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The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLC based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors 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 hospital environment.

The Spacelabs Healthcare Xprezzon Bedside Monitor, Model 91393, is a component of the Spacelabs Healthcare Patient Monitoring System. The Xprezzon Bedside Monitor accepts inputs from the family of Spacelabs Parameter Modules. The monitor accept and displays parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules. The Xprezzon Bedside monitor, model 91393, is configured at installation to operate independent of or connected to the Spacelabs Patient monitoring Network. As an independent bedside monitor the device operates from AC and. presents waveform, numeric data, and alarm conditions, including arrhythmia information, received from parameter modules. When physically networked these monitors are able to share their information with a central station or with other monitors on the network according to conditions establish by the user/system administrator. They are also able to connect, via the healthcare institution's network, through Dynamic Network Access (DNA) to other applications available on the network.

Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

The Spacelabs Medical Patient Monitors are a component of the Spacelabs Medical Patient Monitoring System. The four (4) monitor models 91367, 91369 and 91370 and the stationary monitor model 91387; are all similar in that they are all employ the same software and all accept inputs from the family of Spacelabs Parameter Modules. The monitors accept and display parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules modules. The portable monitors are capable of operating independent of or connected to the Spacelabs Patient monitoring Network. As independent, portable monitors these devices operate from either AC or battery power. All alarm information received from the parameter modules is visually and audibly available at each monitor. When networked, either physically or wirelessly, these monitors are able to share their information with a central station or with other monitors on the network according to conditions establish by the user/system administrator. They are also able to connect, via the healthcare institution's network, through Dynamic Network Access (DNA) to other applications available on the network. The stationary monitor, model 91387, can be configured at installation as either a bedside or central station. As an independent bedside monitor the device operates from AC and. presents waveform, numeric data, and alarm conditions, including arrhythmia information, received from parameter modules. When physically networked these monitors are able to share their information with a central station or with other monitors on the network according to conditions establish by the user/system administrator. They are also able to connect, via the healthcare institution's network, through Dynamic Network Access (DNA) to other applications available on the newt6work. The model 91387 central station monitor provides full monitoring control of remote parameters, including displays and alarms with both visual and audible annunciation for up to 16 patients. All waveform and current numeric data, arrhythmia, ST segment, and trends are available are available at the central station.

The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for: - Adult - Pediatric The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of: - ECG with arrhythmia detection - Respiration - Non-invasive blood pressures - Invasive blood pressures - Body temperature - Functional arterial oxygen saturation, and - End tidal CO2. The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Spacelabs Medical, Inc. (Spacelabs) élance Vital Signs Monitor is a family of portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, respiration, NIBP, temperature, SPO2, invasive blood pressure and EtCO2. Models within the Spacelabs élance family come in two different sized viewing areas (10.2" and 12.1"), two different housing colors (white and black) and offer selected monitoring features. The Spacelabs Medical, Inc. élance Central Station software package is available for use with a customer acquired computer based on specifications provided by Spacelabs Medical. This package allows monitoring of the élance Vital Signs Monitor at a central workstation.

The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Spacelabs Medical mCare 300 Vital Signs Monitor Model 91220 (mCare 300), is a portable patient monitoring device intended to be used by clinicians and medically qualified personnel for monitoring physiological parameters; ECG, respiration, noninvasive and invasive blood pressure, body temperature, SpO2, or End tidal CO2 or ETCO2; in neonatal, of pediatric and adult patients. This device is designed to be used in all general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The Spacelabs Medical Full Disclosure System is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. The Full Disclosure System is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Medical Full Disclosure System is to interface with the Spacelabs monitoring network in order to provide the user with a means of recalling waveform information and retrospectively analyzing up to 72 hours of monitoring patient's most recent ECG waveform data.

The Spacelabs Medical Full Disclosure System (FD), model 91810, is a software application intended to be installed on an Off-The-Shelf (OTS) computer system utilizing a Microsoft operating system. The primary purpose of the FD system is to review, up to 72 hours of monitored patients' historical physiological waveform and alarm event information. The system also provides for a Retrospective Analysis of the stored ECG waveform data. The Full Disclosure system is a software application that provides fulldisclosure functionality for Spacelabs Medical bedside monitors. Depending on options purchased, a maximum of 72 hours of patient waveform history can be viewed for patients connected to the monitoring network. The system supports the following waveform channels: ECG Primary and secondary, Arterial pressure, Pulmonary artery pressure, Central venous pressure, Right atrial pressure, Intracranial pressure, Left atrial pressure, General pressure, Umbilical artery pressure, Pulse oximetry, Umbilical venous pressure, Adult or neonatal ventilator Flexport, Carbon dioxide / multigas Flexport or module, Sp02/ET02 Flexport and Respiration. The Full Disclosure application allows the user to view and print the full array of waveform information collected from Spacelabs Medical bedside monitors connected to the Spacelabs Medical patient monitoring network. The Alarm events, 12 Lead Reports and waveform information is available to the user for up to 72 hours after the information is stored in the network's database. In addition, the system incorporates a shape-based, Retrospective Algorithm that may be applied to the ECG waveform data, if desired. This Retrospective Algorithm can identify clinically significant ECG events and make them available for viewing and printing. When ECG analysis is performed, the results are stored locally, not in the database. Preference information, such as display and report options, is saved on the local machine, not in the database.

The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Spacelabs Medical mCARE 300 Vital Signs Monitor, Model 91220, is a portable patient monitoring device intended to be used by clinicians and medically qualified personnel for monitoring physiological parameters; ECG, respiration, noninvasive and invasive blood pressure, body temperature, Sp02, or End tidal C02 or ETC02; in neonatal, of pediatric and adult patients. This device is designed to be used in all general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.

The intended use of the Spacelabs Medical Clinical Event Interface is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Clinical Event Interface System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient monitoring network. The Clinical Event Interface supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot. The Spacelabs Medical Clinical Event Interface is a secondary alarm. It does not replace the primary alarm function on the monitor.

The Spacelabs Medical Clinical Event Interface (CEI), model 91847, is a software module intended to be installed on an Off-The-Shelf (OTS) computer system utilizing a Microsoft operating system. The primarv purpose of the CEI is to forward patient monitor alarm event information, originating from a Spacelabs Patient Monitoring network, to a messaging and notification system for delivery to the healthcare provider via wireless pagers. The system is also capable of providing vital signs updates at regular intervals. CEI allows nurses to be aware of their patients' alarm conditions when they are away from the patient and the monitoring system. CEI is an open design utilizing an OTS messaging system that is compatible with the Motorola CP1250 paging systems. The Clinical Event Interface includes a software module, created by Spacelabs Medical, that accesses patient data acquired from a Spacelabs Medical Patient Monitoring System. The monitoring system forwards the data to a database. The Spacelabs Medical software module recognizes when new information has become available. It accesses and formats that data for delivery to the Emergin Integrated Messaging System, an OTS software package. The Emergin software accepts input from the Spacelabs program, reformats it and passes it on to the paging encoder, an OTS component of the system. The paging encoder formats the data for the Motorola CP1250 pager and forwards it to the pager base station for transmission to the pager. The Spacelabs Medical CEI provides a complete, end-to-end solution for paging and incorporates all of these components in a single offering. The CEI messaging system provides for the sending patient information in a text only or text and graphic format to the Motorola CP1250 pager. The CEI system is designed to forward alarm information as the alarms are recognized by the patient monitoring network. The system is also cable of being set up to periodically forward a patient's physiological data at predetermined intervals. The Spacelabs Medical ICS Clinical Event Interface (CEI), model 91847, system is a secondary alarm notification system. It does not replace the primary alarm function of the bedside monitor.

The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 is intended for use under the direct supervision of a licensed healthcare 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 Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 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 Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 (BISx Module 91482) is an easy-to-use, slim, single module in the Spacelabs Medical family of Spacelabs Medical Ultraview System (Ultraview) modules. The BISx Module 91482 is a microprocessor based, two-channel EEG unit designed for use on adult and pediatric patients within a hospital or medical facility. Its system configuration includes the BISx Module 91482 with connectors for external serial data connections, a BISx pod, a patient interface cable, disposable sensors, and printer options. The BISx pod, patient interface cable and disposable sensors are manufactured by Aspect Medical Systems, and distributed by Spacelabs Medical for use with the BISx Module 91482, The Spacelabs Medical Ultraview monitor provides the display capabilities for the care provider.

The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is intended to provide a means of monitoring a variety of gas concentrations and to alert clinical personnel when the concentration of anesthetic agent, oxygen, carbon dioxide or nitrous oxide falls outside of user defined limits. The Module 91518 is capable of automatically identifying which anesthetic agent(s) is being administered. The Module 91518 is intended to be used with, and is controlled by, any Spacelabs Medical monitor, except the SLP100. The Module 91518 is intended for use monitoring all hospitalized patients under the direction of qualified medical personnel. Although the Module 91518 alarms when the duration between breaths exceeds user defined limits, it is not intended to be a primary diagnostic apnea monitor and/or recording device.

The Spacelabs Medical Multigas Analyzer Module 91518 (Module 91518) is an easy-to-use modular unit in the Spacelabs Medical product family. The Module 91518 is a multigas sidestream analyzer intended to provide a measurement of the following parameters; - CO2 produced by the patient; - . O2 and N2O administered to the patient; - Anesthetic agents administered to the patient which includes: . - Desflurane; - O Enflurane: - Halothane; O - lsoflurane; and O - Sevorflur-ane. - . Respiratory rate of the patient; and - Calculated MAC and age-dependent MAC values. . The Module 91518 automatically identifies which anesthetic agent or mixture of anesthetic agents is present, and measures the concentration of the identified agent(s). An alarm is issued if a mixture of more than two anesthetic agents is dctected. The Module 91518 interfaces with all Spacelabs Medical monitors, except the SLP100. The monitor provides a numeric display for the gas concentrations and respiratory rate, and a waveform display for O2 and CO2. The Module 91518 is intended to be used for monitoring all hospitalized patients under the direction of qualified medical personnel.

The Spacelabs Medical Multiparameter Module 91496 is intended for use with the PCMS to acquire, monitor and process various clinical parameters from adult or neonatal/infant populations in any type of clinical environment other than home use. Physiologic parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2), and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis. Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (SpO2) readings. Prescription use only.

The Spacelabs Medical Multiparameter Module 91496 with Option M is a slim, lightweight singular modular unit that, when used in conjunction with a Spacelabs Medical Patient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting. The Module 91496 is the primary interface to the patient being monitored. The Module 91496 is capable of acquiring and processing ECG, respiration, invasive and noninvasive blood pressure, temperature, cardiac output and SpO2 parameters for a single patient. The Module 91496 accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical PCMS monitor via SDLC communications. The PCMS monitor will provide the display capabilities for the care provider. Option M utilizes Masimo SET oximetry and sensors and SET-compatible adapter cables.