Basko healthcare Swing phase lock 2 User manual

Gebruiksaanwijzing

Gebrauchsanleitung

Manual

Mode d’emploi

Swing Phase Lock 2

IQ88003 / Stand: 01/2018

Basko Healthcare

1505 HX Zaandam

Fax: +31 (0) 75 - 612 63 73

Internet: www.basko.com

Pieter Lieftinckweg 16

Tel.: +31 (0) 75 - 613 15 13

E-mail: verkoop@basko.com

BASKO HEALTHCARE

P. Lieftinckweg 16

NL 1505 HX Zaandam

Tel.: +31 75 613 15 13

Instructions

for use

This product is distributed in Sweden, Norway, Finland

and Denmark by

Camp Scandinavia AB

Karbingatan 38

SE-254 67 Helsingborg

Phone; +46 42 25 27 00

info@camp.se

www.camp.se

Swing Phase Lock 2Basko Healthcare

Basko Healthcare Swing Phase Lock 2

English

User directives................................................................ 29

Intended use / Indications ..................................................... 29

Indications ..............................................................29

Contraindications.........................................................30

Functional features / Other terms / Usages......................................29

Function ..................................................................... 30

Technical Features SPL 2 ...................................................30

Technical Features SPC .....................................................30

Technical Features Satellite .................................................30

Cleaning / disinfection Instructions............................................. 31

Maintenance Instructions...................................................... 31

Used Materials................................................................ 31

Constructional guidelines ..................................................... 31

Orthosis construction .......................................................31

Measuring ..............................................................31

Orthosis Construction .....................................................32

Joint Alignment ..........................................................32

Dynamic Initial Fitting ......................................................32

Function Check ..........................................................32

Adjusting locking and unlocking .............................................32

Satellite Control ..........................................................33

Shorten satellite cable .....................................................33

Checking all functions......................................................... 35

Package contents ............................................................. 35

Overview Parts ............................................................... 36

Parts SPL 2 Joint..........................................................36

Parts SPC Joint ...........................................................37

Parts Satellite............................................................38

Übersicht der Einzelteile

Satellit

Satellit - Einzelteile

Abb. Artikelnummer Einheit Artikelbezeichnung

AIQ141 1x SPL 2-Satellit (komplett)

BIQ141/01 1x Schraube für Serviceklappe (1 Stück)

CIQ141/02 1x Serviceklappe

DIQ141/03 1x Montageplatte

EIQ141/04 1x Schrauben für Montageplatte (2 Stück)

FIQ140/04 1x Kabelendstück

GIQ140/12 1x Maden-schraube für Kabelendstück

HIQ141/05 1x Kabel-Set (Teonkabel, Stahlkabel inkl. Endkugel)

IIQ140/06 1x Justierschraube

ENG

Swing Phase Lock 2Basko Healthcare

Basko Healthcare Swing Phase Lock 2

User directives

Your doctor is the one whom prescribed the orthosis and stipulates the duration

of treatment. The daily use duration prescribed by the doctor must be observed

closely. The use of the orthosis is done under the supervision of the doctor.

The professional staff, which builds and adapts the articulation system into

the orthosis, is responsible for correct functioning of the Joints. In case of skin

problems, circulation problems, unusual pain or other complications, which to

your opinion are directly related to the product, please contact your doctor or

CO at once.

Intended use / Indications

Usage of the Swing Phase Lock 2 knee Joint system provides an optimum care for patients with Paresis/

Paralyses (e.g. Polio) and as a consequence contributes to a successful therapeutic treatment.Other

usage as prescribed above is not permitted.For a correct application the usage 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.Non-observance of these

regulations excludes any liability claims.The Joint is available in two different version, for usage as a

monolateral Joint or as a bilateral Joint. When used in a monolateral construction, the maximum

patient weight cannot exceed more than 100 kg (220 lbs).

Indications

SPL 2 Orthotic Knee Joint bilateral and monolateral:

■Apoplexy (CVA) (ICD10: I64) ■Paralysis (ICD10: G83.9)

■Multiple sclerosis (ICD10: G35) ■Paresis (peripheral) (ICD10: G83.9)

■Myopathy (ICD10: G72.9) ■Poliomyelitis (ICD10: A80)

Contra Indications

SPL 2 Orthotic Knee Joint Bilateral SPL 2 Orthotic Knee Joint Monolateral

■Flexion Contracture > 10º (ICD10: M24.59) ■Patient weight > 100 kg

■Spasm ■Varus > 10° (ICD10: M21.10/Q74.9)

■Hip Contracture ■Valgus >10° (ICD10: M21.00/Q74.9)

■Weight bearing Orthosis ■Flexion Contracture > 5º

■Spasm

■Hip Contracture

■Weight bearing Orthosis

ENG

Swing Phase Lock 2Basko Healthcare

Basko Healthcare Swing Phase Lock 2

The 3 modes to manually control the SPL 2 Joint are:

1. Automatic locking

2. Permanent unlocking

3. Permanent locking

By deactivating the permanent unlocking mode the Satellite switches into the permanent locking

mode and needs to pushed into the Automatic function.

Cleaning / disinfection Instructions

The SPL 2 Joint may not be greased, oiled or in any other way lubricated.When cleaned, please use

Naphtha (no acetone, dilutions or turpentine, etc.) or some similar cleaning uids or compressed air.

Maintenance Instructions

Maintenance cycles depend strongly on the patients activity level.At a moderate activity level,

the Joints must be checked / serviced every 6 months.When doing this, attention must be paid to

wear and tear, Joint play and damages.If the Joint is no longer running freely, a thorough service is

recommended.

If the Joint has been, due to circumstances, extremely 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. In case the patient constantly walks with a slightly exed knee or regularly usage the safety

stops, adjustment of the extension position towards exion is absolutely necessary.

Used Materials

SPL 2 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

Constructional guidelines

Orthosis construction

Measuring

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

without to much effort to allow full extension (needed to unlock the Joint) once the Orthosis is worn.

When the Alignment Unit is used (Art. nr. 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.

Mode 1 Mode 2 Mode 3

Functional features / Other terms / Usages

This articulating system is meant to compensate weakened or Total Failure of the Knee Extension

function.

The SPL 2 Joint offers knee stability during stance and offers 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 50°C.

Important

The patient must be well informed concerning the functions and possibilities of the Knee Joint system.

Function

Technical Features SPL 2

The technique of the SPL 2 Joint (Swing Phase Lock) is based on a simple internal pendulum

mechanism, which locks and unlocks the knee depending on the angle of the 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 off in preparation for swing. The Joint cannot be unlocked if it is loaded in exion.

The SPL 2 Joint is always to be mounted on the lateral side and is suitable for 19 mm Uprights.

The Joint weight is 340 grams.

Technical Features SPC

De technique of the SPC Joint (Swing Phase Control) usage friction to regulate or inuence excessive

Knee Flexion. 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 19 mm Uprights. The

Joint weight is 190 grams.

Technical Features Satellite

The SPL 2 Joint is controlled by a proximal remote push-button switch (Satellite).The Satellite is

mounted to the thigh part of the orthosis with the mounting bracket that is supplied in the packaging.

ENG

Swing Phase Lock 2Basko Healthcare

Basko Healthcare Swing Phase Lock 2

The 3 modes to manually control the SPL 2 Joint are:

1. Automatic locking

2. Permanent unlocking

3. Permanent locking

By deactivating the permanent unlocking mode the Satellite switches into the permanent locking

mode and needs to pushed into the Automatic function.

Cleaning / disinfection Instructions

The SPL 2 Joint may not be greased, oiled or in any other way lubricated.When cleaned, please use

Naphtha (no acetone, dilutions or turpentine, etc.) or some similar cleaning uids or compressed air.

Maintenance Instructions

Maintenance cycles depend strongly on the patients activity level.At a moderate activity level,

the Joints must be checked / serviced every 6 months.When doing this, attention must be paid to

wear and tear, Joint play and damages.If the Joint is no longer running freely, a thorough service is

recommended.

If the Joint has been, due to circumstances, extremely 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. In case the patient constantly walks with a slightly exed knee or regularly usage the safety

stops, adjustment of the extension position towards exion is absolutely necessary.

Used Materials

SPL 2 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

Constructional guidelines

Orthosis construction

Measuring

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

without to much effort to allow full extension (needed to unlock the Joint) once the Orthosis is worn.

When the Alignment Unit is used (Art. nr. 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.

Mode 1 Mode 2 Mode 3

Functional features / Other terms / Usages

This articulating system is meant to compensate weakened or Total Failure of the Knee Extension

function.

The SPL 2 Joint offers knee stability during stance and offers 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 50°C.

Important

The patient must be well informed concerning the functions and possibilities of the Knee Joint system.

Function

Technical Features SPL 2

The technique of the SPL 2 Joint (Swing Phase Lock) is based on a simple internal pendulum

mechanism, which locks and unlocks the knee depending on the angle of the 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 off in preparation for swing. The Joint cannot be unlocked if it is loaded in exion.

The SPL 2 Joint is always to be mounted on the lateral side and is suitable for 19 mm Uprights.

The Joint weight is 340 grams.

Technical Features SPC

De technique of the SPC Joint (Swing Phase Control) usage friction to regulate or inuence excessive

Knee Flexion. 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 19 mm Uprights. The

Joint weight is 190 grams.

Technical Features Satellite

The SPL 2 Joint is controlled by a proximal remote push-button switch (Satellite).The Satellite is

mounted to the thigh part of the orthosis with the mounting bracket that is supplied in the packaging.

ENG

Swing Phase Lock 2Basko Healthcare

Basko Healthcare Swing Phase Lock 2

Shortening the Satellite Cable

First determine the position where the satellite will be mounted on the

thigh cuff 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 (see Fig. 3).Make sure the joint

is indeed locked.

2. Use the supplied Allen screwdriver to loosen the two screws on the

medial (stainless steel) Cover Plate and remove it (see Fig. 4).

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. 5).

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 Allen screwdriver to loosen the cone point safety screw two to

three turns and slide the Cable End Block of the inner cable (see Fig. 6).

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 (see Fig. 7).Subtract the inner cable

outwards through the Swivel.

7. Loosen the Cone Point Safety Screw on the side of the joint, two turns

will do (see Fig. 8).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 and then two complete turns up again.

9. NOTE: carve the Teon outer cable with a sharp knife to the desired

length and remove the excess outer cable (the inner steel cable will

be shortened in step 14).

Fig.1

Fig.2

Fig.3

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 SPL 2

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 SPL 2 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 SPL 2 joint is constantly locked (e.g. at home, making many turns, etc.).

Fig.4

Fig.5

Fig.6

Orthosis Construction

Basically any type of construction is suitable as long as sufcient torsion rigidity and a 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 SPL 2 should be disassembled by

removing the Satellite – disconnect the cable within the Function Unit (H) and loosen the IQ set screws

(D), Loosen the adjustment screw and gently pull the cable from the housing.Now the Function Unit

(H) can be pushed inside and removed.

The SPC exion Control Unit has to be removed (E) and sealed with Stick Wax (Art. nr. 990035) to

prevent improper resin ow. In this case the Upright spacer can be used (Art. nr. 029860) and aligned,

allowing the Joints to be mounted in a later stage.

Joint Alignment

The Alignment Unit has to 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 need to be checked

■The slotted arm of the Function Unit (H) must be set in neutral 0 position

(see picture) when the Satellite is in the 1st mode.Adjust with the

Proximal adjustment screw (F) on the SPL 2 is necessary.

■Can the SPL 2 Joint lock after swing with the Satellite in the 1st mode?

Adjusting locking and unlocking

Timing settings to lock or unlock can be read or adjusted by moving the

pendulum weight of the Function Unit.

■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.

ENG

Swing Phase Lock 2Basko Healthcare

Basko Healthcare Swing Phase Lock 2

Shortening the Satellite Cable

First determine the position where the satellite will be mounted on the

thigh cuff 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 (see Fig. 3).Make sure the joint

is indeed locked.

2. Use the supplied Allen screwdriver to loosen the two screws on the

medial (stainless steel) Cover Plate and remove it (see Fig. 4).

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. 5).

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 Allen screwdriver to loosen the cone point safety screw two to

three turns and slide the Cable End Block of the inner cable (see Fig. 6).

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 (see Fig. 7).Subtract the inner cable

outwards through the Swivel.

7. Loosen the Cone Point Safety Screw on the side of the joint, two turns

will do (see Fig. 8).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 and then two complete turns up again.

9. NOTE: carve the Teon outer cable with a sharp knife to the desired

length and remove the excess outer cable (the inner steel cable will

be shortened in step 14).

Fig.1

Fig.2

Fig.3

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 SPL 2

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 SPL 2 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 SPL 2 joint is constantly locked (e.g. at home, making many turns, etc.).

Fig.4

Fig.5

Fig.6

Orthosis Construction

Basically any type of construction is suitable as long as sufcient torsion rigidity and a 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 SPL 2 should be disassembled by

removing the Satellite – disconnect the cable within the Function Unit (H) and loosen the IQ set screws

(D), Loosen the adjustment screw and gently pull the cable from the housing.Now the Function Unit

(H) can be pushed inside and removed.

The SPC exion Control Unit has to be removed (E) and sealed with Stick Wax (Art. nr. 990035) to

prevent improper resin ow. In this case the Upright spacer can be used (Art. nr. 029860) and aligned,

allowing the Joints to be mounted in a later stage.

Joint Alignment

The Alignment Unit has to 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 need to be checked

■The slotted arm of the Function Unit (H) must be set in neutral 0 position

(see picture) when the Satellite is in the 1st mode.Adjust with the

Proximal adjustment screw (F) on the SPL 2 is necessary.

■Can the SPL 2 Joint lock after swing with the Satellite in the 1st mode?

Adjusting locking and unlocking

Timing settings to lock or unlock can be read or adjusted by moving the

pendulum weight of the Function Unit.

■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.

ENG

Swing Phase Lock 2Basko Healthcare

Basko Healthcare Swing Phase Lock 2

IQ SPL 2 Joint

(Art.nr.: IQ210R or L)

■1 SPL 2 Joint

■1 Inner hexagonal wrench

■2 Stickers

■2 Cable Clamps

■2 Nyloplex stud with header

■1 Manual

IQ SPC Joint

(Art.nr.: IQ120R or L)

■1 SPC Joint

■1 Inner hexagonal wrench

■1 Manual

IQ Satellite

(Art.nr.: IQ141)

■1 Satellite and Cable

■1 Manual

Package contents

IQ Swing Phase Lock 2 Set

(Art.nr.: IQ200R or L)

■1 SPL 2 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 Swing Phase Lock 2 monolateral

(Art.nr.: IQ250R or L)

■1 SPL 2 Joint

■1 Satellite and cable

■1 Inner hexagonal wrench

■2 Stickers

■2 Cable Clamps

■2 Nyloplex stud with header

■1 Manual

Once all the adjustments are done, the opening on the Function Unit must be re-sealed 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.

■Do all three modes on the satellite switch reliably?

■Can a reliable locking be achieved with free swing?

■Is the locking sufcient (is the cable to the satellite on the right length, is the inner cable in a neutral

position, in the 0 position)?

■Does the Joint unlock reliably after the back swing?

■Are the stops all again in position and does the Joint run without play and smoothly?

10. 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).

11. 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. 9).

12. Recheck the correct position (Mode 3) of the Lever Arm in the

Function Unit of the joint (see Fig. 5).

13. Tighten the Cone Point Safety screw of the Cable End Block rmly on

the inner cable.

14. Use a sharp cutter to cut off the excess inner cable at ± 5 mm above

the Cable End Block.

15. Install the Service Hatch back on the back of the satellite and reattach

the screw.

16. Slide the satellite switch into the Automatic Position (Mode 1) (see Fig. 1)

and check within the Function Unit of the joint if the top of the Lever Arm

has moved and now is parallel with the center marker (see Fig. 10).

17. 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.

18. Tighten the Cone Point Safety screw back in the joint (see Fig. 8).

19. Mount the medial Cover Plate back onto the joint and tighten the screws.

20. Loosen both screws on the front side of the Satellite Housing and

remove the Auxiliary Bracket.

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

on the thigh cuff and contour the bracket if necessary.Mount the

Auxiliary Bracket on the brace and reattach the satellite using the

screws at the front again.

22. Use the provided Cable Clamps to attach the satellite cable in order

to ensure an optimal,

at resting the cable run against the thigh cuff of the orthosis.

Fig.10

Fig.9

Fig.7

Fig.8

ENG