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The AN6255 and AN6265 are digital X-ray general radiography systems intended for use by qualified/trained doctor or technician and are designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremitties and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from these systems are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the x-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOMPACS) network, clinical review station or to a film printer.

Digital Radiology Systems

The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console. All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit. These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.

The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434. The purpose and function of the LIFEGARD II Family is to monitor: - ECG - Heart rate - Non-invasive blood pressure (NIBP) - Functional arterial oxygen saturation (SpO2) - Respiration rate - Temperature and - End-tidal carbon dioxide (EtCO2) - Impedance Cardiography (ICG) - Arrhythmia with ST segment detection - Continuous non-invasive blood pressure (CNIBP) The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below: - Height: 4 ft - 7 ft - 6 in (122 - 229 cm) - Weight: 67 - 350 lbs (30 - 159 Kg) The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

The LIFEGARD II Family is a compact, lightweight device for measuring, processing, printing, and displaying information derived from nine physiological measurements: - Electrocardiogram (ECG). A three lead or five lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optional printer. The design of the ECG function is derived directly from the predicate devices, the parent C3 Family of patient monitors. - Respiration. Waveform and numeric respiration rate value from ECG. Airway respiration rate from EtCO2 if available. The design of the respiration parameter is derived directly from the predicate devices, the parent C3 Family of patient monitors. - Arrhythmia with ST segment analysis software performs five distinct operations: beat detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement. The design of arrhythmia with ST segment function provides VF and ST segment deviation functionality similar to the predicate device, M3046A (M2/M3/M4) Compact Portable Patient Monitor - Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System and Sandman SD20 Amplifier patient monitor and system. - The temperature is measured using thermistor probes for continuous temperature measurements. These are pre-amendment devices. - Blood pressure is measured non-invasively (NIBP) by the oscillometric method. This is the same as in the predicate devices, parent C3 Family of patient monitors. - Continuous non-invasive blood pressure (CNIBP) is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This is the same technology as in the predicate device, Vasotrac APM205A. - End-tidal CO2 (EtCO2) This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system. This is the same as in the predicate devices, parent C3 Family of patient monitors. - Impedance Cardiograph (ICG). This mode uses Thoracic Electrical Bioimpedance (TEB). This is identical in all aspects to the predicate device, the C3 ICG. - An internal thermal printer records waveforms, hemodynamic parameters and tabular trends on a 50-mm wide strip chart. - External USB printing identical to the parent C3 Family. The LIFEGARD II Family is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. A fully charged battery will power the monitor for three hours.

The AN6250 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from the AN6250 Digital Radiology System are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance by the operator, the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The AN6250 is a Stationary, General Radiology X-ray System.

The purpose and function of the ICG mode of the C3 ICG is to monitor Cardiac Output through the use of Impedance Cardiography (ICG) in adult Males and Fernales. When not being used for ICG, the C3 ICG can monitor and display continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2;), respiration rate, temperature and carbon dioxide (CO2) on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. The purpose of the LIFEGARD™ ICG is to non invasively monitor Cardiac Output using Impedance Cardiography (ICG) on adult Males and Females and provide continuous ECG, heart rate, non-invasive blood pressure (NIBP), on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. The C3 ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters when in the ICG mode. The hemodynamic parameters include: Acceleration Index (ACI), Cardiac Index (CI), Cardiac Output (CO), Ejection Time Ratio (ETR), Ejection Velocity Index (EVI), Heart Rate (HR), Heather Index (HI), Left Cardiac Work Index (LCWI), Left-ventricular Ejection Time (LVET), Pre-ejection Period (PEP), Stroke Index (SI), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Systolic Time Ratio (STR), Thoracic Fluid Content (TFC), Thoracic Fluid Volume Index (TFI), Velocity Index (VI). The Impedance Cardiography (ICG) function of the C3 ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare. When not in the ICG mode, the C3 ICG is intended to provide continuous ECG, heart rate, noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpOz), respiration rate, temperature and carbon dioxide (CO2) on Adult and Pediatric patients within a hospital or facility providing patient care. The LIFEGARD™ ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters. The hemodynamic parameters include: Acceleration Index (ACI), Blood Pressure (built-in NIBP), Cardiac Index (CI), Cardiac Output (CO), Heart Rate (HR), Left Cardiac Work Index (LCWI), Left-ventricular Ejection Time (LVET), Pre-ejection Period (PEP), Stroke Index (SI), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Systolic Time Ratio (STR), Thoracic Fluid Content (TFC), Velocity Index (VI). The LIFEGARD™ ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.

The C3 ICG is a compact, lightweight device for measuring, processing, printing, and displaying information derived from six physiological measurements: Electrocardiogram (ECG), Pulse Oximetry (SpO2), Temperature, Blood pressure (NIBP), End-tidal CO2 (EtCO2), and Impedance Cardiograph (ICG). An internal thermal printer records waveforms, hemodynamic parameters and tabular trends on a 50-mm wide strip chart. The C3 ICG is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. The LIFEGARD™ ICG Patient Monitor is a compact, lightweight device for measuring, processing, storing, and displaying information derived from six physiological measurements: Electrocardiogram (ECG), Blood pressure (NIBP). A thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart. The LIFEGARD™ ICG monitor is powered by internal sealed lead-acid batteries.

The C1 Series Patient Monitor series are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure (systolic, dialstolic), functional atterial oxygen saturation and temperature for adult and pediatric patients in all hospital areas and health care facilities.

The C1 Series Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements: Electrocardiogram (ECG), Pulse Oximetry (SpO2), Temperature, Non-invasive Blood Pressure (NIBP), and an external optional thermal printer. It is powered by internal sealed lead-acid batteries.

The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from the AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The AN6150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from the AN6150 are available for preview by the doctor / x-ray technician on the operator's workstation within seconds of the x-ray exposure. After acceptance, by the operator the digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations. The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The AN5150 is a digital X-ray chest system intended for use by qualified/trained doctor or technician and is designed to perform radiographic chest examinations. The AN7150 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position. Images from the AN5150 or AN7150 become available for preview by the doctor /x-ray technician on the operator's workstation seconds after the x-ray exposure. After acceptance digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.

The purpose and function of the C3 patient monitor continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration rate, temperature and carbon dioxide (CO2) for single patient use on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport.

The C3 Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements: - Electrocardiogram (ECG). A three lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optical strip chart recorder. The design of the ECG function is derived directly from the predicate device, the NPB-4000. - Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses a similar printed wiring board, software and firmware that is used in the predicate device, the NPB-4000. - The temperature is measured using thermistor probes for continuous temperature measurements. - Blood pressure is measured non-invasively (NIBP) by the oscillometric method. The design of the NIBP subsystem is an enhanced version of the NIBP subsystem used in the predicate device, the NPB-4000. - End-tidal CO2. This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system. - An optional thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm wide strip chart. The C3 monitor is powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for four hours.