General Cautions

Diaphragm Pacing System Recommendations

TRAVEL

SecurityScreening

There have been no reported interactions between a diaphragm pacing 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 diaphragm pacing 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 enhanced security procedures or opt for a manual search.

See Links Below

The US Food and Drug Administration has released the following information:

Products for Security Screening of People

“Millimeter wave security systems which comply with the limits set in the applicable national non-ionizing radiation safety standard . . . cause no known adverse health effects.”

The US Transportation Security Administration has released the following information:

Advanced Imaging Technology

* Click on Screening Technology on Gov Site.

“The Transportation Security Administration uses millimeter wave Advanced Imaging Technology to keep the traveling public safe. . . The use of Advanced Imaging Technology presents no health or safety concerns for any passenger. . .”

The UK Department for Transport has released the following information:

Information on the Implementation of Security Scanners

“All security scanners must use millimeter wave technology, as it poses no known health and safety risks. Millimeter wave scanners utilize a very low power, non-ionising form of electromagnetic technology. Non-ionising radiation refers to electromagnetic waves which do not alter atoms in molecules by removing electrons. The amount of electromagnetic radiation by millimeter wave security scanners is many times lower than that emitted by a mobile phone.”

Insurance Policies

Policy & Records

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.

Avery Diaphragm Pacing System General Warnings & Cautions

The “General Warnings, Cautions & Side Effects” Regarding Diaphragm Pacing section of the Instruction Manual states the following:

Warnings:

Failure of the Avery Diaphragm Pacing System could lead to respiratory arrest, hypoventilation, and/or death.
Failure of the diaphragm pacing system can occur due to battery failure, or intermittent antenna cable or connector, or component failure in the receiver, electrode wire, or external transmitter.
Infection may occur as a result of the surgical procedure, or in the postoperative period due to wound infection or septicemia. If unresponsive to antibiotics, removal of the implants may become necessary.
Any implant removed from a patient must not be reimplanted.
One patient’s equipment must not be used for another patient.
Do not use any other diaphragm pacing, phrenic nerve stimulation or other stimulating equipment to power our diaphragm pacer implants. This voids warranty and could cause serious injury or death.
Magnetic Resonance Imaging (MRI), shock wave lithotripsy and therapeutic diathermy are contraindicated.
Radio Frequency (RF) may interfere with demand-type cardiac pacemakers. If a cardiac pacemaker is implanted, the cardiac pacemaker leads should be bipolar and the breathing pacemaker receiver should be at least 10cm from the cardiac pacemaker.
The transmitter should not be used within one meter of flammable anesthetics or in oxygen-enriched environments.
If use of a defibrillator is necessary, the implanted receiver and the phrenic nerve could be damaged.
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.

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 aircrafts.
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.
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.
Close proximity to a cell phone may interfere with the operation of the pacer. Cell phones and WiFi-enabled devices should be kept a minimum of 10 cm from the implants.
The transmitter emits a low level of radiofrequency output at 2 MHz which may interfere with other devices in its proximity running at the same frequency.
Do not use the Avery Diaphragm Pacemaker in the presence of electromagnetic or other interference.
Use of the transmitter adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by Avery could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 20 cm (8 inches) to any part of the Spirit transmitter, including cables specified by Avery. Otherwise, degradation of the performance of this equipment could result.

Cautions:

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.
The safety of diaphragm pacing in pregnancy has not been established. Anticipatory guidance and contingency planning for changing ventilatory needs should be reviewed between you and your physician.
The safety of operating the diaphragm pacing system in all types of commercial aircraft environments has not been established.

The Avery Diaphragm Pacemaker has not been tested with other implanted or body worn medical device such as cardiac pacemaker, infusion pump, Implantable Cardioverter Defibrillators (ICDs), Functional Electrical Stimulation (FES), Vagal Nerve Stimulators (VNS) or cochlear implants. The Avery Diaphragm Pacemaker might interfere with operation of other medical devices including those implantable and body worn devices listed above.
Avoid getting closer than 30cm to EAS and metal detectors operating in the frequency ranges between 210Hz and 8.7MHz. Do not use this device around EAS and metal detectors outside of the above-indicated frequency ranges and be aware that EAS devices could be concealed and not visible.

• For further details request our Instructional Manual by contacting Customer Service below.

Customer Service

The Customer Service Department is happy to assist with troubleshooting and provide technical information regarding diaphragm pacing. Our hours are 8:00 am to 4:00 pm (EST) weekdays.