Procedure for Insertion: Caution: Do not pick up and use any component that has fallen on the floor or table.
Do not pour contents of the pouch in the instrument tray.
Do not use the white solid rod to measure uterine cavity length.
Preparing the User: 1. Health care provider should wear sterile gloves and use aseptic technique. Explain the procedure.
2. Prior to insertion, the vagina and cervix should be cleansed with an antiseptic solution.
3. 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.
4. 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 TCu 380A: 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 B-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 B-2: Place the package on a clean, hard, flat surface with the clear plastic side up. Partially open the package from the end marked OPEN, approximately half way to the flange depth gauge.
Step B-3: Hold the package with open end up, and the flaps away from each other. Put the white solid rod into the insertion tube to almost touch 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 solid rod losing its sterility.
Step B-4: Place the package on the clean, hard, flat surface once again with the clear plastic side up.
Step B-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 of 'T' as indicated on the package label insert. Use the other free hand to push the insertion tube against the arms of the 'T'. Note that the arms should not be bent until 5 minutes before insertion.
Step B-6: Complete the bending of the arms of the '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 the 'T'. Insert the folded arms of the 'T' into the insertion tube only as far as 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 B-7: Adjust the movable flange depth gauge with the help of scale printed on label insert or use the preprinted 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 B-8: The TCu 380A 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. Be careful not to dislodge the 'T' by pushing the white solid rod upward. Do not let the insertion assembly touch any unsterile surface that may contaminate it.
Inserting the Loaded TCu 380A: Step C-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 C-2: Holding the white solid rod stationary by one hand, withdraw the insertion tube by the free hand not more than 1/2 inch. This releases the arms of the 'T'.
Step C-3: Once the arms have been released, carefully push the insertion tube upwards, towards the top of the uterus until a feel of 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 C-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 cervical canal. Cut the threads so that they protrude only 3-4 cm into the vagina.
Step C-5: Assist the woman from the table slowly. Be alert to possible dizziness. Instruct her how and when to check threads. Have her check the threads. Invite questions and instruct her about return visit as well as what to do, whom and how to contact for help if needed.
Removal Instructions for TCu 380A: Copper T must be removed by a trained health care provider. This can be done easily and safely in the clinic and takes only a few minutes. Removal is effected by pulling gently 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.
Reminders: The sterile Copper T is for single use only and should not be reused.
On completion of shelf life or on removal after use, dispose the items as per the local regulations governing disposal of non recyclable waste/medical waste.
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