Riester ri-medic Floor

Device Name:

ri-medic Floor

Device Model:

1782-003, 1783-003

Manufacturer:

OBL: Rudolf Riester GmbH, Bruckstraße 31, D-72417 Jungingen, GERMANY.

OEM: SunTech Medical Inc., Suite 117, 507 Airport Boulevard, Morrisville, NC 27560-8200, UNITED STATES.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for patient monitoring

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

Ireland

Device Specifications:

Click here to download the Device Specifications

Description:

The Riester ri-medic Floor is a mobile (floor, stand, trolly) patient 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 bedside patient monitoring.

Assessment:

While the technology used in the Riester ri-medic Floor, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared 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.
BP	BIHS (UK and IRL)	Hospital use	Manufacturer declaration of equivalence to the SunTech 247
BP	ESH (Europe)	Professional use	The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.

Device Family:

Riester ri-medic DeskB, Riester ri-medic FloorB, Riester ri-medic WallB, Suntech 247B
Legend: B BIHS Derivative

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.

Suntech 247

Polo Friz H, Facchetti R, Primitz L, Beltrame L, Galbiati V, Ricioppo A, Bombelli M, Sega R. Simultaneous validation of the SunTech 247 diagnostic station blood pressure measurement device according to the British Hypertension Society protocol, the International Protocol and the Association for the Advancement of Medical Instrumentation standards. Blood Press Monit. 2009 Oct;14(5):222-7. doi: 10.1097/MBP.0b013e328330c873. PMID: 19741510.

ESH-IP:2002 - Pass General population

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

SP10:2002 - Pass General population