Deroyal 72-4301 - PROTECTOR, PHOTOTHERAPY, PREMIE, HEAD BAND, 12 EA/CS

Deroyal 72-4301 - PROTECTOR, PHOTOTHERAPY, PREMIE, HEAD BAND, 12 EA/CS

The Deroyal 72-4301 - PROTECTOR, PHOTOTHERAPY, PREMIE, HEAD BAND is a specialized medical product designed to protect the eyes of premature infants undergoing phototherapy treatment. This protector helps ensure safety and comfort during phototherapy, which is commonly used to treat jaundice in newborns by exposing them to blue light. Below is a detailed overview of the product's design, its intended use, and its advantages:

Product Overview

The Deroyal 72-4301 is a phototherapy eye protector specifically designed for premature infants. It comes in the form of a soft headband with an eye shield component, ensuring that the infant's eyes are shielded from the bright phototherapy light while allowing the light to reach the baby's skin, which is essential for treating jaundice.

Design Features

• Soft, Adjustable Headband: The headband is designed to fit comfortably on premature infants, with adjustable straps to ensure a snug fit without being too tight. The material is soft and gentle on delicate infant skin, reducing the risk of irritation or discomfort.
• Light-Blocking Eye Shield: The eye shield is made from a material that effectively blocks harmful blue light from reaching the infant's eyes during phototherapy. This protects the infants sensitive eyes from potential damage caused by prolonged exposure to the light used in the treatment.
• Velcro Straps: The headband typically features Velcro straps to make it easy to adjust the size, ensuring that the protector stays securely in place without slipping.
• Disposable and Sterile: The product is typically designed for single-use and comes in sterile packaging to ensure that it is safe and hygienic for use in neonatal care.

Purpose and Use in Medical Settings

The Deroyal 72-4301 Protector is primarily used in neonatal units where premature infants are undergoing phototherapy to treat neonatal jaundice. Phototherapy is a non-invasive treatment that uses light to break down excess bilirubin in a babys blood. However, exposure to this light can be harmful to the babys eyes, so proper protection is essential.

Key Applications:

• Neonatal Intensive Care Units (NICU): Premature babies in NICU who require phototherapy for jaundice are the primary users of this product.
• Phototherapy Treatment: During phototherapy, this headband and eye protector ensure that the babys eyes are shielded from the blue light while allowing the treatment to effectively reach the skin.

Certifications, Safety Standards, and Regulatory Approvals

• FDA Approval: As a medical device used in neonatal care, the Deroyal 72-4301 would be classified under the FDA as a medical device, ensuring that it meets safety and effectiveness standards.
• ISO Standards: The product may comply with ISO standards related to sterility, material safety, and neonatal care.
• CE Marking: In the European market, this product would meet CE marking requirements, indicating that it complies with safety, health, and environmental protection standards for medical devices.

Comparison with Other Products

Compared to other phototherapy eye protectors available on the market, the Deroyal 72-4301 offers specific advantages:

• Designed for Premature Infants: While some eye protectors are made for full-term newborns, this protector is specifically designed for premature infants, ensuring a better fit and more effective protection.
• Soft and Non-Irritating Material: The soft material used in the headband is designed to minimize irritation on delicate skin, unlike some other protectors that may use harsher materials.
• Adjustable and Secure Fit: The adjustable Velcro straps allow for a secure, customized fit, reducing the chances of the protector slipping off, a common issue with less adjustable models.
• Sterility: The products sterile packaging ensures that it can be safely used in sensitive neonatal environments, unlike non-sterile alternatives.

Common User Profile

• Neonatal Nurses and Healthcare Providers: Nurses and healthcare providers working in NICUs are the primary users of this product. They apply the protector to premature infants before starting phototherapy to ensure the infants eyes are safeguarded.
• Neonatologists: Neonatologists, who specialize in the care of premature and newborn infants, may prescribe and oversee the use of this protector during phototherapy treatments.

Typical Scenarios for Use

• Phototherapy for Neonatal Jaundice: Premature infants undergoing treatment for jaundice are the most common users of this product. Jaundice is caused by an excess of bilirubin in the blood, and phototherapy is an effective treatment for reducing bilirubin levels.
• NICU and Neonatal Wards: The protector is used in NICUs and neonatal wards, where phototherapy is frequently administered to both premature and full-term newborns.

Best Practices for Using and Maintaining the Product

• Proper Fitting: Ensure that the headband is properly adjusted to fit the infants head snugly without being too tight, as overly tight fitting can cause discomfort or leave marks on the babys skin.
• Position the Eye Shield Correctly: Make sure that the eye shield covers the babys eyes completely to block all light. Adjust the headband if needed to prevent any gaps.
• Monitor During Use: Regularly check on the infant during phototherapy to ensure that the protector remains in place and does not shift, exposing the eyes to light.
• Single Use and Disposal: As the product is typically single-use, dispose of it after the phototherapy session according to hospital protocols. Do not reuse the protector to maintain hygiene and avoid potential contamination.
• Clean Environment: Always handle the protector with clean hands and in a sterile environment to prevent the risk of introducing any contaminants to the infant.

Conclusion

The Deroyal 72-4301 - PROTECTOR, PHOTOTHERAPY, PREMIE, HEAD BAND is a vital tool in neonatal care, specifically designed to protect the sensitive eyes of premature infants undergoing phototherapy. With its soft, adjustable design and effective light-blocking capabilities, this product ensures the safety and comfort of the infant during treatment. Its easy-to-use Velcro straps and sterile packaging make it a convenient and reliable option for healthcare professionals working in NICUs.