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

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

• The automated analysis relies on the quality of the recorded signals. Signals with disturbances may cause problems for the analysis and may result in miss-detection, mislabelling or non-detection of events.

• The automated analysis software (ECG Parser) is not complete diagnostic ECG software. Only beat and rhythm classification, HR and HRV interval measurements are validated in the ECG Parser output. Other output parameters may be used for indication only.

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

• It is also possible that, for some subjects, normal p-waves are not clearly visible in the Lead I ECG signal.

• If many signals are rejected as poor-quality signals by the automated analysis, then:
     o seek alternative ECG examination using other means, and/or
     o make sure the ECGs are manually reviewed, despite the signals being rejected as being of poor quality.

• According to current care guidelines, atrial fibrillation is the only cardiac arrhythmia that can be diagnosed from single-lead ECG such as the PulseOn arrhythmia monitor. If another arrhythmia is suspected, 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.

• The polarity of the ECG depends on which hand the device is worn on. 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). However, the polarity recognition is not always perfect and the ECG may be displayed with incorrect polarity.

• The wrist device is waterproof (IP57) up to an underwater depth of 1 metre. Nevertheless, moisture can affect measurements.
     o The device must be taken off when swimming or having a sauna.
     o The device can be worn while showering, taking a bath or doing housework such as washing dishes or doing laundry. However, it may be necessary to dry the wrist and the device afterwards in order to be able to take an ECG measurement.
     o A moist (for example, sweaty) or wet hand can prevent the initiation of an ECG measurement. Try to make measurements when the palm and wrist are dry.
     o Try 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.
     o A wet environment, such as a shower, can cause accidental ECG measurements to start and the device may then the relevant notifications erroneously. These notifications should be ignored.

• If the red LED light on top of the wrist device is continuously on, the device is in unrecoverable error mode. Please contact the personnel that provided the device. NOTE: If there is a continuous red LED only during charging, please ensure that you are using the power supply unit provided with the product.

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

• Only the 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 15 minutes and continuously – but faintly – blink red until it is placed in the charging dock. The low-battery warning does not disrupt any of the device’s normal functions. To ensure prolonged proper functioning of the device, it must be recharged.

• During charging at the 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 up to more than 1°C above ambient or wrist temperature.

• If for any reason the device feels hot, do not wear it.

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

• A 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 for use at the same time as the use of high frequency (HF) surgical equipment or a defibrillator. A defibrillator may break the device; the wrist device is not defibrillation-proof.  

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

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

• A healthcare professional needs to inspect the equipment for damage or excessive wear prior to each use.

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

• When taking an ECG measurement, make sure that no one else is touching you or the wrist device as this may affect the result.

• The wrist device and other physical parts always need to be properly cleaned before they are used by a 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 contact of the wrist device with the skin. Refer to the instructions within this user guide.

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

• The device and its accessories must not be serviced or undergo maintenance on while being worn or in use.

• The 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 a similar safety standard should be used. The PC must be kept outside the patient environment and have restricted access. The PC should have anti-virus, firewall and operating system updates in use.

• To prevent possible damage to the equipment, maintain to the following environmental conditions:
     o Operating temperature:      +5°C to +38°C
     o Storage temperature:         -20°C to +60°C
     o Relative humidity:               5% to 90%, non-condensing
     o Ambient air pressure:         700 hPA to 1060 hPA