Project 1
1A. A multi-parameter Patient Monitoring System (PMS) is used for multiple critical physiological signs of the patient to transmit the vital information like Electro cardiograph , Respiration Rate, Blood pressure etc. Therefore, multi parameter PMS has always been occupying a very significant position in the field of medical devices.Multiphysiological parameter medical devices must leverage ever-improving technology to meet demands for improvements in accuracy, functionality, and size, as well provide advances in data capture, transmission, storage, and compatibility—ultimately empowering improved healthcare and enhanced patient outcomes.
Beyond the basic lead II ECG (electrocardiogram), medical practice demands quick examination of an increasing array of vital signs—both real-time and trending—to better understand a patient’s current condition, improvement, or deterioration. A typical multiparameter device simultaneously looks at 12-lead cardiac ECG, oxygen saturation (SpO2), CO, hemoglobin, temperature, noninvasive blood pressure, invasive blood pressure, respiration, and implanted pacemaker activity. The multiparameter device used in sleep studies is different: it typically monitors ECG, EEG (electroencephalogram), EOG (electrooculogram), surface EMG (electromyogram), audio, and IR (infrared) temperature. In addition to ECG signals, some Holter monitors are now also recording three-axis acceleration and blood pressure.
Medical device manufacturers are constantly working with clinicians to provide a selectable mix of monitored parameters for specific theaters, from field emergencies through transport to a multidepartment clinical facility, which includes emergency department, intensive care suites, operating suites, post-anesthesia recovery, various labs and treatment suites, and general ward recovery, as well as offsite consulting specialists and freestanding medical providers. Each treatment arena may have differing levels of diagnostic demands, yet need to be compatible and connectable to medical records—including wireless exchanges.
The clinician demands robust, trouble-free operation at competitive costs. The biomedical staff requires rotational interchangeability to reduce model variances, while allowing straightforward use of the basic features without confusion. Recent additional regulatory oversight requirements call for superior detection of patient status deterioration with fully integrated interventions to reduce morbidities and mortalities.
The challenges for the device manufacturer are multiple: The designer of such medical equipment must ensure safety above all other considerations for the patient and the operator under all possible clinical use scenarios, including those of home use by lay patients. The designer must also keep abreast of ever-changing requirements for medical devices from regulatory agencies and must ensure compliance with quality standards for product development and manufacturing. The requirements and recommendations for medical devices vary from country to country; the medical device manufacturer must be aware of these “directives” and “regulations” to ensure compliance.
2A.
4A.
The safety requirements are those requirements that are defined for the purpose of risk reduction. Like any other requirements, they may at first be specified at a high level, for example, simply as the need for the reduction of a given risk. Then they must be refined so that their full details are provided to designers. The totality of the safety requirements for all risks forms the safety requirements specification. At the design stage, the safety requirements are provided by means of safety functions. These are implemented in “safety-related systems” which, as seen in Figure 5.3, need not be restricted to any given technology.
For example, a braking system may be hydraulic. A safety requirement may be met by a combination of safety functions, and these may be implemented in systems of different technologies – for example, a software-based system along with management procedures, checklists, and validation procedures for using it. When a safety function is implemented via software, there also needs to be a hardware platform, in which case a computer system is necessary. Then, the same demands are made of the entire system as of the software. Furthermore, the standard allows for more than one software safety function to be implemented on the same hardware platform, and it imposes rules for this.
ICU design is complex and should include both clinically oriented and design-based Multi-professional team members. Each team member will bring specialized skills and knowledge to focus on the project at hand, which might be a remodeling, an expansion, or a completely new ICU. It is likely that design team members will have been involved in healthcare and ICU projects; it would be less likely for the clinical team members to have been part of such an effort. However, it is helpful for the clinical team to become familiar with the design regulations to help with interdisciplinary team communications. Learning to communicate clearly with those outside of your field may be a challenge. The ultimate ICU design – in cost, size, and details – will most likely be a compromise that balances various, sometimes competing interests.
- Bedside Patient Monitoring Systems-The systems used to monitor patients within the walls of a hospital or doctor’s office are known as bedside patient monitoring systems (also known as “hospital patient monitoring systems”). The conventional bedside patient monitoring system consists of a collection of cords, sensors, and screens that surround a patient’s bed at a hospital. These kinds of monitors allow for continuous monitoring of a patient and the medical staff is continuously updated and informed of any changes in the stats. It also consists of communication links for displaying or recording the results. Sensors usually include biosensors and mechanical sensors. Translating components are responsible for converting the signals from the sensors to some format that can be displayed on the external display or recording device.
- Multi-parameter patient monitors (MPMs) have become more vital in providing patients with high-quality healthcare. The existence of an intrinsic association between distinct vital indicators in a healthy person is well acknowledged in the medical profession. In intensive care units (ICUs) and general wards, multi-parameter patient monitors (MPMs) are commonly used to continuously monitor patients’ health based on the following human vital parameters: heart rate, blood pressure, respiration rate, and oxygen saturation (SPO2). They are most widely used as bed side monitors.
Alarms were added to alert the operator to a condition that was about to exceed a design limit, or had already exceeded a design limit. Additionally, Emergency Shut Down (ESD) systems were employed to halt a process that was in danger of exceeding either safety, environmental or monetarily acceptable process limits.
Alarm were indicated to the operator by annunciator horns, and lights of different colours. (For instance, green lights meant OK, Yellow meant not OK, and Red meant BAD.) Panel boards were usually laid out in a manner that replicated the process flow in the plant.
So instrumentation indicating operating units with the plant was grouped together for recognition sake and ease of problem solution. It was a simple matter to look at the entire panel board, and discern whether any section of the plant was running poorly. This was due to both the design of the instruments and the implementation of the alarms associated with the instruments.
Instrumentation companies put a lot of effort into the design and individual layout of the instruments they manufactured. To do this they employed behavioural psychology practices which revealed how much information a human being could collect in a quick glance. More complex plants had more complex panel boards, and therefore often more human operators or controllers.
Alarms lists should be carefully designed to ensure that high priority alarms are readily identified, that low priority alarms are not overlooked, and that the list remains readable even during times of high alarm activity or with repeat alarms.
Alarms should be prioritised in terms of which alarms require the most urgent operator attention.
Alarms should be presented within the operators field of view, and use consistent presentation style (colour, flash rate, naming convention).
Each alarm should provide sufficient operator information for the alarm condition, plant affected, action required, alarm priority, time of alarm and alarm status to be readily identified.
Management systems should be in place to ensure that the alarm system is operated, maintained and modified in a controlled manner. Alarm response procedures should be available, and alarm parameters should be documented.
The performance of the alarms system should be assessed and monitored to ensure that it is effective during normal and abnormal plant conditions. The monitoring should include evaluation of the alarm presentation rate, operator acceptance and response times, operator workload, standing alarm count and duration, repeat or nuisance alarms, and operator views of operability of the system. Monitoring may be achieved by regular and systematic auditing.
11A.
The most common method of storing data was paper. People would use sheets of paper to document their lives, business dealings, recipes and other forms of information. Paper is still used but is easily destructed from day to day usage. Paper is also a hindrance on the environment since their origins are from our trees. The military, businesses, libraries and other types of organizations used microforms to story data. What is a microform? A microform is the process of reducing an array of images in size photographically or electronically. The images can then be enlarged via an optical viewer for reading or information reproduction. Microforms are used to store data in a compressed manner. (Britannica) There are two well know types of microform: microfilm and microfiche.
Microfilm is a spool of monochrome film containing compressed data. The data is retrieved by utilizing an optical machine to enlarge the data. Microfilm was very useful in storing newspapers, documents, book pages and library archives (TASI)
Microfiche, like microfilm, is a media used for storing data in a compressed manner. The data is retrieved by using a microfiche reader. The reader contains a flat glass holder that is positioned between a light source and an optical lens. The image is enlarged and projected onto a screen for data retrieval. (TASI)
Audio tapes are magnetic tapes used to record sound with the ability to replay the recorded sound. (Ask.com) Audio tapes, like microfiche and microfilm, are still used today but at a much lower volume. This form of data storage can be used to record books, journal thoughts, and document various information. The data is often retrieved by simply playing the audio tape. Doctors and lawyers still use audio tapes and they are transcribed by medical or legal transcriber.