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The BCM2 is intended for use, under the direction of a physician, for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease (ESKD) including those receiving maintenance dialysis.

The device does not generate any real-time alarms and outputs from the device should be used in the context of all clinical data to assess a patient's fluid status.

The device is intended for use in patients 18 years and older.

The BCM2 is a multifrequency bioimpedance device that can be used by a clinician for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease, including those receiving maintenance dialysis. A physician or designated healthcare professional is responsible for interpreting data from the device to determine what action is required as a result of changes in the measurements.

To assess a patient's hydration status, the BCM2 measures impedance by applying a low-level signal (50–800 µA) for less than 10 seconds at 50 different frequencies from 5 kHz to 1,000 kHz. Measurements are performed by dialysis clinicians (e.g., dialysis nurses, patient care technicians) in a healthcare environment such as a dialysis clinic or hospital.

In the normal clinical workflow, the BCM2 provides the following output parameters:

• Overhydration (OH)
• Urea distribution volume (V)

The following calculated and derived parameters are also available:

• Extracellular water (ECW)
• Intracellular water (ICW)
• Total body water (TBW)

The BCM2 system consists of the BCM2 touchscreen console and the electrode set. The BCM2 console powers and measures the bioimpedance spectroscopy frequencies to assess fluid parameters. The device can also be operated in battery mode. Battery mode provides flexibility when moving between patients. The battery charge status is shown in the upper corner of the display regardless of which power source is being used. The power supply connection is located on the rear of the console.

The Calibration Box employs different resistors to calibrate the entire range of the BCM2's measurement (5 kHz to 1,000 kHz). Impedance measurements are performed for each resistor for all frequencies and the data is verified against an expected tolerance range. After the BCM2 has been calibrated, the Test Box is used to verify that the device is functioning properly.

The BCM2 will be available in one (1) configuration for sale within the U.S.

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