Suntech Advantage 2
Device Name:
Advantage 2
Manufacturer:
SunTech Medical Inc., Suite 117, 507 Airport Boulevard, Morrisville, NC 27560-8200, UNITED STATES.
Measuring functions:
Blood pressure
Primary Client Use:
Module intended as a component of a patient monitor
Measurement Site:
Upper Arm
Measurement Occurrence:
Not applicable – e.g. Laboratory equipment or used in conjunction with other device
Availability:
Available Currently
Description:
The Suntech Advantage 2 is a blood pressure module for a patient monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for use in a bedside patient monitor.
Assessment:
The technology used in the Suntech Advantage 2, to measure blood pressure, has passed in a clinical validation study, in a pregnancy population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Recommended for pregnancy only | Validation in pregnancy |
| BP | MDR Criteria | Pregnancy | Published evidence |
Validation Publications:
Kuper SG, Dotson KN, Anderson SB, Harris SL, Harper LM, Tita AT. Validation of the SunTech Medical Advantage Model 2 Series Automated Blood Pressure Module in Pregnancy. Am J Perinatol. 2019 Jan;36(1):67-73. Epub: 2018 Jun 15. doi: 10.1055/s-0038-1660510. PMID: 29906797.
81060-2:2013 - Pass Pregnancy (Normal & High BP) & Pre-Eclampsia (Note: Possible SBP underestimation (> 10 mmHg) in preeclampsia)