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The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations. * Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information. Sending and receiving ECG data to and from the Hospital Information System is optional. The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner. In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.

Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis. It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.

The Cardio P1 Analysis System is intended to acquire, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be a qualified medical professional along with other relevant clinical information. Sending ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

Cardio P1 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its user-oriented design enables ECG examination with a single push of a button. The Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience.

The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. Basic systems deliver 12 lead ECG's, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility. Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients. 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.

Cardio 10 is a device to measure and record ECG of a patient as an ECG recording machine with 12 channels. It provides parameters required for the diagnosis. ECG records of a patient, and automatic diagnosis and prints ECG records and output report if entering patient or user information and efficiently use them for the chart management. At the same time, it is possible to transmit saved data to the PC connected to the network and manage digital files. In addition, it is possible to measure ECG by pressing the button only once in consideration of the convenience of a user as much as possible and save, transmit, and print data all at once after completing the automatic diagnosis. Parameter and automatic diagnosis required on the spirometer record and diagnosis of patients are provided to users while printing the A4 size and Letter size report along with the spirometer records by entering the information of patients or users for the efficient management of chart. At the same time, saved data are delivered to the PC connected to the network managing digital files. In addition, the battery can be internally saved as an optional component making it feasible to carry and use for checkup while moving.

SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings. The general clinical applications include fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging.

The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a Tablet PC or Mobile Phone that utilizes the iOS, Android OS or Windows System. The SonoMe Wireless Probe Type Ultrasound Scanner and SONOFINDER Wireless Probe Type Ultrasound Scanner are a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS, Android OS or Windows System, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and (iv) User Manual, USB charging cable and Wireless Charger (H5C10L only). The Wireless Probe Type Ultrasound Scanner software can be downloaded to Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and utilizes an icon touch-based user interface.

The SPM-300 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients in general practice, specialty physician, and hospital settings.

SPM-300 is a pulmonary function monitoring system consisting of a spirometry data acquisition unit (spirometer handle and mouthpiece) and a host device that provides data analysis and management, display and user interface functions.

The Cardio7 electrocardiograph is one of the tools that clinicians can use to evaluate and diagnose patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

Cardio7 is an EKG monitoring system that provides standard EKG and (optional) pulmonary diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG and pulmonary monitoring, data analysis and data management functions.

The CardioXP electrocardiograph is one of the tools that clinicians can use to evaluate and diagnose patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

CardioXP is an EKG monitoring system that provides standard EKG diagnostic functions. It offers enhanced usability, data analysis and data management. It consists of the several components depicted in Figure 1 that perform EKG monitoring, data analysis and data management functions.

EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device-CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.

The EKG-PLUS II Software is a program which receives, displays, stores and prints out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device.

The patient monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities. Physiological data include but are not restricted to: electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits. The patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.

Bionet BM3Plus Patient Monitor ("BM3Plus" or the "subject device") is a multifunctional device that monitors vital signs of human patients from neonates to adults. Parameters monitored by BM3Plus include electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, noninvasive blood pressure (NIBP), temperature, and respiration. Data output is displayed in numeric and/or wave form(s) on a 7-inch color LCD screen. Selected parameters and waves can also be shown in print via a built-in 58 mm thermal printer. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits. BM3Plus is compact and can be used in either stationary mode or on the move in all professional medical facilities. Its energy source can come from AC input or lithium-ion battery. BM3Plus' LAN connection capability enables the device to be built into a monitoring system, so that one person can monitor several patients at a time.

FC-700 is the fetal monitor that measures, displays numerical value of measured results by LED, prints graphically the fetal heart rate and uterine contraction of a pregnant woman, and also provides the sound from the heart of fetus. It is intended to aid comprehensive assessment for the well being of single fetus. It intended to be used by trained healthcare personnel. It is not intended for home use.

FC-700 is the fetal monitor that measures the fetal heart rate and uterine contraction. FC-700 irradiates ultrasound wave to the abdomen of a pregnant woman and detects the Doppler frequency signal reflected from the heart of the fetus. FC-700 analyzes detected signal and displays the numerical values of the fetal heart rate by LED. FC-700 measures the uterine contraction values of a pregnant woman by pressure sensors, analyzes measured value and displays the numerical values of the uterine contraction by LED. FC-700 provides the sound from the heart of fetus. I C-700 prints graphically the heart rate of the fetus and the values of uterine contraction.