Technical Data En13544-1; Cumulative Drug Deposition – Salbutamol; Symbol Glossary - Philips InnoSpire Go Instructions For Use Manual

Technical data EN13544-1

MMAD
Aerosol output
Aerosol output rate
Max fill volume
Max medication temperature increase at max fill
Noise level
Distribution of particles >5 μm
Distribution of particles in range 2 - 5 μm
Distribution of particles in range <2 μm
Respirable fraction (%<5 μm)
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.
Cumulative drug deposition – Salbutamol
100.0
90.0
80.0
70.0
60.0
50.0
40.0
30.0
20.0
10.0
0.0
0.1 1 10
Upper aerodynamic diameter (μm)
Performance information provided as required by EN 13544-1:2007 may not apply for medications in
suspension or high viscosity form. In such cases information should be sought from the medication supplier.
Performance may vary based on atmospheric pressure depending on altitude above sea level, barometric
pressure, and temperature.
Nebulizer performances are based upon testing that utilizes adult ventilatory patterns and are likely to be
different from those stated for pediatric infant populations.
Electromagnetic information: Portable and RF communication devices such as cellular phones, pagers, etc.
can interrupt operation of electrical medical equipment. For this reason, your nebulizer must be placed far
enough away from these devices to prevent interference. This device meets the IEC60601-1-2 Standard
for Electromagnetic Compatibility (EMC). EMC data sheets are available at the back of this document. The
12
3.99 μm
1.19 mL
0.26 mL/min
8 ml
o
<10 C above ambient temperature
<35dB at 1m
35.6%
52.3%
12.1%
64.4%
10.2%
0.30 mL
100
CE mark on the product denotes compliance with all applicable EU Directives. Note that the Notified Body
number does not apply to the RoHS (restriction of the use of certain hazardous substances in electrical and
electronic equipment) Directive.
Expected service life: Nebulizer handset, battery and mask adapter, 3 years from date of purchase
Mouthpiece assembly, 1 year from date of first use
Masks, 1 year from date of first use

Symbol glossary

l
ON (power)
~
O
OFF (power)
SN Serial number
Follow instructions for use
Complies with RTCA/DO-160F
section 21, category M
IP22 Ingress Protection rating
Class II internally powered
CAUTION
device, double insulated
Alternating current Type BF applied parts
Separate collection Temperature limitation
Atmospheric pressure Humidity
Manufacturer Date of manufacture
ENGLISH
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