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BVI 3000 Operator’s Manual

Technical Description

Scanning Accuracy

Given the tremendous variation of healthy and compromised human 

anatomy, a guaranteed accuracy specification for the instrument used 

on humans would be difficult. For this reason, the following accuracy 

specification assumes usage per instructions, scanning a Verathon

®

 Tissue 

Equivalent Phantom:

Bladder Volume Range:

0 to 999 ml

Accuracy:

0 to 699 ml ± 20%, ± 20 ml 

700 to 999 ml ± 25%, ± 25 ml

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

Ambient temperature

-4° - 140° F (-20° - 60° C)

Relative humidity

20% - 95%, non-condensing

Atmospheric pressure

500 hPa - 1060 hPa

Environmental 

Conditions for Use

Ambient temperature

50° - 104° F (10° - 40° C)

Relative humidity

30% - 75%, non-condensing

Atmospheric pressure

700 hPa - 1060 hPa

Clock/Calendar

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.

Avoiding or 

Identifying and 

Resolving Adverse 

Electromagnetic 

Effects

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 specified 

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, scientific 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.

Summary of Contents for BladderScan BVI 3000

Page 1: ...BladderScan BVI 3000 Bladder Volume Instrument Operator s Manual...

Page 2: ......

Page 3: ...BladderScan BVI 3000 Bladder Volume Instrument Operator s Manual...

Page 4: ...ber 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...

Page 5: ...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...

Page 6: ...clinical utility The ultrasonic output power of the BladderScan BVI 3000 is not user adjustable and is limited to the minimum level necessary for effective performance Data on acoustic output levels c...

Page 7: ...Page 7 BVI 3000 Operator s Manual BladderScan BVI 3000 Components...

Page 8: ...th 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...

Page 9: ...ment 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 fro...

Page 10: ...s partially discharged This is the most common display shown during the majority of the battery s charge life 25 An almost empty battery icon indicates that the battery is nearly discharged While a fe...

Page 11: ...pital clinic or physician supervising use of the BVI 3000 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 s...

Page 12: ...1 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 Press to toggle between the following options 1...

Page 13: ...l when the scanhead is already positioned on the patient s abdomen Selecting Gender Press the Male Female button to select the patient gender The LCD screen shows a male or a female icon to indicate t...

Page 14: ...ximately one inch 3 cm above the symphysis pubis Applying Ultrasound Gel Aim the scanhead so that the ultrasound is projected toward the expected location of the bladder For most patients this means a...

Page 15: ...the patient Clearing the Screen 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 b...

Page 16: ...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 The Scan Results Screen dis...

Page 17: ...ure 4 for an illustration of the printout 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 therm...

Page 18: ...zations 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 co...

Page 19: ...ID number was entered and 0000000000 will be printed on the printout After a scanning procedure has been completed it is possible to annotate the measurement results Press the button marked NOTES on t...

Page 20: ...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 P...

Page 21: ...ark appears this is the thermal side Print Options Adjusting Preferences Various BVI 3000 operating parameters can be customized for individual use via the preference screen To access the Preference s...

Page 22: ...ONLY Bladder outline only 12_PLANES 12_PLANE All 12 scan planes printed as in the ADD_ WALLS mode UTI_rate 0 1000 default 3 Percentage of catheterizations which result in UTI used in cost savings calc...

Page 23: ...histogram to being a new analysis of cost savings Change PIN Select this option to personalize or change the PIN code The current PIN is displayed Enter the desired PIN and press DONE Important Rememb...

Page 24: ...void measurement of bladder volume to check for post void residual PVR Subtract the post void measurement from the pre void measurement and compare to the voided volume The measured volume should be w...

Page 25: ...onnected this image disappears and the instrument will operate normally Too Hot The BVI 3000 displays the message TOO HOT if the print head overheats When this message appears turn off the BVI 3000 Th...

Page 26: ...cal 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 represen...

Page 27: ...Verathon web site at www verathon com If you have any questions or comments about Verathon products and services please contact us at Verathon Inc 20001 North Creek Parkway Bothell WA 98011 USA 800 33...

Page 28: ...adderScan 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 t...

Page 29: ...to IEC 601 1 EN60601 1 and EN 60601 1 2 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 classified as Protection Class II INTERNA...

Page 30: ...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 Avoiding or Ident...

Page 31: ...available circuit diagrams and other technical documentation which will assist the user s appropriately qualified technical personnel to repair this equipment This information is deemed confidential a...

Page 32: ...pheric pressure 70 hPa to 106 hPa Relative humidity 30 to 75 non condensed Ventilation The power supply is designed to operate with free air convection Earth Terminal The earth terminal provided in th...

Page 33: ...nt Type BF applied part To identify a type BF applied part with IEC 60601 1 CE mark in accordance to the Medical Device Directive Canadian CSA Symbol Attention consult accompanying documents Battery P...

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Page 36: ...Your local BladderScan distributor is...

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