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Rossmax Z1
Device Name:
Z1
Manufacturer:
Rossmax International Ltd., 12F - 189 Kang Chien Road, Taipei 114, TAIWAN ROC.
Measuring functions:
Blood pressure, Atrial fibrillation
Primary Client Use:
Intended for professional use with atrial fibrillation detection
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Rossmax Z1 is an automatic 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. With atrial fibrillation detection, it is intended for professional use.
Assessment:
The technology used in the Rossmax Z1, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP BIHS (UK and IRL) Self-measurement Manufacturer declaration of equivalence
BP Stride BP Self-measurement for adults (Preferred) Equivalence claim without published evidence
Device Family:
Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Rossmax CF175f (V1)

Zhang L, Kang YY, Zeng WF, Li Y, Wang JG. Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Apr;20(2):104-7. doi: 10.1097/MBP.0000000000000089. PMID: 25350783.

ESH-IP:2010 - Pass General population