The safe concentration for inhaled molecular hydrogen depends on what is being measured. The classical handbook value applies to closed-system pre-mixed conditions; the value relevant to inhalation devices is the empirically measured one.
The chemistry handbook value for the lower flammability limit (LFL) of hydrogen — approximately 4% — was measured in closed pre-mixed mixtures at rest, for example inside a pipeline or sealed vessel. This is the figure used to set explosion thresholds in process engineering.
Inhaler operating conditions are different: atmospheric pressure, open system, continuous dilution, and a non-zero gas flow. The closed-system assumptions of the classical LFL no longer hold. Empirical measurements under realistic inhalation conditions place the safe operating ceiling at approximately 10%, supported by multiple experimental and case-based lines of evidence.
Theoretically, hydrogen has an upper flammability limit (UFL) of approximately 75%: above that concentration, lack of oxidizer would prevent combustion. This argument is sometimes used to claim that 100%-pure-hydrogen output is intrinsically safe.
In practice:
The argument that "100% pure hydrogen output is intrinsically safe" therefore does not hold.
https://h2-papers.org/en/safety-notes/inhalation-concentration