Rocket Medical KCH Instrucciones De Uso página 5

INSTRUCTIONS FOR USE:
Note: The use of tocolytic agents during and after the procedure may be advisable. Close observation of the condition of the fetus for any sign of
preterm labour is mandatory.
Patient Preparation:
1 Perform ultrasound to ascertain position of the fetus. Manipulation of the fetus in utero may become necessary to allow the most advantageous
access.
2 Sedate the mother if deemed advisable. Sedation of the fetus is not normally required, however if significant manipulation is required or there
is excessive fetal movement fetal and or maternal sedation may be required.
3 Establish using ultrasound that there is sufficient fluid in the amniotic space. Fetal obstruction uropathy commonly causes oligohydramniosis
and amnio-infusion with 500ml-1000ml of warmed normal saline may be required depending on individual patient conditions.
4 At the time of amnio-infusion, it is advisable to administer intra-amniotic antibiotics due to the
threat of choriomnionitis. A broad spectrum antibiotic such as nafcillin (500 – 100mg) or a
cephalosporin (1-2gm) to which penicillin-resistant Staphylococci are sensitive is recommended.
(Note: Administration of specific antibiotics and dosages is dependent on the individual patient's
conditions, and should be determined by the physician on a a case-by-case basis.)
5 Prepare the skin using suitable antibacterial skin prep. Local anaesthetic should be used at the
puncture site.
6 Using a No.11 blade make a 5mm incision sufficient to allow insertion of the trocar and cannula
assembly. (Fig 1.)
7 Under ultrasonic monitoring, introduce the trocar and cannula transabdominally into the uterus
and fetal bladder.
8 Aspiration of urine through the irrigation channel will confirm correct insertion into the fetal
bladder.
9 Remove the trocar and further aspirate sufficient urine to prevent back flow up the open cannula.
Remove the seal from the cannula.
The KCH™ catheter, with its forming wire in place, (Fig.2) is then unrolled gently by hand.
10
Remove the forming wire and red pusher and substitute with the semi rigid guidewire.
11 Using the tapered end of guidewire holder as a support, insert the curved end of the wire
through the whole length of the KCH™ catheter. Gently straighten the catheter to allow passage
of the guidewire.
12 Gently insert the catheter/guidewire combination into the introducer set taking care not to kink
the catheter. When fully inserted, remove the semi rigid guide wire.
13 Using the first stage pusher rod (Fig 3) deliver the distal end of the catheter into the Fetal bladder. Under ultrasound control, confirm that the
fetal component has coiled fully and is in the correct position.
14 Withdrew the tip of the cannula from the Fetal abdomen and insert the second stage pusher rod to deliver the maternal component into the
amniotic cavity forming a vesico-amniotic shunt.
CAUTION: Care must be taken to avoid kinking the catheter during insertion into the introducer set.
Ensure that both coils are free and that no portion of the stent has been left in the uterine wall.
15 Once correct positioning has been confirmed, remove the cannula and dress the puncture site appropriately.
Document the procedure and correct positioning of the KCH™ catheter.
16
17 Monitor the Fetal bladder and ensure that the vesico-amniotic shunt is active and drainage is taking place and that there is no evidence of
Fetal distress or onset of premature labour.
Follow up: Serial ultrasounds should be performed within 24-72 hours to ensure correct function of the stent. Ultrasound examinations should be
performed weekly for the rest of the pregnancy to ensure continued function of the shunt.
Removal: The KCH™ catheter can be removed using conventional aseptic technique following satisfactory paediatric urological evaluation.
Disposal: This device should be handled and disposed of in accordance with local hospital policy and with regard to all applicable regulations,
including but without limitation to, those pertaining to human health & safety and care of the environment.
References: Rodeck. CH., Nicolaides. K.H. "Ultrasound " Guided Invasive Procedures in Obstetrics" in Clinics in Obstetrics & Gynaecology - Vol.
10, No.3, December 1983
CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician with appropriate training and experience.
Unless opened or damaged, contents of package are sterile. Store at room temperature. Avoid prolonged exposure to elevated temperatures
Manufactured in the UK by: ROCKET MEDICAL PLC Sedling Road, Washington, England, NE38 9BZ

0088 ZDOCK045 050917
This device is not manufactured
with natural rubber latex
Rev 12 Copyright© 2003-2017 ROCKET MEDICAL PLC
www.rocketmedical.com
All Rights Reserved. (GB)