Harmony Fabrication Quick Guides

Transcription

1 Harmony Fabrication Quick Guides These Quick Guides describe the 12 Harmony fabrication steps. Follow them in the order they are presented to minimize fabrication time. The first Quick Guide describes how to vacuum cast since not all prosthetists are familiar with this technique. The next nine Quick Guides (Steps 1 9) describe how to fabricate the temporary (test socket) Harmony system. 1. Casting for custom urethane liner 2. Casting for socket 3. Reducing positive mold 4. Marking trim lines and pulling test socket 5. Checking fit of socket 6. Assembling the prosthetic leg 7. Creating vacuum 8. Lowering trim lines and installing gaiter 9. Aligning the prosthesis The last three Quick Guides (Steps 10 12) describe how to fabricate the definitive socket and an optional protective slip cover, and how to vent the pump outside a cosmetic cover. 10. Making definitive socket 11. Making protective slip cover 12. Cosmetic cover modification Full size masters of a worksheet and four charts that you might want to duplicate can be found following the Quick Guides. Mold Reduction Worksheet 4% Reduction Chart 5% Reduction Chart 6% Reduction Chart Elastomer Rod Adjustment Chart

2 Harmony Fabrication Quick Guides 2 Vacuum Casting 1. Pull 2 4 layers of nylon stockinet or a casting sock over the wet plaster for an air wick. Be sure to leave extra material at the distal end. This will ensure that the vacuum line has an air wick when it is pressed up against the bottom of the limb. current shape. So, if needed, gently support tissues before turning on the casting pump. 6. Seal the casting bag proximally, turn on the casting pump (>51 kpa, 15 Hg) and maintain vacuum until the cast has set. Don t worry about folds in the bag. They will not affect the quality of the cast. Wet plaster cast Nylon stockinet or casting sock Extra material Important: If the bag isn t being pulled down tightly against the limb, look for the following causes and use the respective solution. 1. Vacuum line is sealed off against the inside of the bag. Solution: Turn off the pump, reposition the vacuum line so that is in direct contact with the stockinet and turn the pump back on. 2. Casting bag is too snug, causing it so seal off distally on the leg. Solution: Use a larger casting bag. 3. Air wick is saturated with wet plaster. Solution: Add additional layers of air wick. 2. Select a casting bag (small, medium or large) that is small enough to seal proximally, but large enough to provide ample room for the limb. A snug casting bag should not be used since it can deform the limb and prevent the vacuum from extending proximally. The bag may extend beyond the end of the limb as shown. Remember to empty the water trap on the casting pump after vacuum casting. Required Materials and Tools Nylon stockinet Casting sock Casting bags 50/50% alcohol/water mix Casting pump Casting bag 3. Spray a 50%/50% mix of water and alcohol into the inverted bag before rolling it on, if you would like to reduce friction. 4. Attach the vacuum line to the connector at the distal end of the bag. Push and hold the vacuum line against the air wick so that air can be removed from the bag. 5. Support soft tissues if needed before turning on the casting pump. Vacuum holds the soft tissues in their

3 Harmony Fabrication Quick Guides 3 Step 1 Casting for Custom Urethane Liner 1. Complete all required sections of the Order Form, including limb circumferences. Indicate on the Order Form that you are requesting a custom Harmony liner. 2. Apply parting agent to the limb, stopping ~20 cm (8 ) above the top of the patella. Normal Skin: Wrap the limb with plastic wrap or cover with lubricant. Abnormal Skin (Non-closing Invagination or Scaring): Invaginations or deep scaring that do not close when cupped by hand are rare; only 1 2% of all patients. If you encounter one of these cases, fill the invagination/scar with plaster bandage wrap. Apply lubricant to the remainder of the limb. Avoid getting lubricant on the bandage wrap. Make a note on the Order Form to alert Otto Bock of the invagination/scar. 3. Pull a thin casting sock over the limb to a height of ~20 cm (8 ) above the top of the patella. 20 cm (8 ) Cast from this mark down 7. Apply 4 layers of nylon or a casting sock over the cast. 8. Apply casting bag. Extend it up to the thigh to form a seal. 4. Mark the bottom of the patella on the casting sock with an indelible pencil. This mark is used by the Otto Bock technician when manufacturing the custom liner. 9. If necessary, lightly support any distal, redundant soft tissue that gravity has caused to droop so that it remains in line with the rest of the lower limb until the plaster has set. The reason to support the soft tissue is to avoid producing a liner that tends to hold soft tissue off center. 5. Mark a spot on the thigh 9 above the mark at the bottom of the patella as a reference for the top of the cast. Have the patient hold their limb at 10 degrees of flexion. Keeping tissues inline 6. Cast the limb with plaster bandage starting proximally at the mark. 10. Place the knee at 10 degrees of flexion and turn on the casting pump. Maintain vacuum until the cast has set. 11. Write the patient s name on the cast. 12. Ship the cast and completed order form to Otto Bock.

4 Harmony Fabrication Quick Guides 4 Step 1 Casting for Custom Urethane Liner If you have any questions about how to handle non-closing invaginations/scars please contact Otto Bock. Required Materials and Tools Order form Plastic wrap or lubricant Casting sock Indelible pencil Knee angle tool Non-elastic plaster bandage Nylon stockinet Casting bags Casting pump Water bucket Gloves

5 Harmony Fabrication Quick Guides 5 Step 2 Casting for Socket 1. Cast in the morning before the limb loses volume if possible. 2. Examine the limb for characteristics that might influence how you cast the limb. Note the locations of the patella, femoral condyles, tibial tuberosity, fibular head, distal ends of the tibia and fibula, skin anomalies, neuromas and any other points of interest. Also hold the limb and have the patient contract his/her calf muscles to determine whether and how much shape change the muscles cause. 3. Find and mark the anterior midline of the new liner with a permanent marker to aid the patient when donning the liner. The patient s name is lightly inscribed inside the liner at its distal, posterior aspect. Mark the anterior midline of the liner 7. Determine which size casting bag will be used. The bag should seal with the top 5 cm (2 ) of the liner but be loose over the remainder of the limb. Stage 1 Capture femoral condyles 8. Create a 7.5 cm (3 ) wide plaster splint that is 4 6 layers thick as shown. Cut it to a length so that it will go from the medial to the lateral midline of the limb, but not so long as to cover the fibular head. Notch the central section of the splint so that the center section is ~4 cm (1.5 ) wide. This narrow center section should reside between the bottom of the patella and tibial tuberosity. C A 4. Have the patient don the liner and remove all air between the limb and liner. Liner 5. Apply a parting agent such as lubricant or plastic wrap to the liner; stopping ~5 cm (2 ) from the top of the liner. The exposed portion of the liner will seal with the casting bag. 5 cm (2 ) Plastic wrap B A = 7.5 cm (3 ) B = Extends from medial to lateral midlines of tibia C = Distance (~4 cm (1.5 )) between bottom edge of patella and tibial tuberosity 9. Wet the splint and position it on the limb to capture the femoral condyles. The narrow midsection should be positioned between the bottom edge of the patella and the tibial tuberosity. Make sure the top of the splint is aligned with the bottom edge of the patella. This is important because the splint s top edge is used later to identify the height to which the mold is reduced. 6. Roll one layer of nylon stockinet or a casting sock over the parting agent. 10. Pull on two layers of nylon stockinet or a casting sock for an air wick as shown. Vacuum cast the splint, with the knee in 80 of flexion. Seal the bag with the

6 Harmony Fabrication Quick Guides 6 Step 2 Casting for Socket proximal liner. Draw a vacuum of at least 51 kpa (15 Hg) when casting. LIGHTLY press here so the bottom edge of the patella is identifiable 15. Once the plaster sets, make sure the splint stays in position as you remove the casting bag and two layers of stockinet/casting sock. Stage 3 Capture limb volume 16. With the knee still at 5 10 of flexion, plaster wrap the entire limb (and 2 previous splints) from approximately 2.5 cm (1 ) above the top edge of the patella down to the distal end of the limb. Start wrapping proximally and work distally. 11. Once the plaster sets, make sure the splint stays in position as you remove the casting bag and two layers of stockinet/casting sock. Stage 2 Capture prominent bony features 12. Cut a second 4 6 layer splint as shown in the following picture to capture the tibial crest and fibular head. Its width should extend from the medial to lateral midlines of the limb except in the area of the fibular head; in this area the splint should extend posteriorly to capture the entire head of the fibula. Do not extend the splint into the soft tissues posteriorly. The height of the splint should allow it to extend from the center of the patella to 3 6 mm (1/8 1/4 ) proximal of the end of the tibia. A 17. Apply 4 layers of nylon stockinet or a casting sock over the cast for an air wick and vacuum cast as before. 18. In the occasional case where the soft tissue droops down and causes a step at the distal end of the tibia, lightly support the tissues before pulling vacuum to eliminate the step. B C A = center of patella down to 3-6 mm (1/8-1/4 ) proximal of the end of the tibia B = Extends from medial to lateral midlines C = Extension to capture fibular head Eliminating tibial step 13. Wet the splint and position it on the limb to capture the prominent anterior bony features and the fibular head. Pull on two layers of nylon stockinet or a casting sock for an air wick as shown. 14. Vacuum cast with the knee at 5 10 of flexion. 19. If the patient s calf muscles when tensed noticeably change the shape of the limb, have the patient tense the calf muscles prior to and during vacuum casting.

7 Harmony Fabrication Quick Guides Apply vacuum. Once the plaster sets, remove the casting bag and four layers of stockinet or casting sock. Slide the cast off the limb. Required Materials and Tools Permanent marker Skin lotion Urethane liner Lubricant or plastic wrap Nylon stockinet Casting sock Casting bags Non-elastic plaster bandage Scissors Casting pump Gloves Bucket of water Step 2 Casting for Socket

8 Harmony Fabrication Quick Guides 8 Step 3 Reducing Positive Mold When reducing, always maintain the shape of the limb! 1. Pour plaster into the negative cast. Imbed whatever type of anchoring post/adapter your facility normally uses. An embedded metal pipe is illustrated here. mark these holes. Lead pencils will not bleed into the plaster, which is important here since you need to shave the distal end down by 6 mm (¼ ) and no more. Hole pattern in end of mold Pipe 3-stage cast Poured plaster 2. Remove the poured plaster mold by cutting the back of the 3-stage cast where it is only one layer thick. 3. Punch a 6 mm (¼ ) deep hole into the mold with an awl at the bottom edge of the patella. Press an indelible pencil into the hole. 4. Measure from the top of the mold down to the bottom edge of the patella (hole you just punched) and record this distance on the top of the mold should it be needed later. 5. Punch and mark 3 5 additional anterior, 6 mm (¼ ) deep holes distal to the proximal hole (A). These will serve as marks at which circumferences will be measured. The most distal mark should be well short of the sharp curvature at the end of the mold. A B C D 7. Using a rasp, carefully reduce the end of the mold until the five 6 mm (¼ ) deep marks just disappear. 8. Measure and record in millimeters the mold circumferences at each of the anterior marks in the Starting Circ (mm) column in the following worksheet. Mold Reduction Worksheet Patient Name: Date: Starting Circ (mm) Target Circ (mm) Starting Minus Target Rasp Strokes Marks A B C D E F G 9. Calculate the 4, 5 or 6% reduced circumferences by multiplying each circumference by 0.96, 0.95 or 0.94, respectively, or by using one of the following tables. We recommend reducing by 4 % when first making Harmony systems. As you become more experienced, you may find that you need to reduce by 5 or 6%. The reduction should include the final smoothing (screening) of the mold. 6. Punch and mark five 6 mm (¼ ) deep holes on the distal end of the mold; one at the center and four slightly off center; one each in the medial, lateral, anterior and posterior directions. Use a lead pencil to

9 Harmony Fabrication Quick Guides 9 Step 3 Reducing Positive Mold 4% Reduction Chart Circ -4% Circ -4% Circ -4% % Reduction Chart Circ -5% Circ -5% Circ -5% % Reduction Chart Circ -6% Circ -6% Circ -6% Starting with approximately 4 strokes, work your way around the mold until the reduced circumferences are attained. Do not reduce the mold above the height of the proximal mark (A). Be careful to take fewer or less aggressive strokes of the rasp distally where the molds usually are smaller in diameter. Maintain the shape of the limb as you reduce. Be sure to maintain the exact shapes of the bony prominences, such as the fibular head and distal tibia, when reducing them. Caution: It is easy to remove too much plaster from small prominences such as the fibular head. Optional: It is instructive to record the number of millimeters by which the circumferences were reduced. You may record these in the rightmost column in the worksheet and count the number of rasp strokes it took you to create these reductions. Noting these two things allows you get a feel for how many strokes it will take to achieve various reductions in the future. 11. Distally, make sure there is a smooth transition between the sides and end of the mold by creating a smooth radius. 12. Blend the un-reduced (proximal) portion of the mold with the reduced portion. 13. Smooth the mold with a sanding screen.

10 Harmony Fabrication Quick Guides Double check your circumferences after using the sanding screen. Step 3 Reducing Positive Mold Required Materials and Tools Gloves Water Utility knife Indelible and lead pencils Calculator Half round rasp Sanding screen Plaster Anchoring post/adapter Awl Tape measure Paper Full round rasp

11 Harmony Fabrication Quick Guides 11 Step 4 Marking Trim Lines and Pulling Test Socket 1. All trim lines are measured from a circumferential line drawn at the height of the bottom edge of the patella. Place the top edge of a rubber band around the mold at the bottom edge of the patella. Draw a line along the top edge of the rubber band with an indelible pencil. Remove the rubber band. Major vessels and nerves Lateral hamstring tendon Medial hamstring tendons 5. Connect the points with an indelible pencil by drawing curved lines. The trim lines should appear as follows. Note how the medial and lateral trim lines drop down sharply so that they don t wrap around posteriorly. Anterior Medial/lateral Posterior Rubber band 2. Mark the height of the anterior trim line; 40 mm (1.5 ) above the reference line as shown below. 3. Mark the heights of the medial and lateral trim lines; 50 mm (2 ) above the reference line as shown below. 4. Mark three points to identify the heights of the posterior trim liner. At the midline, measure and mark a point 6 mm (¼ ) above the reference line. This should be directly posterior from the center of the patella. For hamstring relief, measure and mark two points 6 mm (¼ ) below the reference line, one for each hamstring. Be sure the two hamstring points are positioned anatomically correct. Anterior Medial/lateral Posterior 40 mm (1.5 ) 50 mm (2 ) 6 mm (1/4 ) Lat Med 6. Place reduced mold upside down in a vacuum stand. Vacuum stand Reference line Lat Med Be aware of the posterior anatomical structures as you make these points. Vacuum line 7. Heat a square of clear plastic (Thermolyn Stiff 616T52) to 170 C (350 F ) in an oven for approximately 15 minutes or until it droops 1/3 1/2 of the height of the mold. 8. Slowly pull the plastic over the mold down and apply vacuum.

12 Harmony Fabrication Quick Guides 12 Step 4 Marking Trim Lines and Pulling Test Socket Vacuum stand Vacuum line 9. Once the plastic has cooled, transfer the trim lines to the test socket. 10. Remove the test socket from the mold and cut the test socket along the trim lines. 11. Clean up the sharp edges of the test socket. Required Materials and Tools Rubber band Tape measure Oven Vacuum source Permanent marker Sander/buffer Indelible pencil Clear plastic sheet Vacuum stand Insulated mittens Cast saw Thermolyn stiff (616T52)

13 Harmony Fabrication Quick Guides 13 There are three checks to determine fit: 1) Total contact 2) Progressive liner drive 3) Patient comfort These three checks are performed before anything is attached to the clear socket so that the entire liner is visible. Step 5 Checking Fit of Socket To prepare for the three checks: 1. Have your patient doff the liner. 2. With a permanent marker, draw 12 vertically aligned dots on the outside of the liner; 3 anteriorly, 3 medially, 3 laterally and 3 posteriorly. The top dots should be at least 4 cm (1.5 ) below the posterior trim line. Anterior midline mark on liner Check 1 Total contact 5. Have the patient stand in the socket using a floor stand. Visually inspect to make sure the donned liner makes total contact with the socket. Anterior, medial and lateral sets of dots 3. Set the liner into the test socket and circle the 12 liner dots on the outside of the socket. Floor Stand Check 2 Progressive Liner Drive 6. Inspect the proximal flow of the 12 liner dots while they are standing with half body weight on the floor stand. The dot (liner) drive should be progressively more in the proximal direction as shown. It is the pattern of liner (dot) drive that should be your focus, more than the absolute amount of drive. The dot movements listed are rough estimates. Focus on the liner drive pattern, not the absolute amounts of the dot movements. 4. Have the patient don the liner and sheath.

14 Harmony Fabrication Quick Guides 14 Step 5 Checking Fit of Socket ~13-19 mm (1/2-3/4 ) ~10-16 mm (3/8-5/8 ) ~6-10 mm (1/4-3/8 ) Floor Stand If the liner drive pattern is not progressive as pictured see the Harmony Troubleshooting Table for the Prosthetist for instructions on how to interpret your drive pattern and use fillers to establish a proper liner drive pattern. If you have to add a full sock to establish proper liner drive, you should make a new socket. Check 3 Patient Comfort 7. Ask your patient if the fit is snug and comfortable. If the patient experiences pain or discomfort, see the Harmony Troubleshooting Table for the Prosthetist. If you reduced the fibular head too much and the patient is complaining of fibular head pressure, it can be resolved by having the patient stand in the socket after heating it up in the fibular head region. Make a dot on the sheath where they feel discomfort. Have them stand in the socket and draw a 5 cm diameter circle around the dot. Remove the socket and heat it at the circle. Have them stand in the heated socket. Required Materials and Tools Permanent marker Floor stand Tape measure

15 Harmony Fabrication Quick Guides 15 Step 6 Assembling the Prosthetic Leg In this step, you will be assembling the leg and attaching it to the test socket. Attach the leg in the order (bottom-up or top-down) in which your lab is accustomed. The top-down approach is described here. If you prefer the opposite approach, start at the foot and work up. Before you start, note the tilt of the socket as they stand on 1. Attach an adapter (6A94=3 or 5R1=6 or 4R111) to the bottom of the socket. Keep in mind your patient s unique alignment when attaching the adapter. In general you want to glue the adapter in a position where the pyramid adjustment screws will be in their neutral positions. Three methods are shown below. Select the one your facility prefers. A. TEC Plate Adapter Method. Set the adapter on the table so the four notches are up and the four hole pattern is oriented correctly. Place Loctite Adhesive 454 into the center of the TEC plate adapter (6A94=3). Lightly spray the bottom of the socket with Loctite Accelerator 712 to promote rapid curing. Set the socket on the TEC plate adapter. Adhesive of the socket with acrylic putty. If flat head screw are used to strengthen the connection between the socket and adapter, be sure to use clear pressure sensitive tape (616F22) to cover the screw heads on the inside of the socket. This will prevent vacuum leaks. Apply acrylic putty Bond adapter 2. Use 50 mm (2 ) fiberglass casting tape to fill the gap between the adapter and socket if it exists. Continue by tightly wrapping the fiberglass casting tape around the adapter (6A94=3 or 5R1=6) and distal end of the socket as shown in the drawing. Wrap a minimum of mm (3 5 ) up from the bottom of the socket to secure the adapter to the socket. If possible, leave a minimum of 65 mm (2.5 ) of the socket exposed between the posterior trim lines and top of the fiberglass wrap for sealing purposes. Accelerator If possible, >2.5 (65 mm) B. Wooden Adapter Method. Place a temporary collar around the distal end of the socket and spray foam into the collar. Once the hard foam has cured, sand it flat to accept the wooden socket adapter (5R1=6) so it is properly aligned. Use sealing resin to bond the 5R1=6 to the sanded foam. Pour foam Sand foam Bond 5R1=6 C. Four Prong Adapter Method. Bend the four prong adapter (4R111) to match the shape of the bottom of the socket. Bond the adapter to the bottom 3-5 ( mm) 3. If you were unable to leave at least 65 mm (2.5 ) of the socket free of fiberglass tape, tightly wrap clear pressure sensitive tape (616F22) over the fiberglass before it cures. This will extend the surface onto which the sealing sleeve can seal. While the clear pressure sensitive tape provides an imperfect sealing surface, it is considerably better than the fiberglass casting tape alone. 4. Install a 90 filtered barbed fitting (4Y350) in the distal, posterior-medial aspect of the socket. This location reduces the risk of the barbed fitting being bumped. If needed, grind through fiberglass/foam to expose a 12 mm (½ ) circular area of the socket in which to thread the barbed fitting.

16 Harmony Fabrication Quick Guides 16 Step 6 Assembling the Prosthetic Leg Lateral Medial mm hex wrench, turn the screw located in the bottom of the pump as far as possible in the clockwise direction. Ground down to socket 5. In the circular area, drill a hole through the socket wall using a 6 mm bit and use the barbed fitting as a tap by threading it into the hole. Or use bit #3 and thread the hole with a ¼ 28 tap. 6. Before using epoxy, thread the barbed fitting into the hole to determine whether a washer is needed to prevent the barbed fitting from protruding into the socket. 7. Epoxy the threads and thread the barb fitting into the socket wall. Avoid getting epoxy in either end of the barbed fitting. 10 mm hex Back the same screw out counter clockwise the number of full turns listed in the following table according to your patient s weight and the pump being used. If you installed a red rod into an HD pump, use the P2 Pump column. 8. Attach the Harmony pump to the adapter. 9. Using the following table, adjust the elastomer rod found inside the distal shaft of the Harmony pump to your patient s weight. This initial adjustment should ensure that the pump displacement during walking is close to what is needed for the pump to create a vacuum of at least 51 kpa (15 Hg). Final adjustment of the elastomer rod will be made later. Using a 10

17 Harmony Fabrication Quick Guides 17 Step 6 Assembling the Prosthetic Leg Patient Weight (kg/lbs) P2 Pump (4R144) Red Rod HD Pump (4R150) Yellow Rod 50/ / / / / / / / / / / Important: Never back the screw out more than 5 full turns, as this may compromise pump function. Loctite 454 adhesive Loctite 712 accelerator Tape measure Pressure sensitive tape Sander TEC plate (6A94=3) Wooden adapter (5R1=6) 4 prong adapter (4R111) Drill bit 6 mm or #3 ¼ 28 tap 5 minute epoxy Right angle barbed fitting 4 mm hex wrench 10 mm hex wrench 5 cm (2 ) fiberglass casting tape 10. Assemble the remainder of the prosthetic leg and adjust its length so that the pelvis is level. Required Materials and Tools

18 Harmony Fabrication Quick Guides 18 Step 7 Creating Vacuum 1. T in the vacuum gauge as shown. The long tubing to the gauge allows the patient to easily view the gauge and place it in his/her pocket. 3. Place an extra piece of tape on the brim of the socket as a reminder that a piece of tape is covering the expulsion port. 4. Activate the pump by hand and confirm that >51 kpa (15 Hg) is created and maintained for ~5 minutes. See Harmony Troubleshooting Table for the Prosthetist if it doesn t. 5. Remove both pieces of tape!! Vacuum gauge Confirm Pump Works and No Leaks below Sleeve 2. Place a small piece of paper over the expulsion port inside the socket. Seal the port by placing a piece of pressure sensitive tape over the piece of paper and port. Tape: reminder to remove tape from expulsion port Vacuum gauge Tape Check for Sleeve Leaks 6. Pull the tapered end of the sleeve down over the socket to the height of the barbed fitting. Wrap a hook-andloop strap or clear pressure sensitive tape (616F22) around the sleeve so that the sleeve is held firmly against the socket; creating a good seal. Paper

19 Harmony Fabrication Quick Guides 19 Step 7 Creating Vacuum Apply lubricant to this exposed surface of the liner 7. Deflect the top portion of the sleeve down over the socket and pump. Have the patient don the liner and sheath, and slide into the socket. Lubricate the exposed portion of the liner with lubricant to improve its seal with the sleeve. If you don t do this the system will usually leak slowly.

20 Harmony Fabrication Quick Guides Roll the sleeve up over the socket, liner and thigh. Step 7 Creating Vacuum Harmony HD Slide o-ring all the way up the shaft before the subject walks Harmony HD O-ring displacement after walking; should be ~6mm (¼ ) O-ring 9. Slide the o-ring up as high as possible on the distal shaft of the pump. Then have the patient take several steps. The o-ring should displace down the shaft ~6 mm (¼ ). 10. If the o-ring displaced much less then 6 mm (¼ ), remove the pylon and turn the 10 mm (3/8 ) elastomer rod screw counterclockwise. If the o-ring displaced much more than 6 mm (¼ ), turn the screw clockwise. 11. Have the patient take ~40 steps. The vacuum gauge should read at least 51 kpa (15 Hg) and stay unchanged for at least 5 minutes. A reading of 78 kpa (23 Hg) is commonly seen with the Harmony mechanical pumps. If vacuum isn t created and maintained, see the Harmony Troubleshooting Table for the Prosthetist. Required Materials and Tools T connector Tubing Vacuum gauge Pressure sensitive tape Paper Lubricant Sleeve Hook-and-loop strap 4 mm hex wrench 10 mm hex wrench

21 Harmony Fabrication Quick Guides 21 Step 8 Lowering Trim Lines and Installing Gaiter Lowering Trim Lines 1. Completely remove the sleeve from the socket. 2. With the patient still standing, make a mark on the socket 1/3 1/2 of the way up from the bottom of the patella. Anterior mark; 1/3-1/2 way up from the bottom of the patella 5. With the patient still sitting, repeat this finger pinch test for each hamstring tendon. Have the patient plant the heel against the floor and try to flex the knee in order to make the hamstring tendons prominent. Again, estimate how much each tendon relief needs to be lowered to prevent your finger from being pinched. 6. Have the patient lower the sealing sleeve. Mark the three points on the posterior trim line; center tab and two hamstring relief s. Be sure to mark directly below each hamstring tendon so each tendon is centered in the relief. Do not lower the three points by more than 3 6 mm (1/8 1/4 ) each time you lower the posterior trim line since material removed cannot be replaced. 3. With the patient still standing in the socket, palpate the tops of the medial (adductor tubercle) and lateral femoral epicondyles. Mark the tops of these epicondyles on the sides of the socket. Be aware of the posterior anatomical structures as you adjust the trim lines. Medial and lateral marks at the tops of femoral epicondyles Major vessels and nerves Lateral hamstring tendon Medial hamstring tendons 4. Have the patient don the sealing sleeve and walk or step in place until a vacuum >51 kpa (15 Hg) is created. With the patient sitting and the knee fully extended, place your finger on top of the center tab at the posterior trim line. Have the patient flex the knee to the point where you feel your finger being lightly pinched. If pinched, estimate how much the center tab needs to be lowered to allow 90º of flexion without your finger being pinched.

22 Harmony Fabrication Quick Guides Connect the six marks by drawing curves similar to those shown. Notice how rapidly the medial and lateral trim lines drop so that they don t wrap around posteriorly. This frees the knee during flexion and prevents chaffing. Step 8 Lowering Trim Lines and Installing Gaiter If 65 mm (2.5 ) is available, install the gaiter 8. Cut and/or grind the socket down to the trim lines and smooth the cut edges. 9. Repeat lowering of the posterior trim line until the patient can sit comfortably with the knee flexed Have the patient reflect the sleeve and sheath down over the socket. While the patient stands equally weighted on both legs, make two permanent marks on the liner, just above the medial and lateral trim lines. Teach your patient to monitor these marks each day to determine whether fillers need to be added to restore good liner drive. If these two marks drop below the trim lines, have them add a spot and/or a half sock. This will normally restore liner drive; causing the marks to be pushed up level with the top of the socket. 12. To install the gaiter, pull the tapered end of the gaiter down over the brim of the socket until it is 13 mm (½ ) below the posterior trim lines as shown. The smooth, shiny coating is the outside surface. Slide down 13 mm (½ ) Medial and lateral marks Donned liner 13. Tape the gaiter circumferentially to the socket with clear pressure sensitive tape. Installing Gaiter 11. Measure the distance between the lowest point on the posterior trim line and top of the fiberglass casting tape. If it is 65 mm (2.5 ), install the gaiter. If not, move on to alignment of the prosthesis. Tape 12. Apply a thin layer of lubricant around the outside of the socket as shown. This will improve the seal between the socket and the sleeve.

23 Harmony Fabrication Quick Guides 23 Step 8 Lowering Trim Lines and Installing Gaiter Apply lubricant in this region 14. Slide the sleeve onto the socket and cinch it to this lubricated surface with the hook-and-loop strap or clear pressure sensitive tape. Reflect both the sleeve and gaiter. Required Materials and Tools Permanent marker Sander/buffer Pressure sensitive tape (616F22) Hook-and-loop strap Casting saw Gaiter Tape measure

24 Harmony Fabrication Quick Guides 24 Step 9 Aligning the Prosthesis Bench Alignment 1. Follow the foot manufacturer s instructions to properly align the foot. Dynamic Alignment 2. Have the patient stand equally-weighted on both feet with the femurs aligned and both knees fully extended. If necessary, make adjustments so that the toes and heels of both feet are aligned. 3. Have the patient don the system and step until >51 kpa (15 Hg) is attained. 4. Have the patient walk. Watch for slight knee flexion at foot strike. If none is observed, coach them to flex the knee slightly immediately after foot strike to absorb the impact force. If coaching doesn t lead to knee flexion, move the foot posteriorly. This will force the patient to flex the knee. Once you observe natural knee flexion, move on to static alignment using the L.A.S.A.R. Posture. Static Alignment (L.A.S.A.R. Posture) 5. Place a strip of masking tape on the lateral aspect of the sleeve at the height of the middle of the patella. Position the Knee Pivot Gauge (743A8) against the patella and against the back of the knee. As shown, mark a spot on the masking tape socket about which the laser should migrate (1.5 cm in front of knee axis). Knee axis caliper Masking Tape 6. Have the patient stand equally-weighted with the amputated limb on the force plate and the nonamputated limb on the compensation plate so that the laser line is projected on the lateral aspect of the amputated leg. The feet should be shoulder width apart. 7. After the laser line stabilizes, confirm that it is within ~6 mm (1/4 ) of the mark on the socket. Laser Line Knee axis Mark here (this is ~1.5 cm anterior of the knee axis) 8. If the laser line is not within ~1/4 (6 mm) of the mark on the socket, plantar flex the ankle to slide the laser forward or dorsiflex the ankle to move the laser backward.

25 Harmony Fabrication Quick Guides 25 Step 9 Aligning the Prosthesis 9. Have the patient stand equally weighted with the amputated limb on the force plate and the nonamputated limb on the compensation plate so that the laser line is projected on the front of the amputated leg. The feet should be shoulder width apart. L.A.S.A.R. Posture Knee Pivot Gauge (743A8) 4 mm hex wrench Permanent marker Masking tape Anterior View (Right leg) 10. Confirm that the laser line passes through the lateral aspect of the patella as shown. If it does, proceed to the next step. Otherwise, re-align the prosthesis by inverting or everting the ankle. 11. Make any necessary final adjustments by using standard alignment procedures as the patient walks. Required Materials and Tools

26 Harmony Fabrication Quick Guides Place prosthesis into a vertical alignment jig. 2. Place a temporary collar around the proximal end of the socket to extend it proximally ~10 cm (4 ). 3. Pour plaster into the test socket ~5 cm (2 ) above the medial-lateral trim lines. Imbed an anchoring post/adapter in the plaster. Step 10 Making Definitive Socket Plaster Collar Space to prevent wrinkles Platen Vacuum line Vertical alignment jig 7. Use a knife to remove the PETG that extends above the mold. Sand the remaining plastic with 60 grit sandpaper. Clean the plastic with isopropyl alcohol. Do not use acetone or thinner because they will degrade the plastic. 8. Slide a full length of fiberglass braid over the mold. Twist it at the distal end of the mold, and reflect it back over the mold so one layer covers the entire mold and two layers cover the bottom ¼ ½ of the mold. 4. Remove the positive mold from the test socket and jig and smooth it if necessary. 5. Mount the mold on a vacuum platen so that there is space between the platen and mold. This will allow the plastic to be pulled under the mold and minimize the risk of having wrinkles in the PETG inner wall of the socket. 6. Pull 3 mm (1/8 ) PETG plastic over the positive mold using a vacuum table. This PETG forms the inner wall of the socket and reduces the chances of air leaking into the socket through laminations that may not have been fully impregnated with resin. This is an important step to prevent vacuum leaks. 9. Pull a PVA bag over the lay up. Pour resin into the top of the bag and apply a vacuum at the bottom of the bag. Work the resin through the laminations by sliding a string down the PVA bag. 10. Tape the top of the PVA bag to pinch any excess resin away from the distal end of the socket. 11. Place the pyramid or four hole adapter on the TEC plate (6A94=3) to determine where to drill one common hole through the TEC plate. Drill the hole all the way through the TEC plate with a 5 mm (or #3)

27 Harmony Fabrication Quick Guides 27 bit. Make sure the drilled hole does not break through into the TEC plate groove. Step 10 Making Definitive Socket Pyramid adapter TEC plate Groove in light putty 17. Sand and clean the outside of the socket with 60 grit sandpaper and isopropyl alcohol. 18. Tie the first layer of carbon fiber braid into the circumferential groove in the light putty. Tie it a second time in the TEC plate groove. Reflect the braid over the socket. 12. From the top (notched) side of the TEC plate, oversize the hole to half its depth with a 6.5 mm bit so that the styrene tube (4Y308) can be inserted. 13. Place the styrene tube into the TEC plate hole. As the socket is lowered to the TEC plate, trim the styrene tube so that it fits against the bottom of the socket as shown. Glue the styrene tube into the TEC plate and against the socket with 5 minute epoxy. 14. Bond the TEC plate to the socket with Loctite 454 or Pedilen foam. To avoid creating a vacuum leak, be careful not to break the epoxy bonds between the styrene tube and socket. Socket Styrene tube First layer of carbon braid tied into the light putty and TEC plate grooves Loctite Apply light putty or similar material to fill the gap between the socket and TEC plate. 16. Create a circumferential groove in the light putty just proximal to the plate. The groove should be as deep as the notches in TEC plate. 19. Tie and reflect additional fiberglass or carbon layers as needed. These are only tied in to the TEC plate groove. 20. Tie a layer of stretch nylon tubing into the TEC plate groove and reflect it over all the laminations. This provides a smoother texture to the walls of the socket. 21. Temporarily cover the bottom of the TEC plate with a foam disk to prevent resin from bonding with the bottom of the plate. 22. Pull a PVA bag over the lay up and laminate it as before. Before the resin sets, tightly wrap clear pressure sensitive tape around the distal edge of the TEC plate so that this edge is visible in the final socket.

28 Harmony Fabrication Quick Guides 28 To save time and additional steps, now is the time to make a protective slip cover if desired. Making a slip cover is highly recommended for all Harmony systems to protect the sealing sleeve. Go to Step 11 Making a Protective Slip Cover which is found on the next page for fabrication instructions. Step 10 Making Definitive Socket 23. Once the resin has cured, from the bottom of the TEC plate, drill a 3 mm (1/8 ) hole through the socket wall. 3 mm (1/8 ) bit 24. From the bottom of the plate, tap the smaller diameter hole with a ¼ 28 tap to make threads for the filtered barbed fitting (4Y344). Use 5 minute epoxy to seal the barbed fitting threads. 25. Before you remove the plaster, mark, cut and smooth the trim lines, we highly recommend that you make a protective slip cover for all your patients as described on the next page. This cover protects the sleeve from being damaged. This is important with Harmony because the patient will lose vacuum if the sleeve is damaged. Required Materials and Tools Vertical alignment jig Pressure sensitive tape Plaster Anchoring post/adapter Sanding screen Vacuum table and platen 3 mm (1/8 ) sheet of PETG 60 grit sandpaper Isopropyl alcohol Fiberglass braiding Carbon braiding PVA bags Resin Scissors Pyramid adapter TEC plate (6A94=3) Drill 5 mm (or #3) bit 6.5 mm bit 3 mm (1/8 ) bit Styrene tube (4Y308) ¼ 28 tap Barbed fitting (4Y344) 5 minute epoxy Loctite 454 adhesive Light putty String Stretch nylon

29 Harmony Fabrication Quick Guides 29 Step 11 Making Protective Slip Cover 1. Skip this step if you have already filled the socket with plaster. Otherwise, place a temporary proximal collar around the socket and pour plaster into the socket. Pour plaster ~5 cm (2 ) above the medial-lateral trim lines. 2. Pull a suspension sleeve over the socket. The sleeve should be pulled approximately 13 mm (½ ) more distal than where the patient normally installs the sleeve. 3. Place two cm (1 2 ) diameter, adhesive-backed hook-and-loop tabs on the medial and lateral aspects of the socket, just distal to the suspension sleeve. Adhere the pile half of the hook-and-loop to the socket. Leave the two halves of the hook-and-loop attached to one another. Sleeve 5. Pull 3 mm (1/8 ) PETG or a PVA bag over the mold. If you use PETG, sand the plastic with 60 grit sandpaper. Clean the plastic with isopropyl alcohol. 6. Pull two layers of fiberglass and two layers of stretch nylon over the mold. 7. Pull a separate PVA bag over these layers and laminate with resin. 8. Cut the slip cover flush with the distal end of the socket and remove the slip cover. 9. Attach the hook halves of each hook-and-loop tab to the inside of the slip cover. Make sure they align with the pile halves of the hook-and-loop on the socket. 10. Trim the medial, lateral and anterior trim lines on the slip cover so that they extend above the socket trim lines by ~3 6 mm (1/8 1/4 ). Trim the posterior trim line of the slip cover ~3 mm (1/8 ) below the posterior trim line of the socket. Hook-andloop tabs Height to which the patient normally installs the sleeve 3-6 mm (1/8-1/4 ) 4. To provide space between the finished slip cover and sealing sleeve, pull four cotton stockinets over the socket. Tape the stockinet as shown. Four cotton stockinets taped distally and proximally Required Materials and Tools Collar for plaster Plaster Suspension sleeve Adhesive hook-and-loop Four cotton stockinets Pressure sensitive tape 3 mm (1/8 ) sheet of PETG 60 grit sandpaper Isopropyl alcohol Fiberglass braiding Stretch nylon PVA bags Resin

30 Harmony Fabrication Quick Guides 30 Step 12 Cosmetic Cover Modification If making a cosmetic cover, construct it as you normally do, but be sure that: a. Tubing is run inside the cosmetic cover from the expulsion valve of the pump to the medial aspect of the ankle, where it exits the cosmetic cover. Failing to vent the pump outside the cosmetic cover will cause steel components to corrode and seize. b. Tubing that is attached to the intake and expulsion valves of the pump should not be compressed by the cosmetic cover. This would restrict air flow and reduce vacuum. c. Cosmetic cover does not cause a vacuum leak between the sealing sleeve and socket. This step describes how to route the expulsion tubing through the cosmetic cover. 1. Extend the tubing from the pump s expulsion valve to the ankle. 2. Drill a 9 mm (23/64 ) hole through the cosmetic cover just posterior to the ankle. 3. Slide the tubing through the hole as shown. 5. Apply glue to the collar of the flange and seat it in the cosmetic cover. Required Materials and Tools Drill bit 9 mm (23/64 ) Tubing Glue Cosmetic cover Tubing Inside Outside 4. Press the tubing into the flange. Flange Tubing Apply glue here

31 Mold Reduction Worksheet Mold Reduction Worksheet Patient Name: Date: Patient Name: Date: Marks Starting Circ (mm) Target Circ (mm) Starting Minus Target Rasp Strokes Marks Starting Circ (mm) Target Circ (mm) Starting Minus Target Rasp Strokes A A B B C C D D E E F F G G Mold Reduction Worksheet Mold Reduction Worksheet Patient Name: Date: Patient Name: Date: Marks Starting Circ (mm) Target Circ (mm) Starting Minus Target Rasp Strokes Marks Starting Circ (mm) Target Circ (mm) Starting Minus Target Rasp Strokes A A B B C C D D E E F F G G

32 4% Reduction Chart (mm) Circ -4% Circ -4% Circ -4%

33 5% Reduction Chart (mm) Circ -5% Circ -5% Circ -5%

34 6% Reduction Chart (mm) Circ -6% Circ -6% Circ -6%

35 Elastomer Rod Adjustment Chart Using a 10 mm hex wrench, turn the screw located in the bottom of the pump as far as possible in the clockwise direction. Back the same screw out counter clockwise the number of full turns listed in the following table according to your patient s weight and the pump being used. If you installed a red rod into an HD pump, use the P2 Pump column. Patient Weight (kg/lbs) P2 Pump (4R144) Red Rod (turns) HD Pump (4R150) Yellow Rod (turns) 50/ / / / / / / / / / / Important: Never back the screw out more than 5 full turns, as this may compromise pump function.