Operating procedure

Requirements

The iCup2® is an instrument used to obtain flexion, limited traction and induced rotation, and it can be used to assist a woman to give birth via the natural birth canal.

The pre-conditions for using this obstetrical device must comply with the following criterias :

• IA clear indication for extraction
• Facilities available to carry out a C section without delay.
• If an extraction is indicated, the obstetrician must take a few minutes to explain the situation to the parents. The consent and active participation of the mother giving birth by a vacuum-assisted fetal extraction is essential in order to obtain effective pushing during traction
• Completely aseptic conditions
• An empty bladder
• The waters must have broken
• Cephalic presentation
• The cervix must be fully dilated
• The orientation, degree of deflexion and asynclitism of the fetal head must be fully established in order to position the instrument properly. The cup should be placed as near to the occiput as possible. The longer the lever (the distance between the atloido-occipital joint and the occiput) the easier it will be to achieve flexion of the head, and the less traction force will have to be applied to achieve it. An error of diagnosis would result in using the cup as a deflexion instrument, leading to dystocia. Vaginal palpation to locate the fontanelles, the sutures or even the ears can correctly determine the presentation. Abdominal palpation, to locate the buttocks and back of the fetus, indicates the side of the occiput. If any doubt remains, do an ultrasound scan in the labor room. Locating the back of the fetus makes it possible to decide whether it is a right or left presentation. If at least one eyeball is easy to see, this will confirm the posterior form, if the eyes cannot be seen, then it is an anterior form. Also make use of the usual anatomical landmarks (cerebellum, thalamus, ...)
• The level of the presentation must be clearly established. The engagement of the fetal presentation in the middle of the pelvis is essential.

Operating procedure

• Remove the cup and its handle from the sterile pouch
• Connect the aspiration tube of the cup to the vacuum pump. It is advisable to use an automatic vacuum pump; this is the only way to ensure that there will be no gradual loss of the vacuum which could result in dislodgement of the cup
• To make the woman giving birth more comfortable, the cup should be inserted during an interval between two uterine contractions
• The cup is grasped between the index and middle fingers, which rest against its flat side, and the thumb
• The cup is then slid towards the fetal occiput
• The first level of vacuum (200 mbar = 0.2 kg) should ideally be produced during an uterine contraction, which makes it easier to apply the cup as the head of the fetus comes down furthest into the pelvis at this point
• After checking that the cup is in place, and that it is not pressing against the mother’s soft tissues, the second level of vacuum is immediately produced, without exceeding 800 mbar = 0.8 kg)
• An experienced and well-trained obstetrician can produce a rapid lowering of pressure in a single operation.
• Traction is then applied immediately synergistically with the uterine contractions boosted by abdominal pushing

Precautions when using the vacuum pump

Choice of a compatible vacuum pump

DO NOT USE THE MURAL SUCTION PUMP
• The pump must produce the lowering of pressure required to assist the extraction of the fetus by the cup in a controlled manner with a visible display of the current pressure measurement in mbar, mmHg or other units (see the appended Equivalence Table of reduced pressure units)
• The specifications of the pump must be within the following limits: Vacuum capacity at sea level: -900 mbar Aspiration capacity: ± 2 L/min CE Mark Standards: ISO 13485-2003, ISO 60 6011, ISO 10079-1
• Check the apparatus and the stability of the display before each use. The manometric indication must increase as soon as the vacuum is triggered and remain stable when the obstetrician stops the pump at the required pressure level
• If there is a leak, check the integrity of the tubing of the vacuum cup and the pump, and make sure that the connection between the pump and the vacuum tube of the cup is leak-proof
• Responsibility for the proper working of the pump falls on the biomedical maintenance service of the hospital
• It is advisable to use a pump with automated pressure control* which can dislodge the cup

* such as the ATMOS 350 A model or the ATMOS 351 Natal. These two automated aspiration instruments have been specially designed for use with an obstetrical vacuum cup, because they allow the operator to preselect two pressure levels at 200 and 800 mbar, and a gradual return to zero negative pressure in the cup.

Operating Precautions – iCup2®

Applying the obstetrical iCup2® device requires a good understanding of obstetrical mechanics, specialist professional training and appropriate conditions of asepsis.

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