3/31/2017 Mech/Electricalexperiment|Report

Project created on 27.10.2016 23:23.

Report for project Mech/Electrical experiment

Task created on 28.03.2017 16:06.

No due date
Thermistor Arduino Connection
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[ temperature_thermistor_bb.png ] Uploaded by Bicong Li on 28.03.2017 16:56.

Circuit board [ IMG_3537.JPG ] Uploaded by Bicong Li on 28.03.2017 16:29.

* Needle Assembly Created by Demi Shen on 31.03.2017 03:35.

Two long wires are welded into the two ends of the thermistor. We used the thermistor with two ends
enclosed with plastic tubes for insulation of signal. The thermistor was then inserted into a hollow
needle. We tried several needle diameter sizes, and can only t the thermistor (with plastic tube
covering) into the biggest needle size we bought (12 mm diameter). The metal needle was also cut
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down to 30 mm to match one of our design speci cs. Dierent needle lengths will be required for our
design speci cations, however, for now, we decide to experiment with the longest length (30mm) as it
is much easier to handle during experiments. As for anchoring the thermistor head inside the needle,
we used hot glue gun to glue the non-tip end (the back end) to make sure the structure stays intact.

Task created on 28.03.2017 15:58.

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Thermistor Arduino Codes (Revised)
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* Converting from resistance to temperature Created by Bicong Li on 28.03.2017 15:59.

// which analog pin to connect

de ne THERMISTORPIN A0
// resistance at 25 degrees C

de ne THERMISTORNOMINAL 10000
// temp. for nominal resistance (almost always 25 C)

de ne TEMPERATURENOMINAL 25
// how many samples to take and average, more takes longer // but is more 'smooth'

de ne NUMSAMPLES 5
// The beta coecient of the thermistor (usually 3000-4000)

de ne BCOEFFICIENT 3450
// the value of the 'other' resistor

de ne SERIESRESISTOR 10000
int samples[NUMSAMPLES];

void setup(void) { Serial.begin(9600); analogReference(EXTERNAL); }

void loop(void) { uint8_t i; oat average;

// take N samples in a row, with a slight delay for (i=0; i< NUMSAMPLES; i++) { samples[i] =
analogRead(THERMISTORPIN); delay(10); }

// average all the samples out average = 0; for (i=0; i< NUMSAMPLES; i++) { average += samples[i]; }
average /= NUMSAMPLES;

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Serial.print("Average analog reading "); Serial.println(average);

// convert the value to resistance average = 1023 / average - 1; average = SERIESRESISTOR / average;
Serial.print("Thermistor resistance "); Serial.println(average);

oat steinhart; steinhart = average / THERMISTORNOMINAL; // (R/Ro) steinhart = log(steinhart); //

ln(R/Ro) steinhart /= BCOEFFICIENT; // 1/B * ln(R/Ro) steinhart += 1.0 / (TEMPERATURENOMINAL +
273.15); // + (1/To) steinhart = 1.0 / steinhart; // Invert steinhart -= 273.15; // convert to C

Serial.print("Temperature "); Serial.print(steinhart); Serial.println(" *C");

delay(1000); }

* thermistor Created by Bicong Li on 28.03.2017 15:59.

// the value of the 'other' resistor

de ne SERIESRESISTOR 10000
// What pin to connect the sensor to

de ne THERMISTORPIN A0
void setup(void) { Serial.begin(9600); }

void loop(void) { oat reading;

reading = analogRead(THERMISTORPIN);

Serial.print("Analog reading "); Serial.println(reading);

// convert the value to resistance reading = (1023 / reading) - 1; reading = SERIESRESISTOR / reading;
Serial.print("Thermistor resistance "); Serial.println(reading);

delay(200); }

Task created on 28.03.2017 16:06.

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Thermistor and Needle integration
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[ IMG_3535.JPG ] Uploaded by Bicong Li on 28.03.2017 16:28.

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* Temperature readings Created by Demi Shen on 31.03.2017 15:47.

With the current set-up, we tested the temperature reading from the thermistor, transmitted to the
computer through wired arduino connection. We put the thermistor head on ice, and the temperature
is 273.15 (Kelvin) most of times, which is 0 degrees in Celsius. However, some variation is observed
regarding the placement of the needle head. The reading was not stable. The variation, however, is
considerably small, and would potentially stay within our design speci cations if it is anchored to the
ice surface instead of us holding it. We also put the needle head into boiling water, and the results also
show that the reading is accurate. Overall, we feel like the readings were right. However, if the accuracy
can be improved, it would be much better. Another concern was that the reading changes from one
temperature to another is not instantaneous. There is a time delay when switching the contact surface
temperature, especially when there is a big dierence between the before and after temperature. We
would love to observe a instantaneous change, however, for our purpose of monitoring a considerably
stable heart muscle temperature during operation, we do not need to measure an abrupt temperature
change. The heart muscle also does not display an instantaneous change when in contact with the cold
perfusion solution. Hence, the thermistor reading would be sucient for our purpose.

Task created on 31.03.2017 14:37.

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Arduino Bluetooth Instructions
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* Next stage experimental plan Created by Demi Shen on 31.03.2017 15:32.

Right now, our Arduino is reading the correct temperature from the thermistor when directly
connecting the arduino board to the computer. Next stage would be to implement the Bluetooth
functionality and test the temperature readings.

* Input and Output Created by Demi Shen on 31.03.2017 15:03.

Each of the 14 digital pins on the BT can be used as an input or output, using pinMode(), digitalWrite(),
and digitalRead() functions. They operate at 5 volts. Each pin can provide or receive a maximum of 40
mA and has an internal pull-up resistor (disconnected by default) of 20-50 kOhms. In addition, some

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pins have specialized functions:

Serial: 0 (RX) and 1 (TX). Used to receive (RX) and transmit (TX) TTL serial data. These pins are connected
to the corresponding pins of the Bluegiga WT11 module.

External Interrupts: 2 and 3. These pins can be con gured to trigger an interrupt on a low value, a
rising or falling edge, or a change in value.

PWM: 3, 5, 6, 9, 10, and 11. Provide 8-bit PWM output with the analogWrite() function.

SPI: 10 (SS), 11 (MOSI), 12 (MISO), 13 (SCK). These pins support SPI communication, which, although
provided by the underlying hardware, is not currently included in the Arduino language.

BT Reset: 7. Connected to the reset line of the Bluegiga WT11 module, which is active high.

LED: 13. There is a built-in LED connected to digital pin 13. When the pin is HIGH value, the LED is on,
when the pin is LOW, it's o.

The BT has 6 analog inputs, each of which provide 10 bits of resolution (i.e. 1024 dierent values). By
default they measure from ground to 5 volts, though is it possible to change the upper end of their
range using the AREF pin and some low-level code. Additionally, some pins have specialized
functionality:

I2C: 4 (SDA) and 5 (SCL). Support I2C (TWI) communication using the Wire library (documentation on
the Wiring website). There are a couple of other pins on the board:

AREF. Reference voltage for the analog inputs. Used with analogReference().

* Connecting to power Created by Bicong Li on 31.03.2017 14:46.

The Arduino BT can be powered via the V+ and GND screw terminals. The board contains a DC-DC
convector that allows it to be powered with as little as 2.5V, a maximum of 12V. Higher voltages or
reversed polarity in the power supply can damage or destroy the board.

The power pins are as follows:

+VIN. The input voltage to the Arduino board (i.e. the same as the V+ screw terminal). We can supply
voltage through this pin, or, if supplying voltage via the screw terminals, access it through this pin.

5V. This pin outputs a regulated 5V from the regulator on the board. The board can be supplied with
power either from the screw terminal (2.5V - 12V) or the VIN pin of the board (2.5V-12V). Supplying
voltage via the 5V or 3.3V pins bypasses the regulator, and can damage our board. We will probably
not consider it.

GND. Ground pins.

* How to avoid breaking the Arduino BT Created by Bicong Li on 31.03.2017 14:44.

The Arduino BT is more fragile and easy to break than a regular Arduino board.

Don't power the board with more than 12 volts or reverse the polarity (power and ground pins) of
power supply, or we might kill the ATmega328 on the Arduino BT. Higher voltages or reversed polarity
in the power supply can damage or destroy the board. The protection for reverse polarity connection is
ONLY on the screw terminal. The Arduino BT can, however, run with a minimum of 2.5 volts, making it
easier to power with batteries.

The microcontroller (an ATmega328) on the Arduino BT is a physically smaller version of the chip on
the USB Arduino boards. We should not remove it, so if we kill it, we need a new Arduino BT.

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There are two extra analog inputs on the Arduino BT (8 total). Two of these, however, are not
connected to the pin headers on the board; we'll need to solder something to the pads next to the
numbers "6" and "7".

Pin 7 is connected to the reset pin of the bluetooth module; we should not use it for anything (except
resetting the module).

* Getting Started with the Arduino BT Created by Bicong Li on 31.03.2017 14:42.

The Arduino BT is an Arduino board with built-in bluetooth module, allowing for wireless
communication. To get started with the Arduino BT, follow the directions for the Arduino NG on your
operating system (Windows, Mac OS X, Linux), with the following modi cations:

First, pair the Arduino BT with computer and create a virtual serial port for it. Look for a bluetooth
device called ARDUINOBT and the pass code is 12345. Select Arduino BT from the Tools | Board menu
of the Arduino environment. When uploading to the Arduino BT, you may need to press the reset
button on the board shortly before (or shortly after) clicking upload in the Arduino software.

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3/31/2017 Researchmaterial|Report

Project created on 27.10.2016 17:19.

Report for project Research material

Task created on 31.03.2017 13:35.

No due date
FDA validation
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* PPQ protocol execution and report Created by Hehaoyu Zou on 31.03.2017 14:10.
Discuss and cross-reference all aspects of the protocol.

Summarize data collected and analyze the data, as speci ed by the protocol.

Evaluate any unexpected observations and additional data not speci ed in the protocol.

Summarize and discuss all manufacturing nonconformances such as deviations, aberrant test results,
or other information that has bearing on the validity of the process.

Describe in su cient detail any corrective actions or changes that should be made to existing
procedures and controls.

State a clear conclusion as to whether the data indicates the process met the conditions established
in the protocol and whether the process is considered to be in a state of control. If not, the report
should state what should be accomplished before such a conclusion can be reached. This conclusion
should be based on a documented justi cation for the approval of the process, and release of lots
produced by it to the market in consideration of the entire compilation of knowledge and information
gained from the design stage through the process quali cation stage.

Include all appropriate department and quality unit review and approvals.

* STATUTORY & REGULATORY REQUIREMENTS FOR VALIDATION

Created by Hehaoyu Zou on 31.03.2017 13:52.
The overarching principle stated by FDA is : The CGMP regulations require that manufacturing
processes be designed and controlled to assure that in-process materials and the nished product
meet predetermined quality requirements and do so consistently and reliably. It involves multiple
aspects of the validation process.

First, Sampling and testing of in-process materials and drug products, requires that control procedures
be established to monitor the output and to validate the performance of those manufacturing
processes that may be responsible for causing variability in the characteristics of in-process material
and the drug product (emphasis added). In addition, the CGMP regulations regarding sampling set
forth a number of requirements for validation: samples must represent the batch under analysis ; the
sampling plan must result in statistical con dence ; and the batch must meet its predetermined
speci cations.

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In addition to sampling requirements, the CGMP regulations also provide norms for establishing in-
process speci cations as an aspect of process validation. The rst principle is that . . . in-process
speci cations for such characteristics [of in-process material and the drug product] shall be consistent
with drug product nal speci cations . . . . The second principle in this regulation further requires that
in-process speci cations . . . shall be derived from previous acceptable process average and process
variability estimates where possible and determined by the application of suitable statistical
procedures where appropriate.

The CGMP regulations also describe and de ne activities connected with process design, development,
and maintenance. Section 211.180(e) requires that information and data about product quality and
manufacturing experience be periodically reviewed to determine whether any changes to the
established process are warranted. Ongoing feedback about product quality and process performance
is an essential feature of process maintenance.

* FDA Validation general guidance Created by Hehaoyu Zou on 31.03.2017 13:41.

A successful validation program depends upon information and knowledge from product and process
development. This knowledge and understanding is the basis for establishing an approach to control
of the manufacturing process that results in products with the desired quality attributes.
Manufacturers should:

Understand the sources of variation

Detect the presence and degree of variation

Understand the impact of variation on the process and ultimately on product attributes

Control the variation in a manner commensurate with the risk it represents to the process and
product

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