Pic Solution Self Check
Device Name:
Self Check
Manufacturer:
Pikdare S.r.l., Via Saldarini Catelli 10, 22070 Casnate con Bernate, ITALY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Pic Solution Self Check 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 wrist. 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 Pic Solution Self Check, to measure blood pressure, has been compared to a clinically validated device, but not 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:
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.
Pic Solution Travel Check
Germano G, Psimenos A, Sarullo F, Venditti A, Pecchioli V, Asmar R. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol: the Pic Indolor Personal Check, Comfort Check, My Check and Travel Check. Blood Press. 2009 Oct;18(1):15-23. doi: 10.3109/08037050903262496. PMID: 20050101.
ESH-IP:2002 - Pass General population