Indications; Contra-Indications; Description And Operating Principle For Pressio® Parenchymal Tunneling Kits; Configurations For Pressio® Parenchymal Tunneling Kits - Sophysa PRESSIO PS0-PT 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.
In addition, the PSO-PTT model enables the intracranial temperature to be read.
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ote
t
he tempeRatuRe and pRessuRe values indicated on
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 pRovide continuous suRveillance
3. Description and Operating Principle
for Pressio® parenchymal 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.
P :
recautioN
o p ®
nly connect Ressio catheteRs to calibRated
Pressio® ICP monitoring kit, parenchymal tunneling PSO-PT (Figure 1):
The PSO-PT kit makes continuous monitoring of the intracranial pressure possible.
It has a 1m long catheter with a diameter of 2.1Fr. At its end is a 1.2mm diameter
capsule enclosing a piezoresistive pressure sensor of the silicon strain gauge type
designed to be placed in the cerebral parenchyma.
Pressio® ICP & ICT monitoring kit, parenchymal tunneling, PSO-PTT (Figure 2):
The PSO-PTT kit makes continuous monitoring of the intracranial pressure
and temperature possible.
It has a 1m long catheter with a diameter of 2.1Fr equipped with a 1.2mm capsule at
its end, enclosing a piezoresistive pressure sensor of the silicon strain gauge type and
a thermistor temperature sensor, designed to be placed in the cerebral parenchyma.
The two kits can be distinguished visually by their respective markings
on the catheter connector.
In both cases, the catheter has centimetric graduation over 10cm from the proximal
end, as well as a marker at 15cm.
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.
.
p ®
Ressio monitoRing systems do not
.
type.
p ® .
Ressio equipment
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 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® parenchymal tunneling monitoring kits are latex-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.
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The tunneling needle [4] enables a passage for the catheter to be created under the scalp.
The stylet [5], which is delivered already inserted into the needle, makes it possible
to avoid coring during the insertion of the needle under the skin. Withdrawing it then
leaves a passage for the catheter.
4
The fixation tab [6] enables the catheter to be attached to the scalp. It is made
of silicone.
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4. Configurations for Pressio®
parenchymal tunneling kits
The Pressio® parenchymal tunneling kits come in two different models: PSO-PT
and PSO-PTT (cf. §3 : " Description and Operating principle for Pressio® parenchymal
tunneling kits ").
In both cases, the specific accessories for the introduction of the catheter into
the parenchyma and its fixation to the scalp are included in the kit, ready-to-use.
Sophysa also offers a sterile disposable hand drill (PSO-DR), enabling the skull
to be perforated in combination with the drill bit supplied in each kit.
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