Invuity PhotonGuide IIluminator, PhotonGuide Instructions For Use Manual

Invuity, Inc.

Emergo Europe

PhotonGuide® Illuminator

Instructions for Use

444 De Haro Street

San Francisco, CA 94107 USA
Tel: [phone]

www.invuity.com

Prinsessegracht 20
2514 AP The Hague
The Netherlands

IFU 12392 Rev B Invuity Customer Service: [phone] 1

Consult Instructions for Use and Symbols

Glossary on this website:

www.invuity.com/documentlibrary

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 gr eater than 300 w atts. Using the PhotonGuide with a xenon light source
with output greater than 300 watts or without an i nf rar ed (I R) filter may cause thermal injury to the patient or us er , 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 outpu t 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 attache d to the Invuity Fiber Optic Cable prior to turning on the light source. The output
of the Fiber Optic Cable is ex tr emely intense and ma y cause bur ns, ign ite 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, imm ediatel y clean th e surf ace with a s pong e or ga uze dam pene d with st erile water or s aline. Blood
or debris that becom es 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 devic e packaging before use. Do not use if the pack aging is opened or if the device has passed the
labeled expiration date.

• Do not use the instrum ents for any pur pose or in an y manner other than descr ibed in this I nstructions f or Use m ay
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 I nv uity 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 sur gic al light so urce, the Bifurc ated F iber O ptic Cabl e req uires two Invui ty devic es to b e used
simultaneously. Never leave one branch (or both branches) of the Single or Bifurcated Fiber Optic Cable unused. The
output of the Fiber O pt ic Cable is extrem el y intense a nd may cause burns, ign ite drapes / go wns, or temporarily blind
vision.

IFU 12392 Rev B Invuity Customer Service: [phone] 2