Philips InnoSpire Go - Charging the battery; Cleaning and maintenance

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ENGLISH
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Technical data EN13544-1
Aerosol output 1.19 mL
Aerosol output rate 0.26 mL/min
Max fill volume 8 ml
Max medication temperature increase at max fill <10
o
C above ambient temperature
Noise level <35dB at 1m
Percentage of fill volume (2.5 mL) as aerosol 10.2%
output (delivered to filter) in one minute
Residual volume 0.30 mL
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.
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 15 L/min
extraction flow
30 L/min
extraction flow
Mass median
aerodynamic
diameter (MMAD)
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
3.99 µm ± 0.73
3.93 µm ± 0.74
4.27 µm ± 0.76
3.90 µm ± 1.04
3.87 µm ± 0.90
4.02 µm ± 0.91
Geometric standard
deviation (GSD)
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
1.82 ± 0.02
1.82 ± 0.03
1.83 ± 0.05
2.02 ± 0.11
2.02 ± 0.18
2.00 ± 0.18
Respirable fraction
1 - 5 µm
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
62.7% ± 11.6
63.6% ± 11.8
58.3% ± 11.2
56.0% ± 11.9
56.6% ± 9.0
47.9% ± 6.4
Coarse particle
fraction >5 µm
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
35.6% ± 12.2
34.7% ± 12.3
40.2% ± 11.6
38.9% ± 14.4
38.1% ± 11.4
40.4% ± 11.6
Fine particle
fraction <5 µm
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
64.4% ± 12.2
65.3% ± 12.3
59.8% ± 11.6
61.1% ± 14.4
61.9% ± 11.4
59.6% ± 11.6
Ultra-fine particle
fraction <1 µm
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
1.7% ± 0.6
1.8% ± 0.6
1.5% ± 0.5
5.2% ± 2.6
5.4% ± 3.2
11.7% ± 5.8
Respirable dose
1 - 5 µm
Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
0.74 mL ± 0.13
0.59 mL ± 0.11
0.59 mL ± 0.14
0.66 mL ± 0.16
0.53 mL ± 0.10
0.49 mL ± 0.08
Delivered dose Salbutamol (5 mg/2.5 ml)
Ipratropium bromide (500 µg/2 mL)
Sodium cromoglicate (20 mg/2mL)
1.19 mL ± 0.06*
0.93 mL ± 0.02*
1.01 mL ± 0.05*
* 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.
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 InnoSpire Go InnoSpire Go with adult
LiteTouch face mask
Mass median aerodynamic diameter (MMAD) 3.99 µm ± 0.73 4.18 µm ± 0.78
Fine particle fraction <5 µm 64.4% ± 12.2 61.3 ± 12.4
Respirable fraction 1 - 5 µm 62.7% ± 11.6 59.7% ± 12.0
Delivered dose 1.19 mL ± 0.06 0.87 mL ± 0.06
Respirable dose 1 - 5 µm 0.74 mL ± 0.13 0.52 mL ± 0.14
1128272R02_InnoSpireGo_IFU_AmericasJapan_6.indd 12-13 11/7/17 8:24 AM