Icelock 544 Technical Presentation. Sarah Mulroy (Clinical Specialist)

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1 Icelock 544 Technical Presentation Sarah Mulroy (Clinical Specialist) AOPA 2016

2 Icelock 544 Series 3 valve Systems in 1 Removing the air between a prosthetic liner and rigid socket compartment (elevated vacuum suspension) has become very common practice in lower limb prosthetics over the past decade. Össur currently offers an external socket valve, designed to connect the Unity series of pumps to the prosthesis (UTT0001 and UTF0001). This solution is not always favoured for cosmetic or practical reasons. Also have external socket valves for TT and TF seal in systems (L and L ) Icelock 544 is a series of valve/adapter solutions, designed to expel air from - Seal-In systems (vacuum suspension using Seal-in-Liners) - Seal-In and Unity combinations (elevated vacuum suspension) - Cushion/sleeve systems (vacuum suspension) 10/19/2016 1

3 Features and benefits Feature Easy and fast fabrication In-line solution Modular and flexible design Benefit Significant time savings No protrusions on the sides of prosthesis Details with vacuum and/or expulsion can be changed and interchanged after fabrication 10/19/2016 2

4 Basic structure (Unity Example) 10/19/2016 3

Configurations Icelock 544 Series offers 3 configurations utilising same socket adapter: L-544611 is designed for Unity (Grey plate) Contains Push button and bard for Unity hose L-544621 has an

5 Configurations Icelock 544 Series offers 3 configurations utilising same socket adapter: L is designed for Unity (Grey plate) Contains Push button and bard for Unity hose L has an exhaust filter instead of a barb connector, used with Seal-In expulsion setup (Orange plate) The expulsion-only check valve, which is suitable with the simplest form of a Cushion-Sleeve setup, where only expulsion is desired 10/19/2016 4

How it Works: Unity plate used as an example Socket Adapter L-544400 is set up on socket along with selected valve configuration Air is pushed through a hole distally in socket (BLUE arrow) A brass

6 How it Works: Unity plate used as an example Socket Adapter L is set up on socket along with selected valve configuration Air is pushed through a hole distally in socket (BLUE arrow) A brass filter traps any solid particles, protecting system and vacuum pump (RED arrow) Air continues towards exhaust port (GREEN arrow) Air is vented towards pump or to air via a check valve (YELLOW arrow) 10/19/2016 5

Dimensions Valve plates are 9.5 mm high.

7 Dimensions Valve plates are 9.5 mm high. L adapter is 16 mm high, diameter 72 mm Standard 4-Hole adapters are mounted directly onto the valve plate Valve plate kits contain M6x25 mm screws, matching all Össur 4-Hole adapters 10/19/2016 6

8 Socket configuration and adapter placement An imperative feature for successful Icelock 544 Series setup is to use rigid thermoplastic inner sheath for the socket, preferably PETG. 3 mm PETG is recommended for the inner surface of a laminated socket, and thicker PETG is good for test sockets This essentially turns the check socket fabrication and definitive socket fabrication into one single effort, which can save time 10/19/2016 7

Test Socket Adapter placement L-544400 socket adapter is supplied with a white dummy already mounted into it. Keep it in place when bonding the socket adapter to the socket.

9 Test Socket Adapter placement L socket adapter is supplied with a white dummy already mounted into it. Keep it in place when bonding the socket adapter to the socket. FSX80016 is the preferred material to seal an Icelock 544 series adapter to a socket. The flexibility of FSX80016 allows slight movements, which are always present in prostheses and will not show microcracks later on. A mix of talc and resin can eventually crack and leak. Generously fill top of the adapter with adhesive. Cover adapter holes and fill center section completely before lowering socket onto adapter. Allow to set for a few minutes. 10/19/2016 8

10 Test Socket Reinforce a test socket with casting tape before weight bearing 10/19/2016 9

11 Drill hole Whether making a test socket or a definitive socket, drill through dummy using a sharp 3 mm drill bit and all the way into the positive cast before removing them and proceeding to assembly. Test socket Definitive socket 10/19/

12 Lamination Process Drape with 3mm PETG Roughen up outside of PETG with sandpaper Insert lamination dummy into plate Insert putty into holes, and apply small amount of release agent onto surface of dummy 10/19/

13 Lamination Process Apply electrical tape into the groove to protect the plate Apply generous amoount of FSX80016 adhesive Lower the positive with plastic onto the plate Allow adhesive to set 10/19/

14 Lamination Process Remove electrical tape and the 4 hole adapter Apply lamination dummy (differs from photo) Tie first layer into groove of plate, then tie it a second time around adhesive area Reflect first layer of carbon. Repeat for desired lay up 10/19/

15 Lamination Process Turn PVA bag inside out for a glossy finish and pull over layup Pour resin into the bag Allow vacuum to pull resin down for the first 3-5cm Continue then to string resin down 10/19/

16 Lamination Process Apply electrical tape to the bottom portion of the lamination dummy to remove any resin from the edge of the plate After resin has set remove tape and PVA bag Remove the excess resin and dummy 10/19/

Lamination Process Use a 3mm drill bit to drill

housing Select expulsion valve, seal in or unity

17 Lamination Process Use a 3mm drill bit to drill through bottom of plate to plaster cast, using the drill hole in the dummy as a guide Insert appropriate seal or duck bill valve and apply housing Select expulsion valve, seal in or unity plate, apply and add 4 hole adapter of choice 10/19/

18 Assembly The larger seal/o-ring goes on top of the valve plate and seals towards the housing/adapter assembly. Use the 4 supplied M6x25 screws for this assembly. 10/19/

19 Maintenance The only known maintenance issues with Icelock 544 are potential dirt and contamination issues. A complete teardown and rinse with Isopropyl alcohol, and/or soapy water is usually the best approach if a quick blowout with compressed air does not do the trick. 10/19/

20 Problem Solving Potential leak points, if at all, are typically found along the red line in the illustration to the right. The risk of leakage is very low when the fabrication of Icelock 544 has been done correctly. PETG is needed in the fabrication process. Icelock 544 series is designed to utilise this inner surface and seal against it. If screws are too long they may pop the adapter off and compromise the seal. Ensure the holes are free from debris also If this occurs, restart the process form the point of bonding the adapter onto the socket to ensure the adapter is fully resealed. Ensure all seals are free of dirt when assembled and seated in the right position Apply a little compression on them when assembling, it is normal to compress the seals 0,.5-1 mm when assembled. 10/19/

Patent pending. Product Manual

Patent pending. Product Manual Patent pending Product Manual Transradial Fabrication Instructions 1. Thermoform flexible inner socket. 2. Contour the attachment ring. The socket attachment ring can easily be contoured by hand or by