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Menntor X7 is intended for use as a multi-parameter physiological patient monitoring system. The Menntor X7, is a modular monitor with a Multi Parameter Module (MX57, MPM) that can monitor ECG/heart rate, invasive blood pressures , temperature, pulse oximetry, respiration, non-invasive blood pressure, and Cardiac Output The Menntor X7 can also monitor EtCO2, Spirometry and EEG, and display aEEG. The MPM (MX57) is equipped with a battery and can continue monitoring it's vital sign when out of the host Menntor X7 This effectively allows the Menntor X7 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multi-parameter waveforms, vital signs, alarm & status messages. The Mennen Medical Menntor X7 is intended for sale as a system for monitoring and recording patient information on any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: - · Critical Care Patients - · Cardiac Step-down Units - · Emergency Departments - · Intra-operative (Anesthesia) Monitoring - · Post Anesthesia Care *The Intended Use of the Menntor X7 as indicated above is same as the Indications For Use.

The Menntor X7 is a modular multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical VitaLogik 6000/6500 and Envoy monitors, with integrated display screen. It is part of the Envoy/VitaLogik Monitor family and runs on same software versions. In general, the Menntor X7 has the same functions, similar intended use and technology as the other members of the Mennen Medical monitor family. The Menntor X7 uses identical display format and patient data as does the VitaLogik 6000/6500 monitor. The Ensemble central station and the Enguard remote monitor can both view the Menntor X7 as well as the other members of the family: VitaLogik 6000/6500, VitaLogik 4000/4500, VitaLogik 5000/ 5500 and Envoy. The Menntor X7 bedside patient monitor consists of MX57 - Multi Parameter plug in Module, (MPM), two additional single parameters plug in modules, a main processing unit, and an integrated color monitor with optional touch screen. The front end electronics incorporated in the MPM has same hardware and software as VitaLogik 6000/6500 . The input connectors are incorporated in the side panel of the MPM. The MPM (MX57) has an optional 5.7" display, that enables the MPM to continue monitoring when taken out of the Menntor X7 host. The Menntor X7 monitor presents vital signs in the same way and the same GUI (Graphic User Interface) as does the VitaLogik 6000/6500 monitor. The Menntor X7 can acquire the following physiological signals of the patient: · ECG - Waveform. Arrhythmia and numeric values of Heart Rate, and ST - · Blood Pressures Waveform and numeric values of, Diastole and Mean pressure - · Temperature As a numeric value in Cº or Fº - · SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate - · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp - · EtCO2 EtCO2, inCO2 and Respiration Rate - · Spirometry - · EEG and aEEG.

The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

The CerebraLogik consists of a dual channel EEG amplifier that is put near the monitored patient. The amplifier is connected, using an interface cable, to a Mennen Medical patient monitor via the UIM input of the monitor. The monitor has display options for both real time EEG and history of Amplitude Integrated EEG - aEEG. The monitor stores both EEG and aEEG signals for the duration of the EEG monitoring.

The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures, and EtCO2. BP waveforms from different heart and vascular sites, are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform, gradients and FFR, can be stored, recorded, analyzed and presented in a variety of report formats.

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The system has a computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard. The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display. The Central System contains the following main devices: Computer, Two local LCD displays, Video line driver, AC Power Unit, Laser printer, Hub, Modem. FFR is a mode that uses two invasive pressure inputs. Pa - Proximal pressure measured with external pressure transducer at the artery or aorta. and Pd - Distal pressure measured with a pressure wire sensor in the coronary arteries across lesion. Mean pressures are calculated and the ratio between the means Pd/Pa is calculated and displayed.

VitaLogik 6000/6500 is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik 6000/6500 can monitor ECG/heart rate, invasive blood pressures , temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik 6000/6500 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical VitaLogik 6000/6500 is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: - · Critical Care Patients - · Cardiac Step-down/Telemetry Units - · Emergency Departments - · Intra-operative (Anesthesia) Monitoring - · Post Anesthesia Care

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The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Horizon XVu system consists of a Front End unit (CFE) and a Central system. The CFE acquires, processes, and converts vital signs from the patient into digital signals and sends them to the central system for process and display. The central system contains a computer workstation, displays, printer, and other components. The system is capable of acquiring and displaying ECG/Heart Rate, ICECG, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature.

The Mennen Medical VitaLogik BIS interface 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 EBG signals. The BIS Index, a processed parameter 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 Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population. The Intended Use of the VitaLogik monitor as indicated above are same as the Indications For Use.

The VitaLogik is a multiparameter physiological patient monitor, capable of monitoring: - ECG/Heart Rate - Invasive blood pressure - Non-invasive blood pressure - Respiration - Pulse oximetry - Two temperature channels - Cardiac output - EtCo2 - Spirometry - BBG - BIS Interface (new subject of this application) Main components of the VitaLogik: The VitaLogik system consists of: (A) a Bed side computer with (B) Display (A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals. The VitaLogik can acquire the following physiological signals of the patient: - ECG Waveform and measures Heart Rate, ST and Arrhythmia - Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure - Temperature As a numeric value in C or F - SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate - NIBP Systolic, Diastolic and Mean pressure with measuring time stamp - EtCO2 EtCO2, inCO2 and Respiration Rate - BIS Index of conciseness and EEG waveform (B) The Display is used to display the measurement and waveforms, and alarms. With touch screen option it provides also the control functions, replacing the use of hardware keys. Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, waveform, Vital Sign Numeric Value, Alarm Status Message. Operation of the VitaLogik is accomplished by interaction with front panel controls. A quickknob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is displayed. The VitaLogik is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration. The VitaLogik monitors the patient's vital sign data derived by the VitaLogik are presented on the monitor as waveform and numeric displays. The VitaLogik acquire vital signs data from the patient, and display their waveforms and alarms indications on the VitaLogik display. The VitaLogik is not a kit and does not contain any drug or biological products. The BIS Interface of the VitaLogik patient monitor is not sold as a stand alone device, but as part of a multiparameter physiological patient monitoring system (VitaLogik). In chapter 1, page 1-2 of the VitaLogik Operating Manual, the following Prescription Notice appears: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only" Functional description of the new VitaLogik BIS Interface: (Interface to Aspect BISx device cleared in K 040183) The BIS Interface is used to monitor dual channel EBG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness. The BIS index together with several quality parameters are displayed and stored by the VitaLogik monitor.

The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats. *The Intended Use of the Horizon XVU is same as the Indications For Use as indicated above.

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Horizon XVu is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature. Heart rate, multi-lead ECG, EtCO2 and BP waveforms from different heart and vascular sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats. The Horizon XVu is used for activities such as coronary and peripheral endovascular procedures and Angioplasty. The basic steps described above (catheter positioning, site definition/acquisition, analysis and acceptance) are performed as an integral part of these procedures. The system has a Sun Ultra 25 computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard. A Laser Printer is provided in the system. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures. The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs (A) from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display.

VitaLogik 4000/4500 is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik 4000/4500 can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the VitaLogik 4000/4500 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical VitaLogik 4000/4500 is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: - * Critical Care Patients - * Cardiac Step-down/Telemetry Units - * Emergency Departments - * Intra-operative (Anesthesia) Monitoring - * Post Anesthesia Care *The Intended Use of the Envoy monitor as indicated above is same as the Indications For Use.

The VitaLogik 4000/4500 is a configured multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical VitaLogik 5000/5500 monitor, with integrated display screen. It is part of the Envoy/VitaLogik family and runs on same software versions. In general, the VitaLogik 4000/4500 has the same functions, intended use and technology as the VitaLogik 5000/5550, the main different between the VitaLogik 4000/4500 and the VitaLogik 5000/5500 is the addition of battery power supply that gives the VitaLogik 4000/4500 same abilities as the VitaLogik 5000/5500 with the ability to use it as a transport monitor. To reduce the power consumption we have also replaced the hard disc memory with a Compact Flash memory. The VitaLogik 4000/4500 uses identical display and patient data as do the VitaLogik 5000/5500 and Envoy monitors. The Ensemble central station and the Enguard remote monitor can both view the VitaLogik 4000/4500, VitaLogik 5000/ 5500 as well as the Envoy. The VitaLogik 4000/4500 bedside patient monitor consists of a main processing unit, and an integrated color monitor with optional touch screen. The front end electronic has same hardware and software as VitaLogik 5000/5500 . The input connectors are incorporated in the side panel of the monitor. The VitaLogik 4000/4500 monitor presents vital signs in the same way and the same GUI (Craphic User Interface) as does the VitaLogic 5000/5500 monitor. The VitaLogik 4000/4500 can acquire the following physiological signals of the patient: - · ECG Waveform and measures Heart Rate, ST and Arrhythmia - · Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure - · Temperature As a numeric value in Cº or Fº - · SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate - · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp EtCO2 - EtCO2, inCO2 and Respiration Rate

The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The Mennen Medical Envoy BIS module 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 BIS Index, a processed parameter 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 Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training. - In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

The Envoy is a multiparameter physiological patient monitor, capable of monitoring: - ECG/Heart Rate . - Invasive blood pressure . - Non-invasive blood pressure ● - Respiration ● - Pulse oximetry - Two temperature channels ● - Cardiac output ● - EtCo2 . - Spirometry ● - EEG ● - BIS module (new subject of this application) . The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time. The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA. The BIS Module is used to monitor dual channel EEG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness. The BIS index together with several quality parameters are displayed and stored by the Envoy monitor.

EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded. The system allows the user to monitor, display and record the signal data. The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

The EMS-XL Cardiac Electrophysiology System consists of a software driven, multichannel amplifier and stimulator that are connected to a computer. Input signals include 12 lead surfaces ECG, two Blood pressure channels and 18 or 50 channel intra-cardiac ECG. The signals are digitized and sent to the computer for analysis, display and storage. Signals are displayed with sweep speeds of 25 to 300mm/sec in either predefined or customized configurations. The system consists of a computer, Front end amplifiers with integrated stimulator. Two display screens, one used for Real Time signal display and the other for Non real Time display for analysis and review and playback of stored signals. A Laser printer is used to print surface and intra-cardiac ECG and a CD or DVD is used for archive of signals. The two display screens are used to show the signals. The real time display, RT, shows the real time signal waveforms. Each waveform channel is color-coded for easy identification. The non real time display, NRT, serves as a Review monitor allowing the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing. The stimulator is computer controlled and provides basic stimulation rate plus up to 4 stimulations delayed after the basic stimuli. Stimulation can be either synchronized to the cardiac electrical activity or non synchronized. Pacing protocols with automatic increment and decrement functions provides refractory period measurements. A variety of stimulation sequences can be created and stored for future use. The EMS-XL can be used for all types of electrophysiological procedures, including His bundle recording, Sinus Node Recovery Time - SNRT, Overdrive, Wenckebach, and tachy-arrhythmias. An interface to ablation generators provide Ablation Start and End information with data on the ablation parameters. Each waveform is color-coded for easy identification. The review monitor allows the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing. Special display options support the signal analysis This includes Trigger mode and template comparison. Event marking. Holter mode: quick. minute-by-minute scrolls and jumps to event, On screen calipers: both real-time and review screen with auto measurement , Auto Tachycardia detection. Free text labeling, and Customized reports in Word™. The input to the amplifiers is via a patient connection box, to which the intra-cardiac catheter electrodes (not manufactured and not supplied by Mennen Medical) are connected.