Pari Trio User manual

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WARNING
CAUTION––US Federal law restricts this
device to sale by or on order of a physician.
Read and understand these Instructions
for Use and all safety precautions it
contains. Improper use can cause serious
or fatal injury and/or illness.
INSTRUCTIONS FOR USE

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TABLE OF CONTENTS
AIntroduction ............................................................................. 1
BSafety Precautions And Important Safeguards ........................... 2
CGetting Started .......................................................................... 3
DUsing “AA” Batteries .............................................................. 4
EUsing Optional AC Power Supply ................................................ 4
FTrio Nebulizer Handset Assembly ..................................... 5-6
GTaking A Treatment ............................................................... 6-7
HTrio Nebulizer Handset Cleaning ....................................... 8-9
ITrio Nebulizer Handset Disinfection .................................... 10
JFunctionality Test ......................................................................... 10
KFrequently Asked Questions And Troubleshooting .................. 10-11
AINTRODUCTION
These Instructions For Use contain information and safety precautions
for the Trio®Electronic Nebulizer. Save these Instructions For Use for
future reference.
Before using your Trio Electronic Nebulizer, you should read and understand
the entire Instructions For Use. If for any reason you do not understand
any part of these Instructions For Use, please call the toll free number
below before proceeding with your treatment.
Take special note of all safety precautions marked DANGER and WARNING.
INDICATIONS FOR USE
The Trio Electronic Nebulizer is a handheld nebulizer that will be used with
patients for whom doctors have prescribed medication for nebulization.
The Trio Electronic Nebulizer is intended for adult and pediatric patients.

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BSAFETY PRECAUTIONS AND IMPORTANT SAFEGUARDS
READ ALL DANGERS AND WARNINGS BEFORE USING
DANGER
To reduce the risk of serious or fatal injury from electrocution:
1. DO NOT place or store the Trio Electronic Nebulizer where it can
be in water or fall into a bathtub, sink, or other liquid. Do not place
or drop into water or other liquid. Do not use while bathing.
2. DO NOT reach for the Trio Electronic Nebulizer if it has fallen into
water or other liquid. Unplug immediately. Retrieve Trio Electronic
Nebulizer ONLY after it has been unplugged.
WARNING
1. The Trio Nebulizer Handset is for single patient use. DO NOT SHARE
your handset with any other people.
2. Read, understand and follow all warnings and instructions in the
Instructions For Use prior to using this device.
3. To reduce the risk of serious or fatal injury from electrocution,
fire, burns and to reduce the risk 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,
call the number below for examination and repair.
d. DO NOT drop or insert any object into any opening on the Trio
Nebulizer System.
e. DO NOT operate where oxygen is being administered in a closed
environment such as an oxygen tent.
4. Always unplug this product immediately after using and
before cleaning.
5. Before use, check your Trio Nebulizer Handset for proper assembly.
All parts must be connected and firmly in place. Use of an
improperly assembled Trio Electronic Nebulizer could diminish or
eliminate the effectiveness of the treatment.
6. Use ONLY adapters and accessories that are authorized for the
Trio Electronic Nebulizer. Use of unapproved adapters and
accessories can lead to improper treatment, injury, or damage to
the Controller.
7. NEVER operate the Controller if it is improperly or incompletely
assembled or damaged. Section G: Taking a treatment, shows
the alerts to these situations when the Trio Electronic Nebulizer
is improperly assembled, or might be damaged.
8. NEVER operate this product if:
a. it has damaged cords or plugs,
b. it is not working properly,
c. it has been dropped or damaged, or
d. it has been exposed to any liquids inside the Controller.
9. To reduce the risk of an infection, illness, or injury from
contamination, clean and dry all parts of the Trio Nebulizer Handset
after each treatment. Follow the instructions in Section H to clean
the Trio Nebulizer Handset properly.
10. Cleaning the Trio Nebulizer Handset properly will help prevent the
Aerosol Head from clogging. If the Aerosol Head becomes clogged,
the aerosol mist will be reduced or stopped, which may make the
treatment ineffective. If clogging occurs, use the instructions in
Section H to clean the Aerosol Head.
11. Cleaning the Trio Nebulizer Handset only removes the medication.
To reduce the risk of serious or fatal illness caused by
contamination of the Trio Nebulizer Handset, YOU MUST ALSO
DISINFECT THE TRIO NEBULIZER HANDSET AT THE END OF EVERY
TREATMENT DAY. See Section I for disinfection instructions.
12. This product contains small parts that may present a choking
hazard to small children. The Nebulizer Connection Cord also
presents a strangulation hazard.
13. DO NOT LEAVE CHILDREN UNATTENDED DURING TREATMENT. ALWAYS
USE CLOSE ADULT SUPERVISION WHEN ADMINISTERING A
TREATMENT TO A CHILD.
14. Close supervision is necessary when this product is used by or
near children or the physically or mentally impaired.
15. DO NOT use your Trio Electronic Nebulizer while driving or in any
situation which takes away your full attention.
16. If the Trio Electronic Nebulizer has been damaged or is not operating
properly, call the number below for details. If you suspect that the
Trio Electronic Nebulizer has been damaged or is not working
correctly, run the Functionality Test described in Section J.
17. DO NOT disassemble the Controller at any time. There are no user
serviceable parts inside the Controller. Call the number below for
all service needs.

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CGETTING STARTED
Check your Trio Electronic Nebulizer package to ensure you have the
following items. If you do not have all the items, please call the number
listed below.
FOUR “AA” BATTERIES
MEDICATION RESERVOIR
AEROSOL CHAMBER
MOUTHPIECE WITH
EXHALATION VALVE
AC POWER SUPPLY
AEROSOL HEAD
INHALATION VALVE
CARRYING CASE
NEBULIZER CONNECTION CORD
CONTROLLER
MEDICATION CAP
(NOTE: THE CAP SEAL AND
CAP WILL COME AS ONE
ASSEMBLED PART)
CAP SEAL
AEROSOL HEAD DETAIL

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EUSING OPTIONAL AC POWER SUPPLY
1. The Controller can also be used with the optional AC Power Supply. The
AC Power Supply is useful as a back-up power supply when the batteries
are depleted. If not already attached, insert the Plug Converter into the
AC Power Supply as shown (Figure 3).
2. The AC Power Supply (Figure 3) can be used with 100-240V outlet
and will automatically adjust to the incoming voltage. It can be used
worldwide, but does require “Plug Converters” for use outside the USA.
Additional Plug Converters for the Trio Electronic Nebulizer are available
as optional accessories. Make sure to use the correct Plug Converter
for the AC outlet.
3. To connect the AC Power Supply to the Controller, place the Controller
on a flat, stable surface. Push the Plug Insert (the round end of the AC
Power Supply cord) into the Plug Inlet Port, located on the under side
of the Battery Door. (Figure 4). Do not attempt to insert the AC Power
Supply Cord into the front of the Controller.
4. Plug the AC Power Supply into the wall outlet.
DUSING “AA” BATTERIES
1. The Trio Electronic Nebulizer is designed to be used with “AA” batteries
or with the optional AC Power Supply. Four (4) new “AA” batteries will
provide approximately 2 hours of continuous treatment. You may also
use “AA” rechargeable batteries. Please see “Specifications” on the back
cover of these Instructions For Use.
NOTE: IT IS STRONGLY RECOMMENDED TO HAVE AN EXTRA BATTERY
SET WITH YOU AT ALL TIMES.
2. Open the Battery Door on the Controller by placing your thumb on the
tab of the Battery Door and firmly pushing the tab to open the
door (Figure 1).
NOTE: The Battery Door is designed to have a tight fit. Questions?
Please call the number below.
3. Load the batteries.
4. Each battery chamber has a small figure that shows the proper position
of each battery (Figure 2). Using the battery “tips” as guides and
starting left-to-right, insert the batteries: Tip Out, Tip In, Tip Out, Tip In.
5. To close the Battery Door, push it closed until you hear it “click” into
place. NOTE: Rechargeable and Disposable Batteries vary considerably
in terms of storage life and output. Operating life of 2 hours of use is
based on disposable batteries that meet the specifications listed in
“Specifications” on the back cover of these Instructions For Use.
NOTE: Prior to storing the device over an extended period of time
(e.g., over 30 days) we recommend you remove the four batteries from
the Controller. Doing so saves the batteries and reduces the risk of
battery leakage.
CONTROLLER
1
Figure
2
Figure
3
Figure
PLUG CONVERTER
4
Figure
BATTERY DOOR
PLUG INSERT
PLUG INLET PORT

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2. Ensure that the Trio Electronic Nebulizer Aerosol Head is marked as
follows: Trio®(Figure 7, blowout). Do not use other eFlow®Technology
Aerosol Heads in this device. Being careful to touch ONLY the plastic
outer ring of the Aerosol Head (Figure 7), press the two flexible plastic
tabs on the side of the Aerosol Head while firmly inserting it into the
Medication Reservoir (Figures 7a-7b). You should feel the plastic tabs
“grab” as you insert it. It is best to avoid touching the metal part of
the Aerosol Head with your fingers (Figure 8).
FTRIO NEBULIZER HANDSET ASSEMBLY
WARNING
The Trio Nebulizer Handset is not sterile. Clean and Disinfect the Trio
Nebulizer Handset before the first use. (see Section H for Cleaning and
Section I for Disinfecting). Inspect all parts to ensure they are clean and
are not visibly damaged. Do not use dirty or damaged parts.
1. The Medication Reservoir and the Aerosol Chamber are attached using
a “hinge”. First, gently pull up on the tab of the Medication Reservoir
(Figure 5a). This will release the Aerosol Chamber so that you may open
it (Figure 5b). Ensure that the Inspiratory Valve is placed correctly in the
Aerosol Chamber (Figure 6a). If not, re-insert as shown (Figure 6b).
AEROSOL HEAD NAME
a
b
TAB
INSPIRATORY VALVE
5
Figure
6a
Figure
6b
Figure
INSPIRATORY VALVE
7
Figure
7a
Figure
7b
Figure
8
Figure
TABS

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3. Close the Trio Nebulizer Handset by pushing the Aerosol Chamber
together with the Medication Reservoir until you hear a slight “snap”
(Figure 9). If you do not hear a slight snap, open the Trio Nebulizer
Handset and ensure that the Inspiratory Valve is seated properly.
4. Attach the Mouthpiece to the Trio Nebulizer Handset with the Exhalation
Valve facing up (Figure 10).
GTAKING A TREATMENT
1. There are 2 ways that you can take your treatments with Trio Electronic
Nebulizer:
a. Trio Nebulizer Handset Attached To Controller: Place the
Controller on a clean, flat, stable surface. Slide the Trio Nebulizer
Handset into the Controller cradle as far as it will go (Figure 11).
b. Trio Nebulizer Handset Attached To Nebulizer Connection
Cord: Snap the Nebulizer Connection Cord onto the rear underside
of the Trio Nebulizer Handset (Figures 12 and 13). Slide the
other end of the Nebulizer Connection Cord into the cradle to
make contact with the metal power plates (Figure 14).
6 |QUESTIONS ABOUT TRIO? 1-888-335-6946
9
Figure
10
Figure
11
Figure
14
Figure
12
Figure
13
Figure
EXHALATION VALVE

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TAB SLOT
TAB
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5. To begin your treatment, sit in a relaxed, upright position. Press and
hold the On/Off button for one second (Figure 17). You will hear one
“beep” and the status light will illuminate green. The Trio Electronic
Nebulizer is now ON.
6. After a few seconds, aerosol mist will begin to flow into the Aerosol
Chamber.
7. Place the Mouthpiece on top of your bottom lip and tongue, and close
your lips around it (Figure 18). Hold the Trio Electronic Nebulizer level.
If held at an angle over 45 degrees, the Trio Electronic Nebulizer will
sound two beeps (and two green lights) and shut off after approximately
30 seconds. If this occurs, hold the Trio Electronic Nebulizer level and
press the start button to complete the treatment.
8. Take slow, deep breaths in and out through the Mouthpiece. Each
breath should be a little deeper than normal, quiet breathing, but not
to your full capacity. Do Not breathe through your nose. Continue to
inhale and exhale comfortably until the treatment is finished.
9. When all of the medication has been delivered:
a. You will hear the “Treatment Complete Alarm” (2 beeps and
2 green lights).
b. The Trio Electronic Nebulizer will automatically shut off.
10. If for any reason you must stop the treatment before completion,
press and hold the On/Off Button for one second. A 1 beep alarm will
sound with 1 red light. To re-start the treatment, press and hold the
On/Off Button for one second and then resume the treatment.
11. After you have completed your treatment, disassemble the Trio Nebulizer
Handset for cleaning. See Section H for full cleaning instructions.
GTAKING A TREATMENT (CONT)
IMPORTANT: Your medication should be at room temperature before use to
ensure that the Trio Electronic Nebulizer operates properly.
2. Pour only the medication prescribed by your physician specifically
for the Trio Electronic Nebulizer into the Medication Reservoir (Figure
15). DO NOT USE MEDICATIONS PRESCRIBED FOR OTHER NEBULIZERS
IN THE TRIO ELECTRONIC NEBULIZER. NOTE: MAXIMUM VOLUME FILL
IS 4 ml. DO NOT OVERFILL THE MEDICATION RESERVOIR.
3. Close the Medication Reservoir by aligning the tabs on the inside of
the Medication Cap with the tab slots in the Medication Reservoir.
Turn the cap clockwise as far as it will go (Figure 16).
15
Figure
16
Figure 17
Figure
18
Figure
STATUS LIGHT

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d. Remove the Inspiratory Valve from the Aerosol Chamber (Figure 23).
e. Being careful to touch ONLY the plastic outer ring of the Aerosol
Head, press the two flexible plastic tabs on the side of the Aerosol
Head and remove the Aerosol Head (Figures 24-25).
NOTE: There is no need to disassemble the Medication Reservoir from
the Aerosol Chamber either for Cleaning or Disinfecting. Doing so may
damage the hinge that holds them together.
HTRIO NEBULIZER HANDSET CLEANING
WARNING
To reduce the risk of infection, contamination and/or improper use,
clean the Trio Nebulizer Handset immediately after every use. Do not
wash the Controller, Nebulizer Connection Cord, AC Power Supply or
Plug Converters. Use liquid soap designed for washing dishes. Do not
use “white” liquid dish soaps (e.g. Ivory or Dove) or antibacterial liquid
dish soaps as these may contain additives harmful to the Trio Nebulizer
Handset.
1. Disconnect the Trio Nebulizer Handset from the Nebulizer Connection
Cord (Figure 19).
2. Disassemble the Trio Nebulizer Handset parts:
a. Remove the Medication Cap from the Medication Reservoir
(Figure 20).
b. Remove the Mouthpiece from the Aerosol Chamber (Figure 21).
c. Gently pull up on the tab of the Medication Reservoir. This will
release the Aerosol Chamber so that you may open it (Figure 22).
a
b
a
b
ab
19
Figure
20
Figure
21
Figure
22
Figure
23
Figure
24
Figure
25
Figure
TAB
ab

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HTRIO NEBULIZER HANDSET CLEANING (CONT)
3. To wash the Trio Nebulizer Handset, start by thoroughly rinsing
each of the disassembled parts under warm running tap water for
approximately 10 seconds each.
Rinse the Aerosol Head for at least 10 full seconds on each side (Figure
26). Never use a brush or any other object to clean the AEROSOL HEAD
(Figure 27). THOROUGH RINSING OF BOTH SIDES OF THE AEROSOL
HEAD HELPS TO PREVENT CLOGGING AND ENSURE PROPER OPERATION.
4. Add a few drops of clear liquid dish soap to a clean bowl or basin and
add warm tap water (Figure 28).
5. Wash all parts of the Trio Nebulizer Handset and rinse thoroughly under
running, warm tap water (Figure 29).
If Disinfecting after Cleaning, skip to section I and follow the steps.
6. Air dry the Trio Nebulizer Handset parts on a clean, lint-free towel
(Figure 30).
7. After the Trio Nebulizer Handset parts are completely dry place them
in a bag for storage. Re-assemble the Trio Nebulizer Handset just prior
to the next treatment.
8. If the Controller needs cleaning, wipe down with a slightly damp, soft
cloth (Figure 31). DO NOT allow liquid to get inside the Controller.
26
Figure
27
Figure
28
Figure
30
Figure
31
Figure
CONTROLLER
29
Figure

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JFUNCTIONALITY TEST
A Functionality Test takes only a few minutes and is helpful if you
suspect the Trio Nebulizer Handset is not working properly. Follow the steps
below and use only 1 ml sodium chloride 0.9% (normal saline) for the
Functionality Test. (Please note that sodium chloride 0.9% is, by US Federal
law, restricted to sale by or on the order of a physician.)
1. Assemble the Trio Nebulizer Handset as described in Section F, but do not
attach the Mouthpiece.
2. Follow the procedure in Section G for taking a treatment. However, for
this Functionality Test only, use 1 ml of sodium chloride 0.9% instead
of your prescribed medication.
3. Using a stop watch or clock with a second hand, time the complete
Functionality Test from when the Trio Nebulizer Handset starts producing
aerosol until the Controller automatically turns off.
4. After the Controller has automatically shut off, remove the Medication
Cap and check the amount of liquid in the Medication Reservoir. Only
a few drops of saline should remain in the Medication Reservoir. If more
than a few drops remain, clean the Aerosol Head and repeat the test.
If, after proper cleaning, there are still more than a few drops remaining
in the Medication Reservoir, call the number below for details.
5. If the time to nebulize 1 ml of sodium chloride 0.9% is about 3 minutes,
the Trio Nebulizer Handset is functioning correctly. If it takes more than
4-5 minutes to nebulize 1 ml of liquid, call the number below for details.
Clean the Trio Nebulizer Handset after this Functionality Test, and prior
to using the your prescribed medication.
K FREQUENTLY ASKED QUESTIONS AND
TROUBLESHOOTING
QUESTION 1: How much medication should be left in the Medication
Reservoir at the end of a treatment?
Answer: Only a few drops of medication should remain after the
treatment in the Medication Reservoir. If more than a few drops remain,
clean the Aerosol Head (Section H). If, after proper cleaning, more than
a few drops remain in the Medication Reservoir, call 1-888-335-6946.
QUESTION 2: How long should each treatment take?
Answer: With normal operation and proper cleaning the Trio Nebulizer
Handset should deliver a 1 ml sodium chloride 0.9% treatment within
3 minutes. Perform a Functionality Test (Section J). If more than 4-5
minutes are required to complete your treatment with 1ml of sodium
chloride 0.9%, call 1-888-335-6946.
QUESTION 3: When I turn on my Trio Electronic Nebulizer , nothing happens.
There does not seem to be any power.
Answer: If you are using batteries, use the figures in each battery
compartment to verify that the batteries are inserted correctly. If the
batteries are positioned properly, check to see if the light is blinking
on the Controller signaling low battery power. If it is, replace the batteries
or use the AC Power Supply.
Answer: If you are using the AC Power Supply, check the adapter
connection to be sure it is firmly connected to the adapter port located
underneath the battery compartment. Be sure that the adapter is
plugged into a working wall outlet.
Continued on back page
ITRIO NEBULIZER HANDSET DISINFECTION
WARNING
To reduce the risk of serious or fatal illness caused by contamination of
the Trio Nebulizer Handset you must also DISINFECT THE HANDSET AT
THE END OF EVERY TREATMENT DAY. In addition, the Trio Nebulizer Handset
is strictly FOR SINGLE PATIENT USE ONLY.
1. Clean the Trio Nebulizer Handset as described in Section H.
2. At the end of every treatment day, disinfect the Trio Nebulizer Handset
with a commercially available medical device disinfectant such as
Control III® (Figure 32). Follow the disinfectant manufacturer's
instructions for use.
3. After the Trio Nebulizer Handset parts are completely dry, place them
in a bag for storage. Re-assemble the Trio Nebulizer Handset just prior
to the next treatment. This is to ensure that the silicone seals do not
become deformed over time.
32
Figure

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KFREQUENTLY ASKED QUESTIONS AND
TROUBLESHOOTING (CONT)
QUESTION 4: How long will a new set of batteries last?
Answer: A new set of batteries will provide approximately 2 hours of
continuous treatment.
Answer: Consider using rechargeable batteries.
QUESTION 5: What if no mist is coming out of the Trio Nebulizer Handset?
Answer: First, check that the Controller has power. Secondly, make
sure the Nebulizer Connection Cord is correctly attached. Thirdly,
check to be sure that the Trio Nebulizer Handset has been assembled
properly (Section F). Lastly, check to be sure medication is in the
Medication Reservoir. If the Trio Electronic Nebulizer still does not
function properly, call 1-888-335-6946.
QUESTION 6: What if liquid is leaking from the Trio Nebulizer Handset during
the treatment?
Answer: Check to see if the Inhalation Valve has been warped
or deformed.
Answer: Be sure the Inhalation Valve is properly attached to the Aerosol
Chamber to prevent leaks (Section F, 6a and 6b).
Answer: Ensure the Aerosol Head is inserted correctly (Section F, 7,
7a, 7b). Next, ensure the Medication Reservoir and the Aerosol
Chamber are closed correctly (Section F, 9).
QUESTION 7: What if my Controller shuts off before my treatment begins,
or does not restart?
Answer: Press the On/Off button for one full second. If it still shuts off
after several (3-4) attempts, call 1-888-335-6946.
QUESTION 8: What if my Controller does not shut off at the end of
my treatment?
Answer: Press the On/Off button again.
Answer: Disconnect the AC Power Supply from the Controller and
remove the batteries. Then, reinsert the batteries following the
procedure in Section D.
Please note that the Controller has a built-in, automatic shutoff after
10 minutes, and it will turn off at that time. If this situation continues
three or four times, call 1-888-335-6946.
LSPECIFICATIONS
Aerosol Head Replacement............................................ Every 90 days
Weight: Controller and Trio Nebulizer Handset ............................. 6 oz
Weight: Controller, Trio Nebulizer Handset, and Batteries ....... 9.5 oz
Dimensions of Trio Nebulizer Handset .................. 1.93" X 2.5" X 5.5"
Electrical Requirements ........................... 110 V - 240 V, 50 Hz/60 Hz
Power Wattage ......................................... 2.0 Watts under normal load
TRANSPORT / STORAGE
Ambient Temperature ........................................................ -4°to 140°F
Ambient Humidity .................................................................. 10% to 95%
RECHARGEABLE BATTERIES
Rechargeable Batteries ..................................... 1.2V-1.5V, min 1500mAh
Rechargeable Battery Operation .............................. About 2 hours of
continuous treatment
Rechargeable Battery Charge Time ................................ up to 15 hours
(depends on type of battery charger)
DISPOSABLE BATTERIES
Panasonic Power Max 3 or equivalent ............................................ 1.5V
Panasonic Power Digital or equivalent ............................................ 1.5V
MANUFACTURED IN GERMANY & DISTRIBUTED BY:
PARI Respiratory Equipment, Inc. SourceCF®
, a subsidiary of
2943 Oak Lake Blvd. Eurand Pharmaceuticals, Inc.
Midlothian, Virginia USA Huntsville, Alabama 35806 USA
1-800-FAST-NEB (327-8632) 1-888-335-6946
PATENT NO.S:
US 5,152,456; US 5,261,601; US 5,518,179; US 6,983,747;
US 6,962,151 Additional Patents Pending
Canadian Patent CA 2,389,936
DESIGN AWARDS:
©2010 PARI Pharma GmbH. All rights reserved. The PARI Pharma logo is a registered trademark, and
Trio is a registered trademark of PARI Pharma GmbH. SourceCF® is a registered trademark of SourceCF,
a subsidiary of Eurand Pharmaceuticals, Inc. Touchspray® Technology is made under license from
the Technology Partnership, plc. Control III is a registered trademark of Maril Products Inc.
078D1004 Rev E 03/10
™