Brief summary statement

BRIEF SUMMARY STATEMENTS

BodyGuardian™ Remote Monitoring System

Indications for Use: The BodyGuardian™ Remote Monitoring System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional.

The BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients who are at least 29 days old in clinical and non-clinical settings to collect and transmit electrocardiogram (ECG) and other health parameters to healthcare professionals for monitoring and evaluation. Health parameters, such as heart rate and ECG data, are collected from external devices such as ECG sensors.

The BodyGuardian Remote Monitoring System does not provide any diagnosis.

Contraindications: The BodyGuardian Remote Monitoring System is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response.

Safety Precautions:

• Use ECG sampling rate of 500Hz with pediatric patients weighing less than 10 kg.

• Operating environments: Professional healthcare facility environment and home healthcare environment.

• The monitor IP Classification code is 67 when used with the Strip. When used underwater or showering with Bridge or lead set, the system is safe to wear on-body; however, data output will be temporarily affected. When the monitor is disconnected and exposed to water, the IPX rating is 0.

• EMC disturbances might cause interference and/or noise to data acquisition. To avoid negative effects on the BodyGuardian Mini electromagnetic compatibility, avoid using the monitor next to or stacked with other devices. Avoid using the monitor at a distance of at least 30 cm (12 inches) from portable RF communications equipment. Do not connect the monitor to other devices that are not intended to be connected to it.

• The strong environmental-based vibrations (for example driving on a bumpy road) can reflect on ECG monitor accelerometer data when the subject does not move.

Accelerometer data is not differentiated for various physical activities.

• The monitor does not have any electrical stimulation capabilities.

• Do not use a monitor if the casing is broken or damaged.

• Do not dispose of the monitors. Return monitors to your health care provider.

• Use accessories approved by Boston Scientific Cardiac Diagnostics only with compatible devices.

• This device provides an output for ST segment deviation; however, ST segment deviation has not been validated for the intended purpose of ischemia diagnosis.

Warnings:

• BodyGuardian Remote Monitoring System does not directly provide diagnosis. A supervising physician is responsible for ECG data interpretation.

• Do not attempt self-diagnosis or self-treatment based on acquired data.

• Do not use the BodyGuardian Remote Monitoring System monitor with high frequency (HF) surgical equipment or with an external defibrillator.

• Do not use the monitor in combination with an external cardiac defibrillator.

• If a patient has been given defibrillation with an external defibrillator while the monitor and applied part are connected to the patient, the monitor and applied part must be sent to manufacturer for checking before continuing device use.

• BodyGuardian Remote Monitoring System monitor cannot be worn while undergoing an MRI or a surgical procedure.

• Patients who have an active implantable medical device (e.g., heart pacemaker or other active implantable device), should consult supervising physician or doctor before use.

• To avoid danger of electrical shock and electromagnetic disturbances, the computer and associated equipment used with the monitor should comply with IEC/EN 62368 (Audio/video, information and communication technology 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 fulfils the requirements.

• Do not touch parts of the computer, docking station or any non-medical electrical equipment and the patient at the same time when operating the monitor.

• The physician must determine if an artifact caused by radiated interference will have a negative impact on measured ECG signal quality and the subsequent diagnosis.

• Do not disassemble, try to repair, or modify the monitor.

• Prop 65: Warning for California residents. Cancer and reproductive harm. For more information go to: www.P65Warnings.ca.gov.

• BodyGuardian Remote Monitoring System is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.