Leckey Kit User manual

Kit

User Manual

Supporting

Children

English

p2 Kit User Manual

The Kit has been designed to offer a high

level of postural positioning while enabling

function and mobility. The manual shows you

how to quickly, easily and safely make use

of all the functions. The instructions on safety

and maintenance will ensure that you will

enjoy the use of this product for a long time.

Kit User Manual p3

CONTENTS

01 Intended use

02 Certication

03 WarningsandCautions

04 Termsofwarranty

05 Producthistoryrecord

06 Producttrainingrecords

07 Safetyinformation

08 PrecautionsAndContraindications

09 Howtounpackandassembletheseatingsystemandtthecushions

10 Clinicalsetupforposturalmanagement

11 Cleaning&careinformation

12 Dailyproductinspection

13 Annualproductinspection

14 ReissuingLeckeyproducts

15 Productservicing

16 Technicalinformation

p4 Kit User Manual

SECTION 01:

INTENDED USE

Intended use

Leckey’sseatingsystemsareintendedto

supportchildrenandyoungadultswho

havemildtocomplexposturalneedsthat

affecttheabilitytositwithoutadditional

support.

Indications for use

Kitisamodularseatingsystemdesigned

tocaterfortheneedsofchildren

andyoungadultswithavarietyof

disabilitieswhicheffecttheirability

tositindependentlywithoutexternal

posturalsupports.Itisindicatedforuse

primarilywithinahome,indoorschool

environmentoroutdoors,ifusedon

amobilitybase.Therearetwosizes;

withapproximateagerangesof12-18

and16+years,bothwithamaximum

userweightof75kgs(165lbs).The

configurableposturalsupportofferedby

Kitisindicatedforuseforchildrenwith

complexposturalneeds(GMFCSV).

SECTION 2:

CERTIFICATION

KitisclassifiedasaClassIMedicalDevice

underEUandUKregulations.Asthe

manufacturer,JamesLeckeyDesign

Limited,declaresthatthisproduct

conformstotheMedicalDeviceRegulation

(2017/745),UKMedicalDeviceRegulations

2002,MedialDeviceDirective(93/42EEC)

andEN12182:2012Assistiveproducts

forpersonswithdisability,general

requirementsandtestmethods.

Notice to the user and/or patient: Any

serious incident that has occurred

in relation to the device should be

reported to the manufacturer and the

competent authority of the Member

State in which the user and/or patient is

established.

NOTE:

General user advice

Notfollowingthese

instructionsmayresultin

physicalinjury,damageto

theproductordamagetothe

environment!

Kit User Manual p5

SECTION 03:

WARNINGS AND CAUTIONS

1) WARNING TOPPLING HAZARD

•Usingtheseatinextremesofitsrange

ofpositionswillreduceitsstability.

Onlyusetheseatatmaximumheight

and/ormaximumseatreclinewhen

onlevelground(lessthan2-degree

slope).

•Whenusingtheseatonslopes/ramps

(upto10degrees)ensurethatthe

seatbackisintheuprightpositionand

theseatheightisbelowhalfheight.

2) WARNING FINGER TRAP HAZARD

•Takecarethatthengersofthe

operatororchildrenontheoordo

notgettrappedinthepoweredseat

raisingandloweringmechanism.

3) WARNING OCCUPANT SECURITY

•Ensurethatalloftheoccupant

harnessesandespeciallythepelvic

beltsarefastenedandadjustedto

holdtheoccupantsecurelyinplace

beforemovingtheseatorleavingthe

vicinityofthestaticseat.

4) CAUTION FINGER PINCH HAZARD

•Takecarewhenassemblingor

adjustingthepositionoftheseat

componentsthatyourngersdo

notgetpinchedwhenpositioning

seatcomponentsandtightening

mountings.

5) CAUTION DAILY CHECKS

•Theseatistobecheckeddailybefore

usetoensurethatallharnesses

andseatingelementsaresecurely

attachedtotheseatandchassis.

Alsocheckthebatterychargingcable

forsignsofdamagebeforeuse.See

section‘Dailyproductinspection’for

detailsofchecks.

6) CAUTION TRIP HAZARD WITH

POWERED CHASSIS

•Ensurethatbatterycharging

connectionforthepoweredchassisis

removedfromtheseatbeforemoving

theseat.

7) CAUTION CLEANING

•Cleantheseatregularlyto

preventthebuild-upofdirtonthe

seatingelementsandthechassis.

Accumulateddirtcanprematurely

weartheseatcushionsandencourage

corrosiononthechassis.Onlyusenon-

abrasivehouseholdcleanersandmoist

cloths,donotuserunningwateron

theupholsterywhilstitisstillattached

totheseat.Seesection‘Cleaning&

careinformation’.

8) CAUTION CLEANING POWER

WASHERS/HOSES

•Donotusehosesorpowerwashers

ontheframecomponents,theelectric

seatliftsystemisnotsealedagainst

p6 Kit User Manual

SECTION 04:

TERMS OF WARRANTY

Thewarrantyappliesonlywhenthe

productisusedaccordingtothe

specifiedconditionsandfortheintended

purposes,followingallmanufacturers’

recommendations(alsoseegeneral

termsofsales,deliveryandpayment).

Athreeyearwarrantyisprovidedon

allLeckeymanufacturedproductsand

components.

SECTION 05:

PRODUCT HISTORY

RECORD

YourLeckeyproductisclassifiedas

aClass1MedicalDeviceandassuch

shouldonlybeprescribed,setupor

reissuedbyatechnicallycompetent

personwhohasbeentrainedintheuse

ofthisproduct.Leckeyrecommendthat

awrittenrecordismaintainedtoprovide

detailsofallsetups,reissueinspections

andannualinspectionsofthisproduct.

runningwaterandmaybedamaged

bywateringress.Seesection‘Cleaning

&careinformation’.

9) CAUTION SERVICING/REPAIR OF

ELECTRONIC COMPONENTS

•Therearenouser-serviceable

componentsintheelectricpowerseat

liftingassembly.Servicingandrepairs

areonlytobecarriedoutbyLeckey-

authorisedpersonnel.

10) CAUTION DISPOSAL

•Onlydisposeoftheseatina

communitywastedisposalsite

andensurethattheelectrical

componentsareremovedfor

separatedisposal.

11) CAUTION BRINGING INTO USE

•Whenbringingtheseatintouse

fromstorage,allowittoacclimatise

toambienttemperaturefor2hours

rst.Wipeoffanymoisturethathas

condensedontheproduct.

Kit User Manual p7

1. Alwaysreadinstructionsfullybefore

use.

2. Usersshouldnotbeleftunattended

atanytimewhileusingLeckey

equipment.

3. OnlyuseLeckeyapprovedcomponents

withyourproduct.Nevermodifythe

productinanyway.Failuretofollow

instructionsmayputtheuserorcarer

atriskandwillinvalidatethewarranty

ontheproduct.

4. Ifinanydoubttothecontinuedsafe

useofyourproductorifanyparts

shouldfail,pleaseceaseusingthe

productandcontactourcustomer

servicesdepartmentorlocaldealeras

soonaspossible.

5. Carryoutallpositionaladjustments

andensurethattheyaresecurely

fastenedbeforeyouputtheuser

intothisproduct.Someadjustments

mayrequiretheuseofatoolwhichis

providedwitheachproduct.Keepall

toolsoutofreachofchildren.

6. Whenplacingtheuserintoaseating

system,forsafetyandpositional

reasons,alwayssecurethePelvic

Cradlerst.

7. Whentheproductisstationaryensure

thatallwheelsarelockedandfacing

awayfromthebaseasthiswillimprove

SECTION 07:

SAFETY INFORMATION

SECTION 06:

PRODUCT TRAINING

RECORD

(PARENTS, TEACHERS & CARERS)

YourLeckeyproductisclassifiedas

aClass1MedicalDeviceandassuch

Leckeyrecommendthatparents,

teachersandcarersusingthe

equipmentshouldbemadeawareofthe

followingsectionsofthisusermanualby

atechnicallycompetentperson.

SECTION 07

SafetyInformation

SECTION 10

Clinicalsetupforposturalmanagement

SECTION 11

CleaningandCareInformation

SECTION 12

DailyProductInspection

Leckeyrecommendthatawrittenrecord

ismaintainedofallthosewhohavebeen

trainedinthecorrectuseofthisproduct

p8 Kit User Manual

productstability.Thisisespecially

importantwhenthetiltinspaceor

backreclinefacilityisinuse.

8. WhentheseatisinuseontheHi-low

chassiswedonotrecommendthatthe

usersaremovedoverunevensurfaces

whenintheequipment.Allduecare

andattentionshouldbetakenwhen

transportingtheuserinandoutofthe

seat.

9. Neverleavetheproductonasloping

surface,greaterthan5degrees.Always

remembertolockallthewheels.

10. 6Onlyusethepushhandlestosteer

andmovetheseatfromoneareato

another.Neverusethetrayforthis

purpose.

11. Theproductcontainscomponents

whichcouldpresentachokinghazard

tosmallchildren.Alwayscheckthat

lockingknobsandboltswithinthe

user’sreacharetightenedandsecure

atalltime.

12. Leckeyproductscomplywithre

safetyregulationsinaccordance

withEN12182.Howevertheproduct

containsplasticcomponentsand

thereforeshouldbekeptawayfromall

directsourcesofheatincludingnaked

ames,cigarettes,electricandgas

heaters.

13. Donotplacehotitemsgreaterthan

40ºcentigradeonthetray.

14. Cleantheproductregularly.Donot

useabrasivecleaners.Carryout

maintenancechecksonaregular

basistoensureyourproductisingood

workingcondition.

15. Whentheproductisnotinuse,

itshouldbestoredinadryplace

thatisnotsubjectedtoextremes

oftemperature.Thesafeoperating

temperaturerangeoftheproductis+5

to+40degreesCelsius.

16. Alwayschecktheratchethandleson

thepushhandlearetightenedsecurely

beforeyoumovetheseatunit.

17. Beforeusingtheseatingsystemalways

checkthattheinterfacehandleon

theseatunitisfullyengagedwiththe

chassisandthelockingpinisengaged.

Ifthehandleisnotengagedproperly,

theseatunitmaycomelooseand

couldcauseseriousinjurytotheuser

orcarer.

Kit User Manual p9

TheKithasbeencrashtestedandpassed

foruseinvehicles.Ithasbeentestedin

itscompleteconfigurationonasurrogate

basewithaLeckeyheadsupport

attached.

KIT – CRASH TEST

IftheKitisbeingusedina

vehicle,thefollowingpoints

mustbeadheredto:

TheKitmustbepositionedforward

facingandusedwithanUnwin

RestraintSystemandaLeckeyhead

support,whichshouldbesuitably

positionedatalltimesduring

transportation.Theheadsupportis

availableasanoptionalaccessory

withtheKit.

TheKitiscrashtestedandmeetsthe

requirementsofISO16840part4.

Theseathasalsobeentestedand

meetstherequirementsof

ISO7176-19.

Thecrashtestswerecarriedoutusing

achestharnessandPelvicCradle.

Forfurtherdetailspleasecontactour

CustomerServiceDepartment.

Important

IfyouareusingtheKitona

wheelchairbase,pleaserefertothe

wheelchairmanufacturer’shandbook

forcrashtestdetails.

MEDICAL DEVICE

COMBINATIONS

ItmaybepossibletocombineKitwith

oneormoreotherMedicalDeviceor

otherproduct.Informationonwhich

combinationsarepossiblecanbefound

atleckey.com.Allcombinationslisted

havebeenvalidatedtomeettheGeneral

SafetyandPerformanceRequirements,

section14.1oftheMedicalDevice

Regulation2017/745.

Guidanceonthecombination,suchas

mounting,canbefoundatleckey.com

p10 Kit User Manual

SECTION 08:

PRECAUTIONS AND

CONTRAINDICATIONS

Precautions

•Fixedspinaldeformitiessuchas

scoliosisorkyphosis

•Severemusclecontractures

•Severemuscularorskeletal

asymmetryincludinghipdislocation

•Progressiveandmusclewasting

conditions

•Highriskorrecenthistoryofbone

fractures

•Highriskofpressurerelatedinjuryor

opensores

•Strong,uncontrolledmovement

patterns

•Poorlycontrolledseizureactivity

•Childrendependentontheuse

ofpercutaneousendoscopic

gastrostomy

•Medicalinstabilityincluding

compromisedrespiratoryor

cardiovascularfunction

•Dependanton3rdpartylife-

sustainingapparatussuchasoxygen

tanks

•Signicantlearningdisabilitiesand/

orbehaviouralissues

Contraindications

Therearenocontraindications

associatedwiththeLeckeySeating

productfamily.

Allprecautionsandcontraindications

aretakenatthediscretionof

theprescribingclinician.Leckey

recommendsatrainedandexperienced

cliniciantobepresentduringtheinitial

assessment,setup,congurationsand

re-issuesinordertominimiserisk.

Kit User Manual p11

SECTION 09:

HOW TO UNPACK AND

ASSEMBLE THE SEATING

SYSTEM AND FIT THE

CUSHIONS

Check parts

CongratulationsonpurchasingyourKit.

Whenopeningthebox,takecarenotto

cutthroughthetapeasyoumaydamage

someofthepartscontainedinside.Allof

thepartswillbecontainedinpolythene

bagswitheachoneclearlylabelled.

Carefullyremovethemfromtheboxes

andcheckallthepartsyouhaveordered.

Someoftheaccessorieswillneedtobe

Safety First

Keeppolythenebagsaway

fromchildren.

assembledbeforeyouattachthemtothe

seatbaseyouhavepurchased.Ifyouare

fittingtheseattoamobilitybase,please

ensureyoufittheinterfaceplatetothe

mobilitybasefirst.Instructionsonhow

toattachtheinterfacetospecificbases

willbeprovidedwiththeinterfaceplate.

Onceyouhavecheckedallthe

componentsyouarereadytoassemble

theKitandattachittoitsbase.Please

followtheordersuggestedasitis

ofteneasiertofitthecushionsbefore

assemblingthehardware.

Tools

Anumberoftheadjustmentswillrequire

theuseofthemulti-tool,T-barallenkey

ora13mmspannerwhichareprovided

witheachseat.

9.1 ATTACHING THE

SEATING SYSTEM TO

THE HI-LOW CHASSIS

Beforeattachingtheseatunittothebase

raisetheheightofthechassistoits

maximumtoreducetheriskofback

strain.

Releasethesafetylockingpinatthefront

oftheseatbypullingthepinAoutand

rotatingitthrough90degrees.Carefully

tilttheseatandplaceitontothe

p12 Kit User Manual

chassis,locatingthechannelB atthe

rearoftheseatoverthetubeattheback

ofthechassisC .PullthehandleD at

thefrontoftheseatunitupandthen

pivottheseatdown.

Oncetheseatisfullylowered,release

thehandleandpushitforwardtoensure

ithasfullyengagedonthefronttube.

RotatethesafetylockingpinAsothatit

engagesinthefrontofthehandle.

Alwayscheckthehandleand

lockingpinarefullyengaged

beforeyouplacetheuser

intheseatingsystem.If

thehandleisnotengaged

properly,theseatunitcan

comelooseandcouldcause

seriousinjurytotheuseror

thecarer.

A

9.2 REMOVABLE

BACKREST SPINE

Theremovablebackrestspinewillbe

detachedforshipping.Insertitintothe

sideplatesoftheseatbase,slippingthe

frontpinAintothefrontslotB onboth

sidesoftheseatbase.Anglethespine

back.PlacethepinC throughthebase

ofthespine.

A

Kit User Manual p13

9.3 FIXED BACKREST

SPINE

Ifthefixedbackrestspineoptionhas

beenordered,simplyrotatethebackrest

intotheverticalpositionandinsertpinA

throughthebaseofthespine.

A

p14 Kit User Manual

9.4 SEAT BASE

CUSHION

FastenthetwopoppersAattheback

oftheseatbase.Pressthecushiondown

ontotheVelcrowhichisontheleg

supportramps.Looptheelasticoverthe

hooksB onthesideoftheseatbase.

A

Fitthesacralcushionoverthehardware

andfastenatthebackwiththepoppers.

Thestandardsacralsupportshouldbe

attachedwiththedoubleflapsAatthe

top.

Toattachthesacralsupport,slidethe

supportontothelowestmounting

bracketonthebackrestspine.Secureit

withaboltB oneitherside.Coverthe

bracketwithaspineupholsteryshroudC .

9.5 SACRAL SUPPORT

A

Kit User Manual p15

Tofitthecontouredsacralsupport

cushion,loosenthelateralsusingthe

screwAonthehinge.Insertlateralsinto

pocketsandfastenpoppersonback.

Slidethesupportontothelowest

mountingbracketonthebackrestspine.

SecureitwithaboltB oneitherside.

Coverthebracketwithaspineupholstery

shroudC .

9.7 CONTOURED

SACRAL SUPPORT

Toattachthehiplateralstothestandard

sacralsupport,loosenthescrewAand

insertthebarofthehiplateralintothe

holeonthesideofthesacralsupport.

Tightenthescrewtosecure.

Toattachthehiplateralcovers,slidethe

coveroverthelateralsupport.

9.6 HIP LATERALS

A

p16 Kit User Manual

9.8 THORACIC

SUPPORT

Fitthecushionoverthehardwareand

fastenatthebackwiththepoppers.

Slidethesupportontothemiddle

mountingbracketonthebackrestspine.

SecureitwithaboltAoneitherside.

Coverthebracketwithaspineupholstery

shroudB .

A

9.9 STANDARD AND

COMPLEX THORACIC

LATERALS

Thestandardandcomplex(horizontal

andvertical)lateralsareattachedinthe

samewaytothethoracicsupport.Before

attachinglaterals,removethethoracic

cushion.Beforeremovingtheboltfrom

thebracketcomponents,makeanoteof

theorderinwhichthepiecesfittogether.

Whileholdingtherestofthecomponents

together,removetheboltandwasher

AwiththeAllentool.Keepingtherest

ofthecomponentstogether,placethe

plasticmouldingintotheslotB .Thebar

shouldgointotherecessofthethoracic

support.Inserttheboltfromtheback

andtighten.Fitthelateralcovers.

A

Kit User Manual p17

9.10 ANGLE

ADJUSTABLE THORACIC

LATERALS

Theangleadjustablelateralsare

attachedtothestandardthoracic

support.Positionthelateralbrackets

overtheslotinthethoracicsupportsand

securewithtwoboltsA.

Fitthecushioncoveroverthehardware

andsecurewiththepoppers.

9.11 SHOULDER

SUPPORT

Tofittheshouldersupportcushion,

loosenthelateralsusingthescrewAon

thehinge.Insertlateralsintopocketsand

fastenpoppersonback.

Slidethesupportontothetopmounting

bracketonthebackrestspine.Secureit

withaboltB oneitherside.Coverthe

bracketwithaspineupholsteryshroud

C .

A

p18 Kit User Manual

9.12 PELVIC CRADLE

FastenthefrontbuckleandsideVelcro

tabsofthePelvicCradle.Ensurethe

“Back”labelAisagainstthebackrest

andthe“Seat”labelB isonthe

seatbasecushion.SticktheVelcrodown

totheseatbasecushion.Attachthefour

sidereleasebucklesC ,twoattheback

oftheseatbaseandtwoattheside.

A

9.13 CHEST PAD

Screwthebucklesontothethoracic

laterals.Attachthechestpadtothe

bucklesA.

Werecommendthatlateralcoversare

alwaysfittedwhenusingthechestpad.

Toattachlateralcovers,slidethemover

thelateralensuringthattheslotisonthe

outsidetoaccessthechestpad

attachmentbuckle.

Kit User Manual p19

9.14 CHEST HARNESS

Toattachthechestharnesstothe

shouldersection,firstremovethecushion

andplasticcover.Feedthewebbinginto

theholesAinthemouldingsandfasten

withthenutsandboltsprovided.Attach

thetopstrapstothesebuckles.Thelower

strapsattachontothebucklesonthe

sacralsupport.Ifthestandardsacral

supportisused,attachthewebbing

throughtheholesB atthetopofthe

mouldingandfastenwiththenutsand

boltsprovided.Ifthecontouredsacral

cushionisused,attachthewebbing

throughtheholesC atthebottomofthe

mouldingandfastenwiththenutsand

boltsprovided.

9.15 HEADREST

Toattachtheheadsupport(Leckey

orOttoBock)slidethestemintothe

receivingbracketAandsecureby

tighteningthescrewB .

A

p20 Kit User Manual

TheKithasbeen

designedtointerfacewitharangeof

othersupportsthatrequireaboxsection

receivingbracket.Insertthebracketbox

sectionintothetopofthespine.Secure

theheadsupportontothisbracket.

Box section bracket

9.16 FEMORAL GABLES

9.17 FOOT SUPPORTS

Femoralgablesareattachedtotheseat

baseusingboltsA.Therearetwobolts

foreachgable.Boltsshouldbefirmly

secured.

LoosenthelegsupportnutsAonthe

undersideoftheseatbasewitha

spanner.Movethelegsupportsforward

oneatatime.Thismakesiteasierto

insertthefootsupports.Openthescrews

B andslideinthefootsupportsfromthe

centre.Retightenthescrews.Reposition

thelegsupportsandretightennuts.

Alwaysmakesurethefoot

supportsareattached

securely.

A

Leckey Kit User manual

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