Intended Use; General Safety Instructions; Fitting Instructions - Ossur PHILADELPHIA 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 cervical spine. This may
include:
• C-Spine precaution for trauma patients
• 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
Proper sizing is critical to achieve comfort and proper immobilization.
Ensure that correct spinal protocol is followed.
Height: Measure the vertical distance from the top of the patient's
shoulder to the tip of the chin (Fig. 1-a). The measurement corresponds
to the height of the device. If the patient's measurement falls between
two consecutive sizes, apply the smaller size first.
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