Indication for Use:
The BBS Revolution™ device projects ultrasound energy through the lower abdomen of the patient to obtain an image of the bladder, which is used to calculate bladder volume non-invasively. Users should consult with a healthcare professional for the interpretation of the results.
Contraindications:
Not intended for fetal use. Not intended for use on pregnant patients. Device is for external use only. Do not use device on patients with open or damaged skin, or wounds in the suprapubic region. Do not use in conjunction with high frequency (HF) surgical equipment. Device lacks protective means for use with HF surgical equipment.
Precautions
Do not immerse the system beyond the level specified in the Cleaning and Maintenance section. If the shipping package is damaged, crushed, punctured, or torn open to reveal contents, isolate the package and contact the shipper for disposition instructions. 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 can cause errors. Accuracy may be affected for patients with ascites or free floating fluid in the peritoneum. Scanner used without ultrasound gel may result in a poor or inaccurate reading. Prolonged use of scanner may result in heating of the outer surface. The scanner and console may shut down if excessive heating is detected. The most accurate measurements are obtained when the patient rests without movement in the supine position. Avoid rough handling. Only use supplied parts.
Please consult product label, inserts, and instructions for use for any indications, contraindications, hazards, warnings, cautions, and directions for use.