2AS2I2003ENerve and Muscle Stimulator

1/44 XFT-2003E NerveandMuscleStimulator(TradeName:UpperExtremityRehabSystem) UserManual Caution:ThisisaclassIIFDAclearedmedicaldevice.Federalregulationsrestrictstheorderordeliveryofthismedical devicetocertifiedclinicianslicensedbythelawoftheStateinwhichhe/shepracticestouseasindicatedwithintheirscopeof practice.Orderanddeliveryofthismedicaldeviceforpatienthomeusemustbeaccompaniedbyaphysicianprescription. Thanksforchoosingourproduct.Pleasereadthismanualbeforeuseandkeepitcarefully. 2/44 Content 1.ForYourHealthandSafety.............................................................................................................................4 2.Overviews........................................................................................................................................................7 3.ProductIllustration..........................................................................................................................................8 4.SetupInstruction............................................................................................................................................11 5.OperationInstruction.....................................................................................................................................15 6.CareandMaintenance...................................................................................................................................33 7.ProductConfiguration...................................................................................................................................34 8.ProductSpecifications...................................................................................................................................34 9.Troubleshooting.............................................................................................................................................37 10.FrequentlyAskedQuestions......................................................................................................................37 11.ElectromagneticCompatibility(EMC)......................................................................................................38 12.After-SaleService......................................................................................................................................43 3/44 Glossary EMG:Electromyography,itisanelectrodiagnosticmedicinetechniqueforevaluatingandrecordingtheelectricalactivity producedbyskeletalmuscles. sEMG:SurfaceEMGuseselectrodelikesensorstoassessesmusclefunctionbyrecordingmuscleactivityfromthesurface abovethemuscleontheskin FES:FunctionalElectricalstimulation NMES:Neuromuscularelectricalstimulationistheelicitationofmusclecontractionusingelectricimpulses. ETS:EMGtriggeredelectricalstimulation. PAS:Powerassistantstimulation. UE:UpperExtremity 4/44 1.ForYourHealthandSafety Toavoidanydangerorinjurycausedbyinappropriateuse,pleasereadthismanualcarefully. Safetyprecautionsincludedangerorinjurycausedbyinappropriateusearecategorizedintosectionsof:danger, warningandattention. Pleasereadthismanualcarefully. ListofSymbols Contraindications,thatmaycausedanger Mandatoryrequirementormaycauseaninjuryorphysicaldiscomfort TypeBFEquipment UsewithCaution Non-IonizingRadiation DateofManufacture Manufacturer Thisproductmustnotbedisposedofwithotherhouseholdwaste Refertousermanual SerialNumber Thenumberofthenotifiedbody(0123) EuropeanAuthorizedRepresentative Fragile Keepupward Keepdry TheprotectionlevelagainstdustandwaterisIP22 Temperaturelimit 5/44 Humiditylimitation Atmosphericpressurelimitation Contraindications  Donotusethedevicewhereacancerouslesioninpresentorsuspected. Donotusethedeviceifyouhaveacardiacpacemaker,implanteddefibrillator,orotherimplantedmetallicorelectronic device.Useofthedeviceinconjunctionwithanyoftheabovemaycauseelectricshock,burns,electricalinterference,or death. Donotusethedeviceonanarmwherearegionaldisorder,suchasafractureordislocation,wouldbeadverselyaffected bymotionfromthestimulation. Warning DonotusetheXFT-2003EwhilereceivinganyMRIscan. DonotusetheXFT-2003Ewhilesleeping,bathingoroperatingavehicle. Thelong-termeffectsofchronicelectricalstimulationareunknown. Stimulationshouldnotbeappliedoverthecarotidsinusnerves,particularlyinpatientswithaknownsensitivitytothe carotidsinusreflex. Stimulationshouldnotbeappliedovertheneckormouth.Severespasmofthelaryngealandpharyngealmusclesmay occurandthecontractionsmaybestrongenoughtoclosetheairwayorcausedifficultyinbreathing.  Stimulationshouldnotbeappliedtransthoracicallyinthattheintroductionofelectricalcurrentintotheheartmaycause cardiacarrhythmias.  Stimulationshouldnotbeappliedoverswollen,infected,orinflamedareasorskineruptions,e.g.,phlebitis, thrombophlebitis,varicoseveins,etc.  Stimulationshouldnotbeappliedover,orinproximityto,cancerouslesions。  Thesafetyofusageduringpregnancyhasnotbeendetermined.  Electrodepads’positioningandstimulationparameters’settingshouldbeconductedbyprofessionals.Ifyoukeepfeeling uncomfortablestimulationorexperienceaskinirritationorrashpleasestopusingthisproduct. Pleasedonotpositiontheelectrodepadsintheareaofmalignantneoplasms,neckarteries(throat)orthrombus. Pleasedonotpositiontheelectrodepadsontheaffectedskinorotheraffectedarea,suchasfractureanddislocation. Pleaseusewithcautionwhenthearteriesofusedareashowpartialocclusion,whenthepatienthasvascularatrophy becauseofhemodialysis,orwhenthevascularsystemshowsinstability. Pleaseusewithcautioniftheusedareashavestructuraldeformity. Thisproductshouldbeprescribedbyaphysician.  Pleasestopusingthisproductifthebodyshowsanyunforeseenadversemedicalconditionwhileusingthisdevice. FCCwarning AnyChangesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoidtheuser'sauthorityto 6/44 operatetheequipment. Note:ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttopart15oftheFCC Rules.Theselimitsaredesignedtoprovidereasonableprotectionagains…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 6 External Photos for SZEM2007006698CR FCC ID: 2AS2I2003E SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 6 1 EUT Constructional Details SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 5 of 6 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 6 of 6

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 7 Internal Photos for SZEM2007006698CR FCC ID: 2AS2I2003E SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 7 1 EUT Constructional Details SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 7 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 7 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 5 of 7 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 6 of 7 Antenna SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 7 of 7

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700669802 Page: 1 of 52 Keny Xu EMC Laboratory Manager TEST REPORT Application No.: SZEM2007006698CR Applicant: Shenzhen XFT Medical Limited Address of Applicant: Room 203 Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Manufacturer: Shenzhen XFT Medical Limited Address of Manufacturer: Room 203 Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Factory: Shenzhen XFT Medical Limited Address of Factory: Room 203 Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road, Pingshan New District, Shenzhen, China Equipment Under Test (EUT): EUT Name: Nerve and Muscle Stimulator Model No.: XFT-2003E FCC ID: 2AS2I2003E Standard(s) : 47 CFR Part 15, Subpart C 15.247 Date of Receipt: 2020-07-20 Date of Test: 2020-07-21 to 2020-08-10 Date of Issue: 2020-08-10 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700669802 Page: 2 of 52 Revision Record Version Chapter Date Modifier Remark 01 2020-08-10 Original Authorized for issue by: Damon Su /Project Engineer Eric Fu /Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700669802 Page: 3 of 52 2 Test Summary Radio Spectrum Technical Requirement Item Standard Method Requirement Result Antenna Requirement 47 CFR Part 15, Subpart C 15.247 N/A 47 CFR Part 15, Subpart C 15.203 & 15.247(b)(4) Pass Radio Spectrum Matter Part Item Standard Method Requirement Result Conducted Peak Output Power 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.9.1 47 CFR Part 15, Subpart C 15.247(b)(3) Pass Minimum 6dB Bandwidth 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.8.1 47 CFR Part 15, Subpart C 15.247a(2) Pass Power Spectrum Density 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.10.2 47 CFR Part 15, Subpart C 15.247(e) Pass Conducted Band Edges Measurement 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.13.3.2 47 CFR Part 15, Subpart C 15.247(d) Pass Conducted Spurious Emissions 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 11.11 47 CFR Part 15, Subpart C 15.247(d) Pass Radiated Emissions which fall in the restricted bands 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 6.10.5 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Radiated Spurious Emissions 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 6.4,6.5,6.6 47 CFR Part 15, Subpart C 15.205 & 15.209 Pass Emission Part Item Standard Method Requirement Result Conducted Emissions at AC Power Line (150kHz-30MHz) 47 CFR Part 15, Subpart C 15.247 ANSI C63.10 (2013) Section 6.2 47 CFR Part 15, Subpart C 15.207 N/A Note：The product could not working when charging. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM200700669802 Page: 4 of 52 3 Contents Page 1 COVER PAGE ............................................................................................................................................ 1 2 TEST SUMMARY ....................................................................................................................................... 3 3 CONTENTS ................................................................................................................................................ 4 4 GENERAL INFORMATION ........................................................................................................................ 6 4.1 DETAILS OF E.U.T. ............................................................................................................................... 6 4.2 CABLE ................................................................................................................................................. 6 4.3 DESCRIPTION OF SUPPORT UNITS ......................................................................................................... 6 4.4 MEASUREMENT UNCERTAINTY .............................................................................................................. 6 4.5 TEST LOCATION .................................................................................................................................... 7 4.6 TEST FACILITY ...................................................................................................................................... 7 4.7 DEVIATION FROM STANDARDS ............................................................................................................... 7 4.8 ABNORMALITIES FROM STANDARD CONDITIONS ..................................................................................... 7 5 EQUIPMENT LIST ...................................................................................................................................... 8 6 RADIO SPECTRUM TECHNICAL REQUIREMENT ............................................................................... 12 6.1 ANTENNA REQUIREMENT .................................................................................................................... 12 6.1.1 Test Requirement: ....................................................................................................................... 12 6.1.2 Conclusion ................................................................................................................................... 12 7 RADIO SPECTRUM MATTER TEST RESULTS ..................................................................................... 13 7.1 CONDUCTED PEAK OUTPUT POWER .................................................................................................... 13 7.1.1 E.U.T. Operation .......................................................................................................................... 13 7.1…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 3 Setup Photos for SZEM2007006698CR FCC ID: 2AS2I2003E SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 3 1 Photographs Radiated Emissions which fall in the restricted bands SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 3 Radiated Spurious Emissions