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The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal - OB Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric

The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.

The FUJIFILM SonoSite Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.

The FUJIFILM SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal - OB Abdominal Pediatric Cardiac Adult Cardiac Pediatric

The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.

The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal – OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.

The FUJIFILM SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Pediatric Small Organ (breast, thyroid, testicles, prostate) Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purposic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readly lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

The SonoSite Maxx™ Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.

The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.

The Bio Z Cardio Profile Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters including: Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Pulse Wave Velocity (PWV), Oxygen Delivery Index (DO2l), Stroke Volume (SV), Stroke Index (SI), Cardiac Output (CO), Cardiac Index (CI), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Left Cardiac Work (LCW), Left Cardiac Work Index (LCWI), Velocity Index (VI), Acceleration Index (ACI), Heather Index (HI), Pre-Ejection Period (PEP), Left Ventricular Ejection Time (LVET), Thoracic Fluid Content (TFC), Thoracic Fluid Content Index (TFCI), Baseline Impedance (Zo), Total Arterial Compliance (TAC), Total Arterial Compliance Index (TACI), Systolic Time Ratio (STR), Systolic Time Ratio Index (STRI). The Bio Z Cardio Profile Hemodynamic Monitor is not intended to be used as a vital sign monitor.

The Bio Z Cardio Profile Hemodynamic Monitor is a data acquisition system that measures and processes ECG and impedance data. In combination with height, weight, age, and gender the hemodynamic parameters are calculated by the user software (Cardio Vascular Lab). Additional parameters are measured with the help of OEM modules (NIBP and SpO2) integrated in the device. The Bio Z Cardio Profile also allows the estimation of the Pulse Wave Velocity (PVVV). For this purpose the pressure cuff (NIBP) is placed on the upper leg. The ICG signal is used to define the opening of the aortic valve and the pressure cuff is used to determine the arrival of the pulse wave after leaving the heart. On this basis the propagation time of the pulse wave in the aorta can be estimated. Pulse Wave Velocity can be calculated when considering the distance between the heart and the pressure cuff placed on the upper leq. The Bio Z Cardio Profile measures SpO2 for the purpose of calculating Oxygen Delivery Index (DO2l). The SpO2 measurements are provided by an integrated OEM module, the Nellcor™ OxiMax™ NELL-1 ™ OEM pulse oximetry module (previously cleared on the Cheetah Reliant by the FDA (K103166)). The Nell-1 module measures functional oxygen saturation non-invasively via a light signal interacting with tissue, by utilizing the time-varying changes in tissue optical properties that occur with pulsed blood flow. The Nell-1 module receives electrical signals from the sensor, which is then run through an algorithm to provide SpO2 values. Utilizing the Nell-1 OEM module, the Bio Z Cardio Profile is capable of measuring: Blood oxygen saturation (SpO2 via finger Oximeter) for use in calculating Oxygen Delivery Index (DO2l); using Oxygen Saturation (SpO2) data from Oximeter and Cardiac Index (CI) data from the ICG function. The Nell-1 module, as part of the Bio Z Cardio Profile, is intended for spot-check measurements of arterial blood oxygen saturation. The SpO2 measurement data is not available to view by the user; it is only used in the calculation of Oxygen Delivery Index (DO2)), which requires an additional ICG Cardiac Index (CI) measurement.

The SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Trans-rectal; Trans-vaginal Peripheral Vessel; Intraoperative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.

The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, Doppler, M-Mode, Color Power Doppler or in a combination of these modes. The hand-carried system weighs less than 6 pounds and has a touch screen interface with minimal controls to facilitate disinfection and cleaning. The system provides measurement capabilities for anatomical structures and fetal biometry to provide information used for clinical diagnostic purposes. The system also includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images, which is used in conjunction with traditional risk assessment models to assess individual cardiovascular disease risk. The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities, including wireless networking, to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images. Security support is also provided to facilitate HIPAA compliance. The system supports the eFilm Lite™ application, which allows studies stored on a memory device in DICOMDIR format to be viewed. This viewing software can be launched on a PC when the license option is enabled. The system includes a variety of accessories including a stand, dock featuring a video in/out port, a printer port, printer, VESA mounting arm and needle guide kits. The system includes three USB host supports for peripherals and an Ethernet port for data transfer of patient data. The system also features SiteLink™ allowing an additional method for the export of patient data. Storage devices include memory sticks. The V-Universal™ stand provides a mobile work platform for the NanoMaxx, as well as a storage area for transducers and other supplies. It also provides connections for system accessories and peripherals. The PowerPark docking stand consists of two components, the dock (plugs into a power outlet and sits on the floor) and the stand module (attaches to underside of stand). An AC adapter on the stand module allows for manual connection to AC power. The PowerPack battery uses lithium-ion technology and mounts on the V Universal™ stand. LED lights on the PowerPack indicate the amount of available battery power, as well as charge status. SonoSite Workflow Solutions (SWS) is a software program for organizing exams from the NanoMaxx. SWS operates on a host server and users require a login to access the program. Patient exam information can be transferred from the ultrasound to SWS by exporting data from the ultrasound to a USB storage device, then importing it from the USB storage device. The use of a USB keyboard, barcode reader and medical grade printer is supported by the system, which allows manual entry of patient demographics, scanning entry of patient demographics and the capability to print images and/or reports. The system/transducer is capable of exceeding a TI or an MI of 1.0 in certain operating modes or mode combinations. The system monitor displays the current output level in terms of the bioeffects indices ("Mechanical Index [M]" and "Thermal Index [TI]") in accordance with the AIUM/NEMA Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.