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The noninvasive FORE-SIGHT ELITE Tissue Oximeter "Module" is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as follows: When used with large sensors, the Module is indicated for use on adults and transitional adolescents ≥40 kg. When used with medium sensors, the Module is indicated for use on pediatric subjects ≥3 kg. When used with small sensors, the Module is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects < 5kg.

The FORE-SIGHT ELITE Tissue Oximeter Module measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Module additionally measures relative changes in oxygenated and deoxygenated hemoglobin concentrations for assessment of oxygenation changes as well as their sum, total hemoglobin concentration, under the sensor. The Oximeter Module consists of a signal acquisition and processing unit, power isolation box, host power and communication cables, and sensor cables to connect with FDA cleared FORE-SIGHT ELITE small, medium and large sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The Module controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The Module provides simultaneous measurements on up to two Sensors. The Module is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. The host monitor also provides numeric and/or realtime graphical display for tissue blood oxygenation saturation and changes in hemoglobin concentrations. Measurement data is delivered to the host through various interfaces including USB and serial connections.

The noninvasive FORE-SIGHT ELITE Module Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The FORE-SIGHT ELITE Module Tissue Oximeter is intended to allow for the display of StO2 on a third party display/patient monitor. The FORE-SIGHT ELITE Module Tissue Oximeter when used with large sensors, is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

The FORE-SIGHT ELITE Module Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation in the tissue (StO2). The Oximeter consists of a module / monitoring unit, power and communication cables and sensor cables to connect with FDA cleared FORE-SIGHT ELITE small, medium and large sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The module unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The module unit provides simultaneous measurements on up to two Sensors with both numeric and real-time graphical display formats appearing on a host monitor. The Module unit is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. Measurement data is delivered to the host through various interfaces including USB and serial connections.

The 740 SELECT series of patient monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients. The 740 SELECT series monitors come with multiple configurations and optional features. Standard and optional parameters include: - . Blood pressure and pulse rate: - Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate; . - Carbon Dioxide concentration of the expired and inspired breath and respiration rate including, with the Covidien Microstream MicroPod option, an Integrated Pulmonary Index (IPI); - . Electronic predictive and temporal artery temperature; - . ECG and heart rate derived from ECG: - . Impedance respiration to detect the rate or absence of respiratory effort with the ECG option for adult, adolescent, child and infant; - . Non-invasive monitoring, with Masimo Rainbow SET technology, of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed includes: Signal IO Wayeform. Low Signal IO (Low SIO), Perfusion Index (PI), and/or Pleth Variability Index (PVI) for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature, etCO2, FiC02 Respiratory rate derived from etC02, ECG and Impedance Respiration in selected modes of operation. The non-invasive blood pressure (NIBP) parameter automatically inflates an occluding cuff and, using the oscillometric step-deflation measurement technique, determines systolic, diastolic and mean arterial pressure as well as pulse rate. Measurement results along with user prompts and error messages are displayed on the front panel. The frequency of NIBP determination can be elected by the user in times between one and ninety minutes. The auto (timed), STAT and manual NIBP operating modes provide additional clinical utility. The pulse oximeter parameter (%SpO2) determines arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through the tissue. Changes in absorption caused by pulsations of blood in the vascular bed are used to determine arterial saturation and pulse rate. The oximeter requires no routine calibration or maintenance. Oxygen saturation and heart rate are displayed on a light emitting diode (LED) digital display. On each detected pulse, the perfusion LED indicates patient perfusion signals. This bar graph gives the user a pulse-by-pulse visual indication of waveform signal quality. An audio "beep" can be enabled that is generated each time the SpO2 module detects a pulse. In addition to % SpO2 the 740 SELECT (equipped with the Masimo Rainbow® Pulse CO-Oximetry™ and Masimo SET ® oximetry) can monitor Pulse Rate (PR), Carboxyhemoglobin (SpC0®), Acoustic Respiration Rate (RRa™) and Pleth Variability Index (PVI®). Alternately, the customer can choose a Nellcor Pulse Oximeter at the of ordering. The Nellcor Oximeter provides Response Mode and Sat Seconds. The 740 SELECT has (2) options for measuring temperature. The Covidien™ FILAC 3000 predictive temperature parameter has the capability of taking temperature in either normal (predictive) or monitor mode. In the normal mode, the thermometer's microprocessor "predicts" body temperature in about four (4) seconds for oral temperatures, about ten (10) seconds for axillary temperatures and about fifteen (15) seconds for rectal temperatures. The default setting used by the monitor for temperature determinations is the Predictive (normal) mode. Alternately, the customer can choose an Exergen TemporalScanner™ (infrared) Thermometer at the time of ordering. The Exergen TemporalScanner Thermometer, which captures core body temperature, has the capability of taking the Temporal Artery (TA) Temperature in about 3 seconds. The Exergen Temporal scanner has the ability to display the measurement of the patient's core temperature in either °F or °C. The 740 SELECT offers the optional choice of Sidestream and/or Mainstream etC02 parameter monitoring. The customer choices for Sidestream C02 monitoring are the Masimo - Phasein™ Infrared Sidestream Gas Analyzer (ISA™) or the Covidien Microstream® MicroPod™ which is integrated with the microMediCO2™ board. Customers may also choose Mainstream etCO2 parameter monitoring by using the Masimo Phasein™ infrared Mainstream Gas analyzer (IRMA™). Each of these CO2 options is externally attached to the SELECT. This clearance adds the parameter ECG and Impedance Respiration.

The noninvasive FORE-SIGHT ELITE Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows: When used with Large Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5 kg.

The FORE-SIGHT ELITE Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Oximeter consists of a monitor unit, preamplifier assembly, and Small, Medium and Large Sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four Sensors with both numeric and real-time graphical display formats. The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.

The 740 SELECT series of monitors is indicated for use as a portable, multi-parameter, variable aculty device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring and recording of: - Blood pressure and pulse rate of adult, pediatric and neonatal patients; . - Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and . neonatal patients; - Additionally the Masimo Rainbow SET technology provides noninvasive monitoring of . carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed on the 740 SELECT with the Masimo Rainbow SET option includes: Signal IQ Waveform, Low Signal IQ (Low SIQ), Perfusion Index (PI), and/or Pleth Variability Index (PVI) indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused; - Carbon Dioxide concentration of the expired and inspired breath and respiration rate of adult, . pediatric, infant or neonatal patient and included, with the Oridion option, an Integrated Pulmonary Index (IPI): - Intermittent predictive body temperature (oral, axillary, rectal) of adult, pediatric and neonatal ● patients; - Infrared (over the temporal artery) measurement of body temperature of people of all ages. .

The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature and CO2 in various modes of operation.

The noninvasive FORE-SIGHT Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows: When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on adults and transitional adolescents ≥ 40 kg.

The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Oximeter consists of a monitor unit, preamplifier assembly, and sensor. The sensor uses multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats. The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB, RS-232 serial or wireless communications.

The 740 SELECT is indicated for use as a bedside, portable device for use by health care professionals, clinicians and medically qualified personnel for spot checking, continuous monitoring and recording of adult, pediatric and neonatal patients. The Monitor features world class technology to facilitate the monitoring of non-invasive blood pressure, pulse rate, functional arterial oxygen saturation (Sp02) and body temperature in a variety of clinical environments.

The 740 SELECT Series Monitor is a portable and rugged non-invasive multi-parameter device used for spot checking, continuous monitoring, and recording of blood pressure, pulse rate, functional oxygen saturation (%Sp02), and predictive body temperature in a variety of clinical environments. The Monitor includes features that are optional or configurable. The 740 SELECT Series Monitor is compact and lightweight in design, allowing it to be easily carried and or configured for use with a mobile stand, wall mount or on a table top. A Lithium lon (Li-lon) rechargeable battery is provided for automatic switching to back-up power if an untended loss of AC power should occur as well as allow the monitor to be used for clinical applications when portable monitoring is required. The 740 SELECT Series Monitor is equipped with a color touchscreen which is the primary interface for the user to control and configure the Monitor (for patient type, alarms, settings and various clinical workflows). A dedicated message area provides patient alarm and technical messages. Date and time as well as the Monitor ID are displayed. A battery gauge provides approximate battery capacity when the monitor is operating on battery power. The Monitor supports both point-of-care and variable acuity monitoring. Spot vital signs measurements from multiple patients can be saved individually. The monitor can be used for continuous patient monitoring with full alarm support.when increased vigilance in necessary based on patient acuity. The Stand-By Mode provides enhanced bedside patient workflow and alarm management permitting sensor attachment, automatic alarm suspension and switch to active monitoring. The color coded Trends Display allows the user to recall all trended physiologic patient. measurement records. Trends can be recalled for saved snapshots as well as timed intervals. The Monitor provides a screen keyboard for entry of patient data (e.g., age, weight, height, gender, date of birth, patient name, and patient identification number). A serial data output is provided for connectivity to hospital EMR systems and external serial devices. An internal isolated relay switch is provided for nurse call systems. The monitor supports an optional externally connected thermal strip chart recorder which is directly powered from the serial port.

The noninvasive FORE-SIGHT Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows: When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and transitional adolescents ≥ 40 kg.

The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2). The Oximeter consists of a monitor unit, preamplifier assembly, and sensor uses multiple wavelengths of light in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The monitor unit controls the measurement sequence, regulating sensor light output and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats. The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.

The noninyasive FORE-SIGHT® Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states and is indicated for use as follows: When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 Kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg. The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.

The FORE-SIGHT Absolute Tissue Oximeter measures a single parameter of oxygenated hemoglobin under the Sensor, allowing the clinican to continuously and accurately determine absolute levels of blood oxygenation in the tissue. The Oximeter monitor features a LASER-SIGHT® Optical Technology generating 4 precise wavelenglis to optimize measurement of targeted hemoglobin states. COOL-LIGHT™ sensor technology ensures zero risk of patient burns. 3 sizes of sensors are available. The Oximeter is for continuous or spot checking use in a variety of hospital settings. A rechargeable battery pack permits the monitor to be used independently from an AC power source.

The FORE-SIGHT® Oximeter. Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain and skeletal muscle. It is intended for use in any individual at risk for reducedflow or no-flow ischemic states. When used with Large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and children over 40 kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 kg. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates ≤ 8 kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on skeletal muscle of infants, children and adolescents between 5 and 50 kg. The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.

The FORE-SIGHT Oximeter, MC-2000 Series, measures brain and skeletal muscle tissue oxygen saturation. The FORE-SIGHT Oximeter consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display with user interface. The noninvasive, reflection mode, optical transducer is placed on the forehead (brain) or skeletal muscle, via a disposable sensor to determine tissue oxygenation. The FORE-SIGHT Oximeter is safe to use because it is designed to operate as a class 1 laser product, the safest FDA laser classification. Additional safety features include a laser interlock system, designed to prevent laser operation in case the optical transducer is not securely attached to the subject.