BVA™ and Volumex® Indication and Important Risk Information

 

Indications and Intended Use

 

The Daxor BVA is an automated system that is used to measure/calculate the red cell mass (mL), plasma volume (mL) and total blood volume (mL), along with the related deviations from ideal values by amount (mL) and percentage (%) in adults. In addition, the Normalized Hematocrit (%) and Albumin Transudation Rate (%/min) are calculated.

 

It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter and accessory convenience kit. The Daxor BVA is intended to calculate human blood volumes by the method of tracer diffusion (Indicator dilution technique) with I-131 as the tracer after injection of I-131 Human Serum Albumin.

 

The Daxor BVA provides a Quantitative Assessment of total blood and plasma volumes using an automated system.

 

Data inputs to the software come from the measured characteristics of patient venous whole blood samples collected in K3EDTA vacutainer tubes (hematocrit and tracer concentration) and tracer calibration standards. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically input to this calculation program. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell volumes are reported, with statistics showing the quality of the results.

 

For in vitro diagnostic use in a Clinical Laboratory setting and operated by laboratory technicians. Rx use only.

 

Contraindications and Clinical Postponement

 

Volumex is contraindicated for use in pregnant women. Furthermore, safety and effectiveness have not been established in pediatric or nursing patients. While there are otherwise no known contraindications for Volumex, the procedure should be deferred if the patient is unwilling to consent, if reliable venous access cannot be established, or if the patient is clinically unstable (e.g., experiencing chest pain or shortness of breath) unless under direct physician oversight.

 

Safety Precautions and Radiation Management

 

Minimize radiation exposure for patients and workers; radiopharmaceuticals must only be handled by qualified, licensed handlers. Lugol’s Solution may be administered starting 24 hours pre-injection to protect the thyroid. Keep the BVA at least 3 meters from interference sources like MRI or electrosurgical equipment.

 

Potential Adverse Events

 

Potential risks include theoretical allergic reactions and injection site infiltration; the total weekly dosage must not exceed 200 microcuries. Ensure accurate, current height and weight are used for “ideal” volume calculations.

 

Device and Material Caution

 

Visually inspect Volumex; discard if particulates are present or if coloration is darker than very pale yellow. Total weekly dosage must not exceed 200 microcuries. Accurate patient height and weight measurements are required to calculate “ideal” volumes; do not use patient history. Clean the unit enclosure with mild detergent or 10% bleach, but never use alcohol on the screen.

 

Disposal Procedures

 

Dispose of empty Volumex syringes in an appropriate sharps container after assaying. Blood samples and cartridges may be discarded as standard medical waste in a biohazard container.