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The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare 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 91390 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. The Qube is 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 devices 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. The Qube 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. The Qube is 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. The Qube 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 Spacelabs Healthcare Qube Compact Monitor (91390) (Qube) is a component of the Spacelabs Medical Patient Monitoring System. The monitor accepts and displays parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules as its predicate, the Spacelabs Medical Model 91370 Patient Monitor. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Heatthcare 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 91390 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. The Qube is 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 devices 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. The Qube 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. The Qube is 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. The Qube 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.

Conditions to be screened, monitored, treated or diagnosed. 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. Yes. Caution statement is provided in the introductory page of the Patient Care Management System which includes the operating instructions for this Module. Parts of body applied to. Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream. Frequency of use. Frequency as directed by physician. Physiological purpose. In conjunction with clinical findings, a screening and diagnostic tool for use in: assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations; monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea; continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure; episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure; continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature; monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.

The Spacelabs Medical Multiparameter Module 91496 with Option N is a slim, lightweight singular modular unit that, when used in conjunction with a ilght Care 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 N utilizes Nellcor Puritan Bennett OxiMax oximetry and sensors and OxiMax-compatible adapter cables.

QUEST is designed to provide ECG information and data to qualified medical personnel for the purpose of assessing the patient's cardiac response to exercise. It is to be used in hospitals, clinics, or physician offices by a qualified and licensed physician, or by trained staff under the direct supervision of that physician. Stress-test or exercise electrocardiography is used a) when the diagnosis of coronary artery disease is suspected, b) to determine the physical performance characteristics of a patient, c) for post myocardial infarction assessment, or d) for cardiac rehabilitation. The test involves the recording of the electrocardiogram during dynamic or, occasionally, isometric exercise. Disease assessment is most prominent in adult patients. The diagnostic value of exercise testing primarily concerns either ST segment depression present in myocardial ischemia, or elevation seen in infarcts (in comparison to P-Q segment as the isoelectric line). In addition, it is important to consider the patient's blood pressure response and physical symptoms. This instrument is not intended to interpret any exercise test results but is to be used as an aid for the physician to determine normal or abnormal response of the patient to exercise. QUEST is not intended for long term monitoring of patient ECG signals. Specifically, it does not substitute for recommended cardiac monitoring devices recognized by AAMI EC13, especially in the area of alarms. This instrument (OUEST) provides a method of collecting a multichannel ECG for dynamic evaluation of exercise performed by the patient. In order to provoke myocardial ischemia, the degree of stress must be sufficient to exceed the critical level of the patient's myocardial oxygen demand. The specificity of ST changes in identification of ischemia increases with the degree , time of onset, and when more than one electrocardiograph lead exhibits the abnormality. These patients can walk on a treadmill in which the speed and elevation can be adjusted (automatically or manually) to suit a variety of graded exercise protocols, or pedal an electronically braked bicycle ergometer. If the test subject is unable to walk, isometric exercise can be performed using a handheld dynamometer, or injecting the patient with heart rate stimulants to stress the myocardial system and then use this instrument's monitoring capability. It is operated from a standing position with design consideration given to ergonomic heights, viewing access of the information display, and control functions. It is cart based, with wheels, to provide easy movement. It can be used in conjunction with echocardiography, nuclear imaging, or pulmonary gas exchange equipment by providing ECG trigger signals and/or treadmill speed and grade levels. This instrument can also serve as an adult resting interpretive electrocardiograph with the addition of Burdick's resting interpretive program. The OUEST with T-Wave Alternans Option is intended for the measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing. The presence of Microvolt T-Wave Alternans as measured by the QUEST with T-Wave Alternans Option in patients with known or suspected ventricular tachyarrhythmia, or who are at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death). The OUEST with T-Wave Alternans Option should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Report Classifier software should be reviewed by a qualified physician. The predictive value of T-Wave Alternans for cardiac events has not been established in patients with active, untreated ischemia. *Microvolt T-Wave Alternans is defined as T-wave alternans which a) is measured from high-resolution multi-segment sensors, b) is present in leads X, Y, Z, VM, or two adjacent precordial leads, c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, d) is at least three standard deviations greater than the background noise level, e) has an onset heart rate of below 110 beats per minute, and f) is sustained for all heart rates above the onset heart rate.

The Quest Exercise Stress System is a computer based electrocardiograph (ECG) exercise stress test system designed for use with both treadmill and bicvcle eraometer exercise protocols. The Quest Exercise stress system provides real time ECG waveforms and calculations to qualified medical personnel while providing automatic or manual control of the exercise equipment. The Quest Exercise Stress System with T-wave alternans option provides measurement of T-wave alternans measurement in addition to the functions of the ECG. The Alternans Report Classifier software used with the Twave alternans option provides a preliminary assessment of the alternans report data.

The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System 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 Ultraview™ Waveform Pager 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 Waveform Paging System 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 Ultraview™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.

The Spacelabs Medical Ultraview™ Waveform Pager System provides caregivers within a clinical environment the ability to remain mobile and be notified when an alarm event occurs. Typically, alarm notification by the pager occurs 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 administration module allows convenient assignment of patients to caregivers from any location on the network, including WinDNA-enabled Universal Clinical Workstations. Patient status updates can also be scheduled for dispatch to the pager on a repeating basis if desired. This system is not a replacement for the primary alarm notification system. The delivery of pages cannot be guaranteed or verified. The Waveform Paging System is intended to augment alarm notification. It is not intended or designed to replace monitoring personnel, good clinical judgment, or to be used in place of bedside and remote alarm notification, or the Alarm Watch function of the monitor. The device subject to this submission is Model 91841. Each Spacelabs Medical Ultraview™ Waveform Pager System consists of a Server which collects and formats data from the monitoring network, a Transmitter which broadcasts the information to the mobile caregiver, and a Receiver which receives the broadcast and displays the formatted information.

Physiological purpose. An accessory to an SpO2 monitoring system for use in noninvasive, continuous monitoring of oxygen saturation for the detection of desaturation due to abnormal pulmonary/circulatory function in adult, pediatric or infant population by the standard photoelectric pulse of oximetric technique.

As an accessory to a pulse oximeter monitoring module in a Spacelabs Medical Patient Care Information System (PCIS), a Spacelabs Medical Disposable SpO2 sensor provides the means to noninvasively acquire SpO2 signals from the patient's fingertip or for the continuous monitoring of pulse saturation signals. The SpO2 sensor converts optical signals into electrical signals from common monitoring sites. The acquired signals are transferred via an adapter cable to a pulse oximeter monitor for subsequent display, review, and editing by the care provider. Sensors are available for specific monitoring sites, including the fingertip and foot, and are sized to meet various adult, pediatric and infant patient needs.

The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected. The Ultraview Digital Telemetry System also provides a means for the episodic monitoring of noninvasive blood pressure (NIBP) signals to detect abnormal events such as high and low blood pressure. The System also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/circulatory functions. The Spacelabs Medical Ultraview Digital Telemetry System Models 90343 and 90347 are intended for use with either adult or neonatal patient populations in a hospital environment. When the NIBP option is selected in the Model 90343 configuration, the NIBP feature is to be used with adult patient populations only.

The Ultraview Digital Telemetry System is a multiple parameter system which provides the capability for wireless central station monitoring of patients within hospitals or medical center facilities. This telecommunications feature converts bedside monitors to telemetry operation and works with a portable monitor for the transport of telemetricallymonitored patients to allow for the remote programming and data retrieval of clinical parameters specific to patient populations, clinical protocols, or operating preferences. Physiological parameters supported by the System are the acquisition and monitoring of electrocardiographic signals (ECG), pulse oximetric oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) parameters, based upon the System configuration options selected by the clinician. The devices subject to this submission are the Models 90343, 90347, and 90478. Each Ultraview Digital Telemetry System configuration consists of a battery-operated Telemetry Transmitter, a Receiver Module, and an antenna system. The Ultraview Digital Telemetry Multi-Parameter Transmitter Model 90343 is a wideband VHF unit that provides 5electrode ECG and continuous or episodic SpO2 monitoring capabilities, with an optional noninvasive blood pressure (NIBP) interface when connected to a Spacelabs Medical Model 90217Ambulatory Blood Pressure (ABP) Monitor (K855127). The Ultraview Digital Telemetry ECG Transmitter Model 90347 is identical to the Model 90343 with the SpO2 measurement function and ABP communications capabilities removed. The Ultraview Digital Telemetry System interfaces to a patient using standard accessories including ECG electrodes and lead wires, NIBP hoses and cuffs, SpO2 cables and sensors, and adapter cables to connect these accessories to the Transmitter. The telemetry system sends raw ECG vectors or preprocessed SpO2 and NIBP data, based upon the capability of the selected Transmitter, to the VHF version of the Model 90478 Modular Receiver via a diversity antenna system. The Modular Receiver collects and processes parameter specific physiologic data for alarm generation and display of numeric values and waveforms on a Spacelabs Medical Patient Care Management System (PCMS) Monitor or Ultraview Care Network via SDLC communications. The monitor provides the display, review, editing and analysis capabilities for the care provider. Hard copy records may be provided by the wide variety of Spacelabs Medical printers and recorders that can be interfaced by either Ethernet or SDLC communications.

The Spacelabs Medical 90519 Anesthesia Delivery System provides intermittent or continuous gas inhalation for adults and children (neonatal and pediatric). It allows the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anesthetic agents: Halothane, Isoflurane, Enflurane, or Sevoflurane, It provides safe and accurate gas flows to maintain patient respiration during anesthesia, and incorporates a ventilator, an oxygen monitor, and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anesthesia machine. It is recommended for use only by trained physicians, in the operating room or similar surgical environments.

The Spacelabs Medical 90519 Anesthesia Delivery System is designed to deliver anesthetic gases in a controlled hospital environment. The System incorporates a valveless patient circuitry design which offers very low resistance during spontaneous breathing since it allows for the ebb and flow of natural breathing gases. Oxygen, nitrous oxygen, and air are supplied to the gas distribution system for mixing with the selected anesthetic agent and delivery to the patient through the ventilation system. Another circuit separately provides for the cycling of patient expiration gases. The operator may select from two operating modes options: in manual mode the patient can be ventilated manually via a hand bag or the patient can breathe spontaneously; alternately, the controls can be set so that the patient is continually ventilated by the device. The control settings provide ease of use for both pediatric and adult patient populations in that the System may be set by the anesthesiologist for the appropriate tidal volume range based on patient needs. The System uses standard, commercially-available anesthesia system accessories appropriate to meet the needs of the clinician and patient. The delivery of gases is time cycled, volume controlled, pressure limited, and monitored for alarm states and error messages. Additional user-selectable convenience features include a hold switch to permit the temporary cessation of mechanical (continual) ventilation to facilitate the taking of imagery (e.g. x-rays) and a "sigh" switch to provide extra volume above the set tidal volume at a defined interval to allow for the more complete expiration of carbon dioxide.

The Spacelabs Medical Integrated Multiparameter Module 90496 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. In conjunction with clinical findings, a screening and diagnostic tool for use in: - assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation, as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations: - monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea: - continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure; - episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure; - continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature; - monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and - noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.

The Integrated Multiparameter Module 90496 is a slim, lightweight singular modular unit that. when used in conjunction with a Spacelabs Medical Palient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting. The Module is the primary interface to the patient being monitored. The Module 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 accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical monitor via SDLC communications. The monitor will provide the display capabilities for the care provider.