Contraindications - Invuity Photonsaber F Gebrauchsanweisung

Description
The PhotonSaber F Handheld Illuminator with Aspiration, previously known as Eigr Saber Waveguide with
Frazier, is a handheld instrument that provides illumination to the surgical field using a high intensity light
source and provides aspiration from the surgical field using a vacuum source. The PhotonSaber F is available
in multiple configurations. It is provided sterile, single-use, pyrogen free, and not made with natural rubber
latex. The PhotonSaber F is compatible with the Invuity Single Fiber Optic Cable, with commercially available
300-watt surgical light sources (with infrared filter), and with commercially available medical suction tubing.
The device is packaged with a stylet, which can be used to clear the device lumen during use.
Indications for Use
The PhotonSaber F is intended to deliver illumination from a high intensity light source and to aspirate from the
surgical site.

Contraindications

There are no known contraindications.
For Use With
Description
Single Fiber Optic Cable, 10 ft [3.05 m], ACMI
Single Fiber Optic Cable, Pink, 10 ft [3.05 m], ACMI
Bifurcated Fiber Optic Cable, 11.5 ft [3.50 m], ACMI
Warnings and Precautions
Cleaning and Sterilization:
• The PhotonSaber F is provided sterile and intended for single-use only. Handle and dispose of in
accordance with accepted medical practice and applicable local, state, and federal laws and
regulation. DO NOT REPROCESS.
Product Use:
• The PhotonSaber F should be handled and operated by trained personnel.
• Inspect device and packaging before use. Do not use if the device or packaging is opened or
damaged.
• Use the PhotonSaber F only with an Invuity Fiber Optic Cable and with a surgical light source that
has an ACMI output jack to connect to the Invuity Fiber Optic Cable. Use of other fiber optic cables
may generate excessive heat at the connector and cause patient or user injury.
• DO NOT USE with a surgical light source greater than 300 watts. Using the PhotonSaber F with a
surgical light source greater than 300 watts or a surgical light source without an infrared (IR) filter
may cause thermal injury to the patient or user or may cause damage to equipment. When using
high-powered surgical light sources, reduce the power output to avoid thermal damage to the
PhotonSaber F.
• DO NOT USE with the BFW ChromaLUME turbo plasma surgical light source. This light source is
not compatible with the PhotonSaber F.
• During use, do not allow the illumination output surface of the PhotonSaber F to be obstructed. The
high intensity illumination has the potential to cause thermal damage or injury if the output surface is
obstructed by tissue, gloves, or other material.
IFU 14462 Rev A
PhotonSaber F – Instructions for Use (IFU)
REF
FC1S
FC1SP
FC1B
2