Insertable Cardiac Monitor

Reveal Insertable Cardiac Monitor

Reveal DX and Reveal XT ICMs are MR conditional,* allowing the ability to safely provide MR testing, when used according to the instructions provided in the clinicians manual. The devices include two surface electrodes to continuously monitor a patient's subcutaneous ECG. They contain no lead wires or large loops of electrically conductive material.

Magnetic and radio frequency (RF) fields produced by MRI may adversely affect the data being stored by the Reveal ICMs. Also, since the ICMs contain ferromagnetic components, the strong magnetic field of the MRI system may apply a mechanical force on the ICMs. The patient may be able to feel this magnetic force on the ICMs. While this does not represent a safety hazard, the patient must be made aware of this possibility to avoid undue patient concern.

Although the Reveal ICMs are considered conditionally safe for use in the MRI environment when used under the specified conditions, other implanted devices or the patients individual medical condition might have an impact on safety and might require additional examination. If applicable, user manuals for the other implanted devices, including abandoned leads, should be consulted before conducting the MRI scan.

Patients with a Reveal ICM that has been implanted for less than 6 weeks are contraindicated for an MRI procedure. The 6-week post-implant waiting period allows sufficient time for implant pocket and wound healing and minimizes the effects of tugging on the device caused by the magnetic fields.

Patients with a Reveal ICM implanted in sites other than the subcutaneous region of the chest are contraindicated for an MRI procedure.

*Reveal DX and Reveal XT ICMs have been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. Please see Reveal DX and Reveal XT ICMs clinician manuals
for more details.