Spengler TB-101

Device Model:

TB-101

Manufacturer:

Spengler S.a.s., 190 rue Paul Langevin, ZAC La Robole, 13856 Aix-en-Provence, FRANCE.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Discontinued but still available

Description:

The Spengler TB-101 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:

While the technology used in the Spengler TB-101, 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)	Self-measurement	Manufacturer declaration of equivalence
BP	ESH (Europe)	Professional use	The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:

HealthWorks SCLV-2007 Cardio-Vascular LabB, K-jump KP-7770D, Spengler KP7500 DB,D, Spengler TB-101B
Legend: B BIHS Derivative, D DET Equivalence

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.

Spengler KP7500 D

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

ESH-IP:2002 - Pass General population