OSSUR N-A Philadelphia Tracheotomy Collar Instructions

: June 4, 2024
: OSSUR

Table of Contents

SYMBOLS
INTENDED USE
GENERAL SAFETY INSTRUCTIONS
FITTING INSTRUCTIONS
USAGE
DISPOSAL
LIABILITY
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Instructions for Use

PHILADELPHIA®
TRACHEOTOMY COLLAR

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.

Circumference: Measure around the patient’s neck (Fig. 2-b). The measurement corresponds to the size circumference of the device.

Measurement A – Neck Height

Infant| 1.25″ (3.2 cm)| | |
---|---|---|---|---
Pediatric| 1.75″ (4.4 cm)| | |
Adult| 2.25″ (5.7 cm)| 3.25″ (8.3 cm)| 4.25″ (10.8 cm)| 5.25″ (13.3 cm)

Measurement B – Neck Circumference

S ize	Circumference
Infant	6″ – 8″ (15.2 – 20.3 cm)
Pediatric	8″ – 11″ (20.3 – 27.9 cm)
Adult Small	10″ – 13″ (25.4 – 33.0 cm)
Adult Medium	13″ – 16″ (33.0 – 40.6 cm)
Adult Large	16″ – 19″ (40.6 – 48.3 cm)
Adult Extra Large	19″+ (48.3 cm+)

Supine Application

Slide the back piece behind the patient´s neck and center it, noting arrow on panel pointing up (Fig. 3).
Note: Long hair should be placed outside of the back piece.
Apply the front piece with the chin secured in the recess and center it to secure neutral alignment. The front piece overlaps the back piece to ensure effective immobilization and comfort (Fig. 4). The front arrow should point upward.
Apply the Hook and Loop strap on both sides. Tighten straps alternately to an equal length on both sides (Fig. 5). Excess may be trimmed.
The Plastazote material can be trimmed or heat moulded as necessary depending on the patient’s anatomy. Ensure that all edges are rounded off smoothly.
Note: Device application must be secure to ensure proper fit, maintain alignment, and prevent the chin from slipping inside.

Device removal
Ensure that correct spinal protocol is followed.
Undo the straps, remove the front piece and slide the back piece out from behind the head.

Accessories and Replacement Parts
Please refer to the Össur catalog for a list of available replacement parts or accessories.

USAGE

Cleaning and care

Wipe with a damp cloth and mild soap.
Air dry.
Note: Do not machine-wash, tumble dry, iron, bleach, or wash with fabric softener.
Note: Avoid contact with salt water or chlorinated water. In case of contact, rinse with fresh water and air dry.