Medical Device Evaluation

BE-3405 – Medical Device Evaluation

Statistical Evaluation of

Multi-function Defibrillator Electrode Bench Test Results

(due on or before 10/28/18)

Objectives:

To properly analyze and compare defibrillator electrode performance measures from three different manufacturers.
To evaluate electrode performance against prevailing IEC standards.
To reinforce the use of the appropriate statistical tools and Minitab in the analysis of experimental data.

Requirements:

Using the appropriate statistical tests and accompanying graphics, analyze the following measures of face-to-face electrode impedance in response to actual defibrillator-delivered current pulses. Specifically, answer the following:

Are there any significant differences in impedance between manufacturers?
- Include some additional research on the clinical and technical implications of impedance.
Are there any significant differences in impedance between pre- and post- pacing?
- Research and describe the effects that extended pacing could have on electrode performance.
Are these data in agreement and compliance with IEC 60601-2-4, section 201.108.1.2? Show how you can properly compare, present, and explain.

AC Large Signal Impedance (ohms)

[as determined and described in IEC 60601-2-4, ed. 3.0, 2010-12]

AED Pads

Covidean

Zoll

Pre-pacing

Post-pacing

Pre-pacing

Post-pacing

Pre-pacing

Post-pacing

1.8
1.7
1.9
2.0
3.0
2.1
2.1
1.4
1.3
2.0
1.2
1.2

3.1
1.8
3.5
3.6
4.0
3.7
3.6
2.7
2.6
3.4
2.2
2.2

2.4

2.1

3.2

3.1

2.9

2.6

3.5

3.1

2.9

2.8

3.0

2.7

3.6

3.0

3.9

4.0

4.1

3.2

5.1

4.8

4.7

3.7

4.3

3.5

2.9

2.8

2.9

3.0

2.7

2.8

2.5

2.6

3.1

3.0

2.8

4.1

4.0

3.9

4.1

4.3

3.9

3.2

3.3

4.5

4.4

4.1

2. Hijacking Catastrophe

Hijacking Catastrophe

Watch Hijacking Catastrophe https://www.youtube.com/watch?v=1gjulR68dIs
AND write 2 pages Argumentative essay- What do you think about it? What is the strengths and weakness for this document?