The basic conditions for medical equipment to continuously improve the level of medical science and technology are also important signs of modernization. Medical equipment has become an important field of modern medical care. The development of medical care depends to a large extent on the development of instruments, and even in the development of the medical industry, its breakthrough bottleneck has also played 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 the required software. The therapeutic effects on the human body surface and in the body are not obtained by means of pharmacology, immunology or metabolism, but the medical device products play a certain auxiliary role. During use, it is intended to achieve the following intended purposes: prevention, diagnosis, treatment, monitoring, and mitigation of the disease; diagnosis, treatment, monitoring, mitigation, compensation for injury or disability; research, substitution, adjustment of anatomical or physiological processes ; pregnancy control.
Medical devices in a broad sense include medical devices, home medical devices, while professional medical devices do not include home medical devices. It can be seen that they are closely related, but also an inclusion relationship. It is not difficult to see the subtle differences.
The maintenance, maintenance, equipment installation and equipment scrapping of large medical equipment are one of the main tasks of the equipment department in the hospital. It is directly related to the safety of the instrument, and it is related to the inspection and detection effectiveness of clinical medical equipment. Collaboration and continuity of medical work throughout the hospital. The basic point of the development and design of the system is how the equipment department can use a limited amount of manpower, material resources and limited resources to ensure the normal use rate of equipment in order to achieve a higher degree of autonomous maintenance. Question.
Intelligent
A large hospital equipment maintenance management system should not simply repeat the manual procedure, it should be a program with intelligent features. This system contains several EOQ modules, and specially set the equipment maintenance alarm prompt. When a repaired equipment is sent to the equipment department for maintenance, the computer will automatically remind you (according to the expiration date of the repair equipment) because the maintenance engineer does not repair it in time, and the alarm is divided into three levels (and sound and light alarm). When the system is in the login interface, the server module type is used, and the inspection is performed once every time. If the maintenance equipment is to be repaired, the system will prompt the engineer to perform maintenance with the sound and light alarm on the operation interface.
The system provides modules such as equipment classification, equipment management, spare parts management, information management, report output and statistical analysis. It can perform statistical analysis on various maintenance work indicators and display statistical analysis results in tabular form. Such as the maintenance statistics of maintenance equipment, the number of equipment inspections, the repair rate of equipment maintenance, the repair rate of equipment maintenance and the inventory of components, the equipment scrap factor analysis.
For data integrity and security, we use code to achieve automatic database backup and recovery, system administrators can also manually back up and restore data. Another technology is a strict authorization mechanism, where administrators assign different administrative privileges depending on the responsibilities of the engineer's operator.
stability
The computer system adopts Windows XP Advanced Server to provide engineers with a high-performance client and server platform through background data collection. The data processing method is quite simple, and can process various display formats and print data reports. Complex data and report processing are free.
There is no power outage in the hospital. Once there is a power outage, it may threaten the patient's life safety. Similarly, medical equipment cannot be powered off, so medical equipment has very strict requirements on the specifications of the power supply. Therefore, there are special specifications in the design of medical device batteries.
China's medical electronics demand growth is higher than the global average - huge population base and the rapidly growing aging population and people's growing awareness of health, the promotion of national policies, medical information and technological revolution. The demand for medical electronic products in China continues to grow rapidly.
In addition, China began to implement the 12th Five-Year Plan, in which the future development of medical equipment has three objectives: 1) speeding up the development of the domestic medical equipment industry; 2) implementing a unified procurement system; 3) domestic medical institutions Priority should be given to purchasing domestic medical equipment. With the gradual implementation of this medical reform program, domestic medical equipment manufacturers have made all the preparations, and take advantage of this rare development opportunity to fully develop a new generation of medical equipment.
In addition to having to comply with internationally recognized standards, medical devices such as basic performance and the power supply used are important because the patient's health is directly or indirectly affected. However, in the case of electronic medical equipment related to patient care, clinical treatment, health monitoring, or image scanning, if the power supply fails to be energized, loses power or other problems, the consequences will directly affect the patient's health, even to the patient. Causes temporary or permanent damage.
Taking laboratory instruments or diagnostic equipment as an example, if there is a problem with the power supply, the medical staff will not be able to make a correct diagnosis in time, and sometimes even more tests will be done, which will waste time and enhance the spirit of the medical staff and the patient. burden.
In addition, once the power of the medical device fails, even if it does not immediately pose a safety problem, its basic functions cannot be performed. Therefore, the medical device developer must not only block the design hole during the concept phase of the product, but even the entire life cycle of the product. The risks are continuously managed to prevent equipment failure.
Medical device circuits are subject to various electrical threats in many ways during their lifetime. In short, any power or communication interface is a potential entry for electrical transients and can be easily compromised during the life of the device. Therefore, pay attention to the power supply (battery pack, DC input, AC input), microprocessor, microphone/amplifier line, communication interface (wired and wireless), sensor, LCD display, keypad and buttons.
For higher-end devices (images, diagnostics, and lab equipment), additional protection devices are needed due to their more complex and more electrical threats. Circuits such as AC power and high-voltage DC power supplies need to be able to cope with surge protection solutions that are much more energy-intensive than portable devices.
Overvoltage suppression device (device):Gas discharge tubes (GDTs) are commonly used to protect signal lines for telecommunication lines, data communication lines, and other devices (devices) from surge voltages. The device can withstand surge currents of up to 40,000 amps, making it ideal for reducing transients caused by lightning.
Varistors (variable resistors) allow currents generated by excessively high transients to bypass sensitive equipment. Divided into two main types:
Multi-layer varistors (MLVs) provide medium to low energy transients (0.05-2.5 joules) for sensitive equipment powered by 0-120V DC. These multi-layer varistors are most commonly used for ESD protection.
Metal oxide varistors (MOVs) provide 0.1-10,000 Joules of rated energy, allowing sensitive components to avoid transient currents. For low-voltage DC power ports or signal ports, varistors combine the advantages of high-surge and small-size discs, making them ideal for space-saving designs. For example, a 10mm varistor can withstand up to 2,000A of inrush current, which is four times the maximum inrush current experienced by a standard MOV of the same size. The device protects the circuit from electrical threats such as induced lightning strikes, system switching transients, and abnormally fast transients in the power supply.
The polymer ESD suppressor has low junction capacitance (~0.05pF) and fast clamping capability, making it ideal for high speed digital I/O and RF lines. Low junction capacitance helps ensure that no errors or distortions occur.
Transient Voltage Suppression (TVS) diodes protect a wide variety of circuits and components from the various threats common to DC power lines. The diode's pn junction cross-section is much larger than conventional diodes, allowing large currents to be conducted to ground without damage, allowing transient voltages to be suppressed below levels using other technologies. Transient power ratings range from 400 watts to 15,000 watts with waveforms up to 15,000A @ 8x20us.
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 with lower clamping voltages than other technologies to provide the best possible protection.
Semiconductor discharge tube design applications suppress transient overvoltages in telecommunications and data communication equipment and can conduct up to 5,000 A of current in a few nanoseconds of breakdown voltage.
Overcurrent protection device:Fuses are the most commonly used overcurrent protection devices and are available in fast-break and slow-break (delay) versions. The second type minimizes the number of repeated changes in the event of a brief but repetitive overcurrent "pulse" in the current. In portable applications, small surface mount fuses are often used to save space and block overvoltage and short circuit currents.
A PTC thermistor is a repeatable device that replaces a fuse. As the current increases, the PTC resistance is increased and the current is automatically limited. Typically, polymer (PPTC) materials are used to create a significant inflection point between impedance and temperature. Once the overload disappears, the PPTC will cool down and return the circuit to normal operation. Therefore, there is no need to replace the fuse.
The first thing to consider in the design of medical electronic products is the requirements of risk management. For example, in addition to complying with the basic risk management requirements set forth in the ISO 14971 standard, it must also meet the requirements of IEC60601-1 Ed.3, IEC62304 and other standards. "In the actual risk management operation, equipment manufacturers should also pay attention to software risk management, post-marketing risk management, etc. In addition, in the design process, manufacturers should pay attention to data collection of similar products, especially when designing some high-risk products. It is very useful for equipment manufacturers, because if we can make a detailed analysis of the collected information, we can effectively avoid the mistakes that have been made by the predecessors and improve the design reliability." Zhou Saixin said.
Currently, the tools used in risk management are commonly used in Process Failure Analysis (PFMEA) and Design Failure Analysis (DFMEA). PFMEA performs failure analysis on the entire production process from the design to the production process; DEFEA performs failure mode impact analysis during the design process. These two analytical techniques are often used in products with high risk and very high reliability requirements. In the failure mode impact analysis, the level of risk is also judged from three points: severity, probability and detectability.
"The design of risk control has two key points. First, we must follow the principles of inherent safety, protective measures, and safety information. Second, we must do a good job of patient safety under a single fault." Zhou Saixin pointed out. Specifically, the trilogy of intrinsic safety, protective measures, and safety information is: If the risk is identified, the primary consideration is how to achieve the inherent design safety; when the inherent safety cannot be achieved, it should take protective measures and mark the safety information. . For example, the first consideration when designing a product is how to make it harm the voltage, instead of how to deal with it after the hazardous voltage; when the hazardous voltage is unavoidable, it should take protective measures such as insulation and stick it in the place where the hazardous voltage may occur. A warning label is displayed to remind the user.
reliabilityThe importance of reliability to medical electronics is self-evident. Due to the increasing complexity of the use environment, the reliability challenges faced by products are also increasing. For example, the previous equipment may only be used at the bedside, but now the in-hospital transshipment, out-of-hospital first-aid, etc. occur frequently. When moving medical equipment, there may be accidents such as dropping and collision; in addition, the load on the equipment is getting heavier and heavy, and many equipment are often used. It is 24 hours without shutting down or even shutting down for several months. How to ensure the reliability of the equipment under these circumstances is a problem that equipment manufacturers should consider.
The upgrading of the electronics industry technology has also brought new challenges to equipment manufacturers. The miniaturization of electronic devices and high-density packaging, high-density BGA/QFN soldering under lead-free technology is an important development trend, and it has become a 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. The current packaging with the industry chain capability is still 0402/0.5mm packaging technology. At this level, most products' SMT patches can guarantee a certain yield. And reliability, but medical electronics manufacturers are always faced with product reliability issues caused by miniaturized packaging. In addition, the continuous advancement of semiconductor technology has led to the rapid update of chips, and the reliability problems caused by chip replacement are inevitable. "When using a new chip, you need to pay attention to the early defects of the chip. Nowadays, the complexity of the chip is getting higher and higher. Don't think that the reliability of the chip will be guaranteed. Like the software, it will have some early immature factors. Using the new chip can enjoy the new technological advances it brings, but at the same time it faces certain risks." Zhou Saixin said.
Software reliability in product reliability design is also critical. Nowadays, the products are becoming more and more software. It is possible to develop a project with 70% or 80% of the energy. Zhou Saixin pointed out that software reliability design should pay attention to two points: the use of OTS software / SOUP software and the choice of operating system. OTS software/SOUP software is software of unknown origin. Some device manufacturers may download some driver software in the open source community. At this time, special attention should be paid because these softwares are not necessarily developed according to the requirements of medical devices. Reliability is difficult to guarantee. In addition, the choice of operating system is also directly related to the reliability of the product. At present, there are many operating systems, open source, closed, and real-time and GUI. Each operating system is mainly selected from the company's products and development. Starting from the ability, choose an operating system that matches your development capabilities.
Other key factorsThe design of medical electronic products needs to meet the safety requirements. Currently, the IEC60601-1 standard is a safety standard widely used in medical equipment worldwide. Since June of this year, Europe has enforced the third edition of the safety standards, which applies to all new and old products. In addition to risk management for safety and basic performance, the third edition of the standard also proposes two different concepts of operator protection measures (MOOP) and patient protection measures (MOPP), including bottom openings, Impact tests, altitude and pollution considerations, etc. New requirements for electrical safety and mechanical safety, equipment manufacturers should ensure that they meet the new requirements in safety regulations when developing products.
From the point of view of the ease of use design of medical products, the main ease-of-use problems faced by current products include false alarms, complicated setup and maintenance, and bidding-oriented function accumulation, which will lead to greatly reduced product usability. Zhou Saixin believes that the solution to the problem is intelligent design, such as adding intelligent alarm engine, intelligent lead switching, intelligent working status recognition and so on. In addition, new technologies for human-computer interaction, including language prompts, new display technologies, and touch UI applications, can be added to increase the usability of the device. He said: "Consumer electronics in the new environment have a great impact on doctors' habits, especially for handheld devices and digital products. Doctors also hope that the equipment used in their work will have similar characteristics."
Under the impetus of Internet technology, the use of wireless technology to achieve inter-device interconnection has become an important development trend of medical electronic products. WiFi, LAN, Bluetooth, ZigBee, 3G, etc. are common wireless technologies. Different wireless technologies have different characteristics and different scopes of application. "I personally are more optimistic about Bluetooth 4.0 technology, which can make the power consumption very low, to meet the current low-power design requirements of the product." Zhou Saixin said. He pointed out that wireless design should also consider a number of factors including frequency band selection, wireless authentication, data roaming, device positioning, pairing, and access speed.
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