(258 days)
CONTEC™ Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and or trained healtheare professionals.
This product is an electrocardiograph collecting 12-lead ECG signal simultaneously and printing ECG waveform with thermal printing system, which features in, recording and displaying ECG waveform with manual or auto mode, measuring and diagnosing ECG waveform parameters automatically, prompting for "Lead off" and "Lack of paper", optional interface languages(Chinese/ English), case database management.
This product is used to assist doctors to analyze and print the ECG waveform of children and adults, which can be applied to ECG room, ward, hospital, etc.
The ECG machine provides medical department human ECG wave group for pattern and rhythm analysis that applied in clinical diagnosis and research.
Essential Performance:Sync collection and display of 12-lead ECG.Display of HR.Print ECG wave with different format,Filter settings,and Auto-measurement of ECG data.
ECG90A is divided into button system, printing system, power supply system, LCD display system, signal collection system, control system
Button system: to collect the user's key operation input, send the control system to process,
Printing system: print the print data sent by the control system, heat the printer head to record the waveform on the thermal printing paper, and feedback whether the lack of paper;
Power system: provide power supply for each system module;
The proposed device adopts two kinds of power supply modes: build-in lithium battery DC power supply and AC-DC adapter power supply.
AC-DC adapter power supply: after the external power adapter connecting with the proposed device, the AC voltage is reduced to 12V via the AC-DC power adapter. The 12V voltage is used to charge the lithium battery via the charging management chip;meanwhile the 12V voltage is reduced to 8.6V via a voltage converter, which is used to power the following circuit and printer. Then the 8.6V voltage is reduced again to 5.0V voltage via the voltage converter, and the 5.0V voltage pass through power isolation and is used to power the signal collection and processing module; meanwhile the 5V voltage will be reduces to 3.3 Vvoltage, which is used to power the control module. Build-in lithium battery DC power supply: when the proposed device is connected with AC-DC adapter power supply, the build-in lithium battery will be charged automatically. The charged battery will power the whole system as DC power supply when the proposed device is not connected with the external AC-DC adapter power supply
LCD display system: display various of settings of waveform information to the user for viewing :
Signal collection system: collect the waveform data,submit the final data to the control system to process; the signal acquisition and process module adopts floating and optical isolation to reduce the external disturbance to signal. After filtering and amplification, the A/C conversion of acquired ECG signal is completed on MCU (Micro Controller Unit); and then the data is transmitted to control system.
after processing the data will be displayed on the LCD screen and the waveform will be printed on the thermal paper. MCU can identify and response the key operation through connecting line, and MCU can connect and communicate with the SD card and USB through the signal line.
Control system: the MCU is used to control the whole system operation. The device parameters setting, the processing of acquired signal, the printing, screen display and charging are all controlled by this module.
The provided document is a 510(k) summary for the CONTEC™ Electrocardiograph (ECG90A). It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria for AI-related functions. The document explicitly states: "No clinical study is included in this submission."
Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or any details related to AI or MRMC studies, as these are not present in the provided text.
The information primarily focuses on establishing substantial equivalence to a predicate device (CONTEC™ Electrocardiograph, ECG300G) based on non-clinical tests and technical specifications.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).