Medical equipment continues to improve the basic conditions of medical science and technology, and is an important symbol of modernization. Medical equipment has become an important area of ​​modern medicine. The development of medical care depends to a large extent on the development of the instrument. Even in the development of the medical industry, its breakthrough bottleneck also plays a decisive role.
Medical equipment refers to instruments, equipment, appliances, materials, or other items used alone or in combination with the human body, as well as software required. The therapeutic effects on human body surface and body are not obtained through pharmacology, immunology or metabolism, but medical device products play a certain role of assistance. During use, it aims to achieve the following objectives: prevention, diagnosis, treatment, monitoring, remission of disease; diagnosis, treatment, monitoring, remission, compensation of injury or disability; research, substitution, regulation of anatomical or physiological processes ; Pregnancy control.
The broad medical equipment includes medical equipment and home medical equipment, while the professional medical equipment does not include home medical equipment equipment. It can be seen that while they are closely related to each other, it is also an inclusive relationship. Subtle differences are not difficult to see.
The maintenance, maintenance, equipment installation and equipment scrapping of large-scale medical equipment are all one of the main tasks in the equipment section of hospitals. It is directly related to the safety of instrument use, and relates to the effectiveness of clinical medical equipment inspection and testing. Collaboration and continuity of medical work throughout the hospital. The basic point for the development and design of this system is how the equipment department uses limited manpower, material resources, and limited resources. It is very important to achieve higher levels of autonomous maintenance by ensuring the normal use of equipment in cost-effectiveness. Subject.
Intelligence
A large-scale hospital equipment maintenance and management system should not simply repeat manual procedures. It should be a program with intelligent features. This system contains several EOQ modules, and special equipment maintenance alarms are set. When a device to be repaired is sent to the Equipment Division for maintenance, the computer will automatically remind (by the expiration date of the maintenance equipment) that the maintenance engineer has not been repaired in time. The alarm is divided into three levels (and is an audible and visual alarm). When the system is in the log-in interface, it uses the server module type, and checks it at regular intervals. If the maintenance equipment is to be maintained, the system will use sound and light alarms to prompt the engineer to perform maintenance on the operation interface.
The system provides equipment classification, equipment management, spare parts management, information management, report output and statistical analysis modules, which can perform statistical analysis on various maintenance work indicators and display statistical analysis results in the form of tables. Such as maintenance equipment maintenance statistics, the number of equipment for inspection, repair rate of equipment maintenance, repair rate of equipment maintenance and inventory statistics of components, analysis of equipment scrap factor.
For data integrity and security, we use the code to implement automatic database backup and recovery functions. System administrators can also manually backup and restore data. Another technique is a strict authorization mechanism in which the administrator assigns different management rights based on the responsibilities of the engineer's operator.
stability
The computer system uses Windows XP Advanced Server to provide engineers with a high-performance client and server platform through background data collection. Using this system, the data processing method is very simple, and it can process various display formats and print data reports. Complex data and reports are handled with ease.
Hospitals cannot be powered off. Once a power failure occurs, it may threaten the lives of patients. Similarly, medical equipment cannot be powered off. Therefore, medical equipment has very strict requirements on power supply specifications. Therefore, there are special specifications on the design of medical device batteries.
The growth in demand for medical electronic products in China is higher than the global average - a huge population base and an aging population that is rapidly increasing year by year and people's growing health awareness, national policies, medical informationization and technological revolution. The demand for medical electronic products in China continues to grow rapidly.
In addition, China has begun to implement the 12th Five-Year Plan, including the following three goals related to the future development of medical equipment: 1) accelerate the development of the domestic medical equipment industry; 2) implement the unified procurement system; 3) domestic medical institutions Priority should be given to the purchase of domestic medical equipment. With the gradual implementation of this medical reform program, domestic medical equipment manufacturers have made all preparations, riding on this rare opportunity for development, to fully develop a new generation of medical equipment.
In addition to medical devices that must comply with internationally recognized standards, other aspects such as basic performance and power supply compliance are very important, because the patient's health will be directly or indirectly affected. However, in the case of electronic medical equipment related to patient care, clinical treatment, health monitoring, or image scanning, if there is a problem with the power supply, power loss, or other problems in the power supply, the consequences will directly affect the health of the patient, even to the patient. Causes transient or permanent damage.
In the case of laboratory instruments or diagnostic equipment, once a problem arises in the power supply, medical personnel will be unable to make correct diagnosis in a timely manner. Sometimes even more tests are required. This wastes time and increases the spirit of medical staff and patients. burden.
In addition, once the medical device's power supply fails, it will not be able to perform its basic functions even if it does not immediately constitute a safety issue. Therefore, medical device developers must not only plug design holes in the ideation phase of the product, but also even during the entire product life cycle. The risk is constantly managed internally so that the equipment does not malfunction.
During its use period, medical device circuits are subject to various electrical threats in many ways. In short, any power or communication interface is a potential entry point for electrical transients and is easily destroyed during the life of the device. Therefore, pay attention to the power supply (battery pack, DC input, AC input), microprocessor, microphone/loudspeaker line, communication interface (wired and wireless), sensor, LCD display, keypad, and buttons.
For more high-end devices (images, diagnostics, and laboratory equipment), additional protection devices are needed because they are more complex and face more electrical threats. Circuits such as AC power supplies and high voltage DC power supplies need surge protection solutions that can handle much higher energy than portable devices.
Overvoltage suppression device (device):Gas discharge tubes (GDTs) are generally used to protect the signal lines of telecommunication lines, data communication lines and other devices (equipment) from surge voltages. The device can withstand up to 40,000 amps of inrush current and is therefore ideal for reducing transients caused by lightning.
Varistors (variable resistors) allow high transient voltages to bypass the sensitive devices. Divided into two main types:
Multilayer varistors (MLVs) provide low to medium power transients (0.05-2.5 joules) for sensitive devices with 0-2020VDC power. These multilayer varistors are most often used for ESD protection.
Metal oxide varistors (MOVs) provide 0.1-10,000 joules of rated energy to keep sensitive components away from transient currents. For low voltage DC power ports or signal ports, varistors combine the advantages of high surge and small size discs, providing an ideal choice for designs that require space savings. For example, a 10mm varistor can withstand a maximum inrush current of 2,000A, which is four times the maximum surge current that a standard MOV of the same size can withstand. The device protects the circuit from electrical threats such as induced lightning strikes, system switching transients, and abnormally fast transients on the power supply.
The polymer ESD suppressor has a low junction capacitance (~0.05pF) and fast clamp capability, making it ideal for high-speed digital I/O and RF circuits. The low junction capacitance helps to ensure that no errors or distortions occur.
Transient Voltage Suppression (TVS) diodes protect a variety of circuits and components from the common threats of DC power lines. The diode has a much larger pn-junction than conventional diodes, allowing large currents to be conducted to ground without damage, allowing the transient voltage to be suppressed below that of other technologies. Transient power ratings are between 400 watts and 15,000 watts, up to 15,000A @ 8x20us waveform.
The semiconductor diode protection array (SPA) is designed to protect analog and digital signal lines from ESD and other transient overvoltages. In addition, multi-channel arrays can be used in smaller spaces to provide ESD protection and clamp voltages lower than other technologies to provide the best possible protection.
The semiconductor discharge tube design application suppresses transient overvoltages in telecommunications and data communications equipment and can conduct currents up to 5,000A to ground in a few nanoseconds up to the breakdown voltage.
Over current protection device:Fuse is the most commonly used over-current protection device, divided into fast-off type and slow-off (delay) type. The second type minimizes the number of repeated changes when the current experiences a brief but repetitive over-current "pulse." In portable applications, small surface mount fuses are often used to save space and block overvoltage and short circuit currents.
PTC thermistors are repeatable devices that replace fuses. As the current increases, the PTC resistance is increased and the current is automatically limited. Under normal circumstances, the use of polymer (PPTC) materials, can form a significant inflection point between the impedance and temperature. Once the overload disappears, the PPTC will cool and return the circuit to normal operation. Therefore, there is no need to replace the fuse.
The first consideration in designing medical electronic products is the requirement of risk management. For example, in addition to complying with the basic risk management requirements set out in the ISO 14971 standard, it must comply with IEC 60601-1 Ed.3, IEC62304, and other standards. "In the actual risk management operations, equipment manufacturers should also pay attention to software risk management, post-listing risk management, etc. In addition, in the design process, manufacturers should pay attention to the collection of similar products, especially when designing some high-risk products. It is very useful for equipment manufacturers, because if we can analyze the collected information carefully, we can effectively avoid the mistakes that have been made by the predecessors and improve the reliability of design, said Zhou Saixin.
Current tools for risk management are more commonly used in Process Failure Analysis (PFMEA) and Design Failure Analysis (DFMEA). PFMEA is to analyze the failure of the entire production process during the transition from design to production; DEFEA is to analyze the failure mode during the design process. These two analysis techniques are often used in products with high risk and high reliability requirements. In the failure mode impact analysis, the risk level is also judged from three points: severity, probability, and detectability.
"There are two key points in the design of risk control. One is to follow the trilogy principle of inherent safety, protective measures, and safety information. The second is to ensure patient safety under single-fault conditions." Zhou Saixin pointed out. Specifically, the trilogy of intrinsic safety, protective measures, and safety information is: If risk is identified, the primary consideration is how to achieve the inherent design safety; when inherent safety cannot be achieved, protective measures should be taken and safety information should be marked. . For example, the primary consideration in designing a product is how to make it harmless to voltage, not how to deal with the voltage after it is hazardous; when the hazardous voltage is unavoidable, it is necessary to take protective measures such as insulation and paste it where the voltage may be hazardous. A warning label warns the user.
reliabilityThe importance of reliability to medical electronics is self-evident. As the use of the environment becomes more complex, the reliability challenges faced by the products are also increasing. For example, the previous equipment may only be fixed at the bedside, but now the situation of trans-hospital transportation, out-of-hospital emergency, etc., occurs frequently. When moving medical equipment, there may be accidents such as drop, collision, etc.; in addition, the use load of the equipment becomes more and more heavy, and many devices often It is 24 hours without shutting down or even several months without shutting down. How to ensure the reliability of the equipment in these situations is a problem for the equipment manufacturer to think about.
The upgrading of technology in the electronics industry also exposes equipment manufacturers to new challenges. High-density BGA/QFN soldering is an important trend in electronic device miniaturization, high-density packaging, and lead-free processes. It has become the mainstream in consumer electronics such as mobile phones and tablet computers. Medical electronics is different from consumer electronics. It has its own unique industrial chain. Currently, the packaging matching the industry chain capability is still the 0402/0.5mm packaging technology. At this level, most products' SMT patches can guarantee a certain yield rate. And reliability, but medical electronic device manufacturers are always faced with product reliability problems brought about by miniaturized packaging. In addition, the ever-improving semiconductor technology brings about rapid replacement of chips, and the reliability problems caused by chip replacement are inevitable. "When using a new chip, we need to pay attention to the chip's early defects. Nowadays the complexity of the chip is getting higher and higher. Do not think that the reliability of the chip can be guaranteed. Like software, it will have some early immaturity factors. The use of new chips can enjoy the new technological advancements it brings, but at the same time it also faces certain risks." Zhou Saixin said.
Software reliability in product reliability design is also critical. Now that the product is becoming more and more software, it is possible to develop a project that is likely to be the design of the software. Zhou Saixin pointed out that software reliability design should pay attention to two points: the use of OTS software/SOUP software and the selection of operating systems. OTS software/SOUP software are software of unknown origin. Some device manufacturers may download certain driver software in the open source community. Special care must be taken at this time, because these softwares are not necessarily developed in accordance with the requirements of medical devices. Reliability is difficult to guarantee. In addition, the choice of operating system is directly related to the reliability of the product. Currently, there are many operating systems, open source, and closed, and each has its own focus on real-time and GUI. Which operating system is mainly selected from the company's products and development? Starting from the capability, select the operating system that matches the development capabilities.
Other key factorsThe design of medical electronic products needs to meet the requirements of safety regulations. At present, the IEC60601-1 standard is a safety standard widely used in the world and applicable to medical equipment. Since June of this year, Europe has begun to implement the third version of safety standards, which applies to all new and old products. In addition to presenting safety and basic performance risk management, the third edition of the standard also proposes two different concepts of operator protection measures (MOOP) and patient protection measures (MOPP) and includes bottom opening, Impact testing, altitude and pollution considerations, etc. New requirements for electrical safety and mechanical safety, equipment manufacturers should ensure that they meet new requirements in safety regulations when developing products.
From the point of view of easy-to-use design of medical products, the major ease-of-use issues currently faced by products include false alarms, complicated setup and maintenance, and the accumulation of functions of tender-directed, which will lead to a significant decrease in the ease of use of products. Zhou Saixin believes that the solution to the problem is an intelligent design, such as adding a smart alarm engine, smart lead switching, and intelligent working status recognition. In addition, new human-computer interaction technologies can be added, including language prompts, new display technologies, and touch UI applications, to increase the ease of use of the device. He said: "Consumer electronics products in the new environment have a great influence on doctors' habits, especially handheld devices and digital products. Doctors also hope that the equipment used in daily work can have similar characteristics."
With the promotion of internet technology, the adoption of wireless technology to realize the interconnection between devices has become an important trend in the development of medical electronic products. WiFi, LAN, Bluetooth, ZigBee, 3G, etc. are all common wireless technologies. Different wireless technologies have different characteristics and different applicable scopes. "I am personally optimistic about the Bluetooth 4.0 technology, it can do a very low power consumption, to meet the current product design requirements for low power consumption." Zhou Saixin said. He pointed out that wireless design should also consider many factors including frequency band selection, wireless authentication, data roaming, device positioning, pairing, and access speed.
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