Invacare TDXSP2 - Prescription Statement; Intended Use; Indication for Use; Regulations

Invacare®TDX®SP2Series
SymbolsintheManual
BatteryRecyclingSymbol—LeadAcid
Recyclethisproduct.RefertoDisposaland
Recyclingsections.
Manufacturer
SymbolsontheProduct
ReadManual
ISO7176–19Compliance—Referto8.2Transport
ReadyOption(TRRO),page57.
ISO7176–19Non-Compliance—Referto8.1
WheelchairTransportBrackets(TRBKTS),page57.
1.3PrescriptionStatement
Per21CFR801.109(b)(1)thedeviceislabeledfor
prescriptionuseonly.
CAUTION!
FederalLaw(USA)restrictsthisdevicetosaleby
orontheorderofalicensedphysician.
1.4IntendedUse
Theintendeduseofthedeviceistoprovidemobilityand
positioningtopersonslimitedtoasittingposition.
1.5IndicationforUse
TheindicationforuseoftheInvacare®TDX®SP2Power
Wheelchairistoprovidemobilityandpositioningtopersons
limitedtoasittingposition.
1.6Regulations
Thevehiclewassuccessfullytestedaccordingtointernational
standardsastoitssafety.Itsatisestherequirements
accordingtoRoHS2011/65/EU,CAL117,ISO7176–series.
ItwasalsotestedsuccessfullyaccordingtoEN60529IPX4
astoitsresistancetospraywater.
1.7ServiceLife
Theexpectedservicelifeisveyears,presumingthat
theproductisuseddailyandinaccordancewithsafety
instructions,maintenanceinstructionsandintendeduse,
statedinthismanual.
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