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5.3 Limitation
Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any
recommendations regarding the use of separated cells for therapeutic purposes
and does not make any claims regarding a clinical benefit.
5.4 Warnings and precautions regarding the
process
Risk of process failure or damage to the instrument.Risk of process
failure or damage to the instrument if procedures are performed by
untrained operators. All processing procedures must be performed by
trained operators only. Operator training will be provided by a qualified
Miltenyi Biotec representative.
For further information refer to the CliniMACS Prodigy User Manual (Instrument).
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