Indications, Safety and Warnings
Indications for Use (US)
The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, in-hospital monitoring for life threatening arrhythmias.
The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and nonclinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation.
Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, weight scales, blood pressure meters and pulse oximeters.
The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.
- Patients with known skin allergies or hypersensitivities to adhesives or hydrogel may experience reactions. Patients should consult with their healthcare professional to select a BodyGuardian Strip or alternate electrode option that is most appropriate for their needs.
- Do not modify this equipment without authorization of the manufacturer.
- United States federal law restricts the device to sale by or on the order of a licensed practitioner or therapist.
- Exposure of the wireless communications features of the device, or its accessories, may be interfered with by other devices that operate on the same frequencies.
- Monitors are not defibrillation proof.
- Do not touch the connectors of the power supplies while wearing BodyGuardian Heart.
- Apply the Strip only to intact, clean skin. Do not apply over open wounds, lesions, infected or inflamed areas.
- Do not use lotions, oils or sprays on skin location where you will apply the Strip.
- This device is for single patient use only.
- BodyGuardian Heart is not intended for infants weighing less than 10 kg.
- Do not dispose of the monitors. Return monitors as directed by your healthcare provider.
- Do not use a monitor if the casing is broken or damaged.
- Do not disassemble the monitors.