FAQs for Training & Test Lung Products and Software
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What is the fundamental purpose of a TTL?There are many situations in which the performance of ventilators or similar respiratory care equipment must be tested. One of the most common is in the Biomedical Engineering department of a hospital, where preventative maintenance testing is routinely performed for a wide variety of medical equipment. But there are many stages in a device’s life cycle at which testing is warranted. Development engineers need to test new ideas and mechanisms as new ventilator technologies are developed, and Production and Quality Control engineers must calibrate and assure the performance of the machines during manufacture. As wear and tear from use take their toll or problems otherwise develop, service personnel need to troubleshoot the systems in order to locate any problems and effect appropriate repairs. For training and teaching applications, use of a realistically simulated patient is also essential. Training the use of ventilators and the employment of various Respiratory Care techniques to medical professionals requires fidelity of the training scenarios, equipment and materials to the real-world, clinical setting. Training and test lungs provide the ability to simulate a huge variety of normal and pathologic pulmonary conditions, and cover the range from very small infant / pediatric to very large adult settings. Training and test lungs can also be used to simulate the spontaneously breathing patient; it is only through such simulation that some of the more advances modes of ventilation, such as Assist/Control, IMV/SIMV and Pressure Support can be taught.
Are there alternative devices currently on the market?In practice, many different types of equipment are used to test or otherwise assess the performance of ventilators and similar respiratory care equipment. These range from simple flow measuring devices, to electronically instrumented, flow meter based “ventilator analyzers”, to fixed and variable volume test lungs, and finally all the way to instrumented, computer controlled, spontaneously breathing lung simulators*. While each has their own advantages and disadvantages in terms of capabilities, convenience and cost, for most testing applications it is essential that at least the basic parameters of pulmonary compliance and resistance are realistically simulated. *Anderson JA: Ventilator Testing Comes of Computer Age. 24x7, June 2003, 35-39.
How are the parameters of pulmonary compliance and resistance realistically simulated?A realistic compliance load, in particular, has profound affects on gas flow, the action of many ventilator components and on the performance of ventilators and similar devices in general. In fact, standards-setting organizations like ASTM and ISO mandate that ventilators be tested under conditions simulating actual use, and using realistic compliance and resistance loads in particular*. *ASTM: F1100-1999 Minimum Performance Specification for Critical Care Ventilators.
In order to obtain accurate results when testing a ventilator, what types of variables interfere with the results?Gas is a compressible substance, and even at the relatively low pressures used in Respiratory Care, volume and flow rate measurements are very sensitive to changes in pressure. This characteristic affects ventilator testing in a number of ways; here are a few examples:
- In order to test the accuracy and reliability of flow and volume sensors that are so frequently part of modern ventilators, pressures and changes in pressures must be realistically simulated during testing of such machines.
- Gas output as part of a breath delivered by a ventilator, but which ends up compressed in the breathing circuit, never makes it to the patient. While many ventilators include sensors and software systems designed to compensate for this common phenomenon, complex mechanisms like this must be tested frequently to ensure their continued integrity and patient safety. Only by realistically simulating the compliance and resistance characteristics of use conditions is it possible to test such systems.
- Many components of ventilators, and especially many components of breathing circuits used in conjunction with ventilators, are designed to work with and respond to specific flow and pressure conditions in order to function properly. Only by realistically simulating the conditions under which these components are designed to operate can they be made to work correctly. Testing under any other conditions will cause these components to function differently, which can affect the apparent overall performance of the ventilator, and which denies the technician the ability to accurately assess the performance of the components themselves.
How does the TTL test lungs and PneuView system model the dynamic compliance characteristic of the human lungs?Pulmonary compliance changes throughout the inhalation and exhalation phases of a breath; this is as true for the TTL test lungs as it is for real, human lungs. The TTL test lungs and PneuView system correctly and accurately model the dynamic compliance characteristic, in addition to upper and lower airway resistances. Each lung is calibrated individually, and each installation of the software system is tuned to specifically match the lung(s) it is connected with. The Michigan Instruments, Inc. TTL/PneuView training and test lung systems are designed to simulate the pulmonary characteristics of patients of all ages, sizes and conditions.
Can the TTL test lung be used to simulate a spontaneously breathing patient?With the addition of the Breath Simulation Module, these devices may also be used to simulate the spontaneously breathing patient. The package of hardware, instrumentation and software provides an unparalleled capacity for testing all types of Respiratory Care equipment under conditions simulating those of actual use. None of the “flow meter” based devices marketed as “ventilator analyzers” can do this, including devices such as the “RT200”, “RespiCal”, “QA-VTM”, “VT Plus” and the “Certifier FA”.
Why do I need to test my ventilator?In a clinical setting, the concept of “ventilator performance” takes on a larger meaning. Even ventilator systems functioning exactly to specifications perform differently depending on the particular patient or other use conditions presented in various real life situations. Even within a specific ventilator system many different modes of operation may be available, and the mode(s) most appropriate for use in a given situation may be subject, at least in part, to certain patient or use conditions. Realistically simulated patient loads can be invaluable in these situations, and caregivers can make effective use of test lungs to allow the widest possible range of treatments to be investigated before application to the patient.
What is factory calibration?Factory calibration encompasses all aspects of sensor, electronic, mechanical and software tuning to ensure maximum accuracy of all measurements and simulated parameters provided by TTL/PneuView systems. Calibration procedures include setting of the compliance and resistance characteristics of the lungs and setting offset and gain characteristics for each of the pressure transducer channels.
Is it possible for the user to calibrate the TTL/PneuView system?Pressure and volume calculation accuracy may be easily verified with the aid of a calibrated syringe and independent pressure measurement device. All versions of the PneuView system ship with pre-formatted templates to aid the user with the verification of calibration accuracy. These templates include step-by-step instructions, which should be followed periodically to ensure maintenance of calibration accuracy or anytime accuracy comes into question, such as if the unit suffers some type of physical damage.
What are the typical settings for the TTL Training Test Lungs for simulating various pulmonary physiologies?The following conditions are based on a “standard” adult human patient who might normally be expected to exhibit pulmonary characteristics as follows: Dual Adult Lung Simulation Compliance: 0.05 L/cmH2O in each lung (0.10 L/cmH2O total compliance) Resistance: Upper airway: Rp5 Lower airway: Rp20 to each lung Single Adult Lung Simulation Compliance: 0.10 L/cmH2O Resistance: Rp20 Diseases affecting the airways: Chronic Obstructive Pulmonary Disease (COPD) – These conditions are characterized by increased resistance to airflow, particularly in the lower airways. Depending on the severity and duration of the disease, pulmonary compliance may be slightly depressed, and upper airway resistance may be increased if the simulated patient is assumed to be intubated. Dual Adult Lung Simulation: Compliance: 0.04 L/cmH2O in each lung (0.08 L/cmH2O total compliance) Resistance: Upper airway: Rp20 Lower airway: Rp50 to each lung Single Adult Lung Simulation: Compliance: 0.80 L/cmH2O Resistance: Rp50 Diseases affecting Lung Compliance: Emphysema – These conditions are characterized by decreased pulmonary compliance (increased lung stiffness). Airway resistance is typically unaffected by the disease, but may be increased if the simulation supposes the patient is intubated. Dual Adult Lung Simulation: Compliance: 0.02 L/cmH2O in each lung (0.04 L/cmH2O total compliance) Resistance: Upper airway: Rp5 Lower airway: Rp20 to each lung Single Adult Lung Simulation: Compliance: 0.02 L/cmH2O to 0.05 L/cmH2O Resistance: Rp20 Acute conditions: Acute Asthma Attack – Characterized by greatly increased airway resistance, with generally normal pulmonary compliance. Compliance will decrease, however, as the duration of the simulated attack increases. Dual Adult Lung Simulation: Compliance: 0.05 L/cmH2O in each lung (0.10 L/cmH2O total compliance) Resistance: Upper airway: Rp5 Lower airway: Rp50 to each lung Single Adult Lung Simulation: Compliance: 0.10 L/cmH2O Resistance: Rp50 Collapsed Lung – Characterized by drastically reduced compliance in the affected lung(s), with normal airway resistance values. If the simulated cause of the collapse includes a blocked airway, use a higher resistance value for that portion of the airway (e.g., replace Rp20 with Rp50). Dual Adult Lung Simulation: Compliance: 0.01 L/cmH2O in affected lung(s) (0.05 L/cmH2O in the normal lung) Resistance: Upper airway: Rp5 Lower airway: Rp20 to each lung Single Adult Lung Simulation: Compliance: 0.01 L/cmH2O to 0.05 L/cmH2O Resistance: Rp20 Pneumothorax / Hemothorax – Similar to the Collapsed Lung scenario, but decrease in pulmonary compliance may not be as marked. Dual Adult Lung Simulation: Compliance: 0.02 L/cmH2O in affected lung(s) (0.05 L/cmH2O in the normal lung) Resistance: Upper airway: Rp5 Lower airway: Rp20 to each lung Single Adult Lung Simulation: Compliance: 0.02 L/cmH2O to 0.05 L/cmH2O Resistance: Rp20
Can the PneuView System function with 3rd Party Equipment Management Programs?Several biomedical test equipment manufacturers develop and market systems used to manage the preventative maintenance (PM) testing and service for all manner of biomedical equipment. These programs typically manage a database of equipment information, test schedules, maintenance procedures and test results. Such systems are widely used to manage large fleets of medical equipment. The programs are meant to be used with a variety of specialized test apparatus, most of which would be manufactured by the same company. Such equipment includes electrical safety testers, electro-surgery testers, ultrasound testers, ECG simulators, etc. Many of these systems may be used as stand-alone equipment management databases or in conjunction with other, intermediary an often more portable, devices that interface directly with the various test apparatus during testing, but which then interface with the host computer system later so that test data may be assimilated into the central database management system. The PneuView system includes facilities allowing for simple compatibility with equipment management systems like those just described. These are designed to be straightforward and intuitive to any user of such a database system. There are at least two ways of linking test data taken by the PneuView system to such 32 database systems: one applicable if the user also employs an intermediary data collection device, and another if he/she instead interfaces directly with a computer hosting the equipment management system. If an intermediary device is used, PM and service templates for testing ventilators (for example) set up using the central equipment management program can be set to include a separate task item calling for a specific PneuView test to be performed as part of the maintenance or service work order (another task might be an electrical safety test). Such a test takes the form of a PneuView Template, designed by either the user or MII, specific to that ventilator. The technician can perform the electrical safety tests (for example) prompted by intermediary device, and then perform tests specified by the PneuView template(s). The intermediary device generates its results text file, and the data export facilities included with PneuView do the same. When the Sentinel 32 system is later used to close that work order, both tasks are closed and the appropriate results text file associated with each respective task is included with the respective test record. In cases where an intermediary device is not used (the norm for ventilator testing, in most cases), the scenario is simpler. Templates stored with the central equipment management system for ventilator tests include a task calling for tests using the PneuView system and detail using PneuView templates. After the user performs the required tests, PneuView generates a results text file, which the user would in turn associate with the test record when that task/work order is later closed using the equipment management system software. In either case, the procedure is straightforward. Equipment management programs generally include a facility for attaching at least a text file to each “Task” itemized on the work orders they are designed and used to generate. While attaching the text results file created by most intermediary devices is automatic, it is simple for the user to attach a separate text file to a task when closing a work order.