Utah Medical Products Filshie Sterishot II User manual

Inservice Reference Guide
A HigHly-effective And SAfe device
for PermAnent femAle SterilizAtion
®
™
Single Patient Use
Filshie®Clip Applicator
IMPORTANT:Thisguideisnotintendedtobeacompleteinstruction.Consultthe
InstructionsforUseforcompleteindications,contraindications,warningsandprecautions.

Product Description
TheFilshieTubalLigationSystemconsistsof:
• Aprecalibrated,sterileSterishotIIApplicatorintray.
• ApairofFilshieclips,packagedwithintheirownboxthatisplacedunder
theSterishotIItray.Theboxalsocontainspatientlotlabelstobeplaced
inapatient’srecord,andaMRIcardtobegiventothepatientafterthe
procedure.
• Asanoption, Elite Kitswhichcontainan8mmport.An8mmportistheideal
sizefortheSterishotIIapplicator.Thisportsizerequireslesstissuedilation
thanthecommonlyavailable10mmports,soisgentlertotissueandmay
reduceincidenceofportsiteherniationordelayedsitehealing.
Loading the Filshie Clip
CarefullyremovetheSterishotIIFilshieClipApplicatorfromitspackaging.Check
theoperationoftheapplicatorpriortouse.Usersmustbeabletoeasilyandfully
compresstheSterishotIItriggertoitsstop.
Ensure the Clip is correctly loaded in the applicator
1.CheckthatthebottomportionoftheClipliesperfectlyatontheoorofthe
applicator‘ClipTray’,notrisingupatthebackorthefront.
2.CheckthatthefrontendoftheClipliesdirectlybehindthe‘ClipStop’ofthe
applicator’slowerjaw.
3.CheckthattheupperportionoftheClipislocatedbetweenthe‘SideGuides’
oftheapplicator’supperjaw.
4.GentlytaptheapplicatoragainstthepalmofthehandtoensuretheClipis
securelyloaded.
Aspictured,pickuptheFilshieClipwith
theblueplastic‘NoTouch’handlealready
tted.
Usinga‘NoTouch’technique,slidethe
bottomoftheFilshieClipalongtheoorof
theapplicator‘ClipTray’untilitiswithin
the‘SideGuides’andagainstthe‘ClipStop’.
Detachthe‘NoTouch’handlebyleveringit
backwards,andthendiscardthehandle.

Entering the Abdomen: The ‘Half Closed’ Position
A feature of the Sterishot II Applicator is a white visual guide located within
the trigger housing, designed to help signal the ‘Half Closed’ position and
hence avoid prematurely closing or distorting the Filshie Clip so that it may
fail to close properly. To ensure the ‘Half Closed’ position is not exceeded, the
edge of the black polished section of the trigger should not pass beyond the
white visual guide located inside the black trigger housing.
Application of the Filshie Clip
• IdentifyandinspecttheFallopiantubethoroughly.
• EnsurethattheFilshieClipcanaccommodatethewholediameterofthe
Fallopiantube.
• LocatetheFilshieClipovertheisthmicportionoftheFallopiantube,1-2cm
fromthecornu.
• HavingestablishedthebestlocationfortheFilshieClipafterinsertion
throughthetrocar,theapplicatorshouldbere-openedandadvancedafew
millimeterstomovetheFallopiantubegentlytothebackoftheFilshieClip,
closetothehinge.
• ClosetheFilshieClipintopositionbyapplyingrm,butgentlepressureon
thetriggerinasmoothactionuntilthetriggerreachesitsmechanicalstop.
• WhentheFilshieClipissecuredinposition,gentlyreleasethetriggerandthe
FilshieClipwillautomaticallyfreeitselffromtheapplicator‘ClipTray’.
• Donotuseanabruptclosureactionorthetubemightbetransected.Should
thisoccur,applyasecondFilshieClipontheproximal(uterine)sideofthe
transection.
Digital photography and video recording of the closure process are encouraged to
support the patient record case file.
Removal of the Applicator from the Abdomen
BeforetheSterishotIIApplicatorcanbewithdrawnfromthe
abdomenitmustbereturnedtothe‘HalfClosed’positionsoit
canpassthroughthecannula.
CorrectClosure
Polished Trigger
Section
White Visual Guide
Trigger Housing
Clipwithapplicator
halfclosed
Clipopenovertube Clipclosedontube
Applicatorjawsin
‘HalfClosed’position
(clipnotprematurelyclosedordistorted)

FILSHIE TUBAL LIGATION USING THE
PATENTED* STERISHOT II APPLICATORS -
A HIGHLY EFFECTIVE CHOICE
FOR PERMANENT CONTRACEPTION
• Quick&easytoapply
• Requiresminimallaparoscopicports
• Canbeappliedimmediatelyfollowingchildbirth
• Non-hormonal,doesnotcontaincopper
• MRIcompatible
• Permanent,yethasbeenshowntoallowhighreversalsuccess
• Consistent,highlyeffectiveresultswithaprecalibratedFilshie
Clipclosuremechanismforeachpatient
• Nopost-surgicalcleaning,sterileprocessing,trackingbetween
proceduresorservicerequired
Order Reference:
SterishotIIStandardLaparoscopicKit..........................................................AVM-951
SterishotIIMinilaparotomyKit......................................................................AVM-951M
SterishotIIEliteKitw/BladelessPort..........................................................AVM-954
FilshieClips(10pairs)........................................................................................AVM-851J
7043South300WestMidvale,Utah84047
Tel866.754.9789Fax+1801.566.2062
utahmed.com/sterishot.html
58406rev071119 *USPatents9,451,966,10,092,296