Indications; Intended Purpose; Device Description; Safe Handling - MIETHKE AAG FV907X Mode D'emploi

GB | INSTRUCTIONS FOR USE

INDICATIONS

Functional test of the shunt system
•
implanted into the patient
Technical functional diagnosis of the
•
shunt system, e.g. detection and locali-
sation of occlusions

INTENDED PURPOSE

The Reader Unit Set is used for the pres-
sure-based functional control of shunt sys-
tems.

DEVICE DESCRIPTION

Designation
Reader Unit Set

SAFE HANDLING

CAUTION
Risk of injury due to incorrect operation of
the product! The product user must have
participated in the product training before
first starting-up the product. Please contact
Christoph Miethke GmbH & Co. KG for infor-
mation about product training.
The following general safety instructions
must be followed when working with electri-
cal medical devices:
Prior to use, check product for proper
•
condition and functioning.
Clean factory-fresh product thoroughly
•
after removing transport packaging (see
chapter on "Manual Cleaning/ Disinfec-
tion").
To prevent nosocomial infection and
•
multiple resistances, the device should
be disinfected after each use. Disinfec-
tion is preferably carried out by wiping
with the disinfectant described in the
section on "Cleaning/ Disinfection".
To prevent damage as the result of
•
improper assembly or operation and to
avoid compromising warranty and liabil-
ity, please note the following:
– Use the product only as specified in
these instructions for use.
– Observe notes on electromagnetic
compatibility (EMC).
32
Article number
75100000 (AAG ref.
FV907X)
– Observe safety information and
maintenance instructions.
– Only combine products and use
accessories by Christoph Miethke
GmbH & Co. KG, see the "Scope of
the system" chapter.
Do not operate the product in the vicin-
•
ity of flammable substances (e.g. anaes-
thetics).
Device and accessories must only be
•
operated and used by persons with the
requisite training, knowledge or experi-
ence.
Keep the instructions for use accessible
•
for the user.
The product must be set up so that the
•
mains plug can easily be disconnected
from the power supply.

INTENDED USE

The Reader Unit Set (hereinafter referred to
as Reader Unit) is used together with the
M.scio for functional diagnostics. They are
used for the reliable and non-invasive detec-
tion and localisation of occlusions within ven-
tricular drainage systems (without intervention
or radiological diagnostics) and the identifica-
tion of mechanical damage to shunt valves.

CONTRAINDICATIONS

Intracranial pressure measurement
•
Intracranial pressure measurement with-
•
out a shunt system
Intracranial pressure management
•
based on measured values
Functional diagnosis of extracorporeal
•
fluid drainage system (cranio-cerebral
trauma)
Reader Unit Set