SOLIS 1100 - Information Regarding Electromagnetic Compatibility (Emc)

15
InformaonRegardingElectromagnecCompability
(EMC)
• MedicalElectricalEquipmentneedsspecialprecauons
regardingEMCandneedstobeusedandputintoservice
accordingtoEMCinformaonprovidedinthismanual.
• PortableandmobileRadioFrequency(RF)communicaons
equipmentcanaectMedicalElectricalEquipment.
• Theuseofaccessories,transducers,andcablesotherthan
thosespeciedbythemanufacturermayresultinincreased
emissionsordecreasedimmunityoftheSolisPainRelief
System.
• TheSolisPainReliefSystemshouldnotbeusedadjacentto
orstackedwithotherequipment.Ifadjacentorstackeduseis
necessary,theSolisPainReliefSystemshouldbeobservedto
verifynormaloperaonintheconguraoninwhichitwillbe
used.
Donotusenearmicrowaveequipment.
Dimensions 6X3.875inches
Weight 3.4oz.
Waveform AsymmetricalBi-phaseSquarePulse
Pulse Rate 40Hz
Pulse Width 150or230microseconds(selectable)
Peak Current 0-80milliamps(500ohms)
PeakVoltage 0-40V(500ohm)
MaximumChargeper
Pulse
20Microcoulombs
Power Supply 9VoltAlkalineBaery
Conductors StainlessSteel
Safety tests
ComplieswithIEC60601-1,IEC60601-
1-2,andIEC60601-2-10
FDA
DraGuidanceforIndustryandSta:Class
IISpecialControlGuidanceDocument:
TranscutaneousElectricalNerveSmulator
forPainRelief(April5,2010)