Product Terms - CardiSong ECG Device

1. Product description

CardiSong® is a telemetric portable ECG device designed to record and remotely transmit cardiac activity by capturing biopotentials from the fingers or from the chest area.

CardiSong is a medical device (Class IIa) with measuring functions for recording and transmitting vital signs - cardiac activity from home (out-of-hospital conditions).

CardiSong is suitable for the early diagnosis and follow-up of patients with, or at risk of, cardiac rhythm and conduction disturbances.

2. Intended purpose

CardiSong is a portable ECG device designed to record and remotely transmit cardiac activity. It is suitable for the early diagnosis and follow-up of patients with, or at risk of, cardiac rhythm and conduction disturbances.

CardiSong:

1. Records cardiac activity (performs an electrocardiographic recording) in two ways - through the fingers or from the chest area.
2. Wirelessly transmits the recorded electrocardiographic (ECG) signal via the patient's mobile phone, in a manner analogous to making a standard telephone call, to the CardiSong Platform.
3. The data-transmission process is analogous to making a phone call: the patient dials the receiving number, hears voice prompts, and starts the audio playback and transmission of the already-captured electrocardiogram.

CardiSong does not require the presence or use of internet, Bluetooth or any other applications.

The CardiSong Platform stores and processes the ECG signals sent by patients, providing:

• The physician reviews the recording and measures the metrics (heart rate, variability, rhythm);
• Generation of reports and visualizations.

3. Data protection and access

• The ECG data in the platform is encrypted and only a telephone number is used as an identifier.
• The patient has access to their ECG upon registration in the platform.
• The platform also allows the registration of physicians after verification against the register of physicians licensed to practise.
• Through the platform, the patient may grant a registered physician access to the ECG recordings stored in it.
• Only you and/or a physician registered in the platform to whom you have granted access can access your ECG recordings.

4. Clinical benefits

CardiSong is a device for the early diagnosis and follow-up of patients at risk of cardiac rhythm and conduction disturbances. CardiSong has not been tested and is not recommended for use with pacemakers and implantable defibrillators.

ECG results are not a diagnosis but data that the patient can record and provide to a physician for clarification or for establishing a diagnosis.

Layout of the components

The front panel contains:

• a power on/off button;
• a display for ECG visualization;
• metal electrodes.

The front side cover has an opening for an audio speaker.

The back panel houses the battery compartment - 2 × AA, and a label providing the unique serial number of the ECG device.

5. Initial activation of CardiSong

To use CardiSong you need to:

• Register in the platform by entering the data required to start remote monitoring - a telephone number and a password of your choice.
• Registration lets you access and view your ECG recordings in the platform at www.cardisong.com at any time, download any recording to provide to a physician of your choice, or grant access to the recordings to a physician registered in the platform.
• When the ECG recordings made with CardiSong are used and read, the physician will provide you with an informed-consent form that you must sign. A sample of the informed consent can also be downloaded from our website www.cardisong.com so you can review it in advance.
• On the website www.cardisong.com you must complete virtual training on using the ECG module, which will be recorded in the system.

Operating Mode 1 - recording an ECG from the chest wall

1. Turn on the device by pressing the on/off button.
2. The device is placed on the chest, at a spot previously marked by your physician, and must make good contact with the body.
3. Stabilizing the recording takes a few seconds, and the recording itself lasts about 20 seconds. A long beep is heard at the end of the recording.
4. Once the recording is complete and the data is stored in the device, the indicated number of the receiving party is dialled via your personal GSM phone. The receiving party confirms by voice message that the connection is established and prompts the user to transmit the recorded electrocardiogram.
5. The user presses the on/off button on the front panel once, which starts the audio playback (sonification) of the electrocardiogram.
6. During ECG transmission, the user's phone must be 2-3 centimetres away from the device.
7. During transmission of the electrocardiogram, the absence of intense ambient noise must be ensured.
8. Successful transmission of the electrocardiogram is announced by a voice message from the receiving party, after which the connection is terminated.
9. If a problem occurred during data transmission, steps 5-7 must be repeated.
10. The device is turned off manually by holding the on/off button, or after 45 seconds.

Operating Mode 2 - recording an ECG through the fingers

1. Turn on the device by pressing the on/off button.
2. The thumbs or index fingers of both hands are placed in parallel on the metal electrodes and must adhere tightly.

The subsequent actions are analogous to the steps described in Mode 1.

Troubleshooting

The ECG device does not start when the button is pressed - check that the batteries are in good condition.

For a quality recording of your ECG, you must be in a quiet environment while recording with CardiSong and while transmitting the signal from the device (its sonification).

Potential risks of partial or full compromise of the examination:

• A signal with major interference due to movement during ECG capture.
• Loud ambient noise.
• No connection with the mobile phone.

If the ECG is not recorded correctly - record again, following the operating steps for the relevant mode and during registration:

• check the mobile phone's coverage and, if necessary, move to a place with guaranteed GSM network connectivity;
• do not move;
• do not press the electrodes too hard.

Safety and care

• The external mechanical construction of the device uses a plastic case with a rubber edge for high impact resistance.
• There are no indications of adverse side effects from body contact with the case. The electrodes are made of stainless steel and fixed to the case with epoxy resin and do not cause allergic reactions on skin contact.
• No specific procedures are required to keep it in working order.
• Periodically, or when used by different users, the electrodes must be cleaned with an alcohol solution.
• Protect the device from water and moisture, extreme temperatures, impact and falls, dirt and dust, excessive heat and cold.
• Do not use the device if you think it is damaged or notice anything unusual.
• The device may be used only for the purposes described in these instructions.
• The manufacturer is not liable for damage caused by improper use.
• The interpretation of the obtained ECGs is performed by a physician.

Technical specifications

Manufacturer and safety reporting

If adverse side effects or malfunctions occur while using the device, please report them to:

• Email:
• Manufacturer: Inovato Clinical Ltd., Sofia 1000, Bulgaria
• Website: www.cardisong.com