The Alert Module of the CareLine HF-Platform is a Class IIa medical device software performing automated multiparametric analyses of patients’ physiological parameters using customizable algorithms and generating related alerts to support remote management of chronic heart failure with the CareLine-HF Platform. It is intended to be used by healthcare professionals providing care to chronic heart failure patients under the supervision of a heart failure specialist.
Remote management of heart failure is not intended to ensure continuous monitoring of patients or provide them with emergency care. Patients should be informed and educated accordingly.
Read carefully the healthcare professional instructions for use.
The CareLine HF-Platform is on the French Assurance Maladie’s reimbursement list for remote medical monitoring activities mentioned by article L. 162-52 of the French Social Security Code. Coverage is conditional to the activities being operated by a declared remote monitoring operator and to the patient following a therapeutic educational program.
