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OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
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Replacement fuses are available through Abbott Medical.
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The power cord is to be used for disconnection from main power.
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Make sure any devices that connect to the network interface of the
OPTIS Integrated Next comply with the appropriate IEC / national
standard and are certified to IEC 60950.
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Use no electrical peripherals within 6 feet (1.83 m) of a patient unless
the peripherals receive power from an isolation transformer that meets
medical safety standards.
Note:
If the OPTIS Integrated Next is used with peripherals that are
powered from a separate wall outlet, the combination is considered to
be a Medical System. It is the user’s responsibility to comply with IEC
60601-1 and test the Medical System according to the requirements.
Explosion Hazard
WARNING:
Do not operate the OPTIS Integrated Next in the presence of
flammable anesthetics. Doing so could lead to an explosion.
System Imaging Limitations
The OPTIS Integrated Next is intended for use by medical personnel who are
knowledgeable in OCT and Physiology procedures. To determine if system use
is appropriate, the user must be aware of system imaging limitations.
Considerations for Optimal Vessel Imaging
The OPTIS Integrated Next can be used to image through vessels or to image
the inner surface of certain vessels. Because the Dragonfly Imaging Catheter is
smaller than the diameter of the vessel being imaged, the position of the
catheter in the vessel has an effect on the portion of the vessel that can be
imaged.
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Imaging range is greatest when the Imaging Catheter is centered in the
lumen.
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Imaging range is least when the Imaging Catheter is placed off-center in
the lumen, against the wall of the vessel.
Considerations for Optimal Tissue Imaging
The maximum imaging depth within a vessel wall ranges from approximately
0.9 mm to 1.3 mm and is limited by optical attenuation caused by scattering of
the optical beam by microstructures in the vessel. For example, penetration of
the OCT beam is deepest in calcified tissue and shallowest in dense fibrotic
tissue.
State: Released
Date: 2021.03.01 22:19 GMT
Effectivity: Upon Release
Summary of Contents for OPTIS 1014933
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