Verification & Validation Report

Group 23: Bicong Li, Demi Shen, Hehaoyu Zou

Project: Myocardial temperature sensor

I. Verification Plan

1. Accuracy

Design specification: 0.2

Accuracy can be measured as the difference between well-known temperature

benchmarks and the actual reading of those benchmarks on this temperature monitor. A most

persuasive verification would consist of measurements at the two extremes of the range along

with another taken at a mid point to show the consistency of performance. In our case, however,

it is hard to find accessible benchmarks at the midpoint. In fact, the only reliable benchmarks

accessible to us are the freezing point and the boiling point of water. We therefore adapt our

plan of verification to what we have on hand. We will stick the thermistor probe into a bowl of ice

and see if the temperature reading is off the standard value by less than 0.2, followed by

another trial of the same fashion in a pot of boiling water. Since the thermistor is capable of a

much larger range than that for surgical needs, a verification of accuracy at 0 and 100 would

suffice to ensure its accuracy performance at a smaller range.

Equipment needed: boiling water, ice

2. Range

Design specification: 0~40

Thermistors T-R curve can be described in equations. The most commonly used
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form is the Steinhart--Hart Equation: = + () + (())3 , where

T = temperature (K)

R = resistance at T ()

A, B, and C = SteinhartHart Coefficients

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 We will connect the thermistor in the Arduino Circuit and measure three voltage-

resistance combinations for obtaining the numerical values of A, B, and C. Because our

intended operating range of is 0~40. One point will be selected at the lower end of the

operating range, 0. One point at 50 will be selected so that the tested temperature range is

wider than intended range. Another point will be selected at 20, at the center of intended

temperature range. We know that measurements will not be completely accurate, so artificial

errors will be inserted into the data to result in temperature errors of 0.2 with alternating signs

at the four measured points. Multiple measurements will be taken at each point and averaged to

reduce noise. We will then insert the three pairs of resistance values and temperatures to the

Steinhart-Hart equation to form three equations and solve using matrix. Then the thermistor

probe will be inserted into a 40 water bath and resistance will be measured, which will be

compared with the resistance calculated using the Steinhart-Hart equation. If the error is within

0.2, then the operating range is verified.

Fig 1. Typical Thermistor T-R curve

Equipment needed: multimeter, water bath

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3. Wireless transmission distance

Design specification: 6-10m

We will test the wireless transmission distance after successfully implementing the

bluetooth arduino model with a receiving computer. One person will hold the bluetooth

transmitting device at different distances from the computer. If the computer can successfully

receive the transmitted signal and display the inputted temperature at a separation distance 6-

10m from the bluetooth transmitter, the distance specification is met.

Equipment needed: receiving computer

4. Needle Stability

Design specification: the needle is expected to stand on its own without falling off during surgery

With the needle inserted into a piece of animal tissue that resembles the target human

myocardium, we will push the tissue from side to side, simulating the surgeons maneuvers

during Cox-maze procedure. If the needle is able to withstand the most violent shaking on its

own, then the stability specification will be met.

Equipment needed: animal tissue

5. Automatic Alarm Triggering

Design specification: customizable desired monitoring range

The aim is to verify the effective connection between alarm and program that allows user

to input the desired monitoring range, so temperature will be inputted directly in the program

instead of measured with the thermistor probe. We will test 10 common ranges from 30 to 40

with the smallest safe range to be 1. We will also test the reaction time of the system to

make sure that the alarm automatically goes off once the temperature falls outside of the safe

range.

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6. Alarming

Design specification: consecutive until back to safe range

Verification of this feature can be combined with the previous one. After the temperature

falls outside of the safe range, we will test if the alarm sound stays on until we mute it in the

program or the temperature falls back to safe range.

7.Needle Length

Design specification: 8mm/15mm/30mm

Needle length can be measured by a ruler.

Equipment needed: ruler

II. Backup Plans if Prototype Fails Testing

1. Major risks

Accuracy and range are not likely to fail because of the industrial standard of the

thermistors

Wireless transmission distance: background noise in operation room may interfere with

our signal resolution

Needle length and needle stability are not likely to fail because needles were purchased

according to the currently most popular myocardial temperature sensor in the market. As

a user of that product, our client informed us that the needle head is very stable once

inserted into human hearts and had never fallen off.

2. Mitigation plans

If the signal resolution turns out to be so disappointing that the guaranteed accuracy of

0.2 is significantly reduced, we would implement an additional signal modulation at the

emitting end. We will try out the classic modulation techniques one by one, from the easiest to

the hardest, in the order of simple filters, QPSK, noise quantization, and delta-sigma noise

shaping, until whichever one or combination of them brings about satisfying SNR.

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III. Validation Plan

Though we aimed high for a product usable and helpful in the Cox-Maze procedures, the

possibility that a surgery of this kind happens to take place during our time window of validation

is very dim. More importantly, surgeons are very unlikely to be persuaded to replace the

conventional ones that they have been using for years with a new one that is not FDA approved.

As a result, we will operate the assembled product without involving actual human heart.

Since this product is intended to be used in operating rooms, we plan to validate our

product in a vacant operating room at Barnes-Jewish Hospital if we get permission from our

client. We will set up the components of our product at different locations in the room according

to their intended use. Temperature monitor will be attached to the monitor they currently have in

the operating room, which displays 3D image of the heart, so that physicians can conveniently

monitor the heart structure and temperature at the same time. Alarm will be installed next to the

computer, so that the monitoring range can be easily adjusted using the program we provide.

Before we begin the validation process, we will turn on every equipment in the room that

will be used during the actual Cox-Maze IV procedure to mimic background noise and ensure

that our signal resolution is up to standard in its actual use. First, we will set a monitoring range

desired by our client. Then we will insert the temperature probe with the thermistor enclosed into

a piece of animal tissue and monitor the temperature while we mimic operation maneuvers.

Next, we will perfuse the animal tissue with cold water until the alarm goes off. Lastly, we will

reset the alarm, set up a new monitoring range, and run this simulation again.