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Technical data EN13544-1
Aerosol output
Aerosol output rate
Max fill volume
Max medication temperature increase at max fill
Noise level
Percentage of fill volume (2.5 mL) as aerosol
output (delivered to filter) in one minute
Residual volume
If the device has been stored at the extremes of the storage temperature, please allow at least 1 hour at room
temperature before using the device.
This table summarizes the performance with the mouthpiece and with a face mask when nebulizing
salbutamol (5 mg/2.5 mL). Values reported are mean and 95% confidence interval. When used with a face
mask the performance can be less and you may need to consult your physician about the treatment frequency
and length of treatment.
Parameter
Mass median aerodynamic diameter (MMAD)
Fine particle fraction <5 µm
Respirable fraction 1 - 5 µm
Delivered dose
Respirable dose 1 - 5 µm
12
1.19 mL
0.26 mL/min
8 ml
<10
o
C above ambient temperature
<35dB at 1m
10.2%
0.30 mL
InnoSpire Go
InnoSpire Go with adult
LiteTouch face mask
3.99 µm ± 0.73
4.18 µm ± 0.78
64.4% ± 12.2
61.3 ± 12.4
62.7% ± 11.6
59.7% ± 12.0
1.19 mL ± 0.06
0.87 mL ± 0.06
0.74 mL ± 0.13
0.52 mL ± 0.14
The following particle size specifications were established via performance tests using a seven stage cascade
impactor at a flow rate of 15 L/min and 30 L/min equipped with a USP <601> induction port throat. 3 device
samples were tested with 3 runs each, for a total of 9 sample points per each drug.
Aerosol was sampled directly from the outlet.
The specifications are listed below with the mean and 95% confidence interval included.
Aerosol specifications
Parameter
Drug
Mass median
Salbutamol (5 mg/2.5 ml)
aerodynamic
Ipratropium bromide (500 µg/2 mL)
diameter (MMAD)
Sodium cromoglicate (20 mg/2mL)
Geometric standard
Salbutamol (5 mg/2.5 ml)
deviation (GSD)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
Respirable fraction
Salbutamol (5 mg/2.5 ml)
1 - 5 µm
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
Coarse particle
Salbutamol (5 mg/2.5 ml)
fraction >5 µm
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
Fine particle
Salbutamol (5 mg/2.5 ml)
fraction <5 µm
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
Ultra-fine particle
Salbutamol (5 mg/2.5 ml)
fraction <1 µm
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
Respirable dose
Salbutamol (5 mg/2.5 ml)
1 - 5 µm
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
Delivered dose
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
* Determined using a simulated breathing pattern (tidal volume = 500 mL, I:E ratio = 1:1, breaths per minute = 15)
Note: Coarse 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.
ENGLISH
15 L/min
30 L/min
extraction flow
extraction flow
3.99 µm ± 0.73
3.90 µm ± 1.04
3.93 µm ± 0.74
3.87 µm ± 0.90
4.27 µm ± 0.76
4.02 µm ± 0.91
1.82 ± 0.02
2.02 ± 0.11
1.82 ± 0.03
2.02 ± 0.18
1.83 ± 0.05
2.00 ± 0.18
62.7% ± 11.6
56.0% ± 11.9
63.6% ± 11.8
56.6% ± 9.0
58.3% ± 11.2
47.9% ± 6.4
35.6% ± 12.2
38.9% ± 14.4
34.7% ± 12.3
38.1% ± 11.4
40.2% ± 11.6
40.4% ± 11.6
64.4% ± 12.2
61.1% ± 14.4
65.3% ± 12.3
61.9% ± 11.4
59.8% ± 11.6
59.6% ± 11.6
1.7% ± 0.6
5.2% ± 2.6
1.8% ± 0.6
5.4% ± 3.2
1.5% ± 0.5
11.7% ± 5.8
0.74 mL ± 0.13
0.66 mL ± 0.16
0.59 mL ± 0.11
0.53 mL ± 0.10
0.59 mL ± 0.14
0.49 mL ± 0.08
1.19 mL ± 0.06*
0.93 mL ± 0.02*
1.01 mL ± 0.05*
13

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