Pari Lonhala Magnair Instruction Manual
MAGNAIR™ NEBULIZER SYSTEM INSTRUCTIONS FOR USE
For use with LONHALA™ (glycopyrrolate) Inhalation Solution only
Warning
Read and understand the full Patient Information (PI) for information and
warnings related to LONHALA. The PI is contained in the LONHALA box.
Warning
Read and understand these Instructions for Use and all safety precautions
it contains. Improper use can cause serious or fatal injury/illness.
Assembly required. LONHALA vials packaged separately.
Marketed by:
MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
2
Instructions for Use
For use with LONHALATM
(glycopyrrolate)
Inhalation Solution
TABLE OF CONTENTS
A. Safety Precautions ..................................................................................................................................... 3
B. Getting Started ........................................................................................................................................... 5
C. Steps for Using Batteries or AC Adapter with MAGNAIR ...........................................................................6
D. Assembling Your MAGNAIR ..................................................................................................................... 8
E. Using LONHALA MAGNAIR .................................................................................................................... 11
F. Cleaning the Handset ............................................................................................................................. 15
G. Troubleshooting .......................................................................................................................................20
H.Specications ........................................................................................................................................... 23
Intended Use and Authorized Users
MAGNAIR is intended for single-patient use in the delivery of LONHALA to patients who self-administer
treatments or have treatments administered by a caregiver or health care provider.
MAGNAIR Handset is not sterile.
MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
3
Instructions for Use
For use with LONHALATM
(glycopyrrolate)
Inhalation Solution
These Instructions for Use contain information and safety precautions for MAGNAIRTM (MAGG-nair)
Nebulizer System for use with LONHALATM (lon-HAL-luh) (glycopyrrolate) Inhalation Solution.
• US Federal law restricts this device to sale by or on order of a physician.
Warning
MAGNAIRisdesignedspecicallyforuseonlywithLONHALA. To reduce the risk of severe
or fatal injury/illness, Never use other medications in MAGNAIR. Read and follow all
warnings and instructions in the Instructions for Use prior to using this device.
Read all Dangers and Warnings before using.
Dangers
To reduce the risk of serious or fatal injury from electrocution:
1. Do Not place or store MAGNAIR where it can be in water or fall into water (e.g., near a bathtub or sink).
Do Not place or drop into water or other liquid. Do Not use while bathing.
2. Do Not reach for MAGNAIR if it has fallen into water or other liquid. If using AC adapter, unplug.
Retrieve MAGNAIR only after it has been unplugged.
Warnings
1. The MAGNAIR Handset is intended for Single Patient Use Only. Do not share your MAGNAIR
with anyone else.
2. MAGNAIRisdesignedspecicallyforuseonlywithLONHALA. To reduce the risk of severe or fatal
injury/illness, Never use other medications in MAGNAIR.
3. Read and follow all warnings and instructions in the Instructions for Use prior to using this device.
4. Toreducetheriskofseriousorfatalinjuryfromelectrocution,re,burns,andtoreducetherisk
of damage and malfunction of the unit:
a. Do Not overload wall outlets or use extension cords.
b. Keep all electrical cords away from heated surfaces.
c. Do Not spray liquids onto the housing of the Controller. Liquid may cause damage to the electrical
parts and could lead to a malfunction. In the event that liquids enter the Controller, contact the
Sunovion Customer Service line (1-888-394-7377).
d. Do Not drop or insert any object into any opening on MAGNAIR.
e. Do Not operate where oxygen is being administered in a closed environment, such as an oxygen tent.
Save these Instructions for Use for future reference.
If for any reason you do not understand any part of these Instructions for Use, please contact the
Sunovion Customer Service line 1-888-394-7377 before proceeding with your treatment.
Take special note of all safety precautions marked Danger and Warning.
A. SAFETY PRECAUTIONS
IMPORTANT INFORMATION FOR USE
MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
4
Instructions for Use
For use with LONHALATM
(glycopyrrolate)
Inhalation Solution
Warnings
5. Always unplug this product from AC power immediately after using and before cleaning.
6. Before use, check your Controller and Handset for proper assembly. All parts must be connected
andrmlyinplace.UseofanimproperlyassembledMAGNAIRcoulddiminishoreliminatethe
effectiveness of the treatment.
7. Use Only adapters and accessories that are authorized for MAGNAIR. Use of unapproved adapters
and accessories can lead to improper treatment, injury, or damage to the Controller.
8. Never operate the Controller if it is improperly or incompletely assembled or damaged.
If you suspect either situation, call the Sunovion Customer Service line (1-888-394-7377).
9. Never operate MAGNAIR if:
a. it has damaged cords or plugs;
b. it is not working properly;
c. the inside of the Controller has been exposed to any liquids.
10. TomaintaintheefciencyofMAGNAIR,removetheAerosolheadfromtheMAGNAIRHandset
body and clean and air-dry all MAGNAIR Handset parts after each treatment. Follow the
instructions in Section F to clean the MAGNAIR Handset properly.
11. Cleaning the MAGNAIR Handset properly will help prevent the Aerosol head from clogging. If the
Aerosol head becomes clogged, the aerosol mist may be reduced, altered, or stopped, which could
increase the nebulization time (up to 15 minutes) and/or diminish the effectiveness of the treatment.
Do Not Stop Treatment until MAGNAIR shuts off.
12. This product contains small parts that may present a choking hazard to small children.
The MAGNAIR AC adapter and Connection cord also presents a strangulation hazard.
13. Close supervision is necessary when this product is used near children or the physically or
mentally impaired.
14. Do Not allow pets near the Connection cord or AC adapter as they may chew on and damage them.
15. Do Not use your MAGNAIR while driving or in any situation that takes away your full attention.
16. Do Not disassemble the blue Controller at any time. There are no user serviceable parts inside the
Controller. Contact the Sunovion Customer Service line (1-888-394-7377) for help.
17. Do Not use alcohol for cleaning and disinfection. Some parts will be damaged by alcohol.
18. TheLONHALAvialisforsingleuseonlyandmustnotbereused,relled,orusedinanyotherdevice.
A. SAFETY PRECAUTIONS (cont.)
MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
5
Instructions for Use
For use with LONHALATM
(glycopyrrolate)
Inhalation Solution
B. GETTING STARTED
Check to make sure you have all of the following
MAGNAIR parts and become familiar with how to
identify each piece. If any parts are missing, call the
Sunovion Customer Service line (1-888-394-7377).
See Fig. B1.
Fig. B1 MAGNAIR Nebulizer System
Controller
Medication cap
Handset body
Mouthpiece
4 AA batteries
AC adapter
Aerosol head
Connection cord
LONHALA vials packaged separately.
Carrying bag
MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
6
Instructions for Use
For use with LONHALATM
(glycopyrrolate)
Inhalation Solution
C. STEPS FOR USING BATTERIES OR AC ADAPTER WITH MAGNAIR
Fig. C1 Open the battery door
of the Controller.
Fig. C2 Load the batteries.
STEPS FOR USING BATTERIES WITH MAGNAIR
MAGNAIR is designed to be used with AA batteries or with the AC adapter.
Four (4) high quality AA batteries will provide
approximately 2 weeks of treatment.
C1. Open the battery door on the Controller
by placing your thumb on the black tab
ofthebatterydoorandrmlypushing
the tab to open the door. Note that the
battery door is designed to have a
tightt.See Fig. C1.
C2. Load the batteries.
Eachbatterychamberhasasmallgure
that shows the proper position of each
battery. Using the battery tips as guides
and starting left-to-right, insert the
batteries: tip out, tip in, tip out, tip in.
See Fig. C2.
4 AA batteries
MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
7
Instructions for Use
For use with LONHALATM
(glycopyrrolate)
Inhalation Solution
Fig. C4-C5 Plug the AC adapter into the inlet
on the black battery door of
the Controller. Then plug the
AC adapter into the wall outlet.
C3. Close the battery door.
To close the battery door, push it closed until
you hear it Click into place. See Fig. C3.
NOTE: Rechargeable and disposable batteries
vary considerably in terms of storage life and
output. If used exclusively, batteries have an
operating life of ~2 weeks, based on high
quality disposable AA batteries that meet the
specicationslistedinSection H and following
the cleaning procedure described in Section F.
To reduce the risk of battery leakage, it is
recommended to remove the batteries if you
plan to store the Controller for more than
30 consecutive days.
C4. Plug the AC adapter into the Controller.
To connect the AC adapter to the Controller,
placetheControlleronaat,stablesurface.
The inlet is located on the underside of the
black battery door. Push the round end of
the AC adapter cord into the inlet. Do Not try
to insert the AC adapter into the blue colored
part of the Controller. See Fig. C4-C5.
If you choose not to use the AC adapter,
it is strongly recommended to have an
extra set of batteries with you at all times.
STEPS FOR USING THE AC ADAPTER WITH MAGNAIR
The AC adapter will automatically adjust to the incoming voltage. The AC adapter will power
MAGNAIR with and without installed batteries.
C5. Plug the AC adapter into the wall outlet.
NOTE: the AC adapter will not charge the
batteries in the Controller. See Fig. C4-C5.
C. STEPS FOR USING BATTERIES OR AC ADAPTER WITH MAGNAIR (cont.)
Black battery door
Inlet
AC adapter
Fig. C3 Close the battery door
of the Controller.
MAGNAIR questions? Contact the Sunovion Customer Service line (1-888-394-7377).
8
Instructions for Use
For use with LONHALATM
(glycopyrrolate)
Inhalation Solution
D. ASSEMBLING YOUR MAGNAIR
Your Handset parts (Medication cap, Aerosol head, Handset body, and Mouthpiece) will be
replaced when you receive your next supply of LONHALA. Discard your old Handset parts and
use the new Handset parts every time you get a LONHALA MAGNAIR Rell Kit.
Warning
Clean the Handset before the rst use
and after every use. (See Section F.)
Inspect all Handset parts to ensure they
are clean and not damaged. Do Not
leave the Aerosol head in the Handset
body after use, and Do Not use dirty
or damaged parts because this can
impair the function of the Handset.
D1. Wash your hands.
Fig. D2 Open the Handset body.
D2. Open the top of the Handset body.
Lift the clasp on top of the Handset
bodyslightlyandipituptoopen.
See Fig. D2.
Fig. D3 Insert the Aerosol head into the
Handset body. Do not touch the
center of the Aerosol head.
D3. Insert the Aerosol head into the Handset
body as shown, taking care Not to touch the
center of the Aerosol head. Hold the Aerosol
head like you would hold a small frying
pan so that the silver text side is facing up
and the brown ring is facing down. Notice
that the Aerosol head has a small tab on
the side. Align the small tab with the
matching notch in the Handset body.
See Fig. D3.
Notch
Text side
Tab Clasp
Clasp
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