Testing medical equipment
Overview
This standard identifies the competences you need to carry out inspections and tests on medical equipment, in accordance with approved procedures. You will be required to carry out tests on a range of medical equipment, such as cardiovascular equipment, physiological monitoring and infusion equipment, anaesthetic and ventilation equipment, operating theatre and surgical equipment, medical imaging equipment, laboratory equipment, dental equipment, therapeutic equipment and mechanical/electromechanical Assisted Technology (AT) equipment, to establish that it is functioning at optimal level and to specification.
You will be required to carry out inspections and tests, which will include open and short circuits, resistance, insulation, earth bonding, pulse width/rise time, AC voltage/current levels, frequency, DC voltage/current levels, logic states, and temperature, pressure and flow measurements.
Your responsibilities will require you to comply with organisational policy and procedures for carrying out the testing activities, and to report any problems with these activities that you cannot personally resolve, or that are outside your permitted authority, to the relevant people. You will be expected to work with a minimum of supervision, taking personal responsibility for your own actions, and for the quality and accuracy of the work that you carry out.
Your underpinning knowledge will provide a good understanding of the procedures for carrying out the required inspections and tests, and will provide an informed approach to applying the necessary test procedures. You will understand the medical equipment being worked on, the test equipment being used, the various testing procedures and their application, in adequate depth to provide a sound basis for carrying out the activities, correcting faults, and ensuring that the equipment operates safely and correctly to the required specification and remains compliant with all standards and regulations. In addition, you will be expected to review the outcome of the tests, compare the results with appropriate specifications, determine the action required, and record/report the results in the appropriate format.
You will understand the safety precautions required when carrying out the inspection and testing activities, especially those for isolating the equipment, and for taking the necessary safeguards to protect yourself and others against direct and indirect electric shock. You will be required to demonstrate safe working practices throughout, and will understand the responsibility you owe to yourself and others in the workplace.
Performance criteria
You must be able to:
- work safely at all times, complying with health and safety legislation and other relevant regulations, directives and guidelines
- follow the appropriate procedures for use of tools and equipment to carry out the required tests
- set up and carry out the tests using the correct procedures and within agreed timescales
- complete and store all relevant documentation of the test outcome in accordance with organisational requirements
- review the results and carry out further tests if necessary
- dispose of waste materials in accordance with safe working practices and approved procedures and leave the work area in a safe condition
Knowledge and Understanding
You need to know and understand:
- the health and safety, infection control and de-contamination requirements of the work area and equipment being serviced, and the responsibility these requirements place on you
- the statutory and advisory documentation relating to medical devices (such as warnings and guidance from the regulatory authority, British and European standards)
- the importance of reporting any equipment adverse incidents to the regulatory authority
- your responsibilities under regulations relevant to the medical equipment testing activities being undertaken
- the isolation procedure that applies to the testing activities (such as electrical isolation, removal of fuses, placing of warning notices, proving that isolation has been achieved and secured)
- the isolation procedure(s) specific to the medical equipment being tested
- how to recognise and deal with victims of electric shock (to include methods of safely removing the victim from the power source, isolating the power source) including the difference of AC and DC electrical shock and how this affects the victim
- how to reduce the risks of a phase to earth shock (such as insulated tools, rubber matting, isolating transformers)
- the specific safety precautions to be taken when carrying out formal inspection, safety and circuit testing of medical equipment
- the hazards associated with testing medical equipment, and with the equipment that is used, and how to minimise them and reduce any risks
- the importance of wearing protective clothing, and other appropriate safety equipment (PPE) during the testing activities
- the importance of keeping the work area clean, tidy and free from waste and surplus materials
- how the testing activities may affect the work of others, and the procedure for informing them of the work to be carried out
- the procedures and precautions to be adopted to eliminate/protect against electrostatic discharge (ESD) when working on sensitive equipment or devices
- how to obtain and interpret the documentation required in the testing activities (such as drawings, flow charts, tables, logic symbols, circuit diagrams, specifications, manufacturers' manuals, test procedures)
- the basic principles of how the medical equipment functions, its operating sequence, the function/purpose of individual units/components, and how they interact
- how to determine the most suitable test points within the equipment
- how to set up the test equipment for the particular tests being carried out
- how to check that tools and equipment are free from damage or defects, are in a safe and usable condition, and are configured correctly for their intended purpose
- how to ensure that the test equipment used is within current calibration dates
- the various testing methods and procedures, and how to apply them to different equipment and operating conditions
- the importance of carrying out tests in the specified sequence, and what could happen if you do not
- what may cause errors or discrepancies with the test results, and how to avoid these
- whom to seek authorisation from if you need to alter or change the test procedures
- how to record the results of each individual test, the documentation that must be used and personal information
- how to interpret test results and make valid decisions about the acceptability of the equipment
- the types and limits of adjustments that can be made to the equipment on completion of the testing activity
- the procedure to be followed if the equipment fails to meet the test specification
- the environmental control requirements and organisational operating procedures relating to functional testing
- the documentation required, and the procedures to be followed, at the conclusion of the test
- the extent of your own authority and to whom you should report if you have problems that you cannot resolve
Scope/range
Carry out all of the following during the testing activities:
- plan the inspection and testing activities so as to minimise disruption to normal working
- obtain and use the correct issue of organisational and/or manufacturers' drawings and maintenance documentation
- adhere to procedures or systems in place for risk assessment, COSHH, personal protective equipment and other relevant safety regulations and procedures to realise a safe system of work
- ensure that the correct equipment decontamination procedure has been adhered to before and after testing
- ensure the safe isolation of equipment where necessary
- provide and maintain safe access and working arrangements for the testing area
- carry out the inspection and testing activities using appropriate techniques and procedures
- take electrostatic discharge (ESD) precautions when handling sensitive components and circuit boards
- return the equipment to service on completion of the testing activities
- dispose of waste materials in accordance with safe working practices and approved procedures and leave the work area in a safe condition
Carry out inspections and tests on three of the following types of medical equipment:
- cardiovascular equipment
- medical imaging equipment
- physiological monitoring and infusion equipment
- laboratory equipment
- anaesthetic and ventilation equipment
- dental equipment
- operating theatre and surgical equipment
- therapeutic equipment
- mechanical/electromechanical AT equipment
Carry out tests on medical equipment, using a range of tools and test equipment, to include all of the following:
- electrical safety analyser
- multimeter
- oscilloscope
- medical equipment simulators
- special purpose testing equipment
Plus two more from the following:
6. residual current (RCD) tester
7. oscilloscope
8. ammeter
9. voltmeter
10. logic analyser
11. signal generator
12. temperature measuring devices
13. logic probe
14. insulation resistance tester
15. flow measuring devices
16. built in test equipment (BITE)
17. pressure measuring devices
18. signal tracer
Carry out thirteen of the following tests/measurements:
- functional check
- pulse width/rise time
- performance tests
- continuity check
- heat dissipation
- condition of assemblies and components
- operating range check
- current leakage
- signal noise/interference levels
- logic states
- power output
- gas/fluid leak tests
- DC voltage/current levels
- protective conductor resistance values
- pressure
- AC voltage/current levels
- flow
- clock/timer switching
- soak tests
- temperature
- earth bonding
- safety device trip speed
- `special-to-type' tests
- open/short circuit
- frequency values
- resistance
Carry out all of the following checks to ensure the accuracy and quality of the tests carried out:
- the test equipment is correctly calibrated
- test equipment used is appropriate for the tests being carried out
- ESD precautions and procedures are applied
- test procedures to be used are up to date and follow laid-down procedures such as those given by manufacturer or local regulations
- test equipment is operated within its specified range
Complete and store all relevant documentation of the test outcome in accordance with organisational requirements, using one of the following:
- preventative maintenance log/report
- organisational-specific reporting procedure
- inspection schedule
- specific test report
- electronic reports