2
Questions about Lamira? Contact the Arikares Support Program at 1-833-ARIKARE (1-833-274-5273)
Safety Precautions
B
Read all dangers and warnings before using.
To reduce the risk of fatal injury from electrocution:
•
Do not place or store the Lamira Nebulizer System near water or
other liquid such as bathtub or sink. Do not place or drop into water
or other liquid. Do not use while bathing.
•
Do not reach for the Lamira Nebulizer System if it has fallen into
water or other liquid. Unplug right away. Pick up the Lamira only
after it has been unplugged.
To reduce the risk of serious injury:
•
The Lamira Nebulizer Handset (Handset) is for single patient use.
Do not share your Handset with other people.
•
The Handset is made just for ARIKAYCE. Never use other
medicine in the Handset. Using other medicine in the Lamira
nebulizer can result in severe injury or death.
•
Read, understand and follow all warnings and instructions in these
Instructions for Use before using the Lamira nebulizer.
•
To reduce the risk of fire, burns and damage or malfunction of the
Controller:
Do not overload wall outlets or use extension cords.
Keep all electrical cords away from heated surfaces.
Do not spray liquids onto the housing of the Controller
(Controller). (See Section C: Getting Started) Liquid may cause
damage to the electrical parts and could lead to a malfunction. If
liquids enter the Controller, contact the Arikares Support
Program at 1-833-ARIKARE (1-833-274-5273).
Do not insert any object into any opening on the Lamira.
Do not operate where oxygen is being given in a closed
environment such as an oxygen tent.
•
Always unplug the Lamira right after using and before cleaning.
•
Before use, check your Lamira for proper assembly. All parts must
be connected and firmly in place. Use of an improperly assembled
Lamira could decrease or stop the effectiveness of your treatment.
•
Use only adapters and accessories that are made for the Lamira.
Use of unapproved adapters or accessories can lead to improper
administration, injury, leading to damage to the Controller.
•
Never substitute the Handset for any other eFlow® Technology
Handset such as Altera®, eRapid® or any other eFlow®. Never use
the Lamira Aerosol Head (Aerosol Head) in any other eFlow®
Technology Handset. This Aerosol Head has unique performance
characteristics for ARIKAYCE.
•
Never operate the Controller if it is improperly or incompletely
assembled or damaged. See Section K: Troubleshooting for more
information about alerts that appear when the Lamira is improperly
assembled or might be damaged.
•
Never operate the Lamira if:
It has damaged cords or plugs,
it is not working properly,
it has been dropped or damaged,
the Controller has been exposed to liquids
•
To reduce the risk of infection, illness, or injury from contamination,
clean and dry all parts of the Handset after each use. Follow the
instructions in Section E to maintain and clean the Lamira.
•
Cleaning the Handset properly will help prevent the Aerosol Head
from clogging. Replace the Aerosol Head with a new one after 7
uses. If the Aerosol Head becomes clogged, the aerosol mist will be
reduced, which may increase your inhalation time of therapy. If
clogging occurs, use the instructions in Section F to clean the Aerosol
Head.
•
Cleaning the Handset and Aerosol Head only removes the medicine
and saliva. To reduce the risk of serious or fatal illness caused by
contamination of the Handset, you must also disinfect the Handset
and Aerosol Head after every cleaning. See Section G for
disinfection instructions.
•
The Lamira contains small parts that may become a choking hazard
to small children. The Lamira Connection Cord (Connection Cord)
also may become a strangulation hazard.
•
Do Not allow pets, for example dogs or rodents, near the cables.
•
Keep the Lamira out of reach of children.
•
Keep the Handset level when in use. Excessive tilting can cause the
Controller to shut off leaving unused ARIKAYCE in the Medication
Reservoir and resulting in incomplete dosing.
•
Closely supervise use when the Lamira is used near children or the
physically or mentally impaired.
•
Do not use your Lamira while driving or in any situation which takes
away your full attention.
•
If the Lamira has been damaged or is not operating properly, contact
the Arikares Support Program at 1-833-ARIKARE (1-833-274-5273).
•
Do not take the Controller apart at any time. There are no user
serviceable parts inside the Controller. Contact the Arikares Support
Program at 1-833-ARIKARE (1-833-274-5273) for all Controller
service needs.
•
Do not modify this equipment without authorization from the
manufacturer.
•
Do not use the device in areas exposed to elevated electromagnetic
or electrical radiation such as a MRI scanner or high frequency
surgical equipment.
•
Do not place near other medical devices during operation unless
both devices are monitored constantly to make sure both are
operating properly.
•
Do not use within 12 inches (30 cm) of portable wireless
communication devices such as cell phones or antenna cables or
external antennas.
•
Do not use near airplane or train control systems. Do not use aboard
aircraft.
•
Do not use the nebulizer near anti-theft systems and Radio
Frequency Identification (RFID) readers, which are used in a wide
variety of settings, including stores, libraries, and hospitals. Do not
power on the nebulizer when passing through security screening
or theft protection (RFID) systems at entrances or exits of stores,
libraries or hospitals. Note that some entrance and exit security
systems are not visible.
Technical electromagnetic compatibility data is available in table form
upon request from PARI Pharma GmbH or on the Internet at
https://www.pari.com/fileadmin/Electromagnetic-compatibility-4.pdf
Danger
Warning
Reference ID: 4327567
Summary of Contents for Lamira
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