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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Indications for Use
The OPTIS™ Integrated Next with a compatible Dragonfly™ OPTIS™ or
Dragonfly OpStar™ Imaging Catheter is indicated for:
For qualitative and quantitative evaluation of vascular morphology in the
•
coronary arteries
As an adjunct to conventional angiographic procedure to provide an
•
image of vessel lumen and wall structures
For imaging of coronary arteries and is indicated in patients who are
•
candidates for transluminal interventional procedure
The system further computes and displays various physiological parameters
based on the output from one or more electrodes, transducers, or measuring
devices.
CAUTION: The OPTIS Integrated Next is intended for use by medical personnel
who are knowledgeable in OCT and physiological procedures. Abbott Medical
and its employees cannot give instructions in the interpretation or diagnosis of
recordings and makes no attempt to do so.
CAUTION: All operators must be knowledgeable in performing OCT and
physiological procedures prior to using the installed software, OPTIS Integrated
Next, and the Dragonfly Imaging Catheter.
Contraindications
Use of the OPTIS™ Integrated Next is contraindicated where introduction of any
catheter would constitute a threat to patient safety.
Contraindications include:
•
Bacteremia or sepsis
•
Major coagulation system abnormalities
•
Patients diagnosed with coronary artery spasm
•
Patients disqualified for coronary artery bypass graft (CABG) surgery
•
Patients disqualified for percutaneous transluminal coronary angioplasty
(PTCA)
•
Severe hemodynamic instability or shock
•
Total occlusion
•
Large thrombus
•
Acute renal failure
•
Inability to tolerate systemic anticoagulation is a contraindication to use
of OCT for coronary imaging.
•
PressureWire™ Guidewire is contraindicated for use in the cerebral
vasculature.
•
The system has no patient alarm functions. Do not use for cardiac
monitoring.
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
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