Safety and performance information leaflet

The device label is located on the back of the device and contains the following information on the Smartheart® manufactured by SHL Telemedicine Ltd.
  • Manufacturer’s name, trade mark or logo
  • Device’s name, model and part number
  • Manufacturer’s full address
  • European representative name and full address
  • Medical device and Serial number symbols
  • Date of manufacture
  • Power source
  • Type of applied part symbol (IEC 60601- 1)
  • CE mark with notified body recognition number
  • Refer to instruction manual/booklet (ISO 7010 – M002)
  • Unique Device Identification (UDI)
Fully detailed user manual supplemented with drawings can be found in paper form and provided with the Smartheart® in the personal package.
Fully detailed application and pairing guide on the Smartheart® call application can be found in paper form and provided with the Smartheart® in the personal package.

Intended Use

The Smartheart® device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and a mobile device (such as a smartphone) or communication device to a remote location. The device is indicated for use in order to acquire a 12-lead electrocardiogram and rhythm strip from an adult individual over 18 years old, including patients with known or suspected heart conditions and health-conscious individuals, for further evaluation and review by a medical professional.

Intended Users

The Smartheart® device is designed to be self-used by a layperson or to be used by a healthcare professional to acquire and transmit a 12 lead ECG and rhythm strip in the near real-time to a remote location equipped with a compatible receiving software (such as Cardio Monitor Center Vision) to enable review by a medical professional.

Smartheart® performance – Transmission of the ECG Data

The Smartheart® acquires and transmits ECG data to a remote Bluetooth-equipped device, which relays the digital data to the Cardio Monitor Center Vision™, which assembles the user’s 12-lead ECG and rhythm strip record. This record can be forwarded to a printer in a remote location such as a doctor’s office. for further information on Smartheart® operation see information for user found in the personal package

Warning

  • ECG performed by the Smartheart® should always be reviewed by a medical professional.
  • The use of this device by a patient should not be substituted for the care recommended by your family physician or cardiologist.
  • No modification of this device is allowed. Tempering or modifying the device may cause operation failure. For support contact [email protected].
  • It is highly recommended to inspect the device for mechanical damage before use or signs of material degradation. In case such is detected please do not use the device and contact us at [email protected].
  • E-waste and batteries should be disposed of at the municipal collection centers or businesses and according to local law and regulation.
  • 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.
  • Use of accessories, transducers 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.
  • 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 Smartheart® , including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

 Caution

  • Verify that the Left arm (triangular) electrode wire is not caught accidentally between the electrode belt and your chest.
  • Make sure the Smartheart® and its components are dry and free of any moisture or perspiration.
  • Always keep the device in the original case when not in use.
  • Do not leave the device in an enclosed warm space where temperature can exceed 70°C (158°F).
  • The Smartheart® should not be immersed in water under any circumstances.
  • The Smartheart® should not be used in the presence of electromagnetic interference or an electrostatic discharge or power overload caused by electrosurgical diathermy instruments.
  • The Smartheart® should not be used in conjunction with an external defibrillator.
  • The Smartheart® should not be used in the presence of flammable anesthetics.
  • The Smartheart® is not designed against the ingress of liquids. Do not submerse during cleaning.
Safety and performance information leaflet, Rev. 01, Nov 2022