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Ergoline Ergoscan Duo
Device Name:
Ergoscan Duo
Manufacturer:
Ergoline GmbH, Lindenstraße 5, 72475 Bitz, GERMANY.
Measuring functions:
Blood Pressure, SpO2 and PR
Primary Client Use:
Intended for ambulatory monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP & SpO2: Intermittent measurements at specified intervals or times
Availability:
Available Currently
Availability according to Countries or Regions:
Ireland
Device Manual:
Description:
The Ergoline Ergoscan Duo is a dual ambulatory monitor for blood pressure and oxygen saturation. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. It is intended for ambulatory monitoring.
Assessment:
Medaval is in the process of checking the validation status of this device. There appears to be no peer-reviewed clinical validation information available on the technology used in the Ergoline Ergoscan Duo to measure peripheral oxygen saturation.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None While a clinical validation is claimed, it cannot be checked properly.