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The SunTech CT40 (Model 260) is a non-invasive oscillometric spot check vital signs device. The CT40 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take one or more vital signs measurements on a patient. The CT40 is only for measurement, recording, and display. It makes no specific diagnoses.

The CT40 (Model 260) is designed to non-invasively measure systolic and diastolic blood pressure, pulse rate, temperature, and oxygen saturation (SpO2) for adult and pediatric patients. All blood pressure, pulse, temperature, and SpO2 values are displayed on a large, easy-to-read LCD. The device has a rechargeable battery and may be use as a desktop unit or on a mobile stand. The CT40 (Model 260) Spot-check Vital Signs Device can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. The CT40 (Model 260) consist of a base unit with NIBP, display, control buttons and knob housed in an ABS plastic enclosure. The left side of the unit has a removable panel were a SpO2 module may be connected. And the right side of the unit has a removable panel where a temperature module may be connected. For measuring blood pressure, a blood pressure cuff is placed around the patient's non-dominant upper arm. The cuff is automatically inflated and the blood pressure is determined by the oscillometric method, which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured. The pulse oximetry function non-invasively measures the patient's percent oxygen saturation of arterial hemoglobin using principles of plethysmography via a SpO2 sensor placed on the patient's finger. Temperature can be measured using one of two different kinds of temperature technology. The oral/axillary/rectal temperature probe contains a thermistor that generates a voltage based on changes in temperature, and these voltages are measured by the temperature circuitry. The touchless infrared temperature probe detects radiated infrared energy from the temporal artery. The CT40 (Model 260) is a portable device, approximately 205 x 190 x 140 mm in size and weighs approximately 1440 g without battery. Control buttons allow the user to stop/start a BP measurement, save a set of measurements to memory, change between BP modes, and return to the home screen. There is also a selection knob that is used to scroll and select different device options. The backlit LCD display shows the user device status and measurement information. The device uses a microprocessor with firmware, which is not accessible to the user. The unit is powered by AC mains power and rechargeable lithium-ion battery. Two USB-A port connections can be used to connect, an optional printer, barcode scanner or Wi-Fi dongle. There is also RJ11 Ethernet port for network connectivity, and a mini-USB port used to connect the device to a PC or laptop for advanced device configuration.

The Oscar 2, Model 250 system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin Pro, a PC-based computer program for the recording of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses. Optionally, The Model 250 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff. It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh (excludes pediatic subjects). BlueTooth, wireless connectivity will be offered as an option.

The Oscar 2 monitor is worn by the patient on a waist belt and is connected to an ABPM blood pressure cuff around the non-dominant upper arm. The cuff is inflated automatically at intervals which can be programmed during setup. Blood pressure is measured by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured. The Oscar 2 is a small hand-held or portable device, approximately 120 x 72 x 32 mm in size and weighs approximately 284 g including batteries. For convenience during a 24 hour study, the device can be worn with an optional pouch on a belt shoulder strap. The ABPM cuff is connected to the device, and the control buttons provide stop/start, day/night switch, event marking and dosage response capabilities. The LCD graphic screen allows for function monitoring and appropriate icon display. The device uses a microprocessor with software, which is not accessible to the user. The unit is powered by two (2) "AA" batteries located at the rear of the device. A USB port connection is used to download the patient information into the AccuWin Pro™ v4 software located on a separate PC. The AccuWin components include a flash drive and a USB cable.

The SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is indicated for use in measuring and displaying blood pressure, heart rate, functional oxygen saturation of arterial hemoglobin (SpO2) of adult patients in hospitals, medical facilities, and subacute environments.

The Tango M2, a microprocessor based blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango M2 has the ability to make blood pressure and saturation measurements at predetermined intervals (normally from a schedule determined by the physician), or on demand. Additionally, the TangoM2 has the ability to make an Oscillometric blood pressure determination at the command of the operator while the patient is stationary.

The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.

The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations: · 15 sizes (five neonate, ten pediatric/adult) · Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers

The SunTech Medical 247 NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.

The 247 BP, Temperature and Pulse Oximeter device, a microprocessor based noninvasive blood pressure, predictive temperature and oxygen saturation measurement system, uses oscillometric signals to determine blood pressure, oral, rectal or auxiliary probes to determine temperature and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff. Deflation of the cuff is controlled by two valves. Implementation of Pulse Oximetry and temperature is achieved through the incorporation of OEM devices from companies with currently marketed products and accessories.

The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying systolic and diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

The Cycle BP Monitor and Pulse Oximeter, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system compatible with ergometer stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. The Cycle has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests. The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.

1 11e Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

The All Purpose Cuff is intended to be used with a manual or automatic non-invasive sphygmomanometer to determine blood pressure parameters on pediatric and adult patients. They are not intended to be used on neonates. They are intended to be used with prescription (clinical grade) blood pressure monitors; they also could be used with Prescription Use X (Part 21 CFR 801 Subpart D) (AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

The All Purpose Cuff is an accessory for noninvasive blood pressure systems. It is comprised of a connector attached to tubing attached to an air tight bladder which is enclosed within an inelastic sleeve. The All Purpose Cuff comes in a range of sizes. Each is marked with the appropriate limb circumference for which the cuff is intended.