natus MiniMuffs Mode D'emploi page 2

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Description:
MiniMuffs® Neonatal Noise Attenuators are single-use, soft foam
earmuffs that fit around a neonate's ears to reduce the level of
sound reaching the ear. The devices are sized and shaped to fit
around the neonate's ear. Each pair of MiniMuffs are attached to a
release liner and are removed from the liner one at a time for use
on the neonates.
Intended Use:
MiniMuffs Noise Attenuators are indicated for short-term (less
than 24 hours) hospital use with neonates in a supervised setting
to reduce the sound level reaching the neonate's ears.
MiniMuffs Noise Attenuators are for single use only and are
disposable.
Intended Users and Patient Target Group:
This product is for use with neonates in a hospital setting or
during clinical transport to reduce noise levels and result in
longer periods of sleep time.
Clinical Benefits:
MiniMuffs Noise Attenuators reduce noise levels, which results in
longer periods of sleep time, optimal oxygenation, and improved
physiological stability.
Contraindications and Side Effects:
There are no known contraindications or side effects related to
Natus MiniMuffs Noise Attenuators.
Operating Instructions:
Important! Follow your facility's infection control and skin care
management protocols for cleaning skin, using hydrogel adhesive
on premature skin, appropriate length of use, and proper
disposal.
1. Remove MiniMuffs earmuffs from the liner and place them on
the infant one at a time. Position in either orientation:
OR
2. Press earmuff edges gently but firmly in place to ensure a
good seal. Avoid placing earmuffs on hair. Do not press on
raised center of earmuffs.
Important! Noise reduction is dependent on a good seal.
Examine the earmuff seal when repositioning the infant.
3. To reduce adhesion of hydrogel on sensitive skin, dab hydrogel
on the surface with a clean cotton swab or gauze pad prior to
placing earmuff on infant.
2
4. Use care when removing earmuffs. Wet a cotton swab or
gauze pad and slowly work under the edge of the earmuff to
loosen the hydrogel. Support the underlying skin and lift the
earmuff gently at the edge.
Understanding Warning Statements:
WARNING
Refers to a hazardous situation that could result in death or serious
injury if not avoided.
Warnings:
WARNING
Be careful not to fold or bend ear. Do not force large ears into
earmuffs. Do not place over compromised skin.
Examine skin according to your facility's skin care management
protocol. Discontinue use if irritation, abrasion, or edema is present.
Compliance Standards:
• ISO 10993-1: 2018 Biological evaluation of medical devices —
Part 1: Evaluation and testing within a risk management
process
Disposal Instructions:
Dispose of MiniMuffs Neonatal Noise Attenuators after a single
use.
Disclaimer:
Natus Medical Incorporated is not responsible for injury,
infection or other damage resulting from the use of this product.
Any serious incident that has occurred in relation to the device
should be reported to Natus Medical Incorporated and the
competent authority of the Member State in which the user and/
or patient is established.
Refer to the Natus website for an electronic copy of this
document.