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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.