Depuy Synthes FMS VUE Bedienungsanleitung Seite 4

CONTRAINDICATIONS
None known.
WARNINGS
•
Outflow and Intermediary tubing is for single use only and must be
discarded after each procedure.
•
Only use with FMS VUE™, FMS VUE™ II, and FMS DUO
•
Sterility is preserved only if the tube installation procedures have been
performed precisely according to the FMS VUE Operator's Manual
(Ref. 110665), FMS VUE II (Ref. 115810), and FMS DUO+ Operator's
Manual (Ref. 109078-KIM).
•
This product is for single-use only. It has not been designed to be re-used/
re-sterilized. Reprocessing may lead to changes in material characteristics
such as deformation and material degradation which may impact the
strength of the device and compromise device performance. Reprocessing
of single use devices can also cause cross-contamination leading to patient
infection. These risks may potentially affect patient safety.
•
The product shall be used in accordance with instructions and standard
aseptic techniques, or cross-contamination, infection may occur.
PRECAUTIONS
•
Outflow Tubing is provided sterile. Sterile only if package is unopened
and undamaged.
•
To avoid damage to tubing, make sure that the tubing is centered on the
groove of the pump.
•
Waste line is intended to connect to waste bag, and is not approved for
external suction systems. If external suction device is used, tubing may
collapse.
POSSIBLE ADVERSE REACTIONS
1. Adverse effects associated with the use of this device include wound
issues, infection, early or late.
2. Local or systemic tissue reaction including allergic reaction.
3. Excess fluid extravasation may lead to edema near the surgical site.
INSTRUCTIONS FOR USE
Refer to the appropriate manual for tubing installation instructions, and
instructions for use.
FMS VUE Operator's Manual (Ref. 110665)
FMS VUE II Operator's Manual (Ref. 115810)
FMS DUO+ Instruction and Service Manual (Ref. 109078-KIM)
2
+.
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