SCI Statement of Intended Use, Warnings, Precautions, Side Effects, and Contradications

NeuRx RA/4 Diaphragm Pacing System®

Product technical manual must be reviewed prior to use for detailed disclosure.

Intended Use

The NeuRx® RA/4 is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.

Contraindications

The NeuRx® RA/4 is contraindicated in patients whom the physician determines are not candidates for surgical procedures due to physical or mental conditions.

Warnings/Precautions/Adverse Events

This device should be kept out of the reach of children. Safety has not been established for pregnancy, patients under the age of 18, patients with suspected or real heart problems, or patients who have implanted electrical devices or epilepsy. The long-term effects of electrical stimulation of the diaphragm are unknown. This device is electrically powered and may produce tissue damage or electrical hazard if improperly used. The system may be affected by excessive moisture, severe mechanical shock, diathermy, electro cauterization, and radiation therapy. Implanted patients should not be connected to high-frequency surgical equipment or subjected to magnetic resonance imaging (MRI). Care should be taken to avoid operation of this device in close proximity to shortwave or microwave therapy equipment. Discontinue use of this device if skin in the implant area becomes swollen, infected, or inflamed or if there are skin eruptions such as phlebitis, thrombophlebitis, or varicose veins. Adverse events related to the system include capnothorax, equipment failure leading to loss of breathing, infection, airway compromise, spasms, pain or discomfort with stimulation, and difficulty eating. Patients must have a mechanical ventilator available at all times.

Humanitarian Use Device

Authorized by Federal Law for use in the treatment of respiratory insufficiency for high-level spinal cord injured patients. The effectiveness of this device for this use has not been demonstrated. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

For More Information, Contact:

Synapse Biomedical, Inc.
300 Artino Street
Oberlin, Ohio 44074
Tel: 888.767.3770
Fax: 440.774.2572
info@synapsebiomedical.com

Synapse Biomedical Europe S.A.R.L
156 Place des Aubépines
95680 Montlignon, France
Tel: +33 (0)9.60.12.44.98
Fax: +33 (0)1.74.18.08.19
mdiop@synapsebiomedical.com