Use Instructions
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