HealthWorks SCLV-2007 Cardio-Vascular Lab
Device Name:
SCLV-2007 Cardio-Vascular Lab
Manufacturer:
HealthWorks France (MedActive), 6 rue de Castellanne, Paris 75008, FRANCE.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Obsolete
Description:
The HealthWorks SCLV-2007 Cardio-Vascular Lab 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 professional use. This device is now obsolete.
Assessment:
While the technology used in the HealthWorks SCLV-2007 Cardio-Vascular Lab, 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) | Professional use | Manufacturer declaration of equivalence |
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
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