D-0128842-E – 2023/10
Luna - Instructions for Use - US Page 4
Components marked for ‘single use’ are not intended to be reprocessed.
Environmental factors
Storage outside temperature range as specified in Section 5 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can meet any of the
electronic components or wiring. Should the user suspect fluids have contacted
the system components or accessories, the unit should not be used until
deemed safe by an authorized service technician.
Do not place the instrument next to a heat source of any kind and allow
sufficient space around the instrument to ensure proper ventilation.
NOTICE
To prevent system faults, take appropriate precautions to avoid PC viruses and
similar.
Please note that connecting the device to a PC implies connecting the device to
an IT-network. The connection to an IT-network may result in previously un-
identified risks which must be identified, analysed, evaluated, and mitigated by
the responsible organisation.
Any change to the IT-network (network configuration, (dis)connection of items,
update, or upgrade of equipment) may introduce new risks that require
additional analysis.
If this apparatus is connected to one or more other devices with medical CE
marking, to make up a system or pack, the CE marking is only valid also for the
combination if the supplier has issued a declaration stating that the
requirements in the Medical Device Directive article 12 are fulfilled for the
combination.
There is no warm-up time for the instrument but allow it to become acclimatized
before use.
The specification for the instrument is valid if the instrument is operated within
the environmental limits specified in technical specifications.
Malfunction
In the event of a product malfunction, it is important to protect patients, users, and other
persons against harm. Therefore, if the product has caused, or potentially could cause such
harm, it must be quarantined immediately.
Both harmful and harmless malfunctions, related to the product itself or to its use, must
immediately be reported to the distributor where the product was acquired. Please remember to
include as many details as possible e.g., the type of harm, serial number of the product,
software version, connected accessories and any other relevant information.
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Interacoustics and the local national competent authority.
Disposal of the product
Interacoustics is committed to ensuring that our products are safely disposed of when they are no longer
usable. The cooperation of the user is important to ensure this. Interacoustics therefore expects that local
sorting and waste regulations for disposal of electric and electronic equipment are followed, and that the
device is not discarded together with unsorted waste.
In case the distributor of the product offers a take-back scheme, this should be used to ensure correct
disposal of the product.
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