Use Of The Product; Safety And Warning Notices; Required Materials; Preparing For Use - MIETHKE proGAV 2.0 Instrucciones De Manejo

proGAV ® 2.0 Tools

3.04 USE OF THE PRODUCT

3.04.01 INTRODUCTION
proGAV 2.0 Tools may only be used by trained
specialists.
proGAV 2.0 Tools can be used to deter-
mine, change and monitor the pressure level of
the adjustable differential pressure unit of the
proGAV 2.0 valve.

3.04.02 SAFETY AND WARNING NOTICES

CAUTION
The proGAV 2.0 Adjustment Ring emits a
magnetic field. Metallic objects and mag-
netic storage media should be placed at a
sufficient safety distance.
Because of the magnets inside the
proGAV 2.0 Tools, proGAV 2.0 Tools must
not be used in the vicinity of active
implants, such as cardiac pacemakers. Fur-
thermore, there is risk of damage to MRI
instruments in their vicinity. For that reason,
the use of proGAV 2.0 Tools is not permit-
ted there!
It is essential only to use the proGAV 2.0
Tools or M.blue plus Instruments to adjust
and check the pressure level of the differ-
ential pressure unit of the proGAV 2.0.
If the proGAV 2.0 is combined with an
adjustable gravitational unit (proSA or
M.blue), proSA Tools must be used to
adjust and check the adjustable pressure
level of the proSA valve. M.blue plus Instru-
ments must be used to check and adjust
the adjustable pressure level of the M.blue.

3.04.03 REQUIRED MATERIALS

Checking and adjusting the adjustable differ-
ential pressure unit of the proGAV 2.0 after
implantation requires the proGAV 2.0 Compass
and the proGAV 2.0 Adjustment Tool.
To adjust the adjustable differential pressure
unit of the proGAV 2.0 before or during valve
implantation, the resterilisable proGAV Check-
mate can be used.
INSTRUCTIONS FOR USE | EN

3.04.04 PREPARING FOR USE

Checking the sterile packaging
Immediately before using the proGAV Check-
mate, the sterile packaging must be visually
inspected in order to check the integrity of the
sterile barrier system. The products should only
be removed from the packaging immediately
prior to use.
Checking the integrity of the proGAV 2.0
Tools
Prior to use, the instruments must be checked
for integrity. To this end, all instruments must be
visually inspected.
3.04.05 ADJUSTING THE proGAV 2.0
Adjusting the opening
proGAV 2.0 requires the following steps:
1. Localisation
WARNING
The proGAV 2.0 Compass should be placed
as centred as possible over the valve, as oth-
erwise the determined opening pressure may
be incorrect.
NOTE
The proGAV 2.0 Compass reacts sensi-
tively to external magnetic fields. In order
to rule out unwanted interactions, the
proGAV 2.0 Adjustment Tool should not
be placed in the immediate vicinity of the
proGAV 2.0 Compass when determining the
opening pressure. We recommend a dis-
tance of approx. 30 cm.
Swelling of the skin can make adjustment
difficult for a few days after the operation.
If the valve setting cannot be checked con-
clusively using the Compass, we recom-
mend carrying out a check using an imag-
ing method.
pressure of the
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