How to Use Your BodyGuardian Monitor

(BODYGUARDIAN: Indications, Safety and Warnings)

BodyGuardian™ MINI and MINI PLUS

Intended Use: The BodyGuardian MINI is intended for use in clinical long-term ambulatory ECG monitoring, data transfer and analysis. BodyGuardian MINI is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments. The sensor does not provide interpretive statements. Final interpretation and diagnosis is the responsibility of a physician. Contraindications: The sensor is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias and for use on pediatric patients weighing 22 lbs. (10kgs) or less. Safety Precautions: The sensor does not directly provide diagnosis as a supervising physician is responsible for ECG data interpretation. Do not disassemble, try to repair, or modify sensor. Sensor does not have any electrical stimulation capabilities. Warnings: Do not attempt self-diagnosis or self-treatment based on acquired data. Not suitable for use in MRI environment. Patients with known skin allergies or hypersensitivities to adhesives or hydrogel may experience reactions. Patients should consult with their health care professional to select a BodyGuardian MINI Strip or alternate electrode option that is most appropriate for their needs. Apply the BodyGuardian MINI Strip or alternate electrode only to intact, clean skin. Do not apply over open wounds, lesions, infected or inflamed areas. The BodyGuardian MINI Strips are for single patient use only. The device is not intended to be used at the same time with high frequency (HF) surgical equipment or with a defibrillator. Patients who have active implantable medical device (for example a heart pacemaker), should consult supervising physician or doctor before use. When using the MINI ECG monitor connected in Bluetooth mode (in the MINI Plus configuration) the monitor should be kept within 10 feet (approximately 3 meters) to the companion device (smartphone) to facilitate wireless communication. To avoid danger of electrical shock and electromagnetic disturbances, the computer and associated equipment used with the ECG Sensor should comply with IEC/EN 60950 (IT and office equipment safety) or EN60601-1 (Medical electrical equipment safety) standard. If a computer that does not comply with the IEC/EN 60601-1 requirements is used in the patient environment, the computer and peripherals must be plugged in using an isolation transformer that fulfills the requirement.

Download Instructional Guides

BodyGuardian MINI
Instructions for Use

BodyGuardian MINI PLUS
Patient Guide

BodyGuardian MINI PLUS
Quick Start Guide

Watch Instructional Videos

BodyGuardian MINI PLUS Strip
Instructional Video

BodyGuardian MINI PLUS Bridge
Instructional Video

BodyGuardian MINI PLUS Lead Wires
Instructional Video

Medical Professionals

patients

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Professionals

patients

About Us

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How to Use Your BodyGuardian Monitor

Download Instructional Guides

BodyGuardian MINI Instructions for Use

BodyGuardian MINI PLUSPatient Guide

BodyGuardian MINI PLUS Quick Start Guide

Watch Instructional Videos

BodyGuardian MINI PLUS StripInstructional Video

BodyGuardian MINI PLUS BridgeInstructional Video

BodyGuardian MINI PLUS Lead WiresInstructional Video

Medical Professionals

patients

About Us

Contact Us

Professionals

patients

About Us

Contact Us

BodyGuardian MINI
Instructions for Use

BodyGuardian MINI PLUS
Patient Guide

BodyGuardian MINI PLUS
Quick Start Guide

BodyGuardian MINI PLUS Strip
Instructional Video

BodyGuardian MINI PLUS Bridge
Instructional Video

BodyGuardian MINI PLUS Lead Wires
Instructional Video