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Orthosensor
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ORTHOSNSR5
User Manual
4 pgs1.7 Mb0

Orthosensor ORTHOSNSR5 User Manual

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ORTHOSENSOR VERASENSE™ KNEE SYSTEM
INSTRUCTIONS FOR USE
DESCRIPTION
N$'+!"#$%&'()%"O+PQFH&QR&QO+S(''+&9)#'C+6"%G>T')+2+C'2()+#%+T9(2C>-2<<9+J2<2(-'+#$'+8(''+T=">(4+N%#2<+S(''+ H"#$"%6<2)#9+UNSHVB+
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
INDICATIONS
N$'+!"#$%&'()%"+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>)+2(+>(#'<<>4'(#+T>)6%)2J<'+#>J>2<+>()'"#+#">2<+I%"+#$'+2TX=)#C'(#+%I+#$'+I'C%"2<+ 8(''+>C6<2(#+#%+"'T=-'+>()#2J><>#9+I"%C+I<'Z>%(+426+2)9CC'#"9B++N$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>)+)#'"><'*+I%"+)>(4<'+62#>'(#+ =)'B+ +
CONTRAINDICATIONS
• H(9+2-#>G'+%"+)=)6'-#'T+<2#'(#+>(I'-#>%(+>(+%"+2J%=#+#$'+8(''+X%>(#B+
• F'I'"+#%+S(''+&9)#'C+,;[+I%"+2TT>#>%(2<+-%(#"2>(T>-2#>%()B+
+
PRECAUTIONS
• F'2T+2(T+I%<<%3+>()#"=-#>%()+I%"+6"%6'"+=)'+2(T+>(#'"6"'#2#>%(+%I+I%"-'+T2#2+T>)6<29'TB+
• &#">-#+2T$'"'(-'+#%+#$'+>(T>-2#>%()*+-%(#"2>(T>-2#>%()*+6"'-2=#>%()+2(T+=)'"\62#>'(#+)2I'#9+I%"+#$>)+6"%T=-#+>)+'))'(#>2<B+
• F'I'"+#%+266"%6">2#'+S(''+&9)#'C+,;[+I%"+2TT>#>%(2<+6"'-2=#>%()B+
• ]2#2+I"%C+#$'+PQFH&QR&Q+S(''+&9)#'C+>)+I%"+"'I'"'(-'+6="6%)' )+%(<9+2(T+)$%=<T+(%#+J'+#$'+)%<'+J2)>)+I%"+)="4>-2<+T'->)>%()B+
• PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>(#'"(2<+-%C6%('(#)+2"'+( % (E)#'"><'B++,CC'T>2#'<9+T>)-%(#>(='+=)'+%I+T'G>-'+>I+2 ( 9+-" 2- 8) *+
T2C24'*+%"+>(#'"(2<+I<=>T+>)+%J)'"G'TB++;2><="'+#%+%J)'"G'+#$')'+32"(>(4)+C29+'Z6%)'+62#>'(#+#%+(%(E)#'"><'+C2#'">2<B+
• N$'+P'"2)'()'O+S(''+&9)#'C+T'G>-'+-%()>)#)+%I+)%6$>)#>-2#'T+-2<>J"2#'T+>(#'"(2<+C>-"%'<'-#"%(>-)B++HG%>T+T>"'-#+>C62-#+3>#$+ C2<<'#+%"+%#$'"+>()#"=C'(#)+3$'(+6%))>J<'B+
• ^2(T<'+PQFH&QR&QO+S(''+&9)#'C+T'G>-'+3>#$+-2"'+3$'(+>()'"#>(4*+2TX=)#>(4+)$>C+)>W'+%"+"'C%G>(4+I"%C+#>J>2<+#"29B+
• ]%+(%#+I%"->J<9+>C62-#+I'C%"2<+>C6<2(#+#">2<+%(#%+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+6<2-'T+>(+#>J>2<+#"29B+++
• ]%+(%#+2##'C6#+#%+=)'+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+3>#$%=#+)'<'-#>%(+2(T+=)'+%I+6"%6'"+)$>C+2(T+266"%6">2#'+)>W'T+
#>J>2<+#"29B+
• _$'(+2##2-$>(4+&$>C+#%+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'*+#28'+-2"'+2(T+-2=#>%(+#%+6"%6'"<9+)<>T'+)$>C+%(#%+T'G>-'+J9+ '(424>(4\)(266>(4+-%C6%('(#)+#%4'#$'"B++_$'(+T'#2-$>(4+2+&$>C+I"%C+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'*+T'#2-$+2(#'">%"+ <>6+I>")#*+T%+(%#+6"9+%II+6%)#'">%"+'T4'B+++ +
USER/PATIENT SAFETY
• PQFH&QR&Q+S(''+&9)#'C+T'G>-'+2(T+&$>C+&'#)+2"'+)=66<>'T+2)+)>(4<'E=)'+)#'"><'B+]%+(%#+"'=)'+%"+"'E)#'"><>W'B+
• ,I+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+%"+&$>C+&'#+62-824>(4+>)+%6'(+%"+T2C24'T*+T%+(%#+=)'+2(T+>CC'T>2#'<9+"'#="(+#%+
!"#$%&'()%"B++
• ]%+(%#+=)'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+2I#'"+#$'+'Z6>"2#>%(+T2#'+%(+#$'+62-824'+<2J'<>(4B+
• ]%+(%#+=)'+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>(+2+#>J>2<+#"29+3>#$%=#+2+&$>C+2##2-$'TB+
• N$'+C'2)="'C'(#+<%2T+"2(4'+%I+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>)+/+#%+:1+6%=(T)+6'"+-%(T9<'B++5%(#2-#+!"#$%&'()%"+I%"+
2TT>#>%(2<+T2#2+"'42"T>(4+T'G>-'+2--="2-9B++
• `2Z>C=C+)2I'+2<<%32J<'+<%2T+I%"+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>)+L1+<J)+6'"+-%C62"#C'(#B+
!"#$%&'()%"*+,(-+ + + + + + + ./01+&234"2))+5%"6%"2#'+7839*+:#$+;<%%"+ &=(">)'+;?*+@@@A@+
333B%"#$%)'()%"B-%C+
+ + +
+
;%"+I="#$'"+>(I%"C2#>%(*+-%(#2-#+#$'+!"#$%&'()%"+5=)#%C'"+&'"G>-'+5'(#'"+J9+6$%('+2#+K/:E/LLELLL1+%"+J9+'EC2><+2#+
-=)#%C'") '"G>-'M%" #$%)'()%"B-%C+%"+4%+#%+333B %"#$%)'()%"B-%CB+
• ,I+C2Z>C=C+)2I' +2 <<% 3 2 J <'+<% 2 T +% I+L 1+<J ) +>)+"' 2-$ 'T +>( +' >#$ ' "+-% C 6 2 "#C'(#*+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+C=)#+J'+ "'C%G'T+I"%C+#$'+8(''+X%>(#+2(T+a"'EW'"%bTc+J9+$%<T>(4+T%3(+#$'+a5!RNF!?c+8'9+2(T+6"'))>(4+#$'+<'##'"+adc+8'9+%(+#$'+ !"#$%&'()%"+?>(8#>%(+8'9J%2"T+#%+"'-2<>J"2#'+#$'+T'G>-'B++
• ,I+#$'+6$9)>->2(+6'"- ' >G' )+2 +T >II' "' (-'+J'#3''(+#$'+<%2T)+T>)6<29'T+%(+#$'+)-"''(+2(T+#$'+6$9)>-2<+I''<*+#$'+6$9)>->2(+)$%=<T+ '>#$'"+"'6<2-'+#$'+T'G>-'+%"+-%(#>(='+#$'+6"%-'T="'+=)>(4+#$'>"+)#2(T2"T+>()#"=C'(#'T+#">2<+#'-$(>Y='+2(T+J')#+-<>(>-2<+ X=T4C'(#B++
• ]%+(%#+<%2T+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+2#+>#)+'T4')B+
• ]%+(%#+)=JX'-#+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+%"+&$>C)+#%+<%2T)+J'9%(T+#$'+C2Z>C=C+2<<%32J<'+<%2TB++
• ]%+(%#+>C62-#+\+$>#+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+%"+2(9+%JX'-#)+>(+-%(#2-#+3>#$+#$'+T'G>-'+2)+#$>)+C29+"')=<#+>(+T2C24'+
#%+>#)+'Z#'">%"+-2)>(4B+
• ]%+(%#+=)'+2+6"9>(4+T'G>-'+T=">(4+)="4>-2<+6"%-'T="'+3$><'+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'++>)+>(+6<2-'+2)+#$>)+C29+"')=<#+ >(+T2C24'+#%+#$'+'Z#'">%"+%I+#$'+T'G>-'B+
• N$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+-%(#2>()+(%(E)#'"><'*+(%(EC'T>-2<+4"2T'+>(#'"(2<+-%C6%('(#)B+,I+#$'+T'G>-'+$%=)>(4+>)+ T2C24'T+%"+-"2-8'T+T=">(4+#$'+6"%-'T="'*+#28'+266"%6">2#'+)#'6)+#%+6"%C%#'+62#>'(#+)2I'#9B+
• ]%+(%#+T>)2))'CJ<'+%"+%#$'"3>)'+C%T>I9+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+%"+&$>C)B++
• ]%+(%#+=)'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>I+>#+266'2")+#%+J'+I=(-#>%(>(4+>C6"%6'"<9B+
• !J)'"G'+2<<+32"(>(4)+2(T+2<2"C)+4'('"2#'T+J9+#$'+!"#$%&'()%"+?>(8#>%(B++
• ;'T'"2<+<23+"')#">-#)+#$>)+T'G>-'+#%+)2<'+J9+%"+%(+#$'+%"T'"+%I+2+<>-'()'T+6$9)>->2(B+
+
INSTRUCTIONS
.B ]'#'"C>('+#$'+)6'->I>-+)>W'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+"'Y=>"'TB++F'C%G'+6%=-$'T+&$>C)+2(T+T'G>-'+I"%C+#$'+
J%Z+2(T+6=#+%(+#$'+)$'<I+%I+#$'+!"#$%&'()%"+?>(8#>%(B+]!+R!N+!7QR+7![5^ +&Q H ?& B+ AB F'-%"T+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+)'">2<+(=CJ'"+U&\RV+%(#%+62#>'(#+2(T+$%)6>#2<+"'-%"T)+2)+"'Y=>"'TB+ @B N%+2-#>G2#'+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'e+
2B ?%-2#'+#$'+PQFH&QR&Q+>-%(+%(+#$'+)-"''(+%I+#$'+?>(8#>%(+2(T+T%=J<'+-<>-8+#$'+>-%(+#%+2-#>G2#'+#$'+
PQFH&QR&Q+&%I#32"'+H66<>-2#>%(B+
JB _>#$+#$'+6"%T=-#+)#><<+>(+#$'+)'2<'T+6%=-$')*+6<2-'+#$'+T'G>-'+T>"'-#<9+%G'"+#$'+C24('#+%(+?>(8#>%(+)$'<If+
2(+%"2(4'+?Q]+<>4$#+3><<+><<=C>(2#'+%(+#$'+2"#>-=<2#>(4+)="I2-'+%I+#$'+T'G>-'B+]%+(%#+C%G'+#$'+T'G>-'+=(#><+ 9%=+%J)'"G'+#$'+I%<<%3>(4e+++
>B ?Q]+#="()+%II+2I#'"+266"%Z>C2#'<9+I%="+U:V+)'-%(T)B+
>>B PQFH&QR&Q+S(''+&9)#'C+[)'"+&%I#32"'+<2=(-$')B+ >>>B ,(>#>2<>W2#>%(+6"%4"'))+J2"+266'2")+2(T+-%C6<'#')B+ >GB 7"%C6#+#%+)'<'-#+<'I#+%"+">4$#+<'4+266'2")+
-B ]'G>-'+C29+(%3+J'+"'C%G'T+I"%C+C24('#B+ :B N$'+PQFH&QR&Q+S(''+&9)#'C+&%I#32"'+3><<+2=#%C2#>-2<<9+6"%C6#+)'<'-#>%(+%I+<'I#+%"+">4$#+<'4B+&'<'-#+266"%6">2#'+<'4B+ /B d'"%+]'G>-'+
2B ;%<<%3+%(+)-"''(+>()#"=-#>%()+#%+W'"%+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'B+
0B _>#$+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+(%3+2-#>G2#'T*+62))+#$'+)'2<'T+6%=-$' ) +#% +# $ ' +( =")')+3>#$>(+#$'+)#'"><'+I>'<T+
%I+#$'+!FB+ LB !6'(+T%=J<'+)'2<'T+6%=-$')+6'"+$%)6>#2<+6"%#%-%<+UPQFH&QR&Q+S(''+&9)#'C+T'G>-'+2(T+&$>C+&'#BV+ gB _>#$+T'G>-'+2(T+&$>C)+"'C%G'T+I"%C+#$'+6%=-$')*+266<9+T')>4(2#'T+&$>C+#%+=(T'")>T'+%I+T'G>-'B+ KB N%+"'C%G'+#$'+&$>C*+%"+'Z-$2(4'+I%"+2(%#$'"+)>W'*+)>C6<9+=()(26+#$'+2(#'">%"+<>6+%I+#$'+2##2-$'T+&$>C+2(T+"'6<2-'B++ .1B _>#$+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'++2(T+&$>C+2##2-$'T*+6$9)>->2(+)$%=<T+C2(=2<<9+-%C6"'))+\+266<9+<%2T+#%+#$'+
T'G>-'+2(T+G'">I9+#$'+"')6%()'+%(+#$'+[)'"+,(#'"I2-'+6">%"+#%+6<2->(4+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>(#%+#$'+#>J>2<+
#"29B++ ..B 5%(I>"C+#$2#+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+3>#$+&$>C+>)+I=<<9+)'2#'T+3$'(+6<2-'T+>(+#$'+#>J>2<+#"29B+ .AB ;<'Z+#$'+X%>(#+#$"%=4$%=#+>#)+I=<<+"2(4'+%I+C%#>%(+#%+'()="'+266"%6">2#'+"')6%()'+%(+#$'+[)'"+,(#'"I2-'B+ .@B 7"%-''T+3>#$+#%#2<+8(''+"'6<2-'C'(#+6"%-'))+6'"+6$9)>->2(+\+$%)6>#2<+6"%#%-%<B+ .:B [6%(+-%C6<'#>%(+%I+#$'+6"%-'T="'*+T'2-#>G2#'+#$'+PQFH&QR&Q+S(''+&9)#'C+&%I#32"'+H66<>-2#>%(+J9+6"'))>(4+#$'+
7%3'"+D=##%(+%(+#$'+[)'"+,(#'"I2-'B+ ./B ]>)6%)'+%I+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+6'"+>()#>#=#>%(2<+4=>T'<>(')+I%"+J>%$2W2"T%=)+C'T>-2<+32)#'B+
+ + + + + +
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