MOUTHPIECE / LARGE MASK
INSTRUCTIONS FOR USE
THIS PRODUCT CAN BE USED RIGHT OUT OF PACKAGE. BEFORE USE, ENSURE THESE INSTRUCTIONS AND THE INSTRUCTIONS SUPPLIED WITH THE METERED DOSE INHALER (MDI) HAVE BEEN READ.
1
2
Carefully examine the product for
damage, missing parts or foreign ob-
jects. Remove any foreign objects
prior to use. The product should be
Remove cap(s)
replaced IMMEDIATELY if there are
from the MDI
any damaged or missing parts. If
and chamber
necessary, use the Metered Dose In-
(if applicable).
haler (MDI) alone until a
replacement is obtained. If the
patient's symptoms worsen, please
seek immediate medical attention.
CLEANING INSTRUCTIONS FOR MASK AND MOUTHPIECE CHAMBERS
THIS PRODUCT CAN BE USED RIGHT OUT OF THE PACKAGE AND THEN CLEANED WEEKLY.
Backpiece
Frontpiece
1
2
Remove the Backpiece.
Soak the parts for 15 minutes
in a mild solution of liquid dish
detergent and lukewarm clean
To detach the Frontpiece, twist chamber as
water. Agitate gently.
shown above.
Rinse parts in clean water.
Remove the mouthpiece cap.
Notes:
• Storage and operating range 5° C - 40° C (41° F - 104° F) at 15 to 95% relative humidity.
• Product may need to be replaced after 12 months of use. Environmental conditions, storage and proper cleaning can affect product life span.
• Do not share this medical device.
• If you notice medication build-up in your chamber, wash the inside of the chamber gently with a soft cloth.
• Dishwashing with overly dirty dishes is not recommended.
• Dishwasher validated up to 158°F (70°C).
© 2011-2012 Monaghan Medical Corporation ™ and ® are trademarks and registered trademarks used under license by Forest Pharmaceuticals, Inc. This device was Made in the USA from US and Canadian parts.
Flow-Vu ® Inspiratory
Flow Indicator
3
4
5
Put mouthpiece into mouth and close
lips around it to ensure an effective seal.
The Flow-Vu ® Inspiratory Flow Indica-
Shake the MDI
immediately
tor (IFI) only moves if the
Insert the
before each
patient has a good seal.
MDI into the
use as per the
Backpiece of
instructions
the chamber.
Apply mask to face and
supplied with
ensure an effective seal.
the MDI.
The Flow-Vu ® Inspiratory Flow Indica-
tor only moves if a good seal is created.
Flow-Vu ® Inspiratory
Flow Indicator
Dishwasher safe under the following conditions:
- Avoid heavy or other cycles that include
heated dry over 158°F
- Parts must be placed on the top rack ONLY
- Secure product face up as pictured
OR
- Use dishwasher detergent and rinse aid
- Do not boil or sterilize
SEE CAUTION #1 BELOW.
INDICATIONS FOR USE
This product is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional.
The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose
Inhalers. The intended environments for use include the home, hospitals and clinics.
Medium Mask
Mouthpiece
Small Mask
Large Mask
6
Breathe out gently and press the MDI at the beginning of a slow inhalation. Use the Flow-Vu ®
IFI to assist in the coordination of this step. Breathe in slowly and deeply through the mouth
until a full breath has been taken. Hold breath for 5 – 10 seconds, if possible. Otherwise, keep
lips tight on the mouthpiece breathing normally 2 – 3 times through the chamber after the MDI
is pressed. Slow down inhalation if you hear the FlowSignal ® Whistle sound. It means you
are inhaling too quickly. Administer one (1) puff at a time.
Breathe out gently and press the MDI at the beginning of a slow inhalation as the Flow-Vu ®
IFI moves towards you. Use the Flow-Vu ® IFI to count breaths. Maintain seal for 5 – 6
breaths after the MDI is pressed. Slow down inhalation if you hear the FlowSignal ®
Whistle sound. It means you are inhaling too quickly. Administer one (1) puff at a time.
3
4
Shake out excess
To reassemble, fit the Frontpiece on the
water from the parts
end of the chamber and twist firmly until
and allow to air dry in a
securely locked into position.
vertical position. Ensure
For mouthpiece models, the protective
parts are dry before re-
cap should always be placed on the
assembly.
mouthpiece when the chamber is not in
use.
CAUTIONS:
1. PRODUCT MAY BE PERMANENTLY DAMAGED IF BOILED, STERILIZED OR CLEANED
IN A DISHWASHER AT TEMPERATURE ABOVE 158°F (70°C).
2. Do not leave the chamber unattended with children.
3. Federal (USA) law restricts the sale of this device on or by the order of a physician.
Distributed by:
FOREST PHARMACEUTICALS, INC.
Subsidiary of Forest Laboratories, Inc.
St. Louis, Missouri 63045
Monaghan Medical Corporation, 5 Latour
Ave., Suite 1600, Plattsburgh, NY 12901
7
Follow
instructions
supplied with
the MDI on
how long to
wait before
repeating
steps 3 – 6 as
prescribed.
Alignment Feature
Flow-Vu ® Inspiratory
Flow Indicator
5
Center the Alignment Feature on the
Backpiece with the Flow-Vu ® Inspiratory
Flow Indicator, as shown. Press firmly to
attach the backpiece.
RMC 14616
16
4
Revision: 08/2012