Hillrom Spot Vital Signs 4400
Device Name:
Spot Vital Signs 4400
Device Model:
44WT-B (BPM, SpO2), 44XT-B (BPM)
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, Temperature
Primary Client Use:
Intended for patient monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP: Single and repeated measurements; SpO2: Continuous measurement
Availability:
Available Currently
Device Manual:
Description:
The Hillrom Spot Vital Signs 4400 is a vital signs monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements 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.
Assessment:
The technology used in the Hillrom Spot Vital Signs 4400, to measure blood pressure, has been validated in its own right, but equivalence still needs to be confirmed to ensure compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4. There appears to be no peer-reviewed clinical validation information available on the technology used in the Hillrom Spot Vital Signs 4400 to measure peripheral oxygen saturation.
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.
Welch Allyn Connex ProBP 3400 with SureBP
Alpert BS. Validation of the Welch Allyn ProBP 3400: a device for modern medical practice. Blood Press Monit. 2011 Jun;16(3):156-8. doi: 10.1097/MBP.0b013e328346d61b. PMID: 21527848.
SP10:2002 - Pass General population (Note: Cirterion 1 only (n=92))
Welch Allyn SureBP Algorithm (Unspecified Device)
Alpert BS. Validation of the Welch Allyn SureBP (inflation) and StepBP (deflation) algorithms by AAMI standard testing and BHS data analysis. Blood Press Monit. 2011 Apr;16(2):96-8. doi: 10.1097/MBP.0b013e328345232f. PMID: 21412074.
SP10:2006 - Pass General population
