MIETHKE proGAV 2.0 XABO Instrucciones De Manejo página 32

| INSTRUCTIONS FOR USE
The following complications can occur in con-
junction with the proGAV 2.0 XABO:
Headaches, dizzy spells, mental confu-
sion, vomiting in cases of possible leakage
from the shunt system and shunt dysfunc-
tion
Redness/irritation of the skin and tightness
around the implantation site as an indica-
tion of a possible infection at the implant
Occlusions caused by protein and/or
blood in the cerebrospinal fluid
Allergic reaction / intolerance to product
materials
Overdrainage/underdrainage
Noise development
Violent external shocks (accident, fall, etc.) may
put the integrity of the shunt system at risk.
As a precaution, a physician must be con-
sulted immediately if the patient suffers from
skin rashes and tightness, severe headaches,
dizzy spells or similar.
The following residual risks exist when using the
proGAV 2.0 XABO:
Persistent headache
Severe infection (e.g. sepsis, meningitis) /
allergic shock
Acute and chronic hygroma/subdural
haematoma
Cerebrospinal fluid accumulations
Tissue damage/puncture
Skin irritation
32
Local shunt irritation
Allergic reactions to catheter compo-
nents, particularly to the active antibiotic
substances rifampicin and clindamycin
hydrochloride
All serious incidents (damage, injuries, infec-
tions, etc.) occurring in relation to the product
must be reported to the manufacturer and the
responsible state authority.
The attending physician is responsible for
informing the patient and/or his/her proxy in
advance. The patient is to be informed about
warnings, precautions, contraindications, pre-
cautionary measures to be taken as well as
restrictions on use in relation to the product (Ch.
4.2, 4.5).
The medical devices must always be trans-
ported and stored in a clean and dry place.
proGAV 2.0 XABO is to be protected from
direct sunlight. The products should not be
removed from the packaging until they are
required.
The proGAV 2.0 XABO is a posture-depen-
dent valve system with an adjustable differen-
tial pressure unit and a pre-set gravitational unit
(SA 2.0) combined with antibiotic impregnated
XABO Catheters.
proGAV 2.0 XABO is used for shunting of cere-
brospinal fluid (CSF) in the treatment of hydro-
proGAV ® 2.0 XABO ®
≤ 40 °C
≤ 30 °C