eps - project - Universitat Politècnica de Catalunya (UPC)
Transkript
eps - project - Universitat Politècnica de Catalunya (UPC)
EPS - PROJECT TITLE: PAEDIATRIC AND NEONATAL LUNG SIMULATOR STUDENTS: ZULKIFLY ABDULLAH ANNA BASIURAS ALEXANDRA DUMAN LAURA VISCARRI GARCIA SUPERVISORS: MARTA DÍAZ (EPSEVG) JOSÉ MATAS (EPSEVG) PEDRO BROTONS (SANT JOAN DE DÉU HOSPITAL) DATE: 9th of June, 2014 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR TITLE: PAEDIATRIC AND NEONATAL LUNG SIMULATOR FAMILY NAME: Abdullah FIRST NAME: Zulkifly HOME UNIVERSITY: EPSEVG SPECIALITY: Mechanical Engineering FAMILY NAME: Basiuras FIRST NAME: Anna HOME UNIVERSITY: Lodz University of Technology SPECIALITY: Biomedical Engineering FAMILY NAME: Duman FIRST NAME: Alexandra HOME UNIVERSITY: Polytechnic University of Bucharest SPECIALITY: Industrial Design Engineering FAMILY NAME: Viscarri Garcia FIRST NAME: Laura HOME UNIVERSITY: EPSEVG SPECIALITY: Industrial Design and Product Development Engineering 1 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR PREFACE The report in front of you has been written for the Lung Simulator (LS) project, carried out within the 2014 European Project Semester (EPS). The goal of this report is to give to all interested parties an overview of the proposed solution and how it has been developed after one semester (between February and June 2014). The project has been supplied by the ’Children’s Hospital Sant Joan de Déu’, represented by Pedro Brotons, and university ’Universitat Politècnica de Catalunya (UPC)’, represented by Marta Díaz. This year was the first year of cooperation with the hospital within EPS programme. The project team consisted of Anna Basiuras, Alexandra Duman, Zulkifly Abdullah and Laura Viscarri. We would like to thank all who had a positive contribution making this project and the final report possible. Our special thanks go out to our supervisor and two other professors at the UPC: to Marta Díaz who has offered her unique vision and guidance throughout the entire semester, to José Matas for his endless supply of knowledge and to Cristobal Raya who offered his assistance and provided us with laboratory equipment during the prototype testing. 2 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR ABSTRACT The aim of this project was to design a paediatric and neonatal lung simulator that would cover hospital’s needs, basically offering innovatory ventilation solutions through a compact, simple and low-cost product used for educational purposes. The proposed solution is able to represent various clinical scenarios via four adjustable features that have the possibility to be remotely controlled: air leakage, air resistance, bag compliance and spontaneous breathing generation which till now was only available in the most expensive and heavy lung simulators The spontaneous breathing generation represents the parameter shown through the prototype, which is made up out of a rigid structure obtained from the 3D Printer, an improvised bellow, a polyurethane foam case and a cylinder supplied by a professor. The testing was possible in a laboratory of the university because an air source and a proportional valve were needed. In hopes of a continuation of the project and manufacturing, recommendations for future students and next steps are enclosed in the final part of the report. Key words: lung simulator, mechanical ventilation, paediatric and neonatal patients, spontaneous breathing generation 3 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR INDEX PREFACE ........................................................................................................................................ 2 ABSTRACT ...................................................................................................................................... 3 1. 2. INTRODUCTION ..................................................................................................................... 8 1.1. ABOUT THE COMPANY .................................................................................................. 8 1.2. PROBLEM STATEMENT AND BRIEF ................................................................................ 8 1.3. PROJECT GOAL AND OBJECTIVES .................................................................................. 9 1.4. CONDITIONS AND CONSTRAINTS .................................................................................. 9 RESEARCH: STATE OF THE ART ............................................................................................ 10 2.1. 2.1.1. TYPES OF SIMULATION IN MEDICINE .................................................................. 10 2.1.2. EFFECTIVENESS OF SIMULATION IN LEARNING .................................................. 13 2.2. 3. SIMULATION IN MEDICAL STUDIES AND RESEARCH ................................................... 10 PAEDIATRIC LUNG SIMULATOR ................................................................................... 16 2.2.1. INTRODUCTION TO HUMAN RESPIRATORY SYSTEM........................................... 16 2.2.2. LUNG SIMULATOR ............................................................................................... 32 REQUIREMENTS ANALYSIS .................................................................................................. 49 3.1. CONTEXT OF USE ......................................................................................................... 49 3.1.1. USERS’ PROFILE ................................................................................................... 49 3.1.2. TASKS ................................................................................................................... 50 3.1.3. ENVIRONMENT AND SOCIAL CONTEXT ............................................................... 51 3.2. STAKEHOLDERS’ SPECIFICATIONS ............................................................................... 55 3.2.1. 3.3. 4. HOSPITAL’S CURRENT DEVICES ........................................................................... 56 REQUIREMENTS DETERMINATION .............................................................................. 60 DESIGN PROCESS ................................................................................................................. 63 4.1. IDEATION OF THE CONCEPT ........................................................................................ 63 4.1.1. MIND MAP........................................................................................................... 63 4.1.2. SKETCHING .......................................................................................................... 64 4.1.3. PRODUCT CONCEPT............................................................................................. 65 4.2. THE BAG ...................................................................................................................... 67 4.2.1. CONCEPTS DESIGN .............................................................................................. 67 4.2.2. CALCULATIONS AND RESULTS ............................................................................. 69 4.3. SPONTANEOUS BREATHING CONTROL SYSTEM ......................................................... 71 4 EPS/IDPS 2014 4.3.1. CONCEPTS DESIGN .............................................................................................. 71 4.3.2. CALCULATIONS AND RESULTS ............................................................................. 72 4.3.3. MECHANISM TO CONTROL THE SPONTANEOUS BREATHING ............................ 74 4.4. COMPLIANCE CONTROL SYSTEM ................................................................................ 79 4.4.1. CONCEPTS DESIGN .............................................................................................. 79 4.4.2. CALCULATIONS AND RESULTS ............................................................................. 81 4.4.3. MECHANISM TO ADJUST THE COMPLIANCE ....................................................... 82 4.5. RESISTANCE CONTROL SYSTEM................................................................................... 83 4.5.1. CONCEPTS DESIGN .............................................................................................. 84 4.5.2. CALCULATIONS AND RESULTS ............................................................................. 85 4.5.3. MECHANISM TO CONTROL THE RESISTANCE ...................................................... 87 4.6. 5. PAEDIATRIC AND NEONATAL LUNG SIMULATOR LEAKS CONTROL SYSTEM ............................................................................................ 91 4.6.1. CONCEPTS DESIGN .............................................................................................. 91 4.6.2. CALCULATIONS AND RESULTS ............................................................................. 92 4.6.3. MECHANISM TO CONTROL THE LEAKS................................................................ 92 4.7. CASE AND PRODUCT APPEARANCE ............................................................................. 96 4.8. THE REMOTE CONTROL ............................................................................................. 101 4.8.1. SELECTION OF THE SYSTEM............................................................................... 101 4.8.2. INTERFACE DESIGN ............................................................................................ 103 MATERIALS AND MANUFACTURING PROCESS .................................................................. 105 5.1. BAG ............................................................................................................................ 105 5.1.1. REASONS FOR CHOOSING THE MATERIAL ........................................................ 105 5.1.2. PROPERTIES ....................................................................................................... 107 5.1.3. MANUFACTURING PROCESS ............................................................................. 108 5.2. RIGID STRUCTURE ..................................................................................................... 109 5.2.1. REASONS FOR CHOOSING THE MATERIAL ........................................................ 109 5.2.2. PROPERTIES ....................................................................................................... 109 5.2.3. MANUFACTURING PROCESS ............................................................................. 110 5.2.4. SIMULATION ANALYSIS OF RESISTANCE............................................................ 111 5.3. TUBE .......................................................................................................................... 115 5.3.1. REASONS FOR CHOOSING THE MATERIAL ........................................................ 115 5.3.2. PROPERTIES ....................................................................................................... 115 5.3.3. MANUFACTURING PROCESS ............................................................................. 116 5.4. ELEMENT TO CONTROL LEAKS .................................................................................. 117 5 EPS/IDPS 2014 5.4.1. REASONS FOR CHOOSING THE MATERIAL ........................................................ 117 5.4.2. PROPERTIES ....................................................................................................... 117 5.4.3. MANUFACTURING PROCESS ............................................................................. 118 5.5. REASONS FOR CHOOSING THE MATERIAL ........................................................ 119 5.5.2. PROPERTIES ....................................................................................................... 119 5.5.3. MANUFACTURING PROCESS ............................................................................. 120 REASONS FOR CHOOSING THE MATERIALS ...................................................... 121 5.6.2. PROPERTIES ....................................................................................................... 121 5.6.3. MANUFACTURING PROCESS ............................................................................. 122 CASE........................................................................................................................... 124 5.7.1. REASONS FOR CHOOSING THE MATERIAL ........................................................ 124 5.7.2. PROPERTIES ....................................................................................................... 124 5.7.3. MANUFACTURING PROCESS ............................................................................. 125 5.8. CAP ............................................................................................................................ 126 5.8.1. REASONS FOR CHOOSING THE MATERIAL ........................................................ 126 5.8.2. PROPERTIES ....................................................................................................... 126 5.8.3. MANUFACTURING PROCESS ............................................................................. 127 PROTOTYPE TESTING ......................................................................................................... 128 6.1. COMPONENTS OF THE PROTOTYPE .......................................................................... 128 6.2. FUNCTIONING OF THE SYSTEM ................................................................................. 130 PRODUCT DEVELOPEMENT ............................................................................................... 132 7.1. MARKETING MIX ....................................................................................................... 132 7.1.1. PRODUCT ........................................................................................................... 133 7.1.2. PLACE................................................................................................................. 134 7.1.3. PRICE ................................................................................................................. 134 7.1.4. PROMOTION ...................................................................................................... 135 7.2. 8. ELEMENT TO CONTROL COMPLIANCE ...................................................................... 121 5.6.1. 5.7. 7. ELEMENT TO CONTROL RESISTANCE......................................................................... 119 5.5.1. 5.6. 6. PAEDIATRIC AND NEONATAL LUNG SIMULATOR COST STRUCTURE ...................................................................................................... 135 7.2.1. COST EQUATIONS .............................................................................................. 135 7.2.2. COST CALCULATIONS......................................................................................... 137 7.3. COMPARISON BETWEEN EXISTING LUNG SIMULATORS ........................................... 139 7.4. SWOT ANALYSIS ........................................................................................................ 140 CONCLUSIONS ................................................................................................................... 141 6 EPS/IDPS 2014 9. PAEDIATRIC AND NEONATAL LUNG SIMULATOR BIBLIOGRAPHY................................................................................................................... 143 9.1. WEBSITES................................................................................................................... 143 9.2. LITERATURE ............................................................................................................... 145 9.3. TABLES AND FIGURES ................................................................................................ 146 9.3.1. TABLES ............................................................................................................... 146 9.3.2. FIGURES ............................................................................................................. 146 10. TABLE OF FIGURES......................................................................................................... 148 11. TABLE OF TABLES.......................................................................................................... 151 12. APPENDIX ..................................................................................................................... 152 7 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR 1. INTRODUCTION Simulation in medicine as a way of teaching the future professionals is one of the most effective ways for students to acquire both theoretical and practical knowledge. This project is focused on simulating, in medical education, the scenario of a paediatric or neonatal patient that needs to be assisted by mechanical ventilation. The aim of including simulation classes for the students is to allow them to learn how they must interpret the graphs and signals emitted by the ventilator to which the patient is connected. To ensure that the simulated scenario is as close as possible to the real one, there is the need of designing a lung simulator that behaves as the real ones, representing standard clinical situations. 1.1. ABOUT THE COMPANY Children’s Hospital Sant Joan de Déu is the institution that has required the design of a new paediatric lung simulator. It is one of the leading medical centres in Europe for childhood and adolescence and offers a comprehensive and multidisciplinary approach to health care from birth through 21 years of age. The paediatric centre of the University of Barcelona is associated with the Clinic Hospital being the hospital alliance most well-known in Spain and one of the international references for highly specialized hospital care, teaching and research. Currently is attending annually more than 25,000 inpatient admissions, 200,000 outpatient visits and 115,000 emergencies. The hospital performs each year more than 14,000 surgical procedures and is attending around 4,000 births. The institution promotes innovation among professionals and gives them support so that they can carry out their ideas, patent them and make the prototype. At the moment the hospital has developed twelve patents that have generated two spin-offs. 1.2. PROBLEM STATEMENT AND BRIEF Current accurate lung simulators in the market are too expensive and sophisticated to be incorporated in a simulation room for educational needs, and the simplest ones are not reliable enough to teach different clinical situations of the patients. Demanding to have a complete lung simulator, Sant Joan de Dèu Hospital has facilitated a briefing for the project with the main features that the designed lung simulator must accomplish to cover their current needs: - Portable device, transportable in a small suitcase. - Two lung sizes: Neonatal lungs (25-50 ml) and paediatric lungs (125-250 ml). - Ability to generate pre-defined common clinical scenarios with several degrees of severity of lungs failure: Decrease of compliance, increase of resistance and creation of leaks. - High precision and reliability 8 EPS/IDPS 2014 - 1.3. PAEDIATRIC AND NEONATAL LUNG SIMULATOR All features remotely controlled (this requirement was added later after the first meeting with the hospital supervisors in April) PROJECT GOAL AND OBJECTIVES The aim of the project is to design a reliable, cheap and portable neonatal and paediatric lung simulator, which will be used for educational and research purposes. The principle objectives that wanted to be achieved in this project are the ones shown below: - Represent the main lung capabilities designing the corresponding internal mechanism. - Make the product Eco-friendly reducing the impact of its Life-cycle. - Deliver a compelling user experience that raises customer approval ratings by 100% over the previous product release. (UCD principles) - Increase the knowledge acquired by students through a reliable lung simulator. 1.4. CONDITIONS AND CONSTRAINTS The conditions for this project include the coordination between the members of the team and supervisors from the hospital and the university and an agreement with Sant Joan de Déu Hospital about our scope of the project. For the development of this project the constraint of time has to be considered, due to the fact of it being a project that must be done in 14 weeks and the constraint of the team’s background, taking into consideration that in some parts external collaboration was necessary. 9 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR 2. RESEARCH: STATE OF THE ART 2.1. SIMULATION IN MEDICAL STUDIES AND RESEARCH Medical simulation is a branch of simulation technology applied in education and training in different medical fields. Its main purpose is to train medical professionals to reduce accidents during surgery, prescription, and general practice. Currently, it is used to train students in anatomy and physiology during their medical courses to become health professionals. Although it is widely recognized the difficulty to represent through simulation the functioning of a human organ or function, technological advances have made possible to simulate practices from yearly family doctor visits to complex operations such as heart surgery. A thorough amount of studies have shown that students engaged in medical simulation training have overall higher scores and retention rates than those trained through traditional means. The main purpose of medical simulation is to properly educate students in various fields through the use of high technology simulators. 2.1.1. TYPES OF SIMULATION IN MEDICINE Medical simulation includes three ways of training depending on the devices used to develop the session: human simulation, mechanical simulation and virtual simulation. HUMAN SIMULATION It uses a trained role-player to act the part of a patient with a specific medical condition. The role-players are often professional actors, sometimes working under equity contract. Human surrogates are well-versed in the symptoms and behavioural effects of patients suffering from a variety of health problems, from coronary and respiratory diseases to stressrelated conditions and depression. In general, they have read the histories of real patients with the conditions they are simulating, and they memorize scripts written to reflect the complaints and symptoms. They are also trained to evaluate the student’s performance and to provide instruction that will enhance the learning experience. Due to ethical constraints, a major limitation of human surrogacy is the inability for students to perform invasive procedures and other therapeutic interventions that could be harmful to the role-player. Figure 1. Example of Human simulation 10 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR MECHANICAL SIMULATION It allows students to use mock (i.e., artificial) parts adequately mimicking the experience that would be gained from interacting with a real patient’s body, organs, or tissues. The classic mechanical simulator is probably Resusci Anne, an instructional mannequin used successfully for many years to train students in airway management, assessment of vital signs, other lifesaving procedures, and related skills for working in teams. The anatomical mock-ups are made from synthetic materials. Due to advances in materials science, the full- and partial-body mannequins have become remarkably realistic in appearance. Concurrent advances in engineering, miniaturization, and computer controls have also produced impressive improvements in the numbers and types clinical scenarios that can be replicated by mechanical simulators. Figure 2. Resusci Anne mannequin VIRTUAL SIMULATION It employs the latest advances in computer technology and visual interfaces to create acceptably realistic learning experiences. Medical applications of virtual simulation commonly employ the tools and techniques of popular video game platforms, such as Sony Play Station and Microsoft Xbox. At the most basic level, students in the health professions can use keyboard commands or joy sticks to interact with images of problems that would be encountered in clinical practice. SIMULATED VISION: 3D PHOTOREALISM The sensation of realistic vision in virtual simulation can be produced in several different ways. The most common is a head-mounted display that presents the wearer with a stereoscopic display via a separate view for each eye. Figure 3. Virtual dental implant training simulator 11 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR The second most-common approach to realistic visualization is the use of special lenses to create a stereoscopic view by merging two offset images in different colours projected on a flat screen. It is a high-end application of the optical technique used in theatres where viewers watch a movie through cardboard glasses with special lenses that sort the on-screen images into the right and left eyes. Finally, a few medical simulations have been created with direct projection of images on to the users’ retina or with holographic displays using laser light. Both approaches produce stunning images, but they are extremely expensive and dependent on equipment that is not widely available. SIMULATED TOUCH: HAPTICS To develop many medical skills, students need to be able to feel what they are doing as well as to see it. Knowing how much pressure to apply when inserting a needle or how hard to push a catheter into a body opening can make the difference between success and failure when a procedure is performed for the first time on a real patient. Therefore, successful medical simulation must accurately convey two types of physical sensation: Proprioception is the response felt within the student’s body when applying a force. It is, for example, the sensation of resistance felt when pressing a scalpel against tissue or the muscular tension experienced when holding a heavy instrument in one hand. Tactility is the body’s response to touch. Tactile sensations are feelings like the relative texture of skin (e.g., smooth to rough, dry to moist), the elevated forehead temperature of a patient with a fever, or the surface distortion caused by a subdural Figure 4. NeuroTouch is the world’s most advanced virtual reality neurosurgical simulator mass. Medical simulation must be able to give the learner a sense of force and touch consistent with the experience that will be encountered in treatment of a real patient. It must also convey these sensations in realistic sequence and alignment with procedures being performed. 12 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR 2.1.2. EFFECTIVENESS OF SIMULATION IN LEARNING HOW TO MEASURE THE EFFECTIVENESS OF SIMULATION The application of medical simulation should provide meaningful assessment of the students’ learning and the ability to reproduce the knowledge acquired in the lessons to the care of real patients. Therefore, simulation training must be done pointing the same goals as in traditional lessons. It is essential to identify measurable learning objectives to select the optimal teaching methodologies and appropriate approaches to assess the students. Although simulation lessons are more costly than traditional ones, it offers some instructional advantages that can justify any extra expense under the right circumstances: - Standardized teaching and evaluation can be assured in medical simulation. - Variations in instructors’ teaching abilities and grading practices are not a problem because an identical system can be used for all students in all settings. - To varying degrees, all three forms of medical simulation can be structured to respond constructively to different errors that students are likely to make. Corrective tutorials related to a student’s thought processes and actions can be embedded very effectively in virtual simulations. - Mechanical and virtual systems can also evaluate students’ responses to hazardous conditions that would not be allowed in learning environments where humans were present, for instance: dealing with an accidental release of mercury, responding to the explosion of a medical gas. To ensure the effectiveness of simulation it is needed to take into account human factors that influence the interaction between the user and the simulation device: - All the required equipment for the simulation must be user-friendly so that an instructionally valid learning experience is not diminished by a dysfunctional manmachine interface, such as malfunctioning equipment or ergonomically harmful positioning to use devices. - The technology should adapt to variations in users’ knowledge, skills, and approaches to learning rather than requiring the users to adapt to the technology. - Portability, versatility, ease of use, and other non-economic factors must also be considered. Research and evaluation of simulation as a teaching tool are beginning to mature in the health professions. Leaders in the field are creating a body of refereed journal articles to validate or invalidate medical simulation as an educationally effective and economically efficient alternative to traditional instruction. Many presentations at recent conferences on medical simulation have included comparisons of the new approach with traditional methods of instruction. 13 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR ADVANTAGES OF SIMULATION The use of simulations in medical education involves important advantages from an educational point of view, and converts simulation based on the ideal tool to overcome new challenges in medical education. It has been shown that the use of simulations shortens the time needed for learning skills, especially because it enables the students training as many times as necessary to acquire the skills trained. Based training simulation allows the students to make mistakes without real impact. The trainee is able to face challenging situations in a safe environment where errors are allowed and learn from them without harming the patient. Indeed, mistakes are learning experiences and offer great opportunities to improve through learning from them and from other students’ errors. This way of teaching allows the learning of practical experience in different types of environments, from the simplest and common ones to the most complex and unusual. The simulations based teaching allows the student to receive feedback in real-time from the teachers and peers and reflect on the action allowing a formative assessment type. Recent studies have supported the efficacy of screen-based and realistic simulators in enhancing technical, behavioural, and social skills in medicine. Identified learning outcomes involving simulation include: Improving Communication Simulations help students learn communication techniques due to the perception of student that their communication improved and simulations increased their confidence in communication. Understanding Classroom Material Skills are part of the material taught in the classroom. Students improve their understanding of the course material as a result of participating in clinical simulation scenarios. This is a benefit of incorporating simulation into nursing and medical programs because when students understand classroom material, they have the opportunity to synthesize knowledge from other sources. Developing Critical Thinking Synthesizing knowledge is one of the steps of critical thinking. Simulation is one of the best ways to help students develop critical thinking taking into account that during simulation classes, students are allowed to think spontaneously and actively in comparison with numerous theoretical lectures that are more passive. Simulation let the students to make decisions independently and take risks. This process helps them gain the critical thinking skills needed in their profession. On the other hand, students have the opportunity to apply theoretical knowledge in a safe and realistic setting during simulations in order to develop a systematic approach to solving problems. 14 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR Facilitating Teamwork Problem solving can effectively be done in teams. Collaborating with team members is also a characteristic of medical experts. Within the team, nursing and medical students have the opportunity to assume leadership roles during simulation, which is important to facilitate teamwork, as empirical evidence shows that individual performance does not provide optimum safety. Nursing students learn teamwork during simulations by functioning as a single, disciplined team. Multidisciplinary healthcare teams can also benefit from simulation experiences. 15 EPS/IDPS 2014 2.2. PAEDIATRIC AND NEONATAL LUNG SIMULATOR PAEDIATRIC LUNG SIMULATOR 2.2.1. INTRODUCTION TO HUMAN RESPIRATORY SYSTEM Before moving on to neonatal and paediatric lung description, the basic introduction to general aspects of respiratory system is necessary. The information presented in this chapter is mostly based on articles from websites of University of Nevada, Stanford School of Medicine and Paediatric Health Library of University of Minnesota Amplatz Children's Hospital. Human body contains a pair of lungs with one lung on both left and right side of the chest. The lungs are soft, made up of sections called lobes and protected by the ribcage. The left lung is composed of upper and lower lobe, as well as the lingula which is a small remnant next to the apex of the heart. The right lung has three lobes: upper, middle and lower. Figure 5. Human respiratory system: general view Figure 6. Human respiratory system: lungs The primary function of the respiratory system is supplying oxygen to the bloodstream and expelling waste gases, mostly carbon dioxide, from the body. The system is responsible for gaseous exchange between circulatory system and the outside world. Air is taken in via the upper airways (the nasal cavity, pharynx and larynx) through the lower airways (trachea, primary bronchi and bronchial tree) and into the small bronchioles and alveoli within the lung tissue. 16 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR BREATHING PROCESS Breathing in is called inspiration; it is a process when air fills the airways in the lungs. Oxygenrich air reaches the balloon-like air sacs – alveoli – at the end of the airways. Oxygen passes into the blood vessels surrounding the sacs. The blood then carries the oxygen to all parts of the body. As the body uses oxygen, it produces carbon dioxide, a waste gas, which the blood carries back to the lungs. While breathing out, carbon dioxide leaves the body through the airways, windpipe, and mouth or nose. Breathing out is called expiration. During inhalation and exhalation, the action of breathing in and out is caused by changes of pressure within the thorax, as compared with the outside environment. When a person inhales the intercostal muscles and diaphragm contract in order to expand the chest cavity. The diaphragm flattens and moves downwards and the intercostal muscles move the rib cage upwards and out. This increase in size reduces the internal air pressure so air from the outside (now with higher pressure than inside of thorax) rushes into the lungs to equalize the pressure. When we exhale, the diaphragm and intercostal muscles relax and return to their resting positions. This reduces the size of the thoracic cavity, thereby increasing the pressure and forcing air out of the lungs. Figure 7. Inhaling and exhaling process 17 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR RESPIRATORY TRACT Air containing oxygen enters the body through the nose and mouth. From there it passes through the pharynx or throat on its way to the trachea (windpipe). The trachea divides into two main airways called bronchi upon reaching the lungs; one bronchus serves the right lung and the other serves the left. The bronchi subdivide several times into smaller bronchi, which then divide into smaller branches called bronchioles. Figure 8. Human respiratory system: bronchi These bronchi and bronchioles are called the bronchial tree because the subdividing that occurs is similar to the branching of an inverted tree. After about 23 divisions, the bronchioles end at alveolar ducts. At the end of each alveolar duct, there are clusters of alveoli (air sacs). Finally, the oxygen transported through the respiratory system is transferred to the bloodstream at the alveoli. The trachea, main bronchi, and approximately the first dozen divisions of smaller bronchi have either rings or patches of cartilage in their walls in order to keep them from collapsing or blocking the flow of air. The remaining bronchioles and the alveoli do not have cartilage and are very elastic which allows them to respond to pressure changes as the lungs expand and contract. Bronchi and bronchioles are accompanied by blood vessels from the pulmonary arterial system. These blood vessels also branch into smaller and smaller units ending with capillaries, which are in direct contact with each alveolus. Gas exchange occurs through this alveolarcapillary membrane with oxygen moving into and carbon dioxide moving out of the bloodstream. Diffusing capacity measures the ease with which gas exchange takes place between the alveoli and capillaries. Certain lung diseases affecting the alveoli and capillary walls can interfere with diffusion and reduce the amount of oxygen reaching the bloodstream. 18 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR 2.2.1.1. Anatomy and physiology of children respiratory system There are several changes in anatomy and physiology of the children respiratory system when compared with the adult respiratory system. They will be explained in this chapter together with their consequences. A child’s respiratory system is similar to an adult’s one. However, some structures differ in size or position. For example, an infant’s tongue takes up more space in the mouth and an infant’s larynx is located in a higher position in the neck than it is in an adult. Below is a list of anatomy parts with their functions: The mouth and nose are the openings through which air enters and exits the body. Sinuses are air-filled chambers within the bones of the face. They help keep the nose moist and free of dust and bacteria. The pharynx is the cavity behind the mouth. The larynx is the upper part of the windpipe, which contains the vocal cords. The windpipe (trachea) provides a pathway for air to enter and exit the lungs. Epiglottis is a flap that covers the trachea during swallowing in order to prevent food from entering the lungs. The lungs are a pair of organs made of spongy tissue. They have five sections, or “lobes,” three in the right lung and two in the left. The lungs allow the body to receive oxygen and get rid of carbon dioxide. Bronchioles (airways) are stretchy “branches” that transport air throughout the lungs. Bands of muscles surround each bronchiole. Bronchioles get smaller as they go deeper into the lungs. Alveoli are clusters of balloon-like air sacs at the ends of the airways. Blood vessels are tubes that carry blood to the lungs and throughout the body. Tiny blood vessels surround the air sacs, allowing an exchange of oxygen and carbon dioxide. The pleural space is an area between the lungs and chest wall, lined on both sides by tissue called pleura. The diaphragm is a muscle in the abdomen that helps with breathing. Mucus is a sticky substance made by cells in the lining of the airways. It traps dust, smoke, and other particles from air breathed in. Cilia are tiny hairs on the cells of the airway lining. They sweep mucus up the airways and to the throat. In Cilia mucus gets swallowed or coughed out. 19 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR Figure 10. Alveoli and mucus Figure 9. Parts of respiratory system of a child The most important differences between adult and child anatomy are presented in table below: Anatomy part Child Adult Tongue Large Normal Epiglottis shape Floppy, omega-shaped Firm, flatter Epiglottis level Level of C3-C4 Level of C5-C6 Trachea Smaller, shorter Wider, longer Larynx shape Funnel-shaped Column-shaped Narrowest point Sub-glottic region At the level of vocal cords Lung volume 250 ml at birth 6000 ml Table 1. Anatomy differences for adult and child 20 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR OTHER PHYSIOLOGICAL CONSEQUENCES When children grow and their spine elongates, the airway enlarges and moves more caudally. Their airway is poorly developed in terms of cartilaginous integrity which allows more laxity throughout the airway. As a result of the narrow airway in children, the resistance is significantly increased according to the formula: R ~ 8l / r4 (where: R = Resistance, l = Airway length, r = Airway radius). Thus, even small change in the airway radius will increase the resistance four times and, as a result the work of breathing for an infant, e.g. in case of a small amount of post-extubation sub-glottic edema. Due to poor cartilaginous integrity children have more complaint trachea, larynx and bronchi which may result in increased work of breathing due to dynamic airway compression. Paediatric patients have more compliant chest walls which is also increasing the work of breathing since the outward pull of the chest is greater. Moreover, the respiratory muscles of paediatric patients require a significant amount of oxygen and metabolite. In particularly stressful situation, the work of breathing may correspond up to 40% of the cardiac output. Another issue to consider is Forced Residual Capacity (FRC) which acts basically as a respiratory reserve. FRC is defined as the residual volume plus the expiratory reserve volume and occurs when the outward pull of the chest wall equals the inward collapse of the lungs. In general, children have smaller FRC which may change when paediatric patients begin to develop respiratory distress. There are two situations where the reduced FRC is most important. Firstly, if the patient is in supine position (lying down), the FRC could be smaller, up to 30% in comparison with sitting patients. The influence on FRC is caused by the fact that the abdominal contents push up on the diaphragm in a supine patient. There are also a few factors applying specifically for the paediatric patient which include a compliant chest wall, small thoracic cage and large abdominal contents. Secondly, the reduced FRC has great impact during pre-oxygenating a patient prior to intubation. It decreases the amount of time allowed to establish an endotracheal tube prior to desaturation. 21 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR 2.2.1.2. Lung Test Parameters There are several lung function tests and they are used for the following purposes: To determine how much air lungs can hold, how quickly the air is moving in and out of the lungs and how well the lungs put oxygen into and remove carbon dioxide from bloodstream. To diagnose lung diseases, measure severity of lung problems and control how well lung treatment is working. Less common are gas diffusion tests which measure the amount of oxygen and other gases that cross the alveoli per minute. These tests evaluate how well gases are being absorbed into the bloodstream from the lungs. Most common lung function test is called spirometry. During the test, a patient breathes into a mouthpiece attached to a recording device (spirometer). The information collected by the spirometer is usually printed out on a chart called a spirogram. The most common lung function parameters measured with spirometry are: Forced Vital Capacity (FVC): The amount of air that can be exhaled with a maximal effort after a maximal inhalation Tidal Volume (TV): The volume of air that is inhaled or exhaled with each breath during quiet, relaxed breathing. Expiratory Reserve Volume (ERV): The maximal amount of air forcefully exhaled after a normal inspiration and expiration. The amount of exhaled air should be greater than the amount inhaled. Inspiratory Reserve Volume (IRV): The maximal amount of air forcefully inhaled after a normal inhalation. Residual Volume (RV): The amount of air remaining in the lungs after the deepest exhalation possible. Vital Capacity (VC): The maximum amount of air that can be exhaled after the fullest inhalation possible. Vital capacity is the sum of the tidal volume, the inspiratory reserve volume, and the expiratory reserve volume. Total Lung Capacity (TLC): The sum of the vital capacity and the residual volume. 22 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR 2.2.1.3. Malfunctioning and diseases AIR LEAKS IN THE NEWBORNS One of the malfunctions of the lungs is air leaks. It takes place when alveoli rupture (break) which causes air to leak into the space between the lungs and the chest wall. These air leaks result in problems with breathing and can lead to lung damage. Below the circumstances due to which the air leaks may occur are listed: Being on a ventilator (breathing machine) for a breathing problem. The pressure of the air provided by the ventilator could cause alveoli to rupture. Meconium aspiration syndrome, a health problem that causes the lungs to become irritated, damaged, and overinflated (filled with too much air). Respiratory distress syndrome, a common problem in premature babies that is a result of immature lung development and causes difficulty in breathing. Vigorous crying, which causes the alveoli to rupture. Some babies cry hard enough to do this at birth, or soon after. Lung problems that require the baby to work harder to breathe. Congenital problems, such as an underdeveloped lung. Unknown causes. There are three main types of air leaks. Their characteristics are presented below. Pulmonary interstitial emphysema (PIE): Tiny ruptures occur in the alveoli, allowing air to leak out into the lung tissue. This puts pressure on the surrounding alveoli. Too many of these tiny leaks can lead to the more severe problems (pneumothorax and pneumomediastinum) which are described below. Pneumothorax (collapsed lung): Air gets trapped between the chest wall and the lung. This trapped air puts pressure on the lung, preventing it from inflating. Thus, the baby has trouble breathing. Pneumomediastinum: Air leaks into the chest, into the space between the two lungs. The trapped air puts pressure on both lungs. 23 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR Figure 12. Air leak treatment Figure 11. Collapsed lung in infant The treatment of air leaks in children depends on severity of air leaks. If the baby is not having breathing problems, treatment probably isn’t needed since a small air leak may heal by itself. For more severe cases, possible treatments include the following: A needle or catheter (small, flexible tube) is inserted into the space between the lungs and the chest wall in order to draw air out. This process helps remove the air that leaked out, so breathing can return to normal. If a lot of air leaked out, though, further treatment may be needed. A chest tube is inserted into the space between the lungs and the chest wall. The chest tube is attached to a suction device that pulls out the trapped air, so the lungs can expand once again. This allows the tear to heal. However, it may take a few days for the tear to heal. The chest tube will stay in during this time. The baby may need breathing support (such as supplemental oxygen or a ventilator) until the air leak heals. 24 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR CHILDHOOD ASTHMA WHAT IS ASTHMA? D Asthma is a chronic (long-term) lung condition in which the airways are inflamed and narrowed, making it harder to breathe normally. WHAT ARE THE SYMPTOMS OF ASTHMA? Children with asthma typically suffer from at least two of the following symptoms: Wheezing (a whistling noise in the chest). Shortness of breath. A tight feeling in the chest (children may say their chest or tummy hurts). Coughing. Figure 13. Childhood bronchial asthma Other signs and symptoms of childhood asthma include: Trouble sleeping caused by shortness of breath, coughing or wheezing. Bouts of coughing or wheezing that get worse with a respiratory infection, such as a cold or the flu. Delayed recovery or bronchitis after a respiratory infection. Trouble breathing that may limit play or exercise. Fatigue, which can be caused by poor sleep. Symptoms normally come and go, often unpredictably. There is a wide variation in the severity, frequency and duration of symptoms. One child’s experiences can be very different to another’s. Many children find their symptoms are worse at night and that they are provoked by particular irritating substances or circumstances known as ‘triggers’. 25 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR CAUSES The underlying causes of childhood asthma aren't fully understood. Developing an overly sensitive immune system generally plays a role. Some factors thought to be involved include: Figure 14. Evolution of the disease Inherited traits. Some types of airway infections at a very young age. Exposure to environmental factors, such as cigarette smoke or other air pollution. Increased immune system sensitivity causes the lungs and airways to swell and produce mucus when exposed to certain triggers. Reaction to a trigger may be delayed, making it more difficult to identify the trigger. These triggers vary from child to child and can include: Viral infections such as the common cold. Exposure to air pollutants, such as tobacco smoke. Allergies to dust mites, pet dander, pollen or mould. Physical activity. Weather changes or cold air. 26 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR EOSINOPHILIC LUNG DISEASES Eosinophils are a type of white blood cell. High numbers of eosinophils (eosinophilia) are generally associated with allergies or are a response to being infected by a parasite, known as an infestation. It can affect the airways, resulting in asthma or allergic Broncho pulmonary aspergillosis (ABPA), a complication of sensitisation to a fungus called aspergillus. Sometimes it affects the alveoli (tiny air sacs) inside the lungs that are involved in the exchange of oxygen and carbon dioxide as we breathe in and out or even the lung vessels (Churg Strauss syndrome). This type of lung disease is rare in children, except when it is caused by parasites. Usually the diagnosis is made by detecting too many eosinophils in the blood and seeing shadows on a chest X-ray, which are due to collections of eosinophils in the lungs. The most common parasites that cause eosinophillic lung diseases are ascaris lumbricolides, toxocaria canis and filaria. The immature forms of the parasites, called larvae, move through the lungs. Symptoms include sudden onset or gradually developing symptoms of breathlessness, wheeze, cough or fever. In cases caused by parasites, the liver, spleen and lymph nodes – the small, oval glands that form part of the immune system and remove unwanted bacteria and particles from the body - often also become enlarged. 27 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR OBSTRUCTIVE SLEEP APNOEA DESCRIPTION OF OSA Obstructive sleep apnoea (OSA) is the term used to describe the most common breathing disorder that happens during sleep. Obstructive = there is obstruction of the airway in the nose, throat or upper airway. Sleep = it happens when your child is asleep. Apnoea = this is a Greek word that means ‘without breath’ – there is not enough air going down into the lungs. When a person goes to sleep, the muscles relax, including those in the throat. In some children, especially those with enlarged tonsils or adenoids, the relaxed muscles cause narrowing, which can reduce the airflow. This can cause snoring and irregular breathing. If the throat obstructs (closes) completely, a child might temporarily stop breathing. This is called ‘apnoea’. If the throat partially closes, breathing is reduced. This is called ‘hypopnoea’. When breathing is interrupted or reduced, there may be a fall in the level of oxygen in the blood. Sensors in the brain will tell the body to re-start or increase breathing. Breathing often re-starts with a gasp or snort. When the problem is severe this can happen many times each night and disturb the quality of sleep. This causes irritability, poor concentration and sometimes drowsiness the following day. HOW COMMON IS IT AND WHAT ARE THE RISK FACTORS? OSA is quite common and may affect up to 1 in 30 children. It affects boys and girls equally. The following factors increase the likelihood that children will be affected. Common factors: Large tonsils and adenoids. Obesity. Family history of OSA. Down’s syndrome. Sickle cell disease. Rarer factors: Craniofacial malformations such as an abnormally small chin, large tongue or cleft palate. An extremely narrow upper airway. Rare diseases of the nerves or muscles, which cause loss of upper airway tone because of poor muscle strength. Problems with control of breathing. 28 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR PULMONARY HYPERTENSION Figure 15. Pulmonary hypertension PULMONARY HYPERTENSION IN NEW-BORN BABIES Pulmonary hypertension is when the blood in the arteries of the lungs is at an abnormally high pressure. It occurs in about 0.2 per cent of live births. The changes that normally happen to the circulation at birth do not occur and circulation continues in the same way as before birth. This means that blood flows in the wrong direction through the new-born baby’s heart. It is a very serious situation and requires early surgical treatment, because not enough oxygen reaches the baby’s vital organs. PH in new-born babies is sometimes due to asphyxia (lack of oxygen) during birth, infection, congenital heart disease or incomplete development of the lungs. When there is no known cause it is referred to as primary pulmonary hypertension. PULMONARY HYPERTENSION IN CHILDREN When PH occurs later in childhood it’s usually a complication of a severe lung problem, such as cystic fibrosis, lung fibrosis (scarring) or the sleep disorder obstructive sleep apnoea. It can also cause complications with diseases of the nerves and muscles or congenital heart disease. It can also happen as a result of an abnormality in the lung arteries themselves, for example clots in the blood vessels in the lungs or a clot (embolism – pleural emboli) travelling through the circulation from elsewhere. Occasionally, emboli are not formed from clots of blood, but are clumps of infected material that have broken off and travelled in the blood from an abscess somewhere else in the body. Lung clots may also be due to abnormalities in the blood’s clotting function and very rarely PH is due to an abnormal overgrowth of tiny vessels (invasive pulmonary capillary haemangiomatosis). 29 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR RESPIRATORY SYNCYTIAL VIRUS Respiratory syncytial virus (RSV), which causes infection of the lungs and breathing passages, is a major cause of respiratory illness in young children. Infants most at risk from RSV are: Premature babies in the first few months of their life Babies born very early who need additional oxygen for more than one month after birth Babies with congenital heart disease Babies with immune problems Babies with cystic fibrosis SYMPTOMS Signs and symptoms of respiratory syncytial virus infection typically appear about four to six days after exposure to the virus. In adults and older children, RSV usually causes mild cold-like signs and symptoms. These include: Congested or runny nose. Dry cough. Low-grade fever. Sore throat. Mild headache. In severe cases: Figure 16. RSV-Respiratory syncytial virus High fever. Severe cough. Wheezing — a high-pitched noise that's usually heard on breathing out (exhaling). Rapid breathing or difficulty breathing, which may make the child prefer to sit up rather than lie down. Bluish colour of the skin due to lack of oxygen (cyanosis). Infants are most severely affected by RSV. They may markedly draw in their chest muscles and the skin between their ribs, indicating that they're having trouble breathing, and their breathing may be short, shallow and rapid. They may cough. Or they may show few, if any, signs of a respiratory tract infection, but will eat poorly and be unusually lethargic and irritable. Most children and adults recover from the illness in one to two weeks. But in young babies, infants born prematurely, or infants or adults who have chronic heart or lung problems, the virus may cause a more severe — occasionally life-threatening — infection that requires hospitalization. 30 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR RESPIRATORY DISTRESS SYNDROME This affects babies who are born too early (premature) whose tiny, immature lungs are unable to inflate properly and deliver enough oxygen to the body. It happens as a result of a combination of factors: being born early and a lack of a substance called surfactant. This helps the lungs to expand and keeps them inflated, preventing the air sacs inside the lungs from collapsing. If your baby doesn’t have enough surfactant in their lungs, air sacs will collapse every time they take a breath, causing their oxygen levels to fall. Neonatal respiratory distress syndrome is the leading cause of death in babies, accounting for 20 per cent of the deaths in new-borns. The more premature the baby, the more likely it is he or she will have respiratory distress syndrome. It is twice as common in boys as girls and more likely to occur: After Caesarean section. If there is lack of oxygen before birth. If the mother is diabetic. It usually presents immediately after birth. Symptoms include blue skin and very distressed breathing, characterised by fast, shallow and irregular breaths. The baby’s chest often draws inwards when they take a breath, which may be accompanied by a grunting sound. Levels of oxygen in the blood are very low, so treatment is needed urgently and involves administering carefully controlled oxygen, usually with the help of a ventilator or breathing machine. Surfactant can be given as a treatment down the breathing tubes. 31 EPS/IDPS 2014 PAEDIATRIC AND NEONATAL LUNG SIMULATOR 2.2.2. LUNG SIMULATOR 2.2.2.1. Description and elements Mechanical ventilation has revolutionized the treatment of critically ill and post-operative patients by making it possible to ventilate and oxygenate patients with markedly reduced lung function. It has facilitated advances in cardiac surgery, improved the survival of premature infants, and helped the recovery of trauma victims. Technological advances have resulted in the development of increasingly sophisticated modes of artificial ventilation, permitting the successful ventilation of very ill patients. Enhanced monitoring modalities have improved the safety of mechanical ventilation, allowing it to become a frequently used life-sustaining therapy. Yet like many rapidly advancing technologies there comes a time when it becomes necessary to rethink the direction and contemplate the consequences of what is being done. Mechanical ventilation is undergoing such a re-examination, from both scientific and economic perspectives. Many principles have been questioned, and the answers have often reversed what were previously considered basic tenets. This article reviews some of these issues and examines what has prompted this review process and the changes in practice that have ensued. A mechanical lung simulator is described (an extension of a previous mechanical simulator) which simulates normal breathing and artificial ventilation in patients. The extended integration of hardware and software offers many new possibilities and advantaged over the former simulator. The properties of components which simulate elastance and airway resistance of the lung are defined in software rather than by the mechanical properties of the components alone. Therefore, a more flexible simulation of non-linear behaviour and the cross-over effects of lung properties is obtained. Furthermore, the range of lung compliance is extended to simulate patients with emphysema. The dependency of airway resistance on lung recoil pressure and trans mural pressure of the airways can also be simulated. The new approach enables one to incorporate time-related, mechanics such as the influence of lung viscosity or cardiac oscillation. The different relations defined in the software can be changed from breath to breath. 32 EPS/IDPS 2014 PEDIATRIC AND NEONATAL LUNG SIMULATOR The main parts of the lung simulator system, including all the devices that can be involved, and the parameters they should be able to show and control are represented in the next figure: 1.2 DISPLAY INTERFACE 3 BODY (MANNEQUIN) 1 VENTILATOR 1.1 CONTROL INTERFACE 2 LUNGS (BAG) - Flow rate - Spontaneous breathing - Pressure - Resistance of airways - Real time monitoring of respiration curves - Leaks of air - Compliance (lung elasticity) - Volume of air 2.1 REMOTE/ MANUAL CONTROL OF LUNG PARAMETERS Main elements Input and output elements Communication Controlled parameters Figure 17. Elements of a Lung Simulator system 33 EPS/IDPS 2014 1. PEDIATRIC AND NEONATAL LUNG SIMULATOR VENTILATOR In its simplest form, a modern positive pressure ventilator consists of a compressible air reservoir or turbine, air and oxygen supplies, a set of valves and tubes, and a disposable or reusable "patient circuit". The air reservoir is pneumatically compressed several times a minute to deliver room-air, or in most cases, an air/oxygen mixture to the patient. If a turbine is used, the turbine pushes air through the ventilator, with a flow valve adjusting pressure to meet patient-specific parameters. When overpressure is released, the patient will exhale passively due to the lungs' elasticity, the exhaled air being released usually through a one-way valve within the patient circuit called the patient manifold. The oxygen content of the inspired gas can be set from 21 percent (ambient air) to 100 percent (pure oxygen). Pressure and flow characteristics can be set mechanically or electronically. Mechanical Ventilator aims to avoid fatigue in patients while keeping the gas exchange vital for life. Typically, during Mechanical Ventilation, the patient inspiratory effort triggers a ventilator that pumps a mixture of air (Oxygen + other gases) through the central airways into the lungs inflating them and increasing the intraalveolar pressure. When the ventilator stops the central airway pressure decreases and air passively flows from the higher pressure lungs to the lower pressure central airways. Triggers that can be used when the ventilator is not automatically are: 1.1. Pressure trigger- the patient effort reduces the pressure till a certain sensitivity value that, when surpassed, activates the ventilator. Flow trigger-the activation of the ventilators take place when the flow, nduced by the pacient effot, surpass a cutoff value. Electrical activity of the diaphragm-the ventilator is activated when the integrated electrical activity of the diaphragm surpasses a treshhold. CONTROL INTERFACE Computer control of mechanical ventilators includes the operator-ventilator interface and the ventilator-patient interface. New ventilation modes represent the evolution of engineering control schemes. The various ventilation control strategies behind the modes have an underlying organization and understanding that organization improves the clinician’s appreciation of the capabilities of various ventilation modes. Through the control interface certain parameters must be controlled, such as resistance, compliance, spontaneous breathing and leaks. The interface must be user centred for an easy and understandable use. All modern ventilators use closed-loop control to maintain consistent pressure and flow waveforms in the face of changing environmental conditions. Closed-loop control is accomplished by using the output as a feedback signal that is compared to the operator-set input. The difference between the two is used to drive the system toward the desired output. For example, pressure-controlled modes use airway pressure as the feedback signal to control 34 EPS/IDPS 2014 PEDIATRIC AND NEONATAL LUNG SIMULATOR gas flow from the ventilator. Manufacturers typically do not use flow at the airway opening as a feedback signal, because they do not trust the flow sensors available for that purpose. Instead, they measure flow inside the ventilator, near the main flow-control valve. Closed-loop control uses a sensor to measure the output of the effector. This signal is passed to a comparator (represented by the circles) that essentially applies a simple equation: error=input-output. If the error in the effector output is large enough, an error signal is sent to the controller. The controller then adjusts the effector so its output is closer to the desired input (i.e., makes the error smaller). The advantage of closed-loop control is that the output is continuously and automatically adjusted so that disturbances are not a problem. The greater complexity of that system makes it more expensive to build and maintain. Figure 18. Schematic diagrams of closed-loop control of a mechanical ventilator. A: Pressure control. B: Flow control. C: The flow signal is integrated to provide a signal for volume control. D: Flow/volume control 35 EPS/IDPS 2014 1.2. PEDIATRIC AND NEONATAL LUNG SIMULATOR DISPLAY INTERFACE Figure 19. Display The main components of the display interface are the monitoring patients’ part and the ventilator settings part. Through the first part certain parameters can be observed such as resistance, compliance and leaks shown with the orange, green and blue lines. In the right side of these lines the current value can be observed and if the values go out of the pre-set interval the numbers will be written in red. With the ventilator settings you can modify the value of different parameters and set them according to the patient’s profile. 2. LUNGS The lungs from the mechanism are represented by a bag that imitates the volume of the real lungs. It is designed to simulate the physical conditions of neonate and paediatrical lungs with widely adjustable resistance, compliance, leakage and spontaneous breathing. There are different types of devices to simulate the human lungs but all of them must be able to change the named clinical parameters, and to have and outlet to connect the ventilator tube that will provide the lung simulator of air. 36 EPS/IDPS 2014 PEDIATRIC AND NEONATAL LUNG SIMULATOR 3. BODY (Mannequin) Figure 20. Premie HAL S3009 With the mannequin, which has inside the lung simulator, several things can be noticed: breathing when the chest rises and lung sounds that are synchronized with selectable breathing patterns, circulation and colour change shown through multiple heart sounds, rates and intensities, the possibility to view ECGs with physiologic variations generated in real-time, the rate and depth of respiration can be controlled, bilateral, brachial and femoral pulses that vary with blood pressure and pulses are synchronized with ECG. 37 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 2.2.2.2. Functionalities LUNG PERFORMANCES The following parameters are the main functions that a Lung simulator must cover in the system in order to simulate the breathing behaviour of the respiratory system. 1. Spontaneous breathing Natural spontaneous ventilation occurs when the respiratory muscles, diaphragm and intercostal muscles pull on the rib cage open, creating a negative inspiratory pressure. This leads to lung expansion and the pulling of air into the alveoli allowing gas exchange to occur. Therefore, spontaneous respiration occurs by negative inspiratory force. Once a patient is intubated, the endo-tracheal tube (ETT) is connected to the ventilator. Depending on the type of ventilator, positive pressure ventilation is provided either by a pneumatic or electric device. The compressed air entering at the alveolar level allows for gas exchange. The significant difference between spontaneous respiration and mechanical ventilation is that during spontaneous respiration, air is pulled into the lungs whereas during mechanical ventilation, air is pushed into the lungs. This difference impacts cardio-pulmonary dynamics, as well as the integrity of lung tissue with the potential for long-term injury. 2. Airway resistance - It is all about a measure of the impedance to airflow through the Broncho pulmonary system and the reciprocal of airway conductance. For examples, in asthma and in smokers, the airway resistance is increased. The airway resistance testing can be able to evaluate the airway responsiveness, airflow resistance or closures and the characterisation of the type of lung disease. In physiology, the obstruction or turbulent flow in the upper and lower airways can cause the resistance to the flow of gases during the ventilation. It also could be defined as the ratio of the difference in pressure between the mouth, nose, or other airway opening and the alveoli. There are some factors that influence the airway resistance which are lung volume and bronchial smooth muscle activity. 3. Lung compliance - - It is a measure of the ease of expansion of the lungs and thorax. It can be determined by pulmonary volume and elasticity. When the compliance is decreasing, it means that there is a greater change in pressure needed for a given a change in volume, such as in atelectasis, edema, fibrosis, pneumonia and absence of surfactant. At the base of the lung, the compliance is higher than at the apex of the lung. The lungs are going to be stiffer and having a greater tendency to collapse if the compliance is low. 38 EPS/IDPS 2014 - PEADIATRIC AND NEONATAL LUNG SIMULATOR There are two distinctive curves with different phases of respiration as shown in the following diagram: o o Inspiratory compliance curve Expiratory compliance curve Figure 21. Example of lung compliance graphically - - Normally, the occurrence of the lung compliance is caused by elastic forces of the lung itself and also due to the elastic forces of the fluid that lines the inside walls of alveoli and other lung air passages. The compliance of the whole system is measured while expanding lungs of totally relaxed or paralysed person. 4. Leaks of air - The presence of system leaks must be synchronised by the ventilators used during the paediatric ventilation. The leak compensation is significantly impacted by the lung mechanics and model size. Usually, the leak is going to be minimised as much as possible in clinical practice. 39 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 2.2.2.3. Analysis of existing solutions This section is focused on analysing a selection of lung simulators systems that are currently in the market, from the simplest ones to the most sophisticated and complete ones, to have an overview of the latest innovation in this field in each of the elements. The purpose is to detect the most interesting features that can be included in the design of the proposed solution before having been specified all the requirements. BENCHMARKING OF LUNG SIMULATOR’S ELEMENTS To have the view of all the different elements of a lung simulator system that exist in the current market and their characteristics, it has been done a selection of three examples of common and interesting ventilators, lung simulators and mannequins. The diagram bellow illustrates all the lung simulator system as it has been presented in the description of a Lung simulator section. 3 BODY (MANNEQUIN) 1.2 DISPLAY INTERFACE 2 LUNGS (BAG) 1 VENTILATOR 1.1 CONTROL INTERFACE - Flow rate - Spontaneous breathing - Pressure - Resistance of airways - Real time monitoring of respiration curves. - Leaks of air - Compliance (lung elasticity) - Volume of air 2.1 REMOTE/ MANUAL CONTROL OF LUNG PARAMETERS Figure 22. Parts of lung simulator 40 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 1. VENTILATOR RESPIRONICS V200 Philips The Respironics V200 critical care ventilator provides state-ofthe-art ventilation modes with synchrony options that reduce work of breathing and streamline patient care. As a busy clinician, you will appreciate the V200's design and its range of treatment modalities for all patient populations. The V200 supports care in any environment by connecting to Philips patient monitors and hospital information systems for a seamless flow of ventilation information. For invasive ventilation, the V200 provides instantly recognizable modes. Behind these modes, the V200 ventilator employs advanced breath delivery algorithms (Auto-Trak, Flow- Figure 23. Ventilator Respironics V200 from Philips Trak, and Baby-Trak) to improve patient-ventilator synchrony. For noninvasive ventilation (NIV), the V200 functions like the BiPAP Vision with Auto-Trak, the gold standard for NIV. By using spontaneous breathing (S) and timed back-up (S/T) with IPAP and EPAP settings, the V200 keeps NIV simple, for new and experienced caregivers. SERVO-U Maquet It is a mechanical ventilator with unprecedented levels of speed in sensing and control, with Workflows, to support protective ventilation strategies. It is provided by a highly intuitive touch screen. Context based views, dialogues and recommendations with well-placed shortcuts. The significance of protective tidal volumes is well documented. SERVO-U automatically calculates tidal volume per kilogram of predicted body weight (VT/ PBW) to help the professionals adhere to ARDSNet protocol strategies. This time-saving new core value is continuously measured and trended, facilitating adjustment of ventilation parameters in all modes. Figure 24. Ventilator SERVO-U from Maquet The Edi respiratory vital sign (Electrical activity of the diaphragm), displayed on screen, helps clinicians track spontaneous breathing efforts. It also supports sedation management in all ventilation modes as well as in standby. This accurate onscreen information allows appropriate and timely response to changing breathing conditions. On screen tutorials help the professionals brush up on their knowledge, and support them when applying settings and ventilation modes. 41 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR SERVO-U gives the opportunity to share patient information for review, research and education. The user can either use the built-in 72 hours trend or use the recording feature. When the recording is made, SERVO-U allows capturing what just happened, with a pre– and posting recording function. HAMILTON-C3 VENTILATOR Hamilton Medical The HAMILTON-C3 has been designed to ventilate adult and paediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The unique Ventilation Cockpit™, with its high definition widescreen, provides exactly the needed information and helps to focus on what’s important. The Dynamic Lung and the Vent Status window assist the doctor in immediately identifying the patient’s lung condition and assessing the weaning process. Adaptive Support Ventilation (ASV) makes ventilation intelligent by providing optimal support with each breath for virtually all patients. This ventilator has been designed with built-in, hot swappable batteries and a turbine-giving the maximum independence and flexibility to accompany your patient everywhere. Figure 25. Ventilator HAMILTON-C3 Interesting features: A 12.1 inch high-resolution widescreen display for more information at a glance. A unique Ventilation Cockpit that is designed to improve safety through intuitive operation and monitoring. Proven closed-loop ventilation that automatically applies lung-protective strategies – reducing the risk of operator errors and promoting early weaning. A single, versatile source of invasive and non-invasive ventilation for adults, paediatrics and neonatal ICUs, emergency and recovery rooms, sub-acute care, and intra-facility transport. Integrated turbine and hot-swappable batteries providing maximum mobility for up to 6.5 hours. 42 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 2. LUNGS (BAG) BABI.PLUS Neonate Lung Simulator Figure 27. Babi.plus lung simulator with the optional manometer Figure 26. Example of the simulator functioning with a manual ventilator This is an ideal neonate test lung for equipment testing, product demonstration and medical personnel training. Test lung has been designed to simulate the physical conditions of a neonate lung. It is calibrated in accordance to different compliances and various airway resistances for neonates thanks to changeable silicone elbow come with four airwaysimulation resistors: 90, 145, 300 or 600cmH2O/L/s. Each lung also has the option of including shell panel to simulate lung compliance. Interesting features: Anatomical design and two different lungs for more precise simulation. Great compliance consistency. Pressure monitoring port for accurate pressure measure. Made of high performance engineering plastic and silicone rubber. Each unit has been calibrated to ensure the resistance and compliance conforms to specifications for different applications. Lightweight, easy and convenient for use and storage. SPONTANEOUS BREATHING NO RESISTANCE OF AIRWAYS 90, 145, 300 or 600cmH2O/L/s LEAKS OF AIR NO COMPLIANCE (LUNG ELASTICITY) YES (innacurate) WEIGHT 0,5 Kg SIZE - PRICE - PARAMETERS 43 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR TL2 PRO TEST LUNG TL2 Pro Test Lung is an advanced training and testing system capable of simulating a wide range of patient conditions. Some of its features include the ProLeak, ProCompliance, and ProBreath controls that allow independent leak, compliance and lung selection settings for the ultimate in flexibility and performance. Interesting features: Figure 28. Lung simulator TL2 PRO 3 leak settings: no leak, low leak and high leak. TEST LUNG Single or double lung breath delivery. Variable secondary lung resistance. Independent lung compliance control, with more tan 20 combinations. Soft sided carrying case included. PARAMETERS SPONTANEOUS BREATHING NO RESISTANCE OF AIRWAYS YES LEAKS OF AIR YES COMPLIANCE (LUNG ELASTICITY) YES (inaccurate) WEIGHT 0,4 Kg SIZE - PRICE 250€ 44 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR ADULT/PEDIATRIC DEMO LUNG Ventilator graphics and advanced modes of ventilation offer the opportunity for improved treatment of ventilator patients. However, they also demand more sophisticated skills of today’s clinicians. The Adult/Paediatric Demonstration Lung Model allows teaching about the dynamics of patient-ventilator interaction in a very visual fashion. Using the Lung Model, it can be easily set up real-world scenarios, including ET-tube and lung leaks as well as spontaneous breathing. Figure 29. Lung simulator DEMO LUNG This lung model is ideal for teaching, training, and ventilator demonstrations where the ability to quickly change patient parameters is essential for the success of instruction. Interesting features: Easy to set up: simply open the lid and select settings. Quickly demonstrate the effects of changes in compliance, resistance, and leaks. Two-bellows system provides realistic simulation of compartmentalized lung problems (leaks, resistive anomalies). Pressure gauges show differences between airway and lung compartment pressure. Peak pressures recorded by drag pointers. SPONTANEOUS BREATHING YES RESISTANCE OF AIRWAYS YES LEAKS OF AIR YES COMPLIANCE (LUNG ELASTICITY) YES WEIGHT 7-8 Kg SIZE 291x 248x 165 mm PRICE 1950€ PARAMETERS 45 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 3. BODY (MANNEQUIN) NEWBORN HAL® by Gaumard Figure 30. Newborn HAL mannequin Newborn HAL® is a mannequin of 40 week newborn, along with breathing, pulses, colour and vital signs and responsiveness to hypoxic events and interventions. Also included are trending, crying, convulsions, oral and nasal intubation, airway sounds and extra tablet PC for control. The features of this model are numerous and corresponding to different kinds of simulations, i.e. connected with respiratory and circulatory system or with speaking patterns. Below there is a list of selected advantages of Newborn HAL® in terms of breathing and airways, based on informative brochure about the product. AIRWAYS BREATHING Multiple upper airway sounds synchronized Control rate and depth of respiration with breathing Automatic chest rise is synchronized with Nasal or oral intubation respiratory patterns Chest rise and lung sounds are synchronized Right mainstream intubation with selectable breathing patterns Accommodates assisted ventilation including Depth of intubation detected by sensors BVM and mechanical support Possibility of airway obstruction Block right lung, left lung, or both lungs Ventilations are measured and logged Detection and logging of ventilations and compressions Head tilt/ chin lift Simulated spontaneous breathing Jaw thrust Variable respiratory rates and inspiratory/expiratory ratios Possibility of using simulated suctioning Remains fully functional even while in transit techniques 20 preprogramed scenarios modifiable by the Bag-Valve-Mask Ventilation instructor even during the scenario Placement of conventional airway adjuncts Create your own scenarios - add/edit Table 2.Newborn HAL mannequin selected features 46 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR PediaSIM® by HELSIM Figure 31. PediaSIM mannequin PediaSIM is a complete reproduction of an actual six-year-old child. Paediatric patient mannequin measures in at 122 cm tall, weighs 38 17.2 kg and is fully operational in the supine, lateral and sitting positions. It was designed to support a wide range of clinical interventions, taking into account differences that make paediatric medicine uniquely challenging, like distinctions in anatomy, reactions to drugs, types of injuries and underlying physical conditions. PediaSim operates on the basis of delicately calibrated mathematical equations which reflect those of the paediatric patient; this highly developed paediatric patient models generate realistic and automatic responses to clinical interventions and drug administrations. Simulated Clinical Experiences: Acute Respiratory Failure Asthma Asystole Bradycardia Hypovolemic Shock Multiple Trauma Pulseless Electrical Activity (PEA) Supraventricular Tachycardia/Ventricular Tachycardia Toxidromes Ventricular Fibrillation AIRWAY TRAUMA AIRWAY FEATURES Swollen Tongue Upper Airway Obstruction Laryngospasm Bronchial Occlusion Esophageal, Nasal and Oral Intubation Oropharyngeal Intubation Nasopharyngeal Intubation Bag-Valve-Mask (BVM) Ventilation Laryngoscopic Procedures Endotracheal Tube Intubation Table 3. PediaSIM mannequin selected features 47 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR CHILD HEART AND LUNG SOUND TRAINING MODEL PP00020 by Simulaids Child Heart and Lung Sound Training Model can be used to play back the recorded voice, lung and heart sounds of a real 4 year old child, with having the ability of choosing sounds and their rate. The sounds are then emitted from 10 lung and 1 heart speaker locations that student can auscultate with a stethoscope. The manikin also features a speaker jack, allowing you to broadcast the sounds to the whole class of students. Figure 32. Child Heart and Lung Sound Training Model LUNG SOUNDS INCLUDED VOICE SOUNDS INCLUDED Asthma Cough Bronchial Crying Coarse crackles Gasp Fine crackles Gurgling Normal breath sounds Sneeze 1 Pneumonia, lobar Wheeze Table 4. Child Heart and Lung Sound Training Model selected features 48 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 3. REQUIREMENTS ANALYSIS 3.1. CONTEXT OF USE The aim of the project is to design a neonatal and paediatric lung simulator, which will be used for research and educational purposes. The different users profile and stakeholders determine the specifications that the new lung simulator has to accomplish depending on their purpose and context of use. The purpose of a lung simulator is to represent real scenarios in a simulated environment. Its application during medical and nursing studies it is useful to teach the future professionals to understand and to know how to interpret the data and graphs shown through the ventilator where the patient with a respiratory disease is connected through intubation or a mask. The function of the lung simulator is to behave as the patient lung being able to represent different diseases and grades of severity. REAL SCENARIO IN THE HOSPITAL ROOM SIMULATION CLASS WITH THE LUNG SIMULATOR Figure 33. Illustration of the purpose of the lung simulator in its context of use 3.1.1. USERS’ PROFILE Taking into consideration the fact that the proposed lung simulator will be a device used by several profiles of users, it is necessary to present a description of each target group that is going to use the product: university professors, medical and nursing students, doctors and researchers. - MEDICAL PROFESSORS: Qualified people from 23 years of age and older with medical studies who work in public and private Spanish universities. Regardless of their personal culture, they can only teach in English or Spanish. Their classes have an extension of time of about 2 hours and they can be in charge of theoretical or practical classes. It is mandatory for them to continue training and acquiring knowledge through research to be updated being able to give students the latest information in their field. 49 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR - MEDICAL AND NURSING STUDENTS: Generally, students are aged between 18 and 30 years and their nationality is Spanish, although it has to be taken into account that foreigners students are also include in this target group. They usually are familiar with new technologies and use to work with electronic devices and new applications. This user profile has the motivation of learning new skills in medicine and to apply their knowledge in practical scenarios to prove their knowledge. They want to learn the specific technical vocabulary during lectures. - DOCTORS AND RESEARCHERS: This type of user is a professional who practices medicine and is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury, and other physical and mental impairments. They may focus their practice on certain disease categories, types of patients, or methods of treatment. They must have detailed knowledge of the academic disciplines, such as anatomy and physiology, underlying diseases and their treatment and also a decent competence in its applied practice. Doctors use and understand the proper medical technicalities. 3.1.2. TASKS PROFESSORS STUDENTS DOCTORS AND RESEARCHERS - To control the lung simulator To transport the device To generate real clinical scenarios and show real diseases To transmit theoretical knowledge through the simulator To evaluate the students - To develop practical and analytical skills To understand the data obtained from the simulation To learn how to interact with a ventilator To learn the different paediatric respiratory diseases To be able to identify different diseases through the simulator behaviour. - To apply the ventilator part of the simulator to real patients To be able to show real diseases with the simulator To be able to update the simulator with new diseases, varying parameters To compare data from different medical scenarios To transport the simulator to different places To save the results obtained. - Table 5. Tasks to do using the simulator by the different users 50 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 3.1.3. ENVIRONMENT AND SOCIAL CONTEXT CURRENT AND MAIN ENVIROMENT FOR THE SIMULATOR Figure 34. Darwin Simulation Centre of Sant Joan de Déu Hospital DARWIN SIMULATION LAB OF SANT JOAN DE DÈU HOSPITAL The Darwin simulation centre of Sant Joan de Déu Hospital's main objective is to improve the training of health professionals in the paediatric and obstetric field, by providing a simulation environment where they can plan and practice a wide range of diagnostic and therapeutic interventions without involving patients. In order to provide medical students and professionals with the proper and most realistic scenarios, the simulation Lab has the following resources: - Real physical spaces Multidisciplinary Training Advanced simulators Learning methods "problem-based" by addressing specific and real clinical cases Basic-Advanced / individual- team training The centre focuses its training in different aspects: - Training in technical skills Training in teamwork Training in decision-making Relational skills Currently, the following areas of the hospital are used in the simulation program: - Emergency Room (ER) Neonatology Anaesthesiology Intensive care Obstetrics 51 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Darwin simulation lab materials and tools The simulation centre occupies an area of about 150 m2, located in the vicinity of Sant Joan de Deu Hospital, in the teaching building. There are multipurpose spaces that allow training in multiple specialties and areas that recreate real clinical environments and have the audiovisual equipment such as surveillance cameras and microphones, advanced recording system, projectors and screens for debriefing. The simulation area has the ability to record their activity in audio and video and also make video streaming and broadcast anywhere in the world. The equipment and tools in the lab are: - Two multipurpose rooms for advanced simulation: Box paediatric ICU; Neonatal ICU; Box of emergency; Delivery Room. A specific room for individual skill training and coaches of various techniques. A control room. A room for viewing and debriefing. The space is equipped with simulators, venting and the medical support equipment required: - Material for advanced training in clinical settings for all paediatric ages’ simulation. Advanced simulation equipment to recreate obstetrics scenarios. Respirators and lung simulators for training in paediatric and neonatal ventilation. Simulators for training of basic life support. PEDIATRIC AND NEONATAL LUNG SIMULATION IN THE DARWIN SIMULATION LAB Currently, the hospital has a ventilator connected to a source of air, and its monitor to control the clinical parameters that must be shown through the screen. On the other hand, there is a lung simulator, which is inaccurate to simulate children lungs. It is composed by a rubber bag that simulates the lung. It will be analysed below to detect all the problems that it has. Figure Hospital’s 35. Hospital’s ventilator ventilator monitor monitor Figure 36. Current lung simulators of the Hospital 52 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR OTHER POSSIBLE ENVIROMENTS - TRANSPORT (PUBLIC AND PRIVATE): There are some ways to transport the lung simulator from the manufacturers to the hospital or university which could be a public or private transport. For example, as the lung simulator is portable, so it can be easily transported or brought by the users via public transport such as train, bus, airplane and taxi or in some cases like the professor or doctor can migrate it via private transports which are their own vehicle and the ambulance from the hospital. Although the lung simulator is portable, it needs an intensive care in order to ensure it is in a good condition and to avoid it from being broken or malfunctioned. So, the users themselves need to be really aware where to put it when they are transporting it from a place to another. Another aspect to bear in mind is the transport by plane, and all the controls that the device must pass in the airports. - LABORATORIES OF THE UNIVERSITY: When it is talked about the laboratories of the medical university, they need to have a high safety providing that there are many medical equipment especially the lung simulator which is going to be used in some practical by the students or the professors in those laboratories. The professor or the person that is in charge and responsible for that Figure 37. Example of a University Laboratory particular laboratory also needs to oversee and watch all the actions from the students during the practical session. So, the situation could be under control and all the expensive medical equipment could be in good condition as usual. Besides, the laboratories should always be neat and orderly so the students and professors could do the work in comfort. - CONFERENCE ROOMS: As is widely known, a conference room is quite extensive in order to ensure all the people from the conference are in good comfort. In addition, it should be completed with all facilities to assist the people in that particular conference to explain about the given topics or give their speech. This conference room could be in either hospital or university for the professors to have a conference with their students or for the doctors to have a conference with other professional doctors or researchers. 53 Figure 38. Example of a University conference room EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Taking into account the environment of the simulation lab and the other possible environments, there are some aspects to bear in mind for the design of the lung simulator: PORTABILITY ACCESSIBILITY - Low weight Compact design Avoid metallic materials Protection of the device - Easy to control all the lung parameters, both remotely and manually. - Compatibility in connexion between the current ventilators. Wireless connexion between the simulator and the remote control. Compatibility of the remote control connexion in different environments. CONNEXION - MANTEINANCE - Easy to clean Exchangeable components Table 6. Requirements for the lung simulator according to the environment 54 EPS/IDPS 2014 3.2. PEADIATRIC AND NEONATAL LUNG SIMULATOR STAKEHOLDERS’ SPECIFICATIONS The stakeholder of the project is the Children’s’ Hospital Sant Joan de Déu, represented by Pedro Brotons, R&D Project Manager from the Innovation and Research Department and José M. Quintillá Martínez, the Coordinator of the Simulation Centre from the Emergency Service. 1.2 DISPLAY INTERFACE 1 VENTILATOR 1.1 CONTROL INTERFACE 2 LUNGS (BAG) - Flow rate - Spontaneous breathing - Pressure - Resistance of airways - Real time monitoring - Leaks of air of respiration curves. - Compliance (lung elasticity) - Volume of air 2.1 REMOTE/ MANUAL CONTROL OF LUNG PARAMETERS HOSPITAL’S NEEDS HOSPITAL’S CURRENT DEVICES Figure 39. Scheme of the whole system divide in: current devices and needs 55 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 3.2.1. HOSPITAL’S CURRENT DEVICES - Lung simulator: SMART LUNG Smart Lung is one of the lung simulators in the current market produced by Imtmedical Company located in Switzerland. This kind of lung simulator has been bought recently by The Paediatric Hospital Sant Joan de Déu, Barcelona for educational purposes to assist all the medical students to get familiar with the simulation before they work in the real situation. Compliance Air bag Airway resistance Leak Tube connector Figure 40. Current hospital simulator: SMART LUNG Parts Description Compliance It can be adjusted by easily moving the slider according to the degrees of lung compliance they like to be simulated without an adapter. Air bag It is used to represent the real lungs of the patient and to show how the lungs work and move depending on those performances (compliance, leak and resistance). It is not replaceable with different bag sizes. Airway resistance It is designed to be able to simulate the lungs with different airway resistances that can be simulated simply by turning the connector. Tube connector It has to be connected by the tube to the ventilator before the simulation is started to give out the results and parameters that are needed to be measured. Leak The leakage can be adjusted by turning the side screw and it requires no adapter. It also enables the ventilators for premature babies or mask ventilation to be checked. Table 7. Main parts of the SMART LUNG 56 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Smart Lung for Adult Resistance Compliance Volume Leak Weight Dimensions (L x W x H) Price 5, 20, 50, 200 mbar/L/s 10, 15, 20, 30 mL/mbar 0 – 600 mL (with 1L bag) 0 – 10 L/min 325 g 300 x 115 x 40 mm 620€ Table 8. Main parameters of the Smart Lung for adult Smart Lung for Infant Resistance Compliance Volume Leak Weight Dimensions (L x W x H) Price 5, 20, 50, 200 mbar/L/s 1, 2, 3, 5 mL/mbar 0 – 200 mL (with 0.5L bag) 0 – 10 L/min 285 g 275 x 115 x 40 mm 620€ Table 9. Main parameters of the Smart Lung for infant The problem of this lung simulator is that good test lungs take up a lot of space. It is also expensive and complicated to be used. The main problem is that is not able to be controlled by a remote. For example, whenever the doctor does not want to be in the simulation room, he cannot control this lung simulator from the outside to adjust the leak, compliance, resistance and especially the spontaneous breathing of the patient. In addition, the results obtained from this lung simulator are not quite precise as for instant there is some air passages come through the simulator. - Ventilator: SERVO-I Maquet Since the introduction of the first SERVO ventilator in 1971, SERVO has become the worlds’ number one ventilation brand. A close partnership with the medical community ensures that SERVO ventilators meet the needs of clinicians, across the spectrum of patient types and treatment situations. SERVO-I Infant offers a wealth of features and functionalities for treating neonatal and paediatric patients. Its unparalleled sensitivity helps clinicians to deliver the best care for the smallest patients. Robust, easy to use and highly mobile, SERVO-i Infant is designed to react to needs of the dynamic neonatal and paediatric intensive care environments. Figure 41. Ventilator SERVO-I Maquet 57 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR SERVO-I offers one platform for treating the range of patient types and conditions. Available in Infant, Adult and Universal configurations, this future-proof modular system can be easily upgraded with new functionality to keep up with the clinician’s changing needs. SERVO-i Infant delivers the performance needed for treating neonatal and paediatric patients. With one ventilator, the clinician can treat a wide range of conditions in patients at differing levels of stability. The system has a range of ventilation modes and treatment extension features that help clinicians address specific needs for a variety of patient characteristics. Performance Sensitive control SERVO controller valves SERVO-I expiratory flow sensor Sensitive trigger Inspiratory Cycle Off Auto mode Time Constant Valve Controller Adjustable rise time Non-invasive support Leakage detection Description High speed in sensing and control is a key element in providing optimal treatment for neonatal and paediatric patients. SERVO-I responds to the smallest deviations from set values which are regulated several hundred times during each breath. A Y sensor measurement option with an airway adapter dead space of less than 0.75 ml and weight of 4 grams allows the clinician to monitor pressure and flow readings as close to the patient as possible. This gives a fast response time ensuring the comfort of the patient. The adjustable Inspiratory Cycle Off ensures an appropriate ventilator response even when leakage is present. This allows automatic patient interaction for shorter weaning times and better patient comfort. It reduces expiratory resistance, continuously calculating the elastic and resistive forces of the respiratory system. This helps reduces work of breathing by allowing a range of flow responses. SERVO-I offers features for non-invasive ventilation via mask or endotracheal tube retracted above the vocal cords, combined with Pressure Support or Pressure Control Ventilation modes. It triggers an alarm if leakage is excessive. Display of leakage fraction shows how well the patient interface fits. Table 10. Parameters of SERVO-i Infant Taking into account that the tube from the ventilator changes depending on the type of mechanical ventilation, the hospital has a tube connector to adapt the tube to each one: - Neonatal ventilation: 14 mm of diameter. - Children ventilation: 22 mm of diameter. - Non-invasive ventilation: 25 mm of diameter. 58 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR HOSPITAL’S NEEDS The requirements that have been decided by the hospital are shown below: Portable device, transportable in a small suitcase: The hospital requires us to develop and design a lung simulator that is more portable than the existing ones and it can be transported or located in a small case, so it could be easier to be handled and brought to the simulation class or conference without any problems. Two lung sizes: - Neonatal lungs (25-50 ml) - Paediatric lungs (125-250 ml) It is mandatory to design a lung simulator of two different sizes of lung. One of them is for neonatal and the other one is for paediatric patients and they have specific range of volume of 25-50 ml and 125-250 ml respectively. Ability to generate pre-defined common clinical scenarios with several degrees of severity of lungs failure: - Decrease of compliance - Increase of resistance - Leaks in neonatal and paediatric scenarios - Spontaneous breathing The other requirement from the hospital is to design a lung simulator which should be able to simulate some common scenarios of the lung of a patient by considering the compliance, air resistance, leaks and the simulation of spontaneous breathing, when the patient starts breathing by himself. High precision and reliability: The lung simulator that is going to be designed should be more precise and reliable as we were told by the hospital in order to obtain a result from the simulation that is more accurate. Remote control: The most important thing to take into account is that the lung simulator must be able to be controlled by a remote control as at this very moment, none of the lung simulators in the market is able to do so. The main purpose to make it so is because in many occasions, doctors or medical professors decide not to be inside the simulation room with the students and adjust the lung simulator manually due to they don’t want to influence the learning process and decisions of the students . So, by making this lung simulator controlled remotely, it could be much easier for them to do the simulation from a different room instead of doing it manually in front of the students. However, just in case of malfunction of the remote control, the lung simulator also needs to be designed to make it able to be used manually. 59 EPS/IDPS 2014 3.3. PEADIATRIC AND NEONATAL LUNG SIMULATOR REQUIREMENTS DETERMINATION Once the context of use and the hospital’s current problems have been specified, a list of requirements attending different features of the lung simulator has been done. The following scheme shows the parts of the system that need to be mandatory included in the development of the lung simulator. 2 LUNGS (BAG) - Spontaneous breathing - Resistance of airways - Leaks of air 4 REMOTE/ MANUAL CONTROL OF LUNG PARAMETERS - Compliance (lung elasticity) Figure 42. Parts of the lung simulator system that have to be designed On one hand, there is the need of designing a new bag that represents the lungs. There is the possibility to design a simulator that includes two bags representing both lungs, or only one bag considering that in numerous occasions it is only needed the representation of the whole respiratory process to detect the constraints that the patient has to be able to adapt the ventilator to his/her demands, independently the lung in which the problem appears. The bag has to be able to simulate the presented main parameters that represent the different problems that a patient intubated or connected to a ventilator could have. On the other hand, it is necessary to control the system remotely ensuring a realistic situation for the students that have to interpret the data shown by the ventilator’s screen without seeing the professor how is he changing the lung simulator parameters taking into account that this can influence their decisions and the evaluation wouldn’t be as reliable as it should be. 60 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR STORYBOARD OF USE 1. Connection of the lung simulator 2. Connection of the ventilator to the air source 3. Adjustment of ventilator’s parameters by the professor 4. Accommodation of the professor and students in respective rooms 5. Adjustment of lung simulator parameters that modify the graphs in the ventilator screen for students’ interpretation 6. Disconnection of all the devices 7. Package and carry of the lung simulator Figure 43. Storyboard of use This storyboard illustrates the whole use of the lung simulator that we want to propose according to the studied requirements. The first step is to connect the lung simulator to the ventilator, and then, the ventilator to the air and oxygen source, that is already installed in the Darwin Laboratory and in the hospitals’ rooms. To start the simulation session, the ventilator’s parameters, such as, rate flow of the air, pressure or the weight of the patient that is simulated to be connected must be adjusted by the professor. The following step is the accommodation of the students and the professor in their respective rooms. Students stay in the Darwin Laboratory and the professor is situated in a room next to the lab that allows seeing what is happening in the other side without being seen by the students. From this side, the professor adjusts the lung simulator parameters that modify the graphs in the ventilator screen for the students’ interpretation. The final steps are: to disconnect all the devices and then package and carry or store the lung simulator in its own case to be protected from knocks and avoid damaging the device. 61 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR MAIN FUNCTIONALITIES AND CHARACTERISTICS According to the analysis done of the context of use and form the stakeholders’ specifications it can be conclude a list of features that each part of the lung simulator must accomplish to start the design process. LUNGS (BAG) General features: - Low weight. Compact. Easy to assemble and disassemble. Compatible connection with SERVO-I ventilator and others. Size bags of 25-50 ml and 125-250 ml. Inclusion of a case. Parameters to control: - Decrease of compliance. - Increase of resistance. - Leaks in neonatal and paediatric scenarios. - Spontaneous breathing. - Accuracy and reliability. REMOTE CONTROL Connexion and control: - Wireless device. Compatibility in the remote connexion in different environments. At least 2 hours of autonomy. Proper control of the device between different rooms. Interface: - User Centred Designed interface for an easy and understandable use. Accurate adjustment of Resistance and compliance. 62 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4. DESIGN PROCESS In this section the whole process to develop the final product is presented. It includes the design of each element that has to be included in the lung simulator: from the bag and each specific element controlling different parameters to the interface design in order to control the device remotely. There are included the best two design options of design, the proper calculations for dimensioning and adjusting the different elements to their constraints and the final design of every element with its corresponding mechanism, that has been selected to have the product prepared for the future implementation of the electronic part in order to control all the parameters remotely. 4.1. IDEATION OF THE CONCEPT 4.1.1. MIND MAP After having specified all the requirements that the product must accomplish, the ideation process was started. It consisted of brainstorming ideas and making a Mind Map including the main aspects to consider in the design in order to arrive at the end with the most complete concept of the lung simulator. Figure 44. Mind Map 63 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4.1.2. SKETCHING After brainstorming all the aspects that the lung simulator had to take into consideration, it was started the sketching phase to decide the general shape of the device. It was thought in many shapes for the simulator but it was really conditioned by all the mechanisms that had to be included in to control remotely the bag. For this reason the final appearance will be explained after presenting all the mechanisms. Here are shown the 4 main ideas that were considered to develop: Figure 45. First sketches of the system with two lungs The first ideas were focused on including two lungs wanting to represent the system as the human; however after discussing this aspect with doctors it has been concluded to design the lung simulator using only a bag that represent both lungs as the important function of the simulator is to behave as the whole breathing process. This issue allows the product being more compact and easy to control. Figure 46. First sketches of the system with one lung These two sketches represent the two studied shapes to use for the simulator. It was thought in revolution volumes for ergonomics reasons in order to make the simulator more portable, avoiding edges. Another issue that was taken into consideration was the ease to remove the bag in order to change from the children size to the neonate size. 64 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4.1.3. PRODUCT CONCEPT The following scheme represents the final shape that was chosen for the product. It points the main elements that will include and where will they be located. In the next sections it will be described each element designed to do all the required functions; this is a general scheme to understand the entire concept. Figure 47. General scheme of the concept MAIN ELEMENTS - BAG: Is the part that simulates the lungs, with its proper volume. It has to be elastic and resistant to the air pressure that goes inside through the ventilator tube where is connected to generate the breathing movement of the bag. - STRUCTURE: It has been thought about a rigid structure to contain the bag inside to ease the generation of the spontaneous breathing, it will act as the diaphragm of the human body respiratory system. Considering the low rigidness of the bag it is necessary a more rigid support to open the bag to simulate this spontaneous breathing in order to be detected by the ventilator. - TUBE: A cylindrical tube represents the airway of the lung and it is where the tube coming from the ventilator will be connected. 65 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR - LEAKS CONTROL: The element to control the leaks will be placed in the tube due to the facility to generate a leakage in the connection between the ventilator and the simulator before arriving at the bag. - RESISTANCE CONTROL: Taking into account that the change of resistance in the human body is generated in the airways it has been decided to place the system to control this resistance in the tube. - COMPLIANCE CONTROL: System applied directly in the bag to adjust the stiffness of it. - BOX: Due to the remote control of the simulator, all the mechanisms and electronic components to control each of the parameters need to be placed inside a compact box. - CAP: An easy open and close cap to access easily to the components inside in case that the lung simulator had to be repaired. 66 EPS/IDPS 2014 4.2. PEADIATRIC AND NEONATAL LUNG SIMULATOR THE BAG RIGID STRUCTURE ELASTIC BAG The bag is the main element of the lung simulator providing that is the one that represents the lungs of the patient simulated. There is the need to design an elastic bag that behaves as the walls of the human lung and a rigid structure that enables to control all the movements that the bag can do when it is provided by air applying a number of constraints that the lung has to simulate. 4.2.1. CONCEPTS DESIGN 4.2.1.1. Balloon shape Figure 48. Bag concept: balloon shape The first idea of shape for the bag that represents the lungs of the patient was taken from a common balloon. One of the interesting aspects of this morphology is its amorphous shape, which is really close to the real lungs. The material applied, an elastomer such as a kind of rubber, allows also an expansion and contraction of the walls when it is inflated simulating the inspiration and expiration process. Considering the application of this bag in the functioning of the whole process of simulation, it needs to include a system to adjust the capacity of air inside and be applicable in the spontaneous breathing control. According to this need, it was designed a rigid structure where the bag is stuck and it can be opened and closed. This concept pretended to enable the adjustment of the two size lungs required through a band system included in the rigid structure but it could be misunderstood with the reduction of the compliance. 67 EPS/IDPS 2014 4.2.1.2. PEADIATRIC AND NEONATAL LUNG SIMULATOR Bellow shape Figure 49. Bag concept: bellow shape This concept has been inspired in a kind of foot pump that uses a bellow to inflate many kinds of inflatable products. Thanks to the two sides rigid surfaces stuck, the bellow made of silicone can be inflated or compressed easily. The shape of this model has been calculated according to the ranges of volume that the two different sizes of lungs must have. This option has independent designs for each size to adapt the morphology of both to the final lung simulator that contains the bags inside. It has a cylindrical connector to fix the tube from the ventilator to the lung simulator in which the bag has to be provided by the air. 4.2.1.3. Final shape NEONATE BAG CHILDREN BAG Figure 50. Final shape of the bag for two lung sizes - Bellow shape Morphology that enables to calculate accurately the volume of air that it can contain within the limits. - 2 independent bags: 125-250 ml and 25-50 ml - Easy control of spontaneous breathing thanks to the rigid sides stuck in the bag. All the information about the dimensions and constructive parameters are available in the ANNEX. 68 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4.2.2. CALCULATIONS AND RESULTS The ranges of volume that the bag has to be able to have are these two: - Children: 125-250 ml= cm3 Neonate: 25-50 ml= cm3 It has to be ensured that the size of the bag allows changing the capacity of the bag from the lowest volume to the higher one, so it was decided to develop two bag sizes that can be replaced easily in the lung simulator box. To calculate the size of the bags it has been used the volume equation: V= A x h CHILDREN BAG Vmin = 125 cm3 = 125,000 mm3 Vmax= 250 cm3 = 250,000 mm3 It was decided to fix the minimum h (height) of the bag in 25 mm. So it could be known the total area for the bag using the lowest volume (125,000 mm3): It has been used the Trapezium area due to be the profile of the selected shape: To adjust the size of the area were made various calculations and approximations and finally it was decided to establish these values: a= 40 mm and b= 80 mm. 69 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR NEONATE BAG To dimension the smallest bag has been considered the shape of the big one and the height of the trapezium has been reduced until have: Vmin = 25 cm3 = 25,000 mm3 Vmax= 50 cm3 = 50,000 mm3 Considering that the minimum h (height) of the bag is 25 mm, the lowest volume is (25,000 mm3): Calculation of the Trapezium area: To adjust the size of the area were made various calculations and approximations and finally it was decided to establish these values: a = 59 mm and b = 67 mm. 70 EPS/IDPS 2014 4.3. PEADIATRIC AND NEONATAL LUNG SIMULATOR SPONTANEOUS BREATHING CONTROL SYSTEM The spontaneous breathing is referred to the situation when a patient connected to the ventilator starts recovering his breathing by himself, so the ventilator has to readjust the flow of air. Thus, the airflow rate has to be synchronised with the breathing rate of the child. In order to simulate expansion of the patient’s lungs due to its recovering, there is a need of a specific system. This system forces the simulator bag to open and generates the entrance of air inside the bag, hence alerting the ventilator that it has to start reducing the flow of air provided initially. It is known that the only condition required for the ventilator to detect the beginning of an spontaneous breathing process is the increase of the bag’s volume of at least 10 ml. This information was confirmed by the doctors from Sant Joan de Dèu Hospital. Another function that the system has to be capable to do is to continue generating this expansion of the bag during 2 minutes to allow the ventilator to adapt to the breathing rate of the patient. Considering the different breathing pathologies of patients, the system has to be able to adjust the rate of breathing from the range of 10-70 respirations per minute. 4.3.1. CONCEPTS DESIGN 4.3.1.1. Cylinder system Figure 51. Sketches of cylinder system for spontaneous breathing The idea is that the upper part of the rigid structure will be moved up by the use of a pneumatic cylinder. That way, the volume of the bag will be expanded slightly, allowing the ventilator to notice the change of pressure inside the bag and respond by adjusting the airflow. 71 EPS/IDPS 2014 4.3.1.2. PEADIATRIC AND NEONATAL LUNG SIMULATOR Final design RIGID STRUCTURE CYLINDER SPONTANEOUS BREATHING GENERATION Figure 52. Final design for spontaneous breathing The structure that allows the bag generating the spontaneous breathing has two guides in each side of the piece to hold the bag inside and a bracket system to avoid the slippage of the bag during the generation of the movement. Figure 53. Structure of the bag Thanks to the pneumatic cylinder application the system has some advantages: - Accurate control of the spontaneous breathing. The user can adjust the breathings per minute in order to generate different scenarios. The cylinder takes profit from the air source that all the hospitals’ and laboratories’ rooms have installed. 4.3.2. CALCULATIONS AND RESULTS According to the selected system to generate the expansion of the bag, the height of the bag with 10 ml more has to be calculated in order to determine the career of the stroke of the cylinder. 72 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR CHILDREN BAG AREA OF THE BAG= 5000 mm2 It is took the minimum volume of the bag taking into consideration that is the volume of the lung before the inhalation. VOLUME OF THE BAG= 125,000 mm3 To this volume there have to be summed 10,000 mm3 so the volume to work with is 135,000 mm3. The initial h of the bag was determined in 25 mm, so the stroke of the cylinder only has to expand the bag with a displacement of 3 mm. NEONATE BAG AREA OF THE BAG= 1000 mm2 VOLUME OF THE BAG= 25,000 mm3 To this volume there have to be summed 10,000 mm3 so the volume to work with is 35,000 mm3. In this case the displacement is of 10 mm and considering that the displacement of the bag is not flat and generates an angle, the displacement will need to be slightly higher. The generation of the spontaneous breathing needs to be tested with the mechanical ventilator in order to prove that the ventilator detects the bag expansion. 73 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR NEEDED CYLINDER STRENGTH The initial h of the bag was determined in 25 mm, so the stroke of the cylinder only has to expand the bag with a displacement of 10 mm. The diagram below shows the amount of force is being applied to the structure. Actually, the force is directly from cylinder used in this mechanism. Figure 54. Results of the simulation: displacement of the structure The image shows the result of the displacement of the structure obtained from the simulation with the coloured map showing the different grades of displacement. 4.3.3. MECHANISM TO CONTROL THE SPONTANEOUS BREATHING As it has been described, the mechanism to generate the spontaneous breathing consists in a pneumatic cylinder system. To have the proper functioning of the cylinder it is necessary to choose different pneumatic elements that will control the movement of the piston in order to be adjusted to the simulator specifications for the spontaneous breathing. There have been selected two options of system to control this parameter that are presented in the following page. 74 EPS/IDPS 2014 4.3.3.1. PEADIATRIC AND NEONATAL LUNG SIMULATOR Electrovalve + flow regulator CYLINDER AIR SOURCE 3atm (IN HOSPITAL LABORATORY) FLOW REGULATOR ELECTROVALVE INSIDE THE SIMULATOR CASE Figure 55. Mechanism to generate the spontaneous breathing: electrovalve + flow regulator This system consists in a double effect cylinder in order to control both movements of the stroke controlled by a distribution valve 5/2 driven electrically. In order to adjust the flow of the air to control the velocity of the stroke it has thought about including an electrically controlled flow regulator. The problem of this system is that is not as compact as it must be to adapt it inside the case of the simulator. 4.3.3.2. Proportional control valve CYLINDER AIR SOURCE 3atm (IN HOSPITAL LABORATORY) PROPORTIONAL CONTROL VALVE Figure 56. Mechanism to generate the spontaneous breathing: proportional control valve In this case the proportional control valve unifies the flow regulator and the electrovalve, reducing the space used. In this case it is a 5/3 position valve. 75 EPS/IDPS 2014 4.3.3.3. PEADIATRIC AND NEONATAL LUNG SIMULATOR Chosen system Due to the simplicity of the system with the inclusion of the proportional valve it has been selected to be implemented in the simulator. The supplier chosen for all the elements is FESTO. It has been decided to use all the components of the system from the same company to ensure the compatibility between them. CYLINDER To select the cylinder it has been taken into account the career that it has to be at least of 35 mm considering that the neonate bag has to increase this high to generate the spontaneous breathing. AND-16-40-A-P-A Career Stroke diameter 40 mm 16 mm Male thread Normalized Pneumatic connexion M6 ISO 21287 M5 Material Weight Steel alloy 139 g Figure 57. Chosen system to generate the spontaneous breathing: cylinder The chosen cylinder has as the main characteristics to be applied to the simulator the following ones: - Inclusion of position sensors to allow the electronic system that controls the movement when the stroke of the cylinder has raised the top part. Thanks to this functionality the system can be programmed to move the cylinder as faster as it is needed to generate different clinical scenarios. - Male threat to include the cylindrical plate in order to distribute the pressure to push the structure that contains the bag. 76 EPS/IDPS 2014 - PEADIATRIC AND NEONATAL LUNG SIMULATOR Pressure of functioning: 0,6-10 bar. Considering that the pressure of the air from the air source is close to 3 bar it is ensured the compatibility with the cylinder. More information about dimensions is specified in the ANNEX. PROPORTIONAL CONTROL VALVE This valve has the function of a distribution valve. This valve will control this cylinder through a 5/3 double effect. The second functionality of this valve is the adjustment of the flow of air that comes from the air source installed in the hospital which works with 3 atm of pressure, adjusting electrically with the vary of voltage the flow in order to vary the velocity of movement in the cylinder, generating thanks to this variation, different breathing scenarios that are between 10-70 respirations/min. The principle requirements to choose the proportional control valve are the following ones: - Pneumatic connection M5 to fit with the cylinder. Electric control to be programmed from the Arduino board. Reduced weight and size in comparison with the other presented option. MPYE-M5 Pneumatic connection Standard nominal flow rate Voltage Functioning pressure Drive Weight M5 100 l/min 17…30 V DC 0…10 bar Electrical 290 g Figure 58. Chosen system to generate the spontaneous breathing: proportional control valve More information about dimensions is specified in the ANNEX. FITTINGS + TUBING The complements for the assembly of all the pneumatic system are push-in fittings to enable an easy connection of all the elements through the normalized tubing for pneumatic connections. 77 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR According to the selected valves and cylinder the pneumatic connection of the fitting has to be M5 and the push-in connector with a diameter of 4 mm. From that data is chosen all the tubes with a section of 4 mm. QSM-M5-4 PUN-4X0, 75-BL Figure 59. Chosen system to generate the spontaneous breathing: fittings + tubing The following image shows the real connection of the described components and their position inside the lung simulator. The cylinder is gonna be connected with two tubes; the one for pushing up the stroke and the other to retunr it back and it will be conected to the hospital’s air source through the indicated push-in fitting allowing to connect the simulator easily. It is necessary to add a connector between the simulator and the tube from the air source because the diamater of that tube is 14 mm. The connector will reduce the diammeter from 14 to 4 mm. PROPORTIONAL CONTROL VALVE CYLINDER Tube Fitting Figure 60. Top view of the lung simulator to see the pneumatic elements position and their connections 78 EPS/IDPS 2014 4.4. PEADIATRIC AND NEONATAL LUNG SIMULATOR COMPLIANCE CONTROL SYSTEM Compliance (C) measures the expansibility of the lungs and describes the elastic features of the breathing apparatus. It is expressed by relationship of the volume change in the lungs for each unit change in intra-alveolar pressure, according to the formula: If additional volume is pressed into an elastic body such as a balloon, that has a certain volume and is under a certain pressure, the volume changes by the value ΔV and the pressure increases by the value Δp. The volume change involves complete filling of the lungs from the beginning to the end of a taken breath. The larger the compliance, the less the pressure increases at a certain filling volume. Normal values: Child age Compliance [mL/mbar] Newborn Infants Small children 3-5 10-20 20-40 Table 11. Standard values for compliance depending on child age Compliance values for the Simulator: Compliance [mL/mbar] 1 2 3 5 Table 12. Values of compliance chosen for lung simulator 4.4.1. CONCEPTS DESIGN 4.4.1.1. Screw system The first idea of how to control compliance, was to apply screw at the end of the rigid structure and change compliance by turning it. This system would have successfully restrained bag movement however it could be only controlled manually. Due to this and also the fact that this part of the simulator was occupied by spontaneous breathing system, the idea of screw system was abandoned. Figure 61. Sketches of screw system for controlling compliance 79 EPS/IDPS 2014 4.4.1.2. PEADIATRIC AND NEONATAL LUNG SIMULATOR Band system Figure 62. Sketches of band system for controlling compliance The second idea consisted of band system with the elastomeric band which surrounds the bag and is fixed to the rigid structure of the bag on the one side. The band would be rolled into pulley inside the case with each turn of the pulley corresponding to fixed value of compliance. By decreasing the length of the band constraining the bag, the bag is allowed to move less and less freely. The movement of the pulley can be controlled remotely which is why this system is to be applied to proposed lung simulator. 4.4.1.3. Final design BAND PULLEY BAG WITH STRUCTURE COMPLIANCE GENERATION Figure 63. Final design of the system for controlling compliance The band with pulley system has been chosen because is the system that can adjust the stiffness of the bag remotely controlled. Depending on the laps of the pulley, the band will stretch to pull the bag wall closer to the other. The structure has 4 grooves where the band passes through. In the top face the band is held from side to side by the grooves in the guides of the piece. Top grooves Base grooves Figure 64 and 65. Grooves in the rigid structure Holding point of the band 80 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4.4.2. CALCULATIONS AND RESULTS The first calculation is about the band length. The band length required for the system can be divided into a few parts: 1) L1 – The part fixed to the pulley It corresponds to the half of the circumference of the pulley. Since the diameter of the pulley is d = 25 mm, this part of the band is equal: * d * π = * 25 mm * π = 39 mm = 2) L2 – The part between pulley and rigid structure of the bag Since the distance between the outer part of the pulley and upper part of rigid structure is equal 109 mm, this part is equal 109 - 25 - 50 mm = 34 mm = L2. 3) L3 – The part surrounding the bag itself This part consists of twice the distance between the upper and lower part of ridid structure and the width of the rigid structure itself when the band is to be placed (75.5 mm). This first part can be calculated due to intercept theorem, since the band is placed in the middle of the length of rigid structure: = Where: C = 180 mm D = 25 + 10 mm (for maximal expansion of the bag for spontaneous breathing) = 35 mm B = 82.4 mm Then: = = 16 mm Thus, this part is equal 2 * 16 mm + 75.5 mm = 91.5 mm = L3 4) L4 – The safety length In order to ensure that the band does not restrain in any way the movement of the bag, some extra length is advisable. 10% of the previously calculated length should be enough to make sure that the presence of the band does not influence in any manner the behaviour of the bag, unless the specific value of the compliance is required. ( ( ) ) Finally the whole length of the band can be calculated: 91.5 + 16.5 = 180 mm 81 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Therefore, the whole band should have 180 mm of length and 12 mm of width, since this is the width of the space in pulley where the band will be placed. The expected values of compliance will be obtained by rotating the pulley by a specific angle. However, those values can only be obtained experimentally due to the relationship between change in volume and change in pressure that defines compliance. Therefore, this part of calculations can be only solved after checking behaviour of the prototype with compliance control system which is not part of this project. 4.4.3. MECHANISM TO ADJUST THE COMPLIANCE The main elements to be taken into account in this mechanism are a pulley, a motor and an elastomeric band. Actually, one side of the elastomeric band will be glued or pasted on the pulley and the other side will be put across the bag which represents the lung. While, the pulley will be connected to the motor to ensure that it can be rotated perfectly. Once it is rotated, the band will be stretched more or less depending on the value of the compliance that is introduced. Figure 66. Mechanism to adjust compliance PULLEY The pulley that will be used in this mechanism is being shown in the following picture. This design is the most suitable and compatible to be used to create this kind of scenario or in other words to control the compliance of the lung simulator. Other than that, it could easily roll up the elastomeric band once the motor is being rotated. DC MOTOR This motor is exactly the same as before but only has different length of shaft which is 35mm. This length is compatible with the length of the pulley, so it can be positioned very well on the motor without any difficulties. ELASTOMERIC BAND This kind of band is so flexible, so it can be stretched out more without having any problems. It will be placed across the bag and being pulled up by a pulley controlled by a motor. 82 EPS/IDPS 2014 4.5. PEADIATRIC AND NEONATAL LUNG SIMULATOR RESISTANCE CONTROL SYSTEM Resistance (R) is a measure of airflow resistance and is defined by the pressure difference between the beginning and end of a tube (ΔP) and the flow of gas volume per time unit (V): For the pulmonary airways, ΔP corresponds to the difference between atmospheric pressure inside the mouth and the alveolar pressure. In case of children, the airflow resistance is considerably higher than for adults, due to anatomical and physiological features of the respiratory organs which were described in section 2.2.1. In the below table there are presented normal values for the resistance depending on age of a child: Child’s age Newborns Infants Small children Airway resistance [mbar/l/sec] 30 - 50 20 - 30 20 Table 13. Typical values of airway resistance The values of resistance of the proposed Lung Simulator were provided by Sant Joan de Dèu Hospital’s doctors in accordance to their needs and experience. Those values are shown in the table below: Resistance [mbar/l/sec] 5 20 50 100 Table 14. Values of resistance for lung simulator 83 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4.5.1. CONCEPTS DESIGN 4.5.1.1. Push and pull system Figure 67. Sketches of push and pull system for controlling resistance The first idea of controlling resistance was push and pull system presented below. The system would have been controlled manually by pushing the bar in order to reach proper diameter corresponding to different values of airflow resistance. This idea was dismissed after the meeting with the doctors when we learned that hospital would like to have all parameters controlled remotely. 4.5.1.2. Wheel system Figure 68. Sketches of wheel system for controlling resistance Second option was the ring with the holes of different diameters which would be rotated in order to represent specific resistance. This system was decided to be used for the product because of it can be easily controlled remotely. 84 EPS/IDPS 2014 4.5.1.3. PEADIATRIC AND NEONATAL LUNG SIMULATOR Final design RESISTANCE WHEEL TUBE RESISTANCE CONTROL Figure 69. Final design of the system to control resistance The resistance piece is going to be the connector between the lung simulator and the ventilator. In one side is connected the tube of the simulator and in the other the tube from the ventilator. Between the two sides the diameter of the interior wheel will determine the resistance value of the airway. The tube exterior diameter is 20 mm and the interior is 16 mm. These dimensions have been considered taking into account the total size of the wheel and the resistance holes. The ventilator tube has not got an important influence on the dimensioning because it is necessary to use a connector depending on the mechanical ventilation type as it has been specified in the requirements analysis section of the report. 4.5.2. CALCULATIONS AND RESULTS DIAMETER OF THE HOLES To calculate the adjusted diameters for each resistance value there have been taken into account the following parameters: - Length of the tube that represents the airway Diameter of the tube that represents the airway Flow of air Usually, the relationship between airway resistance and radius of the tube can be analysed using the Poiseuille Law. It can be described by following formula: Where: µ - fluid viscosity L - length of the tube r - radius of the tube 85 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Thus, for the simple tube the resistance is inversely proportional to the fourth power of the radius. However, since inside the tube there is a resistance mechanism designed to influence airflow, the relationship based on Poiseuille Law is no longer valid. That is why the values of diameters from resistance mechanisms from existing lung simulator were measured and analysed in order to propose the conceptual design. The results of these measurements are presented in the table below: Resistance [mbar l/s] 5 20 50 200 Diameter [mm] 8 6 4 1 Table 15. Diameters for existing lung simulator The results of measurements were plotted and function fitting them was found using software Logger Pro. From the graph, the missing value for 10 mbars l/s can be read: Figure 70. Curve fit for resistance measurements Therefore, the values of the diameters for different resistances of the lung simulator were obtained: Resistance [mbar l/s] Diameter [mm] 5 8 20 6 50 4 100 2 Table 16. Diameters for proposed lung simulator Those values need to be checked experimentally due to the fact that measuring airflow resistance require measuring simultaneously change in pressure and volume in the bag of lung simulator. Therefore, the values of the resistances for each chosen diameters are only approximated and exact values would be obtained by testing the prototype with resistance mechanism. 86 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4.5.3. MECHANISM TO CONTROL THE RESISTANCE To control the airway resistance of the lung simulator remotely, the main components that have to be included are Geneva Wheel and a DC motor to control the system. Figure 71. Mechanism to control resistance GENEVA WHEEL (4 steps) Figure 72. Mechanism to control resistance: Geneva wheel In general, the Geneva wheel is a gear mechanism that translates a continuous rotation into an intermittent rotary motion. The rotating drive wheel has a pin that reaches into a slot of the driven wheel advancing it by one step. Actually, the type of drive wheel that is shown in the figure above is an exterior drive wheel. However, the idea for this kind of mechanism is the same but in this lung simulator the drive wheel that will be used is an interior wheel; it is a little bit different with that shown in the previous figure. The following picture shows the real mechanism will be used and the motor will be connected to the driven wheel which is in red. The motor then will rotate the driven wheel and automatically the drive wheel will be rotated step by step. Figure 73. Mechanism to control resistance: Specification The base contains the wheels and includes the tubes connectors. The drive wheel is controlled by the motor and transforms the continuous movement in a step by step one The driven piece is moved in a 90º angle by the drive Wheel. It has the different resistance holes. 87 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR In this mechanism, the airway resistance will be measured by using the internal Geneva mechanism which is being controlled by a motor. Equations for the Internal Geneva Wheel: The values of a, n, d and p are being considered given or assumed. a = crank radius of driving member n = number of slots d = roller diameter p = constant velocity of driving crank, rpm b = centre distance = am D = inside diameter of driven member = m= ( √ ) ω = constant angular velocity of driving crank, rad/sec = rad/sec α = angular position of driving crank at any time, degrees β = angular displacement of driven member corresponding to crank angle √ ( Angular velocity of driven member = ) [( Angular acceleration of driven member = Maximum angular velocity occurs at α = 0° and equals ( ) ) ] rad/sec Maximum angular acceleration occurs when roller enters slot and equals rad/sec2 √ 88 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Given parameters a = 9mm n = 4 slots d = 24.4mm p = 3750 rpm (same as motor’s velocity) Figure 74. Internal Geneva Wheel: parameters Calculations: The calculations of all the parameters needed to be known of the internal Geneva wheel. ( √ ) ( ) √ √ √ 89 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR DC MOTOR This kind of motor actually has the shaft of 7mm long and it is compatible with the Geneva Wheel. The role of this motor is to rotate the driven wheel. The motors for all the mechanisms: resistance, compliance and leaks are from the same model but with different lengths of shaft. The picture shows an example of a Direct Current (DC) motor of Model RE-280 which is approximately 45g of weight and it is made up of ANSI38 (Aluminium). This kind of motor is the most suitable to be put in the case of Figure 75. DC motor for controlling the lung simulator because it is very small, so it does not need resistance more space to be installed and it is really light. These characteristics are interrelated with those from the hospital; as a result, the simulator would be portable. These three motors will be connected to the Arduino Uno electronic board, then it will be programmed in order to control it remotely. The following table represents the specifications of the motor that will be used for the lung simulator. The motor has enough power output to be used in those mechanisms. This type of motor will be needed a nominal voltage of 1.5V, on other word, it needs at least 1.5V of power supply in order to ensure it will work perfectly. Moreover, the rotation speed of the motor is sufficient to rotate the motor together with the load. MODEL VOLTAGE NO LOAD AT MAXIMUM EFFICIENCY STALL TORQUE OPERATING RANGE NOMINAL SPEED RPM CURRENT A SPEED RPM CURRENT A oz - in TORQUE g - cm OUTPUT W EFF % oz - in g - cm Table 17. Motor specification 90 RE - 280 1.5 – 3.0 1.5V CONSTANT 4600 0.12 3750 0.53 0.16 11.53 0.44 56.2 0.86 62 EPS/IDPS 2014 4.6. PEADIATRIC AND NEONATAL LUNG SIMULATOR LEAKS CONTROL SYSTEM Air leakage in lungs is a major problem in long-term assisted ventilation both invasive and noninvasive that becomes even more important during sleep. This problem causes the reduction of air volume introduced in the lung cavity. In this section is presented the system to simulate the leakage of air in three scenarios: Big, small and no leaks during respiration. 4.6.1. CONCEPTS DESIGN 4.6.1.1. Pull and push system Figure 76. Sketches of pull and push system for controlling leaks The first idea was the pull and push system with the bar with holes of different diameters. By placing the bar in different positions, the air would be allowed to escape the tube or not. 4.6.1.2. Ring system Figure 77. Sketches of ring system for controlling leaks Second idea was based on the ring outside of the tube. When the hole in the ring was placed near the hole in the tube, the leakage occurred. The position of the ring can be controlled remotely. 4.6.1.3. Final design LEAKS RING TUBE LEAKS GENERATION Figure 78. Final design of the system for controlling leaks 91 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Leakage will be simulated through the position of the leaks ring. This ring has 2 sizes holes to simulate big and small leaks that will rotate to match with the orifice in the tube of the simulator to let the air scape from it. The toothed shape of the ring is to allow the control through a gear. 4.6.2. CALCULATIONS AND RESULTS Due to the fact that the hospital did not requested specific values of leaks in the simulator, the values of hole diameters were chosen arbitrarily. The ‘big leak’ is when the air is escaping from the tube by the hole of diameter 10 mm while for ‘small leak’ this value is 5 mm. The option ‘no leaks’ is when there is no hole in the ring near the hole in the tube. 4.6.3. MECHANISM TO CONTROL THE LEAKS For this mechanism, there are some components which are really important in order to ensure the system is working perfectly. Those important components are a leaks ring, a motor and two gears. Figure 79. Mechanism for controlling leaks LEAKS RING By considering how big the leaks could be, this ring is being designed to have two different sizes of holes or two holes with different diameters whereas one is small and the other is big hole. The following ring looks like a gear as it will be controlled by two gears indeed. There have been used 2 gears instead of one because of the motor position inside the box of the simulator, if it wouldn’t have been this constraint the ring could be controlled only with one gear. 92 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR DC MOTOR As one of the two gears needs to be connected to this motor and suits it well, so the shaft of the motor has the same length of the gears that is 20mm. This motor will rotate and control the gear, then the leaks ring will be rotated to open the hole that allows the air from the tube to go out and simulate the leaks. GEARS As there is not enough space to place only one gear together with the motor stacked on it on an upper side, so this mechanism will be using two gears where one of them is being connected to the motor and the other one will be placed on the top of that gear and at the same time the upper gear will be positioned into a plastic stick which is a part of the simulator case. Those two gears are exactly the same size and have the same number of teeth as well as the leaks ring. When the motor is turning on, for instant it will start to rotate clockwise. After that, the gear that is connected to the motor will also start to rotate clockwise. Then, the second gear which is placed on top of the first gear will begin to rotate on the other way or anticlockwise and lastly, the effect of the rotation of the second gear will let the leaks ring to rotate clockwise. For example, the motor should be rotating half of a cycle in order to obtain a small leak or otherwise it should be rotating one half-cycle more to gain the big leaks. Type of gear: In this mechanism, the simplest gear that would be used is spur gear. It is a cylindrical shaped gear, in which the teeth are parallel to the axis and it is the most commonly used gear with a wide range of applications and it is the easiest to manufature. Gear trains: The gear train for this mechanism is the single-stage train with an idler as shown in the following diagram. There are three gears with different diameters shown in that diagram but in the real situation, it would be three gears with the same diameter and number of teeth. Out Idler Gear 3 (z3, n3) Gear 2 (z2, n2) In Gear 1 (z1, n1) Figure 80. Mechanism for controlling leaks: gear trains 93 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Gear tooth profiles: For power transmission gears, the tooth form most commonly used today is the involute profile. Involute gears can be manufactured easily and the gearing has a feature that enables smooth meshing depsite the misalignment of center distance to some degree. The table below shows the standard values of module sizes of the gears and the unit is in mm. Figure 81. Mechanism for controlling leaks: gear tooth profiles The real specification of the gear that will be used in this leaks mechanism: All these information are from the manufacturing process of the gear Calculation of gear dimensions: Gear dimensions are determined in accordance with their specifications. Calculations of external dimensions such as tip diameter are necessary for processing the gear blanks. Tooth dimensions are considered when gear cutting. 94 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR The following table represents the calculations for standard spur gear like the one that will be used in this mechanism. No. Item Symbol 1 Module Pressure angle Number of teeth Center distance Pitch diameter Base diameter Addendum Tooth depth Tip diameter Root diameter m 2 3 4 5 6 7 8 9 10 Formula α Example Gear 1.75 20° Set Value z 16 ( a ) 28 d 28 db 26.3114 ha 1.7500 h 3.9375 da 31.5000 df 23.6250 Table 18. Calculations for standard spur gear Calculation of angular speed output: In this case, those three gears have the same diameter and number of teeth, so the ratio speed, i is equal to 1. This means that their angular speeds should be the same value. In this mechanism, the speed of the motor that will be used is 3750rpm. ( ) It is important to clarify that the motor has to be check in a future step when it will have to be programmed the electronic instructions to control the motor in order to stop it every 90º of rotation to position the ring in the desired position. 95 EPS/IDPS 2014 4.7. PEADIATRIC AND NEONATAL LUNG SIMULATOR CASE AND PRODUCT APPEARANCE CASE SHAPE 130 278 141 Figure 82. Case shape The general shape of the lung simulator was decided once all the elements to control each parameter were chosen. The compactness of the product was the main principle to take into account for the design of the whole product, for this reason all the elements had to be included in a closed case. The total dimensions of the device are the ones shown in the picture. The shape of the case was conditioned by all the elements that had to be placed inside and by the dimensions and morphology of the bag with its structure, the most important component of the simulator. For dimensioning reasons that have already been detailed, the bag shape is a trapezium that is located in a structure that facilitates the spontaneous breathing generation. Considering the cylindrical piece to push the structure up, the bag and to give an appearance similar to the lung it was designed the structure morphology. Taking care of the compactness aspect and the shape of the structure, the case has been designed transforming the shape of the structure into a regular volume in order to make the product portable, avoiding sharp corners. The result is a cylindrical profile that can contain all the elements inside. In order to ease the access to the mechanisms that are inside the case it has been designed a cap with a joint system provided by its own geometry. CASE CAP 96 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Both, structure and case have been designed thinking about the changing of the bag from the children size to the neonate bag. Because of this all the elements can be removed from the case slipping them, thanks to the included slots. In order to remove the bag is only needed to pull it from the structure but this piece can be also extracted from the case through the same system. Figure 83. Elements removal The following image shows a view of all the main elements of the simulator to specify their position in relation with the rest of components. Figure 84. Simulator components COLOR AND TRIM The main colour of the product, chosen for the case, is white. It has been taken into consideration to give a clinical and neat aspect to the product for being intended to be a medical device. Since the simulator is supposed to be an innovative product in comparison with the ones in the market thanks to the remote control technology it has been applied a brightly green providing the product this connotation. 97 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR For the cap of the simulator it has been chosen the same green tonality but with a different trim. It is transparent in order to contrast with the case that is completely white and to break the visual weight concentrated in this piece; this difference of texture provides the product of visual balance. The visible structure uses a colour mimesis, as it has been done with its shape, with the human lungs. It has been chosen this maroon to contrast with the white case and let the user identify easily which part of the simulator represents the lung cavity. GRAPHICAL ELEMENTS The case of the product includes useful graphical information for the user to identify the parts of the simulator they must interact with. Figure 85. Graphical elements of the case In one side of the case there are the elements related with the power source of the device: the power button and an USB plug to charge the device before being used. The black icons inform the user about the functions of the elements. Figure 86. Power icon On/off button is illuminated when is pressed alerting that the simulator is functioning. Once it is disconnected the button turns off. Figure 87. Battery status icons The information of the battery state will be shown in the remote, but is also indicated in the simulator using a LED button under the USB groove. The LED will be red if it is out of energy, an orange flashing light if it starts to be low of battery and green to indicate when it is charged. 98 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Figure 88. Spontaneous breathing icon Figure 89. Leaks and resistance icons The fitting to introduce the tube for the spontaneous breathing generation is pointed by a pictogram that represents this parameter in order to inform the user. The same method is applied for the control of the leaks and resistance to ensure that in case the device had to be controlled manually the user would not confuse the elements. The iconography is explained in the design of the remote interface description. INTERIOR MECHANISMS OF THE CASE The following image shows the position of the mechanical elements inside the box and the position between them. All the elements are fixed in the box by subjection elements that have been selected. All of them are extrusions in the box to ensure that they cannot be moved fixed with screws in their corresponding cover. The dimensions of those pieces are in the technical drawings in the ANNEX. LEAKS RINGWHEEL GENEVA ELASTOMERIC BAND ELECTROVALVE MOTOR RESISTANCE GEARS CYLINDER MOTOR MOTOR PULLEY LEAKS COMPLIANCE Figure 90. Interior mechanisms of the case 99 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Box for electronic components Subjection of the elements Figure 91. Placement of the elements inside the case The three motors that the simulator has, are attached by extruded parts of the case that addapts to their shape and is fixed with a piece by 4 screws, as shown in Figure 92. All the elements that need to be hold are fixed to the case ensuring the proper functioning and also easy disassembling. Figure 92. Subjection piece for motors Figure 93. Bottom view of the case to show subjection elements Figure 94. Subjection piece for the cylinder These images show the pieces used to attach the motors and the cylinder in the case. The screws are M2 0.4 of nominal diameter. The length varies according to the element to fix. Subjection pieces technical drawings are in the ANNEXES for more information. 100 EPS/IDPS 2014 4.8. PEADIATRIC AND NEONATAL LUNG SIMULATOR THE REMOTE CONTROL 4.8.1. SELECTION OF THE SYSTEM TABLET/SMARTPHONE Figure 95. Design of the remote In order to control the lung simulator remotely it has been chosen to use a tablet or smartphone through an application considering that the lung simulator has been designed to be controlled through ARDUINO. CONNECTIVITY Bluetooth is a brand name of a wireless networking technology which uses short-wave radio frequencies to interconnect cell phones, portable computers, and other wireless electronic devices over short distances. Figure 96. Principle of Bluetooth technology A fundamental advantage of Bluetooth wireless technology is its ability to simultaneously handle data and voice transmissions. This feature, among other beneficial qualities like low cost and low energy consumption, means that there are many applications of Bluetooth technology including: Wireless control and communication between mobile and hands-free headsets Wireless networking between multiple computers in areas with limited service Replacement of conventional wired communication, like GPS receivers, medical equipment, traffic control devices and bar code scanners 101 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR For low-bandwidth applications, when a higher USB bandwidth is not desired Managing short-range data transmission between medical and other tele-health devices Mobile phone communication with digital enhanced cordless telecommunication (DECT) Identifying and tracking object positions with the real-time location system Tracking livestock and prisoner movement Due to the widespread usage of Bluetooth technology in almost the whole globe, any Bluetooth enabled device can connect to other Bluetooth enabled devices located in close proximity to each other. The wireless communication between these devices is possible thanks to the piconets which are short-range, ad hoc networks. Piconets are established in dynamic and automatic manner depending on if the devices are within radio proximity which means that connection and disconnection is up to users’ convenience. Each device in a piconet can simultaneously communicate with up to seven other devices within that single piconet and it is also possible to one device to belong to several piconets at the same time. Bluetooth technology operates in the unlicensed ISM band (industrial, scientific and medical band) at the frequency between 2.4 and 2.485 GHz. It uses a spread-spectrum, frequencyhopping, full-duplex signal at a nominal rate of 1600 hops/sec. The 2.4 GHz ISM band is available and unlicensed in most countries. There are two elements required in order to make the lung simulator the Bluetooth enabled device. One of them is connecting a Bluetooth board to Arduino and the other is Android application to control the board. Below, the Arduino scheme and picture of one of possible applications - BlueTerm are presented: Figure 97. Scheme with Bluetooth board Figure 98. BlueTerm application 102 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 4.8.2. INTERFACE DESIGN Simulator battery Exit icon Selection of the resistance Selection of the leaks Selection of the compliance Activation and adjustment of The spontaneous breathing Figure 99. Interface design ICONOGRAPHY Figure 100. Iconography of the interface There has been selected an icon that represents the lungs to be used as the image that indicates the different parameters to control applying referential points that indicate the parameter adjusted: - RESISTANCE: It has the airways marked because is the part of the lung where the resistance changes. COMPLIANCE: Referring to the lung walls because the compliance depends on the elasticity of the lungs’ bag. LEAKS: The coloured zone means the air escaping due to the leak. SPONTANEOUS BREATHING: A child with green narrows that indicates the moment when the patient starts recovering his breathing. 103 EPS/IDPS 2014 - PEADIATRIC AND NEONATAL LUNG SIMULATOR BATTERY INFO: The energy source of the simulator is a battery, so it is necessary to inform the user through the interface the level of energy that the simulator has. EXIT: It closes the application. FUNCTIONING Figure 101. Interface: compliance The interface is divided in the 4 parameters to be controlled by the user. Once inside the application, the icons inform about the parameter to control and this has a button for each established value. In the case of resistance, leaks and compliance the user only has to tap in the value that is wanted to be applied in the simulator and the signal will be sent to the device. For spontaneous breathing, due to be a parameter that can be or not activated there is an on/off option. When the spontaneous breathing is selected, the user can adjust the breathing per minute from 10 to 70. Figure 102. Interface: spontaneous breathing 104 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5. MATERIALS AND MANUFACTURING PROCESS In this section the process for choosing the materials for each component of the lung simulator is presented, also the most important characteristics, the manufacturing process, the final weight for each part and what the cost will be, these two final elements will be found in the Appendix part of the project. An Eco-Audit analysis will be made to see the impact of these materials on the environment, specifying that these materials were elected based on their Eco properties and this analysis will be found in the Appendix as well. 5.1. BAG Figure 103. Bag 5.1.1. REASONS FOR CHOOSING THE MATERIAL The material wanted for the bag is the silicone rubber because of its excellent mechanical, thermal and electrical properties. It offers good resistance to extreme temperatures, some properties such as elongation, creep, cyclic flexing, tear strength, compression set, dielectric strength(at high voltage), thermal conductivity, fire resistance and in some cases tensile strength can be—at extreme temperatures—far superior to organic rubbers in general, although a few of these properties are still lower than for some specialty materials. Silicone rubber is a material of choice in industry when retention of initial shape and mechanical strength are desired. Silicone rubber is highly inert and does not react with most chemicals. Due to its inertness, it is used in many medical applications. Silicone and flour-silicone elastomers have long chains of linked O-Si-O-Si group (replacing the C-C-C-C- chains in carbon-based elastomers), with methyl (CH3) or fluorine (F) side chains. Silicones are based on the repetition of silicon and oxygen in the polymer chain; it can be used as an elastomer or a thermoset. Additionally, this material had improved fatigue properties as evaluated using a torsion-fatigue test. 105 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR ADHESIVE For the lung simulator an adhesive is needed to bind the bags with their surrounding structure, which together will go in the rigid structure. The use of adhesives offers many advantages such as the ability to bind different materials together, to distribute stress more efficiently across the joint, the cost effectiveness of an easily mechanized process, an improvement in aesthetic design, and increased design flexibility. The best choice in this case was considered to be Bisphenol B epoxy resin which is a thermosetting product known for its excellent surface and sub-surface adhesion, mechanical properties and chemical resistance. The system is made up of an epoxy resin and a hardener (catalyst) and it also contains organic solvents, fiberglass and pigments. RIGID PART SURROUNDING THE BAG Because the bag comes in two sizes and will be switched according to the doctor’s needs, a system was required that could facilitate the change in a very fast and easy way. The proposed solution consists of two rigid sides that will be attached to the bag using the proper adhesive and these parts will be placed in the rigid structure with the help of the two brackets positioned on each side of the rigid structure. The concept of the two rigid surfaces glued to the bag allows a very easy inflation or compression and the size for each one was selected in order to adapt the morphology of both to the final lung simulator. The material chosen for the two sides is HDPE, the same as for the rigid structure, in order to avoid friction. HDPE has excellent mechanical properties and after a stress analysis done with the program NX it was proven that the shock wasn’t very big and the structure wouldn’t break. 106 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.1.2. PROPERTIES Odourless and tasteless, silicone rubber is prized by many industries for its inherent inertness. Its attributes make it ideal for the medical industries, where silicone rubber is used in bottle nipples, conveyor belting, tubing and even implants. General properties Density: 1.3e3 – 1.8e3 kg (m^3) Price: 12.9 – 14.2 USD/kg Mechanical properties Thermal properties Processability Young’s modulus: 0.005 – 0.02 GPa Glass temperature: -123 - -73.2 ⁰C Castability: 4 – 5 Shear modulus: 0.002 – 0.0066 GPa Maximum service temperature: 227 – 287 ⁰C Minimum service temperature: -73.2 - 48.2 ⁰F Moldability: 4 – 5 Yield strength (elastic limit): 2.4 – 5.5 MPa Tensile strength: 2.4 – 5.5 MPa Machinability: 2 – 3 Weldability: 1 Compressive strength: 10 – 30 MPa Elongation: 80 – 300 %strain Fatigue strength at 10^7 cycles: 2,28 – 4 MPa Fracture toughness: 0.03 – 0.5 MPa*m^ (1/2) Table 19. General properties of silicone rubber Eco properties The use of silicones, siloxanes and silanes generates energy savings and greenhouse-gas emission reductions that outweigh the impacts of production and end-of-life disposal by a factor of 9. Also striking is that a relatively small quantity of silicone, siloxane or silane can lead to a comparatively large increase in the efficiency of processes and the use of energy and materials. Examples include high-performance thermal insulation products, foam-control agents for washing, paint additives that increase the durability of vehicles and construction materials, and silanes used to reduce the rolling resistance of tyres. Table 20. Eco properties of silicone rubber 107 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.1.3. MANUFACTURING PROCESS The process through which the bag is obtained is injection moulding due to its several advantages like a fast production, material and colour flexibility, labour costs low, design flexibility and low waste. Figure 104. Manufacturing process of the bag Injection moulding is a manufacturing process for producing parts by injecting material into a mould. Material for the part is fed into a heated barrel, mixed, and forced into a mould cavity where it cools and hardens to the configuration of the cavity. After a product is designed, usually by an industrial designer or an engineer, moulds are made by a mould maker (or toolmaker) from metal, usually either steel or aluminium, and precision-machined to form the features of the desired part. Injection moulding is widely used for manufacturing a variety of parts, from the smallest components to the biggest ones. 108 EPS/IDPS 2014 5.2. PEADIATRIC AND NEONATAL LUNG SIMULATOR RIGID STRUCTURE Figure 105. Rigid structure 5.2.1. REASONS FOR CHOOSING THE MATERIAL The desired material for the structure that surrounds the bag is HDPE (high-density polyethylene) due to the fact that it exhibits a higher capacity for tolerating surge pressures. The unique performance characteristic of the HDPE polymer chains disentangling under sudden stress and then returning at its normal state, provides the HDPE with the ability to absorb some of the energy generated by the pressure surge. 5.2.2. PROPERTIES It is very used in the industry due to its several advantages like the low price, impact resistant from -40 C to 90 C, moisture resistance, good chemical resistance and readily processed by all thermoplastic methods. General properties Density: 952 – 965 kg/m^3 Price: 1.76 – 1.94 USD/kg Mechanical properties Composition overview Young’s modulus: 1.07 – 1.09 GPa Base: polymer 100% Shear modulus: 0.377 – 0.384 GPa Polymer class: thermoplastic semicrystalline Yield strength (elastic limit): 26.2 – 31 MPa Polymer type full name: Polyethylene, high density Filler type: Unfilled Tensile strength: 22,1 – 31 MPa Compressive strength: 18,6 – 24,8 MPa Elongation: 1,12e3 – 1,29e3 %strain Fatigue strength at 10^7 cycles: 8,84 – 12.4 MPa Fracture toughness: 1.52 – 1.82 MPa.m^0.5 Eco properties Embodied energy; primary production: 90.3 – 99.9 MJ/kg CO2 footprint, primary production: 3.64 – 4.03 kg/kg Water usage: 167 – 185 l/kg Table 21. General properties of high-density polyethylene 109 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.2.3. MANUFACTURING PROCESS Because of many advantages of the process like the fact that it is continuous and has high production volumes, low cost per pound, efficient melting and good mixing the best option, for this part is the polymer extrusion. Figure 106. Manufacturing process of rigid structure Every extrusion process has eight main steps: 1. Pre-treatment of extruded material which includes drying of materials, feeding of additives and preheating. 2. The material is put into the extruder through the throat. 3. Force the feeders if the process is difficult or needs to be constant. 4. The raw material is conveyed from the feeding zone to the die, in this case it is very important that the friction between the screw is lower than the friction between the cylinder. 5. The melted material is pumped through the die into the final form. 6. The next step is to calibrate the extrudate in the final dimensions and form. 7. Post-processing of extrudates. After the extrusion is finished, the machining process will begin in order to make the hole through which the tube will go. 110 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.2.4. SIMULATION ANALYSIS OF RESISTANCE Figure 107. Simulation analysis of resistance The result of the stress distribution on the structure obtained from the simulation where the structure withstands the maximum stress around the red areas. With that amount of force applied to the structure, it seems that it would not be broken. In this case, the maximum stress is 6.09MPa. CROSS-SECTIONAL AREA OF THE STRUCTURE - Material: High Density Polyethylene (HDPE) - Young’s Modulus: E = 1000MPa - Poisson’s Ratio: = 0.4 111 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Figure 108. Cross-sectional area of the structure Calculation Section Moment of Inertia Shear Modulus 112 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Bending Moment M=F·x Shear Force Diagram of Moment and Force Diagram of bending moment Diagram of shear force Maximum Normal Stress (Navier’s Law) M .y Ix ( ) Shear Stress T .m b.I x ( ( ) ) ( ( ) ) 113 ( ) EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Diagram of Stress ( ) Neutral axis ( ) In order to reach the maximum expansion volume of the bag which is 250ml, the rigid structure if the lung simulator should be displaced or moved up by 10mm from the original position by the piston in this mechanism. This means, the piston should be applied by a sufficient force to achieve that displacement. As shape of the piece is very complicated, so the calculation of the amount of force that is needed to be applied to the piston cannot be done theoretically. On the other words, it has to be done by doing the simulation through the software (Solidworks or NX). During the simulation, the value of force needs to be assumed until it gives the displacement of the structure approximately 10mm. Afterwards, once the value of that force is known, the calculation of the stresses, bending moment and shear force could be done easily by applying those formulas. But before that, to be able to do that calculation, the moment of inertia and the shear modulus need to be calculated first. 114 EPS/IDPS 2014 5.3. PEADIATRIC AND NEONATAL LUNG SIMULATOR TUBE Figure 109. Tube 5.3.1. REASONS FOR CHOOSING THE MATERIAL The best option for this element is considered to be PVC (Polyvinyl chloride) with 20% glass fibre that has extrusion as its manufacturing process. PVC is used in many critical applications such as in medical products, for example blood and intravenous bags as well as many of the tubes and catheters used in hospitals throughout the world. 5.3.2. PROPERTIES General properties Density: 1,43e3 – 1.5e3 kg/m^3 Price: 2.4 – 2.79 USD/kg Mechanical properties Composition overview Eco properties Young’s modulus: 4,69 –6,69 GPa Base: polymer 100% Embodied energy; primary production: 54,4 – 60,2 MJ/kg Shear modulus: 1.71 – 2,44 GPa Polymer class: thermoplastic amorphous Polymer type full name: Acrylonitrile butadiene styrene Filler type: Unfilled CO2 footprint, primary production: 2.5 – 2.76 kg/kg Yield strength (elastic limit): 47.4 – 70,6 MPa Tensile strength: 59.3 – 88,3MPa Compressive strength: 56.9 – 84.8 MPa Elongation: 2 – 5 %strain Fatigue strength at 10^7 cycles: 23.7 – 35.3 MPa Fracture toughness: 2.73 – 3.27 MPa.m^0.5 HV: 14.2 – 21.2 HV Table 22. General properties of polyvinyl chloride 115 Water usage: 214 – 236 l/kg EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.3.3. MANUFACTURING PROCESS Considering the shape of this part, the easiest process through which it could be manufactured is extrusion. Figure 110. Extrusion process The extrusion process is a very simple one and that is why it represents a great choice in this case. It begins with the pre-treatment of the material which includes drying the PVC, adding additives and preheating it. Next the material is put in the throat of the extruder and the raw material is conveyed from the feeding zone to the die. The melted material is pumped through the die into the final form where the calibration of the extrudate takes places and the final step is the post-processing of the extrudate. Once the extrusion is done and the tube is out a machining process will start in order to obtain the hole with which the leak parameter is shown. 116 EPS/IDPS 2014 5.4. PEADIATRIC AND NEONATAL LUNG SIMULATOR ELEMENT TO CONTROL LEAKS Figure 111. Element to control leaks 5.4.1. REASONS FOR CHOOSING THE MATERIAL The ABS (Acrylonitrile Butadiene Styrene) makes an ideal choice because of its excellent impact resistance, its good appearance for design purposes, a moderate strength and a good flow. It is also a recyclable material and easily extruded and injection moulded, two very important aspects to take into consideration when choosing a material. 5.4.2. PROPERTIES The final properties will be influenced to some extent by the conditions under which the material is processed to the final product. For example, moulding at a high temperature improves the gloss and heat resistance of the product whereas the highest impact resistance and strength are obtained by moulding at low temperature. The aging characteristics of the polymers are largely influenced by the polybutadiene content, and it is normal to include antioxidants in the composition. General properties Density: 1,03e3 – 1.06e3 kg/m^3 Price: 2.84 – 3.13 USD/kg Mechanical properties Composition overview Eco properties Young’s modulus: 2.07 – 2.76 GPa Base: polymer 100% Embodied energy; primary production: 90.3 – 99.9 MJ/kg Shear modulus: 0.74 – 0.987 GPa Polymer class: thermoplastic amorphous CO2 footprint, primary production: 3.64 – 4.03 kg/kg Yield strength (elastic limit): 34.5 – 49.6 MPa Polymer type full name: Acrylonitrile butadiene styrene Filler type: Unfilled Water usage: 167 – 185 l/kg Tensile strength: 37.9 – 51.7 MPa Compressive strength: 39.2 – 86.2 MPa Elongation: 5 – 60 %strain Fatigue strength at 10^7 cycles: 15.2 – 20.7 MPa Table 23. General properties of Acrylonitrile Butadiene Styrene 117 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.4.3. MANUFACTURING PROCESS ABS is an amorphous thermoplastic copolymer blended from Acrylonitrile, Butadiene and Styrene. Being an amorphous thermoplastic, it is easily extruded and by this the highest impact resistance and strength are obtained. There are numerous advantages to ABS extrusion such as good electrical properties, impact resistance, combines strength, rigidity and toughness in one material, excellent load stability and is lightweight. For the actual manufacturing process there are some easy steps to follow, as I said before. First, the material is fed into the throat, moved from one zone to the other and pumped through the die into the final form. The leaks ring needs to undertake a machining process to get two holes through which air will pass. 118 EPS/IDPS 2014 5.5. PEADIATRIC AND NEONATAL LUNG SIMULATOR ELEMENT TO CONTROL RESISTANCE Figure 112. Element to control resistance 5.5.1. REASONS FOR CHOOSING THE MATERIAL For the element that will control the resistance it was chosen the same material as for the leaks rings, this being ABS, because the two are located on the same tube and need to have similar characteristics. As it was said before, ABS has many advantages such as dimensional stability, toughness-even at low temperatures, chemical resistance and that is why it is a perfect choice for this part as well. 5.5.2. PROPERTIES The ABS three monomer systems can be tailored to yield a good balance of properties. Basically, styrene contributes ease of processing characteristics, acrylonitrile imparts chemical resistance and increased surface hardness and the butadiene contributes impact strength and overall toughness. General properties Density: 1,03e3 – 1.06e3 kg/m^3 Price: 2.84 – 3.13 USD/kg Mechanical properties Composition overview Eco properties Young’s modulus: 2.07 – 2.76 GPa Base: polymer 100% Embodied energy; primary production: 90.3 – 99.9 MJ/kg Shear modulus: 0.74 – 0.987 GPa Polymer class: thermoplastic amorphous CO2 footprint, primary production: 3.64 – 4.03 kg/kg Yield strength (elastic limit): 34.5 – 49.6 MPa Polymer type full name: Acrylonitrile butadiene styrene Filler type: Unfilled Water usage: 167 – 185 l/kg Tensile strength: 37.9 – 51.7 MPa Compressive strength: 39.2 – 86.2 MPa Elongation: 5 – 60 %strain Fatigue strength at 10^7 cycles: 15.2 – 20.7 MPa Fracture toughness: 1.46 – 4.29 MPa.m^0.5 HV: 10.4 – 14.9 HV Table 24. General properties of Acrylonitrile Butadiene Styrene 119 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.5.3. MANUFACTURING PROCESS Due to its light weight the ABS has two possibilities regarding manufacturing, injection moulding and extrusion. The best option in the case of the element that controls the resistence is the injection moulding. The process of injection is very easy to do, in four steps: 1. Granules of ABS are fed to a hopper that stores them until it is needed. 2. Due to the heater that heats up the tube until it gets to a high temperature, a screw thread starts turning. 3. The thread is then turned by a motor and pushes the ABS granules along the heater section which melts then into a liquid. The liquid is forced into a mould where it cools into the desired shape. 4. The final step consists in the opening of the mould and recovering the unit. Figure 113. Manufacturing process for the element controlling resistance When the product is cooled, through the machining process, the four holes that show different resistances will be made. 120 EPS/IDPS 2014 5.6. PEADIATRIC AND NEONATAL LUNG SIMULATOR ELEMENT TO CONTROL COMPLIANCE 5.6.1. REASONS FOR CHOOSING THE MATERIALS 5.6.1.1. BAND For this element used in the control of compliance a material with great wear properties is needed, also it must have good mechanical and impact properties, it should be self-lubricating and abrasion resistant, extremely durable. For these reasons and many more, PA (Polyamide) or better known as nylon represented the optimal solution. Figure 114. Band 5.6.1.2. PULLEY The material used for the pulley is PEEK (Poly ether ether ketone), which is a semi-crystalline thermoplastic with high tensile strength, stiffness, good wear resistance, low coefficient of friction, excellent chemical resistance and very low moisture absorption. This broad range of useful properties in addition to its ability to retain them over a long period under elevated mechanical stress and demanding environmental conditions make it a premium choice for this application. Figure 115. Pulley 5.6.2. PROPERTIES 5.6.2.1. General properties Density: 1,22e3 – 1.24e3 kg/m^3 Price: 5.26 – 5.79 USD/kg BAND Mechanical properties Composition overview Eco properties Young’s modulus: 3.13 – 3.91 GPa Base: polymer 85% Embodied energy; primary production: 107 - 118 MJ/kg Shear modulus: 1.26 – 1.33 GPa Polymer class: thermoplastic semicrystalline Polymer type full name: Polyamide/nylon 6 Filler type: Glass fiber 15% CO2 footprint, primary production: 6.98 – 7.72 kg/kg Water usage: 192 – 212 l/kg Yield strength (elastic limit): 68.5 – 85.5 MPa Tensile strength: 63.9 – 78.1 MPa Elongation: 8.44 – 12.1 %strain Fatigue strength at 10^7 cycles: 27 – 29.8 MPa Fracture toughness: 3.94 – 4.36 MPa.m^0.5 Table 25. Properties of Polyamide 121 EPS/IDPS 2014 5.6.2.2. General properties Density: 1,3e3 – 1.32e3 kg/m^3 Price: 99.1 – 109 USD/kg PEADIATRIC AND NEONATAL LUNG SIMULATOR PULLEY Mechanical properties Composition overview Eco properties Young’s modulus: 3.76 – 3.95 GPa Base: polymer 100% Embodied energy; primary production: 101 - 111 MJ/kg Shear modulus: 1.36 – 1.43 GPa Polymer class: thermoplastic semicrystalline Polymer type full name: Poly ether ether ketone Filler type: Unfilled CO2 footprint, primary production: 5.65 – 6.24 kg/kg Water usage: 177 – 195 l/kg Yield strength (elastic limit): 87 – 95 MPa Tensile strength: 70.3 – 103 MPa Compressive strength: 118 – 130 MPa Elongation: 30 – 150 %strain Fatigue strength at 10^7 cycles: 28.1 – 41.2 MPa Fracture toughness: 2.73 – 4.3 MPa.m^0.5 Table 26. General properties of Poly ether ether ketone 5.6.3. MANUFACTURING PROCESS 5.6.3.1. BAND Nylon is made through a complex two-step chemical and manufacturing process that first creates the fibre’s strong polymers, then binds them together to create a durable fibre. The first thing that needs to be done is to combine two sets of molecules. One set has an acid group on each end and the other set has an amine group, made up of basic organic compounds, on each end. When these two substances are combined, thick crystallized “nylon salts” result. These are commonly known as nylon 6, 6 or simply 6-6. The name is based on the number of carbon atoms between the two acid groups and the two amine groups. The crystals that result must be soaked in water to dissolve them, then acidified and heated to create a chain that is nearly unbreakable on a chemical level. A specially designed machine must be used to get the polymers heated to the right temperature, and then combine the molecules to form a molten substance that is forced into a spinneret, separating it into thin strands and exposing it to air for the first time. The air causes the strands to harden immediately, and once they are hard they can be wound onto bobbins. The fibres are stretched to create strength and elasticity, which is one of the material’s main benefits. 122 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR From here the filaments are unwound and then rewound onto another, smaller spool. This process is called drawing and is used to align the molecules into a parallel structure. The strands that result are multipurpose threads that can be used for a variety of different purposes. They can be woven or bound as they are, or they can be combined and further melted. After the material has been wound onto the smaller spool, it is ready to be turned into the band needed for the lung simulator and this is done through the extrusion process explained in detail before. 5.6.3.2. PULLEY Because the pulley needs to have certain dimensions to fit in the proposed case it needs to be specially manufactured for the lung simulator. The process through which this is done is injection moulding that represents the best solution due to its several advantages that were named before. Plastic material which has the form of small pellets is fed into the unit and after heated transforming them from a solid state to a liquid one. After reaching the right temperature, the hot molten plastic is forced into the mould where a screw controls the pressure and speed of this phase of the process. This phase is called the dwelling phase, which ensures that the mould cavities are completely filled before cooling begins. The next and final step is the cooling one after which the object is released and the process begins all over again. 123 EPS/IDPS 2014 5.7. PEADIATRIC AND NEONATAL LUNG SIMULATOR CASE Figure 116. Case 5.7.1. REASONS FOR CHOOSING THE MATERIAL For the box that will contain all the mechanisms a material very resistant, but also flexible was needed, so PC (polycarbonate) with 10% glass fibre was considered the best option. Some of the advantages of this material are: lightweight, polycarbonate has a very high stiffness to weight ratio; durable, PC has UV inhibitor co-extruded on the outer surface which prevents the radiations from penetrating the sheet, meaning a longer life and prevention of yellowing and deterioration; damage resistance, polycarbonate has impact resistance up to 200 times stronger than glass. 5.7.2. PROPERTIES General properties Density: 1,27e3 – 1.28e3 kg/m^3 Price: 4.99 – 5.49 USD/kg Mechanical properties Composition overview Eco properties Young’s modulus: 3.1 – 4.14 GPa Base: polymer 90% Embodied energy; primary production: 101 - 111 MJ/kg Shear modulus: 1.12 – 1.49 GPa Polymer class: thermoplastic amorphous CO2 footprint, primary production: 5.65 – 6.24 kg/kg Yield strength (elastic limit): 58.6 – 69 MPa Tensile strength: 48.3 – 69 MPa Compressive strength: 82.7 – 96.5 MPa Elongation: 4 – 10 %strain Fatigue strength at 10^7 cycles: 19.3 – 27.6 MPa Fracture toughness: 3.63 – 4.51 MPa.m^0.5 Polymer type full name: Polycarbonate Filler type: Glass fiber 10% Water usage: 177 – 195 l/kg Table 27. Properties of polycarbonate 124 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.7.3. MANUFACTURING PROCESS The process used to manufacture the case is injection moulding and there are several things to take into account when working with this type of machine, like the ones presented next. Polycarbonate tends to lose heat from the melt to the mould, barrel, nozzle and air faster than most plastics, which can lead to “delamination” when processing polycarbonate. Due to thermal diffusivity, polycarbonate temperatures can be difficult to control. Proper temperature control constants can help reduce the time needed to stabilize the process after start-up and help melt temperature override. The optimal temperature control system for polycarbonate products features high density, high response mineral-filled bands and an auto tune controller. It is very important the temperature control zone used for the end cap of the barrel. End cap designs on older machines often have many transitions in the flow path, which can “shear” the polycarbonate and cause degradation. Such end caps typically don’t seal well against the higher pressures of a polycarbonate process. Newer designs have only three consolidated components, including the nozzle tip, and a constant taper flow path for a more a streamlined delivery. Polycarbonate products will not mould well on a machine that has the “general purpose” olefin screw. These screws tend to develop material degradation in the rapid compression (transition) sections. Screws with moderate feed lengths (7 turns) and long, gentle compression sections (8-10 turns) may process more efficiently. Also, the non-return valve (NRV) portion of the screw is not universal. For example, the correct valve for polypropylene can cause shear heating of polycarbonate products and require “suckback” to seat. Polycarbonate products tend to adhere to high iron alloys and in pitted metals. Therefore, the screw should be plated to create a smooth surface and reduce contact with the screw base metal. Without careful purging, polycarbonate materials can “weld” together two pieces of steel. The valve can break off when the screw is turned because it has become “welded” to the end cap. Or, if the screw is not allowed time to warm up before it is turned, the melted material can become glue-like and pull the plating off the screw. To avoid these problems, the machine should be thoroughly purged after manufacturing polycarbonate products. Drying polycarbonate can be a challenge since the pellets tend to adsorb moisture rapidly from the plant air during transport to the machine and while waiting to be moulded. Moulding undried polycarbonate not only causes splay, it destroys some physical properties like tensile and impact strength. For optimal performance, polycarbonate products should be dried to less than 0.02% moisture with a desiccant drier. 125 EPS/IDPS 2014 5.8. PEADIATRIC AND NEONATAL LUNG SIMULATOR CAP Figure 117. Cap 5.8.1. REASONS FOR CHOOSING THE MATERIAL A thing that must be mentioned is that the cap will be removed and put back as often as needed, depending if the professor will need to check some mechanism or replace a part if it is broken. The chosen material is the same as for the box, but it will have besides the base of polymer 5% silicone to give a little flexibility in order to avoid future cracking from overuse. 5.8.2. PROPERTIES The advantage in combining these two materials is the maintenance of inherent benefits of polycarbonate-based urethanes, including high pressure resistance; tensile-strength and superior chemical resistance combined with silicone’s industry recognized advantages such as heightened elongation, superior elasticity and a low coefficient of friction. General properties Density: 1,45e3 – 1.47e3 kg/m^3 Price: 4.59 – 5.58 USD/kg Mechanical properties Composition overview Eco properties Young’s modulus: 6.04 – 6.34 GPa Base: polymer 65% Embodied energy; primary production: 85.6 – 94.6 MJ/kg Shear modulus: 2.2 – 2.31 GPa Polymer class: thermoplastic amorphous Yield strength (elastic limit): 84 – 92.8 MPa Tensile strength: 105 – 116 MPa Polymer type full name: Polycarbonate Filler type: Glass fiber 30% Silicone 5% CO2 footprint, primary production: 4.79 – 5.29 kg/kg Water usage: 197 – 218 l/kg Compressive strength: 101 – 111 MPa Elongation: 3.47 – 3.74 %strain Fatigue strength at 10^7 cycles: 38.8 – 50.4 MPa Fracture toughness: 4.6 – 5.53 MPa.m^0.5 Table 28. Properties of polycarbonate 126 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 5.8.3. MANUFACTURING PROCESS In its natural state polycarbonate raw material is clear granules. Due to its excellent properties it has many applications, one of them being a casing or in the present case the cap of the box. The chosen manufacturing process for this part is the injection moulding, because it is more efficient then extrusion, the material loss is smaller and you can make more parts with the same mould. The process was explained before because it was chosen for most parts of the lung simulator but to sum up, with injection moulding granular plastic is fed by gravity from a hopper into a heated barrel. As the granules are slowly pushed forward by a screw-type plunger, the plastic is forced into a heated chamber called the barrel where it is melted. As the plunger advances, the melted plastic is forced through a nozzle that seats against the mould sprue bushing, allowing it to enter the mould cavity through a gate and runner system. The mould remains at a set temperature so the plastic can solidify as soon as the mould is filled. 127 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 6. PROTOTYPE TESTING In order to provide the project of a practical result, it was developed a first prototype to test the Spontaneous Breathing function. The purpose for doing this prototype was to test the proper functioning of the remote control of the pneumatic system controlled through a Bluetooth application from the mobile phone. Initially it was desired to test the resistance of the rigid structure but considering that it was not possible to print it with the final real material the results wouldn’t be as reliable as it must, even though it was printed layer by layer and with a less resistant material, the structure resists in terms of fatigue the application of the cylinder strength, what it can ensure the success of the real future piece. 6.1. COMPONENTS OF THE PROTOTYPE 1. Rigid structure: This white rigid structure as shown in the figure on the right side is being printed with a sophisticated 3D printer to be having in the prototype testing of one of the functionalities of the lung simulator which is the spontaneous breathing mechanism. Actually, this piece is being placed on a box which represents the case of the real lung simulator and it is stuck on that box to ensure it will not move during the testing. 2. Piston: The piston or cylinder that is being used in the prototype is different with the one that will be used in the real product which has the series name DSNU-10-25-P-A because there is none of the unused pistons in the automation laboratory of the university which is exactly the same as the proposed one. As soon as it is working without any problems, so it can be used as the real one. One more difference of that piston is that it has the stroke of 25mm instead of 35mm like the real one. In the prototype, this piston is placed inside the box which is directly vertically under the rigid structure and it is connected by two tubes to the proportional valve to let the air from the compressor enters the piston once the valve is opened. Figure 118. Prototyping: piston 3. Cylinder plate: This object is being placed at the end of the piston stroke to avoid the stroke from being pushed up towards the rigid structure directly on the structure’s surface. Besides, it is also to make the structure being pushed up easily by the piston by having the cylinder plate on the stroke. Actually, this cylinder plate is a little bit higher than the one that will be used in the real product because the length of the stroke is not long enough to push up the structure until a certain height as wanted as in the real design. So, by having the cylinder plate with a bit higher, it could be more helpful. Figure 119. Prototyping: cylinder plate 128 EPS/IDPS 2014 4. PEADIATRIC AND NEONATAL LUNG SIMULATOR Arduino Uno: Arduino is actually a single-board microcontroller to create the application of interactive objects or environments more accessible. The hardware consists of an open-source hardware board that has been designed around an 8-bit Atmel AVR microcontroller, or a 32-bit Atmel ARM. The feature of the current models includes a USB interface, 6 analog input pins, as well as 14 digital I/O pins that allows the user attaching various extension boards. Figure 120. Prototyping: Arduino Uno The picture beside shows the current model of the Arduino electronic board available in the market nowadays. This electronic device is one of those low-costs out there. This idea has been selected to create the system that can be controlled remotely whether by Bluetooth system or any other system compatible with this kind of electronic board. Furthermore, in the real situation, this board will be placed into the case of the lung simulator together with other components and parts but before that, it will be programmed first according to how the system will be working to create those scenarios; resistance, compliance and leaks of the lung simulator. In addition, the aside picture represents the Arduino and Figure 121. Prototyping: electronic board other electronic boards which are being connected with a Bluetooth receiver and after that it will be connected to proportional valve in order to control the airway to enter the piston. This board also is being connected to a power supply with 24V. The good is the user can connect and control it by installing the Arduino application available for Android and Apple in the market store named ‘BlueTerm’. So, the system can be handled remotely easily. Figure 122. Prototyping: BlueTerm app 5. Bag: The bag that is being used in the prototype is totally different from the real one. In this prototype, the bag is not made from silicone rubber but paper. It is just to show how actually the real bag in the final product will be working. This bag is being glued in between the rigid structure as shown in the figure. Figure 123. Prototyping: bag 129 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 6. Box: The box actually represents the case of the lung simulator which is being used to place the piston with cylinder plate inside it and the rigid structure with the bag on top of it. This box is used just to assemble some components and to ensure they are placed in correct position in order to make it works perfectly. 7. Proportional valve: This kind of valve is used to control the airway from the compressor to the piston. It is connected to the piston by two tubes as represented in the figure which is in colour blue. Figure 124. Prototyping: Proportional valve 6.2. FUNCTIONING OF THE SYSTEM Figure 125. Prototyping: laboratory system Firstly, all the components of the lung simulator need to be set up correctly in their position as the figure shows and the compressor must be turned on to let the air enters the system through the piston. The Arduino board must be connected to a battery of 9V to supply the voltage, while the electronic board with the Bluetooth receiver needs another source of power of 24V for the valve to be functioned perfectly. Then, the two tubes have to be connected to the piston and the proportional valve as well. Once all the components are connected properly and all the sources of power are switched on, the LED from the Bluetooth receiver will be blinking as there is no device connected to it yet. The only thing to be done is to connect this application to the Bluetooth receiver on the Arduino by turning on the Bluetooth sign on the smartphones or tablets and then connect them. When the two devices are properly connected, the LED from the Bluetooth receiver will stop blinking. 130 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR After that, the application will only detect two capital letters which are ‘E’ and ‘H’. These two letters have their own meaning which ‘E’ means ‘ON’ and ‘H’ means ‘OFF’. When the letter ‘E’ is being pressed, the piston will be pushing up the rigid structure to a certain height and, once the letter ‘H’ is selected, the piston will be going down and the system will be going back to its original position. The flow of the air that enters the piston can be controlled, whether slower or faster, by adjusting the two screw adjusters on the piston in order to control the speed of the piston that pushes up the rigid structure. Finally, the system needs to be shut down by unplugging the power supplies, disconnecting the Bluetooth between the two devices, switching off the compressor and keeping all the components safely once the prototype is not being tested anymore. 131 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 7. PRODUCT DEVELOPEMENT In the product development chapter a cost analysis is made of the whole system. It is important to take into account that the calculations in this chapter are done to estimate the production and sale cost of the LS system and the numbers are estimated. 7.1. MARKETING MIX For a product to be successful at the launch time, it is required to address aspects related to the product marketing innovation. After the cost analysis and market study several things will be noticed such as the type of approach of the market and suitable market for Lung Simulator, competition and optimization of the cost for the entire life cycle will be possible, including new products related to recycling. The customer must be at the centre of concerns with the elements of marketing mix surrounding him, the 4P’: product, price, placement and promotion which are presented in the next figure. Figure 126. The 4P's description 132 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR The 4P’s show the conception of target market and they must correlate with the 4C of the buyer in order to obtain a competitive position in the market and a bigger profit. 4P Product Price placement Promotion 4C Customer demands and wishes Customer cost Convenience acquisition Communication Table 29. 4P & 4C 7.1.1. PRODUCT Sant Joan de Déu Hospital is the company that develops the lung simulator in collaboration with Universitat Politècnica de Catalunya. The product is a lung simulator that will be used in educational and research purposes by doctors and professors who will be able to show the students through the product different scenarios in which a lung can be used and after seeing these scenarios the students must be able to detect what disease does the patient have. The designed concept of the lung simulator was focused on the main requirements that have been established. It is a portable device developed to simulate the spontaneous breathing, different scenarios of resistance in the airways, compliance or stiffness of the lungs and leakage of air, all prepared to be controlled remotely through a tablet application in order to test the ventilator’s functioning in practical classes for medical students. It has been designed to be wireless, allowing the simulator to be used without electricity. The product offers the customer the possibility to use two lung sizes in the simulation according to his needs due to the practical design of the product. It can be easily transported and it is very accessible for maintenance. The interface page has a simple graphic and it is very easy to use. Figure 127. Final product 133 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR USE Figure 128. Context of use Connect the air source with the tube in order to move the interior cylinder and show the spontaneous breathing generation and connect the simulator to the ventilator’s external tube. All the elements are connected to start the simulation class. The simulator has to be placed in a flat platform. Students are focused on interpreting the ventilator data while the medical professor adjusts the parameters remotely in order not to influence their interpretations. 7.1.2. PLACE The simulator has been developed in one of the laboratories of UPC. The distribution channel is direct; producer to consumer without any interfering parties. Sant Joan de Déu Hospital is located in Barcelona, Spain therefore giving it the ability to deliver directly to people who need to use it. The product will be available to purchase straight from the hospital or through a virtual store on the internet. 7.1.3. PRICE The product’s price is flexible and it depends on consumer’s needs. The price varies according to: - The number of bags the customer wants to buy. If the customer wants insurance. If the customer wants a special addition to the product or has a specific requirement regarding of the components. 134 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 7.1.4. PROMOTION This represents all of the communications that marketers may use in the marketplace in order to increase awareness about the promoted product and its advantages for the targeted segment. There are two ways in which promotions can be realized, online and offline. Through the online one means that the product can be promoted using webpages, social networks and advertising, while the offline one refers to events in which the product can be presented, flyers or banners, articles in magazines or newspaper or a more direct approach in which the potential customer is contacted directly. 7.2. COST STRUCTURE 7.2.1. COST EQUATIONS The cost of production is an economic indicator, its calculation takes place in all economic units and requires consideration of the relationship between cost and sale price. The production cost is only a part of the sale price, the part that includes the expenses incurred by the manufacturer. (eq.1) Pv = sale price Cown= own cost (global cost) Pf = profit MATERIAL COST • Material cost (CM) is obtained by summing the unique cost and overall cost of the material. CM = CUM + COM (eq.2) • Unique cost material CUM is calculated based on the amount of material used (QM) multiplied by the cost per unit of material (cUM). CUM = QM + cUM (eq.3) • Overall cost of the material (COM): include for example costs of supplies, material storage space and storage cost. COM = CUM ∙ (SCOM%) (eq.4) SCOM%= Supplement overall cost of materials is generally between 5-20% 135 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR MANUFACTURING COST The manufacturing cost is obtained from salary expenses of those directly involved in the production (manufacturing salary costs) and overall manufacturing cost. CF = CSF + COMa (eq.5) They include actual manufacturing costs of the parts and their assembly to achieve the finished product. • Salary costs for production (CSF): calculate the salary cost per unit of time and the time required to manufacture a piece: CSF = cs ∙ t (eq.6) cs = salary cost per unit of time [euro/min; euro/h] t= time required to manufacture a piece [min or h] • Overall manufacturing cost (COMa): is calculated based on the manufacturing salary costs and supplement overall manufacturing cost. COMa = CSF ∙ (SCOF%) (eq.7) SCOF = Supplement overall manufacturing cost is between 200-500% Supplement overall manufacturing cost is for example energy consumption, equipment cost, salary of auxiliary production department (e.g. Economic unity or marketing). PRODUCTION COSTS • Cost of preparation/ finish of manufacture (CPIF) is the cost of testing devices and represent 3% from production cost. • Production costs (CP ) include material costs, manufacturing costs and preparation/finish cost of manufacture. This cost is worth around 68.6% of the own cost and could include the cost of design and development too. CP = CM + CF + CPIF (eq.8) OWN COSTS The own cost is obtained from the sum of production costs, research – development costs and sale costs. Cown = CP + CRDD + CUV + CRS (eq.9) 136 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR SALE PRICE The final price is extremely important because it plays a significant role in maximizing the profit. From costs plus desired profit the net selling price can be obtained. SALE PRICE CALCULATED Own cost (Cown) Production cost (CP) Research, develop.and design (CRDD) Profit Unique cost related with sale (CUV) Overall cost for sale and representative (CRS) Figure 129. Sale price structure 7.2.2. COST CALCULATIONS MATERIAL COST *The total material list can be found in chapter Materials and manufacturing process. The lung simulator can be divided in two parts: Internal part € 229 External part: € 6 (eq. 3) CUM = € 235 (eq. 4) COM = 235 ∙ 5% = € 11.75 (eq. 2) CM = 235 + 11.75 = € 246.75 MANUFACTURING COST To produce a lung simulator there are required one employee, one employee’s salary being € 20.000/year and the required time for manufacturing is a week. cs = 9 €/h t = 30 h (eq. 6) CSF =€ 270 137 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR (eq. 7) COMa = 270 ∙ 200% = € 540 (eq. 5) CF = 270 + 540 = € 810 PRODUCTION COST (8) CP = 246.75 + 810 + CP CP = 1089.40 CPIF = 32.65 OWN COST CP =1089.40 => 68.6% from own cost Research development and design costs => 8.6% from own cost. CROD = € 136.57 Unique cost related with sale =>3.7% from own cost CUV = € 58.75 Overall cost for sale and representative =>19.1% from own cost CRS = € 303.30 The own cost is € 1580. Although the price is quite high in comparison with the one that is used in Sant Joan de Dèu Hospital, it has to be taken into consideration that the proposed lung simulator is more sophisticated allowing a better experience for students in their learning process, including the possibility of it being remotely controlled which require certain parts that are quite expensive. 138 EPS/IDPS 2014 7.3. PEADIATRIC AND NEONATAL LUNG SIMULATOR COMPARISON BETWEEN EXISTING LUNG SIMULATORS This table shows a number of significant characteristics about the most completed paediatric lung simulators that were analysed in this project. This enables to compare the developed product with the others in the market, especially with Imtmedical smartlung which is the one used in Sant Joan de Déu Hospital. Number of lungs Compliance adjustment Leak adjustment Resistance adjustment Spontaneous breathing generation Remote control of the parameters Volume (L) Resistance (cmH20/L/S) Compliance (mL/cmH20) Weight (kg) Price(€) TL2 PRO test lung Ingmar Med Imtmedical smartlung SUMLUNG 2 2 1 1 YES YES YES YES YES YES YES YES YES YES YES YES NO YES NO YES NO NO NO YES 2.0 2.0 0.6 0.25 and 0.05 0, 5, 20, 50 15, 25, 50 5, 20, 50, 200 5, 20, 50, 100 5-50 inaccurate 15-80 inaccurate 13, 17, 23, 30 1,2,3,5 0.4 7 0.3 1.7 €250 €1,950 €620 Table 30. Comparison between lung simulators 139 €1580 EPS/IDPS 2014 7.4. PEADIATRIC AND NEONATAL LUNG SIMULATOR SWOT ANALYSIS Weaknesses Strengths - The interactive interface is not completely developed (add application ) -Lightweight - The product shows spotaneous breathing generation -Lack of electronic background -All parameters can be controlled remotely -Short period of time -Low cost compared to existing products with the same features. -Ergonomic and easy to control SWOT Threats Opportunities -The competition could launch the product faster - This might be the first product on the market that includes all these features controlled remotely - Some competitors can produce lower price products. -the electronic part could be done very fast by an expert -This product will improve practical classes in medical universities. 140 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 8. CONCLUSIONS SUMLUNG is an innovative paediatric and neonatal lung simulator that fulfils the main requirements established by the Hospital Sant Joan de Dèu, which were to develop a new concept of lung simulator, one that imitates the breathing of neonates and children, that can be remotely controlled and that covers different clinical scenarios, which will be used for educational purposes in hospitals and universities of medicine. The most important issue that can be improved thanks to this new concept is the experience of students during practical classes allowing a more reliable evaluation of their skills this being translated in the increase of efficiency during the future implementation of their knowledge in real clinical scenarios. The fact that the product is quite sophisticated in comparison with current lung simulators and initial demands from the hospital, is due to a differential factor, which means that the fully developed simulator could be seen in the future as a new product to introduce in the market as an educational training device. Because of the shortness of time and not having a member in the team with an electronic background, it has not been possible to achieve the level that we would have liked to, in order to present a completely developed control of all parameters of the simulator. However, thanks to the collaboration of two professors of the university, Cristobal Raya and José Matas and the help of some students from electronics, we could successfully control remotely the most relevant parameter out of the four, the spontaneous breathing. RECOMMENDATIONS AND FURTHER WORK To ensure the future development of this conceptual simulator and hopefully the manufacturing of it we would like to detail some recommendations for further work: - To develop a more completed prototype to test all the parameters. Due to a lack of time, it was not possible to make a complete prototype with all the functions of the simulator working. In order to ensure the well-functioning of them it is necessary to develop a final prototype to be tested. - To design a bag to carry the simulator. The project was focused on developing a new simulator with all its elements and developing a prototype to test one of the functions. Although designing a bag was one of our established requirements, we didn’t achieve this point; nevertheless it has to be included according to the requirements analysis that was made. - To develop the electronics to control all the elements. In the concept design the electronic system to control all the parameters has been considered as a black box that has to be developed. 141 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR - To develop an interactive interface prototype. In this project it has been developed the interface that the user is going to use to control the simulator but it is necessary to develop the prototype to test it with the users. - Make usability tests using the whole product in the real scenario. Once having developed a complete prototype of the simulator and the interface, it is necessary to test the functioning of all the system with the hospital ventilator in order to redesign and develop the final product. 142 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 9. BIBLIOGRAPHY 9.1. WEBSITES [1] Human Anatomy and Physiology. The Respiratory System’, from website of University of Nevada, available on the Internet: http://faculty.unlv.edu/jyoung/BIOL440-respiration.pdf [2] ‘Overview of Pulmonary Anatomy and Physiology’ from NIOSH Spirometry Training Guide, available on the Internet: http://www.cdc.gov/niosh/docs/2004-154c/pdfs/2004-154c.pdf, pages 15-23 [3] ‘Pediatric Airway & Respiratory physiology’ by S. Kache, MD, Stanford School of Medicine, available on the Internet: http://peds.stanford.edu/Rotations/picu/pdfs/10_Peds_Airway.pdf [4] ‘Anatomy of Your Child’s Respiratory System’ from Paediatric Health Library of University of Minnesota Amplatz Children's Hospital, available on the Internet: http://www.uofmchildrenshospital.org/healthlibrary/Article/88967 [5] ‘Diseases and conditions’ from website of Monroe Carell Jr. Children's Hospital at Vanderbilt, available on the Internet: http://www.childrenshospital.vanderbilt.org/library/article.php?ContentT [6] ‘Lung Function Tests’ from Lung Disease & Respiratory Health Centre, available on the Internet: http://www.webmd.com/lung/lung-function-tests [7] ‘Mannequins’ from HealthPartners Clinical Simulation & Learning Center website, available on the Internet at: http://www.hpclinsim.com/mannequins.html [8] “Newborn HAL brochure”, available [online]: https://store45a09.mybigcommerce.com/product_images/productbrochures/S3010_B rochure_2011NoPrices.pdf [9] PediaSIM® description from HELSIM, available [online]: http://www.hellenic-simulations.com/Pedia_Sim.html [10] Child Heart and Lung Sound Training Model description from Simulaids, available [online]: http://www.anatomystuff.co.uk/product-child-heart-lung-sound-trainer_247256.aspx [11] Gear Technical Reference ‘The Role Gears are Playing’ from Kohara Gear Industry Co., LTD. available [online]: http://www.khkgears.co.jp/en/gear_technology/pdf/gear_guide1.pdf 143 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR [12] Part No’s. 919D7 – 919D14. Timing Pulleys. [online]: http://lars.mec.ua.pt/public/LAR%20Projects/RescueRobotics/2009_DanielAfonso/fon tes/catalogos/MFA/gearbox_colour_brochure_12-19.pdf [13] 3 Position Cylinder by SMC Co. available [online]: http://www.smc.eu/portal/NEW_EBP/07)Speciality_Cylinder/7.1)Specialty_Cylinder/m )RZQ/RZQ_EU.pdf [14] Cylinders, Valves and Tubing by Festo Co. available [online]: http://www.festo.com/net/startpage/ [15] ‘Mannequins’ from HealthPartners Clinical Simulation & Learning Center website, available on the Internet at: http://www.hpclinsim.com/mannequins.html [16] “Newborn HAL brochure”, available [online]: https://store45a09.mybigcommerce.com/product_images/productbrochures/S3010_B rochure_2011NoPrices.pdf [17] PediaSIM® description from HELSIM, available [online]: http://www.hellenic-simulations.com/Pedia_Sim.html [18] Child Heart and Lung Sound Training Model description from Simulaids, available [online]: http://www.anatomystuff.co.uk/product-child-heart-lung-sound-trainer_247256.aspx [19] ‘Background of Silicon’ available [online]: http://www.madehow.com/Volume6/Silicon.html [20] ‘Injection Molding Manufacturing Process’ available [online]: http://en.wikipedia.org/wiki/Injection_molding [21] ‘The Difference between HDPE and PVC – A Functional Comparison’ available [online]: http://www.mcelroy.com/pdf/HDPEvsPVC.pdf [22] ‘The Advantages, Disadvantages and Applications of HDPE’ by United Plastic Components (UPC) Co. available [online]: http://www.upcinc.com/resources/materials/HDPE.html [23] ‘The Extrusion Manufacturing Process’ available [online]: https://www.tut.fi/ms/muo/tyreschool/moduulit/moduuli_6/hypertext/3/3_2.html [24] ‘The Background and Properties of ABS’ available [online]: http://en.wikipedia.org/wiki/Acrylonitrile_butadiene_styrene 144 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR [25] ‘The Advantages and Disadvantages of ABS’ by RTP Co. available [online]: http://www.rtpcompany.com/products/product-guide/acrylonitrile-butadienestyrene-abs/ [26] ‘The Injection Moulding of Plastics’ available [online]: http://www.technologystudent.com/equip1/inject1.htm [27] ‘The Background and Properties of Polycarbonate (PC)’ available [online]: http://en.wikipedia.org/wiki/Polycarbonate [28] ‘Basics of Injection Molding Design’ by 3DSYSTEMS available [online]: http://www.3dsystems.com/quickparts/learning-center/injection-molding-basics [29] ‘Electroválvula proporcional compacta’ by SMC Co. available [online]: http://content2.smcetech.com/pdf/PVQ_ES.pdf [30] ‘The Definition of Bluetooth’ by Techcopedia Co. available [online]: http://www.techopedia.com/definition/26198/bluetooth [31] ‘The Basics of Bluetooth Technology’ by available [online]: http://www.bluetooth.com/Pages/Basics.aspx [32] ‘Controlling Arduino Board by Android Phone’ by available [online]: http://www.instructables.com/id/How-control-arduino-board-using-an-androidphone-a/ 9.2. LITERATURE [1] C. BAUER Jeffrey, Ph.D: (2006), “The Future of Medical Simulation: New Foundations for Education and Clinical Practice”. [online]. [2] PALÉS ARGULLÓS, J.L. and GOMAR SANCHO, C: (2010) “El uso de las simulaciones en educación médica” from Universidad de Salamanca. [online]. [3] VAZQUEZ-MATA, G. and GUILLAMET-LLOVERAS, A: (2009) “El entrenamiento basado en la simulación como innovación imprescindible en la formación médica” , Educ. méd. vol.12, n.3, pp. 149-155. ISSN 1575-1813. [online]. [4] HUNTER, C and K. RAVERT, P: “Nursing Students’ Perceptions of Learning Outcomes throughout Simulation Experiences” article from Brigham Young University. [online]. 145 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR [5] Meduri GU, Johanson WG Jr: International Consensus Conference: “Clinical investigation of ventilator-associated pneumonia”. Introduction [Editorial]. Chest 102:551S-552S, 1992 (supply) [6] Berry AJ: “Respiratory support and renal function”. Anaesthesiology 55:655-667, 1981 [7] A.F.M. Verbraak, P.R. Rijnbeek, J.E.W. Beneken, J.M. Bogaard, A. Versprille: “A new approach to mechanical simulation of lung behaviour -pressure controlled and time related piston movement.” Medical & Biological Engineering & Computing, 2001, Vol. 39M [8] Sarah Heili-Frades, German Peces-Barba, Maria Jesus Rodriguez-Nieto: Design of a Lung Simulator for Teaching Lung Mechanics in Mechanical Ventilation. Arch Bronconeumol. 2007:43(12):674-9 [9] Stefano Cecchini, Emiliano Schena, Sergio Silvestri: “An open-loop controlled active lung simulator for preterm infants.” Medical Engineering & Physics (2011) 47-55edical [10] Robert L. Chatburn: “Computer Control of Mechanical Ventilation”. Respiratory Care, May 2004 Vol. 49 No. 5 [11] Datasheet of TL2 PRO Test Lung System [online]. [12] “Maquet Critical Care” AB (2007) [online]. [13] John H. Bickford: “Mechanisms for Intermittent Motion; Chapter 9 – Geneva Mechanisms” pg. 127-138 [online]. 9.3. TABLES AND FIGURES 9.3.1. TABLES [1] ‘Eco Audit of Lung Simulator’ available on CES EDUPACK 2013. [2] ‘Weights and Prices of The Components’ available on SOLIDWORKS 2013. [3] ‘Materials and Manufacturing Process’ available on CES EDUPACK 2013. 9.3.2. FIGURES [1] ‘The 4P’s of Marketing – Marketing Mix Strategies’ available [online]: http://business-fundas.com/2011/the-4-ps-of-marketing-the-marketing-mixstrategies/ [2] ‘Arduino Uno Electronic Board’ by Arduino Co. available [online]: http://arduino.cc/en/Main/arduinoBoardUno 146 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR [3] ‘Stress Simulation Analysis’ available on NX 8.0 and SOLIDWORKS 2013. [4] ‘Injection Molding Process’ by Anole Injection Tech. available [online]: http://www.anole-hot-runner.com/injection-molding-process_296.htm [5] ‘Plastics Extrusion Process’ available [online]: http://en.wikipedia.org/wiki/Plastics_extrusion [5] ‘Injection Moulding of Plastics’ available [online]: http://www.technologystudent.com/equip1/inject1.htm [6] ‘Bluetooth’ by Electronic Design available [online]: http://electronicdesign.com/sitefiles/electronicdesign.com/files/uploads/2013/07/1003_DSblu2th_Fig3.gif [7] ‘BlueTerm Application’ available [online]: https://lh6.ggpht.com/C_tzFrjoZ4NsbAhe57mgwqK5fCeJG64QkXgR5W0JSAz29YFhfhv32Sw5pM8klJtJfJ7=h310-rw [8] ‘Arduino Electronic Board’ available [online]: http://cdn.instructables.com/FI6/B1WK/HD7TZGDS/FI6B1WKHD7TZGDS.MEDIUM.jpg 147 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 10.TABLE OF FIGURES Figure 1. Example of Human simulation ..................................................................................... 10 Figure 2. Resusci Anne mannequin ............................................................................................. 11 Figure 3. Virtual dental implant training simulator..................................................................... 11 Figure 4. NeuroTouch is the world’s most advanced virtual reality neurosurgical simulator .... 12 Figure 5. Human respiratory system: general view .................................................................... 16 Figure 6. Human respiratory system: lungs ................................................................................ 16 Figure 7. Inhaling and exhaling process ...................................................................................... 17 Figure 8. Human respiratory system: bronchi............................................................................. 18 Figure 9. Parts of respiratory system of a child........................................................................... 20 Figure 10. Alveoli and mucus ...................................................................................................... 20 Figure 11. Collapsed lung in infant .............................................................................................. 24 Figure 12. Air leak treatment ...................................................................................................... 24 Figure 13. Childhood bronchial asthma ...................................................................................... 25 Figure 14. Evolution of the disease ............................................................................................. 26 Figure 15. Pulmonary hypertension ............................................................................................ 29 Figure 16. RSV-Respiratory syncytial virus .................................................................................. 30 Figure 17. Elements of a Lung Simulator system ........................................................................ 33 Figure 18. Schematic diagrams of closed-loop control of a mechanical ventilator .................... 35 Figure 19. Display ........................................................................................................................ 36 Figure 20. Premie HAL S3009 ...................................................................................................... 37 Figure 21. Example of lung compliance graphically .................................................................... 39 Figure 22. Parts of lung simulator ............................................................................................... 40 Figure 23. Ventilator Respironics V200 from Philips ................................................................... 41 Figure 24. Ventilator SERVO-U from Maquet.............................................................................. 41 Figure 25. Ventilator HAMILTON-C3 ........................................................................................... 42 Figure 26. Example of the simulator functioning with a manual ventilator ............................... 43 Figure 27. Babi.plus lung simulator with the optional manometer ............................................ 43 Figure 28. Lung simulator TL2 PRO TEST LUNG........................................................................... 44 Figure 29. Lung simulator DEMO LUNG ...................................................................................... 45 Figure 30. Newborn HAL mannequin .......................................................................................... 46 Figure 31. PediaSIM mannequin ................................................................................................. 47 Figure 32. Child Heart and Lung Sound Training Model ............................................................. 48 Figure 33. Illustration of the purpose of the lung simulator in its context of use ...................... 49 Figure 34. Darwin Simulation Centre of Sant Joan de Déu Hospital ........................................... 51 Figure 35. Hospital’s ventilator monitor ..................................................................................... 52 Figure 36. Current lung simulators of the Hospital ..................................................................... 52 Figure 37. Example of a University Laboratory ........................................................................... 53 Figure 38. Example of a University conference room ................................................................. 53 Figure 39. Scheme of the whole system divide in: current devices and needs .......................... 55 Figure 40. Current hospital simulator: SMART LUNG ................................................................. 56 Figure 41. Ventilator SERVO-I Maquet ........................................................................................ 57 Figure 42. Parts of the lung simulator system that have to be designed ................................... 60 148 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Figure 43. Storyboard of use ....................................................................................................... 61 Figure 44. Mind Map ................................................................................................................... 63 Figure 45. First sketches of the system with two lungs .............................................................. 64 Figure 46. First sketches of the system with one lung ................................................................ 64 Figure 47. General scheme of the concept ................................................................................. 65 Figure 48. Bag concept: balloon shape ....................................................................................... 67 Figure 49. Bag concept: bellow shape......................................................................................... 68 Figure 50. Final shape of the bag for two lung sizes ................................................................... 68 Figure 51. Sketches of cylinder system for spontaneous breathing ........................................... 71 Figure 52. Final design for spontaneous breathing..................................................................... 72 Figure 53. Structure of the bag ................................................................................................... 72 Figure 54. Results of the simulation: displacement of the structure .......................................... 74 Figure 55. Mechanism to generate the spontaneous breathing: electrovalve + flow regulator 75 Figure 56. Mechanism to generate the spontaneous breathing: proportional control valve .... 75 Figure 57. Chosen system to generate the spontaneous breathing: cylinder ............................ 76 Figure 58. Chosen system to generate the spontaneous breathing: proportional control valve77 Figure 59. Chosen system to generate the spontaneous breathing: fittings + tubing................ 78 Figure 60. Top view of the lung simulator to see the pneumatic elements position and their connections ................................................................................................................................. 78 Figure 61. Sketches of screw system for controlling compliance ............................................... 79 Figure 62. Sketches of band system for controlling compliance ................................................ 80 Figure 63. Final design of the system for controlling compliance .............................................. 80 Figure 64 and 65. Grooves in the rigid structure ........................................................................ 80 Figure 66. Mechanism to adjust compliance .............................................................................. 82 Figure 67. Sketches of push and pull system for controlling resistance ..................................... 84 Figure 68. Sketches of wheel system for controlling resistance ................................................. 84 Figure 69. Final design of the system to control resistance ........................................................ 85 Figure 70. Curve fit for resistance measurements ...................................................................... 86 Figure 71. Mechanism to control resistance ............................................................................... 87 Figure 72. Mechanism to control resistance: Geneva wheel ...................................................... 87 Figure 73. Mechanism to control resistance: Specification ........................................................ 87 Figure 74. Internal Geneva Wheel: parameters .......................................................................... 89 Figure 75. DC motor for controlling resistance ........................................................................... 90 Figure 76. Sketches of pull and push system for controlling leaks ............................................. 91 Figure 77. Sketches of ring system for controlling leaks ............................................................. 91 Figure 78. Final design of the system for controlling leaks ......................................................... 91 Figure 79. Mechanism for controlling leaks ................................................................................ 92 Figure 80. Mechanism for controlling leaks: gear trains ............................................................. 93 Figure 81. Mechanism for controlling leaks: gear tooth profiles ................................................ 94 Figure 82. Case shape.................................................................................................................. 96 Figure 83. Elements removal....................................................................................................... 97 Figure 84. Simulator components ............................................................................................... 97 Figure 85. Graphical elements of the case .................................................................................. 98 Figure 86. Power icon .................................................................................................................. 98 Figure 87. Battery status icons .................................................................................................... 98 149 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Figure 88. Spontaneous breathing icon ................................................................................ 99 Figure 89. Leaks and resistance icons .................................................................................. 99 Figure 90. Interior mechanisms of the case ................................................................................ 99 Figure 91. Placement of the elements inside the case ............................................................. 100 Figure 92. Subjection piece for motors ..................................................................................... 100 Figure 93. Bottom view of the case to show subjection elements ................................. 100 Figure 94. Subjection piece for the cylinder………………………………………………………………………..100 Figure 95. Design of the remote ............................................................................................... 101 Figure 96. Principle of Bluetooth technology............................................................................ 101 Figure 97. Scheme with Bluetooth board ............................................ 102 Figure 98. BlueTerm application ............................................................................. 102 Figure 99. Interface design ........................................................................................................ 103 Figure 100. Iconography of the interface.................................................................................. 103 Figure 101. Interface: compliance ............................................................................................. 104 Figure 102. Interface: spontaneous breathing.......................................................................... 104 Figure 103. Bag .......................................................................................................................... 105 Figure 104. Manufacturing process of the bag ......................................................................... 108 Figure 105. Rigid structure ........................................................................................................ 109 Figure 106. Manufacturing process of rigid structure .............................................................. 110 Figure 107. Simulation analysis of resistance ........................................................................... 111 Figure 108. Cross-sectional area of the structure ..................................................................... 112 Figure 109. Tube........................................................................................................................ 115 Figure 110. Extrusion process ................................................................................................... 116 Figure 111. Element to control leaks ........................................................................................ 117 Figure 112. Element to control resistance ................................................................................ 119 Figure 113. Manufacturing process for the element controlling resistance............................. 120 Figure 114. Band....................................................................................................................... 121 Figure 115. Pulley ...................................................................................................................... 121 Figure 116. Case ........................................................................................................................ 124 Figure 117. Cap.......................................................................................................................... 126 Figure 118. Prototyping: piston................................................................................................. 128 Figure 119. Prototyping: cylinder plate ..................................................................................... 128 Figure 120. Prototyping: Arduino Uno ...................................................................................... 129 Figure 121. Prototyping: electronic board ................................................................................ 129 Figure 122. Prototyping: BlueTerm app .................................................................................... 129 Figure 123. Prototyping: bag ..................................................................................................... 129 Figure 124. Prototyping: Proportional valve ............................................................................. 130 Figure 125. Prototyping: laboratory system ............................................................................. 130 Figure 126. The 4P's description ............................................................................................... 132 Figure 127. Final product .......................................................................................................... 133 Figure 128. Context of use ........................................................................................................ 134 Figure 129. Sale price structure ................................................................................................ 137 150 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 11. TABLE OF TABLES Table 1. Anatomy differences for adult and child ....................................................................... 20 Table 2.Newborn HAL mannequin selected features ................................................................. 46 Table 3. PediaSIM mannequin selected features........................................................................ 47 Table 4. Child Heart and Lung Sound Training Model selected features .................................... 48 Table 5. Tasks to do using the simulator by the different users ................................................. 50 Table 6. Requirements for the lung simulator according to the environment ........................... 54 Table 7. Main parts of the SMART LUNG .................................................................................... 56 Table 8. Main parameters of the Smart Lung for adult .............................................................. 57 Table 9. Main parameters of the Smart Lung for infant ............................................................. 57 Table 10. Parameters of SERVO-i Infant...................................................................................... 58 Table 11. Standard values for compliance depending on child age ............................................ 79 Table 12. Values of compliance chosen for lung simulator ........................................................ 79 Table 13. Typical values of airway resistance ............................................................................. 83 Table 14. Values of resistance for lung simulator ....................................................................... 83 Table 15. Diameters for existing lung simulator ......................................................................... 86 Table 16. Diameters for proposed lung simulator ...................................................................... 86 Table 17. Motor specification ..................................................................................................... 90 Table 18. Calculations for standard spur gear ............................................................................ 95 Table 19. General properties of silicone rubber ....................................................................... 107 Table 20. Eco properties of silicone rubber .............................................................................. 107 Table 21. General properties of high-density polyethylene .................................................... 109 Table 22. General properties of polyvinyl chloride ................................................................... 115 Table 23. General properties of Acrylonitrile Butadiene Styrene ............................................. 117 Table 24. General properties of Acrylonitrile Butadiene Styrene ............................................. 119 Table 25. Properties of Polyamide ............................................................................................ 121 Table 26. General properties of Poly ether ether ketone ......................................................... 122 Table 27. Properties of polycarbonate ...................................................................................... 124 Table 28. Properties of polycarbonate ...................................................................................... 126 Table 29. 4P & 4C ...................................................................................................................... 133 Table 30. Comparison between lung simulators....................................................................... 139 151 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR 12. APPENDIX TABLE OF COMPONENTS COMPONENT QUANTITY MATERIAL REGULATIONS PRICE 1 PC with 10% glass fiber - 3€ 1 PC with 30% glass fiber and 5% silicone - 0.82€ 1 HDPE - 0.14€ 1 Silicone rubber - 0.83€ 1 Silicone rubber - 0.28€ 1 PVC - 0.02€ 1 HDPE - 0.0005€ Case Cap Rigid structure Children bag Neonate bag Tube Bracket 152 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Cylinder surface 1 ABS - 0.03€ 1 Aluminium ISO 21287 43€ 1 Standard ISO 15407-1 180€ 1 Standard ISO 14644-1 20€ 500 mm max. Polyurethane ISO 5599 7.70€ 1 ABS (medium impact) - 0.07€ 1 ABS (medium impact) - 0.02€ 2 ABS (medium impact) - 1.15€ 3 Standard - 1.37€ 3 Standard - 2€ Cylinder Proportional valve Fitting Tubing Geneve wheel Leaks ring Gear Motor Motor subjection 153 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Screw 14 Steel M2 0.4 4€ 1 PA type wth 15% glass fiber - 0.03€ 1 PEEK - 3.80€ 1 Standard ANSI/UL 8750 0.05€ 1 Standard ISO9001 25€ 1 1 Standard Standard - 14€ 4.50€ 1 Standard - 100€ Band Pulley LED Arduino board Bluetooth receiver Battery Tablet 154 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR WEIGHT OF LUNG SIMULATOR This table shows the weight of the product having included all the components. It was done through the application for calculating the weight of SOLIDWORKS program. WEIGHT (g) case 856,95 cap 233,95 Rigid structure 103,53 neonate bag 43,48 tube 11,21 bracket 0,38 cylinder surface 8,22 geneva wheel 25,97 leaks ring 5,24 gear 15,33 band 3,31 pulley 52,46 arduino uno 28 motor 45 piston 139 screw 3 LED 0,44 Bluetooth receiver 5 TOTAL COMPONENTS QUANTITY TOTAL WEIGHT (g) 1 1 1 1 1 1 1 1 1 2 1 1 1 3 1 14 1 1 856,95 233,95 103,53 43,48 11,21 0,38 8,22 25,97 5,24 30,66 3,31 52,46 28 135 139 42 0,44 5 1724,8 155 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR ECO-AUDIT INTERPRETATION The CES Edupack software is used for better understanding of environmental issues, create material charts, perform materials and processes selection and eco audit or life cycle analysis allowing alternative design choices to meet the engineering requirements and reduce the environmental burden. An energy and CO2 eco audits were performed for the lung simulator. The parts are manufactured closed to Spain and shipped 100 km to Spain, where it is sold and used. It weighs 1.7 kg of which 1 kg is Polycarbonate representing the case and cap, 105 gr Highdensity Polyethylene and the rest a mixture between PVC, ABS, silicone rubber and aluminum. The parts that consume the most energy to be processed are the case and the cylinder surface and the biggest CO2 footprint is the one of the cylinder and Geneva wheel. From the graphs in page 1, regarding Energy and CO2 footprint, it can be observed that the main problems are in usage, material and a small proportion, in comparison with the other, in manufacturing and while the results are approximate, there is a need to retain sufficient discrimination to differentiate between alternative choices, this is not a tool to calculate the full life cycle analysis. After seeing and interpreting the results, the conclusion is that some materials of certain parts need to be changed so that the impact on the environment and the future generations can be diminished. By application of renewable and recycled sources the life cycles of building materials can be closed. Renewable sources will be reproduces by nature during life time of the material and the recycled materials will enter a second life, without taking resources from nature. 156 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Eco Audit Report Product Name Lung Simulator Product Life (years) 7 ENERGY AND CO2 FOOTPRINT SUMMARY: 157 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Energy (MJ) Energy (%) CO2 (kg) CO2 (%) Material 2.07e+05 45.2 1.2e+04 43.5 Manufacture 3.32e+04 7.2 2.47e+03 8.9 77.8 0.0 5.53 0.0 2.18e+05 47.5 1.31e+04 47.5 338 0.1 23.7 0.1 4.59e+05 100 2.76e+04 100 Phase Transport Use Disposal Total (for first life) End of life potential 0 0 158 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Eco Audit Report ENERGY ANALYSIS Energy (MJ)/year Equivalent annual environmental burden (averaged over 7 year product life): 6.55e+04 DETAILED BREAKDOWN OF INDIVIDUAL LIFE PHASES Material: Component Material Recycled content* (%) Part mass (kg) Qty. Total mass processed** (kg) Energy (MJ) % case PC (10% glass fiber) Virgin (0%) 8.6e+02 1 8.6e+02 9.1e+04 43.8 cap PC (30% glass fiber, 2% silicone) Virgin (0%) 2.3e+02 1 2.3e+02 2.1e+04 10.2 rigid structure PE-HD (20-30% long glass fiber) Virgin (0%) 1e+02 1 1e+02 7.8e+03 3.7 neonate bag Silicone (VMQ, heat cured, low hardness) Virgin (0%) 43 1 43 6e+03 2.9 PVC (semi-rigid, molding Virgin (0%) and extrusion) 11 1 11 6.5e+02 0.3 tube bracket cylinder surface cylinder geneva wheel PE-HD (20-30% long glass fiber) Virgin (0%) 0.38 1 0.38 29 0.0 ABS (extrusion) Virgin (0%) 8.2 1 8.2 7.8e+02 0.4 1 1.4e+02 2.7e+04 13.1 1 26 2.5e+03 1.2 Aluminum, 319.0, Virgin (0%) 1.4e+02 permanent mold cast, T6 ABS (medium-impact, injection molding) Virgin (0%) 159 26 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR ABS (medium-impact, injection molding) Virgin (0%) 5.2 1 5.2 5e+02 0.2 gear ABS (high-impact, injection molding) Virgin (0%) 15 2 31 2.9e+03 1.4 motor Aluminum, 6063, wrought, O Virgin (0%) 45 3 1.4e+02 2.8e+04 13.6 screw Bake hardening steel, YS260 (cold rolled) Virgin (0%) 3 14 42 1.1e+03 0.5 band PA (type 6, 15% glass fiber) Virgin (0%) 3.3 1 3.3 3.7e+02 0.2 pulley PEEK (unfilled) Virgin (0%) 52 1 52 1.6e+04 7.5 Diodes and LEDs Virgin (0%) 0.44 1 0.44 2e+03 1.0 32 1.7e+03 2.1e+05 100 leaks ring LED Total *Typical: Includes 'recycle fraction in current supply '**Where applicable, includes material mass removed by secondary processes Manufacture: Process % Removed Amount processed Energy (MJ) % case Polymer molding - 8.6e+02 kg 2e+04 60.2 cap Polymer molding - 2.3e+02 kg 5.3e+03 16.1 rigid structure Polymer molding - 1e+02 kg 2.5e+03 7.5 Component 160 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR neonate bag Polymer molding - 43 kg 6.4e+02 1.9 tube Polymer extrusion - 11 kg 67 0.2 tube Cutting and trimming - 0 kg 0 0.0 bracket Polymer extrusion - 0.38 kg 2.4 0.0 cylinder surface Polymer extrusion - 8.2 kg 50 0.2 cylinder surface Fine machining - 0 kg 0 0.0 Casting - 1.4e+02 kg 1.6e+03 4.7 geneva wheel Polymer molding - 26 kg 5.4e+02 1.6 geneva wheel Fine machining - 0 kg 0 0.0 leaks ring Polymer molding - 5.2 kg 1.1e+02 0.3 leaks ring Fine machining - 0 kg 0 0.0 gear Polymer molding - 31 kg 5.5e+02 1.7 motor Rough rolling, forging - 1.4e+02 kg 2e+02 0.6 screw Extrusion, foil rolling - 42 kg 2.2e+02 0.7 band Polymer extrusion - 3.3 kg 21 0.1 pulley Polymer molding - 52 kg 1.4e+03 4.2 paiting casing Painting - 0.6 m^2 7.2 0.0 add adhesive Adhesives, heat curing - 0.2 m^2 5.4 0.0 3.3e+04 100 cylinder Total 161 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Transport: Breakdown by transport stage Stage name Transport of parts Total product mass = 1.7e+03 kg Transport type Distance (km) Energy (MJ) % 32 tonne truck 1e+02 78 100.0 1e+02 78 100 Total Breakdown by components Component mass (kg) Energy (MJ) % case 8.6e+02 39 50.7 cap 2.3e+02 11 13.8 rigid structure 1e+02 4.8 6.1 neonate bag 43 2 2.6 tube 11 0.52 0.7 bracket 0.38 0.017 0.0 cylinder surface 8.2 0.38 0.5 1.4e+02 6.4 8.2 geneva wheel 26 1.2 1.5 leaks ring 5.2 0.24 0.3 gear 31 1.4 1.8 motor 1.4e+02 6.2 8.0 screw 42 1.9 2.5 band 3.3 0.15 0.2 pulley 52 2.4 3.1 Component cylinder 162 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR LED 0.44 0.02 0.0 Total 1.7e+03 78 100 Use: Static mode Energy input and output type Mobile mode Electric to mechanical (electric motors) Fuel and mobility type Use location Use location Spain Spain Product mass (kg) Power rating (kW) 10 Usage (hours per day) 3 Usage (days per year) 1e+02 Product life (years) 1e+02 Usage (days per year) 50 Product life (years) 7 7 Mode Energy (MJ) % Static 1.6e+05 75.6 Mobile 5.3e+04 24.4 Total 2.2e+05 100 Breakdown of mobile mode by components Energy (MJ) % case 2.7e+04 50.7 cap 7.4e+03 13.8 rigid structure 3.3e+03 6.1 neonate bag 1.4e+03 2.6 163 1.7e+03 Distance (km per day) Relative contribution of static and mobile modes Component Diesel - heavy goods vehicle EPS/IDPS 2014 tube PEADIATRIC AND NEONATAL LUNG SIMULATOR 3.5e+02 0.7 12 0.0 cylinder surface 2.6e+02 0.5 cylinder 4.4e+03 8.2 geneva wheel 8.2e+02 1.5 leaks ring 1.7e+02 0.3 gear 9.7e+02 1.8 motor 4.3e+03 8.0 screw 1.3e+03 2.5 band 1e+02 0.2 pulley 1.7e+03 3.1 LED 14 0.0 Total 5.3e+04 100 bracket Disposal: End of life option % recovered Energy (MJ) % case Landfill 100.0 1.7e+02 50.7 cap Landfill 100.0 47 13.8 rigid structure Landfill 100.0 21 6.1 neonate bag Landfill 100.0 8.7 2.6 tube Landfill 100.0 2.2 0.7 Component 164 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR bracket Landfill 100.0 0.076 0.0 cylinder surface Landfill 100.0 1.6 0.5 cylinder Landfill 100.0 28 8.2 geneva wheel Landfill 100.0 5.2 1.5 leaks ring Landfill 100.0 1 0.3 gear Landfill 100.0 6.1 1.8 motor Landfill 100.0 27 8.0 screw Landfill 100.0 8.4 2.5 band Landfill 100.0 0.66 0.2 pulley Landfill 100.0 10 3.1 LED Landfill 100.0 0.088 0.0 3.4e+02 100 % Total EoL potential: End of life option % recovered Energy (MJ) case Landfill 100.0 0 cap Landfill 100.0 0 rigid structure Landfill 100.0 0 neonate bag Landfill 100.0 0 tube Landfill 100.0 0 bracket Landfill 100.0 0 Component 165 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR cylinder surface Landfill 100.0 0 cylinder Landfill 100.0 0 geneva wheel Landfill 100.0 0 leaks ring Landfill 100.0 0 gear Landfill 100.0 0 motor Landfill 100.0 0 screw Landfill 100.0 0 band Landfill 100.0 0 pulley Landfill 100.0 0 LED Landfill 100.0 0 0 Total Notes: 166 100 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Eco Audit Report CO2 FOOTPRINT ANALYSIS CO2 (kg)/year Equivalent annual environmental burden (averaged over 7 year product life): 3.95e+03 DETAILED BREAKDOWN OF INDIVIDUAL LIFE PHASES Material: Component case cap Qty. Total mass processed** (kg) CO2 footprint (kg) % Virgin (0%) 8.6e+02 1 8.6e+02 5.1e+03 42.4 PC (30% glass fiber, 2% Virgin (0%) 2.3e+02 silicone) 1 2.3e+02 1.2e+03 9.8 Material PC (10% glass fiber) Recycled content* (%) Part mass (kg) rigid structure PE-HD (20-30% long glass fiber) Virgin (0%) 1e+02 1 1e+02 3e+02 2.5 neonate bag Silicone (VMQ, heat cured, low hardness) Virgin (0%) 43 1 43 3.9e+02 3.2 PVC (semi-rigid, molding Virgin (0%) and extrusion) 11 1 11 28 0.2 tube bracket cylinder surface cylinder PE-HD (20-30% long glass fiber) Virgin (0%) 0.38 1 0.38 1.1 0.0 ABS (extrusion) Virgin (0%) 8.2 1 8.2 31 0.3 1 1.4e+02 1.6e+03 13.5 Aluminum, 319.0, Virgin (0%) 1.4e+02 permanent mold cast, T6 Geneva wheel ABS (medium-impact, injection molding) Virgin (0%) 26 1 26 99 0.8 leaks ring ABS (medium-impact, injection molding) Virgin (0%) 5.2 1 5.2 20 0.2 167 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR gear ABS (high-impact, injection molding) Virgin (0%) 15 2 31 1.2e+02 1.0 motor Aluminum, 6063, wrought, O Virgin (0%) 45 3 1.4e+02 1.7e+03 14.3 screw Bake hardening steel, YS260 (cold rolled) Virgin (0%) 3 14 42 77 0.6 band PA (type 6, 15% glass fiber) Virgin (0%) 3.3 1 3.3 24 0.2 pulley PEEK (unfilled) Virgin (0%) 52 1 52 1.2e+03 10.1 Diodes and LEDs Virgin (0%) 0.44 1 0.44 1e+02 0.8 32 1.7e+03 1.2e+04 100 LED Total *Typical: Includes 'recycle fraction in current supply' **Where applicable, includes material mass removed by secondary processes Manufacture: Process % Removed Amount processed CO2 footprint (kg) % case Polymer molding - 8.6e+02 kg 1.5e+03 60.7 cap Polymer molding - 2.3e+02 kg 4e+02 16.2 rigid structure Polymer molding - 1e+02 kg 1.9e+02 7.5 neonate bag Polymer molding - 43 kg 51 2.1 tube Polymer extrusion - 11 kg 5.1 0.2 tube Cutting and trimming - 0 kg 0 0.0 Component 168 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR bracket Polymer extrusion - 0.38 kg 0.18 0.0 cylinder surface Polymer extrusion - 8.2 kg 3.7 0.2 cylinder surface Fine machining - 0 kg 0 0.0 Casting - 1.4e+02 kg 94 3.8 geneva wheel Polymer molding - 26 kg 40 1.6 geneva wheel Fine machining - 0 kg 0 0.0 leaks ring Polymer molding - 5.2 kg 8.1 0.3 leaks ring Fine machining - 0 kg 0 0.0 gear Polymer molding - 31 kg 41 1.7 motor Rough rolling, forging - 1.4e+02 kg 15 0.6 screw Extrusion, foil rolling - 42 kg 16 0.7 band Polymer extrusion - 3.3 kg 1.5 0.1 pulley Polymer molding - 52 kg 1e+02 4.2 paiting casing Painting - 0.6 m^2 0.59 0.0 add adhesive Adhesives, heat curing - 0.2 m^2 0.94 0.0 2.5e+03 100 cylinder Total 169 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR Transport: Breakdown by transport stage Stage name Transport of parts Total product mass = 1.7e+03 kg Transport type Distance (km) CO2 footprint (kg) % 32 tonne truck 1e+02 5.5 100.0 1e+02 5.5 100 Total Breakdown by components Component mass (kg) CO2 footprint (kg) % case 8.6e+02 2.8 50.7 cap 2.3e+02 0.76 13.8 rigid structure 1e+02 0.34 6.1 neonate bag 43 0.14 2.6 tube 11 0.037 0.7 bracket 0.38 0.0012 0.0 cylinder surface 8.2 0.027 0.5 1.4e+02 0.45 8.2 geneva wheel 26 0.085 1.5 leaks ring 5.2 0.017 0.3 gear 31 0.1 1.8 motor 1.4e+02 0.44 8.0 screw 42 0.14 2.5 band 3.3 0.011 0.2 Component cylinder 170 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR pulley 52 0.17 3.1 LED 0.44 0.0014 0.0 Total 1.7e+03 5.5 100 Use: Static mode Energy input and output type Mobile mode Electric to mechanical (electric motors) Fuel and mobility type Use location Use location Spain Spain Product mass (kg) Power rating (kW) 10 Usage (hours per day) 3 Usage (days per year) 1e+02 Product life (years) Diesel - heavy goods vehicle Distance (km per day) 1e+02 Usage (days per year) 50 Product life (years) 7 7 Relative contribution of static and mobile modes Mode CO2 footprint (kg) % Static 9.3e+03 71.2 Mobile 3.8e+03 28.8 Total 1.3e+04 100 Breakdown of mobile mode by components Component CO2 (kg) % case 1.9e+03 50.7 cap 5.2e+02 13.8 171 1.7e+03 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR rigid structure 2.3e+02 6.1 neonate bag 97 2.6 tube 25 0.7 0.85 0.0 18 0.5 3.1e+02 8.2 geneva wheel 58 1.5 leaks ring 12 0.3 gear 69 1.8 motor 3e+02 8.0 screw 94 2.5 band 7.4 0.2 pulley 1.2e+02 3.1 LED 0.98 0.0 Total 3.8e+03 100 bracket cylinder surface cylinder Disposal: End of life option % recovered CO2 footprint (kg) % case Landfill 100.0 12 50.7 cap Landfill 100.0 3.3 13.8 Component 172 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR rigid structure Landfill 100.0 1.4 6.1 neonate bag Landfill 100.0 0.61 2.6 tube Landfill 100.0 0.16 0.7 bracket Landfill 100.0 0.0053 0.0 cylinder surface Landfill 100.0 0.12 0.5 cylinder Landfill 100.0 1.9 8.2 geneva wheel Landfill 100.0 0.36 1.5 leaks ring Landfill 100.0 0.073 0.3 gear Landfill 100.0 0.43 1.8 motor Landfill 100.0 1.9 8.0 screw Landfill 100.0 0.59 2.5 band Landfill 100.0 0.046 0.2 pulley Landfill 100.0 0.73 3.1 LED Landfill 100.0 0.0062 0.0 24 100 % Total EoL potential: End of life option % recovered CO2 footprint (kg) case Landfill 100.0 0 cap Landfill 100.0 0 Component 173 EPS/IDPS 2014 PEADIATRIC AND NEONATAL LUNG SIMULATOR rigid structure Landfill 100.0 0 neonate bag Landfill 100.0 0 tube Landfill 100.0 0 bracket Landfill 100.0 0 cylinder surface Landfill 100.0 0 cylinder Landfill 100.0 0 Geneva wheel Landfill 100.0 0 leaks ring Landfill 100.0 0 gear Landfill 100.0 0 motor Landfill 100.0 0 screw Landfill 100.0 0 band Landfill 100.0 0 pulley Landfill 100.0 0 LED Landfill 100.0 0 0 Total Notes: 174 100 15 16 17 18 19 1 2 14 3 4 5 13 6 12 11 10 9 8 7 20 B B 20 Fitting 1 19 Bracket 1 18 Motor sujection 2 1 17 Leaks ring 1 16 Tube 1 15 Geneve stop wheel 1 14 Geneve index wheel 1 13 Geneve base 1 12 Motor 3 11 Gear 2 10 Motor sujection 1 2 9 Band 1 8 Pulley 1 7 Electrovalve 1 6 Cap 1 5 Cylinder 1 4 Case 1 3 Cylinder surface 1 2 Children/neonate bag 1 Rigid structure Signal Name DATA Drawn by Professor Id. Ser. No 28/05/2014 1 1 Pieces Regulation Material Weight SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 1:2 Dimensions European and Industrial design project semester EPS/IDPS 2014 LUNG SIMULATOR Name of the project: Pediatric and neonatal lung simulator Drawing number: Material: 118 20 29 21 SECTION B-B SCALE 1 : 2 99,70 75,48 A R1 10 R4 3,7 B 25 R9 3 ° 118,7 82,4 12,5 93,50 180,2 28 4 R1 R4 B 19,44 2 R6 1, 3 6 A SECTION A-A SCALE 1 : 2 27,3° 1 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 1:2 European and Industrial design project semester EPS/IDPS 2014 RIGID STRUCTURE Name of the project: Pediatric and neonatal lung simulator Drawing number: Material: 1 1,35 R1 2 8,5 12,3 M2x0.4 30,25 33,20 10 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 MOTOR SUJECTION 1 Name of the project: Pediatric and neonatal lung simulator Drawing number: 10 Material: 20 31,3 28 5 4 Teeth number 16 Pressure angle 20 Primitive diametre 28 11 DATA Drawn by Professor Id. Ser. No 28/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 GEAR Name of the project: Pediatric and neonatal lung simulator Drawing number: 11 Material: F 1,9 F 26, 3 28, 4 3,8 9 60 3,8 9 13, 8 25, 3,8 7 19 3,8 14, 5 SECTION F-F 13 DATA Drawn by Professor Id. Ser. No SURNAME, NAME 21/05/2014 The team Boladeras Díaz, Marta Projection Scale 1:1 European and Industrial design project semester EPS/IDPS 2014 GENEVE BASE Name of the project: Pediatric and neonatal lung simulator Drawing number: 13 Material: ,8 R3 6 R6 A A 56,2 3,4 4 53,7 ,8 3,8 8 2 24,3 SECTION A-A 14 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 1:1 European and Industrial design project semester EPS/IDPS 2014 GENEVE INDEX WHEEL Name of the project: Pediatric and neonatal lung simulator Drawing number: Material: 14 3,4 3,8 1,9 2,1 9 4 24, 15 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 GENEVE STOP WHEEL Name of the project: Pediatric and neonatal lung simulator Drawing number: 15 Material: 20 O 82,3 O 16 SECTION O-O 10 16 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 TUBE Name of the project: Pediatric and neonatal lung simulator Drawing number: 16 Material: 20 31,3 10 20 28 5 4 Teeth number 16 Pressure angle 20 Primitive diametre 28 5 17 DATA Drawn by Professor Id. Ser. No SURNAME, NAME 28/05/2014 The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 LEAKS RING Name of the project: Pediatric and neonatal lung simulator Drawing number: 17 Material: 1,35 R1 2 24,60 20,40 M2x0.4 30,25 33,20 18 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 MOTOR SUJECTION 2 Name of the project: Pediatric and neonatal lung simulator Drawing number: 18 Material: ° ,94 92 105 2 93,9 2 19 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 Bracket Name of the project: Pediatric and neonatal lung simulator Drawing number: 19 Material: 26 18 24 R2 73 25,7 5,5 11 1 20 87,9 124,6 ,6° ° ,3 76 R2 1 80 25 8,3 2 40 2 45,5 86,4 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 1:1 European and Industrial design project semester EPS/IDPS 2014 CHILDREN BAG Name of the project: Pediatric and neonatal lung simulator Drawing number: 2 Material: 26 24 9,6 41,1 29,5 1 20 1 3° ,8° 61 , 86 1 27,8 R1 76 ,3 ° 15 27,5 51,8 R2 2 67 8,30 25 59 62 73,8 2 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 1:1 European and Industrial design project semester EPS/IDPS 2014 NEONATE BAG Name of the project: Pediatric and neonatal lung simulator Drawing number: 2 bis Material: 40 5 6,50 31° 5 3 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 CYLINDER SURFACE Name of the project: Pediatric and neonatal lung simulator Drawing number: 3 Material: 15 8 ,6 136,9 270 0 R7 5 6 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 1:2 European and Industrial design project semester EPS/IDPS 2014 CAP Name of the project: Pediatric and neonatal lung simulator Drawing number: 6 Material: 15 N 50 N 35 30 20 10 12,5 2 SECTION N-N 6° 26, 15 25 8 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 1:2 European and Industrial design project semester EPS/IDPS 2014 PULLEY Name of the project: Pediatric and neonatal lung simulator Drawing number: 8 Material: 1 180 12 9 DATA Drawn by Professor Id. Ser. No 21/05/2014 SURNAME, NAME The team Boladeras Díaz, Marta Projection Scale 2:1 European and Industrial design project semester EPS/IDPS 2014 BAND Name of the project: Pediatric and neonatal lung simulator Drawing number: 9 Material: Resumen de configuración para Cilindro compacto ADN-16-30-A-P-A #536224 Función Características básicas Feature Función Diámetro del émbolo en mm Carrera en mm Rosca del vástago Amortiguación Detección de posiciones Value ADN Cilindro compacto, de doble efecto, en base a ISO 21287 16 mm 30 mm A Rosca exterior P Anillos elásticos / placas de amortiguación en ambos lados A Para detector de posiciones Otras opciones de productos Feature Value Seguro antigiro Tipo de vástago K2 - Rosca prolongada del vástago K5 - Rosca especial Resistencia a temperaturas Funcionamiento constante marcha suave Mayor duración Protección contra corrosión Mayor fuerza tranversal Placa de identificación imperdible Muy temperatura baja Rascador Certificación EU (ATEX) Sin Vástago simple Sin Rosca estándar en el vástago Estándar Sin Estándar Sin Estándar Sin Placa de características pegada Sin Estándar Sin 24.05.2014 - Reservado el derecho de modificación - Festo AG & Co. KG 1/1 Proportional directional control valves MPYE • High dynamics • Final control element for closed control loops • 5/3 –way function 2012/06 – Subject to change Internet: www.festo.com/catalog/... 1 Proportional directional control valves MPYE Key features General information • The directly actuated proportional directional control valve has a position-controlled spool. This transforms an analogue input signal into a corresponding opening cross-section at the valve outputs. • In combination with an external position controller and displacement encoder, a precise pneumatic positioning system can be created. • Flow control function for varying cylinder speed • 5/3-way function for varying the direction of movement Wide choice of variants • Setpoint value input – Analogue voltage signal – Analogue current signal 2 • Flow rates from 100 … 2 000 l/min Internet: www.festo.com/catalog/... Subject to change – 2012/06 Proportional directional control valves MPYE Key features and type codes Short machine cycle times – fast switching of programmed flow rates A: Proportional valves allow different speed levels and speed ramps to be set. B: Speed regulation with directional control valves is more difficult and is performed by means of exhaust air flow control. Rapid speed Cylinder speed • Reduce machine cycle times by optimising cylinder speeds – Assembly technology – Handling technology – Furniture industry Medium speed Creep speed Cylinder stroke Flexible cylinder speeds – Achieving variable flow rates Cylinder speed • Flexibly adapting cylinder speeds to the process. Traversing individual acceleration ramps (gentle approach with delicate goods) – Automobile suppliers – Production technology – Conveyor technology – Test engineering Cylinder stroke Proportional directional control valve as final control element – Dynamic and fast changing of flow rates Cylinder speed • Fatigue tests • Pneumatic positioning with SPC200 • SoftStop with end-position controller SPC11 Time Type codes MPYE — 5 — x LF — 010 — B Type MPYE Proportional directional control valve Valve function 5 5/3-way valve Pneumatic connection M5 x LF x HF ¼ y M5 Gx Low Flow Gx High Flow G¼ Gy Setpoint value input 010 420 Analogue voltage signal Analogue current signal Generation B B series 2012/06 – Subject to change Internet: www.festo.com/catalog/... 3 Proportional directional control valves MPYE Peripherals overview 9 3 7 6 5 4 8 2 1 2 1 1 Accessories 1 2 3 4 5 6 7 8 9 4 Brief description Page/Internet Push-in fitting QS Silencer For connecting compressed air tubing with standard external diameters quick star For fitting in exhaust ports u Setpoint module MPZ Sensor socket SIE-WD-TR Sensor socket SIE-GD Connecting cable KMPYE Connecting cable KVIA-MPYE Proportional directional control valve MPYE Digital input/output For generating 6+1 analogue voltage signals – Angled, 4-pin, M12x1 8 Straight, 4-pin, M12x1 8 – 8 Connecting cable to the analogue module of valve terminal type 03 8 – 5 For controlling the setpoint module – Internet: www.festo.com/catalog/... Subject to change – 2012/06 Proportional directional control valves MPYE Technical data Variants • Setpoint value input as analogue voltage signal 0 … 10 V • Setpoint value input as analogue current signal 4 … 20 mA Function Voltage 17 … 30 V DC Flow rate 100 … 2 000 l/min Pressure 0 … 10 bar General technical data Pneumatic connection Valve function Constructional design Sealing principle Actuation type Type of reset Type of pilot control Direction of flow Type of mounting Mounting position1) Nominal size Standard nominal flow rate Product weight 1) M5 [mm] [l/min] [g] Gx Low flow G¼ Gy 8 1 400 530 10 2 000 740 High flow 5/3-way, normally closed Piston spool, directly actuated, controlled piston spool position Hard Electrical Mechanical spring Direct Non-reversible Via through-holes Any 2 4 6 100 350 700 290 330 330 If the proportional directional control valve is in motion during operation, it must be mounted at right angles to the direction of movement. Current type MPYE-5-…-420-B q [%] q [%] Flow rate q at 6 > 5 bar as a function of the setpoint voltage U Voltage type MPYE-5-…-010-B Iw [mA] Uw [V] 2012/06 – Subject to change Internet: www.festo.com/catalog/... 5 Proportional directional control valves MPYE Technical data Electrical data Pneumatic connection Power supply Max. current consumption Setpoint value Max. hysteresis1) Valve mid-position in mid-position at full stroke Voltage type Current type Voltage type Current type Duty cycle2) Critical frequency3) Safety setting Protection against polarity reversal Protection class Electrical connection 1) 2) 3) M5 Voltage type Current type [V DC] [mA] [mA] [V DC] [mA] [%] [V DC] [mA] [%] [Hz] Gx Low flow G¼ Gy High flow 17 … 30 100 1 100 0 … 10 4 … 20 0.4 5 (±0.1) 12 (±0.16) 100 125 100 100 90 Active mid-position in the event of setpoint value cable break For all electrical connections For setpoint value IP65 4-pin plug socket, round design, M12x1 65 Referred to the maximum stroke of the piston spool. The proportional direction control valve automatically switches off if it overheats (goes to mid-position) and switches back on once it cools down. Corresponds to the 3dB frequency at the maximum movement stroke of the piston spool. Operating and environmental conditions Operating pressure Operating medium Note on operating/pilot medium Ambient temperature Vibration resistance1) Continuous shock resistance1) CE symbol Temperature of medium [bar] [°C] [°C] 0 … 10 Compressed air in accordance with ISO 8573-1:2010 [6:4:4] Operation with lubricated medium not possible 0 … 50 To DIN/IEC 68 Parts 2 -6, severity level 2 To DIN/IEC 68 Parts 2 -27, severity level 2 To 89/336/EEC (EMC regulation) 5 … 40, condensation not permitted * 1) If the proportional directional control valve is in motion during operation, it must be mounted at right angles to the direction of movement. Materials Sectional view 1 1 2 3 – 6 2 Housing Valve spool Housing for electronics Seals 3 Anodised aluminium Tempered aluminium Galvanised acrylic butadiene styrene Nitrile rubber Internet: www.festo.com/catalog/... Subject to change – 2012/06 Proportional directional control valves MPYE Technical data Download CAD Data www.festo.com/us/cad Dimensions Pneumatic connection D1 B B1 D ∅ H H1 H2 H3 H4 M5 Gx G¼ Gy 26 26 35 40 – – 26 26 5.5 5.5 6.5 6.5 129.9 149.3 164.6 176.6 69 88.4 103.7 115.7 56.1 71.3 79.6 98.4 38.1 55.1 68.1 79.4 32.1 45.8 56.6 65.4 Pneumatic connection D1 M5 Gx G¼ Gy H5 H6 H7 H8 L L1 L2 L3 L4 20.1 26.8 33.6 37.4 38.1 55.3 68.1 82.4 26.1 36.3 45.1 51.4 14.1 17.3 22.1 20.4 45 45 58 67 – – 45 45 14.8 14.8 14.8 14.8 3.2 3.2 3.2 3.2 32 35 46 54 Terminal allocation 1 2 3 4 Ordering data Pneumatic connection M5 Gx G¼ Gy 24 V DC, supply voltage GND Uw/IW, setpoint input GND Voltage type 0 … 10 mV Current type 4 … 20 mA Part No. Type Part No. Type 154 200 151 692 151 693 151 694 151 695 MPYE-5-M5-010-B MPYE-5-xLF-010-B MPYE-5-xHF-010-B MPYE-5-¼-010-B MPYE-5-y-010-B 162 959 161 978 161 979 161 980 161 981 MPYE-5-M5-420-B MPYE-5-xLF-420-B MPYE-5-xHF-420-B MPYE-5-¼-420-B MPYE-5-y-420-B 2012/06 – Subject to change Internet: www.festo.com/catalog/... 7 Proportional directional control valves MPYE Accessories Ordering data Description Cable length [m] Part No. Screened 5 151 909 X length1) 151 910 KMPYE-… 5 161 984 KVIA-MPYE-5 10 161 985 KVIA-MPYE-10 0.3 170 239 KMPYE-AIF-1-GS-GD-0,3 2 170 238 KMPYE-AIF-1-GS-GD-2 Straight, 4-pin, M12x1 – 18 494 Technical data Internet: sie-gd SIE-GD Angled, 4-pin, M12x1 – 12 956 Technical data Internet: sie-wd SIE-WD-TR Generation of 6+1 analogue setpoint values – 546 224 Technical data Internet: mpz MPZ-1-24DC-SGH-6-SW5 Connecting cable Connecting cable to the analogue module of valve terminal type 03 Connecting cable to the axis interface of the axis controller SPC200 Sensor socket Sensor socket Setpoint module 1) 8 Type Technical data Internet: kmpye, kvia KMPYE-5 Max. 10 m Internet: www.festo.com/catalog/... Subject to change – 2012/06 Product Range and Company Overview A Complete Suite of Automation Services Our experienced engineers provide complete support at every stage of your development process, including: conceptualization, analysis, engineering, design, assembly, documentation, validation, and production. Custom Automation Components Complete custom engineered solutions Custom Control Cabinets Comprehensive engineering support and on-site services Complete Systems Shipment, stocking and storage services The Broadest Range of Automation Components With a comprehensive line of more than 30,000 automation components, Festo is capable of solving the most complex automation requirements. Electromechanical Electromechanical actuators, motors, controllers & drives Pneumatics Pneumatic linear and rotary actuators, valves, and air supply PLCs and I/O Devices PLC's, operator interfaces, sensors and I/O devices Supporting Advanced Automation… As No One Else Can! Festo is a leading global manufacturer of pneumatic and electromechanical systems, components and controls for industrial automation, with more than 12,000 employees in 56 national headquarters serving more than 180 countries. For more than 80 years, Festo has continuously elevated the state of manufacturing with innovations and optimized motion control solutions that deliver higher performing, more profitable automated manufacturing and processing equipment. Our dedication to the advancement of automation extends beyond technology to the education and development of current and future automation and robotics designers with simulation tools, teaching programs, and on-site services. Quality Assurance, ISO 9001 and ISO 14001 Certifications Festo Corporation is committed to supply all Festo products and services that will meet or exceed our customers’ requirements in product quality, delivery, customer service and satisfaction. To meet this commitment, we strive to ensure a consistent, integrated, and systematic approach to management that will meet or exceed the requirements of the ISO 9001 standard for Quality Management and the ISO 14001 standard for Environmental Management. © Copyright 2008, Festo Corporation. While every effort is made to ensure that all dimensions and specifications are correct, Festo cannot guarantee that publications are completely free of any error, in particular typing or printing errors. Accordingly, Festo cannot be held responsible for the same. For Liability and Warranty conditions, refer to our “Terms and Conditions of Sale”, available from your local Festo office. All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise, without the prior written permission of Festo. All technical data subject to change according to technical update. Printed on recycled paper at New Horizon Graphic, Inc., FSC certified as an environmentally friendly printing plant. Festo North America Festo Regional Contact Center United States 5300 Explorer Drive Mississauga, Ontario L4W 5G4 Canada USA Customers: For ordering assistance, Call: 1.800.99.FESTO (1.800.993.3786) Fax: 1.800.96.FESTO (1.800.963.3786) Email: customer.service@us.festo.com For technical support, Call: 1.866.GO.FESTO (1.866.463.3786) Fax: 1.800.96.FESTO (1.800.963.3786) Email: product.support@us.festo.com USA Headquarters, East: Festo Corp., 395 Moreland Road, Hauppauge, NY 11788 Phone: 1.631.435.0800; Fax: 1.631.435.8026; Email: info@festo-usa.com www.festo.com/us Canadian Customers: Call: 1.877.GO.FESTO (1.877.463.3786) Fax: 1.877.FX.FESTO (1.877.393.3786) Email: festo.canada@ca.festo.com Canada USA Headquarters Festo Corporation 395 Moreland Road P.O. Box 18023 Hauppauge, NY 11788, USA www.festo.com/us USA Sales Offices Appleton North 922 Tower View Drive, Suite N Greenville, WI 54942, USA Headquarters: Festo Inc., 5300 Explorer Drive, Mississauga, Ontario L4W 5G4 Phone: 1.905.624.9000; Fax: 1.905.624.9001; Email: festo.canada@ca.festo.com www.festo.ca Boston 120 Presidential Way, Suite 330 Woburn, MA 01801, USA Mexico Chicago 1441 East Business Center Drive Mt. Prospect, IL 60056, USA Dallas 1825 Lakeway Drive, Suite 600 Lewisville, TX 75057, USA Detroit – Automotive Engineering Center 2601 Cambridge Court, Suite 320 Auburn Hills, MI 48326, USA New York 395 Moreland Road Hauppauge, NY 11788, USA Silicon Valley 4935 Southfront Road, Suite F Livermore, CA 94550, USA Headquarters: Festo Pneumatic, S.A., Av. Ceylán 3, Col. Tequesquinahuac, 54020 Tlalnepantla, Edo. de México Phone:011 52 [55] 53 21 66 00; Fax: 011 52 [55] 53 21 66 65; Email: festo.mexico@mx.festo.com www.festo.com/mx Central USA Western USA Festo Corporation 1441 East Business Center Drive Mt. Prospect, IL 60056, USA Phone:1.847.759.2600 Fax: 1.847.768.9480 Festo Corporation 4935 Southfront Road, Suite F Livermore, CA 94550, USA Phone: 1.925.371.1099 Fax: 1.925.245.1286 Festo Worldwide Argentina Estonia Lithuania Slovakia Australia Finland Malaysia Slovenia www.festo.com Austria France Belarus Germany Mexico South Africa Belgium Great Britain Netherlands South Korea Brazil Greece New Zealand Spain Bulgaria Canada Chile Hong Kong Hungary India Norway Sweden Peru Switzerland Philippines Taiwan China Colombia Indonesia Poland Thailand Iran Croatia Ireland Romania Turkey Czech Republic Israel Russia Ukraine Italy Denmark Japan Serbia United States Latvia Singapore Venezuela Resumen de configuración para Cilindro compacto ADN-16-30-A-P-A #536224 Función Características básicas Feature Función Diámetro del émbolo en mm Carrera en mm Rosca del vástago Amortiguación Detección de posiciones Value ADN Cilindro compacto, de doble efecto, en base a ISO 21287 16 mm 30 mm A Rosca exterior P Anillos elásticos / placas de amortiguación en ambos lados A Para detector de posiciones Otras opciones de productos Feature Value Seguro antigiro Tipo de vástago K2 - Rosca prolongada del vástago K5 - Rosca especial Resistencia a temperaturas Funcionamiento constante marcha suave Mayor duración Protección contra corrosión Mayor fuerza tranversal Placa de identificación imperdible Muy temperatura baja Rascador Certificación EU (ATEX) Sin Vástago simple Sin Rosca estándar en el vástago Estándar Sin Estándar Sin Estándar Sin Placa de características pegada Sin Estándar Sin 24.05.2014 - Reservado el derecho de modificación - Festo AG & Co. KG 1/1 Proportional directional control valves MPYE • High dynamics • Final control element for closed control loops • 5/3 –way function 2012/06 – Subject to change Internet: www.festo.com/catalog/... 1 Proportional directional control valves MPYE Key features General information • The directly actuated proportional directional control valve has a position-controlled spool. This transforms an analogue input signal into a corresponding opening cross-section at the valve outputs. • In combination with an external position controller and displacement encoder, a precise pneumatic positioning system can be created. • Flow control function for varying cylinder speed • 5/3-way function for varying the direction of movement Wide choice of variants • Setpoint value input – Analogue voltage signal – Analogue current signal 2 • Flow rates from 100 … 2 000 l/min Internet: www.festo.com/catalog/... Subject to change – 2012/06 Proportional directional control valves MPYE Key features and type codes Short machine cycle times – fast switching of programmed flow rates A: Proportional valves allow different speed levels and speed ramps to be set. B: Speed regulation with directional control valves is more difficult and is performed by means of exhaust air flow control. Rapid speed Cylinder speed • Reduce machine cycle times by optimising cylinder speeds – Assembly technology – Handling technology – Furniture industry Medium speed Creep speed Cylinder stroke Flexible cylinder speeds – Achieving variable flow rates Cylinder speed • Flexibly adapting cylinder speeds to the process. Traversing individual acceleration ramps (gentle approach with delicate goods) – Automobile suppliers – Production technology – Conveyor technology – Test engineering Cylinder stroke Proportional directional control valve as final control element – Dynamic and fast changing of flow rates Cylinder speed • Fatigue tests • Pneumatic positioning with SPC200 • SoftStop with end-position controller SPC11 Time Type codes MPYE — 5 — x LF — 010 — B Type MPYE Proportional directional control valve Valve function 5 5/3-way valve Pneumatic connection M5 x LF x HF ¼ y M5 Gx Low Flow Gx High Flow G¼ Gy Setpoint value input 010 420 Analogue voltage signal Analogue current signal Generation B B series 2012/06 – Subject to change Internet: www.festo.com/catalog/... 3 Proportional directional control valves MPYE Peripherals overview 9 3 7 6 5 4 8 2 1 2 1 1 Accessories 1 2 3 4 5 6 7 8 9 4 Brief description Page/Internet Push-in fitting QS Silencer For connecting compressed air tubing with standard external diameters quick star For fitting in exhaust ports u Setpoint module MPZ Sensor socket SIE-WD-TR Sensor socket SIE-GD Connecting cable KMPYE Connecting cable KVIA-MPYE Proportional directional control valve MPYE Digital input/output For generating 6+1 analogue voltage signals – Angled, 4-pin, M12x1 8 Straight, 4-pin, M12x1 8 – 8 Connecting cable to the analogue module of valve terminal type 03 8 – 5 For controlling the setpoint module – Internet: www.festo.com/catalog/... Subject to change – 2012/06 Proportional directional control valves MPYE Technical data Variants • Setpoint value input as analogue voltage signal 0 … 10 V • Setpoint value input as analogue current signal 4 … 20 mA Function Voltage 17 … 30 V DC Flow rate 100 … 2 000 l/min Pressure 0 … 10 bar General technical data Pneumatic connection Valve function Constructional design Sealing principle Actuation type Type of reset Type of pilot control Direction of flow Type of mounting Mounting position1) Nominal size Standard nominal flow rate Product weight 1) M5 [mm] [l/min] [g] Gx Low flow G¼ Gy 8 1 400 530 10 2 000 740 High flow 5/3-way, normally closed Piston spool, directly actuated, controlled piston spool position Hard Electrical Mechanical spring Direct Non-reversible Via through-holes Any 2 4 6 100 350 700 290 330 330 If the proportional directional control valve is in motion during operation, it must be mounted at right angles to the direction of movement. Current type MPYE-5-…-420-B q [%] q [%] Flow rate q at 6 > 5 bar as a function of the setpoint voltage U Voltage type MPYE-5-…-010-B Iw [mA] Uw [V] 2012/06 – Subject to change Internet: www.festo.com/catalog/... 5 Proportional directional control valves MPYE Technical data Electrical data Pneumatic connection Power supply Max. current consumption Setpoint value Max. hysteresis1) Valve mid-position in mid-position at full stroke Voltage type Current type Voltage type Current type Duty cycle2) Critical frequency3) Safety setting Protection against polarity reversal Protection class Electrical connection 1) 2) 3) M5 Voltage type Current type [V DC] [mA] [mA] [V DC] [mA] [%] [V DC] [mA] [%] [Hz] Gx Low flow G¼ Gy High flow 17 … 30 100 1 100 0 … 10 4 … 20 0.4 5 (±0.1) 12 (±0.16) 100 125 100 100 90 Active mid-position in the event of setpoint value cable break For all electrical connections For setpoint value IP65 4-pin plug socket, round design, M12x1 65 Referred to the maximum stroke of the piston spool. The proportional direction control valve automatically switches off if it overheats (goes to mid-position) and switches back on once it cools down. Corresponds to the 3dB frequency at the maximum movement stroke of the piston spool. Operating and environmental conditions Operating pressure Operating medium Note on operating/pilot medium Ambient temperature Vibration resistance1) Continuous shock resistance1) CE symbol Temperature of medium [bar] [°C] [°C] 0 … 10 Compressed air in accordance with ISO 8573-1:2010 [6:4:4] Operation with lubricated medium not possible 0 … 50 To DIN/IEC 68 Parts 2 -6, severity level 2 To DIN/IEC 68 Parts 2 -27, severity level 2 To 89/336/EEC (EMC regulation) 5 … 40, condensation not permitted * 1) If the proportional directional control valve is in motion during operation, it must be mounted at right angles to the direction of movement. Materials Sectional view 1 1 2 3 – 6 2 Housing Valve spool Housing for electronics Seals 3 Anodised aluminium Tempered aluminium Galvanised acrylic butadiene styrene Nitrile rubber Internet: www.festo.com/catalog/... Subject to change – 2012/06 Proportional directional control valves MPYE Technical data Download CAD Data www.festo.com/us/cad Dimensions Pneumatic connection D1 B B1 D ∅ H H1 H2 H3 H4 M5 Gx G¼ Gy 26 26 35 40 – – 26 26 5.5 5.5 6.5 6.5 129.9 149.3 164.6 176.6 69 88.4 103.7 115.7 56.1 71.3 79.6 98.4 38.1 55.1 68.1 79.4 32.1 45.8 56.6 65.4 Pneumatic connection D1 M5 Gx G¼ Gy H5 H6 H7 H8 L L1 L2 L3 L4 20.1 26.8 33.6 37.4 38.1 55.3 68.1 82.4 26.1 36.3 45.1 51.4 14.1 17.3 22.1 20.4 45 45 58 67 – – 45 45 14.8 14.8 14.8 14.8 3.2 3.2 3.2 3.2 32 35 46 54 Terminal allocation 1 2 3 4 Ordering data Pneumatic connection M5 Gx G¼ Gy 24 V DC, supply voltage GND Uw/IW, setpoint input GND Voltage type 0 … 10 mV Current type 4 … 20 mA Part No. Type Part No. Type 154 200 151 692 151 693 151 694 151 695 MPYE-5-M5-010-B MPYE-5-xLF-010-B MPYE-5-xHF-010-B MPYE-5-¼-010-B MPYE-5-y-010-B 162 959 161 978 161 979 161 980 161 981 MPYE-5-M5-420-B MPYE-5-xLF-420-B MPYE-5-xHF-420-B MPYE-5-¼-420-B MPYE-5-y-420-B 2012/06 – Subject to change Internet: www.festo.com/catalog/... 7 Proportional directional control valves MPYE Accessories Ordering data Description Cable length [m] Part No. Screened 5 151 909 X length1) 151 910 KMPYE-… 5 161 984 KVIA-MPYE-5 10 161 985 KVIA-MPYE-10 0.3 170 239 KMPYE-AIF-1-GS-GD-0,3 2 170 238 KMPYE-AIF-1-GS-GD-2 Straight, 4-pin, M12x1 – 18 494 Technical data Internet: sie-gd SIE-GD Angled, 4-pin, M12x1 – 12 956 Technical data Internet: sie-wd SIE-WD-TR Generation of 6+1 analogue setpoint values – 546 224 Technical data Internet: mpz MPZ-1-24DC-SGH-6-SW5 Connecting cable Connecting cable to the analogue module of valve terminal type 03 Connecting cable to the axis interface of the axis controller SPC200 Sensor socket Sensor socket Setpoint module 1) 8 Type Technical data Internet: kmpye, kvia KMPYE-5 Max. 10 m Internet: www.festo.com/catalog/... Subject to change – 2012/06 Product Range and Company Overview A Complete Suite of Automation Services Our experienced engineers provide complete support at every stage of your development process, including: conceptualization, analysis, engineering, design, assembly, documentation, validation, and production. Custom Automation Components Complete custom engineered solutions Custom Control Cabinets Comprehensive engineering support and on-site services Complete Systems Shipment, stocking and storage services The Broadest Range of Automation Components With a comprehensive line of more than 30,000 automation components, Festo is capable of solving the most complex automation requirements. Electromechanical Electromechanical actuators, motors, controllers & drives Pneumatics Pneumatic linear and rotary actuators, valves, and air supply PLCs and I/O Devices PLC's, operator interfaces, sensors and I/O devices Supporting Advanced Automation… As No One Else Can! Festo is a leading global manufacturer of pneumatic and electromechanical systems, components and controls for industrial automation, with more than 12,000 employees in 56 national headquarters serving more than 180 countries. For more than 80 years, Festo has continuously elevated the state of manufacturing with innovations and optimized motion control solutions that deliver higher performing, more profitable automated manufacturing and processing equipment. Our dedication to the advancement of automation extends beyond technology to the education and development of current and future automation and robotics designers with simulation tools, teaching programs, and on-site services. Quality Assurance, ISO 9001 and ISO 14001 Certifications Festo Corporation is committed to supply all Festo products and services that will meet or exceed our customers’ requirements in product quality, delivery, customer service and satisfaction. To meet this commitment, we strive to ensure a consistent, integrated, and systematic approach to management that will meet or exceed the requirements of the ISO 9001 standard for Quality Management and the ISO 14001 standard for Environmental Management. © Copyright 2008, Festo Corporation. While every effort is made to ensure that all dimensions and specifications are correct, Festo cannot guarantee that publications are completely free of any error, in particular typing or printing errors. Accordingly, Festo cannot be held responsible for the same. For Liability and Warranty conditions, refer to our “Terms and Conditions of Sale”, available from your local Festo office. All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise, without the prior written permission of Festo. All technical data subject to change according to technical update. Printed on recycled paper at New Horizon Graphic, Inc., FSC certified as an environmentally friendly printing plant. Festo North America Festo Regional Contact Center United States 5300 Explorer Drive Mississauga, Ontario L4W 5G4 Canada USA Customers: For ordering assistance, Call: 1.800.99.FESTO (1.800.993.3786) Fax: 1.800.96.FESTO (1.800.963.3786) Email: customer.service@us.festo.com For technical support, Call: 1.866.GO.FESTO (1.866.463.3786) Fax: 1.800.96.FESTO (1.800.963.3786) Email: product.support@us.festo.com USA Headquarters, East: Festo Corp., 395 Moreland Road, Hauppauge, NY 11788 Phone: 1.631.435.0800; Fax: 1.631.435.8026; Email: info@festo-usa.com www.festo.com/us Canadian Customers: Call: 1.877.GO.FESTO (1.877.463.3786) Fax: 1.877.FX.FESTO (1.877.393.3786) Email: festo.canada@ca.festo.com Canada USA Headquarters Festo Corporation 395 Moreland Road P.O. Box 18023 Hauppauge, NY 11788, USA www.festo.com/us USA Sales Offices Appleton North 922 Tower View Drive, Suite N Greenville, WI 54942, USA Headquarters: Festo Inc., 5300 Explorer Drive, Mississauga, Ontario L4W 5G4 Phone: 1.905.624.9000; Fax: 1.905.624.9001; Email: festo.canada@ca.festo.com www.festo.ca Boston 120 Presidential Way, Suite 330 Woburn, MA 01801, USA Mexico Chicago 1441 East Business Center Drive Mt. Prospect, IL 60056, USA Dallas 1825 Lakeway Drive, Suite 600 Lewisville, TX 75057, USA Detroit – Automotive Engineering Center 2601 Cambridge Court, Suite 320 Auburn Hills, MI 48326, USA New York 395 Moreland Road Hauppauge, NY 11788, USA Silicon Valley 4935 Southfront Road, Suite F Livermore, CA 94550, USA Headquarters: Festo Pneumatic, S.A., Av. Ceylán 3, Col. Tequesquinahuac, 54020 Tlalnepantla, Edo. de México Phone:011 52 [55] 53 21 66 00; Fax: 011 52 [55] 53 21 66 65; Email: festo.mexico@mx.festo.com www.festo.com/mx Central USA Western USA Festo Corporation 1441 East Business Center Drive Mt. Prospect, IL 60056, USA Phone:1.847.759.2600 Fax: 1.847.768.9480 Festo Corporation 4935 Southfront Road, Suite F Livermore, CA 94550, USA Phone: 1.925.371.1099 Fax: 1.925.245.1286 Festo Worldwide Argentina Estonia Lithuania Slovakia Australia Finland Malaysia Slovenia www.festo.com Austria France Belarus Germany Mexico South Africa Belgium Great Britain Netherlands South Korea Brazil Greece New Zealand Spain Bulgaria Canada Chile Hong Kong Hungary India Norway Sweden Peru Switzerland Philippines Taiwan China Colombia Indonesia Poland Thailand Iran Croatia Ireland Romania Turkey Czech Republic Israel Russia Ukraine Italy Denmark Japan Serbia United States Latvia Singapore Venezuela Racor rápido roscado QSM-M5-4 Número de artículo: 153304 Programa básico Rosca exterior con hexágono exterior. Hoja de datos Característica Propiedades Tamaño Diámetro nominal Tipo de junta del eje atornillable Posición de montaje Tamaño del depósito Construcción Presión de funcionamiento en función de la temperatura Fluido Indicación sobre los fluidos de funcionamiento y de mando Clase de resistencia a la corrosión KBK Temperatura ambiente Homologación Par de apriete máximo Peso del producto Conexión neumática Mini 2,2 mm Junta anular indistinto 10 Principio Push-Pull -0,95 ... 14 bar Aire comprimido según ISO 8573-1:2010 [7:-:-] Opción de funcionamiento con lubricación 1 -10 ... 80 °C Germanischer Lloyd 1,5 Nm 3,2 g Rosca exterior M5 für Schlauch Außen-Ø 4 mm azul Conforme con RoHS latón niquelado POM NBR Acero inoxidable de aleación fina Color del anillo extractor Indicación sobre el material Información sobre el material del cuerpo Información sobre el material del anillo de liberación Información sobre el material de la junta del tubo flexible Información sobre el material del segmento de sujeción del tubo flexible 24.05.2014 – Reservado el derecho de modificación – Festo AG & Co. KG 1/1