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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Safety Information
General
WARNING: Failure to follow the guidelines described in these Instructions for
Use and in the Instructions for Use provided with the accessories may result in
injury to patients and damage to equipment.
WARNING: Failure to abide by the precautions detailed below causes the
system and its use to be out of compliance with regulations and places the
patient and the operator at risk of injury or death.
WARNING: Connecting to External Equipment / Accessories - 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.
WARNING: Failure to secure the DOC holster to the procedure table rail may
present a hazard to the patient, due to movement of the monitor boom, which
could pull on a catheter while it is in the patient.
WARNING: Electrical Shock Hazard - Do not remove OPTIS Integrated Next
covers. To avoid electrical shock, use only the power cord supplied with the
system and connect only to properly grounded wall outlets. Refer to "System
Setup" and "Safety Information" for electrical safety information.
WARNING: The Dragonfly Imaging Catheter 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 may compromise the structural integrity of this device. Adverse
effects of using a non-sterile or re-sterilized catheter may include, but are not
limited to: local and / or systemic infection, mechanical damage, inaccurate
results.
WARNING: Do not use the PressureWire™ Guidewire if there are any signs of
damage.
CAUTION: Please note Abbott Medical makes no representation or warranty
that use of the OPTIS Integrated Next complies with applicable privacy,
security, and confidentiality laws, but encourages you to assess your own risk
as you use, disclose, control, process, or transfer patient health information
with the OPTIS Integrated Next.
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OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
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