1. Product Name and Purpose

2. Product Features

• Robust and Insulated Chamber Structure
  • The chamber is constructed with a heavy-duty, corrosion-resistant outer shell, typically made of stainless steel. The interior is lined with high-quality insulation materials that minimize heat transfer and maintain precise temperature and humidity gradients. The door is equipped with a reliable sealing mechanism and a viewing window, allowing operators to monitor the test process without disturbing the internal environment. The overall design is optimized to withstand the rigors of continuous operation and provide a stable testing environment.
• Precision Temperature and Humidity Control System
  • At the heart of the chamber lies a sophisticated control system. It can achieve a wide temperature range, typically from -20°C to +60°C, with an accuracy of ±0.3°C. The humidity control range extends from 10% to 95% relative humidity, with an accuracy of ±2% RH. The system utilizes high-performance refrigeration units, electric heaters, humidifiers, and dehumidifiers, all coordinated by a precise PID controller. Multiple temperature and humidity sensors are strategically placed throughout the chamber to provide real-time feedback, enabling the control system to make instantaneous and accurate adjustments to maintain the desired environmental conditions.
• Programmable Testing Modes
  • The chamber is equipped with a highly programmable control panel. It allows operators to easily set up and execute a variety of test sequences as per ASTM requirements. These include temperature cycling, where medical devices are exposed to alternating high and low temperatures; humidity cycling, to assess the impact of moisture on device performance; and combinations of both, simulating real-world scenarios such as storage and transportation conditions. The programmable nature of the chamber ensures accurate and repeatable testing, enabling manufacturers to obtain reliable data for product improvement and compliance.
• Intuitive Control Panel and Data Acquisition Interface
  • The equipment is furnished with an intuitive control panel that simplifies the operation and parameter setting. Operators can effortlessly adjust temperature, humidity, test durations, and other parameters using a user-friendly interface. The control panel also provides real-time displays of the current environmental conditions, as well as any alarms or warnings. The chamber is integrated with a comprehensive data acquisition system. It records all relevant test data, including temperature and humidity histories, rate of change of environmental parameters, and any observable changes in the medical device samples. The data can be stored in a built-in memory or exported to external storage devices for further analysis. The system can also generate detailed test reports in various formats, facilitating easy documentation and sharing of results.
• Safety Features and Alarms
  • To ensure the safety of operators and the integrity of the testing process, the chamber is equipped with a range of safety features. These include over-temperature and over-current protection, emergency stop buttons, and alarms for abnormal temperature fluctuations, humidity levels, or equipment malfunctions. The safety features are designed to prevent damage to the chamber, the medical device samples, and the surrounding environment, providing peace of mind during the testing operation.

3. Specific Parameters

• Temperature Range and Accuracy
  • With a temperature range of -20°C to +60°C and an accuracy of ±0.3°C, the chamber can subject medical devices to a wide spectrum of temperatures. This is crucial for testing devices that may be stored in cold chain conditions or exposed to higher temperatures during transportation or use. The accurate temperature control ensures that the test conditions are precisely maintained, providing reliable and repeatable results.
• Humidity Range and Accuracy
  • The humidity range of 10% to 95% RH, with an accuracy of ±2% RH, allows for a comprehensive evaluation of the effect of moisture on medical devices. The ability to precisely control the humidity level is essential for understanding how devices such as electronic medical equipment, implants, and surgical tools respond to different moisture environments.
• Testing Volume and Payload Capacity
  • The chamber offers a customizable testing volume, typically ranging from 100L to 500L, depending on the specific model. The payload capacity can handle a significant amount of medical device samples, with a maximum capacity of up to 200 kg, depending on the size and density of the devices. This allows for efficient testing of multiple devices or larger medical equipment.
• Data Sampling Frequency and Resolution
  • The data acquisition system samples data at a frequency of up to 200 Hz, providing a highly detailed record of the temperature and humidity changes. The resolution of the temperature data is 0.1°C, and the humidity data is 0.1% RH. This high-resolution data is invaluable for identifying even the slightest trends and potential failure points, allowing for a more accurate assessment of medical device performance.

4. Product Functions

• Accurate Simulation of Environmental Conditions
  • The primary function of the chamber is to provide a precise and reliable simulation of temperature and humidity conditions. By subjecting medical devices to controlled environmental stresses, it allows manufacturers and researchers to evaluate their performance and durability. This is crucial for ensuring the quality and safety of medical devices, as any degradation or failure during use could have serious consequences for patient health.
• Product Design Optimization and Quality Control
  • Through a series of tests on different medical device prototypes, the data obtained from the chamber can be used to optimize product designs. Engineers can analyze the behavior of various materials and components under different temperature and humidity stresses and make modifications to enhance the overall performance and integrity. The chamber also serves as a vital tool for quality control, ensuring that each batch of medical devices meets the required environmental resistance standards. For example, in the manufacturing of implantable devices, testing in the chamber can help ensure the stability and biocompatibility of the device under different storage and transportation conditions.
• Research and Development Support
  • In the field of medical device research and development, the Custom Climate Chamber Programmable offers valuable insights. Researchers can use it to study the fundamental properties of medical device materials and their interactions with different environmental factors. They can explore new formulations and designs that are more resistant to temperature and humidity extremes. For instance, materials scientists can test the performance of novel coatings or sterilization-resistant materials under various environmental conditions, using the chamber to evaluate their effectiveness and paving the way for advancements in medical technology.
• Compliance Testing and Certification
  • The equipment is essential for conducting compliance testing to meet industry regulations and international standards. The medical device industry has strict requirements regarding the stability and integrity of products under different environmental conditions, and the chamber can be used to perform tests according to ASTM standards. The test results can then be used to obtain product certifications and ensure market acceptance.

5. Production and Quality Assurance

• Stringent Manufacturing Process
  • The Custom Climate Chamber Programmable for Medical Device Testing is manufactured under strict quality control procedures. Each component, from the outer shell and insulation materials to the temperature and humidity control units, and safety features, is sourced from reliable suppliers and undergoes thorough inspection and testing. The assembly process is carried out by highly trained technicians in a clean and controlled environment. The chamber is calibrated and verified at multiple stages during production to ensure its accuracy and performance.
• Quality Certification and Validation
  Our chamber has obtained relevant quality certifications and has been validated by independent medical device testing laboratories. It has been proven to provide accurate and reliable test results, conforming to ASTM standards and other international and national standards for medical device environmental testing. We also continuously update and improve our product based on the latest technological advancements and customer feedback from the medical device industry to ensure its long-term performance and compliance.

6. Application Areas and Success Stories

• Implantable Device Testing
  • A medical device manufacturer used the chamber to test a new type of cardiac implant. The implant was subjected to temperature and humidity cycling according to ASTM standards. The testing revealed that the device's packaging was not sufficient to protect it from moisture at higher temperatures. By changing the packaging material and adding a desiccant, the manufacturer was able to enhance the implant's stability and shelf life, ensuring its safety and effectiveness when implanted in patients.
• Diagnostic Equipment Evaluation
  • A research institution tested a new diagnostic imaging device in the chamber. The device was exposed to different temperature and humidity conditions to evaluate its accuracy and reliability. The results showed that the device's calibration was affected by high humidity levels. Based on these findings, the researchers developed a calibration compensation algorithm, improving the device's performance and ensuring accurate diagnostic results.
• Surgical Instrument Durability Testing
  • A surgical instrument manufacturer tested a new line of surgical tools in the chamber. The tools were subjected to a combination of temperature, humidity, and vibration (simulating the handling during surgery) to assess their durability. The testing identified a weakness in the handle's grip material, which tended to deteriorate under certain environmental conditions. By using a more durable material for the handle, the manufacturer was able to enhance the tools' lifespan and performance in the operating room.

7. Service and Support

• Pre-Sales Technical Consultation
  Our team of medical device testing experts provides in-depth technical consultations to help customers understand the capabilities and suitability of the chamber for their specific testing needs. We offer demonstrations and training, tailored to the medical device industry, to familiarize customers with the operation and functionality of the chamber before purchase. We also assist in selecting the appropriate test parameters and accessories based on the medical devices to be tested.
• After-Sales Service and Maintenance
  We offer comprehensive after-sales service, including on-site installation and commissioning. Our technicians are available for regular maintenance, calibration, and emergency repairs. We provide spare parts and upgrades to keep the chamber operating at peak performance. We also offer service contracts that include preventive maintenance and priority technical support, ensuring the long-term reliability and availability of the tester for medical device temperature and humidity testing.
• Training and Technical Support
  We conduct training programs for new users to ensure they can effectively operate the Custom Climate Chamber Programmable and interpret the test results. Our technical support team is available 24/7 to answer questions, provide troubleshooting assistance, and offer guidance on test method optimization and compliance with ASTM and other medical device environmental testing standards. We also provide software updates and support for the data acquisition and analysis systems, enabling customers to take full advantage of the latest features and technologies in testing.