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HD Steth is an electronic Stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running. The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision
Federal law restricts this device to sale to or on the order of a clinician.
When using the device standard procedures for proper auscultation and optimal patient positioning should be followed This manual provides instructions for the use of HD StethTM and mobile applications. It is assumed that the user is familiar with basic mobile application. To transmit sounds to the HD StethTM , the Stethoscope and device must be connected via Bluetooth, and in order to fully use certain functions, the mobile device must be connected to the smart display unit / mobile. HD StethTM uses a Bluetooth Class 2 wireless data link. The Bluetooth range will be reduced when objects (walls, furniture, people, etc.) are between the Device and a paired mobile device. To improve Bluetooth connection, reduce the distance and ensure a line of sight between HD StethTM and mobile device.
Heart Rate Variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval. ScanBo allows you to measure HRV while taking ECG
Failure to follow the directions given in this manual could result in damage to the device and/or possible injury to the user/patient. Failure to follow operating and maintenance instructions, listed in the manual could result in malfunction of the device. The device is not recommended for use in the presence of equipment producing strong electromagnetic radiation/MRI and stacked device environment as it may affect the device functionality.
Heart rate display on the device. BLE pairing of device and smart device. The Heart sounds and ECG signal are transferred in real time via BLE to the smart device. Visual representation of ECG and heart sounds are displayed on the smart device screen are stored on the smart Device. If any pairing issue occurs between device and smart device, automatically the issue will get resolved and get paired. No information is stored on the device. The Heart sounds and ECG signal are communicated in real time via BLE to the smart device, displayed on the smart device screen and are stored on the smart Device.
