Product Overview
The Deroyal 1044-12 Philadelphia Collar, Rigid with Tracheostomy, 4.25" is a high-quality cervical collar designed to provide immobilization and support for patients with neck injuries or recovering from cervical surgeries. Its rigid structure ensures firm cervical spine stabilization, while the tracheostomy opening allows access for patients with tracheal tubes or those requiring emergency airway procedures. The collar is 4.25" in height, offering excellent support for patients who require medium-height cervical immobilization.
This collar is constructed from hypoallergenic, latex-free materials and features a comfortable design, making it suitable for both short-term and long-term wear in clinical, emergency, or home care settings.
Device Characteristics
| Category | Information |
|---|
| MRI Safety Information in Labeling | Labeling does not contain MRI Safety Information |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) | No |
| Device labeled as "Not made with natural rubber latex" | Yes |
| For Single-Use | Yes |
| Prescription Use (Rx) | Yes |
| Over the Counter (OTC) | No |
| Kit | No |
| Combination Product | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) | No |
Key Benefits
- Rigid Cervical Immobilization: Provides firm support to immobilize the cervical spine, aiding in recovery from injuries, surgeries, or managing conditions that require neck stabilization.
- Tracheostomy Opening: The built-in tracheostomy opening allows for easy access to the trachea, making it ideal for patients with tracheostomy tubes or those needing emergency airway access.
- 4.25" Height: This medium-height collar is designed to fit patients needing moderate neck support, ensuring proper alignment and stabilization of the cervical spine.
- Comfortable and Hypoallergenic: Made from lightweight, hypoallergenic materials that are latex-free, providing comfort during extended wear without causing skin irritation.
- Easy to Apply and Adjust: The collar is designed for easy application, with adjustable straps for a secure fit, making it convenient for healthcare providers and caregivers.
Compatibility and Applications
The Deroyal 1044-12 Philadelphia Collar is ideal for use in a wide range of medical and emergency situations where cervical immobilization and tracheal access are required, including:
- Cervical Spine Injuries: Used to stabilize the neck following traumatic injuries, such as fractures, dislocations, or whiplash, preventing further damage during recovery.
- Post-Surgical Recovery: Provides support for patients recovering from cervical spine surgeries, helping maintain proper alignment and preventing complications.
- Emergency Airway Access: The tracheostomy opening allows for easy access to the airway, making the collar suitable for patients with tracheostomy tubes or those who may need emergency airway management.
- Chronic Neck Conditions: Ideal for patients with chronic neck conditions, such as arthritis or spondylosis, requiring ongoing support and stabilization.
Usage Guidelines
To use the Deroyal 1044-12 Philadelphia Collar:
- Position the collar around the patients neck, ensuring that the tracheostomy opening aligns with the tracheal area if applicable.
- Secure the adjustable straps to achieve a snug and comfortable fit, ensuring the collar provides adequate immobilization without restricting breathing or circulation.
- Follow healthcare provider recommendations for how long the collar should be worn, especially in post-surgical or trauma recovery situations.
- Regularly inspect the collar for signs of wear or damage and replace it if necessary to ensure continued support and patient safety.
For more detailed instructions, refer to the product manual or consult with your healthcare provider for proper application and adjustment.
Certifications, Safety Standards, and Regulatory Approvals
The Deroyal 1044-12 Philadelphia Collar meets necessary safety and quality standards, including:
- FDA Compliance: Approved by the FDA for use in medical environments, ensuring the collar meets stringent safety and performance standards.
- ISO Certification: Manufactured in compliance with ISO 13485 standards, ensuring consistent quality and reliability for medical orthopedic devices.
Comparison with Competitor Products
The Deroyal 1044-12 Philadelphia Collar offers superior cervical immobilization and tracheal access compared to standard cervical collars. Its rigid design ensures better support for patients recovering from serious neck injuries or surgeries, while the built-in tracheostomy opening makes it a more versatile option for patients requiring airway management. Additionally, its hypoallergenic and latex-free materials provide more comfort and safety compared to collars made from less skin-friendly materials.
Typical User Profile and Application Scenarios
- Post-Surgical Patients: Individuals recovering from cervical spine surgeries who need rigid immobilization to promote healing and prevent further injury.
- Trauma Patients: Suitable for patients who have experienced neck trauma or fractures and require immediate immobilization to prevent spinal cord damage.
- Chronic Condition Patients: Used by individuals with chronic neck conditions who require long-term support for pain management and stabilization.
- Patients with Tracheostomies: Ideal for patients with tracheostomy tubes, as the collar allows easy access to the tracheal area for airway management.
Best Practices for Use and Maintenance
- Ensure Proper Fit: Regularly check the fit of the collar to ensure it is providing adequate support without causing discomfort or restricting airflow.
- Clean Regularly: Follow the manufacturers instructions for cleaning the collar to maintain hygiene, especially for long-term wearers.
- Inspect for Wear: Regularly inspect the collar for signs of wear or damage, and replace it if necessary to ensure continued support and patient safety.
Regulatory and Safety Information
The Deroyal 1044-12 Philadelphia Collar complies with FDA regulations and ISO standards, ensuring that it meets all necessary safety and quality requirements for use in medical and emergency environments. These certifications provide healthcare professionals and patients with confidence in the products reliability and effectiveness for cervical immobilization.
How to Order
To order the Deroyal 1044-12 - Philadelphia Collar, Rigid, with Tracheostomy, 4.25", visit the CIA Medical website and add the product to your cart. For bulk orders or additional inquiries, contact CIA Medical customer service at (312) 275-5850 or use the contact form on the website for assistance.
