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The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.

The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory electrocardiograph (ECG) recorder capable of providing a 3-lead recording. It is connected to the patient using a custom, disposable, single-patient only, 3-lead sensor patch that is adhesively attached to the patient's chest. The Eclipse MINI is powered by batteries that are integrated in the Eclipse Sensor Patch. These batteries are primary cells which cannot be recharged and power the recorder for up to 15 days. For an extended recording multiple Eclipse Sensor Patches may be required. The single patient event button allows the patient to indicate symptomatic episodes in the recording for correlation with the patient diary. The Eclipse MINI is fully sealed and waterproof. The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor Patch by inserting the USB connector on the sensor patch into the USB receptacle on the bottom of Eclipse MINI housing. Patient data from the Eclipse MINI is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse MINI, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921). Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

The Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient's ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either or at home. The device does no cardiac analysis and is used with a Holter Analysis System.

The Eclipse PRO Model 98700 (Eclipse PRO) is an ambulatory electrocardiograph (ECG) recorder capable of providing a true 12-channel recording for up to 72 hours or a 3-lead recording for up to 14 days. It is connected to the patient using Eclipse PRO-specific 3, 4, or 10 lead wire cables with the recorder located in a pouch on a lanyard. The Eclipse PRO has a large, color display which allows the user to view recorder status, configure the recorder and to view ECG lead application. It has an internal, fast-charge, long-life, rechargeable lithium-ion battery, which is charged when connected by a cable between the USB port of a personal computer (PC) or a USB charger, and the recorder's USB-C connector. Two (2) arrow keys on the front of the Eclipse PRO are used to navigate and select options in the recorder's menu or as a patient event button when the patient desires to indicate symptomatic episodes in the recording. The Eclipse PRO is fully sealed and waterproof. Patient cables are attached to the Eclipse PRO using the USB connector on the bottom of the housing and protective cable retention loop. Patient data from the Eclipse PRO is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse PRO, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921). Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

The Spacelabs Lifescreen PRO Analyzer (Model 98800 Analyzer) is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Lifescreen PRO is capable of analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists. Lifescreen PRO can be used as a triage tool for assessment of ambulatory ECG from supported devices; supporting selection and export of ECG segments for more detailed analysis in the Spacelabs Pathfinder SL Analyzer.

The Spacelabs Lifescreen PRO Analyzer is a rapid analysis software product that can be used to analyze electrocardiology (ECG) recordings of up to 30 days in duration from Spacelabs Healthcare's range of Ambulatory ECG recorders. The ECG recordings are downloaded into the Sentinel Cardiology Information Management System (Sentinel), cleared by FDA in 510(k) submission K152881, imported into Lifescreen PRO, and then analyzed. Lifescreen PRO is designed to provide a rapid analysis of the detection and reporting of major arrhythmic events and patient reported symptomatic events including AF, Pause, VT, V-Run (>3 beats), Trigeminy and Bigeminy, SVT, SV-Run, and Bradycardia. Individual normal, ventricular, and supraventricular beat burdens are presented as a percentage of the total beat counts. No automated algorithm for arrhythmia detection offers 100% sensitivity and accuracy for the detection of arrhythmia events. Laboratory testing and clinical studies have shown that scanning and a review of analyzed results by a trained user provides the highest degree of report accuracy. Following analysis, the report should be reviewed by a physician prior to initiating or changing patient treatment. ECG data with a lot of noise, which can result from poor hook-up and/or poor-quality electrodes, can result in beat misclassification. The algorithm monitors the ECG quality throughout and will inhibit analysis during periods of noise; the inhibited analysis is clearly shown in grey. This allows the user to review the inhibited areas to ensure that significant events have not been missed. Various tools are provided in Lifescreen PRO to allow the trained user to quickly view the full disclosure ECG, add, delete, or reclassify events and beats, or artefact periods of noisy ECG. Where more detailed analysis is required, Lifescreen PRO also has the ability to export sections of a recording up to 7 days in duration into the Sentinel Cardiology Information Management System for further analysis using the Pathfinder SL analysis system.

The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and facility information. The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel. The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates. Sentinel supports importing reports from external systems and provides an HL7 interface to external systems. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment. The Sentinel Cardiology Information Management System is not intended for patient monitoring.

The Spacelabs Healthcare Ltd. (Spacelabs) Sentinel Cardiology Information Management System (Spacelabs) is a stand-alone software product which can capture, store, access and manage electrocardiograph (ECG), ambulatory blood pressure (ABP), stress test, ergospirometry, spirometry, event and plethysmography data with Holter analyses and reports, together with the corresponding patient information. Sentinel can be used as a single stand-alone installation, or as part of a multi-user network. Sentinel may be used for recording and reviewing of ECG of adults and pediatrics in a clinical environment inside and outside of hospitals.

The Spacelabs Model OnTrak (9027) Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Spacelabs Model OnTrak (90227) Ambulatory Blood Pressure (ABP) Monitor (Spacelabs OnTrak) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) measurements for a 24 hour, 48 hour, or longer period. These The Spacelabs OnTrak does not have any physiological alarms, but does have an audible low battery indicator. The Spacelabs OnTrak utilizes the same NIBP cuffs as the predicate device.

The intended use of the Spacelabs Healthcare CardioExpress (CardioExpress) is to acquire ECG signals from adult and pediatric patients using ECG electrodes. CardioExpress is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only.

The Spacelabs Healthcare (Spacelabs) CardioExpress, Models 98400-SL3-IEC, 98400-SL3-AHA, 98400-SL6-IEC, 98400-SL6-AHA, 98400-SL12-IEC, and 98400-SL12-AHA, are a series of electrocardiographs (ECGs) designed to acquire, analyze, display, and record ECG signals from ECG electrodes connected to a patient. After been amplified, filtered and analyzed, the ECG signal waveforms and analysis results are presented on a liquid crystal diode (LCD) display, and recorded on the paper through either a thermal or USB printer. ECG data, result and patient information may be stored in the memory file. The file can be transmitted to a personal computer (PC) through either an UART or Ethernet connection. The CardioExpress can optionally contain auto analysis software which assists in performing auto measurement and auto interpretation of data. The CardioExpress consists of two (2) basic components: (1) the signal acquisition module, and (2) the central processing unit. All models contain a rechargeable battery. The CardioExpress series of ECG monitors are provided in three (3) primary models: CardioExpress SL-3; CardioExpress SL-6; and CardioExpress SL-12.

The Spacelabs Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis results, and construct a report for physician use. The Spacelabs Pathfinder SL Holter Analyzer is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

Spacelabs Pathfinder SL Holter Analyzer (Pathfinder SL) is a software-only ECG analysis system for recording and analyzing up to 24 hours of 12 lead EGC or seven days of continuous 3 lead ambulatory ECG. Pathfinder SL is designed to operate on a Microsoft Windows® based personal computer (PC) platform, and contains provisions for networking. Pathfinder SL is compatible with Windows XP, Vista, or Windows 7 32-bit (ensure the latest service packs installed) operating systems. Pathfinder SL is used in conjunction with Spacelabs Healthcare's Sentinel Cardiology Information Management System (Sentinel), and is sold only for use with Sentinel. In conjunction with Sentinel, Pathfinder SL can acquire data from Spacelabs Holter recorders, analyze up to 12 channels of ECG data, providing classification, editing, and reporting of arrhythmia, ST segment, heart rate variability and pacer performance, and allows the operator to construct a report for physicians to use within their diagnosis of patients. Pathfinder SL is compatible with Lifecard CF, Lifecard 12, evo and Aria Holter Recorders. ECG from pre-existing stored analyses created with the previous Spacelabs Healthcare Impresario or Pathfinder Holter analyzer systems can be analyzed from scratch using Pathfinder SL. Pathfinder SL should be used by an operator trained in electrocardiography. A qualified medical practitioner should make any diagnosis.

The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

an anesthesia workstation that contains all the pneumatic circuitry, controls, monitoring, ancillaries and storage required to control, distribute and mix medical gases and anesthetic agents in order to deliver them to a patient system. It is capable of delivering oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The Spacelabs BleaseSirius is the latest generation product in a family of anesthesia workstations. The same breathing circuits used with the predicate device, the Blease Frontline Sirius 2000, 3000 cleared by FDA in 510(k) premarket notification K051629, are used with the Spacelabs BleaseSirius.

The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems.

The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor (Model 90217A) is a small, lightweight unit designed to take non-invasive blood pressure (NIBP) and heart rate (HR) measurements for a 24 hour, 48 hour, or longer period. These measurements are recorded in the monitor and may be transferred to Spacelabs ABP analysis systems. The Model 90217A allows the use of an automated or manual inflation system, and utilizes the oscillometric NIBP measurement method. The pressure sensor signal is amplified, digitized by an analog to digital converter (ADC), and supplied to a microprocessor which has control of the pump and vent valve. Measurements are made during the stepwise deflation of the cuff. The Model 90217A NIBP and HR algorithms are identical to that of the predicate. Additionally, the NIBP patient cuffs used with the Model 90217A are the same as those used with the predicate. A block diagram of the Model 90217A is presented in Figure 2. The Model 90217A is powered by three (3) "AA" alkaline or rechargeable NiCad batteries; there is no capability to connect the Model 90217A to AC mains power. A lithium battery is used to provide backup power for the Model 90217A memory. Both battery types need to be periodically replaced. The Model 90217A is carried in a pouch that is strapped and/or belted to the side of the patient. NIPB and HR measurements are taken using a blood pressure cuff attached to the patients arm. This information is recorded in the monitor, and can be transferred over a modem link, or by direct connection, between the Model 90217A and one of the ABP analysis systems.