The Frontier X Plus ECG monitor is intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation. It is intended for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring such as palpitations, shortness of breath, dizziness, lightheadedness, presyncope, syncope, fatigue, or anxiety. The Frontier X Plus ECG monitor is not intended to provide diagnostic interpretation to the patient. The Frontier X Plus ECG monitor is a prescription-only device, and the reported information is provided for review by a physician to render a diagnosis based on clinical judgment and experience. Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which she/he practices to use or order the use of the device
- Should not be used by individuals under the age of 22 years.
- Do not use it in case of potentially life-threathening arrhythmias requiring hospitalization or when real time or in-patient monitoring should be prescribed.
- Do not use it in combination with external cardiac defibrillators or high frequency surgical equipment.
- Although the device is not intended to be used in a hospital setting but should not be used in combination with MRI or near strong magnetic fields.
- Do not use a defibrillator with the device on as it may damage the device, post which it may not perform as intended. Please move the device from the defibrillator electrode placement areas
- Frontier X Plus is not indicated to be used by pregnant women.
- Do not use it in case of injuries or injured skin near the chest strap.
- Frontier X Plus should not be used for detection of cardiac conditions such as ischemia, myocardial infarction, LVH.
- After ECG analysis, the app may identify ventricular flutter, ventricular bigeminy, and ventricular trigeminy heart conditions as unreadable. Please consult with your physician.
- Fourth Frontier does not guarantee that you are not experiencing an arrhythmia or other health conditions when labeling an ECG as normal. You should notify your physician for possible changes in your health.