device validation
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Author(s):  
Ahmet Sanverdi ◽  
Eda Nur Karagoz ◽  
Mehmet Lutfi Yola

The emergency health service is for all interventions that are made up of people who have received special education in their field, who work together in order to provide the best emergency response to the sick and injured in the shortest time possible in line with the possibilities available. In this context, although the emergency health service provided during the pandemic process requires the implementation of special procedures for healthcare professionals, it is important in the validation of the biomedical devices used during the provision of this service. Especially the fact that this process was a disaster that took place in an unexpected time period caused everyone to be caught unprepared and this situation caused the current workload of healthcare workers to increase even more. In this study, we conducted a literature search to shed light on the problems experienced by 112 emergency healthcare professionals during the pandemic period and how the validation of the biomedical devices used by these personnel in the ambulance should be. The type of research is descriptive research. The Covid-19 pandemic was accepted as a case and the literature was reviewed, with this case being the focus. During the literature search, up-to-date keywords such as "emergency health service, Covid-19, disaster preparedness, emergency aid unit employees, biomedical device technologies", which are also mentioned in the keywords, were scanned. Care was taken to ensure that the studies included in the review section were up to date and in accordance with the academic guide. In addition, due to the limitation of resources in the validation section of the research, assistance was received from the relevant legislation and expert medical company engineers and from the active staff in the field of healthcare professionals' problems. As a result of this research, we have reached the conclusion that legal regulations should be made regarding the problems experienced by healthcare professionals due to the pandemic and that existing standards related to device validation should be updated after the pandemic.


Author(s):  
Asri Arbie ◽  
Puput Salsabina F. Satri ◽  
Dewa Gede Eka Setiawan ◽  
Abd. Wahidin Nuayi ◽  
Trisnawaty Junus Buhungo

ABSTRAKPenelitian ini merupakan penelitian pengembangan perangkat pembelajaran yang bertujuan untuk menghasilkan perangkat pembelajaran yang berkualitas. Rumusan masalah penelitian ini adalah bagaimana kualitas perangkat pembelajaran yang dikembangkan dengan model pembelajaran Team Based Learning. Perangkat pembelajaran ini dikembangan dengan menggunakan model pengembangan Plomp. Teknik pengumpulan data yaitu dengan validitas melalui validasi perangkat, kepraktisan melalui observasi keterlaksanaan, angket respon guru dan peserta peserta didik. Dari penelitian ini diperoleh hasil: (1) perangkat yang dikembangkan valid melalui uji validitas konstruk dengan rata-rata persentase validitas untuk silabus sebesar 98,33% dengan kategori valid, RPP sebesar 78,48% termasuk kategori valid dengan revisi kecil, bahan ajar sebesar 79,68% termasuk kategori valid dengan revisi kecil, dan LKPD sebesar 76,04% yang termasuk dalam kategori valid dengan revisi kecil; (2) perangkat yang dikembangkan praktis ditunjukkan oleh rata-rata presentase keterlaksanaan pembelajaran sebesar 92,26% kategori sangat baik, kemudian respon guru terhadap perangkat pembelajaran yang dikembangkan sebesar 99,39% kategori sangat baik serta respon peserta didik terhadap proses pembelajaran menggunakan perangkat yang dikembangkan sebesar 82,66% kategori baik. Kata kunci: Perangkat pembelajaran; Team Based Learning; Problem Solving; Plomp. ABSTRACTThis research is research and development of learning tools that aim to produce quality learning tools. The formulation of the research problem is how the quality of learning tools developed with the Team-Based Learning learning model is. This learning device was developed using the Plomp development model. Data collection techniques are valid through device validation, practicality through implementation observation, teacher and student response questionnaires. From this study obtained results: (1) devices developed valid through construct validity tests with an average percentage validity for syllabus of 98.33% with valid categories, RPP of 78.48% including valid categories with small revisions, teaching materials of 79.68% including valid categories with minor revisions, and LKPD of 76.04% which fall into valid categories with minor revisions; (2) devices developed practically indicated by an average percentage of learning implementation of 92.26% excellent category, then teacher response to learning devices developed by 99.39% excellent category and learners' response to the learning process using developed devices by 82.66% good category. Keywords: Learning tools; Team-Based Learning; Problem Solving; Plomp.


2021 ◽  
Vol 7 (2) ◽  
pp. 108-119
Author(s):  
Aditya Kurniawan ◽  
Kholilatul Wardani ◽  
Ilham Penta

Adanya pandemi Covid-19 membuat dibatasinya aktivitas pembelajaran dalam bentuk pertemuan fisik. Kondisi tersebut mempengaruhi pembelajaran pada sekolah vokasi, termasuk politeknik, yang aktivitas praktiknya memerlukan pertemuan tatap muka. Agar kegiatan praktik dapat tetap  dilaksanakan dengan baik, perlu dikembangkan metode praktikum jarak jauh yang memanfaatkan teknologi. Penelitian ini mengembangkan alat yang memadukan teknologi Internet of Things dan kamera berbasis Internet Protocol yang disebut Smart Helmet First Person View (Set-fpv). Perangkat Set-fpv yang digunakan dalam penelitian ini terdiri dari sebuah helm yang dimodifikasi dengan IP cam nirkabel, dan headphone Bluetooth yang tersambung ke Smartphone atau komputer praktikum. Penelitian dilakukan selama satu semester di Politeknik Kota Malang, Program Studi Teknik Mekatronika. Responden penelitian sebanyak 29 mahasiswa konsentrasi Otomasi Industri, dan 24 mahasiswa Konsentrasi Alat Berat yang mengikuti mata kuliah Elektro Pneumatik. Sebelum dan sesudah mengikuti praktik seluruh responden diberikan soal pretest dan posttest secara daring, kemudian hasil test antara kelompok kontrol yang menggunakan perangkat lunak simulasi FluidSim dengan kelompok eksperimen yang menggunakan Set-fpv diperbandingkan nilai reratanya. Penggunaan bandwidth tertinggi pada perangkat Set-fpv sebesar 102,43 Mbps untuk melakukan streaming selama satu semester dengan resolusi 1080p terhadap delapan perangkat. Validasi perangkat dilakukan oleh ahli teknologi dengan indikator tujuh poin. Berdasarkan penilaian ahli teknologi nilai rerata penerimaan produk sebesar 88,5 persen yang tergolong baik, sedangkan hasil penilaian ahli materi dan ahli media sebesar 82,6 persen dengan penerimaan tergolong baik. Hasil penelitian menunjukan terjadi kenaikan nilai posttest dari pretest yaitu dengan peningakatan sebesar 9,59% dengan nilai rerata sebesar 8,1 terhadap kelompok eksperimen, sedangkan pada kelompok kontrol sebesar 7,9. The Covid-19 pandemic has restricted learning activities in the form of physical meetings. These conditions affect learning experience in vocational schools, including polytechnics. In order for the practical course to be carried out properly, it is necessary to develop a remote practical course method that utilizes technology. This research develops a tool that combines Internet of Things technology and Internet Protocol-based camera called Set-fpv (Smart Helmet First Person View). The Set-fpv device used in this study consisted of a modified helmet with a wireless IP cam, and Bluetooth headphones connected to a Smartphone or a computer. The research was conducted for one semester at the Politeknik Kota Malang, Mechatronic Engineering Program. The research respondents were 29 students of Industrial Automation concentration, and 24 students of Heavy Equipment Concentration who took the Electrical Pneumatics course. Before and after participating in the practical course, all respondents were given online pretest and posttest questions, the test results between the control group using the FluidSim simulation software and the experimental group using Set-fpv were compared with the mean values. The highest bandwidth usage on Set-fpv devices is 102.43 Mbps to stream for one semester with 1080p resolution on eight devices. Device validation is carried out by experts based on seven-point indicators. The results shows that (1) the validation results from tech experts, materials experts, and media experts with seven indicator points, reached 88.5% of validity by tech experts meaning a good acceptance conclusions and 82.6% by material and media experts meaning a good acceptance conclusions. (2) The highest total internet bandwidth usage (while using 1080p streaming) and 8 IoT smart switch devices is 102.43 Mbyte for 1 semester, and (3) Grades that are taken from a homogeneous student groups shows an increased in their practical performances. The results showed an increase of 9.59% with the the pretest value of 8.1 to the experimental group, while in the control group it was 7.9.


2021 ◽  
Vol 10 (4) ◽  
Author(s):  
Wasilatul Murtafiah ◽  
Ika Krisdiana ◽  
Titin Masfingatin ◽  
Vera Dewi Susanti ◽  
Reza Kusuma Setyansah

This study aims to develop an e-learning tool based on video presentations to enhances attitudes, skills and pedagogical knowledges of prospective teacher students during the Covid-19 pandemic. This type of research is Research and Design (R & D) using the Plomp development model, which consists of 3 stages: a preliminary study, design, and assessment. Data collection was carried out through observation, device validation, distribution of response questionnaires, and assessment of student learning outcomes. The results of the data analysis show that at the preliminary study stage, it was found that there were still no devices that supported learning during the Covid-19 pandemic. At the stage of design was designed, including RPS, LMS Settings, and Video Presentations. At the assessment stage, it was found that all the tools developed had valid criteria, students gave a positive response to the small and broad trials respectively of 97.68%; 98.32% so that the tools developed were included in practical criteria. The assessment of learning outcomes in the aspects of attitudes, skills, and knowledge had average completeness on the small and broad trials respectively of 82.92%; 86.99% so that the equipment used was included in the effective criteria. Thus the device developed can be said to be feasible because it meets the criteria of validity, practicality, and effectiveness. The development of e-learning based on video presentations can be used to enhance attitudes, skills, and pedagogical knowledge of prospective mathematics teacher students.


2021 ◽  
Vol 5 (S1) ◽  
pp. 201-213
Author(s):  
Khamdun Khamdun ◽  
Suparmi Suparmi ◽  
Maridi Maridi ◽  
Ani Rusilowati

This study aims to produce a Vocational High School Natural Science learning tool to improve project-based soft skills that are valid, practical and effective in developing student soft skills. The method used is Research and Development (R&D) referring to the 4-D model suggested by Thiagarajan with the stages namely define, design, develop, and disseminate. The population in this study were students of class XI in the machine technology group of SMK Negeri 2 Kudus in the academic year 2019/2020 (N = 61). The sample in the study were students of class XI with the expertise of machine technology (n = 34) who were taken by random sampling technique. The data were collected using the device validation sheet, the implementation observation sheet, the teacher's response questionnaire and the student response questionnaire. Data about the validity and practicality of the device in developing learning tools to improve project-based soft skills were analyzed using the right-hand t-test with ? of 0.05. 


Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1232
Author(s):  
David O. Rodriguez-Duarte ◽  
Jorge A. Tobon Vasquez ◽  
Rosa Scapaticci ◽  
Giovanna Turvani ◽  
Marta Cavagnaro ◽  
...  

This paper experimentally validates the capability of a microwave prototype device to localize hemorrhages and ischemias within the brain as well as proposes an innovative calibration technique based on the measured data. In the reported experiments, a 3-D human-like head phantom is considered, where the brain is represented either with a homogeneous liquid mimicking brain dielectric properties or with ex vivo calf brains. The microwave imaging (MWI) system works at 1 GHz, and it is realized with a low-complexity architecture formed by an array of twenty-four printed monopole antennas. Each antenna is embedded into the “brick” of a semi-flexible dielectric matching medium, and it is positioned conformal to the head upper part. The imaging algorithm exploits a differential approach and provides 3-D images of the brain region. It employs the singular value decomposition of the discretized scattering operator obtained via accurate numerical models. The MWI system analysis shows promising reconstruction results and extends the device validation.


2021 ◽  
Vol 12 (3) ◽  
pp. 1729-1739
Author(s):  
Chinta Sharvani ◽  
Vikas Jain ◽  
Hemanth Kumar ◽  
Gangadharappa H V

Computer Systems Validation is a method used to ensure information is generated by a computer-based system that satisfies a set of specified requirements. Compliance with computerized systems is becoming increasingly relevant in the pharmaceutical industry as computer system validations have many benefits, such as enhancing quality control, reducing other validation costs and time, improving compliance with GMP 21 CFR Part 11 Regulation which affects the quality, health, identification or effectiveness of products subject to the GMP Regulations. Both the European Medicines Agency of Europe along with the Food & Drug Administration of the USA has developed CSV practice guidelines. An overview of relevant documents which fulfil the computer system validation along with its best practices implemented is presented below. Official requirements and standards of the USA, Europe, and Switzerland are taken as the main focus. The taken basic GMP guidelines' like Gamp, AVP and PDA implies the same principles and theories. They explain majorly about what to do view point of validation, whereas GAMP describes how to do validation. We strive to define the computer device validation needs of equipment conducted from a pharmaceutical industry perspective. The categorization of a computer system into various frameworks or categories gives the flexible approach for the validation of complex as well as simple computerized systems. The present review article discusses the implementation and various good practices of the pharmaceutical industry to maintain computer system validation. Implementing various good computer system validation activities reduces the re-work and always maintains the quality standards as per the user requirements; as a result of which the future trends will notice merging of various new implemented terminology and techniques as a common practice in mixed sectors.


10.2196/25371 ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. e25371
Author(s):  
Kent Arnold Lorenz ◽  
Shlomo Yeshurun ◽  
Richard Aziz ◽  
Julissa Ortiz-Delatorre ◽  
James Robert Bagley ◽  
...  

Background Metabolic carts measure the carbon dioxide (CO2) produced and oxygen consumed by an individual when breathing to assess metabolic fuel usage (carbohydrates versus fats). However, these systems are expensive, time-consuming, and only available in health care laboratory settings. A small handheld device capable of determining metabolic fuel usage via CO2 from exhaled air has been developed. Objective The aim of this study is to evaluate the validity of a novel handheld device (Lumen) for measuring metabolic fuel utilization in healthy young adults. Methods Metabolic fuel usage was assessed in healthy participants (n=33; mean age 23.1 years, SD 3.9 years) via respiratory exchange ratio (RER) values obtained from a metabolic cart as well as % CO2 from the Lumen device. Measurements were performed at rest in two conditions: fasting, and after consuming 150 grams of glucose, in order to determine changes in metabolic fuel usage. Reduced major axis regression and simple linear regression were performed to test for agreement between RER and Lumen % CO2. Results Both RER and Lumen % CO2 significantly increased after glucose intake (P<.001 for both) compared with fasting conditions, by 0.089 and 0.28, respectively. Regression analyses revealed an agreement between the two measurements (F1,63=18.54; P<.001). Conclusions This study shows the validity of Lumen for detecting changes in metabolic fuel utilization in a comparable manner with a laboratory standard metabolic cart, providing the ability for real-time metabolic information for users under any circumstances.


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