Indications; Contra-Indications; Description And Operating Principle For Pressio® Ventricular Tunneling Kits - Sophysa PRESSIO PSO-VT Notice D'emploi

R
EAD THE INSTRUCTIONS FOR USE CAREFULLY BEFORE IMPLANTING THE DEVICE
1.

Indications

The use of a Pressio® monitoring kit is indicated in patients requiring continuous
monitoring of intracranial pressure.
The use of a ventricular kit (Model PSO-VT) makes simultaneous drainage
of the cerebro-spinal fl uid possible.
In addition, the PSO-VTT model enables the intracranial temperature to be read.
N :
OTE
T
HE TEMPERATURE AND PRESSURE VALUES INDICATED ON
DO NOT PREJUDGE THE HEALTH STATUS OF THE PATIENT
2.

Contra-indications

Contra-indications to the use of a Pressio® kit are the following:
- established or suspected infections in the tissues in direct contact with
monitoring system components (meningitis, ventriculitis, septicemia
or bacteremia) or any infection present in any part whatsoever of the body
- patients on anticoagulant therapy or presenting with bleeding diathesis.
W :
ARNING
D P ®
O NOT USE THE RESSIO MONITORING KIT IF THERE ARE NO TRAINED PERSONNEL AVAILABLE TO
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PROVIDE CONTINUOUS SURVEILLANCE
3. Description and Operating Principle
for Pressio® ventricular tunneling kits
The Pressio® monitoring catheters are single use implantable devices.
The Pressio® monitoring catheters are of the " BF "
Only use with a Pressio® monitoring system.
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RECAUTION
O P ®
NLY CONNECT RESSIO CATHETERS TO CALIBRATED
Pressio® ICP monitoring kit, ventricular tunneling PSO-VT (Figure 1)
The PSO-VT kit makes continuous monitoring of intracranial pressure
and simultaneous drainage of the cerebro-spinal fl uid possible.
The 3.1 mm diameter catheter designed to be placed in a cerebral ventricle has three
distinct lumina:
• The fi rst contains a 1m long catheter with a diameter of 2.1Fr equipped with
a 1.2 mm diameter capsule at its end, enclosing a piezoresistive pressure sensor
of the silicon strain gauge type.
• The second contains the pre-inserted introduction stylet.
• The third is for the drainage of the cerebro-spinal fl uid.
Pressio® ICP & ICT monitoring kit, ventricular tunneling PSO-VTT (Figure 2)
The PSO-VTT kit makes continuous monitoring of the intracranial pressure
and temperature and simultaneous drainage of the cerebro-spinal fl uid possible.
The 3.1 mm diameter catheter designed to be placed in a cerebral ventricle has three
distinct lumina:
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RESSIO MONITORING SYSTEMS
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type.
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RESSIO EQUIPMENT
• The fi rst contains a 1m long catheter with a diameter of 2.1Fr equipped
with a 1.2 mm diameter capsule at its end, enclosing a piezoresistive pressure
sensor of the silicon strain gauge type and a thermistor temperature sensor.
• The second contains the pre-inserted introduction stylet.
• The third is for the drainage of the cerebro-spinal fl uid.
The two kits can be distinguished visually by their respective markings
on the catheter connector.
In both cases the catheter has depth markers at 5, 10 and 15 cm starting
at the proximal end, and centimeter markers between the 5 and 10 cm markers.
The end of the catheter opposite the capsule has a connector which makes it possible
to connect the catheter to a Pressio® monitoring system (PSO-3000 or PSO-IN00)
via a catheter extension cable (PSO-EC20).
The catheter extension cable transmits the measurement signals in the form
of analogue signals from the sensor(s) to the Pressio® monitoring system.
The catheter also exchanges a digital signal containing data, such as sensor
calibration, value and date on which the pressure sensor was zeroed,
with the Pressio® monitoring system.
This data is memorized in the catheter connector and is thus independent
of the Pressio® monitoring system used.
P :
RECAUTION
D
O NOT ALLOW THE CONNECTOR TO COME INTO CONTACT WITH LIQUID
The external catheter is made of silicon. At its distal end there is a Luer-Lock type
connector for connection to an external drainage system.
The capsule enclosing the sensor(s) is made of titanium and the catheter sheath
is made of polyamide.
The entire length of the catheter is radiopaque.
The Pressio® ventricular tunneling monitoring kits are latex-free and phthalate-free
products.
The drill bit [1] allows intracranial access.
It has a diameter of 3.5mm.
An adjustable stop [2] makes it possible not to exceed the chosen drilling depth.
The Allen wrench [3] enables the position of this stop on the drill bit to be adjusted.
The tunneling trocar [4] makes it possible to create a passage for the catheter under
the scalp. Prior insertion of the tunneling catheter into the trocar sheath makes it
possible to pass it under the scalp [5].
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