ANEXO 2: Fichas técnicas y manuales...N W A3 D Af i ni b o t A3 1 U s e r M a nu a l 1 . A s s e mb...

ANEXO 2: Fichas técnicas y manuales

TÍTULO:

FABRICACIÓN DIGITAL EN EL DISEÑO Y DESARROLLO DE PRÓTESIS

AUTOR: RIENDA MANRIQUE, JAVIER

FECHA DE PRESENTACIÓN: 9 de Julio, 2019

Anexo 2: Fichas técnicas y manuales

ÍNDICE DE FICHAS TÉCNICAS Y MANUALES

1. Ficha técnica Escaner 3DScanner XYZPrinting .............................................................. 3

2. Manual Impresora 3D Creality CR-10 ............................................................................. 5

3. Ficha técnica Plástico para impresión PLA Extrafill ....................................................... 31

4. Resina XTC3D .............................................................................................................. 32

5. Ficha Técnica Arandela Grower DIN127 ....................................................................... 34

6. Ficha técnica Tornillo Allen M10 DIN912 ...................................................................... 39

7. Adaptador piramidal de 4 agujeros 7H03CK ................................................................. 41

8. Ficha técnica Pilón ajustable......................................................................................... 43

9. Ficha técnica pie protésico Pro-Flex LP Torsion ........................................................... 45

10. Manual Liner para sistema de vacío Iceross Seal-In X5 ............................................... 49

XYZprinting, Inc.

Light and Portable Fast Scanning ability Full Body Mode Scan Engine

XYZprinting 3D Scanner

‧ Windows 8.1 and above (64-bit)‧ 4th Generation Intel® Core™ i5 Process (PC)‧ 4G RAM Basic (8G RAM Recommended)‧ USB 3.0‧ Desktop: NVIDIA GeForce GTX 750 ti (or above) with 2G VRAM‧ Laptop: NVIDIA GeForce GTX 840m (or above) with 2G VRAM

Hardware Requirement

Take it Wherever You GoUse the clip on the back of the XYZprinting 3D Scanner 1.0A to a tablet, laptop, or any other one of your favorite devices for increased portability.

https://global.xyzprinting.com/global_en/Home

£199

How IT Works

Specifications

HoldSimply hold it horizontally with your left hand.

ScanHold the scanner at 0.1 - 0.7 meters from the target and move the scanner steadily around the target to capture the images in different angles.

SaveEnjoy the digital replicas in just a few minutes.

PrintBring the replicas to life with your 3D printer!

Real Sense, Real PowerfulPowered by Intel® RealSense™ module, the XYZprinting 3D Scanner 1.0A is fast in both scanning ability and processing speed. It allows for a 3.93 - 27.55 inch operating range with the wide scanning distance of 5.9 - 9.84 inch, and the quality resolution of 640 x 480 at 30FPS.

Scan with EaseThe XYZprinting Handheld 3D Scanner 1.0A has a compact and light design which allows you to move it around the desired target for scanning with ease. No large, complicated equipment necessary!

Great AffordabilityAt just $249, the XYZprinting 3D Scanner 1.0A is the most versatile, lightweight, and affordable 3D scanner on the market.

Scan and PrintTurn your physical world into digital replicas, where you can modify them, and then reproduce them with 3D printing. Need to replace that broken part that you can't find in stores? Want to make a gift for someone but don't know how to 3D model it? Simply scan the desired objects to recreate them in different sizes, or change it completely to create new ones!

Scan Engine

Maximum Scan Volume (WxDXH)

Minimum Scan Volume (WxDXH)

Scan Resolution

Depth Image Size

Color Image Size

Operating Range

Data Interface

Dimension

Weight

Intel® RealSense™ Camera

Head Mode : 15.7 x 9.84 x 15.7 inch

Object Mode : 23.6 x 23.6 x 11.8 inch

Body Mode :39.3 x 39.3 x 78.7 inch

5cm x 5cm x 5cm

1.0 ~2.5mm

640 x 480 @ 30 FPS

640 x 480 @ 30 FPS

10 ∼ 70 cm

USB 3.0

41 x 157 x 61 mm

238g

XYZscan Handy/.stl, .obj, .ply

Windows 8.1 and above (64-bit)

4G RAM Basic (8G RAM Recommended)

Desktop: NVIDIA GeForce GTX 750 ti (or above) with 2G VRAM

Laptop: NVIDIA GeForce GTX 840m (or above) with 2G VRAM

Software

Output File Types

Operating System

Hardware

Minimum Hardware Requirement

Additional Requirements for Full Body Mode

XYZprinting, Inc. E-mail ▶ ▶

URL ▶ ▶

4th Generation Intel® Core™ i5 Process (PC)

Afinibot A31 User Manual

1. Assembly 2. Fine-Tuning 3. Leveling the Build Plate 4. Loading and Unloading Filament 5. Operation: The Four Steps of 3D Printing 6. Troubleshooting 7. Additional Resources

© 2017 NWA3D LLC Version 1.1

NWA3D Afinibot A31 User Manual

1. Assembly

1. Remove the parts from the box and remove any tape and padding from the parts.

Inspect the parts to make sure they were not damaged in shipment.

2. Install the gantry frame (A) to the base frame (B).

a. On the gantry frame, make sure the nozzle assembly is to the front, and the long vertical lead screw is to the back. On the base frame, make sure the black belt cover is on the front, and the stepper motor is on the back.

b. Use the M5x20 screws (4) and lock washers (4). Raise the base frame above the table with two blocks (boxes, books, etc.) Install the screws through the base frame into the threaded holes in the gantry frame. Tighten with the M5 hex key (Allen) wrench.

A B

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3. Install the two T-shaped frame reinforcement plates. The plate with the limit switch goes on the left. The plate without the limit switch goes on the right.

a. Loosen the t-nuts by hand and turn them so they will fit inside the grooves on the frames. You want the nuts to be loose so that when you tighten the bolts, the nuts will rotate 90° and grab onto the inside of the groove.

b. Align the nuts to the grooves and insert the T-shaped plates into the frames.

c. Tighten all eight bolts using the M4 hex key (Allen) wrench.

4. Attach the white PTFE Bowden tube coming out of the hot end to the yellow tube coupler on the extruder. Firmly push the tube into the connector on the extruder. You should feel it slide in and lock into place.

5. Cut and discard the tie wrap holding the nozzle to the gantry frame.

6. Install the filament spool holder.

a. Attach the bracket to the top of the power & control box using two thumbscrews. Tighten the screws by hand. Do not overtighten.

b. Remove the first nut from the double-nut side of the filament holder tube. Install the tube into the bracket and re-install the nut to hold it in place. Tighten the two nuts by hand so that the tube is snugly attached to the

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bracket. Do not overtighten.

c. Tighten the nut on the other end of the tube by hand. Do not overtighten.

7. Connect all electrical cables.

a. Put the power & control box on the left side of the printer with the screen facing forward.

b. On the right side of the power & control box, make sure the red voltage select switch reads “110V.” If it doesn’t, select “110V” by gently sliding the switch with a screwdriver or other tool.

c. Connect the heater cables to the power & control box. The cable for the build plate heater has four pins. The cable for the nozzle heater has eight pins. Rotate the connector until the pins slide easily into the socket. Do not force them. After the pins are fully inserted, hand-tighten the knurled nuts so they don’t become unplugged.

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d. Connect the stepper motor and limit switch cables. The Y cables go to the motor and switch at the back of the base frame that move the build plate. The Z cables go to the motor and switch on the left side of the base frame that raise and lower the nozzle. The X and E (extruder) cables go onto the gantry frame. The X cables go to the motor and switch that runs the belt and the E cable goes to the motor that feeds the filament. Hint: Install the smaller limit switch connectors first. Small hands are an advantage. Try not to bend the pin connectors as you push them in.

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e. Connect the power cord to the back of the power & control box and to a standard 110-volt electrical outlet.

f. Turn the power on using the switch on the back of the power &control box.

g. To operate the controls, rotate the button to scroll and push the button to select.

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2. Fine-Tuning

1. Adjust the tension of the build plate assembly on the Y-axis on the base frame. a. Check the tension of the build plate assembly. Hold the build plate carriage

under the build plate and try to wiggle it left and right. If the build plate assembly wiggles back and forth on the Y-axis track, it is too loose.

b. To tighten the build plate assembly, rotate the three eccentric nuts that connect the three wheels to the right side of the build plate assembly. Use the open-end wrench to rotate the nuts slightly—a quarter turn is usually enough—until each of the three wheels is snug against the Y-axis frame and the carriage no longer wobbles.

c. Re-check the tension of the build plate assembly. The assembly and the belt should move forward and backward without much effort, but there should have no side-to-side wiggle or play.

2. Adjust the tension of the gantry on the right pillar of the gantry frame. a. Check the tension of the gantry assembly at the right pillar of the frame. Hold

the gantry and try to wiggle it up and down. If the gantry wobbles on the right pillar frame, it is too loose.

b. To tighten the carrgantryiage, rotate the one eccentric nut that connects the wheel to the inside of the gantry. Use the open-end wrench to rotate the nut slightly—a quarter turn is usually enough—until the wheel is snug against the frame pillar and the gantry no longer wobbles.

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3. Adjust the tension of the nozzle assembly on the X-axis on the gantry frame. a. Check the tension of the nozzle assembly. Hold the mounting bracket behind

the nozzle and try to wiggle it back and forth. If the nozzle assembly wobbles on the X-axis track, it is too loose.

b. To tighten the nozzle assembly, rotate the one eccentric nut that connects the wheel to the bottom of the nozzle assembly. Use the open-end wrench to rotate the nut slightly—a quarter turn is usually enough—until the wheel is snug against the X-axis frame and the assembly no longer wobbles.

c. Re-check the tension of the nozzle assembly. The assembly and the belt should move left and right without much effort, but there should have no side-to-side wiggle or play.

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4. Check the tension of the belt driving the Y-axis (under the build plate). The belt should be taut, with no slack or slop. a. If the belt is loose:

Loosen the four bolts at the front of the base frame holding the belt follower pulley to the base frame.

Using an Allen wrench as a lever, push the follower pulley to tighten the belt.

Holding the belt taut, tighten the four bolts.

5. Check the tension of the belt driving the X-axis (on the gantry). The belt should be taut, with no slack or slop. a. If the belt is loose:

Loosen the two bolts at the right side of the gantry holding the belt follower pulley to the gantry.

Using an Allen wrench as a lever, push the follower pulley to tighten the belt.

Holding the belt taut, tighten the two bolts.

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3. Leveling the Build Plate

To build good parts, the build plate needs to be level, and the nozzle needs to be about 0.1–0.2mm from the build plate in all locations. If you have a LokBuild print surface, we recommend a distance of 0.20–0.25mm. This is about the thickness of two pieces of paper (or one piece folded in half to double its thickness). If you use painter’s tape as your print surface, we recommend a distance of 0.1mm. This is about the thickness of a single piece of paper. You want to adjust the height of the build plate so that you can barely slide the paper between the nozzle and the build plate with only a little resistance.

1. Select Control > Temperature > Bed. Turn the bed temperature to 55°. Then

navigate back to the Info Screen. This will heat the bed to actual printing conditions, making the leveling more accurate.

2. Select Prepare > Preheat PLA. This will heat the nozzle and melt any hardened plastic that might be on the nozzle and affect the leveling process.

3. Select Prepare > Auto home. This will move the nozzle to the home position at the front left corner of the build plate.

4. Select Prepare > Disable steppers. This will allow you to move the nozzle assembly (X axis) and build plate (Y axis) by hand.

5. Pro Tip: The Z axis stepper is also disabled, and you don’t want it to move at all. So you should handle the printer gently during the leveling process. Keep it flat and move the nozzle assembly carefully.

6. Wait for the print bed temperature to reach 55° and the nozzle temperature to reach 195°C. The Info screen displays this information below the nozzle and bed icons.

7. Slide a piece of paper between the nozzle and the build plate.

8. Adjust each of the four thumbscrews under the bed until the piece of paper slides, with just a tiny bit of drag, in all locations on the build plate.

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9. Select Prepare > Auto home, then Prepare > Disable steppers, and recheck in several places. This is to make sure the Z-axis lead screw didn’t rotate during the leveling process.

10. You may need to make fine adjustments to the bed level when you start printing. The first layer of the print will show whether the distance between the nozzle and build plate is correct. Refer to the following graphic.

a. If the bed is too low, the extruded plastic may not stick to the build plate. Parallel lines of filament on the first layer will look rough, with high tracks and low valleys that are not stuck to the build plate.

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b. If the bed is too high, the extruded plastic will squeeze out the sides of the nozzle. The nozzle will plow through the plastic and leave a first layer that is too thin.

c. You can try to carefully adjust the thumbscrews during the first layer of the build while the plate is moving until the distance between the build plate and the nozzle is producing smooth extruded lines. Be careful of the moving parts to not get pinched.

d. After you have fine-tuned the bed level during the first layer, you may want to stop the build, clear the build plate, and restart the build.

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4. Loading and Removing Filament 1. Loading filament

a. Load a spool of filament into the spool holder.

b. Cut off the used or bent end of the filament at an angle and it will be easier to feed into the extruder and Bowden tube.

c. Feed the end of the filament into the extruder with one hand as you squeeze the extruder release lever with your other hand.

d. Push the filament all the way through the Bowden tube until it stops when it hits the back of the nozzle.

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e. Select Prepare > Preheat PLA.

f. When the printer is fully heated, check to make sure the filament is fully loaded. This also removes all of the previous material left in the printer from other prints. To do this, manually push filament through the heated nozzle until the new color begins coming out of the nozzle.

g. Pro Tip: Never leave the printer preheated with material inside of it for long periods of time. This will cause the filament to bake inside of the nozzle assembly and can cause it to clog.

2. Removing filament To remove the filament cleanly, you should do a “soft pull.” This involves heating the nozzle to 100°C, then pulling the filament out of the printer. a. Select Prepare > Preheat PLA and wait until the nozzle temperature reaches

100°C. (You can also select Control > Temperature > Nozzle, spin the temperature to 100°C, and then navigate back to the Info Screen.)

b. Wait for the nozzle to reach the set temperature.

c. When the nozzle temperature is 100°C, squeeze the extruder release lever with one hand and pull the filament out of the extruder with your other hand in one fluid motion.

d. Cut the end of the filament to remove the partly melted plastic.

e. Pro Tip: Feed the end of the filament into the hole on the side of the spool. This will insure it doesn’t get tangled and cause a build to fail the next time you use it.

f. Remove the filament spool from the spool holder.

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5. Operation: The Four Steps of 3D Printing

3D printing involves four steps: 1. Create or find a 3D file 2. Slice the file for 3D printing 3. Send the file to the printer 4. Print!

1. Create or find a 3D file

a. You can create a 3D model—a digital geometry—using any CAD (computer-aided design) software program. We recommend free programs, such as TinkerCAD, OnShape, and Blender. Another is SketchUp, which has free licenses available for schools. These programs take some time to learn, and can be challenging. But they are also rewarding, especially when you see your own creation being printed on your 3D printer! Every CAD program allows users to save or export digital files for 3D printing. You want to save your file as an STL file (“filename.stl”). The STL file is the standard file format for 3D printing. In some programs, it’s as easy as the Save command. In others, you need to select the File > Export option, and choose the STL format. OBJ files can also be sliced and 3D printed.

b. You can find 3D models in many online libraries of digital content. Thingiverse.com, GrabCAD.com, and Instructables.com are examples, and many other sites exist.

2. Slice the file for 3D printing Slicing is the process of converting your 3D model into the layered print language your printer can understand, called G-Code. We recommend using free, open-source slicer programs. Our favorite slicers are Cura and Repetier Host. Both are free and easy to use. We’ve included Cura and its setup .ini file on your printer’s SD card because it’s easier for beginners. We recommend that you install Cura on a PC or Mac and use it to do your slicing. There are a lot of slicers that will create G-Code automatically for your printer. All you have to do is input the correct settings for your printer (using the files we included), import your 3D model, and click slice! It’s that easy.

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https://www.blender.org/

http://www.sketchup.com/

https://ultimaker.com/en/products/cura-software/list

https://www.tinkercad.com/

https://www.instructables.com/

https://www.thingiverse.com/

https://www.onshape.com/

https://grabcad.com/

https://www.repetier.com/


a. Install the Cura program on a PC or Mac.

b. Open the Cura application. You’ll be given several options. In the Configuration Wizard, choose the RepRap Machine and Mendel in other machine settings (RepRap (Marlin/Sprinter) G-Code Flavor, if it asks).

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c. Once you add the new machine, click Machine > Machine settings and change the machine settings to: Max width 300, Max depth 300, Max height 400, Extruder count 1, and check Heated bed. You can also rename the machine to “A31” or “Our Giant 3D Printer” if you’d like. Click “OK.”

d. Select File > Open Profile and select “NWA3D A31 Printer Profile.ini” from the microSD card. This is the medium-quality settings for the A31 printer.

e. The “A31 Printer Profile.ini” settings in Cura for the A31 are shown on a screen capture on the microSD card. They are also shown in the following image.

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f. Use these default settings for printing. You may need to change the support type to “Everywhere” depending on the shape of the part you are printing. Also, you can change the layer height from 0.2mm to 0.1mm for a smoother part, although the print will take longer. As you become more advanced with 3D printing, you may want to experiment with many settings. But remember that you can always revert to these default settings at any time, or ask us for help at nwa3d.com/support.

g. Load the model file in Cura. Rotate the file to the best orientation for printing. You may want to scale the file at this point as well.

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https://www.nwa3d.com/support/


h. When you are satisfied with the Cura settings and the position, orientation, and scale of the model, select the “Save toolpath” (or “SD” if the microSD card is inserted) icon or File > Save GCode. Save the file to the microSD card that came with your printer.

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3. Send the file to the printer

a. After saving the G-Code to the it, remove the microSD card from the computer.

b. Insert the microSD card, upside-down, into the slot on the right side of the control box.

c. By using this method, no computer needs to be plugged into your printer and it will run autonomously until the print is finished.

4. Print!

a. On the A31 control screen, select Init./Change SD card, the last selection on the bottom of the main screen.

b. Select Print from SD.

c. Select your print (.gcode) file.

d. Watch the 3D printer create your model!

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6. Troubleshooting This section covers the most common printing problems and how to fix them. Because 3D printing is still an emerging technology, a small level of tinkering and troubleshooting is needed. But if this section doesn’t solve your printing problems, then contact us by filling out the Troubleshooting Request on our website. We’re here to help you every step of the way to get you 3D printing!

1. Step-by-Step Troubleshooting

a. Step 1: Diagnose the problem. This may seem obvious, but many problems can be solved if you take a step back and see exactly what the printer is doing incorrectly.

b. Step 2: Determine if the problem is mechanical or digital.

● Mechanical problems are in the actual operation of the printer, such as the motors that drive the X, Y, and Z axes, the motor that pushes the filament, the nozzle heater, and the level of the build plate. The most common mechanical problems are caused by a build plate that is not adjusted correctly, a clogged nozzle, or an unplugged connector on a motor or limit switch.

● Digital problems are in the slice file that you prepare in Cura or other slicing program. Important slice file settings include layer height, print (nozzle) temperature, and print speed.

c. Step 3: Fix the problem. Once you’ve discovered what the actual problem is, you can fix it with the following procedures. (If none of these fix the problem, contact us.)

2. Digital problems: Slicer settings

a. Check your slice file in Cura. Make sure the print is centered in the build area, making good contact with the build surface, and isn’t too big for the build envelope.

b. Check the slice settings. Make sure that the layer height is between 0.1mm (high quality prints) and 0.3mm (low quality prints).

c. Check the speed and temperature. For PLA, they should be set to 30–50mm/s and 230°C.

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https://www.nwa3d.com/support



d. Make sure the filament diameter is 1.75mm and the flow rate is 100%.

e. Check the Fill Density (infill) and make sure it is at least 5%. You may need to adjust this value to your liking for your model.

f. Your part may need supports. If it’s rounded you may need to select “Everywhere” for the support type. If it’s intricate, it may need to select “Raft” for the Platform adhesion type. A raft is a hatch pattern on the build plate that the model will print on. If the part warps when you begin to build it, you may need to select “Brim” Adhesion support type and reslice the file. (A brim will help the part stick so it doesn’t curl up at the edges.)

If your slice settings are really messed up, try re-loading the Printer Profile.ini file from the microSD card. The profile will configure medium quality settings that will automatically reset all the values to ones that will work well. Click File > Open Profile to navigate to the printer profile “NWA3D A31 Printer Profile.ini” that came on the microSD card in the Cura folder.

3. Mechanical problem: Leveling the build plate

Many of the failures in 3D printing are caused by a build plate that is not level or is not the correct distance from the nozzle. See the section “Leveling the Build Plate” in this manual.

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4. Mechanical problem: Filament is not coming out of the nozzle

When filament is not coming out of the nozzle, the nozzle may be clogged. You have several options for clearing a clogged nozzle.

● You can pull the clog backward out of the nozzle using the “soft pull” method. ● You can “floss” the clog out of the nozzle using a nozzle cleaner while the

nozzle is heated. ● You can heat the nozzle and push the clog through the nozzle.

This video explains how to unclog a nozzle

NOTE: Never leave your printer nozzle at build temperature (220°C) while the printer is idle. The melted plastic remaining in the nozzle will “bake” onto the nozzle and become a hard carbon blockage.

a. Try to pull the clog out of the nozzle using the “soft pull” method:

● Turn the machine on, select Prepare PLA, and wait until the temperature reaches 100°C.

● When the nozzle temperature reaches 100°C, squeeze the extruder release lever with one hand and pull the filament out of the extruder with the other hand.

● Inspect the end of the filament. If the end of the filament has the shape of interior of the nozzle—a thicker cone-shaped plug—you have successfully pulled all of the filament out of the nozzle, including the clog.

● If the clog did not clear using the “soft pull” method, repeat the process.

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https://www.youtube.com/watch?v=_GhEMJ35k8Q&t=6s


NOTE: Every time you change filament on your 3D printer, remove the filament with the nozzle at around 100°C. This method usually removes all the old color of filament from the hot end, so when you begin printing again, the new color will begin printing immediately.

b. Use a nozzle cleaner to clear the nozzle:

● Select Prepare > Preheat PLA. Wait for the nozzle to reach the set temperature of 195°C for PLA.

● Raise the Z-axis carriage by selecting Prepare > Move axis > Move 1mm > Move Z and spinning the knob. (You can also manually rotate the lead screw to move the carriage up.)

● When the nozzle has reached 195°C, carefully insert the nozzle cleaner up into the tip of the nozzle. Squeeze the extruder release lever with one hand and push the filament into the extruder with your other hand.

● Alternate “flossing” with the nozzle cleaner and pushing the filament through the extruder until a consistent bead of filament is extruded through the nozzle.

● Reload the filament and move on to step c.

c. Try to push the clog through the nozzle:

● Select Prepare > Preheat PLA. Wait for the nozzle to reach the set temperature of 195°C for PLA.

● When the nozzle has reached 195°C, squeeze the extruder release lever with one hand and push the filament into the extruder with your other hand.

● Watch to see if any plastic is coming out of the nozzle.

● Turn the machine off and wait 10 minutes. The nozzle needs to cool down completely.

● Do a “soft pull” (step a.) to remove remaining filament in the nozzle.

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7. Additional Resources

nwa3d.com NWA3D’s Troubleshooting Form How to unclog a nozzle Simplify3D Troubleshooting page provides good explanations and photographs of common problems in 3D printing: https://www.simplify3d.com/support/print-quality-troubleshooting/

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https://www.nwa3d.com/


https://www.youtube.com/watch?v=_GhEMJ35k8Q&t=6s

https://www.simplify3d.com/support/print-quality-troubleshooting/

PLA Extrafill

Physical properties Typical Value Test Method Test Condition Material density 1,24 g/cm3 ASTM D792

Melt flow index 6 g/10 min ASTM D1238 210 °C, 2,16 kg

Diameter tolerance ± 0,05 mm

Weight 750 g of filament (+ 250 g spool)

Mechanical properties Typical Value Test Method Test Condition

Tensile strength 60 MPa ASTM D882 at yield

53 MPa ASTM D882 at break

Elongation at break 6 % ASTM D882

Tensile modulus 3600 MPa ASTM D882

Flexural strength 83 MPa ASTM D790

Flexural modulus 3800 MPa ASTM D790

Izod impact strength 16 J/m ASTM D256 23 °C, notched

Thermal properties Typical Value Test Method Test Condition Glass transition temperature 55–60 °C ASTM D3418

Heat distortion temperature 55 °C ASTM E2092 0,45 MPa

Printing properties Recommended Notes Print temperature 190–210 °C Recommended settings!

It may differ according to the printer and the object. Try your own settings before printing. Hot pad 50–60 °C

Bed adhesive Magigoo

Workability of 3D printing filament is at least 12 months from delivery. The information was processed with the best knowledge of the manufacturer and it is for information only. Fillamentum Manufacturing Czech s.r.o. (+420) 720 060 947 nam. Miru 1217, 768 24 Hulin [email protected] Czech Republic www.fillamentum.com

Description:

Fillamentum PLA Extrafill is a material for the FFF (also known as FDM) 3D printing technology.

The advantage of this material is that it can be used in 3D printers easily, that it allows a high quality of printing even in tricky details and an excellent lamination of the printed object.

PLA filament is made of natural ingredients and is easily biodegradable by composting. It complies with the require-ments for food contact.

The material may be used for production of electrical and electronic equipment. It doesn’t contain the restricted substances.

Fillamentum guarantees high precision of filament dimensions within the tolerance of +/- 0,05 mm, which is strictly controlled throughout the production.

Printing filaments reported on the marked under the trademark Fillamentum are produced in a wide variety of colours in accordance with the colour charts RAL and Pantone, and also in own unique colour ranges.

Fillamentum guarantees high precision of filament dimensions within the tolerance +/- 0,05 mm, which is strictly controlled throughout production.

PRODUCT OVERVIEWXTC-3D™ is a protective coating for smoothing and finishing 3D printed parts. It does not melt plastic. Two liquids are mixed together and brushed onto any 3D print. Coating self-levels and wets out uniformly without leaving brush strokes. Working time is 10 minutes and cure time is about 4 hours (depending on mass and temperature). XTC-3D™ cures to a hard, impact resistant coating that can be sanded, primed and painted. Adding colors and metal effects is easy.

Inexpensive to Use – 1 oz covers 100+ square inches (see coverage information below).

90% Time & Labor Savings: XTC-3D™ fills in 3D print striations and creates a smooth, high gloss finish. The need to post finish is almost eliminated.

Coat any 3D Print Surface - XTC-3D™ can be applied to both SLA and SLS prints. It works with PLA, ABS, Laywoo, Powder Printed Parts and other rigid media. It also can be used to coat EPS, EPDM and urethane foam as well as wood, plaster, fabric, cardboard and paper.

XTC-3D™ does not contain VOC’s, phthalates or phosphates.

XTC-3D™High Performance 3D Print Coating

www.smooth-on.com

PROCESSING RECOMMENDATIONSPreparation – Materials should be stored and used in a room temperature environment (73°F/23°C). Elevated temperatures will reduce Pot Life. XTC-3D™ Part A resin and Part B Hardener must be properly measured and thoroughly mixed to achieve full, high-strength, solid-cure properties. Because no two applications are quite the same, a small test application to determine suitability for your project is recommended if performance of this material is in question.

Avoid eye and skin contact. Avoid breathing fumes - use in a well ventilated area. NIOSH approved respirator is recommended. Wear safety glasses, long sleeves and rubber gloves to minimize skin contact. This material has a high exotherm (generates heat). Do not mix components in glass or foam containers.

Coverage – A very small amount of XTC-3D™ is needed to coat an average size 3D print. 1 oz / 28.3 grams of mixed material will cover 101 in2 (651 cm2) applied at 1/64” (.04 cm) thickness.

Pre-Mix Part B: Before using, shake container vigorously.

Measuring and Dispensing – You need to be accurate in measuring for XTC-3D™ to cure properly. Parts A and B can be measured by either volume or weight. Dispense proper proportions of parts A and B into clean plastic, metal or wax-free paper containers (do not use foam or glass cups).

Extending Working Time - If left in a mixing cup with a concentrated mass, pot life will be short and material may cure in your cup due to exotherm. Important - Reduce the mass of the mixture to increase working time. Example: layer two sheets of aluminum foil together and create a single-use flat tray with vertical sides to contain the liquid resin. After mixing parts A and B, pour mixture into the aluminum foil to reduce the mass. Your working time will be significantly increased.

Mixing – Be sure mixing utensils have a square edge and are clean. Combine and mix proper amounts of Parts A and B. Mix thoroughly for at least 1 minute. Aggressively scrape the sides and bottom of mixing container several times. Use the square edge of mixing stick to bring material off of the sides and bottom of container and blend.

Important - Mixed XTC-3D™ Resin is exothermic, meaning it generates heat. A large, concentrated mass of mixed material in a container can generate enough heat to melt a plastic cup, burn your skin or ignite combustible materials. If material begins to exotherm, move it outside to an open air environment.

Material Properties

Mix Ratio By Volume 2A : 1B

Mix Ratio By Weight 100A : 42B

Mixed Viscosity - CPS. (ASTM D2393) 350

Specific Gravity - Mixed; g./c.c. (ASTM D1475) 1.09

Spec. Volume - Mixed; cu. in./lb. (ASTM D792) 25.1

Pot Life In Mass - (ASTM D2471)* 10 minutes

Pot Life In Flat Tray (Reduced Mass) 15 Minutes

Thin Film Working Time 20 minutes

Thin Film Tacky Recoat Time 90 minutes

Thin Film Tack Free Time 2 hours

Cure Time In Mass (100 g) 2 hours

Cure Time In Thin Layer 3.5 hours

Color In Thin Layer(Slightly Yellow In Thick Sections) Clear

Shore D Hardness (ASTM D2240)** 80D

* Dependant on mass ** Value measured after 7 days at 73°F / 23°C

Adding Color - XTC-3D™ can be colored with UVO™ or IGNITE™ colorants. Pre-mix color with Part A before combining with Part B.

Adding Fillers - A variety of dry fillers can be added such as Cast Magic™ or bronze or other metal powders, Glow Worm™, Quarry Tone™ or Ure-Fil™ powders. The maximum filler load is an amount equal to Part A by volume. Pre-mix filler with Part A before combining with Part B.

Applying XTC-3D™ - Use a disposable chip brush or foam brush to apply XTC-3D™. To achieve the thinnest coating possible we recommend applying material with a foam brush. Brushing on one thin layer of mixed material is recommended for most prints to create a smooth, uniform coating: less than 1/64“(.039 cm). To avoid drips and runs, continue brushing and working the surface until the resin begins to set up. For particularly complicated prints with intricate detail you may want to coat one a section at a time for better control. XTC-3D™ bonds to itself.

If Adding More Layers - allow first layer to partially cure until “tacky hard” before applying the next layer. For best results, each layer should be applied thinly: less than 1/64“(.039 cm).

Curing: One layer will cure tack free in about 2 hours at room temperature (73°F/23°C). Mild heat (150° F/60° C) will cure material within 15 minutes. Be careful: some 3D print media will melt at temperatures above 200°F. Fully cured material will be hard and unable to penetrate with a finger nail.

Post Finishing – Cured material can be machined or sanded (wear NIOSH approved respirator mask to prevent inhalation).

Painting – XTC-3D™ can be painted and/or primed and then painted with acrylic enamel paints. For best results, lightly sand surface prior to painting.

Thinning XTC-3D™ for Coating Starch / Powder Printed Parts: Viscosity can be lowered with acetone or denatured alcohol to penetrate porous parts.

Mix Ratio Cure TimeThin: Mix 200 Parts A + 100 Parts B + 25 Parts Solvent. 12 Hours

Thinner: Mix 200 Parts A + 100 Parts B + 50 Parts Solvent. 24 Hours

The more solvent added, the longer XTC-3D™ will take to cure. Cured material will be more flexible.

Smoothing Surface – granular surface texture can be smoothed by applying a second coat of XTC-3D™ (for glossy finish) or lightly sanding for matte finish.

Applying a Release Agent – For applications where adhesion is not desired, a spray release Ease Release 200 available from Smooth-On may be used.

Removing Uncured Material: Scrape as much material as possible from the surface using a scraper. Clean the residue with E-POX-EE KLEENER™ available from Smooth-On, lacquer thinner, acetone or alcohol. Follow safety warnings pertaining to solvents and provide adequate ventilation.

Making Molds of Models Coated with XTC-3D™: Liquid mold making rubbers will adhere to cured XTC-3D™. Before mixing and applying Smooth-On silicone or urethane mold making rubbers, apply a thorough coating of Ease Release™ 200 or 205 release agent over cured XTC-3D™ and let dry.

Safety First!

The material safety data sheet (MSDS) for this or any Smooth-On product should be read before using and is available on request. All Smooth-On products are safe to use if directions are read and followed carefully.

XTC-3D™ Resin PART A:

WARNING: IRRITANT TO EYES, SKIN & MUCOUS MEMBRANES.

XTC-3D™ Resin is irritating to the eyes and skin. Avoid prolonged or repeated skin contact to prevent possible sensitization. Avoid breathing vapors and use only with adequate ventilation. Wear personal protective equipment.

First Aid: In case of eye contact, flush thoroughly with water for 15 minutes and get immediate medical attention. In case of skin contact, wipe clean with white vinegar and wash thoroughly with soap and water. If irritation persists, get medical attention. If swallowed, do not induce vomiting. Drink 1 - 2 glasses of water and get immediate medical attention.If vapors are inhaled or if breathing becomes difficult, remove person to fresh air. If symptoms persist, get medical attention.

Keep Out Of Reach Of Children.

XTC-3D™ PART B Hardener:

WARNING: IRRITANT TO EYES, SKIN & MUCOUS MEMBRANES.

Epoxy Hardeners are corrosive materials and can cause severe eye and skin burns. They are sensitizers that may cause dermatitis from skin contact or vapor inhalation. Use these products only with adequate ventilation. Remove contaminated clothing and wash from skin with soap and water.

First Aid: In case of eye contact, flush thoroughly with water for 15 minutes and get immediate medical attention.

Keep Out Of Reach Of Children.

IMPORTANT: The information contained in this bulletin is considered accurate. However, no warranty is expressed or implied regarding the accuracy of the data, the results to be obtained from the use thereof, or that any such use will not infringe upon a patent. User shall determine the suitability of the product for the intended application and assume all risk and liability whatsoever in connection therewith.

Call Us Anytime With Questions About Your ApplicationToll-free: (800) 381-1733 Fax: (610) 252-6200

The new www.smooth-on.com is loaded with information about mold making, casting and more. 050719-JR

All your fastener needs from a single source

Aspen Fasteners 4807 Rockside Road, Suite 400, Independence, OH 44131 USA www.aspenfasteners.com | [email protected] | 1-800-479-0056

Headquarters: Independence OH USA; Montreal QC Canada;

Distribution Centers: Boston MA; Chicago IL; Cincinnati KY; Dallas TX; Denver CO; Houston TX; Jersey City NJ; Los Angeles CA; Miami FL; San Francisco CA; Seattle WA; Washington VA; Toronto ON; Calgary AB; Vancouver BC; Jiutepec (Temixco); Mexico City; Monterrey

Product Dimensions and Weights DIN 127 Specifications

Metric DIN 127 Helical Spring Split Lock Washers

Nominal Diameter

D min. D max. D1

max. B S H min. H max.

Weight kg /1000pcs

M2 2.1 2.4 4.4 0.9 ± 0.1 0.5 ± 0.1 1 1.2 0.033

M2.2 2.3 2.6 4.8 1 ± 0.1 0.6 ± 0.1 1.2 1.4 0.05

M2.5 2.6 2.9 5.1 1 ± 0.1 0.6 ± 0.1 1.2 1.4 0.053

M3 3.1 3.4 6.2 1.3 ± 0.1 0.8 ± 0.1 1.6 1.9 0.11

M3.5 3.6 3.9 6.7 1.3 ± 0.1 0.8 ± 0.1 1.6 1.9 0.12

M4 4.1 4.4 7.6 1.5 ± 0.1 0.9 ± 0.1 1.8 2.1 0.18

M5 5.1 5.4 9.2 1.8 ± 0.1 1.2 ± 0.1 2.4 2.8 0.36

M6 6.4 6.5 11.8 2.5 ± 0.15 1.6 ± 0.1 3.2 3.8 0.83

M7 7.1 7.5 12.8 2.5 ± 0.15 1.6 ± 0.1 3.2 3.8 0.93

M8 8.1 8.5 14.8 3 ± 0.15 2 ± 0.1 4 4.7 1.6

M10 10.2 10.7 18.1 3.5 ± 0.2 2.2 ± 0.15 4.4 5.2 2.53

M12 12.2 12.7 21.1 4 ± 0.2 2.5 ± 0.15 5 5.9 3.82

M14 14.2 14.7 24.1 4.5 ± 0.2 3 ± 0.15 6 7.1 6.01

M16 16.2 17 27.4 5 ± 0.2 3.5 ± 0.2 7 8.3 8.91

M18 18.2 19 29.4 5 ± 0.2 3.5 ± 0.2 7 8.3 9.73

M20 20.2 21.2 33.6 6 ± 0.2 4 ± 0.2 8 9.4 15.2

Cont…

http://www.aspenfasteners.com/

mailto:[email protected]






Nominal Diameter

D min. D max. D1

max. B S H min. H max.

Weight kg /1000pcs

M22 22.5 23.5 35.9 6 ± 0.2 4 ± 0.2 8 9.4 16.5

M24 24.5 25.5 40 7 ± 0.25 5 ± 0.2 10 11.8 26.2

M27 27.5 28.5 43 7 ± 0.25 5 ± 0.2 10 11.8 28.7

M30 30.5 31.7 48.2 8 ± 0.25 6 ± 0.2 12 14.2 44.3

M36 36.5 37.7 58.2 10 ± 0.25 6 ± 0.2 12 14.2 67.3

M39 39.5 40.7 61.2 10 ± 0.25 6 ± 0.2 12 14.2 71.7

M42 42.5 43.7 66.2 12 ± 0.25 7 ± 0.25 14 16.5 111

M45 45.5 46.7 71.2 12 ± 0.25 7 ± 0.25 14 16.5 117

M48 49 50.6 75 12 ± 0.25 7 ± 0.25 14 16.5 123

M52 53 54.6 83 14 ± 0.25 8 ± 0.25 16 18.9 162

M56 57 58.5 87 14 ± 0.25 8 ± 0.25 16 18.9 193

M60 61 62.5 91 14 ± 0.25 8 ± 0.25 16 18.9 203

M64 65 66.5 95 14 ± 0.25 8 ± 0.25 16 18.9 218

M68 69 70.5 99 14 ± 0.25 8 ± 0.25 16 18.9 228

M72 73 74.5 103 14 ± 0.25 8 ± 0.25 16 18.9 240

M80 81 82.5 111 14 ± 0.25 8 ± 0.25 16 18.9 262

M90 91 92.5 121 14 ± 0.25 8 ± 0.25 16 18.9 290

M100 101 102.5 131 14 ± 0.25 8 ± 0.25 16 18.9 318

All measurements are in mm

Metric DIN 127 Helical Spring Split Lock Washers are commonly used metric lock washers – It is a split metal ring that is bent into a helical shape. Split Lock Washers are a left hand helix and allow the nut to be tightened in a right hand direction only. When compressed by tightening the nut, the washer bites into the substrate and exerts a spring force between the bolt and the substrate creating frictional resistance to rotation. Aspen Fasteners offers over 500,000 unique fastener products from stock in inch and metric standard in a variety of materials and finishes. The following sizes of DIN 127 Helical Spring Lock Washers are available for immediate shipping from stock: Diameters ranging from M3 to M72 in steel and stainless steel A2 and A4. View parts by clicking on the following link: DIN 127 Helical Spring Lock Washers

DIN (Deutsches Institut für Normung - German Institute for Standardization) standards are issued for a variety

of components including industrial fasteners as Metric DIN 127 Helical Spring Split Lock Washers. The DIN

standards remain common in Germany, Europe and globally even though the transition to ISO standards is

taking place. DIN standards continue to be used for parts which do not have ISO equivalents or for which

there is no need for standardization as in the case for DIN 127 Helical Spring Split Lock Washers.




http://www.aspenfasteners.com/Metric-Standard-Fasteners-s/1917.htm





1) Mechanical properties of stainless steel for metric DIN 127 Helical Spring Split Lock Washers

Stainless steels can be divided into three groups of steel - austenitic, ferritic and martensitic. Austenitic steel is by far the most common type (>90% of commercial fasteners). The steel groups and strength classes are designated by a four-digit sequence of letters and numbers (eg A2-70) as shown in the following table. DIN EN ISO 3506 governs screws and nuts made from stainless steel.

Steel group

Steel grade

Strength

class

Screws, Nuts and Bolts

Tensile

strength N/mm2

Tensile

strength PSI

Dia range

Nut Load

N/mm2

Austenitic

A2 and A4

50 500 70,000 <=M39 500

70 700 100,000 <=M20 700

80 800 118,000 <=M20 800

The tensile stress is calculated with reference to the tensile stress area (see DIN EN ISO 3506-1979). Nuts to be paired with same grade of stainless steel screws

Steel

group

Property

Strength

class

Made From

Characteristics

Austenitic

50 A1, A2 Soft; cold worked, turned and soft pressed fasteners

70,000

<=M39

500

70 A2, A4 Cold worked, normal strength formed fasteners

fasteners

70,000

<=M39

500

80 A2, A4 Extreme cold worked, high strength, special applications fasteners fasteners

70,000

<=M39

500








2) Chemical composition of stainless steel metric DIN 127 Helical Spring Split Lock Washers

Grade

USA Grade

Material

designation

Material

no.

C

%

Si

≤ %

Mn

≤ %

Cr

%

Mo

%

Ni

%

A 2

304

X 5Cr Ni 1810

1.4301

≤

0.07

1.0

2.0

17.5

to

19.5

-

8.0

to

10.5

X 2 Cr Ni 1811

1.4306

≤

0.03

1.0

2.0

18.0

to

20.0

-

10

to

12.0

X 8 Cr Ni 19/10

1.4303

≤

0.07

1.0

2.0

17.0

to

19.0

-

11.0

to

13.0

A 4

316

X 5 Cr Ni Mo 1712

1.4401

≤

0.07

1.0

2.0

16.5

to

18.5

2.0

to

2.5

10.0

to

13.0

X 2 Cr Ni Mo 1712

1.4404

≤

0.03

1.0

2.0

16.5

to

18.5

2.0

to

2.5

10

to

13

3) Chemical composition of steel metric DIN 127 Helical Spring Split Lock Washers

PROPERTY

CLASS

MATERIAL AND TREATMENT

CHEMICAL COMPOSITION LIMITS %

TEMPERING TEMP ºC MIN. C P S

min. max. max. max.

4.6, 4.8, 5.8, 6.8 Low or medium carbon steel - 0.55 0.05 0.06 -

8.8 Medium carbon steel quenched, tempered 0.25 0.55 0.04 0.05 425

9.8 Medium carbon steel quenched, tempered 0.25 0.55 0.04 0.05 425

10.9 Medium carbon steel additives e.g. boron, Mn, Cr or

Alloy steel - quenched, tempered 0.20 0.55 0.04 0.05 425

12.9 Alloy steel - quenched, tempered 0.20 0.50 0.035 0.035 380








4) Mechanical properties of steel for metric DIN 127 Helical Spring Split Lock Washers

MECHANICAL PROPERTY

PROPERTY CLASS

4.8

5.6

5.8

6.8

8.8

9.8

10.9

12.9 Up to M 16

Over M 16

Tensile Strength (Rm, N/mm²)

nom. 400 500 600 800 900 1000 1200

min. 420 500 520 600 800 830 900 1040 1220

Vickers Hardness min. 130 155 160 190 250 255 290 320 385

max 250 320 336 360 380 435

Brinell Hardness min. 124 147 152 181 319 242 266 295 353

max. 238 385 319 342 363 412

Rockwell Hardness

min. HR 71 79 82 89 -

HRC - - - - 20 23 28 32 39

HR 95 99 -

max. HRC - - - - 32 34 37 39 44

Yield Stress ReL. N/mm²

nom. 320 300 400 480 -

min. 340 300 420 480 -

Stress at permanent set limit N/mm²

nom. - 640 720 900 1080

min. - 640 660 720 940 1100

Disclaimer Dimensional data and technical information for Metric DIN 127 Helical Spring Split Lock Washers was obtained from publicly available sources and not acquired through standards agencies. It has been completed and compiled for reference purposes only; where discrepancies are found they are subject to change without notice. Aspen Fasteners makes no warranties or representations regarding the accuracy and validity of the compiled information and data. Contact the relevant standards authorities for accurate and detailed information.




www.opac.net

TORNILLERÍA 12.9 DE ALTA RESISTENCIA12.9 HIGH STRENGTH FASTENERS • VISSERIE 12.9 À HAUTE RÉSISTANCE • PARAFUSOS 12.9 DE ALTA RESISTÊNCIA

DM2

(x0,40)M2,5

(x0,45)M3

(x0,50)M4

(x0,70)M5

(x0,80)M6

(x1,00)M8

(x1,25)M10

(x1,50)M12

(x1,75)

D1 (max.) 3,8 4,5 5,68 7,22 8,72 10,22 13,27 16,27 18,27

D2 (max.) 2,6 3,1 3,6 4,7 5,7 6,8 9,2 11,2 13,7

K (max.) 2 2,5 3 4 5 6 8 10 12

S nom. 1,5 2 2,5 3 4 5 6 8 10

L1* (min.) 16 17 18 20 22 24 28 32 36

Sección útil mm2 2,07 3,39 5,03 8,78 14,2 20,1 36,6 58 84,3

N.m 0,69 1,43 2,48 5,85 12,0 20,3 48,8 97,5 165

L

4 5 5 5 6 8 10 10 12

5 6 6 6 8 10 12 12 15

6 8 8 8 10 12 14 15 16

8 10 10 10 12 14 15 16 20

10 12 12 12 14 15 16 18 25

12 15 14 15 16 18 20 30

16 15 16 18 20 22 35

20 16 18 20 22 25 40

25 18 20 22 25 30 45

30 20 22 25 30 35 50

35 22 25 30 35 40 55

25 30 35 40 45 60

30 35 40 45 50 65

35 40 45 50 55 70

40 45 50 55 60 75

45 50 55 60 65 80

50 55 60 65 70 90

60 65 70 75 100

65 70 75 80 110

70 75 80 90 120

80 80 90 100 130

90 90 100 110 140

100 100 110 120 150

110 120 130 160

120 130 140 170

140 150 180

150 160 190

160 180 200

200 220

220 240

240 260

260 280

280 300

300

Tornillo de cabeza cilíndrica con hexágono interiorSocket head cap screwVis six pans creux tête cylindriqueParafuso de cabeça cilíndrica com sextavado interior

Acero aleado de alta resistenciaHeat treated alloy steelAcier allié haute résistanceLiga de aço de alta resistência

Calidad: 12.9Property class: 12.9Classe: 12.9Classe de resistência: 12.9

Holo-Code: M5 - M36

ISO 4762 (DIN 912)

Ref.= H912- XX - XXX

D L

Ref. = H912-6-20

ejemplo example exemple exemplo

DIN 912M6x20

Normas ISO 898-1Standards ISO 898-1Normes ISO 898-1Normas ISO 898-1chaflán

chamferchanfreinchanfro

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TORNILLERÍA 12.9 DE ALTA RESISTENCIA12.9 HIGH STRENGTH FASTENERS • VISSERIE 12.9 À HAUTE RÉSISTANCE • PARAFUSOS 12.9 DE ALTA RESISTÊNCIA

Resistencia a la tracciónTensile strength

Résistance à la ruptureResistência à tração

Temperaturas de usoWorking temperatures

Températures d’emploiTemperaturas de utilização

1220 N/mm2 min. 39 HRC min.

-29º a +204ºC 8%Alargamiento mínimo a la ruptura Minimum elongation at fracture

Allongement minimum à la ruptureElongação mínima à rutura

x1x5

x25 x50 x100 x10

DurezaHardness

DuretéDureza

M14(x2,00)

M16(x2,00)

M20(x2,50)

M24(x3,00)

M27(x3,00)

M30(x3,50)

M36(x4,00)

M42(x4,50)

M48(x5,00)

D

21,33 24,33 30,33 36,39 40 45,39 54,46 63,46 72,46 D1 (max.)

15,7 17,7 22,4 26,4 30,4 33,4 39,4 45,6 52,6 D2 (max.)

14 16 20 24 27 30 36 42 48 K (max.)

12 14 17 19 19 22 27 32 36 S nom.

40 44 52 60 66 72 84 96 108 L1* (min.)

115 157 245 353 459 561 817 1.120 1.470 Sección útil mm2

265 413 825 1.425 2.008 2.775 4.875 7.536 11.545 N.m

20 25 30 40 50 50 80 60 70

L

25 30 35 45 60 60 90 65 80

30 35 40 50 70 70 100 70 90

35 40 45 55 80 80 110 80 100

40 45 50 60 90 90 120 90 110

45 50 55 65 100 100 130 100 120

50 55 60 70 110 110 140 110 130

55 60 65 75 120 120 150 120 140

60 65 70 80 130 130 160 130 150

65 70 75 90 140 140 170 140 160

70 75 80 100 150 150 180 150 180

75 80 90 110 160 160 200 160 200

80 90 100 120 180 180 220 180 220

85 100 110 130 200 200 240 200 240

90 110 120 140 220 220 260 220 260

100 120 130 150 240 240 280 240 280

110 130 140 160 260 260 300 260 300

120 140 150 180 280 340 280 320

150 160 200 300 360 300 340

160 180 220 320 380 320 360

180 200 240 340 400 340 380

200 220 260 360 420 360 400

210 240 280 380 440 380 420

220 260 300 420 460 400 440

230 280 320 480 420 460

240 300 340 520 440 480

250 320 360 540 460 500

260 340 380 560 480

280 400 580 500

300 600

320 640

340 650

Sección útil mm2 Usable Section mm2

Section utile mm2 Secção útil mm2

Cantidad en cajaBox qty.Boîtage Quantidade na caixa

Par de apriete recomendado Recommended tightening torque Couple de serrage recommandé Binário de aperto recomendado

N.m

* Los tornillos por encima de la línea azul estan totalmente roscados, por debajo de la línea diponen de rosca parcial según L1.* According to L1, fasteners above the blue line are completely threaded while those below are partially threaded. * Vis entièrement filetées pour les dimensions au dessus de la ligne, vis partiellement filetées pour les dimensions en dessous de la ligne suivant L1.* Os parafusos acima da linha azul estão totalmente roscados, abaixo da linha dispõem de rosca parcial conforme L1.

M42 y M48 bajo consulta. M42 & M48 upon request. M42 et M48 sur demande. M42 e M48, disponíveis sob consulta.

INSTRUCCIONES DE USO Y CONSERVACIÓNEstimado Cliente,Por favor, lea las instrucciones atentamente. Asegúrese de que el usuario entienda las ins-trucciones de uso, prestando especial atención a las advertencias de seguridad y manteni-miento.

APLICACIÓNEl anclaje piramidal se utiliza en prótesis de miembros inferiores y sirve para la unión de mó-dulos y encajes de superficie de apoyo plana con cuatro orificios roscados M6; y de módulos con cojinete de superficie esférica interior y tornillos de fijación M8.

CARACTERÍSTICAS TÉCNICAS

Código 7Н03СK 7Н03ТK

Distancia entre centros A, mm 36 36

Peso del artículo, g 98 66

Material de la carcasa 1 A. Inox Titanio

Para pacientes con peso, kg no superior a 125 150

Rango de temperaturas para el uso De -40 a +40°C.

Regulación angular en el conjunto de la prótesis en los planos frontal y sagital

De -7,5 a +7,5°

Período de garantía 2 años

DESCRIPCIÓN DE LA ESTRUCTURALa carcasa 1 del anclaje piramidal (ver Fig. 1) cuenta con el cojinete de superficie esférica B y la pirámide C para la unión con otros módulos de la prótesis. Esta unión permite realizar el ajuste angular en los planos frontal y sagital en un rango de -7,5 a +7,5°.El lado opuesto de la carcasa 1 tiene una superficie plana y lleva cuatro tornillos 2 para la unión con el encaje. El anclaje piramidal es compatible con los sistemas protésicos modulares de miembros in-feriores de Orliman.

А А 2

1 B C

1 Carcasa 1 unid.2 Tornillo 4 unid.

INSTALACIÓN DEL ARTÍCULO EN LA PRÓTESISPara la unión del anclaje piramidal al encaje, se utilizan los tornillos 2 que sobresalen 11 mm con respecto a la superficie de fijación.Durante el montaje final de la prótesis se recomienda aplicar fija tornillos tipo Loctite 241 sobre la superficie roscada de los tornillos 2 y se apretarán con un par de apriete de 14 Nm.

RECOMENDACIONES - ADVERTENCIASEstos productos no deben ser usados para otros fines que los descritos en estas instruccio-nes. Sólo deben ser utilizados por una única persona y en las condiciones prescritas.Antes de su utilización el producto debe ser adaptado por un técnico ortopédico.Para el deshecho del envase y el producto, cumpla estrictamente con las normas legales de su comunidad.En las articulaciones de rodilla existe riesgo de atrapamiento, tenga precaución.El producto incluye componentes metálicos por lo que extreme las precauciones en caso de Resonancia Magnética.

GARANTÍAEstos productos son conformes a la Directiva Europea de Productos Sanitarios 93/42/CEE (RD 1591/2009). Se han realizado los ensayos conforme a la normativa internacional EN ISO 22523 de Prótesis y Ortesis, y EN ISO 10328 de Prótesis de Miembros Inferiores.ORLIMAN, S.L.U. garantiza todos sus productos, siempre que estos no hayan sido manipu-lados ni alterados en su configuración original. No garantiza aquellos productos en que por mal uso, deficiencias o roturas de cualquier tipo, sus características se vean alteradas. Si observara alguna deficiencia o anomalía, comuníquelo inmediatamente al establecimiento expendedor para proceder a su cambio.

ORLIMAN S. L. U. C/ Ausias March, 3 - Pol. Ind. La Pobla-L Eliana · Apdo. de correos 49C.P.: 46185 - La Pobla de Vallbona Valencia - España (Spain)Tel.: +34 96 272 57 04 - Fax: +34 96 275 87 00 - Tel. Exportación: +34 96 274 23 33E-mail: [email protected] · Export mail: [email protected] - www.orliman.com

7Н03СK - 7Н03ТK Anclaje piramidal macho 4 agujeros

EDICIÓN: 05/2015

LB-I-7H03

GARANTÍA 2 años a partir de la compra

Referencia nº de lote

Fecha de compra

Firma y sello de la ortopédia Para la validez de la garantía es necesario cumplimentar estos datos.

INSTRUCTIONS FOR USE AND MAINTENANCEDear Customer,Please read the instructions carefully. Make sure that the user understands the instructions for use, paying particular attention to the safety and maintenance warnings.

APPLICATIONThe 4-hole male pyramid is used in lower-limb prostheses and serves to connect modules and sockets with flat supporting surfaces and four threaded M6 holes, and modules with inner spherical surface bearings and M8 fixing screws.

TECHNICAL CHARACTERISTICS

Code 7Н03СK 7Н03ТK

Distance between centres A, mm 36 36

Item weight, g 98 66

Housing 1 material Stainless steel Titanium

For patients weighing, kg no higher than 125 150

Temperature range for use From -40 to +40°C.

Angular adjustment of the whole prosthesis on the frontal and sagittal planes

From -7.5 to +7.5°

Warranty period 2 years

DESCRIPTION OF THE STRUCTUREHousing 1 of the 4-hole male pyramid (see Fig. 1) features spherical surface bearing B and pyramid C for connection to other modules of the prosthesis. This connection enables angu-lar adjustment on the frontal and sagittal planes in a range of -7.5° to +7.5°.The opposite side of housing 1 has a flat surface and four screws 2 for connection to the socket. The 4-hole male pyramid is compatible with Orliman’s modular lower-limb prosthetic sys-tems.

А А 2

1 B C

1 Housing 1 unit2 Screw 4 unit

FITTING THE ITEM TO THE PROSTHESISTo connect the 4-hole male pyramid to the socket, screws 2, which protrude 11 mm with respect to the fixing surface, are used.During final assembly of the prosthesis, it is recommended to apply Loctite 241 threadlocker to the threads of screws 2 and tighten them with a torque of 14 Nm.

RECOMMENDATIONS - WARNINGSThese products should not be used for purposes other than those described in these instruc-tions. They should only be used by one person and under the conditions prescribed.Before use, the product must be adapted by an orthopaedic technician.When disposing of the product and packaging, strictly comply with the refuse disposal reg-ulations of your community.In knee joints, there is risk of entrapment, use caution.As the product features metal components, use caution in the case of magnetic resonance.

WARRANTYThese products comply with European Medical Devices Directive 93/42/EEC (Spanish Royal Decree 1591/2009). They have undergone tests in accordance with international standard EN ISO 22523 for prostheses and orthoses and EN ISO 10328 for lower-limb prostheses.ORLIMAN, S.L.U. guarantees all of its products, provided that they have not been tampered with or altered from their original form. The company does not guarantee products whose characteristics have been altered through any kind of misuse, breakage or defect. If you notice any defect or abnormality, notify the supplier immediately in order for the product to be replaced.

ORLIMAN S. L. U. C/ Ausias March, 3 - Pol. Ind. La Pobla-L Eliana · Apdo. de correos 49C.P.: 46185 - La Pobla de Vallbona Valencia - España (Spain)Tel.: +34 96 272 57 04 - Fax: +34 96 275 87 00 - Exports Tel.: +34 96 274 23 33E-mail: [email protected] · Exports email: [email protected] - www.orliman.com

7Н03СK - 7Н03ТK 4-hole male pyramid

LB-I-7H03

WARRANTY 2 years from purchase

Reference Batch no.

Date of purchase

Signature and stamp of the orthopaedic establishment

For the warranty to be valid, it is necessary to complete these details.

EDITION: 05/2015

HEIGHT ADJUSTABLE PYLON

Save time, improve your patients' experience, and keep

looking professional when seeing patients outside your

clinic. The Height Adjustable Pylon enables you to quickly

adjust the height, rotation, and angular alignment

without cutting or grinding. Approved for definitive and

preparatory use, available in adult and junior sizes, and

included in the Össur Complete Leg program.

“Saves me time during every patient visit,

keeps me looking professional regardless

of the setting, and I can use it on nearly

every prep and definitive prosthesis.”

Chris DiGioia, CP, CFo

1 revolution equals 1/16" (1.25mm)

of height adjustment

FEATURES & BENEFITS

• Quick and easy height, rotation and angular adjustments

• No cutting, grinding, hacksaw, pipe cutters, or deburring tool

necessary

• Time savings for both patient and practitioner, no more

“safety cuts”

• Eliminates wasted pylon scraps

• Maintain professional appearance when fitting at skilled

nursing, rehab facilities and home visits

• Ideal for juniors, easily add built height as the amputee grows

• Included in Össur Complete Leg packages

SPECIFICATIONS

• Designed, tested and approved for definitive use from K2

to K4 activity level

• Testing Standard: ISO 10328 at A100 (P5) load level

• Comparable weight to existing “pylon & tube clamp” assembly

• 1 revolution = 1/16" (1.25mm) of height adjustment

© ÖSSUR, 12.2018. P-953930

FOLLOW ÖSSUR ON USA (800) 233-6263WWW.OSSUR.COM

CANADA (800) 663-5982 WWW.OSSUR.CA

* The responsibility for accurate coding lies solely with the provider treating the patient. Össur assumes no responsibility or liability for the provider’s coding decisions. Össur’s coding suggestions rest on its best judgment and are subject to revision.

ORDERING INFORMATION

Model Diameter Extension Range Patient Weight Limit Part Numbers

Long 34mm 9.4cm - 12.8cm (3 3/4" - 5") 100 kg (220 lb) A-542360

Standard 34mm 7.7cm - 9.5cm (3" - 3 3/4") 100 kg (220 lb) A-542350

Junior 30mm 7.6cm - 10.2cm (3" - 4") 45 kg (99 lb) AJ-542350

Long Standard Junior

REIMBURSEMENT

Manufacturer's Suggestred Retail Pricing (MSRP):

$550.00

Suggested coding language:

L5999 – Addition, Lower Limb Prosthesis, Vertical

Adjusting Pylon Feature

SUGGESTED BILLING CODE*L-5999

Watch the Height Adjustable Pylon testimonial video online: ossur.com/complete-legs

https://www.ossur.com/complete-legs

WWW.OSSUR.ES

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ÖSSUR DYNAMIC SOLUTIONS

PRO-FLEX® LP TORSION

Este resistente pie con almacenamiento de energía ofrece absorción de impacto rotacional para reducir las fuerzas de cizallamiento en el miembro residual. El módulo de torsión se combina con el módulo de pie Pro-Flex LP para ofrecer un nivel de potencia de tobillo, retorno de energía y dinámica general que no se había logrado en personas con muñones más largos. El Pro-Flex LP Torsion se ha diseñado especialmente para aportar estos beneficios, además de proporcionar una progresión plantar excepcionalmente fluida. La unidad de torsión-amortiguación compensa la rotación fisiológica y la absorción vertical de impactos de las articulaciones perdidas, lo que aporta más comodidad al usuario final y reduce la tensión en el muñón.

El Pro-Flex LP Torsion ofrece una alto grado de movimiento de tobillo, lo que supone una mejora significativa con respecto a los pies de fibra de carbono de perfil bajo tradicionales. Incorpora una quilla de longitud completa y la nueva tecnología ‘cónica inversa’, lo que permite una mayor dorsiflexión.

Menor carga y mayor dinámica significa que las personas con un muñón más largo pueden disfrutar de mayor comodidad en una amplia gama de actividades. La ligera funda cosmética con perfecto diseño anatómico incluye una suela de agarre para asegurar la estabilidad con el pie descalzo sobre superficies húmedas o resbaladizas y un dedo de pie con sujeción para sandalia, además de ser adecuada para una amplia gama de calzado.

Össur recomienda el uso del Pro-Flex LP Torsion junto con Unity, el sistema de suspensión por vacío sin rodillera. Este sistema añade un peso mínimo, no requiere mayor altura de montaje y no interfiere con la dinámica del Pro-Flex LP Torsion. El sistema Unity está diseñado para proporcionar una suspensión segura en combinación con la tecnología de Iceross Seal-In®, al tiempo que estabiliza las fluctuaciones de volumen y mantiene un ajuste cómodo del encaje durante todo el día.

Información de usuario

Nivel de amputación: Transfemoral y transtibial

Nivel de impacto: Bajo a alto

Peso máximo del paciente: 147 kg

RESPUESTA

PROPORCIONAL

TALÓN ACTIVO,

CARBON-X®

QUILLA DE

CARBONO

COMPLETA

PROGRESIÓN

TIBIAL ACTIVA

AMORTIGUACIÓN

DE IMPACTO

VERTICAL

QUILLA SEPARADA DIVISIÓN DE

ANTEPIÉ

DEDO SEPARADO

PARA SANDALIAS

WEATHERPROOF

Información del pie

Categorías: 1-8

Tamaños: 22-30

Peso del pie: (Tamaño 27) 960 g con funda cosmética y calcetín

Altura de montaje: (Tamaño 27)

147 mm con funda cosmética y pirámide macho

Altura del talón: 10 mm

Opciones de adaptador: Pirámide macho

Información del sistema Unity

Vacío máximo: -23 inHg (-600 mmHg)

Presión normal de funcionamiento:

-16-20 inHg

Peso añadido al sistema:75 g con bomba, tubo y válvula de encaje

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INFORMACIÓN DE PEDIDO

PIE COMPLETO

Seleccione el kit de módulo de bomba Unity adecuado en función del tamaño del módulo de pie cuando realice su pedido y Unity se le entregará preinstalado en el pie. Para mayor comodidad y compatibilidad del sistema, se recomiendan los kits de válvula Unity para la conexión del encaje.

Puede consultar los cuadros de selección de liners y los números de artículos en las páginas correspondientes de Iceross Seal-In..

PIE COMPLETO CON UNITY

CUADRO DE SELECCIÓN DE CATEGORÍA

Peso kg 45-52 53-59 60-68 69-77 78-88 89-100 101-116 117-130 131-147

Peso lb 99-115 116-130 131-150 151-170 171-194 195-220 221-256 257-287 288-324

Nivel de impacto bajo

Tamaños 22-24 1 1 2 3 4 5 N/A N/A N/A

Tamaños 25-27 1 1 2 3 4 5 6 7 8

Tamaños 28-30 3 3 3 3 4 5 6 7 8

Nivel de impacto moderado

Tamaños 22-24 1 2 3 4 5 N/A N/A N/A N/A

Tamaños 25-27 1 2 3 4 5 6 7 8 N/A

Tamaños 28-30 3 3 3 4 5 6 7 8 N/A

Nivel de impacto alto

Tamaños 22-24 2 3 4 5 N/A N/A N/A N/A N/A

Tamaños 25-27 2 3 4 5 6 7 8 N/A N/A

Tamaños 28-30 3 3 4 5 6 7 8 N/A N/A

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DISTANCIA AL SUELO

*Nota: el Pro-Flex LP Torsion con Unity tiene la misma altura de montaje que el Pro-Flex LP Torsion sin Unity.

KITS

PRO-FLEX LP TORSION CON PIRÁMIDE MACHO

REF.

PLT0

TAMAÑO DE PIE (22-30)

CATEGORÍA (1-8)

L/R (IZQUIERDO/DERECHO)

Incluye:• Módulo de pie• Funda cosmética extraíble* con calcetín Spectra negro

*Si desea el Pro-Flex LP Torsion con funda cosmética marrón, añada “BR” al número de referencia.

UNITY

KITS UNITY

Foto Ref. Descripción Applicable Foot Kits

1 UPL0024 Bomba Unity PLP, tamaños 22-24 Pro-Flex LP/ LP Torsion, tamaños 22-24

1 UPL0030 Bomba Unity PLP, tamaños 25-30, cat. 1-5 Pro-Flex LP/ LP Torsion, 25-37, cat. 1-5

1 UPL0930Bomba Unity PLP, tamaños 22-27Cat. 6-9 y tamaños 28-30 (todas las categorías)

Pro-Flex LP/ LP Torsion 25-27, cat. 6-9 y 28-30 (todas las categorías)

2 UTT0001 Kit de válvula Unity TT Todos

3 UTF0001 Kit de válvula Unity TF Todos

4 UTF0006 Kit de tubo Unity TF Todos

5 L-5446XX Kit Icelock 544 Todos

22-24 141mm, 5 9/1625-27: 147mm, 5 13/16"28-30: 152mm, 6"

10mm (3/8")

Build Height

1. 3.2. 4. 5.

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COMPONENTES DE REPUESTO DE UNITY

Part# Descripción

UPL00021 Componentes de Unity PLP, 22-24

UPL00022 Componentes de Unity PLP, 25-27, cat. 1-5

UPL00023 Componentes de Unity PLP, 25-27, cat. 6-9 y 28-30

Incluye:

• Amortiguador • Tubo• Lámina de resorte • Abrazadera• Membrana • Válvulas de retención• Pieza de montaje • Puerto de salida de Unity• Tornillos • Puerto de entrada de Unity

KITS DE PIE COMPATIBLES CON UNITY

PRO-FLEX LP TORSION

REF.

PLTU

TAMAÑO DE PIE (22-30)

CATEGORÍA (1-8)


Incluye:• Módulo de pie • Funda cosmética extraíble* con calcetín Spectra negro

*Si desea el Pro-Flex LP con funda cosmética marrón, añada “BR” al número de referencia Nota: Unity se entrega preinstalado en el pie si se pide con el PLTU

ACABADO COSMÉTICO

KIT DE FUNDA COSMETICA, BEIGE O MARRON*

FST0

REF.TAMAÑO DE PIE (22-30)


Incluye:• Funda cosmética*• Fijación para funda cosmética• Calcetín Spectra negro

*Nota: Si desea una funda marrón, añada “BR” al final del número de referencia.

Ref. Descripción Tamaño Color

FCX63022-15 Pro-Flex Calcetin 15 pc 22-25 cm Negro

FCX63026-15 Pro-Flex Calcetin 15 pc 26-30 cm Negro

FCX63022 Pro-Flex Calcetin 1 pc 22-25 cm Negro

FCX63025 Pro-Flex Calcetin 1 pc 26-30 cm Negro

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Instructions for Use

ICEROSS SEAL-IN® X5For TT/TF users

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1 2

3 4

5 6

7 8

9 10

4

11 12

13

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ENGLISHINTRODUCTIONThank you for choosing a high quality silicone liner from Össur. We can assure you that you have made the right choice. Please carefully review and follow these instructions before fitting a patient with the liner or accessory products. Remember that informing the patient concerning proper handling and care of the liner, as set forth in these instructions, is important to achieve patient comfort and maximum product life.

CONTRAINDICATIONS FOR USEContraindications are:1. Unstable limb volume.2. Extremely conical limbs (See ICEROSS® DISTAL CUP).3. Very short residual limbs.

Minimum recommended length:Transtibial: To assess the minimum recommended length, measure the residual limb length from the mid patella tendon to the distal end, with knee in full extension.Transfemoral: Measure the residual limb length with the tissue hanging down, from the perineum to the distal end.

• Compare the measurement to the table below.• Low trimlines of the hard socket can affect suspension and should be

assessed on individual basis.

Liner Sizes Minimum Length

18–23 11.0 cm

25–30 12.5 cm

32–40 13.5 cm

45–50 15.5 cm

55 16.5 cm

NOTE: Low posterior trim lines of the hard socket can affect suspension and should be assessed on individual basis.

LINER SIZING (Figure 1)To determine the correct Iceross size:1. Measure the circumference of the residual limb at 4 cm from the

distal end with the tissue hanging down.2. Choose the Iceross size, which corresponds to the measurement or

which, is immediately below the indicated measurement.3. DO NOT choose a liner size, which exceeds the measurement, or

round up.

EXAMPLE: If the residual limb measures 31 cm at the indicated location, choose size 30 NOT size 32.Selecting the correct size is very important. If the liner is too tight, this may cause pistoning and/or numbness and blistering. A Seal-In liner that is too tight will also produce excessive ring tension to the residual limb from the seals. If the liner is too loose, increased perspiration and/or movement of the limb inside the liner may occur. Perspiration and movement can lead to blisters and rashes. If any of the above symptoms or any other indication of improper fit are noted, the user should be

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instructed to contact his/her physician or prosthetist immediately.

TRIMMING AN ICEROSS LINER (Figure 2)Iceross liners may be trimmed for user preference and to increase range of motion. The Iceross CurveMaster is specifically designed for this function and to produce a smooth, rounded edge, which will minimize the risk of skin irritation and/or tears of the liner.Do not cut the liner below or through any of the Seals or below the proximal trim-lines of the socket. Excessive trimming may reduce the natural suction between the liner and limb and/or compromise suspension.

DONNING THE ICEROSS SEAL-IN® X5To don the liner use the Clean & Simple Lubricant Spray (See ICEROSS® CLEAN & SIMPLE LUBRICANT SPRAY).Before donning a new liner clean it with lukewarm water, and dry it with lint free cloth as the natural oils in the silicone make it difficult to grip.

1. Turn the liner inside out by gripping the distal end from the inside as shown in the illustration. (Figure 3).

2. Grip the top of the liner and slide it over the hand until the inner surface is fully exposed. (Figure 4).

3. Spray lubricant into the inverted liner for easier roll on. (Figure 5).4. After exposing as much of the distal end of the liner as possible,

position it against the residual limb and with light compression roll upward onto the limb. Check that no air pockets are present. (Figure 6).

5. Roll the liner all the way up the limb, taking care not to damage it with fingernails. Do not tug or pull.

6. Ensure the seals sit horizontally around their full circumference.

NOTE: Be very careful that the inside of the liner is clean, dry and free from any foreign objects that can cause skin irritation.NOTE: With use the silicone will soften, which will facilitate application.

DONNING THE PROSTHESISThe Iceross Seal-In X5 liner is to be used with Icelock Expulsion Valves 551 or 552 (See ICEROSS® DISTAL CUP). The valves are specifically designed to maintain suspension when using Seal-In liners. A knee sleeve is not required.

1. Lightly spray the Seals around their full circumference, and inside the hard socket for smoother entry. (Figure 7).

2. Align the prosthesis as instructed by the prosthetist and push into the hard socket expelling air. (Figure 8).

NOTE: If the user is having difficulty donning the prosthesis, more lubricant may be needed or the valve is blocked.NOTE: If the user feels the skin of the residual limb is being stretched to one side after donning the prosthesis, the distribution of the lubricant is inadequate around the full circumference of the Seals.

VOLUME SOCKSIf volume reduction is experienced in the residual limb, volume socks may be added to restore socket fit.

7

Volume sock application:• Pull the volume sock over the Seals and ensure it is placed level

between the two most proximal Seals.• The volume sock can extend over the top two Seals as long as

suspension is maintained.• Don the prosthesis as normal.

NOTE: Placing volume socks over the three distal Seals will result in loss of suspension.

ICEROSS® CLEAN & SIMPLE LUBRICANT SPRAYIceross Clean & Simple lubricant spray has to be used to facilitate donning of the liner and the prosthesis.The lubricant is designed to evaporate quickly after donning to maintain maximum suspension. A spray pen accompanies the Seal-In Liner, small enough to fit in a pocket and/or a handbag. It can be refilled with the Iceross Clean & Simple lubricant spray.WARNING: Do not apply to the skin. Avoid contact with eyes.INGREDIENTS: Propanol and water.

ICELOCK® EXPULSIONS VALVESThe Össur Icelock Expulsion Valves are designed and tested to continually expel air when loading the prosthesis, thus maintaining hypobaric suspension.

Product Number Description Benef its

L-551000 Expulsion Valve 551 Small, cosmetic & easy installation

L-552000 Expulsion Valve 552 Removable valve and large smooth opening

ICEROSS® DISTAL CUPIceross Distal Cups (I-3000xx) provide enhanced comfort for conical limbs with poor soft tissue coverage. They can also be used as a fitting tool in conjunction with the Iceross Original liners to ensure total contact between the silicone and residual limb. The dermogel silicone in the Iceross Distal Cup conforms to the limb, thus minimizing pressure over bony prominence during gait.

To correctly f it a Distal Cup:1. Measure the circumference of the residual limb at 4 cm from the

distal end. (Figure 1)2. Choose the Distal Cup two or three sizes smaller than the

measurement3. Roll the Distal Cup directly over the limb. (Figure 9)4. When using an Iceross liner in combination with a Distal Cup, the

liner measurement (4 cm from the distal end) should be made with the Distal Cup in place (i.e. over the Distal Cup). (Figure 10)

5. Choose the correct Iceross liner size based on the measurement obtained with the Distal Cup in place (See LINER SIZING).

ICEROSS® PADS (Figure 11)Iceross Pads (I-6103xx) can be used to fill in any problem areas (i. e. voids or scars) to ensure better fit and to minimize trapped air. Iceross Pads may also be used to distribute body pressure and to protect the skin. In some cases, custom-formed pads may be required for irregular shapes or

8

problem areas. See Össur Prosthetic Product Catalogue for more information.

LINER CARE (Figure 12)Proper product care is important. The liner needs to be washed inside and out every day, following use.Remove the liner, turn the liner inside out and wash it with pH balanced, 100% fragrance- and dye-free soap. The liner can also be machine washed (40 °C/Hot) with a mild detergent. Fabric softeners or bleaches or other products or cleaning solutions may damage the liner and should NOT be used. After cleaning, the patient should rinse the liner thoroughly with water and wipe both sides dry with a lint-free cloth.

An Iceross liner can be used directly after washing. It does not need to dry overnight. Always return the liner to its normal position with the distal attachment facing out as soon as possible after cleaning. The Seals must be clean and free from dirt prior to use.

Iceross liners should always be checked for damage or wear. Any damage may weaken the effectiveness of the liner and should be reported to the user’s prosthetist immediately. Misuse may result in potential loss of suspension.

Care must be taken by both the prosthetist and the patient not to expose a liner to glass or carbon fibres or other foreign particles. Such substances can become embedded in the silicone causing aggravation of the skin. Washing alone may not be sufficient to eliminate the problem and the patient should be instructed to return the liner to the prosthetist if the liner is inadvertently exposed to any foreign substances or chemicals. The liner silicone contains Aloe Vera extract. This acts as a natural moisturizer and is known for its active healing and soothing effects on the skin. Initially, the inner surface of the liner should be moist to the touch. For these reasons, the liner should not be left inside out for extended period or exposed to excessive heat or sunlight.

SKIN CARE (Figure 13)Daily cleaning of the residual limb is also essential. We recommend use of a mild liquid, pH balanced, 100% fragranceand dye-free soap.If dry skin is noted, apply a pH balanced, 100% fragrance- and dye-free lotion to nourish and soften the skin. Do NOT apply lotion to the residual limb immediately prior to donning the liner.

NOTE: Many common household or bath products, including soaps, deodorants, perfumes, aerosol or alcohol sprays or abrasive cleaners may cause or contribute to skin irritation and the patient should be so advised.

LIABILITYThe manufacturer recommends using the device only under the specified conditions and for the intended purposes. The device must be maintained according to the instructions for use. The manufacturer is not liable for damage caused by component combinations that were not authorized by the manufacturer.

PRODUCT WARRANTYÖssur offers a written warranty on the Iceross Seal-In X5 liner for the

9

indicated period from the invoice date. Said warranty shall be in lieu of all others, whether express or implied by law.

Iceross Seal-In® X5 – 6 months.

For further information, please contact Össur or your local Össur distributor. You can also visit the Össur web page at www.ossur.com.

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DEUTSCHEINLEITUNGWir freuen uns, das Sie sich für einen hochwertigen ICEROSS Silikonliner der Firma Ossur entschieden haben. Bitte lesen Sie diese Anleitung aufmerksam durch und richten sich nach den folgenden Anweisungen. Um einen optimalen Tragekomfort und die Haltbarkeit des Produktes zu gewährleisten, ist es wichtig, Ihren Patienten in die richtige Behandlung und Pflege des Liners sowie dessen Zubehörteilen einzuweisen.

KONTRAINDIKATIONENEs bestehen folgende Kontraindikationen:1. Instabiles Stumpfvolumen.2. Extrem konischer Stumpf (Siehe ICEROSS® DISTAL CUP).3. Sehr kurzer Stumpf.

Empfohlene Mindestlänge:Transtibial: Um die empfohlene Mindestlänge zu ermitteln, messen Sie bei vollständig gestrecktem Knie die Länge des Stumpfs von der mittleren Patellasehne zum distalen Ende.Transfemoral: Messen Sie bei herunterhängendem Weichteilgewebe die Stumpflänge vom Perineum zum distalen Ende.

• Vergleichen Sie die Maße mit der nachstehenden Tabelle.• Der untere Randverlauf des Hartschafts kann die Haftung

beeinflussen und sollte individuell ermittelt werden.

Liner Größen Empfohlene Mindestlänge

18–23 11.0 cm

25–30 12.5 cm

32–40 13.5 cm

45–50 15.5 cm

55 16.5 cm

HINWEIS: Die hintere untere Schnittkante des Hartschafts kann den Halt beeinträchtigen und sollte individuell angepasst werden.

GRÖSSENAUSWAHL (Abbildung 1)Wahl der richtigen Iceross-Größe:1. Messen Sie den Stumpfumfang 4 cm oberhalb des distalen

Stumpfendes mit hängendem Weichteilgewebe.2. Wählen Sie die ICEROSS Größe, die diesen Maßen entspricht, bzw.

die nächst kleinere Größe.3. Wählen Sie keinen Liner aus, dessen Größe über das gemessene Maß

hinausgeht.4. Reduzieren Sie NIEMALS um mehr als eine Linergröße, um unnötig

hohe Kompression zu vermeiden.

BEISPIEL: Bei einem Stumpfmaß von 31cm an der genannten Stelle wählen Sie einen Iceross Größe 30, NICHT die Größe 32.Die Auswahl der richtigen Größe ist sehr wichtig. Sitzt der liner zu eng, kann dies zu Hub, Taubheitsgefühlen und Blasenbildung führen. Sitzt der liner zu locker, kann es zu vermehrter Schweißbildung und Stumpfrotation im liner kommen, was zu Blasenbildung und Hautausschlägen führen kann. Wenn der Seal-In liner zu eng anliegt,

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kann es am Stumpf zu ringförmigen Abschnürungen durch den Dichtungsring kommen. Beim Auftreten eines der hier beschriebenen Symptome oder anderer Probleme sollte der Anwender sofort seinen Arzt oder Orthopädietechniker aufsuchen.

KÜRZEN DES ICEROSS-LINERS (Abbildung 2)Iceross Liner können entsprechend den individuellen Bedürfnissen des Prothesenträgers und zur Erweiterung von dessen Bewegungsfreiheit gekürzt werden. Der ICEROSS Curvemaster wurde speziell zur Bearbeitung von Silikonlinern entwickelt. Sie erhalten glatte abgerundete Schnittkanten, um Hautirritationen und Risse im Silikon zu vermeiden. Den liner nicht durch eine der Dichtungen hindurch oder darunter und auch nicht unterhalb der proximalen Schnittkanten des Schafts abschneiden. Ein zu starkes Kürzen kann die Adhäsion zwischen liner und Stumpf behindern und damit die Haftung herabsetzen.

ANLEGEN DES ICEROSS SEAL-IN® X5Zum Anlegen des liners die Clean & Simple Anziehhilfe verwenden (Siehe ICEROSS® CLEAN & SIMPLE ANZIEHHILFE). Einen neuen liner vor dem Anlegen mit lauwarmem Wasser reinigen und mit einem faserfreiem Tuch trocknen, da er aufgrund der natürlichen Öle des Silikons schwer zu greifen ist.

1. Zum Anziehen des liners drehen Sie ihn mit der Innenseite nach außen, indem Sie das untere Ende wie auf der Abbildung von innen greifen. (Abbildung 3).

2. Die Spitze des liners fassen und über die Hand ziehen, bis die gesamte Innenseite zu sehen ist. (Abbildung 4).

3. Damit sich der liner leichter aufrollen lässt, sprühen Sie Anziehhilfe in den umgestülpten liner. (Abbildung 5).

4. Rollen Sie den liner nun mit leichtem Druck nach oben. Vermeiden Sie Lufteinschlüsse, die zu erhöhter Schweißbildung führen können. (Abbildung 6).

5. Rollen Sie den liner vollständig auf den Stumpf auf und achten Sie darauf, ihn nicht mit den Fingernägeln zu beschädigen.

6. Achten Sie darauf, dass die Dichtungen über den gesamten Umfang waagerecht sitzen.

WICHTIG: Alle Stoffe, die sich zwischen Haut und Liner befinden, können beim Tragen zu Hautirritationen führen. Achten Sie deshalb darauf, dass der Liner innen sauber, trocken und frei von Reiningungsmittelresten ist.HINWEIS: Mit der Zeit wird das Silikon weicher, so dass das Anlegen einfacher wird.

ANLEGENDERPROTHESEDer Iceross Seal-In X5 liner ist für die Verwendung mit den Icelock Ausstoßventilen 551 oder 552 (Siehe ICEROSS® DISTAL CUP) vorgesehen.Die Ventile wurden speziell für die Aufrechterhaltung der Haftung bei Verwendung des Seal-In liner konzipiert. Eine Kniekappe ist nicht erforderlich.

1. Leichtes Einsprayen der gesamten Dichtungen und der Innenseite des Hartschafts erleichtern das Anziehen. (Abbildung 7).

2. Bauen Sie die Prothese gemäß den Anweisungen Ihres

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Orthopädietechnikers auf, und steigen Sie in den Hartschaft ein. Dabei entweicht Luft. (Abbildung 8).

HINWEIS: Bei Schwierigkeiten beim Anziehen der Prothese ist eventuell mehr Anziehhilfe-Spray erforderlich oder das Ventil blockiert.HINWEIS: Wenn nach dem Anlegen der Prothese die Haut des Stumpfes zu einer Seite gezogen wird, ist die Anziehhilfe nicht gleichmäßig über die gesamten Dichtungen verteilt.

VOLUMENSTRÜMPFEBei Volumenabnahme des Stumpfes haben Sie die Möglichkeit, durch einen speziellen Volumenstrumpf dieses Volumen wieder auszugleichen.

Anlegen des Volumenstrumpfes:• Ziehen Sie den Volumenstrumpf über die Dichtungen und achten Sie

darauf, dass er plan zwischen den beiden oberen Dichtungen liegt.• Der Volumenstrumpf kann über die beiden oberen Dichtungen

gezogen werden, solange das Vakuum erhalten bleibt.• Ziehen Sie nun die Prothese wie gewohnt an.

HINWEIS: Wenn der Volumenstrumpf über den drei unteren Dichtungen liegt, besteht die Gefahr, dass das Vakuum verloren geht und sich die Prothese löst.

ICEROSS® CLEAN & SIMPLE ANZIEHHILFEUm das Einziehen des Liners und der Prothese zu vereinfachen, sollte das Iceross Clean & Simple Spray verwendet werden.Das alkokolhaltige Gleitmittel verdunstet nach dem Einziehen des Liners schnell und sorgt für eine optimale Haftung.Dem Seal-In Liner ist ein praktischer Pumpzerstäuber beigefügt, der in einer Kleidungs- oder Handtasche mitgeführt werden kann. Er passt in eine Hosentasche oder Handtasche und kann mit Iceross Clean & Simple Anziehhilfe nachgefüllt werden.WARNHINWEIS: Nicht zur Anwendung auf der Haut geeignet. Kontakt mit den Augen vermeiden.INHALTSSTOFFE: Propanol und Wasser.

ICELOCK® AUSSTOSSVENTILEDie Icelock Ausstoßventile von Ossur sind so konzipiert, dass sie bei Belastung der Prothese kontinuierlich Luft ausstoßen und durch den entstehenden Unterdruck für eine gute Haftung sorgen.

Artikelnummer Beschreibung Vorteile

L-551000 Ausstoßventil 551 Kompakt, kosmetische& einfache Installation

L-552000 Ausstoßventil 552 HerausnehmbaresVentil und große Öffnung

ICEROSS® DISTAL CUPDas DermoGel-Silikon des Distal Cups (I-3000xx) bieten bei konischen Stümpfen mit geringer Weichteildeckung mehr Tragekomfort. Sie werden in Kombination mit Iceross linern verwendet, um konische Stumpfformen auszugleichen und zusätzlich zu polstern.Das Dermo Gel Silikon des Distal Cups passt sich dem Stumpf an und minimiert so beim Gehen den Druck auf empfindliche Knochenpunkte.

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Richtiges Anpassen des Distal Cups:1. Messen Sie den Stumpfumfang 4cm oberhalb des distalen

Stumpfendes. (Abbildung 1)2. Wählen Sie die ICEROSS Größe, die diesen Maßen entspricht, bzw.

die nächst kleinere Größe.3. Rollen Sie das Distal Cup direkt auf den Stumpf auf. (Abbildung 9)4. Um die richtige Größes des liners zu ermitteln, messen Sie nun 4 cm

oberhalb des Stumpfendes bei angelegtem Distal Cup (d.h.Sie messen ÜBER dem Distal Cup). (Abbildung 10)

5. Wählen Sie die Iceross-Größe, die diesen Maßen entspricht, bzw. die nächst kleinere Größe (siehe GRÖßENAUSWAHL).

ICEROSS PADS (Abbildung 11)Iceross Silikonpads (I-6103xx) werden innerhalb des Liners getragen. Sie können damit empfindliche Stumpfenden, Narbeneinzüge oder sensible Hautstellen zusätzlich abpolstern. Auch Hohlräume, die vor allem durch schwierige Stumpfformen, gerade Stumpfenden oder Narbeneinzüge entstehen, können durch die Pads gut ausgepolstert werden. Dadurch vermeiden Sie Lufteinschlüsse, die zu erhöhter Schweißbildung führen können. Bei besonders schwierigen Versorgungen können auch individuell geformte Pads verwendet werden. Nähere Informationen finden Sie im Prothetik-Produktkatalog von Ossur.

LINERPFLEGE (Abbildung 12)Eine gute Pflege des liners ist wichtig. Er sollte täglich innen und außen vom Anwender gereinigt werden. Entfernen Sie den Liner, indem Sie ihn von innen nach außen drehen und waschen Sie ihn mit einer pH-neutralen, 100% geruchs- und farbstofffreien Seife ab. Gut mit Wasser nachspülen, damit alle Reinigungsmittelreste entfernt sind und auf beiden Seiten mit einem weichen, fusselfreien Tuch trocken.

Der Iceross-liner kann gleich nach dem Waschen wieder angezogen werden. Der liner sollte nach der Reinigung wieder auf rechts gedreht werden; der Distalanschluss zeigt nach außen. Dies erhöht die Lebensdauer des Silikons. Die Seal-Dichtungsringe müssen dabei sauber und frei von Verschmutzungen sein.

Sowohl Orthopädietechniker als auch Anwender müssen darauf achten, dass der liner nicht in Kontakt mit Glas- oder Karbonfasern oder anderen Fremdpartikeln kommt. Solche Materialien sind durch normale Reinigung nicht zu beseitigen und können auf dem Silikon Rückstände hinterlassen, die zu Hautreizungen führen.

Informieren Sie den Anwender, dass der liner bei einem versehentlichen Kontakt mit entsprechenden Substanzen oder Chemikalien an den Techniker zurückgegeben werden soll. Das Silikon des liners enthält Aloe-Vera-Extrakte, die natürliche Feuchtigkeit spenden und für ihre pflegende und heilende Wirkung bekannt sind. Der liner fühlt sich daher anfangs auf der Innenseite leicht ölig an und sollte deshalb auch nicht über längere Zeit mit der Innenseite nach außen gelagert werden. Vermeiden Sie auch starke Wärme- oder Sonneneinstrahlung.

HAUTPFLEGE (Abbildung 13)Auch die tägliche Stumpfreinigung ist wichtig. Wir empfehlen die Verwendung einer milden, pH-neutralen, 100% geruchs- und farbstofffreien Flüssigseife. Verwenden Sie bei Auftreten von trockener

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Haut eine pH-neutrale, 100% geruchs- und farbstofffreie Lotion , um die Haut mit Nährstoffen zu versorgen und geschmeidig zu machen. Verwenden Sie KEINE Feuchtigkeitslotion unmittelbar bevor Sie den liner anziehen.

BEACHTEN SIE: Viele der handelsüblichen Pflege- und Reinigungsmittel enthalten hautreizende Stoffe, die in Kombination mit einem Silikonliner zu Hautirritationen führen können. Bitte weisen Sie den Anwender darauf hin, nur sehr milde, pH-neutrale Produkte zu verwenden und bei Hautreizungen eine solche Unverträglichkeit in Erwägung zu ziehen.

HAFTUNGDer Hersteller empfiehlt, das Gerät nur unter den angegebenen Bedingungen und zu den vorgesehenen Zwecken zu verwenden. Die Vorrichtung muss entsprechend den Gebrauchshinweisen gepflegt werden. Der Hersteller haftet nicht für Schäden, die durch Kombination von Komponenten verursacht werden, die nicht vom Hersteller zugelassen sind.

PRODUKT GARANTIEOssur bietet eine Garantie für den unten angegebenen Zeitraum, beginnend ab Rechungsdatum. Diese Garantie ersetzt alle anderen gesetzlichen Ansprüche. Weitere Informationen finden Sie auf unserer Garantiekarte.

Iceross Seal-In® X5 – 6 Monate Garantie.

Für weitere Informationen wenden Sie sich bitte an unseren Kundenservice oder unseren Außendienstmitarbeiter Ihres Vertrauens. Sie finden uns auch auf der Webseite www.ossur.com und www.ossur.de.

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FRANÇAISINTRODUCTIONNous vous remercions d’avoir choisi le manchon en silicone de très haute qualité de la société Ossur et nous vous assurons que vous avez fait un excellent choix. Nous vous demandons de relire et de suivre attentivement les instructions suivantes avant d’appliquer un manchon sur un patient ou les dispositifs complémentaires. Nous souhaitons vous rappeler qu’il est important de donner au patient les instructions contenues dans cette notice concernant la manipulation correcte du manchon et ses modalités d’entretien afin d’optimiser le confort du patient et la durée de vie maximum du manchon.

CONTRE-INDICATIONSLes contre-indications sont:1. Un volume instable du membre.2. Des membres extrêmement coniques (voir CUPULE DISTALE

ICEROSS (DISTAL CUP)).3. Moignons très courts.

Longueur minimum recommandée :Transtibiale: Pour évaluer la longueur recommandée minimum, mesurez la longueur du moignon à partir du tendon du centre de la rotule jusqu’à l’extrémité distale tout en maintenant le genou en extension complète.Transfémorale: Mesurez la longueur du moignon du périné à l’extrémité distale avec le membre en position de relaxation .

• Comparez la mesure prise dans le tableau ci-dessous.• Les lignes de découpe basses de l’emboîture risquent d‘influencer la

suspension et doivent être évaluées individuellement

Tailles de manchon Longueur minimum recommandée

18–23 11.0 cm

25–30 12.5 cm

32–40 13.5 cm

45–50 15.5 cm

55 16.5 cm

REMARQUE: Les profils postérieurs inférieurs de l’emboîture peuvent influencer la suspension et doivent être évalués individuellement.

TAILLE DU MANCHON (Figure 1)Afin de déterminer la taille correcte du manchon Iceross:1. Mesurez la circonférence du moignon à 4 cm de l’extrémité distale

avec le membre relâché.2. Choisissez la taille du manchon Iceross qui correspond à la

circonférence mesurée ou celle immédiatement inférieure à celle-ci.3. NE PAS choisir une taille de manchon dépassant la mesure ou arrondir.

EXEMPLE: si le moignon mesure 31 cm, sélectionnez un Iceross de mesure 30 et NON de mesure 32.Il est très important de choisir la bonne taille. Si le manchon est trop serré, cela peut causer un pistonnement et/ou des engourdissements et une formation de cloques. Si le manchon est trop lâche, cela peut

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entraîner une augmentation de la transpiration et/ou un déplacement du membre à l’intérieur du manchon. La transpiration et le mouvement peuvent provoquer une formation de cloques et des éruptions cutanées. Un manchon seal-In liner trop serré peut également provoquer une tension excessive de l’anneau sur le moignon à partir des membranes hypobariques. Si l’un des symptômes décrits ci-dessus ou toute autre indication d’une mauvaise adhérence apparaît, l’utilisateur doit contacter immédiatement son médecin ou prothésiste.

COUPE D’UN MANCHON ICEROSS (Figure 2)Il est possible de couper le bord proximal du manchon Iceross afin d’accroître le confort de l’utilisateur et d’augmenter les amplitudes de mouvement. L’Iceross CurveMaster, a été spécialement conçu pour cet effet et permet d’obtenir une coupe à bords arrondis et lisses qui réduisent le risque d’irritation de la peau et/ou de déchirure du manchon. Ne coupez pas au dessous ou à travers les membranes hypobariques ainsi qu‘en dessous des bords proximaux de l’emboîture.Une coupe trop accentuée au niveau distal peut entrainer la réduction de la succion naturelle entre le manchon et le moignon et/ou compromettre la suspension.

MISE EN PLACE D’UN MANCHON ICEROSS SEAL-IN® X5Pour mettre en place le manchon, utilisez le Spray Lubrifiant Clean & Simple (Voir SPRAY LUBRIFIANT ICEROSS® CLEAN & SIMPLE). Avant de mettre en place un nouveau manchon, nettoyez-le à l’eau tiède et séchez-le à l’aide d’un chiffon n‘émettant pas de peluches car les huiles naturelles présentes dans le silicone le rendent difficile à saisir.1. Tournez le manchon sur l’envers en saisissant l’extrémité distale de

l’intérieur, comme le montre l’illustration. (Figure 3)2. Saisissez le haut du manchon et enfilez-le sur la main jusqu’à ce que

la surface interne soit complètement exposée. (Figure 4)3. Vaporisez le lubrifiant sur l’envers du manchon pour une mise en

place plus facile. (Figure 5)4. Après avoir exposé la plus grande partie possible de la cupule distale

du manchon, positionnez-la contre le moignon et en pratiquant une légère compression, déroulez le manchon vers le haut sur le moignon. Assurez-vous qu’il ne reste aucune poche d’air. (Figure 6)

5. Roulez le manchon jusqu’en haut du moignon en prenant bien soin de ne pas l’endommager avec les ongles. Ne tirez pas par saccades ou brutalement.

6. Assurez-vous que la circonférence totale des membranes hypobariques soit en position horizontale.

REMARQUE: assurez-vous toujours que l’intérieur du manchon est propre et sec et qu’il ne contient aucune particule susceptible de provoquer une irritation de la peau. Assurez-vous que la collerette en silicone n’est pas retournée et qu’elle est correctement positionnée sur toute sa circonférence.REMARQUE: À l’utilisation, le silicone s’amollira, ce qui facilitera l’application.

MISE EN PLACE DE LA PROTHÈSELe manchon Iceross Seal-In X5 doit être utilisé avec les valves d’expulsion Icelock 551 ou 552 (Voir VALVES D’EXPULSION ICELOCK®). Les valves sont spécifiquement conçues pour maintenir la suspension lors de l’utilisation du manchon Seal-In. Une genouillère n’est alors pas nécessaire

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1. Vaporisez légèrement le contour des membranes hypobariques et l’intérieur de l’emboîture pour faciliter l‘insertion. (Figure 7)

2. Alignez la prothèse comme indiqué par le prothésiste et poussez-là à l’intérieur de l’emboîture en expulsant l’air. (Figure 8)

REMARQUE: Si l’utilisateur éprouve des difficultés pour mettre en place sa prothèse, il peut être nécessaire de vaporiser plus de lubrifiant ou il se peut que la valve soit bloquée.REMARQUE: Si l’utilisateur sent que la peau du moignon tire sur un des côtés une fois la prothèse mise en place, cela signifie que le lubrifiant n’a pas été vaporisé correctement sur tout le contour des membrans hypobariques.

BONNETS POUR MANCHONSSi une diminution de volume survient au niveau du moignon, il est possible d’ajouter des bonnets afin d’adapter le manchon.

Mise en place du bonnet :• Tirez le bonnet par-dessus les membranes hypobariques et assurez-

vous qu’il soit placé entre les deux membranes hypobariques situées au niveau le plus proximal.

• Il est possible de tirer le bonnet par-dessus les deux membranes hypobariques supérieures tant que la suspension est maintenue.

• Placez la prothèse normalement.

REMARQUE: La mise en place du bonnet par-dessus les trois membranes hypobariques situées au niveau distal peut provoquer une perte de suspension.

SPRAY LUBRIFIANT ICEROSS® CLEAN & SIMPLEL’atomiseur de lubrifiant Iceross Clean & Simple doit être utilisé pour faciliter le chaussage du manchon et de la prothèse.Le lubrifiant est conçu pour s’évaporer rapidement après le chaussage afin de maintenir une suspension maximale.Un stylo atomiseur accompagne le manchon Seal-In, suffisament petit pour tenir dans une poche ou dans un sac à main. Il peut être rempli à l’aide du spray lubrifiant Iceross Clean & Simple.AVERTISSEMENT: Ne pas appliquer sur la peau. Éviter tout contact avec les yeux.INGRÉDIENTS: Alcool isopropylique et eau.

VALVES D’EXPULSION ICELOCK®

Les valves d’expulsion Ossur Icelock sont conçues et testées pour expulser de l’air en permanence lors du chargement de la prothèse, permettant ainsi de maintenir une suspension hypobarique.

Numéro de produit Description Avantages

L-551000 Valved’expulsion 551

Petite, cosmétique etfacile d‘installation

L-552000 Valved’expulsion 552

Valve amovible etlarge ouverture facile

CUPULE DISTALE ICEROSS (DISTAL CUP)La cupule distale Iceross (I-3000xx) permet d’augmenter le confort des moignons coniques ayant une faible couverture de tissu mou. On peut les utiliser conjointement avec les manchons Iceross pour normaliser la

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forme du moignon et assurer un contact total.Le silicone DERMOGEL de la cupule distale s‘adapte au moignon ce qui permet de minimiser la pression sur les reliefs osseux lors de la marche.

Mise en place correcte de la cupule distale:1. Mesurez la circonférence du moignon à 4 cm de son extrémité

distale. (Figure 1)2. Choissez la taille de la cupule qui correspond à la circonférence

mesurée ou celle immédiatement inférieure à celle-ci.3. Déroulez la cupule distale directement sur le moignon. (Figure 9)4. Si vous utilisez un manchon Iceross en combinaison avec une cupule

distale, la mesure de circonférence servant à choisir la taille du manchon sera prise lorsque la cupule est déjà mise en place (c’est à dire PAR DESSUS la cupule). (Figure 10)

5. Choisissez la bonne taille de manchon Iceross en vous basant sur la mesure obtenue avec l’étui distal en place ou la taille suivante ci-dessous (Voir TAILLE DU MANCHON).

COUSSINETS ICEROSS® (Figure 11)Les coussinets Iceross peuvent être utilisés sur toutes les zones à problèmes (c’est-à-dire les trous ou cicatrices) afin d’assurer une meilleure adhérence et pour réduire l’emprisonnement d’air. Les coussinets Iceross peuvent également être utilisés pour répartir la pression du corps et pour protéger la peau. Dans certains cas, des coussinets personnalisés peuvent être nécessaires pour certaines formes ou zones à problèmes irrégulières. Voir le Catalogue des Prothèses Ossur pour de plus amples informations à ce sujet.

ENTRETIEN DU MANCHON (Figure 12)Il est très important de pratiquer un entretien soigneux des produits. Retirez le manchon, tournez le manchon de l'intérieur vers l'extérieur et lavez-le avec un savon au pH équilibré, sans parfum et sans colorant. Le manchon peut être lavé en machine (40˚C). Utilisez une lessive douce. Les adoucissants, les détachants ainsi que les produits javellisés risquent d’endommager le manchon: ne les employez pas! Après avoir procédé au nettoyage, le manchon doit être rincé abondamment à l’eau claire et essuyé sur ses deux faces avec un chiffon doux et non pelucheux.

Il est tout à fait possible d’utiliser un manchon directement après lavage. Il n’est pas nécessaire de le faire sécher toute une nuit. Immédiatement après le lavage, remettez le manchon dans sa position normale, c’est à dire avec le textile sur sa face externe. Avant toute utilisation, vérifiez que la membrane hypobarique est propre et exempte de poussière.

Il faut toujours contrôler que les manchons Iceross ne soient pas endommagés ou ne comportent pas de traces d’usure. Tout dommage pourrait affaiblir le manchon. Ceci doit être signalé au prothésiste immédiatement. Un usage inadéquat pourrait entraîner une perte de suspension.

Les prothésistes et les patients doivent être attentifs à ne pas mettre le manchon en contact avec des fibres de verre ou de carbone ou toute autre particule étrangère. Elle pourraient s’incruster dans le silicone et causer ainsi de graves irritations de la peau. Au cas où le silicone serait, par inadvertance, mis en contact avec ce genre de matériau ou avec des produits chimiques, il ne suffit pas toujours de procéder à un nettoyage à

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l’eau claire. Le patient doit immédiatement ramener son manchon au prothésiste. Les produits silicone DermoSil et DermoGel contiennent de l’extrait d’Aloe Vera qui agit comme un hydratant naturel et est également connu pour activer le processus de cicatrisation tout en apaisant la peau. Le silicone du manchon contient un extrait à l’aloe vera. Celui-ci agit comme un hydratant naturel, est connu pour ses effets actifs de cicatrisation et ses effets adoucissants sur la peau. Lorsque le manchon est neuf, sa surface interne doit être humide au toucher. Pour ces raisons, le manchon ne doit jamais être laissé longtemps retourné ou exposé aux rayons du soleil ou à une chaleur extrême.

SOIN CUTANÉS (Figure 13)Un nettoyage quotidien du moignon est également indispensable. Nous conseillons d'utiliser un savon liquide doux, au pH équilibré, sans parfum et sans colorant. Si vous remarquez que la peau est sèche, appliquez une lotion au pH équilibré, sans parfum, sans colorant afin de nourrir et d'adoucir la peau. N’appliquez PAS de lotion sur le moignon avant de chausser le manchon.

REMARQUE: Le patient doit être informé sur le fait que de nombreux produits d’utilisation courante tels que les détergents, les produits de bain y compris les savons, les déodorants, les parfums, les sprays avec ou sans alcool et les produits d’entretien peuvent provoquer des irritations cutanées ou y contribuer.

RESPONSABILITÉLe fabricant recommande d'utiliser le dispositif uniquement dans les conditions spécifiées et aux fins prévues. Le dispositif doit être entretenu conformément aux consignes d'utilisation. Le fabricant ne peut être tenu pour responsable des dommages causés par des associations de composants non autorisés par le fabricant.

GARANTIE DES PRODUITSLe Manchon Iceross Seal-In, produit Ossur, fait l’objet d’une garantie écrite. La période de garantie débute le jour de la date de facturation. Cette garantie remplace toute autre garantie qu’elle soit légalement consentie ou de façon implicite.

Iceross Seal-In® X5 – 6 mois

Pour tous renseignements complémentaires, veuillez bien vouloir contacter la société Ossur ou votre chef des ventes agréé Ossur. Vous pouvez aussi consulter notre page web à l’adresse suivantewww.ossur.com

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ESPAÑOLINTRODUCCIÓNLe agradecemos que haya elegido este encaje de silicona de alta calidadde Össur. Podemos asegurarle que ha realizado la elección correcta.Por favor, lea cuidadosamente estas instrucciones antes de proceder ala adaptación al paciente del encaje o accesorios. Recuerde que es muyimportante informar al paciente sobre el cuidado y manejo adecuado delencaje que se exponen en estas instrucciones, a fin de lograr confort enel paciente y la máxima durabilidad del producto.

CONTRAINDICACIONES DE USOContraindicado en caso de:1. Volumen del muñón inestable.2. Muñones extremadamente cónicos (Ver COPA DISTAL ICEROSS®).3. Miembros residuales muy cortas.

Longitud mínima recomendada:Transtibial: Para evaluar la longitud mínima recomendada, medir la longitud del miembro residualdesde la mitad del tendón rotuliano hasta el extremo distal, con la rodilla completamente extendida.Transfemoral: Medir la longitud del miembro residual con el tejido suspendido, desde el periné hasta el extremo distal.

• Comparar las medidas con la tabla que se muestra a continuación.• Las líneas de corte de la parte posterior del encaje rígido puede

afectar a la suspensión y debería evaluarse individualmente.

Tamaños de funda Longitud mínimarecomendada

18–23 11.0 cm

25–30 12.5 cm

32–40 13.5 cm

45–50 15.5 cm

55 16.5 cm

NOTA: Las líneas de corte de la parte posterior del encaje rígido puedenafectar a la suspensión y deben comprobarse individualmente.

ELECCIÓN DE LA TALLA (Figura 1)Para elegir la talla correcta de Iceross:1. Mida la circunferencia del miembro residual a 4 cm del extremo distal

con el tejido colgando.2. Elija la talla de Iceross correspondiente a la medida obtenida, o bien a

una talla inferior.3. NO elija un tamaño de funda superior a la medida ni redondee hacia

arriba.

EJEMPLO: Si el muñón mide 31cm, elija la talla 30, NUNCA la talla 32.Seleccionar el tamaño adecuado es muy importante. Si el encaje estádemasiado apretada, puede causar un efecto pistón y/o adormecimientoy ampollas. Si el encaje está demasiado suelta, puede aumentar la transpiración y/o el movimiento del miembro residual dentro del encaje. La transpiración y el movimiento pueden producir ampollas y urticarias. Un encaje seal-In demasiado apretada puede producir además una

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tensión excesiva en la zona de la membrana. Si se detecta alguno de los síntomas anteriores o algún otro síntoma de ajuste incorrecto, el usuariodebe contactar de inmediato a su médico o técnico ortopedico.

RECORTE DEL ICEROSS (Figura 2)El encaje puede ser recortado según las preferencias del usuario paraobtener una mayor adaptación para la marcha. Para cortar el encaje, utilice el CurveMaster Iceross. El CurveMaster Iceross está diseñado parahacer un corte uniforme, redondeando el borde y minimizando el riesgode irritación en la piel y desgarros en el encaje.No corte el encaje a la altura de los sellos o por debajo de éstos ni pordebajo de las líneas de corte proximales del encaje rígido. Esto puedereducir la succión entre el encaje y el muñón y/o comprometer la suspensión.

COLOCACIÓN DEL ENCAJE DE SILICONA ICEROSS SEAL-IN® X5Para colocar el encaje, utilice el spray lubricante Clean & Simple (Ver SPRAY LUBRICANTE CLEAN & SIMPLE DE ICEROSS®). Antes de colocar un encaje nuevo, límpiela con agua tibia y séquela con un paño sin pelusas, ya que los aceites naturales de la silicona dificultan el agarre.

1. Ponga el encaje del revés sujetando el extremo distal desde el interior como se muestra en la ilustración. (Figura 3)

2. Sujete la parte superior de el encaje y deslícela por encima de la mano hasta que toda la superficie interior quede fuera. (Figura 4)

3. Aplique el spray lubricante en la silicona del revés para facilitar su enrollado. (Figura 5)

4. Dejando descubierto el extremo distal de la silicona al máximo posible, coloque la silicona frente el muñón y, ejerciendo una ligera compresión, extiéndala colocándola sobre él. Asegúrese de que no quede aire dentro de la funda. (Figura 6)

5. Desenrolle el encaje al máximo, teniendo cuidado de no dañarlo con las uñas.

6. Compruebe que los sellos estén horizontales en toda su circunferencia.

NOTA: preste especial atención a que el interior de la silicona esté limpio, seco y no contenga cuerpos extraños que puedan irritar la piel.NOTA: Con el uso, la silicona se ablandará, lo que hará más fácil la aplicación.

COLOCACIÓN DE LA PRÓTESISEl Iceross Seal-In X5 liner se debe utilizar con las válvulas de expulsión Icelock 551 ó 552 (Ver COPA DISTAL ICEROSS®). Las válvulas están diseñadas específicamente para mantener la suspensión al utilizar el Seal-In liner. No se necesita rodillera.

1. Pulverice ligeramente los sellos en toda su circunferencia y dentro del encaje rígido para que entre con más suavidad. (Figura 7)

2. Alinee la prótesis siguiendo las instrucciones del técnico ortopedico y empuje el encaje rígido que expulsa el aire. (Figura 8)

NOTA: si el usuario tiene dificultades para colocarse la prótesis, puede que sea necesario aplicar más lubricante o que la válvula esté bloqueada.NOTA: si el usuario siente que la piel del miembro residual tira hacia un lado tras la colocación de la prótesis, la distribución del lubricante en

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toda la circunferencia de los sellos es inadecuada.

CALCETAS PARA CAMBIOS DE VOLUMENSi se experimenta una reducción de volumen en el miembro residual, pueden añadirse calcetas de volumen para ajustar el encaje rígido.

Aplicación de la calceta:• Tire la calceta por encima de los sellos y asegúrese de que está

nivelado entre los dos sellos más próximos.• La calceta puede extenderse por encima de los dos sellos superiores

si se mantiene la suspensión.• Coloque la prótesis normalmente.

NOTA: colocar calcetas por encima de tres sellos distales puede producir una pérdida de suspensión.

SPRAY LUBRICANTE CLEAN & SIMPLE DE ICEROSS®

El spray lubricante Iceross® Clean & Simple (Limpio y Simple) se debe utilizar para facilitar la colocación del encaje y la prótesis.El lubricante está diseñado para que se evapore de manera rápida tras la colocación para mantener una suspensión máxima. Se incluye un spray en forma de bolígrafo con el encaje Seal-In, lo suficientemente pequeño para caber en un bolsillo y/o un bolso. Puede rellenarse con el spray lubricante Clean & Simple de Iceross.ADVERTENCIA: No lo aplique directamente sobre la piel. Evite el contacto con los ojos.INGREDIENTES: propanol y agua.

VÁLVULAS DE EXPULSIÓN ICELOCK®

Las válvulas de expulsión Icelock de Ossur están diseñadas y probadas para expulsar aire de manera continua al cargar la prótesis, así se mantiene la suspensión hipobárica.

Número deProducto Descripción Ventajas

L-551000 Válvula deexpulsión 551

Pequeña, cosmética yde fácil instalación

L-552000 Válvula deexpulsión 552

Válvula extraíble ygran apertura lisa

COPA DISTAL ICEROSS®

La Copa Distal Iceross (I-3000xx) puede proporcionar un aumento del confort en aquellos muñones cónicos con poco tejido blando. La silicona DERMOGEL de la Copa Distal Iceross sustituye el tejido blando y se ajusta al miembro, de modo que impide la aparicion de puntos de presión sobre prominencias óseas durante la marcha.

Para elegir la talla correcta de Copa Distal:1. Tome la medida de la circunferencia del muñón 4cm por encima del

extremo distal. (Figura 1)2. Seleccione la talla de la Copa Distal según la medida obtenida, o una

inferior.3. Desenrolle la Copa Distal directamente sobre el miembro. (Figura 9)4. Cuando se utiliza un encaje Iceross en combinación con una Copa

Distal, mida la circunferencia del muñón SOBRE la Copa Distal, 4cm

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por encima del extremo distal. (Figura 10)5. Seleccione el tamaño del encaje Iceross correcto según la medición

obtenida con la copa distal colocada o el tamaño inmediatamente inferior (Ver ELECCIÓN DE LA TALLA).

ALMOHADILLAS DE ICEROSS® (Figura 11)Las almohadillas de Iceross (I-6103xx) pueden utilizarse para rellenar cualquier área problemática (p.ej. huecos o cicatrices) para mejorar el ajuste y minimizar la cantidad de aire atrapado. Las almohadillas de Iceross también pueden utilizarse para distribuirla presión corporal y proteger la piel. En algunos casos, las almohadillas con forma personalizada pueden ser necesarias para las formas irregulares o las áreas problemáticas. Encontrará más información en el catálogo de productos protésicos de Ossur.

CUIDADOS DEL ENCAJE DE SILICONA (Figura 12)Es muy importante una adecuada higiene del producto. Retire el liner, póngalo del revés y lávelo con un jabón con pH equilibrado, y libre de colorantes y fragancias al 100%. El encaje puede ser lavado también a máquina (40°C en caliente) con detergente neutro. No se deben utilizar suavizantes o lejía ya que pueden dañar el encaje de silicona. Después de limpiar el encaje, enjuáguelo con abundante agua y séquelo con un paño que no suelte hilos.

El encaje puede ser usado directamente después de haber sido lavado. No necesita ser secado de nuevo al quitárselo por la noche. Vuelva siempre a dejar el encaje en su posición normal, con el adaptador distal en el exterior , después del lavado. Antes de poderlo utilizar, la membrana de sellado de silicona debe estar limpio y no debe tener impurezas en su superficie.

Los encajes de silicona Iceross deben comprobarse regularmente por si existen daños, ya que éstos pueden reducir la efectividad de la silicona. El uso inadecuado puede provocar la pérdida de suspensión.

En el técnico ortopédico y el paciente deben tener cuidado de no dejar el encaje en contacto con fibra de vidrio o fibra de carbono, u otros elementos extraños. Estas sustancias pueden incrustarse en la silicona y causar problemas en la piel, siendo muy difícil de extraer durante el lavado. En el caso de que ocurra accidentalmente, debe instruirse al paciente para que lo devuelva inmediatamente al técnico ortopédico. La silicona del encaje contiene extracto de aloe vera. Éste actúa como una crema hidratante natural y es conocido por sus activos efectos curativos y calmantes en la piel. En principio, la superficie interior del encaje debe dar la sensación de estar siempre hidratada y suave al tacto. Por estas razones, el encaje no debe dejarse con el interior expuesto mucho tiempo, ni ser expuesto a excesivo calor o luz solar.

CUIDADO DE LA PIEL (Figura 13)El aseo diario del miembro residual también es esencial. Recomendamos el uso de un jabón con pH equilibrado, y libre de colorantes y fragancias al 100%. Si observa la piel seca, aplique una loción con pH equilibrado, y libre de colorantes y fragancias al 100% para nutrir y suavizar la piel. NO aplicar la loción en el miembro residual inmediatamente antes de colocar el encaje de silicona.

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NOTA: Muchos productos comunes de baño y cuidado, como desodorantes, colonias, sprays de alcohol o productos abrasivos puedenprovocar irritación en la piel, y el paciente debe estar avisado.

RESPONSABILIDADEl fabricante recomienda usar el dispositivo únicamente en las condiciones especificadas y para los fines previstos. El dispositivo debe mantenerse de acuerdo a lo especificado en las instrucciones para el uso. El fabricante no se hace responsable de los daños causados por el uso de combinaciones de componentes que no hayan sido autorizados por el mismo.

GARANTÍAOssur ofrece una garantía escrita para el encaje de silicona IcerossSeal-In por el periodo indicado a partir de la fecha de la factura. Dichagarantía reemplaza cualquier otra, ya sea explícita o ímplicita en la ley.

Encaje de sellado Iceross® X5 – 6 meses

Para más información, puede ponerse en contacto con Ossur o sudistribuidor local. También puede visitar la página web de Ossurwww.ossur.com.

ANEXO 2: Fichas técnicas y manuales...N W A3 D Af i ni b o t A3 1 U s e r M a nu a l 1 . A s s e mb...

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