BTL BTL-08 ABPM (V2)
Device Name:
BTL-08 ABPM
Manufacturer:
OBL: BTL Industries Inc., 47 Loring Drive Framingham, MA 01702, UNITED STATES.
Measuring functions:
Blood pressure
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
Description:
The BTL BTL-08 ABPM (V2) is an ambulatory 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 ambulatory blood pressure monitoring.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the BTL BTL-08 ABPM (V2) to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven 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:
BTL BTL-08 ABPM (V2)Z, Tensiomed TensiodayB, Unimedic TensiodayB
Legend: B BIHS Derivative, Z Almost Certain
Legend: B BIHS Derivative, 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.
Tensiomed Tensioday
Németh Z, Móczár K, Deák G. Evaluation of the Tensioday ambulatory blood pressure monitor according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 2002 Jun;7(3):191-7. PMID: 12131077.
BHS:1993 - Pass (A/A) General population
SP10:1992 - Pass General population