Use Instructions

SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page12of79
Riskofinjurytothepatientanddevicedamageduetosittingandleaningbackwardonasurfacewhilewearing
thedevice!
Ifthepatientwearingthedevicesitsandleansbackontoasurface(e.g.,chair),itmaycausediscomfort,skin
pressure,and/ordevicedamage.
Donotleanbackwardontoasurfacewhilewearingthedeviceandsitting.
Riskofinjurytothepatientduetoskinpressure!
Ifthepatienthassomethingintheirpocketsoriswearingabeltwhilewearingthedevice,thismaycause
discomfortandpressureonthepatient'sbody.
Beltsshouldberemovedpriortoputtingonthedevice.
Pocketsshouldbeemptiedpriortoputtingonthedevice.
Riskofpotentiallyfallingduetousingdischargedbattery!
Useofthedevicewithalowbatterymayresultinthedevicemaysuddenlyturningoffduringrehabilitation
whichstopstheassistiveforce.Thismayresultinthepatienthavingdifficultybalancingandpotentiallyfalling.
Toensurecontinuouspowerduringuse,alwayschargethebatteryattheendofeachtrainingsession.
Whenthebatterylevelisbelow20%,chargethebatterywithin5minutes.
Riskofelectricalshockhazardandperformancedegradationwhenthedeviceisdropped!
Shouldthedevicebedroppedduringuse,itcanaffectthesafetyandeffectivenessoftheequipment.
Stopusingitimmediatelyandreportthesituationtothemanufacturer.
3.3.Safetystandards
TheGEMS‐Hconformstothefollowinginternationalstandards:
IEC60601‐1:2005+A1:2012
IEC60601‐1‐2:2014
IEC60601‐1‐6:2010+A1:2013
IEC62366‐1:2015
IEC62304:2006
ISO15223‐1:2012
ISO14971:2007
ISO13485:2016