Suntech Oscar 2 + SphygmoCor
Device Name:
Oscar 2 + SphygmoCor
Device Model:
250
Manufacturer:
SunTech Medical Inc., Suite 117, 507 Airport Boulevard, Morrisville, NC 27560-8200, UNITED STATES.
Other: Cardiex Limited, Suite 301, 55 Lime St., Barangaroo 2000, Sydney, AUSTRALIA.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for ABPM with central aortic pressure
Measurement Site:
Upper Arm
Measurement Occurrence:
Continuous and intermittent measurements
Availability:
Available Currently
Device Manual:
Description:
The Suntech Oscar 2 + SphygmoCor is an ambulatory blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for ABPM, along with central aortic pressure.
Assessment:
Medaval is in the process of checking the validation status of this device.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |