Safety Notices

PulseOn Arrhythmia Monitor System (AMS-1)

Warnings

• The user shall be instructed to discontinue using the device in case of significant skin reactions.

• Not a toy. Not for small children. Choking hazard. The equipment may contain small parts. Keep them out of the reach of small children. Strangulation may result from baby or child entanglement in power cables.

• The wrist device may give an ECG measurement notification when it is not safe to take an ECG measurement (e.g. while driving a car). In such situations ignore the notification and do not take an ECG measurement.

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the medical equipment or medical system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

• Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

• Do not position the power supply of charging dock (or gateway) in a place or position so that it is difficult to disconnect it.

• An additional multiple socket-outlet or extension cord should not to be used with the system.

• When several items of medical equipment are interconnected the total leakage current may increase.

• Do not touch the recharger (charging dock) and the patient simultaneously, and do not remove the silicone cover from the charging dock as it provides IP21 protection against dripping water (vertically falling drops).

Caution

• 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

Notes

• The wrist device and its LEDs do not emit harmful radiation.

• The wrist device will automatically turn off (LEDs on the bottom turn off) if the battery level gets too low.

• The wrist device gives a vibration when placing a palm on top of it for starting an ECG measurement. If there is no vibration the device is inoperational. The operation of the optical measurement can be inspected by looking under the device. If the yellow LED lights are on, the optical measurement is operational.

• The quality of the measured ECG data may be affected by the use of other medical equipment, including but not limited to ultrasound machines.

• Wrist area with tattoos, dense body hair or dark skin can have a negative effect on the performance of the wrist device, as well as cold skin or otherwise reduced blood perfusion.

• Excessive light does not harm the device, but can cause issues with the optical sensors and can result in false notifications.

• The wrist device is a type BF applied part fulfilling the EN 60601-1 (IEC60601-1) standard. Wrist device electrodes should not contact any other conductive parts including earth.

Contraindications

• The wrist device shall not be used in case the potential user suffers from hypersensitivity for silicone. The user should be instructed to discontinue using the device in case of significant skin reactions.

• The wrist device shall not be used on a wrist having an infected eczema or otherwise broken skin.

• The wrist device shall not be used by children nor for assessment of cardiac arrhythmias of children.

• The wrist device shall not be used for life-sustaining measurements.

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