Contraindications - pajunk NRFit Gebrauchsanweisung

Contraindications

Administration of intrathecal agents, blind intrathecal puncture in spinal abnor-
mality or injury. Where distortion of normal anatomy is suspected, the use of
direct imaging guidance is strongly recommended. Intrathecal puncture is con-
traindicated in the presence of local skin infections over proposed puncture site,
in uncontrolled bleeding conditions or anticoagulant therapy.
Complications
Systemic toxicity of the local anesthetics used (observe dosage!), infection.
Users must inform patients of complications typically associated with the
procedure.
If complications occur while using the device, follow the protocols of your
organisation. If this does not resolve the complications, or if they are
regarded as serious or untreatable, carefully stop the procedure and remove
invasive device components from the patient.
Warnings
for sterile product:
This is a disposable medical device for use with only one patient.
This device must not be re-used under any circumstances.
This device must not be resterilised under any circumstances.
The materials used in the manufacture of this device are not suitable for repro-
cessing or resterilisation.
This device is not designed to be reprocessed or resterilised.
Unauthorised re-use or reprocessing
• can cause the device to lose the essential performance properties
intended by the manufacturer.
• leads to a significant risk of cross-infection/ contamination as a result of
potentially inadequate processing methods.
• may cause the device to lose functional properties.
• may cause materials to break down and lead to endotoxic reactions
caused by the residues.
in the application:
1. Do NOT attempt to RE-INFUSE CSF!
2. Do not administer any medication which is not indicated for the intended
use. This may lead to serious injury of the patient.
3. Do not use the product under any circumstances in case of known material
incompatibilities and/ or individual intolerances towards material!
4. Always provide for aseptic conditions at the injection point.
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