Intended Use; General Safety Instructions; Fitting Instructions - Ossur PAPOOSE Gebrauchsanweisung

ENGLISH
SYMBOLS
Medical Device
Magnetic Resonance (MR) safe

INTENDED USE

The device is intended to provide gross immobilization to the cervical
spine.
The device must be fitted and adjusted by a healthcare professional.
X-ray and CT lucent.
Indications for use
Conditions requiring gross immobilization of the infant cervical spine.
This may include:
• C-Spine precaution
• Immobilization for pre and post c-spine surgery
No known contraindications.
Warnings and Cautions:
These instructions do not supersede the specific orders of your
healthcare professional.
The use of a cervical collar may increase intracranial pressure (ICP)
through jugular venous compression.
If an unstable fracture is suspected or unknown, with or without
a sustained trauma, ensure additional spinal precautions are
implemented to immobilize the spine.
Regular cleaning of the device and the skin beneath along with inspection
of the skin for any signs of irritation is required to reduce the risk of skin
ulceration. Bedridden patients are at an increased risk for skin ulceration.

GENERAL SAFETY INSTRUCTIONS

The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
The patient should immediately contact a healthcare professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, or unusual reaction occurs with the use of
the device.
The device is for single patient – multiple use.

FITTING INSTRUCTIONS

Size Selection
The device's size is based upon Broselow-Luten color-code for the age 0-3
months.
At least two people are needed for initial device placement: to maintain
the patient's head, neck, and airway in proper alignment; and one to apply
and fit the brace.
Ensure that correct spinal protocol is followed.
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