Intended Purpose; Intended Use; Intended Patient Groups; Indication - Pari Lamira Notice D'utilisation

Intended purpose

®
The Lamira Nebuliser System is
intended to administer ARIKAYCE
liposomal 590 mg nebuliser dispersion as
an aerosol for inhalation.

Intended use

The nebuliser system must only be used
in accordance with its intended purpose.
For hygienic reasons and to avoid cross-
infections, the Lamira
must only be used by one patient.
Only original PARI accessories must be
used to operate the system.
The device is maintenance-free.
CAUTION:
Using accessories and spare parts other
than those supplied by the manufacturer
may cause increased electromagnetic
emissions or reduced electromagnetic
immunity, leading to a malfunction.
PARI Pharma GmbH is not responsible
for damage to the system if it is used
improperly or contrary to the intended use.
The device must only be serviced by
PARI Pharma GmbH or a service location
expressly authorised by
PARI Pharma GmbH.

Intended patient groups

The nebuliser system is only suitable for
use by patients who can breathe
unassisted and are conscious.
The nebuliser system is intended for use
by patients for whom ARIKAYCE
been prescribed.
®
Lamira - 2020-08
®
®
nebuliser system
®
has

Indication

®
The Lamira Nebuliser System is indi-
cated to deliver ARIKAYCE
the treatment of non-tuberculous myco-
bacterial (NTM) lung infections in adults.
For the indication of ARIKAYCE
mal refer to the package leaflet of the
medicine.

Contraindications

No contraindications are known for the
®
Lamira Nebuliser System. For contrain-
dications of ARIKAYCE
the package leaflet of the medication.
Life cycle of the medical
device
- The expected life cycle of the eBase
Controller is 3 years.
- Each pack of ARIKAYCE
®
a Lamira nebuliser handset and
®
4 Lamira aerosol heads. The nebuliser
handset is designed for a treatment
cycle of 28 days. Replace the aerosol
head every week, every time you start
a new pack of seven vials.
en
®
liposomal for
®
liposo-
®
, please refer to
®
®
also contains
35