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.
Distributed by: FOREST PHARMACEUTICALS, INC.
Subsidiary of Forest Laboratories, Inc. St. Louis, Missouri 63045
SMALL MASK / MEDIUM MASK Small 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.
Flow-Vu ® Inspiratory Flow Indicator
1
Carefully examine the product for damage, missing parts or foreign objects. Remove any foreign objects prior to use. The product should be replaced IMMEDIATELY if there are any damaged or missing parts. If necessary, use the Metered Dose Inhaler (MDI) alone until a replacement is obtained. If the patient's symptoms worsen, please seek immediate medical attention.
2
Remove cap from the MDI.
3 56 7 4
Shake the MDI immediately before each use as per the instructions supplied with the MDI.
Insert the MDI into the backpiece of the chamber.
Apply mask to face and ensure an effective seal. The Flow-Vu® Inspiratory Flow Indicator (IFI) only
moves if a
good seal is created.
Press the MDI at the beginning of a slow inhalation as the Flow-Vu® Inspiratory Flow Indicator moves towards the patient. Use the Flow-Vu® Inspiratory Flow Indicator to count breaths. Maintain seal for 5-6 breaths after the MDI is pressed. Administer one (1) puff at a time.
Follow
instructions supplied with the MDI on how long to wait before repeating steps 3 – 6 as prescribed.
3
1 2
TIPS Give praise and rewards.
Use teddy bears or dolls to ‘pretend’ to use the chamber to make it look like a game.
If possible, give treatments when the child is happy and not crying.
Medium Mask Mouthpiece Large Mask
Monaghan Medical Corporation, 5 Latour Ave., Suite 1600, Plattsburgh, NY 12901
CLEANING INSTRUCTIONS
THIS PRODUCT CAN BE USED RIGHT OUT OF THE PACKAGE AND THEN CLEANED WEEKLY. Backpiece
Frontpiece
12 Remove the Backpiece.
To detach the Frontpiece, twist chamber as shown above.
3
Soak the parts for 15 minutes in a mild solution of liquid dish detergent and lukewarm clean water. Agitate gently.
Dishwasher safe under the following conditions: - Avoid heavy or other cycles that include heated dry over 158°F
OR Rinse parts in clean water.
- Parts must be placed on the top rack ONLY - Secure product face up as pictured - Use dishwasher detergent and rinse aid - Do not boil or sterilize SEE CAUTION #1 BELOW.
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).
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.
© 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. RMC 14617 164 Revision: 08/2012
Shake out excess water from the parts and allow to air dry in a vertical position. Ensure parts are dry before reassembly.
4
To reassemble, fit the Frontpiece on the end of the chamber and twist firmly until securely locked into position.
Alignment Feature 5
Center the Alignment Feature on the backpiece with the Flow-Vu® Inspiratory Flow Indicator, as shown. Press firmly to attach the backpiece.
Flow-Vu ® Inspiratory Flow Indicator
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