Evaluation: Medtronic Vital Sync Virtual Patient Monitoring Platform (VPMP) and Informatics Manager for Continuous Vital Signs Monitoring

May 24, 2017 | Evaluations & Guidance

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  • The primary purpose of the device:
    • The Nellcor PM1000N Bedside Respiratory Patient Monitor or the Capnostream 20p Bedside Capnography Monitor, which can be used with the Vital Sync VPMP and Informatics Manager, continuously measures, stores, and displays oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), and end-tidal carbon dioxide (EtCO2) values and trends for adult, pediatric, infant (ages 1 and over), and neonatal patients in lower-acuity settings.
    • The Vital Sync VPMP and Informatics Manager analyzes and interprets vital signs data to offer trends and alerts clinicians to emergent events such as high RR or low SpO
  • The Vital Sync platform also offers published (i.e., MEWS—Modified Early Warning Score, NEWS—National Early Warning Score, SEWS—Scottish Early Warning Score, WEWS—Wellington Early Warning Score) or hospital-defined EWS algorithms for detecting and notifying clinicians to early signs of patient deterioration. 2. Supplementary uses of the device:
    • In addition to connecting with Medtronic's proprietary bedside, wireless, and wearable medical devices, the Vital Sync VPMP and Informatics Manager can also interface with third-party medical devices such as ventilators, infusion pumps, and nonproprietary multiparameter patient monitors.
    • The Vital Sync VPMP and Informatics Manager also supports clinical decision support applications for high-acuity monitoring. (These applications are outside the scope of this Evaluation.) The Vital Sync Weaning Readiness and Spontaneous Breathing Trial (SBT) monitoring application supports a protocol-driven process for weaning from mechanical ventilation by continuously monitoring a patient's physiologic parameters, including information from the ventilator (e.g., RR, tidal volume), multiparameter patient monitor (e.g., heart rate, blood pressure), and spot checks (e.g., temp). The application also tracks a patient's readiness to initiate an SBT based on published guidelines or custom, facility-specific weaning readiness protocols.
  • Major device components and software features:
    • Nellcor PM1000N Bedside Respiratory Patient Monitoring System—The monitor is usually mounted near the bedside and receives patient vital signs (SpO2 and PR) from an SpO2 probe attached to the device. The PM1000N also offers an option to derive respiration rate (RR) in adult patients from the photoplethysmogram (or pleth) waveform. 1The PM1000N can also function as a stand-alone monitor. The monitor communicates and transfers information unidirectionally to the central Vital Sync VPMP and Informatics Manager display or to a mobile device over a wireless IEEE 802.11 a/b/g network or a wired Ethernet connection. The monitor is used to:
      • View graphical and tabular trends for SpO2, RR, and PR.
      • View real-time data, including visible and audible alarm signals.
      • Transmit patient data to a central monitoring display or a mobile device equipped with Vital Sync VPMP and Informatics Manager application.
    • Capnostream 20p Bedside Capnography Monitor—The Capnostream is a multiparameter (EtCO2, fractional concentration of inspired carbon dioxide FiCO2, RR, SpO2, PR) monitor that is mounted near the bedside or available on a rolling stand. This monitor receives patient vital signs data from the probes (nasal cannula and SpO2 probe) attached to the device. The Capnostream 20p communicates and transfers information unidirectionally to the central Vital Sync VPMP and Informatics Manager display, computers on wheels, or a mobile device over a wireless IEEE 802.11 a/b/g network (using a LANtronix PremierWave XN intelligent gateway server) or over a wired Ethernet connection. The Capnostream can also function as a stand-alone monitor to detect respiratory depression in postoperative adult, pediatric, and infant patients who are on parenteral or neuraxial opioids. For additional information, see Evaluation: Medtronic Capnostream 20p Monitor—Findings for Detection of Respiratory Depression. The monitor is used to:
      • View graphical and tabular trends for EtCO2, SpO2, RR, and PR.
      • View real-time data, including visible and audible alarm signals.
      • Transmit patient data to a central monitoring display or a mobile device equipped with Vital Sync VPMP and Informatics Manager.
      • View a proprietary, fully automated early warning score, the Integrated Pulmonary Index (IPI), intended to provide clinicians with the patient's (adult and pediatric) respiratory status. The IPI, derived from EtCO2, SpO2, and RR values, is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 to 10, where 10 indicates optimal pulmonary status. The IPI is an adjunct to, and is not intended to replace, vital signs monitoring.
    • Accessories—The following accessories are offered with the Nellcor PM1000N and Capnostream 20p monitor:
      • PM1000N accessories:
        • SpO2 finger or foot/toe sensor—Available with Nellcor OxiMax Pulse Oximetry technology for adult, pediatric, infant, and neonatal patient populations
        • SpO2 forehead sensor—Designed for adult and pediatric use
      • Capnostream 20p accessories:
        • Nasal/oral cannula—Available with or without oxygen administration tubing and with or without an in-line filter for long-term use on adult and pediatric patients
        • Nasal-only cannula—Adult, pediatric, and neonatal, available with or without oxygen administration tubing and with or without an in-line filter for long-term use

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