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AirStrip ONE Web Client with ACM is intended to allow clinicians to capture and display waveforms (such as ECG, SpO2, ART), discrete parameters, patient demographics, alarms, and other information from medical devices on a desktop device. This software is intended as a diagnostic aid to provide access for professional staff to view patient clinical data when the professional cannot observe the source system directly. AirStrip ONE Web Client with ACM does not store Protected Healthcare Information on the device accessing the data. Data available on the web viewer is in "near real time" and is displayed to show a full range of clinical data available, even when the data sources are obtained from different devices. AirStrip ONE Web Client with ACM gathers data from the medical devices that are connected to the patient. AirStrip ONE Web Client with ACM is not directly connected to the individual, but to a networked medical device receiving data, and connects that data to individuals by medical record number or defined patient ID. AirStrip ONE Web Client with ACM is intended to be used by clinicians for the following purposes: • To visualize physiological data using a web viewer to assess clinical status of a patient when the source system cannot be observed directly by the clinician. - · To view the near real-time and historic waveforms. · To view other near real-time patient data from a monitored system. · To provide a request for remote consultation regarding a patient's waveform or other data. - · To send electronic images of the cardiac rhythm to the medical record. - · To allow clinicians to manage secondary alarm transmission by suppressing non-critical alarms. AirStrip ONE Web Client with ACM is appropriate for use in pediatric (0-21 years), adult and geriations, as the networked medical devices AirStrip collects data from are already cleared for these populations. AirStrip ONE Web Client with ACM software can display the following physiologic parameters and waveforms captured by other cleared medical devices: - · ECG Waveform - · Heart Rate - · Respiratory Rate - · Oxygen Saturation - Intracranial Pressure - · Central Venous Pressure - Pulmonary Capillary Wedge Pressure - Pulmonary Artery Pressure - Cardiac Index - Cardiac Output - · Cerebral Perfusion Pressure - · Temperature - · Temperature Source o Bispectral index (BIS) o Umbilical Artery - o Body Weight - Systolic Blood Pressure Invasive - · Mean Arterial Pressure Invasive - Diastolic Blood Pressure Invasive - · Systolic Blood Pressure Cuff - · Mean Arterial Pressure Cuff - · Diastolic Blood Pressure Cuff - Vasoactive Infusions - Ventilators - · Allergies - IV Fluid Delivery Rate - IV Medication Dose - Pulse Rate - Bispectral Parameters - Monitored Events - Right Atrial Pressure - · Left Atrial Pressure - · Laboratory Data, including - o Blood Gas - o Chemistry - o Hematology - o Coagulation - · Hemodynamic Calculated Values - · Medications - IV Volume Infused - · ETCO2 - · Fractional Inspired Concentration O2, CO2 - Case Consumption Liquid Medications - · Case Consumption Respiratory Gas

The AirStrip Technologies, Inc. (AirStrip) ONE Web Client, the predicate device being modified to include the AirStrip Alarm Communication Management (ACM), provides visualization of monitoring data, waveforms, and events for clinicians who are away from the bedside to support and enhance their collaboration with other care team members who are with the patient. All data, waveforms and events displayed by AirStrip ONE Web Client are generated by primary monitors, not by AirStrip ONE Web Client. Events that triggered alarms by the primary monitor system populate in AirStrip ONE Web Client in near real time so a remote (i.e. not at bedside) clinician can review these items while they are collaborating with other care team members. The AirStrip ONE Web Client remote patient monitoring is a visualization and collaboration aid. It allows for the display of waveform, monitoring data, and events that triggered primary patient monitor alarms without itself originating alarms. The clinical use of AirStrip ONE Web Client presupposes nurses or other clinicians will be at the hospital, either at the bedside or a near-by monitoring station. The AirStrip ONE Web Client with Alarm Communication Management (ACM) module is a "rules engine" module that, when used in conjunction with, and as a part of, the existing AirStrip ONE Web Client to gather alarms from various alarm sources, processes the alarms through a rules configuration tool (the proposed device) using clinical rules established by the customer, typically a healthcare institution, to filter and distribute those alarms to a third-party server connected to mobile devices carried by healthcare providers. The display device stays in a notification state until the healthcare provider dispositions the alarm.

AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: • By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital • To view the near real-time waveforms remotely • To remotely review other standard or critical near real-time patient data from the monitored system • To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the following the physiologic data captured by other medical devices: • ECG Waveform • Heart Rate Monitored • Respiratory Rate • Oxygen Saturation • Intracranial Pressure • Central Venous Pressure • Pulmonary Capillary Wedge Pressure • Cardiac Index • Cardiac Output • Cerebral Perfusion Pressure • Urine Output • Urine/Stool Mix Output • Systolic Blood Pressure Invasive • Mean Arterial Pressure Invasive • Diastolic Blood Pressure Invasive • Systolic Blood Pressure Cuff • Mean Arterial Pressure Cuff • Diastolic Blood Pressure Cuff • Vasoactive Infusions • Antiarrhythmics • Sedation • Paralytics • Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation • Allergies • Medications Contraindications AirStrip RPM software is intended for installation on cellular telephones and other wireless devices, and is not intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use by clinicians when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.

The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System in hospitals to allow health care professionals the ability to view near real-time patient data remotely. AirStrip RPM works by retrieving patient data from the InvisionECG System monitoring system and providing that data to the end user's device via Wi-Fi or cellular modem over the Internet.

This device is intended to be used by clinicians for the following purposes: - To view the near real-time waveforms remotely - To remotely review other standard or critical near real-time patient data from the monitored system - To provide a request for remote consultation regarding a patient's waveform or other data This device software can display the following the physiologic data captured by other medical devices: - ECG Waveform - Heart Rate Monitored - Respiratory Rate - Oxygen Saturation - Intracranial Pressure - Central Venous Pressure - Pulmonary Capillary Wedge Pressure - Cardiac Index - Cardiac Output - Cerebral Perfusion Pressure - Systolic Blood Pressure Invasive - Mean Arterial Pressure Invasive - Diastolic Blood Pressure Invasive - Systolic Blood Pressure Cuff - Mean Arterial Pressure Cuff - Diastolic Blood Pressure Cuff

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The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home. It is to be used by health care professionals and patients on the order of a physician. Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment. Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

The Sense4Baby System, Model B+ (MSA) is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine contractions during antepartum (non-stress) testing. The system transmits the measured data to a gateway device, and then a HIPAA Compliant web based portal for storage and physician review.

AirStrip RPM for LIFENET Consult is an optional data transmission system that provides the capability to receive notifications at a remote location. Data is received from the field and can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.

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