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The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms. · For %SpO2 and pulse rate, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients who are well or poorly perfused, during both motion and non-motion conditions in professional healthcare facilities, mobile, and EMS settings. · For %rSO2, the H500 System is intended for spot-checking and/or measuring during clinician assessment of adult, pediatric, infant, and neonate patients in professional healthcare facilities, mobile, and EMS settings. · For %COHb and %MetHb, the H500 System is intended for spot-checking, multiple spot-checks to observe change, and/ or measuring during clinician assessment of adult and pediatric patients in professional healthcare facilities, mobile, and EMS settings.

The Nonin Medical CO-Pilot™ Model H500 Multi-Sensing Oximetry System is a small handheld wireless device intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2) of adult, pediatric and neonate patients. It is intended for professional use only, in healthcare facilities, mobile and EMS environments. The system is not provided sterile and is not a reprocessed single-use device. The H500 System consists of three components which are the display, the signal processor and associated sensors. It is intended to be used with specific parts, accessories and compatible sensors which are outlined in Table 1 below.

The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick, under non-motion conditions. For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 – 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.

The Model 9591 Finger Pulse Oximeter is a small, lightweight, portable, reusable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. The SpO2, pulse rate, and respiration rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate of poor pulse quality that may affect the readings. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. It is intended for spot-checking of adult and pediatric patients who are well or poorly perfused with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.

The Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rSO2) of blood underneath the sensor of adult and pediatric patients weighing ≥ 88 pounds (≥ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment. Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Nonin's Model 8006CA sensor. The sensor and patient interface is in hospitals, long-term care, medical facilities, sleep laboratories, and subacute environments.

The Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface work together for use with the Nonin Medical SenSmart Model X-100 Universal Oximetry System (Model X-100).

Model X-100C Nonin's Model X-100C CO-Met™ Oximetry System is indicated for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (>66 lbs / 30 kg) using the Model 8300AA sensor. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. The X-100C system is indicated for use by trained personnel in clinical settings, including Emergency Medical Service (EMS). hospitals, medical facilities, and mobile environments. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms. Model 8300AA The Model 8300AA reusable finger clip sensor is intended for noninvasive measuring of function of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), methemoglobin saturation (%MetHb), and pulse rate of adult and pediatric patients (> 66 lbs / 30 kg). The measurements may be multiple spot-checks to observe change and/or continuous monitoring. It is intended for use in Emergency Medical Service (EMS), hospitals, medical facilities, and mobile environments. This device is not meant for sole use in clinical decision making: it must be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Model X-100C CO-Met Oximetry System displays (COHb), methemoglobin (MetHb), pulse oxygen saturation (SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of the signal processor to the monitor. The monitor receives, displays, provide alarm management, and storage of COHb, MetHb, SpO2, and PR. The device is capable of running on battery power or on AC power via an external power supply. The device is equipped with patient alarms to alert the user to abnormal conditions and shall provide real time data output of COHb, MetHb, SpO2, and PR.

Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 Ib; 6100CP: pediatrics > 10 kg / 22 1b ; 6100CI: infants > 2 kg / 4 1b; and 6100CN: neonates < 2 kg / 4 1b and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments. Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 1b ; 6101CI: infants > 2 kg / 4 1b; and 6101CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors: Nonin's Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 Ib; 6102CP: pediatrics > 10 kg / 22 1b ; 6102C1: infants > 2 kg / 4 1b; and 6102CN: neonates < 2 kg / 4 1b and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments. Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments. Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor: The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions. The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 - 60 kg / 18 - 132 lb) who are well or poorly perfused. during both motion and non-motion conditions. It is intended for use in hospitals, medical facilities. Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8100Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments. The recommended application site is the earlobe. Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8101Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. The recommended application site is the earlobe. Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor: The Model 8102Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or ing of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments. The recommended application site is the earlobe.

The Model 6100C Series, Model 6101C Series and Model 6102C Series Pulse Oximeter Sensors are single-patient use. non-sterile disposable pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100). The Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 Pulse Oximeter Sensors are reusable, non-sterile pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100).

The Nonin® Model 3231 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients with digits between 0.8 - 2.5 cm (0.3 - 1.0 inch) thick.

Model 3231 Pulse oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate if there is poor pulse quality that may affect the readings. All associated electronics and the microcontroller are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused. The modification of the Model 3230 to the Model 3231, include the removal of Bluetooth LE 4.0 and the addition USB 2.0 for serial communication. This modification includes moving from batteries to the USB 2.0 to power the Model 3231. The oximeter circuitry, software and electro optical elements of the Model 3231 are identical to the Model 3230. There are no technological characteristic changes to the device that affect the measurement or display of SpO2 or pulse rate to the user.

Model X-100: Nonin's SenSmart™ Model X-100 Universal Oximetry System is a modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6) channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors. The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused. Model 8100S(x): Nonin's Model 8100S(X) reusable soft sensor is indicated for non-invasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments. SenSmart Download Software: The SenSmart Download Software is an optional accessory for use with Nonin's X-100M SenSmart Monitor only. It is intended for use by healthcare professionals when 1) transferring data from the X-100M to a computer in order to maintain individual records of oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

The SenSmart X-100 Oximetry System performs both pulse oximetry and regional oximetry measurements. The SenSmart X-100 Oximetry System works with all Nonin Equanox regional oximetry sensors (Model 8004CA, Model 8003CA, Model 8004CB and Model 8004CB-NA). The SenSmart compatible pulse oximetry Soft Sensor Model 8100S(x) is used with the Model X-100 System. The system consists of the sensor, the X-100SP signal processor (up to 6), extensions cables, the X-100H hub for multiple channels, the X-100M SenSmart Monitor which includes display, alarms, and memory. The SenSmart Download software is included for data storage review and reporting on a Windows PC.

The Model 3230 Finger Pulse oximeter is a small, lightweight portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot checking of adult and pediatric patients on digits between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.

Model 3230 Bluetooth® Smart Pulse oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate if poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.

Model 8004CB (Adhesive Version) The 8004CB Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms).. The sensor may be repositioned or replaced with another 8004CB sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments. Model 8004CB-NA (Non-Adhesive Version) The 8004CB-NA Non-Adhesive, Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8004CB-NA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments. I Model 7600 Regional Oximeter System Nonin's non-invasive Model 7600 4- Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. It is intended for spot-checking or continuous monitoring of adult, or neonate, infant and pediatric patients. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Nonin's® EQUANOX Advance Neonatal/Pediatric Sensor 8004CB Series for use with the Model 7600 4-Channel Regional Oximeter System continuously monitors and records the mixed arterial/venous blood oxygen levels (rSO2) through non-invasive near-infrared spectroscopy of tissue under the sensors. The 7600 system is comprised of three subsystems; sensor, patient oximetry device (pod) and display unit. The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is sized appropriately for the patient population. The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning via the sensor photodiodes. From these measurements, the 7600PA pod determines specific absorption values and calculates the rSO2 value. The pod then communicates the rSO2 readings and other data to the display unit. Up to 4 pods with attached sensors may be used with a single 7600 display unit. The 7600 display unit displays real-time regional oximetry data. It is a battery-backed, mains-powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module or serial RS-232 connection.

The Nonin® Onyx Vantage 9590 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on digits, including the thumb and toes, that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The device's intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and home healthcare services.

Onyx Vantage 9590 is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LED display contained within the device. A tricolor LED provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to indicate the pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates an inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking of adult and pediatric patients who are well or poorly perfused on digits, including the thumb and toes.