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Indications for Use for CARESCAPE Canvas 1000: CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time. CARESCAPE Canvas 1000 is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). CARESCAPE Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas 1000 also shows alarms from other ECG sources. CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. CARESCAPE Canvas 1000 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. CARESCAPE Canvas 1000 is not intended for use in an MRI environment. Indications for Use for CARESCAPE Canvas Smart Display: CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time. CARESCAPE Canvas Smart Display is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and · respiratory (impedance respiration, airway gases (CO2) CARESCAPE Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources. CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events. CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. CARESCAPE Canvas Smart Display is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. CARESCAPE Canvas Smart Display is not intended for use in an MRI environment. Indications for Use for CARESCAPE Canvas D19: CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device. CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms. Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status. Indications for Use for F2 Frame; F2-01: The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder. The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility. The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

Hardware and software modifications carried out on the legally marketed predicate device CARESCAPE B850 V3.2, resulted in new products CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display, along with the CARESCAPE Canvas D19 and F2 Frame (F2-01) all of which are the subject of this submission. CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are new modular multi-parameter patient monitoring systems. In addition, the new devices CARESCAPE Canvas D19 and F2 Frame (F2-01) are a new secondary display and new module frame respectively. The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display patient monitors incorporates a 19-inch display with a capacitive touch screen and the screen content is user-configurable. They have an integrated alarm light and USB connectivity for other user input devices. The user interface is touchscreen-based and can be used also with a mouse and a keyboard or a remote controller. The system also includes the medical application software (CARESCAPE Software version 3.3). The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display include features and subsystems that are optional or configurable. The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are compatible with the CARESCAPE Patient Data Module and CARESCAPE ONE acquisition device via F0 docking station (cleared separately). For the CARESCAPE Canvas 1000 patient monitor, the other type of acquisition modules, E-modules (cleared separately) can be chosen based on care requirements and patient needs. Interfacing subsystems that can be used to connect the E-modules to the CARESCAPE Canvas 1000 include a new two-slot parameter module F2 frame (F2-01), a five-slot parameter module F5 frame (F5-01), and a seven-slot parameter module F7 frame (F7-01). The CARESCAPE Canvas 1000 can also be used together with the new secondary CARESCAPE Canvas D19 display. The CARESCAPE Canvas D19 display provides a capacitive touch screen, and the screen content is user configurable. The CARESCAPE Canvas D19 display integrates audible and visual alarms and provides USB connectivity for other user input devices.

The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources. The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Contraindications for using CARESCAPE B650: The CARESCAPE B650 is not intended for use in a controlled MR environment.

CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 includes features and subsystems that are optional or configurable.

The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of: - · hemodynamic (including ECG, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), - · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and - · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources. The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Contraindications for using the monitor The CARESCAPE B850 is not intended for use in a controlled MR environment.

CARESCAPE B850 is a new version of a modular multi- parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU), the CARESCAPE Software, and a module frame F5 or F7. CARESCAPE B850 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 includes features and subsystems that are optional or configurable.

The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources. The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility

CARESCAPE B450 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software and one or two batteries. CARESCAPE B450 is equipped with an ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 includes features and subsystems that are optional or configurable.

The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The monitor B105M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner. The monitor B105M, B155M, B105P and B125P are not intended for use during MRI. The monitor B105M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network. The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric noninvasive blood pressure (systolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/ Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT). The monitor B105M, B125M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors that were developed based on predicate Monitor B125/B105(K201941) to provide additional monitored parameter: neuromuscular transmission (NMT), by supporting additional optional modules previously cleared by FDA: E-NMT module (K051635) with existing interface rack and/or second frame (B1X5-F2). In addition to the added parameter, the proposed monitors B105M, B125M, B155M, B105P and B125P offer several software enhancements: - Support 12-lead ECG measurement mode; - Additional SPV (Systolic Pressure Variation) and PPV (Pulse Pressure Variation) values calculation; - Enabled the Impedance Respiration measurement from lead RL-LL: - Display Pulse Rate (PR) from NIBP when performing NIBP determination; - Display real-time GE SpO2 Perfusion Index (PI) value; . - Adoption of TruSignal V3 SpO2 algorithm; - Additional optimizing IBP waveform scale function; - Additional connectivity capabilities within GE CARESCAPE network (K032582) including Bed-to-Bed View and Automatic View on Alarm (AVOA); - Additional remote service function: - Additional cybersecurity enhancements. The proposed monitors B105M, B125M, B155M, B105P and B125P include improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate Monitor B125/B105(K201941) while maintaining the same primary function and operation. The five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options. As with the predicate Monitor B125/B105 (K201941), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters whic include CO2 and Gases parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardic Output parameter provided by the E-COP module (K052976), and thermal recorder B1X5-REC. In addition, the predicate Monitor B125/B105 (K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P consists of the same interface to a variety of existing central station systems via a cabled or wireless network interface which implemented with identical integrated WIFI module. (WIFI feature is disabled in B125P/B105P) Moreover, both the predicate Monitor B125/B105(K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport. The monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner. The monitor B125/B105 is not intended for use during MRI. The monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network. The monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/ Bladder/Axillary/Skin/Airway/Room/Myocardial/ Core/Surface temperature, impedance respiration rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac output (C.O.) and Entropy. The monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed Monitor B125/B105 is a multi-parameter patient monitor that was developed based on predicate Monitor B125/B105 (K171580) to provide additional monitored parameters: Airway gases, Entropy and Cardiac output, by supporting additional optional modules previously cleared by FDA: CARESCAPE Respiratory module (K171028), Airway Ga Option N-CAiO(K151063), E-Entropy Module (K150298) (E-ENTROPY-01) and E-COP module (K052976) with extension interface rack and/or second frame(B1X5-F2). In addition to the added parameters, the proposed Monitor B125/B105 offers several enhanced software features: - Enabled the Impedance Respiration measurement for Neonates (in addition to Ped/Adult); - Option called "Full Disclosure" to allow the display of parameter waveforms for up to 36 hours; - National Early Warning Score (NEWS) calculation provided ; - Additional printing capabilities to a remote recorder/Laser printer connected to a central station; - Adoption of EK-Pro V14 ECG algorithm (previously cleared K191323) to support enhanced arrhythmia detection performance; - Added Irregular, SV Tachy and Supra Ventricular Contraction (SVC), three more arrhythmia alarms; - Enhanced parameter alarm priority adjustment/ configuration options, - Cybersecurity enhancements. The proposed monitor B125 and B105 is based on the previous design, and therefore shares a common software and hardware platform with its primary predicate, the Monitor B125/B105 (K171580). The primary function and operation of the monitors remain unchanged from the predicate. The difference between the two models (B125 and B105) is the LCD screen size. B125 has a 12-inch display; B105 has a 10-inch display. There is no change from the predicate in the display size. As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 is a multi-parameter patient monitor, utilizing an LCD display with an integrated keypad and an identical pre-configuration patient parameter measurement module (Hemo module) which provides basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2. The proposed Monitor B125/B105 uses the identical E-MiniC module (K052582) and equivalent optional thermal recorder module as the predicate B125/B105 (K171580). As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 interfaces to a variety of existing central station systems via a cabled or wireless network interface. The wireless interface is implemented with the identical integrated WIFI module (WLAN module type: B1x5-01. FCC ID: OU5B1X501) as used in the predicate Monitor B125/B105 (K171580). As with the predicate Monitor B125/B105 (K171580), proposed Monitor B105/B125 includes features and subsystems that are optional or configurable. It can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The monitors are additionally intended for use in transport situations within hospital environments. The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only. BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients. The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients. The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused. The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments.

The IntelliVue Patient Monitors MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis. The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located at the patient bedside vicinity and can also be used during patient transport inside hospitals. The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display. The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

The CARESCAPE B850 is a multi-parameter patient montor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of: · hemodynamic (including ECC, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources. The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Contraindications for using the monitor The CARESCAPE B850 is not intended for use in a controlled MR environment.

The CARESCAPE B850 is a new version of a modular multi-parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "ePort" interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 V3 includes features and subsystems that are optional or configurable.

The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources. The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

CARESCAPE B450 V3 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 V3 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software version 3 and one or two batteries. CARESCAPE B450 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 V3 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 V3 includes features and subsystems that are optional or configurable.

The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of: • hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), • respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and • neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources. The CARESCAPE B650 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

CARESCAPE B650 V3 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 V3 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software version 3 and the battery. CARESCAPE B650 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B650 V3 is also equipped with two module slots where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B650 V3 includes features and subsystems that are optional or configurable.