Orthosensor ORTHOSNSR6 VERASENSE Mako Restoris PKA User Manual LB 03000 012 IFU 27

Orthosensor, Inc VERASENSE Mako Restoris PKA LB 03000 012 IFU 27

User Manual

!"#$%&'()%"*+,(-.+ + + + + + +/011+2"3443(+5%67+&83#'+9:;/<+=6(36+>'6-$*+?@+;;<<A:BB<<++CCC.%"#$%)'()%".-%D+++++@>:<;<<<:</B+5'E+B+F%E'DG'"+B</;++?%"+48"#$'"+3(4%"D6#3%(*+-%(#6-#+#$'+!"#$%&'()%"+H8)#%D'"+&'"E3-'+H'(#'"+GI+J$%('+6#+000:K1L:K0AL+%"+GI+':D63M+6#+-8)#%D'")'"E3-'N%"#$%)'()%".-%D+%"+O%+#%+CCC.%"#$%)'()%".-%D.+ORTHOSENSOR VERASENSE™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• !"#$%&'()%"Q+RS59&SF&SQ+T(''+&I)#'D+4%"+>,!^SP®+R9F2_95=®+H%DJM'#'+T(''+&I)#'D]+o >^P:R2H5L;*+>^P:R2H5K/*+>^P:R2H5K`*+>^P:R2a&L;*+>^P:R2a&K/*+>^P:R2a&K`+• !"#$%&'()%"Q+RS59&SF&SQ+T(''+&I)#'D+4%"+^6U%+5S&P!5,&b+aT9+,DJM6(#)+o /K<KA<+• !"#$%&'()%"Q+RS59&SF&SQ+T(''+&I)#'D+4%"+&P5cTS5®+P5,9Pd@!F®+T(''+&I)#'D+o &cT:P5H5<B, &cT:P5H5<;*+&cT:P5H5<A*+&cT:P5H5<1*+&cT:P5H5<L*"&cT:P5H5<K*+&c5:P5a&<B*+&c5:P5a&<;*+&c5:P5a&<A*+&c5:P5a&<1*+&c5:P5a&<L*+&c5:P5a&<K+• !"#$%&'()%"Q+RS59&SF&SQ+T(''+&I)#'D+4%"+e3DD'"b+F'f2'(b+T(''+5'JM6-'D'(#+&I)#'D+o +e^5:F2H5Hd;A*+e^5:F2H5Hd1L*+e^5:F2H5HdK<*+e^5:F2a&H=;A*+e^5:F2a&S?;A*+e^5:F2a&S?1L++INDICATIONS P$'+!"#$%&'()%"+RS59&SF&S+T(''+&I)#'D+7'E3-'+3)+6+#%%M+4%"+#$'+67[8)#D'(#+%4+#$'+4'D%"6M+U(''+3DJM6(#+#%+"'78-'+3()#6G3M3#I+4"%D+4M'f3%(+O6J+6)IDD'#"I.++P$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+3)+)#'"3M'*+4%"+)3(OM'+J6#3'(#+8)'.++CONTRAINDICATIONS • 9(I+6-#3E'+%"+)8)J'-#'7+M6#'(#+3(4'-#3%(+3(+%"+6G%8#+#$'+U(''+[%3(#.+• 5'4'"+#%+T(''+&I)#'D+,?_+4%"+6773#3%(6M+-%(#"63(73-6#3%().++PRECAUTIONS • 5'67+6(7+4%MM%C+3()#"8-#3%()+4%"+J"%J'"+8)'+6(7+3(#'"J"'#6#3%(+%4+4%"-'+76#6+73)JM6I'7.+• &#"3-#+67$'"'(-'+#%+#$'+3(73-6#3%()*+-%(#"63(73-6#3%()*+J"'-68#3%()+6(7+8)'"YJ6#3'(#+)64'#I+4%"+#$3)+J"%78-#+3)+'))'(#36M.+• 5'4'"+#%+6JJ"%J"36#'+T(''+&I)#'D+,?_+4%"+6773#3%(6M+J"'-68#3%().+• =6#6+4"%D+#$'+RS59&SF&S+T(''+&I)#'D+3)+4%"+"'4'"'(-'+J8"J%)')+%(MI+6(7+)$%8M7+(%#+G'+#$'+)%M'+G6)3)+4%"+)8"O3-6M+7'-3)3%().+• RS59&SF&S+T(''+&I)#'D+7'E3-'+3(#'"(6M+-%DJ%('(#)+6"'+(%(:)#'"3M'.++,DD'736#'MI+73)-%(#3(8'+8)'+%4+7'E3-'+34+6(I+-"6-U)*+76D6O'*+%"+3(#'"(6M+4M837+3)+%G)'"E'7.++?63M8"'+#%+%G)'"E'+#$')'+C6"(3(O)+D6I+'fJ%)'+J6#3'(#+#%+(%(:)#'"3M'+D6#'"36M.+• P$'+R'"6)'()'Q+T(''+&I)#'D+7'E3-'+-%()3)#)+%4+)%J$3)#3-6#'7+-6M3G"6#'7+3(#'"(6M+D3-"%'M'-#"%(3-).++9E%37+73"'-#+3DJ6-#+C3#$+D6MM'#+%"+%#$'"+3()#"8D'(#)+C$'(+J%))3GM'.+• d6(7M'+RS59&SF&SQ+T(''+&I)#'D+7'E3-'+C3#$+-6"'+C$'(+3()'"#3(O*+67[8)#3(O+)$3D+)3Z'+%"+"'D%E3(O+4"%D+#3G36M+#"6I.+• =%+(%#+4%"-3GMI+3DJ6-#+4'D%"6M+3DJM6(#+#"36M+%(#%+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+JM6-'7+3(+#3G36M+#"6I.+++• =%+(%#+6##'DJ#+#%+8)'+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+C3#$%8#+)'M'-#3%(+6(7+8)'+%4+J"%J'"+)$3D+6(7+6JJ"%J"36#'+)3Z'7+#3G36M+#"6I.+• g$'(+7'#6-$3(O+6+&$3D+4"%D+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'*+7'#6-$+6(#'"3%"+M3J+43")#*+7%+(%#+J"I+%44+J%)#'"3%"+'7O'.++++USER/PATIENT SAFETY • RS59&SF&S+T(''+&I)#'D+7'E3-'+6(7+&$3D+&'#)+6"'+)8JJM3'7+6)+)3(OM':8)'+)#'"3M'.+=%+(%#+"'8)'+%"+"':)#'"3M3Z'.+
!"#$%&'()%"*+,(-.+ + + + + + +/011+2"3443(+5%67+&83#'+9:;/<+=6(36+>'6-$*+?@+;;<<A:BB<<++CCC.%"#$%)'()%".-%D+++++@>:<;<<<:</B+5'E+B+F%E'DG'"+B</;++?%"+48"#$'"+3(4%"D6#3%(*+-%(#6-#+#$'+!"#$%&'()%"+H8)#%D'"+&'"E3-'+H'(#'"+GI+J$%('+6#+000:K1L:K0AL+%"+GI+':D63M+6#+-8)#%D'")'"E3-'N%"#$%)'()%".-%D+%"+O%+#%+CCC.%"#$%)'()%".-%D.+• ,4+RS59&SF&S+T(''+&I)#'D+7'E3-'+%"+&$3D+&'#+J6-U6O3(O+3)+%J'(+%"+76D6O'7*+7%+(%#+8)'+6(7+3DD'736#'MI+"'#8"(+#%+!"#$%&'()%".++• =%+(%#+8)'+RS59&SF&S+T(''+&I)#'D+7'E3-'+64#'"+#$'+'fJ3"6#3%(+76#'+%(+#$'+J6-U6O'+M6G'M3(O.+• =%+(%#+8)'+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+3(+6+#3G36M+#"6I+C3#$%8#+6+&$3D+6##6-$'7.+• P$'+D'6)8"'D'(#+M%67+"6(O'+%4+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+3)+1+#%+A<+J%8(7)+J'"+-%(7IM'.++• ^6f3D8D+6MM%C6GM'+M%67+4%"+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+3)+K<+MG)+J'"+-%DJ6"#D'(#.+• ,4+#$'+J$I)3-36(+J'"-'3E')+6+7344'"'(-'+G'#C''(+#$'+M%67)+73)JM6I'7+%(+#$'+)-"''(+6(7+#$'+J$I)3-6M+4''M*+#$'+J$I)3-36(+)$%8M7+'3#$'"+"'JM6-'+#$'+7'E3-'+%"+-%(#3(8'+#$'+J"%-'78"'+8)3(O+#$'3"+)#6(76"7+3()#"8D'(#'7+#"36M+#'-$(3\8'+6(7+G')#+-M3(3-6M+[87OD'(#.++• =%+(%#+3DJ6-#+Y+$3#+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+%"+6(I+%G['-#)+3(+-%(#6-#+C3#$+#$'+7'E3-'+6)+#$3)+D6I+"')8M#+3(+76D6O'+#%+3#)+'f#'"3%"+-6)3(O.+• =%+(%#+8)'+6+J"I3(O+7'E3-'+78"3(O+)8"O3-6M+J"%-'78"'+C$3M'+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+3)+3(+JM6-'+6)+#$3)+D6I+"')8M#+3(+76D6O'+#%+#$'+'f#'"3%"+%4+#$'+7'E3-'.+• P$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+-%(#63()+(%(:)#'"3M'*+(%(:D'73-6M+O"67'+3(#'"(6M+-%DJ%('(#).+,4+#$'+7'E3-'+$%8)3(O+3)+76D6O'7+%"+-"6-U'7+78"3(O+#$'+J"%-'78"'*+#6U'+6JJ"%J"36#'+)#'J)+#%+J"%D%#'+J6#3'(#+)64'#I.+• =%+(%#+73)6))'DGM'+%"+%#$'"C3)'+D%734I+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+%"+&$3D).++• =%+(%#+8)'+RS59&SF&S+T(''+&I)#'D+7'E3-'+34+3#+6JJ'6")+#%+G'+48(-#3%(3(O+3DJ"%J'"MI.+• !G)'"E'+6MM+C6"(3(O)+6(7+6M6"D)+O'('"6#'7+GI+#$'+!"#$%&'()%"+@3(U&#6#3%(.++• ?'7'"6M+M6C+"')#"3-#)+#$3)+7'E3-'+#%+)6M'+GI+%"+%(+#$'+%"7'"+%4+6+M3-'()'7+J$I)3-36(.++INSTRUCTIONS /. ='#'"D3('+#$'+)J'-343-+)3Z'+RS59&SF&S+T(''+&I)#'D+7'E3-'+"'\83"'7.++5'D%E'+J%8-$'7+&$3D)+6(7+7'E3-'+4"%D+#$'+G%f+6(7+J8#+%(+#$'+)$'M4+%4+#$'+!"#$%&'()%"+@3(U&#6#3%(.+=!+F!P+!aSF+a!_Hd+&S9@&.+B. 5'-%"7+RS59&SF&S+T(''+&I)#'D+7'E3-'+)'"36M+(8DG'"+V&YFW+%(#%+J6#3'(#+6(7+$%)J3#6M+"'-%"7)+6)+"'\83"'7.+;. P%+6-#3E6#'+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-']+6. @%-6#'+#$'+RS59&SF&S+3-%(+%(+#$'+)-"''(+%4+#$'+@3(U&#6#3%(+6(7+7%8GM'+-M3-U+#$'+3-%(+#%+6-#3E6#'+#$'+RS59&SF&S+&%4#C6"'+9JJM3-6#3%(.+G. g3#$+#$'+J"%78-#+)#3MM+3(+#$'+)'6M'7+J%8-$')*+JM6-'+#$'+7'E3-'+73"'-#MI+%E'"+#$'+D6O('#+%(+@3(U&#6#3%(+)$'M4X+6(+@S=+M3O$#+C3MM+3MM8D3(6#'+%(+#$'+6"#3-8M6#3(O+)8"46-'+%4+#$'+7'E3-'.+=%+(%#+D%E'+#$'+7'E3-'+8(#3M+I%8+%G)'"E'+#$'+4%MM%C3(O]+++3. @S=+#8"()+%44+64#'"+6JJ"%f3D6#'MI+4%8"+VAW+)'-%(7).+33. RS59&SF&S+T(''+&I)#'D+_)'"+&%4#C6"'+M68(-$').+333. ,(3#36M3Z6#3%(+J"%O"'))+G6"+6JJ'6")+6(7+-%DJM'#').+3E. a"%DJ#+#%+)'M'-#+M'4#+%"+"3O$#+M'O+6JJ'6")+-. ='E3-'+D6I+(%C+G'+"'D%E'7+4"%D+D6O('#.+A. P$'+RS59&SF&S+T(''+&I)#'D+&%4#C6"'+C3MM+68#%D6#3-6MMI+J"%DJ#+)'M'-#3%(+%4+M'4#+%"+"3O$#+M'O.+&'M'-#+6JJ"%J"36#'+M'O.+1. e'"%+='E3-'+6. ?%MM%C+%(+)-"''(+3()#"8-#3%()+#%+Z'"%+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'.+L. _J%(+-%DJM'#3%(+%4+#$'+7'E3-'+3(3#36#3%(+J"%-'))+6)+J"%DJ#'7+%(+#$'+@3(U&#6#3%(*+J6))+#$'+)'6M'7+J%8-$')+#%+#$'+(8")')+C3#$3(+#$'+)#'"3M'+43'M7+%4+#$'+!5.+K. !J'(+7%8GM'+)'6M'7+J%8-$')+J'"+$%)J3#6M+J"%#%-%M+VRS59&SF&S+T(''+&I)#'D+7'E3-'+6(7+&$3D+&'#.W+0. g3#$+7'E3-'+6(7+&$3D)+"'D%E'7+4"%D+#$'+J%8-$')*+6JJMI+7')3O(6#'7+&$3D+#%+8(7'")37'+%4+7'E3-'.++F%#']+!(-'+#$'+J"%78-#+3)+"'D%E'7+4"%D+#$'+J%8-$*+#$'+6JJM3-6#3%(+%4+#$'+3(3#36M+)$3D*+34+6JJM3-6GM'*+"'M6#')+#%+7'E3-')+C3#$%8#+D%8(#'7+)$3D)+V^6U%*+&#"IU'"+6(7+e3DD'"W.++?%"+#$'+>3%D'#+46D3MI*+#$'+/<DD+)$3D+3)+6M"'67I+D%8(#'7.++`. P%+"'D%E'+#$'+&$3D*+%"+'f-$6(O'+4%"+6(%#$'"+)3Z'*+)3DJMI+8()(6J+#$'+6(#'"3%"+M3J+%4+#$'+6##6-$'7+&$3D+6(7+"'JM6-'.++/<. g3#$+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+6(7+&$3D+6##6-$'7*+J$I)3-36(+)$%8M7+D6(86MMI+-%DJ"'))+Y+6JJMI+M%67+#%+#$'+7'E3-'+6(7+E'"34I+#$'+"')J%()'+%(+#$'+_)'"+,(#'"46-'+J"3%"+#%+JM6-3(O+RS59&SF&S+T(''+&I)#'D+7'E3-'+3(#%+#$'+#3G36M+#"6I.++//. H%(43"D+#$6#+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+C3#$+&$3D+3)+48MMI+)'6#'7+C$'(+JM6-'7+3(+#$'+#3G36M+#"6I.+/B. ?M'f+#$'+[%3(#+#$"%8O$%8#+3#)+48MM+"6(O'+%4+D%#3%(+#%+'()8"'+6JJ"%J"36#'+"')J%()'+%(+#$'+_)'"+,(#'"46-'.+/;. a"%-''7+C3#$+#%#6M+U(''+"'JM6-'D'(#+J"%-'))+J'"+J$I)3-36(+Y+$%)J3#6M+J"%#%-%M.+/A. _J%(+-%DJM'#3%(+%4+#$'+J"%-'78"'*+7'6-#3E6#'+#$'+RS59&SF&S+T(''+&I)#'D+&%4#C6"'+9JJM3-6#3%(+GI+J"'))3(O+#$'+a%C'"+>8##%(+%(+#$'+_)'"+,(#'"46-'.+
!"#$%&'()%"*+,(-.+ + + + + + +/011+2"3443(+5%67+&83#'+9:;/<+=6(36+>'6-$*+?@+;;<<A:BB<<++CCC.%"#$%)'()%".-%D+++++@>:<;<<<:</B+5'E+B+F%E'DG'"+B</;++?%"+48"#$'"+3(4%"D6#3%(*+-%(#6-#+#$'+!"#$%&'()%"+H8)#%D'"+&'"E3-'+H'(#'"+GI+J$%('+6#+000:K1L:K0AL+%"+GI+':D63M+6#+-8)#%D'")'"E3-'N%"#$%)'()%".-%D+%"+O%+#%+CCC.%"#$%)'()%".-%D.+/1. =3)J%)'+%4+RS59&SF&S+T(''+&I)#'D+7'E3-'+J'"+3()#3#8#3%(6M+O837'M3(')+4%"+G3%$6Z6"7%8)+D'73-6M+C6)#'.++F%#']+,4+D6f3D8D+6MM%C6GM'+M%67+%4+K<+MG)+3)+"'6-$'7+3(+'3#$'"+-%DJ6"#D'(#*+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+D8)#+G'+"'D%E'7+4"%D+#$'+U(''+[%3(#+6(7+h"':Z'"%i7j+GI+$%M73(O+7%C(+#$'+hH!FP5!@j+U'I+6(7+J"'))3(O+#$'+M'##'"+hej+U'I+%(+#$'+!"#$%&'()%"+@3(U&#6#3%(+U'IG%6"7+#%+"'-6M3G"6#'+#$'+7'E3-'.++++VERASENSETM TROUBLESHOOTING +Issue"Cause"Solution"RS59&SF&S+='E3-'+@S=+7%')+(%#+M3O$#+8J+RS59&SF&S+='E3-'+G6##'"3')+6"'+7'67+=3)-6"7+ RS59&SF&S+='E3-'+6(7+"'JM6-'+RS59&SF&S+='E3-'+(%#+#"6()D3##3(O+76#6+#%+@3(U&#6#3%(+RS59&SF&S+='E3-'+3)+%8#+%4+C3"'M'))+"6(O'+^%E'+@3(U&#6#3%(+-M%)'"+#%+RS59&SF&S+='E3-'+^%E'+ @3(U&#6#3%(+#%+ 6-$3'E'+ 6(+8(%G)#"8-#'7+ M3(':%4:)3O$#+ #%+ #$'+RS59&SF&S+='E3-'+43'M7+%4+8)'+RS59&SF&S+='E3-'+3)+J%C'"'7+%44+9-#3E6#'+C3#$+@3(U&#6#3%(+D6O('#+RS59&SF&S+='E3-'+G6##'"3')+6"'+M%C+=3)-6"7+ RS59&SF&S+='E3-'+6(7+"'JM6-'+RS59&SF&S+='E3-'+G"'6U6O'+RS59&SF&S+='E3-'+M%67'7+G'I%(7+M3D3#+RS59&SF&S+='E3-'+ 3(#'"(6M+-%DJ%('(#)+ 6"'+ (%(:)#'"3M'+ 6(7+ (%(:D'73-6M+O"67'.++S()8"'+J6#3'(#+)64'#I.++=3)-6"7+='E3-'+6(7+"'JM6-'+@6O+3(+"'J%"#'7+76#6+&%4#C6"'+M6#'(-I+^63(#63(+ U(''+ J%)3#3%(+ 8(#3M+ 76#6+)'##M')+V6JJ"%f3D6#'MI+1+)'-%(7)W+F%#']+ &$%8M7+ 6(I+ %4+ #$'+ 3))8')+ 6G%E'+ 6"3)'+ JM'6)'+ -%(#6-#+ !"#$%)'()%"+ H8)#%D'"+ )'"E3-'+ 6#+ V000W+ K1L:K0AL+ 4%"+ "'#8"(+ %"+"'JM6-'D'(#+6))3)#6(-'.+VERASENSE™ KNEE SYSTEM DEVICE SPECIFICATIONS P$3)+7'E3-'+-%DJM3')+C3#$+a6"#+/1+%4+#$'+?HH+58M').+!J'"6#3%(+3)+)8G['-#+#%+#$'+4%MM%C3(O+#C%+-%(73#3%()]+V/W+#$3)+7'E3-'+D6I+(%#+-68)'+$6"D48M+3(#'"4'"'(-'*+6(7+VBW+#$3)+7'E3-'+D8)#+6--'J#+6(I+3(#'"4'"'(-'+"'-'3E'7*+3(-M873(O+3(#'"4'"'(-'+#$6#+D6I+-68)'+8(7')3"'7+%J'"6#3%(.++P$3)+ '\83JD'(#+ $6)+ G''(+ #')#'7+ 6(7+ 4%8(7+ #%+ -%DJMI+ C3#$+ #$'+ S^H+ M3D3#)+ 4%"+ #$'+ ^'73-6M+ ='E3-'+ =3"'-#3E'+ `;YABYSSH+ VSF+11<//+HM6))+>+6(7+SF+L<L</:/:B.W++P$')'+M3D3#)+6"'+7')3O('7+#%+J"%E37'+"'6)%(6GM'+J"%#'-#3%(+6O63()#+$6"D48M+3(#'"4'"'(-'+3(+6+#IJ3-6M+D'73-6M+3()#6MM6#3%(.++P$3)+'\83JD'(#+O'('"6#')*+8)')*+6(7+-6(+"6736#'+"673%+4"'\8'(-I+'('"OI+6(7*+34+(%#+3()#6MM'7+6(7+8)'7+3(+6--%"76(-'+C3#$+#$'+3()#"8-#3%()*+D6I+-68)'+$6"D48M+3(#'"4'"'(-'+#%+%#$'"+7'E3-')+3(+#$'+E3-3(3#I.++d%C'E'"*+#$'"'+3)+(%+O86"6(#''+#$6#+3(#'"4'"'(-'+C3MM+(%#+%--8"+3(+6+J6"#3-8M6"+3()#6MM6#3%(.++,4+#$3)+'\83JD'(#+7%')+-68)'+$6"D48M+3(#'"4'"'(-'*+C$3-$+-6(+G'+7'#'"D3('7+ GI+#8"(3(O+#$'+'\83JD'(#+%44+6(7+%(*+#$'+8)'"+3)+'(-%8"6O'7+#%+#"I+#%+ -%""'-#+#$'+3(#'"4'"'(-'+GI+%('+%"+D%"'+%4+#$'+4%MM%C3(O+D'6)8"')]+: 5'%"3'(#+%"+"'M%-6#'+#$'+"'-'3E3(O+7'E3-'+: ,(-"'6)'+#$'+)'J6"6#3%(+G'#C''(+#$'+'\83JD'(#.+: H%()8M#+!"#$%&'()%"+4%"+$'MJ.++P$3)+ 7'E3-'+ -%DJM3')+ C3#$+ a6"#+ `1+ %4+ #$'+ ?HH+ "8M').+ + P$3)+ 7'E3-'+ D6I+ (%#+ 3(#'"4'"'+ C3#$+ )#6#3%()+ %J'"6#3(O+ 3(+ #$'+ A<<./1<kA<L.<<<+ ^dZ+ G6(7+ 3(+ #$'+ ^'#'%"%M%O3-6M+ 937)*+^'#'%"%M%O3-6M+ &6#'MM3#'*+ 6(7+ S6"#$+ SfJM%"6#3%(+ &6#'MM3#'+ &'"E3-')+ 6(7+ D8)#+6--'J#+6(I+3(#'"4'"'(-'+"'-'3E'7*+3(-M873(O+3(#'"4'"'(-'+#$6#+D6I+-68)'+8(7')3"'7+%J'"6#3%(.++^%7343-6#3%(+%4+#$3)+7'E3-'+D6I+E%37+#$'+8)'"i)+68#$%"3#I+#%+%J'"6#'+#$'+'\83JD'(#+8(7'"+#$'+?HH+"8M')+6G%E'.++++++
!"#$%&'()%"*+,(-.+ + + + + + +/011+2"3443(+5%67+&83#'+9:;/<+=6(36+>'6-$*+?@+;;<<A:BB<<++CCC.%"#$%)'()%".-%D+++++@>:<;<<<:</B+5'E+B+F%E'DG'"+B</;++?%"+48"#$'"+3(4%"D6#3%(*+-%(#6-#+#$'+!"#$%&'()%"+H8)#%D'"+&'"E3-'+H'(#'"+GI+J$%('+6#+000:K1L:K0AL+%"+GI+':D63M+6#+-8)#%D'")'"E3-'N%"#$%)'()%".-%D+%"+O%+#%+CCC.%"#$%)'()%".-%D.++++++++++Model:"RS59&SF&SQ+T(''+&I)#'D+Quantity:"/++Type:"&3(OM'+a"%-'78"'+!(MI.+=%+(%#+"':)#'"3M3Z'+ Sterile:"S#$IM'('+!f37'+ Device"Type:"PIJ'+>?++FCC"ID:"lF@:!5Pd!&F&5/+lF@:!5Pd!&F&5B+lF@:!5Pd!&F&5;+lF@:!5Pd!&F&51+lF@:!5Pd!&F&5L+Operating"Range:" 6.5 ft [2m] Unobstructed Mode"of"Operation:"P'DJ%"6"I+V)3(OM':8)'W+ +Power"Supply:",(#'"(6MMI+J%C'"'7+6#+M'))+#$6(+;.;+R=H+Battery"Life:"A<+D3(8#')+V6JJ"%f3D6#'W+Temperature:"Operation"15°C 37°C Storage"0°C 50°C  Relative"Humidity:";<m+++++++/<<m*+)8GD'")3%(+/<m+++++++0<+m*+(%(:-%(7'()3(O+Atm"Pressure:"AK<:/<L<+$a6+;L<:/<L<+$a6 Rx"Only:"_.&.+?'7'"6M+@6C+"')#"3-#)+#$3)+J"%78-#+#%+)6M'+GI+%"+%(+#$'+%"7'"+%4+6+J$I)3-36(+

Navigation menu