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Biomedical device Technology: Principles and Design
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It is especially important in clinical settings, where errors are often intolerable. In a situation in which visual alarms might be overlooked, loud audible alarms to alert one to critical events should be available. For therapeutic devices, ergonomic studies should be carried out in the design stage to ensure that the procedures could be performed in an effective and efficient manner.
Critical devices should be intuitive and easy to set up. For example, a paramedic should be able to correctly perform a cardiac defib- rillation without going through complicated initialization procedures since every second counts when a patient is in cardiac arrest. Overview of Biomedical Instrumentation Each should be studied to identify the most appropriate choice for the application. A device should be ergonomically designed to minimize the strain and potential risk to the users, including long-term health hazards.
For example, a heavy X-ray tube can create shoulder problems for radiology technologists who spend most of their working days maneuvering X-ray tubes over patients. Studies show that user fatigue is a major contribu- tor to user errors. User fatigues include motor, visual, cognitive, and memo- ry.
Traditionally, human factor engineering is task-oriented. It examines and optimizes tasks to improve output quality, reduce time spent, and minimize the rate of error. Proactive human interface designers tend to be user-cen- tered, who integrate the physical and mental states of the user into the design, including the level of fatigue and stress, as well as recruit emotional feedback. Ideally, a good human interface design will produce a device that is both user-intuitive and efficient.
However, in most cases, there is a balance and trade-off between the two. An intuitive design is easy to use, that is, a user can learn to operate the device in a short time. However, the operation of such a device may not be efficient. An example of such a device is a PACS picture archiving and communication system using a standard computer mouse as the human machine interface between the user and the PACS.
The mouse is intuitive to most users. However, a radiologist may require going through a large number of moves and clicks to complete a single task.
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On the other hand, a specially designed, multibutton, task-oriented controller may be difficult to learn initially but will become more efficient once the radiologist has gotten used to it. Figure 1—11 shows the efficiency-time learn- ing curve of a device by a new user. The learning time for an intuitive device is shorter than a specially designed device, but the efficiency is much lower once the user becomes proficient with the specially designed device.
Traditionally, in designing a medical device, much attention is given to the safety and efficacy of the system. Time Figure 1— Learning Curve. A good medical device design should be aesthetically pleasing to the eye and will not interfere with the nor- mal routines of the patient. The patient may feel threatened when the clinician points it into his or her ear and pulls the trigger. It disturbs the sleep of the baby and may even inflict hearing damage. In designing a medical device, the ergonomics of maintenance tasks such as cleaning and servicing are often overlooked.
Apart from its desired appli- cation, a medical device will be handled by many parties during its life cycle. A device that has difficult-to-assess hollow cavities will have problems in cleaning and sterilization and hence is not suitable for some medical proce- dures. Some devices are not service-friendly; many poorly designed devices require extensive dismantling in order to get access to replacement parts such as lightbulbs and batteries.
Other devices may not have taken into con- sideration the operating environment, which in most cases will result in expensive and labor-intensive maintenance. An example is a fan-cooled device used in a dusty environment. In addition, poor design of accessories may increase the chance of incorrect assembly, which can impose unneces- sary risk on the patients.
A simple system has a single input and a single output. When we study a medical device using the systems approach, the first step is to analyze the input to the device. In most cases, input signal to biomedical devices are physiological signals.
fleecmilsancruff.tk In order to study the characteristics of the output, one must understand the nature of the processes that the device applies to the input. In addition to the main input and output signals, most medical devices have one or more control inputs Figure 1— These control inputs are used by the operator to select the functions and control the device. Table 1—3 lists some examples of input, output, and control signals in biomedical devices. Control Figure 1— Medical Device System. Table 1—3. Medical devices in many respects are similar to devices we use in every- day life.
In fact, most technologies used in health care were adapted from the same technologies used in the military, industrial, and commercial applica- tions. Since medical devices are used on humans, their reliability and safety requirements are usually more stringent than other devices. In addition, medical devices are often used in situations in which patients are vulnerable to even minor errors; therefore, special consideration in minimizing risk is necessary in designing medical devices.
Listed next are some of the factors and constraints in designing medical devices.
Therefore, very sensitive transducers as well as good noise rejection methods are required. Many signal sources are inside the human body and hidden by other anatomy. Biomedical measurements and procedures often require invasive means to obtain access to specific anatomy. For example, to access a nerve fiber for electrical activity measurement, the electrode must go through the skin, muscle, and other tissues.
Some measurement sites are very small. In order to measure the signal coming from these tiny sites while at the same time to avoid picking up the surrounding activities, special sensors that allow isolated measurement at the source are required. For example, in EMG measurement, needle electrodes with insulated stems are used to measure the electrical signal produced at a specific group of muscle fibers. As we cannot voluntarily turn ON or OFF, or remove tissue or organ to take a measurement, the measurand is subjected to much interference.
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