OSSUR N-A Philadelphia Tracheotomy Collar Instructions
- June 4, 2024
- OSSUR
Table of Contents
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.
DISPOSAL
The device and packaging must be disposed of in accordance with respective local or national environmental regulations.
LIABILITY
Össur does not assume liability for the following:
- Device not maintained as instructed by the instructions for use.
- Device assembled with components from other manufacturers.
- Device used outside of recommended use condition, application, or environment.
Össur Americas
27051 Towne Centre Drive
Foothill Ranch, CA 92610, USA
Tel: +1 (949) 382 3883
Tel: +1 800 233 6263
[email protected]
Össur hf. Grjótháls 1-5
110 Reykjavík Iceland
WWW.OSSUR.COM
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IFU0400 1378_001 Rev. 11