Table des Matières
Publicité
Les langues disponibles
Les langues disponibles
Table of contents
1.
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.
Contra-indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.
Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.
Sterilization - Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.
Patient education . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
6.1.
6.2.
7.
Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7.1.
7.2.
7.3.
8.
Guarantee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
9.
Processing of the products after use . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
9.1.
9.2.
10.
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
11.
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
WARNINGS :
Read all instructions, precautions and warnings prior to
use.
Federal Law (USA) restricts this device to sale by or on the
order of a physician.
1. Indications
These devices are intended for use as a means of
temporary external diversion of CSF.
DE-105 External Ventricular Catheter (large lumen) is
particularly recommended in the cases of hemorrhagic
CSF or subdural hematomas.
The main indication for drainage and monitoring of CSF
is the treatment of raised intracranial pressure when the
ventricles or sub-arachnoid spaces are accessible.
External drainage can also be used for the control of
hydrocephalus in cases where an internal drainage system
is infected.
External drainage can also be used either prior to
implanting an internal shunt, or in an attempt to avoid the
need for it.
External ventricular drainage is indicated in acute or sub-
acute hydrocephalus (secondary to intra ventricular or
massive meningeal haemorrhages, severe meningitis, etc.)
Drainage catheter placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Obstruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Return of products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
. . . . . . . . . . . . . . . . . . . . . . . . . 5
2. Contra-indications
This device is not intended for any use other than those
indicated.
Intracranial pressure monitoring with a ventricular catheter
is contraindicated in patients receiving anticoagulants or
who are known to have a bleeding diathesis.
A patient undergoing external drainage and monitoring
must be kept under continuous, close supervision
especially to prevent complications (for more information
see complications section). The use of a ventricular or
lumbar drainage catheter is contraindicated where trained
personnel are not available to supervise monitoring and
drainage on a 24-hour-a-day basis.
The use of a ventricular catheter is contraindicated if
infection is present.
3. Device description
Sophysa external drainage ventricular catheters are
available as individual components or included in complete
drainage system kits. Sophysa ventricular catheters are
intended to be used with Sophysa drainage systems.
DE-106 External Ventricular Catheter (Figure1) is a
transparent silicon tubing with a radiopaque stripe, 29 cm
long and has an outer diameter of 3.0 mm and an inner
diameter of 1.5 mm. This ventricular catheter is
multiperforated over a distance of 23 mm from the proximal
tip and has depth markings at 5, 10 and 15 cm from the
proximal tip.
ENGLISH - 3
Publicité
Chapitres
Table des Matières
