Disposable Balloon for Cervical Ripening

Model: CVB-18F-II

Description:
The 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.

Intended Use:
The 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.

Contraindications:

• Patients being treated with exogenous prostaglandins.


• Placenta previa, vasa previa, or placenta percreta.


• Transverse fetal position.


• Umbilical cord prolapse.


• 
  History of hysterectomy, classical uterine incision, myomectomy, or other full-thickness uterine incisions.
  


• Pelvic structural abnormalities.


• Active genital herpes infection.


• Invasive cervical cancer.


• Abnormal fetal heart rates.


• Breech presentation.


• Maternal heart disease.


• Multiple pregnancy.


• Polyhydramnios.


• Fetal position above the pelvic inlet.


• Severe maternal hypertension.


• Any contraindication to labor induction.


• Ruptured membranes.

Warnings:

• 
  Concomitant use with exogenous prostaglandins may increase the risk of adverse events.
  


• 
  Do not leave the device in place for more than 12 hours.
  


• 
  The safety and effectiveness of the device have not been established in women with a history of low transverse cesarean section.
  


• 
  Always inflate the balloon with sterile saline solution.
  


• 
  Do not overinflate to avoid balloon rupture.
  


• 
  The device is sterile and valid for three years if properly stored. Do not reuse. Use immediately after opening the package.
  

Potential Adverse Events:

• Placental abruption.


• Uterine rupture.


• Spontaneous rupture of membranes.


• Spontaneous onset of labor.


• Device expulsion.


• Device entrapment or fragmentation.


• Maternal discomfort during and after insertion.


• Failure to dilate or need for cesarean delivery.


• Cervical laceration.


• Bleeding.


• 
  Risk of preterm labor and delivery in subsequent pregnancies.
  

Materials and Safety:

• 
  Latex and Phthalates: Latex-free and phthalate-free.
  


• 
  Sterilization: Sterilized with ethylene oxide (EtO).
  


• 
  Composition: Silicone. Tyvek®, paper and PE film blister. Non-toxic materials.
  


• 
  Classification: Class IIa medical device, compliant with Directive 93/42/EEC and subsequent amendments.
  

Instructions for Use:

Patient Preparation:

1. 
   Confirm singleton pregnancy and cephalic presentation with an abdominal ultrasound.
   


2. Place the patient in the lithotomy position.


3. 
   Insert a vaginal speculum to gain cervical access.
   


4. Clean the cervix with an appropriate cleansing solution.

Device Placement:

1. 
   Insert the device into the cervix until both balloons enter the cervical canal.
   


2. 
   Inflate the uterine balloon with 40 ml of saline solution using a standard 20 ml Luer-lock syringe through the red "U" valve.
   


3. 
   Pull the device back to position the uterine balloon against the internal cervical os.
   


4. 
   Inflate the vaginal balloon with 20 ml of saline solution using a standard 20 ml Luer-lock syringe through the green "V" valve.
   


5. 
   Add fluid to each balloon alternately, in 20 ml increments up to a maximum of 80 ml per balloon.
   


6. 
   If necessary, secure the proximal end of the catheter to the patient's thigh with adhesive tape.
   


7. 
   Remove the device after 12 hours or if the membranes rupture spontaneously.
   

Device Removal:

1. 
   Deflate both balloons through the "U" and "V" valves.
   


2. Remove the device vaginally.

Storage:

• 
  Store in a dry place, away from direct sunlight and heat sources.
  

Packaging:

• Product packaged in sterile blister.