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The Early Vue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility. The intended use of measurement parameters for each patient type is shown in table below (Parameter (patient types)): Non-invasive BP--NBP (Adult, Pediatric, Neonatal); SpO2 --Masimo rainbow SET or Philips FAST (Adult, Pediatric, Neonatal); Pulse Rate -- PR -- derived from SpO2 or NBP (Adult, Pediatric, Neonatal); Temperature-Predictive, Temporal (Adult, Pediatric, Neonatal); end tidal CO2--etCO2 (Adult, Pediatric, Neonatal); Respiration Rate: airway respiration--awRR (Adult, Pediatric, Neonatal); Respiration Rate: acoustic respiration--RRa (Adult, Pediatric); Non-invasive Total Hemoglobin--SpHb (Adult, Pediatric) Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.

The subject device EarlyVue VS30 is a platform redesigned from the predicate device Suresign VS4 to provide the measurement of the same physiological parameters. It is a multi-parameter compact, portable monitor, offering several configurations and optional features that are intended to meet the customer's needs. The VS30 is designed with a simple, intuitive user interface for ease of operation. It is used to measure or monitor NBP, SpO2, SpHb, RRa, CO2 and optional temperature primarily in non-acute settings. The subject VS30 also provides the wireless option. The wireless functions for VS30 are for the monitors to communicate with the hospital EMR system or to communicate with Philips IGS software over the hospital's wireless infrastructure.

Indications for Use for SureSigns VS3 Vital Signs Monitor The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal) Contraindications: Not for transport outside the healthcare facility Indications for Use for SureSigns VS4 Vital Signs Monitor The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric. Neonatal); CO2 (Adult, Pediatric. Neonatal); RRa (Adult, Pediatric); SpHb (Adult, Pediatric) Contraindications: Not for transport outside the healthcare facility

The subject VS3 and VS4 will be modified with the current QuickAlert to include On-device multi-parameter configurable Modified Early Warning Scores (MEWS).

The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. | | Patient Types | | | |-------------|---------------|-----------|----------| | Parameter | Adult | Pediatric | Neonatal | | NBP | √ | √ | √ | | SpO2 | √ | √ | √ | | Temperature | √ | √ | √ | The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. | | Patient Types | | | |-------------|---------------|-----------|----------| | Parameter | Adult | Pediatric | Neonatal | | NBP | √ | √ | √ | | SpO2 | √ | √ | √ | | Temperature | √ | √ | √ | | CO2 | √ | √ | √ | | RRa | √ | √ | | | SpHb | √ | √ | |

The subject devices are SureSigns VS3 and SureSigns VS4 multi-parameter patient monitors. Modifications include adding connectivity to IntelliVue GuardianSoftware (IGS), adding Temporal Temperature measurement to VS3, and other enhancements such as additional title bar indicators, expanded patient records pane, display patient name or primary ID, expanded QuickCapture entries, default CO2 setting alignment (VS4 only), temperature high and low alarms color change, increased SpO2 alarm delay defaults, option to prevent inadvertently clearing NBP programs, and RFID patient ID entry.

The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are multi-parameter patient monitors, specifically the SureSigns VS3 and SureSigns VS4. Modifications to the VS4 include the addition of CO2, SpHb, Respiratory Rate RRa, and Masimo SpO2 measurements. Both VS3 and VS4 have the QuickNBP mode added.

The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardiopleqia doses, and tracks the volume of cardioplegia delivered.

The Sarns 8000 Cardioplegia Monitor is only compatible with the Sarns 8000 Modular Perfusion System. The Sarns 8000 Cardioplegia Monitor can display two pressures and three temperatures from attached probes. The pressure has alert and alarm levels which are set by the operator. The Sarns 8000 Cardioplegia Monitor also has a timer for use in tracking the time during and between doses of cardioplegia. With the new added features, it also displays the volume of cardioplegia delivered to the patient. The Sarns 8000 Cardioplegia Monitor communicates with the Sarns 8000 Roller Pump for obtaining volume information and to stop the roller pump (designated for cardioplegia delivery) during a pressure alarm condition if set by the operator to do so. The Sarns 8000 Cardioplegia Monitor also communicates with the Sarns 8000 Data Communications Module for purposes of data acquisition.