Nabtesco Hybrid Knee NI-C3 Series User manual

Introduction
ThankyouforpurchasingNabtesco'sHybridKnee.
HybridKneeisatotallynewintelligentprostheticknee
jointtoprovidesafeandpleasantwalkingthrough
integrationofhydraulicandpneumaticcontroland
computercontrol.
Forsafeuse,besuretoreadthismanualandfamiliarize
yourselfwiththeHybridKnee.Carefullykeepthis
manualconvenientlyavailableforfuturereference.
AlsoreadthroughtheUser'sManualandgivethe
amputeesafetyinformationcontainedthereinbefore
handingittohim/her.
InstructionManual
(NI-C3 Series)
81-SS00076

1
TableofContents
1 SafetyPrecautions...................................................................................................................... 2
1-1 DefinitionofSymbols..................................................................................................... 2
1-2 “Must”ItemsforSafety .................................................................................................. 3
2 BasicConstructionandOperationalPrinciple ................................................................ 5
2-1 BasicConstruction........................................................................................................... 5
2-2 OperationalPrinciple......................................................................................................6
2-3 StancePhaseControl ..................................................................................................... 6
2-4 SwingPhaseControl ...................................................................................................... 7
3 BeforeUse ..................................................................................................................................... 9
3-1 ScopeofDelivery ............................................................................................................. 9
3-2 AssemblyProcedure....................................................................................................... 9
3-2-1 StaticAlignment.................................................................................................... 9
3-2-2 AssemblingtheTube.........................................................................................10
3-2-3 InsertingtheBatteryConnector....................................................................10
3-2-4 PrecautionsonSocketForming ....................................................................11
4 Adjustment .................................................................................................................................12
4-1 AdjustingtheStancePhaseControl ......................................................................12
4-1-1 AdjustingtheHydraulicResistance .............................................................13
4-1-2 WalkingonaLevelFloor ..................................................................................15
4-1-3 AdjustingSensitivity(OFF-timing)...............................................................16
4-2 AdjustingtheSwingPhaseControl........................................................................17
4-3 AdjustingYieldingforDescendingaSlopeorStairs.......................................19
4-4 PrecautionsWhenSittinginandStandingupfromaChair.........................21
5 Troubleshooting .......................................................................................................................22
6 Maintenance...............................................................................................................................24
6-1 ReplacingtheExtensionStopperRubber............................................................24
6-2 ReplacingtheBattery...................................................................................................25
6-3 ReplacingtheCylinderModule................................................................................27
7 OutlineoftheProduct............................................................................................................29
8 PeriodicInspectionandWarranty .....................................................................................30

2
1SafetyPrecautions
1-1 DefinitionofSymbols
WARNING
CAUTION
Prohibition
Mandatory
Action
Indicatesapotentiallyhazardoussituationcaused
bynonobservanceofthissymbolwhich,ifnot
avoided,couldresultinseriousinjury.
Indicatesapotentiallyhazardoussituationcaused
bynonobservanceofthissymbolwhich,ifnot
avoided,mayresultinminorormoderateinjuryor
propertydamage.
Indicatesageneralcautiontobeobserved.
Indicatesprohibitionofaspecificaction.
Indicatesobligationofaspecificaction.

3
WARNING
1-2 “Must”ItemsforSafety
Upondetectingany
abnormalnoise,play,or
dropinhydraulicresistance,
discontinueuseandcontact
yourlocalsales
representative/dealer.
Continuedusedespiteadetected
abnormalitymaycausedamageof
parts,leadingtofalling.
DONOTattemptto
charge,disassemble,
heat,short-circuit,ortoss
intothefireabattery.
Failuretoobservethiswarningcan
causeanexplosionorfiring.
DONOTplacethehand
behindthekneewhen
flexingtheknee.
DONOTtouchtheknee
whenextendingit.
Thehandcanbecaught,causing
injury.
Neverattemptto
disassembleormodify
HybridKnee.
Failuretoobservethiswarningcan
causebreakageofparts,leadingto
falling.
DONOTuseforaperson
whoweighsover100kg.
Ifusedtoapersonwhoweighsover
100kg,damageofpartsmayoccur,
leadingtofalling.This,however,does
notprecludeloadingandunloading
ofbaggage,etc.occurringindailylife.
Besuretohandthe
separateGuideforUse
directlytoauserand
explainprecautionsfor
use.
Improperusecancausefallingor
injury.
Prohibition
Prohibition Prohibition
Prohibition
Mandatory
Action
Mandatory
Action

4
CAUTION
Asocketshouldbeformed
andalignedsothatneither
thesocketnoranyother
partcontactsthe
pneumaticcylinderatthe
maximumflexionangle.
Itwillleadtodamageofthepneu-
maticcylinder,impedingnormal
walking.
DONOTimmerseinany
liquidsuchaswaterand
seawater.
Failuretoobservethiscautionwill
causerustonparts,resultinginfailure
oftheunit.
DONOTdroppartssuch
asascrewintheframe.
Continueduseafteranypartis
droppedwillcausedamageofa
pneumaticcylinder,impedingnormal
walking.
Besuretoattendthe
operationtrainingcourse
offeredbyyourlocalsales
representative/dealer.
Incorrectadjustmentcannever
providepleasantwalking.
Besuretoundergo
periodicinspectionevery
year.
IftheHybridKneeisusedwithout
inspection,partsabrasioncanbe
accelerated.
Prohibition
Prohibition
Prohibition
Mandatory
Action
Mandatory
Action

5
Kneeplate
Proximitysensor
Hydraulicrotary
damper
MRSsystem
Adjustingplug
(Seepage12.)
Carbonframe
Rotaryaxis
(Kneeaxis)
Cushionvalve
Pneumatic
cylinder
Swingphasecontrolsection
Printed
circuitboard
Steppingmotor
Battery
Stancephasecontrolsection
2BasicConstructionand
OperationalPrinciple
2-1 BasicConstruction
HybridKneehasaccomplishedsophisticatedintegrationofthehydraulic
rotarydampertocontrolthestancephase,theMRSsystem,andthe
microprocessor-controlledpneumaticcylinderfortheswingphase.
Fig.1MainComponents

6
Hydraulic
rotarydamper Pneumatic
cylinder
Sensingpoint
HydraulicresistanceisON. HydraulicresistanceisOFF.
2-2 OperationalPrinciple
Thehydraulicrotarydamperreliablyfunctionswhiletheprosthesisisin
contactwiththefloor,thuspreventingabruptbuckling.Whentheprosthesis
leavesthefloor,themicroprocessor-controlledpneumaticcylinderfunctions,
providingcadenceresponsiveswingcontrol.
2-3 StancePhaseControl
Whenakneeisflexed,thehydraulicrotarydamperproduceshydraulic
resistance,thuspreventingabruptbucklingtooccur.TheMRS(Mechanism
ofReactionForceSensing)systemmechanicallydetectsfloorreactionforce
andsetsON/OFFofhydraulicresistance.Whenfloorreactionforceexistsat
theheelsidefromthesensingpoint,hydraulicresistanceisturnedon.When
itexistsatthetoeside,thehydraulicresistanceisturnedoff.
Fig.2LevelFloor
Fig.3MRSSystem

7
● Yieldingfunction
Byhavingtheheellandfirst,anamputeecan
slowlyflexthekneewhileapplyingbodyweight
totheknee.Aftergettingfamiliarwiththe
yieldingfunction,heorshecanperformvarious
actssuchasdescendingaslopeandstairs.
Note:HybridKneeisintendedtoassistcapabilityofapersonwhousesa
prosthesis.Withoutpropergaittraining,nobodyisabletodescenda
steepslopeorstairs.
Inordertomakeyieldingfunctioneffective,be
suretostrikethefloorwiththeheelfirst.Ifyou
strikethefloorwiththetoefirst,hydraulic
resistanceisturnedoffandthebodyweight
cannotbesupported.Thereisariskthatknee
bucklingmaytakeplace,causingfalling-down.Forsafeuse,fullyunderstand
theoperationalprincipleandproperwalkingmethod,andprovidethe
amputeewithinstructions.JSee
Fig.4Stairs
POINT1(page15).

Timeforonecycle
Stancephase
OFF OFF
ON
8°
Swingphase
8°
2-4 SwingPhaseControl
Themicroprocessor
calculatesthetimefor
onewalkingcycleby
usingdataonkneejoint
flexionasdetectedby
theproximitysensor.
Also,thismicroproces-
sormemorizesforeach
amputeetheadjusting
dataonthemaximum
10stageswhichconsist
ofcadenceandreaction
forceofthepneumatic
cylinder.Whencadencechanges,themicroprocessorcommandsthestep-
pingmotortoactivatetheneedlevalveimmediatelysothataswingspeedof
theprosthesisisselected.
Fig.5
WARNING

8
WalkingSpeed
(Slow) (Fast)
30
0
Valveopening
(Cylinderreactionforce)
(Low)
(High)
MT FT ST
SV
MV
FV
Slow
Fast
V1
V2
V3
V4
V5
V7
B9
V6
V8
B6 B5 B4 B3 B2 B1
V9
V10
B8 B7
Normal
● Datastore
Asadjustmentdataisstoredinthememory,itwillnotbedeletedevenifthe
batteryconnectorispulledout.Inotherwords,readjustmentisnotrequired
evenwhenthebatteryisreplaced.
● Whenwalkingstops
Whenanamputeestopswalkingfor8secondsormore,theneedlevalveis
automaticallysettothehis/hernormalcadence.
● Whenthebatteryisrunninglow
Whenremainingbatterypowerisreduced,theneedlevalveisautomatically
settothehis/hernormalcadence.Afterthat,itcannotrespondtoacadence
changebutanamputeecanwalkataconstantspeed.
Fig.610-StageSetting

9
0to10mm
3BeforeUse
3-1 ScopeofDelivery
3-2 AssemblyProcedure
3-2-1 StaticAlignment
● Alignmentoffrontalplane
Performstaticalignmentaccordingtothe
followingprocedure.
Completealignmentsothattheloadline
passesthroughthecenterofthekneejoint
andfallsintheheelcenterofthefootsection.
● Alignmentofsagittalplane
AsshowninFig.7,completealignmentso
thattheweightloadlinepassestherangeof
0to10mminfrontofthecenterofthe
kneeaxisofthekneejoint.
・Hybridknee ･･･････････････････････1
・Dedicatedlithiumbattery ･･･････････1(alreadyset)
・Userʼsmanual･･････････････････････1
(Afterexplainingthecontent,handitdirectlytotheamputee.)
・Instructionmanual(thisbook) ･･･････1
Pleaseconfirmthatthefollowingitemsareincluded.
Whentherecommendedalignmentisout
ofline,excessloadisimposedtotheparts,
acceleratingwear.
Forahipprosthesis,useofatorsion
adapterisrecommended. Fig.7
CAUTION

10
Outerclamp
Innerclamp
Batteryconnector
Clampingbolt
Tube
Batteryconnector
Circuitboard
connector
Thebatteryconnectorhas
beendisconnectedforship-
ment.TousetheHybridKnee,
besuretoinsertthebattery
connectorintothecircuit
boardconnector.
3-2-2 AssemblingtheTube
3-2-3 InsertingtheBatteryConnector
Forsafeuse,youarerecom-
mendedtousethetubemade
byNabtesco.Whenusingone
madebyanyothermanufac-
turerduetounavoidablecircum-
stances,besuretouseonewhose
outsidedimensiontoleranceis
within+/-0.05mm.
Beforeinsertingthebattery
connector,besuretoelimi-
natestaticelectricityby,for
example,touchingadesk.
・Connectingtheadjustmentunit,performreset.
・Confirmthatmotorsoundisnormal.
*Whenthemotorcontinuestorun,performtheresetoperation.(Thereis
ariskthatbatteryelectricitymaybeabnormallyconsumed.)
Fig.8aAssemblingtheTube
Fig.8bInsertingtheBatteryConnector
1 Looseningtheouterclampbolts,insertthetubeintotheinnerclampand
pushthetubeuntilithitsthestopperoftheinnerclamp.
2 Whenassemblingthetube,besuretoalignthesplitgrooveoftheouter
clampwiththatoftheinnerclamp.
3 Tightentheboltstoatorqueof
4.5to5.0N･m.
CAUTION
CAUTION
CAUTION

11
3-2-4 PrecautionsonSocketForming
Fig.9
Atthetimeofsocketforming,make
surethatneitherthesocketnor
partstouchthepneumatic
cylinderwhenthekneejoint
isflexedtothefullestextent.
Failuretodosomaycause
damagetothepneumatic
cylinder,adverselyaffecting
thefunction.
CAUTION
Avoid
interference.
Pneumatic
cylinder

12
Hydraulic
resistance
adjustingplug
Adjusting
plug
Resistance Yieldingstrength
(Hydraulicresistance)
Differentbodyweightand
activitylevel
Sensitivity
(OFF-timing)
Increasingeffectiveness
andsustainability(OFF-
timing)ofyielding
function.
Atthetimewhenstickingoccurs
duringtransitingtostancephase.
Atthetimewhentheyield
durationisinsufficient
Effect Whentoperform
adjustment
A
Hydraulic
sensitivity
adjustingplug
B
A
B
Time
Hydraulicresistance
Strength
A
Time
Hydraulicresistance
OFF-timing
B
4Adjustment
4-1 AdjustingtheStancePhaseControl
First,adjustthestancephase
control.Asthehydraulic
damperhastwokindsof
adjustingplugs,asshownin
Fig.10andTable1.
Fig.10LocationoftheAdjustingPlugs
Table1HowtoSelectAdjustingPlugs

13
10
5
0
15
Mark
Hexwrench
(3mm)
4-1-1 AdjustingtheHydraulicResistance
Insertingahexwrenchobliquelyupwardintothehydraulicresistance
adjustingplug,turnittochangehydraulicresistance.
・Clockwise(Scalereadingsbecomesmall.):
Hydraulicresistancebecomeshigheratthestancephase.
・Counterclockwise(Scalereadingsbecomelarge.):
Hydraulicresistancebecomesloweratthestancephase.
Adjustbyusingscalereadingsasaguide.Readthescaleatthemarkonthe
window.
Fig.11HowtoAdjustHydraulicResistance
Adjustingscaleasviewed
throughthewindow(for10)
Theadjustingplugshavebeensettothepositionswhicharecommon
tomostpeopleinthefactorydefaultsetting.
Whenyoucannotfindsuitablepositions,turntheplugstotheir
originalposition.
 Hydraulicresistanceadjustingplug: Settothescale10.
Hydraulicsensitivityadjustingplug: Settothescale15.
IMPORTANT
A
B

14
Fig.12
Threemethodsareavailableaccordingtoapplicationofbodyweight:
Whenbodyweightisappliedtotheheel,yieldingfunctioncanwork.
Whenbodyweightisappliedtothetoe,yieldingfunctioncannotwork.
Afterfullyapplyingbodyweighttotheheel,whenanamputeeshifts
bodyweighttowardthetoewhileyieldingfunctionisretained,
hydraulicresistanceissustainable.
POINT1: HowtoObtainYieldingFunction
A
A B C
B
C
YieldingON OFF ON
Bodyweightshift
ON
Sustainable
1Makesurethatthescalereads10attheprojection
onthewindow.Thenlettheamputeestandwithin
parallelbars.(Fig.12)
3Havetheamputeefeeltwodifferentlevelsof
yieldingstrengthbyadjustingthescaleasfollows.
(1)Scalereading0*(strongest)
(2)Scalereading15(weak)
*:Thereading“0”iswheretheplugisfullyclosedby
turningclockwise.
Procedure
2Havetheamputeeplacehisorherweightonthe
prosthesisandconfirmthatyieldingfunction
worksproperly.JSee  .
POINT1
4Takingthereading10asthebenchmark,finelyadjusttheadjustingplug
andchooseadesirablelevelofstrength.JSee  .
POINT2

15
4-1-2 WalkingonaLevelFloor
DONOTusereadingsof19andabove.Whentheplugisloosenedonefull
turnormorefromthefullyclosedposition(reading0),ariskofoilleakageis
created.Oilresistancedoesnotchangeeveniffurtherlooseningisadded.
1Lettheamputeewalkwithintheparallelbars.Providepracticesothat
theamputeefullyextendsthekneejointintheinitialstancephasein
normalwalkingonalevelfloor.
2Confirmthatthereisnostickingcausedbyyieldingfunctionatthetime
oftransitionfromstancephasetoswingphase.
3Whentheamputeebecomesfamiliarwithwalking,performgaittraining
outsidetheparallelbars.Whenstickingoccurs,makeanadjustment
accordingtothetroubleshootingmethod(seepages22and23).
・Althoughhydraulicresistancevariesby
weightandactivity,thestandardlevelis
generallybetween5and15.Ifyouarenot
sure,setitto10.
・Hydraulicresistancemaybefeltweaker
duetoinsufficientheelload.
Providesufficientgaittrainingfor.
POINT2:
GuideforIntensityofHydraulicResistance
Fig.13
POINT1
5
0
15
10
CAUTION
Provideappropriatealignment,footselection,andgaittrainingsothatan
amputeecanfullyapplyhisorherbodyweighttotheheel.Whenheelload
isinsufficient,yieldingfunctionmaynotbesustainable.
CAUTION

16
Themaximumadjustablerangeofthesensitivityadjustingplugisone
looseningturnfromthefullyclosedposition.Thefactorydefaultisset
tothescale15.Whenyoucannotfindanappropriateposition,itis
recommendedthattheprosthesisisusedinthefactorydefaultsetting.
IMPORTANT
Neverloosenthesensitivityadjustingplugmorethanoneturnfromthefully
closedposition.Theplugisdesignedforanti-dropping.Iftheplugis
loosenedmorethanoneturn,thepartsmaybedamaged.
Sensitivityissettothestandardconditionatthefactory.
Whennoproblemexists,adjustmentisunnecessary.
Fig.14AdjustingSensitivity
Referringtothefigurebelow,turnthesensitivityadjustingplugonthe
right-handsidebyusingahexwrench.Whentheplugisturned,hydraulic
resistancewillchangeasfollows:
Clockwise(forward): Yieldingfunctionbecomesmoreeffectiveand
moresustainable.
Counterclockwise(rearward) :Yieldingfunctionbecomeslesseffectiveand
lesssustainable.
4-1-3 AdjustingSensitivity(OFF-timing)
ReferringtoTable1(seepage12),performsensitivityadjustment.
CAUTION
15
10
5
0
Mark
Hexwrench
(3mm)
Adjustingscaleasviewed
throughthewindow(for15)

17
4-2 AdjustingtheSwingPhaseControl
Enterwalkingdataintothemicroprocessortoenablechangesincadence.As
foradjustmentprocedure,refertotheseparateadjustmentinstructionmanual.
Whenundesiableterminalimpactoccurs,adjustthecushionvalvelocated
abovethepneumaticcylinderinthefollowingprocedure:
● Programmingforswingphase
● Adjustingterminalimpact
Fig.15FixingProcedureoftheCushionValve
1AsshowninFig.15,turnthecushionvalvewithahexwrench(2mm).
Clockwise:Cushioneffectisenhancedandimpactisreduced.
Counterclockwise:Cushioneffectisweakenedandimpactisincreased.
2Lettheamputeewalkslowlybysecuringsafetywithparallelbarsand
confirmthatthekneeextendsfully.
Ifthekneedoesnotfullyextend,turnthecushionvalvetotheleftto
weakencushioneffect.
3Lettheamputeegraduallyincreasehisorhercadence.Confirmingsound
levelofterminalimpact,selectanappropriatevalveposition.

18
Neverusetheprosthesiswithexcessivelystrongcushioneffect.Failureto
observethiscautioncancausefallingasthekneedoesnotextendfully.
Also,itmaycauseyieldingfunctiontoworkunintentionally,resultingin
sticking.
・Cushionadjustmentshould
bemadeinconsiderationof
swingstrengthofeach
amputee.Asageneralrule,
however,settothevaluein
themarkedrange.
・Thefactorydefaultsetting
is1turntotheleftfromthe
fullyclosedposition.
POINT3: GuidetoCushionAdjustment
Fig.16
CAUTION
-360°
(Factory
default
setting)
-180°

19 Fig.17aDescendingaSlope Fig.17bDescendingStairs
Beforedescendingaslopeorstairs,performfineadjustmentsofhydraulic
resistanceandsensitivity.
Concerninguseforwalkingonaslopeorstairs,anamputeeshouldbefully
instructedtosecuresafetybyholdingahandrail.Asfloorconditionsarenot
good,thereisariskthattheamputeemaylosebalance,resultingin
falling-down.
Inordertomaketheyieldingfunctioneffective,besuretotouchthefloor
withtheheelfirst.Ifthetoetouchesthefloorfirst,thereisariskof
occurrenceofkneebuckling,resultinginfalling-down.
Beforeusingtheprosthesisforwalkingonaslopeorstairs,performgait
training.
Ifappropriateuseofyieldingisjudgeddifficultaftergaittraining,useof
yieldingfunctionshouldbeprohibited.Failuretoobservethisinstruction
maycauseaseriousaccidentsuchasfalling-down.
WARNING
Mandatory
Action
4-3 AdjustingYieldingforDescendingaSlopeorStairs