1.1 GENERAL WARNINGS, PRECAUTIONS AND SAFETY

A warning alerts FX+ users about situations which, if not avoided, could result in death or serious injury or other potential serious adverse reactions or safety hazards.

A precaution describes situations which, if not avoided, may result in minor or moderate injury or damage to the equipment or other property or to alert against unsafe practices.The word caution may also be used as the signal word for a precaution statement.

General safety statements contain important additional information about using the FX+.

• THE FX+ SHOULD NOT BE USED IN CASE OF EMERGENCY. IN CASE OF EMERGENCY, IMMEDIATELY CONTACT 911 OR YOUR LOCAL EMERGENCY SERVICES

• Do not immerse or expose FX+ to water, excessive perspiration or any other liquids, fire, explosion, or other hazards.

• Do not leave FX+ unattended around children or persons who cannot express their consent to use.

• The FX+ is not intended for diagnosis or treatment of cardiac conditions. This device should never be used as a basis for starting or modifying treatment without independent confirmation by professional medical examination.

• This device does not detect or measure all heart rate, heart rhythm and heart waveform changes, especially those related to ischemic heart conditions, LVH, Bundle branch block or other conditions requiring precise electrode placements.

• The FX+ contains small parts (USB covers) which are a choking hazard. Keep covers stored in the provided packaging and out of reach of small children and pets when not attached to the device. Keep the device in its packaging out of reach of small children and animals when not in use.

• The FX+ should not be used with a cardiac pacemaker, ICDs, or other implanted electronic devices.

• Do not wear the strap on top of open wounds.

• Do not use the FX+ in environments containing explosive gases or high oxygen concentrations.

1.1.b. Precautions

• Do not attempt to charge the FX+ while wearing it. The FX+, the charging function will not work.

• Do not use a power cable that is not approved or supplied by Fourth Frontier.

• No modification of this equipment is allowed.

• Do not perform any modifications to FX+ or its charging cable to allow wearing FX+ while recharging.

• Do not use FX+ for any purpose other than as specified in this User Manual.

• Do not bend or drop the FX+ device module.

• Do not apply excessive force, shocks or vibrations to FX+, as this may result in damage to the device.

• Do not expose FX+ to temperatures outside the storage or operating range.

• Do not expose FX+ to direct sunlight for extended periods of time.

• Do not disassemble, modify, remanufacture, puncture or damage FX+.

• Your FX+ has an IP rating of IP22 under IEC standard 60529 therefore it is not intended to be water resistant

• The FX+ should not be used on broken or irritated skin.

• Avoid using sunscreen or other lotions under the FX+ as it may affect signal quality.

• Although the device is not intended to be used in a hospital environment this device is susceptible to interference from RF energy sources (lowered RF immunity) which exceed the IEC 60601-1-2 limits, such as power line bursts, other medical devices, and certain cellular products, information technology equipment and radio/television transmission.

• Do not expose yourself to strong electromagnetic fields.

• Artifacts on the ECG caused by electromagnetic interference should be evaluated by physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment.

• Do not go swimming or bathing with your FX+ or wear your FX+ in a sauna or steam room.

• Do not expose your FX+ to pressurized water or high velocity water, for example, water skiing, wakeboarding, surfing, jet skiing, and so on.

• Self-diagnosis of measurement results and self- treatment are potentially dangerous. You should always consult your doctor.

• Like all electronic devices, this cardiograph is susceptible to electrostatic discharge (ESD). Electrostatic discharge typically occurs when electrostatic energy is transferred to the patient, the electrodes, or the cardiograph. ESD may result in ECG artifacts that may appear as narrow spikes on the cardiograph display or on the printed report. When ESD occurs, the cardiograph’s ECG interpretation may be inconsistent with the physician’s interpretation.

• The risk of external devices with spurious emissions in 2.4GHz spectrum interfering with bluetooth communication causing a delay in data transfer. The equipment which can cause such interference includes induction cooktop, microwave oven etc.

• Exclusions for the FX Plus include hospitals, MRIs and other areas of high EM disturbances

• Do not take a recording if the chest strap is not clean. Please review the Cleaning Section 5.2.c.

• Do not charge unless the charging port is dry, particularly the inside of the micro-USB port. Failure to do so can cause issues such as slow charging or overheating.

• The device shall only be charged using the charger provided in the box which is rated between 0.5 - 1 A,5V and is 60601-1 Certified.

• Please read the User Manual carefully before using the FX+ ECG monitor.

• This device is not to be used by patients who have a pacemaker. If you have an internal electronic device, consult your physician before using an ECG monitor, like FX+.

• ECG PDF reports display the ECG at standard magnification. The Web App allows magnification other than 100% which may appear distorted and could lead to misinterpretation.

• Ensure you have an adequately charged phone for functions such as live stream ECG and data sync to prevent disruption of data transmission.

• Telecommunications, network, computer, server or Internet downtime-related coverage limitations could significantly delay transmission and analysis of patient monitoring data. Patients should contact Fourth Frontier immediately if problems are experienced using the system or if signs of physical discomfort occur, and to discontinue use of the system if the physician or Fourth Frontier believe service discontinuation is advisable.”

1.1.c. General Safety

• FX+ is not intended to be a replacement for a 12- lead ECG.

• FX+ has features that are only available to those users who are under the care of a physician. These features are available to prescription users only and may not be available in all regions or all languages.

• If you suffer from an irregular heartbeat, measurements taken with this device should be evaluated with your doctor.

• This device may only be used for the purposes described in this User Manual. The manufacturer cannot be held liable for damage or injury caused by incorrect use. Always follow the operating procedures described in this User Manual.

• The FX+ has features that are only available to those users who are under the care of a physician. These features are available to users with a prescription for the FX+.

• The FX+ is not intended for use on an ambulance or in a hospital environment

• Do not take recordings in close vicinity to other equipment emitting ultrasonic acoustics.

• Do not use the sensor on a portion of the body with too much body fat, body hair or very dry skin, a successful recording may not be possible.

• Fourth Frontier warranty is invalidated as a result of abuse, alteration, misuse, neglect, or failure to maintain the products as instructed. Interpretations made by this device are potential findings, not a complete diagnosis of cardiac conditions.

All interpretations should be reviewed by a medical professional for clinical decision making.

• Allow the device to return to normal room temperature before use or charging if potentially stored or transported outside of normal operating temperature, pressure and humidity conditions. It is recommended that it is stored at room temperature on initial receipt for 24 hours before first use.

• Allow the device to cool from the maximum storage temperature between uses for at least 24 hours until it is ready for intended use.

• Allow the device to warm from the minimum storage temperature between uses at least 24 hours until it is ready for intended use.

• Do not use Fourth Frontier X plus with any competitor or third party product. Only use approved Fourth Frontier chest straps and USB cable accessories as this could affect the electromagnetic immunity and or result in improper operation.

• Always consult your physician before you begin or modify any exercise program.

• Users should notify their doctor of a possible change in health: a labeling of the ECG as normal should not be relied on as a guarantee of absence of arrhythmias or other health conditions.

• The heart rate analysis is only valid if there is a valid rhythm (QRS complex visible).