{"product_id":"palloncino-monouso-per-maturazione-cervicale-cervical-maturation-balloon-e-un-catetere-a-doppio-palloncino-in-silicone-conf-10-pz","title":"Disposable cervical maturation balloon (Cervical Maturation Balloon) is a double balloon silicone catheter, pack of 10 pcs.","description":"\u003cp\u003e\u003cstrong class=\"ef-titolo4\"\u003eDisposable Balloon for Cervical Ripening\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eModel: CVB-18F-II\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eDescription:\u003c\/strong\u003eThe disposable balloon for cervical ripening (Cervical Maturation Balloon) is a double-balloon silicone catheter. Each balloon has a maximum inflation capacity of 80 ml. The device is used for the physical dilation of the cervical canal before induction of labor.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eIntended Use:\u003c\/strong\u003eThe device is used to dilate the cervical canal, stimulating the production and release of prostaglandins to promote cervical ripening. It shortens the birth process and reduces labor pain.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eContraindications:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\u003cli\u003ePatients being treated with exogenous prostaglandins.\u003c\/li\u003e\u003cli\u003ePlacenta previa, vasa previa, or placenta percreta.\u003c\/li\u003e\u003cli\u003eTransverse fetal position.\u003c\/li\u003e\u003cli\u003eUmbilical cord prolapse.\u003c\/li\u003e\u003cli\u003eHistory of hysterectomy, classical uterine incision, myomectomy, or other full-thickness uterine incisions.\u003c\/li\u003e\u003cli\u003ePelvic structural abnormalities.\u003c\/li\u003e\u003cli\u003eActive genital herpes infection.\u003c\/li\u003e\u003cli\u003eInvasive cervical cancer.\u003c\/li\u003e\u003cli\u003eAbnormal fetal heart rates.\u003c\/li\u003e\u003cli\u003eBreech presentation.\u003c\/li\u003e\u003cli\u003eMaternal heart disease.\u003c\/li\u003e\u003cli\u003eMultiple pregnancy.\u003c\/li\u003e\u003cli\u003ePolyhydramnios.\u003c\/li\u003e\u003cli\u003eFetal position above the pelvic inlet.\u003c\/li\u003e\u003cli\u003eSevere maternal hypertension.\u003c\/li\u003e\u003cli\u003eAny contraindication to labor induction.\u003c\/li\u003e\u003cli\u003eRuptured membranes.\u003c\/li\u003e\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWarnings:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\u003cli\u003eConcomitant use with exogenous prostaglandins may increase the risk of adverse events.\u003c\/li\u003e\u003cli\u003eDo not leave the device in place for more than 12 hours.\u003c\/li\u003e\u003cli\u003eThe safety and effectiveness of the device have not been established in women with a history of low transverse cesarean section.\u003c\/li\u003e\u003cli\u003eAlways inflate the balloon with sterile saline solution.\u003c\/li\u003e\u003cli\u003eDo not overinflate to avoid balloon rupture.\u003c\/li\u003e\u003cli\u003eThe device is sterile and valid for three years if properly stored. Do not reuse. Use immediately after opening the package.\u003c\/li\u003e\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003ePotential Adverse Events:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\u003cli\u003ePlacental abruption.\u003c\/li\u003e\u003cli\u003eUterine rupture.\u003c\/li\u003e\u003cli\u003eSpontaneous rupture of membranes.\u003c\/li\u003e\u003cli\u003eSpontaneous onset of labor.\u003c\/li\u003e\u003cli\u003eDevice expulsion.\u003c\/li\u003e\u003cli\u003eDevice entrapment or fragmentation.\u003c\/li\u003e\u003cli\u003eMaternal discomfort during and after insertion.\u003c\/li\u003e\u003cli\u003eFailure to dilate or need for cesarean delivery.\u003c\/li\u003e\u003cli\u003eCervical laceration.\u003c\/li\u003e\u003cli\u003eBleeding.\u003c\/li\u003e\u003cli\u003eRisk of preterm labor and delivery in subsequent pregnancies.\u003c\/li\u003e\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eMaterials and Safety:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\u003cli\u003e\u003cstrong\u003eLatex and Phthalates:\u003c\/strong\u003e Latex-free and phthalate-free.\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eSterilization:\u003c\/strong\u003e Sterilized with ethylene oxide (EtO).\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eComposition:\u003c\/strong\u003e Silicone. Tyvek®, paper and PE film blister. Non-toxic materials.\u003c\/li\u003e\u003cli\u003e\u003cstrong\u003eClassification:\u003c\/strong\u003e Class IIa medical device, compliant with Directive 93\/42\/EEC and subsequent amendments.\u003c\/li\u003e\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eInstructions for Use:\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003ePatient Preparation:\u003c\/strong\u003e\u003c\/p\u003e\u003col\u003e\u003cli\u003eConfirm singleton pregnancy and cephalic presentation with an abdominal ultrasound.\u003c\/li\u003e\u003cli\u003ePlace the patient in the lithotomy position.\u003c\/li\u003e\u003cli\u003eInsert a vaginal speculum to gain cervical access.\u003c\/li\u003e\u003cli\u003eClean the cervix with an appropriate cleansing solution.\u003c\/li\u003e\u003c\/ol\u003e\u003cp\u003e\u003cstrong\u003eDevice Placement:\u003c\/strong\u003e\u003c\/p\u003e\u003col\u003e\u003cli\u003eInsert the device into the cervix until both balloons enter the cervical canal.\u003c\/li\u003e\u003cli\u003eInflate the uterine balloon with 40 ml of saline solution using a standard 20 ml Luer-lock syringe through the red \"U\" valve.\u003c\/li\u003e\u003cli\u003ePull the device back to position the uterine balloon against the internal cervical os.\u003c\/li\u003e\u003cli\u003eInflate the vaginal balloon with 20 ml of saline solution using a standard 20 ml Luer-lock syringe through the green \"V\" valve.\u003c\/li\u003e\u003cli\u003eAdd fluid to each balloon alternately, in 20 ml increments up to a maximum of 80 ml per balloon.\u003c\/li\u003e\u003cli\u003eIf necessary, secure the proximal end of the catheter to the patient's thigh with adhesive tape.\u003c\/li\u003e\u003cli\u003eRemove the device after 12 hours or if the membranes rupture spontaneously.\u003c\/li\u003e\u003c\/ol\u003e\u003cp\u003e\u003cstrong\u003eDevice Removal:\u003c\/strong\u003e\u003c\/p\u003e\u003col\u003e\u003cli\u003eDeflate both balloons through the \"U\" and \"V\" valves.\u003c\/li\u003e\u003cli\u003eRemove the device vaginally.\u003c\/li\u003e\u003c\/ol\u003e\u003cp\u003e\u003cstrong\u003eStorage:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\u003cli\u003eStore in a dry place, away from direct sunlight and heat sources.\u003c\/li\u003e\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003ePackaging:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\u003cli\u003eProduct packaged in sterile blister.\u003c\/li\u003e\u003c\/ul\u003e\u003cp\u003e \u003c\/p\u003e","brand":"Securlab","offers":[{"title":"Default Title","offer_id":57603312648574,"sku":"43.03.10001","price":688.5,"currency_code":"EUR","in_stock":true}],"url":"https:\/\/www.securlab.it\/en\/products\/disposable-cervical-maturation-balloon-cervical-maturation-balloon-is-a-double-balloon-silicone-catheter-pack-of-10-pcs","provider":"Securlab","version":"1.0","type":"link"}