• PulseOn Arrhythmia Monitor system provides indication of possible arrhythmias to doctors but it does not provide diagnosis.

• The automated analysis result is not a diagnosis, and the results shall be reviewed by a trained professional (e.g. cardio-tech or cardiologist) in order to verify the result, and additional information may be needed before a trained professional can establish a complete diagnosis.

• It may be difficult to notice arrhythmia from the ECG signal if the heartbeat rhythm is not irregular and the heartrate is slow. This may be the case for example with atrial flutter; it is possible that the flutter waves of the atrial contractions are not clearly visible in Lead I ECG signal.

• It is also possible that with some people normal p-waves are not clearly visible in Lead I ECG signal.

• According to current care guidelines, atrial fibrillation is the only cardiac arrhythmia that can be diagnosed from single-lead ECG such as PulseOn arrhythmia monitor. If suspecting other arrhythmia, confirm the diagnosis with other methods recommended by your local care guideline, such as 12-lead ECG.

• In case of atrial fibrillation, verify that your local care guideline allows diagnosis with single-lead short-term ECG

• Optical arrhythmia detection is based on analysis of heartbeat interval variations. Cardiac arrhythmias showing stable rhythm such as common types of atrial flutter are thus not recognized by the optical measurement device.

• Polarity of the ECG depends on the hand where the device is worn. ECG algorithms recognize the polarity and convert the signal if needed (the signal needs to be converted if the device is worn on the right hand). The polarity recognition is however not always perfect and it is possible that the ECG is shown with incorrect polarity.

• The wrist device is waterproof (IP57) until 1 meter under water, but moisture can cause issues with measurements.
    • The device should be taken off when swimming or going to a sauna.
    • The device can be worn while showering, taking a bath or doing housework such as washing dishes or doing laundry, but drying the wrist and the device may be necessary afterwards in order to be able to take an ECG measurement.
    • A moist (for example sweaty) or wet hand can prevent initiating an ECG measurement. Strive to make measurements with dried palm and wrist.
    • Strive to keep the space between the wrist device and the skin both clean and dry. If necessary, take the device off to clean and dry both the wrist and the bottom of the device with a soft cloth.
    • A wet environment, such as a shower, can cause accidental ECG measurements to start and the device to give the relevant notifications erroneously. These notifications should be ignored.

• If red LED light on top of the wrist device is continuously on, the device is in irrecoverable error mode. Please contact the personnel that provided the device for you.

• Damaged or suspected inoperative equipment must be removed from use and be checked and repaired by qualified service personnel prior to continuing the use.

• Only accessories and detachable parts mentioned in this user guide should be used with the PulseOn Arrhythmia Monitor. Only the supplied charger should be used to recharge the device.

• Battery low notification. When the wrist device battery is running low, the device will vibrate every 30 minutes and continuously – but faintly – blink red until it is set into the charging dock. Low battery warning does not disrupt any normal functions of the device. To ensure prolonged proper functioning of the device it should be recharged.

• During charging in maximum usage temperature (38 °C), the wrist device may heat up to 42 °C. Once removed from the charger and taken into use, the device will cool down. During normal operation the device does not heat more than 1 °C over ambient or wrist temperature.

• Motion affects performance of the wrist device. PPG based arrhythmia analysis is performed when the patient is stationary. When taking an ECG measurement the patient should stay still.

• Non-scheduled ECG measurement notification may sometimes be triggered due to signal artefacts or by the user having high non-pathological heart rate variation.

• The wrist device is not intended to be used at the same time with high frequency (HF) surgical equipment or with a defibrillator. Defibrillator may break the device; the wrist device is not defibrillation-proof.

• The wrist device is not intended to be used in magnetic resonance imaging (MRI) environment.

• The device is not intended to be used with a pacemaker.

• Healthcare professional should inspect the equipment for damage or excessive wear prior to each use.

• The equipment should be used by only one patient at a time.

• The wrist device and other parts of the system should be properly cleaned between each patient. Refer to the cleaning instructions within this user guide.

• The device needs to be configured for each patient by a healthcare professional. Refer to the instructions within this user guide.

• Correct tightness of the wrist band is important for optimal wrist device contact with skin for good operation of the device. Refer to the instructions within this user guide.

• No modification of the equipment is allowed. Do not try to disassemble, repair, or modify any parts of the equipment.

• The device or its accessories should not be serviced or done maintenance on while worn or in use.

• Charging dock can be connected to a personal computer (PC) to download/upload wrist device data. Only a CE approved PC complying with IEC 60950-1 or similar safety standard shall be used. The PC shall be kept outside of the patient environment and shall have only restricted access.

• To prevent possible damage to the equipment, the following environmental conditions must be adhered to:
          • Operating Temperature: +5 to +38 °C
          • Storage Temperature: -20 to +60 °C
          • Relative Humidity: 5 to 90%, non-condensing
          • Ambient Air Pressure: 700 to 1060 hPA