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simultaneously) Ensure the tabs are engaged by
firmly pressing the two halves together
iv. Reattach the mouthpiece
4 DISINFECTION
If considered clinically necessary for the patient,
healthcare professionals can instruct the patient
to clean and disinfect the device following specific
methods and frequencies (after each use)
Prior to disinfection follow the disassembly and
cleaning instructions but do not reassemble the
device
Disinfect the Aerobika* device using any one of the
following methods
A
Electronic Steam Sterilizer
i. Place the four parts in an electronic steam sterilizer
and follow the manufacturer's instructions for use
ii. Remove from the unit and allow the parts to air dry
thoroughly before reassembly
B
Boiling
i. Place the four parts in a pot with boiling water and
boil for 5 minutes
Note: Place a small rack on the bottom of the pot to
prevent plastic parts from coming in contact with the
hot bottom
ii. Remove from the water without touching the
water and allow parts to air dry thoroughly before
reassembly
C
Microwave Steam Bag
i. Place the four parts in a microwave steam bag
(ie Quick-Clean
MicroSteam
†
manufacturer's instructions for use
Note: Position parts in bag as shown in Figure
(page 2)
ii. Remove from bag and allow parts to air dry
thoroughly before reassembly
D
Isopropyl Alcohol
i. Soak the four parts in 70% isopropyl alcohol for
5 minutes
ii. Rinse thoroughly with sterile water
iii. Allow to air dry thoroughly before reassembly
E
Hydrogen Peroxide
i. Soak the four parts in 3% hydrogen peroxide for
30 minutes
ii. Rinse thoroughly with sterile water
iii. Allow to air dry thoroughly before reassembly
F
Bleach
i. Soak the four parts in a 1:50 bleach to water
solution (approximately 1 tablespoon bleach in 3¼
cups water) for 3 minutes
Note: You may substitute a respiratory equipment
disinfectant (such as Milton
Cidex
) for the bleach solution Follow the disinfectant
†
instructions for use
ii. Rinse thoroughly with sterile water
iii. Allow to air dry thoroughly before reassembly
bag) and follow the
†
, Dodie
, Control III
†
†
†
NOTE
Any serious incident that has occurred in relation to
the device should be reported to the manufacturer,
and the competent authority of the Member State,
the MHRA, the Saudi Food and Drug Authority, or
local regulatory authorities as appropriate
STORAGE
After the Aerobika* device is fully dry and assembled,
store in a clean plastic bag or container
DISPOSAL
The device can be disposed of with domestic waste
unless this is prohibited by the disposal regulations
prevailing in the respective member countries
ADDITIONAL INFORMATION
Use Temperature Range
Storage Temperature Range
• Product is free of Bisphenol A, Phthalates, Latex,
Lead and PVC
FR
UTILISATION PRÉVUE
Le dispositif de pression expiratoire positive par
oscillations Aerobika* est destiné à être utilisé
comme dispositif de pression expiratoire positive
(PEP) Le dispositif Aerobika* peut également être
utilisé en même temps qu'un médicament en aérosol
administré à l'aide d'un nébuliseur Le dispositif est
destiné à être utilisé par des patients capables de
générer un débit d'expiration de 10 L/min pendant
5
3 à 4 secondes
INDICATION(S)
Le dispositif de PEP par oscillations Aerobika*
est un dispositif thérapeutique de dégagement
des voies respiratoires utilisé pour mobiliser les
sécrétions pulmonaires excédentaires et améliorer
la respiration Il peut être utilisé pour la prise en
charge des affections respiratoires comme la MPOC,
la bronchectasie et la fibrose kystique
Utilisation chez un seul patient
CONTRE-INDICATIONS
L'utilisation du dispositif n'est pas recommandée
dans les cas suivants :
• L'utilisation du dispositif n'est pas recommandée
dans les cas suivants :
• Patients incapables de tolérer tout effort
respiratoire accru
• Pression intracrânienne (PIC) > 20 mm Hg
• Instabilité hémodynamique (instabilité de la
or
tension artérielle)
• Chirurgie ou traumatisme récent du visage, de la
bouche ou du crâne
• Sinusite aiguë
+15 °C to +40 °C
-40 °C to +60 °C
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