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The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the monitoring of the following parameters: - Non-invasive blood pressure - Impedance respiration - Invasive blood pressure - Temperature - Functional arterial oxygen saturation (SpO2) - End-tidal & inspired CO2 - ECG monitoring with arrhythmia & ST-segment - 12-Lead resting ECG - Cardiac output The Mortara Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters: - Non-invasive blood pressure - Impedance respiration - Invasive blood pressure - Temperature - Functional arterial oxygen saturation (SpO2) - End-tidal & inspired CO2 - ECG monitoring with arrhythmia - 12-Lead resting ECG The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Mortara Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations. Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5" display and comes with an optional 2 channel printer. The Survevor S12 and S19 are intended for continuous monitoring in both bedside and portable applications and are manufactured in various fixed configurations. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, noninvasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO2), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output. The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Mortara Survevor Network, the Survevor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station (K131929) which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms. The new Surveyor S12, S19, V3.0.1 has added Wireless LAN capability and a Bedside-to-Bedside (B2B) feature that allows remote viewing of monitors when connected to a Surveyor Central Station

The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the following paramaters: - Non-invasive blood pressure - Impedance respiration . - Invasive blood pressure . - Temperature . - Functional arterial oxygen saturation (SpO2) . - End-tidal & inspired CO2 . - ECG monitoring with arrhythmia & ST-segment - 12-Lead resting ECG - Cardiac output . The Mortara Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters: - Non-invasive blood pressure ● - Impedance respiration - . Invasive blood pressure - Temperature - Functional arterial oxygen saturation (SpO2) ● - End-tidal & inspired CO2 ● - ECG monitoring with arrhythmia ● - 12-Lead resting ECG . The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Mortara Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations. Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5"display and comes with an optional 2 channel printer. The Surveyor S12 and S19 are intended for continuous monitoring in both bedside and portable applications and are manufactured in various fixed configurations. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, non-invasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO₂), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output. The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Mortara Surveyor Network, the Surveyor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station (K131929) which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms.

CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements. CardioConfirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.

CardioConfirm is a software component that is embedded into a host application (e.g. EMR) as a Dynamic Link Library (DLL) or launched as an executable application. CardioConfirm allows the user to display, edit and finalize diagnostic cardiology ECG, Stress and Holter reports. A Clinician can open a diaqnostic cardiology test from a workstation application and pass it to CardioConfirm as a DICOM object for viewing or editing. CardioConfirm is able to open and edit diagnostic cardiology ECG, Stress and Holter reports from Mortara Instrument, Inc. devices and offers an optional version which can edit diagnostic cardiology ECG, Stress and Holter reports from multiple diagnostic cardiology equipment vendors. CardioConfirm allows the clinician the ability to view, measure, and compare previously acquired resting ECGs as well as perform visual and textual serial comparison of acquired ECGs. With visual serial comparison, the clinician can view current and previous ECG's simultaneously superimposed on the screen. Textual serial comparison allows the clinician to enter or edit text that describes the significant differences between the ECG's. For adult ECG's the initial text can be generated by the VERITAS SERIAL COMPARISON algorithm. The algorithm generates comparative statements automatically on the basis of the VERITAS INTERPRETATION statements originally made by the Mortara acquiring devices, measurements and the ECG waveforms. The clinician can edit the patient demographics, previous measurements and interpretations and the serial comparison statements, and then sign final ECG reports. The clinician can also view and edit stress and Holter reports that includes editing patient demographics, summary statistics and physician conclusions. The clinician can electronically sign both stress and Holter final reports in CardioConfirm and print final reports or generate PDF copies to store in the host application. If a physician wants to amend a previously finalized report with additional information, CardioConfirm has an option to perform amendments to final reports and store the updated test in the host application. CardioConfirm is available in two versions. The standard version is intended to be used with tests generated by Mortara equipment. The professional version is intended to be used with tests generated by any equipment that produces DICOM 12-lead ECG Waveform and Encapsulated PDF objects.

The Surveyor S4 Mobile Monitor is indicated for use: • The Surveyor S4 Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own. • The Surveyor S4 processes Heart Rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm. • The Surveyor S4 can deliver data from a 3/5-lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station • The Surveyor S4 Mobile Monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure. • The Surveyor S4 Mobile Monitor is indicated for use in adults, adolescents and children. • The Surveyor S4 Mobile Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.

The Surveyor™ S4 Mobile Monitor is a battery operated patient worn transceiver that communicates via IEEE 802.11 Wi-Fi technology to the Surveyor™ Central Station (K131929) which is the primary monitoring display and alarm source. The Surveyor S4 transmitter has a touch sensitive, color display allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and Surveyor Central Station slot information. The Surveyor S4 can display physiological waveforms, measured parameters, demographic data and other status information. The Surveyor S4 acquires, filters, and processes ECG or ECG and SpO2 parameters and sends filtered signals and parameters to the Surveyor Central Station where alarm processing and annunciation occurs. The Surveyor Central is designed to communicate with the Surveyor S4 within a healthcare facilities Wi-Fi network infrastructure. The Surveyor Central provides primary monitoring of telemetry patients when used with the Surveyor S4. The central station displays numeric values, waveforms, alarm generation and management, data storage, individualized patient management, report generation and printing functionality. The Surveyor S4 provides continuous data acquisition which can be visualized on the S4 itself for the following parameters: - o Electrocardiography (ECG) including heart rate and ECG waveforms - · Saturation percentage of peripheral oxygen (SpO2), including SpO2 plethysmogram waveform, pulse rate, and signal quality index. - o No alarm status or processing information of ECG or SpO2 is shown on the Surveyor S4 device. - o The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias, by utilizing Mortara VERITAS™ ECG algorithm and sends ECG data packets, including arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole to the Surveyor Central Station for alarm processing and annunciation. - o The Surveyor S4 utilizes proprietary ECG lead cables available in AHA or IEC, snap or clip, 3-Lead, 5-Lead, and diagnostic 12 Lead configurations. - o The Surveyor S4 processes SpO2 percentage, pulse rate and signal quality through the Mortara SpO2 algorithm and sends data packets for SpO2 to the Surveyor Central Station for alarm processing and annunciation. - o Multiple SpO2 sensor styles allow connection of adults, adolescents, and children. SpO2 sensors are specified for use with the Surveyor S4 and available through Mortara Instrument.

The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

The H3+ Holter Recorder is part of a Holter Analysis system. The H3+ Holter Recorder provides multiple channels of continuous multi-day ECG data recording and pacemaker spike detection markers. The H3+ Holter Recorder is extremely small and lightweight. The H3+ includes a display that allows the clinician to confirm patient identification, preview the waveform, and check the quality of lead connections during patient hook-up. The H3+ also has a patient activated event button which allows the insertion of event marks into the recorded data if directed by the clinician. The H3+ uses a single battery and stores acquired data in digital form on internal, non-volatile memory. Stored data is then imported for analysis at a compatible Holter analysis system [ e.g. HScribe (K004017) or Vision (K945985)]. The recorded data will remain in memory until it has been cleared by the clinician. The data provided by H3+ to the Holter Analysis system is used by trained medical personnel to assist in the diagnosis of patient conditions.

The XScribe/Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment. The device is not intended to be used as a vital signs physiological monitor.

The XScribe / Q-Stress device is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules. The device is able to generate risk scoring via recognized protocols. The device is capable of obtaining a resting ECG with automatic interpretation. The device can interface with equipment for pulmonary evaluation. The device has several built in exercise protocols for connection and control of exercise equipment such as treadmills and ergometers. The device supports measurement of non-invasive blood pressure. The device can output analog ECG signals or digital QRS trigger signals for synchronizing an external device. The device supports a touch screen interface as well as a keyboard / mouse interface and a wired remote control unit. The device will store a complete record of diagnostic quality test data from which the user can generate and review stress test reports. The device can function as standalone workstation or can connect via network to a database server allowing for remote review capabilities. The device can communicate with electronic record keeping systems to obtain work lists and patient data, and to provide test result reports.

The Surveyor S4 Mobile Monitor is indicated for use: - The Surveyor S4 mobile monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG signals. - The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. - The Surveyor S4 mobile monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. - The Surveyor S4 mobile monitor is indicated for use to acquire and output electrocardiographic data. - The Surveyor S4 mobile monitor is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network. - The Mortara Li-Ion Battery Charger is intended for charging only the Mortara Rechargeable Li-Ion battery pack.

The Surveyor S4 incorporates wireless electrocardiographic technology to achieve real-time acquisition and RF transmission of simultaneous diagnostic quality 12-lead ECG data to a network access point while allowing the patient to be ambulatory. It provides a means to acquire and transmit 12-lead cardiac signals through the network access point to a compatible monitoring device where the signals are displayed. The Surveyor S4 Mobile Monitor allows the patient complete freedom of movement. Extended range can be obtained with additional network access points). The Surveyor S4 Mobile Monitor uses a similar patient cable as the T12S. The S4 requires use of a proprietary ECG patient cable for use with snap electrode hookups. The patient cables use the same wire as present Mortara predicate lead-form cables. The cable is unique to the S4 and is distributed as a device component with the device. The patient cable acquires a continuous ECG signal. A design option will allow the user to set the patient cable type in case of reduced lead (less than 12-lead) options. ECG patient cable is worn by the patient in a standard torso electrode hook-up, which connects to snap type electrodes. Utilizing a frequency range of 2400.96Mhz to 2482.56MHz. ECG data is acquired, processed and transmitted via a Wi-Fi wireless network comprised of one or more network access points. The wireless network is used for patient data transmission and for other system-level command / control and communication. The data network uses modulation / control schemes that share spectrum based on standard IEEE 802.11 Wi-Fi at 2.5GHz range. The Surveyor S4 includes data integrity checks and bi-direction protocols to provide robust data transmission. The device also includes a mechanism to inform the user through a compatible centralized monitor of various device states including low battery, lead quality issues, or out of range condition. It has a color, touch-screen display as the primary interface for user input and graphical display of physiological waveforms, measured parameters, demographic data and other status information. The unit operates with a set of single-use commonly available disposable, non-spillable batteries or from a specified rechargeable battery back that is compatible standards. The battery charger is capable of charging up to five multi-use (rechargeable) batteries at one time and prevents overcharging. The Surveyor S4 uses a touch screen user interface for operator interaction that allows control over the device via selection of menu items and icons as well as entry of relevant configuration. While in normal operation, the display will show other status information such as a battery level indicator, Wi-Fi Signal Strength and Central Station Slot information.

The Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates. The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults and pediatric patients, using the oscillometric method on a cuffed arm.

The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring system. The Ambulo 2400 can measure systolic and diastolic blood pressure and pulse rate over and pulse rate over a 24 hour period. It is easily configured and individually-fitted for each patient by a physician or health care professional. Measurements are automatically captured, without medical supervision, by the Ambulo 2400 and later downloaded to a computer for analysis and interpretation by a physician.

The Monitoring Waveform Viewer is indicated for use as follows: The Monitoring Waveform Viewer is a software component utilized within another software application. The Monitoring Waveform Viewer performs the following: - Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters. - Display of reported alarm states produced by such monitoring systems. - Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon. - Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waver displays still waveforms. - Provide selected waveform episodes to the host application for printing or inclusion in the patient record. The Monitoring Waveform Viewer: - Is not a primary or secondary alarm device. - Does not provide a user interface for acknowledging or silencing active alarms. - Does not generate audible or visual (flashing) notifications of active alarms. The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.

The Monitoring Waveform Viewer is a software component that includes a system for reviewing snapshots of monitoring data and offers a measurement module with user controlled calipers and magnifier glass. Medical device data or information system applications may utilize the Monitoring Waveform Viewer software component that includes a stand-alone executable module that functions as a host application. The Monitoring Waveform Viewer is organized as a drawing surface with three areas: - a parameters area located at the bottom of the window, . - a parameter waveform area located at the right and - . a main waveform area. The parameters area is dedicated to report the values of parameters not associated with displayed waveforms. The parameter waveform area is dedicated to report the values of parameters associated to the displayed waveforms. The application supports several numerical parameters such as: ECG (electrocardiogram), ART (arterial pressure), PA (pulmonary artery invasive blood pressure), ICP (intracranial pressure), IABP (intra-aotic balloon pump pressure), RR (respiration rate), EtCO2 (end tidal carbon dioxide), SpO2 (oxygen saturation), etc. The Monitoring Waveform Viewer receives data parameters and waveforms supplied from multi-parameter patient monitoring systems. The Monitoring Waver is able to display alarm states by highlighting the corresponding parameter box. The Monitoring Waveform Viewer operating in near real time mode supports alarm priorities of High Priority, Medium Priority, and Low Priority. The Monitoring Waveform Viewer allows the user to right-click over any ECG lead or the ECG parameter box to activate a context menu for selecting the ECG gain and displayed leads. The user is able to select a list of active (with data) ECG leads received from the host application. It also allows the user to select gains of 5, 10, 20 and 40mm/mV. The Monitoring Waveform Viewer provides a caliper tool for performance amplitude and interval measurements on the displayed traces. The caliper can be placed anywhere on the waveform display area.

The device is indicated for use to acquire, analyze, display and print electrocardiograms. The device is indicated for use to provide interpretation of the data for consideration by a physician. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. The device is indicated for use on adult and pediatric populations. The device is not intended to be used as a vital signs physiological monitor.

The ELI 380 is a multichannel, high-performance resting interpretive electrocardiograph utilizing a large high resolution color LCD for display of ECG waveforms, menu options and status information. The LCD provides a preview of the ECG for the clinician to assess its quality. The overall design of the ELI 380 is a "clamshell" style where the LCD screen can be closed over the printer when the unit is shipped or not in use. The ELI 380 operates from an internal battery or AC power. A full size keyboard is part of the ELI 380 design and allows patient data entry as well as control of the functions and options available for the unit. The keyboard includes alphabetic, numeric, symbol, cursor control, special function keys and integrated pointing device. The ELI 380 keyboard is constructed of a continuous surface of chemically strengthened glass permitting ease of cleaning and disinfection. The ELI 380 is designed to be installed on an optional transport cart. The ELI 380 is able to acquire data via direct or wireless patient connection. Once the data is acquired it can be analyzed, reviewed, stored, printed or transmitted. The ELI 380 is able to retrieve and transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: LAN, WLAN, and/or USB port. The ELI 380 incorporates a full size thermal writer that allows printouts using several formats. The writer is also used for real time, continuous rhythm printouts at various speeds. The ELI 380 offers, adult and pediatic interpretation capability to assist the physician over-read of the electrocardiogram. The ELI 380 maintains a running buffer and a condensed display allowing the user to identify a preferred 10 second sample to acquire. The ELI 380 can also suggest the "Best 10" second segment from the buffer based on the quality of the ECG.