Sophysa Pressio PSO-PB - 4 Configurations for Pressio Parenchymal Kits with Bolt; 5 Units of Measurement; 6 Sterilization of Pressio Kits; 7 Instructions

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A spacer ring [8] mounted on the bolt makes it possible to adjust the seating depth
for the bolt depending on the thickness of the skull bone of the patient.
The guide stylet [9] is inserted into the bolt [4] (nut [6] unscrewed). It makes it
possible to create a passage through the parenchyma to facilitate the introduction
of the Pressio® catheter.
It is delivered inserted into the bolt.
Congurations for Pressio® parenchymal kits 4.
with bolt
The Pressio® parenchymal kits with bolt come in two dierent models: PSO-PB and
PSO-PBT (cf. §3: “ Description and Operating principle for Pressio® parenchymal kits
with bolt ”).
In both cases the specic accessories for the introduction of the catheter into
the parenchyma and its xation using a bolt are included in the kit, ready-to-use.
Sophysa also o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).
Specic case for the PSO-PBT:
To make the best use of an intracranial temperature and pressure catheter, a Pressio®
monitor, Model PSO-3000 Software Version V2, must be used.
No t e s :
V
e r s i o n V2 o f t h e s o f t w a r e c a n b e i d e nt if i ed d u r i n g t h e se l f -t e s t o f t h e m o n i t o r :
o n s t a r t i n g t h e so p h y s a l o g o a n d s o f t w a r e V e r s i o n a r e d i s p l a y e d .
if y o u d o n o t h a V e a pre s s i o ® s o f t w a r e Ve r s i o n V2 m o n i t o r , y o u c a n u s e t h e c a t h e t e r
o n o n e o f t h e o t h e r pre s s i o ® m o n i t o r i n g s y s t e m s , n a m e l y t h e pr e s s i o ® pso-3000 m o n i t o r
s o f t w a r e V1 o r t h e pr e s s i o ® pso-in00 in t e r f a c e .
i
n t h i s c a s e o n l y t h e p r e s s u r e w i l l b e d i s p l a y e d . th e t e m p e r a t u r e w i l l n o t b e d i s p l a y e d b u t
t h e p e r f o r m a n c e o f t h e p r e s s u r e s e n s o r w i l l b e i d en ti c a l .
Units of measurement5.
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
2
O and to 133 Pa.
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.
Sterilization of Pressio® kits6.
The Pressio® monitoring kits are packed individually in double peel-o, sterile,
pyrogen-free packaging. They are sterilized with ethylene oxide.
Wa r N i N g s :
d
o n o t u s e t h e pR e s s i o ® m o n i t o R i n g k i t i f t h e s t e R i l e p a c k a g i n g is o p e n o R d a m a g e d ,
o R i f t h e e x p i R y d a t e h a s p a s s e d .
pRe s s i o ® m o n i t o R i n g k i t s a R e s i n g l e u s e de v i c e s . do n o t R e -s t e Ri l iz e o R R e -u s e a f t e R
u n p a c k i n g a n d /o R e x p l a n t a t i o n .
t h e i R p e R f o R m a n c e (d R i f t , e l e c t R i c a l s a f e t y, e t c .) c o u l d b e a f f e c t e d d u R i n g d e c o n t a m i n a t i o n
a n d t h e R i s k o f i n f e c t i o n w o u l d b e s i gn i fi a n t .
N
o t e :
s
o p h y s a c a n n o t b e h e l d R e s p o n s i b l e f o R t h e p e R f o R m a n c e o f a n y p R o d u c t t h a t h a s b e e n
R e -s t e R i l i z e d a n d /o R R e -u s e d , n o R f o R a n y c o m p l i c a t i o n s w h i c h m i g h t R e s u l t f R o m t h i s .
Instructions7.
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®
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.