OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
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If resistance is encountered during advancement or withdrawal of the
Dragonfly Imaging Catheter, stop manipulation and evaluate under
fluoroscopy. If the cause of resistance cannot be determined or
mitigated, carefully remove the Dragonfly Imaging Catheter and guide
wire as a unit from the patient.
•
The Dragonfly Imaging Catheter should never be forced into lumens that
are narrower than the Dragonfly Imaging Catheter body or forced
through a tight or heavily calcified lesion.
•
The Dragonfly Imaging Catheter should not be advanced through
abnormally tortuous anatomy.
•
When advancing or retracting a Dragonfly Imaging Catheter with a
monorail tip through a stented vessel, the Dragonfly Imaging Catheter
may engage the stent between the junction of the Dragonfly Imaging
Catheter and guide wire, resulting in entrapment of catheter / guide wire,
catheter tip separation, stent dislocation, and / or vascular injury.
•
Refer to the contrast media Instructions for Use for general warnings and
precautions relating to use of contrast media.
•
Before creating an OCT recording, review the installed software User
Manual for additional warnings and cautions.
Precautions (OCT)
•
Follow all instructions, warnings, and cautions provided in “Patient
Safety” on page 6 and in “Operator Safety” on page 8.
•
Protect the exposed connector inside the DOC from fluids at all times.
Fluid contact can disable the DOC and require service.
•
For optimal imaging, only use 100% contrast media.
•
When using saline, heparinized saline is recommended.
•
Use the minimum flush rate and volume required to image the desired
anatomy.
•
Never attempt to attach or detach a Dragonfly Imaging Catheter to the
DOC while the "lock" LED is lit.
•
Do not kink, sharply bend, pinch, or crush the Dragonfly Imaging Catheter
at any time.
•
After use, the Dragonfly Imaging Catheter may be a potential biohazard.
Handle and dispose of in accordance with accepted medical practice and
applicable laws and regulations.
•
The Dragonfly Imaging Catheter has no user serviceable parts. Do not
attempt to repair or alter any part of the catheter assembly as provided.
State: Released
Date: 2021.03.01 22:19 GMT
Effectivity: Upon Release
Summary of Contents for OPTIS 1014933
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