Accuracy Redefined

Healthcare providers need the highest possible accuracy to monitor patients’ key vital signs. But the current oximeter devices are only accurate when patients are motionless. And variations in skin coloration, tattoos and nail polish pose further challenges for traditional pulse oximeters.

Clinical Evidence

Medtor’s FDA cleared SafeSAT technology has been proven to significantly outperform current technology in a series of independent clinical studies, delivering the highest motion-tolerant Sp02 accuracy ever available. Our technology moves vital sign monitoring from an old technology through a doorway to tomorrow.

Hypoxia Accuracy Studies

The small hardware footprint of the SafeSAT® sensor can be packaged in a variety of ways, giving hardware makers the flexibility needed to make products as compact as possible with no sacrifice in accuracy.

HYPOXIA STUDY: FINGER SENSOR SITES

• Performed November 2014

• 7 Subjects

• Skin pigmentation light to dark

• 2 SafeSAT® Oximeters with finger clip sensors, one on each hand were able to acquire both red/ir and white SpO2 data for all subjects for the full saturation range

• Both red/ir and white-based SpO2 data follow well defined transfer functions with respect to the reference oximeter used by Clinimark with ARMS value of 2.56 for the entire saturation range from 99% to 70% 

• Both SafeSAT® systems were able to acquire accurate data on all study subjects, independent of skin type

• Study validates the ability of the SafeSAT® oximeter technology to provide a parallel white LED based SpO2 data stream leveraging the proprietary spectral sensor technology

  
  

HYPOXIA STUDY: FINGER & WRIST SENSOR SITES

• Performed March 2015

• 15 Subjects

• Skin pigmentation light to dark

• The wrist sensor delivered white LED derived values with ARMS of 1.9% SpO2 over the full saturation range

• The finger clip sensor connected to the SafeSAT® oximeter white-LED derived saturation data delivered values with an ARMS of 3.2% SpO2 between 70% and 100% saturation compared to the Covidien oximeter

Motion & Low Perfusion Studies

Our SafeSAT® sensors (both reflectance and transmissive) and proprietary algorithm have been evaluated in several independent clinical studies referenced both to transfer standard oximeters and blood gas based reference data. Our sensors and hardware were able to produce results that reduced absolute errors more than three-fold and root mean standard deviations more than two-fold when referenced to current state-of-the-art clinical sensors and oximeters.

CLINICAL AMBULATORY MOTION STUDY: WRIST & FINGER SENSOR SITES

• Performed May 2015 Clinimark Hypoxia Lab

• 10 Subjects

• Skin pigmentation light to dark

• Greatly enhanced real-time stability of SpO2 and read-through motion ability of SafeSAT® finger and wrist reflective sensors

• Compared to Covidien Max adhesive finger sensors, SafeSAT® non-adhesive finger sensor performs with 3x greater motion tolerance

• Compared to adhesive MaxFact Forehead sensor, the SafeSAT® non-adhesive wrist sensor still provides a 30% reduction in STDEV of oxygen saturation data

• The SafeSAT® Oximeter effectively filters out motion artifacts in both finger and wrist site when compared to Covidien adhesive finger and forehead sensors placed on the same subject

COMPARATIVE MOTION & LOW PERFUSION STUDY VS. MASIMO AND MEDTRONIC

• Performed Feb 2016 Clinimark Hypoxia Lab

• 12 Subjects

• Skin pigmentation light to dark

• Total motion events out of spec (>4 points absolute error for SpO2 or HR)

• Results

  • Medtor SafeSAT®: 43.0% for SpO2 and 45.1% for HR

  • Masimo Racical: 44.4% for SpO2 and 49.1% for HR

  • Covidien N600x: 65.7% for SpO2 and 58.5% for HR

  • 35% reduction in out of spec SpO2 events for Medtor vs. Covidien

COMPARATIVE MOTION & LOW PERFUSION STUDY VS. MASIMO AND MEDTRONIC

• Performed December 2016 Toulon France

• Study compared mean SpO2 bias, SpO2 standard deviation and relative data availability referenced to SaO2 blood gas reference on 21 patients admitted to the site ICU

• 15 Male & 6 Female Subjects

• Age Range : 21 to 87 years

• 5 patients with Septic Shock

• 14 patients considered 'challenging' by PI

• Direct comparison of Medtor SafeSAT™ oximeter to Masimo Radical 7 and Nihon Koden

• 30 min recorded data for 21 patients and Co-ox blood-gas reference sample taken mid-point

• 'Real-world' study environment with majority very challenging patients recorded

• Results

  • Medtor performed best in Mean Bias & Standard-Deviation vs. Blood-gas sample

  • Medtor performed best in Data Availability on the "Challenging patient' group
    

CLINICAL ACCURACY STUDY WITH TWO TYPES OF RANDOM MOTION & INDUCED HYPOXIA AS REFERENCED TO SAO2 BLOOD GAS REFERENCE COMPARING SAFESAT™ OXIMETER TO NELLCOR OXIMAX™ AND MASIMO™ OXIMETER SYSTEMS

Performed December 2017 UCSF Hypoxia Lab

• 12 Subjects

• Skin pigmentation light to dark

• Finger Clip sensors for all systems compared

• Two types of random subject induced motion during hypoxia

• Data collected at an independent clinical study laboratory in the United States

• Results (FDA Guidance requires Arms < 3.0)

  • SafeSAT™ Oximeter Arms 70 to 100% SpO2 - 2.69

  • Nellcor Oximax Arms 70 to 100% SpO2 - 3.43

  • Masimo Rainbow: Arms 70 to 100% SpO2 - 5.64