INDICATIONS:
Intrauterine contraception
SMB Cu 375 is intended for single use only, and has to be inserted by a doctor.
It is recommended to be inserted in uteri with a sound length between 6 and 9 cm.

TIME FOR INSERTION :
The optimum time for insertion of an IUD is the last days of the menstrual flow or in the first days afterwards (so-called interval insertion). This is to reduce the possibility of insertion in the presence of an existing undiagnosed pregnancy. An IUD may also be inserted immediately (within 10 minutes) post-abortion or post-partum, although in these cases the chances of pregnancy, translocation, and expulsion are higher. Immediate post-abortion or post-partum insertion does not adversely affect uterine involution or breastfeeding. If a post-abortion or postpartum insertion is not done immediately, it should be delayed until involution is complete i.e. at least 6 weeks after delivery or abortion (socalled delayed post-partum insertion). After caesarean section, insertion should not be attempted until 12 weeks after delivery.

INSERTION TECHNIQUE:
It is imperative that a no touch technique is employed throughout the insertion procedure to ensure sterile handling. The intrauterine device should not be used in the event of the inner packaging being damaged.

It is imperative that a no-touch technique is employed throughout the insertion procedure to ensure sterile handling. The intrauterine device should not be used in the event of the inner packaging being damaged.

A. Interval Insertion
Preparation

• Perform a careful bimanual examination to determine the version, flexion and uterine axis.
• Insert a vaginal speculum to expose the cervix. Cleanse the cervix and vaginal walls with sterile cotton wool dipped in antiseptic solution. Wipe all secretion away from the external os.
• Grasp the anterior lip of the cervix with a single-tooth tenaculum, taking a good bite through the cervical lip so that steady downward traction to straighten the uterine axis can be maintained without risk of cervical laceration
  Reflex contraction, which causes cramp of the uterus when the tenaculum is applied, can be prevented by injection of a local anaesthetic into the anterior lip or a paracervical block.
• Carefully sound the uterus to determine its depth and to confirm the direction of its axis. If the sound meets more than normal resistance at the internal os, it may be advisable to gently dilate the cervical canal to 4-5mm, using sterile, tapered rather than cylindrical dilators. In the absence of other instruments for measurement of the internal dimensions of the uterine cavity, the sound may be used to obtain an idea of its configuration.

The vertical stem of SMB Cu 375 is already preloaded in the introducer tube. The side arms do not require loading into the tube. They are sufficiently flexible to adapt to the shape of the cervical canal.

• Peel the pouch open partially from the end marked OPEN.
• Peel the pouch back so far that the introducer tube (with IUD) can be picked up at its distal end, grasping the tube and the threads, but without taking Cu 375 out of the pouch
• Hold the cervical stop with the thumb of one hand and adjust the position of the top of Cu 375 by moving the introducer tube with the other hand until it corresponds with the mark indicating, approximately, the sounded uterine length in centimeters.
  Reflex contraction, which causes cramp of the uterus when the tenaculum is applied, can be prevented by injection of a local anaesthetic into the anterior lip or a paracervical block.
• The distal end of the introducer may be held without risk of contaminating the device. Holding the threads together with the tube ensures that the device does not fall out of the introducer tube. Cu 375 can now be taken out of the pouch.
• Carefully insert Cu 375 into the uterus until it touches the fundus and the cervical stop rests against the external os while maintaining steady downward traction with the tenaculum to straighten the uterine axis. No attempt should be made to force insertion.
  Insufficient axial straightening may, on occasion, result in a subendometrial insertion. This risk may be reduced by exerting an adequate downward pulling force on the cervix, thereby fully straightening the axis of the uterus against its ligamentous supports.
• When Cu 375 touches the fundus, it is released into the uterine cavity by simply withdrawing the introducer tube . During this procedure continue to apply downward traction with the tenaculum. No push rod is required to insert SMB Cu 375. Check the cervical canal with the sound to ensure that the tail of IUD is entirely within the uterine cavity. Trim the threads of Cu 375 to 2 to 3 cm measured from the external os.
• It is imperative to follow precisely the recommended insertion procedure in order to minimize the risk of a sub-endometrial insertion, which may, in turn, lead to full or partial endometrial embedding of the IUD. Should this occur, a higher than normal force may need to be applied to remove the IUD from this incorrect location, which may increase the risk of side-arm breakages. Furthermore, it may be clinically difficult to confirm the IUD's sub-endometrial location, since this is usually not obvious to the doctor during insertion of the device and the patient probably experiences no pain. It is anticipated that correctly inserting the device may reduce the incidence of both side-arm breakages and perforations.

Copper-bearing IUDs may show discoloration in their sterile packaging, but this should not cause alarm. The copper tarnishes because air passes through the sterile IUD package causing an oxide or sulfide film to form on the surface. The IUD packaging has to be permeable to sterilize the devices. If the package is not damaged and the expiration date on the package has not passed, the IUD will be sterile even if the copper on the device is tarnished. Laboratory studies show the tarnishing does not affect the safety or effectiveness of the IUD.

SMB Cu 375 Intrauterine Contraceptive Devices should be replaced every five years.

Prepare the vulva, insert the speculum and cleanse the cervix as for insertion. To facilitate removal, a tenaculum should always be used to straighten out the uterine axis, thereby also minimising the risk of side-arm breakages. Use a forceps to grasp both threads of the IUD as near to the exit from the external os as possible. Using steady downward traction with the tenaculum to straighten the uterine axis, the SMB Cu 375 should be able to be easily withdrawn from the uterus. No excessive force must be used.

Sometimes difficulties are encountered when removing the IUD. In the event of a more than usual force being required for removal, consideration should be given to the probability that the SMB Cu 375 is embedded. There have been reports of part of an embedded device (in particular an embedded side-arm) breaking off within the uterine cavity, when a greater than normal force needs to be applied for removal. Retained fragments may be expelled painlessly with the menstrual period and embedded side-arms may be freed by uterine contractions. There have also been some rare reports of breakage not associated with embedding.

If the device cannot be withdrawn by normal force or if a fragment has remained behind, diagnostic steps including ultrasound should be taken to exclude perforation or embedding. Plastic fragments, such as the side-arms, may be located using, ultrasound or hysteroscopy. The latter technique allows removal at the same time. However, reports indicate that routine curettage for removal of a fragment, whether or not located in advance, is successful in many cases. Removal of fragments should always be attempted.

In rare occasions an IUD may pass the uterine wall. If this occurs an operation is required to remove the IUD and repair the uterine-wall.

Prior to insertion of an IUD the medical contraindications for IUD use should be excluded on the basis of both the medical history and the physical examination of the woman. Physical examination should include a pelvic examination, cervical smear, and if possible, appropriate tests for sexually transmitted disease.

After interval insertion IUD users should be re-examined shortly after the first period and after immediate post-abortion or post-partum insertion monthly during the first three months. Thereafter, appropriate examination should be carried out at regular intervals e.g. every six months.

If IUD threads cannot be felt in a woman who has not noticed expulsion, examination is necessary to exclude perforation or unnoticed expulsion. Ultrasound may be used to locate the device.