International standards are established for Maintaining Quality of Healthcare systems. The Regulations are applied at the Time of design and manufacturing which includes various mandatory requirements by Govt's for Pre Market Approval, Manufacturing, After Sales services etc; also it is mandatory to Test and Calibrate the Equipment in specified intervals at Hospitals. Eg: CE by European Govt, FDA by USA, Govt.
What is Test Equipment?
A patient can’t explain you their experience while undergoing a Therapy on a ventilator, but a ventilator test Equipment ‘Gas flow analyzer’ can ensure the safety, Performance and Effective delivery of Therapy. It is essential to Test and certify various equipments as per the International safety and Performance standards. Test Equipments can simulate and analyze the output of various medical equipments. Majorly Tests are performed for Safety and Performance aspects of specific Medical Device.
What is Testing Standard?
Standards are set of regulations applied for safety and Performance of Medical Equipment ensures optimal performance and reduces the risks to Patients and Users. Proper Testing and calibration will prevent Clinical accidents which results from poor performance of Equipments. Maintenance of equipments as per the standards also extends the life of Medical Equipments. Standards by IEC (International Electro Technical Commission),
Test Equipments
Few Major Test Equipments are explained below.
1. Electrical Safety Analyzer
A very Important Test Equipment for Ensuring Safety of Medical Equipments. It tests various parameters like, Leakage current, Insulation Resistance etc; A Thorough understanding of Electrical design of Medical Equipments, safety standards and operation of the equipment is required to perform the test.
2. Multipara Patient Simulator
Multipara patient Simulator can generate various vital signs like ECG, Spo2, Etco2, NIBP, IBP etc; importantly a simulator acts like a patient and it generates waveforms similar to various diseases/Physical conditions.
3. Electrosurgical Analyzer
Electrosurgery Unit is widely used in Operation Theatres Perform surgical procedures. High Frequency current waveforms of a Electrosurgery unit can be Tested with Electrosurgery Analyzer. Parameters are Power Output, Crest Factor, Return Electrode Monitoring.
4. Defibrillator Analyzer
Defib analyzer test the output of defibrillator. It can analyze Energy, Time, Waveform, Modes, Pacing and various other parameters of the defibrillator equipment.
5.Gas Flow Analyzer
Gas flow analyzers can Test various Parameters of a Ventilator Equipment. It helps in ensuring the desired performance as well as in performing calibration. Parameters Tested are Tidal Volume, FiO2, Pressure and Volume Parameters etc
6. X - Ray Analyzer
Comprehensive X-ray test tools include solid state detector, dosimeter, ion chambers, shunts etc. It can be used for Testing Radiographic, dental, fluoroscopic and CT imaging systems.
7. Infusion Analyzer
Variety of devices like volumetric pumps, drip meter, anesthesia pumps and ambulatory pumps can be tested with Infusion analyzer. It can test parameters like Volume, Flow rate, Time, Leakage etc.
8. Incubator and Radiant warmer Analyzer
An Infant can’t explain what is wrong with a Incubator or warmer. Incubators and radiant warmers confirm to IEC 60601-2-1 9
9. Fetal Simulator
It simulates Fetal and Maternity ECG as well as uterine activity to test and troubleshoot fetal monitors. Parameters : Tocco(Uterus Pressure), Fetal Heart Rate(FHR) etc
10. Lux Meter
Lux Meter is a device used for Measuring the Intensity in which the brightness appears to Human eye. It is used for testing various applications like Dental lights, OT lights, Surgical Head lamps, Light sources and Endoscopes.
11. Endoscopy Testing
Endoscopy quality testing reduces risks to Patients and Users. Testing parameters are Image Quality, Resolution, Field of view, Angle of view, Lens deformity, Channel breakage etc.
12. Dialysis Tester
Dialysis Tester is used for testing performance of a Dialysis system. It tests parameters like conductivity, Temperature, Pressure, Flow, pH etc
Dialysis Tester(Left Image)
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Register for online training from Fluke Biomedical where you can get the certification also.
https://www.flukebiomedical.com/knowledge-center/training
Fluke Biomedical is known for its accuracy and repeatability, Their are vast range of products available for BIOMEDICAL, Radiation etc. Fluke is only company which has most of Testing, Simulation, calibration instruments.
These are the Most expensive Tools of a Biomedical Engineer. Costs $2500 to $1.5L
Analyzer of the Analyzer