The Sleuth system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:

• Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• Patients who experience transient symptoms that may suggest a cardiac arrhythmia

There are no known contraindications to the Sleuth HD-ILR or subcutaneous Antenna (Antenna). However, contraindications may exist to the implantation of any subcutaneous, chronically implanted device. Therefore, the individual patient's medical condition must be considered.

To avoid damage to their implanted HD-ILR, patients should avoid diathermy, unipolar electrocautery, therapeutic ultrasound, and therapeutic and ionizing radiation. The HD-ILR will function normally after but possibly not during diagnostic ultrasound, bipolar electrocautery, electromagnetic interference (EMI), external defibrillation, internal defibrillation, lithotripsy, magnetic resonance (MR) imaging, and x-ray. Following any of these procedures, verify proper HD-ILR function. Refer to the Instructions for Use manual for precautions, implant procedures, programming information, and product specifications.

The Sleuth high-definition implantable loop recorder (HD-ILR) triggers automatic detection of bradycardia or tachycardia when heart rate thresholds are exceeded as set by the physician. The Sleuth system does not automatically classify different types of arrhythmias. Classification of recorded events as specific arrhythmias, including atrial fibrillation, is accomplished by interpretation of the recorded ECG by medically qualified individuals.

Federal law (USA) restricts this device to sale by or on the order of a physician.