Confi Gurations For Pressio® Ventricular Tunneling Kits; Units Of Measurement; Sterilization Of Pressio® Kits; Instructions - Sophysa PRESSIO PSO-PVT Manual De Instrucciones

4
The fi xation tab [6] enables the catheter to be attached to the scalp. It is made
of silicone.
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4. Confi gurations for Pressio® ventricular
tunneling kits
The Pressio® ventricular tunneling kits come in two diff erent models: PSO-VT and PSO-VTT
(cf. §3: "Description and Operating principle for Pressio® ventricular tunneling kits").
In both cases the specifi c accessories for the introduction of the catheter into
the ventricle and its fi xation to the scalp are included in the kit, ready-to-use.
Sophysa also off ers a sterile disposable hand drill (PSO-DR), enabling the skull
to be perforated in combination with the drill bit supplied in each kit.
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).
Specifi c case for the PSO-VTT
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 ®
ON 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
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.
-
TEST OF THE MONITOR
.
V V2 ,
ERSION MONITOR YOU CAN USE THE CATHETER
, P ® PSO-3000
NAMELY THE RESSIO
.
NTERFACE
. T
HE TEMPERATURE WILL NOT BE DISPLAYED
.
O and to 133 Pa.
2
6. Sterilization of Pressio® kits
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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
OR IF THE EXPIRY DATE HAS PASSED
P ®
RESSIO MONITORING KITS ARE SINGLE USE DEVICES
/
UNPACKING AND OR EXPLANTATION
T (
HEIR PERFORMANCE DRIFT
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
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).
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.
Before opening the packaging which guarantees the sterility of the Pressio®
MONITOR
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.
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®
MONITORING KITS IF THE STERILE PACKAGING IS OPEN OR DAMAGED
.
. D
O NOT RE
.
, , .)
ELECTRICAL SAFETY ETC COULD BE AFFECTED DURING DECONTAMINATION
.
/ - ,
OR RE USED NOR FOR ANY COMPLICATIONS WHICH MIGHT RESULT FROM THIS
,
- -
STERILIZE OR RE USE AFTER
.