Units Of Measurement; Sterilization Of Pressio® Kits; Instructions; Preparation Of A Pressio® Catheter Before Implantation: Zeroing The Pressure Sensor - Sophysa Pressio PSO-PT Manual De Instrucciones

Pressio® catheters are used with one of the Pressio® monitoring systems and the
appropriate accessories (cf. PSO-3000, PSO-IN00, and PSO-MT00 instructions for use).
Specific case for the PSO-PTT:
To make the best use of an intracranial temperature and pressure catheter, a Pressio®
monitor, Model PSO-3000 Software Version V2, must be used.
N :
otes
v v2
eRsion of the softwaRe can be identified duRing the self
s
on staRting the ophysa logo and softwaRe veRsion aRe displayed
i p ®
f you do not have a Ressio softwaRe
p ®
one of the otheR Ressio monitoRing systems
v1 p ® pso-in00 i
softwaRe oR the Ressio
i
n this case only the pRessuRe will be displayed
but the peRfoRmance of the pRessuRe sensoR will be identical
5.

Units of measurement

Catheter diameters (D)
D(mm) = Fr / 3
Fr = D(mm) x 3
Intracranial pressure
The pressures mentioned are in mmHg.
1 mmHg corresponds to 13.60 mmH O and to 133 Pa.
2
Intracranial temperature
The intracranial temperature can be displayed in degrees Celsius (°C) or degrees
Fahrenheit (°F).
°F = °C x (9/5) + 32
°C= (°F - 32) x (5/9)
Equivalence in Kelvin (K):
K = °C + 273.15
K = °F x (5/9) + 255.37
Consult the Pressio® monitor instructions for use to choose the temperature unit
to be displayed.
6. Sterilization of Pressio® kits
The Pressio® monitoring kits are packed individually in double peel-off, sterile,
pyrogen-free packaging. They are sterilized with ethylene oxide.
W :
arNiNgs
d p ®
o not use the Ressio monitoRing kits if the steRile packaging is open oR damaged
.
oR if the expiRy date has passed
p ®
Ressio monitoRing kits aRe single use devices
/ .
unpacking and oR explantation
t ( ,
heiR peRfoRmance dRift electRical safety
and the Risk of infection would be significant
N :
ote
s
ophysa cannot be held Responsible foR the peRfoRmance of any pRoduct that has been
- / - ,
Re steRilized and oR Re used noR foR any complications which might Result fRom this
7.

Instructions

Before any implantation, it is recommended that the instructions for use
of the Pressio® monitoring system used be consulted for installing and
setting it up (Pressio® monitor or interface).
-
test of the monitoR
.
v v2 ,
eRsion monitoR you can use the catheteR on
, p ® pso-3000 m
namely the Ressio
.
nteRface
. t
he tempeRatuRe will not be displayed
.
. d - -
o not Re steRilize oR Re
, .)
etc could be affected duRing decontamination
.
Preparation of a Pressio® catheter BEFORE IMPLANTATION:
zeroing the pressure sensor
Before implanting the Pressio® catheter it is necessary to zero the pressure sensor
(calibration in relation to atmospheric pressure).
The intracranial temperature sensor is factory calibrated. Therefore the temperature
setting does not need prior zeroing.
: Ensure that the asepsis of the Pressio® monitoring kit is maintained throughout this step.
1) Powering up the monitoring system
Connect the catheter extension cable (PSO-EC20) to the Pressio® monitoring system.
onitoR
Before opening the packaging which guarantees the sterility of the Pressio®
monitoring kit, turn on the Pressio® monitoring system (PSO-3000 or PSO-IN00).
Refer to the instructions for use of the Pressio® Monitor or Interface.
2) Connecting the catheter to the monitoring system
Make the connection between the catheter and the extension cable (PSO-EC20)
respecting the guide pin.
Align the blue arrow on the catheter connector and the blue arrow on the cable
connector: the catheter connector will be guided safely into the cable connector.
Push up to the stop to ensure that the connection is complete.
The message " ZERO SENSOR " is then displayed on the Pressio® monitor (PSO-3000).
The appearance of error codes, "E001", "E002", "E005" or the message, "CONNECT
SENSOR" on the Pressio® monitor after connecting the catheter to the extension cable
may be a sign of an incorrect connection.
In this case, make sure that the catheter connector is pushed right up to the stop in
the catheter extension cable, and that the latter is correctly connected to the Pressio®
monitor.
3) Preparation of the sterile water cup
Prepare a sterile saline solution (or even sterile water) and a cup in a sterile environment.
Pour the sterile saline solution (or sterile water) into the cup.
,
use afteR
.
P :
recautioN
p
RessuRe sensoR zeRoing must be peRfoRmed in shallow liquid
Receptacle could lead to hydRostatic pRessuRe gReateR than atmospheRic zeRo
would then lead to an eRRoneous RefeRence zeRo
5/78
(~5 ). u
mm sing a deep
,
which
.