Detalo Clinical™ – Blood Volume Measurement Device
Medical Device for Blood Volume Measurement
Blood volume is a critical parameter in the treatment of several major diseases such as heart failure and kidney diseases. Clinical evidence demonstrates significant improvements in patient outcomes if medical treatment is based on blood volume status. The Detalo Clinical™ is an CE-certified (MDR) medical device allowing for routine blood volume assessment in standard clinical care.
Clinical Benefits
Detalo Clinical allows for easy and rapid determination of intravascular volume status that may serve as input to patient treatment:
- Determine if a patient is hypovolemic or hypervolemic.
- Determine if anemia is related to a reduction in red blood cell volume, augmented plasma volume, or a combination of both.
- Determine if polycythemic patient is related to augmented red blood cell volume reduced plasma volume
- Determine and track the effectiveness of a treatment intended to change blood volume.
Intended use
The intended use of the Detalo Clinical device is to facilitate Carbon Monoxide (CO) rebreathing with the purpose of quantifying haemoglobin mass (Hbmass), red blood cell volume (RBCV), plasma volume (PV), and total blood volume (BV).
The device is intended for adult patients with a disease in which anemia, dilutional anemia, polycythemia, spurious polycythemia, hypovolemia, or hypervolemia is a known complication. This includes patients diagnosed with chronic kidney disease, heart failure, and polycythemia.
Performance
The Detalo Clinical is quick in use, measures equally well as compared to other blood volume measurement technologies, and has very high precision in use for repeated measurements over a short period of time:
- Detect a change in blood volume of 5%
- Perform repeated measurements of blood volume that deviate less than 5% from one another
- Detect a decrease in hemoglobin mass of 5%
- Perform repeated measurements of hemoglobin mass that deviate less than 5% from one another
- Measure values for blood volume with the device are comparable to those obtained with radioactive tracer methodology
- Complete the measurement procedure and deliver results within 15 minutes
CE Certified Medical Device (MDR)
The Detalo Clinical has been certified according to the following standards for medical devices:
IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance is an international standard that applies to the basic safety and essential performance of medical electrical equipment
IEC 62304 Medical device software — Software life cycle processes
Blood Volume Measurement in 15 Minutes
Detalo blood volume analyzers determine total blood volume, red blood cell volume, and plasma volume in humans in a rapid, safe, and precise manner.
The Detalo Clinical™ is a CE-certified (MDR) medical device for routine blood volume assessment in standard clinical care. The device allows healthcare professionals to distinguish between true anemia and dilutional anemia and to determine if a patient is euvolemic, hypovolemic, or hypervolemic. Finally, it allows clinicians to evaluate and track the effectiveness of a treatment intended to change blood volume.
