Omron ne-c801 instruction manual Technical Data, Particle Specifications

Technical Data

Particle Specifications

A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rate of 15 l/min equipped with a USP <601> induction port throat. Aerosol was sampled directly from the outlet. Three (3) device samples were tested with 3 runs each, for a total of 9 sample points per each drug.

The specifications are listed below with intervals given for a 95% confidence level.

Mean / Std. Dev	Pulmicort®		Intal®	Salbutamol®
	(250μg/mL)		(10mg/mL)	(5mg/mL)
Total Delivered Dose (μg)	391.11	± 16.51	12368.89 ± 269.61	7883.33	± 116.96
Total Delivered Dose Fraction (%)	78.2%	± 3.3%	61.8% ± 3.1%	77.0%	± 2.5%
Particle size (MMAD) μm	3.88 ± 0.28		2.91 ± 0.14	2.54 ± 0.28
Geometric Standard Deviation	1.93 ± 0.20		2.27 ± 0.02	2.62 ± 0.03
Respirable Fraction (0.5-5μm)	61.9% ± 4.0%		70.5% ± 1.3%	66.4% ± 1.6%
Total Respirable Dose	242.17	± 18.90	8729.49 ± 497.57	5235.02	± 233.61
(μg between 0.5-5μm)
Medication Captured on USP Throat	13.34	± 3.40	253.66 ± 27.42	144.94	± 16.32
Medication Captured on USP	3.4% ± 0.4%		2.0% ± 0.1%	1.8% ± 0.1%
Throat Fraction (%)
Medication Retained in Device	96.11 ± 9.61		8000.00 ± 438.21	2072.22	± 257.90
Medication Retained in Device	19.2%	± 1.9%	40% ± 2.2%	41.4%	± 5.2%
Fraction (%)
Coarse Particle Fraction (%) (>4.7μm)	37.1% ± 2.9%		27.7% ± 1.5%	26.6% ± 2.3%
Fine Particle Fraction (%) (<4.7μm)	59.6% ± 3.5%		70.2% ± 1.5%	71.6%	± 2.3%
Ultra-Fine Particle Fraction (%)	3.5% ± 1.7%		8.9% ± 2.1%	16.9%	± 5.3%
(<1.0μm)

Note: Course particles (oro-pharyngeal deposition) and ultra-fine particles (exhaled) are not likely to deposit in the patient’s airway and thus provide limited clinical benefit.

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