`
`1, Lou Fiorini, declare as follows:
`
`1.
`
`I am the Director_of Operations at Innovative Test Solutions, Inc.
`
`(“ITS”), an ISO 1702522005 accredited, mechanical testing laboratory located in
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`Schenectady, New York.
`
`2.
`
`I have a Bachelor’s degree in Mechanical Engineering from SUNY
`
`Institute of Technology. I have approximately 18 years of work experience in the
`
`field of mechanical testing, including approximately 12 years of experience
`
`overseeing mechanical testing projects.
`
`3.
`
`Patterson Belknap Webb & Tyler LLP (“PBWT”) retained ITS to
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`perform heat treatments on certain shanks of nickel-titanium endodontic files,
`
`followed by stiffness testing of the shanks in accordance with ISO 3630-1 :2008,
`
`Section 7.5. I designed the test apparatus, and oversaw the heat treatments,
`
`stiffness testing, and preparation of a report that summarizes the heat treatment
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`cycles, test apparatus, test procedure, and results. A copy of that report, entitled
`
`“ISO 3630-1, Section 7.5 Stiffness Testing,” and identified as “Test Report ITS —
`
`16141.02,” is attached to this declaration as Exhibit A. Based on my personal
`
`knowledge, the report was prepared at the time the testing was conducted, and in
`
`the course of the regularly-conducted business of ITS. Further, the information
`
`contained in the report is true and accurate.
`Page 1 of 46
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`PGR2015-00019 — Ex. 1041
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`US Endodontics, LLC, Petitioner
`
`Page 1 of 46
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`PGR2015-00019 – Ex. 1041
`US Endodontics, LLC, Petitioner
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`
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`4.
`
`In May 2016, ITS received from PBWT five plastic containers, each
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`containing six nickel-titanium endodontic files. The containers were in their
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`original, unopened packaging, which indicated the files were ProFile® brand, and
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`of size 20, .04 taper, and 25 mm length. Each file consisted of a nickel-titanium
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`shank portion and a handle. Prior to heat treatment, the handles of the files were
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`removed at the point at which they were attached to the shanks.
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`5.
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`ITS heat treated the shanks at the following times and temperatures:
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`
`
`
`
`
`
`Number
`
`of Shanks
`
`2
`
`—
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`
`
`6.
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`All of the heat treatments were performed by placing the shanks in an
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`air atmosphere in an industrial oven that was maintained at the indicated
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`temperature. After being treated in the furnace for the indicated times, the shanks
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`were removed and allowed to cool at room temperature.
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`7.
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`Thereafter, and as mentioned above, the heat-treated shanks were
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`subjected to stiffness testing in accordance with ISO 3630-1 :2008, Section 7.5; the
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`Page 2 of 46
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`Page 2 of 46
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`
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`test materials, equipment, techniques, and results are summarized in the report
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`attached as Exhibit A.
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`I declare under penalty of perjury that the following is true and correct.
`
`Executed on August
`
`£1
`
`, 2016
`
`
`
`ou Fiorini
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`Page 3 of 46
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`
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`EXHIBIT A
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`
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`EXHIBIT AEXHIBIT A
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`Page 4 of 46
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`
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`ISO 3630-1, Section 7.5 - Stiffness Testing
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`Author: James Dutelle
`
`Test Report ITS – 16141.02
`
`Wednesday, August 03, 2016
`
`551 Kings Road
`Schenectady, NY 12304 (USA)
`Ph.:
`(518) 688-2851
`Fax:
`(518) 688-2855
`E-mail: info@its-inc.com
`URL: www.its-inc.com
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`Page 5 of 46
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`
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
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`Page 2 of 42
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`Report Title: ISO 3630-1, Section 7.5 Stiffness Testing
`
`REPORT DATE: August 3, 2016
`CUSTOMER: Abhishek Bapna
`
`
`
`COMPANY: Patterson Belknap Webb &
`Tyler LLP
`1133 Avenue of the Americas
`
`ADDRESS:
`
`16141.02
`ITS PROJECT NO:
`CUSTOMER P.O.: NA
`
`CUSTOMER JOB NO: NA
`
`SPECIMEN SOURCE: Customer
`
` New York, NY 10036
`
`TEST STAND NO: NA
`
`PHONE NO:
`
`(212) 336-2617
`
`FAX NO: NA
`
`DESCRIPTION OF WORK REQUESTED:
`
`Innovative Test Solutions, Inc. (ITS) was requested to perform stiffness testing on endodontic
`files per section 7.5 of the ISO 3630-1 standard.
`
`SUMMARY OF TEST RESULTS:
`
`ITS tested samples in accordance with section 7.5 of the ISO 3630-1 standard. Twenty samples
`were tested and the results are summarized in this report.
`
`James Dutelle
`
`
`
`
`
`Lou Fiorini
`
`
`
`
`
`Original Copy Signed in Blue Ink
`Original Copy Signed in Blue Ink
`Report Author
`
`Laboratory Director
`
`I HEREBY CERTIFY THAT THE DATA CONTAINED IN THIS REPORT HAVE BEEN GENERATED IN ACCORDANCE WITH AND
`MEETS THE REQUIREMENTS OF THE PURCHASE ORDERS LISTED.
`
`Sam Acevedo
`
`
`
`
`
`
`
`
`
`
`
`Original Copy Signed in Blue Ink
`Quality Manager
`
`
`
`
`Note: This report shall not be reproduced except in full without the written approval of Innovative Test Solutions (“ITS”). The recording of false,
`fictitious, or fraudulent statements or entries on this document may be punished as a felony under federal law. This Test Report and the
`information contained herein represents the results of testing articles/products identified and selected by the client. The tests were performed to
`specifications and/or procedures approved by the client. ITS makes no representations expressed or implied that such testing fully demonstrates
`the performance, efficiency, reliability, or any other characteristics of the articles/products tested. This Test Report is not an endorsement or
`certification by ITS of the articles/products tested.
`
`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
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`Page 3 of 42
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`Table of Contents
`Cover ........................................................................................................................................................................ 1
`Signature Page ......................................................................................................................................................... 2
`Table of Contents ..................................................................................................................................................... 3
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`Section Heading ............................................................................................ Page #
`1.0
`INTRODUCTION .............................................................................................................. 4
`2.0
`PROCEDURE ..................................................................................................................... 5
`3.0
`RESULTS ........................................................................................................................... 9
`4.0
`APPENDIX ....................................................................................................................... 10
`
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
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`1.0
`
`INTRODUCTION
`Innovative Test Solutions, Inc. (ITS) was contacted by Abhishek Bapna from Patterson
`Belknap Webb & Tyler LLP (PBWT) to perform stiffness testing per section 7.5 of the
`ISO Standard 3630-1 (2008). PBWT sent ITS plastic six-pack containers of ProFiles
`nickel titanium endodontic files in their original, unopened packaging. The packaging
`indicated that the files were of size 20, 0.04 taper, 25 mm length, and included the part
`number “PIT042025”. A total of 20 samples of such files were tested with various heat
`treatments. Post heat treatment and post-test pictures were taken using a digital
`microscope to determine the bend angle. All samples were bend tested to 45 degrees and
`the torque was recorded at that angular displacement.
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`2.0
`
`PROCEDURE
`2.1 Test Apparatus:
`A test apparatus was designed following the specifications called out in section 7.5 of the
`ISO 3630-1 standard. The design can be seen in Figure 1 below and the fully assembled
`test apparatus can be seen in Fixture 2 below. The apparatus included a clamping
`mechanism that secured 3 millimeters of the tip of the sample. The clamping fixture was
`secured to a torque cell and a DC gear motor applied load to the sample. The angular
`displacement was measured using the position potentiometer.
`
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`Figure 1 – Concept Design
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`Figure 2 – Test Apparatus
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`Wednesday, August 03, 2016
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`2.2 Testing Procedure:
`Samples were prepared by removing the handle using wire cutters at the point at which
`the handle was attached to the shaft of instrument. Once all samples were prepared, they
`were heat treated as described in section 2.3. After the heat treatment process, the
`samples were photographed using a digital microscope to measure the pre-test bend
`angle. Determining the pre-test bend angle on the samples is described in section 2.4.
`Once the pre-test bend angle was determined and the direction of the initial bend was
`marked, the samples were ready to be installed into the fixture for bend testing.
`
`The tip of the sample was clamped at a depth of 3 millimeters into the fixture using a
`thumb screw which can be seen in Figure 3 below. The sample was positioned so that the
`bending would occur in the opposite direction of the pre-test bend. The fixture was
`attached to the torque cell, which was mounted to apparatus base plate. A catch pin was
`aligned until the pin was lightly touching the specimen. At this point the angular
`displacement limiting switch was set to zero. The gear motor was then rotated until it
`reached an angular displacement of 45°.
`
`Figure 3 – Clamping Fixture
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`2.3 Heat Treatment Process:
`Prior to bending testing, the test samples were heat treated in an industrial oven in air.
`Table 1 below shows the heat treatment cycles. After heat treating and prior to bend
`testing, the samples were allowed to cool completely.
`
`
`Table 1 – Heat Treatment Cycles
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`Wednesday, August 03, 2016
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`2.4 Angle Measurements:
`For each sample, the pre-test bend angle and post-test bend angle were measured. This
`was done using a digital microscope and a fixture that securely held the sample. Figure 4
`below shows the sample being held in the microscope fixture. The samples were rotated
`in the fixture so that the maximum pre-test bend angles could be found and measured.
`The pre-test bend angle was marked on each sample.
`
`
`
`Figure 4 – Sample Fixture for Digital Photos
`
`
`
`
`Figure 5 below demonstrates how the angle was measured using the digital microscope.
`It starts by measuring 3 millimeters in from the tip and making a (red) reference line.
`This line is drawn from the tip of the sample to 3 millimeters in, through the center of the
`width of the sample. A (yellow) reference line was then extended parallel to the (red) 3
`millimeters reference line. A (green) reference point was marked at half the shaft
`diameter. Finally a (blue) reference line was connected from the (green) reference point
`to the (red) reference point. The angle between the (yellow) and (blue) reference lines
`was the angle reported.
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`Figure 5 – Determine Bend Angle
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`
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`3.0
`
`RESULTS
`Test results from the stiffness testing are reported in Table 2 below. For the torque vs.
`angular displacement plots, refer to Figures 6 to 25. Pre-test and post-test photographs of
`the samples can be seen in Figures 26 to 65.
`
`
`Table 2 – ISO 3630-1 Section 7.5 Test Results
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`4.0
`
`APPENDIX
`4.1 Torque vs. Angular Displacement Plot:
`Figure 6 – Sample 1 Torque vs. Angular Displacement
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`
`Figure 7 – Sample 2 Torque vs. Angular Displacement
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`Figure 8 – Sample 3 Torque vs. Angular Displacement
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`Figure 9 – Sample 4 Torque vs. Angular Displacement
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`Figure 10 – Sample 5 Torque vs. Angular Displacement
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`Figure 11 – Sample 6 Torque vs. Angular Displacement
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`Figure 12 – Sample 7 Torque vs. Angular Displacement
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`Figure 13 – Sample 8 Torque vs. Angular Displacement
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`Figure 14 – Sample 9 Torque vs. Angular Displacement
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`Figure 15 – Sample 10 Torque vs. Angular Displacement
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`Figure 16 – Sample 11 Torque vs. Angular Displacement
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`Figure 17 – Sample 12 Torque vs. Angular Displacement
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`Figure 18 – Sample 13 Torque vs. Angular Displacement
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`Figure 19 – Sample 14 Torque vs. Angular Displacement
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`Figure 20 – Sample 15 Torque vs. Angular Displacement
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`Figure 21 – Sample 16 Torque vs. Angular Displacement
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`Figure 22 – Sample 17 Torque vs. Angular Displacement
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`Figure 23 – Sample 18 Torque vs. Angular Displacement
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`Figure 24 – Sample 19 Torque vs. Angular Displacement
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`Figure 25 – Sample 20 Torque vs. Angular Displacement
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`4.2 Angle Measurements Photos:
`Figure 26 – Sample 1 Pre-Test Angle Measurement
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`Figure 27 – Sample 1 Post-Test Angle Measurement
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`Figure 28 – Sample 2 Pre-Test Angle Measurement
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`Figure 29 – Sample 2 Post-Test Angle Measurement
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`Figure 30 – Sample 3 Pre-Test Angle Measurement
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`Figure 31 – Sample 3 Post-Test Angle Measurement
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`Figure 32 – Sample 4 Pre-Test Angle Measurement
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`Figure 33 – Sample 4 Post-Test Angle Measurement
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`Figure 34 – Sample 5 Pre-Test Angle Measurement
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`Figure 35 – Sample 5 Post-Test Angle Measurement
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`Figure 36 – Sample 6 Pre-Test Angle Measurement
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`Figure 37 – Sample 6 Post-Test Angle Measurement
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`Figure 38 – Sample 7 Pre-Test Angle Measurement
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`Figure 39 – Sample 7 Post-Test Angle Measurement
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`Figure 40 – Sample 8 Pre-Test Angle Measurement
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`Figure 41 – Sample 8 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 31 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
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`Page 28 of 42
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`Figure 42 – Sample 9 Pre-Test Angle Measurement
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`Figure 43 – Sample 9 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 32 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 29 of 42
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`Figure 44 – Sample 10 Pre-Test Angle Measurement
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`Figure 45 – Sample 10 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 33 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 30 of 42
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`Figure 46 – Sample 11 Pre-Test Angle Measurement
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`Figure 47 – Sample 11 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 34 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 31 of 42
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`Figure 48 – Sample 12 Pre-Test Angle Measurement
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`Figure 49 – Sample 12 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 35 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 32 of 42
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`Figure 50 – Sample 13 Pre-Test Angle Measurement
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`Figure 51 – Sample 13 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 36 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 33 of 42
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`Figure 52 – Sample 14 Pre-Test Angle Measurement
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`Figure 53 – Sample 14 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 37 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 34 of 42
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`Figure 54 – Sample 15 Pre-Test Angle Measurement
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`Figure 55 – Sample 15 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 38 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 35 of 42
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`Figure 56 – Sample 16 Pre-Test Angle Measurement
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`Figure 57 – Sample 16 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 39 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 36 of 42
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`Figure 58 – Sample 17 Pre-Test Angle Measurement
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`Figure 59 – Sample 17 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 40 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 37 of 42
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`Figure 60 – Sample 18 Pre-Test Angle Measurement
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`Figure 61 – Sample 18 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 41 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 38 of 42
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`Figure 62 – Sample 19 Pre-Test Angle Measurement
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`Figure 63 – Sample 19 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 42 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 39 of 42
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`Figure 64 – Sample 20 Pre-Test Angle Measurement
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`Figure 65 – Sample 20 Post-Test Angle Measurement
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 43 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 40 of 42
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`4.3 Equipment List:
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 44 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 41 of 42
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`4.4 Calibrations:
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`C-1105 5 in-oz Torque Load Cell
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 45 of 46
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`ISO 3630-1, Section 7.5 Stiffness Testing
`Test Report ITS – 16141.02
`Wednesday, August 03, 2016
`
`Page 42 of 42
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`C-1106 Angular Displacement Potentiometer
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`I n n o v a t i v e T e s t S o l u t i o n s , I n c P h . : 5 1 8 - 6 8 8 - 2 8 5 1 F a x : 5 1 8 - 6 8 8 - 2 8 5 5 w w w . i t s - i n c . c o m
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`Page 46 of 46