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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.

EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.

EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR). EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient. EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense. EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient). During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).

ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax. ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm. ENLIGHT 2100 does not measure regional ventilation of the lungs

ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycle, and which are linearly related to Variations in Regional Air Content within the lung.

The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments. The LM-8 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP). The LM-10 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP) and Expired CO2. The LM-12 monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 chamels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The LM-15 monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP, NIBP), Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The arrhythmia detection and ST Segment analysis are intended for adult and pediatric patients. The monitors are not intended for MRI environments.

LM-8, LM-10, LM-12 and LM-15, patient monitor integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Replaceable built-in battery facilitates patient transport. Large high-resolution display provides clear view of 10 waveforms and full monitoring parameters. Patient Monitor can monitor vital signal such as ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), temperature (TEMP), invasive blood pressure (IBP), cardiac output (C.O.), CO2 and anesthetic gas (AG). Those signals are digitized, processed and examined for alarm conditions, after that presents all those information on the color TFT display. The monitor also provides advantageous operating control for the user.

The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanice cardiography (ICG). BIS is intended for use on adult and pediatric patients. ICG monitoring is intended for use on adults only. The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are additionally intended for use during patient transport inside hospitals. The monitors are not intended for MRI environments.

LMPLUS series Patient Monitor including LMPLUS-12, LMPLUS-15 and LMPLUS-17 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The LMPLUS series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure and pulse rate), TEMP, ECG, RESP (respiration), CO2, IBP, C.O. and AG (anesthetic gas), RM (respiratory mechanics), BIS (bispectral index) and ICG (impedance cardiography). The above is the maximum configuration for LMPLUS series Patient Monitor, the user may select different monitoring parameters in according with their requirements. LMPLUS-12 configures with 12.1-inch color TFT touch screen, LMPLUS-15 and LMPLUS-17 with same screen except different sizes 15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.

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 CARESCAPE Respiratory Modules, (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients. When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy. These modules are intended for use by qualified medical personnel only.

The CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients. Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the signals detected by the module sensors, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system. The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device. This 510(k) introduces two new module models in the CARESCAPE Respiratory Modules family: E-sCAiOE and E-sCAiOVE. These new module models include added hardware compared to the modules cleared in K183394. The operation, measured parameters and performance specifications of the E-sCAiOE and E-sCAiOVE is identical to E-sCAiO and E-sCAiOV when used with the current module host devices cleared in the USA. The added modules E-sCAiOE and E-sCAiOVE have the same software as CARESCAPE Respiratory Modules cleared in K183394.

Linshom Respiratory Monitoring Device (LRMD) is indicated for use by healthcare professionals in healthcare facilities, such as procedural areas and recovery rooms, to monitor breathing in adult (at least 22 years of age) patients. LRMD is a non-invasive system that graphically displays temperature changes against time and reports values of respiratory rate and seconds since last breath, along with a trend of tidal volume. LRMD measurements are used as an adjunct to other clinical information sources.

The Linshom Respiratory Monitoring Device (LRMD) is a medical device designed to monitor a patient's respiratory rate, tidal volume trend and seconds since last breath within a healthcare setting. The LRMD is a thermistor based respiratory monitor which includes the Thermistor Sensor Assembly (TSA), Integrated Linshom Module (ILM) Core, the power supply and software.