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510(k) Data Aggregation

    K Number
    K133810
    Device Name
    VC150 VITAL SIGNS MONITOR
    Manufacturer
    INNOKAS YHTYMA
    Date Cleared
    2014-10-30

    (318 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOKAS YHTYMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VC150 is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport. The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients. The optional GE TruSignal pulse oximetry and accessories are indicated for continuous nonitoring of functional oxygen saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients. The optional Masimo Rainbow SET® Pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of: · functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfusion) for adult, pediatric and neonatal patients, · carboxyhemoglobin saturation (SpCO) for adult and pediatric patients, - · methemoglobin saturation (SpMet) for adult, pediatric and neonatal patients, · total hemoglobin concentration (SpHb) for adult and pediatric patients, and/or · respiratory rate (RRa) for adult and pediatric patients. The optional Nellcor™ oximetry and accessories are indicated for the continuous, noninyasive monitoring of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The optional Oximax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The optional Nellcor™ Respiration Rate parameter is intended for the continuous noninvasive monitoring of respiration rate in adult patients who are well perfused during non-motion conditions. The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure oral, axillary, and rectal temperature of adult and pediatric pational Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages. A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver. The portable device is designed for use in hospital-type facilities. The VC150 can also be used in satellite areas or alternate care settings. "Portable" refers to the ability of the VC150 to be easily moved by the caregiver, such as on a roll stand. The VC150 is not intended to be used for continuous monitoring during patient transport.
    Device Description
    The VC150 is a portable vital signs monitor for use in hospitals and hospital-type facilities. It can be used also in satellite areas or alternate care settings. The monitor is used for adult, pediatric, and neonatal patients, one at a time. The battery-operated monitor offers non-invasive determination of blood pressure (systolic, diastolic, and mean arterial blood pressure), pulse rate, temperature, oxygen saturation, total hemoglobin, carboxyhemoglobin, methemoglobin, and respiration rate. The VC150 monitor includes features and measurement modules that are optional or configurable. The monitors can be equipped with the following parameters and technologies: - NIBP and pulse rate: GE SuperSTAT or Classic (auscultatory) algorithms - SpO2 and pulse rate: GE TruSignal, Nellcor OxiMax, or ● Masimo Rainbow SET - Respiration rate: Nellcor OxiMax or Masimo Rainbow SET - Hemoglobin (SpHb), Methemoglobin (SpMet), Oxygen Content (SpOC), and Carboxyhemoglobin (SpCO): Masimo Rainbow SET - . Temperature: Welch Allyn SureTemp Thermometer or Exergen Temporal Arterial Thermometer The VC150 monitors include a wireless network connection. An integrated printer is optional. The VC150 has an 8.4-inch LCD panel with a touch screen and an alarm light integrated in the front bezel on top of the display. An optional cable connection is available to interface with a traditional nurse-call system for triggering remote alarms. A computer can be connected to the VC150 via a cable to retrieve electronic patient records stored on the device in PDF format.
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