Lydia Model T Cu 380 A

Lydia Model T Cu 380 A

Manufacturer:

DKT

Distributor:

MCE
Full Prescribing Info
Contents
Intrauterine contraceptive device.
Description
Lydia Model T Cu 380 A is an intrauterine contraceptive device made of polyethylene. The stem is covered with copper wire and there are copper sleeves on each of the horizontal arms. The total surface area of the copper is approx. 380 mm2.
What is unique to this model: The classic model and popular world-wide.
Action
Lydia Model T Cu 380 A IUDs offer almost complete protection against pregnancy, having a shelf life of 7 years and it remains effective for a period of 10 years. Correctly inserted, Lydia Model T Cu 380 A IUDs are safe for women at low risk for sexually transmitted diseases.
The side arms are flexible and shaped in such a way as to keep the Lydia Model T Cu 380 A IUD adjacent to the fundus, without stretching the uterine cavity or touching the cornua. The contraceptive action of the device is probably due to a number of foreign body reactions with the uterine endometrium and the presence of metallic copper.
Mechanism of Action: Copper IUDs act by greatly reducing the likelihood of fertilization. Data and analysis indicate that the main anti-fertility effect of copper bearing IUDs involve inhibition of egg or sperm transport and/or the capacity of sperm to fertilize egg. Reduced gametic transport and capacitation inhibits fertilization and occurs before the ovum reaches the uterine cavity from the copper wire and copper sleeves enhance the contraceptive effect of Copper T 380 A.
Indications/Uses
Intrauterine contraception in women of childbearing age.
Who is most suitable for this model: Suitable for women who have had children before or who are close to menopause.
Dosage/Direction for Use
When is it inserted: Any time of the month following a pregnancy test, or during menstruation.
Duration of Use: 10 yrs.
Contraindications
Absolute: Malignant diseases of the genital tract; undiagnosed vaginal bleeding; pregnancy; past history of ectopic pregnancy or predisposing factors; infections of the genital tract; sexually transmitted diseases during the last 12 months (except bacterial vaginitis, repeated herpes infection, hepatitis B); abortion with infection during the last 3 months, pelvic inflammatory disease; uterine malformations (congenital or acquired); allergy to copper.
Relative: Anemia; valvular heart disease; coagulation disorders; anti-inflammatory treatment; Wilson's disease; multiple exposures to different sexual partners.
Special Precautions
Follow-Up Guidelines for Physicians: The physician should encourage the user to come for a follow up visit 4-6 weeks after the IUD insertion, in case of any problem or doubt regarding usage of the IUD. During follow-up, the physician should pay particular attention to the following points: Heavier bleeding, indicates the possibility of anemia.
If pregnancy has occurred, the Copper T should be removed, if possible.
If a woman gets pregnant with IUD in place, there is a chance of having an ectopic pregnancy, which should be evaluated.
Removal of Copper T is advisable, if user is exposed to conditions that substantially increase the risk of pelvic inflammatory disease.
Prior to use inspect package for any visible damage or defect.
The device is for single use only.
Use In Pregnancy & Lactation
If pregnancy has occurred, the Copper T should be removed, if possible.
If a woman gets pregnant with IUD in place, there is a chance of having an ectopic pregnancy, which should be evaluated.
Caution For Usage
When should Lydia IUD Model T Cu 380 A be inserted: Lydia Copper T Cu 380A should be inserted only when a woman is not pregnant. The best time for insertion is during menstruation, to prevent insertion during a non-diagnosed pregnancy. As this time the external and internal cervical os are physiologically dilated. This facilitates the insertion of the IUD without the need to dilate the canal in most instances. Alternatively, the IUD may be introduced within 5 days of unprotected coitus or within 15 minutes and up to 48 hours after delivery of the placenta or abortion. In the last two cases, a higher expulsion rate must be accepted. Insertion immediately after unprotected coitus can increase risk of PID (pelvic inflammatory disease). If the IUD cannot be inserted immediately after delivery of the placenta or after abortion, insertion should be delayed for at least four weeks.
Procedure for Insertion Caution: Do not pick up and use any component that has fallen on the floor or table.
Do not pour the contents of the pouch in the instrument tray.
Do not use the white solid rod to measure uterine cavity length.
Preparing the User: Operator should wear sterile gloves and use aseptic technique. He/She should explain to the client what he/she is doing.
Prior to insertion, the vagina and cervix should be cleansed with an antiseptic solution.
The cervix should be visualized by means of speculum and its anterior lip grasped with a tenaculum. Gentle traction on the tenaculum will tend to reduce the angle between the cervical canal and endometrial cavity and will greatly facilitate introduction of the uterine sound. The tenaculum should remain on the cervix, throughout the insertion of the Copper T so that gentle traction on the cervix can be maintained.
The uterine sound should then be introduced in the endocervical cavity until it reaches the fundus. As soon as the direction and length of the cervical canal and endometrial cavity have been determined, the Copper T may be prepared for insertion.
Loading the T Cu 380 A: Do not open the sterile package or bend the arms of 'T' into the insertion tube until immediately before it is introduced into the uterus. The Copper T can be prepared for insertion inside the sterile package as per the instructions given as follows: Step 1: Ensure that the vertical arm of 'T' is fully inside the insertion tube and the opposite end of the insertion tube will be close to the package bottom seal.
Step 2: Place the package on a clean, flat surface with the clear plastic side up. Partially open the package from the end marked OPEN, approximately halfway to the flange depth gauge.
Step 3: Holding the package with open end up, and the flaps away from each other, put the white solid rod into the insertion tube to almost the bottom of the 'T'. Be careful not to touch tip of solid rod or brush it against another surface as this could lead to the white rod losing its sterility.
Step 4: Place the package on the clean, hard, flat surface once again with the clear plastic side up.
Step 5: Through the plastic clear cover, place the thumb and index finger over the ends of the horizontal arms of the 'T' and bend the arms towards the stem 'T' as indicated on the package label insert. Use the other free hand to push the insertion tube against the arms of 'T'. Note that the arms should not be bent until 5 minutes before insertion.
Step 6: Complete the bending of the arms of 'T' by bringing the thumb and index finger together. While using the other hand to maneuver the insertion tube to pick up the arms of 'T'. Insert the folded arms of the 'T' into the insertion tube only as far necessary to ensure the retention of the arms. Do not try to push the copper bands (sleeves) of the 'T' arms into the insertion tube, they will not fit.
Step 7: Adjust the movable flange depth gauge with the help of scale printed on label insert or use the pre-printed scale on the insertion tube so that it indicates the depth of uterus (as measured earlier by uterine sound). The flange should be positioned so that it is on the same plane as the arms of the 'T'.
Step 8: The T Cu 380 A is now ready for insertion. Peel the remaining cover of the package and lift the loaded insertion tube, keeping it horizontal; so that the 'T' or white solid rod does not fall out and also be careful not to dislodge the 'T' by pushing the white solid rod upward. Do not let insertion assembly touch any unsterile surface that may contaminate it.
Inserting the Loaded T Cu 380 A: Step 1: Gently introduce the loaded insertion assembly through the cervical canal and advance upwards until the 'T' lies in contact with the fundus and flange comes in contact with the cervix. Ensure that the flange is in the horizontal plane.
Step 2: Holding the white solid rod stationary by one hand, withdraw the insertion tube by the free hand not more than ½ inch. This releases the arms of the 'T'.
Step 3: Once the arms have been released, carefully push the insertion tube upwards, towards the top of the uterus until the patient feels a slight resistance. This step ensures that the arms of the 'T' are as high as possible in the uterus. Excessive force could cause perforation of the fundus.
Step 4: Gently withdraw first the white solid rod (hold the insertion tube stationary while removing the white solid rod) and then the insertion tube from the vagina.
Step 5: Assist woman from the table slowly (be alert to possible dizziness) and instruct how and when to check threads. Have her check the threads. Invite questions and instruct about return visit as well as what to do, whom and how to contact for help, if needed.
Removal Instructions for T Cu 380 A: Copper T must be removed by a trained healthcare provider. This can be done easily and safely in the clinic and takes only a few minutes. Removal is effected by pulling gently at one of the exposed threads. Excessive force in pulling the threads could result in breakage of threads. Some cramping or bleeding may be experienced during removal.
Risk of Re-Use: Loss of sterility & corresponding risk of infection.
Loss of efficacy due to lesser copper than the designed specification.
Directions for IUD Users: Longer and heavier menstrual periods, or bleeding or spotting between periods may occur during the first weeks after insertion. If they continue or are severe, report to the clinic.
Cramping may occur following insertion, usually for short time, but could last for several hours to even days. This can be relieved by taking mild analgesic tablets, using hot compresses on abdomen and/or exercising moderately.
Check periodically, and particularly after menstruation, to make certain that the threads still protrude from the cervix. If threads are missing, shorter or longer, return to the clinic.
If Copper T is expelled, return to the clinic. There is no continuing protection after expulsion.
Return to the clinic for check up or for replacement of the Copper T (end of ten years after insertion), as instructed by physician.
If the period is delayed (with symptoms of pregnancy such as nausea, tender breasts, etc.) report immediately to the clinic.
If there is abdominal pain, during intercourse, infections (such as gonorrhoea), abnormal discharge, fever, and chills, consult the physician.
Presentation/Packing
IUD insertion kit 1's.
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