Omron ne-c801 instruction manual Technical Data, Particle Specifications

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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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Contents NE-C801 Contents Introduction Staple your purchase receipt hereIntended Use Safety Information Operating the DeviceSafety Information Risk of Electrical Shock Maintenance and Storage Know Your Unit Nebulizer Kit Compressor Main UnitKnow Your Unit ComponentsPreparing the Nebulizer for Use Preparing the Nebulizer for USE Using the Adult Mask Optional Using the Nosepiece OptionalUsing the Child Mask Optional Attaching the Air Tube Using the Device Hold the nebulizer kit as illustrated on the rightUsing the Device Using the Child Mask or the Adult Mask OptionalUsing the Device Cleaning after Each Use Daily Disinfecting Handling the BaffleChanging the Air Filter Insert a new air filterCaring for the Device Troubleshooting Guide CauseLimited Warranty FCC Statement Specifications ContentsTechnical Data Particle SpecificationsGuidance and Manufacturers Declaration Electromagnetic emissions IEC60601-1-2Electromagnetic immunity IEC60601-1-2 Recommend separation distance KHz to 80 MHz KHz to 800 MHz MHz to 2.5GHz Page Omron Healthcare, Inc
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