AeroPace Safety Information
Intended Use
The AeroPace System is intended for temporary stimulation of the phrenic nerve(s) to increase diaphragmatic strength. The AeroPace System is intended for use in hospitals and hospital-type facilities which provide care for patients requiring mechanical ventilation. The device is intended to be used by appropriately trained personnel under the direction of a physician.
The AeroPace Neurostimulation Catheter is intended for use as part of a Lungpacer System, and for short-term (< 30 days) central venous access for administering IV fluids, blood products, medications, and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.
Indication for Use: The AeroPace System is indicated to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on mechanical ventilation ≥ 96 hours and who have not weaned.
Intended Use
The AeroPace System is indicated to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on mechanical ventilation ≥ 96 hours and who have not weaned.
Contraindications
Do not use the AeroPace System with active implanted cardiac pacemakers, defibrillators, or other implantable electronics within proximity to the AeroPace Neurostimulation Catheter. The AeroPace System has not been clinically evaluated for safety with these implantable electronic devices.
AeroPace System Warnings: Read all AeroPace System warnings, cautions, and instructions prior to use. Failure to observe warnings for the AeroPace System may result in severe injury or death.
AeroPace System Warnings
Read all AeroPace System warnings, cautions, and instructions prior to use. Failure to observe warnings for the AeroPace System may result in severe injury or death.
Potential Complications Associated with Central Venous Catheters
Adverse tissue response • Allergic reaction • Arrhythmia • Bleeding / Hemorrhage • Bradycardia • Bruising, swelling or seroma at insertion site • Cardiac structure damage • Central line-associated blood stream infection • Cerebrovascular event • Discomfort • Embolism • Hematoma • Hemothorax • Hypertension / hypotension • Inadvertent arterial or venous puncture • Infection • Lung injury • Lymphatic / thoracic duct injury • Mediastinal injury • Nerve injury • Pain, tenderness, swelling, discomfort at access site • Pneumohematoma • Pneumomediastinum • Pneumothorax • Procedural complications • Pseudo aneurysm or AV fistula at access site • Sepsis • Seroma • Skin irritation • Syncope • Thrombosis / stenosis • Tissue inflammation, fibrosis or damage • Vessel occlusion • Vessel wall damage / perforation • Wound healing issues • Wound infection / phlebitis
Potential Complications Associated with Diaphragm or Phrenic Nerve Stimulation
Arrhythmia • Bradycardia • Diaphragm injury • Discomfort • Hypercapnia / hypocapnia • Hypoxia • Liberation of lung mucus plugs/secretions • Muscle fatigue or discomfort • Nerve injury • Pain or discomfort during stimulation • Inappropriate stimulation • Phrenic nerve damage or injury • Syncope