General Cautions

Security Screening

There have been no reported interactions between a breathing pacemaker system and any of the enhanced screening technology now in use at airports worldwide.

X-ray backscatter devices, whether active or passive, operate in the X-ray band of the electromagnetic spectrum. Millimeter wave scanner use extremely high frequency radio waves which are far above those used to power the implanted receivers. Based on this information, the likelihood of an adverse interaction between those screening technologies and a breathing pacemaker system is nearly zero. However, ABD has not conducted scientific testing to validate that statement. Therefore, it is left to each patient’s discretion to decide if they wish to go through the enchanced security procedures or opt for a manual search.

The US Food and Drug Adminstration has released the following information:
Products for Security Screening of People

The US Transportation Security Administration has released the following information:
Advanced Imaging Technology

The UK Department for Transport has released the following information:
Information on the Implementation of Security Scanners

Insurance Policies

Due to the costs involved in replacing an external transmitter, ABD highly recommends that the patient’s external transmitter be covered against loss under an insurance policy. This can be done either as a separate policy or as a rider to an existing homeowner’s or renter’s policy. Please contact the ABD accounting department if you require an invoice or other documentation for this purpose.

Product Samples

In addition to your proprietary designs, we have dozens of cuff and button-style electrode configurations available for rapid deployment. Examples include:

e325
e377
e327
extension
accessories

Common variables include contact size, contact spacing, and lead length. A variety of lead terminations, including IS-1 connectors, are available to mate your custom electrode design to commercially available IPGs and external test confiurations. Single and dual-channel radiofrequency transmitters with implantable receivers are optional.

Physical samples and prototyping available upon request.

General Cautions

The “General Cautions Regarding Diaphragm Pacing” section of the Instruction Manual states the following:

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 the cardiac pacemaker. 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:

pdf MRI-Caused Injuries in Patients with Implanted Neurological Stimulators

pdf Diathermy Interactions with Implanted Leads and Implanted Systems with Leads

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.