Starhealth SH-A3

Device Name:

SH-A3

Manufacturer:

Star Health Medical, Huoying Hualongyuanzhongli, Changping District, Beijing, China, 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

Description:

The Starhealth SH-A3 is an 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 Starhealth SH-A3, 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)