Integra-lifesciences Cervical Dilator Set, Reusable User Manual download pdf

Description

Cervical dilators are smooth and ﬂexible, light in weight and can be easily

inserted and removed for their intended applications. They are made of

medical-grade Teﬂon and are latex-free.

The OS Locator

One molded band above the tactile handle and opposite the distal end of the

device identiﬁes the disposable OS locator. The OS locator may be used to

ﬁnd and gently dilate the external OS. The OS locator oﬀers gradual dilation,

tip ﬂexibility, and a smooth surface. The OS locator is tapered 23 mm to an

intermediate diameter of 3.8 mm.

The Canal Dilator

Two molded bands above the tactile handle identify the canal dilator from the

OS locator and the fundus sound. Its longer tapered tip is 45 mm and extends

to an intermediate diameter of 3.8 mm. The canal dilator may be used to slowly

dilate the length of the cervical canal.

The Fundus Sound

Three molded bands opposite the distal tip identify the fundus sound from the

others as described above. The tapered length from the distal tip is 85 mm. The

smooth and ﬂexible fundus sound is designed to pass through the entire length

of the cervix, dilate the internal OS and sound the fundus to determine

uterine depth.

Indications

Cervical dilators are useful in locating and dilating the external OS, cervical

canal and internal OS of the uterus. Cervical dilators may be used on post-

menopausal patients with cervical stenosis.

Contraindications

Cervical dilators should not be used under the following conditions:

• Acutegenitaltrackorpelvicinfections.

• Apregnancyorthesuspicionofapregnancy.

• Anyinvasivecancerthatisvisibleuponexamination.

• Anynon-compliantpatient.

Warnings

This procedure should only be performed by a trained medical professional.

The use of excessive force should be avoided.

Cervical dilators should not be used for prolonged periods of time.

Precautions

• Reusablecervicaldilatorsetisprovidednon-sterile.

Dilators must be sterilized prior to use.

• Visuallyinspectthedilatorsforanysurfacedamagepriortouse.

• Dilatorsthataredamagedmustnotbeused.

Instructions

Dilation of the cervix may be required for many diagnostic and treatment

procedures. This procedure should always be performed by a medical professional

whoistrainedintheprocedureandawareofallpossiblecomplicationsandrisks

that may be present.

1.Apelvicexaminationofthepatientshouldbeperformedpriortodilationto

 determineconditionspresentandrisksofdilation.

2. The insertion of a weighted speculum may assist with visualization of the cervix.

3. Uterine tenaculum forceps should be used to grasp the cervix. Stabilization of the

tenaculum should be maintained during the dilation procedure to absorb

resistance and avoid trauma to surrounding anatomical structures.

4. The OS locator is used to gently dilate the external OS to allow access to the

 cervicalcanal.Holdingthedilatorlikeapen,gentlyinsertthedilatorintothe

 externalOS.Slight,slowmovementscanbeusedtobreakupconnectivetissues

that may exist. Proceeding slowly allows the OS to gently stretch to

accommodate the dilator.

5. The canal dilator is oen needed next to continue the dilation of the cervical

canal to gain access to the internal OS. The canal may become atrophic and rigid

in post menopausal patients. Proceeding slowly using the technique referenced

above, allows the canal to gently stretch over the dilator.

6. The fundus sound is utilized to complete the dilation of the internal OS and

palpate the depth of the uterus. Dilation of the internal OS should also proceed

slowly to allow the tissues to gently stretch over the dilator. Continuing to hold

 thedilatorlikeapen,careshouldbeexercisedtominimizetheriskofperforation

of the uterus or tearing of the internal OS.

7. If additional dilation is required, the use of progressively larger diameter dilators

can be utilized following the same process allowing for slow dilation of the

cervix to accommodate instrumentation needed for the procedure.

8. If resistance is met to any size dilator it is advisable to leave it in the internal

OS for several seconds to allow the tissues to expand around it.

Cleaning Instructions/Sterilization Instructions

1. Cleaning: submerge in enzymatic cleaner for 20 minutes. Cleaning was validated

using MRapidMulti-Enzyme.Otherenzymaticcleanersmaybeeectivebut

have not been validated.

 Removefromenzymaticcleanerandrinsethoroughlywithwater.Demineralized

water is recommended for rinsing.

 Allowtodrycompletelypriortosterilization.

2. Disinfecting: use Cidex® disinfecting solution for 12 minutes. Follow the

disinfecting solution’s instructions for use. Other disinfecting solutions may

be eﬀective but have not been validated.

 Removefromdisinfectingsolutionandrinsethoroughlywithdemineralizedwater.

 Allowtodrycompletelypriortosterilization.

See reverse more more information

Integra

Miltex

Reusable Cervical Dilator Set

Directions for Use / English

LOT

REF

30-3000 Reusable Cervical Dilator Set

0434

1 2 3 4 5 6 ... 11 12

Summary of Contents

Page 1 - Directions for Use / English

DescriptionCervical dilators are smooth and ﬂexible, light in weight and can be easily inserted and removed for their intended applications. They are

Page 2

3.Parametriraccomandatiperlasterilizzazione:Direive per il reso dei prodoiI prodoi devono essere restituiti in confezioni chiuse con i sigilli

Page 3

BeschrijvingCervicale oprekkers of dilatatoren zijn glad en ﬂexibel, licht in gewicht en gemakkelijk in te brengen en te verwijderen voor het bedoelde

Page 4

3.Aanbevolensterilisatieparameters:Beleid voor retourneren van artikelenAlleenproductendieinongeopendeverpakkingenmetdeverzegelingvandef

Page 5 - Français

3.RecommendedSterilizationParameters:Returned Goods Policy Productsmustbereturnedinunopenedpackageswithmanufacturer’ssealsintact to be ac

Page 6

DescripciónLos dilatadores cervicales son suaves, ﬂexibles, livianos y pueden insertarse y retirarse fácilmente cuando se los utiliza de acuerdo con e

Page 7 - Gebrauchsanweisung / Deutsch

3. Parámetros de esterilización recomendados:Política de devolución de productosLos productos deben devolverse en paquetes sin abrir, con los sellos d

Page 8

DescriptionLes dilatateurs cervicaux sont lisses et souples, légers et peuvent être insérés et retirés facilement pour leur application désignée. Ils

Page 9

3. Paramètres de stérilisation recommandés:Politique des marchandises retournées Les produits doivent être retournés dans des emballages non ouverts

Page 10

BeschreibungZervikaldilatatoren sind gla, ﬂexibel und leichtgewichtig und können leicht zur beabsichtigten Anwendung eingeführt und herausgezogen wer

Page 11 - Herbruikbare Cervix Oprekset

3. Empfohlene Sterilisationsparameter:Hinweise zur Rücksendung von WarenProdukte müssen in der ungeöﬀneten Verpackung mit intaktem Herstellersiegel zu

Page 12

DescrizioneI dilatatori cervicali sono levigati, ﬂessibili, leggeri e facili da inserire e rimuovere per l'applicazione per cui sono previsti. Re