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  CLINIMARK         Clinical Testing & Validation Services for Medical Devices

80 Health Park Dr. Louisville, CO 80027
(+US) 303-926-5432

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 Pulse OximetryBlood PressureRespiratory RateTemperature Additional ParametersAirway Device Testing Services

Pulse Oximetry
Regulatory Tests

Co-oximeter Validation Blood tests (Regulatory Accuracy – Clinical Trial): Hypoxia compared to Arterial     Co-oximetry [ISO 9919]
    Human Desaturation Study: Steady state accuracy testing during saturation plateaus over the specified
    range (usually 70-100% SaO
2) in increments of 1-2% (Co-ox data point each 1-2% over the range
            This is the Validation Submission Clinical Trial which is the required test for FDA submission – it is 
            an Accuracy Validation Blood Study.  We will analyze the data and provide a report from this study that
            you can submit directly to the FDA.  It meets (and exceeds) the ISO 9919 Pulse Oximetry Standard and
            also the FDA Reviewer Guidance Document.
            This test is usually done as the last step in product Validation and is submitted to the FDA.  It is a human
            hypoxia study that compares the test pulse oximeter and or sensor to simultaneous blood samples that
            are analyzed on a Bench Co-oximeter. 


Motion Accuracy Validation:
Hypoxia compared to Arterial Co-oximetry [ISO9919]
     Human Desaturation Study during motion conditions:
Steady state accuracy testing with motion during
     saturation plateaus over the specified range.

Perfusion Accuracy Validation: Hypoxia compared to Arterial Co-oximetry [ISO 9919]

    Human Desaturation Study during low perfusion levels (low signal modulation): As measured by
    Perfusion Index during saturation plateaus.

Neonatal Accuracy: Hospital Data Collection compared to Arterial Co-oximetry [FDA Guidance]
    Data collection in on hospitalized infants: Steady state saturation plateus.

: Intended Population evaluation [FDA Guidance]

    Data collection in hospitalized patients and non-hospitalized subjects:  Evaluate sensor application in
    the intended
population and ability to obtain clinically usable readings (not accuracy verification).

Pulse Rate Accuracy: NEED TEXT HERE

 Pulse Oximerty Regulatory Tests Product Development Testing Hospital Data Collection