Introduction
Zonar GPS units include a cellular modem to facilitate communication. These cellular modems are very similar to the radio frequency (RF) components found in consumer-grade cellular phones. As such, cautionary measures applicable to cell phones regarding pacemakers also apply to Zonar GPS units.
General FDA Information
The U.S. Food and Drug Administration is aware of the potential for RF producing equipment to interfere with pacemakers. The following is an excerpt from the FDA website discussing this issue:
Radio frequency energy (RF) from cell phones can interact with some electronic devices. This type of interference is called electromagnetic interference (EMI). For this reason, FDA helped develop a detailed test method to measure EMI of implanted cardiac pacemakers and defibrillators from cell phones. This test method is now part of a standard sponsored by the Association for the Advancement of Medical Instrumentation (AAMI). This standard will allow manufacturers to ensure that cardiac pacemakers and defibrillators are safe from cell phone EMI.
FDA continues to monitor the use of cell phones for possible interactions with other medical devices. Should harmful interference be found to occur, FDA will conduct testing to assess the interference and work to resolve the problem.
Thus, manufacturers of pacemakers test their devices to make sure that their pacemakers are not at risk when combined with normal cell phone use.
The FDA advises that pacemaker users adopt the following cell phone habits: (1) Hold the phone to the ear opposite the side of the body where the pacemaker is implanted to add some extra distance between the pacemaker and the phone, and (2) Avoid placing a turned-on phone next to the pacemaker implant (e.g. don’t carry the phone in a shirt or jacket pocket directly over the pacemaker).
Zonar Equipment Considerations
Zonar recommends installing GPS units at least 10 inches (25 cm) away from the driver. In practice, GPS installations tend to be 12+ inches from the driver, significantly reducing the chance of interference.
Additionally, all of Zonar’s cell phone based GPS devices have been approved by the FCC.
In summary, the FDA has developed procedures for medical device manufacturers to use to ensure that pacemakers can be used in environments where cell phones are present, studies have shown that there is little risk of cell phone interference with properly designed pacemakers so long as the cell phone is not placed immediately adjacent to the pacemakers (i.e., over the chest), and when properly installed in vehicles Zonar cell phone based GPS devices will be much farther away from a driver than his or her personal cell phone.