Directions For Use - Invuity PhotonGuide IIluminator Instructions For Use Manual

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Handle all instruments with care. Use caution to prevent damage to the PhotonGuide during surgery. If damaged,
remove and dispose. Replace with a new PhotonGuide. Irrigate surgical site and remove any debris prior to continuing
procedure.
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Inspect all reusable retractors for damage before and during a procedure. If reusable retractor is damaged, follow
hospital standards for disposal.
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Do not leave illuminated device unattended.
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To avoid damage to the PhotonGuide, do not pry the device out of the Retractor by pulling out from the bottom of the
PhotonGuide.
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When removing the Fiber Optic Cable from the light source, grasp the connector, not the black insulation, as pulling
on the insulation with excess force can cause product damage.
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DO NOT RESTERILIZE OR REUSE. The PhotonGuide is provided sterile and is intended for single use only.
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After use, handle and dispose of the PhotonGuide according to hospital procedures and in accordance with local,
state and federal laws and regulations.
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Refer to the Instructions for Use for the Invuity Fiber Optic Cables, Sterilization Trays and Retractors and Accessories
for additional information.

Directions for Use

1. Identify the appropriate Invuity Fiber Optic Cable for the PhotonGuide.
2. Inspect the PhotonGuide(s) for damage prior to assembling. If damaged, discard and replace with a new
PhotonGuide.
3. Verify the surgical light source is LED or 300 watts or less and is equipped with an infrared (IR) blocking filter. Reduce
the intensity setting of the light source to the minimum level before turning on the power.
Note: 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.
4. Inspect all reusable retractors for damage before and during a procedure. If reusable retractor is damaged, follow
hospital standards for disposal.
5. Insert the PhotonGuide into the appropriate Invuity retractor.
6. Attach the Fiber Optic Cable to the PhotonGuide fiber optic connector.
Note: Use the Single Fiber Optic Cable when one PhotonGuide is needed. Use the Bifurcated Fiber Optic
Cable when two Invuity devices are needed.
7. Connect the Fiber Optic Cable to the ACMI port on the surgical light source.
8. Reduce the intensity setting of the light source to the minimum level before turning on the power. Then, turn the
surgical light source on.
9. Increase the intensity setting of the light source to 60% and assess the illumination transmitted by the PhotonGuide.
Avoid increasing the intensity setting of the light source beyond the level of illumination required to perform the
procedure. If using a xenon light source, DO NOT increase the light intensity below 60%.
10. If the output surface of a PhotonGuide is obstructed with debris or blood, immediately clean the surface with a sponge,
wipe, 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 dry with a dry gauze or wipe 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 PhotonGuide or injury to the patient.
Note: If the surface of the PhotonGuide is contaminated, the high intensity illumination has the potential to
cause thermal damage to the device.
11. During the procedure, the PhotonGuide(s) and Fiber Optic Cable may be transferred to another Invuity retractor. To
transfer the PhotonGuide to another retractor:
i. First, fully reduce power
ii. Flush, wipe and blot dry the PhotonGuide prior to transferring it.
12. Remove the PhotonGuide by pressing in and up on the retention clip, then lifting the device up and out of the Retractor
(Figure 1).
Figure 1: Removing the PhotonGuide
from the Retractor
IFU 12392 Rev B Invuity Customer Service: +1-866-711-7768
Step 1
Step 2
Slide Up
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