OSSUR Miami J Cervical Neck Collar Instruction Manual

OSSUR -Miami J -Cervical- Neck -Collar

Instructions for Use

DESCRIPTION OF SYMBOLS

• Medical Device
• Magnetic Resonance (MR) safe

Product Overview

• Front
• Chin Support
• Tracheal Opening
• Sternal Pad
• Hook and Loop Strap
• Angulation Buttons
• Occipital Support
• Back

INTENDED USE
The device is intended to provide gross immobilization to the cervical spine.

• X-ray and CT lucent The device must be fitted and adjusted by a healthcare professional.

INDICATIONS FOR USE

• C-Spine precaution for trauma patients
• Immobilization for pre- and post-c-spine surgery
•  Other conditions requiring gross immobilization of the mid-cervical spine

CONTRAINDICATIONS

None Known.

WARNING AND CAUTIONS

Warning: If an unstable fracture is suspected or unknown, with or without a sustained trauma, ensure additional spinal precautions are implemented to immobilize the spine.
Warning: Use of a cervical collar may increase intracranial pressure (ICP) through jugular venous compression.
Caution: Regular cleaning of the collar, pads, 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.
Caution: Federal law restricts this device to sale by, or on the order of, a physician.
Precaution: Unless otherwise specified by the physician, the patient should not remove the collar except to wash under it and change the pads. These instructions do not supersede hospital protocol and/or direct orders of patient´s physician.

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.

Warning: 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.

Warning: The device should be used directly on intact skin and never an open wound. Inspect the contact area before and after each use. The device is for single patient – multiple use.

PRODUCT SELECTION

Miami J Collar Sizes

Miami J collar sizes are phenotype-driven. To determine the appropriate collar size, identify your patient´s phenotype according to the Sizing Silhouettes (Fig. 2) & Simple Sizing Questions below.
Specialty sizes < 40% of Population

• 200S – Super Short/Kyphotic: Does your patient have a kyphotic(chin-on-chest) neck? Kyphotic / Chin-on-chest / Geriatric / Osteoporitic and/or ankylosing spondylitic.

• 200L – Stout: Does your patient have a very large neck circumference?Very large circumference / Obese / “No-neck” / Massive shoulders.

• 250 – Xs: Does your patient have a very short, thin neck? Very short thin neck / Principally female / More prevalent in the Asian population / Rare.

• 500 – Tall: Does your patient have a long tall neck? Long, tall neck / “Swan neck” / Young women / Adolescents.
  Standard sizes > 60% of Population

• 400 – Regular: Is your patient female? Female / Standard size for mature women / Thin, mature men.

• 300 – Short: All other adults. Standard size for adult men / Short-necked women.

Quick Size Check (Optional)
Use your fingers to measure the vertical chin-to trapezius distance. On the collar, this measurement corresponds to the distance from the bottom of the chin support to the bottom edge of the collar plastic.

NOTE : Proper sizing is critical to achieving comfort and proper immobilization.

FITTING INSTRUCTIONS

Supine Application
Ensure that correct spinal protocol is followed throughout the application.

1. Slide the Back behind the patient´s neck and center it, noting arrow on panel pointing up (Fig. 4). Ensure the Sorbatex™ padding extends beyond the edge of the plastic.
   NOTE: Long hair should be placed outside of the plastic.

2. Flare the sides of the Front out, slide it up the chest wall and scoop it up under the chin Sides of the collar Front should be oriented up, off the trapezius, and toward the ears.

3. While holding the Front securely, curl the ends snugly against the patient´s neck . With the Front of the collar inside the Back, apply the Hook and Loop Strap and secure the opposite side of the collar in the same fashion. Tighten straps alternately to an equal length on both sides.

4. Hook and Loop Straps must be aligned to the Front adhesive sections. Excess may be trimmed .
   NOTE: Collar application must be secure to ensure proper fit, maintain alignment, and to prevent the chin from slipping inside. If the patient can slip his/her chin inside the collar, it is clear indication that it is not snug enough.
   Final Adjustments
   Angulation Buttons: may be used to fine-tune the fit of the collar for better anatomical conformity, pressure distribution and comfort. It is easier to adjust the Angulation Buttons if you first remove the collar .
   Chin Support Positioning Guidelines

• Slide up to relieve chin tip pressure or discomfort.
• Slide down to relieve jaw mandibular pressure or discomfort

Occiput Support Positioning Guidelines

• Slide up to relieve occipital pressure or discomfort.
• Slide down to enhance extension control.
  NOTE: For a predominately supine patient keep Occipital Support Buttons set to top position. This will direct the top edge of the collar shell into the bed. Sternal Pad: The sternal pad may be removed if the anatomy dictates, for comfort during sleep and/or during meals to make chewing and swallowing easier

Other Modifications
Upon physician recommendation, collar corners and edges may be modified or trimmed to relieve discomfort or pressure.
Final Fitting Checklist
A Properly applied Miami J will look like

• Collar extends from mandible to just below sternal notch.
• Chin is centered comfortably in Chin Support. Chin should not extend over edge of Sorbatex™ pad, nor fall inside collar.
• Hook and Loop Straps are equal length and aligned to Front adhesive sections
• Sides of Back should overlap sides of Front.
• Front of collar angled up toward ears. Lower plastic edge should not be resting on patient´s clavicles nor digging into trapezius.
• No plastic touching skin. Sorbatex™ pads extend beyond all plastic edges.
• No slack or gaps in any of the straps.
• Tracheal opening and posterior vent are midline.
• Collar sits away from the neck. There should be a “finger” gap between the tracheal opening and the neck. If the collar is fit too closely/tightly to the neck, size up to the next taller size.

ACCESSORIES AND REPLACEMENT PARTS

Please refer to the Ossur Catalog for a list of available replacement parts or accessories.

CLEANING AND CARE

• Remove the pads from the plastic shells.
• Hand-wash the pads with mild soap and water. DO NOT use harsh detergents or bleach.
• Rinse. Wring out the excess water and squeeze in towel. Lay flat to air dry.
• Wipe the plastic collar shells clean with mild soap and water.
• Replace pads by attaching the grey/dull side to the hook on the inside of the collar.

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.

References

• Össur. Life Without Limitations.

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