i-limbtm digits component assembly guide...use the t6 screwdriver (3) to attach the knuckle assembly...

i-limbTM digitsComponent Assembly GuidePart number MA01073: Issue 1, December 2012

2

This symbol signifies important information and is used throughout the manual.

This document provides instruction for prosthetists in the assembly of i-limb digits components necessary in the fabrication of i-limb digits prostheses. The instructions within should be read in full prior to fabrication. It is highly recommended that the use of this manual is made in conjunction with instruction from a clinician experienced in the use of i-limb digits.

Refer to www.touchbionics.com to ensure the latest copy of this document.

Part number MA01073: Issue 1, December 2012

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i-limb digits Fabrication of a Five Finger Socket with Remote Electrodes

Check Socket - Silicone Socket

1 Make an initial cast of the patient’s residual hand and up to approximately mid forearm level. Mark on the cast the position of the zip if planned and the four anchors used to fix the frame to the silicone socket, two on the palmer surface and two on the dorsal surface.

N.B. the anchors on the dorsal surface should be spaced around 4cm apart to cater for the Wristband attachment dummy.

This stage of fabrication (points 1 to 9) details a method of creating a silicone socket used for the check socket. It is accepted that a number of alternative methods are possible.

2 If a zip is required then prepare by burning a series of holes with a soldering iron in the fabric on each side of the zip. This will provide improved adherence between the zip and the silicone (zip not supplied).

A ratchet strap, as well as a creative socket design maybe incorporated to aid socket suspension (contact customer service if a rachet strap is required).

3 Fill the center holes of the four anchors with clay and paint with a silicone primer.

Standard and Small Silicone Support Anchors are provided with all kit orders (091089A Silicone Support Anchor; 091117A Silicone Support Anchor, Small), alternatively Mesh Silicone Support Anchors (SA091121A) are available separately if required.

N.B. The number of anchors required will be dependent on socket design.

43


4 Shape four silicone discs, one for each anchor and silicone strip for attachment of the zip. Silicone discs should be sized slightly larger than the anchor to be used.

Experience with shore hardness between 35 to 50 has provided good results. A harder shore may provide the option for a smaller frame, and should be considered as apart of the full design process.

5 Position the silicone, anchors, zip and zip protector on the cast.

6 Roll a 2mm silicone sheet and layup on the cast to incorporate the anchors and zip.

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7 Apply six layers of stockinette with a plastic airtight layer and vacuum for approximately 45 minutes. Remove the plastic layer and check the silicone at the mid-way stage for any irregularities.

8 Remove stockinette and trim the silicone to shape as required.

9 Cure the silicone socket at 75°C for 7 hours, or fast cure at 95°C for 2 hours.


Check Socket - FrameThis section of the guide (points 10 to 20) details a method of fabricating a frame and joining to the silicone socket to form the check socket.

10 Apply a cutting strip to the zip area and pull over a single denier stockinette.

11 Drape a rigid, clear thermoplastic frame directly on to the cast. Experience with frames of finished thickness of between 2 to 3mm has shown good results.

12 Apply vacuum and ensure a good seal to create good form to the frame shape.

13 If the patient has a small residuum, then it may be necessary to build up the cast to create a more anatomical position for the Knuckle Mounting Plate (9, 10 or 11). This can be done using plasticine to give an estimate position.


14 Generously grease the silicone and plasticine.

15 Duplicate using impression material.

16 Remove plasticine from the impression

17 Create a plaster cast.

18 Drape with thermoplastic in the same manner as points 11 and 12


19 Cut the frame away from the cast, shape and smooth the edges, prepare drill holes to cater for anchor screws in line with the anchors on the silicone socket.

20 Join the silicone socket and frame together with 091081A M4 Socket Button Head Screws (42), engaging with the four anchors.

N.B. The position of the electrodes or FSR’s can be marked on the transparent frame, directly from markings on the patient’s residuum, highlighting the optimal position for controls. The electrode positions are then drilled through the frame and transferred directly to the cast. The cast can then be used to position the controls on the definitive socket. Refer to point 28 for further information on electrode placement.

See Appendix for further information on the use of FSR’s.

42


Check Socket Digit and Wristband PositioningThis section (points 21 to 25) details the method of positioning the Wristband and digits and aeration of the socket.

15

14

Figure 7a

21 Positioning of the Remote Electrode and Socket Terminal Dummy

For fabrication, place the Remote Electrode Dummy (14) and the Socket Terminal Dummy (15) on the Dorsal surface of the residual hand (figure 1a).The position should be central to the midline of the wrist and elbow joints. A distance of 30mm should be left between the Socket Terminal Dummy and the center of the wrist joint to enable good range of movement at the wrist (figure 1b). If a dorsal interosseous myo-site is used, the Remote Electrode Dummy (14) may require repositioning. Figure 1a

14

15

16

Midline

Final position of Dual Remote Electrode Assembly

= = =

Wrist

Approx. 30mm

Optimal Wristband Assembly position

Figure 7b

Figure 7d

Figure 7c

Ultimately, the final position of the Dual Remote Electrodes (16) will match the position of the corresponding dummies (figure1c) and optimal position of the wristband (figure 1d).

Figure 1dFigure 1b

16

Midline


= = =

Wrist

Approx. 30mm


Figure 7b

Figure 7d

Figure 7c Figure 1c

16

16

Midline


= = =

Wrist

Approx. 30mm


Figure 7b

Figure 7d

Figure 7c

Approx 30mm


22 Select either a Multiple Knuckle Mounting Plate (10 or 11) or Single Knuckle Mounting Plate (9) (figure 2). Multiple Knuckle Mounting Plates can be cut to cater for patients with 3 or 2 finger loss.

3

2

1

Figure 1

23 Removal of the Knuckle Fairing Remove the two M2 x 9mm Torx Screws (1) from the

Knuckle Fairing (2) using the T6 Screwdriver (3).

Remove Knuckle Fairing (2) by sliding the fairing away from the joint.

(Figure 3)

Figure 3

Figure 2

1

2

10 11 9

3

7

4

5 6

Figure 2

24 Removal of the Digit from the Knuckle Use the T8 Screwdriver (4) to remove the M2 Digit Screw

(5) from the Knuckle Assembly (6).

The Digit (7) can now be freely disengaged from the Knuckle Assembly (6).

(Figure 4)

Figure 4

4

56

7


7

6

5 4

Figure 4

25 Attachment of the Knuckle Mounting Plate

Use the T6 Screwdriver (3) to attach the Knuckle Assembly (6) to either a Single Knuckle Mounting Plate (9) or a Multiple Knuckle Mounting Plate (10 or 11) using three M2 x 6mm Torx Screws (8).

Lamination tabs can be bent or shortened as appropriate at this stage. The single hole on the Single Knuckle Mounting Plate faces the dorsum of the hand when in the correct position.

Consider fabrication before cutting and removing tabs, some tab length will be needed for fixation of the plate to the frame.

(Figure 5)

26 Attachment of the Digit to the Knuckle Assembly

Firmly place the digit (7) into the Knuckle Assembly (6).

Insert the M2 Digit Screw (5) using the T8 Screwdriver (4).

(Figure 6)

10

11

9

3

8

6

Figure 3 Figure 5

Figure 6

3

8

6

9

1110

6

7

4 5

Take care not to over tighten screws.


Ground Contact (Middle)

Connects to Wrist Band Loom

Contact Set 1

Contact set 2

16

Figure 8b

Contact

Ground Contact

Adjustment dial

Figure 8a

27 Remote Electrode Wiring Map The Dual Remote Electrode Assembly (16) is arranged

with a single Ground position and two electrode contact points for each electrode (figure 7b).

Optimal setting for the Adjustment dial is 4.

(Figure7a)Figure 7a

Figure 7b

16

Ground Contact (Middle)

Connects to Wrist Band Loom

Contact Set 1

Contact set 2

16

Figure 8b

28 Position of the Remote Electrode Domes

Identify potential electrode sites (figure 8a). Create a clear thermoplastic check socket over the patient’s positive cast ensuring coverage of the proposed electrode dome sites (figure 8b).

Potential electrode sites Figure 9a Figure 8a


Ø3.2

10mm

10mm

10mm

10mm

10mm

10mm

Figure 9c

Figure 9b

Drill a 5 x 3 matrix of Ø3.2mm holes at a distance of 8 to 10mm apart in the check socket, over the potential sites (figure 8c).

Figure 8b

Figure 8c

10mm

10mm

mm

10mm 10mm 10mm 10mm

Ground Dome Position

Dorsum View Figure 10

29 Position of Ground Electrode Dome Both of the Ground Contact wires, the middle wire from

the Remote Electrode Assemblies, use the same dome.

Drill a Ø3.2mm hole beneath the position of the Socket Terminal, in the midline (figure 9).

If this position is unavailable, select an alternative position away from muscle sites over bone and distal to the wrist.

Figure 9


30 Insertion and Connection of Electrode Domes

Insert an electrode dome (21) into the Ground Dome Position and connect the middle wire from each Dual Remote Electrode (16) using the washers and locking nut (17, 18, 19, 20, 21) provided (figure 10a).

Insert two domes into two of the holes previously drilled, per electrode site. Connect the contact wires from one electrode to each pair of domes (figure 10b), connecting the M3 Nut (17), Electrode Eye (18) and Conical Washer (19) as illustrated in Figure 10a.

It is important to have one hole between electrodes and ensure electrodes run in series with the muscle fibers (figure 10b and 10c).

21

19

18

17

20

Figure 11a

CORRECT

Electrode domes are in line with the muscle fibers and one hole separates domes Figure 11c

INCORRECT

In general the above Dome arrangements are not op2mal for EMG signals. Figure 11d

Figure 10a

Figure 10b

Figure 10c

17

18

19

20

21


N.B. It may take a number of attempts to find the optimal position for digits. Positioning should be based on function rather than anatomical position. Test the prosthesis on the patient, considering compensatory movements at the elbow and shoulder; in addition to movements in all planes as well as rotational movements. Assessment should use a variety of different objects and tasks, checking all grip options.

31 Fit the patient with the check socket and connect to biosim. Analyze Fit the patient with the check socket and connect to biosim. Analyze. Analyze muscle signals. If required reposition domes

using predrilled holes to obtain optimal outputs.

32 Testing for Optimal Digit Positioning and Socket Aeration

Glue the digit mount to the test socket using fast set urethane adhesive. Glue thumb position to provide the best opposition to the Index and Middle digits. Thumb Setting Bar (25) may be used to aid alignment.

33 Aerate the socket as required cutting apertures into the silicone socket and frame, ensure that all wiring is adequately protected within the socket and edges are smoothed. Users may find aeration preferable as it will increase sensation while decreasing weight, heat build up and associated sweating.

N.B. During the fitting process the position of electrodes and wiring routes are established.


28

29

Figure 14b

Insert the Alignment Bars (28) into the Single Knuckle Dummies (27) and lock each in place using M2 x 5mm Countersunk Torx Screw (29) and the T6 Screwdriver (use one per digit when using Single Knuckle Mounting Plates (9) and a minimum of two per assembly for Multiple Knuckle Mounting Plates), (figure 11b).

Figure 11b

28

27

29

Transfer of Alignment

3

26

27

Figure 14a

35 Transfer of Digit Alignment with Thumb Rotator Assembly from Check Socket

Remove the Digits (7), Knuckle Assemblies (6) and Thumb Setting Bars (22 or 23) from the check socket. Attach the Single Knuckle Dummies (27) to the Knuckle Mounting Plate (9, 10 or 11) using three M2 x 12mm Countersunk Torx Screw (26) and the T6 Screwdriver (3), (figure 11a).

Figure 11a

3

26

27

Definitive Socket

34 Fabricate the definitive silicone socket as per the process for the check socket with added pigment (stages 1 to 8).


36 Position the check socket on the original cast and mount in a vertical alignment jig. Capture alignment in lower container with impression material or plaster and allow to cure.

37 Remove the cast from the vertical alignment jig and then remove the check socket from the cast. Replace with the definitive silicone socket and reposition on the vertical alignment jig, whilst protecting the silicone with cling film. The definitive socket and the Knuckle Mounting Plate will now be accurately positioned with a space in between.

38 Fill the space between knuckle and silicone with clay.

N.B. Consideration must be given to the position of the electrical connectors for supply of power to each individual digit. If space is available between the silicone socket and the frame then place the connection points for each digit within this space. If space is limited then an additional area must be build up with plasticine to provide additional space within the frame.


39 Remove from the vertical jig and set upright. Place the the dummies for the Wristband connection and remote electrodes on the back of the hand. Blend in the contours of the connection using clay.

40 Create routes for the wiring using clay or similar material.

41 Remove the Knuckle Mounting Plate(s) (9, 10 or 11).

42 Using silicone impression material duplicate the model to make a plaster mould, as per points 15 to 17.

43 Laminate the plaster with two layers of Nyglass.


Figure 15b

Figure 15a

44 Transfer of Digits Alignment with Thumb Rotator for the Definitive Socket

The inner Silicone and primary lamination will have been completed at this stage.

Transfer to the Definitive Socket using the chosen method (also refer to the Alignment Section in the Fabrication guide).

Assemble the second set of Mounting Plates to the Dummy components and fix to the Definitive Inner Socket accordingly. Ensuring the Alignment bars are held in position during the process (figure 12a).

Remove the Dummy components (figure 12b).

Figure 12a

Figure 12b

Re-attach the Thumb Setting Bar (22 or 23) with the with the Thumb Mounting Plate (25) attached (figure 12c).

Figure 15c Figure 12c

23

25

22


Fix the Thumb Mounting Plate (25) in position using an appropriate adhesive and remove the Thumb Setting Bar (22 or 23). Alignment has been transferred (figure 12d).

Figure 15d Figure 12d

45 Fabrication Preparation and Dummy Component Assembly

Once final alignment checks have been carried out, remove all digits and re-assemble the Fabrication Dummy components and position the Thumb Mounting Dummy (32).

Use clay to fill the screw heads and any other gaps to ensure no resin seepage (figure 13).

32

Figure 16 Figure 13

32


46 Layup the model with two layers of woven glass, apply a PVA bag and laminate.

48 Remove the lamination blocks and grind down further to the surface of the Knuckle Mounting Plate (9, 10 or 11). Clean up around the Thumb Mounting Plate (25) to allow the assembly of the thumb.

49 Remove the cast from the frame. Trim the frame as desired and create apertures as per the check socket. Aeration of the socket is desirable to enhance sensitivity and to reduce heat build up and associated sweating.

Aeration of the dorsal aspect of the frame is not recommended. Ensure that aeration does not compromise the strength of the frame.

47 When the lamination is fully cured grind down to reveal the lamination blocks.


51 The hole in the right hand side of each knuckle must be cleared of debris to accept the wire from the Knuckle Assembly (6).

52 Attach Knuckle Assembly (6) using M2 x 6mm Torx Screws (8), three screws are needed per Knuckle Assembly.

50 Drill a hole at the Thumb Mounting Plate (25) in the frame to allow digit wire to pass through, as per image.

AssemblyThis section details the assembly of the definitive prosthesis (points 51 to 59).


53 Attach the Thumb Hinge Plate (41) to the Thumb Rotator Assembly (34 or 35).

55 Attach each digit using the supplied screws. Screws are recommended to be single use.

56 Attach the remote electrode to the silicone socket as per the method used for the check socket.

N.B. The black earth wire is positioned on the dorsal surface of the hand, the red wire attached to signal site positions.

54 Thumb Rotator Assembly – Setting and Assembly

The full Thumb Rotator Assembly is illustrated (34 or 35) (Figure 14a). To increase the force required to rotate the thumb, remove the Nut Cap (36) and use the 8mm Spanner (33) to tighten the Self Locking Nut (35) to tighten the M4 Locking Nut (37).

Hand tighten with fingers and then turn a further 120 to 150° to give the desired Thumb Friction depending on patient preferences (figure 14b), using the 8mm Spanner (33).

Ensure the Clutch Plate (39) is not contaminated, as this will affect performance.

402

39

35

34

36

Figure 17a

35

33

36

35

Figure 17b Figure 14b Figure 14a

33

3725

36

37

5

6

41

38

39

40

34

35


57 Attach the Wristband and secure using 091081A M4 Socket Button Head (42).

58 Connect the digit wires to each two-way connector from the Wristband.

59 Connect the four-way connector to the remote electrode.

60 Insert the silicone socket into the frame and attach using 09181A M4 Socket Button Head Screws (42).

N.B. The order of attachment is un-important as this is later mapped using the biosim software (see the biosim section in the i-limb digits Clinician Manual for full details).

N.B. The connection plugs between each digit and the Wristband, along with any excess wiring, should be positioned between the silicone socket and the frame, beneath the base of the Knuckle Mounting Plate.

42

61 i-limb digits Skin Active covers Slide the i-limb digits Skin Active and i-limb digits Thumb

Skin Active coverings (30 and 31) in place over the digits (figure 15a), aligning the contours of the covers with the digit (figure 15b).

Figure 18a

30

31

Figure 18b Figure 15b Figure 15a

31

30


63 FSR Control When using FSR control, the head of the FSR must not be distorted as failure of the device is likely to occur.

The FSR is sited between the silicone socket and the frame (a second light weight inner frame may be created to support the FSR and protect the wiring).

The silicone socket should be a maximum of 1mm thick, 20 shore silicone in the region of the head of the FSR for ease of activation.

Routing of wires and fixing points are then established and incorporated within the silicone socket.

A flat area must be created within the frame to cater for the head of each FSR. This can be done by taking a cast of the silicone socket mounted on the cast. The cast is then poured to create a positive model. A flat area is then made at the site of the FSR using a plastic disc which is blended into the cast. This ensures a flat surface for the FSR.

Appendix

62 Removal of Transport Bracket (for replacement of digits only)

Remove the O-Ring (12) from the rear of the M2 Digit Screw (5).

Withdraw the M2 Digit Screw (5) from Digit (7) and the Transport Bracket (13).

Retain parts for future return to service center.

(Figure 16)

7

12

13

5

Figure 6 Figure 16

12

7

13

5


64 List of i-limb digits Components

Item Part Number Description

1 069185A M2 x 9mm Torx Screw

2 069176A Knuckle Fairing

3 069292A T6 Screwdriver

4 069293A T8 Screwdriver

5 069180A M2 Digit Screw

6 SA069389A Knuckle Assembly

7 Various* Digit

8 069435A M2 x 6mm Torx Screw

9 SA069366A Single Knuckle Mounting Plate

10 SA069405A Multiple Knuckle Mounting Plate, LHS

11 SA069406A Multiple Knuckle Mounting Plate, RHS

12 069408A O-Ring

13 069385A Transport Bracket

14 069409A Remote Electrode Dummy

15 069361A Socket Terminal Dummy

16 SA069416A Dual Remote Electrode

17 901018A M3 Nut

18 NA** Electrode Eyelet

19 069308A Conical Washer

20 091120A Electrode Dome Spacer

21 091119A Electrode Dome

22 069077A Thumb Setting Bar, LHS


23 069076A Thumb Setting Bar, RHS

24 Various* Thumb

25 069277A Thumb Mounting Plate

26 069402A M2 x 12mm Countersunk Torx Screw

27 069219B Single Knuckle Dummy

28 069400A Digit Alignment bar

29 069401A M2 x 5mm Countersunk Torx Screw

30 Various* i-limb digit Thumb Skin Active

31 Various* i-limb digit Thumb Skin Active

32 069455A Thumb Mounting Dummy

33 000049A 8mm Spanner

34 PL069250B Thumb Rotator Assembly, RHS

35 PL069087A Thumb Rotator Assembly, LHS

36 069294A Nut Cap

37 1900010A M4 Locking Nut

38 069231A Thumb Spring

39 069252A Clutch Plate

40 069228A Thumb Spigot

41 069234A Thumb Hinge Plate

42 091081A M4 Socket Button Head Screw

43 091089A Silicone Support Anchor

44 091081A Silicone Support Anchor, Small

*Depending on digit size**Comes as part of a set, does not have an individual product code

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North American Customers(Canada, Mexico & US)

Touch Bionics35 Hampden Road

Mansfield MA 02048USA

Tel: +1 855 MY iLIMB (694 5462)

International CustomersTouch Bionics

Unit 3, Ashwood CourtOakbank Park Way

Livingston EH53 0THScotland

Tel: +44 1506 438 556Email: [email protected]

For address details and further information please visit www.touchbionics.com

Third party products and brand names may be trademarks or registered

trademarks of their respective owners

© Copyright 2012 Touch Bionics Inc. and Touch EMAS Ltd. All rights reserved.

Issue No. 1, December 2012 Part number: MA01073

i-limbtm digits component assembly guide...use the t6 screwdriver (3) to attach the knuckle assembly...

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