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

1. Product Introduction

The LS-HG vertical pressure steam sterilizer is a highly efficient disinfection and sterilization device widely used in fields such as healthcare, biopharmaceuticals, and scientific research institutions and universities. It utilizes the strong penetration of high-temperature and high-pressure steam to quickly kill microorganisms such as bacteria, viruses, and spores, ensuring that items such as medical devices, dressings, laboratory equipment, and culture media reach a sterile state.

This unit features an intelligent control system and LCD display, offering user-friendly operation with stable and reliable performance. Its unique steam-water internal circulation system prevents aerosol generation and eliminates steam emission, maintaining a clean and dry environment. It is an ideal choice for modern medical institutions and laboratories.

II. Technical Parameters

III. Performance Features

Ø The unit is made of SUS304,and features a manually operated sliding fast-opening door with self-sealing, it also includes a heat-resistant lid cover for enhanced safety.

Ø Equipped with stainless steel basket, specifically designed for loading sterilized items to ensure secure placement during the sterilization process.

Ø It is microcomputer controlled, equipped with a 4.3" LCD ,dynamically display the temperature, pressure, and time during the sterilization process throughout and show the operating status in real time.

Ø With fixed modes including instruments, dressings, liquid. The users can freely set the  sterilization temperature, sterilization time, and drying time. It is equipped with two-level password protection and memory function.

Ø Appointment feature: Enables scheduled program launch, allowing to set the time to a specific date and time.

Ø It has melting and heat preservation functions, with melting time ranging from 1 to 9999 minutes and heat preservation time ranging from 1 to 9999 minutes.

Ø The pressure sensor and mechanical pressure gauge work together to provide dual display of both mechanical and digital pressure readings.

Ø Timer: when the sterilization temperature reaches the preset value, the timer will automatically start a countdown. Upon completion of sterilization, the system will automatically release pressure and exhaust steam while cutting off the heating power supply. The exhaust and pressure release will be accompanied by an alarm sound to indicate the end of the program.

Ø Equipped with two cooling water tanks and steam-water internal circulation system, it features an internal steam cooling system to prevent aerosol generation and avoid the steam emission, ensuring a clean and dry environment. Manual replacement of cooling water is available to achieve continuous sterilization.

Ø The sterilization chamber is equipped with an automatic cold air venting device to ensure sterilization efficacy.

Ø The immersion-type heating tube is with high thermal efficiency and operates at AC220V ,which must be reliably grounded during use.

Ø Equipped with automatic over-temperature and over-pressure protection:

l Equipped with an open-type safety valve, the valve remains closed during normal sterilization. When the pressure inside the sterilizer exceeds the maximum allowable operating range, the safety valve automatically opens to release the over-pressure steam. It reverts to the normal state once the steam pressure within the sterilizer returns to the normal value, thereby ensuring safe operation.

l The door cannot be opened when the internal pressure exceeds 0.027MPa, as it features a self-locking mechanism.

l Overheat protection of the steam generator: If no water is added or there is a water shortage or interruption during use, the power will be automatically cut off. When faults happened such as water interruption, the pressure relief valve will automatically open and release the steam.

Ø The circuit is equipped with an overload and leakage current protector, which automatically cuts off the power supply when leakage current or over-voltage occurs in the line.

Ø If the door is not closed, the program cannot be started. Once the program is started and running, the sealed door will be locked and cannot be opened to ensure operation safety.

Ø It is equipped with a built-in printer, which can print sterilization data in real time. Additionally, there is a USB port for connecting a USB flash drive to store data.

Ø (Optional) Drying function: The drying function can be automatically activated after the sterilization process is completed.