brochure anno 2009 - · pdf filebrochure anno 2009. ... the two superior laminates function...

Design and manufacture of aids for disabled people www.roadrunnerfoot.com

Brochure Anno 2009

IINNTTRROODDUUZZIIOONNEE

Roadrunnerfoot Engineering s.r.l. was born on March 13th 2007, on initiative of Daniele Bonacini, amputee, mechanical engineer and paralympic athlete (Athens 2004). This company is a spin‐off of Politecnico Innovazione, a society of Politecnico di Milano which promote and support the birth of new company. Our mission is “Technology accessible to users”: Roadrunnerfoot wants to achieve a quality/price ratio better than competitors; our company’s aim is to supply high quality products, with high performance, made of new materials, and constantly controlled during manufacturing cycles. Our products are CE marked and comply with CE 93/42 (about medical devices) and ISO standards. All products are Made in Italy. Therefore Roadrunnerfoot Engineering s.r.l. is the first Italian company that design, manufacture and sells aids for disabled people and components for prostheses. The main innovation given by our company concerns the methodology of the design process: each product is designed considering users’ needs: we start from Gait Analysis, with normal and disabled people, to define components characteristics, in order to simulate sound limbs. This kind of methodology is unique because it requires vanguard and high cost technologies, like optoelectronic systems, IR cameras, force platforms and specific software to analyze Gait data. Our product lines are basically three: for young people we design high performance aids, which allow a complete recover of motor functions and a high mobility; for elder people we design aids which allows a great comfort and safety; for women we design aids with an high aesthetic finishing. Associates such as Refraschini and Alessio Abrami, associate of Modelcar, allow Roadrunnerfoot to acquire an high industrial profile and productive capabilities. We are proud to present you our complete catalog of prosthetic components. If necessary you can contact us using the following addresses: Roadrunnerfoot Engineering s.r.l Via Gadames 128, 20151 Milan ‐ Italy Phone: 02.87380808 Fax: 02.87380809 Mail: [email protected], [email protected] www.roadrunnerfoot.com

RUNNING FOOT: SPRINTER’S KING The Sprinter's King is an high performance foot suitable for agonistic athletes to achieve maximum performances on track, but also beginners can use it to minimize energy during jogging. You have to use a hob‐nailed shoe on track and a simple rubber insole on street. Design aims were: ‐ to eliminate the negative force component (Fx) opposite to forward direction during foot's loading, this is a functional limits of commercially feet; ‐ to have same functionality of soleus‐Achilles’ tendon complex of the sound limb which gives to the limb its 90% of elasticity; ‐ to set the points of maximum peak of vertical force (Fz) and forward force (Fx) during the foot’s contact to the ground (Mid‐stance), when femur is perpendicular to the ground, to allow user to take advantage of foot’s elastic response; - to increase elastic response: major force during contact phase in shorter time;

a better vertical force and forward force modulus ratio: the stride is wider and knee trajectory is closer to the ground; - to achieve a more efficient ankle plantar‐flexion (40°).

The design of this foot could be realized thanks to the analysis of normal and amputee athletes’ running. These analysis showed competitors feet’s limits. After taking anthropometric measurements and subject and prosthesis markerization it’s possible

to acquire running with an optoelectronic system (Vicon) and a force platform (Kistler). Data elaborations allow to see all temporal –spatial parameters (stride length, cadence, velocity, etc.), joints angles graphs and the Ground Reaction Forces diagram, for both prosthetic and sound limb.

Ground reaction forces (Fz and Fx) have a lower value in amputees and they are asymmetrical in sound and prosthetic limbs: this causes a lower efficiency in running. For normal people Fz range is 2600‐3500 N, for amputees, in the sound limb Fz range is 2500‐3200 N, in prosthetic limb it’s 2400‐2550 N; Fx amputee athletes is 250‐300 N, about half normal athletes Fx (450‐600 N.

In competitors feet the following characteristics can be marked: ‐ foot’s loading phase is higher in prosthetic limb than sound one; ‐ foot response, Energy releasing, must be faster in order to compare it with the sound limb. ‐ during Toe‐off, the forward part of prosthetic foot do not allow a safe support, therefore stride length between the two limb, is different. ‐ During loading phase the foot deflects, the vertex of the posterior curve goes down and back, due to rigidity of foot’s sections: the linking line between ground contact point and heel, rotates 5° clockwise and the rotation generate a negative force that push backward (increasing hip muscles effort). All these limits lead to a shorter stride and velocity of prosthetic limb. The Innovative morphology of Sprinter’s King consists in:

1‐ the inclination between virtual V° metatarsus and virtual heel, allow a plantar‐flexion real close to normal ankle one

2‐ the fixing point of the foot and the inclination of the bracket were designed to have the same functionality of triceps surae muscles and tendons.

3‐ The curve of artificial ankle reduce elastic response time to increase foot’s efficiency.

4‐ Variable thickness in different foot’s sections determinate different stiffness in order to provide comfortable limb cinematic.

5‐ The forefoot has the same transversal section of the human foot, therefore provide a safe support during contro‐lateral limb swing phase.

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Foot simulations during working: Elasto‐cinematic and structural performances of Sprinter’s King foot were been evaluated in comparison with human foot behavior and other competitor’s feet (Cheetah – Ossur, Spriglite – Otto Bock), through FEM analysis. ISO 10328, about prosthetic components, and CE 93/42, about medical devices, do not include sporting aids, therefore we adapted these standards for this kind of foot: SK exceed 7000N during ultimate strength test, where the standards prescribes 3360 N and in normal condition GRF is about 3000N for sound limb and 2500N for prosthetic limb).

The cycle test was made with a cycle force of 3000N for 300.000 cycles, like one year daily training at maximum performance. Each component was tested at Department of Mechanical Engineering, Politecnico di Milano and certificated. The assembling of foot and bracket depends on amputation level, but the bracket makes this process very easy. The anchor point is always posterior the socket. This foot is supplied in 4 sizes, depending on athlete shoe number:

Material: carbon fiber Warranty: 12 months

Sprinter’s King characteristics User characteristicsCode Size Category Weight

range

Shoe number

User’s height

Ground‐Foot’s apex distance

Foot’s apex distance to vertical axis

1.001.1.IV soft IV

SOFT 65‐80 Over 42 Over 180 450‐540 65‐90

1.001.1.IV hard HARD 80‐100 1.001.1.III soft

III SOFT 50‐65

38‐41 170‐180 415‐490 59‐75 1.001.1.III hard HARD 65‐80 1.001.1.II soft

II SOFT 45‐60

34‐37 160‐170 365‐440 53‐65 1.001.1.II hard HARD 60‐75 1.001.1.I soft

I SOFT 40‐55

30‐33 150‐160 325‐390 49‐60 1.001.1.I hard HARD 55‐65

RROOAADDWWAALLKKIINNGG ((HHIIGGHH PPEERRFFOORRMMAANNCCEE WWAALLKKIINNGG FFOOOOTT))

Roadwalking foot is an highly dynamic foot for young and/or very active people, with a mobility level 4 (K‐level). Its 4 laminated structure allow a foot’s response during all stance phase: in every moment at least 2 laminates work together to support the amputee user in his/her daily activities. In the other feet available on market there are downtime during which the foot doesn't work, such as the final phase of the stance.

This prosthetic foot is composed by 4 main laminates: an one inferior laminate, which define the calcaneus and the forefoot; one posterior laminate, which define the heel and functions like soleus‐Achilles’ tendon apparatus; two superior laminates, which define the instep and functions like anterior tibialis muscle. A pyramid adapter closer to the ankle help the pylon attachment.

The inferior laminate starts its work during Initial Contact: the durability and elasticity must allow load acceptance and storage with a shock absorption function to guarantee comfort to the user, but at the same time stability. Its functions stops during the final phase of Toe‐off, when the forefoot gives the final propulsion.

The posterior laminate functions like Achilles tendon and soleus , which work in eccentric contraction during second rolling, to steady the foot on the sagittal plane; when the foot reach the contact with the ground, during mid‐stance, the posterior laminate starts loading and it release propulsion, allow the transition from Mid‐stance to final stance phase.

The two superior laminates function like the anterior tibialis muscle permitting a gradual foot roll‐over until forefoot contact to the ground managing the transit from Initial Contact to the Mid‐stance phase. Through their loading, they guarantee dorsiflexion during Mid‐Stance phase and plantar‐flexion during final propulsive phase These laminates are connected to the inferior laminate with two screws in the forefoot and other two in the ankle area. Gait Analysis of 4 below knee amputees allowed to define functional limits of other feet and set the design targets. The materials of this new design prosthetic foot and laminates’ stiffness were chosen through FEM analyses, simulating working conditions to verify foot’s behavior comply with design targets.

The pattern of the ground reaction forces guarantee a high comfort in the loading phase when we have the first foot contact with the ground (A) and allow to produce an high propulsion force in the final stance phase (B), while in competitors' feet it's lower. This foot comply with ISO 10328 standard. It performed the following tests: ultimate strength test ( A60, 2415 N), and cycle test (2.000.000 cycles, 1330 N), made at Dept. of Mechanical Eng., Politecnico di Milano. Roadwalking foot is CE marked. It’s available in 5 sizes, depending on shoe number.

Material: carbon fiber. Warranty: 36 months

Code Size Shoe Number

Weight[Kg] Category

1.002.01.I I 35‐36 40‐50 Soft50‐60 Hard

1.002.01.II II 37‐38 45‐55 Soft55‐68 Hard

1.002.01.III III 39‐40 50‐60 Soft60‐75 Hard

1.002.01.IV IV 41‐42 55‐70 Soft70‐85 Hard

1.002.01.V V 43‐44 65‐80 Soft80‐100 Hard

CCAARRBBOONN FFIIBBEERR PPYYLLOONN

The Carbon Fiber Pylon is a structural device which play the same role of the human femur and/or tibia and fibula, depending on amputation level. It play also a role of connection between prosthetic components. The attachment with both foot and socket it's made through two modular adapters locked up on the pylon, supplied apart (Torque=5 Nm).

Four screws allow the alignment of the prosthesis.

Gait Analysis of 4 below knee amputees allows to define loads applied on the pylon and the design targets. Simulation of ISO 10328 tests were made by a computer which recreate test conditions. The system is bound in its superior load alignment point. The force application point was bound to move in just load direction. In op position to ISO standard which imposes load condition I and II in different test, we perform a simulation of cycle test with alternately load condition I and II, estimating in each pylon section stress conditions. Carbon Fiber Pylon complied with ISO 10328. It performer the following tests: ultimate strength test (load condition I, A100, 3360 N; load condition II, A80, 2717 N), and cycle test (3.000.000 cycles, 1330 N).

This product is CE marked. Material: carbon fiber Sizes: Short = 250mm (5.001.1.SH), Long = 500mm (5.001.1.LG) External diameter: 30mm Thickness: 2,5 mm Max. user weight: 110 Kg Warranty: 36 months

STUMP SHOCK ABSORBER

The Stump Shock Absorber is a security device who, in case of movements between stump and socket, due to thinning of morphologic variation of the stump, protects the latter from impacting on the rigid wall of the socket.

Material: silicon

Mechanical properties of silicon resin: ‐ Tensile strength: 1,5 MPa according to ASTM D 412 ‐ Ultimate elongation: 400% according to ASTM D 412 ‐ Tear strength: 4 KN/m according to ASTM D 624 ‐ Hardness : 8 Shore A according to ASTM D 2240 Warranty: 12 months This product is CE marked and comply with all ASTM test standards Sizes according circumference of the stump, taken 6 cm from its apex:

CODE

SIZE CIRCUMFERENCE of the STUMP [cm]

• 4.001.1.S S 14‐19 • 4.001.1.M M 20‐23 • 4.001.1.L L 24‐27 • 4.001.1.XL XL 28‐31 • 4.001.1.XXL XXL 32‐35 • 4.001.1.XXX XXX 36‐38

CCAALLZZAA TTUUBBOOLLAARREE IINN FFIIBBRRAA DDII CCAARRBBOONNIIOO

Technical sheet:

CODE DIAMETER[mm] 6.002.1.D15 15 6.002.1.D39 39 6.002.1.D60 60 6.002.1.D100 100

Diam 15 Diam 39 Diam 60 Diam 100 Diameter at ±45°(mm) 15 39 60 100 Weight at ±45°(g/ml) 14 41 68 136 Weight at ±45°(g/m2) 288 330 360 432 Diameter a ±30°(mm) 11 28 42 71 Weight at ±30°(g/ml) 11 33 55 111 Weight at ±30°(g/m2) 333 380 416 499 Diameter a ±60°(mm) 18 48 73 122 Weight at ±60°(g/ml) 19 58 96 192 Weight at ±60°(g/m2) 333 380 416 499 Roving 3K T300 12K T300 6K T300 6K T300 Thickness at 50% 0.31 0.37 0.41 0.57 Supplied meters (m/1m a ±45°)

1.28 1.36 1.39 1.45

EPOXY RESIN This resin is clear with light blue reflex and low tendency to turn yellow. Suggested to cold stratifications with glass, carbon fiber and Kevlar, allows to achieve high quality laminates with high mechanical properties, rigidity and impact resistance. The distortion point is close to 70°C. This kind of resin is highly versatile and easy to use: low viscosity and a good wet properties of fibers promote impregnation. Light tissue laminates are transparent with bright and not greasy surfaces. The hardening process can be accelerated using heat; moreover, a post cooking at 40°C gives to the laminates better properties.

LAMINATE'S PHYSICAL PROPERTIES 6 HOURS AT 80°C

Unit Value

Elastic modulus N/mm2 19500 Flexural strength N/mm2 440Elongation at break % 2.3Distortion temperature °C 75

Mixture characteristics Unit Value Mixture viscosity at 25°C cPs 1200‐1300

Density at 20°C g/cm3 1.06

Base/hardener ratio 100/50 Pot‐life for 200g mass at 25°C min 20

Apparent hardening at 25°C h 12 Total hardening at 25°C h 72

Apparent hardening at 50°C h 3 Total hardening at 80° with con post cooking h 5

LAMINATE'S PHISICAL PROPERTIES 7 DAYS ROOM TEMPERATURE Unit Value

Elastic modulus N/mm2 16800 Flexural strength N/mm2 465Elongation at break % 2.4Distortion temperature °C 68

CCAARRBBOONN FFIIBBEERR TTAAPPEE

DESCRIPTION NCU 380 (Available with width 5 and 10 cm) Weave style

REPS

Fiber Warp High strength carbon T700 12K – 8000 dtex (o

equivalent) Weft Polyester – 55 dtex

Finishing None

FABRIC PROPERTIES Properties Unit Typical values Standard methods Areal weight

g/m2 387 ± 4% UNI 5114

Thickness µm 350 ± 15% UNI EN ISO 5084

Count Treads/cm Warp Weft UNI EN 1049‐2

4.6 ± 0.3 6.1 ± 0.3

Tensile strength

N/cm Warp Weft UNI EN 13934‐1 N/A N/A

DESCRIPTION: TCU 420 WIDTH 5 cm

Warp Weft

Fiber 12 K HR Carbon EC9 68 tex Inches per cm. 4.8 (ISO 4602) 2.0x2 (ISO 4602) Weight % 93% 7%

FABRIC PROPERTIES

Weight g/m2 411 ± 5% ISO 4605

Weave style plain ISO 2113

Fiber type Carbon 12 K

Width mm 50 ‐> 200 Thickness mm 0.45 ± 5% ISO 4603

CARBON TAPE

CODE TYPE WEIGHT gr/mq THICKNESSWEAVE STYLE

FIBER ‐ TEX WIDTH mm WARP WEFT

Suitable for reinforcements, binding, joints and little modeling constructions.

TC‐181 NCT‐50/1

105 0,12 balanced cloth

carb. 1k carb. 1k 25

TC‐182 NCT‐50/3

105 0,12 Balanced cloth


Reinforcements, joints, bindings in composite constructions, boats, surf boards and planes; modeling.

TC‐183 NCT‐100/3

198 0,24 Balanced cloth


High resistant reinforcements for axial stresses. Construction of pipe, structural shake. Construction of longerons and leaf springs. Reinforcements of rudder, fins and tail fins.

Omega binding and reinforcements.

TC‐188 NCUD‐25/3

125 0,19 simplex. 85% carb. 3k carb. 3k 100

TC‐189 NCUD‐50/3

180 0,24 simplex. 90% carb. 3k glass 22tx

50

TC‐190 NCUD‐100/3

180 0,24 simplex. 90% carb. 3kglass 22tx

100

KEVLAR TAPE

CODE TYPE WEIGHT gr/mq

THICKNESSWEAVE STYLE

FIBER ‐ TEX WIDTHmm WARP WEFT

Reinforcement of plane’s fuselage.

TC‐201 NK‐30 176 0,22 balanced cloth

kevl. 127tx

kevl. 127tx

30

Helicopters’ rotor blade.

TC‐202 NK‐50 176 0,22 Balanced cloth

kevl. 127tx

kevl. 127tx

50

Reinforcement in naval and air sectors

TC‐203 NK‐100 176 0,22 Balanced cloth

kevl. 127tx

kevl. 127tx

100

Structural shake under flexion stresses, suspensions; sporting tools; frames; reinforcements and bindings; modeling.

CCAARRBBOONN FFIIBBEERR MMAATTSS

CF 206: Fabric Twill 2x2 0°/90° Available width 1 m.

CBX (400/600):

DESCRIPTION

Weave style Twill 2/2

Fiber Warp High strength carbon T700 12K – 8000 dtex (o equivalent)

Termoplastic fiber ( ~ 1%) Weft High strength carbon T700 12K – 8000 dtex (o equivalent)

Finishing None

FABRIC PROPERTIES

Properties Unit Typical value Standard methods

Areal weight

g/m2 200 ± 4% UNI EN 12127

Thickness µm 450 ± 15% UNI EN ISO 5084

Count Treads/cm Warp Weft UNI EN 1049‐2

1.25 ± 0.3

1.25 ± 0.3

Tensile strength

N/cm Warp W UNI EN 13934‐1 N/A N/A

DELIVERY FORM & PACKAGING

Fabric rolled on a cardboard tubes Width TBD Length TBD

Type 400 600 Material 100% Carbon Total Weight 400 [g/m2 ] 600 [g/m2] Standard Width 1270 [mm] 1270 [mm] Dry Thickness 0.45(±15%) [mm] 0.60(±15%) [mm] Fiber orientation ±45° ±45° Weight 200 [g/m2] 300 [g/m2] Fiber Type Carbon 12K T700 FC50C Carbon T700 (o equivalent)

[Compatible with epoxy and polyester resin

CC201: Fiber T700 3K, weight 200 g/m2 H = 127 o 135 cm Fibers orientation: 0°/90° Weave style: PLAIN

DESCRIPTION CC 201

Weave style Plain

Fiber Warp Carbon T300 3K ‐ 2000 dtex (o equivalent)

Weft Carbon T300 3K ‐ 2000dtex (o equivalent)

Finishing None

TISSUE PROPERTIES

Properties Unit Tipical values Standard

Weight g/m^3 194 +/‐ 4% UNI EN 12127

Thickness µm 250 +/‐ 15% UNI EN ISO 5084

Counts Treads/cm Warp Weft

UNI EN 1049‐2 4.9 +/‐ 0.3 4.9 +/‐ 0.3

Tensile strength N/cm Warp Weft

UNI EN 13934‐1 N/A N/A

C205: Fiber T700 3K, weight circa 200g/m^2, H= 127 o 135 cm Fibers orientation: 0°/90°, armatura: TWILL 2X2

DESCRIPTION CC 205

Weave style Twill 2x2

Fiber Warp Carbon T300 3K ‐ 2000 dtex (o equivalent)

Weft Carbon T300 3K ‐ 2000dtex (o equivalent)

Finishing None

TISSUE PROPERTIES

Properties Units Tipical values Standard

Weight g/m^3 194 +/‐ 4% UNI EN 12127

Thickness µm 250 +/‐ 15% UNI EN ISO 5084

Counts Treads/cm Warp Weft

UNI EN 1049‐2 4.9 +/‐ 0.3 4.9 +/‐ 0.3

Tensile strength N/cm Warp Weft

UNI EN 13934‐1 N/A N/A

OTHER CARBON FIBER TISSUES


THICKNESS WEAVECOUNTS

TREADS/CM FIBER‐TEX. WIDTH

CM. WARP WEFT WARP WEFT

TC‐141

C‐95/T 660 0,1 Plain 7 7 1k 1k 100

TC‐142

C‐120/T

416 0,12 Plain 9 9 1k 1k 100

TC‐143

C‐200/T

300 0,25 Plain 5 5 3k 3k 100‐120

TC‐144

C‐200/D

280 0,25 batavia

4 5 5 3k 3k

100‐120

TC‐145

C‐280/T

280 0,3 Plain 7 7 3k 3k 100‐120

TC‐146

C‐280/D

195 0,3 batavia2/2

7 7 3k 3k 100

TC‐147

C‐300/R

195 0,31 Turk’s satin da 4

3,5 3,5 6k 6k 100‐120

TC‐148

C‐420/D

120 0,5 batavia 2/2

4 4 6k 6k 100‐120

TC‐149

C‐660/D

95 0,75 batavia 2/2

4,5 4,5 6k 6k 100

GLASS FIBER TISSUES

GLASS FIBER TISSUE VES 50 Very light cloth tissue in order to obtain perfectly transparent laminates.



COUNTS TREADS/CM

FIBER‐TEX. WIDTH CM.

WARP WEFT WARP WEFT

TV‐122

VES ‐ 50

49 0.05 plain 23.5 18.5 11 11 110

GLASS FIBER TISSUE VE 165 Very light cloth tissue in order to obtain perfectly transparent laminates.



COUNTS TREADS/CM

FIBER – TEX WIDTH CM.

WARP WEFT WARP WEFT

TV‐126

VE ‐ 165

165 0.12 batavia

4 11.8 12 68 68 100

GLASS FIBER TISSUE VT 200 Medium weight tissue for generic use and for composite constructions.



COUNTS TREADS/CM


WARP WEFT WARP WEFT

TV‐127

VES ‐ 200

200 0.19 Tela 7.3 7.3 136 136 100

GLASS FIBER TISSUE VE 290 – GLASS FIBER TISSUE VE 295 Batavia tissue with high weight



COUNTS TREADS/CM


WARP WEFT WARP WEFT

TV‐131

VES ‐ 290

290 0.21 Batavia

4 7 7 3X68 204 100

TV ‐ 133

VES ‐ 295

295 0.25 Batavia

4 7.5 7.5 204 204 120

KEVLAR TISSUE High resistant tissue to high stresses, like flexion and impact. Do not use in manufactures expose to high frequency vibrations.



COUNTS TREADS/CM

FIBER – TEX WIDTH

WARP WEFT WARP WEFT

TA‐153

K‐170/D

170 0,25 batavia 2/2

6,7 6,7 127 127 100

HYBRID TISSUE CARFON FIBER ‐ KEVLAR

CK‐200/D Balanced hybrid tissue made by 2 kevlar treads and 1 carbon treads both in warp that in weft counts. CK‐204/P Balanced hybrid tissue made by warp carbon fiber treads and weft kevlar treads.



COUNTS TREADS/CM


WARP WEFT WARP WEFT

TI‐161 CK‐

200/D 195 0,22

batavia 2/2

2 carb., 4 Kevl.

2 carb., 4

Kevl.

3k 127 tex

3k 127 tex

120

TI‐162 CK‐

204/P 204 0,24

batavia 2/2

7 carb. 7

Kevl.3k

127 tex

120

TITANTEX TISSUE

The Titantex is a titanium fiber made by high temperature fusion of titanium and other materials. The fusion mass goes through a platinum die with several holes; at the end the fiber is stretched till the setting diameter and frozen. The single flosses are then grouped in a defined number to form the tread o the roving. 2 type of grammar exist, of Titantex 200 gr/mq and 290 gr/mq, and both have good mechanical qualities. High chemical resistance. Higher mechanical performances than glass, which have higher costs. The Titan tex Batavia or twill is used mainly in batavia weave style. Treads have a loosened interleave, in order to obtain more deformability then a cloth weave style.

Batavia tissue has, though, less dimensional stability and more deformability when handled. Batavia tissues can be twill 2/2 or twill 3/1 and have the same design on both sides.

RRIIGGIIDD TTHHEERRMMOOPPLLAASSTTIICC SSHHEEEETTSS STIFF Styrene‐butadyene copolymer SOFT Polyethylene‐ methacrylate copolimer EXTRASOFT EVA‐Polietilene EVA – Polyethylene copolimer PE300, PE500, PE1000 Polyethylene High density PP Polypropylene PETG Tereftalato Polyethylene – terephtalate copolimer

Technical characteristics:

Stiff Soft Extra‐soft

PE 300 PE 500 PE 1000

Density g/cm3 1.01 0.95 0.95 0.95 0.95 0.93 Tensile strength MPa 21 25 10 30 35 30 Elongation at break % 250 350 800 500 400 300 Flexural (F)/ Tensile (T) Modulus

MPa 1150(F) 350(F) 30(F) 900 (T) 1100 (T) 700 (T)

Impact resistence kJ/m2 No

break No

break No

break No

break No

break No

break Hardness (Shore D) 68 65 33 63 66 62 Working temperature °C 170 150 150 ‐ ‐ ‐

Precaution before using Stiff, soft and extrasoft sheets:

- The workplace must be well‐ventilated to avoid overheating. However, there should be no draughts to avoid unequal cooling of the activated material.

- Ensure that all necessary tools are within reach to be able to work quickly and efficiently. - Wear suitable clothing and avoid contact with the materials at very high temperatures. Always

wear proper isolating gloves.

PRODUCT THICKNESS [mm]

Stiff 8 10 12

Soft

4.7 6.3 8.5 11.5

Extra‐soft 9 12 15

PE 300

6 8 10 12

PE 500 8 10 12

PE 1000 8 10 12

Activation technique:

1. For making orthoses, Sheet can be activated on a heating plate, or in a plate oven or convection oven. To make a prosthetic socket, it is required to use a convection oven which can contain a frame, allowing the thermoplastic material to sag.

2. Each Sheets material has its own optimum activation temperature: ‐ Stiff: 170°C ‐ Soft: 150°C ‐ Extra‐Soft: 150 3. Make sure the thermometer of the oven is working properly and has been correctly adjusted (it is possible to gauge this with a glass thermometer . The Sheet is not mouldable enough at excessively low temperatures and will flow abundantly at excessively high temperatures.

4. The oven plate must be covered with a Teflon‐film and it is recommended to clean both Sheets and the Teflon film with a little aceton before activation.

5. For activating a prosthetic socket, the Sheet is locked in a frame and heated so that the plastic gradually sags and forms a droplike bubble. When the length of this bubble has reached approximately 2/3 of the length of the positive plaster mould (minimum 15 cm), Sheet is ready to be formed.

Activation time depends on the material and the thickness of the sheet:

Type THICKNESS AVARANGE ACTIVATION TIME

(MIN.)

Stiff 8 10 12

20 25 27

Soft

4.7 6.3 8.5 11.5

12 16 18 24

Extra‐ Soft 9 12 15

11 14 17

6. Never use an open flame for the activation of the plastic because of risk of fire.

Working properties (prosthetic stump socket): Forming 1. The positive plaster mould has to be dry and must have a smooth and dust‐free surface. It is

preferably preheated to 60°C (140°F) which allows for more working time. 2. Take the activated material out of the oven with isolating gloves. Turn the “drop” upside down and

pull it slowly along the length of the plaster mould until the frame covers the basic platform. 3. Turn on the vacuum pump gently so that wrinkles in the plastic can be worked away before the

vacuum is completed.

Cooling 1. The cooling process must occur over a long period of time and at room temperature. 2. Leave the Sheet on the plaster mould until it is fully cooled to avoid internal stresses that may alter

the shape. 3. Cut the socket from the frame with a cutter and cut away the surplus of material. Wear protective clothing and gloves when using a cutter.

Finishing 1. The edges of the Sheets are finished by grinding and polishing using adapted wheels and at a speed

of 3000 rpm. Pay attention to security measures when using grinding and polishing machines.

Maintenance and waste management

- Prostheses and orthoses made with our Sheets must be cleaned daily. Use lukewarm water and soap or a biological detergent, and rinse well.

Never use solvents. - Disinfection of prosthetic sockets and orthoses is possible with alcohol, quarternary ammonium

or a solution of commercial disinfection soaps (HAC®, Sterilium®, etc.). - After use, prosthetic sockets and orthoses can be disposed of with normal household waste

without harming the environment. Advice for the patient Give the patient sufficient information about the exact use and maintenance of the orthosis or the prosthetic socket. Storage Plastics must be stored in their original packaging and in a dry room at a temperature of min. 10°C (50°F) and max. 30°C (86°F). Avoid exposure to light. General safety advices • Sheets may not be used for internal applications, on open wounds or in the mouth. • Use gloves when manipulating the heated plastic. • Always work in a well‐ventilated room. • Never use an open flame for the activation of the plastic because of risk of fire.

Technical characteristics of PE 300 sheet:

Good chemical properties, high workability, low hardness.

Lesser impact tensile and tear resistance than PE 1000. ‐ Good chemical resistances ‐ Impact resistance even at low temperature ‐ Low specific gravity ‐ Feed compatibility FDA ‐ ECC 90/128 ‐ Low mechanical resistances (tensile, flexural, tear, ecc.) ‐ Limited dimensional stability ‐ Hard to paint, stick or weld in high frequency ‐ Low weather resistance

Properties UM Method PE ‐ HD Density g / cm3 ISO 1183 ‐ DIN 53479 ‐ ASTM D 792 0,95 Feed compatibility (UE) ‐ EEC 90/128 Yes Feed compatibility (USA) ‐ FDA Yes Tensile and break resistance N / mm2 ISO 527 30 Elongation at break % ISO 527 500 Tensile Elastic Modulus N / mm2 ISO 527 ‐ DIN 53455 900 Penetration resistance (Brinell) N / mm2 ISO 2039.1 ‐ DIN 53456 40 Hardness Shore (durometer) ‐ ISO 868 ‐ DIN 53505 ‐ ASTM D‐2240 D63 Charpy shock resistance, no carving KJ / m2 ISO 179 ‐ DIN 53453 n.b. Charpy shock resistance, with carving KJ / m2 ISO 179‐3C ‐ DIN 53453 15 Creep: strain 1 % in 1000 h N / mm2 ISO 899‐1 3 Minimum working temperature C° ‐ ‐50 Working temperature C° ‐ 80 Working temperature for short time with no load

C° ‐ 90

Strain at temperature HDT ‐ A C° ISO 75 45 Strain at temperature HDT ‐ B C° ISO 75 75 Melting point C° ‐ 130 Thermal conductivity W / Km DIN 52612 0,39 Linear thermal expansion coefficient 10‐6 K‐1 ASTM E 831 DIN 53752 VDE 0304/1 180 Humidity absorption 50% u.r. % ISO 62 0 Water absorption (at saturation) % ISO 62 0,02 Oxygen Index ( LOI ) % ISO 4589 18 Behavior with flames UL 94 ‐ UL 94 HB

Technical characteristics of PE 500 sheet: Molecular weight = 500.000; mechanical properties better than PE 1000 due to higher stiffness; good workability; good chemical resistance.

‐ Good impact resistance even at low temperature ‐ Higher dimensional stability than PE 300 ‐ Low specific gravity ‐ Feed compatibility FDA ‐ ECC 90/128 (for colored sheets this compatibility must be confirmed

each time) ‐ Low mechanical resistances (tensile, flexural, tear, ecc.) ‐ Lower impact resistance and higher coefficient of fiction than PE1000 ‐ Hard to paint, stick or weld in high frequency ‐ Low weather resistance

Properties UM Methods PE ‐ HML Density g / cm3 ISO 1183 ‐ DIN 53479 ‐ ASTM D 792 0,95 Feed compatibility (UE) ‐ EEC 90/128 Yes Feed compatibility (USA) ‐ FDA yes Tensile and break resistance N / mm2 ISO 527 35 Elongation at break % ISO 527 400 Tensile Elastic Modulus N / mm2 ISO 527 ‐ DIN 53455 1100 Penetration resistance (Brinell) N / mm2 ISO 2039.1 ‐ DIN 53456 45 Hardness Shore (durometer) ‐ ISO 868 ‐ DIN 53505 ‐ ASTM D‐2240 D66 Rockwell HR Hardness ‐ ISO 2039.2 R60 Charpy shock resistance, no carving KJ / m2 ISO 179 ‐ DIN 53453 n.b. Charpy shock resistance, with carving KJ / m2 ISO 179‐3C ‐ DIN 53453 50 Creep: strain 1 % in 1000 h N / mm2 ISO 899‐1 3 Minimum working temperature C° ‐ ‐100 Working temperature C° ‐ 80 Working temperature for short time with no load

C° ‐ 90

Strain at temperature HDT ‐ A C° ISO 75 45 Strain at temperature HDT ‐ B C° ISO 75 75 Melting point C° ‐ 130 Thermal conductivity W / Km DIN 52612 0,39 Linear thermal expansion coefficient 10‐6 K‐1 ASTM E 831 DIN 53752 VDE 0304/1 180 Humidity absorption 50% u.r. % ISO 62 0 Water absorption (at saturation) % ISO 62 0,02 Oxygen Index ( LOI ) % ISO 4589 18 Behavior with flames UL 94 ‐ UL 94 HB

Technical characteristics of PE 1000:

Molecular weight up to 6 000 000 ; high impact resistance and low coefficient of friction; better tear resistance and dimensional stability

‐ Good impact resistance even at low temperature ‐ High chemical resistance ‐ Low specific gravity ‐ Feed compatibility FDA ‐ ECC 90/128 ‐ Hard to paint, stick or weld in high frequency ‐ Low weather resistance

Properties UM Metodo PE ‐

UHMW Density g / cm3 ISO 1183 ‐ DIN 53479 ‐ ASTM D

792 0,93

Feed compatibility (UE) ‐ EEC 90/128 Yes Feed compatibility (USA) ‐ FDA yes Tensile and break resistance N / mm2 ISO 527 30 Elongation at break % ISO 527 300 Tensile Elastic Modulus N / mm2 ISO 527 ‐ DIN 53455 700 Penetration resistance (Brinell) N / mm2 ISO 2039.1 ‐ DIN 53456 40 Hardness Shore (durometer) ‐ ISO 868 ‐ DIN 53505 ‐ ASTM D‐

2240 D62

Rockwell HR Hardness ‐ ISO 2039.2 R60 Charpy shock resistance, no carving KJ / m2 ISO 179 ‐ DIN 53453 n.b. Charpy shock resistance, with carving KJ / m2 ISO 179‐3C ‐ DIN 53453 n.b. Creep: strain 1 % in 1000 h N / mm2 ISO 899‐1 3 Minimum working temperature C° ‐ ‐200 Working temperature C° ‐ 80 Working temperature for short time with no load

C° ‐ 90

Strain at temperature HDT ‐ A C° ISO 75 40 Strain at temperature HDT ‐ B C° ‐ 130 Melting point W / Km DIN 52612 0,39 Thermal conductivity 10‐6 K‐1 ASTM E 831 DIN 53752 VDE

0304/1 160

Humidity absorption 50% u.r. % ISO 62 0 Water absorption (at saturation) % ISO 62 0,02 Oxygen Index ( LOI ) % ISO 4589 18 Behavior with flames UL 94 ‐ UL 94 HB

PLYPROPYLENE Very good chemical resistance. High impact resistance but not at low temperature.

‐ High chemical resistance ‐ Low specific gravity and low cost ‐ Easy workability ‐ Colors: gray RAL 7032, natural or black ‐ Lower mechanical, tensile, flexural, tear resistance than PE, because it’s stiffer ‐ Low resistance to oxidation agent ‐ Hard to paint, stick or weld in high frequency ‐ Low weather resistance

Properties UM Metodo PP Density g / cm3 ISO 1183 ‐ DIN 53479 ‐

ASTM D 792 0,91

Feed compatibility (UE) ‐ EEC 90/128 Yes(natural) Feed compatibility (USA) N / mm2 ISO 527 30 Tensile and break resistance % ISO 527 50 Elongation at break N / mm2 ISO 527 ‐ DIN 53455 1400 Tensile Elastic Modulus N / mm2 ISO 2039.1 ‐ DIN 53456 70 Penetration resistance (Brinell) ‐ ISO 868 ‐ DIN 53505 ‐

ASTM D‐2240 D70

Hardness Shore (durometer) ‐ ISO 2039.2 R64 Rockwell HR Hardness KJ / m2 ISO 179 ‐ DIN 53453 n.b. Charpy shock resistance, no carving KJ / m2 ISO 179‐3C ‐ DIN 53453 7 Charpy shock resistance, with carving N / mm2 ISO 899‐1 4 Creep: strain 1 % in 1000 h C° ‐ 0 Minimum working temperature C° ‐ 95 Working temperature C° ‐ 110 Working temperature for short time with no load

C° ISO 75 65

Strain at temperature HDT ‐ A C° ISO 75 100 Strain at temperature HDT ‐ B C° ‐ 160 Melting point W / Km DIN 52612 0,22 Thermal conductivity 10‐6 K‐1 ASTM E 831 DIN 53752

VDE 0304/1 160

Humidity absorption 50% u.r. % ISO 62 0 Water absorption (at saturation) % ISO 62 0,03 Oxygen Index ( LOI ) % ISO 4589 18 Behavior with flames UL 94 ‐ UL 94 HB

EXPANDED FOAMS CLOSE CELLS

MATERIAL APPLICATION WRIST

ORTHESES CERVICAL COLLAR

INSOLES POST‐SURGERY SHOE

PROSTHETIC LIMBS

PLASTAZOTE polyethylene expanded foam, close cells, low density

LD15 density 15 kg/m3, compression strength 90 KPa

White‐black

X


White‐black

X


White‐black

X


White‐black

X X X X X


White‐black

X X X X X

EVAZOTE co-polymeric ethylene foam

with close cells structure

VA25 density 25 kg/m3, compression strength 90 KPa

White X X

EV50 density 50 kg/m3, compression strength 110 KPa

White X X X

Plastazote and Evazote are thermoplastic expanded materials widely used in clinical environment in contact with the skin. Evazote is more resistant and elastic. They are pure and inert, with no residuum after expansion and a structure with uniform cellular walls. No latex contents, no toxic and hypoallergenic. These material are expanded with no moulds and have low deformation tendency during conversion. They are easy to transform into final products, and even make complex forms. They are suitable for thermo‐moulding process, both compressing and vacuum. It’s possible to divide, to mill, to cut with water‐jet, to butt weld them. • No toxic and safe • light and lasting • close cellular structure, waterproof • excellent chemical resistance • different density • Excellent thermal isolation • purity and meager odor • high resistance to lotions or creams • Easy to modeling • transparent to MNR e CAT • No CFC & HCFC

HOW TO USE AZOTE FOAMS: It’s possible to cut and modeling Azote foams, with a sharp cutter or scissor. These foam can be sawed, reduced, drilled, sanded, milled, moulded, cut with water‐jet, butt welded and laminated in order to obtain more thickness. Azote foams can be thermo‐moulded by heat and pressure to realize complex shapes. They can be used for several medical applications.

MODULAR ADAPTERS with RRF Electric shield treatment

FOOT ADAPTER with oval section Material: Hokotol(aluminium alloy) and titanium Hokotol mechanical characteristics are higher than Ergal ones.

TUBOLAR ADAPTERS Material: Hokotol (aluminium alloy) and titanium

Ceramic treatment which increase surface resistance and stump shielding in presence of scattered electric currents



FOOT ADAPTERS with centered and off‐centered pyramid Material: Hokotol( aluminium alloy) and titanium

CCOOSSMMEETTIICC CCOOVVEERRSS SSttaannddaarrdd ssiilliiccoonn ccoovveerr ffoorr RRooaaddwwaallkkiinngg ffoooott

Shore A Specific

volume Specific gravity

Mixed viscosity

Tear strenght Tensile strenght

40 25,08 1,07 35000cps 120 pli 800 psi

Code Shoe Number

Size Foot Length[mm]

2.002.01.01 35 22 220

2.002.01.02 36 22,5 226

2.002.01.03 37 23 232

2.002.01.04 38 24 240

2.002.01.05 39 25 248

2.002.01.06 40 25,5 255

2.002.01.07 41 26 260

2.002.01.08 42 26,5 265

2.002.01.09 43 27 270

2.002.01.10 44 28 276

RRF PU 35 COVER:

Densità: 35 kg/m^3 Colore: pelle Altezza blocco: cm. 50 (gamba) ‐ 100 (coscia)

NO FREON OR CLORURAL SOLVENT Density +/‐ 5% (Metodo ASTM D 3574‐86) Comp. resistance +/‐ 15% (Metodo DIN53577‐ISO 3386) Indentation +/‐ 15% (Metodo ISO 2439) Tensile resistance +/‐ 5% (Metodo ASTM D 3574‐86

COSTUM COSEMTIC COVERS: FOOT AND LEG It’s made a cast on the sound limb to make an aesthetic cover close to the sound limb. Material: silicon.

Characteristics Tensile resistance Def. Per.

Comp. Resistance 40% [KPa]

Indentation [N] Tensile strength[KPa]

Elongation [%]

Compression 50% 25% 40% 65%

3.9 140 165 285 110 215 2

REFRASCHINI

A family business company founded by Eligio Re Fraschini in 1946, now under the management of his sons Piero and Massimo. It consists of engineering dept., workshop, composite dept. and testing room with a total surface of 3300 sqm.

Now is directed by Piero Refraschini and Massimo Refraschini, each with direct experience acquired in different sectors. Piero is more oriented to the commercial and organizing fields; Massimo deals with customers and suppliers and thanks to his skills he helps run and coordinate production. They took over as managers in 1983; the first N.C. machine and relevant programming system CAD‐CAM were installed in 1986. This gave rise to modernization and technological development, which justifies the actual leading role of the Company in the field.

Activities: Engineering and manufacturing of tools and tooling equipment, CNC milled parts and limited series parts. Carbon fiber tools, big lay‐up tools, infusion tools, bonding tools, stretching tools and trimming tools, compression moulds, master models, drilling jigs.

The materials used are: Carbon fibers, aluminium, stainless steel, composite material, new testing materials.

Industries: Aeronautics and aerospace, Automotive, Marine and boat building, Racing.

Composite department: In 2002 the Firm introduced a new machinery in the composite material sector, thus arranging a vast area where modern machines and plants for the manufacturing of the equipment of such materials are installed. 4 new autoclaves have been installed, with a diameter to 2800 mm and 6 meters long. The pressure and the temperature are entirely computer‐controlled. It is possible to have automatic ventilation of the bags, a continual programmed recording of the internal temperature, the pressure, the specific local temperature and the vacuum of every single bag; reports of machine repairs and alarm process on request. A quality check report related to each variable of the above‐mentioned items available. Nitrogen pressurizing. Clean room Class 5000 with a surface of about 300 sqm including a dedicated area for automatic cut (Lectra Vector 2500). 3 refrigereted compartments, detaching material dedicated area with closed‐off cell under forced ventilation, postcure oven with internal dimensions 1000x 1000 x 1000, cycle monitored by programmer and paper recording and max temperature 350°C.

ALESSIO ABRAMI, associate of ModelCar, CarStudio e TecnoCar

Car Studio: Activities: Styling, Reverse Design, Engineering, Calculations Sector competences: Automotive, Trasportation, Motocycle, Earthmover Software: Catia, UniGraphics, ProE, Alias Studio, Computer Vision, Euclid

Model Car: Activities: Hand Modeling (style), Milling, Rapid Prototyping, Sintering, Silicone / Resin Mould, Zama / AL Moulding, Assembly, Dimensional Control "Poli"

Tecno Car: Activities: PUR Foaming, R.Rim Moulding, VTR Moulding, Assembly

Exemples of products: Alfa 166: Reverse Design Engineering, 3D Modelling Technologies: Termoforming, PU foaming, 3D modelling, rapid prototyping

ALINTEC

Politecnico Innovazione, now Alintec, supported ROADRUNNERFOOT ENGINEERING srl, which works in design, manufacturing and developments of prostheses in high tech materials, during the start‐up phase of this new company established by Daniele Bonacini, for technology transfer towards Roadrunnerfoot, to get new funds through National and European competitions and to improve organization and innovation of products and processes.

‐ In 2006‐2007 Politecnico Innovazione supported Roadrunnerfoot in drafting of its Business Plan, in its strategic placement and in managing of the intellectual property of 2 patents: one regarding Sprinter’s King competition foot, the other concerning Roadwalking foot.

brochure anno 2009 - · pdf filebrochure anno 2009. ... the two superior laminates function...

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