Rossmax X9 BT - Medaval

Description:

The Rossmax X9 BT 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:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Rossmax X9 BT to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant 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.

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 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 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