Leckey Freestander User manual

Freestander
User Manual
Supporting
Children
English

p2 Freestander User Manual
The Leckey Freestander has been designed
to promote weight bearing and mid line
symmetry. This manual shows you how you
can quickly and easily make use of all of the
functions. The instructions on the safety and
maintenance of the product will ensure that
you will enjoy it for a long time.

Freestander 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Record
07 SafetyInformation
08 PrecautionsandContraindication
09 Howtounpackandassemble
10 Clinicalsetupforposturalmanagement
11 Frequentadjustmentsfordailyuse
12 Cleaning&careinformation
13 Dailyproductinspection
14 Annualproductinspection
15 ReissuingLeckeyproducts
16 Productservicing
17 Technicalinformation
18 TechnicalDetails

p4 Freestander User Manual
SECTION 01:
INTENDED USE
Intended use
Thedevicesareintendedtoassist
childrenthatcannotstandormaintain
astandingpositionindependentlyas
partofasupportedweightbearing
program.
Indications for use
Freestanderhasbeendesignedfor
usedathomeorinschoolforupright
standing.Thestanderisavailable
inthreesizescateringfortheneeds
ofchildrenfromtheageof1-18.
Size1hasamaximumuserweight
amaximumuserweightof60kgs
(132lbs),size280kgs(176lbs)andthe
size390kgs(198lbs).Suitablefor:
• Childrenandadultswithdisabilities
suchasCerebralPalsy,traumatic
braininjuries,musculardystrophyand
otherconditionswheresupported
standingprogramsareencouraged.
• Childrenpresentingwith
developmentaldelaywhoare
currentlynon-ambulating.
• Childrenwhereearlyinterventionis
indicated.
SECTION 02:
CERTIFICATION
TheFreestander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!

Freestander User Manual p5
SECTION 03:
WARNINGS AND
CAUTIONS
1) WARNING TOPPLING HAZARD
•Neverusetheproductonasloping
surfacegreaterthan5degrees.
•Alwayscheckoperationoflineardrives,
gasstruts,andmotordrivesbeforeuse.
•Whenadjustingthestanderangle
ensurethereisadequateaccessspace
onallsidesoftheproduct.
•Alwayslockcastersfacingoutwards
beforeplacingtheuserintheproduct.
2) WARNING FINGER TRAP HAZARD
•Ensurethattheuserorcarerdoesnot
touchanymovingjointorpivotthatis
notlocked.
•Whiletheuserisintheproduct,the
carershouldstrivetokeepproduct
adjustmentstoaminimum.
3) WARNING OCCUPANT SECURITY
•Usertransfersinandoutof
theproductmustbedonewith
appropriateequipmentand
personnel.
•Whentransferringtheuserintothe
product,rstusethepelvicbandto
securetheuser.
•Ensurethatallharnesses,sandal
strapsandchestpadaresecurely
applied.
•Iftheuserexhibitsanyformof
distress,removefromtheproductas
quicklyasissafelypossible.
4) CAUTION FINGER PINCH HAZARD
•Whiletheuserisintheproduct,the
carershouldstrivetokeepproduct
adjustmentstoaminimum.
•Takecarewhenassemblingor
adjustingthepositionofthestander
componentsthatyourngersdo
notgetpinchedwhenpositioning
standercomponentsandtightening
mountings.
•Duringproductassemblyand
adjustment,thecarershouldavoid
ngerpinchingriskoftheproduct’s
jointsorpivots.
•Duringtransfersandadjustments,the
carershouldavoidthengerpinching
riskofover-centrebucklesandlatches.
5) CAUTION DAILY CHECKS
•Thestanderistobecheckeddaily
beforeusetoensurethatallharnesses
andstandercomponentsaresecurely
attached.
•Alwayscheckoperationoflineardrives,
gasstruts,andmotordrivesbeforeuse.
6) CAUTION TRIP HAZARD WITH
POWERED CHASSIS
•Beforemovingapoweredstander
ensurethatbatterycharging
connectionisremoved.
7) CAUTION CLEANING
•Cleanthestanderregularlytoprevent
thebuild-upofdirt.Accumulated
dirtcanprematurelywearthefabric
componentsandencouragecorrosion
onthestander.Onlyusenon-abrasive

p6 Freestander 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.
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
•Hosesandpowerwashersarenotto
beusedtocleantheproduct.Standers
withtheelectricliftsystemarenot
sealedagainstrunningwaterandmay
bedamagedbywateringress.See
sectionCleaning&CareInformation.
9) CAUTION SERVICING/REPAIR OF
ELECTRONIC COMPONENTS
•Allelectronicandelectrical
componentsareNOTuser-serviceable.
Servicingandrepairsareonlytobe
carriedoutbyLeckey-authorised
personnel.
10) CAUTION DISPOSAL
•Whendisposingoftheproductusing
acommunitywastedisposalsite,the
frameandanyelectricalcomponents
shouldbedisposedofseparately.
11) CAUTION BRINGING INTO USE
•Beforeuse,allow2hoursforthe
producttoacclimatisetoroom
temperature.

Freestander User Manual p7
SECTION 07
SafetyInformation
SECTION 11
FrequentAdjustmentsforDailyUse
SECTION 12
CleaningandCareInformation
SECTION 13
DailyProductInspection
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 06:
PRODUCT TRAINING
RECORD
(PARENTS, TEACHERS & CARERS)
SECTION 07:
SAFETY INFORMATION
1. Alwaysreadinstructionsfully
beforeuse.
2. 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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. Wewouldrecommendthatusers
arenevertransferredstraight
fromseatingtostandingwithout
preparationandstretching.Thisis
bestdonewhilstlyingonamatbut
canbecarriedoutinawheelchair
orseatingsystemifrequired.
6. Carryoutallpositionaladjustments
andensurethattheyaresecurely
fastenedbeforeyouputtheuser
intothisproduct.
7. Whenplacingtheuserintoa
standingframe,forsafetyreasons,
alwayssecurethepelvicbandrst.
Leckeyrecommendthatawritten
recordismaintainedofallthosewho
havebeentrainedinthecorrectuseof
thisproduct.

p8 Freestander User Manual
Thechestandkneestrapsshould
thenbefastened.
8. Whentheproductisstationary
ensurethatallcastorsarelocked
andfacingawayfromthebaseas
thiswillimproveproductstability.
9. Neveradjusttheoverallheightof
theFreestanderwhiletheframe
isinuse.Othernerpositional
adjustmentsmaybecarriedout
safelywhentheuserisinthe
frame.
10. Neverleavetheproductona
slopingsurface,greaterthan5
degrees.Alwaysremembertolock
allthecastors.
11. 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.
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ofgreater
than40degreesonto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. 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.

Freestander User Manual p9
Contraindications
• Childrenexperiencingpainor
discomfortthatcannotberesolvedby
adjustmentofsupport/positioning
• Childrenwithhip/kneeflexion
contracturebeyondthelimitsofthe
stander
Allprecautionsandcontraindications
aretakenatthediscretionofthe
prescribingclinicianorparent.
Leckeyrecommendsatrainedand
experiencedcliniciantobepresent
duringallinitialassessment,set
ups,configurations,andreissuesto
minimiserisk.
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

p10 Freestander User Manual
SECTION 09:
HOW TO UNPACK
AND ASSEMBLE
Check parts
Congratulationsonpurchasingyour
LeckeyFreestander.Whenyoureceive
yourFreestanderitwillbeboxed
andwrappedinseveralparcels.Your
Freestandercomesasstandardwith
chestplateincludingexiblelaterals,
kneeplate,pelvicstrap,activitytray
andbowl,basewithcastors,inner
polesandsandals.
TheTotstanderissuppliedwithout
castors,trayandwithacheststrap
insteadofasolidchestplate.Carefully
removealltheparcelsfromthebox
andcheckyouhaveallthepartsyou
haveordered.
Safety First
Keeppolythenebagsaway
fromchildren.
9.1 ASSEMBLING THE
FREESTANDER
ToassembleyourFreestander,rstly
loosentheheightadjustmentbolt’son
A theouteruprightpolesandremove
theinnerpoles.
Inserttheinnerpolesintoplaceinto
thereceivertubesonthebasecastor
frame.Theallenkeyprovidedtighten
thetwosmallsocketscrewsoneach
receivertubesecurely B .
Thenslidethemainouterframeover
theinnerpolesandtightenthetwo
heightadjustmentboltsC atthe
desiredheight.
A