Leckey Mygo Seat Manuale utente

Mygo Seat -

Size 3

User Manual

Supporting

Children

English

p2 Mygo Seat - Size 3 Stander User Manual

The Mygo Seat - Size 3 has been

designed to offer a high level of postural

positioning while enabling function and

mobility. This manual shows how you can

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.

Mygo Seat - Size 3 Stander User Manual p3

CONTENTS

01 Intended use p.4

02 Certication p.4

03 WarningsandCautions p.5

04 Termsofwarranty p.6

05 Producthistoryrecord p.6

06 Producttrainingrecord p.7

07 Safetyinformation p.7

08 PrecautionsandContraindications p.9

09 Howtounpackandassembletheseat p.10

10 Fittingthecushions p.21

11 Clinicalsetupforposturalmanagement p.26

12 Frequentadjustmentsfordailyuse p.38

13 Cleaning&careinformation p.48

14 Dailyproductinspection p.49

15 Annualproductinspection  p.49

16 ReissuingLeckeyproducts p.51

17 Productservicing p.52

18 Technicalinformation p.53

19 TableofSymbols p.56

p4 Mygo Seat - Size 3 Stander 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

MygoSeat–Size3isamodular

seatingsystemdesignedtocaterfor

theneedsofchildren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.MygoSeat–

Size3hasanapproximateagerange

of10-16years,withamaximum

userweightof70kgs(154lbs).The

congurableposturalsupportoffered

byMygoSeat–Size3isindicatedfor

useforchildrenwithmoderateto

complexposturalneeds(GMFCSIV-V).

SECTION 02:

CERTIFICATION

MygoSeat–Size3isclassied

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!

Mygo Seat - Size 3 Stander User Manual p5

SECTION 03:

WARNINGS AND

CAUTIONS

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.

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.

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.

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.

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.

Caution Trip Hazard with Powered

Chassis:

• Ensurethatbatterycharging

connectionforthepowered

chassisisremovedfromtheseat

beforemovingtheseat.

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’.

p6 Mygo Seat - Size 3 Stander User Manual

Thewarrantyappliesonlywhen

theproductisusedaccordingto

thespecied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 04:

TERMS OF WARRANTY

SECTION 05:

PRODUCT HISTORY

RECORD

YourLeckeyproductisclassied

asaClass1Medicaldeviceandas

suchshouldonlybeprescribed,

setuporreissuedforuse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setups,reissue

inspectionsandannualinspectionsof

thisproduct.

Caution Cleaning Power Washer/

Hose:

• Donotusehosesorpower

washersontheframe

components,theelectricseat

liftsystemisnotsealedagainst

runningwaterandmaybe

damagedbywateringress.

Seesection‘Cleaning&care

information’.

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.

Caution Disposal

• Onlydisposeoftheseatina

communitywastedisposalsite

andensurethattheelectrical

componentsareremovedfor

separatedisposal.

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.

Mygo Seat - Size 3 Stander User Manual p7

(Parents, Teachers & Carers)

YourLeckeyproductisaprescribed

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7:SafetyInformation

Section12:FrequentAdjustmentsfor

DailyUse

Section13:Cleaning&Care

Information

Section14: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.

SECTION 06:

PRODUCT TRAINING

RECORD

1. Alwaysreadinstructionsfully

beforeuse.

2. Toimprovesafetywerecommend

thatusersshouldnotbeleft

unattendedatanytimewhilst

usingLeckeyequipment.

SECTION 07:

SAFETY INFORMATION

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Leckeyproduct

orifanypartsshouldfail,please

ceaseusingtheproductand

contactourCustomerCareTeam

oryour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the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puttingtheuserintoa

seatingsystem,bothforpositional

andsafetyreasons,alwayssecure

thepelvicharnessrst.

7. Whentheproductisstationary

ensurethatallcastorsarelocked

andfacingawayfromthebase,as

thiswillimprove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aHi-

lowchassispleaseensurethatthe

heightadjustmentpedalandtilt-

in-spaceleverarelockedoffand

cannotbeadjustedaccidentally

p8 Mygo Seat - Size 3 Stander User Manual

byotherchildren.

9. WhentheLeckeyseatsareused

ontheHi-lowchassiswedonot

recommendthatusersaremoved

overunevensurfaceswhenin

theequipment.Allduecare

andattentionshouldbetaken

iftransportinginandoutofthe

seat.

10. Neverleavetheproductona

slopingsurface,greaterthan5

degrees.Alwaysremembertolock

allthecastors.

11. Onlyusethepushhandletosteer

andmovetheseatfromonearea

toanother.Neverusethetrayor

headrestforthispurpose.

12. Theproductcontainscomponents

whichcouldpresentachoking

hazardtosmallchildren.Always

checkthatlockingknobsand

boltswithinthechild’sreachare

tightenedandsecureatalltimes.

13. Leckeyproductscomplywith

resaftey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andgas

heaters.

14. Donotplaceobjectshotterthan

40˚Conthetray.

15. Cleantheproductregularly.

Donotuseabrasivecleaners.

Carryoutmaintenencechecks

onaregularbasistoensure

yourproductisingoodworking

condition.

16. Theproductisdesignedforindoor

useandwhennotinuse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degCelsius.

17. Alwayschecktheplastichand

knobsonthepushhandleare

tightenedsecurelybeforeyou

movetheseatunit.

18. Beforeusingtheseatalways

checkthattheinterfacehandleon

theseatunitisfullyengagedwith

thechassis.Ifthehandleisnot

engagedproperlytheseatunit

maycomelooseandcouldcause

seriousinjurytothechildorcarer

19. Pleasebeawareofthegapon

theundersideoftheTraywhere

achildcouldinserttheirnger

betweenthemetalbracketand

thebaseoftheplastictray.

Crash Test

TheMygoSeat-Size3Shasbeen

crashtestedandpassedforuse

invehicles.Ithasbeentestedin

itscompletecongurationona

surrogatebasewithaLeckeyhead

supportattached.

IftheMygoSeat-Size3isbeingused

inavehiclethefollowingpointsmust

Mygo Seat - Size 3 Stander User Manual p9

beadheredto:

TheMygoSeat-Size3mustbe

positionedforwardfacingandused

withanUnwinRestraintSystemand

aheadsupportwhichshouldbe

suitablypositionedatalltimesduring

transportation.Theheadsupportis

availableasanoptionalaccessory

withtheMygoSeat-Size3.

TheMygoSeat-Size3iscrashtested

andmeetstherequirementsof

ISO16840part4.Forfurtherdetails

pleasecontactourCustomerCare

Team.

Important

Thesecrashtestdetails

refertotheMygoSeat-

Size3andinterfaceplate

only.Ifyouareusingthe

MygoSeat-Size3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

theMygoSeat-Size3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

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

p10 Mygo Seat - Size 3 Stander User Manual

SECTION 09:

HOW TO UNPACK

AND ASSEMBLE

Check parts

Congratulationsonpurchasingyour

MygoSeat-Size3.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.

Safety First

Keeppolythenebagsaway

fromchildren.

Someoftheaccessorieswillneed

tobeassembledbeforeyouattach

theseattothebaseyouhave

purchased.Ifyouarettingtheseat

toamobilitybasepleaseensureyou

ttheinterfaceplatetothemobility

baserst.Instructionsonhowto

attachtheinterfacetospecicbases

willbeprovidedwiththeinterface

plate.Onceyouhavecheckedallthe

componentsyouarethenreadyto

assembletheMygoSeat-Size3and

attachittoitsbase.

Thebackrestwillbefoldeddownfor

shipping.Raiseitintothevertical

positionand,whiledoingso,slide

theinnertubeintothereceiving

outertube.Securethebackrestin

anuprightpositionandtightenthe

socketcap.Checkthatitissecure

anddoesnotmovewhenpressureis

applied.Iftheuserthrustsforwardor

backwardstheycouldcauseinjuryto

themselvesortheircarers.

9.1 SETTING THE

BACKREST

• 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.

Indice

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