OmniGuide FELS-25A, Руководство пользователя

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L-1633 Rev. 3 © OmniGuide, Inc. Page 13
The distal-end of the OmniGuide fiber should not touch tissue.
3.2. Warnings specific to compressed Gas
(Disclaimer: The supply of the gas per OmniGuide specifications, the gas delivery system, and the gas
supply operation and maintenance procedures, including the observation of compressed gas safety
precautions, are the responsibility of the healthcare-providing facility. Refer to general safety regulations
for handling of compressed gases.)
If gas is being supplied to the Adapter via a compressed gas tank, review the proper procedures for
handling of compressed gases before connecting the Adapter to the gas tank. Only personnel trained in
compressed gas safety procedures should be allowed to connect the adapter to a compressed gas tank.
Using pressurized gas during some endoscopic procedures (e.g. gastrointestinal, gynecological, etc.)
could lead to over-insufflations and the danger of tissue perforation. An approved system for pressure
monitoring and gas evacuation, chosen by a physician, is required to prevent over-insufflations and
ensure patient safety. Use of insufflators or other approved gas evacuation devices that are equipped
with a sensor for internal pressure and a pressure relief valve are recommended. Refer to the
manufacturer’s instructions for equipment set up and detailed instructions.
For sterile cases where Gas Filter Unit is used, never exceed the maximum gas pressure rated for the Gas
Filter Unit.
Always monitor the vital signs of the patient for symptoms of gas embolism
Always monitor patient’s blood oxygen level.
Before the start of a medical procedure using the OmniGuide Adapter and fiber, verify that the gas
delivered to the system is of the proper type and pressure for the fiber being used. This information can
be found on the insert provided with each fiber.
3.3. Sterility Warnings
The OmniGuide fiber is supplied sterile. The method of sterilization is radiation.
Do not use the product if the package is damaged, opened, or if sterility is compromised.
The product is sold sterile for single use. Reuse poses risk of infection.
Wear sterile gloves and observe proper surgical aseptic technique while handling the sterile fiber.
Do not use an OmniGuide Adapter in a sterile procedure without the Gas Filter Unit (cat# ACC-GFU-
100).
CAUTIONS
4.1. Cautions for Laser Surgical Procedures
Physicians performing Laser procedures should be trained and compliant with their relevant health care
facility requirements in:
o
Laser safety
o
Clinical use of CO
2
Lasers