Federal (USA) law restricts this device to sale by or on the order of a physician.

Failure of the diaphragm pacer could lead to respiratory arrest.

A device for providing artificial ventilation by mask, mouth piece, or tracheal tube should be available for those patients who are continually dependent on the phrenic pacemaker as an alternative to mechanical ventilation.

An apnea alarm should be provided to summon help should diaphragm pacer failure occur.

Failure of the diaphragm pacing system can occur due to battery failure, broken battery connector wire, or intermittent antenna cable or connector, or component failure in the receiver, electrode wire, or external transmitter.

Monopolar diaphragm pacing may interfere with demand-type cardiac pacemakers. If a cardiac pacemaker is involved, it is advisable to use bipolar electrodes for both the cardiac and diaphragm pacemakers. The electrodes should be at least 10 cm. from the heart pacemaker.

Magnetic Resonance Imaging (MRI), shock wave lithotripsy, and diathermy are contraindicated. If use of a defibrillator is necessary, the implanted receiver and the phrenic nerve could be damaged.

Note: The US FDA has released the following relevant public health notifications:

The safety of diaphragm pacing in pregnancy has not been established.

Exposure to a powerful transmitter such as navigational, maritime or amateur communications may interfere with the operation of the pacer. According to U.S. F.C.C. and foreign tables of frequency allocation, transmissions in the 2 MHz region may include: Radio navigation (LORAN-A), mobile distress, and emergency position indicating radio beacon (EPIRB) for aircraft.

Exposure to therapeutic dosages of ionizing radiation may damage implanted components or interfere with the operation of the pacer. Any damage to the implanted components may not be immediately detectable.

Exposure of the implanted components to therapeutic levels of ultrasound energy should be avoided as an implanted device may inadvertently concentrate the ultrasound field and cause harm.

Diaphragm pacing systems should not be used aboard commercial aircraft without prior clearance with the pilot or airline.

Any implant removed from one patient must not be reimplanted in another patient.

One patient's transmitter must not be used for another patient.

Do not use any other stimulating equipment with our diaphragm pacer implants. This voids the warranty, and could cause serious injury or death.

A permanent tracheostomy may be required to obtain adequate ventilation. Diaphragm pacing can induce or worsen upper airway obstruction. Augmentation of the force of inspiration and laryngeal and pharyngeal musculature is the probable cause.