Orthosensor ORTHOSNSR5 Verasense User Manual
Orthosensor, Inc Verasense
User Manual
!"#$%&'()%"*+,(-+ + +++++
./01+&234"2))+5%"6%"2#'+7839*+:#$+;<%%"+
&=(">)'+;?*+@@@A@+
333B%"#$%)'()%"B-%C+
+
+
+
+?DE1@111E1.A+F'G+.+
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+
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-=)#%C'")'"G>-'M%"#$%)'()%"B-%C+%"+4%+#%+333B%"#$%)'()%"B-%CB+
ORTHOSENSOR VERASENSE™ KNEE SYSTEM
INSTRUCTIONS FOR USE
DESCRIPTION
N$'+!"#$%&'()%"O+PQFH&QR&QO+S(''+&9)#'C+6"%G>T')+2+C'2()+#%+T9(2C>-2<<9+J2<2(-'+#$'+8(''+T=">(4+N%#2<+S(''+
H"#$"%6<2)#9+UNSHVB+
+
N$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+>)+2(+>(#'<<>4'(#+T>)6%)2J<'+#>J>2<+>()'"#+#$2#+C'2)="')+T9(2C>-+<%2T)+>(+#$'+C'T>2<+2(T+
<2#'"2<+-%C62"#C'(#)+%I+#$'+8(''+2(T+3>"'<'))<9+#"2()C>#)+#$'+C'2)="'T+<%2T+T2#2+#%+#$'+!"#$%&'()%"+?>(8#>%(+I%"+)="4'%(+
G>)=2<>W2#>%(B++,(T>G>T=2<+PQFH&QR&QO+T'G>-')+2"'+62-824'T+)#'"><'*+I%"+)>(4<'+62#>'(#+=)'+3>#$+2+&$>C+&'#+I%"+#$>-8('))+
2TX=)#C'(#)B+
+
N$'+!"#$%&'()%"+?>(8#>%(+2(T+PQFH&QR&Q+S(''+&9)#'C+&%I#32"'+H66<>-2#>%(+2"'+"'Y=>"'T+I%"+=)'+%I+#$'+PQFH&QR&Q+S(''+
&9)#'C+T'G>-'B++N$'+?>(8#>%(+-%(#2>()+2+-%C6=#'"+2(T+2<<+6'">6$'"2<+'Y=>6C'(#+"'Y=>"'T+#%+T>)6<29+#$'+C'2)="'T+<%2T+T2#2+
J9+6"%G>T>(4+2+4"26$>-2<+2(T+(=C'">-2<+6"')'(#2#>%(+%I+#$'+<%2T)+>(+J%#$+#$'+C'T>2<+2(T+<2#'"2<+-%C62"#C'(#)+%I+#$'+8(''B+++
+
PQFH&QR&Q+S(''+&9)#'C+T'G>-')+2"'+>C6<2(#+)9)#'C+)6'->I>-+T='+#%+G2">2#>%()+>(+>C6<2(#+T')>4(B+
+
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)*+
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• 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-$'TB+
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+
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-=)#%C'")'"G>-'M%"#$%)'()%"B-%C+%"+4%+#%+333B%"#$%)'()%"B-%CB+
• ,I+C2Z>C=C+)2I'+2<<%32J<'+<%2T+%I+L1+<J)+>)+"'2-$'T+>(+'>#$'"+-%C62"#C'(#*+#$'+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+%(+#$'+
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• ,I+#$'+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+"')=<#+
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• N$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+-%(#2>()+(%(E)#'"><'*+(%(EC'T>-2<+4"2T'+>(#'"(2<+-%C6%('(#)B+,I+#$'+T'G>-'+$%=)>(4+>)+
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• ]%+(%#+T>)2))'CJ<'+%"+%#$'"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+
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+
INSTRUCTIONS
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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#'+#$'+
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2(+%"2(4'+?Q]+<>4$#+3><<+><<=C>(2#'+%(+#$'+2"#>-=<2#>(4+)="I2-'+%I+#$'+T'G>-'B+]%+(%#+C%G'+#$'+T'G>-'+=(#><+
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>B ?Q]+#="()+%II+2I#'"+266"%Z>C2#'<9+I%="+U:V+)'-%(T)B+
>>B PQFH&QR&Q+S(''+&9)#'C+[)'"+&%I#32"'+<2=(-$')B+
>>>B ,(>#>2<>W2#>%(+6"%4"'))+J2"+266'2")+2(T+-%C6<'#')B+
>GB 7"%C6#+#%+)'<'-#+<'I#+%"+">4$#+<'4+266'2")+
-B ]'G>-'+C29+(%3+J'+"'C%G'T+I"%C+C24('#B+
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2B ;%<<%3+%(+)-"''(+>()#"=-#>%()+#%+W'"%+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'B+
0B _>#$+#$'+PQFH&QR&Q+S(''+&9)#'C+T'G>-'+(%3+2-#>G2#'T*+62))+#$'+)'2<'T+6%=-$')+#%+#$'+(=")')+3>#$>(+#$'+)#'"><'+I>'<T+
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LB !6'(+T%=J<'+)'2<'T+6%=-$')+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+#%+#$'+
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.AB ;<'Z+#$'+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+
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7%3'"+D=##%(+%(+#$'+[)'"+,(#'"I2-'B+
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+
+
+
+
+
+
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+
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+
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-=)#%C'")'"G>-'M%"#$%)'()%"B-%C+%"+4%+#%+333B%"#$%)'()%"B-%CB+
+
+
+
+
VERASENSETM TROUBLESHOOTING
+
Issue%
Cause%
Solution%
PQFH&QR&Q+]'G>-'+?Q]+T%')+(%#+<>4$#+=6+
PQFH&QR&Q+]'G>-'+J2##'">')+2"'+T'2T+
]>)-2"T+ PQFH&QR&Q+]'G>-'+2(T+
"'6<2-'+
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"2(4'+
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]'G>-'+
`%G'+ ?>(8#>%(+#%+ 2-$>'G'+ 2(+
=(%J)#"=-#'T+ <>('E%IE)>4$#+ #%+ #$'+
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PQFH&QR&Q+]'G>-'+>)+6%3'"'T+%II+
H-#>G2#'+3>#$+?>(8#>%(+C24('#+
PQFH&QR&Q+]'G>-'+J2##'">')+2"'+<%3+
]>)-2"T+ PQFH&QR&Q+]'G>-'+2(T+
"'6<2-'+
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)'##<')+U266"%Z>C2#'<9+/+)'-%(T)V+
+
VERASENSE™ KNEE SYSTEM DEVICE SPECIFICATIONS
N$>)+T'G>-'+-%C6<>')+3>#$+72"#+./+%I+#$'+;55+F=<')B+!6'"2#>%(+>)+)=JX'-#+#%+#$'+I%<<%3>(4+#3%+-%(T>#>%()e+U.V+#$>)+T'G>-'+C29+(%#+
-2=)'+$2"CI=<+>(#'"I'"'(-'*+2(T+UAV+#$>)+T'G>-'+C=)#+2--'6#+2(9+>(#'"I'"'(-'+"'-'>G'T*+>(-<=T>(4+>(#'"I'"'(-'+#$2#+C29+-2=)'+
=(T')>"'T+%6'"2#>%(B+
+
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//1..+5<2))+D+2(T+QR+0101.E.EABV++N$')'+<>C>#)+2"'+T')>4('T+#%+6"%G>T'+"'2)%(2J<'+6"%#'-#>%(+242>()#+$2"CI=<+>(#'"I'"'(-'+>(+2+
#96>-2<+C'T>-2<+>()#2<<2#>%(B++N$>)+'Y=>6C'(#+4'('"2#')*+=)')*+2(T+-2(+"2T>2#'+"2T>%+I"'Y='(-9+'('"49+2(T*+>I+(%#+>()#2<<'T+2(T+
=)'T+>(+2--%"T2(-'+3>#$+#$'+>()#"=-#>%()*+C29+-2=)'+$2"CI=<+>(#'"I'"'(-'+#%+%#$'"+T'G>-')+>(+#$'+G>->(>#9B++^%3'G'"*+#$'"'+>)+(%+
4=2"2(#''+#$2#+>(#'"I'"'(-'+3><<+(%#+%--="+>(+2+62"#>-=<2"+>()#2<<2#>%(B++,I+#$>)+'Y=>6C'(#+T%')+-2=)'+$2"CI=<+>(#'"I'"'(-'*+3$>-$+
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N$>)+ T'G>-'+ -%C6<>')+ 3>#$+ 72"#+ K/+ %I+ #$'+ ;55+ "=<')B+ + N$>)+ T'G>-'+ C29+ (%#+ >(#'"I'"'+ 3>#$+ )#2#>%()+ %6'"2#>(4+ >(+ #$'+ :11B./1h
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!"#$%&'()%"*+,(-+ + +++++
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Model:%
PQFH&QR&QO+S(''+&9)#'C+
Quantity:%
.+
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Type:%
&>(4<'+7"%-'T="'+!(<9B+]%+(%#+"'E)#'"><>W'+
Sterile:%
Q#$9<'('+!Z>T'+
Device%Type:%
N96'+D;+
+
FCC%ID:%
iR?E!FN^!&R&F.+
iR?E!FN^!&R&FA+
iR?E!FN^!&R&F@
Operating%Range:%
6.5 ft [2m] Unobstructed
Mode%of%Operation:%
N'C6%"2"9+U)>(4<'E=)'V+ +
Power%Supply:%
,(#'"(2<<9+6%3'"'T+2#+<'))+#$2(+@B@+P]5+
Battery%Life:%
:1+C>(=#')+U266"%Z>C2#'V+
Temperature:%
Operation%
15°C 37°C
Storage%
0°C 50°C
Relative%Humidity:%
@1j+++++++.11j*+)=JC'")>%(+
.1j+++++++/1j*+(%(E-%(T'()>(4+
Atm%Pressure:%
:L1E.101+$72+
@01E.101+$72
Rx%Only:%
[B&B+;'T'"2<+?23+"')#">-#)+#$>)+6"%T=-#+#%+)2<'+J9+%"+%(+#$'+%"T'"+%I+2+6$9)>->2(+