Rossmax X3 (V1)

Description:

The Rossmax X3 (V1) 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. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Rossmax X3 (V1), 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 Assessment	Recommendation	Basis
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 to the Rossmax CF175f (V1)
BP	ESH (Europe)	Self-measurement	The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
BP	Stride BP	Self-measurement for adults (Preferred)	Equivalence to the Rossmax CF175f (V1) claim without published evidence

Device Family:

Alvita MA-801FB, Alvita CG-155FB, Aspen C5B, Aspen CF155FB, Lloyds CardioZ, Rossmax AC1000f (V1)B, Rossmax CF155fB, Rossmax CF175f (V1)B,P, Rossmax CH155f (V2)B, Rossmax X1 (V1)B,P, Rossmax X3 (V1)B,P, Rossmax X5 (V1)B, Rossmax X9B,P, Rossmax Accumed Carrdio C5B, Rossmax AC1000f (V2)P, Rossmax X5 (V2)P, Rossmax CH155f (V1)B, Rossmax X9 BTZ, Rossmax Z1B,P, Rossmax Z5B,P
Legend: B BIHS Derivative, P Stride Equivalence, Z Almost Certain

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 AC1000f (V2)

Huang JF, Li Y, Wang JG. Validation of the Rossmax AC1000f upper-arm blood pressure monitor in adults according to the British Hypertension Society Protocol. Blood Press Monit. 2020 Aug;25(4):231-235. Epub: 2020 May 11. doi: 10.1097/MBP.0000000000000452. PMID: 32404598.

BHS:1993 - Pass (A/A) General population

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