Leckey Mygo User manual

Mygo Max
User Manual
Supporting
Children
English

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The Mygo Max 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 of the functions. The
instructions on safety and maintenance will
ensure that you will enjoy the use of the
product for a long time.

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CONTENTS
01 Intended Use
02 Certication
03 WarningsandCautions
04 TermsofWarranty
05 ProductHistoryRecord
06 ProductTrainingRecord
07 SafetyInformation
08 PrecautionsandContraindications
09 HowtoUnpackandAssemble
10 FittingtheCovers
11 ClinicalSetupforPosturalManagement
12 FrequentAdjustmentsforDailyUse
13 CleaningandCareInformation
14 DailyProductInspections
15 AnnualProductInspections
16 ReissuingLeckeyProducts
17 TechnicalInformation

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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
TheMygoMax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.Thereisonesize;with
anapproximateagerangeof12-18
yearswithamaximumuserweight
of85kgs(187lbs).Theconfigurable
posturalsupportofferedbytheMygo
Maxisindicatedforuseforchildrenand
youngadultswithmoderatetocomplex
posturalneeds(GMFCSIV-V).
SECTION 02:
CERTIFICATION
MygoMax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!
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 Pinch Hazard
• Takecarethatthefingersofthe

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operatororchildrenonthefloor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fingers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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
first.Wipeoffanymoisturethathas
condensedontheproduct.

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SECTION 05:
PRODUCT HISTORY
RECORD
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 07 Safety Information
Section 12 Frequent Adjustments for
Daily Use
Section 13 Cleaning and 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
(PARENTS, TEACHERS & CARERS)
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.
YourLeckeyproductisclassified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.

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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.
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
servicesdepartment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Leeway
PelvicCradle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byother
children.
9. WhentheLeckeyseatingsystems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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
SECTION 07:
SAFETY INFORMATION

Mygo Max User Manual p8
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40oC
onthetray.
15. If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byotherchildren.
16. 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.
17. 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.
18. Alwayschecktheplastichandknobs
onthepushhandlearetightened
securelybeforeyoumovetheseatunit.
19. Beforeusingtheseatingsystem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.
MEDICAL DEVICE COMBINATIONS
ItmaybepossibletocombineMygoMax
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

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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
• Significant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,
configurationsandre-issuesinorderto
minimiserisk.

Mygo Max User Manual p10
SECTION 09:
HOW TO UNPACK
AND ASSEMBLE THE
SEATING SYSTEM
Check parts
Congratulationsonpurchasingyour
MygoMax.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.