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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Warnings and Precautions
Warnings and Precautions (Fractional Flow Reserve [FFR],
Resting Full-Cycle Ratio [RFR])
WARNING:
CAUTION:
Connecting to External Equipment / Accessories
WARNING:
16
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
•
The PressureWire Guidewire is sterilized by ethylene oxide and is
intended for one-time use only. Non-pyrogenic. Do not use if the
package is opened or damaged. Do not reuse or re-sterilize. Any
attempt to reuse or re-sterilize the PressureWire Guidewire may
compromise the structural integrity of this device. Adverse effects of
using a non-sterile or re-sterilized guide wire may include, but are not
limited to: local and / or systemic infection, mechanical damage,
inaccurate results.
•
Patients with potential microvascular dysfunction and borderline index
values should be interpreted with caution, and management strategies
should be guided not only by pressure measurement, but also by
possibly supplementary clinical risk stratification and other tests.
•
Before performing a physiological parameter procedure, review the
installed software User Manual for additional warnings and cautions.
•
After use, the PressureWire Guidewire may be a potential biohazard.
Handle and dispose of in accordance with accepted medical practice
and applicable laws and regulations.
•
The system may place the point of index value at the wrong location due
to abnormal heart beat or artifact in Pa from flushing the guiding catheter.
The responsible physician should confirm that the point selected by the
system is a valid point of index value.
•
If the cursor position has been saved, the index value is changed
accordingly.
•
Before creating a physiological parameter recording, review the installed
software User Manual for additional warnings and cautions.
•
When used in the patient environment, all equipment connected to the
OPTIS Integrated Next must meet the requirements for medical isolation
according to the IEC 60601 safety standards. Connection of equipment
that does not follow relevant IEC standards (e.g., IEC 60601 series for
medical electrical equipment) may lead to patient injury or death.
•
Inside the catheterization laboratory only port-powered USB drives may
be connected to the USB port. Connecting externally powered devices to
the USB port in the patient vicinity may compromise electrical isolation
and cause patient injury.
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