NovaSure ADVANCED Instructions for Use and Controller Operators Manual Rev 009 Oct 2016

E N G L IS H

B A C K T O T O C

N o v a S u reD is p o s a b leD e v ic eD e s c rip tio n

N o v a S u reM o d e l0 8 -0 9 R FC o n tro lle rs

T h eN o v a S u red is p o s a b led e v ic ec o n s is tso fas in g le -p a tie n tu s e ,

N o v a S u reM o d e l1 0 R FC o n tro lle r

c o n fo rm a b leb ip o la re le c tro d ea rra ym o u n te do na ne x p a n d a b le fra m eth a tc a nc re a teac o n fu e n tle s io no nth ee n tirein te rio r s u rfa c ea re ao fth eu te rin ec a v ityT h ed is p o s a b led e v ic eisin s e rte d tra n s c e rv ic a llyin toth eu te rin ec a v ity ,a n dth es h e a thisre tra c te dto a llo w th eb ip o la re le c tro d ea rra ytob ed e p lo y e da n dc o n fo rm toth e u te rin ec a v ity T h eb ip o la re le c tro d ea rra yisfo rm e dfro m am e ta liz e d ,p o ro u s fa b ricth ro u g hw h ic hs te a m a n dm o is tu rea rec o n tin u o u s ly s u c tio n e dfro m th ed e s ic c a te dtis s u eT h ed is p o s a b led e v ic e w o rk sinc o n ju n c tio nw ithad e d ic a te dN o v a S u reR F c o n tro lle rto p e rfo rm c u s to m iz e d ,g lo b a le n d o m e tria la b la tio nina na v e ra g e o fa p p ro x im a te ly9 0s e c o n d sw ith o u tth en e e dfo rc o n c o m ita n t h y s te ro s c o p icv is u a liz a tio no re n d o m e tria lp re tre a tm e n tT h e s p e c ifcc o n fg u ra tio no fth eb ip o la re le c tro d ea rra ya n dth e p re d e te rm in e dp o w e ro fth ec o n tro lle rc re a teac o n tro lle dd e p tho f a b la tio ninu te ri s o u n d in gle s sth a no re q u a l to1 0c m a n dh a v in ga m in im u m c o rn u -to -c o rn ud is ta n c eo f25c m N o v a S u reR FC o n tro lle rD e s c rip tio n

D u rin gth ea b la tio np ro c e s s ,th efo w o fra d iofre q u e n c y(R F )e n e rg y v a p o riz e sa n d /o rc o a g u la te sth ee n d o m e triu m re g a rd le s so fits

T h eN o v a S u reR F c o n tro lle risac o n s ta n tp o w e ro u tp u tg e n e ra to rw itha

th ic k n e s sa n dd e s ic c a te sa n dc o a g u la te sth eu n d e rly in g ,s u p e rfc ia l

n o m in a lm a x im u m p o w e rd e liv e ryc a p a b ilityo f1 8 0w a ttsT h ec o n tro lle r

m y o m e triu m

a u to m a tic a llyc a lc u la te sth ep o w e ro u tp u tb a s e do nth eu te rin ec a v ity le n g th(s o u n dm e a s u re m e n tm in u sth ele n g tho fth ee n d o c e rv ic a lc a n a l)

T h ec o n tro lle ra u to m a tic a llyc a lc u la te sth eo p tim a lp o w e rle v e l (W )

a n dw id thm e a s u re m e n tsth a tth eu s e rk e y -e n te rsin toth ec o n tro lle r

re q u ire dfo rth etre a tm e n to fth eu te rin ec a v ity ,b a s e do nu te rin e

M o n ito rin gtis s u eim p e d a n c ed u rin gth ea b la tio np ro c e s sa u to m a tic a lly

s iz eA stis s u ed e s tru c tio nre a c h e sa no p tim a ld e p th ,in c re a s in g

c o n tro lsth ed e p tho fe n d o -m y o m e tria la b la tio nT h eN o v a S u rep ro c e d u re

tis s u eim p e d a n c ec a u s e sth ec o n tro lle rtoa u to m a tic a llyte rm in a te

s e lf-te rm in a te so n c ee n d o m e tria lv a p o riz a tio na n ds u p e rfc ia lm y o m e tria l

p o w e rd e liv e ry ,th e re b yp ro v id in gas e lf-re g u la tin gp ro c e s sB lo o d ,

d e s ic c a tio nh a v ere a c h e d5 0o h m so fim p e d a n c ea tth etis s u e -e le c tro d e

s a lin ea n do th e rliq u idp re s e n tinth eu te rin ec a v itya tth etim e

in te rfa c e ,o rw h e nth etre a tm e n ttim e rre a c h e stw om in u te sIn te g ra l

o fth ep ro c e d u re ,a sw e ll a sv a p o rlib e ra te dfro m th ed e s ic c a te d

toth ec o n tro lle risth ec a v ityin te g ritya s s e s s m e n ts y s te m (C IA )w h ic h

tis s u e ,a ree v a c u a te db yc o n tin u o u s ,a u to m a tics u c tio n in g

isd e s ig n e dtod e te rm in ew h e th e rth e reisad e fe c to rp e rfo ra tio ninth e T h ed is p o s a b led e v ic eisc o n n e c te dtoth ec o n tro lle rv iaa

w a ll o fth eu te ru sA fte rth ed is p o s a b led e v ic eisp la c e din toth eu te rin e

c o rdc o n ta in in gth eR F c a b le ,s u c tio ntu b in gu s e dfo rp re s s u re

c a v ity ,C Oisd e liv e re dth ro u g hth ec e n tra l lu m e no fth ed is p o s a b le

m o n ito rin gd u rin gth ec a v ityin te g ritya s s e s s m e n tc y c lea n dfo r

2

d e v ic ein toth ec a v ity ,v iath ev a c u u m fe e d b a c ktu b in g ,a tas a fefo w

s u c tio nd u rin gth ea b la tio nc y c le ,a n dv a c u u m fe e d b a c ktu b in gu s e d

ra tea n dp re s s u reIfth eC Op re s s u reinth ec a v ityism a in ta in e dfo ra

fo rc a rb o nd io x id ed e liv e ryd u rin gth ec a v ityin te g ritya s s e s s m e n t

2

s h o rtp e rio do ftim e ,in d ic a tin gth a tth eu te rin ec a v ityisin ta c t,th e nth e

c y c lea n dv a c u u m m o n ito rin gd u rin gth ea b la tio nc y c le

C IA w ill a llo w th eN o v a S u reR F c o n tro lle rtob ee n a b le da n dp ro c e e dw ith th etre a tm e n tp h a s eA v a c u u m p u m pc o n ta in e dw ith inth eN o v a S u re R F c o n tro lle rc re a te sa n dm a in ta in sav a c u u m inth eu te rin ec a v ity th ro u g h o u tth ee n d o m e tria la b la tio np ro c e d u reO n c eth ev a c u u m is s ta b iliz e d ,th ev a c u u m le v e l ism o n ito re dth ro u g h o u tth ere m a in d e ro f th ea b la tio np ro c e s s

2

B A C K T O T O C

E N G L IS H

• ap a tie n tw h oisp re g n a n to rw h ow a n tstob e c o m ep re g n a n tinth e

N o v a S u reS u c tio nL in eD e s ic c a n t

fu tu reP re g n a n c ie sfo llo w in ga b la tio nc a nb ed a n g e ro u sfo rb o th

D e s c rip tio n

m o th e ra n dfe tu s

T h eN o v a S u res u c tio nlin ed e s ic c a n t isan o n -s te rile ,s in g le -p a tie n tu s e

• ap a tie n tw ithk n o w no rs u s p e c te de n d o m e tria lc a rc in o m a(u te rin e

c o m p o n e n tth a tth eu s e ra tta c h e s

c a n c e r)o rp re -m a lig n a n tc o n d itio n so fth ee n d o m e triu m ,s u c ha s u n re s o lv e da d e n o m a to u sh y p e rp la s ia

in -lin ew ithth es u c tio ntu b in g ,p rio r

• ap a tie n tw itha n ya n a to m icc o n d itio n(eg,h is to ryo fp re v io u s

toc o n n e c tin gth ed is p o s a b led e v ic e toth eN o v a S u reR F c o n tro lle rT h e

c la s s ic a lc e s a re a ns e c tio no rtra n s m u ra lm y o m e c to m y )o rp a th o lo g ic

d e s ic c a n ta b s o rb sth em o is tu re

c o n d itio n(eg,lo n g -te rm m e d ic a l th e ra p y )th a tc o u ldle a dto w e a k e n in go fth em y o m e triu m

re m o v e dfro m th eu te rin ec a v ityv ia

• ap a tie n tw itha c tiv eg e n ita lo ru rin a rytra c tin fe c tio na tth etim eo f

th es u c tio ntu b in gd u rin gth ea b la tio n

th ep ro c e d u re(eg,c e rv ic itis ,v a g in itis ,e n d o m e tritis ,s a lp in g itiso r

p ro c e d u re

c y s titis )

N o v a S u reF o o tS w itc h D e s c rip tio n

• ap a tie n tw itha nin tra u te rin ed e v ic e(IU D )c u rre n tlyinp la c e

T h eN o v a S u refo o ts w itc hisa

• ap a tie n tw ithau te rin ec a v ityle n g thle s sth a n4c mT h em in im u m

p n e u m a tics w itc hth a tc o n n e c tstoth e

le n g tho fth ee le c tro d ea rra yis4c mT re a tm e n to fau te rin ec a v ityw ith

N o v a S u reR F c o n tro lle rfro n tp a n e l

ale n g thle s sth a n4c m w ill re s u ltinth e rm a l in ju rytoth ee n d o c e rv ic a l c a n a l

Itisu s e dtoa c tiv a teth eN o v a S u reR F

• ap a tie n tw ithau te rin ec a v ityw id thle s sth a n25c m ,a sd e te rm in e d

c o n tro lle ra n dd o e sn o tc o n ta ina n y

b yth eW ID T H d ia lo fth ed is p o s a b led e v ic efo llo w in gd e v ic e

e le c tric a lc o m p o n e n ts

d e p lo y m e n t • ap a tie n tw itha c tiv ep e lv icin fa m m a to ryd is e a s e

N o v a S u reC OC a n is te r D e s c rip tio n

2

W A R N IN G S

T h eN o v a S u reC Oc a n is te risa1 6 -

F A IL U R E T O F O L L O W A N Y IN S T R U C T IO N S O R F A IL U R E T O H E E D

2

g ra m C O(U S P )c a n is te r Itisa tta c h e d

A N Y W A R N IN G S O R C A U T IO N S C O U L D R E S U L TIN S E R IO U S P A T IE N T

2

toth ere g u la to rlo c a te do nth eb a c k

IN J U R Y .

p a n e lo fth eN o v a S u reR F c o n tro lle r

T H E N O V A S U R E D IS P O S A B L E D E V IC E M U S TB E U S E D O N L Y IN

p rio rtoa p p ly in glin ev o lta g eto

C O N J U N C T IO N W IT H T H E N O V A S U R E R FC O N T R O L L E R .

th eN o v a S u reR F c o n tro lle rT h e

T H E N O V A S U R E P R O C E D U R E IS IN T E N D E D T O B E P E R F O R M E D O N L Y

C Oisu s e db yth ec a v ityin te g rity 2

a s s e s s m e n ts y s te m top re s s u riz eth e

O N C E D U R IN G A S IN G L E O P E R A T IV E V IS IT .T H E R M A LIN J U R Y T O T H E

u te rin ec a v ity

B O W E LM A Y O C C U R W H E N M U L T IP L E N O V A S U R E T H E R A P Y C Y C L E S A R E P E R F O R M E D D U R IN G T H E S A M E O P E R A T IV E V IS IT .

N o v a S u reA C P o w e rC o rd D e s c rip tio n

U te rin eP e rfo ra tio n

T h eN o v a S u reA C p o w e rc o rd ,

•U s ec a u tio nn o ttop e rfo ra teth eu te rin ew a ll w h e ns o u n d in g ,d ila tin g

am e d ic a lg ra d ec o rd ,c o n n e c ts

o rin s e rtin gth ed is p o s a b led e v ic e

th eN o v a S u reR F c o n tro lle rto

• Ifth ed is p o s a b led e v ic eisd iffc u lttoin s e rtin toth ec e rv ic a lc a n a l,

th ea p p ro p ria telin ev o lta g eT h e

u s ec lin ic a l ju d g m e n ttod e te rm in ew h e th e ro rn o tfu rth e rd ila tio nis

re c e p ta c lefo rth ep o w e rc o rd ,th e

re q u ire d

p o w e rin p u tm o d u le ,islo c a te do n

•T h eN o v a S u res y s te m p e rfo rm sac a v ityin te g ritya s s e s s m e n t(C IA )

th eb a c kp a n e lo fth eN o v a S u reR F

toe v a lu a teth ein te g rityo fth eu te rin ec a v itya n ds o u n d sa na la rm

c o n tro lle r

w a rn in go fap o s s ib lep e rfo ra tio np rio rtotre a tm e n t(S te p23 6 ) (A lth o u g hd e s ig n e dtod e te c t ap e rfo ra tio no f th eu te rin ew a ll,it is

IN D IC A T IO N S

a nin d ic a to ro n lya n dit m ig h tn o td e te c ta ll p e rfo ra tio n su n d e ra ll

T h eN o v a S u res y s te m isin te n d e dtoa b la teth ee n d o m e tria l lin in go fth e

p o s s ib lec irc u m s ta n c e sC lin ic a l ju d g m e n tm u s ta lw a y sb eu s e d)

u te ru sinp re -m e n o p a u s a lw o m e nw ithm e n o rrh a g ia(e x c e s s iv eb le e d in g )

• If au te rin ep e rfo ra tio niss u s p e c te d ,th ep ro c e d u res h o u ldb e

d u etob e n ig nc a u s e sfo rw h o m c h ild b e a rin gisc o m p le te

te rm in a te dim m e d ia te ly C O N T R A IN D IC A T IO N S

T h eN o v a S u reim p e d a n c ec o n tro lle de n d o m e tria la b la tio ns y s te m is c o n tra in d ic a te dfo ru s ein :

3

E N G L IS H

B A C K T O T O C

• If th ec a v ityin te g ritya s s e s s m e n t fa ilsa fte rre a s o n a b lea tte m p ts

s c re e na p p e a rs(M o d e l1 0R F C )a n da na u d ib lep u ls e dto n es o u n d s

toim p le m e n t th etro u b le s h o o tin gp ro c e d u re s(s te p23 6 ),a b o rt

th ro u g h o u tth ep u rg ep ro c e d u reW h e nth eto n ea n dth eL E D /s c re e n m e s s a g es to p sitiss a fetoin s e rtth ed is p o s a b led e v ic e

th ep ro c e d u re

•F o rp a tie n tsinw h o m th ep ro c e d u rew a sa b o rte dd u etoas u s p e c te d

•F o rp a tie n tsw ithc a rd ia cp a c e m a k e rso ro th e ra c tiv eim p la n ts ,a

u te rin ew a ll p e rfo ra tio n ,aw o rk -u pfo rp e rfo ra tio ns h o u ldb e

p o s s ib leh a z a rde x is tsd u etoin te rfe re n c ew ithth ea c tio no fth e

c o n s id e re dp rio rtod is c h a rg e

p a c e m a k e rth a tm a yo c c u ra n dm a yd a m a g eth ep a c e m a k e rC o n s u lt th ep a c e m a k e rm a n u fa c tu re rfo rfu rth e rin fo rm a tio nw h e nu s eo fth e

G e n e ra l

N o v a S u res y s te m isp la n n e dinp a tie n tsw ithc a rd ia cp a c e m a k e rs

•E n d o m e tria la b la tio nu s in gth eN o v a S u res y s te m isn o tas te riliz a tio n

•C a res h o u ldb eta k e ntoe n s u reth ep a tie n td o e sn o tc o n ta c tm e ta l

p ro c e d u reT h e re fo re ,th ep a tie n ts h o u ldb ea d v is e do fa p p ro p ria te

p a rtsw h ic ha ree a rth e do rw h ic hh a v ea na p p re c ia b lec a p a c ita n c eto

b irthc o n tro lm e th o d s

e a rth ,s u c ha sd ire c tc o n ta c tw ithth em e ta lo nta b le s

•E n d o m e tria la b la tio nd o e sn o te lim in a teth ep o te n tia l fo re n d o m e tria l

•D on o tu s einth ep re s e n c eo fafa m m a b le a n g e r:e x p lo s io nh a z a rdD

h y p e rp la s iao ra d e n o c a rc in o m ao fth ee n d o m e triu m a n dm a ym a s kth e

a n e s th e ticm ix tu reD on o tu s einth ep re s e n c eo ffa m m a b leg a s e so r

p h y s ic ia n ’sa b ilitytod e te c to rm a k ead ia g n o s iso fs u c hp a th o lo g y

liq u id s

•E n d o m e tria la b la tio nisin te n d e dfo ru s eo n lyinw o m e nw h od o

•F a ilu reo fth eN o v a S u reR F c o n tro lle rc o u ldre s u ltina nu n in te n d e d

n o td e s iretob e a rc h ild re nb e c a u s eth elik e lih o o do fp re g n a n c yis

in c re a s eino u tp u tp o w e r

s ig n ifc a n tlyd e c re a s e dfo llo w in gth ep ro c e d u reP re g n a n c yfo llo w in g a b la tio nm a yb ed a n g e ro u sfo rb o thm o th e ra n dfe tu s

P R E C A U T IO N S

•P a tie n tsw h ou n d e rg oe n d o m e tria la b la tio np ro c e d u re sw h oh a v e

• Ith a sb e e nre p o rte dinth elite ra tu reth a tp a tie n tsw ithas e v e re ly

p re v io u s lyu n d e rg o n etu b a l lig a tio na rea tin c re a s e dris ko fd e v e lo p in g

a n te v e rte d ,re tro fe x e do rla te ra llyd is p la c e du te ru sa rea tg re a te rris k

p o s ta b la tio ntu b a ls te riliz a tio ns y n d ro m ew h ic hc a nre q u ire

o fu te rin ew a ll p e rfo ra tio nd u rin ga n yin tra u te rin em a n ip u la tio n

h y s te re c to m yT h isc a no c c u ra sla tea s1 0y e a rsp o s tp ro c e d u re

•A fa ls ep a s s a g ec a no c c u rd u rin ga n yp ro c e d u reinw h ic hth eu te ru s

•A h e a lthh a z a rdm a ye x is tinth ec a s ew h e reth eN o v a S u rep ro c e d u re

isin s tru m e n te d ,e s p e c ia llyinc a s e so fs e v e rea n te v e rte dre tro fe x e d

isp e rfo rm e dinth ep re s e n c eo fath e rm a llya n de le c tric a llyc o n d u c tiv e

o rala te ra llyd is p la c e du te ru sU s ec a u tio ntoe n s u reth a tth ed e v ic eis

®m E s s u re ic ro -in s e rtth a tisim p ro p e rlyp o s itio n e d(eg,p e rfo ra tin gth e

p ro p e rlyp o s itio n e dinth eu te rin ec a v ity

fa llo p ia ntu b eo rth em y o m e triu m ) Ifth iso c c u rs ,h e a tc a nb ed ra w n

•T h eN o v a S u res y s te m c o n s is tso fth efo llo w in gc o m p o n e n ts :

a w a yfro m th ein te n d e dtre a tm e n ta re ato w a rdo th e rtis s u ea n d /o r

-s in g le -p a tie n tu s eN o v a S u red is p o s a b led e v ic ew ithc o n n e c tin gc o rd

o rg a n sinc o n ta c tw ithth ec o n d u c tiv eo b je c t,w h ic hm a yb es u ffc ie n t

-N o v a S u reR F c o n tro lle r

toc a u s elo c a liz e db u rn sA sare s u lt,c o rre c tp la c e m e n to fth eE s s u re

-N o v a S u reC Oc a n is te r

m ic ro -in s e rtm u s tb ec o n frm e d ,eg,b yo b ta in in gth ere p o rto fth e

2

-N o v a S u red e s ic c a n t

E s s u reC o n frm a tio nT e s t(E C T ),p rio rtop e rfo rm in gth eN o v a S u re

-N o v a S u refo o ts w itc h

p ro c e d u reIfth ere p o rta n d /o rE C T flm sa reu n a v a ila b le ,th eE C T s h o u ldb ere p e a te dtoc o n frm c o rre c tp la c e m e n to fth eE s s u rem ic ro -

-p o w e rc o rd

in s e rtsp rio rtop e rfo rm in gth eN o v a S u rep ro c e d u re

T oe n s u rep ro p e ro p e ra tio n ,n e v e ru s eo th e rc o m p o n e n tsw ithth e N o v a S u res y s te mIn s p e c tth ec o m p o n e n tsre g u la rlyfo rd a m a g e ,

T e c h n ic a l

a n dd on o tu s eth e m ifd a m a g eisa p p a re n tT h eu s eo fa n yc a b le so r

•D on o tu s eth es te rile ,s in g le -p a tie n tu s ed is p o s a b led e v ic eifth e

a c c e s s o rie so th e rth a nth o s es p e c ife dinth e s ein s tru c tio n sm a yre s u lt

p a c k a g in ga p p e a rstob ed a m a g e do rth e reise v id e n c eo fta m p e rin g

inin c re a s e de m is s io n so rd e c re a s e dim m u n ityo fth eR F c o n tro lle r

•T h ed is p o s a b led e v ic eisfo rs in g le -p a tie n tu s eo n lyD on o tre u s eo r

•T h eR F c o n tro lle rm u s tb ein s ta lle da n dp u tin tos e rv ic ea c c o rd in g

re -s te riliz eth ed is p o s a b led e v ic e

toth eg u id a n c ep ro v id e dinth e s ein s tru c tio n stoe n s u reits

• Ifa n yh y s te ro s c o p yp ro c e d u reisp e rfo rm e dw ithh y p o to n ics o lu tio n

e le c tro m a g n e ticc o m p a tib ilityR e fe rtoth ee le c tro m a g n e tice m is s io n s

im m e d ia te lyp rio rtoN o v a S u retre a tm e n t,th e nth eu te rin ec a v itym u s t

a n dim m u n ityta b le sinth eS p e c ifc a tio n ss e c tio n

b efu s h e dw ithn o rm a ls a lin ep rio rtotre a tm e n tw ithth eN o v a S u re

•T h eR F c o n tro lle rs h o u ldn o tb eu s e da d ja c e n ttoo rs ta c k e dw itho th e r

s y s te mT h ep re s e n c eo fh y p o to n icfu idm a yre d u c eth ee ffc ie n c yo f

e q u ip m e n t Ifa d ja c e n to rs ta c k e du s eisn e c e s s a ry ,th eR F c o n tro lle r

th eN o v a S u res y s te m

s h o u ldb eo b s e rv e dtov e rifyn o rm a lo p e ra tio ninth ec o n fg u ra tio nin

•P lu g g in gth ed is p o s a b led e v ic ein toth ec o n tro lle rs ta rtsC Ofo w to

w h ic hitw ill b eu s e d

2

p u rg ea n ya iro u to fth ed is p o s a b led e v ic ea n dtu b in gT h isp u rg in g

•P o rta b lea n dm o b ileR F c o m m u n ic a tio n se q u ip m e n tc a na ffe c tth e

o p e ra tio nta k e sa p p ro x im a te ly1 0s e c o n d sa n dm u s tb ep e rfo rm e d

R F c o n tro lle rR e fe rtoth ee le c tro m a g n e ticim m u n ityta b le sinth e

w ithth ed is p o s a b led e v ic ee x te rn a l toth ep a tie n t toe lim in a te

S p e c ifc a tio n ss e c tio nfo rre c o m m e n d e ds e p a ra tio nd is ta n c e s

h eN o v a S u reR F c o n tro lle rC A V IT Y th eris ko fa iro rg a se m b o lis mT

•P a tie n tsw h oh a v eu n d e rg o n ee n d o m e tria la b la tio na n da rela te r

A S S E S S M E N T L E D fa s h e sre d(M o d e l0 8 -0 9R F C s )o rap u rg in gd e v ic e

p la c e do nh o rm o n ere p la c e m e n tth e ra p ys h o u ldh a v eap ro g e s tin

4

B A C K T O T O C

E N G L IS H

in c lu d e dinth e irm e d ic a tio nre g im e nino rd e rtoa v o idth ein c re a s e d

•T h ec e rv ic a lc o lla rm u s tb efu llyre tra c te dtoitsp ro x im a lp o s itio nin

ris ko fe n d o m e tria la d e n o c a rc in o m aa s s o c ia te dw ithu n o p p o s e d

o rd e rtom in im iz eth ep o te n tia l fo rd a m a g etoth es h e a thw h e nc lo s in g

e s tro g e nre p la c e m e n tth e ra p y

th ea rra y

•T h es a fe tya n de ffe c tiv e n e s so fth eN o v a S u res y s te m h a sn o tb e e n

N o v a S u re3 -Y e a rC lin ic a lD a ta

fu llye v a lu a te dinp a tie n ts : A d v e rs eE v e n ts

-w ithau te rin es o u n dm e a s u re m e n tg re a te rth a n1 0c m ;

T h eN o v a S u res y s te m w a se v a lu a te dinara n d o m iz e d ,p ro s p e c tiv e ,

-w iths u b m u c o s a l fb ro id sth a td is to rt th eu te rin ec a v ity ;

m u lti-c e n te rc lin ic a ls tu d yo f2 6 5p a tie n tsw itha b n o rm a lu te rin e

-w ithb ic o rn u a te ,s e p ta teo rs u b -s e p ta te u te ri;

b le e d in gc o m p a rin gth eN o v a S u res y s te m toac o n tro la rm o fw irelo o p

-w ithm e d ic a l (eg,G n R H a g o n is t)o rs u rg ic a lp re tre a tm e n t;

re s e c tio no fth ee n d o m e triu m fo llo w e db yro lle rb a ll a b la tio n

-w h oh a v eu n d e rg o n eap re v io u se n d o m e tria la b la tio nin c lu d in gth e N o v a S u ree n d o m e tria la b la tio np ro c e d u re ;o r ,

T a b le1 A . In tra -O p e ra tiv eA d v e rs eE v e n ts

-w h oa rep o s t-m e n o p a u s a l

N o v a S u re

•D on o ta tte m p ttore p a irth ec o n tro lle rifp ro b le m sa res u s p e c te d

L o o pR e s e c tio n P lu sR o lle rb a ll

C a ll H o lo g icT e c h n ic a lS u p p o rto raH o lo g ics a le sre p re s e n ta tiv efo r

A d v e rs eE v e n t

n = 1 7 5(% )

n = 9 0(% )

B ra d y c a rd ia

1( 06 % )

0( 00 % )

U te rin ep e rfo ra tio n

0( 00 %

3( 33 % )

•T h eu s e rs h o u ldin s p e c tth ed is p o s a b led e v ic efo rd a m a g ep rio rtou s e

C e rv ic a l te a r

0( 00 %

2( 22 % )

•T h es u c tio nlin ed e s ic c a n tisn o n -s te rile ,a n dth ep a c k a g in gs h o u ldn o t

C e rv ic a ls te n o s is

0( 00 %

1( 11 % )

T O T A L

1(06 % )

6(67 % )

in s tru c tio n s •C a b le stoth ed is p o s a b led e v ic es h o u ldb ep o s itio n e ds u c hth a tc o n ta c t w ithp a tie n to ro th e rle a d sisa v o id e d

b ep la c e dinth es te rilefe ld • If th eA R R A Y P O S IT IO N L E D lig h t isillu m in a te do nM o d e ls0 8 0 9 ,o ra nA rra yP o s itio nm e s s a g eisd is p la y e do nth eM o d e l1 0 s c re e n ,s e eth eT ro u b le s h o o tin gs e c tio nu n d e r“A R R A Y P O S IT IO N

T a b le1 B .P o s t-O p e ra tiv eA d v e rs eE v e n ts<2 4H o u rs

A L A R M ”

N o v a S u re

•D on o tu s eth eN o v a S u res u c tio nlin ed e s ic c a n tifd e s ic c a n tm a te ria l is

L o o pR e s e c tio n P lu sR o lle rb a ll

p in kinc o lo r

A d v e rs eE v e n t

•T h ed is p o s a b led e v ic em u s tb ee x te rn a l to(o u ts id eo f)th ep a tie n t b e fo rec o n n e c tin gth ec o rdtoth ea p p ro p ria tep o rto nth efro n tp a n e lo f th ec o n tro lle r(s te p21 5 ) •T h ec a rb o nd io x id ec a n is te rc o n ta in sg a su n d e rh ig hp re s s u reInth e

n = 1 7 5(% )

n = 9 0(% )

P e lv icp a in /c ra m p in g

6( 34 % )

4( 44 % )

N a u s e aa n d /o rv o m itin g

3( 17 % )

1( 11 % )

T O T A L

9(51 % )*

5(56 % )**

* N in ee v e n tsre p o rte din6(34 % )p a tie n ts

e v e n to fab re a c h e dC Oc a n is te ro rlin e ,a llo w th ec a n is te rtoe x h a u s t

** F iv ee v e n tsre p o rte din4(44 % )p a tie n ts

2

c o m p le te ly ,a n da llo w th ec a n is te ra n d /o rlin e stoe q u ilib ra tetoro o m T a b le1 C .P o s t-O p e ra tiv eA d v e rs eE v e n ts>2 4H o u rs–2W e e ks

te m p e ra tu rep rio rtoh a n d lin g •C Oc o n tin u o u s lyfo w sfro m th etim eth a tth ed is p o s a b led e v ic eis

N o v a S u re

2

p lu g g e din toth ec o n tro lle ru n til th eC IA p o rtio no fth ep ro c e d u reis

L o o pR e s e c tio n P lu sR o lle rb a ll

A d v e rs eE v e n t

n = 1 7 5(% )

n = 9 0(% )

H e m a to m e tra

1(06 % )

0( 00 %

U rin a rytra c tin fe c tio n

1(06 % )

1( 11 % )

V a g in a l in fe c tio n

1(06 % )

0( 00 %

E n d o m e tritis

0(00 %

2( 22 % )

d is p o s a b led e v ic eo rinc lo s ep ro x im itytoth ee le c tro d ea rra ym a y

P e lv icin fa m m a to ryd is e a s e

0(00 %

1( 11 % )

d ra w c u rre n ta w a yfro m th ea rra yT h ism a yre s u ltinlo c a liz e db u rn s

H e m o rrh a g e

0(00 %

1( 11 % )

toth ep a tie n to rp h y s ic ia no rind is to rtio no fth ee le c tric a l fe ldo fth e

P e lv icp a in /c ra m p in g

1(06 % )

1( 11 % )

c o m p le teT om in im iz eth ed u ra tio no fC Ofo w a n dp o te n tia l ris ko f 2

e m b o lis m ,p e rfo rm th es e a tin gp ro c e d u reim m e d ia te lya fte rin s e rtin g th ed is p o s a b led e v ic ea n dp ro c e e dd ire c tlyfro m th es e a tin gp ro c e d u re toth eC IA •E le c tric a llyc o n d u c tiv eo b je c ts(eg,m o n ito rin ge le c tro d e sfro m o th e r d e v ic e s )th a ta reind ire c tc o n ta c tw ithth ee le c tro d ea rra yo fth e

a rra y ,w h ic hw o u ldc h a n g eth eth e ra p e u tice ffe c t(u n d e r-tre a tm e n to r o v e r-tre a tm e n t) Itm a ya ls ore s u ltind is to rtio no fth ec u rre n tinth e c o n d u c tiv eo b je c t,eg,m o n ito rsm a yd is p la yfa ls ere a d in g s •G ro u n d in gre lia b ilityiso n lya c h ie v e dw h e ne q u ip m e n tisc o n n e c te dto

N a u s e aa n d /o rv o m itin g

1(06 % )

1( 11 % )

T O T A L

5(29 % )*

7(78 % )**

* F iv ee v e n tsre p o rte din4(23 % )p a tie n ts ** S e v e ne v e n tsre p o rte din6(67 % )p a tie n ts

are c e p ta c lem a rk e d“h o s p ita lg ra d e ”

5

E N G L IS H

B A C K T O T O C C lin ic a lS tu d y

T a b le1 D .P o s t-O p e ra tiv eA d v e rs eE v e n ts>2W e e ks–1Y e a r

N o v a S u re

a fe tya n de ffe c tiv e n e s so fth eu s eo fth eN o v a S u res y s te m P u rp o s e :S

L o o pR e s e c tio n

w a sc o m p a re dtow irelo o pre s e c tio no fth ee n d o m e triu m fo llo w e db y

P lu sR o lle rb a ll

ro lle rb a ll a b la tio ninp re m e n o p a u s a lw o m e ns u ffe rin gfro m m e n o rrh a g ia

A d v e rs eE v e n t

n = 1 7 5 (% )

n = 9 0(% )

H y s te re c to m y

3( 17 % )

2( 22 % )

H e m a to m e tra

1( 06 % )

2( 22 % )

U rin a rytra c tin fe c tio n

2( 11 % )

2( 22 % )

V a g in a l in fe c tio n

5( 29 % )

2( 22 % )

a ne n d o m e tria lp re tre a tm e n t

E n d o m e tritis

2( 11 % )

1( 11 % )

h ep rim a rye ffe c tiv e n e s sm e a s u rew a sav a lid a te d S tu d ye n d p o in ts :T

P e lv icin fa m m a to ryd is e a s e

2( 11 % )

0( 00 %

m e n s tru a ld ia rys c o rin gs y s te m d e v e lo p e db yH ig h a m (H ig h a m J M ,

H e m o rrh a g e

1( 06 % )

0( 00 %

O ’B rie nP M S ,S h a w R W 9 9 0 ;9 7 :7 3 4 -9 ) B rJO b s te tG y n a e c o l1

P e lv icp a in /c ra m p in g

5( 29 % )

6( 67 % )

2 1(1 20 % )*

1 5(1 61 7 % )**

T O T A L

s e c o n d a rytob e n ig nc a u s e s a tie n tsra n d o m iz e din toth eN o v a S u rea rm re c e iv e d P re tre a tm e n t:P n oe n d o m e tria lp re tre a tm e n t(eg,h o rm o n e ,D & C o rp a tie n ttim in g ) P a tie n tsra n d o m iz e din toth ec o n tro la rm re c e iv e dw irelo o pre s e c tio na s

A s s e s s m e n to fm e n s tru a lb lo o dlo s sw a sp e rfo rm e du s in gap ic to ria l b lo o dlo s sa s s e s s m e n tc h a rt(P B L A C )P a tie n ts u c c e s sw a sd e fn e da s are d u c tio ninm e n s tru a l fo w a t1y e a rp o s t-p ro c e d u retoad ia rys c o re o f< 7 5S tu d ys u c c e s sw a sd e fn e da sas ta tis tic a ld iffe re n c eo fle s s

* 2 1e v e n tsin1 9(1 09 % )p a tie n ts ** 1 5e v e n tsin1 5(1 67 % )p a tie n ts

th a n2 0 % inp a tie n ts u c c e s sra te sb e tw e e nth eN o v a S u reim p e d a n c e

A n tic ip a te dP o s t-P ro c e d u ra lC o m p lic a tio n s

c o n tro lle de n d o m e tria la b la tio ns y s te m a n dw irelo o pre s e c tio np lu s

F o ra n ye n d o m e tria la b la tio np ro c e d u re ,c o m m o n lyre p o rte dp o s t-

ro lle rb a ll a b la tio nP a tie n tsw e rec o n ta c te da ttw oa n dth re ey e a rsa n d

o p e ra tiv ee v e n tsin c lu d eth efo llo w in g :

a s k e das e rie so fq u e s tio n sre g a rd in gth e irb le e d in go v e rth ep re v io u s

•C ra m p in g /p e lv icp a inw a sre p o rte dfo r34 % o fth eN o v a S u rep a tie n ts

1 2m o n th sE a c hp a tie n t’sm e n s tru a lb le e d in gs ta tu sw a sd e te rm in e d

a n d44 % o fth ew irere s e c tio nlo o pp lu sro lle rb a ll-tre a te dp a tie n ts

a ttw oa n dth re ey e a rsu s in gth eo n e -y e a rP B L A C s c o rea n db le e d in g

w ith in2 4h o u rso fth ep ro c e d u reP o s to p e ra tiv ec ra m p in gc a nra n g e

p a tte rna sare fe re n c eT h u s ,itw a sp o s s ib letod ire c tlyc o m p a rea

fro m m ildtos e v e reT h isc ra m p in gw ill ty p ic a llyla s tafe w h o u rsa n d

p a tie n t’sb le e d in gp a tte rno rm e n s tru a ls ta tu sa to n ey e a rtoth eb le e d in g

ra re lyc o n tin u e sb e y o n dth efrs td a yfo llo w in gth ep ro c e d u re

p a tte rna ttw oa n dth re ey e a rs

•N a u s e aa n dv o m itin gw e rere p o rte dfo r17 % o fth eN o v a S u rep a tie n ts

S e c o n d a rye n d p o in tsin c lu d e da n e s th e s iare g im e n ,le n g tho fp ro c e d u re

a n d11 % o fth ew irelo o pre s e c tio np lu sro lle rb a ll p a tie n tsw ith in

a n dre s p o n s e sfro m aq u a lity -o f-lifeq u e s tio n n a ireS a fe tye v a lu a tio nw a s

2 4h o u rso fth ep ro c e d u reW h e np re s e n t,n a u s e aa n dv o m itin g

b a s e do nth ea d v e rs ee v e n tsre p o rte dd u rin gth es tu d y

ty p ic a llyo c c u rim m e d ia te lyfo llo w in gth ep ro c e d u re ,a rea s s o c ia te d ra n d o m iz e d(2 :1 ),p ro s p e c tiv ec lin ic a ls tu d yw a sc o n d u c te d M e th o d s :A

w itha n e s th e s iaa n dc a nb em a n a g e dw ithm e d ic a tio n

a t9c lin ic a ls ite sa n din c lu d e d2 6 5p a tie n tsd ia g n o s e dw ithm e n o rrh a g ia

•V a g in a ld is c h a rg e

M e n s tru a ld ia rys c o re sw e rec o lle c te dp re -o p e ra tiv e lya n dm o n th lyfo r

•V a g in a lb le e d in g /s p o ttin g

1 2m o n th sp o s t-p ro c e d u reP a tie n tsw e retre a te da ta n ytim einth e ir

O th e rA d v e rs eE v e n ts

m e n s tru a lc y c leN o n eo fth ep a tie n tsre c e iv e dh o rm o n a lp re tre a tm e n t

A sw itha ll e n d o m e tria la b la tio np ro c e d u re s ,s e rio u sin ju ryo rd e a thc a n

toth inth ee n d o m e tria l lin in gC o n tro lp a tie n tsre c e iv e dh y s te ro s c o p ic

o c c u r

w irelo o pre s e c tio no fth ee n d o m e triu m a sam e c h a n ic a lm e a n so f

T h efo llo w in ga d v e rs ee v e n tsc o u ldo c c u ro rh a v eb e e nre p o rte din

e n d o m e tria lp re tre a tm e n tfo llo w e db yro lle rb a ll a b la tio nS tu d ys u b je c ts

a s s o c ia tio nw ithth eu s eo fth eN o v a S u res y s te m :

w e rere q u ire dtom e e tth efo llo w in gk e yp a tie n ts e le c tio nc rite ria :

•p o s t-a b la tio ntu b a ls te riliz a tio ns y n d ro m e

In c lu s io nc rite ria

•p re g n a n c y -re la te dc o m p lic a tio n s(N O T E :P R E G N A N C Y F O L L O W IN G

•R e fra c to rym e n o rrh a g iaw ithn od e fn a b leo rg a n icc a u s e(d y s fu n c tio n a l

E N D O M E T R IA LA B L A T IO N IS V E R Y D A N G E R O U S F O R B O T H T H E

u te rin eb le e d in g )

M O T H E R A N D T H E F E T U S .)

•A g e s2 5to5 0y e a rso fa g e

• th e rm a l in ju rytoa d ja c e n ttis s u e

•U te rin es o u n dm e a s u re m e n to f60 – 1 00c m (e x te rn a lo stoin te rn a l

•p e rfo ra tio no fth eu te rin ew a ll

fu n d u s )

•d iffc u ltyw ithd e fe c a tio no rm ic tu ritio n

•M in im u m P B L A C s c o reo f> 1 5 0fo r3m o n th sp rio rtos tu d ye n ro llm e n t;

•u te rin en e c ro s is

o rP B L A C s c o re> 1 5 0fo ro n em o n thfo rw o m e nw h o :

•a iro rg a se m b o lis m

-h a da tle a s t3p rio rm o n th s(d o c u m e n te d )fa ile dm e d ic a l th e ra p y ;

• in fe c tio no rs e p s is

-h a dac o n tra in d ic a tio ntom e d ic a l th e ra p y ;o r

•c o m p lic a tio n sle a d in gtos e rio u sin ju ryo rd e a th

- re fu s e dm e d ic a l th e ra p y

6

B A C K T O T O C

E N G L IS H

E x c lu s io nc rite ria

T a b le2 .P a tie n tA c c o u n ta b ility

•P re s e n c eo fb a c te re m ia ,s e p s iso ro th e ra c tiv es y s te m icin fe c tio n N u m b e ro fP a tie n ts

•A c tiv eo rre c u rre n tc h ro n icp e lv icin fa m m a to ryd is e a s e

N o v a S u re

W ireL o o p R e s e c tio n

•P a tie n tw ithd o c u m e n te dc o a g u lo p a th ie so ro na n tic o a g u la n ts

P lu sR o lle rb a ll

•S y m p to m a tice n d o m e trio s is L o s ttofo llo w -u p *

-5

-2

th a tin te rru p tsth ein te g rityo fth eu te rin ew a ll eg,tra n s m u ra l

H o d g k in ’sd is e a s e *

-1

0

m y o m e c to m yo rc la s s ic a lc e s a re a ns e c tio n

P e lv icP a in-a d m in is te re d

-1

0

1 5 7

8 2

A d d itio n a l tre a tm e n t*

-2

-1

H y s te re c to m y *2

-3

-1

L o s ttofo llo w -u p *

-2

-5

S p e c ifc a lly :

M is s e dv is it

-1

-1

-s e p ta teo rb ic o rn u a teu te ru so ro th e rc o n g e n ita lm a lfo rm a tio no fth e

D e c lin e dtop a rtic ip a te *

-1

0

P re g n a n c y *

-1

0

1 4 7

7 4

A d d itio n a l tre a tm e n t*

0

-4

H y s te re c to m y *2

-5

-1

L o s ttofo llo w -u p *

-4

-2

3 6 -M o n thfo llo w -u p

1 3 8

6 7

+ 1

+ 1

1 3 9

6 8

•P rio ru te rin es u rg e ry(e x c e p tlo w s e g m e n tc e s a re a ns e c tio n )

•P rio re n d o m e tria la b la tio n

le u p ro lid e *

•P a tie n to nm e d ic a tio n sth a tc o u ldth inth em y o m e tria lm u s c le ,s u c ha s

1 2 -M o n th

lo n g -te rm s te ro idu s e

fo llo w -u pd a taa v a ila b le

•P a tie n td e s iretoh a v ec h ild re no rtop re s e rv efe rtility •P a tie n tc u rre n tlyo nh o rm o n a lb irthc o n tro l th e ra p yo ru n w illin gtou s e an o n -h o rm o n a lb irthc o n tro lp o s t-a b la tio n •A b n o rm a l/o b s tru c te dc a v itya sc o n frm e db yh y s te ro s c o p y ,S IS o rH S G

u te rin ec a v ity -p e d u n c u la te d ,s u b m u c o u sle io m y o m a tao ro th e rle io m y o m a taw h ic h

2 4 -M o n th

d is to rtth ec a v ity ;p o ly p s(la rg e rth a n2c m )w h ic ha relik e lytob eth e

fo llo w -u pd a taa v a ila b le

c a u s eo fth ep a tie n t’sm e n o rrh a g ia -p re s e n c eo fa nIU D •S u s p e c te do rc o n frm e du te rin em a lig n a n c yw ith inth ela s tfv ey e a rs a sc o n frm e db yh is to lo g y •E n d o m e tria lh y p e rp la s iaa sc o n frm e db yh is to lo g y •U n a d d re s s e dc e rv ic a ld y s p la s ia

S u b je c tlo s ttofo llo w -u pa t

•E le v a te dF S H le v e lsc o n s is te n tw itho v a ria nfa ilu re> 4 0IU /m l

2 4m o s,re tu rn e da t3 6m o s

•P re g n a n c y

3 6 -M o n thfo llo w -u pd a ta

•A c tiv es e x u a llytra n s m itte dd is e a s e

a v a ila b le

to ta lo f2 6 5p a tie n tsw e ree n ro lle dinth iss tu d y P a tie n tp o p u la tio n :A

* D is c o n tin u e dp a tie n ts

P a tie n tsw e reb e tw e e nth ea g e so f2 5to5 0w ith4 6 % u n d e rth ea g e o f4 0a n d5 4 % 4 0y e a rso fa g eo ro ld e rT h e rew e ren od iffe re n c e sin d e m o g ra p h ico rg y n e c o lo g ic a lh is to ryp a ra m e te rsb e tw e e nth etre a tm e n t

1

F o u rN o v a S u red idn o tm e e tp ro to c o l In c lu s io nC rite ria ;T w oR o lle rb a ll h a du te rin ep e rfo ra tio n

2

F o rh y s te re c to m y ,s e eT a b le7

R e s u lts

g ro u p s ,b e tw e e nth ea g eg ro u p in g so ra m o n gth en in ein v e s tig a tio n a l

P rim a rye ffe c tiv e n e s se n d p o in t: b le e d in gs c o re

s ite s

P a tie n ts u c c e s sa t1 2 -m o n th sp o s t-p ro c e d u reisd e fn e da sare d u c tio n ind ia rys c o refro m > 1 5 0p re -o p e ra tiv e lyto< 7 5p o s t-p ro c e d u re

T a b le2 .P a tie n tA c c o u n ta b ility

A m e n o rrh e aisd e fn e da sas c o reo f0S u c c e s sa t2 4a n d3 6m o n th s , N u m b e ro fP a tie n ts

N o v a S u re

W ireL o o p

b a s e do nte le p h o n eq u e s tio n n a ire s ,isd e fn e da se lim in a tio no fb le e d in g

R e s e c tio n

o rre d u c tio ntolig h to rn o rm a l fo wD a tap re s e n te dinT a b le3(b e lo w )

P lu sR o lle rb a ll E n te re din toS tu d y

re p re s e n tth ec lin ic a l re s u ltsb a s e do nth eto ta ln u m b e ro f2 6 5p a tie n ts

1 7 5

9 0

-4

-2

(d e s c rib e dinT a b le2fo rp a tie n ta c c o u n ta b ility )isc o u n te da sa“fa ilu re ”

1 7 1

8 8

fo rc a lc u la tin gth ev a lu e slis te dinth eta b le

A d d itio n a l tre a tm e n t*

-4

-2

H y s te re c to m y *2

-3

-2

ra n d o m iz e d(In te n t-to -T re a tg ro u p(IT T ))fo rth es tu d yT h ew o rs t-c a s e

(In te n t-to -T re a tp o p u la tio n )

A b o rte dp ro c e d u re s *1 T re a te d

s c e n a rioisp re s e n te dw h e re b ye a c ho fth ed is c o n tin u e dp a tie n ts

7

E N G L IS H

B A C K T O T O C

T a b le3 .E ffe c tiv e n e s s :S u c c e s sR a te s – In te n t-T o -T re a tP a tie n ts

T a b le4 .E ffe c tiv e n e s s :Q u a lityo fL ife(Q O L )

W ireL o o pR e s e c tio n

W ireL o o pR e s e c tio n

M o n th sp o s ta b la tio n

N o v a S u re

P lu sR o lle rb a ll

(n = 1 7 5 )

(n = 9 0 )

1 2 *

2 4 **

3 6 **

1 2 *

2 4 **

3 6 **

1 3 6

1 4 3

1 3 4

6 7

6 8

6 3

N o v a S u re

N u m b e ro f s u c c e s s fu lp a tie n ts S tu d ys u c c e s sra te

A m e n o rrh e ara te

6 4

5 8

2 9

2 6

86 % *

2 4M o n th s

1 45 % *

1 50 % *

3 6M o n th s

1 63 % *

1 33 % *

F e e lA n x io u sD u etoM e n s e s

7 77 %8 17 %7 66 %7 44 %7 56 %7 00 %

6 3

99 % *

P e rc e n to fP a tie n tsR e p o rtin gS o m e tim e s ,F re q u e n tlyO rA lw a y s

#o fp a tie n tsw ith A m e n o rrh e a

P lu sR o lle rb a ll

1 2M o n th s

2 3

3 60 %3 66 %3 31 %3 22 %2 89 %2 56 %

* B a s e do nd ia rys c o re s

P re -o p e ra tiv e ly

7 47 %

6 89 %

1 2M o n th s

2 36 % *

1 85 % *

2 4M o n th s

2 42 % *

1 92 % *

3 6M o n th s

1 87 % *

1 91 % *

P e rc e n to fP a tie n tsR e p o rtin gS o m e tim e s ,F re q u e n tlyO rA lw a y s

** B a s e do nte le p h o n eq u e s tio n n a ire s

M is sS o c ia lA c tiv itie sD u etoM e n s e s

S e c o n d a rye ffe c tiv e n e s se n d p o in t: q u a lityo f life

P re -o p e ra tiv e ly

6 33 %

6 22 %

P a tie n tq u a lityo flife(Q O L )w a sa s s e s s e db ya d m in is te rin gth eq u a lityo f

1 2M o n th s

85 % *

86 % *

lifeq u e s tio n n a ire(S F -1 2 )a n dth em e n s tru a l im p a c tq u e s tio n n a irep rio r

2 4M o n th s

90 % *

1 11 % *

3 6M o n th s

81 % *

1 08 % *

totre a tm e n ta n da t3 ,6 ,1 2 ,2 4a n d3 6m o n th sp o s t-p ro c e d u reT a b le4 s h o w sth ep a tie n tre s p o n s e sfo rb o thg ro u p sp re -o p e ra tiv e ly ,w h e re

#N o ta ll p a tie n tsc o m p le te dq u e s tio n n a ire

a p p ro p ria te ,a n da t1 2 ,2 4a n d3 6m o n th sp o s t-p ro c e d u re

* S ta tis tic a llys ig n ifc a n td iffe re n c efro m p re -o p e ra tiv ere s p o n s e(C h i-S q u a re ;p<00 5 ) &S ta tis tic a llys ig n ifc a n td iffe re n c eb e tw e e nN o v a S u rea n dR o lle rb a ll G ro u p s (C h i-S q u a re ;p=00 2 )

T a b le4 .E ffe c tiv e n e s s :Q u a lityo fL ife(Q O L )

S a fe tye n d p o in t

W ireL o o pR e s e c tio n N o v a S u re

A d v e rs ee v e n tin fo rm a tio nisd e s c rib e dinth e“A d v e rs eE v e n ts ”s e c tio n

P lu sR o lle rb a ll

o fth ism a n u a l

N u m b e ro fP a tie n tsR e s p o n d in gtoQ u a lityo fL ifeQ u e s tio n a ire

#

P re -o p e ra tiv e ly

1 7 5

9 0

1 2M o n th s

1 5 4

8 2

2 4M o n th s

1 4 3

7 3

3 6M o n th s

1 3 9

6 7

S e c o n d a rye n d p o in t: p ro c e d u retim e

P ro c e d u retim e ,as e c o n d a rye n d p o in t,w a sd e te rm in e dfo re a c hp a tie n t b yre c o rd in gth etim eo fd e v ic ein s e rtio na n dth etim eo fd e v ic ere m o v a l T h em e a np ro c e d u retim efo rth eN o v a S u rep a tie n tsw a ss ig n ifc a n tly

P e rc e n to fP a tie n tsS a tis ife dO rV e ryS a tis ife d

le s sth a nth ep ro c e d u retim efo rth ero lle rb a ll g ro u p ,(42±35m in u te s

1 2M o n th s

9 28 %

9 39 %

a n d2 42±1 14m in u te s ,re s p e c tiv e ly )M e a ntim efo ra p p lic a tio no fR F

2 4M o n th s

9 39 %

8 91 %

e n e rg yw a s8 40±2 50s e c o n d sinas u b s e to fm o n ito re dN o v a S u re

3 6M o n th s

9 63 %

8 97 %

p a tie n ts(T a b le5 )

P e rc e n to fP a tie n tsW h oP ro b a b lyO rD e fn ite lyW o u ldR e c o m m e n d T a b le5 .O p e ra tiv eP ro c e d u reT im e

T h isP ro c e d u re

1 2M o n th s

9 67 %

9 59 %

2 4M o n th s

9 66 %

9 45 %

3 6M o n th s

9 78 %

W ireL o o pR e s e c tio n O p e ra tiv eP a ra m e te rs

9 26 %

N u m b e ro ftre a te dp a tie n ts *

P e rc e n to fP a tie n tsw ithD y s e m e n o rrh e a

P re -o p e ra tiv e ly

5 71 %

5 56 %

P ro c e d u retim em in u te s( ±S D )

1 2M o n th s

& 2 08 %

*,& 3 42 %

( D e v ic ein s e rtio ntod e v ic e

2 4M o n th s

2 03 % *

3 01 % *

re m o v a l)

3 6M o n th s

1 73 % *

2 84 % *

P ro c e d u retim eins e c o n d s( ± S D )

P e rc e n to fP a tie n tsw ithP M S

6 51 %

6 67 %

1 2M o n th s

3 64 % *

3 54 % *

2 4M o n th s

4 40 % *

4 66 % *

n = 9 0

1 7 1

8 8

42±35 **

2 42±1 14 **

8 40±2 50

# N D

3 6M o n th s

3 45 % *

4 12 % *

* S e eT a b le2fo rp a tie n ta c c o u n ta b ility ** S ta tis tic a llys ig n ifc a n td iffe re n c eb e tw e e ntre a tm e n tg ro u p s(S tu d e n t’st-te s t;p<00 5 ) #

P e rc e n to fP a tie n tsR e p o rtin gS o m e tim e s ,F re q u e n tlyO rA lw a y s H a v eD iffc u ltyP e rfo rm in gW o rkO rO th e rA c tiv itie sD u etoM e n s e s

6 63 %

P lu sR o lle rb a ll

n = 1 7 5

( T im eo fe n e rg yd e liv e ry )

P re -o p e ra tiv e ly

P re -o p e ra tiv e ly

N o v a S u re

6 55 %

8

N o td e te rm in e d

B A C K T O T O C

E N G L IS H

S e c o n d a rye n d p o in t: a n e s th e s iare g im e n

P a tie n tC o u n s e lin g

A n e s th e s iaw a sle fttoth ed is c re tio no fe a c hp a tie n t,c lin ic a l in v e s tig a to r

A sw itha n yp ro c e d u re ,th ep h y s ic ia nn e e d stod is c u s sris k s ,b e n e fts

a n da tte n d in ga n e s th e s io lo g is tF o rth eN o v a S u rep a tie n ts ,2 70 %

a n da lte rn a tiv e sw ithth ep a tie n tp rio rtop e rfo rm in ge n d o m e tria l

(4 7 /1 7 4 )h a dth ep ro c e d u rep e rfo rm e du n d e rg e n e ra la n e s th e s iao r

a b la tio nP a tie n t’se x p e c ta tio n ss h o u ldb es e tinaw a yth a tth ep a tie n t

e p id u ra la n d7 30 % (1 2 7 /1 7 4 )u n d e rlo c a la n d /o rIV s e d a tio nO n e

u n d e rs ta n d sth a tth ea im o fth etre a tm e n tisth ere d u c tio ninb le e d in gto

p a tie n td idn o th a v eare p o rte da n e s th e s iare g im e ninth isg ro u pIn

n o rm a l le v e ls

th ero lle rb a ll g ro u p ,8 22 % (7 4 /9 0 )o fth ep a tie n tsw e retre a te du n d e r

T h ed is p o s a b led e v ic eisin te n d e dfo ru s eo n lyinw o m e nw h od o

g e n e ra la n e s th e s iao re p id u ra la n d1 78 % (1 6 /9 0 )u n d e rlo c a la n d /o rIV

n o td e s iretob e a rc h ild re nb e c a u s eth elik e lih o o do fp re g n a n c yis

s e d a tio n(T a b le6 )

s ig n ifc a n tlyd e c re a s e dfo llo w in gth ep ro c e d u reP a tie n tso fc h ild b e a rin g c a p a c itys h o u ldb ec a u tio n e do fp o te n tia lc o m p lic a tio n s ,w h ic hm a y

T a b le6 .A n e s th e s iaR e g im e n

e n s u eifth e ys h o u ldb e c o m ep re g n a n tT h isc o u n s e lin gs h o u ldin c lu d e W ireL o o pR e s e c tio n N o v a S u re

P lu sR o lle rb a ll

n = 1 7 5 *

n = 9 0

G e n e ra lo re p id u ra l

2 70 %

8 22 %

L o c a la n d /o rIV s e d a tio n

7 30 %

1 78 %

th en e e dfo rp o s t-p ro c e d u rec o n tra c e p tio nw h e rein d ic a te dT h is p ro c e d u reisn o tas te riliz a tio np ro c e d u rea n ds u b s e q u e n tp re g n a n c ie s m a yb ed a n g e ro u sfo rth em o th e ra n dfe tu s V a g in a ld is c h a rg eisty p ic a llye x p e rie n c e dd u rin gth efrs tfe w w e e k s fo llo w in ga b la tio na n dm a yla s ta slo n ga sam o n thG e n e ra lly ,

*O n ep a tie n td idn o th a v eare p o rte da n e s th e s iare g im e n

th ed is c h a rg eisd e s c rib e da sb lo o d yd u rin gth efrs tfe w d a y s ; s e ro s a n g u in e o u sb ya p p ro x im a te lyo n ew e e k ;th e np ro fu s ea n dw a te ry

C lin ic a lo b s e rv a tio n s

th e re a fte rA n yu n u s u a lo rfo u l-s m e llin gd is c h a rg es h o u ldb ere p o rte dto

H y s te re c to m y

th ep h y s ic ia nim m e d ia te lyO th e rc o m m o np o s t-p ro c e d u ra lc o m p lic a tio n s

F ifte e nw o m e nh a dah y s te re c to m yw ith inth eth re ey e a rsfo llo w in gth e

in c lu d ec ra m p in g /p e lv icp a in ,n a u s e aa n dv o m itin g

a b la tio np ro c e d u reT a b le7lis tsth ere a s o n sfo rh y s te re c to m y

U te rin ep e rfo ra tio ns h o u ldb ec o n s id e re dinth ed iffe re n tia ld ia g n o s iso f a n yp o s t-o p e ra tiv ep a tie n tc o m p la in in go fa c u tea b d o m in a lp a in ,fe v e r ,

T a b le7 .H y s te re c to m y

s h o rtn e s so fb re a th ,d iz z in e s s ,h y p o te n s io no ra n yo th e rs y m p to m th a t W ireL o o pR e s e c tio n

m a yb ea s s o c ia te dw ithu te rin ep e rfo ra tio nw itho rw ith o u td a m a g e

N o v a S u re

P lu sR o lle rb a ll

toth ea d ja c e n to rg a n so fth ea b d o m in a lc a v ityP a tie n tss h o u ldb e

n = 1 7 5

n = 9 0

1

1

th e irp h y s ic ia n

F ib ro id s

2

0

P re tre a tm e n tP re p a ra tio no fP a tie n t

P e lv ica b s c e s s

1

1

T h eN o v a S u reim p e d a n c ec o n tro lle de n d o m e tria la b la tio ns y s te m

E n d o m e trio s is

3

0

A d e n o m y o s is

4

0

H e m a to m e tra

0

1

p ro life ra tiv eo rth es e c re to ryp h a s eo fth ec y c leA lth o u g hth es a fe tya n d

M e n o rrh a g ia

0

1

e ffe c tiv e n e s so fth eN o v a S u res y s te m h a sn o tb e e nfu lly -e v a lu a te din

1 1(63 % )

4(44 % )

R e a s o nF o rH y s te re c to m y

A d e n o c a rc in o m ad ia g n o s e da t tim eo fa b la tio np ro c e d u re

T O T A L

c o u n s e le dth a ta n ys u c hs y m p to m ss h o u ldb eim m e d ia te lyre p o rte dto

s u c c e s s fu llytre a tsau te rin ec a v ityo v e rara n g eo fe n d o m e triu m th ic k n e s sT h elin in go fth eu te ru sd o e sn o th a v etob eth in n e dp rio rto th ep ro c e d u re ,a n dth ep ro c e d u rem a yb ep e rfo rm e dd u rin ge ith e rth e

p a tie n tsw ithm e d ic a lo rs u rg ic a lp re tre a tm e n t,ith a sb e e ne v a lu a te dina lim ite dn u m b e ro fp a tie n tsw h oh a db e e np re tre a te dw ithG n R H a g o n is ts

7H y s te re c to m ie sw e reinp a tie n ts< 4 0y e a rs(7N o v a S u re)a n d8h y s te re c to m ie sw e reinp a tie n ts> 4 0y e a rs

w ithn oc o m p lic a tio n so ra d v e rs ee v e n ts

(4N o v a S u re;4R o lle rb a ll)

A c tiv eb le e d in gw a sn o tfo u n dtob ealim itin gfa c to rw h e nu s in g

P a tie n tS e le c tio n

th eN o v a S u res y s te mItisre c o m m e n d e dth a tan o n s te ro id a la n ti-

M e n o rrh a g iac a nb ec a u s e db yav a rie tyo fu n d e rly in gp ro b le m s ,

in fa m m a to ryd ru g(N S A ID )b eg iv e na tle a s to n eh o u rp rio rtotre a tm e n t

in c lu d in g ,b u tn o tlim ite dto ;e n d o m e tria lc a n c e r ,m y o m a s ,p o ly p s ,d ru g s

a n dc o n tin u e dp o s to p e ra tiv e lytore d u c ein tra o p e ra tiv ea n dp o s to p e ra tiv e

a n dd y s fu n c tio n a lu te rin eb le e d in g(a n o v u la to ryb le e d in g )P a tie n ts

u te rin ec ra m p in g

a lw a y ss h o u ldb es c re e n e da n de v a lu a te dtod e te rm in eth ec a u s eo f e x c e s s iv eu te rin eb le e d in gb e fo rea n ytre a tm e n to p tio nisin itia te d

N o v a S u reIm p e d a n c eC o n tro lle dE n d o m e tria lA b la tio nS y s te m

C o n s u ltm e d ic a l lite ra tu rere la tiv etov a rio u se n d o m e tria la b la tio n

In s tru c tio n sF o rU s e

te c h n iq u e s ,in d ic a tio n s ,c o n tra in d ic a tio n s ,c o m p lic a tio n sa n dh a z a rd s

P le a s ere a da ll in s tru c tio n s ,c a u tio n sa n dw a rn in g sp rio rtou s e

p rio rtoth ep e rfo rm a n c eo fa n ye n d o m e tria la b la tio np ro c e d u re

9

E N G L IS H

B A C K T O T O C

1 .0S e t-u p

13 S c re w th eC Oc a n is te rin toth ere g u la to ro nth eb a c kp a n e lo fth e 2

c o n tro lle ru n til tig h te n e d T o g g le s w itc h

C O c a n is te r

A C p o w e r c o rd N o v a S u re D IS P O S A B L E D E V IC E W IT H C O N N E C T IN G C O R D , IN C L U D IN G S U C T IO N L IN E D E S IC C A N T

N o v a S u re R F C O N T R O L L E R

2

14 F u llyro ta teth eC Ore g u la to rk n o btoth eH Ip o s itio n(ife q u ip p e d ) 2

N O T E :N e w e rm o d e lc o n tro lle rsa ren o te q u ip p e dw ithak n o bo nth e re g u la to r,th u sa llo w in gth eC Ofo wtob ea u to m a tic a llyre g u la te d 2

If y o u rc o n tro lle risn o te q u ip p e dw ithare g u la to rk n o b ,p ro c e e dto s te p15 N o v a S u re P O W E R C O R D

15 P re s sth eto g g les w itc ho nth eb a c kp a n e lo fth ec o n tro lle rin toth e

N O V A S U R E S U C T IO N L IN E D E S IC C A N T

“o n ”p o s itio n 16 C o n n e c tth efo o ts w itc htoth ea p p ro p ria tep o rto nth efro n tp a n e lo f th ec o n tro lle r

N o v a S u re C OC A N IS T E R

®F N O V A S U R E O O TS W IT C H

2

P o rt

11 T h efo llo w in gite m sa rere q u ire dw h e nu s in gth eN o v a S u res y s te m : •o n es te rile ,s in g le -p a tie n tu s eN o v a S u red is p o s a b led e v ic ew ith c o n n e c tin gc o rd •o n eN o v a S u reR F c o n tro lle r •o n eN o v a S u refo o ts w itc h •o n eN o v a S u reA C p o w e rc o rd

N O T E :T h efrs t tim eth eM o d e l1 0R F C istu rn e do n ,th e“S e le c tY o u r

•o n eN o v a S u ren o n -s te riles u c tio nlin ed e s ic c a n ta s s e m b ly

L a n g u a g e ”s c re e nw ill d is p la yT h ed e fa u lt s e ttin gisinE n g lis hT o

•o n eN o v a S u reC Oc a n is te r

s e le c ta n o th e rla n g u a g e ,p re s sth eb u tto nw ithth en a m eo f th a t

2

L o c kR e le a s e B u tto n

la n g u a g eS a v eth es e le c tio nb yp re s s in gth efa s h in gg re e nb u tto n

C a v ityL e n g thS e ttin g

T h ela n g u a g es e le c tio nw ill b ere ta in e dT oc h a n g eth ela n g u a g e

V a c u u m R e lie fV a lv e

W ID T H D ia l

s e le c tio na fte rth ein itia ls e tu p ,u s eth e“S e ttin g s ”s c re e nP re s sth e

C e rv ic a lC o lla r

n a m eo f th ela n g u a g etoc h a n g eth ela n g u a g eu s e do nth es c re e n d is p la yT os a v ec h a n g e stoth es e ttin g s ,p re s sth efa s h in gg re e n b u tto nT oc a n c e l as e le c tio n ,p re s sth eB lu e“X ”

S u c tio n L in e R e a r H a n d le

V a c u u m F e e d b a c k L in eB a rb F ro n tH a n d le

2 .0 P ro c e d u re S h e a th

21 P re p a reth ep a tie n tfo rth ea n e s th e s ia 22 P la c ep a tie n tind o rs a l lith o to m yp o s itio n

B ip o la r E le c tro d e A rra y

23 In d u c ea n e s th e s iaa c c o rd in gtos ta n d a rdp ra c tic e 24 P e rfo rm b im a n u a le x a m in a tio nE v a lu a tefo rs e v e rea n te v e rs io no r re tro v e rs io n

N O T E :P le a s eh a v ea v a ila b lea t le a s to n ee x trad is p o s a b led e v ic e ,

25 P re p a rea n dd ra p ep a tie n ts im ila rtop re pfo rD & C

d e s ic c a n ta s s e m b lya n dC Oc a n is te r

26 In s e rtas p e c u lu m in toth ev a g in a

2

12 P re p a reth eN o v a S u reR F c o n tro lle rP la c eito nas m a ll ta b letoo n e

27 G ra s pth ec e rv ixw ithate n a c u lu m

s id eo fth ep a tie n tw ith inv is u a l fe ldo fth es u rg e o nA tta c hth eA C p o w e rc o rdtoth ec o n tro lle ra n dp lu gitin toth eA C o u tle t

1 0

B A C K T O T O C

E N G L IS H

28 T a k eas o u n dm e a s u re m e n to fth eu te ru stom e a s u reth ele n g th

W A R N IN G :D on o tu s eth es te riles in g le -p a tie n tu s ed is p o s a b le

fro m fu n d u stoe x te rn a lc e rv ic a lo sT h ee ffc a c yo f th eN o v a S u re

d e v ic eif th ep a c k a g in ga p p e a rstob ed a m a g e do rth e reise v id e n c e

s y s te m h a sn o tb e e nfu llye v a lu a te dinp a tie n tsw ithau te rin e

o f ta m p e rin g

s o u n dm e a s u re m e n tg re a te rth a n1 0c m

29 D e te rm in eth ele n g tho f th ec e rv ic a lc a n a la n dd ila teth ec a n a l fo rd e v ic ein s e rtio n N O T E :T h ed ia m e te ro f th eN o v a S u red is p o s a b led e v ic eisa n o m in a l 6m m

21 0U s in gth eu te rin es o u n da n dc e rv ic a lc a n a lm e a s u re m e n ts ,c o n s u lt th ec a v ityle n g thta b le(b e lo w )too b ta inth ea p p ro p ria tec a v ity le n g ths e ttin g sO nth eu p p e re n do fth eta b le ,d im e n s io n sh a v e b e e na d ju s te dtore fe c tth ed is p o s a b led e v ic ee le c tro d ele n g th C o rre c td e te rm in a tio no fth ec a v ityle n g thisim p o rta n tfo rs a fea n d

21 2O p e nth en o n -s te riles u c tio nlin ed e s ic c a n tb o xa n dp o u c h

e ffe c tiv etre a tm e n tO v e re s tim a tin gth ec a v ityle n g thm a yre s u ltin

R e m o v eth ere dc a p s

th e rm a l in ju rytoth ee n d o c e rv ic a lc a n a l W A R N IN G :U s ec a u tio nn o t top e rfo ra teth eu te rin ew a ll w h e n s o u n d in g ,d ila tin go rin s e rtin gth ed is p o s a b led e v ic e T A B L E 8 .C A V IT YL E N G T H

C A U T IO N :T h es u c tio nlin ed e s ic c a n t isn o n -s te rilea n dth e

U te rin eS o u n d(c m )

p a c k a g in gs h o u ldn o tb ep la c e dinth es te rilefe ld

C e rv ix

C A U T IO N :If th es u c tio nlin ed e s ic c a n t isp in k ,th e nre p la c eit p rio r

L e n g th (c m )

toin itia tin gth ea b la tio np ro c e d u re 1 0

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21 3C o n n e c tth ed e s ic c a n ttoth eb a rb so nth es u c tio ntu b in go f d is p o s a b led e v ic eE n s u reth eb a rb sa refu llyin s e rte din toth e tu b in go nth ed e s ic c a n t

21 4C A U T IO N :D is p o s a b led e v ic em u s tb ee x te rn a l to(o u ts id eo f)

*T h ev a lu eo f65isn o tin te n d e dtore fe c tth en u m e ric a ld iffe re n c eb e tw e e nth es o u n dle n g th

th ep a tie n tb e fo rep e rfo rm in gs te p21 5

a n dth ele n g tho f th ec e rv ic a lc a n a l

21 5C o n n e c tth ed is p o s a b led e v ic ec o rdtoth ea p p ro p ria tep o rto nth e

T h ev a lu e65w a se n te re db e c a u s eit re p re s e n tsth em a x im u m le n g thth a t th eN o v a S u re a rra yc a nb ee x te n d e d

fro n tp a n e lo fth ec o n tro lle r

C O N T R A IN D IC A T IO N :D on o t tre a t ap a tie n tw ithau te rin ec a v ity le n g thth a t isle s sth a n4c m ,a sc e rv ic a lc a n a ld a m a g em a yo c c u r N O T E :P a tie n tsw ithau te rin ec a v ityle n g thg re a te rth a n60c m h a d o b s e rv e ds u c c e s sra te sth a tw e relo w e rth a no v e ra ll s tu d ys u c c e s s ra te s

21 1O p e nth es te rileN o v a S u red is p o s a b led e v ic ep a c k a g eP la c eth e

D is p o s a b leD e v ic e P o rt

d is p o s a b led e v ic ew ithth ec o n n e c tin gc o rdin toth es te rilefe ld w h ileb e in gc a re fu l tok e e pth en o n -s te riles u c tio nlin ed e s ic c a n t

W A R N IN G :P lu g g in gth eN o v a S u red is p o s a b led e v ic ein toth e

b o xo u to fth es te rilefe ld

N o v a S u reR F c o n tro lle rs ta rtsC Ofo wtop u rg ea n ya iro u t 2

o f th ed is p o s a b led e v ic ea n dtu b in gT h ep u rg in go p e ra tio n ta k e sa p p ro x im a te ly1 0s e c o n d sa n dm u s tb ep e rfo rm e dw ith th ed is p o s a b led e v ic ee x te rn a l toth ep a tie n tT h eN o v a S u reR F

1 1

E N G L IS H

B A C K T O T O C

c o n tro lle rC A V IT Y A S S E S S M E N TL E Da s h e sre d(M o d e l0 8 -0 9

21 9M a k es u reth ea rra yisc o m p le te lye n c lo s e db yth ee x te rn a ls h e a th

R F C s )o rap u rg in gd e v ic em e s s a g ed is p la y s(M o d e l1 0R F C )a n da n

22 0C h e c kth a tth eW ID T H d ia l re a d sa p p ro x im a te ly05c m

a u d ib lep u ls e dto n es o u n d sth ro u g h o u t th ep u rg ep ro c e d u reW h e n

22 1U s in gth eu te rin es o u n dm e a s u re m e n ta n dc e rv ic a lc a n a l

th eto n ea n dth eL E D /s c re e nm e s s a g es to p ,it iss a fetoin s e rt th e

m e a s u re m e n ts ,c o n s u ltth ec a v ityle n g thta b le(a b o v e )too b ta inth e

N o v a S u red is p o s a b led e v ic e

a p p ro p ria tec a v ityle n g ths e ttin g sa sd e s c rib e dins te p21 0a b o v e C O N T R A IN D IC A T IO N :D on o t tre a t ap a tie n tw ithau te rin ec a v ity

C A U T IO N :C Oc o n tin u o u s lyfo w sfro m th etim eth a t th ed is p o s a b le 2

d e v ic eisp lu g g e din toth ec o n tro lle ru n til th eC IA p o rtio no f th e

le n g thth a t isle s sth a n4c m ,a sc e rv ic a lc a n a ld a m a g em a yo c c u r

p ro c e d u reisc o m p le teT om in im iz eth ed u ra tio no fC Ofo w

22 2U s in gth ec a v ityle n g thta b leins e c tio n21 0 ,s e le c tth ev a lu e

2

a n dp o te n tia l ris ko fe m b o lis m ,p e rfo rm th es e a tin gp ro c e d u re

o b ta in e dfo rle n g thin toth eN o v a S u reR F c o n tro lle rin p u ts c re e nb y

im m e d ia te lya fte rin s e rtin gth ed is p o s a b led e v ic ea n dp ro c e e d

d e p re s s in gth eU P /D O W N a rro w s

d ire c tlyfro m th es e a tin gp ro c e d u retoth eC IA

22 3A d ju s ta n dlo c kth ec a v ityle n g ths e ttin gfe a tu reo nth ed is p o s a b le

W A R N IN G :U s ec a u tio nn o t top e rfo ra teth eu te rin ew a ll w h e n

d e v ic etoth ev a lu eo b ta in e da b o v e(S e es te p22 1)E n s u reth a tth e

s o u n d in g ,d ila tin go rin s e rtin gth ed is p o s a b led e v ic e

c e rv ic a lc o lla risfu llyre tra c te dtoitsp ro x im a lp o s itio n

21 6D e p lo yth ed is p o s a b led e v ic eo u ts id eo fth ep a tie n ta n de n s u reth e c o n tro lle rA R R A Y P O S IT IO N L E D ise x tin g u is h e d(M o d e l0 8 -0 9R F C s ) o rth es c re e nm e s s a g ed o e sn o td is p la y(M o d e l1 0R F C )w h e nth e a rra yiso p e n e dIfth eL E D isn o te x tin g u is h e d(M o d e l0 8 -0 9R F C s ) o rth es c re e nm e s s a g eiss till d is p la y e d(M o d e l1 0R F C ),c lo s e a n do p e nth ed is p o s a b led e v ic ea g a inIfth isd o e sn o tre s o lv eth e p ro b le m ,re p la c eth ed is p o s a b led e v ic e 21 7B ec e rta inth eW ID T H d ia l re a d sg re a te rth a no re q u a l to40c m W ID T H d ia l

22 4C o n frm th a tth ec e rv ixisd ila te dtoam in im u m 6m m (th en o m in a l d ia m e te ro fth eN o v a S u red is p o s a b led e v ic e ) 22 5M a in ta inas lig h ttra c tio no nth ete n a c u lu m tom in im iz eth ea n g leo f th eu te ru s 22 6A n g leth ed is p o s a b led e v ic ein -lin ew ithth ea x iso fth eu te ru sa s th ed is p o s a b led e v ic eisin s e rte dtra n s c e rv ic a llyin toth eu te rin e c a v ityB yh o ld in gth efro n th a n d le ,a d v a n c eth ed is p o s a b led e v ic e u n til th ed is ta le n do fth es h e a thto u c h e sth efu n d u s

N O T E :If th eW ID T H d ia l re a d sle s sth a n40c m ,c lo s eth ed is p o s a b le d e v ic ea n dre p e a ts te p21 6a b o v eIf th eW ID T H d ia ls till re a d s le s sth a n40c m ,o p e nan e wd is p o s a b led e v ic ea n dre tu rnth eo ld d is p o s a b led e v ic etoH o lo g icT e c h n ic a lS u p p o rt

21 8U n lo c kth ed is p o s a b led e v ic eb yp re s s in gth elo c kre le a s eb u tto n C lo s eth ed is p o s a b led e v ic eb yh o ld in gth efro n th a n d les ta tio n a ry a n dg e n tlyp u llin gth ere a rh a n d leb a c k w a rd su n til th ec lo s e da rra y in d ic a to r ,lo c a te da tth eh in g eo fth efro n ta n dre a rh a n d le s ,re a d s , “A R R A Y C L O S E D ”T h isin d ic a te sth a tth ea rra yh a sb e e nre tra c te d in toth es h e a tha n dth ed is p o s a b led e v ic eisinth ec lo s e dp o s itio n

A R R A Y C L O S E D in d ic a to r

L o c kre le a s e b u tto n

1 2

B A C K T O T O C

E N G L IS H N O T E :O n c eth ed is p o s a b led e v ic eh a n d le sa relo c k e d ,th eu te ru s s h o u ldm o v einc o n ju n c tio nw ithth ed is p o s a b led e v ic e

W A R N IN G :If th ed is p o s a b led e v ic eisd iffc u lt toin s e rt in toth e c e rv ic a lc a n a l,u s ec lin ic a l ju d g m e n t tod e te rm in ew h e th e ro rn o t fu rth e rd ila tio nisre q u ire d

22 9G e n tlym o v eth ed is p o s a b led e v ic eu s in ga n te rio r ,p o s te rio ra n d la te ra lm o v e m e n ts

22 7W ith d ra w th ed is p o s a b led e v ic ea p p ro x im a te ly05c m fro m th e fu n d u sS lo w lys q u e e z eth eh a n d le s(D O N O T L O C K )u ptoth ep o in t o fin c re a s e dre s is ta n c e T h eW ID T H d ia ls h o u ldre a da p p ro x im a te ly05c mA tth isp o in t,th e e x te rn a ls h e a thh a sb e e nre tra c te d 05c m

23 0T oc o m p le tep la c e m e n t,s lig h tlyp u ll b a c kth ed is p o s a b led e v ic e u n til th eW ID T H d ia l re a d in gre d u c e sb ya p p ro x im a te ly02 – 05c m

22 8C o n tin u etos lo w lys q u e e z eth ed is p o s a b led e v ic eh a n d le sto g e th e r w h ileg e n tlym o v in gth ed is p o s a b led e v ic e~ 05c m toa n dfro m th efu n d u sa n dro ta tin gth eh a n d leo fth ed is p o s a b led e v ic e4 5 ° c o u n te rc lo c k w is efro m th ev e rtic a lp la n ea n d4 5 °c lo c k w is efro m th ev e rtic a lp la n eu n til th eh a n d le slo c k T h eW ID T H d ia ls h o u ldre a dg re a te rth a n25c m

1 3

E N G L IS H

B A C K T O T O C

23 1H o ldth ete n a c u lu m ,a d v a n c eth ed is p o s a b led e v ic es lo w lya n d

23 3R e a dth ec o rn u -to -c o rn um e a s u re m e n t(25c m m in im u m )o nth e

g e n tlytoth efu n d u sT h eW ID T H d ia ls h o u ldre a dg re a te rth a no r

W ID T H d ia l in d ic a to r

e q u a l toth ep re v io u sm e a s u re m e n t 23 2S lid eth ec e rv ic a lc o lla rfo rw a rdu s in gg e n tlep re s s u reo nth eta bo n th ec e rv ic a lc o lla r ,u n til th ec e rv ic a lc o lla rfo rm sas e a la g a in s tth e e x te rn a lc e rv ic a lo s

C O N T R A IN D IC A T IO N :D on o t tre a t ap a tie n tw ithau te rin ec a v ity w id thle s sth a n25c m ,a sd e te rm in e db yth eW ID T H d ia lo f th e

G e n tlep re s s u re

d is p o s a b led e v ic efo llo w in gd e v ic ed e p lo y m e n t C A U T IO N :If th eA R R A Y P O S IT IO N n o tifc a tio na p p e a rs ,s e eth e T ro u b le s h o o tin gs e c tio nu n d e r“A R R A Y P O S IT IO N A la rm ”

23 4S e le c tth ev a lu ein d ic a te do nth eW ID T H d ia l in toth eN o v a S u reR F c o n tro lle rin p u ts c re e nb yd e p re s s in gth eU P /D O W N a rro w s 23 5T h es y s te m c a nb eo p e ra te dine ith e ra u to m a ticm o d eo rm a n u a l

S lig h tp re s s u re

m o d eIna u to m a ticm o d eth ea b la tio nc y c lew ill s ta rta u to m a tic a lly u p o ns u c c e s s fu lc o m p le tio no fth ec a v ityin te g ritya s s e s s m e n t (C IA ) Inm a n u a lm o d eth ea b la tio nc y c lew ill n o ts ta rta u to m a tic a lly fo llo w in gas u c c e s s fu lC IA

N O T E :C o rre c tp la c e m e n to f th ee le c tro d ea rra ya g a in s t th efu n d u sisim p o rta n t tos a fea n de ffe c tiv etre a tm e n t If p a rt o f th ee le c tro d ea rra y o rth ed is ta le d g eo f th ee x te rn a ls h e a thiss e a te dinth ee n d o c e rv ic a lc a n a ld u rin gtre a tm e n t,th e reisa nin c re a s e dris ko fe n d o c e rv ic a l th e rm a l in ju ry IN C O R R E C TP L A C E M E N T

C O R R E C TP L A C E M E N T

F u n d u s

F u n d u s

E le c tro d eA rra y

E le c tro d eA rra y

S h e a thE d g e E n d o c e rv ic a l C a n a l

S h e a thE d g e

E n d o c e rv ic a l C a n a l

S h e a the d g ere s id e sin lo w e ru te rin es e g m e n t

S h e a the d g ere s id e sin e n d o c e rv ic a lc a n a l

1 4

B A C K T O T O C

E N G L IS H

M O D E L0 8 -0 9R FC O N T R O L L E R S

M O D E L1 0R FC O N T R O L L E R

F o llo wn e x ts te p so np a g e s1 6th ro u g h1 9 .

F o llo wn e x ts te p so np a g e s2 0th ro u g h2 3 .

T a b leo fC o n te n tsfo rb o thM o d e ls0 8 -0 9a n dM o d e l1 0R FC o n tro lle rs A d d itio n a lT ro u b le s h o o tin g

2 4

R e p la c e m e n t In s tru c tio n s

2 4

S p e c ifc a tio n s

2 4

C le a n in ga n dS a n itiz in g

2 8

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2 8

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2 8

T e c h n ic a lS u p p o rt a n dP ro d u c tR e tu rnIn fo rm a tio n

2 8

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2 9

1 5

Y L N O S R E S U C F R9 08 0e ld o M

E N G L IS H

B A C K T O T O C

O p e ra tin gth eM o d e l0 8 -0 9R FC o n tro lle rs

B Ifth eC IA te s tfa ilsa g a in ,c h e c kfo rle a k sinth es y s te m ,a n db e tw e e n th ec e rv ixa n dc e rv ic a lc o lla rB es u retoc h e c ka ll tu b in gc o n n e c tio n s , a n de n s u reth a tas u c tio nlin ed e s ic c a n th a sb e e nin s ta lle dIfth e le a ka p p e a rstob ea tth ec e rv ixa n dc a n n o tb ere s o lv e db yu s in gth e c e rv ic a lc o lla r ,u s ea n o th e rte n a c u lu m tog ra s pth ec e rv ixa ro u n dth e s h e a thR e p e a tth eC IA b yp re s s in gth efo o ts w itc h N O T E :C Ole a k a g em a yo c c u ra t th ee x te rn a lc e rv ic a lo sd u etoth e 2

p re s e n c eo fa no v e r-d ila te dc e rv ix V is ib leb u b b le so rth e“h is s in g ” s o u n do fe s c a p in gg a sm a ya c c o m p a n yC Ole a k a g eu n d e re ith e ro f 2

th e s ec o n d itio n s

C Ifth ec a v ityin te g ritya s s e s s m e n tfa ilsa fte rre a s o n a b lea tte m p tsto im p le m e n tth etro u b le s h o o tin gp ro c e d u re s(s te p23 6 ),a b o rtth e p ro c e d u re N O T E :R e m o v in gth ed is p o s a b led e v ic efro m th eu te rin ec a v itya fte r c o m p le tin gac a v ityin te g ritya s s e s s m e n tw ill re q u irea na d d itio n a l C IA te s t tob ep e rfo rm e du p o nd is p o s a b led e v ic ere -in s e rtio n (w h e th e ro rn o t th eC IA p re v io u s lyp a s s e d )p rio rtoin itia tin ga n AA u to m a ticm o d e

a b la tio n

T oo p e ra teth es y s te m ina u to m a ticm o d e ,p re s sth eE N A B L E

23 7M a n u a lm o d eo n ly

b u tto np rio rtob e g in n in gth eC a v ityIn te g rityA s s e s s m e n t(C IA ) P ro c e e dtos te p23 6 ,b u td on o tfo llo w s te p23 7ifo p e ra tin gth e

W h e no p e ra tin gth es y s te m inm a n u a lm o d e ,th ea b la tio nc y c le

s y s te m ina u to m a ticm o d e

w ill n o ts ta rta u to m a tic a llya fte rth es u c c e s s fu lc o m p le tio no fth e C IAO n c eas u c c e s s fu lC IA h a sb e e nc o m p le te d ,p re s sth eE N A B L E

BM a n u a lm o d e

b u tto na n dd e p re s sth efo o ts w itc has e c o n dtim etoin itia teth e a b la tio nc y c le

T oo p e ra teth es y s te m inth em a n u a lm o d e ,d on o tp re s sth e E N A B L E b u tto np rio rtob e g in n in gth eC a v ityIn te g rityA s s e s s m e n t (C IA )F o llo w s te p s23 6a n d23 7 23 6B e g inth eC IA p ro c e d u reb ys te p p in go nth efo o ts w itc ho n c e T h eC A V IT Y A S S E S S M E N T L E D fa s h e sg re e ninc o n ju n c tio nw ith a na u d ib leto n ea tara teo fo n c ep e rs e c o n dw h e nth es y s te m isp e rfo rm in gaC IAT h ed u ra tio no fth ete s tw ill ra n g eb e tw e e n a p p ro x im a te ly7a n d3 0s e c o n d sA s te a d yg re e nL E D a p p e a rs w h e nth eC IA h a sp a s s e da n dth es y s te m c a nd e liv e rR F e n e rg y P o w e rc a n n o tb ea p p lie dtoth ed is p o s a b led e v ic eu n til th eC A V IT Y A S S E S S M E N T L E D isas te a d yg re e nlig h t Ifth ec a v ityin te g ritya s s e s s m e n tfa ils ,th e nth eC A V IT Y

M A N U A LM O D E

A S S E S S M E N T L E D o nth eN o v a S u reR F c o n tro lle rw ill fa s hre d , a n dara p ida u d ib leto n ew ill s o u n da tara teo ffo u rtim e sp e r

N O T E :Ins o m eM o d e l0 9R F c o n tro lle rs ,av a c u u m p re -c h e c k

s e c o n d

o c c u rsa u to m a tic a llyp rio rtoin itia tio no f th ea b la tio nc y c leT h e V A C U U M L E D w ill fa s ha n da na u d ib leto n ew ill b eh e a rdfo ru pto 1 0s e c o n d sd u rin gth ev a c u u m p re -c h e c k

D u rin gth ea b la tio nc y c le ,ab lu eR F O N L E D w ill illu m in a teA tth e c o m p le tio no fth ea b la tio nc y c le ,th eR F p o w e rd e liv e ry(R F O N L E D ),a sw e ll a ss u c tio n ,w ill s w itc ho ffa u to m a tic a llyT h ep h y s ic ia n c a ns to pth ep ro g re s so fth ep ro c e d u rea ta n ytim eb yd e p re s s in g th efo o ts w itc h N O T E :R F p o w e rd e liv e ryc a nb es to p p e da ta n ytim eb yp re s s in g

Ifth ec a v ityin te g ritya s s e s s m e n tfa ils ,p re s sth efo o ts w itc htos to pth e

th efo o ts w itc h

s o u n dN e x t: A Ifap e rfo ra tio niss u s p e c te d ,th ep ro c e d u res h o u ldb ete rm in a te d im m e d ia te ly

1 6

E N G L IS H

23 8A fte ra u to m a ticte rm in a tio no fth ea b la tio nc y c le(a p p ro x im a te ly

24 1T u rno ffth eN o v a S u reR F c o n tro lle rC lo s eth eC Ore g u la to r 2

9 0s e c o n d s ),fu llyre tra c tth ec e rv ic a lc o lla rb yu s in gth eta bo n

24 2P e rfo rm p o s to p e ra tiv ep a tie n tc a rea c c o rd in gtos ta n d a rd

th ec e rv ic a lc o lla rF u llyre tra c tth ec e rv ic a lc o lla rb ys lid in gittoits

p ro c e d u re sT h eu s e dd is p o s a b led e v ic em u s tb etre a te da s

p ro x im a lp o s itio n

b io h a z a rd o u sw a s tea n dd is p o s e do fa c c o rd in gtos ta n d a rd p ra c tic e so fth eh o s p ita lo rc lin icw h e reth etre a tm e n tis

C A U T IO N :T h ec e rv ic a lc o lla rm u s tb efu llyre tra c te dtoitsp ro x im a l

p e rfo rm e d

p o s itio nino rd e rtom in im iz eth ep o te n tia l fo rd a m a g etoth es h e a th w h e nc lo s in gth ea rra y

24 3D is c h a rg eth ep a tie n tfro m th eh o s p ita lo ro ffc ea sin d ic a te d b yth em a n a g in gp h y s ic ia n

C e rv ic a l C o lla r

P e rio d icM a in te n a n c ea n dS e rv ic e

T h e reisn os e rv ic em a n u a l fo rth eN o v a S u reR F c o n tro lle rs in c e th e rea ren ofe lds e rv ic e a b lec o m p o n e n tsw ith inth eu n it W A R N IN G :N om o d ifc a tio no f th ise q u ip m e n t isa llo w e d P e rio d icm a in te n a n c e

R e c o m m e n d e dp e rio d icm a in te n a n c ein c lu d e sR F p o w e ro u tp u t te s tin ga n ds ta n d a rds a fe tyte s tss u c ha sle a k a g ec u rre n tin a c c o rd a n c ew ithU L6 0 6 0 1 -1 ,a lo n gw ithre g u la rc le a n in g s , 23 9U n lo c kth ed is p o s a b led e v ic eb yp re s s in gth elo c kre le a s eb u tto n

d e s c rib e dinth e“C le a n in ga n dS a n itiz in g ”s e c tio n

C lo s eth ed is p o s a b led e v ic eb yh o ld in gth efro n th a n d les ta tio n a ry a n dg e n tlyp u llin gth ere a rh a n d leb a c k w a rd su n til th ec lo s e da rra y

R Fp o w e ro u tp u t te s t

in d ic a to r ,lo c a te da tth eh in g eo fth efro n ta n dre a rh a n d le s ,re a d s

T h eN o v a S u reR F c o n tro lle rM o d e l0 8 -0 9in te g ra te sa u to m a tic

“A R R A Y C L O S E D ”T h isin d ic a te sth a tth ea rra yh a sb e e nre tra c te d

p o w e ro u tp u tte s tin gin toap o w e ro ns e lfte s t(P O S T )D u rin gth e

in toth es h e a tha n dth ed is p o s a b led e v ic eisinth ec lo s e dp o s itio n

P O S T th ec o n tro lle r’sp o w e ro u tp u t(P c )isd e liv e re din toas h u n t

(S e es te p21 8)

re s is to r(R s )lo c a te din s id eth ec o n tro lle rP cista rg e te dtob e1 8 0

N O T E :If it isd iffc u lt toc lo s ea n dre m o v eth ed is p o s a b led e v ic e ,

w a ttsa n dR sisn o m in a lly2 5o h m sD u rin gth eP O S T ,n op o w e r

s e eth eT ro u b le s h o o tin gs e c tio n ,“D iffc u ltyc lo s in ga n dre m o v in g

isd e liv e re dtoth ed is p o s a b led e v ic ec o n n e c to ra tth efro n to fth e

th ed is p o s a b led e v ic ep o s t-a b la tio n”

c o n tro lle r

C A U T IO N :T oa v o idd a m a g in gth ed e v ic e ,e m p lo yg e n tlete c h n iq u e

N O T E :If aN o v a S u red is p o s a b led e v ic eisc o n n e c te da t

w h e nre tra c tin gth ea rra y

th etim eth ec o n tro lle risp o w e re du p ,th eP O S Tw ill n o tb e

Y L N O S R E S U C F R9 08 0e ld o M

B A C K T O T O C

p e rfo rm e da n dth ec o n tro lle rw ill re tu rnton o rm a lo p e ra tio nIf ad e v ic eisc o n n e c te dd u rin gth eP O S Ts e q u e n c e ,th eP O S Tw ill te rm in a tea n dth ec o n tro lle rw ill re tu rnton o rm a lo p e ra tio n

T h efo llo w in gp ro c e d u reisu s e dtoe x e c u teth eP O S T a n dd is p la yth e a c tu a lv a lu eo fP ca n dR sd e te rm in e d : 1 W ithth es w itc ho nth ep o w e rin p u tm o d u leinth eo ffp o s itio n , c h e c ktom a k es u read is p o s a b led e v ic eisn o tc o n n e c te dtoth e R F c o n tro lle r 2 D e p re s sa n dh o ldth ele n g thU P a n dle n g thD O W N a rro w s s im u lta n e o u s ly ,th e nto g g leth ep o w e rs w itc ha tth ep o w e rin p u t 24 0W ith d ra w th ed is p o s a b led e v ic efro m th ep a tie n t

m o d u lew h ilec o n tin u in gtod e p re s sth ea rro w sT h iss te pin itia te s th eP O S T ,w h ic hp ro c e e d sa u to m a tic a lly 3 U p o nth ec o m p le tio no fth eP O S T (a p p ro x im a te ly5s e c o n d s ),th e R F c o n tro lle rw ill g e n e ra teo n ea u d ib leto n e ,a n dth e nd is p la yth e a c tu a lv a lu eo fP cfo rtw os e c o n d so nth ep o w e rs e tL E D 4 A fte rtw os e c o n d se la p s e ,th ep o w e rs e tL E D w ill c h a n g etod is p la y th ea c tu a lv a lu eo fR sfo rtw os e c o n d s 5 T h ep o w e rs e tL E D w ill th e nc h a n g eto0 0 ,a n dth eR F c o n tro lle rw ill re tu rnton o rm a lo p e ra tio nw ith o u tfu rth e rin p u tfro m th eu s e r

1 7

Y L N O S R E S U C F R9 08 0e ld o M

E N G L IS H

B A C K T O T O C

T h ea c c e p ta b lelim itso nP c=1 8 0W ±1 0 % IfP cisn o tw ith in

o n ,n o rc a np o w e rb ed e liv e re dtoth ea rra yw h e nth eA R R A Y P O S IT IO N

s p e c ifc a tio n ,as y s te m fa u ltw ill o c c u rT h ea c tu a lv a lu eo fR sis

L E D isillu m in a te d

fo rre fe re n c eo n ly

m in a te sintw oc o n d itio n s : V A C U U M L E D :illu

N O T E :If as y s te m fa u lt o c c u rsd u rin gth eP O S T ,to g g leo ff th e

1F la s h e sre da c c o m p a n ie db ya na u d ib leto n ew h ileth es y s te m is

p o w e ra t th ep o w e rin p u tm o d u lea n dre p e a t th eP O S TIf a

s ta b iliz in gth ev a c u u m le v e l fo ru pto1 0s e c o n d sb e fo ree n e rg y

s y s te m fa u lt o c c u rsas e c o n dtim e ,re m o v eth eR F c o n tro lle r

d e liv e ryc o m m e n c e s(o n lyfo rM o d e l0 9c o n tro lle rsw ithav a c u u m

fro m s e rv ic ea n dc o n ta c tH o lo g icc u s to m e rs e rv ic e

p re -c h e c kfu n c tio n )

C A U T IO N :D on o ta tte m p t tore p a irth ec o n tro lle rif p ro b le m s

2Illu m in a te sre dw h e nth ev a c u u m re lie fv a lv eiss tu c kinth ec lo s e d

a res u s p e c te dF o llo wth etro u b le s h o o tin gg u id einth is

p o s itio n ,w h e nab lo c k a g eisd e te c te dinth ed is p o s a b led e v ic eo rth e

m a n u a l If p ro b le m sp e rs is t,c a ll H o lo g icT e c h n ic a lS u p p o rt

c o n n e c tio ntu b in go rw h e nth es y s te m h a sale a kS u c has itu a tio n

fo rin s tru c tio n s

m ig h tb ec re a te db y : a no v e r-d ila te dc e rv ixw ithp o o rc o n ta c tb e tw e e nth ec e rv ic a lc o lla r •

S te rileN o v a S u red is p o s a b led e v ic e :N om a in te n a n c eisn e c e s s a ry

a n dth ee x te rn a lo s ;

S in g le -p a tie n tu s eo n lyD on o tre u s eo rre -s te riliz eth eN o v a S u re d is p o s a b led e v ic e

•

•

N o v a S u reR FC o n tro lle rL E D D e s c rip tio n s

•

T h efo llo w in gisad e s c rip tio no fth ea le rtL E D so nth e

ap o o ra tta c h m e n to fth ed e s ic c a n ttu b etoth es u c tio ntu b in g ; a no b s tru c tio ninth ed is p o s a b led e v ic etu b in g ;o r a no b s tru c tio ninth ed is p o s a b led e v ic e

m in a te sre difth es y s te m fa u ltso rifth e reisa S Y S T E M F A U L TL E D :illu

N o v a S u reR F c o n tro lle r

s e lf-d ia g n o s ticc h e c kfa ilu rew ithth es y s te m c lo c ko rp o w e rd e liv e ryIf

m in a te sinfo u rm o d e s : C A V IT Y A S S E S S M E N TL E D :illu

th ise v e n to c c u rs ,te rm in a teth ep ro c e d u reim m e d ia te lya n dc o n ta c ta n a u th o riz e dH o lo g ics e rv ic ere p re s e n ta tiv efo rin s tru c tio n s

1F la s h e sre dinc o n ju n c tio nw itha na u d ib leto n ea tara teo f o n c ep e rs e c o n dfo rth efrs t1 0s e c o n d sw h e nth es y s te m is

T ro u b le s h o o tin gM o s tC o m m o nA la rm s

p u rg in ga iro u to fth ed is p o s a b led e v ic eA fte r1 0s e c o n d s ,th eL E D C A V IT Y A S S E S S M E N TL E D illu m in a te dre d

a n da u d ib leto n ew ill c e a s e ,a lth o u g hC Ow ill c o n tin u etofo w o u t o fth ev a c u u m fe e d b a c klin e

2

Ifth eC A V IT Y A S S E S S M E N T L E D iss te a d yre d ,th ec a v ityin te g rity

2F la s h e sg re e ninc o n ju n c tio nw itha na u d ib leto n ea tara teo f

a s s e s s m e n th a sfa ile dIfth ec a v ityin te g ritya s s e s s m e n tfa ils ,th e nth e

o n c ep e rs e c o n dw h e nth es y s te m isp e rfo rm in gac a v ityin te g rity

C A V IT Y A S S E S S M E N T L E D o nth eN o v a S u reR F c o n tro lle rw ill fa s hre d ,

a s s e s s m e n t

a n dara p ida u d ib leto n ew ill s o u n da tara teo ffo u rtim e sp e rs e c o n d T h eC IA te s tm a yb etrie da g a in

3S te a d yg re e nlig h ta p p e a rsw h e nth ec a v ityin te g rity a s s e s s m e n th a sp a s s e da n dth es y s te m c a nd e liv e rR F e n e rg y

If ap e rfo ra tio niss u s p e c te d ,th ep ro c e d u res h o u ldb ete rm in a te d

P o w e rc a n n o tb ea p p lie dtoth ed is p o s a b led e v ic eu n til th eC A V IT Y

im m e d ia te ly

A S S E S S M E N T L E D isas te a d yg re e n

Ifth ec a v ityin te g ritya s s e s s m e n tfa ils ,p re s sth efo o ts w itc htos to pth e

4S te a d yre dlig h tsa n da na u d ib leto n ea tara teo ffo u rtim e s

s o u n dT h ec a u s eo fth ec a v ityin te g ritya s s e s s m e n tfa ilu reisth ein a b ility

p e rs e c o n do c c u rw h e nth ec a v ityin te g ritya s s e s s m e n th a sfa ile d

top re s s u riz eth ec a v ityItm a yb ec a u s e db y :

T h eC IA te s tm a yb etrie da g a in

1 D e v ic ele a k :e n s u reth a tth es u c tio nlin ed e s ic c a n tflte rh a sb e e n

m in a te sa m b e rw h e nth eu s e rp re s s e sth e E N A B L E L E D :illu

in s ta lle dC h e c ka ll tu b in gc o n n e c tio n stoe n s u reth a tth e ya retig h tly

E N A B L E b u tto nA c tsa sas a fe tys oth a tth eN o v a S u red is p o s a b le

c o n n e c te d

d e v ic ew ill n o ta c c id e n ta llya c tiv a tew h e nth efo o ts w itc his

2 L e a ka tth ee x te rn a lo so fth ec e rv ix :L o o kfo rv is ib leb u b b le so ra

to u c h e dT h eE N A B L E L E D w ill n o tillu m in a tew h e nth eA R R A Y

“h is s in g ”s o u n da tth ee x te rn a lo so fth ec e rv ix

P O S IT IO N L E D iso n

U s eth eta bo nth ec e rv ic a lc o lla rtoa d v a n c eth ec e rv ic a lc o lla r m in a te sb lu ew h e nth ea b la tio nisp ro c e e d in g(th efo o t R F O N L E D :illu

to w a rd sth ee x te rn a lo so fth ec e rv ixtoe n s u reth e reisatig h ts e a l

s w itc hh a sb e e nd e p re s s e dtoa c tiv a teth eN o v a S u reR F c o n tro lle rw ith

T e s ta g a inIfth ete s tfa ilsa g a in ,u s eas e c o n dte n a c u lu m tog ra s p

th eN o v a S u red is p o s a b led e v ic ea rra yinp la c einth eu te ru s )

th ec e rv ixa ro u n dth es h e a tho fth eN o v a S u red is p o s a b led e v ic eT e s t

m in a te sw h e nth etis s u eim p e d a n c e P R O C E D U R E C O M P L E T E L E D :illu

a g a in

re a c h e s5 0o h m sa n dth ea b la tio np ro c e d u reru n sam in im u m o f

3 U te rin ep e rfo ra tio n :If au te rin ep e rfo ra tio niss u s p e c te d ,th e

3 0s e c o n d s

p ro c e d u res h o u ldb ete rm in a te dim m e d ia te ly

m in a te sre dw h e no n ep o leo fth ee le c tro d e A R R A Y P O S IT IO N L E D :illu

N O T E :C Ole a k a g em a yo c c u ra t th ee x te rn a lc e rv ic a lo sd u etoth e

a rra ym a yb einc o n ta c tw itha n o th e rT h isL E D s h o u ldb eillu m in a te d

p re s e n c eo fa no v e r-d ila te dc e rv ix V is ib leb u b b le so rth e“h is s in g ”

2

w h e nth ea rra yisn o tfu llyd e p lo y e dT h eE N A B L E L E D c a n n o tb eto g g le d

1 8

E N G L IS H

s o u n do fe s c a p in gg a sm a ya c c o m p a n yC Ole a k a g eu n d e re ith e ro f th e s ec o n d itio n s

C Oc a n is te r lo wo re m p ty

2

2

T h eN o v a S u reR F c o n tro lle rw ill g e n e ra tea na u d ib leto n ea tara te o ffo u rtim e sp e rs e c o n dd u rin gth isa la rm c o n d itio nL E D sth a t

Ifth ec a v ityin te g ritya s s e s s m e n tfa ilsa fte rre a s o n a b lea tte m p tsto

w e reillu m in a te dp rio rtoth ea la rm w ill re m a ininth es a m es ta te

im p le m e n tth etro u b le s h o o tin gp ro c e d u re s(s te p23 6 ),a b o rtth e

d u rin gth elo w C Oe v e n tP re s s in gth efo o ts w itc hw ill n o ttu rno ff

p ro c e d u re

2

th ea u d ib lea la rm N O T E :R e m o v in gth ed is p o s a b led e v ic efro m th eu te rin ec a v itya fte r

1 R e p la c eth eC Oc a n is te rtos to pth ea u d ib leto n e

c o m p le tin gac a v ityin te g ritya s s e s s m e n tw ill re q u irea na d d itio n a l

2

C IA te s t tob ep e rfo rm e du p o nd is p o s a b led e v ic ere -in s e rtio n

N O T E :It isn o tn e c e s s a rytore m o v eth ed is p o s a b led e v ic e

(w h e th e ro rn o t th eC IA p re v io u s lyp a s s e d )p rio rtoin itia tin ga n

fro m th ep a tie n tp rio rtore p la c in gth ec a n is te r

a b la tio n

2 C o n tin u ew ithth ep ro c e d u re

V A C U U M L E D illu m in a te d

A R R A Y P O S IT IO N L E D illu m in a te d

T h eV A C U U M L E D illu m in a te sw h e nth ev a c u u m le v e l iso u ts id eits

1 G e n tlym o v eth ep ro x im a le n do fth ed is p o s a b led e v ic ea n d

s p e c ife dra n g eT h isc a no c c u ra sare s u lto fo n eo rm o reo fth e

o b s e rv eifth eA R R A Y P O S IT IO N L E D e x tin g u is h e sIfitd o e sn o t,

fo llo w in g :

p ro c e e dw ithth efo llo w in g :

•a no v e r-d ila te dc e rv ix ;

2 A tte m p tg e n tlere s e a tin go fth eN o v a S u red is p o s a b led e v ic e : A

•p o o rc o n ta c tb e tw e e nth ec e rv ic a lc o lla ra n dth ee x te rn a lc e rv ic a lo s ;

P a rtia llyre tra c tth ea rra yin toth es h e a thb yre le a s in gth e d is p o s a b led e v ic eh a n d lelo c kre le a s eb u tto n ;

• th ev a c u u m re lie fv a lv eisinth ec lo s e dp o s itio n ; •a no b s tru c tio ninth ed is p o s a b led e v ic eflte r(s )(tw o )o rd e s ic c a n t;o r •a no b s tru c tio nw ith inth ed is p o s a b led e v ic e

B

P u ll th ed is p o s a b led e v ic eb a c ks lig h tlyfro m fu n d u s ;

C

S lo w lyre d e p lo yth ed is p o s a b led e v ic ea rra yw h ileg e n tly

Y L N O S R E S U C F R9 08 0e ld o M

B A C K T O T O C

ro c k in gth ed is p o s a b led e v ic eb a c ka n dfo rtha n dlo c k in g T oe lim in a teth isc o n d itio n ,p e rfo rm th efo llo w in g :

th ed is p o s a b led e v ic eh a n d le s ;a n d D

•G e n tlyp re s sa2 – 35m m u te rin ed ila to ro rs o u n din s id eth ev a c u u m

R e s e a tth ed is p o s a b led e v ic ea g a in s tfu n d u su s in gth e s e a tin gp ro c e d u red e s c rib e dins te p s22 6th ro u g h23 3

re lie fv a lv e

3 Ifth eu te ru sisre tro v e rte d ,ta k es p e c ia lc a retoa v o id

•C h e c kth ec e rv ic a lc o lla rp o s itio n ,a n dre p o s itio nitifn e c e s s a ryU s e th eta bo nth ec e rv ic a lc o lla rtoa d v a n c eth ec e rv ic a lc o lla rto w a rd sth e

p e rfo ra tio nA p p lyg e n tlec a u d a dtra c tio ntoth ec e rv ixw ithth e

e x te rn a lo so fth ec e rv ixtoe n s u reth e reisatig h ts e a lV e rifyth a ta iris

te n a c u lu m ,a n de le v a teth ed is p o s a b led e v ic eh a n d leu p w a rd

n o tb e in gd ra w nth ro u g hth ec e rv ixb yalo o s eftb e tw e e nth ec e rv ic a l

to w a rdth ec e ilin g(in -lin ew ithth ea x iso fth eu te ru s )w h ile p e rfo rm in gth es e a tin gp ro c e d u re

c o lla ra n dth ee n tra n c etoth ec e rv ic a lc a n a l Ifa irisb e in gd ra w nin th ro u g hth ec e rv ic a lc a n a l,trytore p o s itio nth ec e rv ic a lc o lla ra n d

4 Ifth eA R R A Y P O S IT IO N L E D iss till illu m in a te d ,fu llyre tra c tth e

d is p o s a b led e v ic es h a fttop re v e n ta irin g re s s

d is p o s a b led e v ic ea rra ya n dre m o v eth ed is p o s a b led e v ic e

•E n s u reth es u c tio nc a n is te ro nth ed is p o s a b led e v ic eisv e rtic a la n dth e d e v ic etu b in gisn o td ra p e do v e rth ep a tie n t’sle g

fro m th ep a tie n t 5 D e p lo yth ed is p o s a b led e v ic eo u ts id eth ep a tie n t’sb o d y ;e n s u reth e e le c tro d ea rra yisu n d a m a g e da n dth a tth eA R R A Y P O S IT IO N L E D

•C h e c ka ll tu b in gc o n n e c tio n stoe n s u reth a tth e ya retig h tlyc o n n e c te d

e x tin g u is h e s

C h e c kth ep u s h -o ntu b in gc o n n e c to rsa tth ed e s ic c a n ttu b eR e p la c e th ed e s s ic a n tifitisp in kE n s u reth a tth eflte rlo c a te dn e a rth e

6 A tte m p tre in s e rtio n ,re d e p lo y m e n ta n dre s e a tin go fth ed is p o s a b le

d is p o s a b lec o n n e c tio no nth ev a c u u m fe e d b a c klin eistig h te n e d

d e v ic eu s in gth es e a tin gp ro c e d u red e s c rib e dins e c tio n20

•R e a tte m p ta b la tio n

7 Ifth eA R R A Y P O S IT IO N L E D re m a in sillu m in a te d ,re p la c ew ithan e w d is p o s a b led e v ic e

Ifth eV A C U U M L E D illu m in a te sa g a in :

8 Ifth eA R R A Y P O S IT IO N L E D re m a in sillu m in a te dw ithan e w

•D is c o n n e c tth ed is p o s a b led e v ic efro m th eR F c o n tro lle r

d is p o s a b led e v ic e ,te rm in a teth ep ro c e d u re

•R e m o v eth ed is p o s a b led e v ic efro m th ep a tie n t,th e n ; •E x c h a n g eth ed is p o s a b led e v ic ew ithan e w d is p o s a b led e v ic e •R e a tte m p tth ea b la tio nw ithth en e w d e v ic e

P le a s etu rntop a g e2 4fo r th ere m a in d e ro f

Ifav a c u u m a la rm o c c u rsw ithth en e w d e v ic e ,a b o rtth ep ro c e d u re :

th eIn s tru c tio n sfo rU s e .

N O T E :R e m o v in gth ed is p o s a b led e v ic efro m th eu te rin ec a v itya fte r c o m p le tin gac a v ityin te g ritya s s e s s m e n tw ill re q u irea na d d itio n a l C IA te s t tob ep e rfo rm e du p o nd is p o s a b led e v ic ere -in s e rtio n (w h e th e ro rn o t th eC IA p re v io u s lyp a s s e d )p rio rtoin itia tin ga n a b la tio n

1 9

Y L N O S R E S U C F R0 1e ld o M

E N G L IS H

B A C K T O T O C

O p e ra tin gth eM o d e l1 0R FC o n tro lle r

C Ifth ec a v ityin te g ritya s s e s s m e n tfa ilsa fte rre a s o n a b lea tte m p tsto im p le m e n tth etro u b le s h o o tin gp ro c e d u re s(s te p23 6 ),a b o rtth e p ro c e d u re N O T E :R e m o v in gth ed is p o s a b led e v ic efro m th eu te rin ec a v itya fte r c o m p le tin gac a v ityin te g ritya s s e s s m e n tw ill re q u irea na d d itio n a l C IA te s t tob ep e rfo rm e du p o nd is p o s a b led e v ic ere -in s e rtio n (w h e th e ro rn o t th eC IA p re v io u s lyp a s s e d )p rio rtoin itia tin ga n a b la tio n

23 7M a n u a lM o d eO n ly W h e no p e ra tin gth es y s te m inm a n u a lm o d e ,th ea b la tio nc y c le w ill n o ts ta rta u to m a tic a llya fte rth es u c c e s s fu llyc o m p le tio no fth e c a v ityin te g ritya s s e s s m e n t(C IA )O n c eas u c c e s s fu lC IA h a sb e e n c o m p le te d ,p re s sth eE N A B L E b u tto na n dd e p re s sth efo o ts w itc ha s e c o n dtim etoin itia teth ea b la tio nc y c le N O T E :Ina ll M o d e l1 0R F c o n tro lle rs ,av a c u u m p re -c h e c ko c c u rs a u to m a tic a llyp rio rtoin itia tio no f th ea b la tio nc y c leA “V a c u u m C h e c kinP ro g re s s ”s c re e nw ill a p p e a ra n da na u d ib leto n ew ill b e AA u to m a ticm o d e

h e a rdfo ru pto1 0s e c o n d sd u rin gth ev a c u u m p re -c h e c k

T oo p e ra teth eM o d e l1 0R F C inA u to m a ticM o d e ,p re s sth e

D u rin gth ea b la tio nc y c le ,a n“R F O N ”s c re e nw ithatim e rw ill

“S w itc hM o d e ”b u tto nw h e nita p p e a rsa tth eb o tto m o fth e

a p p e a rtotra c kth ed u ra tio no fth ea b la tio n

s c re e nP ro c e e dtos te p23 6 ,b u td on o tfo llo w s te p23 7if o p e ra tin gth es y s te m ina u to m a ticm o d e BM a n u a lm o d e N O T E :M a n u a lM o d eisth ed e fa u lt s y s te m o p e ra tio n

T oo p e ra teth es y s te m inm a n u a lm o d e ,d on o tp re s sth e“S w itc h M o d e ”b u tto np rio rtob e g in n in gth ec a v ityin te g ritya s s e s s m e n t (C IA )F o llo w s te p s23 6a n d23 7

N O T E :R F p o w e rd e liv e ryc a nb es to p p e da ta n ytim eb yp re s s in g

23 6B e g inth eC IA p ro c e d u reb ys te p p in go nth efo o ts w itc ho n c e

th efo o ts w itc h

“C a v ityA s s e s s m e n tinP ro g re s s ”w ill d is p la yo nth es c re e nw h ile

23 8A fte ra u to m a ticte rm in a tio no fth ea b la tio nc y c le(a p p ro x im a te ly9 0

fv ed o tslig h to ffa n do ns e q u e n tia llyT h ed u ra tio no fth ete s t

s e c o n d s ),fu llyre tra c tth ec e rv ic a lc o lla rtoitsp ro x im a lp o s itio nb y

w ill ra n g eb e tw e e na p p ro x im a te ly7a n d3 0s e c o n d sA “C a v ity

u s in gth eta bo nth ec e rv ic a lc o lla r

A s s e s s m e n tC o m p le te ”s c re e nd is p la y sw h e nth eC IA h a sp a s s e d

C A U T IO N :T h ec e rv ic a lc o lla rm u s tb efu llyre tra c te dtoitsp ro x im a l

a n dth es y s te m c a nd e liv e rR F e n e rg yP o w e rc a n n o tb ea p p lie dto

p o s itio nino rd e rtom in im iz eth ep o te n tia l fo rd a m a g etoth es h e a th

th ed is p o s a b led e v ic eu n til th eC IA C o m p le tes c re e nd is p la y s

w h e nc lo s in gth ea rra y

Ifth ec a v ityin te g ritya s s e s s m e n tfa ils ,as c re e nw ill d is p la y

C e rv ic a l C o lla r

“C a v ityA s s e s s m e n tF a ilu re ”w ithtro u b le s h o o tin gs te p s AIfap e rfo ra tio niss u s p e c te d ,th ep ro c e d u res h o u ldb e te rm in a te dim m e d ia te ly BIfth eC IA te s tfa ilsa g a in ,c h e c kfo rle a k sinth es y s te m ,a n d b e tw e e nth ec e rv ixa n dc e rv ic a lc o lla rB es u retoc h e c ka ll tu b in g c o n n e c tio n s ,a n de n s u reth a tas u c tio nlin ed e s ic c a n th a sb e e n in s ta lle dIfth ele a ka p p e a rstob ea tth ec e rv ixa n dc a n n o tb e re s o lv e db yu s in gth ec e rv ic a lc o lla r ,u s ea n o th e rte n a c u lu m tog ra s pth ec e rv ixa ro u n dth es h e a thR e p e a tth eC IA te s tb y p re s s in gth efo o ts w itc h N O T E :C Ole a k a g em a yo c c u ra t th ee x te rn a lc e rv ic a lo sd u etoth e 2

p re s e n c eo fa no v e r-d ila te dc e rv ix V is ib leb u b b le so rth e“h is s in g ” s o u n do fe s c a p in gg a sm a ya c c o m p a n yC Ole a k a g eu n d e re ith e ro f th e s ec o n d itio n s

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