Cervical Dilator :

(Vaginal Dilator)

The SMB Cervical Dilator, also known as the Progressive Dilator, is a medical device featuring a round tip designed to facilitate cervical dilation for Endo-Uterine Examination. The distal part of the dilator, depending on the Small and Large models, comprises 4 to 5 segments, each measuring 1.5 cm, with a progressively increasing diameter from the distal end. The rounded tip of the dilator serves to prevent puncture of the uterine wall.

This device is specifically crafted to dilate the cervical canal, enabling entry into the uterus for the evaluation of the cervical canal or uterine cavity. It ensures maximum safety, allowing medical professionals to examine the cervix and endocervical canal with excellent control. Cervical dilation becomes necessary when there is a need to insert an instrument through the cervical canal, and the canal is not sufficiently dilated to permit free passage for that instrument.

Cervical Dilator

Intended Use:

It is employed to dilate the narrow opening of the cervix during gynecological examinations, treatments, or surgical procedures.
The device should be utilized by or under the supervision of a qualified and trained healthcare professional, physician, or gynecologist.

Sterilization: Gamma Radiation Sterilization

Intended population: Women

Contraindications:

Hypovolemic shock
Cardiac decompensation (Class IV)
Coagulopathy/blood dyscrasias
Cervical biopsy performed during active local infection, especially caused by Herpes Simplex, Chlamydia, or Gonococcus, as they may increase the risk of Pelvic Inflammatory Disease (PID).

Warning:

Bleeding after dilation can be controlled by applying direct pressure with a cotton swab. If continuous oozing occurs, Silver Nitrate solution can be used to manage it.
Vaginal Discharge
Spotting
Intercourse should be avoided for at least 72 hours after the procedure

Precaution:

Never apply pressure while inserting the cervical dilator if resistance is felt; otherwise, it may perforate the uterine cavity. If perforation occurs, the patient must be observed to determine whether laparoscopy/laparotomy needs to be performed.
Adequate local anesthesia and visualization should be achieved before initiating the procedure.
Ensure adequate visualization of the entire cervix with sufficient lighting to assure proper placement of the cervical dilator.
Stabilize the cervix with a tenaculum to the anterior cervical lip to allow visualization of the OS and entry to the cervical canal.

Direction for Use:

Once the size and direction of the uterus are determined, prepare the cervix for the insertion of the device according to the normal protocol for such procedures.
Grasp the handle with a comfortable grip, ensuring that the direction of curvature of the distal end of the device aligns with the direction of the uterus.
Place the distal tip of the device against the cervical surface and softly explore until you identify the opening of the external OS.
Slowly advance the distal end to gradually dilate the endocervical canal. Some resistance will be felt as the distal tip encounters the internal cervical OS. Maximum dilation requires further insertion of the distal part, limited by each patient's uterine anatomy.
Slowly continue to advance the device while gently manipulating the curvature of the device's distal segment in the direction that follows the curvature of the patient's uterus.
When the fundus of the uterine cavity is determined to have been reached or when encountering resistance that cannot be overcome with very gentle probing, this marks the measured depth of the uterine cavity.
Completely remove the device and confirm the depth at which the presence of mucus ends.

The device is intended for a single use only. Refrain from using it if the packaging has been opened or damaged.

The sterility of the device is ensured unless the package is compromised. Adhere to regulations by not reusing the device; instead, it should be discarded after use to prevent potential pelvic infections associated with reuse.

Storage:

Store the item appropriately in a dry place, keeping it away from direct sunlight, heat sources, water, and mechanical damage.

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