Samsung GEMS-H User manual
GEMS‐H
InstructionsforUse
Publishingdetails
GEMS‐HPoweredLowerExtremityExoskeleton,Instructionsforuse
DocumentNo.:SAIT‐IFU‐GEMS‐H
RevisionNo.:1.1
Revisiondate:2019.11.05
Applicationversion:1.4
Manufacturer
SamsungElectronicsCo.,Ltd.
129, Samsung‐Ro,Yeongtong‐Gu,
Suwon‐Si,Gyeonggido,RepublicofKorea,16677
+82‐31‐8061‐1114
www.samsung.com
Copyright
This document is protected by copyright. All rights reserved. Notably, no portion of this publication may be
reproduced or made available to third parties, in any form, online or offline, without the written consent of
SamsungElectronicsCo.,Ltd.Further,noportionofthispublicationmaybetranslatedintoalanguageorcodethat
canbeutilizedformachines,inparticular,dataprocessingsystems,or
theinternet.Thisdocumentmayexclusively
beusedtoproperlyusetheproductsdescribedhereinin accordancewiththecontractual termsforsuchproduct.
Copyright©2019SamsungElectronicsCo.,Ltd.
TableofContents
Chapter1.General...................................................................................................................................................5
1.1.Abouttheseinstructionsforuse...............................................................................................................................5
1.2.Explanationofsymbols.............................................................................................................................................5
Chapter2.Introduction.............................................................................................................................................6
2.1.Indicationsforuse....................................................................................................................................................6
2.2.Training.....................................................................................................................................................................6
2.3.Safeenvironments....................................................................................................................................................6
2.4.Intendeduserprofile.................................................................................................................................................7
2.5.Operatingprinciple...................................................................................................................................................7
2.6.Contraindications......................................................................................................................................................7
Chapter3.Safety......................................................................................................................................................9
3.1.Symbols.....................................................................................................................................................................9
3.2.Safety......................................................................................................................................................................10
3.3.Safetystandards.....................................................................................................................................................12
3.4.Environmentalconditions.......................................................................................................................................13
3.5.Disposal..................................................................................................................................................................13
3.6.Patientenvironment...............................................................................................................................................13
Chapter4.Devicedescription..................................................................................................................................14
4.1.Packagecontents....................................................................................................................................................14
4.2.Deviceoverview......................................................................................................................................................16
4.3.Accessory:waistextensionbelt..............................................................................................................................17
4.4.Accessory:thighsupportframe..............................................................................................................................17
4.5.Accessory:thighsupportstrap...............................................................................................................................18
4.6.Markingplate.........................................................................................................................................................19
Chapter5.Preparation............................................................................................................................................20
5.1.Devicefittingprocedure.........................................................................................................................................20
5.2.Determinethewaistpartsize.................................................................................................................................21
5.3.Adjustthewaistpartwidth....................................................................................................................................23
5.4.Wearthewaistbelt&fastenthighsupportframes...............................................................................................24
5.5.Fastenboththighsupportstraps............................................................................................................................26
5.6.Waistpartposition.................................................................................................................................................28
5.7.Checkpriortouse/operationofthedevice.............................................................................................................29
Chapter6.Operatingthedevice.............................................................................................................................30
6.1.Turnonthedevice..................................................................................................................................................30
6.2.OpeningandclosingtheGEMS‐Happlication........................................................................................................31
6.3.Loginscreen............................................................................................................................................................33
6.4.OverallGEMS‐Huserinterface...............................................................................................................................35
6.5.The‘PatientInfo’tab..............................................................................................................................................36
6.6.The‘DeviceConnect’tab........................................................................................................................................39
6.7.The‘DeviceControl’tab..........................................................................................................................................40
6.8.Safetyfeatures........................................................................................................................................................53
Chapter7.Shutdown..............................................................................................................................................59
7.1.Stoptheassistance.................................................................................................................................................59
7.2.Turnoffthedevice..................................................................................................................................................59
7.3.Howtotakeoffthedevice......................................................................................................................................60
Chapter8.Maintenance..........................................................................................................................................61
8.1.Storage...................................................................................................................................................................61
8.2.Regularmaintenance(WeeklyChecklist)...............................................................................................................62
8.3.Cleaning..................................................................................................................................................................62
8.4.HowtochargetheGEMS‐H....................................................................................................................................63
Chapter9.Troubleshooting.....................................................................................................................................65
9.1.Troubleshooting......................................................................................................................................................65
9.2.Devicemessages.....................................................................................................................................................66
Chapter10.Technicalspecifications.........................................................................................................................70
10.1.Specifications........................................................................................................................................................70
10.2.EMC(ElectromagneticCompatibility)...................................................................................................................72
Chapter11.Clinicalstudies......................................................................................................................................77
11.1.Introduction..........................................................................................................................................................77
11.2.Adverseevents......................................................................................................................................................77
11.3.Summaryofstudies..............................................................................................................................................78
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page5of79
Chapter1.General
1.1.Abouttheseinstructionsforuse
TheseinstructionsforuseprovidetheinformationnecessarytooperatetheGEMS‐Hdevice. PLEASE READ THESE
INSTRUCTIONS FOR USE BEFORE OPERATING THE SYSTEM.Ifanypartoftheseinstructionsforuseisnotclear,
pleasecontactCustomerSupportforassistance.
1.2.Explanationofsymbols
Safetynotes
Safetynotesintheseinstructionsforuseareintroducedwithasymbolandasignalwordtodescribetheseverityof
thehazard.
Followthesesafetynotesandproceedwithcautiontoavoidaccidents,personalinjury,damagetoproperty,andto
ensurepatient
safety.
Safetynotes Meaning
This symbol and the word “WARNING” indicate a possible hazardous
situationthat,ifnotavoided,couldcausedeathorseriousinjury.
Thissymbolandtheword“CAUTION”indicateapossiblehazardoussituation
that,ifnotavoided,couldresultinminorormoderateinjury.
Thissymbolandtheword“NOTICE”indicateapossiblehazardoussituation
that,ifnotavoid,couldresultindamagetopropertyortheenvironment.
Hints,recommendations
Symbol Meaning
This symbol emphasizes useful tipsandrecommendationsaswellas
informationfortheefficientandtrouble‐freeuseoftheproduct.
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page6of79
Chapter2.Introduction
2.1.Indicationsforuse
TheGEMS‐Hisaroboticexoskeletonthatfitsorthoticallyonthewearer’swaistandthigh,outsideofclothing.The
deviceisintendedtohelpassistambulatory function inrehabilitationinstitutesunderthesupervisionofa trained
physicaltherapistforthefollowingpopulation:
Individualswithstrokewhohave gaitdeficitsandexhibit gait speedsofatleast 0.4m/sandare ableto
walkatleast10meterswithassistancefromamaximumofoneperson.
Thetrainedphysicaltherapistmustsuccessfullycompleteatrainingprogrampriortouseofthedevice.Thedeviceis
notintendedforsports.
2.2.Training
TheGEMS‐HshouldbeusedonlybymedicalpersonnelwhohavereceivedspecifictrainingprovidedbySamsung,Inc.
intheuseofthisdevice.TrainingprovidedbySamsungislimitedtotheuseoftheGEMS‐Handdoesnotreplacethe
necessarymedicaltrainingandexperiencerequiredtoperformrehabilitation.
2.3.Safeenvironments
The GEMS‐H is intended to be used under the supervision of a trained physical therapist in all use environments.
Suitableuseenvironmentsinclude:
Hospital’sinternalfacilities(indooronly):arehabilitationtreatmentroom,hospitalhallway,orgaitanalysislab
Surfacetype:smooth,cement,carpet,transitions,thresholds
Stairsofheightlessthannine(9)inches
Surfacesinclinedat5degreesorfewer
Treadmills
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page7of79
2.4.Intendeduserprofile
Occupation • Physicaltherapists
Education • Earnedadegreeinphysicaltherapyandobtainedacurrentphysicaltherapistlicense.
Experience/
Abilities
• FamiliarwiththeapplicationofthetabletPC.
• BeabletosetuptheBluetoothcommunicationbetweenthedeviceandthetabletPC.
• CompleteatrainingprogramprovidedbySamsungonhowtousethedevice.
2.5.Operatingprinciple
GEMS‐Hisa wearablepoweredexoskeletonthatactivelyassistsindividualstowalk.TheGEMS‐Hconsistsof snap‐
together components weighing 4.7 lbs (2.1 kg) in total. The waist part houses two actuator modules, a Bluetooth
module,andacontrolpack.Eachactuatormodulehousesamotoraswellasanembeddedangularpositionsensor
andcontroller.Inthecontrolpack,there isacentralprocessor, anIMUsensor,arechargeablebatterypackanda
powerswitch.
TheGEMS‐Hhastheabilitytoassistwearers’walking.TheGEMS‐HhasonlyoneWalkAssistmode,whichisoperated
basedontheDOC(DelayedOutputControl)algorithm.IntheDOCalgorithm,anon‐boardmicroprocessorreceives
signalsfrom integratedsensors which provide information on the patient’sjoint angles. The sensorsin the device
detect the hip joint angle and associated angular velocity fromthepatient’sgait,basedonwhichthecentral
processordeterminestheoptimalassistivetorqueoutput.Theactuatormodulethentransmitstheassistiveforceto
thepatient’shipjointtoreducethephysicaleffortinwalking.
FCCinformation:
‐Frequencyrange&Numberofchannels:2402㎒~2480㎒_Bluetooth(79ch)
‐Modulation:GFSK,π/4DQPSK,8DPSK
‐Max.Tune‐uppower:0.5dBm
2.6.Contraindications
Severeconcurrentmedicaldiseases:infections,circulatory,heartorlung,pressuresores
Lowerextremityfracture
Heterotopicossificationorsevereosteoporosis
Psychiatricorcognitivesituationsthatmayinterferewithproperoperationofthedevice
Pregnancy
Forpatientswithaweightof100kg(220lb)ormore,orBMI≥35kg/m2,useoftheGEMS‐Hisnotprohibited,butthe
GEMS‐Hmayonlybeusedforthosepatientsaftercarefulconsultationwithmedicalprofessionals.
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page8of79
Forfurtherinformationwithregardtotheclinicalstudies,referto“Chapter11.Clinicalstudies”.
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page9of79
Chapter3.Safety
3.1.Symbols
Symbol Meaning
Serialnumber
Manufacturerinformation
Manufacturedate
TypeBappliedpart
Followinstructionsforuse
Non‐ionizingelectromagneticradiation
Degreeofprotectionagainstparticulatematter
Caution:Federallawrestrictsthisdeviceforsalebyoronthe order of a
physician
This mark is a Nationally Recognized Testing Lab (NRTL) markingand
indicatesconformancewithUL60601‐1.
Fragile
Keepdry
Temperaturelimit
Atmosphericpressurelimitation
Humiditylimitation
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page10of79
3.2.Safety
Riskofelectricalshockhazardandperformancedegradationifthisequipmentismodified!
Unauthorizedmodificationofthisequipmentcanaffectthesafetyandeffectivenessoftheequipment.
‐ Donotmodifythisequipmentwithoutauthorizationofthemanufacturer.
Riskofseriousinjuryduetomisuse!
Useofthedevicewithouttrainingcanresultinseriousinjurytothepatient.
‐ UsersmustsuccessfullycompleteatrainingprogramprovidedbySamsungpriortouseoftheGEMS‐H.
Riskofseriousinjuryduetouseofthedeviceinimproperenvironments!
Useofthedeviceinenvironmentsnotrecommendedbythemanufacturermayresultininjurytothepatient.
‐ Do not use in improper environments (e.g., on the sand, in stony areas, or any surface that is not
recommendedbymanufacturer).Refertosection2.3Safeenvironments.
Riskofseriousinjurytothepatientwhoisdistractedorcannotpayattentiontotasks!
Ifthepatientisdistractedorusesthedevicewithoutcaution,itcouldresultinlossofbalanceandpossibleinjury.
‐ TheGEMS‐Hmustbeusedundersupervisionofatrainedphysicaltherapist.
‐ Theusershouldceaseusingthisdevicewithpatientswhoaredistractedorcannotpayattentiontothe
tasks.
Riskofseriousinjuryduetomisuse!
Useofthedevicewithoutfittingandcustomizingcanresultinseriousinjury(e.g.,fracture)tothepatient.
‐ TheGEMS‐Hmustbefittedtoeachpatientproperlybyatrainedphysicaltherapist.
‐ Softwaresettingsmustbecustomizedforeachpatientbyatrainedphysicaltherapist.
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page11of79
Riskofseriousinjurytothepatientduetolossofcontrol!
Shouldthetherapistlosecontrolofthedevice,orifadeviceisusedwithoutthesupervisionofthetrained
physicaltherapists,thismayresultinthepatienthavingdifficultybalancingandpotentiallyfallingwhileusing
thedevice.
‐ Atleastonetherapistshouldmonitorpatientsatalltimeswhilethedevicesareturnedonand/orwhilethe
patientsarewalking.
Riskofseriousinjurytothepatientbypotentiallyfallingduetoadevicemalfunction!
Shouldthedevicemalfunction,the12Nmtorqueprovidedbythedevicemaysuddenlystop.Thismayresultin
thepatienthavingdifficultybalancing,andpotentiallyfalling.
‐ Inordertopreventmalfunctions,usersshouldmakesurethatthedevicehasbeenmaintainedaccordingto
specificationsandthatthesoftwareisinworkingorderpriortouse.
‐ Usersmayconductrehabilitationwithagaitbeltoraharness(e.g.,bodyweightsupportsystem)and
assistivedevicessuchascaneorawalkerasneeded.
Riskofseriousinjurytothepatientduetoimproperfittingorfittingtootightly!
Skinabrasions,includingdiscomfort,skinpressure/friction,bruising,pain,orunusualswelling,mayresultfrom
thedevicebeingimproperlyfittedorfittedtootightly.
‐ Thedevicemustbefittedoverclothingtopreventskinabrasions.
‐ Whenputtingonthedevice,thethighsupportstrapsshouldbefittedwiththekneesslightlybenttoavoid
excessivetighteningorpressing.
‐ Usersshouldexaminethediscomfortandskinpressureofthepatient.
‐ Careshouldbetakentoavoidpinchingskinwhenfittingthedevice.
Riskofmusclesorenesstothepatientduetoexcessiverehabilitation!
Shouldthepatientperformdynamicandcomplextrainingatthefirsttimeofuse,thismayresultinmuscle
sorenessafterthetrainingsession.
‐ Patientsshouldstartwithsimpleactivities,thenincreasetheintensityofthetrainingincludingmore
dynamicandcomplexactivities.
‐ Patientsshouldbeprovidedwithadequaterestperiodsandaskedaboutdiscomfortregularly.
Riskofinjurytothepatientanddevicedamageduetopressingonthepatient'sbody!
Ifthepatientopensthelegexcessivelytothesidewhilewearing,itmaycausediscomfort,skinpressure,and/or
devicedamage.
‐ Donotopenthelegexcessivelytothesidewhilewearing.
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page12of79
Riskofinjurytothepatientanddevicedamageduetosittingandleaningbackwardonasurfacewhilewearing
thedevice!
Ifthepatientwearingthedevicesitsandleansbackontoasurface(e.g.,chair),itmaycausediscomfort,skin
pressure,and/ordevicedamage.
‐ Donotleanbackwardontoasurfacewhilewearingthedeviceandsitting.
Riskofinjurytothepatientduetoskinpressure!
Ifthepatienthassomethingintheirpocketsoriswearingabeltwhilewearingthedevice,thismaycause
discomfortandpressureonthepatient'sbody.
‐ Beltsshouldberemovedpriortoputtingonthedevice.
‐ Pocketsshouldbeemptiedpriortoputtingonthedevice.
Riskofpotentiallyfallingduetousingdischargedbattery!
Useofthedevicewithalowbatterymayresultinthedevicemaysuddenlyturningoffduringrehabilitation
whichstopstheassistiveforce.Thismayresultinthepatienthavingdifficultybalancingandpotentiallyfalling.
‐ Toensurecontinuouspowerduringuse,alwayschargethebatteryattheendofeachtrainingsession.
‐ Whenthebatterylevelisbelow20%,chargethebatterywithin5minutes.
Riskofelectricalshockhazardandperformancedegradationwhenthedeviceisdropped!
Shouldthedevicebedroppedduringuse,itcanaffectthesafetyandeffectivenessoftheequipment.
‐ Stopusingitimmediatelyandreportthesituationtothemanufacturer.
3.3.Safetystandards
TheGEMS‐Hconformstothefollowinginternationalstandards:
• IEC60601‐1:2005+A1:2012
• IEC60601‐1‐2:2014
• IEC60601‐1‐6:2010+A1:2013
• IEC62366‐1:2015
• IEC62304:2006
• ISO15223‐1:2012
• ISO14971:2007
• ISO13485:2016
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page13of79
3.4.Environmentalconditions
Operation Storage&Transport
Temperature 32℉to86℉(0℃to30℃) ‐77℉to158℉(‐25℃to70℃)
Humidity 30to85%(non‐condensing) 10to94%(non‐condensing)
Pressure 700hPato1060hPa 500hPato1060hPa
3.5.Disposal
Thisdevicecontainselectricalandelectronicequipmentwaste,whichmustbedisposedofseparatelyfromunsorted
municipal waste. Please contact the manufacturer or an authorized disposal company to decommission your
equipmentaccordingtolocalregulations.
3.6.Patientenvironment
Partwithinthepatientenvironment Device,TabletPC
Partoutsidethepatientenvironment Devicecharger,TabletPCcharger
ThedevicechargerthatsuppliesthepowerseparatelyisspecifiedasaME(MedicalElectrical)system.
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page14of79
Chapter4.Devicedescription
4.1.Packagecontents
TheGEMS‐Hsalespackagecontainsthefollowingitems:
Waistpart(Sizes:S,M,L)
Thighsupportframe(Sizes:S,M)
Thighsupportstrapwithbuckles(Sizes:S,M,L)
TabletPC
TabletPCcase
Devicecharger
TabletPCcharger
Hipwidthruler
Extensionbelt
Torquewrench
Storagecase
Instructionsforuse
Dependingonthewearer’ssize,thesecomponentsareusedincombination.Forsafestorage,placetheGEMS‐Hin
thecaseaftereachuse.
Waistpart(Sizes:S,M,L) Thighsupportframe(Sizes:S,M)–left/right
Thighsupportstrapwithbuckles(Sizes:S,M,L)–
left/right TabletPC
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page15of79
Devicecharger TabletPCcharger
Hipwidthruler Extensionbelt
Torquewrench Storagecase
TabletPCcase(optional) Instructionsforuse
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page16of79
4.2.Deviceoverview
No. Parts Description
1Controlpack Computingunitandbuilt‐inbattery
2Battery Powersupplier
3Powerswitch PowerON/OFFswitch(switchup:ON,switchdown:OFF)
4Waistbelt Waistbelt
5Actuatormodule Motorandreductiongearsforgeneratingtheassistiveforce
6Thighsupportframe Rigidframedeliveringtheassistiveforcetothewearer’sthigh
7ThighsupportstrapFasteningstrapconnectingthethighsupportframeandtothewearer’sthigh
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page17of79
4.3.Accessory:waistextensionbelt
Theextensionbeltmaybeusedtoincreasethelengthofthewaistbeltby5.9inches(150mm).Itisusedwhenthe
waistbeltofthedeviceistooshorttofastencompletelyandcomfortablyaroundthepatient’swaist.
4.4.Accessory:thighsupportframe
Smallsize Mediumsize
Length,inches(mm) 9.1(230)10.0(255)
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page18of79
4.5.Accessory:thighsupportstrap
Smallsize Mediumsize Largesize
Length,inches(mm) 14.2(360)16.1(410)17.7(450)
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page19of79
4.6.Markingplate
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page20of79
Chapter5.Preparation
5.1.Devicefittingprocedure
① Measurethewearer’shipwidthusingtheprovidedhipwidthruler.
② Selecttheappropriatewaistpartsizeaccordingtothewearer’shipwidth.
hipwidth:12.4~14.4”(315~365mm)Small
hipwidth:14.0~15.9”(355~405mm)Medium
hipwidth:15.9~17.9”(405~455mm)Large
③ Usethetorquewrenchprovidedtoadjustthewaistpartwidthaccordingtothewearer’shipwidth.Detailsof
thewaistpartadjustmentareshowninsection5.3Adjustthewaistpartwidth.
④ Usetheextensionbeltifthelengthofthewaistbeltistooshort.
Theextensionbeltmaybeusedtoincreasethelengthofthewaistbeltbyupto5.9inches(150mm).
⑤ UseaMedium‐sizethighsupportframeinitially.Ifthethighsupportframeareacomesincontactwiththeknee
cap,thenusetheSmall‐sizethighsupportframe.
⑥ Usethethighsupportstrapsizewhichfitsthewearer’sthigh.
Choosethestrapsizeadequately,sothattheVelcrocanbesecurelyfastened.
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