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The Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatic populations. The basic system delivers three (3), six (6) or twelve (12) channels of ECG parameters (waveform, arrhythmia and rhythm measurements, interpretation and heart rate). The device is indicated in situations where an instantaneous display of ECG information or a hard copy record may be required. The device is intended to be used under the direct supervision or a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is meant to acquire and record cardiac action potentials from patients. The device is design to be used in Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be applied. Waveforms, heart rate and analysis data from these patients are available to the diagnostic or may be recorded. The FX-8322 is an Electrocardiograph. The main part consists of the Main Control Board (model: PCB-7285), the Operation Board (model: PCB-7234), the AMP Board (model: PCB-6731), the LCD Module (model: TX17DO1VM2CAA / FD-42-3D), the Power Supply Unit (model: APAU003-07), the Recorder Unit. In addition, the Patient Cable (model: CP-105L), the Chest Electrode (model: TEE-01 / TEE-01RA) and the Limb Electrode (model: TEE-43 / TEE-43RG). Furthermore, the device is designed so it can be connected to USB, LAN cable, Serial cable, SD Card and an external monitor. There are two (2) types of the external monitors depending on the display size desired: 17 inch LC monitor L-560T-C: 19 inch LC monitor MX-191: The user interfaces, touch screen panel and key panel are located on the top surface of the device. The touch screen display has a variable number of keys that are activated by software and depends on the display/function that the user selects. In addition, there are sixty-five (65) fixed keys on the bottom of the LCD display. The Fukuda Denshi Model CardiMax FX-8222 provides acquiring and recording ECG (standard 12 lead), heart rate along with the standard 12-Lead ECG analysis software module. The Fukuda Denshi Model CP-105L Patient Cable provides the ECG signal through Electrocardiograph Electrodes. Additional standard features include the LAN connection, which is a proprietary network system through either a built in Ethernet LAN connector for connection to the hospital system. Standard features include a USB connection and SD Card connection, which is intended to store the ECG data and connect the USB Wireless LAN adaptor, and the Serial Connection, which is intended to connect to an External Monitor connection and the R-sync connection available when an R-Wave synchronized signal is needed.

The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor provides a simple and reliable method to display and document the continuous hemodynamic. cardiovascular observations that are typically required of critically ill patients. The target populations of the system are adult, pediatric, and neonatal patients, who may be located in a hospitals ICU, CCU, OR, ER, recovery or other critical care area, with the exception of the ST segment, arrhythmia analysis, and SpHb for which the target populations are adult and pediatric only excluding neonates. The DS-8000 Series monitor can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients mav be in a clinic or other healthcare environment under the care of a physician. The availability of DS-LAN connection, through either a built in Ethernet LAN or external telemetry transmitter, allows remote monitoring when combined with Fukuda Denshi Central Station Monitors. Parameters such as ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb), plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N>O), oxygen concentration (0>), anesthetic agent concentration (AG), and Spirometry may be monitored individually or in any grouping required by the clinician. The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is not recommended for home use, when it has not been ordered by a physician.

The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder. The model DS-8500 is a modular monitor. The system consists of the main control unit (model: DSC-8510/DSC-8530), the display unit (model: LC-8019T/LC-8019TC/LC-8015T/LC-8015TC), the Super Unit (model: HS-8312N/HS-8312M), the HS Adapter (model: HSA-80) for the Super Unit attachment, the Input Box (model: IB-8004), the Expansion Modules (model: HM-800/HG-810/HG-820/HP-800) that plug into the input box, the Expansion Units (model:MGU-801P/MGU-802/ MGU-803/MGU-811P/MGU-812/MGU-813/HR-800), CO2 Gas Unit (model: HCP-800), and Gas Unit I/F (model: HPD-800). The main body of the system in designed so it can be remotely located from the display unit, the Super Unit, the Recorder Unit, and the Input Box. There are two (2) types of the main units depending on the built-in display board configuration as follows. - External Monitor Output (1ch) DSC-8510: - External Monitor Output (1ch), Extended Display Monitor Output (2ch), DSC-8530: LAN (TCP/IP) IF (1ch) There are four (4) types of the display units depending on the display size and filter as follows. LC-8019T: 19 inches LC-8019TC: 19 inches with Circular Polarizing Filter LC-8015T: 15 inches LC-8015TC: 15 inches with Circular Polarizing Filter The display unit contains a 15/19 inches diagonal, active matrix TFT color display and a clear touch screen. The 15/19"display is capable of presenting up to 20/28 waveforms. The user interfaces, the touch screen panel, is located on the front of the display unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. And there are five (5) fixed keys (Alarm Silence, NIBP Start/Stop, Home, Menu, and Prev. Disp.) and Jog Dial on the right side of the front of the display unit. The infrared remote-control command is also available (optional). The right side of the display unit contains two (2) Mouse/Keyboard Connection Connectors (PS/2 port). The model DS-8200 is a modular monitor. The system consists of the Display Unit (model: LC-8210), the HS Adapter (model: HSB-80), the Base Unit (model: BS-8210), the Super Unit (model: HS-8312N/HS-8312M), CO2 Gas Unit (model: HCP-800), Gas Unit I/F (model: HPD-800), and the Recorder Unit (model: HR-800). The Display Unit (LC-8210) contains a 10.2 inches diagonal, active matrix TFT color display and a clear touch screen. The 10.2"display is capable of presenting up to 14 waveforms. It also contains the Standby Switch, the Power Supply Indicator, and the Battery Charge LED on the bottom left of the front side, an alarm indicator, which alerts to alarm conditions, on the top, Telemeter Module (HLX) Insertion Slot (with the cover), one (1) CF Card Slot, one (1) CF Card Access Indicator, one (1) SD Card Slot, and one (1) SD Card Access Indicator on the right side, one (1) Display Unit Extension Cable Connector on the left side, and interface connector to the HS Adapter (HSB-80) on the rear side. The HS Adapter (HSB-80) contains one (1) Display Unit Connector, the Display Unit Extension Cable Connector, the Operation Mode Change Switch (reserved), and the Battery Charge LED on the front side, one (1) module-LAN Connector on the right side, and the Super Unit Connector and the Battery Insertion Slot (with the cover) on the left side. The Base Unit (BS-8210) contains the Power Supply Indicator, the Battery Charge LED, the Battery Insertion Slot (with the cover), and one (1) Serial Connector (COM1) on the front side, the AC Mains Input Connector, one (1) Serial Connector (COM2), one (1) External Monitor Connector, two (2) Status Input/Output Connectors, and one (1) DS-LAN Connector on the rear side, one (1) U-LINK Connector on the left side, and the HS Adapter Connector on the top. The user interfaces, the touch screen panel, is located on the front of the display unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. The infrared remote-control command is also available (optional). An option battery, which is built in to the Base Unit (BS-8210) and/or HS Adapter (HSB-80), operation allows a patient to continue to be monitored during intra-hospital transport. The HS-8312N/HS-8312M Super Unit provides monitoring of ECG (Up to 12lead), heart rate, respiration (RESP), non-invasive blood pressure (NIBP), pulse rate (PR), arterial oxygen saturation (SpO>), plethysmograph, and up to six (6) channels of parameters in any combination of invasive blood pressure (IBP), temperature (TEMP), and cardiac output (CO) using three (3) multiparameter connectors. In addition, the HS-8312M provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The NIBP measurement for the HS-8312N/M utilizes the NIBP module that is the exact same technology and algorithm as approved in the Fukuda Denshi Model DS-7000 Series Patient Monitor and provides the 510(k) #K083697. And the 12-Lead ECG monitoring provides the 12-Lead ECG analysis function using the 12-Lead ECG analysis software module that is the same as that used in the Fukuda Denshi CardioMax model FX-4010 Multi Channel Electrocardiograph, 510(k) #K981066. The HS-8312N for SpO2 measurement utilizes a technology of an OxiMax N-560 Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) #K021090. The HS-8312M for SpO2, SpCO. SpMet, and SpHb measurement utilizes a technology of a Masimo Rainbow SET® RADICAL 7R CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K100428. The NIBP Start /Stop Key with indicator, which lights during NIBP measuring, BP Zero Balance Key with indicator, which lights during BP zero balancing, Alarm Silence Key with indicator, which lights during the alarm silence condition, and Power Supply Indicator are located on the top of the front panel. And all parameter connectors are on the front panel and are labeled. The left side of the unit contains the Analog Output Connector that outputs the ECG and BP waveforms, including the QRS SYNC output signal. To connect the Super Unit to the Main Unit, the HSA-80 HS Adapter (for DS-8500)/HSB-80 HS Adapter (for DS-8200) is required. The HCP-800 CO2 Gas Unit or HPD-800 Gas Unit I/F provides monitoring of carbon dioxide concentration (CO2) by connecting to the AUX Connector on the front of the Super Unit. The CO2 Gas Unit (HCP-800) that utilizes Oridion Medical 1987 Ltd. technology "Microstream" and previously cleared under 510(k) #K094012. The Gas Unit I/F (HPD-800) allows to connect the Capnostat 5 Mainstream CO2 Sensor, 510(k) #K042601, manufactured by Respironics Novametrix, LLC. to the Super Unit with serial communication protocol for CO2 monitoring. The HM-800 Multi Module provides monitoring of up to four (4) channels of parameters in any combination of invasive blood pressure (IBP), temperature (TEMP), and cardiac output (CO) using two (2) multiparameter connectors, which are on the front panel and are labeled. The Power Supply Indicator and BP Zero Balance Key with indicator, which lights during BP zero balancing, are located on the top of the front panel. The HG-810/MG-820 SpO2 Module provides monitoring of arterial oxygen saturation (SpO2), plethysmograph, and pulse rate (PR). The HG-810 also provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The MG-810 utilizes a technology of a Masimo Rainbow SET® RADICAL 7R CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K100428. The HG-820 utilizes a technology of an OxiMax N-560 Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) # K021090. And the SpO2 connector is on the front panel and is labeled and the Power Supply Indicator is located on the top of the front panel. In addition, in conjunction with the Super Unit. it provides monitoring of two (2) different sites of arterial oxygen saturation (SpO2). In case of HG-810 in conjunction with the HS-8312M, the monitoring of two (2) different sites of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb) is also available. The HP-800 Multiport Module contains two (2) Status Input/Output Connectors for serial communications with the external device and one (1) Analog Input Connector, which 2 channels of inputs are available, to input analog signal from the external device. All connectors related to connection with the external devices are on the front panel and are labeled and the Power Supply Indicator is located on the top of the front panel. The IB-8004 Input Box provides the expansion monitoring by plugging the Expansion Modules, such as HM-800, HG-810/MG-820, and HP-800, into. There are four (4) slots for Expansion Module plug-in. Within one (1) DS-8500 system, the connectable number of Input Box is up to two (2), so the plugging of up to eight (8) Expansion Modules is available. The MGU-800 series (MGU-801P/MGU-802/MGU-803)/ 810 series (MGU-811P/MGU-812/MGU-813) Multigas Unit provides monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG). It utilizes a technology of the sidestream multigas analyzer manufactured by ARTEMA Medical AB. and previously cleared under 510(k) # K053234 by Mindray. Depending on the following model type of the Multigas Unit, the measurable gas parameters are as follows. MGU-801P/MGU-811P: CO2, N2O, O2, and AG MGU-802/MGU-812: CO2, N2O, and AG MGU-803/MGU-813: CO2, and N2O In addition, the MGU-810 series (MGU-811P/MGU-812/MGU-813) provides monitoring of spirometry that utilizes the respiratory mechanics analyzer and flow sensor, manufactured by ARTEMA Medical AB, which is similar to a technology previously cleared under 510(k) # K062754 by Datascope. All connectors related to measurement are on the front panel and are labeled and the Power Supply Indicator is located on the top of the front panel. The HR-800 Recorder Unit, a dot matrix thermal printer, provides hard copy recording s of all monitored parameters and can print up to three (3) waveforms simultaneously. On the top of the front panel, the Power Supply Indicator, Print Key with indicator, which lights during printing, and Paper Feed Key with indicator, which lights during paper feeding, are located. The Open/Close Lever to open/close the paper holder is located on the right upper part of the front of the unit. Additional standard features include the DS-LAN connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors.

Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder. The DS-8100N/8100M provides monitoring of ECG (Up to 7lead), heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, and parameters in combination of invasive blood pressure (IBP) (max. 2ch.), temperature (max. 4ch.), and cardiac output (max. 1ch.) using the multiparameter connector. In addition, the DS-8100M provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The DS-8100N for SpO2 measurement utilizes a technology of an OxiMax N-600x Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) # K060576. The DS-8100M for SpO2, SpCO, SpMet, and SpHb measurement utilizes a technology of a Masimo RADICAL 7 Pulse CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K110028. All parameter connectors are on the front panel and are labeled on the left side of the main unit. By connecting the optional CO2 Gas Unit (HCP-800/HCP-810) or Gas Unit I/F (HPD-800/HPD-810) to the AUX Connector on the rear side of the main unit, it provides monitoring of carbon dioxide concentration (CO2) The CO2 Gas Unit (HCP-800/HCP-810) that utilizes Oridion Medical 1987 Ltd. technology "Microstream"" and previously cleared under 510(k) #K094012. The Gas Unit I/F (HPD-800/HPD-810) allows to connect the Capnostat 5 Mainstream CO2 Sensor, 510(k) #K042601, manufactured by Respironics Novametrix, LLC. to the main unit with serial communication protocol for CO2 monitoring. The DS-8100N/8100M is a self-contained monitor, which includes a 10.2 inch TFT color LCD display which can display up to 14 waveforms and up to 14 numeric displays. The user interfaces, the touch screen panel, is located on the front of the main unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. And there are five (5) fixed keys (Alarm Silence, NIBP Start/Stop, Home, Menu, and Prev. Disp.) and Jog Dial on the right side of the front of the main unit. The infrared remote-control command is also available (optional). By attaching the optional Recorder Unit (HR-800) or Recorder/Expansion Port Unit (HR-811), a dot matrix thermal printer, on the bottom of rear of the main unit, it provides hard copy recordings of all monitored parameters and can print up to three (3) waveforms simultaneously. In addition, the Recorder/Expansion Port Unit (HR-811) contains the Analog Output Connector that outputs the ECG and BP waveforms, including the ORS SYNC output signal, VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor. By attaching the Expansion Port Unit (CU-810) on the bottom of rear of the main unit, it provides the VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor or connects to the laser printer as general LAN. Additional standard features include DS-LAN connection, which is a proprietary network system based on an Ethernet LAN (#K970585), through a built in Ethernet LAN, and a wireless connection using the optional telemetry transmitting module (Model: HLX-801) and a wireless bidirectional communication using the optional Bidirectional Wireless Communication Module (Model: HTC-702) allow remote monitoring when combined with Fukuda Denshi Central Station Monitors. An option battery operation allows a patient to continue to be monitored during intra-hospital transport. The DS-8100N/8100M is small and lightweight at 3.5 kg. The physical dimensions of the device are 300 mm (W) x 265 mm (H) x 75 mm (D).

The Fukuda Denshi VaSera model VS-1500AU is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measing non-invasive blood pressures, heart rate, pulse volume recordings and heart sounds. The device also has the capability of calculating ABI (Ankle Brachial Index), TBI (Toe Brachial Index), and pulse wave velocity measurements. The device is intended to be used under the order of a physician, in hospitals, doctor's offices, clinics or other medical facilities where non-invasive peripheral vascular tests are performed. The device is intended to be used on adult population only. The device is not intended for home use.

The Fukuda Denshi VaSera model VS-1500AU is a prescriptive device intended for use by health care professionals. It is designed to be used to assist the clinician in the detection of peripheral vascular diseases and has been designed and tested to automate published clinical diagnostic test methods. The device is capable of measuring non-invasive blood pressures, non-invasive pulse volume recordings and heart sounds. In addition, the device is capable of calculating specific clinically recognized indices such as ABI (Ankle Brachial Index), TBI (Toe Brachial Index) and pulse wave velocity.

The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.

The Fukuda Denshi model LX-7230KM/7230N is a patient worn Transmitter that transmits physiological data such as ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate from a patient to a Fukuda Denshi Central Monitor. The front LCD display information such as ECG, heart rate, respirogram, respiration rate, SpO2, plethysmograph, pulse rate, pulse amplitude level, battery level, and the conditions of the ECG electrodes and SpO2 sensor. For the SpO2 measurement, the LX-7230N utilizes Nellcor SpO2 module technology (K060576) and the LX-7230KM utilizes Konica-Minolta SpO2 module technology (K053419). Both transmitters can only be used as an interface device of the previously cleared Fukuda Denshi Central Monitor (K970585, K000746, K020084) utilizing the central telemetry receiver (K980728). Both transmitters utilize digital FSK (frequency shift keying) technology and operate in the WMTS 608 to 614 MHz transmission frequencies. One or two channel ECG waveforms are selectable with lead selection available using the two buttons (Enter and down arrow) on the front panel. (In case of using a 3-electrode lead cable or a 5-electrode chest lead cable). Both transmitters are battery powered using 2 AA alkaline batteries with available continuous operation for 6 days (LX-7230KM) or 3 days (LX-7230N). The LX-7230KM/7230N is small and lightweight at 190 grams including batteries. The physical dimensions of the device are 72 mm (W) x 98 mm (H) x 24.8(D) mm.

Use of the Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N20), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7000 Series Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000 Series Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-7000 Series Patient Monitor (Model: DS-7000/7000M/7210/7210M) is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. An optional Battery Pack operation allows the DS-7210/7210M to be used to monitor patients during intra-hospital transport. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder. The DS-7000 Series Patient Monitor allows for the monitoring of ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, temperature, invasive blood pressure (IBP), and cardiac output. This subject modified DS-7000 Series Patient Monitor extended the NIBP measurement target populations from adult and pediatric to adult. pediatric, and neonatal and the DS-7210/7210M of the DS-7000 Series includes ECG 12 Lead monitoring. The DS-7000/7000M of the DS-7000 Series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG), which utilizes Criticare Systems technology (K012059), by using the option Multigas Unit (MGU-701/MGU-702) . And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 6 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. No new functions for the options are being added and are not the subject of this submission for the DS-7000/7000M. This subject modified DS-7210/7210M of the DS-7000 series Patient Monitor allows for the monitoring of carbon dioxide concentration (CO2), which utilizes Oridion Medical 1987 Ltd. technology "Microstream"" (K060065), by using the option CO2 measurement unit (MGU-722). Or, by using the option Mainstream CO2 interface Unit (MGU-721), the Capnostat 5 Mainstream CO2 Sensor (K042601) manufactured by Respironics Novametrix, LLC. is allowed to connect to the DS-7210/7210M with serial communication protocol for CO2 monitoring. And, by using the option Unit (HU-71/HU-72/HU-73), invasive blood pressure (up to 5 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. For the SpO2 measurement monitoring, the DS-7000 utilizes Nellcor technology (K021090) and the DS-7000M utilizes Masimo one (K033296). No new functions for SpO2 measurement are being added and are not the subject of this submission. This subject modified DS-7210/7210M has the same feature. The DS-7000 Series Patient Monitor is a self contained monitor which includes a 12.1 inch TFT color LCD display which can display up to 12 (for DS-7000/7000M) or 14 (for DS-7210/7210M) waveforms and up to 20 (for DS-7000/7000M) or 16 (for DS-7210/7210M) numeric displays. Input operation is performed by the touch screen panel, 5 fixed keys (only DS-7000/7000M), or infrared remote-control command (optional). Additional standard features of the DS-7000 Series Patient Monitor include the DS-LAN II connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously, and an alarm indicator feature on the top of device that alerts to alarm conditions. The DS-7000/7000M of the DS-7000 Series is small and lightweight at 9.0 kg. The physical dimensions of the device are 324mm (W) x 260mm (H) x 179mm (D). The option Multigas Unit (MGU-701/MGU-702) weight is 1.8 kg. The physical dimensions of the device are 248mm (W) x 138mm (H) x 82mm (D). No weight and physical dimensions are being changed and are not the subject of this submission for the DS-7000/7000M. The subject modified DS-7210/7210M weight is 9.9 kg. The physical dimensions of the device are 310mm (W) x 351mm (H) x 245mm (D). The option CO2 measurement Unit (MGU-722) weight is 260g and Mainstream CO2 interface unit (MGU-721) weight is 200g. The both physical dimensions of the device are 141.5mm (W) x 41mm (H) x 79mm (D). For the DS-7000 Series option Unit (HU-71/HU-72/HU-73) weight is 180g. The physical dimensions of the device are 37mm (W) x 99 mm (H) x 90 mm (D). No weight and physical dimensions are being changed and are not the subject of this submission.

The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes, etc.), cardiac (adult and pediatric), transvaginal, peripheral vessel, and musculo-skeletal (Conventional and Superficial). The device incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The device is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes, etc.), Cardiac, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Fukuda Denshi Model FF Sonic UF-750XT Ultrasound System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode or the combined mode (i.e. B/M Mode). The device consists of two parts: the scanner, and one of up to seven (7) different probes. In addition, the probe sclector unit provides two probes connection capability. The Fukuda Denshi Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates, and it is intended for use in abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, and musculoskeletal (general and superficial) exams. This subject modified Ultrasound System also provides 3D imaging (Guided free hand 3D and Free hand 3D) with an optional 3D imaging unit (UF-750XT-3DU). New measurement functions have been added by the option 3D imaging unit (UF-750XT-3DU). No new transducers are being added and are not the subject of this submission.

Use of the Fukuda Denshi DynaScope Model DS-7000/7000M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), oxygen concentration (O2), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7000/7000M is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000/7000M also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-7000/7000M Patient Monitor is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder. The DS-7000/7000M allows for the monitoring of ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), pulse wave, temperature, invasive blood pressure (IBP), and cardiac output. By using the option Multigas Unit (MGU-701/MGU-702), the monitoring of carbon dioxide concentration (CO2), nitrous oxide concentration (N2O), which utilizes Criticare Systems technology (K012059), oxygen concentration (O2), and anesthetic agent concentration (AG) are also possible. And, by using the option Unit (HU-71/HU-72/HU-73), blood pressure (up to 6 channels), cardiac output, temperature (up to 3 channels) can be additionally monitored. For the SpO2 measurement monitoring, the DS-7000 utilizes a Nellcor technology (K021090) and the DS-7000M utilizes a Masimo one (K033296). The DS-7000/7000M is a self contained monitor which includes a 12.1 inch TFT color LCD display which can display up to 12 waveforms and up to 20 numeric displays. Input operation is performed by the touch screen panel, 5 fixed keys, or infrared remote-control command (optional). Additional standard features include the DS-LAN II connection, which is a proprietary network system based on an Ethernet LAN (K970585), through either a built in Ethernet LAN or external telemetry transmitter (the Fukuda Denshi DS-5000 series telemetry model HLX-501/561, K980728) connection for connection to the Fukuda Denshi Central Station Monitors, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously, and an alarm indicator feature on the top of device that alerts to alarm conditions. The DS-7000/700M is small and lightweight at 9.0 kg. The physical dimensions of the device are 324mm (W) x 260 mm (H) x 179 mm (D). The option Multigas Unit (MGU-701/MGU-702) weight is 1.8 kg. The physical dimensions of the device are 248mm (W) x 138 mm (H) x 82 mm (D). The option Unit (HU-71/HU-72/HU-73) weight is 180g. The physical dimensions of the device are 37mm (W) x 99 mm (H) x 90 mm (D).

The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-850XTD incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-850XTD is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

The Fukuda Denshi model UF-850 XTD is a full featured general purpose Track III diagnostic ultrasound system. The device consist of a mobile console approximately 19" wide, 31"deep and 53-57" (adjustable) high, that provides digital acquisition, processing and display capabilities. The user interface includes a keyboard, specialized controls and either a color CRT or LCD display.

The Fukuda Denshi DS-5000 series Telemetry Monitoring System is indicated in those situations where centrally located hemodynamic monitoring (central station monitoring) of one or more patients cardiovascular condition is desired and those patients are currently monitored by a Fukuda Denshi bedside monitor, or is wearing a Fukuda Denshi telemetry transmitter. Use of this device is indicated only in a medically supervised healthcare environment (e.g. ER, ICU or clinic). It is not intended for home use. This device is intended for Prescription Use Only

The Fukuda Denshi model DS-5000 series Telemetry Monitoring System consists of a series of interface devices which include a central transmitter receiver, an HLX-501 Multi-parameter transmitter, LX-5120 patient worn ECG/Respiration transmitters, and a Fukuda Denshi DS-5000 series Central Patient Monitor (K970585, K000746, K020084). The unit's are processor based software control devices. The receiver module can receive data for 4 or 8 patients and can be connected either directly or by local area network (LAN) to the DS-5000 series Central Patient Monitor. Each patient data when received at the central transmitter receiver is considered as a separate network node. Input signals are provided from the patient worn LX series transmitters or from the HLX-501 Multi-parameter transmitter when connected to a Fukuda Denshi DS-5000 series patient monitor. Patient physiological data displays, controls, recordings and alarms are controlled from the Central Patient Monitor. Recordings can also be initiated from the bedside monitor or from the patient worn transmitters. System functions such as trending, arrhythmia and ST monitoring and data access are available to the user from the central monitor. The HLX-501 multi-parameter transmitter may provide up to six waveforms and numeric data from the bedside monitor. Parameter monitored may include ECG, SpO2, Resp, BP, NIBP and Temp. The patient worn LX-5120 transmitter provides monitoring of ECG and Respiration parameters. The modified transmitter subject to this submission, the patient worn LX-5630 provides ECG and Respiration monitoring identically as the LX-5120 and adds SpO2 transmission through the integration of an Pulse Oximetry OEM module designed and manufactured by Konica Minolta Sensing Inc and cleared as the Minolta Pulseox-3 LI (K010413).