MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
23
Instructions for Use
For use with LONHALA
TM
(glycopyrrolate)
Inhalation Solution
H. SPECIFICATIONS
ELECTRICAL
AC adapter
Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 V-240 V, 50 Hz/60 Hz
Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.5 V
Batteries
Disposable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 x 1.5 V (high quality alkaline or photography-grade)
Rechargeable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 x 1.2 V (Ni-Cd)
OPERATIONAL
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41° to 104°F (5° to 40°C)
Relative humidity (non-condensing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15% to 93%
Air pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 to 15 PSI (700 to 1060 hPa)
Aerosol output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.85-1.15 mL
Aerosol output rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.4 mL/min
MECHANICAL
MAGNAIR Handset weight, without medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .approx. 2.6 oz (73 g)
MAGNAIR Controller weight (with batteries) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approx. 7.6 oz (220 g)
Nebulizer dimensions (W x H x D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4 in. x 4.7 in. x 7.19 in. (6 x 12 x 18 cm)
Controller dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . H 1.6 in. (4 cm), Ø 4.6 in. (11.6 cm)
TRANSPORT / STORAGE
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -13° to 158° F (-25 to +70°C)
Relative humidity (non-condensing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 to 93%
Air pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 to 15 PSI (500 to 1060 hPa)
HANDSET MATERIALS
Polypropylene, polyoxymethylene, polyamide, silicone, stainless steel, thermoplastic elastomers.
Does not contain any natural rubber (latex).
DISPOSAL
The MAGNAIR parts and batteries must be thrown away in accordance with local (state, county, or municipal) regulations.
PERFORMANCE CHARACTERISTICS
LONHALA (glycopyrrolate) Inhalation Solution, 25 mcg/mL
Mean
1
95% Confidence Range
2
Delivered dose by breath simulation (mcg)
14.20
11.11–17.29
Delivered dose by breath simulation (% Label Claim)
56.80
44.45–69.16
MMAD
3
(μm) by NGI
4
3.71
2.92–4.49
Coarse Particles (Dia. >5 μm) by NGI (mcg)
Coarse Particles (Dia. >5 μm) by NGI in % of Delivered Dose
5.83
27.72
2.32–9.33
11.20–44.24
Fine Particles (Dia. ≤5 μm) by NGI (mcg)
Fine Particles (Dia. ≤5 μm) by NGI in % of Delivered Dose
15.20
72.28
11.46–18.93
55.77–88.79
Extra-Fine Particles (Dia. <1 μm) by NGI (mcg)
Extra-Fine Particles (Dia. <1 μm) by NGI in % of Delivered Dose
0.11
0.55
0.03–0.20
0.15–0.94
GSD
5
by NGI
1.66
1.49–1.83
1
n=15 devices from 3 device lots; 5 devices tested per drug product batch x 3 batches drug product
2
95% Confidence Range: Two-sided tolerance interval, Proportion of total population=0.95,
Confidence (1- Alpha)=0.95
3
MMAD: Mass Median Aerodynamic Diameter
4
NGI: Next Generation Impactor
5
GSD: Geometric Standard Deviation
