Otto Bock Harmony P3 Technical Information

Fabricating a transtibial prosthesis
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Harmony system
Fabricating a transtibial prosthesis using example of Harmony P3
Technical information 2.1.8

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Summary of Contents for Otto Bock Harmony P3

  • Page 1 Harmony system Fabricating a transtibial prosthesis using example of Harmony P3 Technical information 2.1.8...
  • Page 2: Table Of Contents

    Table of contents Table of contents Introduction ................................. Flowchart ............................Preparation ................................Collecting the materials and tools ......................Procedure ................................Selecting the liner ..........................Plaster cast ............................3.2.1 Preparing the Plaster Cast ........................3.2.2 Moulding the femoral condyles and tibial plateau ..................
  • Page 3: Introduction

    There are both mechanical and electronic Harmony vacuum pumps. In this document, the fitting procedure is explained on the example of a Harmony P3 vacuum pump. The central work steps can be applied to all Harmony vacuum pumps. For detailed information, please read the corresponding instructions for use.
  • Page 4: Collecting The Materials And Tools

    The materials and tools used in the photos within this technical information are listed in the tables below. The pros­ thetist assumes full responsibility for the use of any other materials. Components and auxiliary devices Designation Reference number Harmony P3 4R147* Liner – Liner FitKit...
  • Page 5: Procedure

    Procedure Designation Reference number Vacuum tube (with vacuum sealing disc) 755X104=360 Vacuum pump 755E9 Torque wrench 710D4 Torque wrench (adjustable to 0.5 Nm) – 3 Procedure 3.1 Selecting the liner CAUTION Use of an incorrect liner Skin irritation due to vacuum on the skin ►...
  • Page 6: Plaster Cast

    Procedure Ordering a custom liner Custom liners are custom-produced for the user. This allows them to meet specific requirements and be appropriate for all residual limb shapes. • Determine the necessary measurements on the patient and fill out the order form for the desired custom liner (see Page 31).
  • Page 7: Moulding The Femoral Condyles And Tibial Plateau

    Procedure Pull a nylon stockinette over the residual limb. Optional: Add markings to facilitate modelling, for example: • MPT line • Patella • Prominent areas of residual limb • Femoral condyles • Distal end of the tibia 3.2.2 Moulding the femoral condyles and tibial plateau Objective In the first phase of plaster casting the femoral condyles and the tibial plateau are moulded with a plaster splint.
  • Page 8: Moulding The Tibia And The Head Of The Fibula

    Procedure Wet the plaster splint and place it on the residual limb. Pull a nylon stockinette over the residual limb. Pull a suitable latex casting bag over the plaster cast and seal proximally. Connect the vacuum hose and position the distal con­ nection of the casting bag on the nylon stockinette.
  • Page 9: Moulding The Volume

    Procedure Required tools and materials • Plaster bandages, plaster cast scissors, 99B25 nylon stockinette, 683G1=* latex casting bag, 755Z19=230 vacuum pump Cut a four-layer plaster splint. INFORMATION: The plaster splint is part of the plaster cast and remains in the cast. Place the plaster splint on the residual limb and ensure it is seated correctly.
  • Page 10: Fabricating The Plaster Model

    Procedure Required tools and materials • Plaster bandages, plastic film, 2x 99B25 nylon stockinette or 623T3=* Perlon stockinette, 683G1=* latex cast­ ing bag, 755Z19=230 vacuum pump Instruct the patient to tense the residual limb muscles briefly. Check the change in shape of the residual limb. Position the residual limb such that the flexion angle is approx.
  • Page 11 Procedure Required tools and materials • 645C2=* copying pen, tape measure, measurement sheet and reduction table (see appendices), 716Y3 half- round file, 716Y4 round file, 649G22=180 grit cloth Remove the plaster cast from the residual limb, fill with plaster, insert a reinforcing bar and allow the plaster model to cure.
  • Page 12: Fabricating The Test Socket

    Procedure Smooth the plaster model. Mark the course of the socket brim on the plaster mod­ el. Use the MPT line as a reference. Anteriorly, the edge is located 2.5 cm (1") proximal • to the reference line Medially and laterally, the edge is located 6 cm •...
  • Page 13: Checking The Fit

    Procedure Drill a 7.5 mm hole in the position where the socket connector should be attached. Remove the prosthetic socket from the plaster model. Deburr the inside and outside of the hole. Grind and smooth the socket brim of the prosthetic socket.
  • Page 14 Procedure Don the liner. Apply the lubricating cream to the outside of the liner. This allows the liner to move in the prosthetic socket. Don the prosthetic socket. Ask the patient to stand on the plaster device and dis­ tribute the load equally between the prosthetic socket and the contralateral side.
  • Page 15: Checking The Course Of The Socket Brim

    Procedure If all of the points of the liner are located within the circles, the liner is not compressed sufficiently. Put on a residual limb sock from the liner FitKit to increase the compression. TIP: If the residual limb sock hides the points on the liner, wear the residual limb sock under the liner.
  • Page 16: Aligning The Prosthesis

    Procedure Required tools and materials • 743A11 plaster device, 743L20=230 L.A.S.A.R.-Line, waterproof marker, check socket, liner Ask the patient to sit down. Position the residual limb in 90° flexion. The distal contact of the residual limb has to be ensured in the prosthetic socket. Mark the course of the socket brim: •...
  • Page 17: Optional: Transferring The Adapter Position

    Procedure 3.6.2 Optional: Transferring the adapter position Objective If the static alignment was performed without the Harmony P3 unit, the transfer device can be used to transfer the adapter position to the Harmony P3 unit. Required tools and materials •...
  • Page 18: Replacing The Functional Ring

    Open the pre-compression device and remove the func­ tional ring. 3.6.4 Replacing the functional ring Objective Loosen the tube clamp of the Harmony P3 unit. Remove the tube adapter with the prosthetic foot. Unscrew the retaining screw (1) on the distal end of the Harmony P3 unit.
  • Page 19: Dynamic Trial Fitting

    Procedure 3.7 Dynamic trial fitting INFORMATION Using the check prosthesis The user should only use the check prosthesis under the supervision of an orthopaedic technician. On the basis of his or her professional experience, the orthopaedic technician can decide whether the user can take the check prosthesis home for an extended trial fitting.
  • Page 20: Transferring The Adapter Position

    Procedure 3.8.1 Transferring the adapter position Objective The transfer device is used to transfer the adapter position from the check prosthesis to the definitive prosthesis. The check socket is then filled with plaster and adapted to the plaster model. Required tools and materials •...
  • Page 21: Laminating

    Procedure Roughen the plastic with sandpaper and clean with iso­ propyl alcohol. NOTE: Do not use acetone or thinners. These sub­ stances damage the plastic. 3.8.3 Laminating Objective The ThermoLyn PETG layer is laminated with carbon. Required tools and materials •...
  • Page 22: Optional: Producing A Sleeve Protector

    Procedure Attach the 2R117=0 socket connector according to the instructions for use. TIP: If no PUR adhesive is available, two-component epoxy adhesive can also be used. Check the system for leaks (see Page 19). Instruct the user in the proper and safe use of the product.
  • Page 23: Optional: Attaching A Cosmetic Cover

    Smooth the edges carefully. 3.9 Optional: Attaching a cosmetic cover Objective A foam cover can be used as a cosmetic cover. Correct attachment ensures the function of the Harmony P3 unit. Required tools and materials: • Foam cover with 34 mm opening, silicone spray, Superskin or 99B116* SoftTouch sock Cut the foam cover so it is not crushed.
  • Page 24: Tips And Tricks

    Tips and tricks 4 Tips and tricks 4.1 Checking the system This section gives a methodical troubleshooting procedure for when the vacuum system leaks. To check the system for leaks, the prosthesis is divided into areas. Area 1: Prosthetic socket and sealing sleeve •...
  • Page 25: Solutions To Problems

    Tips and tricks 4.2 Solutions to problems Topic: Knee Problem Cause Solution Knee flexion difficult Medial and lateral socket brim • Cut socket brim so it no longer runs so far in the runs too far in the posterior or bulging in the hol­ posterior direction.
  • Page 26 Tips and tricks Topic: Residual limb Problem Cause Solution User wears liner with textile Red welt on the skin • Only use liners without textile or with partial textile cover. at top of the liner cover. The textile cover prevents the seal between the liner and seal­...
  • Page 27 Tips and tricks Topic: Residual limb Problem Cause Solution Pressure in the prox­ pressure in the proximal area. imal area The vacuum pulls the liner and the residual limb into a gap distally and also creates the feel­ ing of pressure. The proximal pressure is usually the dominant sensation.
  • Page 28 Tips and tricks Topic: Residual limb Problem Cause Solution Inadequate blood flow to the Cramp­ • Go through the "Pressure in the proximal area" sec­ ing/aching/throbbing residual limb. tion of this table to rule out squeezing in the proxim­ while standing or sit­ al area.
  • Page 29 Tips and tricks Topic: Vacuum Problem Cause Solution Outlet opening of the pros­ Vacuum is only gen­ • Remove the adhesive tape. erated distal to the thetic socket covered with adhesive tape. prosthetic socket. (The sealing sleeve is Outlet opening of the pros­ •...
  • Page 30: Appendix

    Appendix 5 Appendix 5.1 Reduction tables 3% reduction 205 210 215 220 225 230 235 240 245 250 255 260 265 270 275 280 285 290 295 300 199 204 209 213 218 223 228 233 238 243 247 252 257 262 267 272 276 281 286 291 305 310 315 320 325 330 335 340 345 350 355 360 365 370 375 380 385 390 395 400 296 301 306 310 315 320 325 330 335 340 344 349 354 359 364 369 373 378 383 388 405 410 415 420 425 430 435 440 445 450 455 460 465 470 475 480 485 490 495 500...
  • Page 31: Measurement Form

    Distal connector Maximum circumference (requires the selection of a textile coating) Comments: Otto Bock HealthCare GmbH · Max-Näder-Str. 15 · 37115 Duderstadt T +49 5527 848-3030 · F +49 5527 848-1585 · servicefertigung@ottobock.de · www.ottobock.com Harmony System Ottobock | 31...
  • Page 32 32 | Ottobock Harmony System...
  • Page 33 Harmony System Ottobock | 33...
  • Page 34 34 | Ottobock Harmony System...
  • Page 35 · www.ottobock.com.au Otto Bock Bulgaria Ltd. info@ottobock.sk · www.ottobock.sk 41 Tzar Boris III‘ Blvd. · 1612 Sofia · Bulgaria Beijing Otto Bock Orthopaedic Industries Co., Ltd. T +359 2 80 57 980 · F +359 2 80 57 982 Otto Bock Sava d.o.o. B12E, Universal Business Park info@ottobock.bg · www.ottobock.bg Industrijska bb ·...
  • Page 36 Printed by: Otto Bock HealthCare GmbH Max-Näder-Straße 15 · 37115 Duderstadt · Germany T +49 5527 848-0 · F +49 5527 72330 healthcare@ottobock.de · www.ottobock.com Ottobock has a certified Quality Management System in accordance with ISO 13485.

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