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 ..................
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.
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...
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 ►...
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).
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.
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.
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.
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.
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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.
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 •...
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.
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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.
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.
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: •...
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 •...
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.
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.
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 •...
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 •...
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.
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.
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 •...
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.
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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...
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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.
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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.
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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 •...
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...
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· 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 ·...
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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.