Effects of Scuba Diving and Hyperbaric Oxygen Therapy on SJM Confirm™ Implantable Cardiac Monitors
Hyperbaric oxygen therapy (HBOT) is the medical use of oxygen at a level higher than atmospheric pressure. A pressure chamber is used to deliver 100 percent oxygen. Scuba diving and Hyperbaric oxygen therapy (HBOT) may increase or decrease pressure gradients. Interference with normal device operation of an implanted SJM Confirm™ as a result of scuba diving or HBOT is not anticipated. It is important to note that the SJM Confirm™ provides no therapy to the patient and is a cardiac diagnostic monitor only.
SJM Confirm™ has been tested to an absolute level of five atmospheres (four atmospheres gauge pressure, or approximately 4.1 kg/cm2 (58 psi), at sea-level) with no effect on device function. HBOT should not interfere with or cause permanent damage to a device up to this tested limit. In addition, St. Jude Medical has not received any reports of a SJM Confirm™ being adversely affected by scuba diving or HBOT.
SJM Confirm™ should not be exposed to absolute pressures above five atmospheres or the equivalent depth of 40 meters (132 feet) of saltwater (four atmospheres above ambient sea-level pressure).
If you have any questions on this topic, please contact St. Jude Medical Technical Services at 46-8-474-4147 or 1-800-722-3774 (in the U.S.).
Effects of Scuba Diving and Hyperbaric Oxygen Therapy on SJM Confirm™ Implantable Cardiac Monitors (18.1kb)