Contec CMS50DL
Device Model:
CMS50DL
Manufacturer:
Contec Medical Systems Co. Ltd., 112 Qinhuang West Street, Economic &Technical Development Zone, Qinhuangdao 066004, Hebei Provice, CHINA.
Measuring functions:
SpO2, Pulse Rate
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Specifications:
Description:
The Contec CMS50DL is a fingertip automatic pulse oximeter. Although its oxygen saturation measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Oxygen saturation measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Contec CMS50DL, to measure peripheral oxygen saturation, has been assessed, in a general population, according to a non-standard protocol.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| SpO2 | Medaval | None | When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol. |
Validation Publications:
Lipnick MS, Feiner JR, Au P, Bernstein M, Bickler PE. The Accuracy of 6 Inexpensive Pulse Oximeters Not Cleared by the Food and Drug Administration: The Possible Global Public Health Implications. Anesth Analg. 2016 Aug;123(2):338-45. doi: 10.1213/ANE.0000000000001300. PMID: 27089002.
Ad Hoc protocol General population (Note: Modified ISO 80601-2-61:2011 study)