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The Re:Balans is intended for use under the direction of a physician, for the non-invasive monitoring of patients with fluid management-related health conditions. The device measures thoracic bioimpedance in patients to assist the physician in fluid management assessment.

The device is indicated for adult patients with fluid overload such as end-stage renal disease, and patients at risk of dehydration.

The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's fluid status.

The Re:Balans is a non-invasive wearable device measuring impedance in patients with fluid management-related health conditions.

The device has the form factor of an adhesive patch, with four integrated electrodes, which is applied on the back of the patient. The impedance signal is obtained by applying a small, safe battery-generated current and measuring the resulting electrical impedance.

The impedance signal reflects the electrical resistance of the tissue and is modulated by the changes in fluid levels. The impedance signal is captured at multiple unique frequencies to enable the calculation of base impedance, extracellular and total resistance values. The Impedance decreases when fluid increases and increases when fluid decreases in the thorax. Normal upper body base impedance range is between 35– 65 Ohms. However, every person has their own baseline values. Fluid status changes should be noted and shared with professional medical clinicians when impedance readings vary from typical daily values.

Once the device is successfully placed and activated on the patient, the Re:Balans will collect impedance data over a period of up to 7 days. Re:Balans is a medical electrical equipment, non-sterile, and single-use device for intact skin only. Re:Balans is designed for use in clinic and home settings.

The data readout is performed on the Re:Balans software application compatible with iOS iPad.

The Re:Balans device is an assessment tool. It is not intended to be a medical diagnostic device. This monitor is intended to be operated by technically qualified medical personnel.

The physician or designated healthcare provider is responsible for interpreting what assessment, intervention, or action is required as a result of changing impedance values.

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