Monteris Medical Neuroblate, Инструкция по эксплуатации

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NeuroBlate® System Instructions for Use
80469 Rev D – Nov 16, 2018
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4.3.2. Advanced Probe Driver, Robotic Probe Driver and LDP Warnings
The following are specific warnings that apply to the NeuroBlate Probe Drivers (APD
and RPD) and Laser Delivery Probe (LDP).
WARNING:
•
For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or
re-sterilization may compromise the structural integrity of the device and/or
lead to device failure which in turn may result in patient injury, illness or death.
Reuse, reprocessing or re-sterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
•
Ensure that all cables and umbilical in the vicinity of the MRI bore do not form
loops as this may result in heating and RF interference.
•
Contact between the cables and umbilicals with the inner surface of the MRI
bore may result in heating and RF interference.
• The reduced diameter 2.2 series of LDP achieve target accuracy only if the
pathway is first created to the target with an appropriate dilator probe such as a
biopsy needle or stylet.