Verathon BVI 3000 User manual

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BladderScan® BVI 3000

Bladder Volume Instrument

Operator’s Manual

BladderScan® BVI 3000

Bladder Volume Instrument

Operator’s Manual

BladderScan, Sontac, and Verathon are trademarks of Verathon Inc. Other products and companies named in this Operator’s Manual may be trademarks of their respective companies.

The BladderScan instrument documented in this manual is protected by U.S. Patent Number 5,235,985. Other international patents pending.

This Operator’s Manual is Verathon Part No. 0900-0383.

Information in this Operator’s Manual may change at any time without notice. Examples described or illustrated in this User’s Guide are ctitious and do not in any way represent real patient or exam data.

Verathon Inc. 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.

Linnaeusweg 11 3401 MS IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512

For additional contact information, please visit our web site at www.verathon.com.

0900-0383-11-60

Table of Contents

Important Information .................................................................................................................6

BladderScan

Description of the BladderScan

BVI 3000 Components ........................................................................................7

BVI 3000 ...............................................................................8

Preparation For Use ....................................................................................................................8

Customizing the BladderScan

Operating the BladderScan

BVI 3000 ................................................................................11

BVI 3000 .....................................................................................13

Verifying Aim ..............................................................................................................................15

Printing Results .........................................................................................................................17

Histogram of Cost Savings .......................................................................................................18

Adding a Patient ID and Notes .................................................................................................19

Print Options ..............................................................................................................................20

Adjusting Preferences ..............................................................................................................21

Additional Features ...................................................................................................................23

Regular Inspections and Maintenance ....................................................................................24

Troubleshooting ........................................................................................................................25

Warranty and Disclaimer Information ......................................................................................26

Contacting Verathon

................................................................................................................27

Safety and Performance Summary ..........................................................................................28

Parts and Accessories ..............................................................................................................29

Technical Description ...............................................................................................................29

Technical Description: Battery Charger ..................................................................................31

Symbol Directory .......................................................................................................................33

Page 5BVI 3000 Operator’s Manual

Important Information

Product Description

Notice to All Operators

Biological Safety

The BladderScan® BVI 3000 is a B-mode ultrasonic instrument, portable and battery operated, intended for the noninvasive measurement of urinary bladder volume. A mechanical sector scanning transducer provides cross-sectional images of the bladder from twelve scan planes. Based on these images, the BladderScan automatically calculates the estimated bladder volume in milliliters and displays it on a screen.

The BladderScan BVI 3000 should be used only by individuals who have been trained and authorized by a physician or the institution providing patient care. All operators should read this manual prior to using the BVI

3000. Failure to comply with these instructions may compromise the performance of the instrument.

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 exposure times possible commensurate with clinical utility.

The ultrasonic output power of the BladderScan BVI 3000 is not useradjustable and is limited to the minimum level necessary for effective performance. Data on acoustic output levels can be found in the section titled “Technical Description,” beginning on page 29.

Statement of Prescription

Statement of Intended Use

Cautions

Caution: United States Federal law restricts this instrument to use by or on the order of a physician.

The BladderScan BVI 3000 projects ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder, which is used to determine bladder volume noninvasively.

Warning: Not intended for fetal use.

Warning: Not intended for use on pregnant patients.

Warning: There is the hazard of possible explosion if the BVI 3000

instrument is used in the presence of ammable anesthetics.

The BVI 3000 should not be used on a patient with open skin or wounds in the suprapubic region.

The patient should not have a catheter in his/her bladder. This could affect the accuracy of the instrument.

Use care with suprapubic/pelvic surgery patients. Scar tissue, incisions, sutures and staples affect ultrasound transmission and reection.

Accuracy may be affected for patients with ascites or free oating uid in the peritoneum.

Page 6 BVI 3000 Operator’s Manual

BladderScan® BVI 3000 Components

Page 7BVI 3000 Operator’s Manual

Description of the BladderScan® BVI 3000

The BladderScan BVI 3000 consists of 4 main components: The Scanhead, Control Unit, Rechargeable Battery, and the Battery Charger.

Scanhead

The scanhead transmits and receives ultrasound, automatically moving its internal transducer 360º to scan twelve planes and produce a three-dimensional image of the urinary bladder. The scanhead is connected to the control unit by means of a cable.

Control Unit

The control unit provides all operating controls for the scanning procedure by means of six soft keys. The measured bladder volume and a target-shaped aiming icon are clearly displayed on the LCD screen, helping the operator to achieve accurate measurement results.

Batteries & Charger

Two NiMH rechargeable batteries are included with the BladderScan BVI 3000. One battery can be recharged in the battery charger while the other is being used to power the BVI 3000. This ensures that there is no instrument downtime. The charger brings the battery to a full charge in 6 hours or less.

(See picture and instructions for charging the battery on the following page.)

Preparation For Use

Connecting the Scanhead

Connect the scanhead to the input socket at the back of the instrument by aligning the tabs on the scanhead plug with the matching slots on the instrument socket. Press the plug straight in until you hear a click.

To remove the plug, grasp the black plastic ring and pull straight out. Do not twist.

Page 8 BVI 3000 Operator’s Manual

Preparation For Use

To charge a battery, plug the charger into an electrical outlet. Remove the label covering the battery contacts and slip the battery into the recess on the top of the 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 battery.

Rechargeable Battery and Battery Charger

Check the color indicator lights on top of the battery charger to determine the battery’s power status while charging.

Solid Green: When the battery is low on charge, charging begins in the fast charge mode. During fast charge mode, the green light is solid. For a fully discharged battery, fast charge mode lasts about two to three hours.

Quickly Blinking Green: When the battery reaches 80% of its charge level, the charger starts to “top off” the charge and the green light blinks quickly. At this point, you can use the battery in the BVI 3000 instrument.

Amber Light: In some cases the charger displays an amber light. The amber light means the battery temperature is stabilizing before recharging can begin. This may occur when the battery is taken from a very cold or warm environment, or if the battery is defective. If the light remains amber for over an hour, the battery is defective and must be replaced.

Charging the

Batteries

Note: Battery life is extended

if you wait for about three

hours until the battery is fully

charged. Verathon recommends

that you store your spare

battery in the charger to

prevent instrument downtime

due to discharged batteries.

Note: Plugging and

unplugging the charger while

a battery is inserted causes no

damage. There is no danger

when the charger is plugged in

without the battery inserted.

Slowly Blinking Green Light: If the green light blinks slowly upon inserting a battery, then the battery level is too low for fast charging. The charger trickle charges the battery until the power level is high enough to begin fast charging. At this point, fast charging begins automatically.

When the battery has been properly charged, install it in the BVI 3000 as demonstrated in the illustration below.

Installing a Battery

Page 9BVI 3000 Operator’s Manual

Preparation For Use

Battery release button. To remove the battery, press the battery release button.

Battery Icon

Battery Care

The battery icon, located in the upper right corner of the LCD screen, indicates the power status of the battery currently installed in your instrument. Read the battery icon as follows:

A fully darkened battery icon indicates that the battery is

100%

The BladderScan® BVI 3000 draws very little power when it is turned off; however, if you do not plan to use your instrument for several weeks, you should remove the battery to prevent it from becoming discharged.

fully charged and ready for use.

A battery icon that is almost full indicates a partially discharged battery.

75%

When the battery icon is half-darkened, the battery is partially discharged. This is the most common display,

50%

shown during the majority of the battery’s charge life. An almost empty battery icon indicates that the battery

is nearly discharged. While a few more scans can still be

25%

performed, the battery should be replaced at this point. When the battery is fully discharged, the battery icon is

completely clear and the BVI 3000 does not work. The

discharged battery must be replaced with a charged one.

The battery that is not in use should be stored in the charger so it remains fully charged.

Page 10 BVI 3000 Operator’s Manual

Customizing the BladderScan® BVI 3000

You can customize the BladderScan BVI 3000 instrument by entering your facility name and the current date and time. This information will subsequently be included on all printouts of exam results. To customize the BVI 3000:

• Turn the BVI 3000 on by pressing the on/off button

• On the Main Menu screen, press the ALT button to display the Alternate Menu screen, illustrated below.

Important: If your BVI 3000 came with the PIN code option enabled, you must enter your PIN code before you can access the Alternate Menu. The default PIN code is “0000.” For information about how to personalize the PIN code, see the section titled, “Adjusting Preferences,” on page 21.

• Press the NAME button. The Name Preset screen, with a 4 x 13 grid containing alphabetic, numeric, and punctuation characters, is displayed.

Programming the

Facility Name

Note: Diagnostic Ultrasound

Corp. is now called

Verathon Inc.

Note: You may use any

combination of up to 27

characters when entering the

facility name. For example,

you can enter the name of the

hospital, clinic, or physician

supervising use of the

BVI 3000.

• Use the “arrow right” à and “arrow down” â buttons to highlight the rst character you want to enter.

• When the desired character is highlighted, press the SEL button to select it. The character(s) you have selected are displayed below the character grid.

• Continue to use the “arrow right,” “arrow down,” and SEL buttons to enter all the characters in your facility’s name. If you make a mistake, use the ERASE button to delete the last character entered.

• When you are nished, press DONE to return to the Main Menu. The programmed facility name will now be displayed on the Main Menu screen.

Note: You can use the empty

character as a space to

separate words.

Note: When the arrow buttons

are held down, the cursor

moves one character a second.

When the cursor reaches the

end or bottom of the grid of

characters, it wraps around to

the rst character again.

Page 11BVI 3000 Operator’s Manual

Customizing the BladderScan® BVI 3000

Setting the Date

Note: Once set, the BVI 3000 clock recognizes the number of days in each month, including February during leap years. It has its own lithium battery and maintains the correct date and time for at least ten years, even if the rechargeable battery is removed.

• On the Main Menu screen, press the ALT button to access the Alternate Menu (if prompted, enter your PIN number). Then press the DATE button.

• The Date Preset screen displays the current setting for the date, in U.S. format (two digits each for the month, day, and year).

• Press the MM button until the correct month is displayed. Only values from 01 to 12 are allowed (12 is followed by 01).

• Press the DD button until the correct day is displayed. Only values from 01 to 31 are allowed (31 is followed by 01).

• Press the YY button until the correct year is displayed. Only values from 97 to 19 (for 1997 to 2019) are allowed.

Setting the Time

Note: Enter the time in 24hour format (“military time”). To convert standard clock time to 24-hour format, after 12noon add 12 hours to the clock time (Example: 3:00 pm + 12 hours = 15:00 hours).

• Press âá to toggle between the following options: 1) values are increased, or 2) values are decreased, when the month, day, and year buttons are pressed.

• When the date is set, press DONE to return to the Main Menu screen.

• On the Main Menu screen, press the ALT button (and then enter your PIN code, if required) to access the Alternate menu. Next, press the TIME button. The Time Preset screen displays the time that is currently set.

• Press the HH â or HH á to set the hour.

• Press the MM â or MM á buttons to set the minutes.

• When the time is set, press DONE to return to the Main Menu screen.

Page 12 BVI 3000 Operator’s Manual

Operating the BladderScan® BVI 3000

Note to First Time Users: Verathon® advises new operators to use the BladderScan BVI 3000 on patients with moderately full bladders, rather than initially attempting to locate nearly empty bladders. An in-service training video has been supplied with your BVI 3000. We recommend that you view the video to supplement the information in this manual with an actual demonstration of BVI 3000 use.

• Turn the BVI 3000 on by pressing the on/off button

• The Main Menu screen is displayed.

• From the Main Menu, press the SCAN button to go to the Scanning screen.

Turning On the

BVI 3000

Note: If the calibration

due date for your BVI 3000

has passed, the message

“Calibration Due” will

appear every time you turn

on the instrument. You can

still measure bladder volume;

however, this message will

continue to appear until

an authorized Verathon

Service Center calibrates

the instrument. Press OK to

continue.

Note: The Scanning screen

may also be selected by

pressing the scan button on the

scanhead. This is especially

practical when the scanhead

is already positioned on the

patient’s abdomen.

• Press the Male/Female button to select the patient gender. The LCD screen shows a male or a female icon to indicate the gender that is selected. Use the female option ONLY for women who have NOT undergone a hysterectomy (the “Female” option allows the instrument to exclude the uterus from the measurement, which may resemble the bladder ultrasonically). For all other patients, use the “Male” option.

• Clean the rounded end of the scanhead by wiping it gently with a cleaning pad dampened in isopropyl alcohol or a hospital disinfectant solution.

Selecting Gender

Preparing the

Scanhead

Page 13BVI 3000 Operator’s Manual

Operating the BladderScan® BVI 3000

Applying Ultrasound Gel

Measuring Bladder Volume

Have the patient lie in the supine position with abdominal muscles relaxed. Palpate the patient’s symphysis pubis (pubic bone). Place an ample amount of gel midline on the patient’s abdomen approximately one inch (3 cm) above the symphysis pubis.

• Locate the patient icon on the scanhead and make sure the head of the icon will point toward the head of the patient when you place the scanhead on the patient’s abdomen.

• Place the scanhead on the gel on the patient’s abdomen.

View from patient’s right side View from the patient’s feet

Note: While scanning, avoid making any changes in the position, angle or pressure of the scanhead.

• Aim the scanhead so that the ultrasound is projected toward the expected location of the bladder. For most patients, this means aiming the tip of the scanhead toward the patient’s coccyx.

• Press and release the scan button located on the scanhead.

• Hold the scanhead steady throughout the scan. The scanhead clicks once at each scan plane. When the scanhead beeps, the scan is complete. The Aiming screen is then displayed.

Page 14 BVI 3000 Operator’s Manual

Verifying Aim

The greatest measured bladder volume is displayed in large type in the upper left-hand corner of the Aiming screen. Also displayed are the target-shaped Aiming Icon, the instrument status (READY TO SCAN), and the current volume measurement.

The BVI 3000 always displays two volumes; the largest volume measured and the current volume.

Verathon maximum accuracy. The BVI 3000 assumes that the largest volume measured is the true bladder volume, because in most cases the largest volume is the most accurate. Exceptions occur when the operator moves the probe during the scan, or fails to select the female gender when required. In these situations, the largest volume measurement may be higher than the actual bladder volume, and the operator should clear the aiming screen before rescanning the patient.

recommends that you take several measurements to ensure

Aiming Screen

Largest Volume and

Current Volume

To clear the scan results screen, press the clear button, which is labeled with an “X” on the LCD screen. If your instrument does not have a clear button, clear the screen by pressing the DONE button and then pressing the SCAN button to start over. Then rescan your patient. In the following section, we explain how to ensure maximum accuracy by adjusting your aim.

The light area inside the target-shaped Aiming Icon represents the position of the bladder relative to the scanhead. Accurate results are obtained when the bladder image is centered on the crosshairs of the Aiming Icon. If the bladder is not centered, re-aim the scanhead and rescan the patient. Repeat until the image is properly centered (see Figure 1).

The Aiming Icon displays the bladder as viewed when looking down on the patient’s abdomen. To adjust your aim, slightly move or angle the scanhead toward the direction of the bladder image on the Aiming Icon (target). For example, if the bladder image is located on the right side of the icon, aim the scanhead so the ultrasound will be projected further to the right.

Clearing the Screen

The Aiming Icon

Adjusting Aim

Page 15BVI 3000 Operator’s Manual

Verifying Aim

In Figure 1, the bladder image is centered on the crosshairs of the Aiming Icon. This indicates that the scanhead was properly aimed and the bladder volume measurement is accurate.

In Figure 2, the bladder image is not centered on the crosshairs; the bladder overlaps one side of the Aiming Icon. This indicates that the scanhead was not properly aimed and part of the bladder was outside its eld of vision. In such cases, the measured volume is lower than the true bladder volume. The BVI 3000 recognizes this condition and displays a > (greater than) symbol before the bladder volume measurement. To achieve an accurate measurement, the operator should re-aim the scanhead toward the bladder image and repeat the scan.

In Figure 3, the bladder overlaps two sides of the Aiming Icon. This indicates that the bladder is too large to be fully contained within the scanhead’s eld of vision. The BVI 3000 recognizes this condition and displays a > (greater than) symbol before the bladder volume measurement. In such cases, repositioning or re-aiming the scanhead will do little to improve accuracy; however, this situation arises almost exclusively in patients with very large bladder volumes. At these high volumes, measurements are clinically useful even if they underestimate the true bladder volume.

The Scan Results Screen

Note: The longitudinal scan plane is marked by a gender icon bisected by a vertical line. The horizontal scan plane is marked by a gender icon bisected by a horizontal line.

The Scan Results Screen displays the longitudinal and horizontal scan planes from the largest image taken during the exam. The light areas represent the bladder. The dark, triangular surfaces, called scan planes, represent the scanhead’s eld of vision. The volume measurement is accurate when the light colored bladder images are completely contained within the dark, triangular scan planes.

If the light surface in either scan plane is overlapping the edge of the black area, or appears to be cut off, then part of the bladder was not contained in the scanhead’s eld of vision and the measurement may underestimate the patient’s bladder volume. Press the SCAN button to clear the results of the last scan and return to the Scanning screen. Reposition the scanhead and repeat the scanning procedure.

When the bladder images are completely contained in both scan planes, the measurement results are accurate. Pressing either the PRINT or MAIN button completes the scanning procedure and stores the measurement results in the instrument’s memory.

Page 16 BVI 3000 Operator’s Manual

Printing Results

To print the scan results, press the PRINT button to open the Print Menu shown below.

Press PRINT to obtain a printout of the most recent exam. Printing takes about one minute. See Figure 4 for an illustration of the printout.

More information about printing can be found in the “Print Options” section on page 20.

To stop a print in progress, press the ABORT PRINT button.

Figure 4

Printing Results

Note: If the facility name, date,

and time have not been set,

those lines will be skipped on

the printout. The BVI 3000

prints on thermal paper. Over

time, the thermal printout will

fade. For maximum storage life, Verathon® recommends

that you photocopy the

printout.

Page 17BVI 3000 Operator’s Manual

Histogram of Cost Savings

Note: The default settings can be changed in the Preference screen to reect the rates and costs at your facility. For more information, see the section titled, “Adjusting Preferences,” beginning on page 21.

Note: For reference articles on UTI Rate and UTI Costs, please visit our web site at www.verathon.com.

Each volume measurement from a completed scanning procedure is stored in the instrument’s memory. Measurement data is stored in one of eleven volume ranges (each with a 100 ml increment). This data is analyzed and can be printed at any time in a Histogram of Cost Savings (see Figure 5).

Cost savings are calculated based on the following criteria:

• Catheterizations Avoided - Urinary catheterization below a certain

volume is deemed unnecessary. Thus, by using the BVI 3000, these catheterizations are avoided. The default setting (for volume below which catheterization is unnecessary) is 200 ml.

• UTI’s Avoided - Studies indicate that a certain percentage of

catheterizations lead to urinary tract infections (UTI’s). By avoiding unnecessary catheterizations, the resulting UTI’s may be prevented. The default setting (for percent of catheterizations leading to UTI’s) is 3%.

Associated Costs:

• Cost of UTI’s Avoided - Literature suggests that the additional

costs associated with treating UTI amount to $680.00 per patient infection. The default setting is $680.00.

• Cost of Catheter Kits - The default setting is $3.00 (per kit).

Total Cost Savings as a Result of Using the BVI 3000:

• (Caths Avoided x Catheter Costs) + (UTI’s Avoided x UTI Costs)

Figure 5

HISTOGRAM

Volume 000-099 100-199 200-299 300-399 400-499 500-599 600-699 700-799 800-899 900-999 >1000

# of Scans 870 1,219 589 488 252 176 154 87 69 5 4

Catheterizations Avoided: 2089

UTIs Avoided 63

Savings $49,107

Page 18 BVI 3000 Operator’s Manual

Adding a Patient ID and Notes

A patient ID number (maximum 10 digits) can be added to the scan result and will be included on the printout. To add a patient ID number, press the # button on the Scan Results screen. The screen displays

0000000000.

• Use the ß (arrow left) and à (arrow right) buttons to select the digit

you want to change (the selected digit is underlined).

• Use the + (plus) or -- (minus) buttons to select the correct number.

• Continue to use the ß (arrow left) and à (arrow right) buttons and the

+ (plus) or -- (minus) buttons to enter all the digits of the patient ID number.

• When the patient ID number has been entered, press the DONE button to return to the Scan Results screen.

The patient ID number will now be included on the printout of the scan.

After a scanning procedure has been completed, it is possible to annotate the measurement results. Press the button marked NOTES on the Scan Results screen. When the Notes option is selected, notes appear on the printout of the exam data.

Adding a Patient ID

Number

Note: Only press the button

marked # when a patient ID

number is required. If the #

button is used and no patient

ID number is entered, the BVI

3000 will assume a patient

ID number was entered and

0000000000 will be printed on

the printout.

Adding Notes

The operator can change the following settings to annotate the exam:

Exam Type

Default settings:

• If the measured bladder volume is less than 100 ml, the BVI 3000 assumes the measurement was taken after patient voiding and “POSTVOID” is displayed on the screen.

• If the measured bladder volume is between 100 ml and 400 ml, the BVI 3000 assumes the measurement was taken prior to patient voiding and “PREVOID” is displayed on the screen.

• If the measured bladder volume is greater than 400 ml, the BVI 3000 assumes the measurement was taken prior to patient voiding and the bladder was lled to maximum capacity. “CAPACITY” is displayed on the screen.

• If the default does not apply, the Exam Type setting can be changed by pressing the EXAM TYPE button to toggle between options. The selected exam type will appear on the right side of the LCD screen.

Page 19BVI 3000 Operator’s Manual

Adding a Patient ID and Notes

Adding Notes (continued)

Print Options

Action Taken

Using the SEL â button, you can also note the action taken as a result of the current bladder volume measurement. Possible selections are:

No Action: The default selection Patient Voided: The patient was able to void Patient

Catheterized: Allowed to Fill: The patient’s bladder was not as

The patient’s bladder was emptied using a urinary catheter

full as desired and voiding was postponed

Adjusting Volume Approximation

The instrument assumes that the amount of urine voided or catheterized is equal to the volume measured by the BVI 3000 (rounded to the nearest 10 ml). This value can be adjusted up or down using the + and -- buttons.

The Print screen can be accessed by selecting PRINT, either from the Main Menu screen or from the Scan Results screen after a scan is completed. The following table describes the different print options. From the Print screen, use the SEL button to select a print option. An X appears in front of the option selected.

Option Description

Last Image

Cost Savings

Test Print

This option prints the most recent measurement data on the built-in thermal printer. Different types of images can be selected from the Preference screen, using the “Printout” option. (The default is B-mode grayscale images with highlighted bladder walls).

This option is used to print a Histogram of Cost Savings based on the volume history of the instrument. Cost savings are calculated based on the catheter and UTI costs avoided due to BVI 3000 use. For details, see the section titled, “Histogram of Cost Savings,” in this manual. Histogram settings can be changed in the Preference Menu (for instructions, see the section titled, “Adjusting Preferences,” in this manual).

Select this option to test if the built-in thermal printer works. Alphanumeric characters and a simple grayscale test pattern are printed out.

Page 20 BVI 3000 Operator’s Manual

Print Options

The BVI 3000 has an automatic paper loading mechanism. To load a new roll of paper, open the paper well door at the top of the instrument and insert the end of a new paper roll, with the thermal side down, into the paper input slot. The BVI 3000 senses the presence of the paper and feeds automatically (paper is forwarded through the paper eject slot in the top of the instrument).

It is important that you feed a straight edge into the paper feed mechanism. Cut off the rst inch of a new paper roll before loading the paper.

Caution: To avoid paper jams, never fold the end of the paper roll or cut it diagonally or to a point.

Caution: If the paper does not advance, or it appears to be stuck in the printer, turn off the instrument. Lower the printhead release lever, located adjacent to the paper advance thumb wheel. Gently pull the paper backward while moving the thumb wheel counterclockwise. If the

paper jam is inaccessible, contact your authorized Verathon

Service

Center or local Verathon distributor for service.

Loading Paper

Tip: To verify that you are

loading the paper with the

thermal side down, ick your

nail over the paper. If a black

mark appears, this is the

thermal side.

Adjusting Preferences

Various BVI 3000 operating parameters can be customized for individual use via the preference screen. To access the Preference screen and adjust your instrument settings, go to the Main Menu and then press “ALT” to access the Alternate Menu. (If required, enter your PIN code to access the Alternate Menu. See the section below titled, “The PIN Code Option,” for more information.) Then press the “PREF” button.

On the Preference screen, a list of adjustable parameters is displayed. Use the SEL â and SEL á buttons to select a parameter. Use the “+” and “-” buttons to adjust the parameter value. Press DONE to save the new setting. For a description of the adjustable parameters, see the table below.

If the PIN code option is enabled, users must enter a PIN code in order to access the Alternate Menu and change instrument settings. This prevents unauthorized users from changing the instrument settings. The default PIN code is “0000.” Enter this default code the rst time you access the Alternate Menu.

To personalize your PIN code, select the change PIN option on the Preference screen. The current PIN is displayed. Enter a new PIN and then press DONE.

Important: Remember your PIN code. If your existing PIN code is forgotten, only a qualied Verathon Service Center can reset the PIN code.

The PIN Code Option

Personalizing the

PIN Code

Page 21BVI 3000 Operator’s Manual

Adjusting Preferences

Parameter Range & Value Descriptions

Backlight AUTO (default)

ON OFF

Beep Volume 0-9 (default = 5) Allows user to adjust sound volume (lower values are

Language ENGLISH (default),

DANISH, DUTCH, FINNISH, FRENCH, GERMAN, ITALIAN, NORWEGIAN, PORTUGUESE, SPANISH, SWEDISH, TURKISH

Date MM/DD/YY (default)

DD/MM/YY YY/MM/DD

Printout ADD_WALLS (default) ADD_WALLS - Print grayscale B-mode images with

NO_IMAGES NO_IMAGES = Do not print any B-mode images. RAW_ONLY RAW_ONLY = Print grayscale B-mode images without

WALLS_ONLY WALLS_ONLY = Bladder outline only. 12_PLANES 12_PLANE = All 12 scan planes, printed as in the ADD_

UTI_rate 0-1000 (default = 3%) Percentage of catheterizations which result in UTI; used in

UTI_cost 0-2000 (default = $680) Cost to treat a UTI; used in cost savings calculations Cath_cost 0-20 (default = $3) Cost of a catheter; used in cost savings calculations Cath_vol 0-1000 ml (default = 3000

ml)

Flash ON (default) ON = Flash memory enabled and scan results are saved

Time Zone GMT ± 0-12 This function is currently not used. Contrast

Adjust

Note: An immediate effect is seen only when adjusting the contrast volume up. Adjusting the contrast volume down becomes visible when the instrument is turned off and on again.

30-63 (default = 57) Adjust display contrast ratio; the higher the value, the

AUTO = Backlight turns on and off automatically, depending on ambient light conditions. ON = Backlight always on OFF = Backlight always off

quieter) Species the language used for displays and printouts.

Select the date format (order of month, day, year)

bladder walls highlighted.

identifying.

WALLS mode.

cost savings calculations.

Bladder volume below which catheterization in unnecessary; used in cost savings calculations

even is power is removed. OFF = Scan results are not saved if instrument is turned off; however, processing time is slightly faster.

darker the background.

Page 22 BVI 3000 Operator’s Manual

Adjusting Preferences

Parameter Range & Value Descriptions

Currency $ € £ ¥ (default = blank) Set the currency for calculating cost savings. Choose US

Dollars, Euros, Pounds, or Yen. When a different currency is selected, the calculations are not affected.

Scan Count Screen

Reset Histogram

Change PIN Select this option to personalize or change the PIN code.

Number of scans performed Select this option to monitor instrument use. There are two

scan counters: one is resettable, one is not. “Clear Count” to clear the resettable counter to zero. To reset the nonresettable counter, contact an authorized Verathon center.

Reset the histogram to being a new analysis of cost savings.

The current PIN is displayed. Enter the desired PIN and press DONE.

Important: Remember your PIN code! If your existing PIN is lost or forgotten, you must contact a Verathon Service Center to reset the PIN code.

service

To perform an instrument test, go to the Main Menu and press the ALT button (enter the PIN code if required) to access the Alternate Menu.

From the Alternate Menu, press the SELF TEST button. The instrument then performs the following tests:

ROM TEST - Program Memory

BUS TEST - Microprocessor Bus

NVRAM TEST - Non-Volatile Battery Backed Memory

SRAM TEST - Main Memory

FLASH TEST - Flash Memory

Additional Features

Self-Test

Page 23BVI 3000 Operator’s Manual

Regular Inspections and Maintenance

Weekly Inspections

Monthly Accuracy Check

Caution: In the event of changes in the performance of the instrument, discontinue use and contact your authorized Verathon Service Center or your local Verathon distributor.

Verathon® recommends that the BVI 3000 be certied by an authorized Verathon Service Center once a year. Certication service includes a comprehensive inspection and testing of the instrument, to ensure accurate measurement performance. For more information, please contact your Verathon Service Center or your local Verathon distributor.

Once a week, you should inspect the scanhead and cable for physical faults or cracks. Cracks that allow the leakage or ingress of uid may affect the performance of the instrument. Any apparent faults or cracks must be referred to your authorized Verathon Service Center or your local Verathon distributor.

Each month, or whenever accuracy assessment is desired, the accuracy of the BVI 3000 should be tested using the following procedure:

• Take a pre-void measurement of bladder volume.

• Void or catheterize into a measurement beaker.

• Take a post-void measurement of bladder volume to check for postvoid residual (PVR).

• Subtract the post-void measurement from the pre-void measurement and compare to the voided volume.

• The measured volume should be within a range of ± 20%, ± 20 ml of the voided volume for volumes less than 699 ml, or ± 25%, ± 25 ml for volumes larger than 699 ml.

Care, Cleaning and Disinfecting

The BVI 3000 instrument may be cleaned with a soft cloth dampened in isopropyl alcohol.

• The round, black, plastic dome of the scanhead can be disinfected

with any liquid disinfecting agent suitable for use with Lexan polycarbonate. In the United States, Cidex® and Cidex 7 are FDAcleared for this purpose. Follow the instructions provided by the manufacturer of the disinfecting agent.

• Do not immerse any part of the scanhead or the control unit in a cleaning or disinfecting solution.

• Do not use Cidex Plus, as it is not recommended for use with Lexan polycarbonate.

• Do not subject any part of the BVI 3000 instrument to steam sterilization or ethylene oxide sterilization.

Page 24 BVI 3000 Operator’s Manual

Troubleshooting

If the instrument does not turn on, this is usually due to a dead or discharged battery and can be xed simply by replacing the dead battery with a charged one. Check the battery icon in the upper-right corner of the LCD screen. If the battery icon is clear (empty), replace the battery.

When the battery’s charge is too low to allow normal operation (but not too low to permit operation of the internal circuitry) the BVI 3000 displays the following message: BATTERY CHARGE LEVEL IS TOO LOW FOR INSTRUMENT OPERATION. RECHARGE BEFORE NEXT USE. In this event, the battery must be recharged or replaced with a charged one.

This image is displayed if the user presses the SCAN button when the scanhead is not connected to the control unit.

• When the scanhead is connected, this image disappears and the instrument will operate normally.

The BVI 3000 displays this image when the printer is out of paper:

Instrument Does Not

Turn On

Battery Recharge

Message

No Scanhead

Message

No Paper

• For instructions on how to load the paper, see the section titled, “Loading Paper,” on page 21.

The BVI 3000 senses when the print head is disengaged and displays the following image until the print head release lever is positioned up as far as it can go:

The BVI 3000 displays the message “TOO HOT” if the print head overheats. When this message appears, turn off the BVI 3000. This condition may be the result of a paper jam (see the following section for more information).

If the paper will not advance through the printer, lower the print head release lever (located adjacent to the paper advance thumb wheel). Gently pull the paper backward, while moving the thumb wheel counterclockwise, to clear the paper jam.

Caution: If the paper jam is inaccessible, do not try to disassemble the printer. Contact your authorized Verathon Verathon distributor for service.

Service Center or your local

Disengaged Print

Head

Too Hot

Clearing a Paper Jam

Page 25BVI 3000 Operator’s Manual

Warranty and Disclaimer Information

Warranty

Verathon® warrants the BladderScan® BVI 3000 against defects in material and workmanship for one (1) year from the date of purchase from Verathon Inc. This warranty is given only to the original purchaser of the BladderScan instrument.

Pursuant to this warranty, a service center authorized by Verathon Inc. will repair or replace products which prove to be defective during the warranty period.

This warranty does not cover equipment sold as used.

This warranty does not apply if the product has been damaged by misuse or as the result of service or modication by anyone other than a service center authorized by Verathon. The instrument shall be used in accordance to the instructions contained in this Operator’s Manual.

Consumable items shall be used in conformance with Verathon product specications. Consumable items are not covered under this warranty.

Warranty conditions may differ in some countries. Contact your local distributor for warranty terms.

Warranty extensions are available. For more information, please talk to your local Verathon Medical representative, or contact the Verathon Medical Customer Care department using the contact information on page 27.

Disclaimer of Additional Warranties

There are no understandings, agreements, representations of warranties expressed or implied (including warranties of merchantability or tness for a particular purpose) other than those set forth in the preceding Warranty section. The contents of this Operator’s Manual do not constitute a warranty.

Some states disallow certain limitations on applied warranties. The purchaser, user and patient should consult state law if there is a question regarding this disclaimer.

The information, descriptions, recommendations, and safety notations in this Operator’s Manual are based upon Verathon experience and judgment, as of March 2010, with respect to the BladderScan BVI 3000 instrument. This product involves a relatively new area of medical technology. The contents of this Operator’s Manual should not be considered to be all inclusive or covering all contingencies.

The physician(s) at your institution directing the use of the BVI 3000 instrument is responsible for keeping current with developments in the literature on bladder volume. Please direct any questions or problems concerning bladder volume, the use of the instrument, or interpretation of data, to the responsible physician(s).

Page 26 BVI 3000 Operator’s Manual

The team at Verathon Inc. is committed to modernizing healthcare delivery by putting patients rst. Our products support healthcare professionals by providing the highest level of accuracy, utility, and excellence. For additional product and company information, visit the

Verathon

web site at www.verathon.com. If you have any questions or

comments about Verathon products and services, please contact us at:

Contacting Verathon

Verathon Inc. 20001 North Creek Parkway

Email: customerservice@verathon.com

Bothell, WA 98011 USA

800.331.2313 (US and Canada only)

425.867.1348

Fax: 425.883.2896

Verathon Medical (Europe) B.V.

Email: customerserviceEU@verathon.nl

Linnaeusweg 11 3401 MS IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512

For additional contact information, please visit our web site at www.verathon.com.

Page 27BVI 3000 Operator’s Manual

Safety and Performance Summary

• The BladderScan® BVI 3000 computes the volume of the urinary bladder based upon twelve, cross-sectional ultrasound images. For maximum accuracy, be sure to hold the scanhead motionless while scanning.

• The most accurate measurements are obtained when the patient rests quietly in the supine position.

• Accuracy is compromised if the user does not obtain an optimal, repeatable image.

• Errors in usage tend to result in the underestimation of bladder volume, except in cases where the scanhead is moved during scanning. In this case, the measurement may overestimate the patient’s bladder volume.

• The BladderScan BVI 3000 is not intended for use on pregnant patients.

• The patient being scanned should not have a catheter in his or her bladder. This could create micro bubbles in the bladder, which affect the accuracy of the measurement.

• Do not use the BVI 3000 on patients with open skin or wounds in the suprapubic region.

• Use care when scanning suprapubic and pelvic surgery patients. Scar tissue, surgical incisions, sutures, and staples can affect ultrasound transmission and reection.

• To conserve power, the BladderScan BVI 3000 turns off automatically when not in use.

• Verathon

recommends that new operators rst use the BVI 3000 on patients with moderately full bladders, rather than initially attempting to locate a bladder with a low volume.

Warning: There is the possible hazard of explosion if the BVI 3000 is used in the presence of ammable anesthetics.

Page 28 BVI 3000 Operator’s Manual

Part Number Description

0570-0090 BladderScan

BVI 3000 Instrument 0570-0091 Dome Scanhead Assembly 0400-0036 Battery Charger 0400-0039 Battery, 7.2 V 0800-0166 Carrying Case 0800-0167 Rolling Cart 0800-0005 Acoustic Coupling Gel, 0.25 liter 0800-0042 Printer Paper (5 rolls) 0900-0383 Operator’s Manual 0900-0396 Training Video

Parts and Accessories

Technical Description

Verathon® certies that the BladderScan® BVI 3000 is in compliance with all applicable international and national standards and regulations, including, but not limited to, IEC-601-1 (EN60601-1) and EN 60601-12; MDD 93/42/EEC Annex 1, CSA22.2 No. 125 (Risk class 2) (LR 76129-1), and UL544. Per the provisions of IEC-601-1, this device is classied as:

Protection Class II, INTERNALLY POWERED EQUIPMENT

TYPE BF, suitable for CONTINUOUS USE

Per the MDD, the BladderScan BVI 3000 is a Class IIa device.

Temporal Average Power: 1 mW maximum Focal 20 dB Beam-Area: 1.4 cm

Transducer Dimension: 3 mm diameter Working Frequency: 2 MHz

Peak Instantaneous Intensity: 14 W/cm

maximum

Pulse Repetition Frequency: 180 pulses/second

Compliance With

Standards

Scanning

Specications

Scanning Specications

Technical performance assessment (for example, in an acoustic laboratory) may require partial immersion of the scanhead. Immerse the black plastic dome no further than the point at which it connects to the black body.

Page 29BVI 3000 Operator’s Manual

Technical Description

Scanning Accuracy

Note: The accuracy that an individual achieves using the BVI 3000 depends on properly aiming the scanhead so that the bladder falls entirely within the measurement cone.

Environmental Conditions for Storage

Environmental Conditions for Use

Given the tremendous variation of healthy and compromised human anatomy, a guaranteed accuracy specication for the instrument used on humans would be difcult. For this reason, the following accuracy specication assumes usage per instructions, scanning a Verathon Equivalent Phantom:

Bladder Volume Range: 0 to 999 ml Accuracy: 0 to 699 ml ± 20%, ± 20 ml

700 to 999 ml ± 25%, ± 25 ml

Ambient temperature -4° - 140° F (-20° - 60° C) Relative humidity 20% - 95%, non-condensing Atmospheric pressure 500 hPa - 1060 hPa

Ambient temperature 50° - 104° F (10° - 40° C) Relative humidity 30% - 75%, non-condensing Atmospheric pressure 700 hPa - 1060 hPa

Tissue

Clock/Calendar

Avoiding or Identifying and Resolving Adverse Electromagnetic Effects

The internal clock is accurate to better than one minute per month at 25 degrees Celsius. It will operate for at least 10 years from an internal lithium battery. It knows the number of days in each month and will correctly handle February in a leap year.

There are no restrictions for the use of the BladderScan® BVI 3000 due to its electromagnetic characteristics. Both the emissions from the BVI 3000, and the susceptibility of the BVI 3000 to interference from other sources, are within prescribed limits of all applicable standards at the date of manufacture. The emissions test procedure used is that specied in EN55011: 1991 for Group 1, Class A equipment (per EN60601-1-2,

36.201.1.7).

The BVI 3000 is suitable for use in ISM (industrial, scientic and medical) environments, and in domestic environments under the jurisdiction of a health care professional. An indication of adverse electromagnetic effects from the BVI 3000 on another electronic device would be a degradation of performance in that other device when the BVI 3000 is operated simultaneously.

If such interference is suspected, separate the two devices as much as possible, or discontinue simultaneous operation, if practical, and contact Verathon.

Page 30 BVI 3000 Operator’s Manual

Technical Description

The BVI 3000 will operate normally in the proximity of other potential interference sources, and has demonstrated immunity at a eld strength of 3 V/m (per EN60601-1-2, 36.202.2.1). In addition, the BVI 3000 detects outside interference and will display “RESCAN” instead of a volume measurement if detected interference is of sufcient magnitude to possibly compromise measurement accuracy. If this “RESCAN” display occurs repeatedly, attempt to locate and disable or remove the interference source, or use the BVI 3000 away from the interference source. If these efforts do not restore normal operation, contact the distributor.

No other precautions need be taken regarding exposure in reasonably foreseeable environmental conditions to magnetic elds, pressure or variations in pressure, acceleration, or thermal ignition sources.

Verathon Inc., upon written request, will make available circuit diagrams and other technical documentation which will assist the user’s appropriately qualied technical personnel to repair this equipment. This information is deemed condential and proprietary and its use is limited solely to such repair applications. Repair should be performed only by Verathon® or a Verathon authorized service organization.

Avoiding or

Identifying and

Resolving Adverse

Electromagnetic

Effects

(continued)

Technical

Documentation

Technical Description: Battery Charger

The battery charger (Verathon Part No. 0400-0036) can be used with an input of 100-250 V ~ sat 47 to 63 Hz. Its output is 9 V at 1 Amp.

Use only the battery charger supplied. Use of any other charger may damage the battery pack.

The battery charger used with the BVI 3000 is tested to IEC 601-1 requirements and is in compliance with UL and CSA equivalent standards.

The power supply is not intended for direct patient contact. The batteries used in the BVI 3000 are charged separate from the control unit and not during patient use.

The battery charger and batteries are designed to operate under the following conditions:

Input Voltage

Input frequency

100-120 VAC/North American (LZA-) units, 200250 VAC/European (LZE-) units, 100-250 VAC/ Universal (LZU-) units

50-60 Hz

Battery Charger

Specications

Certication

Technical

Specications

Page 31BVI 3000 Operator’s Manual

Technical Description: Battery Charger

Technical Specications (continued)

Environmental Conditions For Use

Input Current

Output

Input Connection

Insulation

Indoor use

Temperature

Transient

overvoltage

Pollution degree

Atmospheric

pressure

Relative humidity

Ventilation

Earth Terminal

Fuses

Cleaning

0.39 A/North American (LZA-) units. 0.25/ European (LZE-) units. 0.38 A/Universal (LZU-) units

No load to full load at rated voltage. Refer to unit label

The power supply employs a direct plug in AC prongs for wall plug in units

The power supply is Class I with basic insulation to each terminal

50° - 104° F (10° - 40° C)

Category II

70 hPa to 106 hPa

30% to 75%, non-condensed

The power supply is designed to operate with free air convection.

The earth terminal provided in this unit is a functional earth terminal, as indicated by the ground symbol on the unit. It is not utilized in the power supply to provide earth protection. Various ground options are available upon request.

The fuses used in the power supply are rated at 250 VAC, 2 A, quick acting.

No cleaning is needed. If desired, a dry or slightly damp cloth may be used to clean the surface of the power supply while it is disconnected from the AC source. In no instance should water be allowed to enter the unit

Page 32 BVI 3000 Operator’s Manual