Precautions For Monitoring, Care And Nursing Of The Patient; Complications / Side Effects; Infection; Cerebral Hemorrhage - Sophysa Pressio PSO-PT Manual De Instrucciones

8. Precautions for monitoring,
care and nursing of the patient
W :
arNiNg
d p ®
o not use the Ressio monitoRing kit if theRe aRe no tRained peRsonnel available to pRovide
.
continuous suRveillance
P :
recautioNs
t
he patient should only be monitoRed by an anesthetist
.
qualified peRson
i
t is Recommended that the clip be used on the catheteR extension cable to pRevent
.
any disconnection of the catheteR
During monitoring, look after the catheter implantation site in compliance with
standard hospital procedures.
P :
recautioNs
h
andle the patient with caRe to pRevent any disconnection of the cable oR any movement
. c
of the implanted catheteR heck the connection of the catheteR to the extension cable
p ®
and to the Ressio monitoRing system afteR handling the patient
t p ®
he Ressio catheteRs aRe not sensitive to the effects that could occuR duRing an
examination but they could be a souRce of aRtifacts
d p ®
o not use a Ressio monitoRing system and the implanted
-
time as a high fRequency electRo suRgical instRument oR a defibRillatoR
/
and oR monitoRing system could be damaged oR theiR opeRation could be distuRbed
9.

Complications / Side effects

Complications which may result from the implantation of a Pressio® monitoring system
include the inherent risks in any surgical intervention and the insertion of a foreign body.

Infection

The major complication associated with this type of monitoring is infection.
The infection risks can be reduced by adhering to asepsis techniques for the handling
and implantation of the catheter and also adhering to the maximum duration for
catheter implantation (5 days). If monitoring must be continued after this timescale,
it is recommended that a new system is put in place on another site.
Adherence to the tunneling technique recommended in these instructions for use will
also make it possible to reduce the risks of infection.
If there is infection, removal of the system is indicated in conjunction
with the start of a specific treatment by a general or intrathecal route.

Cerebral hemorrhage

Cerebral hemorrhage may also be observed during monitoring of this type.
The probability of this complication may be reduced by limiting the number
of cerebral incisions during the introduction procedure and by ensuring that
this procedure is only performed by trained, competent professionals.
These complications require the rapid intervention of a doctor.
10.

Guarantee

The performances of the Pressio® monitoring kit are only guaranteed with the range
of Pressio® monitoring systems and the accessories designed, tested and
manufactured by Sophysa.
Sophysa guarantees that this medical device is free from defects in material or
manufacturing. Apart from this guarantee, Sophysa does not grant any other
guarantee, express or implicit, including marketing or adaptation for a specific
use. Sophysa cannot be held responsible for any incident, complication, damage
or prejudice resulting directly or indirectly from the use of this device. Sophysa does
not authorize anyone to take responsibility on its behalf for its products.
,
a neuRosuRgeon oR otheR
.
mRi
.
p ®
Ressio catheteR at the same
. t
he catheteR
.
9/78
11.

Processing of the products after use

Destruction after use

An unpacked, used or explanted Pressio® monitoring kit must be destroyed in accordance
with the procedures in force in the medical establishment.

Return of products

If an explanted Pressio® monitoring kit needs to be returned to Sophysa for analysis,
indicating if necessary whether cleaning has been performed.
In order to assess the returned product properly, it must be accompanied by an explanatory
Return to Manufacturer Authorization form.
N :
ote
f ,
oR moRe effective analysis it is Recommended that the device is not cleaned
12.

Symbols

Catalog reference
Manufacturer
Sterilization Method using Ethylene Oxide
Do not re-use
Do not re-sterilize
Use until
Batch code
L OT
Serial number
CE Conformity Marking
Refer to the instructions for use
BF TYPE EQUIPMENT: Procuring an appropriate
degree of protection against electric shock, having
a Type F insulated applied section (floating).
Temperature conditions for storage and transport
Store in a dry place
Fragile, handle with care
.