Meditech card(X)plore
Device Name:
card(X)plore
Manufacturer:
Meditech Ltd., Mikszath Kalman utca 24, 1184 Budapest, HUNGARY.
Measuring functions:
Blood pressure, ECG, Activity level
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Device Manual:
Device Specifications:
Description:
The Meditech card(X)plore is a dual ambulatory monitor for blood pressure and holter ecg. 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 ambulatory blood pressure monitoring.
Assessment:
The technology used in the Meditech card(X)plore, 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. |
| BP | ESH (Europe) | ABPM | Published evidence |
Device Family:
BIOS ABP-01Z, BTL Cardiopoint BTL-08 ABPM (V1)B, Meditech ABPM-04B,D, Meditech ABPM-05B,D, Meditech card(X)ploreD, Omron M24/7 (ABPM-BP5)B, VectraCor ABPM-05Z
Legend: B BIHS Derivative, D DET Equivalence, Z Almost Certain
Legend: B BIHS Derivative, D DET 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.
Meditech ABPM-04
Barna I, Keszei A, Dunai A. Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol. Blood Press Monit. 1998;3(6):363-8. PMID: 10212378.
BHS:1993 - Pass (B/B) General population
SP10:1992 - Pass General population