Fillauer SPL2 Product Manual

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SPL2

Product Manual

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Package Contents

IQ SPL2 Set

1 SPL2 Joint 1 SPC Joint 1 Satellite and Cable 1 Inner Hexagonal Wrench 2 Stickers 2 Cable Clamps 2 Nyloplex Stud with Header 1 Manual

IQ SPL2 Joint

1 SPL2 Joint 1 Inner Hexagonal Wrench 2 Stickers 2 Cable Clamps 2 Nyloplex Stud with Header 1 Manual

IQ SPL2 Unilateral

1 SPL2 Joint 1 Satellite and Cable 1 Inner Hexagonal Wrench 2 Stickers 2 Cable Clamps 2 Nyloplex Stud with Header 1 Manual

IQ SPC Joint

1 SPC Joint 1 Inner Hexagonal Wrench 1 Manual

IQ Satellite

1 Satellite and Cable 1 Manual

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Overview Parts

SPL2 Joint Parts

Fig. Part Number Unit Description

A IQ210L or R 1x Swing Phase Lock 2 Joint

B IQ110/03 1x Joint Cover Plate Set

IQ110/03/01 4x Cover Plate Screws

IQ110/03/02 1x Medial Cover Plate

IQ110/03/03 1x Lateral Cover Plate

C IQ110/04 1x Joint Screw and Nut Kit

IQ110/04/01 1x Joint Nut

IQ110/04/02 1x Joint Screw

D IQ110/05 1x Set Screw

E IQ210/07 1x Bumper

F IQ110/08 1x Teon Bushing Set

G IQ130L or R 1x Function Unit

H IQ130/01 1x Function Unit Spring Pin

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SPC Joint Parts

Fig. Part Number Unit Description

A IQ120L/R 1x Swing Phase Control Joint

B IQ120/03 1x Joint Cover Plate Set

IQ110/03/01 2x Cover Plate Screws

IQ120/03/02 1x Lateral Cover Plate

C IQ120/04 1x Joint Screw and Nut Kit

IQ120/04/01 1x Joint Nut

IQ120/04/02 1x Joint Screw

D IQ120/08 1x Teon Bushing Set

E IQ120/09 1x Flexion Control Set

IQ120/09/01 1x Flexion Control Bumper Pin

IQ120/09/02 1x Flexion Control Spring Nut

IQ120/09/03 1x Flexion Control Spring

E1E

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Satellite Parts

Fig. Part Number Unit Description

A IQ141 1x IQ SPL Satellite Complete

B IQ141/01 1x IQ SPL Satellite Service Hatch Screw 2.2 x 8 mm

C IQ141/02 1x IQ SPL Satellite Service Hatch

D IQ141/03 1x IQ SPL Satellite Mounting Bracket

E IQ141/04 1x IQ SPL Satellite Mounting Plate Screws 2.5 x 12 mm

F IQ140/04 1x IQ SPL Satellite Cable End Block

G IQ140/12 1x IQ Satellite Set Screw for Cable End Block

H IQ141/05 1x IQ SPL Satellite Cable Set

I IQ140/06 1x IQ SPL Satellite Set Screw

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Product Specications

Usage of the SPL2 knee joint system provides optimum care for patients with paresis/paralyses (e.g. polio) and contributes to a successful therapeutic treatment. This articulating system is meant to compensate weakened or complete failure of the knee extension function. The joint is available in two

dierent versions: a.unilateral joint or b.bilateral joint.

Indications

SPL2 Orthotic Knee Joint Bilateral and Unilateral

• Apoplexy (CVA) (ICD10: I64)

• Multiple sclerosis (ICD10: G35)

• Myopathy (ICD10: G72.9)

• Paralysis (ICD10: G83.9)

• Paresis (peripheral)

(ICD10: G83.9)

• Poliomyelitis (ICD10: A80)

Contraindications

SPL2 Orthotic Knee Joint Bilateral

• Flexion Contracture > 10º

(ICD10: M24.59)

• Spasm

• Hip Contracture

• Weight bearing Orthosis (e.g. quad brim)

SPL2 Orthotic Knee Joint Unilateral

• Patient weight > 100 kg

• Varus > 10°

(ICD10: M21.10/Q74.9)

• Valgus >10°

(ICD10: M21.00/Q74.9)

• Flexion Contracture > 5º

• Spasm

• Hip Contracture

• Weight bearing Orthosis

Warranty Period

12 months from date of patient tting

Note: The satellite/remote control is not covered under warranty. The warrant y will be void if the item has been fabricated or installed outside Fillauer ’s recommendations, if the item has been exposed to a corrosive environment, or if the item has been used in extremely abusive activities that could result in injury.

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Important Terms and Usages

The SPL2 joint oers knee stability during stance and oers free movement

of the knee during swing. This feature is fully automatically activated with each step. It is prohibited to be used in water or exposed to temperatures

exceeding 122°F (50°C).

Correct application, in combination with the satellite in the orthosis, is mandatory. The joint system has been designed only as a non-weight bearing joint (KAFO/KO) and should not be used in any weight bearing orthoses. Nonobservance of these regulations excludes any liability claims.

Important: The patient must be well informed concerning the functions and possibilities of the knee joint system, including the satellite/remote control.

Function

SPL2 Technical Features

The technique of the SPL2 (Swing Phase Lock) joint is based on a simple internal pendulum mechanism, which locks and unlocks the knee depending on the angle of the knee joint in the sagittal plane. During gait, the device locks at the end of swing phase, just prior to heel strike, and unlocks the

knee at heel o in preparation for swing. The joint cannot be unlocked if it is loaded in exion.

SPC Technical Features

The technique of the SPC (Swing Phase Control) joint uses friction to regulate

or inuence excessive knee exion. The moment to full exion is somewhat

shortened and slightly variable.

The SPC joint is always to be mounted on the medial side and is suitable for

¾in. (19 mm) uprights. The joint weight is 6.7oz. (190 grams).

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Satellite Technical Features

The SPL2 joint is controlled by a proximal remote push-button switch. The satellite is mounted to the thigh part of the orthosis with the mounting bracket that is supplied in the packaging.

The three modes to manually control the SPL2 joint are:

1. Automatic locking/unlocking

2. Permanent unlocking/free motion

3. Permanent locking

By deactivating the permanent unlocking/free motion mode the satellite switches into the permanent locking mode and needs to be raised into the automatic function (Mode 1).

1. 2. 3.

Cleaning & Disinfection Instructions

The SPL2 joint may not be greased, oiled, or lubricated in any way. To clean,

use naphtha or similar cleaning uid or compressed air. Do not use acetone,

dilutions or turpentine, etc.

Maintenance Instructions

Maintenance cycles depend strongly on the patient’s activity level. At a moderate activity level, the joints must be checked or serviced every six months. When doing this, attention must be paid to wear and tear, joint play, and damages. If the joint is no longer working freely, a thorough service is recommended.

If the joint has been heavily loaded in a exed position, e.g. with stumbling,

tripping, or walking (falling) down the staircase, the joint has to be inspected

by the orthotist. If the patient walks constantly with a slightly exed knee or

regularly uses the safety stops, adjustment of the extension position towards

exion is absolutely necessary.

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Casting and Fabrication Instructions

Component Construction

SPL2 Joint: Housing: stainless steel

Function unit: brass Cover plates: ABS plastic

SPC Joint: Housing: stainless steel

Cover plates and bumper pin: ABS plastic

Satellite: Housing: ABS, POM plastic

Cable: Teon

Measuring

Casting must be done with a fully neutral extended leg. Stretching, however,

should be possible without too much eort to allow full extension (needed to

unlock the joint) once the orthosis is worn.

When the alignment unit is used (IQ150) to construct the orthosis, make sure the square with the T-bar is placed horizontal in the frontal plane to keep

the axis straight. Alignment should be based on the plumb line to create a neutral baseline for the function unit.

Orthosis Construction

Any type of construction is suitable, as long as sucient torsion rigidity and possibility of changing the exion position during the initial tting is taken

into account.

When the joint is used in a carbon ber-reinforced construction, the SPL2

should be disassembled by removing the satellite. Disconnect the cable

within the function unit (G) and loosen the IQ set screws (D), loosen the

adjustment screw, and gently pull the cable from the housing. Now the

function unit (G) can be pushed inside and removed.

The SPC exion Control Unit must be removed (E) and sealed with stick wax to prevent improper resin ow. In this case, the upright spacer (029860) can

be used and aligned, allowing the Joints to be mounted in a later stage.

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Joint Alignment

The alignment unit must be parallel to the plumb line. The SPC joint should not be aligned in full extension. If the joint is aligned without using the unit, the cover plates (B) may be removed allowing the joint axis to be used for parallel alignment.

Dynamic Initial Fitting

Function Check

Prior to the initial tting, the proper setting of

the joint needs to be checked.

• The slotted arm of the function unit (G) must be set in neutral 0 position (Fig. A) when the satellite is in Mode 1. Adjust the proximal adjustment screw (F) on the SPL2 as necessary.

• Check to see if the SPL2 joint lock after swing with the satellite in Mode 1. If it cannot lock,…

Adjusting Locking and Unlocking

Timing settings to lock or unlock can be read or adjusted by moving the pendulum weight of the function unit.

Figure A

• Moving the pendulum ANTERIOR (forward),

DECREASES the tendency to lock, because its

weight is shifted forward.

• Moving the pendulum POSTERIOR (backward),

INCREASES the tendency to lock because its

weight is shifted backward.

Figure B

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Satellite Control

The patient needs to be instructed on functionality and how to operate

thesatellite.

Mode 1—Automatic Locking and Unlocking

The slider on the satellite is positioned in the middle. This is the normal position by which the SPL2 joint automatically locks and unlocks during walking. In this mode, the joint can also be unlocked once, by slightly pushing the switch upwards. The automatic mode is activated again when the joint is fully extended.

Mode 2—Permanently Unlocked

The slider on the satellite is slid upward from the center. In this

mode the SPL2 joint is permanently unlocked. NOTE: When

deactivating the permanent unlocking (by pushing the central button), the satellite automatically shifts into the permanent locking mode and thus needs to be slid up into the automatic locking/unlocking mode.

Mode 3—Permanently Locked

For this purpose the central button on the satellite is to be pressed for the slider to slid fully down. This is a safety mode in which the SPL2 joint is constantly locked when in full extension (e.g. at home,

making many turns,etc.).

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Shortening the Satellite Cable

First determine the position where the satellite will

be mounted on the thigh cu of the orthosis in

order to establish the correct cable length. Bear in mind that the cable should have a slight S-shape.

1. Position the joint in full extension and set the

satellite in Mode 3 by pressing the button on

the satellite. Make sure the joint is indeed locked.

2. Use the supplied hex screwdriver to loosen

the two screws on the medial (stainless steel)

cover plate and remove it (see Fig.1).

3. After removal of the cover plate check if

the upper side of the lever arm (holding the satellite cable) is parallel to the lower of the

three markers on the function unit (see Fig.2).

4. Using a Phillips screwdriver, loosen the screw

of the service hatch at the back of the satellite and remove the cover and screw.

5. Use the hex screwdriver to loosen the cone

point safety screw two to three turns and

slide the cable end block o the inner cable (see Fig.3).

6. Twist the Teon outer cable from the swivel

connector at the bottom of the satellite. Place the swivel in one hand between your thumb

and forenger and the Teon outer cable

in the other hand between the thumb and

forenger and unscrew (counterclockwise)

the outer cable from the Swivel Connector.

Retract the inner cable outwards through the

swivel.

7. Loosen the cone point safety screw on the

side of the joint two turns (see Fig.4). Do not

remove the screw from the joint.

8. Turn the satellite set screw (which connects

the Teon cable to the joint) completely in

the joint, followed by two complete turns

up again. Trim the Teon outer cable with a

sharp knife to the desired length and remove

DO NOT:

• TAMPER

• GREASE

• OIL

• LUBRICATE

Figure 1

Figure 2

Figure 3

Figure 4

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the excess outer cable. The inner steel cable

will be shortened in step 13.

9. Now slide the inner cable through the bottom

of the swivel connector into the satellite

housing and screw the Teon outer cable

onto the swivel. Place the swivel in one hand

between your thumb and forenger and the Teon cable in the other hand between the thumb and forenger. Press and turn (clockwise) the two parts rmly together (the

swivel is self-tapping).

10. Slide the cable end block back over the steel

inner cable and position the end block back into the corresponding slot in the satellite

(see Fig.5).

11. Recheck the correct position (Mode 3) of the

lever arm in the function unit of the joint (see

Fig.2).

12. Tighten the cone point safety screw of the

cable end block rmly on the inner cable.

13. Use wire cutters to cut o the excess inner

cable at ± 5 mm above the cable end block.

14. Install the service hatch back on the back of

the satellite and reattach the screw.

15. Slide the satellite switch into the automatic

position (Mode 1) and check within the functional unit of the joint if the top of the lever arm has moved and now is parallel with

the center marker (see Fig.6).

16. Use the satellite set screw (which connects

the Teon cable to the joint) to ne tune and adjust the position described in step 16.

17. Tighten the cone point Safety screw back in

the joint (see Fig.4).

18. Mount the medial cover plate back onto the

joint and tighten the screws.

19. Loosen both screws on the front side of the

satellite housing and remove the mounting bracket.

Figure 5

Figure 6

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20. Determine the exact position where the satellite is to be mounted

on the thigh cu and contour the bracket if necessary. Mount the

mounting bracket on the brace and reattach the satellite using the screws at the front again.

21. Use the provided cable clamps to attach the satellite cable in order to

ensure an optimal, at resting cable run against the thigh cu of the

orthosis.

Once all the adjustments are done, the opening on the function unit must

be resealed using the IQ sticker. This reduces the likelihood of dirt and

clothing bers getting in.

Checking All Functions

All functions must be checked once again.

1. Do all three modes on the satellite switch reliably?

2. Can reliable locking be achieved with free swing, and is the locking

sucient (is the cable to the satellite on the right length, is the inner

cable in a neutral position, in the 0 position)?

3. Does the joint unlock reliably after the posterior swing?

4. Are the stops all again in position, and does the joint run without play

and smoothly?

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Fillauer LLC

2710 Amnicola Highway Chattanooga, TN 37406

423.624.0946 Fax 423.629.7936www.llauer.com