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Deroyal TM500D - WARMER, SCOPE, LAPAROSCOPIC, STERILE, 10 EA/CS
The Deroyal TM500D - Warmer, Scope, Laparoscopic, Sterile is a specialized medical device designed to maintain the temperature of laparoscopic scopes during surgical procedures. This sterile device ensures that the scope remains fog-free and functional throughout the procedure, allowing surgeons to maintain clear visibility in minimally invasive surgeries. It is commonly used in laparoscopic surgeries where maintaining clear vision is critical to the success of the procedure.
Product Overview
The Deroyal TM500D Scope Warmer is specifically designed for laparoscopic instruments, ensuring that the scope stays at an optimal temperature during surgery to prevent fogging, which can obstruct the surgeon's view. The warmer is sterile and single-use, providing a safe and efficient solution for improving the visibility of the surgical field in laparoscopic procedures.
Product Characteristics
Question | Answer |
---|---|
What MRI safety information does the labeling contain? | 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 |
Design Features
- Sterile Design: The scope warmer is supplied in sterile packaging, making it safe for direct use in the sterile field during surgical procedures.
- Single-Use: The device is designed for single-use, eliminating the need for sterilization after the procedure and reducing the risk of contamination.
- Optimal Temperature Control: The warmer maintains the laparoscopic scope at the ideal temperature to prevent fogging, ensuring that the scope provides clear and consistent visualization during the entire surgery.
- Compatible with Laparoscopic Scopes: The warmer is designed to be compatible with standard laparoscopic scopes, making it versatile for use in various minimally invasive surgeries.
Purpose and Use in Medical Settings
The Deroyal TM500D Scope Warmer is primarily used in laparoscopic surgeries to prevent the lens of the scope from fogging, which can occur when the instrument is introduced into the body. By maintaining a consistent temperature, the scope warmer ensures that the surgeon has a clear, unobstructed view of the surgical site, which is essential for precision in minimally invasive procedures.
Key Applications:
- Laparoscopic Surgeries: The warmer is used to maintain the clarity of the laparoscopic scope, preventing fogging and ensuring the surgeon has a clear view during procedures such as gallbladder removal, hernia repair, or appendectomy.
- Minimally Invasive Procedures: In procedures where small incisions are used, the scope warmer helps maintain the functionality of the scope, allowing for accurate navigation and tissue manipulation.
- Sterile Surgical Environments: The sterile design ensures the warmer can be used directly in the sterile surgical field without risking contamination.
Certifications, Safety Standards, and Regulatory Approvals
- FDA Compliance: The Deroyal TM500D Scope Warmer meets FDA safety and effectiveness standards for medical devices, ensuring it is suitable for use in laparoscopic surgeries.
- ISO Standards: The product complies with ISO standards for medical devices, ensuring high-quality manufacturing and safety in clinical use.
- CE Marking: If distributed in Europe, the scope warmer carries CE marking, indicating it complies with health, safety, and environmental protection standards.
Comparison with Other Products
The Deroyal TM500D Scope Warmer offers several key advantages over other warming solutions:
- Sterile, Single-Use Design: Unlike reusable warmers, the single-use design of the Deroyal TM500D ensures sterility and eliminates the need for cleaning or reprocessing between uses, reducing the risk of infection or contamination.
- Consistent Temperature Maintenance: The warmer ensures that the scope stays at an optimal temperature throughout the procedure, preventing fogging and improving visibility for the surgeon.
- Ease of Use: The device is easy to implement in surgical procedures, requiring minimal setup and providing immediate benefits in scope clarity.
Common User Profile
- Surgeons: Laparoscopic surgeons use the warmer to prevent fogging of the scope, ensuring they have a clear view of the surgical site during minimally invasive procedures.
- Operating Room Nurses and Technicians: These healthcare professionals assist in setting up the warmer and ensuring that the laparoscopic scope remains fog-free and functional during surgery.
Typical Scenarios for Use
- Gallbladder Surgery (Cholecystectomy): In procedures like laparoscopic gallbladder removal, the warmer ensures that the surgeon can maintain clear vision throughout the procedure, which is critical for precision.
- Hernia Repair: The warmer is used during laparoscopic hernia repairs to prevent the scope from fogging, allowing for better tissue manipulation and repair.
- Appendectomy: During laparoscopic appendectomies, the scope warmer ensures that the camera provides clear imaging, allowing the surgeon to work effectively in a minimally invasive manner.
Best Practices for Using and Maintaining the Product
- Ensure Proper Sterile Handling: Open the sterile packaging in the operating room under sterile conditions to maintain the integrity of the sterile field.
- Use with Compatible Scopes: Ensure that the scope warmer is compatible with the laparoscopic scope being used in the procedure.
- Dispose of After Use: Since the scope warmer is a single-use device, dispose of it in accordance with hospital protocols after the procedure is completed.
How to Order
- Online Ordering: Add the Deroyal TM500D - Warmer, Scope, Laparoscopic, Sterile to your cart and proceed to checkout on the CIA Medical website.
- Customer Service: For bulk orders or inquiries, contact CIA Medical customer service at (312) 275-5850 or use the contact form available on this page.
Conclusion
The Deroyal TM500D - Warmer, Scope, Laparoscopic, Sterile is a critical tool for laparoscopic surgeries, ensuring that the surgical scope remains fog-free and functional throughout the procedure. Its sterile, single-use design makes it ideal for use in sterile surgical environments, reducing the risk of contamination and improving patient safety. By maintaining optimal temperature control, the warmer enhances the surgeon's ability to perform minimally invasive surgeries with precision and clarity, making it a valuable addition to any laparoscopic surgery setup.