Sterilization - Decontamination; Patient Education; Instructions; Drainage Catheter Placement - Sophysa DE-106 Notice D'emploi

DE-105 External Ventricular Catheter (large lumen)
(Figure 2) is a barium impregnated radiopaque silicon
tubing, 35 cm long and has an outer diameter of 4.0 mm
and an inner diameter of 2.3 mm. This ventricular catheter
(large lumen) is multiperforated with 2.0 mm holes over a
distance of 25 mm from the proximal tip and has depth
markings at 5, 7.5, 10, 15 and 20 cm from the proximal tip.
Each ventricular catheter is supplied with a female luer-
Lock connector (for connecting the catheter to the tubing
set), an introducer stylet (for introduction), a trocar (for
tunneling), and a fixation tab (for catheter fixation to the
scalp). DE-105 External Ventricular Catheter fixation tab is
pre-attached to the catheter at 25 cm from the proximal tip.

4. Sterilization - Decontamination

Products are packed individually in double peel-off, sterile,
pyrogen-free packaging, sterilized with ethylene oxide.
WARNINGS :
Do not use the products if sterile packaging is open or
damaged, or if the expiration date has passed.
This product is intended for SINGLE USE ONLY. It is
intended to be used once only for a single patient. Do not
re-sterilize or re-use after unpacking and/or explantation.
Resterilization can damage product, potentially leading to
patient injury. Re-use of this device may change its
mechanical or biological features and may cause device
failure, allergic reactions or bacterial infections.
NOTE:
Sophysa cannot be held responsible for the performance
of any product that has been re-sterilized, nor for any
complications which might result from this.

5. Patient education

It is physician's responsibility to educate the patient and
/or their representative(s) regarding external drainage and
monitoring. This should include a description of associated
complications, and explanation of potential alternative
products and treatments.

6. Instructions

WARNINGS :
In order to minimize the possibilities of infection, meningitis
or ventriculitis, aseptic technique is necessary in all phases
of the use of this device.
It is imperative that this device not be handled with bare
fingers or come into contact with lint. Silicone elastomer
is highly electrostatic and therefore susceptible to
contamination by airborne or surface particles, thus
minimize exposure of silicone to air. The presence of these
contaminants could cause adverse tissue reaction. Rubber-
shod clamps or washed, gloved hands are the best means
of handling implantable, silicone devices.
4 – ENGLISH

6.1. DRAINAGE CATHETER PLACEMENT

WARNING:
In order to ensure against ventricular collapse and the
possible consequence of tentorial herniation, care should
be taken so as little CSF as possible is lost during the
insertion of the catheter when the ventricle is first punctured
during the insertion of the catheter.
Several techniques can be used to introduce the catheter
into the ventricular spaces. The surgeon should choose the
one most suited to the needs of the patient and to his
experience.
What follows is given as general guidance for optimal use
of the product
6.1.1. Insertion site preparation
Once the implantation site has been chosen, the area is
shaved and prepared aseptically.
An incision of about one centimeter is made down to the
bone. Make sure the bony plate is well exposed and
perform hemostasis on the wound edges. Perforation is
performed through the internal and external skull plates.
6.1.2. Ventricular catheter insertion
1. Puncture the dura (with a lumbar punction needle for
instance).
2. Implant the ventricular catheter in the direction of the
ventricle thanks to its pre-inserted stylet. To get to the
ventricle, catheter is guided in the direction of inner
canthus of the opposite eye (Cf. Figure 3). After the
catheter has been advanced about 5-6 cm, adequate
flow of CSF is typically obtained
3. Once the catheter is properly positioned in the
ventricle, remove the stylet while holding the catheter
in place. A sampling of CSF can be done at this level.
F 3 - V
IGURE ENTRICULAR CATHETER INSERTION
6.1.3. Ventricular catheter tunnelization
WARNING:
To minimize the possibilities of infection tunneling of the
catheter should be approximately 3 to 5 cm.
1. Insert the trocar in the catheter (Cf. Figure 4 A).
2. Inserted the trocar between the scalp and the skull
from the burr hole towards the emergence site (Cf.
Figure 4 B).
3. Pull the catheter out of the tunnel, taking good care of
maintaining it in place in the ventricle,
4. Carefully remove the trocar
.