Deroyal 28-0701 - Laparoscopic Defog Kit with Tube and Insufflation: Essential for Clear Vision During Procedures, 10 EA/CS
Product Overview
The Deroyal 28-0701 Laparoscopic Defog Kit with Tube and Insufflation is designed to enhance visibility during laparoscopic surgeries by preventing fogging on the camera lens. Clear visualization is critical for the success of minimally invasive surgeries, and fogging can severely hinder the surgeons ability to see, increasing the risk of complications. This kit includes a defogging solution, insufflation tubing, and accessories that ensure a consistent flow of gas and defogging capabilities throughout the procedure.
This all-in-one kit is an essential tool for laparoscopic procedures, ensuring a smooth operation by preventing vision impairment caused by condensation or lens fogging.
Product Characteristics
| Category | Details |
|---|---|
| MRI Safety Information in Labeling | Labeling does not contain MRI Safety Information |
| Required Labeling for Natural Rubber Latex or Dry Natural Rubber (21 CFR 801.437) | No |
| Labeled as "Not made with natural rubber latex" | Yes |
| For Single-Use | Yes |
| Prescription Use (Rx) | No |
| Over the Counter (OTC) | No |
| Kit | Yes |
| Combination Product | No |
| Human Cell, Tissue, or Cellular or Tissue-Based Product (HCT/P) | No |
Key Benefits
- Prevents Fogging: The defogging solution and equipment work together to maintain a clear laparoscopic lens, preventing condensation that can obscure the surgeons view.
- All-In-One Kit: Includes all necessary componentsdefog solution, insufflation tubing, and accessoriesmaking it convenient for surgical teams to have everything needed in one package.
- Reliable Insufflation: The insufflation tubing provides a steady flow of gas, ensuring proper abdominal distension and a clear surgical field.
- Compatible with Standard Equipment: Designed to work seamlessly with most laparoscopic camera systems and insufflation setups, ensuring wide compatibility across medical facilities.
- Sterile and Ready to Use: The kit comes pre-packaged in a sterile environment, ready for immediate use in operating rooms, ensuring patient safety and reducing preparation time.
Compatibility and Applications
The Deroyal 28-0701 Laparoscopic Defog Kit is essential for use in a variety of laparoscopic procedures where clear visualization is critical, including:
- General Surgery: Used in laparoscopic appendectomies, cholecystectomies, and hernia repairs to ensure clear visualization.
- Gynecological Surgery: Ideal for gynecological laparoscopic procedures such as hysterectomies or endometriosis treatment.
- Urological Surgery: Ensures a fog-free environment for procedures like prostatectomies or kidney surgeries.
- Bariatric Surgery: Provides essential support in laparoscopic weight loss surgeries like gastric bypass or sleeve gastrectomies.
Usage Guidelines
To use the Deroyal 28-0701 Laparoscopic Defog Kit:
- Apply the defogging solution to the laparoscopic camera lens before inserting it into the abdominal cavity.
- Attach the insufflation tubing to the appropriate ports, ensuring proper connection to the gas supply.
- Monitor the flow of gas and maintain clear visualization by reapplying the defog solution as needed throughout the procedure.
- Ensure that all equipment remains sterile and follow healthcare provider protocols for laparoscopic procedures.
For more detailed instructions, refer to the product manual or consult with your surgical team for proper integration into the operating room setup.
Certifications, Safety Standards, and Regulatory Approvals
The Deroyal 28-0701 Laparoscopic Defog Kit meets all necessary safety and quality standards, including:
- FDA Compliance: Approved by the FDA for use in laparoscopic surgeries, ensuring that the kit meets stringent safety and performance standards.
- ISO Certification: Manufactured in compliance with ISO 13485 standards, ensuring consistent quality and reliability for medical devices.
Comparison with Competitor Products
The Deroyal 28-0701 Laparoscopic Defog Kit offers superior performance compared to standard defog solutions. Its all-in-one design simplifies the surgical setup, and the inclusion of insufflation tubing provides a comprehensive solution for maintaining visibility and proper abdominal distension. Unlike products that only offer defogging solution, this kit ensures the entire processfrom defogging to gas flowis covered, reducing the need for multiple products.
Typical User Profile and Application Scenarios
- Surgeons: Ideal for use by general surgeons, gynecologists, urologists, and bariatric surgeons who perform laparoscopic procedures requiring clear vision.
- Operating Room Staff: Essential for nurses and technicians responsible for preparing and maintaining laparoscopic equipment during surgery.
- Healthcare Facilities: Suitable for hospitals and surgical centers performing high volumes of minimally invasive surgeries, where clear visualization is essential to patient outcomes.
Best Practices for Use and Maintenance
- Ensure Proper Application: Apply the defogging solution to the camera lens before every procedure and reapply as needed during surgery to prevent fogging.
- Check Tubing Connections: Ensure all connections between the insufflation tubing and gas ports are secure to maintain consistent gas flow throughout the procedure.
- Maintain Sterility: Follow strict sterile techniques when handling and setting up the kit to prevent contamination during surgery.
- Dispose After Use: The kit is designed for single use and should be properly disposed of after each procedure to maintain safety and hygiene standards.
Regulatory and Safety Information
The Deroyal 28-0701 Laparoscopic Defog Kit complies with FDA regulations and ISO standards, ensuring that it meets all necessary safety and quality requirements for use in laparoscopic surgery. These certifications provide healthcare professionals with confidence in the products reliability and effectiveness in maintaining clear visualization during critical procedures.
How to Order
To order the Deroyal 28-0701 - Laparoscopic Defog Kit with Tube and Insufflation, 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.
