Spacelabs OnTrak (90227)
Device Name:
OnTrak
Device Model:
SL-90227
Manufacturer:
Spacelabs Healthcare, 35301 SE Center St., Snoqualmie, WA 98065, 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
Availability according to Countries or Regions:
Canada
Device Specifications:
Description:
The Spacelabs OnTrak (90227) is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the Spacelabs OnTrak (90227), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | ★ Recommendation | Recent clinical validation; older protocol |
| BP | BIHS (UK and IRL) | ABPM | Published evidence |
| BP | Hypertension Canada | ABPM (Gold) | Published evidence |
| BP | Stride BP | ABPM for adults (Preferred) | Published evidence |
| BP | FDA (US) | 510(k) | 510(k) K141113 |
Validation Publications:
de Greeff A, Shennan AH. Validation of the Spacelabs 90227 OnTrak device according to the European and British Hypertension Societies as well as the American protocols. Blood Press Monit. 2020 Apr;25(2):110-114. Epub: 2019 Dec 10. doi: 10.1097/MBP.0000000000000424. PMID: 31833949.
81060-2:2013 - Pass General population
ESH-IP:2010 - Pass General population
BHS:1993 - Pass (A/A) General population