The utility model relates to a female reproductive tract health self-examination medical device designed for family use·
The gynecological examination lens is an innovative medical device specifically designed for self-examination of female reproductive health. This user-friendly device is intended for family use, empowering women to take charge of their reproductive health in the comfort of their own homes. By combining traditional gynecological examination techniques with cutting-edge digital imaging technology, this device offers a unique solution for monitoring reproductive health.
The gynecological examination lens represents a significant advancement in women's health technology. By combining traditional examination methods with modern digital imaging, it offers a practical and empowering solution for self-examination of reproductive health. This innovative device not only enhances accessibility and privacy but also promotes proactive health management, ultimately contributing to better health outcomes for women.
·The utility model relates to a female reproductive tract health self-examination medical device designed for family use
·It integrates the traditional gynecological medical examination technology and the modern digital imaging technology
·To realize self-examination of reproductive tract health of users.
Gynecological Examination Lens: A Core Tool for Modern Gynecological Diagnosis
1. Product Overview
The gynecological examination lens is a precision optical device designed for visualizing the female reproductive system. Leveraging high-resolution imaging technology, it enables clinicians to observe lesions in the vagina, cervix, and surrounding tissues in real time. This tool enhances diagnostic accuracy and efficiency, particularly in early detection of conditions such as cervical cancer, cervicitis, polyps, and cysts.
2. Operational Principle
The lens operates on optical imaging principles, integrating cold light illumination with multi-magnification technology. Internal tissue details are projected onto an external display via digital signal processing. Key features include:
• Real-time dynamic imaging and photo documentation.
• Reduced blind spots through optimized light reflection capture.
3. Clinical Applications
Primary use cases include:
• Screening: Early detection of cervical intraepithelial neoplasia (CIN).
• Assessment: Evaluation of vaginal mucosal damage, inflammation, or infections.
• Surgical Planning: Pre-procedure exploration for procedures like IUD insertion or biopsy.
• Specialized Diagnostics: Support for endometriosis evaluation and postoperative follow-ups.
4. Key Features & Advantages
• Ultra-High Resolution: 4K clarity with 10–40x magnification for detailed visualization.
• Advanced Functionality:
• Auto-focus and anti-glare coatings.
• Flexible probes for navigating complex anatomies.
• Safety & Hygiene:
• Antimicrobial coatings and disposable sheaths for sterile use.
• Intelligence Integration: AI-powered anomaly detection and preliminary reporting in premium models.
5. Design Requirements
• Ergonomics: Lightweight handles and adjustable angles to minimize operator fatigue.
• Biocompatibility: ISO 10993-compliant materials for safe tissue contact.
• Durability: Scratch-resistant coatings and heat/pressure sterilization tolerance.
• Compatibility: Modular interfaces for integration with third-party imaging systems.
6. Material Selection
• Optics: High-transmittance quartz glass or sapphire lenses for clarity and impact resistance.
• Structural Components: Medical-grade ABS resin or aluminum alloys balancing strength and weight.
• Sealing: Silicone gaskets and antimicrobial polymer coatings for airtight, hygienic operation.
• Electronics: Heat-resistant PCBs and energy-efficient LEDs for prolonged lifespan.
7. CDMO Partner Selection Criteria
When selecting a Contract Development and Manufacturing Organization (CDMO):
• Regulatory Compliance: Certifications like ISO 13485, FDA 510(k), or CE MDR.
• Technical Agility: Rapid iteration capabilities for optical/mechanical refinements based on clinical feedback.
• End-to-End Capabilities: Full-cycle solutions from prototyping to mass production.
• Risk Management: Robust traceability and recall systems for adverse event handling.
8. OEM Manufacturing Services
Key offerings include:
• Customization: Tailored specifications (e.g., dimensions, focal lengths, branding).
• Supply Chain Management: Stable sourcing of compliant materials.
• Regulatory Assistance: Support for medical device registration documentation.
• Logistics: Global cold-chain transportation and inventory systems.
9. ODM Innovation Pathways
Opportunities for Original Design Manufacturing (ODM) enhancement:
• Smart Integration: Wireless data transmission or AI-driven diagnostic algorithms.
• Modular Design: Compatibility with ancillary devices (e.g., colposcopes).
• User-Centric Features: Touchscreen interfaces and VR-based training modules.
• Sustainability: Biodegradable materials to reduce medical waste.
10. Comprehensive Solution Value
A full-service partner delivers:
• Custom Product Development: Specialized lenses (e.g., narrow-band imaging for cervical cancer screening).
• Training Programs: End-to-end education on operation, image interpretation, and maintenance.
• Aftercare: 48-hour troubleshooting and lifetime technical support.
• Market Access: Regulatory guidance and tender document preparation for global markets.
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