Search Results

MySOZO Software version 6.0.1.2 has the following uses:

The MySOZO Software version 6.0.1.2 is intended for adult patients living with heart failure.

This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

For adult human patients at risk of lymphedema:

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.

The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.

The MySOZO Software version 6.0.1.2 may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).

The MySOZO Software version 6.0.1.2 may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:

• Fat mass
• Fat-free mass
• Total body water
• Intracellular fluid
• Extracellular fluid
• Skeletal muscle mass

The following outputs are also presented:

• Body Mass Index (BMI)
• Basal metabolic rate (BMR; based on Mifflin - St. Jeor's algorithm) displayed in calories per day
• Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.

The MySOZO Software version 6.0.1.2 device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xe), and impedance (Z), which are used to estimate the above body composition parameters. The device/ software will also display the Cole plot, subject height, weight, age and sex.

MySOZO Software version 6.0.1.2 is the cloud-based software component of the overall ImpediMed SOZO Digital Health Platform device system. SOZO Digital health platform consists of several elements. MySOZO Software allows for bioimpedance measurements to be made with either the predicate (K232089) SOZO Pro or the reference (K180126) SOZO device.

Bioimpedance measurements are facilitated via the MySOZO Software with either the SOZO Pro or SOZO devices, which allows clinicians to evaluate patient fluid levels. Following the collection of the patient data (e.g., weight, height, dominant limb, age), the patient contacts the SOZO or SOZO Pro with their bare hands and feet on the stainless-steel electrodes. The MySOZO Software version 6.0.1.2 impedance measurement takes about 30 seconds, during which the SOZO or SOZO Pro®, applies small levels of electrical energy (200μA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels. MySOZO Software transmits the impedance data to the database, calculates the values, and retrieves and displays the results upon request.

N/A

Ask a specific question about this device