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510(k) Data Aggregation
K Number
K123148Device Name
PARACE MD EKOSCOPE IS100
Manufacturer
Date Cleared
2013-11-19
(410 days)
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
PARACE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (ECG) function with three modes of operation. The Bell mode processes sounds having a frequency range of 20 Hz -500 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The stethoscope function is used for the detection and amplification of sounds from the heart, lungs, arteries, veins and other internal organs during physical assessment. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.
The ECG mode utilizes one of three modes to detect cardiac electrical activities, specifically from the limb leads, to determine the state of the heart beyond the abilities of a stethoscope. The ECG are detectable by a series of electrodes marked as #1 and #2 as referred in the user manual to user manual to register, record and display the electrical activity of the cardiac cycle in real time. This assessment will allow for the medical professional to then analyze, interpret and diagnose heart rate and rhythm based on recorded limb lead electrocardiogram information. This ECG is not a standard 12-lead ECG and is not suitable for detection of ischemia or infarction. The EKOSCOPE is suitable for adults and pediatrics but not intended for use on infants and in utero. The device is intended for use in hospitals or health care facilities by doctors and trained health care professionals.
Device Description
The Ekoscope iS100 Device is an electronic stethoscope with 6 leads EKG capability. The electronic microphone can detect sounds between 1.0 Hz to 2KHz from the heart, vessels, lungs and abdomen. The detected sounds are then processed and filtered to reduce ambient noises and transmitted to a removable headset that contains a built in speaker. The sound may also be amplified or attenuated upon demand. The visceral sounds are processed via three stethoscope modes. The first is the Bell Mode. The Bell mode processes sounds having a frequency range of 20 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The acquired visceral sounds, along with EKG data, are stored in 30 seconds increments into the device's 2 Gigabyte SD card for playback, delete or upload via USB to a PC using Microsoft Window® version Operating System. The Ekoscope iS100 is powered by a rechargeable Lithium battery. The battery is rechargeable via a micro USB. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.
The Ekoscope iS 100 also features 6 electrodes. The electrodes are positioned on the head of the device and body of the device. The strategically placed electrodes are used for the detection of 6 channel electrocardiograph (ECG) signals. The ECG signals are from the chest, hands and left leg, via three designated modes: A, B and C. The acquired data is first stored on the Ekoscope iS 100, and can be uploaded to a compatible PC for printing or sending to another location via the internet.
The sample frequency of ECG signal is 200Hz and the bit resolution is 16bit: Adopts 50/60Hz interference suppression. The sample frequency of heart sounds signal is 48kHz and bit resolution is 16bit. Different digital filters will be used in the Bell Mode, Diaphragm Mode and Diaphragm Plus Mode. The device embedded software, proprietary filter and Digital Signal Processing (DSP) technologies, attenuate ambient noises of sounds within a frequency range of 1.0 Hz to 2.0KHz. The sounds are attenuated while preserving native auscultated sounds of interest.
The display speed of the ECG wave and heart sound wave is different on the device's TFT color screen. The ECG wave has two display speed 12.5mm/s and 25mm/s. The display speed of heart sound is 153mm/s. The display range of the ECG wave is selectable and they are 'x0.5', 'x1' and 'x2'. The display range of heart sound wave is not alterable. ECG display is marked with 'ECG' while the Sound Wave display is marked with 'Sound'.
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