1. Ergonomic Housing improvements to Personal Smoke Monitoring Device Team: Evan Wozniak Sarah Kostuk Christina Smith Aaron Prahst Multidisciplinary Senior Design Systems Level Design Review

2. Background Device measures: – Puff volume – Volume drawn into lungs

3. Purpose Current cigarette testing may not reflect actual smoker puff profiles. The personal monitoring device will be used as part of a clinical study to gather information on real smoker puff profiles.

4. History P10054 Produced Proof of concept P10057 Improved upon Proof of concept FSI Developed proof of concept further and produced a functional first generation Prototype P12056 Will take the First Generation Prototype and improve on the ergonomics of the device including moving the pressure sensor into the hand piece. A wire will be used to transmit data rather than the current tubes. This project will also allow room in this hand piece for wireless components. Generation Three Will integrate wireless components into system.

5. Customer Needs 1.Cigarette holder does not alter the smoking behavior or manner in which the smoker smokes the cigarette. 2.Cigarette holder is ergonomic. For example it is lightweight and feels like holding a cigarette. 3.Cigarette holder will support the cigarette independent of the user 4.Cigarette holder will not hinder the act of lighting the cigarette. 5.Cigarette holder includes a flow path with and orifice plate to measure flow rate. 6.Cigarette holder encompasses the pressure sensor for flow rate measurements. See Appendix A of Preread.

6. Customer Needs 7.Cigarette holder has room for all the wireless electronic components needed to record and transmit the signal to the base unit and support any additional desired indicator lights. 8.Cigarette holder transmits pressure signal by wire to the base unit or an external fixture for testing. 9.Cigarette holder can handle a wide range of cigarettes including electronic cigarettes. 10.Cigarette holder and base unit are easy to maintain by the user. For example there is an easy way to store the holder to avoid loss. There is a comfortable way to attach the base unit to the subject 11.Base unit housing size is minimal yet has room for all wireless components. Preferably the size is no bigger than a cellphone 12.The final design includes ergonomic considerations, and potentially an improved solution for the chest bands to enhance wearability. See Appendix A of Preread.

7. Risks 1.Lead time on Pressure sensor causes delays on analysis for decision 2.Requirements are too large for ergonomic hand hold 3.Might not have means to survey a "powerful" sample size 4.Smoker does not want to use the product See Appendix B of Preread.

8. Risks 5.Rapid prototyping does not allow for accurate tolerances on orifice plate 6.Design hinders smoker ability to cover/ not cover vent holes 7.Not all plastic is FDA approved 8.Smoker does not hold ergonomic hand hold the way it was intended 9.Handhold is too heavy and breaks the cigarette See Appendix B of Preread.

9. Overview Decomposition See Appendix C of Preread.

10. P12056 Decomposition See Appendix D of Preread.

11. Benchmarking Current Prototype

13. Existing Pressure Sensor Specifications Measurement Range – 0-2” H2O Differential Pressure Resolution – Typ. 0.1% of Full-Scale Benchmarking Current Prototype

14. Benchmarking Existing Smoke Monitoring Devices CReSS Pocket by Borgwaldt Mobile SPA/M by Sodim

15. FSI Software Flowchart Benchmarking Current Prototype See Appendix E of Preread.

16. Benchmarking Results: Previous project 9 people were surveyed Avg. Age: 23.11yrs (Std. Dev 3.58 years) 8 Males, 1 Female Answer questions on scale 1-5 (1= BEST, 5=Worst) Questions regarding comfort of; hand piece, chest belt, and belt pack Results were inconclusive

17. Survey Plan: – Usability of current plan Survey data Actual device data – Calibrate sensor – Calibrate chest band Survey can be seen in appendix F of Preread Benchmarking Current Prototype

18. Benchmarking Marking Sample Size One way to prove that the new design is an improvement of the current design is to do an hypothesis test to show a statistically significant difference The original hypothesis is that the mean (µ) of the survey response of original product is “=“ the mean of the survey response of the new product The alternative hypothesis (what we want to prove) is that the mean (µ) of the survey response of original product is “≠ “ the mean of the survey response of the new product H 0 : µ 0 = µ a H A : µ 0 ≠ µ a

19. Yield a standard deviation of 1.3 (from results of previous project’s survey) Calculate the sample size needed to prove a statistically significant difference of 1.0 or 0.5 With an alpha (α) = 0.5 And a Power (confidence level) of 90%, 95%, or 99% Benchmarking Sample Size Alpha = 0.05 Assumed std dev= 1.3 Factors: 1 Number of levels: 2 Maximum Sample Target Actual Difference Size Power Power 1.0 37 0.90 0.903914 1.0 45 0.95 0.950397 1.0 64 0.99 0.990815 0.5 144 0.90 0.901930 0.5 177 0.95 0.950364 0.5 250 0.99 0.990146

20. Rapid Prototyping Concerns Lead time on Prototyping Strength of Parts – Strength of multiple part connections FDA approval of plastic for oral use Tolerances

21. Professor Cormier’s Input RIT’s equipment is better for larger parts Fastline is a company that does FDA approved rapid prototying Rapid prototyping is feasible outside RIT – Definitely cheaper that injection molding – Cost is dependent on material height

22. Input from FSI Needed wireless components – Physical room needed to be allotted for wireless components Are our prototypes sizes appropriate or do they need to be modified Do we design and fabricate the belt pack and if so what are the internal dimensions that FSI needs – If we are not fabricating it is it a purchased part?

23. FSI’s Input Rechargeable battery would be smaller than supplied dimensions 2 week life cycle with battery recommended Belt pack can be made smaller – Half the size in the x and y direction – Use mockup from previous group Chest belt: – How to make more user friendly Rather than spend a lot of money on a orifice plate that is exact, each mouth piece can be calibrated in a lab setting before use

24. FSI Input Could split board in half if needed.

25. Hand Piece Concepts 12 3 4

26. 5 6 7 8

27. 9 10 11 12

28. Hand Piece Concepts 13 14 15 16

29. Hand Piece Concepts 17 18 19 20

30. Hand Piece Concepts 21 22 23

31. Hand Piece Selection Brainstorm hand piece concepts (15 to 20)Produce prototypes of conceptsConduct Survey using prototypesAnalyze Survey Create scoring matrix to narrow down concepts to final selections Create 5 prototypes with full scale space claimConduct Survey In Ergonomics ClassNarrow Down to Three results

32. Input from Professor Marshal Have no more than 5 options for final survey Rigid finger holds are frowned upon for ergonomics Don’t need smokers to narrow down hand pieces Look at similar productions like a hookah mouthpiece.

33. A survey will be conducted where smokers are asked to simulate smoking using the 24 prototypes. They will be asked three questions about each object. The survey questions can be found in appendix G of the preread. Hand Piece Survey Plans

34. Handpiece Survey Plan In order to score the handpieces the mean survey response must be proven the be the neutral response of 3 This can be proven statistically using an hypothesis test ( 1 sample Z test) The original hypothesis is that the mean (µ) of the survey response of the design concept is “=“ 3 The alternative hypothesis (what we want to prove) is that the mean (µ) of the survey response of the design concept is “>” or “<“3 (this will be 2 separate tests) H 0 : µ 0 = 3 H A : µ a > 3 or µ a < 3

35. Yield a standard deviation of 1.3 (from results of previous project’s survey) Calculate the sample size needed to prove a statistically significant difference of 1.0 or 0.5 ( -1.0 or -0.5; alternative hypothesis of < 3) With an alpha (α) = 0.5 And a Power (confidence level) of 90%, 95%, or 99% Testing mean = null (versus > null) Calculating power for mean = null + Δ Alpha = 0.05 Assumed std dev = 1.3 Sample Target Actual Difference Size Power Power 1.0 15 0.90 0.908958 1.0 19 0.95 0.956195 1.0 27 0.99 0.990668 0.5 58 0.90 0.900480 0.5 74 0.95 0.951917 0.5 107 0.99 0.990193 Hand Piece Survey Plans

36. Pressure Sensor Selection Process See Appendix H of Preread. Please see next slide for graph with losses using discharge coefficient.

37. Pressure Sensor Selection Process

38. Criteria for picking a differential pressure sensor: – It should have an operating pressure of at least 0 to 2.0” H2O – It should be small enough to fit inside the hand piece – It should be able to run off of a future battery inside hand piece

39. Sources http://www.servoflo.com/downloads/item/mb-lps1- 01-r-datasheet.html http://www.servoflo.com/downloads/item/mb-lps1- 01-r-datasheet.html http://edge.rit.edu/content/P10057/public/Home http://edge.rit.edu/content/P10054/public/Home Incropera, Frank P., David P. Dewitt, Theodore L. Bergman, and Adrienne S. Lavine. Fundamentals of Heat and Mass Transfer. 6th ed. Wiley, 2007. Print. The team would also like to thank Dr. Robinson and FSI for their support in this project.

40. Thank you for your time Questions/Comments