Mid-Term EXAMINATION WINTER 2019 DURATION: 1.5 HOURS Department Name & Course Number : No. Of Students: 49 Systems and Computer Engineering SYSC4202 Course Instructor: Timothy Zakutney, MHSc, PEng, CCE AUTHORIZED MEMORANDA NONE Students MUST count the number of pages in this examination question paper before beginning to write, and report any discrepancy to a proctor. This question paper has 1 pages + cover page = _2_ pages in all. This examination question paper MAY NOT be taken from the examination room. In addition to this question paper, students require: an examination booklet : Scantron Sheet: Name: Student Number: Question 1: Question 2: Question 3: Question 4: Question 5: Question 6: Question 7: Question 8: Question 9: Question 10: Bonus : ______ / 2 ______ / 2 ______ / 8 ______ / 3 ______ / 8 ______ / 8 ______ / 8 ______ / 6 ______ / 4 ______ / 4 ______ / 2 Total: _______/ 53 Carleton University Department of Systems and Computer Engineering SYSC 4202A Clinical Engineering, Winter 2018/2019 Mid-Term Examination Tuesday, February 12, 2019, 16:05 – 17:35 1. Define a Clinical Engineer. (2) 2. Define a Medical Device. (2) 3. With respect to the Canada Health Act: a. List and describe the principles of the Act (5) b. Discuss the relationship between the federal and provincial government as it relates to healthcare for Canadians. (3) 4. A healthcare organization has decided to purchase new manual defibrillators to replace older technology used for treatment of patients. Describe the first task to be completed and how would you perform this? (3) 5. List and describe the various classification levels of medical devices as determined by Health Canada with examples. (8) 6. In Canadian hospitals, list and describe the various financial sources that are used fund medical devices and technology. (8) 7. List and discuss 4 aspects of “safety and effectiveness” that a manufacturer must show in the context of obtaining a medical device license for their product. (8) 8. A healthcare organization has decided to purchase new manual defibrillators for the Operating Room. a. Describe the first task to be completed and how to perform it? (4) b. Given the limited budget for new and replacement medical equipment, explain what aspects of this project that would increase its importance during the selection prioritization process? (2) 9. Describe what service philosophies a Clinical Engineering should strive for. (4) 10. You are a Director of a Clinical Engineering department and have been asked to prepare a budget for servicing a large scale hospital. a. In a zero based budget model describe the components needed to be included in your budget preparation. (2) b. For an all-encompassing budget model, describe what additional components need to be included in your departmental budget. (2) BONUS: Who is considered the father of health care in Canada? (2) 53