Thisproductcomplieswiththerequirementsconcerningmedicaldevicesfromthefollowingregulatorybodies.Formoreinformationabout
compliance,refertotheRegulatoryandSafetyGuideforthisproduct.
DateofrstCEmark—2010.
Thedocumentpartnumberandrevisionareoneachpageofthedocument.Therevisionidentiesthedocument’supdatelevel.Therevision
historyofthisdocumentissummarizedinthefollowingtable.
Revision
Date
History
A
01October2009Initialreleaseofmanual
B
14October2009Revisedperfeedbackfromvalidation
C28June2011
RevisedIntendedUsestatement.Added
CardioSoftconguration.UpdatedSerial
Transmission.
D
15July2013UpdatedtheTUVsymbol,theproductlabel,
andtheBackViewphoto.
E
7July2016Addedwarningandsymbols.Updatedback
viewimageofproduct.
F
28June2017
Removedcleaningproceduresforpatient
cables,leadwires,andelectrodes.
G
13July2017UpdatedimagesofBackViewinEquipment
OverviewandinConnectingtheACDCPower
AdapterinMaintenance.
H
15February2019UpdatedCerticationInformation.
2047426-001KMAC™6003