Description; Indications For Use; Contraindications; Warnings - Invuity PhotonGuide IIluminator Instructions For Use Manual

PhotonGuide Illuminator - Instructions for Use (IFU)

Description

The Invuity PhotonGuide Illuminator provides illumination in a surgical field for a wide variety of surgical procedures. The
PhotonGuide is sterile, single-use, pyrogen free, and not made with natural rubber latex. It is compatible with LED, infrared
radiation-filtered 300-watt xenon or metal halide high intensity surgical light sources, Invuity surgical retractors, and Invuity
Fiber Optic Cables.

Indications for Use

The Invuity PhotonGuide is intended to provide surgical site illumination from a high intensity light source.

Contraindications

There are no known contraindications.

Warnings

•
It is recommended to use PhotonGuide with an LED light source. When using shorter retractor lengths, the need
for higher light output from a Xenon light source is reduced. The lower intensity light output from an LED light source
reduces the risk of thermal injury to patient or user or to the PhotonGuide. LED light sources are available from Invuity,
Stryker, Sunoptics, and Cuda Surgical.
•
Maintain a minimum distance of 2 cm (approximately the width of two fingers) between the distal face of the
PhotonGuide and the surrounding tissue when using a Xenon light source. If the 2 cm distance cannot be maintained,
use an LED light source.
•
Do not use with a xenon light source greater than 300 watts. Using the PhotonGuide with a xenon light source
with output greater than 300 watts or without an infrared (IR) filter may cause thermal injury to the patient or user, or
may cause damage to equipment. Consult Invuity's Light Source Identification Guide on this website:
www.invuity.com/documentlibrary for more information on commonly used light sources.
•
Do not use with a xenon light source output setting above 60% The light intensity of a Xenon light source varies
greatly during the life of the bulb, therefore it is necessary to use the lowest power output necessary up to a maximum
of 60% in order to avoid potential thermal injury to the patient or user or thermal damage to the PhotonGuide.
•
PhotonGuide must be attached to the Invuity Fiber Optic Cable prior to turning on the light source. The output
of the Fiber Optic Cable is extremely intense and may cause burns, ignite drapes/gowns, or temporarily blind vision.
Therefore, it is important to attach PhotonGuide to the Fiber Optic Cable before turning on the light source.
•
Do not obstruct the output surface of the PhotonGuide. The high intensity illumination has the potential to cause
thermal damage or injury if the surface is obstructed by dried blood, tissue, gloves, or other material.
•
Keep the PhotonGuide clean throughout the procedure. If the output surface of a PhotonGuide is obstructed with
debris or blood, immediately clean the surface with a sponge or gauze dampened with sterile water or saline. Blood
or debris that becomes lodged underneath the PhotonGuide should be flushed with sterile water or saline. After
flushing, blot or wipe with a dry gauze to remove excess fluid. Absorption of light energy by fluid under the
PhotonGuide, or dried blood or debris on the output surface, can cause thermal damage to the device or injury to the
patient.

Precautions

•
The PhotonGuide should be handled and operated by hospital personnel familiar with and trained in its use, assembly,
and disassembly.
•
Inspect the device packaging before use. Do not use if the packaging is opened or if the device has passed the
labeled expiration date.
•
Do not use the instruments for any purpose or in any manner other than described in this Instructions for Use may
cause device damage or failure, which could result in patient or user injury.
•
Do not use PhotonGuide without an Invuity compatible retractor.
•
Use the PhotonGuide only with the appropriate Invuity Fiber Optic Cable and with a surgical light source that has an
ACMI connector. Using non-Invuity fiber optic cables may generate excessive heat at the connector and cause
thermal injury to the patient or user.
•
When attached to the surgical light source, the Bifurcated Fiber Optic Cable requires two Invuity devices to be used
simultaneously. Never leave one branch (or both branches) of the Single or Bifurcated Fiber Optic Cable unused. The
output of the Fiber Optic Cable is extremely intense and may cause burns, ignite drapes/gowns, or temporarily blind
vision.
IFU 12392 Rev B Invuity Customer Service: +1-866-711-7768 2