Description Vaginal dilators are smooth and flexible; light in weight; shaped to stay in place; and can be easily inserted and removed for their intended applications. They are made of silicone and are latex-free. Indications Silicone vaginal dilators are removable devices that are placed into the vagina to enlarge the vaginal cavity for the purpose of an examination, a surgical procedure, or for the relief of vaginismus. Contraindications Vaginal dilators should not be used under the following conditions: • Acute genital tract infections • Pelvic infections • Any non-compliant patient The aending physician must advise a pregnant patient if this product may be used. Warnings • The use of excessive force should be avoided. Precautions • Silicone vaginal dilators are designed for single patient use and are supplied non-sterile. • Dilators must be cleaned and sterilized prior to use. • Visually inspect the dilators for any surface damage prior to use. Dilators that are damaged must not be used. • A vaginal lubricant may be required for the patient’s comfort before insertion of a dilator. Instructions: 1. Perform a normal pelvic examination prior to the fiing and introduction of a dilator. A pelvic exam helps determine the appropriate size. 2. The length of time a patient should use a vaginal dilator is usually between 5 to 20 minutes per day. The physician may alter the frequency and duration of dilator usage as the prescribed therapy proceeds to the larger sizes in the set. 3. Once the dilator family size or set is determined, the smallest dilator should be inserted into the vagina with the base or flange in the downward position. 4. The dilator should be large enough for its indication, yet not cause any undue pressure or discomfort. 5. The patient should be instructed to gradually increase the dilator size over a suggested period of time until the patient is comfortable with the insertion of the largest size in the set. 6. Tell the patient to report any discomfort immediately. Removal, Cleaning and Suggested Follow-Up: 1. To remove a dilator, gently pull downward on the exposed flange until the dilator is completely removed. 2. Aſter removal, the dilator can be cleaned with mild soap and warm water. (The physician should follow the suggested cleaning and sterilization procedures listed below prior to patient use.) 3. Discuss with the patient the importance of following instructions and the expected length of time for dilator use. 4. Patient must be examined within 24-48 hours aſter initial use to ensure the patient is not allergic to the dilators. Examine the vagina and ask the patient if there has been any discomfort, irritation, pressure, sensitivity, or unusual vaginal discharge. Also determine if there has been any improvement in her personal symptoms. 5. Schedule follow-up visits to fit the needs of the patient. Cleaning Instructions/Sterilization Instructions 1. Cleaning: submerge in enzymatic cleaner for 20 minutes. Remove from enzymatic cleaner and rinse thoroughly with demineralized water Allow to dry completely prior to sterilization. 2. Disinfecting: use disinfecting solution for 12 minutes. Be sure to review and follow the disinfecting solution’s instructions of use. Remove from disinfecting solution and rinse thoroughly with demineralized water Allow to dry completely prior to sterilization. 3. Recommended Sterilization Parameters: Instructions for the Patient: Your physician has recognized the need for you to use a set of silicone vaginal dilators. As instructed by your physician, begin your vaginal therapy with the smallest dilator. When it is inserted properly into the vagina, you may be conscious of a mild feeling of pressure. Gradually, over a period of time, your physician will advise you to select the next dilator size for insertion and so on until you are completely comfortable using the largest dilator in the set. At any time, should the dilators become uncomfortable, promptly notify your physician. Removal and Cleaning: 1. To remove a dilator, gently pull downward on the exposed flange until the dilator is completely removed. 2. Aſter removal, the dilator can be cleaned with mild soap and warm water. see reverse for more information Integra ® Miltex ® Silicone Vaginal Dilator Sets Directions for Use / English REF LOT Sterilizer Exposure Temperature Exposure Time Minimum Dry Time Pre-Vacuum (Wrapped) 132°C (270°F) 4 minutes 20 minutes Pre-Vacuum (Un-wrapped) 132°C (270°F) 4 minutes - Gravity Steam 121°C (250°F) 30 minutes 30 minutes Gravity Steam 132°C ~ 135°C (270°F ~ 275°F) 10 minutes 30 minutes NOT MADE WITH NATURAL RUBBER LATEX LATEX LATEX
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Description
Vaginal dilators are smooth and flexible; light in weight; shaped to stay in place; and can be easily inserted and removed for their intended applications. They are made of silicone and are latex-free.
Indications
Silicone vaginal dilators are removable devices that are placed into the vagina to enlarge the vaginal cavity for the purpose of an examination, a surgical procedure, or for the relief of vaginismus.
Contraindications
Vaginal dilators should not be used under the following conditions:
• Acutegenitaltractinfections
• Pelvicinfections
• Anynon-compliantpatient
The attending physician must advise a pregnant patient if this product may be used.
2. The length of time a patient should use a vaginal dilator is usually between 5 to 20minutesperday.Thephysicianmayalterthefrequencyanddurationofdilator usageastheprescribedtherapyproceedstothelargersizesintheset.
3.Oncethedilatorfamilysizeorsetisdetermined,thesmallestdilatorshouldbe inserted into the vagina with the base or flange in the downward position.
4. The dilator should be large enough for its indication, yet not cause any undue pressure or discomfort.
5.Thepatientshouldbeinstructedtograduallyincreasethedilatorsizeovera suggested period of time until the patient is comfortable with the insertion ofthelargestsizeintheset.
6. Tell the patient to report any discomfort immediately.
Removal, Cleaning and Suggested Follow-Up:
1. To remove a dilator, gently pull downward on the exposed flange until the dilator is completely removed.
2.Afterremoval,thedilatorcanbecleanedwithmildsoapandwarmwater.(The physicianshouldfollowthesuggestedcleaningandsterilizationprocedureslisted below prior to patient use.)
3.Discusswiththepatienttheimportanceoffollowinginstructionsandthe expected length of time for dilator use.
4.Patientmustbeexaminedwithin24-48hoursafterinitialusetoensurethepatient is not allergic to the dilators. Examine the vagina and ask the patient if there has been any discomfort, irritation, pressure, sensitivity, or unusual vaginal discharge. Alsodetermineiftherehasbeenanyimprovementinherpersonalsymptoms.
Yourphysicianhasrecognizedtheneedforyoutouseasetofsiliconevaginaldilators.Asinstructedbyyourphysician,beginyourvaginaltherapywiththesmallest dilator. When it is inserted properly into the vagina, you may be conscious of a mild feeling of pressure. Gradually, over a period of time, your physician will adviseyoutoselectthenextdilatorsizeforinsertionandsoonuntilyouarecompletelycomfortableusingthelargestdilatorintheset.Atanytime,shouldthedilators become uncomfortable, promptly notify your physician.
Removal and Cleaning:
1. To remove a dilator, gently pull downward on the exposed flange until the dilator is completely removed.
Productsmustbereturnedinunopenedpackageswithmanufacturer’ssealsintacttobe accepted for replacement or credit unless returned due to a complaint of product defect.DeterminationofaproductdefectwillbemadebyIntegra.Productswillnotbeaccepted for replacement if they have been in the possession of the customer for more than 90 days.
30-3001 Large Set Length Small OD Large ODExtraLarge 150.0 mm 30.0 mm 38.0mmLarge 138.0mm 25.5 mm 32.0 mmMedium 128.0mm 22.5 mm 28.0mmSmall 120.0 mm 19.5 mm 24.0 mm
30-3002 Medium Set Length Small OD Large ODExtraLarge 95.0 mm 26.0 mm 33.0 mmLarge 86.0mm 22.5 mm 28.0mmMedium 78.0mm 19.5 mm 23.0 mmSmall 75.0mm 12.5 mm 17.0mm
30-3003 Small Set Length Small OD Large ODExtraLarge 75.0mm 13.5 mm 18.0mmLarge 65.0 mm 12.0 mm 16.0 mmMedium 60.0 mm 10.5 mm 14.0 mmSmall 50.0 mm 9.5 mm 13.0 mm*Silicone vaginal dilators are only available as a set of 4 as indicated.
ConsultInstructionforUse
CAUTION:Federal(USA)lawrestricts this device to sale by or on the order of a physician
ManufacturerPanpac Medical Corporation i6F-2,No.202,Sec.3,Ta-TongRd.,Shi-ChihDist.,NewTaipeiCityiTAIWAN,R.O.C.iPhone:886-2-8647-2242Fax:(886)28647-2770
Sumédicohaidentificadolanecesidaddequeutiliceunjuegodedilatadoresvaginalesdesilicona.Comiencesuterapiavaginalconeldilatadormáspequeñosiguiendo las indicaciones de su médico. Si introduce el dilatador correctamente en la vagina, puede experimentar una sensación de presión suave. Gradualmente, eneltranscursodelaterapia,sumédicoleaconsejaráqueinserteelpróximotamañodedilatadoryasísucesivamentehastaquesesientatotalmentecómodausando eldilatadormásgrandedeljuego.Comuniqueinmediatamenteasumédicosi, enalgúnmomento,experimentaalgúntipodeincomodidadalusarlosdilatadores.
Extracción y limpieza:
1. Pararetirareldilatador,tiredelrebordeexpuestosuavementehaciaabajohastaextraerlo por completo.
Extra grande 150,0 mm 30,0 mm 38,0mmGrande 138,0mm 25,5 mm 32,0 mmMediano 128,0mm 22,5 mm 28,0mmPequeño 120,0 mm 19,5 mm 24,0 mm
30-3002 Juego mediano Longitud
Diámetro exterior pequeño
Diámetro exterior grande
Extra grande 95,0 mm 26,0 mm 33,0 mmGrande 86,0mm 22,5 mm 28,0mmMediano 78,0mm 19,5 mm 23,0 mmPequeño 75,0mm 12,5 mm 17,0mm
30-3003 Juego pequeño Longitud
Diámetro exterior pequeño
Diámetro exterior grande
Extra grande 75,0mm 13,5 mm 18,0mmGrande 65,0 mm 12,0 mm 16,0 mmMediano 60,0 mm 10,5 mm 14,0 mmPequeño 50,0 mm 9,5 mm 13,0 mm*Losdilatadoresvaginalesdesiliconaestándisponiblesúnicamenteenjuegosde 4unidadessegúnloindicado.
ConsultelasInstruccionesdeuso
PRECAUCIÓN:LasleyesfederalesdeEE.UU.restringen la venta de este dispositivo a médicos o por prescripción médica
Nocontienelátex
Fabricante
Númerodecatálogo
Númerodelote
¡Precaución!Consultelasadvertencias y precauciones
FabricantePanpac Medical Corporation i6F-2,No.202,Sec.3,Ta-TongRd.,Shi-ChihDist.,NewTaipeiCityiTAIWÁN(REPÚBLICADECHINA).iTeléfono:886-2-8647-2242Fax:(886)28647-2770
Lesdilatateursvaginauxsontsouples,légers,deformeanatomiquepourévitertoutdéplacement et peuvent être insérés et retirés facilement pour leur application désignée. Ilssontfaitsdesiliconeetsontsanslatex.
Indications
Lesdilatateursvaginauxensiliconesontdesdispositifsamoviblesplacésdanslevaginpouragrandirlacavitévaginalesauxfinsd'unexamen,d'uneprocédurechirurgicale ou du soulagement du vaginisme.
3. Unefoisquelagammedetaillesdedilatateuraétédéterminée,insérezlepluspetitdilatateur de la gamme dans le vagin avec la base ou la collerette dirigée vers le bas.
4. Lapatientedoitêtreexaminéedansles24à48heuressuivantl'utilisationinitialepourassurerqu'ellen'estpasallergiqueauxdilatateurs.Examinezlevaginetdemandezàlapatientesielleressentunesensationd'inconfort,d'irritation,depression,desensibilitéousiunedéchargevaginaleanormales'estproduite.Déterminezégalementsi une amélioration de ses symptômes personnels a pu être constatée.
30-3001 Ensemble de grande taille Longueur Petit DE Grand DEExtra grand 150,0 mm 30,0 mm 38,0 mmGrand 138,0 mm 25,5 mm 32,0 mmMoyen 128,0 mm 22,5 mm 28,0 mmPetit 120,0 mm 19,5 mm 24,0 mm
30-3002 Ensemble de taille moyenne Longueur Petit DE Grand DEExtra grand 95,0 mm 26,0 mm 33,0 mmGrand 86,0 mm 22,5 mm 28,0 mmMoyen 78,0 mm 19,5 mm 23,0 mmPetit 75,0 mm 12,5 mm 17,0 mm
30-3003 Ensemble de petite taille Longueur Petit DE Grand DEExtra grand 75,0 mm 13,5 mm 18,0 mmGrand 65,0 mm 12,0 mm 16,0 mmMoyen 60,0 mm 10,5 mm 14,0 mmPetit 50,0 mm 9,5 mm 13,0 mm*Lesdilatateursvaginauxensiliconenesontdisponiblesqu'enensemblesde 4unités,commeindiqué.
Silikondilatatoren sind glatt, flexibel und leichtgewichtig, so geformt, dass sie nicht verrutschen;undkönnenleichtzurbeabsichtigtenAnwendungeingeführtundherausgezogenwerden.SiebestehenausSilikonundsindlatexfrei.
4.PatientinnenmüssennachdererstenVerwendunginnerhalbvon24-48Stundenuntersuchtwerden,umsicherzustellen,dassdiePatientinnichtallergischaufdieDilatatorenreagiert.UntersuchenSiedieVaginaundfragenSiediePatientin, obsieUnbehagen,Reizung,Druck,SchmerzempfindlichkeitoderungewöhnlichenVaginalausflussempfindet.StellenSieauchfest,obeineVerbesserungihrerpersönlichen Symptome gegeben hat.
5.SetzenSieentsprechendderBedürfnissederPatientinTerminefürFolgeuntersu-chungen an.
Extragroß 150,0 mm 30,0 mm 38,0mmGroß 138,0mm 25,5 mm 32,0 mmMittelgross 128,0mm 22,5 mm 28,0mmKlein 120,0 mm 19,5 mm 24,0 mm
30-3002 Mittleres Set Länge
Kleiner Außen-durchmesser
Großer Außen-durchmesser
Extragroß 95,0 mm 26,0 mm 33,0 mmGroß 86,0mm 22,5 mm 28,0mmMittelgross 78,0mm 19,5 mm 23,0 mmKlein 75,0mm 12,5 mm 17,0mm
30-3003 Kleines Set Länge
Kleiner Außen-durchmesser
Großer Außen-durchmesser
Extragroß 75,0mm 13,5 mm 18,0mmGroß 65,0 mm 12,0 mm 16,0 mmMittelgross 60,0 mm 10,5 mm 14,0 mmKlein 50,0 mm 9,5 mm 13,0 mm*SilikonvaginaldilatatorensindnurwieangegebeninSätzenvon4erhältlich.
HerstellerPanpac Medical Corporation i6F-2,No.202,Sec.3,Ta-TongRd.,Shi-ChihDist.,NewTaipeiCityiTAIWAN,R.O.C.iTelefon:886-2-8647-2242Fax:(886)28647-2770
2.Lapazientedovrebbeutilizzareildilatatorevaginalediregolatra5e20minutialgiorno.Ilmedicopuòprescrivereunadiversafrequenzaeduratadeldilatatorein base alla terapia scegliendo il dilatatore di dimensione immediatamente superiore del set.
3.Unavoltadeterminatalamisuradelgruppodidilatatoriodelset,inserireinvagina il dilatatore più piccolo con la base o la flangia rivolta in basso.
5.Invitarelapazienteaintrodurregradualmenteildispositivodimisurasuperiore,dopounperiododitempostabilito,finchénonsitroveràasuoagioconlamisuramassima del set.
4.Visitarelapazientedopo24-48oredall'usoinizialeperaverelacertezzachenonsiaallergicaaidilatatori.Esaminarnelavaginaechiedereallapazienteriguardoall'eventualepresenzadidisagio,irritazioni,pressioni,sensibilitàoperditevaginaliinsolitechepotrebberoessersiverificate.Determinareinoltresevisiastatounmiglioramento dei sintomi personali.
IlmedicocuranteharilevatolanecessitàperLeidiutilizzareunsetdidilatatorivaginali.Suinvitodelmedico,inizilaterapiavaginaleconildilatatoredellamisurapiùpiccola.Quandoildilatatoreèinseritoappropriatamenteinvagina,potrebbeavvertire una leggera pressione. Gradualmente, con il tempo, il suo medico le consiglieràdiselezionareildilatatoredellamisuraimmediatamentesuperioreecosìviafinchénonsitroveràperfettamenteasuoagioconildilatatoredellamisurapiùgrandedelset.Inqualsiasimomento,semaidovesseavvertiredisagiconildilatatore, ne informi tempestivamente il medico.
30-3001 Set grande Lunghezza OD piccolo OD grandeExtralarge 150,0 mm 30,0 mm 38,0mmGrande 138,0mm 25,5 mm 32,0 mmMedio 128,0mm 22,5 mm 28,0mmPiccolo 120,0 mm 19,5 mm 24,0 mm
30-3002 Set medio Lunghezza OD piccolo OD grandeExtralarge 95,0 mm 26,0 mm 33,0 mmGrande 86,0mm 22,5 mm 28,0mmMedio 78,0mm 19,5 mm 23,0 mmPiccolo 75,0mm 12,5 mm 17,0mm
30-3003 Set piccolo Lunghezza OD piccolo OD grandeExtralarge 75,0mm 13,5 mm 18,0mmGrande 65,0 mm 12,0 mm 16,0 mmMedio 60,0 mm 10,5 mm 14,0 mmPiccolo 50,0 mm 9,5 mm 13,0 mm*Idilatatorivaginaliinsiliconesonodisponibiliunicamenteinsetdi4,comeindicato.
Vaginaleoprekkersofdilatatorenzijngladenflexibel,lichtingewichtendankzijhunvormblijvenzijophunplaats;zijzijngemakkelijkintebrengenenteverwijderenvoorhetbedoeldegebruik.Zijzijnvervaardigduitsiliconeenvrij van latex.
Indicaties
Siliconevaginaledilatatorenzijnverwijderbareapparatendieindevaginawordengeplaatstomdezeopterekkenvooreenonderzoek,eenchirurgischeingreepofvoor het verlichten van vaginisme.
Contra-indicaties
Onder de volgende omstandigheden mogen vaginale dilatatoren niet worden gebruikt:
5.Depatiëntedientinstructiestekrijgenomdemaatdilatatorgeleidelijktevergrotenbinneneenaanbevolenperiodetotzijgeenongemakmeervoeltbijhetinbrengen van de grootste maat uit de set.
2.Naverwijderingkandedilatatorgereinigdwordenmetmildezeepenwarmwater.(Vóórgebruikdoordepatiëntedientdeartsdehieronderaanbevolenreinigings-en desinfectieprocedure te volgen.)
Instructies voor reiniging/instructies voor sterilisatie
1. Reiniging:onderdompeleninenzymatischereinigergedurende20minuten. Uitdeenzymatischecleanernemenengrondigafspoelenmetgedemineraliseerdwater. Volledig laten drogen alvorens te steriliseren.
2.Desinfectering:gebruikeendesinfecteringsoplossinggedurende12minuten. Volgdeaanwijzingenvandedesinfecteringsoplossingvoorhetgebruik. Uitdedesinfecteringsoplossingnemenengrondigafspoelenmetgedemineraliseerd water. Volledig laten drogen alvorens te steriliseren.
3.Aanbevolensterilisatieparameters:
Instructies voor de patiënte:
Uwartsheeftbijudenoodzaakvoorgebruikvaneensetsiliconevaginaledilatatorenvastgesteld.Zoalsaangegevendooruwartsbegintudevaginaletherapiemetdekleinstedilatator.Wanneerdezejuistindevaginawordtgeplaatst,kuntueenlichtedrukwaarnemen.Uwartszaluaanradenomgeleidelijkaandevolgendemaatdilatatorintebrengenenzoverdertegaantotugeenongemakmeervoeltbijgebruikvandegrootstedilatatorindeset.Mochthetgebruikvandedilatatoren op enig moment onprettig aanvoelen, informeer dan direct uw arts.
Extra Groot 150,0 mm 30,0 mm 38,0mmGroot 138,0mm 25,5 mm 32,0 mmMiddelgroot 128,0mm 22,5 mm 28,0mmKlein 120,0 mm 19,5 mm 24,0 mm
30-3002 Set Medium Lengte
Kleine buitendiameter
Grote buitendiameter
Extra Groot 95,0 mm 26,0 mm 33,0 mmGroot 86,0mm 22,5 mm 28,0mmMiddelgroot 78,0mm 19,5 mm 23,0 mmKlein 75,0mm 12,5 mm 17,0mm
30-3003 Set Small Lengte
Kleine buitendiameter
Grote buitendiameter
Extra Groot 75,0mm 13,5 mm 18,0mmGroot 65,0 mm 12,0 mm 16,0 mmMiddelgroot 60,0 mm 10,5 mm 14,0 mmKlein 50,0 mm 9,5 mm 13,0 mm*Siliconevaginaledilatatorenzijnslechtsverkrijgbaarineensetvan4,zoalsaangegeven.
Raadpleeg gebruiksinstructies
LETOP:volgensdeAmerikaansefederale wet mag dit instrument uitsluitend verkocht worden door ofopvoorschriftvaneenarts