Use Instructions

SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page10of79
3.2.Safety
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Riskofelectricalshockhazardandperformancedegradationifthisequipmentismodified!
Unauthorizedmodificationofthisequipmentcanaffectthesafetyandeffectivenessoftheequipment.
‐ Donotmodifythisequipmentwithoutauthorizationofthemanufacturer.
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Riskofseriousinjuryduetomisuse!
Useofthedevicewithouttrainingcanresultinseriousinjurytothepatient.
‐ UsersmustsuccessfullycompleteatrainingprogramprovidedbySamsungpriortouseoftheGEMS‐H.
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Riskofseriousinjuryduetouseofthedeviceinimproperenvironments!
Useofthedeviceinenvironmentsnotrecommendedbythemanufacturermayresultininjurytothepatient.
‐ Do not use in improper environments (e.g., on the sand, in stony areas, or any surface that is not
recommendedbymanufacturer).Refertosection2.3Safeenvironments.
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Riskofseriousinjurytothepatientwhoisdistractedorcannotpayattentiontotasks!
Ifthepatientisdistractedorusesthedevicewithoutcaution,itcouldresultinlossofbalanceandpossibleinjury.
‐ TheGEMS‐Hmustbeusedundersupervisionofatrainedphysicaltherapist.
‐ Theusershouldceaseusingthisdevicewithpatientswhoaredistractedorcannotpayattentiontothe
tasks.
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Riskofseriousinjuryduetomisuse!
Useofthedevicewithoutfittingandcustomizingcanresultinseriousinjury(e.g.,fracture)tothepatient.
‐ TheGEMS‐Hmustbefittedtoeachpatientproperlybyatrainedphysicaltherapist.
‐ Softwaresettingsmustbecustomizedforeachpatientbyatrainedphysicaltherapist.
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