User Manual

p4 Pronestander 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
Pronestanderhasbeendesignedfor
useathomeorschool.Therange
ofproneanglesavailableallowthe
gradualincreasesofweightbearing
astoleranceincreases.Pronestander
isintendedforchildrenfromtheages
1-17years.Suitablefor:
• Children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Pronestander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!