BLADDERSCAN BVI 3000, Руководство по эксплуатации и техническому обслуживанию, Страница: 57 / 72

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Operations & Maintenance Manual: Product Specifications
PRODUCT SPECIFICATIONS
SAFETY & 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 reflection.
• To conserve power, the BladderScan BVI 3000 turns off automatically when not in use.
• Verathon
®
recommends that new operators first 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 flammable
anesthetics.
ACCURACY RANGE
Given the tremendous variation of healthy and compromised human anatomy, a guaranteed accuracy
specification for the instrument used on humans would be difficult. The accuracy that an individual achieves
when using the BVI 3000 depends on properly aiming the scanhead so that the bladder falls entirely within
the measurement cone. Ensure that you follow the instructions for use in the chapter Using the Instrument on
page 24.
It is suggested that you verify instrument accuracy by scanning a calibrated adult bladder tissue‑equivalent
phantom (if available) or by completing the procedure Verify Instrument Accuracy on page 47.
Table 6. Scanning Accuracy Range
BLADDER VOLUME ACCURACY RANGE
0 to 699 ml ± (20% + 20 ml)
700 to 999 ml ± (25% + 25 ml)