Vital indicators are important in informing about the patient's condition and the severity of the disease in healthcare facilities. Patient monitors continuously monitor these vital signs and give warnings in the event of a serious incident. Each anomaly is important for alerting signal values to clients and to some extent provides direct physiological input data for monitoring connected life support devices.


COVID and other factors have led to an increase in patient admissions, increasing the demand for patient monitors worldwide. An aging population, increasing patient complexity and declining healthcare are detrimental to healthcare organizations. Lack of customers and technological advances have led to extra surveillance of patients at a distance.


Memories of medical devices still remain as important as ever. The FDA states that devices for monitoring vital signs have many different problems and do not adjust to - sometimes lead to patient injury. FDA database contains numerous bug reports NIBP, incorrect values of oxygen, ECG errors and hear any alarms for abnormal vital signal. This includes the importance of ensuring that patients monitoring systems are accurate and secure.


In addition, like all medical technologies, these monitors need to be regularly inspected and inspected to ensure that they are working properly and safely so as not to endanger the operator and patients. Regular performance tests at regular intervals are required to ensure that the monitors are working as intended.


The primary function of the patient monitor is to provide accurate data on all available vital indicators. Such accuracy is verified from time to time based on risk assessments, manufacturer's recommendations and monitor life cycle phases.


Performance tests are usually performed using calibrated simulators on multiple key signal parameters, and all involve acceptability testing, control cycle continuity, or correction. A typical test cycle for a key indicator monitor may include visual inspection, self-tests, electrical safety tests, test equipment integrity, accuracy of temperature parameters, pressure, SpO2, ECG, and respiration. Alarm tests for pitch, frequency and volume are required, as well as dynamic physiological simulations.


The patient simulation was performed using the following performance verification methods according to the medical device manufacturer's service manuals. In essence, the multiparameter patient simulator is used to test devices in a series of tests and provides a practical approach for biomedical techniques. Each parameter has a different performance testing method.


Non-invasive blood pressure


The principles of NIBP measurement depend mainly on the oscillometric method. It determines systolic, diastolic and mean arterial values by detecting vibrations in the arterial wall at various pressure points through an inflated cuff. Monitor accuracy testing includes static and dynamic pressure simulations at specific values; the method also includes system leak and overpressure tests, which are implemented with a manometer and built-in pump to ensure patient safety.


Invasive blood pressure


IBP is an invasive form of blood pressure measurement and uses a fluid catheter that is placed in an artery. Arterial pressure is converted to an electrical signal by a pressure transducer. Testing the linear sensitivity of the monitor is important to determine accuracy. The patient simulation was performed by performing the specified DCV values.


Pulse oximetry


SpO2 estimates the amount of oxygen in the blood by analyzing the light uptake by hemoglobin on two LEDs with different wavelengths (RED / IR). When more red light is absorbed than infrared light, there are fewer oxygenated blood cells. SpO2 simulation is commonly performed using optical simulation "fingers". These devices provide different red light attenuation and IR wavelengths.


Electrocardiograph


The ECG measures small electrical signals from the heart using ECG leads located on different parts of the body. These signals are amplified, measured and displayed on the patient monitor. ECG simulation of electrically generated cardiac arrhythmias as power curves with preset amplitudes and frequencies.


Respiration


Respiration uses an ECG lead to measure transthoracic impedance. As the chest cavity expands with inspiration, breast impedance increases. When exhaling, the breast impedance decreases. The respiration simulation includes a set of basic impedances with delta impedances that provide the respiration rate.


Temperature


Temperature measurements on patient monitors are primarily performed using NTC thermistors. This means that the resistance of the thermistor decreases with increasing temperature. The temperature simulation is provided by the set number of resistors depending on the sensor type (YSI400 / YSI700).


Why is testing important? Proper operation and operation of a medical facility is equally important to the function it performs. Thus, incorrect reading or missing condition can have many consequences for the patient; the person performing the maintenance must be technically competent, well trained and know the various parameters that need to be verified.


Therefore, as with any technology, the equipment must be regularly inspected and checked for proper and safe operation so as not to endanger the operator and patients. It is the responsibility of the medical device manufacturer to ensure verification procedures that ensure that maximum performance is achieved and maintained. The person or organization performing the maintenance must be familiar with the required procedures and operation of the medical facility. If in doubt, contact the manufacturer.


Scheduled maintenance inspections are also an important aspect of the life of medical electrical equipment. Procedures are required to ensure patient and operator safety, which include visual inspection, electrical safety tests (usually NFPA 99), performance and functional tests, and record keeping.


Always make sure you understand the function and operation of the equipment under test before beginning scheduled preventive maintenance. Without a full understanding of function and / or operation, visual inspections, electrical safety tests, and functional tests may be incorrect or incomplete. Before performing any tests, make sure that the manufacturer's recommendations are valid, as they often replace all instructions in the general inspection.


Regular performance checks on patient monitoring devices maintain accuracy and performance. This is especially important for modern healthcare providers and hospitals. Biomedical engineers, technologists and technicians have an important responsibility, but using the latest vital signs and testing equipment to monitor the patient can effectively contribute to compliance and performance requirements and ensure that safety measures can be effectively adhered to in all hospitals and healthcare facilities.  


MEDICAL DEVICES GLOBAL {MDG}