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Introduction To Biomedical Test Equipment

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Introduction To Biomedical Test Equipment

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    1. Introduction To Biomedical Test Equipment Michael R. Erwine Founder & Managing Director MRE Dynatech NV LLC Carson City, NV http://mredynatech.com

    2. Topics / Technology Areas Electrical Safety Testers Patient Simulators Non-Invasive Blood Pressure (NIBP) Simulators Electrosurgery (ESU) Analyzers

    3. Electrical Safety Testers The oldest piece of biomedical test equipment out there Various types Fully manual Semi-automated Fully automated With or without leads or applied parts connectors 120 VAC or 230 VAC or Universal AAMI ANSI ES1 or IEC (e.g. 60601) Test Loads 2-terminal & 4-terminal resistance measurement Specialty / special-purpose testers

    4. Why do we do electrical safety? Ensure patient safety Protect against macroshock Protect against microshock Test for electrical internal breakdown / damage to power cord, AC mains feed, etc. Meet codes & standards AAMI, IEC, UL, NFPA, etc. Protect against legal liability In case of a patient incident

    5. Simple Manual Testers

    6. Simple Manual Testers Require the user to manually. Select test mode Step through test steps manually Take readings manually from display Simple LED or LCD displays Rotary switches or pushbutton switches Low level / limited P functions Typically 15-amp or lesser service with low duty cycle ratings Typically utilize 2-terminal resistance technique

    7. Advanced Manual Testers

    8. Advanced Manual Testers ECG & performance waveform simulation Larger graphical displays on some newer models Some have RS232 or USB for remote control Some are rated at 20-amp (115 VAC) and have more robust duty cycles than simpler units Heavier duty construction than simpler units longer service life Typically utilize 4-terminal resistance technique and GFCI breakers

    9. Fully Automated Testers

    10. Fully Automated Testers Fully automated testing autosequences support minimal user intervention and adjustment Automatic comparison of leakage readings against accepted limits (regulatory standards) and flagging of out of tolerance results Some have internal test data record storage Some can print directly to an external printer Some have internal strip printers RS232, USB, Ethernet, Centronics printer ports High-level P functions Some have large graphical displays Some control other test equipment / peripherals Some interface to computerized record keeping software systems

    11. Specialty Testers TEE Transducer Electrical Leakage Current Testers

    12. Specialty Testers TEE transducer electrical leakage current testers Analyze the quality of the insulation barrier that protects the patient from internal electrical signals Advanced models store test results for printing Some models can adjust test voltage & frequency Advanced models support on-board user configurable libraries of manufacturer & model transducers with limits Meet requirements of major ultrasound manufacturers for TEE transducer testing

    13. Electrical Safety Testers How do they basically work? What do they all have in common? What are the subtle differences?

    14. Electrical Safety Testers

    15. Electrical Safety Testers

    16. Electrical Safety Testers

    17. Electrical Safety Testers

    18. Electrical Safety Testers

    19. Electrical Safety Testers

    20. Electrical Safety Testers

    21. Electrical Safety Testers

    22. Electrical Safety Testers

    23. Electrical Safety Testers

    24. Electrical Safety Testers

    25. Electrical Safety Testers

    26. Electrical Safety Testers

    27. Electrical Safety Testers

    28. Electrical Safety Testers

    29. Electrical Safety Testers

    30. Electrical Safety Testers

    31. Electrical Safety Testers

    32. Patient Simulators Two major types ECG Only ECG + some arrhythmias Multi-Parameter ECG + arrhythmias Respiration Cardiac Output Temperature Invasive Blood Pressure

    33. ECG-Only Simulators

    34. ECG-Only Simulators 5 or 10 lead models Very simplistic user interface Single 9-volt battery operation ECG NSR (Normal Sinus Rhythm) at variable rates Typically resistively divided lead outputs ECG Performance Waves Square waves (0.125 & 2 Hz) Sinusoidal waves at various frequencies (0.05, 0.5, 1, 10, 25, 30, 40, 50, 60, 100 Hz) Triangular wave (2 Hz) Pulse 1 Hz 80 ms Some arrhythmias in select models

    35. Independent vs: Resistively Divided Outputs Resistively divided Utilizes a resistor divider network to derive various lead & limb ECG signals at near-normal amplitudes but ALL waveforms are the same and only differ in orientation and amplitude Typically on ECG-only and lower cost multi-parameter simulators due to manufacturing cost Independent outputs Utilizes a separate DAC for each lead and produces physiologically correct ECG waveforms Usually in higher-level multi-parameter simulators only due to cost of manufacturing

    36. ECG-Only Simulators

    37. ECG-Only Simulators

    38. ECG-Only Simulators

    39. ECG-Only Simulators

    40. Multi-Parameter Simulators

    41. Multi-Parameter Simulators Advanced level simulation Much more complex user interface ECG output complete library Independently derived outputs on leads for high-end units Advanced library of arrhythimas Respiration various rates Selective reference electrode Temperature variable Cardiac Output Fetal / Maternal (some with mechanical Toco) Invasive blood pressures (IBP) Multi-channel (up to 4 independent channels) Physiologically synchronized outputs for ECG, IBP, Respiration, etc. Some models have advanced level controllers available

    42. Multi-Parameter Simulators

    43. Multi-Parameter Simulators

    44. Multi-Parameter Simulators - IBP

    45. Invasive Blood Pressure

    46. Fetal - Maternal Capability

    47. Multi-Parameter Simulators - CO

    48. Multi-Parameter Simulators CO

    49. Non-Invasive Blood Pressure Simulators (NIBP)

    50. NIBP Simulators NIBP is weird science simulation Manufacturer & model specific software algorithms at work in the NIBP monitor Parameters Systolic pressure Diastolic pressure Mean arterial pressure (MAP) Heart rate

    51. NIBP Simulators The data measured is 90. so what are the two specific test results based upon this data? This is the challenge of NIBP.

    52. NIBP Simulators Todays NIBP Monitors predominantly utilize oscillometric technology The NIBP Monitor actually directly measures ONLY the MAP and calculates the Systolic AND Diastolic values!!! Each technology manufacturer has their own proprietary algorithm for calculating Systolic & Diastolic pressure from MAP, as gathered during clinical trials. The Oscillometric NIBP simulator produces small pressure pulses to simulate the physiological phenomenon that is seen by the monitor as changing amplitude pressure pulses coming from the BP cuff. Even the acoustical characteristics of the blood pressure cuff and tubing used can have a dramatic effect on the NIBP measurements!

    53. NIBP Simulators

    54. NIBP Simulators

    55. NIBP Simulators

    56. NIBP Simulators

    57. Electrosurgery Analyzers

    58. Electrosurgery Analyzers Two general technologies Voltage measurement across the test load Current measurement through the test load Considered to be a high technology testing application Very few test equipment manufacturers due to technical challenges Check output of generators from 400 KHz to 4 MHz (current typical range of general surgery electrosurgery generators) Continuous output analyzers (conventional) Valleylab, Covidien, etc. Pulse output analyzers (newer technology) Conmed, Erbe, Synergetics, Peak Surgical, etc. Specialty generators with highly specialized outputs and capabilities bring specialized testing capabilities to the table

    59. Electrosurgery Analyzers Typical measurement parameters: RF current (ma) RF power (watts) Crest Factor (CF) the measure of Vpeak / VRMS 1.414 to 1000 range Duty cycle (pulsed waveforms) 1% - 100% range Through non-inductive test loads from 0O to > 5000O 5th generation parameters include Frequency Pulsed parameters such as time on, time off, total cycle time, duty cycle

    60. Electrosurgery Analyzers Five distinct generations of technology 1st: Simple RF Thermocouple Ammeters 2nd: Active processing voltage measurement units 3rd: Active processing current measurement units 4th: Advanced level voltage measurement units 5th: New generation current measurement units Ultra-high speed digital signal processing Only generation that can digest pulsed waveforms Closed loop communications with new technology generators

    61. Electrosurgery Analyzers

    62. Electrosurgery Analyzers

    63. Electrosurgery Analyzers Electrosurgery 101

    64. Electrosurgery Analyzers

    65. Electrosurgery Analyzers

    66. Electrosurgery Analyzers 1st Generation

    67. Electrosurgery Analyzers 2nd Generation

    68. Electrosurgery Analyzers 2nd Generation & Forward

    69. Electrosurgery Analyzers 3rd Generation

    70. Electrosurgery Analyzers 4th Generation

    71. Electrosurgery Analyzers 5th Generation

    72. Electrosurgery Analyzers

    73. Electrosurgery Analyzers

    74. Electrosurgery Analyzers

    75. Electrosurgery Analyzers

    76. Electrosurgery Analyzers

    77. Questions ?

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