Evaluation: Fukuda Denshi Dynascope DS-8400 ICU Physiologic Monitoring System

July 18, 2018 | Evaluations & Guidance


  • Depending on their configuration, physiologic monitoring systems measure and display waveforms and numeric data for various parameters, including ECG, respiratory rate, noninvasive blood pressure (NIBP) and invasive blood pressure (IBP; systolic, diastolic, and mean), body temperature, pulse rate, arterial hemoglobin oxygen saturation (SpO2), mixed venous oxygen saturation (SvO2), cardiac output, end-tidal carbon dioxide (EtCO2), intracranial pressure, and airway gas concentrations (particularly during the administration of anesthesia).
  • Major device components and software features:
    • Dynascope DS-8007 monitor—This unit offers a 17.8 cm (7 in) LCD touchscreen display and is intended for continuous measurement of adult, pediatric, and neonatal physiologic parameters. The DS-8007 monitor docks into the Dynascope DS-8400 bedside monitor as a patient measurement module and can also function as a transport monitor with wireless communication directly to the central station over a WMTS (Wireless Medical Telemetry Service) network (608-614 MHz and 1427-1432 MHz). (For detailed information on the parameters measured using the DS-8007 monitor, see Table 3 below.)
    • Dynascope DS-8400 bedside monitor—A high-acuity bedside monitor intended for continuous monitoring of adult, pediatric, and neonatal patients. The DS-8400 is intended to:
      • Admit and discharge patients via an automatically populated list from the hospital's admit/discharge/transfer (ADT) system by using a bar-code scanner or through a patient search
      • Display numeric data, graphical trends, and waveforms received from an HS-8312 measurement module or a DS-8007 monitor (functioning as a patient measurement module), as well as communicate visual and audible alarm signals
      • Serve as a connectivity hub to integrate patient data from different stand-alone medical devices connected to the patient (e.g., ventilators) using the HP-800 Multiport Module
      • Communicate with and transfer patient data to a DS-8900 central monitor over a wired Ethernet connection or wireless WMTS network (608-614 MHz and 1427-1432 MHz)
      • Specifications
        • Display: 39.6 cm (15.6 in) (Model LC-8016TC) or 47 cm (18.5 in) (Model LC-8018TC) LCD touchscreen
        • Parameters monitored—see Tables 2 and 3 below.

c) DS-8900 system central monitor and DynaBase CVW-6000 (Central Viewer Workstation) server—The DS-8900 central monitor allows centralized display of up to 32 patients and is intended to enable viewing of patient information from the bedside monitors and telemetry transmitters. The DynaBase CVW-6000 server stores medical device data and device diagnostic information obtained from the DS-8900 central monitor and routes it to third-party annunciation systems (e.g., pagers and mobile devices), the DynaBase Client PC (for remote viewing of patient data), the electronic medical record (EMR), and hospital information systems (HISs). A single CVW-6000 server supports up to eight central monitors for monitoring 128 beds. The DS-8900 central monitor, as part of the DynaBase CVW-6000 server, is used to:
- Admit and discharge patients.
- Connect to the ADT feed to enable patient ID and demographics.
- View near-real-time numeric data, alarm history, full-disclosure waveforms, and graphical and tabular trends.
- Serve as a secondary source of audible and visual alarm signals.
- Store patient information. The CVW-6000 server stores patient data for 14 days during hospitalization and 14 days postdischarge.
- Communicate to secondary notification systems or middleware solutions for clinical notification.
- Provide reporting and analytics of patient information and alarm information.
- Send patient vitals data and notifications to the patient EMR via an HL7 (Health Level 7) interface at a hospital-defined time interval.
- Specifications for standard features—see...

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