roller shear testing on fusion 1k system 80° mattre ssorthotecmedical.com/pdfs/moxi roller shear...

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CONFIDENTIAL

\\Ecfile\Production\0632 Moxi Roller Shear Test\Reports\Moxi Roller Shear Report.doc Page 1 of 13

Project Number: 0632 Date: 27-July-2012 Project Description/Title:

Roller Shear Testing on Fusion 1K System 80° mattress

Scott Fiss

Moxi Enterprises 1939 South Vandeventer Ave.

St. Louis, MO 63110 [email protected]

EC Service, Inc. Contact: Justin Pedersen 915 South Frontage Road

Centerville, UT 84014 (801) 296-0451

CONFIDENTIAL


Project Number: 0632 Date: 27-July-2012

TABLE OF CONTENTS

1. BACKGROUND: ...................................................................................................3 2. EXECUTIVE SUMMARY: ...................................................................................3 3. REFERENCES:......................................................................................................3 4. MATERIALS: ........................................................................................................3 5. TEST ENVIRONMENT ........................................................................................3 6. METHOD: ..............................................................................................................3 7. RESULTS: ..............................................................................................................5 8. CONCLUSIONS: ..................................................................................................8 9. STATEMENT OF UNCERTAINTY.....................................................................8

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1. BACKGROUND: 1.1. The capability of a mattress to support an individual without allowing that individual

to “bottom out” can be greatly influenced by age of the mattress. This study was undertaken to characterize the Fusion 1K System 80°’s ability to continue to support an individual by aging the mattress for an estimated 5 and 10 year aging times using ASTM D 3574-I2:2005 Test I2, Fatigue test by roller shear.

2. EXECUTIVE SUMMARY:

2.1. The Fusion 1K System 80° showed no breakdown of failure over the simulated 10 years of roller shear aging.

2.2. Upon inspection, no noticeable damage or wear was present, aside from some minor abrasions at the surface of the cover from the test fixture.

2.3. The Fusion 1K System 80° provided proper support to the test occupant following 10 years of roller shear aging when a head of bed angle of 30° and 45° from horizontal was performed. The peak pressure was measured at 47 mmHg at the 45° head of bed angle.

3. REFERENCES:

3.1. ISO 554:1976E Standard Atmospheres for Conditioning and/or testing 3.2. ISO Guide to Expression of Uncertainty in Measurement 3.3. ASTM D 3574-I2:2005, Flexible Cellular Materials – Slab, Bonded, and Molded

Urethane Foams – Test I2: Dynamic Fatigue Test by the Roller Shear at Constant Force Section 86-94.

4. MATERIALS:

4.1. Samples Provided by Customer 4.1.1. Fusion 1K System 80° (Foambase80, FUSCOVTOP80 FUSDD,

FUSFOAMINS80) provided by Moxi Enterprises, ECSR#0659 4.2. Testing Equipment

4.2.1. Mattress Roller Shear Device, Tool# 16038 4.2.2. Bed Frame capable of head of bed angle up to 45° from horizontal, Tool# 11161 4.2.3. Plywood base of dimensions: !” x 36” x 82”, Tool# 11159 4.2.4. Camera to document results 4.2.5. Rigid NPUAP 50th percentile Male Test Mannequin, Serial# 001 4.2.6. Weights to bring Rigid Mannequin to 178lbs 4.2.7. Human test subject: Male, 165lbs, 74” tall 4.2.8. IPSA- Interface Pressure Sensor Array by XSensor, Model# X6912 4.2.9. Pentium computer with XSensor 4.2 Medical Software to record results

5. TEST ENVIRONMENT

5.1. For roller shear testing, an environment with temperature of 50 +/-2 °C as specified in ASTM D 3574-I2:2005.

5.2. For pressure mapping, an environment with ambient temperature of 23 +/-2 °C and relative humidity 50% +/- 5% which is specified in ISO 554-1976(E).

6. METHOD:

6.1. Test Set Up 6.1.1. The roller shear head, as specified in ASTM D 3574-I2:2005, was attached to a

steel frame such that is could be placed over the mattress.

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6.1.2. The steel frame was positioned at the pelvic-thorax region of the mattress and was fixed to a rigid table.

6.1.3. The mattress was positioned in the frame and secured in place along the outside perimeter of the mattress. See Figure 1, below.

6.1.4. A load of 14.7 lbs was applied to the roller shear test head. 6.1.4.1. A load of 64 ± 1 lbs is the force observed in the pelvic region of a 50th

percentile male with an average contact area of 228.5 in2. The contact area of the roller shear head is 52.48 in2. The load of 14.7 lbs was calculated by the following equation:

( ) ( )rRollerShea

lethpercenti

rRollerShealethpercentiForce

aContactAre

aContactArexForce=

50

50

6.1.5. An insulation box with a heater and fan were constructed to encase the mattress

and roller, allowing the mattress to be kept a 50°C. See Figure 2, below. Figure 1 – Roller Shear head setup for

mattress testing.

Figure 2 – Roller Shear Fixture with Insulation and heater box.

6.2. Pressure Mapping

6.2.1. Pressure mapping was used to measure the difference between the performance of the mattress at the simulated aging intervals.

6.2.2. Pressure mapping was performed at each interval using a rigid mannequin loaded to 178 lbs, and a male subject with a weight of 165 lbs.

6.2.3. The plywood base was placed on the bed frame. 6.2.4. The mattress was placed on the plywood base. 6.2.5. The pressure map was placed on the mattress. 6.2.6. The mannequin or participant rested on the pressure map for 120 seconds while

the pressure was recorded.

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6.2.7. A 300 second recovery period was allowed for the mattress between trials. 6.2.8. A total of five pressure map intervals were performed for each configuration

(human or mannequin). 6.2.9. All data and analysis were stored at the following filepath:

\\ecfile\production\0632 Moxi Roller Shear Test\Testing and Analysis.

6.3. Roller Shear Testing 6.3.1. The mattress was placed in the test chamber with the roller head on the surface. 6.3.2. The heating box was place around the mattress and the chamber was allowed to

reach 50°C. 6.3.3. Once the temperature was reached, the roller shear testing was started. 6.3.4. The mattress was inspected every morning and night, approximately once every

eight hours. 6.3.4.1.Inspected for:

6.3.4.1.1. Wears or tears on the inside of the mattress 6.3.4.1.2. Delamination of the materials under the cover 6.3.4.1.3. Sever set or collapse of materials

6.3.5. Roller Shear testing was performed for 35,000 cycles (estimated at five years worth of aging).

7. RESULTS: 7.1. No failures occurred after 35,000 cycles (five years worth of aging). At the request of

the customer, an additional 35,000 cycles were tested (ten years worth of aging total). No failures were identified.

7.2. A small visible sag of approximately 0.250” was identified at the pelvic region, but not the point of failing the mattress. See Figure 3, below. Figure 4 shows the mattress without the cover.

7.3. The cover had some rub marks from the roller fixture, this represents test artifact from the edges of the roller and is not a surface failure. See Figure 3, below.

7.4. Pressure mapping data was performed at the following intervals: pre-aging, five years aging, and ten years aging. See Figure 5 and Figure 6 for the average pressure and peak pressure index for the 50th percentile mannequin and male participant values, respectively. Refer to Table 1 and Table 2 of the Appendix for the analyzed pressure mapping data for the mannequin and male participant, relatively. Refer to Figure 7 through Figure 9 of the Appendix for the pressure mapping screen shots of the pre-aging, 35,000 cycle, and 70,000 cycle data, respectively.

7.4.1. The Peak Pressure Index (PPI) is the average of the 9x9 grid of pressures with the maximum pressure value at the center of the array. It is measured to average out the peak pressure with the values around it.

7.5. Additionally, the customer requested a quick check with the pressure mapper to identify if the roller shear aging had caused a deterioration of the structure. A single trial of pressure mapping was performed with the male participant by rotating the head of the bed to 30° and 45° from horizontal. No bottoming out occurred, the pressures never reached above 50 mmHg for either of the head of bed angles. Refer to Table 3 of the Appendix for pressure mapping data of the Head of Bead angles. Refer to Figure 10 and Figure 11 of the Appendix for the pressure mapping screen shots of the 30° and 45° head of bed angle from horizontal data, respectively.

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Figure 3 – Roller Shear testing produced a small compressive set at the roller surface. The rub marks from the roller can be seen at the edges. No cut formed.

Figure 4 – Pelvic to Thorax region of the mattress without the cover, no delamination occurred.

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Figure 5 – Pressure mapping data for 50th percentile mannequin (178 lbs).

Roller Shear Testing

Mannequin Pressure Mapping

0

10

20

30

40

50

60

Pre-Aging 5-Years 10-Years

Pre

ssu

re (

mm

Hg

)

Pelvis Average Pressure

Pelvis Peak Pressure Index

*Alpha = 0.05

Figure 6 – Pressure mapping data for male subject (74 inches tall, 165 lbs).

Roller Shear Testing

Human Pressure Mapping

0

5

10

15

20

25

30

35

40

Pre-Aging 5-Years 10-Years

Pre

ssu

re (

mm

Hg

)

Pelvis Average Pressure

Pelvis Peak Pressure Index

*Alpha = 0.05

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8. DISCUSSION:

8.1. This study was undertaken to characterize the Fusion 1K System 80°’s ability to resist shear generated when raising the head of bed angle from horizontal. The primary location of large shear values is at the pelvic region while the head of bed is elevated. A roller shear device, as described in ASTM D 3574-I2:2005, was used to apply cyclic shear to the surface of the mattress from the pelvic region to the thorasic region. The test was designed to deliver the approximate equivalent of 5 years use. The test was then extended to the approximate equivalent of 10 years of typical use. Pressure mapping data was recorded at pre-aging, five year equivalent, and ten year equivalent intervals to measure the mattresses ability to withstand shear stresses.

9. CONCLUSIONS:

9.1. The Fusion 1K System 80° did not fail or compromise during the five or ten-year roller shear simulated aging.

9.2. No noticeable damage or wear was present upon inspection except as noted below. 9.2.1. Abrasion on the cover due to the roller shear fixture being in contact with the

surface during testing. 9.2.2. Minor sag of approximately 0.25” during testing.

Note: Based on our lab test experience, typical urethane and viscoelastic foam mattresses would fail with visible sag of 2-3”.

9.3. A small deformation occurred at the pelvis-thorax region where the roller was applied, but this did not warrant a failure.

9.4. The Fusion 1K System 80° provided proper support to the test occupant following 10 years of roller shear aging when a head of bed angle of 30° and 45° from horizontal was performed. The peak pressure was measured at 47 mmHg at the 45° head of bed angle.

9.5. All internal components remained in the original position through out the test. 9.6. No delamination was detected in the cover or the mattress internal components. 9.7. The tested area of the mattress demonstrated a robust maintenance of original

performance characteristics throughout the test period. 10. STATEMENT OF UNCERTAINTY

10.1. All error bars in the above graphs represent the 95th percent confidence interval (alpha = 0.05).

10.2. No confidence statements can be made about the head of bed angle testing of 30° and 45° as only one trial was performed.

- END -

CONFIDENTIAL


APPENDIX

CONFIDENTIAL


Table 1 – Pressure Mapping analysis for 50th percentile mannequin (178 lbs)

Pelvis Average Pressure (mmHg) Confidence*

Pelvis Peak Pressure

Index (mmHg) Confidence*

Pre-Aging 34.80 ±0.78 48.82 ±4.31 5-Years 28.82 ±0.50 36.18 ±2.73

10-Years 29.64 ±0.77 40.76 ±2.69

*Alpha = 0.05

Table 2 – Pressure Mapping analysis for male participant (165 lbs)

Pelvis Average Pressure (mmHg) Confidence*

Pelvis Peak Pressure

Index (mmHg) Confidence*

Pre-Aging 22.38 0.37 28.11 5.33 5-Years 21.81 1.07 27.93 1.69

10-Years 21.67 1.31 30.27 7.17

*Alpha = 0.05

Table 3 – Pressure mapping analysis for head of bed angles (30° and 45°). NOTE: Only one trial performed at each configuration using male participant (165 lbs)

Pelvis Average Pressure (mmHg)

Pelvis Average Pressure (mmHg)

30° head of bed Angle 22.64 43

45° head of bed Angle 23.43 47

Figure 7 – Pressure mapping of male participant Pre-Aging of mattress

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Figure 8 – Pressure mapping of male participant after 35,000 cycles (Five years)

Figure 9 – Pressure mapping of male participant after 70,000 cycles (Ten years)

Figure 10 – Pressure mapping of male participant head of bed angle to 30° from horizontal after 70,000 cycles (Ten years)

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Figure 11 – Pressure mapping of male participant head of bed angle to 45° from horizontal after 70,000 cycles (ten years)

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Quality Inspection

Object Checked by: Date Project number labeled BB 27-July-2012

Date report submitted BB 27-July-2012

Page numbers in footer BB 27-July-2012

File path in footer BB 27-July-2012

Customer contact information correct BB 27-July-2012

Table of contents displaying correct page numbers/headers

BB 27-July-2012

Background statement depicts necessity of testing BB 27-July-2012

Executive summary encompasses testing conclusions BB 27-July-2012

References are accurate (ie, correct protocol listed) BB 27-July-2012

All testing materials listed along with any ECS Receipt numbers, lot numbers, version numbers, and detailed description

BB 27-July-2012

Method accurately describes testing performed BB 27-July-2012

Check all Figure/Table numbers match with reference to Figure/Table

BB 27-July-2012

Data and analysis file path labeled BB 27-July-2012

Confirm Pass/Fail Values N/A N/A

Alpha values (or percent confidence) are identified for all confidence intervals

BB 27-July-2012

Conclusions accurately describe results from data BB 27-July-2012

Conclusions make sense and are clear and concise BB 27-July-2012

All pictures/figures in document are compressed to "print" with a resolution of 200 dpi

JMP 27-July-2012

Statement of uncertainty included with confidence interval statements

BB 27-July-2012

Document signed and signatures displayed on title page BB 27-July-2012

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