Information Services & Technology (IST) | Information ...joelsd/capstone/Appendix C Team 10... · Web viewX-RAY CONTROL READY FOR AN EXPOSURE - At this point, the READY indicator

SCOPE23.1 Description23.2 Strategy3APPLICABLE DOCUMENTS3DEFINITIONS3SETUP3EQUIPMENT RECORD3TEST CASES4[Test Case 010] Catheter Inner Layer Diameter (Outdated)4[Test Case 015] Catheter Inner Layer Diameter (Updated, Demo 2)6[Test Case 020] Catheter Middle Layer Diameter8[Test Cases 030] Tungsten Wire Coiling Measurement10[Test Case 040] Catheter Outer Layer Diameter12[Test Plan 050] Catheter Weight14[Test Plan 060] Catheter Flexibility16[Test Plan 070] Systems Flow Test (Outdated)18[Test Plan 075] Systems Flow Test (Updated, Demo 2)20[Test Plan 110] Systems X-ray Visibility Test*22[Test Plan 120] Systems Baclofen Stability Test*24[Test Plan 130] Systems Antibacterial Test27[Test Plan 210] Catheter Radiopacity Degradation*29[Test Plan 220] Drug Stability Failure Rate*32ATTACHMENTS34

Document #: IICT.01

Last Modified: 04/28/2020

SYSTEM TEST PLAN

Author: Owais Aftab, Swathi Pavuluri, Sahiti Seetamraju, Siraj Shaikh

Author: Owais Aftab, Swathi Pavuluri, Sahiti Seetamraju, Siraj Shaikh Page 1 of 36

1. SCOPE

This document describes the test plan for verifying the design of the Improved Intrathecal Catheter as described in IIC.01. It provides the necessary procedures for the validation test of the device.

2. REASON FOR RE-ISSUE

Issue

Reason for Re-Issue

1

MR #IICxxxxxx

This is the first time the plan has been issued

3. INTRODUCTION

3.1 Description

The following tests will be performed:

Test Case

Direct Requirement

Test

Physical Requirements Measurements

010

REQ5.1.020

Inner Layer Diameter (Outdated)

REQ5.2.120

015

REQ5.1.020

Inner Layer Diameter (Updated, Demo 2)

REQ5.2.120

020

REQ5.1.040

Catheter Middle Layer Diameter

030

REQ5.1.050

Tungsten Wire Coiling Measurement

040

REQ5.1.080

Outer Layer Diameter

050

REQ5.2.110

Catheter Weight

060

REQ5.2.130

Catheter Flexibility

070

REQ5.2.140

Systems Flow Test (Outdated)

075

REQ5.2.140

Systems Flow Test (Updated, Demo 2)

Chemical Requirements

110

REQ5.3.220

Systems X-ray Visibility Test

120

REQ5.3.240

Systems Baclofen Stability Test

130

REQ5.1.3.235

Antibacterial Test

Reliability Requirements

210

REQ6.1.310

Catheter Radiopacity Degradation

230

REQ6.1.330

Drug Stability Failure Rate

3.2 Strategy

1. The Improved Intrathecal Catheter is a new product. All tests will be conducted.

4. APPLICABLE DOCUMENTS

This plan is based on requirements from IIC.01 Improved Intrathecal Catheter Functional Requirements.

5. DEFINITIONS

IIC - Improved intrathecal catheter

6. SETUP

This testing requires the following units as a minimum: A balance, X-Ray, caliper, ruler, E. Coli bacterial culture, incubator.

7. EQUIPMENT RECORD

The following test equipment, or equivalent, is needed to execute the tests in this plan.

Item

Model Number(s)

Calibration Required?

Balance

N/A

Yes (zeroed)

Digital Caliper

N/A

No

Ruler

N/A

No

X-Ray

CT scanner Discovery CT750 HD

No

Incubator

Labnet I5110A

No

8. TEST CASES[Test Case 010] Catheter Inner Layer Diameter (Outdated)

Purpose: To test the inner and outer diameter of the inner layer of the IIC

Specification:

Direct specification source IIC.01 Section 5.1.1 (REQ020)

Test Architecture:

Figure 1: Outer and Inner Diameter Measurements by Lower and Upper Jaws Shown by Arrows 1 and 2

Equipment:

1. Caliper

2. Inner layer of catheter

Test Procedure:

1. Use the upper jaws of the caliper to measure the inner diameter of the inner layer of the catheter.

2. Use the lower jaws of the caliper to measure the outer diameter of the silicone tubing layer of the catheter.

3. Subtract the diameter measured in step 2 from the diameter measured in step 1 and divide by two to determine the thickness of the inner layer of the catheter.

Expected Results

Test passes if all of the following occurs:

1. The diameter of the inner layer of the catheter is 0.80375 mm with a tolerance of + 0.01 mm

2. The outer diameter of the inner layer of the catheter is 2.33125 mm with a tolerance of 0.05

Test Results:

Item

Test Result: Diameter or Thickness (mm)

Pass/Fail

Inner Layer Inner Diameter

0.794 mm

Pass

Inner Layer Outer Diameter

2.33 mm

Pass

Inner Layer Thickness

1.539 mm

Pass

[Test Case 015] Catheter Inner Layer Diameter (Updated, Demo 2)

Purpose: To test the inner and outer diameter of the inner layer of the IIC

Specification:


Test Architecture:


Equipment:

1. Completed IIC prototype

2. Digital caliper

3. Cutting tool

Test Procedure:

1. Cut the IIC prototype into 3 different pieces

2. Use the upper jaws of the caliper to measure the inner diameter of the catheter layer of the first piece. Repeat for other two pieces

3. Use lower jaws to measure the outer diameter of the catheter layer of the first piece. Repeat for the other two pieces.

4. Subtract two values to determine catheter layer thickness for the first piece. Repeat for the other two pieces.

5. Record thickness of the IIC as well as the inner diameter of the IIC.

Expected Results


1. The diameter of the inner layer of the catheter is 0.80375 mm with a tolerance of + 0.01 mm

2. The outer diameter of the inner layer of the catheter is 2.33125 mm with a tolerance of 0.05

Test Results:

Item


Pass/Fail

Inner Layer Inner Diameter

0.791 mm

Pass

Inner Layer Outer Diameter

2.33 mm

Pass

Inner Layer Thickness

1.539 mm

Pass

[Test Case 020] Catheter Middle Layer Diameter

Purpose: To test the outer and inner diameters and thickness of the middle layer of the IIC.

Specification:


Test Architecture:


Equipment:

1. Caliper

2. Middle layer of catheter

Test Procedure:

1. Use the upper jaws of the caliper to measure the outer diameter of the inner layer of the catheter’s silicone tubing.

2. Use the inner jaws of the caliper to measure the inner diameter of the outer layer of polyurethane.

3. Subtract the diameter measured in step 2 from the diameter measured in step 1 and divide by two to determine the thickness of the middle layer of the catheter.

Expected Results


1. The thickness of the middle layer of the catheter is 0.1 mm with a tolerance of 5%

2. The outer diameter of the middle layer of the catheter is 3.00 mm with a tolerance of 5%

Test Results:

Item


Pass/Fail

Middle Layer Inner Diameter

3.050

Pass

Middle Layer Outer Diameter

3.181 mm

Pass

Middle Layer Thickness

0.131

Pass

[Test Cases 030] Tungsten Wire Coiling Measurement

Purpose: To determine the spacing between the coils of the tungsten wire when wrapped around the silicone tubing.

Specifications


Test Architecture

Figure 2: Sample ruler & methodology for measuring in cm

Equipment:Tungsten Wire

Ruler

Test Procedure:

1. Using a ruler, measure the distance between each tungsten wire coil.

Expected Results:

Test Passes is all of the following occur:

1. The distance between each coil is 2.54 cm with a tolerance of +/- 10%

Test Results:

Item

Test Result: Spacing (mm)

Pass/Fail

Mean of Spacing Between Coils

2.55

Pass

St Dev of Spacing Between Coils

0.35

Pass

[Test Case 040] Catheter Outer Layer Diameter

Purpose: To test the outer and inner diameters and thickness of the outer layer of the IIC.

Specification:


Test Architecture:

Figure 1: Outer and Inner Diameter Measurements by Lower and Upper Jaws Shown by Arrows 1 and 2 and depth rod shown by arrow 3

Equipment:

1. Caliper

2. Outer layer of catheter

Test Procedure:

1. Use the lower jaws of the caliper to measure the outer diameter of the polyurethane layer of the catheter.

2. Use the depth rod of the caliper (the bottom piece measuring depth), as shown in Figure 3, to measure the thickness of the polyurethane layer of the catheter while the beam of the catheter (the length of it) is placed along the outer diameter of the catheter.

Expected Results


1. The outer diameter of the outer layer of the catheter is 3.875 + 0.4125 mm

2. The thickness of the outer layer of the catheter is 0.4 mm with a tolerance of 5%

Test Results:

Item


Pass/Fail

Outer Layer Outer Diameter

4.00

Pass

Outer Layer Thickness

0.395

Pass

[Test Plan 050] Catheter Weight

Purpose: To determine the weight of the Improved Intrathecal Catheter

Specification:

Direct specification source IIC.01 Section 5.1.3 (110)

Test Architecture:

Figure 3: High Precision Analytical Digital Balance Precision Balances PL602E

Equipment:

IIC

Balance

Test Procedure:

1. Zero the balance by ensuring thereare not objects on the balance and pressing the “Zero” button.

2. Weigh the catheter on the balance and record the measured weight.

Expected Results:

Test Passes if the following occurs:

1. The weight of the catheter does not exceed 100 g.

Test Results:

Item

Test Result: Weight of Catheter (g)

Pass/Fail

Catheter Weight

17.1

Pass

[Test Plan 060] Catheter Flexibility

Purpose: To determine the bending radius of the Improved Intrathecal Catheter

Specification:

Direct specification source IIC.01 Section 5.3 (REQ130)

Test Architecture:

Figure 4: Bending Resistance Tester Setup. R refers to the radius of the loop

Equipment:

Improved Intrathecal Catheter (IIC) prototype

Centimeter Ruler

Test Procedure:

1. Using IIC prototype, create a loop in the middle of the catheter. Make loop as small as possible without creating any kinks in the catheter

2. Measure the radius of the loop in mm.

Expected Results:


1. The catheter bending radius is less than 3.6 mm.

Test Results:

Item

Test Result: Bending Radius

Pass/Fail

Bending Radius

3.4 mm

Pass

[Test Plan 070] Systems Flow Test (Outdated)

Purpose: To determine the ability of the completed catheter to facilitate fluid flow

Specification:


Test Architecture:

Figure 5: Elastomeric Pump

Equipment:

IIC

Pump or Pipette

Timer

Test Procedure:

1. Prepare a pump or pipette that is able to maintain a minimum flow of 22 mL/min for 5 minutes by loading the pump with 200 mL of water.

2. Attach the pump or pipette to the distal end of the IIC.

3. Have the pump or pipette pump 22 mL/min for 5 minutes through the catheter.

4. When fluid starts exiting the catheter, begin the timer.

5. When fluid stops exiting the catheter, stop the timer.

6. Calculate flow rate by dividing the amount of water pumped through the catheter by the total time it takes for the fluid to travel through the catheter.

Expected Results:


1. The Improved Catheter has a minimum flow rate of 22 mL/min, keeping in practice with the standard of a 24 gauge catheter that is 0.75 in long.

Test Results:

Item

Test Result: Flow Rate

Pass/Fail

IIC

35 mL/min

Pass

[Test Plan 075] Systems Flow Test (Updated, Demo 2)

Purpose: To determine the ability of the completed catheter to facilitate fluid flow

Specification:


Test Architecture:

Figure 6: Elastomeric Pump

Equipment:

550 mL of water or similar fluid

IIC

Pump or Pipette

Timer

Test Procedure:

1. Connect the IIC prototype to a pump that is loaded with 550 mL of water or another fluid of choice and provides a constant driving pressure (either the Level 1Technologies Inc. System 250 Fluid Warmer or Medtronic Baclofen Pump).

a. Note this procedure is borrowed from the American Society of Anesthesiologists at http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2008&index=8&absnum=709

2. Start the timer, and turn the pump/fluid warmer on.

3. Measure the amount of time that it takes for the 550 mL of fluid to pass through the catheter.

4. Record results. The test will be considered a success if the mean flow rate is at least 22 mL/min, the standard for 22 G catheters.

Expected Results:


1. The Improved Catheter has a minimum flow rate of 22 mL/min, keeping in practice with the standard of a 24 gauge catheter that is 0.75 in long.

Test Results:

Item

Test Result: Flow Rate

Pass/Fail

IIC

> 22 mL/min

Pending (COVID-19)

[Test Plan 110] Systems X-ray Visibility Test*

Purpose: To determine the ability of the tungsten wire to show up on an x-ray in a completed catheter

Specification:


Test Architecture:

Figure 7: Diagram demonstrating sample x-ray beam producer

Equipment:

Improved intrathecal catheter

X-ray machine & Computer for analysis

Dead organic tissue (eg, sacrificed rats)

*PLEASE NOTE: This is a dangerous procedure. This examination should be performed by an experienced, licensed professional.

Test Procedure:

1. Insert the catheter beneath the skin of the sacrificed animal.

2. Inside a closed room, place the tissues with the catheter placed inside in front of the x-ray machine.

3. Capture the image using the x-ray machine using the procedure outlined in Section 9.1.

4. Determine the average intensity of the tungsten coil regions of the catheter using MATLAB to assess whether it is sufficiently radiopaque.

a. Upload the image into MATLAB and save it as a variable image.

b. Convert the image into a grayscale image using the function rbg2gray(image).

c. Find the locations of tungsten wire in the image and use these to find the corresponding intensity values in the grayscale image array created.

d. Average the intensity values of the tungsten wire. The catheter can be considered sufficiently radiopaque if the average value of intensity of these regions is between 200 and 255.

Expected Results:


1. The parts of the catheter containing tungsten wire exhibit an average intensity between 200 and 255 in a grayscale converted image in MATLAB

Test Results:

Item

Test Result: Radiopacity/Image Intensity

Pass/Fail

X-Ray of Catheter

> 200 in intensity on a grayscale image in MATLAB

Pending (COVID-19)

[Test Plan 120] Systems Baclofen Stability Test*

Purpose: To determine the stability of the completed catheter when the inner silicone layer is exposed to baclofen

Specification:


Test Architecture:

Figure 8: Sample catheter being loaded with fluid using a syringe

Figure 9: Labeled Diagram of Electronic Weighing Balance

Equipment:


Stopper/piece of tape

Scale

2000 micrograms Baclofen

*PLEASE NOTE: Baclofen presents a potential hazard to the body. This examination should be performed by an experienced, licensed professional.

Test Procedure:

1. Measure the starting weights of both catheters.

2. Place a stopper or piece of tape on one end of the IIC.

3. Using the other end, pump as much baclofen as is needed to ensure the entire inner silicone layer is in contact with baclofen.

4. Leave both the control catheter and IIC overnight.

5. After 24 hours, remove the tape and flush out the baclofen.

6. Weigh the catheter again. Calculate the percent weight change of the IIC.

Expected Results:


1. The Improved Catheter does not lose more than 0.01% of its starting weight.

Test Results:

Item

Test Result: Percent Weight Change

Pass/Fail

IIC

< 0.01%

Pending (COVID-19)

[Test Plan 130] Systems Antibacterial Test

Purpose: To determine the antibacterial activity of the silver nanoparticle layer of the IIC.

Specification:


Test Architecture:

Figure 10: Inoculation of bacteria from a sample culture

Equipment:

Luria Broth (LB)

Agar culture plate

Bacterial inoculation strain (E. coli)

Cell culture hood (Shaking incubator)

Sterile pipette tip or toothpick

Aluminum foil

Ruler

UV Sterilizer

Improved Intrathecal Catheter


Test Procedure:

1. Drop the tip or toothpick into the liquid LB + antibiotic and swirl.

2. Loosely cover the culture with sterile aluminum foil or a cap that is not air tight.

3. Drag the tip over the agar plate to inoculate and plant the bacterial colony.

4. Cut a 1 inch segment of the catheter. UV sterilize & place it in the middle of the agar plate.

5. Incubate bacterial culture at 37°C for 12-18 hr in a shaking incubator.

6. After incubation, check for growth, which is characterized by a cloudy haze in the media.

7. Using a ruler, measure the radius of the circle where bacteria did not grow around the catheter (the zone of inhibition).

Expected Results:


1. The Zone of inhibition >0.05 mm

Test Results:

Item


Pass/Fail

Zone of Inhibition

>0.05 mm

Pending (COVID-19)

[Test Plan 210] Catheter Radiopacity Degradation*

Purpose: To determine the reliability of the catheter against degradation upon implantation and exposure to X-ray

Specification:

Direct specification source IIC.01 Section 6 (REQ310)

Test Architecture:

Figure 11: Diagram demonstrating sample x-ray beam producer

Figure 12: Labelled Diagram of Electronic Weighing Balance

Equipment:


Balance

X-ray

*PLEASE NOTE: This is a dangerous procedure. This examination should be performed by an experienced, licensed professional.

Test Procedure:

1. Zero the balance

2. Weight the catheter before exposure

2. Expose the catheter to intensities of 0.02 to 4 microGray following procedure outlined in Section 9.1.

3. Weigh the catheter after exposure

Expected Results:


1. The Improved Catheter does not lose more than 0.05% of its total mass after exposure at all intensities.

Test Results:

Item


Pass/Fail

Control Catheter

< 0.05%

Pending (COVID-19)

IIC

< 0.05%

Pending (COVID-19)

[Test Plan 220] Drug Stability Failure Rate*

Purpose: To determine the reliability of the catheter for stable flow of the drug over time

Specification:

Direct specification source IIC.01 Section 6 (REQ330)

Test Architecture:

Figure 13: Sample catheter being loaded with fluid using a syringe

Equipment:


2000 micrograms Baclofen

Scale


Test Procedure:

1. Place a stopper or piece of tape on one end of the IIC.

2. Weigh the catheter.

3. Using the other end, pump as much baclofen as is needed to ensure the entire inner silicone layer is in contact with baclofen.

4. After 1 hour, remove the tape and flush out the baclofen from the catheter.

5. Weigh the catheter again.

Expected Results:


1. The pumped baclofen proves to be stable and does not interact with the catheter (ie, that catheter does not change by more than 0.01% weight)

2. The test occurs with a 99.9% confidence rate.

Test Results:

Item

Test Result: Change in Catheter Weight

Pass/Fail

IIC weight

< 0.01%

Pending (COVID-19)

9. ATTACHMENTS

Cover Sheet for QUALITY RECORDS

Test Plan Name

Test Engineer

Test Date

Version

(HW) (SW)

System Name

Tests covered

MRs written?

Yes or No [see next page]

Data Attached?

Yes or No

Old Results appended?

Yes or No

Record Type

System Test Results

Date Filed

Storage Location (Room #)

Approval Signature(s)

TEST STATUS

Test Case

TEST PASSED?

IF TEST FAILED

MR#

IF TEST FAILED, MR NOT ENTERED

REASON

COMMENT

010

Yes

015

Yes

020

Yes

030

Yes

040

Yes

050

Yes

060

Yes

070

Yes

075

N/A

Pending due to COVID-19

110

N/A


130

N/A


210

N/A


230

N/A


9.1 Manual for X-Ray of Spine

In reference to “National Health and Nutrition Examination Survey III: X-ray Procedures Manual”

“ 2.3.3.1Preparation for Radiographic Exposure

1. Switch on the x-ray control by selecting POWER OFF-ON switch to ON.

2. Depress AUX pushbutton

3. You will normally be using the conventional timing, therefore, select required exposure time using TIMER selectors switch.

4. Select the required mA using the mA selector switch.

5. Observe kV meter and select required voltage using MAJOR and MINOR kV selector switches.

6. X-RAY CONTROL READY FOR AN EXPOSURE - At this point, the READY indicator should illuminate. If not, x-ray tube overload condition exists and kV, TIMER or mA indicator should be reselected. When correct (within the x-ray tube’s limitations) the READY indicator will be illuminated. NOTE: In borderline situations, the READY indicator will flicker. If this occurs, readjust kV selectors to increase kV if at lower limit and decrease kV if at 5.0 kV or at upper limit. Usually the necessary correction will be obtained by adjusting the kV MINOR selector.

2.3.3.1.1Automatic Control

Automatic exposure control (AEC) will not be the normal mode in which x-rays will be taken in the mobile examination center. With the AEC feature, sensors terminate the exposure when an x-ray of optimum quality has been obtained. Therefore, the radiation exposure to the SP is kept to a minimum. If for some reason you do use the AEC, use the following guidelines:

a. Depress the AEC button on the x-ray control panel to activate the AEC. 2-23

b. Set the correct exposure for the part of the body to be x-rayed turning the exposure dial to one of the five density selections. The same setting will generally be used for PA and lateral views.

AEC Selection

-2 (50% less than normal)

-1 (25% less than normal)

N (normal)

+1 (25% greater than normal)

+2 (50% greater than normal)

c. When taking a lateral film, depress the left or right sensor (topmost and bottommost of the three sensor selection buttons). When taking a PA film, depress the center sensor (the center of the three sensor selection buttons).

2.3.3.Procedure for Exposure Using Panel Pushbutton

1. When the READY indicator is illuminated, depress and hold the ROTOR and EXPOSURE pushbuttons

IMPORTANT: The exposure command will be immediate when the rotor pushutton has been depressed 1 (one) second prior to depressing the exposure pushbutton, If only the exposure pushbutton is depressed, exposure will result automatically, after a delay of approximately 1 (one) second for rotor to attain operating speed.

2. During a long exposure, the mA meter will indicate the selected mA. On a short exposure, the response time of the meter is too slow for the meter to reach final values, therefore, only a partial deflection , the pointer will be observed.

3. If the mAs pushbutton is depressed before the ROTOR and EXPOSURE pushbutton are depressed, the mA-mAs indicator will display value, (mA x time) and will continue to do so while the mAs and EXPOSURE pushbuttons are held in, even after the exposure is terminated. Refer to Reference Data for mA, TIMER, and mAs values

4. When it is necessary to withhold exposure until the precise moment of examinee immobilization desired to obtain a sharp radiograph, the ROTOR push button will have to be depressed and held for at least 1 second before the EXPOSURE pushbutton is depressed.

This allows the x-ray tube rotor to attain operating speed.

NOTE: During the exposure cycle, the EXPOSURE indicator will be illuminated and a constant audible signal will sound. The end of exposure is indicated by the audible signal stopping and indicator extinguishing.”

END OF DOCUMENT

Documents

Information Services & Technology (IST) | Information ...joelsd/capstone/Appendix C Team 10... · Web viewX-RAY CONTROL READY FOR AN EXPOSURE - At this point, the READY indicator