A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of the Dayspring Technology for Patients With Breast Cancer Related Lymphedema (BCRL) After Lymphatic Surgery

Exclusion Criteria

• •Individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
• •Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• •Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
• •Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
• •Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
• •Diagnosis of lipedema
• •Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study
• •Diagnosis of acute thrombophlebitis (in last 2 months)
• •Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• •Diagnosis of pulmonary edema
• •Diagnosis of congestive heart failure (uncontrolled)
• •Diagnosis of chronic kidney disease
• •Diagnosis of epilepsy
• •Patients with poorly controlled asthma
• •Women who are pregnant, planning a pregnancy or nursing at study entry
• •Participation in any clinical trial of an investigational substance or device during the past 30 days
• •Bilateral limb edema