Thayer Medical Corporation LITEAIRE 1803 Instrucciones De Uso

REF 1803 LITEAIRE BASIC VALVED HOLDING CHAMBER
®
INSTRUCTIONS FOR USE (single-patient use only)
INDICATIONS FOR USE
The LiteAire ® is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications
delivered via a pressurized metered dose inhaler (MDI). The LiteAire
standard MDI mouthpieces. It is a non-sterile device for single-patient use. The LiteAire
adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under
the care or treatment of a physician or licensed healthcare professional.
CONTRAINDICATIONS
The LiteAire ® should not be prescribed for individuals who require the use of a mask.
HOW TO ASSEMBLE YOUR LITEAIRE
1. Open packaging and remove LiteAire device. (Fig. 1)
®
2. Place your fingers in the middle of the LiteAire ® along the long sides of the chamber. (Fig. 2)
3. Gently squeeze the device to make the LiteAire ®
HOW TO USE YOUR LITEAIRE ® WITH YOUR MDI
1. Remove the cap from the inhaler mouthpiece. (Fig. 4)
2. Shake the inhaler prior to use as directed by the manufacturer. (Fig. 4)
3. Look inside the mouthpiece and chamber of the LiteAire
lint, buttons, etc.). (Fig. 5)
4. Insert the inhaler canister mouthpiece firmly into the LiteAire
5. Firmly grasp your LiteAire ® with your thumb and fingers on either side at the point where you feel the cardboard inner wall.
Gently squeeze the side panels to ensure the most effective treatment. (Fig. 7)
6. Close your lips firmly around the small holes on the mouthpiece of the LiteAire
7. Exhale fully into the mouthpiece (Fig. 7). As you begin to inhale, press down on the canister to spray one puff of medication.
Continue inhaling slowly and deeply. Hold your breath for 5 to 10 seconds. (Fig. 8)
8. If your physician has directed you to take more than one puff, repeat step 6.
9. Remove the inhaler and flatten LiteAire between uses. (Fig. 9 and Fig. 10)
®
ADDITIONAL INFORMATION
The environment for use include the homes, hospitals and clinics.
No cleaning, disinfection or sterilization of the LiteAire
ensure these instructions and the instructions supplied with the MDI have been read. Always follow your physician's instructions.
SIDE EFFECTS
The device is not anticipated to cause any undesirable side effects; however, if the user experiences undesirable side effects from
the administered MDI medication, they should consult with a physician immediately. Please refer to the MDI medication Instructions
for Use for more information.
FOR BEST RESULTS
1. Hold side panels near the mouthpiece where you feel the paperboard inner wall.
2. For maximum results, start inhaling at the same time that you squeeze the MDI canister.
3. Inhale as slowly and deeply as possible through your mouth, to fill your lungs with the medication. Be sure to hold your breath
for 5 to 10 seconds.
4. Each LiteAire ® is good for multiple uses*. We recommend that you replace your LiteAire
soggy, contaminated or discolored.
* A single use of your LiteAire ® is defined by your prescribed dose, and can include more than one puff of medication per use.
5. Do not store your LiteAire in a sealed or airtight container as this will not allow the LiteAire
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storing your LiteAire ® in an unsealed bag or the plastic sleeve created once the device is removed from its packaging. (Fig. 10)
WARNING
Always look inside the mouthpiece and chamber before you use the LiteAire
inhaled (such as coins, lint, buttons, etc.)
CAUTION
Do not clean, disinfect or sterilize your LiteAire. ® The LiteAire
if cleaned, disinfected or sterilized. Potential risks include: product degradation and failure of the device to perform as intended.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician or other practitioner licensed to
prescribe by law.
REF
1803 LITEAIRE BASIC VALVED HOLDING CHAMBER
®
1 LiteAire BASIC
®
THAYER MEDICAL CORPORATION
4575 S. Palo Verde Rd., Ste 337
Tucson, AZ 85714 USA
www.ThayerMedical.com
Made in USA
® features a standard port designed for compatibility with
is intended to be used by adults,
®
®
pop up fully. The side panels will snap into place. (Fig. 2 and Fig. 3)
® to be sure there are no small objects that could be inhaled (such as coins,
inhaler port. (Fig. 6)
®
.
®
® is needed. This product can be used right out of the package. Prior to use,
® weekly or sooner if it becomes crushed,
to dry between uses. We recommend
®
® to be sure there are no small objects that could be
® is made from paper products and may be permanently damaged
LITEAIRE BASIC VALVED HOLDING CHAMBER PARTICLE SIZE AND DOSING CHARACTERISTICS
®
ENGLISH
EN
The LiteAire Valved Holding Chamber was evaluated for particle size and dosing characteristics using an 8 stage cascade impactor.
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The LiteAire ® was connected to the induction port of the cascade impactor with a mouthpiece adapter. Air was drawn through
the assembly at a flow rate of 28 L/min (simulating adult use in Table 1) and 14 L/min (simulating pediatric use in Table 2). Three
LiteAire were used 3 times each to evaluate each drug (N=9 evaluations/drug).
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Table 1 – LiteAire ® BASIC Valved Holding Chamber Particle Size and Dosing Characteristics (28 L/min)
Drug Tested
Labeled Metered Dose per Actuation (from mouthpiece)
Particle Size (MMAD) (µm ± SD)
95% Confidence Interval
Geometric Standard Deviation (GSD) (µm ± SD)
95% Confidence Interval
Total Delivered Dose (µg ± SD)
95% Confidence Interval
Total Respirable Dose (< 4.7 µm) ( µg ± SD)
95% Confidence Interval
Total Non-respirable Dose (> 4.7 µm) ( µg ± SD)
95% Confidence Interval
Fraction of Total Delivered Dose
(% of Total Delivered Dose ± SD)
**trademarks and registered trademarks of their respective companies
Table 2 – LiteAire BASIC Valved Holding Chamber Particle Size and Dosing Characteristics (14 L/min).
®
Drug Tested
Labeled Metered Dose per Actuation (from mouthpiece)
Particle Size (MMAD) (µm ± SD)
95% Confidence Interval
Geometric Standard Deviation (GSD) (µm ± SD)
95% Confidence Interval
Total Delivered Dose (µg ± SD)
95% Confidence Interval
Total Respirable Dose (< 4.7 µm) ( µg ± SD)
95% Confidence Interval
Total Non-respirable Dose (> 4.7 µm) ( µg ± SD)
95% Confidence Interval
Fraction of Total Delivered Dose
(% of Total Delivered Dose ± SD)
Catalog, reorder or reference number
Use by Date (YYYY-MM-DD)
Batch Code or lot number
O
Consult instructions for use
G-1662 rev B
Proventil ** HFA
108 µg
2.17 ± 0.05
2.14 – 2.21
1.43 ± 0.08
1.37 – 1.49
54.75 ± 4.96
50.94 – 58.56
54.66 ± 4.99
50.83 – 58.50
0.09 ± 0.26
0 – 0.29
Coarse Particles (>4.7 µm) 0.2 ± 0.5
Fine Particles (1 - 4.7 µm) 99.8 ± 0.5
Extra-Fine Particles (<1 µm) 9.0 ± 0.8
Proventil ** HFA
108 µg
2.02 ± 0.12
1.93 – 2.11
1.35 ± 0.02
1.34 – 1.36
54.27 ± 4.85
50.54 – 57.99
53.55 ± 4.81
49.85 – 57.24
0.72 ± 0.70
0.18 – 1.26
Coarse Particles (> 4.7 µm) 1.3 ± 1.2
Fine Particles (1 - 4.7 µm) 98.7 ± 1.2
Extra-Fine Particles (<1 µm) 20.2 ± 5.6
**trademarks and registered trademarks of their
MD
Medical Device
respective companies
Manufacturer Prescription only in the U.S where Federal law restricts this
device to the sale of a physician or a licensed practitioner
CAUTION
to prescribe.
Please visit Thayer Medical's website for a complete
Single Patient Multiple Use
symbols glossary. www.ThayerMedical.com
Flovent** HFA Atrovent** HFA
110 μg 17 μg
2.52 ± 0.03 0.57 ± 0.14
2.50 – 2.54 0.46 – 0.67
1.41 ± 0.03 3.90 ± 1.81
1.39 – 1.43 2.51 – 5.29
41.27 ± 6.33 7.46 ± 0.61
36.41 – 46.14 6.99 – 7.92
41.27 ± 6.33 7.46 ± 0.61
36.41 – 46.14 6.99 – 7.92
0 ± 0 0 ± 0
0 – 0 0 – 0
0 ± 0 0 ± 0
100 ± 0 100 ± 0
0 ± 0 78.7 ± 2.4
Flovent** HFA Atrovent** HFA
110 μg 17 μg
0 ± 0 0.67 ± 0.00
0 – 0 0 – 0
0 ± 0 1.92 ± 0.00
0 – 0 0 – 0
35.09 ± 5.33 8.05 ± 0.47
30.99 - 39.18 7.69 – 8.42
35.09 ± 5.33 8.05 ± 0.47
30.99 – 39.18 7.69 –8.42
0 ± 0 0 ± 0
0 – 0 0 – 0
0 ± 0 0 ± 0
100 ± 0 100 ± 0
0 ± 0 95.2 ± 1.9