software, license, and accessories) is available with the purchase of any BladderScan instrument. Comprehensive service and warranty are provided under the ScanPoint Total ReliabilitySM Plan. For details, please contact your local Verathon Medical representative at 1.800.331.2313.
page 12 |
User’s Manual |
Introducing the BladderScan Bladder Volume Instruments
ScanPoint® Local Client (LC) is a stand-alone, non-networked version of the software. It is available for use with the BVI 6100, BVI 6400, BVI 9400, and FloPoint® Elite products.
ScanPoint with QuickPrint is a network-based version of the application. Archived patient data is stored securely on HIPAA-compliant, Verathon®- maintained servers. Users can access records from any Internet-enabled Windows®-based PC. ScanPoint with QuickPrint allows users to maintain the most recent software for their devices, to calibrate their devices themselves without having to send them in for service, and also enables remote diagnostics and troubleshooting by Verathon service technicians.
ScanPoint with QuickPrint is available for use with Verathon BladderScan® BVI 6000 series, BVI 9000 series, and FloPoint Elite products.
User’s Manual |
page 13 |
Getting Started |
BladderScan BVI 6000 Series Bladder Volume Instruments |
Getting Started
To get up and running as quickly as possible, follow this sequence:
Unpack the BladderScan® instrument and related accessories.
Charge the device in the Charging Cradle. (Instructions begin on page 19)
Install optional items as desired (ScanPoint® software and ScanPoint Label Writer)
Unpack the Box and Check the Components
Set the shipping container right side up and carefully open the top flaps (do not insert anything sharp through the top of the box). Remove the contents and verify that you have received everything listed below. If anything is missing or damaged, notify your authorized Verathon Medical representative or the Verathon Medical Customer Care Department at 1.800.331.2313.
Part and Part Number |
Name and Description |
|
BladderScan BVI 6100 or BVI 6400: |
|
Handheld, wireless, battery-operated, ultrasound |
|
bladder volume instrument. |
0570-0154 (BVI 6100)
0570-0167 (BVI 6400)
Charging Cradle: Use the Charging Cradle to charge the BladderScan instrument’s internal battery. The Charging Cradle plugs directly into an electrical wall outlet. Before using your BladderScan device you must charge it for a minimum of six hours.
0270-0234
page 14 |
User’s Manual |
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