CCD 20mm Sliding Rigister Instructions

CCD 20mm Sliding Rigister

Specifications

• Brand Name: Commercial Code
• Product Name/Model: Sliding Register
• Available Diameters: 20mm, 25mm, 30mm, 35mm
• Accessory: Bloc Connector
• Sterilization Method: Ethylene Oxide

Product Information

• Place the patient on the fluoroscopic machine in a gynecologic examination position.
• Clean the external genital area with an antiseptic solution.
• Insert a sterile speculum into the vagina for good visualization of the cervix.
• Disinfect the cervix with an antiseptic solution.
• Before introducing the catheter:
• Discomfort or moderate pain
• Infection
• Mild to moderate uterine cramps
• Allergic reaction to the contrast agent
• Uterine perforation and tubal rupture (very rare)
• Pregnancy or suspicion of pregnancy
• Acute pelvic inflammation or infection
• Unexplained pelvic tenderness
• Presence of an intrauterine contraceptive device
• Allergy to contrast product
• Single Packaging
• Do not use if primary packaging is damaged or opened before the medical procedure.
• Store away from direct sunlight in a dry place.
• Use before the expiry date mentioned on the packaging.
• Dispose of the product according to guidelines for handling potentially infectious materials after use.

FAQ

• Q: What is the Sliding Register used for?
• A: The Sliding Register is used for Hysterosalpingography (HSG) and chromopertubation procedures.
• Q: What are the complications associated with using the Sliding Rigister?
• A: Complications may include discomfort or moderate pain, infection, mild to moderate uterine cramps, allergic reactions to contrast agents, and very rare events like uterine perforation and tubal rupture.

Medical devices for hysterosonography and chromopertubation

Accessoire/ Accessory
1507000| Bloc Connector

DocuSign Envelope ID: 9ED79B3F-729A-43A9-9421-C9D4103BC4EF

Description

The Sliding Register is used for HSG and chromopertubation. It includes:

• A tapered and transparent cup with a central cone-shaped cannula, fitted onto a cylindrical handle, external diameters 20, 25, 30 or 35 mm
• A lateral catheter attached to the cup to be connected to a vacuum system,
• A central injection tubing slides into the cup and has 4 markings spaced 2cm apart.

The cup is available in 4 different diameters: (20, 25, 30, 35 mm) allowing to adapt to different morphologies of the cervix. It is a sterile, single-use device.
*The Bloc Connector is an accessory of the Sliding Rigister & the Rigister that allows their connection to a vacuum source.

Sterilization

• Sterilization with ethylene oxide

Indication
The Sliding Rigister is a medical device designed to be used during hysterosalpingography which is a radiographic examination. The indications of that use are the following cases:

• Infertility with or without the presence of repeated miscarriages
• Congenital or anatomic abnormalities
• Anomalies of the menstrual cycle.
• Pain in the pelvis tract
• Abnormal menses
• Preoperative control for uterine or tubal surgery

The sliding Rigister is also used for chromopertubation during laparoscopy and allows to verification of tubal permeability

Precautions of use

• The product is intended for use by health professionals with knowledge of gynecology/obstetrics, in compliance with aseptic measures.
• Laboratoire CCD strongly recommends that the health professional take note of the information given in the IFU.
• The product is delivered in a sterile state. Before use, make sure that the packaging has not been opened, and/or damaged, and check the expiry date, and the integrity of the product.
• The product is intended for single use only, and must not be cleaned, or resterilised. In case of cleaning, and/or re-sterilization, its characteristics can no longer be guaranteed and may cause cross-infection regardless of the method used.
• Use only under the conditions indicated.

Instructions for use

1. Place the patient on the fluoroscopic machine in a gynecologic examination position.
2. Clean the external genital area with an antiseptic solution
3. Insert a sterile speculum into the vagina for good visualization of the cervix.
4. Disinfect the cervix with an antiseptic solution
5. Before introducing the catheter:
   • Allow at least 10 cm of the sliding injection catheter to stick out from the cup.
   • Connect the injection catheter to a syringe containing the solution to inject.
   • Purge the whole set. The solution’s progression can be viewed easily within the sliding catheter.
   • Connect the lateral catheter to the vacuum system (Bloc connector or syringe luer lock).
6. Introduce the extremity of the injection catheter 1 or 2 cm into the cervical orifice.
7. Push gently the cup towards the cervix by sliding it along the injection catheter maintained immobile. The cup is easily guided along the catheter and fits automatically over the centre of the cervix providing a perfect seal. The guide marks every 2 cm on the proximal section of the injection catheter indicate the length of the catheter inside the cervix. This length can be changed during the examination, as the catheter can slide in or out from the cup.
8. Create the negative pressure progressively while controlling the vacuum to seal the cervix without any risk of bruising. Use the clamp on the lateral catheter to avoid air backflow.
9. To avoid the discomfort of the patient, the opening of the speculum can be reduced during the procedure.
10. Inject slowly the radiopaque solution or sterile methylene blue inside the uterine cavity. Use the valve on the central catheter to adjust the amount of liquid injected.
11. The cup and cannula set is radiolucent and allows control of the proximal zone of the endocervix; the radiologist can thus operate at a distance from the radiological field while conveniently mobilizing the uterus.
12. Unclamp the side tubing and carefully remove the entire device at the end of the procedure.

Complications

• Discomfort or moderate pain
• Infection.
• Mild to moderate uterine cramps.
• Allergic reaction to the contrast agent.
• Uterine perforation and tubal rupture: very rare

Contraindications
Do not use these products:

• In case of pregnancy, or suspicion of pregnancy,
• In case of acute pelvic inflammation or infection
• In case of unexplained pelvic tenderness
• In case of the presence of an intrauterine contraceptive device
• In case of allergy to contrast product

Storage conditions

• Single packaging.
• The product must not be used in the event of damaged, or open primary packaging before the medical procedure.
• Store away from direct sunlight.
•  Store in a dry place.

Validity date

• Use before the expiry date stated on the packaging.

Elimination

• After use, this product presents a potential biological hazard. It should be disposed of under current guidelines for the handling, and disposal of potentially infectious materials.

Symbols and meanings

• Warning: Read the instructions carefully before use
• Warning: Read the instructions carefully before use
• Manufacturer’s name and address
• Product reference
• Batch number
• Complies with European requirements
• Do not reuse
• Date of manufacture
• Do not re-sterilize
• Do not use it if the packaging is damaged
• Use until – the expiration date
• Store away from the sun
• Sterilized with Ethylene Oxide
• Protect from humidity
• Single sterile barrier system
• Single sterile barrier system with protective packaging outside
• Medical Device

Class Is medical devices

First CE marking

DocuSign Envelope ID: 9ED79B3F-729A-43A9-9421-C9D4103BC4EF

Contact for medical information and materiovigilance

• Infomed@ccdlab.com

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