Product info
- Product name：35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave
- Product code：CCS-35HG
Packaging Specifications
- Outer Packaging Size：0.73 × 0.5 × 1.17 m
- Gross Weight：96 kg
- Net Weight：0 kg
- Volume：0.43
Description
35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave - Professional Medical Device
Product Description
35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave is a professional-grade ct/imaging scanner designed for healthcare applications. This device represents advanced biomedical engineering combined with clinical expertise, manufactured to meet international medical device standards and regulatory requirements.
The 35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave is engineered to provide reliable performance in demanding clinical environments. It combines cutting-edge technology with user-friendly design, ensuring optimal functionality for trained medical professionals. The device is suitable for use in hospitals, clinics, diagnostic centers, imaging facilities, and medical research institutions worldwide.
This product has been developed through extensive research, development, and clinical testing to ensure patient safety, treatment efficacy, and operational reliability. Every unit undergoes rigorous quality control testing and meets or exceeds all international regulatory requirements and quality standards.
Key Product Features & Specifications
- Multi-slice imaging technology for comprehensive volumetric data
- High-speed scanning with rapid image acquisition
- Advanced reconstruction algorithms for superior image quality
- Low dose technology with dose optimization features
- Real-time imaging with instant visualization capabilities
- 3D reconstruction capability for complex anatomical assessment
Detailed Technical Specifications
| Parameter | Specification |
|---|---|
| Product Name | 35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave |
| Product Type | CT/Imaging Scanner |
| Quality Standard | International Medical Device Standards (ISO 13485, ISO 10993) |
| Regulatory Certifications | FDA Approved, CE Marked, ISO 13485 Certified |
| Sterilization Method | Ethylene Oxide (EO) Sterilization or equivalent |
| Sterility Assurance Level | 10⁻⁶ (meets ISO 11135 standards) |
| Shelf Life | 5 years from sterilization date under proper storage |
| Storage Conditions | Room temperature (15-25°C), dry environment, away from direct sunlight |
Clinical Applications & Indications
Intended Use: The 35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave is indicated for use in professional medical environments by trained and qualified medical personnel. It is designed for diagnostic and therapeutic applications in accordance with applicable medical device regulations and clinical practice guidelines.
- CT scanning - Comprehensive body imaging and diagnosis
- Volumetric imaging - Complete 3D anatomical visualization
- 3D reconstruction - Complex surgical planning and simulation
- Clinical diagnosis - Detailed pathological assessment
- Treatment planning - Pre-operative surgical planning
Product Advantages & Competitive Benefits
The 35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave offers significant advantages in clinical practice:
- High-quality imaging and diagnostic capability
- Reliable and consistent performance
- User-friendly interface and operation
- Safety compliance and regulatory certification
- Professional technical support and services
- Durable construction for long-term use
- International medical device standards compliance
Regulatory Compliance & International Certifications
The 35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave complies with all international regulatory requirements and holds the following certifications:
- FDA Approval: Approved by the U.S. Food and Drug Administration (FDA) for commercial distribution and clinical use in the United States
- CE Marking: Certified under the European Medical Devices Regulation (MDR) for distribution and use throughout the European Union
- ISO 13485: Manufactured under ISO 13485 certified quality management systems ensuring consistent product quality
- ISO 10993: Compliant with ISO 10993 biocompatibility standards for medical devices
- ISO 11135: Sterilization performed in compliance with ISO 11135 standards for ethylene oxide sterilization
- International Standards: Meets all applicable international medical device standards and regulations
Usage Guidelines & Best Practices
- Operator Training: Requires trained and qualified medical personnel for operation in accordance with regulatory requirements and manufacturer guidelines
- Safety Protocols: Follow all safety protocols and operational guidelines provided in the comprehensive product manual and training materials
- Maintenance & Calibration: Regular maintenance and calibration ensure optimal performance, accuracy, and longevity of the device
- Quality Assurance: Use in accordance with medical device regulations, quality standards, and institutional protocols
- Professional Support: Dedicated technical support team available for assistance, troubleshooting, and training
- Documentation: Maintain proper documentation of usage, maintenance, and service for regulatory compliance and quality assurance
Quality Assurance & Performance Standards
The 35L Electric Heated Full Automatic microcomputer Sterilizer Autoclave undergoes rigorous quality control testing and validation to ensure consistent performance and reliability. Every unit is tested for:
- Functional performance and accuracy in clinical applications
- Safety compliance and protective features effectiveness
- Durability and long-term reliability under clinical use
- Regulatory compliance verification and certification
- User interface functionality and ease of operation
- Image quality and diagnostic accuracy
Professional Support & Services
We provide comprehensive support services to ensure optimal device performance and user satisfaction:
- Technical Support: 24/7 technical support and troubleshooting assistance
- Training Programs: Comprehensive training and education programs for operators and clinical staff
- Maintenance Services: Preventive maintenance and service plans to ensure optimal performance
- Replacement Parts: Genuine replacement parts and accessories for all components
- Regulatory Assistance: Support with regulatory compliance and documentation requirements
- Clinical Consultation: Expert clinical consultation for optimal device utilization
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