Operator Safety - Abbott OPTIS 1014933 Operation And Maintenance Manual

State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Safety Information
Techniques to Minimize Patient Exposure
The OPTIS Integrated Next meets the performance standards of laser-emitting
products as established by IEC 60825-1. Although no harmful effects have been
demonstrated for the near-infrared light wavelengths, intensities, and exposure
times used during examinations with the OPTIS Integrated Next, Abbott Medical
recommends that you carefully read the warning labels on the system (refer to
"Avoiding Operator Light Emission Hazards" [page 8]) and follow these
examination guidelines:

Operator Safety

Avoiding Operator Light Emission Hazards
To avoid any potential light emission hazards to you or to patients, adhere to the
information provided in the safety labels that are located on the system (figure
below) and observe the precautions outlined in this section.
WARNING: Failure to follow any of these precautions may cause possible
serious damage to your eyes.
Figure 1. Connector Panel Laser Safety Label
8
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
• Use only compatible Dragonfly Imaging Catheters. Always use under
appropriate imaging guidance (endoscopy, x-ray fluoroscopy, or other
appropriate guidance method).
• Use only compatible wireless PressureWire Guidewires to report aortic
distal pressure. Always use under appropriate imaging guidance
(endoscopy, x-ray fluoroscopy, or other appropriate guidance method).
•
Always read and follow the Instructions for Use supplied with the
Dragonfly Imaging Catheter and with the PressureWire Guidewire.
•
Always use controls, make adjustments, and perform procedures as
specified in these Instructions for Use.
•
Use OCT only when there is a good reason to do so.
•
Use techniques that enable quick collection of clinical data and shorten
procedure time.