Intended Users; Intended Usage Environment; Technical Description; System Components - MIETHKE proGAV 2.0 Mode D'emploi

EN | INSTRUCTIONS FOR USE

2.06 INTENDED USERS

In order to avoid risks due to false diagnoses,
incorrect treatments and delays, the product
must only be used by users with the following
qualifications:
Medical specialists, e. g. neurosurgeons
Knowledge about the function and proper
use of the product
Successful participation in product training

2.07 INTENDED USAGE ENVIRONMENT

Professional Healthcare Facilities
Healthcare facilities, such as hospitals,
doctors' surgeries or rehabilitation facilities

2.08 TECHNICAL DESCRIPTION

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.
The proGAV 2.0 is a position-dependent valve
to drain cerebrospinal fluid (CSF) in the treat-
ment of hydrocephalus. It consists of an
adjustable differential pressure unit and a grav-
itational unit (Fig. 1).
Fig. 1: proGAV 2.0
The proGAV 2.0 Compass (Fig. 2) is used for
localising and reading out the adjustment unit
in the proGAV 2.0.
Opening the instrument reveals a template that
can be used to localise the valve in the patient's
head using the index finger. After this, the
proGAV 2.0 Compass template is adjusted to
the flow direction of the CSF and placed over
the valve. Folding the Compass down results in
the automatic reading and display of the pres-
sure level.
20
Fig. 2: proGAV 2.0 Compass
The proGAV 2.0 Adjustment Tool (Fig. 3) can
also be used to set the opening pressure of the
adjustment unit of the proGAV 2.0 from 0 to
20 cmH O.
2
Fig. 3: proGAV 2.0 Adjustment Tool
The opening pressure of the adjustable differ-
ential pressure unit of the proGAV 2.0 can be
changed before or after implantation. It is pre-
set by the manufacturer at 5 cmH

2.09 SYSTEM COMPONENTS

proGAV 2.0 Tools can be used to set the open-
ing pressures of the following valves:
Product name
proGAV 2.0
proGAV ® 2.0 Tools
O.
2