Use Instructions

SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page6of79
Chapter2.Introduction
2.1.Indicationsforuse
TheGEMS‐Hisaroboticexoskeletonthatfitsorthoticallyonthewearer’swaistandthigh,outsideofclothing.The
deviceisintendedtohelpassistambulatory function inrehabilitationinstitutesunderthesupervisionofa trained
physicaltherapistforthefollowingpopulation:
 Individualswithstrokewhohavegait deficitsandexhibitgaitspeeds ofatleast0.4 m/sandareableto
walkatleast10meterswithassistancefromamaximumofoneperson.
Thetrainedphysicaltherapistmustsuccessfullycompleteatrainingprogrampriortouseofthedevice.Thedeviceis
notintendedforsports.
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2.2.Training
TheGEMS‐HshouldbeusedonlybymedicalpersonnelwhohavereceivedspecifictrainingprovidedbySamsung,Inc.
intheuseofthisdevice.TrainingprovidedbySamsungislimitedtotheuseoftheGEMS‐Handdoesnotreplacethe
necessarymedicaltrainingandexperiencerequiredtoperformrehabilitation.
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2.3.Safeenvironments
The GEMS‐H isintended to beused under the supervision of a trained physicaltherapist in all use environments.
Suitableuseenvironmentsinclude:
 Hospital’sinternalfacilities(indooronly):arehabilitationtreatmentroom,hospitalhallway,orgaitanalysislab
 Surfacetype:smooth,cement,carpet,transitions,thresholds
 Stairsofheightlessthannine(9)inches
 Surfacesinclinedat5degreesorfewer
 Treadmills
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