Indications; Intended Purpose; Device Description; Safe Handling - MIETHKE 75100000 Instrucciones De Uso

Reader Unit Set for SENSOR RESERVOIR

INDICATIONS

· Functional test of the shunt system implan-
ted into the patient
· Technical functional diagnosis of the shunt
system, e.g. detection and localisation of
occlusions

INTENDED PURPOSE

The Reader Unit set for SENSOR RESERVOIR
is used for the pressure-based functional con-
trol of shunt systems.

DEVICE DESCRIPTION

Description
Reader Unit Set for
SENSOR RESERVOIR

SAFE HANDLING

Risk of injury due to incorrect operation of
the product!
Appropriate product training prior to using
the product is
contact Christoph Miethke GmbH & Co. KG
for information about product training.
· Clean factory-fresh product thoroughly after
removing transport packaging (see chapter
on "Manual Cleaning/Disinfection").
· Ensure that the product is in proper condition
and fully functional prior to use (see chapter
on "Inspection").
· To prevent nosocomial infection and multiple
resistances, the device should be disinfected
after each use. Disinfection is preferably
carried out by wiping with the disinfectant
described in the section on "Cleaning/Disin-
fection".
· To prevent damage as the result of improper
assembly or operation and to avoid compro-
mising warranty and liability, please note the
following:
· Use the product only as specified in these
instructions for use.
· Observe safety information and maintenance
instructions.
Article number
75100000
(AAG ref. FV905X)
recommended. Please
INSTRUCTIONS FOR USE |
· Use only products by Christoph Miethke
GmbH & Co. KG in combination, see chapter
on "Reader Unit System Components".
· Device and accessories must only be ope-
rated and used by persons with the requisite
training, knowledge or experience.
· Keep the instructions for use accessible for
the user.

INTENDED USE

In conjunction with the SENSOR RESERVOIR /
SENSOR PRECHAMBER, the Reader Unit
Set for the SENSOR RESERVOIR / SENSOR
PRECHAMBER (henceforth: the reader unit) is
used for the functional diagnostic of shunts and
for the reliable non-invasive detection of shunt
systems (without intervention or radiological
diagnostics) as well as for the identification of
mechanical damage to shunt valves in the treat-
ment of hydrocephalus.

CONTRAINDICATIONS

· Intracranial pressure measurement
· Intracranial pressure measurement without a
shunt system
· Intracranial pressure management based on
measured values
· Functional diagnosis of extracorporeal fluid
drainage system (traumatic brain injury)
Fig. 1: The working distance for telemetric data trans-
mission, i.e. the distance between the antenna and
the SENSOR RESERVOIR / SENSOR PRECHAMBER
is 10-30 mm
GB
33