Hillrom Spot Vital Signs LXi (45NTO)
Device Name:
Spot Vital Signs LXi
Device Model:
45NTO
Manufacturer:
OBL: Hill-Rom Holdings Inc., Suite 1000, 130 East Randolph Street, Chicago, IL 60601, UNITED STATES.
Former: Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.
Measuring functions:
Blood Pressure, SpO2, PR and Temperature
Primary Client Use:
Intended for patient monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP & SpO2: Single measurements only
Availability:
Obsolete
Description:
The Hillrom Spot Vital Signs LXi (45NTO) is a vital signs monitor. Its blood pressure measurement technology has been proven to be accurate and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. It is intended for bedside patient monitoring. This device is now obsolete.
Assessment:
The technology used in the Hillrom Spot Vital Signs LXi (45NTO), 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. There appears to be no peer-reviewed clinical validation information available on the technology used in the Hillrom Spot Vital Signs LXi (45NTO) to measure peripheral oxygen saturation.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Legacy approval | Older clinical validation; older protocol |
| BP | FDA (US) | 510(k) | 510(k) K101680 |
Validation Publications:
Alpert BS. Clinical evaluation of the Welch Allyn SureBP algorithm for automated blood pressure measurement. Blood Press Monit. 2007 Aug;12(4):215-8. PMID: 17625393.
BHS:1993 - Pass (A/A) General population
SP10:1996 - Pass General population