Description

Horizontal Cylindrical Pressure Steam Sterilizer Autoclave - Professional Medical Device Product Description  Horizontal Cylindrical Pressure Steam Sterilizer Autoclave is a professional-grade medical device 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  Horizontal Cylindrical Pressure Steam 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 Professional-grade quality for healthcare applications Advanced technology integrated for optimal performance Safety features ensuring patient and operator protection Reliable performance in demanding medical environments International standards compliance and certification User-friendly design for trained medical personnel Detailed Technical Specifications Parameter Specification Product Name Horizontal Cylindrical Pressure Steam Sterilizer Autoclave Product Type Medical Device 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 Horizontal Cylindrical Pressure Steam 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. Medical imaging - Diagnostic and therapeutic applications Clinical diagnosis - Patient assessment and diagnosis Healthcare delivery - Professional medical care Patient care - Comprehensive patient management Medical research - Clinical research and development Product Advantages & Competitive Benefits The Horizontal Cylindrical Pressure Steam 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 Horizontal Cylindrical Pressure Steam 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 Horizontal Cylindrical Pressure Steam 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

Use

The sterilizer uses pressure saturated steam to sterilize the articles. Pulsating vacuum exhaust is used to eliminate the influence of cold air on temperature. Finally, vacuum dehumidification combined with jacket drying is used to dry the articles. It makes use of the physical characteristics that pressure saturated steam can release a large amount of latent heat when condensing, so that the articles to be sterilized are in a high temperature and humidity state. After a certain period of time, all bacteria and spore tissues in the articles are destroyed, so as to achieve the purpose of sterilization. Mainly used in hospitals, chemical, food, scientific research, pharmaceutical and other units, surgical instruments

Characteristics

• Automatically controlled the sterilizing process, easy to operate.

• It has three times or more pulsating vacuum. It is suitable for all kinds of packed, non packed, hollow porous and internal pipeline instruments.

• The sterilizer is equipped with a steam generator, and one set of movable sterilization plate is randomly adapted.

• The inner cavity of the sterilizer is a circular double-layer design, which is composed of a sterilization chamber and a jacket, and has the function of deep drying.

• With printing function, the printer can record the whole process of sterilization.

• With Bowie & Dick test function for steam penetration test.

• With over-temperature, over-pressure auto-protect.

• Safety interlock device: when the door is not closed tightly, steam can not enter the main body of the inner layer and give an alarm. When the pressure in the sterilization room is greater than 0.027mpa, the door is interlocked and cannot be opened.

• Over-pressure protection: when the pressure exceeds the working pressure, the safety valve will automatically relieve the pressure

• Low water level protection device: the water can not be started until the high water level, and it will be automatically cut off when the low water level is short of water.

• Over current protection: when the current overload, the power circuit breaker will automatically cut off the power supply.

• Sealing door: manual door opening and closing, radial rod rotary table type, equipped with two-stage self-locking, interlocking safety device, single door (double door optional), with pressure safety interlock device.

• The sterilization room is made of high quality stainless steel.

Technical Data