Basic HTML Version

|  | Table of Contents |  | View Full Version

Page 5 - Abbott
P. 5

    Description
                    The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart
                    failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
                    The system includes the following components:
                       Implantable wireless sensor with delivery catheter
                       Patient or Hospital Electronics System
                       Patient database
                    The wireless sensor is designed for permanent implantation into the distal pulmonary artery. Once implanted, the CardioMEMS PA
                    Sensor provides non-invasive hemodynamic data that is collected in the physician’s office, clinic, hospital, or patient’s home. The
                    data provided by the system includes:
                       PA pressure waveform
                       Systolic, Diastolic, and Mean PA pressure
                       Heart Rate
                    This hemodynamic data is transmitted to a secure website that serves as the patient database so that PA monitoring information is
                    available at all times through the internet. Changes in PA pressure can be used in conjunction with heart failure signs and symptoms
                    to guide adjustments to medications.
                    For information on the use of the sensor, please refer to the User’s Manual. For information on the operation of the patient database,
                    please refer to the Merlin.net™ Patient Care Network Heart Failure Management Application Help Manual. For clinical study
                    information, please refer to the Clinical Study Information section.
                    Indications
                    The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in
                    New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year.
                    The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure
                    hospitalizations.
                    Contraindications
                    The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month
                    post implant.
                    Warnings
                    Before use of the system, read this guide.
                       Only trained personnel should use this product.
                       Avoid excessive or damaging force when using the Hospital Electronics System (Model # CM3000).
                       Do not change the system configuration without authorization from the manufacturer.
                       If two electronic units are proximate to each other and are used at the same time, pressure measurements may be affected due
                       to interference between the two systems. In such isolated cases, it is recommended that operation of each electronics unit
                       occur at separate times.
                       Two hospital electronics systems may interfere with each other. Only operate one electronics unit at a time in the same general
                       vicinity.
                       The CM3000 requires special precautions regarding electromagnetic compatibility (EMC) and needs to be placed into service
                       according to the EMC information provided. If interference is noted, remove or stop using the interfering equipment.
                       The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold
                       by the manufacturer of the CM3000 as replacement parts for internal components, may result in increased emissions or
                       decreased immunity of the CM3000. The use of other attachable parts other than the parts provided may result in inaccurate
                       readings, damage to the system, or injury to the user.
                       The CM3000 should not be used adjacent to or stacked with other equipment. If it is necessary to operate adjacent or stacked
                       with other equipment, observe the CM3000 to verify normal operation in the configuration in which it will be used.
                       Other equipment may interfere with the CM3000 operation, even if the other equipment complies with CISPR emission
                       requirements. Refer to the EMI/EMC and Troubleshoot Procedure sections for guidance.
                       There are minimum amplitudes for the CM3000 to measure physiological signals. Operation of the equipment below the
                       minimum amplitudes may cause inaccurate results.
                       Do not attempt to connect the Hospital Electronics System to any network or data coupling equipment in the hospital other than
                       those specified.
                       Follow instructions on shutting down equipment. Failure to do so may cause file corruption.
                       While in use, ensure that the power supply is easily accessible since unplugging the device from the outlet is the only means of
                       completely isolating from mains.
                       Ingestion of any part of the system may cause injury.
                       Care should be taken to keep all cables away from the neck and face to prevent airway blockage.
                       Patients should be advised that if they develop redness of the skin or a change in skin sensitivity occurs, they should
                       discontinue use of this product immediately and contact their physician.

                                                                1

| 1 2 3 4 5 6 7 8 9 10 |