The protocol for SMB® TCu 380A with Safeload involves several key steps for healthcare professionals:

• Pre-insertion:
  1. Patient Evaluation
  2. Informed Consent
  3. Uterine Assessment
• Insertion:
  1. Preparation
  2. Loading the IUD
  3. IUD Insertion
  4. Placement Verification
  5. Thread Trimming
• Post-insertion:
  1. Patient Education
  2. Follow-up

• The TCu 380A IUD is indicated for intrauterine contraception in women of childbearing age.
• It can be inserted after a birth or abortion.
• It can also be used as emergency contraception, but the risk of pelvic inflammatory disease is higher in this case.

TCu 380A IUD:

• Material: Flexible plastic frame with a copper core.
• Shape: T-shaped with horizontal arms for secure positioning.
• Size: 380A refers to the length of the vertical arm (38 mm).
• Mechanism of Action: Releases copper ions to create an inflammatory response in the uterus, preventing sperm fertilization.
• Effectiveness: Highly effective with a typical failure rate of less than 1% per year.
• Reversibility: Fully reversible.

Safeload Insertion Device:

• Material: Likely sterile medical-grade plastic.
• Function: Simplifies and facilitates aseptic insertion of the TCu 380A IUD.
• Design: Intended for single-use and aids in loading and guiding the IUD into the uterus.
• Benefit: Reduces the risk of infection associated with IUD insertion.

Perform a complete medical history and physical examination to assess suitability for IUD use. Aseptically prepare the vagina and cervix. Load the TCu 380A IUD into the Safeload insertion device and insert it into the uterus using aseptic technique. Verify correct placement and instruct the patient on follow-up procedures.

Additional Information:

• The SMB® TCu 380A with Safeload is highly effective with a typical failure rate of less than 1% per year.
• It is reversible, allowing for removal at any time to regain fertility.
• Potential side effects include irregular bleeding, spotting, pelvic pain, and cramping.

Contraindications:

• Known or suspected pregnancy
• Acute pelvic inflammatory disease (PID) or other untreated genital tract infection
• Postpartum endometritis or septic abortion within the past 3 months
• Uterine malformations or fibroids that distort the uterine cavity
• History of hypersensitivity to copper
• Unexplained vaginal bleeding
• Cervical cancer or precancer

After-care:

Instruct the patient about follow-ups and to check for the IUD threads regularly to ensure it remains in place.