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Mac-Lab: The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements which may then be displayed and/or transmitted. CardioLab: The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements which may then be displayed and/or transmitted. ComboLab: The ComboLab system is indicated for use on patients of all ages when a physician determined that a patient would benefit from either a hemodynamic or electrophysiology procedure. Combol ab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements which may then be displayed and/or transmitted. MLCL Client Software: The MLCL Client Software is intended for recording, documenting and/or reviewing clinical data for hemodynamic and electrophysiology procedures and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.

Mac-Lab and CardioLab are hemodynamic and electrophysiology (EP) recording systems, respectively. A third configuration, ComboLab, allows the user to access both CardioLab and Mac-Lab functions, though only one application may be accessed at a time. These devices are used during interventional and related procedures to process, display and record hemodynamic and electrophysiology (EP) data depending on the type of procedure performed. The data is acquired and displayed real-time for multiple physiological parameters to allow the user to view the data. The data may be entered manually through the use of a dedicated keyboard/mouse/barcode scanner or acquired via procedural information devices, imaging devices and interfaced data devices, and may then be displayed, filtered, digitized, amplified, measured, and calculated. A fourth configuration, called the MLCL Client Software, is the core Mac-Lab and CardioLab application software which is available for installation on a stand-alone workstation (i.e. outside of the Mac-Lab/CardioLab/ComboLab acquisition systems described above). The MLCL Review Software may be used to record, document, analyze, store and transmit data, including data from supported patient monitors. Mac-Lab, CardioLab, ComboLab and the MLCL Client Software provide the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity but may also be used stand-alone (not connected to a network). Mac-Lab, CardioLab, ComboLab and the MLCL Client Software are not intended to be used as a patient monitor and are not intended to alert the licensed health care practitioner of a change in patient status.

The Portrait VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport. The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients. The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients. The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients. The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The optional Welch Allyn® SureTemp® Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients. The optional Exergen TemporalScanner thermometer is intermittent measurement of human body temperature of patients of all ages. The optional HeTaiDa electronic infrared non-touch thermometer is intermittent measurement of human body temperature of patients of all ages. A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver. The portable device is designed for use in hospital-type facilities. The Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings. The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner. The Portrait VSM vital signs monitor is not intended for use during MRI. "Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.

The proposed Portrait™ VSM is a vital signs monitor which is developed based on primary predicate vital signs monitor VC150(K133810) with integrated NIBP and SpO2 design from a secondary predicate monitor B105M (K213490) and provided additional non-contact infrared body temperature measurement option by supporting OEM thermometer (K171888) previously cleared by FDA. In addition to the added non-contact infrared body thermometer, the proposed monitor Portrait™ VSM also offer several enhancements: New hardware platform Adopted equivalent NIBP design from B105M(K213490) Adopted equivalent SpO2 design from B105M(K213490) Compatible with Recorder B1X5-REC Support Round Advisor in spot check mode Support automatically screens brightness adjustment. Improved Early Warning Score Addtional alarm management enhancement. Additional cybersecurity enhancement The proposed monitor Portrait™ VSM adopts larger 10-inch LCD touch screen with improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate monitor VC150 (K133810) while maintaining the same primary function and operation. As with the predicate Monitor VC150 (K133810), the proposed Portrait™ VSM is Vital Signs Monitor, utilizing an LCD display and can measure the most commonly used vital signs of patient: Non-invasive Blood Pressure (NIBP), Pulse Rate (PR), Temperature (Temp), and Pulse Oxygen Saturation (SpO2). Same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM also has three choices for SpO2 include GE TruSignal™; Nellcor™ or Masimo SET® and temperature measurement from Exergen® TemporalScanner™, and Welch Allyn® SureTemp®. Both the predicate monitor VC150 (K133810) and the proposed monitor Portrait™ VSM can be configured to be used for Spotchecking or for continuous morning, the device can send measured patients' data to EMR (Electronic Medical Record) system by interfacing to Hospital Information Systems (HIS) over a wired or wireless network. Moreover, same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM can be powered by battery or AC, has a carrying handle and can be placed on a shelf or table or mounted in a variety of ways using a mounting plate located on the bottom of the monitor.

The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). Physiological parameters and waveforms supported are: - Pulse oximetry (SpO2/pulse rate) - Respiration rate (RR) Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications. The Portrait Mobile Monitoring Solution 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. This device is not an Apnea monitor (i.e., do not rely on the device for detection of alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment.

The Portrait Mobile Monitoring Solution V1.1 is a wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. The Portrait Mobile Monitoring Solution V1.1 consists of the following general categories of medical devices: Central Monitoring Devices: - Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems. - Portrait Central Viewer Application software hosted on a Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients. - Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer. Mobile Monitoring Devices: - Portrait Mobile Patient Monitor Hardware, a battery-powered, wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarms, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). Compared to the predicate (K230626), the Portrait Mobile Patient Monitor has been split into separate hardware and software components for serviceability. The Portrait Mobile Patient Monitor Hardware is shipped with no clinical software installed. The clinical software (i.e., Portrait Mobile Patient Monitor Software) is installed at the customer site before the device is put into use. The Portrait Mobile Patient Monitor Hardware when the Portrait Mobile Patient Monitor Software is installed (prior to patient use) is then what we will refer to as the Portrait Mobile Patient Monitor. Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly. - Portrait Mobile Patient Monitor Software is the clinical software which gets installed at the customer site on the Portrait Mobile Patient Monitor Hardware. The Portrait Mobile Patient Monitor Software is this submission is equivalent to the software installed on the predicate Portrait Mobile Patient Monitor cleared in K230626 with minor changes as discussed in this submission. - Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly. - Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor. - Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use). - Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist - Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients. The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection. The arrhythmia detection portion of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms. CASE V7.0 Cardiac Testing System and Cardiac Testing System provide the control of external devices (typically a treadmill or bicycle ergometer) and communicate with centralized electronic/digital storage system via data networks. CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available. CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data. CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used primarily in the hospital but can also be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed. CASE V7.0 Cardiac Testing System and Cardiac Testing System offer no diagnostic opinion to the user. Instead, it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion. CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended to be used as a transport device or for home use. CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended for use as a vital signs physiological monitor. CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use. CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device. CASE V7.0 Cardiac Testing System and Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators. CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System before using the high frequency surgical unit.

The CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometry, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft V7.0 Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE V7.0 Cardiac Testing System is a turnkey product utilizing the CardioSoft V7.0 Cardiac Testing software.

The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). Physiological parameters and waveforms supported are: · Pulse oximetry (SpO2/pulse rate) · Respiration rate (RR) Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications. The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. This device is not an Apnea monitor (i.e., do not rely on the device for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. The Portrait Mobile Monitoring Solution is not in a controlled Magnetic Resonance (MR) environment. Portrait Central Viewer Application (Portrait CVA01): The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications. The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait Core Services (Portrait CSS01): The Portrait Core Services are a set of software services that enable the communication of the Portrait Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Monitoring Solution. Portrait Clinical Alarming Unit (Portrait CAU01): The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability. The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait Mobile Patient Monitor (Portrait HUB01): The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services. The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01): The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait SpO2 Attachment Accessory Band (Portrait AAB01): The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist. The Portrait Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01): The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediativ (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection. The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait RR Electrode Patch (Portrait RRP01): The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential signals from the patient and transmits them to the wearable respiration rate sensor. The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait RR Electrode Patch is not in a controlled Magnetic Resonance (MR) environment. Portrait Sensor Battery (Portrait SBT01): The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait wearable sensors and to provide wireless communication to a host device. The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Bedside Charger (Portrait BCH01): The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use). The Portrait Bedside Charger is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment. Portrait Mobile Patient Monitor Pouch (Portrait MMP01): The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Mobile Patient Monitor to be carried while the patient is ambulatory. The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Monitoring Solution is a new wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. This device is not an Apnea monitor (i.e., do not to rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. Do not attempt to use this device to detect sleep apnea. The Portrait Mobile Monitoring Solution consists of the following general categories of medical devices: Central Monitoring Devices: Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems. Portrait Central Viewer Application software hosted on a . Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients. . Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer. Mobile Monitoring Devices: Portrait Mobile Patient Monitor, a battery-powered, . wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarming, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). . Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly. . Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly. . Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor. . Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use). . Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist. . Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory.

The blood pressure cuff is an accessory used in con-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.

ONE-CUF blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems to obtain a blood pressure measurement. Blood pressure cuffs are non-sterile and single-patient use and may not be reprocessed for use on additional patients. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated. Blood pressure cuffs do not include serviceable parts or components. Non-Invasive Blood Pressure Cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. The cuff includes one or two flanges for attaching flexible tubing. This allows air to flow in and out of the cuff bladder for inflation and deflation. Inflation allows for occlusion of an artery to facilitate the measurement of automated noninvasive blood pressure (NIBP). The cuff tubes are terminated with connectors that allow for attachment to a blood pressure hose. This cuff will be offered with two different connection systems, bayonet and DINACLICK.

Mural Clinical Viewer is a patient monitoring software application intended for the electronic collection, display, trending, annotation, measurement and export of clinical data. Data is acquired from medical devices, Electronic Health Records (EHRs) and other data sources on a hospital's network. The application is designed to accept a patient selection from a host Electronic Health Record (EHR) program and then display that particular patient's data and waveforms within the EHR. The device is intended to be used by healthcare professionals in general hospital (including ICU) or remote clinical support settings while operating within a single patient's EHR. This product does not control or alter any of the medical devices providing data across the hospital network. All information, alerts or visual indications provided are intended to support the judgement of medical professionals. The product is not a bedside patient monitor and can only receive processed signal data from a hospital network.

Mural Clinical Viewer is a software only, information management system designed to enable viewing of patient's monitoring data. The system is accessible from the Electronic Health Record (EHR) application. Its use covers near real time and retrospective display of patient vitals, waveforms and events. The system also covers documentation of patient vitals including discrete values and waveform strips. The software is integrated with a healthcare facility's Electronic Health Records (EHR) and Medical Gateway Interface (MGI) for electronic collection, display, trending, annotation, measurement and export of clinical data. The software accessed as an integral part of the host EHR application, provides a single place to view patient monitoring data and to record documentation in EHR system without having to switch between multiple different applications and devices.

EK12 V2 analyzes 10 or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements. EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnosic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG. EK 12 V2 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or physician's office.

EK12 V2 algorithm is a software only product that provides computerized measurements from the ECG parameter data acquired by the host device. EK12 V2 analyzes ECG recordings for rhythm and measurements that is deployed as part of a host system used to generate ECG reports

The MAC 5 Resting ECG Analysis System is a non-invasive prescription device. • The device is indicated for use to acquire, analyze, display and print electrocardiograms. • The device is indicated for use to provide interpretation of the data for consideration by a physician. • The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data. • The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device can capture 3, 6, or 12 lead electrocardiograms, provide interpretive analysis, and print reports. The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow. The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.