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The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only. The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.

The Midmark Diagnostics IQmark® Vital Signs Monitor consists of the following three individual measurement Modules: a. Noninvasive blood pressure (NIBP) b. Pulse Oximeter c. Temperature In the Automatic or STAT Modes of operation, the NIBP Module automatically inflates an occluding cuff placed around the patient's arm or leg. It uses the oscillometric measurement technique to measure and record the patient's systolic and diastolic pressure as well as pulse rate. From these measurements the IQmark VSM also calculates the mean arterial blood pressure (MAP). Measurement results along with operator prompts and error messages are indicated on the front panel display. The frequency of NIBP determination can be selected by the operator at fixed times between one and ninety minutes. The Manual Mode of operation also covers a variety of clinical uses. A variety of reusable and disposable cuff types and sizes is available for adult, pediatric, and neonatal applications. The NIBP Module requires routine calibration and maintenance. The Pulse Oximeter Module measures and records the patient's arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through tissue (SpO₂). Changes in absorption caused by pulsations of blood in the patient's vascular bed are used to determine arterial oxygen saturation and pulse rate. Oxygen saturation and heart rate are indicated on the front panel display. A bar graph display gives the user a pulse visual indication of waveform signal quality. An audible indicator can be enabled which automatically generates a sound each time the SpO2 sensor detects a pulse. The 1Qmark VSM utilizes the Masimo Set" oximeter. A variety of reusable and disposable sensor types and sizes is available for adult, pediatric and neonatal applications. These oximeter does not require routine calibration or maintenance. The Temperature Module measures and records a patient's temperature in either the Predictive or Continuous Mode of operation using either oral (also used for axillary) or rectal probes. In the Predictive Mode, the thermometer's software predicts body temperature in about 15 seconds for oral and axillary temperatures. The IQmark VSM Temperature Module does not support Predictive Mode measurements for the rectal temperature probe. The default mode used by the IQmark VSM for oral temperature determinations is the Predictive Mode. The Continuous Mode is usually used for longer-term monitoring or when difficult situations prevent accurate patient temperature measurement in the Predictive Mode. Temperature probe covers are required and are available for the oral/axillary and rectal probes. The Temperature Module requires routine calibration and maintenance. When the Alarm Setting Mode is activated, high and low alarm limits can be set (within specification and safety limits) for heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and SpO2.