Leckey Mygo Seat User manual

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.