Thesis (M.S.)--Ball State University, 2008. / Title from PDF t.p. (viewed on Sept. 01, 2009). Research paper (M.S.), 3 hrs. Includes bibliographical references (p. [80-82])

Today’s endeavor of performance and accomplishment might bring more efficiency in many ways, but it has a price. Stress related diseases have increased in numbers the last decades and the field of stress is an exceptionally live issue. Linkura is a company which partly works towards identifying and decreasing stress. To be able to monitor and detect stress in people’s daily life, an ECG-device is used. This thesis is divided into two parts. The first part consisted of analyzing and comparing four different ECG based stress measures. These stress measures were RMSSD, Heart Rate, high frequency (HF) band and ratio between low and high frequency bands (LF/HF), last two based in frequency domain. These were taken from healthy test subjects for periods of relaxation where the stress level presumably would decrease. What could be seen for all measures was that they all showed a statistical significant decrease in stress level (p<0.05) during the relaxation period. LF/HF ratio was the one performing best and showed clearest decrease in stress. Biofeedback is a growing treatment, or rather, health monitoring, which purpose is to gain awareness of physiological functions to manipulate them at will. The second part of the thesis compared two ECG-related respiratory components, to find out which one would be most suited for biofeedback purpose to lower stress in the form of breathing exercises. The two respiratory components investigated were beat to beat heart rate and R-peak amplitude. For this part, a real-time application in the form of a mobile application was created and connected to the ECG-device. This enabled real-time measurement, which was crucial for the second part. Different time and frequency based algorithms were made to compare the two respiratory components. What could be seen was that the beat to beat heart rate signal was the respiratory component following breathing pattern the most.

The development of automated vehicles is something most vehicle manufacturers are working on these days. Different levels of automation allow the driver to perform other tasks while traveling than focus on the dynamic driving tasks. For professional drivers where there are strict laws for the amount of driving hours that is allowed without stopping and taking a break, resting while the vehicle is in an automated driving mode can increase the transport efficiency and the comfort of the driver. With data collected from 11 professional long-haul truck drivers in the ADAS&ME project, the goal of this thesis is to investigate if it is possible to obtain rest during autonomous driving (simulated with a confederate driver). Pre- and post-drive tests, KSS and SUS ratings, HRV features obtained from ECG data and blink features obtained from vertical EOG data was used in order to evaluate if rest could be obtained during simulated autonomous driving compared to normal driving. The results show that no clear trends or statistically significant differences can be seen while comparing simulated autonomous driving with normal driving. However one of the participants showed indications in KSS and SUS ratings together with the HRV features that rest was obtained during the simulated autonomous driving. The results indicate that it could be possible to obtain rest during autonomous driving, but a larger set of participants and a more demanding study setup is needed to verify the impact of autonomous driving as a substitute for regular rest breaks in terms of obtaining rest.

To facilitates tasks in modern healthcare, innovative solutions can be used and the product Sippi is an example of this. Sippi is a self-emptying siphon device used for monitoring a patient ́s urine production. This report examines one of the two main components of Sippi, known as the disposable unit. The unit consist of a siphon which is self-emptying without needing any mechanical assistance. The purpose of the report is to understand how some vital components of Sippi affect the emptying rate and determine the optimal length of the outlet tube. Theoretical calculations and experiential methods are used for the investigation. From the data and with help of software from Observe Medical, results could be generated in various forms, leading to several conclusions. The examined components, which were the bell and the filter had a negative effect on the emptying rate, resulting in a decreased rate when in use. Regarding the pressure drop, it was concluded that longer pipes generated greater pressure drop across the pipe. Additional studies are required to establish the ideal length of the outlet tube.

During this project, the risk management of a medical device under development that deals with drug administration has been done. The aim of the project is to evaluate if part of the device is safe according to the current regulations in Sweden. The complexity of the risk management processes, particularly in healthcare, together with the lack of standardised methods to develop these kind of processes leads to a need of new tools to reduce the time, resources and complexity in this stage of the development. That is why two tools have been used and tested in order to assess the suitability under medical device development regulation conditions: the Hazard Ontology (HO) and a Fault Injection System(FIS). HO is a novel tool used to identify all hazards and threads from a predefined system in a structured way. On the other hand, FIS is a testing technique that aims to help with the study of systems when they are under faulty conditions. To ensure that the current regulations in Sweden regarding medical device are fulfilled, the EN ISO 14971 has been used as a guide for the methods applied during the work. The results of the project are exposed for every step of the process. At the end, the main result of the risk management process is a list of the mitigation measures that must be included as safety specifications of the device. Both tools, HO and the FIS, have proofed to be suitable with the current regulations as well as being useful for the process. HO gave as output a list of the main hazards of the system and the FIS have been used in the verification step of the mitigation measures. Three mitigation measures to test with the FIS has been chosen. They deal with faults regarding a speed sensor, a potentiometer and the PWM signal controlling the motor. The mitigation measures have been verified for both PWM signal and the potentiometer faults. However ,a faulty condition that leads to an unsafe behaviour has been found for the speed sensor. Therefore, we demonstrated that the medical system under study has still many control measures to implement, verify or improve before it can be said that it is a safe medical device. / Under detta projekt, har en riskhantering av medicinsk utrustning som hanterar läkemedel gjorts. Målet med projektet är att utvärdera om utrustningen är säker enligt de svenska bestämmelserna. Komplexiteten med riskhanteringsprocessen, speciellt inom sjukvård, tillsammans med brist på standardiserade metoder för utveckling av dessa typer av processer leder till behov av nya verktyg för att minska tiden, resurserna och komplexiteten i detta skede av utvecklingen. Det är därför två verktyg som har använts och testats för att bedöma lämpligheten under de bestämmelserna för medicinsk utrustnings utvecklingsförhållande: Riskontologin (HO) och felinjektionssystem(FIS). HO är en ny metod som används för att identifiera alla faror och hot för ett identifierat system på ett strukturerat sätt. Å andra sidan är FIS en testteknik vars syfte är att hjälpa att studera systemet när det är under felaktiga förhållande. För att försäkra sig att de svenska bestämmelserna rörande medicinsk utrustning är uppfyllda, har EN ISO 1497 använts som en guide för de metoder som applicerats under projektet. Resultatet av projektet är synligt för varje steg av processen. Till slut, är det huvudsakliga resultatet av riskhanteringsprocessen en lista av de mildrande åtgärder som måste vara inkluderade som säkerhetsspecifikation av utrustningen. Båda verktyg, HO och FIS, har visat sig vara lämpliga med nuvarande bestämmelser och användbara för processen. HO gav oss, som data en lista med de huvudsakliga farorna av systemet och FIS användes i verifieringssteget av de mildrande åtgärder. Tre begränsningsåtgärder att testa med FIS har valts.De åtgärdar de fel för hastighetssensor, en potentiometer och PWM signalen som driver motorn. De begränsningsåtgärderna har verifierats för både PWM-signalenoch potentiometerfelen. Emellertid har ett felaktigt tillstånd som leder till ett osäkert beteende hittats. Därmed visade vi att det medicinska system som studeras fortfarande har många kontrollåtgärder för att genomföra, kontrollera eller förbättra innan det kan sägas att det är en säker medicinteknisk produkt.

In this study a structured light prototype device was evaluated for the possible use as a respiratory gating device in PET/CT. The device functions by measuring the movement in the vertical direction of the obtained 3D-surface of the chest and abdomen with the breathing.The aim of the thesis was to evaluate if and in what way a respiratory signal could be measured for patients undergoing a PET/CT examination. The system was verified against a second gating device, Sentinel by C-RAD, for 15 healthy test-persons. A high Pearson correlation coefficient between the two systems was measured indicating a similar performance in the measurement of the respiratory phase, while there were some differences in the measurement of the mean peak-to-peak amplitude between the systems. 42 patients were examined with the device at Akademiska Sjukhuset in order to test if it were possible to measure a respiration signal from the patients in the PET/CT. An useful respiratory signal was obtained for 41 patients. The size of the FOV is large enough to cover two bed-positions in the PET/CT to be respiratory gated. The prototype device has the potential to be used as a respiratory gating device with the possible benefits of having a fully contact-less system. However, improvements of the 3D-surface quality has to be made in order to ensure a constant position of the respiratory gating point, as well as further testing about the ability to measure the amplitude accurate. / I denna studie utvärderades en prototyp av en optisk gating-utrustning som använder sig av strukturerat mätljus för att mäta hur en 3D-yta av bröstet och buken av patienten rör sig vertikalt med andningen. Målet med examensarbetet var att utvärdera om och på vilket sätt en andningssignal kunde mätas för patienter som genomgår en PET/CT undersökning. Prototypen verifierades i tester där den jämfördes mot en annan redan existerande produkt för andningsgating, Sentinel från C-RAD där 15 friska testpersoner var med. Resultatet av testerna var en hög Pearson korrelationskoefficient mellan de två systemen vilket tyder på likvärdig översättning av testpersonernas andningsfas, medan det var skillnader i medelamplituden mellan mätningarna. 42 patienter undersöktes i en klinisk studie med prototyputrustningen på Akademiska Sjukhuset för att testa om det gick att mäta en andningssignal på patienterna när de genomgick en PET/CT undersökning. En användbar andningssignal gick att få fram för 41 av patienterna. Storleken på FOV var stor nog för att täcka de två säng positionerna som ska gateas. Prototypen har potential att användas som en andningsgating utrustning i PET/CT med de potentiella fördelarna att vara ett system helt utan patientkontakt. För att kunna använda systemet måste det däremot utföra förbättringar på kvaliteten på 3D-ytorna för att kunna säkerställa att punkten på ytan för gatingen kan hållas konstant. Dessutom behöver det ske mer utredningar kring utrustningens prestanda för att mäta amplituden.

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Ultraljud är en användbar teknik för att utföra undersökningar i realtid samtidigt som det ej utsätter patienter för joniserad strålning. Det finns en potential för ultraljud att fylla ett gap på dagens marknad inom medicinsk avbildning då den kan tillämpas i mindre format. Utgångspunkten för detta arbete var att se om det går att konstruera en miniultraljudstransducer i ett tillräckligt litet format så det enkelt kan appliceras på kroppen och på så sätt kunna utföra kontinuerliga mätningar vid områden av intresse. En omfattande genomsökning av liknande projekt och vad som finns på dagens marknad genomfördes. Resultatet av studien och marknadsanalysen var att det inte fanns liknande produkter på marknaden idag, utan mycket var fortfarande under ett utvecklingsstadie. Riktningen som valdes för projektet var att konstruera en piezoelektrisk transducer. Komponenter som ingår i en sådan konstruktion är ett backing layer, en piezoelektrisk kristall, ett matching layer och elektroder som genererar ström till kristallen. Ett problem som uppstod under arbetet var konstruktionens matching layer dels då den tjocklek som eftersträvs är så liten att de blir svårt att ta fram utan mekaniska hjälpmedel, dels då den inte kunde förinstalleras på det piezoelektriska elementet. Miniultraljudstransducern testades vid två mättillfällen. Första mättillfället resulterade i signal som var svår att tyda. Det antas bero på att totalreflektion uppstått samt att instrumenten ej var korrekt inställda. Vid mättillfälle två, där samtliga fel från första mätningen hade åtgärdats så kunde den förväntade signalen avläsas. / Ultrasound is a medical imaging method which is done in real time without the drawback of exposing the patients for ionizing radiation. This method has great potential of filling a gap that exists withing the medical imaging market due to its possibility of being greatly reduced in size. The starting point for this work was to see if it would be possible to create a mini ultrasound transducer which is small enough for it to easily be connected to the body where it can perform continuous measurements at areas of interest. An extensive literature study of similar projects and market analysis was carried out. This resulted in that there were no similar products on the market, due to it still being under development and researched. The direction which was chosen was to design a piezoelectric transducer. Components included in such a construction consists of a backing layer, piezoelectric crystals, matching layer and electrodes which will supply the crystal with current. A problem that arose during the work was constructions matching bearings partly because the thickness sought is so small that they become difficult to produce without mechanical aids, partly because it could not be pre-installed on the piezoelectric element.The mini ultrasound transducer was tested on two measuring occasions. The first measurement opportunity resulted in a signal that was difficult to decipher. It is assumed that this is due to the fact that total reflection occurred since the construction was not completely optimally designed, so there was room for air between the crystal and the matching layer and that the instruments were not set correctly. At measurement occasion two, where all errors from the first measurement had been rectified the expected signal could be read.

No description available.

Thesis (MCur. (Faculty of Health Sciences))--University of Pretoria, 2005. / Summary in English. Includes bibliographical references.