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
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ORTHOSENSOR VERASENSE™ KNEE SYSTEM
INSTRUCTIONS FOR USE
DESCRIPTION
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+
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#$'+!"#$%&'()%"+@3(U#3%(+4%"+)8"O'%(+E3)86M3Z6#3%(.++,(73E3786M+RS59&SF&SQ+7'E3-')+6"'+J6-U6O'7+)#'"3M'*+4%"+)3(OM'+J6#3'(#+
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+
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6"'+)J'-343-+4%"+#$'+T(''+&I)#'D+?6D3MI]+
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o &cT:P5H5<B, &cT:P5H5<;*+&cT:P5H5<A*+&cT:P5H5<1*+&cT:P5H5<L*"&cT:P5H5<K*+&c5:P5a&<B*+&c5:P5a&<;*+
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• !"#$%&'()%"Q+RS59&SF&SQ+T(''+&I)#'D+4%"+e3DD'"b+F'f2'(b+T(''+5'JM6-'D'(#+&I)#'D+
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+
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
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• 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'+#$'+)%M'+G6)3)+4%"+)8"O3-6M+7'-3)3%().+
• RS59&SF&S+T(''+&I)#'D+7'E3-'+3(#'"(6M+-%DJ%('(#)+6"'+(%(:)#'"3M'.++,DD'736#'MI+73)-%(#3(8'+8)'+%4+7'E3-'+34+6(I+-"6-U)*+
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• P$'+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+&$3D+&'#)+6"'+)8JJM3'7+6)+)3(OM':8)'+)#'"3M'.+=%+(%#+"'8)'+%"+"':)#'"3M3Z'.+
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+
+
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+
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-8)#%D'")'"E3-'N%"#$%)'()%".-%D+%"+O%+#%+CCC.%"#$%)'()%".-%D.+
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• P$'+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+
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+
INSTRUCTIONS
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#"6I.++
//. H%(43"D+#$6#+#$'+RS59&SF&S+T(''+&I)#'D+7'E3-'+C3#$+&$3D+3)+48MMI+)'6#'7+C$'(+JM6-'7+3(+#$'+#3G36M+#"6I.+
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+
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+
+
VERASENSETM TROUBLESHOOTING
+
Issue"
Cause"
Solution"
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&%4#C6"'+M6#'(-I+
^63(#63(+ U(''+ J%)3#3%(+ 8(#3M+ 76#6+
)'##M')+V6JJ"%f3D6#'MI+1+)'-%(7)W+
F%#']+ &$%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(+ #$'+ A<<./1<k
A<L.<<<+ ^dZ+ G6(7+ 3(+ #$'+ ^'#'%"%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(+