Instructions; Implantation Technique; Precautions For The Daily Life Of The Patient; Complications / Side Eff Ects - Sophysa SiphonX Manual De Instrucciones

8.

Instructions

The decision to add a SiphonX® gravitational anti-siphon device to a shunt valve is
left to the discretion of the neurosurgeon, depending on the clinical needs of the
patient.

Implantation Technique

Implantation of a SiphonX® gravitational anti-siphon device must take account of
current aseptic neurosurgical practices.
The implantation of a shunt including a SiphonX® gravitational anti-siphon device
may be performed in several ways.
The surgeon will choose the technique depending upon his experience and the
clinical status of the patient.
However, thoracic implantation of the SiphonX® may facilitate the positioning of the
device perfectly parallel to the vertical axis of the patient's body.
The surgeon must select the implantation area taking into account the fact that
the anti-siphon device is a potential source of artifacts when an MRI examination is
performed (cf. § 6 "Behavior during Magnetic Resonance Imaging (MRI)").
P :
RECAUTION
D
O NOT PERFORM THE IMPLANTATION OF AN ANTI
.
DEVICE AVAILABLE IN CASE IT IS REQUIRED
W :
ARNING
D
O NOT CARRY OUT ANY ADDITIONAL TESTS BEFORE IMPLANTATION
E S X® -
ACH IPHON GRAVITATIONAL ANTI SIPHON DEVICE HAS BEEN INDIVIDUALLY CHECKED
OPERATIVE PRESSURE TESTS WILL INCREASE THE RISK OF INFECTION
For the implantation of the shunt, refer to the instructions for use for the implants
used.
To incorporate a SiphonX® gravitational anti-siphon device SiphonX® SX-200 model
into the shunt:
- Connect the anti-siphon device downstream of the valve. Delicately ligate the
catheter to the outlet connector of the valve and the inlet connector of the
SiphonX®.
- Check that the anti-siphon device arrow is correctly oriented in the direction
of the CSF fl ow.
- Position the SiphonX® absolutely parallel to the vertical axis of the patient's
body for optimal function (Cf. Figure 6 and § 3 "Description and Operating
Principle").
P :
RECAUTIONS
O
RIENT THE ARROW LOCATED ON THE BODY OF THE
. A
CORRECTLY IN THE DIRECTION OF THE FLOW SSEMBLY IN THE OPPOSITE DIRECTION WILL NOT ALLOW
S X® .
THE IPHON TO FULFIL ITS ROLE CORRECTLY
T S X® -
HE IPHON GRAVITATIONAL ANTI SIPHON DEVICE MUST BE POSITIONED PARALLEL TO THE AXIS
' .
OF THE PATIENT S BODY
I S X®
F THE IPHON IS NOT COMPLETELY VERTICAL WHEN THE PATIENT IS STANDING
THE PRESSURE ADDED BY THE DEVICE TO THAT OF THE VALVE WILL NOT RESULT IN THE EXPECTED
.
PRESSURE
-
SIPHON DEVICE WITHOUT HAVING A REPLACEMENT
.
. A
NY PRE
.
S X® -
IPHON GRAVITATIONAL ANTI SIPHON DEVICE
(
OR SITTING
D
O NOT PLACE THE DEVICE IN A MANNER THAT REQUIRES PULLING THE DEVICE SUBCUTEANOUSLY
PULLING THE DEVICE BY THE DISTAL CATHETER MAY LEAD TO DISCONNECTION OF THE CATHETER FROM
.
THE DEVICE
- Purge the SiphonX® of air:
To prevent any risk of introducing an air bubble, it is recommended that the "Valve +
SiphonX®" assembly be left to fi ll directly with the patient's CSF. For this, make sure it
is kept horizontal. In the majority of cases the "valve + anti-siphon device" assembly
fi lls immediately.
However, in patients with low intracranial pressure or if the valve is set to a high
pressure, the "Valve + SiphonX®" assembly may not fi ll spontaneously.
In this case:
check that the Siphon-X® is properly horizontal,
then:
place a piece of catheter on the outlet connector and slowly aspirate the CSF
using a syringe fi tted with a Luer connector,
or even:
press the dome of the reservoir if possible.
- Check that the "Valve + SiphonX®" assembly is correctly fi lled with CSF and
there are no air bubbles inside the valve. If this is not the case, continue to
purge. The presence of air bubbles could cause a signifi cant change to the
operating pressure of the device.
- Check the fl ow of CSF.
- Connect and ligate the outlet connector on the anti-siphon device to the distal
catheter of the shunt.
-
If it is necessary to check the shunt system after implantation, refer to the instructions
for use for the valve used.
9.

Precautions for the Daily Life of the Patient

The doctor is responsible for informing the patient or his/her family that the person
fi tted with a shunt must avoid any activity that may subject this shunt to direct
shocks (violent sports, etc.) as these are likely to damage it.
P :
RECAUTION
T
HE PATIENT MUST BE WARNED THAT VIBRATIONS DUE TO THE
.
THE DEVICE IS FITTED ON THE SKULL
10.

Complications / Side eff ects

Complications which may result from the implantation of a CSF shunt system include
the inherent risks in the use of drugs, any surgical intervention and the insertion of
a foreign body.
),
PRECAUTION:
P
ATIENTS TREATED WITH A SHUNT SYSTEM MUST BE CLOSELY MONITORED POST
TO DETECT ANY SIGNS OF COMPLICATIONS EARLY
The main complications of shunts are obstruction, infection and over-drainage. These
complications require rapid intervention by the physician.
Refer to the instructions for use for the shunt implant used, for a description of
possible complications associated with the shunt.
Failure of a shunt system may also be linked to disconnection of its various
components.
7
CSF
FLOW MAY POSSIBLY BE FELT IF
-
OPERATIVELY IN ORDER
.
.