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Mechanical
Weight: Controller and Handset ................................................................................................................ approx. 8.2 oz.
Weight: Controller, Handset, and Batteries ............................................................................................... approx. 11 oz.
Handset Dimensions (W x H x D) ............................................................................................................. 2.0" X 2.4” X 5.5"
Controller Dimensions (H x Ø) ................................................................................................................. 1.6” X 4.6"
Minimum Fill Volume ............................................................................................................................... 0.5 mL
Maximum Fill Volume .............................................................................................................................. 8.4 mL
Electrical
Electrical Requirements .............................................................................................................. 110 V - 240 V, 50 Hz/60 Hz
Power Wattage ........................................................................................................................... 2.0 Watts under normal load
Transport and Storage
Temperature ............................................................................................................................................. -13° to 158° F
Relative Humidity (non-condensing) ......................................................................................................... 0% to 93%
Air Pressure .............................................................................................................................................. 9 to 15 PSI
Operational
Temperature ............................................................................................................................................. 41° to 104° F
Relative Humidity (non-condensing) ......................................................................................................... 15% to 93%
Air Pressure .............................................................................................................................................. 10 to 15 PSI
Device Classification According to IEC 60601-1
Type of electric shock protection (AC power adapter) .............................................................................. Protection Class II
Degree of protection from electric shock of part used (nebulizer) ............................................................ Type BF
Degree of protection against water ingress per IEC 60529 IP rating (nebulizer) ...................................... IP 21
Degree of protection when in the presence of flammable mixtures .......................................................... No protection
Continuous operation................................................................................................................................ Operating mode
Device Performance Characteristics
Mean
Range
a
Total Delivered Dose by Breath Simulation
b
(mg)
312.1
273.8 – 350.4
Total Delivered Dose by Breath Simulation (% of label claim
c
)
52.9
46.4 – 59.4
MMAD
d
by NGI
e
(µm)
4.45
4.38 – 4.52
GSD
f
1.59
1.59 – 1.60
Respiratory Dose by NGI (≤ 5µm, mg)
327.1
316.5 – 337.6
Respiratory Fraction by NGI (≤5µm, % of delivered dose)
55.6
53.8 – 57.4
a
Range - two-sided tolerance interval, proportion of total population=0.95
b
Breath simulation - tidal volume of 500 mL, 15 breath per minutes, and inhalation:exhalation ratio is 50:50
c
label claim - 590 mg
d
MMAD - Mass Median Aerodynamic Diameter
e
NGI - Next Generation Impactor
f
GSD - Geometric Standard Deviation
Handset materials
Polypropylene, polyamide, silicone, stainless steel, thermoplastic elastomers. Does not contain any natural rubber (latex).
Disposal
The Lamira components and batteries must be disposed of in accordance with local (state, county or municipal) regulations.
Manufactured by:
PARI Respiratory Equipment, Inc.
2412 PARI Way
Midlothian, Virginia 23112 USA
For patent information: www.PARI.com/ip
©2018 PARI Pharma GmbH. All rights reserved. The PARI logo is a registered trademark of PARI GmbH. Altera®, eRapid
®
, and eFlow® logo are registered trademarks of PARI
Pharma GmbH. Lamira™ is a trademark of PARI Pharma GmbH. ARIKAYCE is a registered trademark of Insmed Incorporated.. Touchspray® made under license from the Technology
Partnership.
This Instructions for Use has been approved by the U.S. Food and Drug Administration
678D0204 Draft Rev 18a 9/18
Specifications
L
Reference ID: 4327567
Summary of Contents for Lamira
Page 1: ...Reference ID 4327567...
