Directions For Use - Invuity Photonsaber F Gebrauchsanweisung

• When an illuminated PhotonSaber F is out of the surgical field, it is recommended to place the
device in a holster, reduce the intensity, or ensure that there is no material in close proximity that can
obstruct the output surface. High intensity illumination has the potential to cause thermal damage or
injury. Do not place on top of drape.
• When using PhotonSaber F for aspiration of smoke, note that smoke evacuation systems produce a
strong vacuum. Adjust the airflow and the position of the inlet end of the PhotonSaber F to prevent
patient injury and to prevent suction of surgical materials and surgical specimens. If the smoke
evacuator is activated while the airflow is set to a high speed, it may produce a sudden, strong
suction action. Check the airflow setting before activating the smoke evacuator to prevent patient
injury and to prevent suction of surgical materials and surgical specimens.
• Use caution to prevent damage to the PhotonSaber F during surgery. If the device is damaged during
surgery, irrigate the surgical site to remove debris, dispose of the device in accordance with accepted
medical practice, and use a new device. The application of excessive force may cause damage to the
instrument and should be avoided.
Safety:
• Use of this instrument for any purpose or in any manner other than described in this Instructions for
Use may cause instrument damage or failure, which could result in patient or user injury. Do not use
instruments that appear broken, cracked, deformed, or chipped.

Directions for Use

1. Prior to use, verify that the PhotonSaber F is not damaged. If damaged, discard and replace with a new
device.
2. Verify the surgical light source is 300 watts or less and equipped with an IR blocker.
3. The PhotonSaber F has two proximal connectors, an ACMI connector and a barbed connector. Attach
the ACMI connector to the Invuity Single Fiber Optic Cable. Attach the barbed connector to the suction
tubing. Verify that both connectors are securely attached.
4. Turn the vacuum source on and verify that the device distal tip is drawing a vacuum.
5. Reduce the intensity setting of the light source to the minimum level before turning on the power.
6. Turn the light source on and verify that the device has light output.
7. Increase the intensity setting of the light source to approximately 50% and assess the illumination
transmitted by the PhotonSaber F. It is recommended to avoid increasing the intensity setting of the light
source beyond the level of illumination required to perform the procedure to minimize any thermal
hazard.
8. Direct the active light output and suction toward the surgical field ONLY. If the device is oriented away
from the surgical field, it may cause temporary glare or blindness. When the device is not being used in
the surgical field, either reduce the intensity setting of the light source, place in a holster or ensure that
there is no material in close proximity that can obstruct the output surface. Do not place on top of drape.
9. If the illumination output surface of the PhotonSaber F is obstructed with blood or debris, rinse with
saline to clean the surface. Absorption of intense light energy by blood or debris on the output surface
can cause thermal damage to the waveguide.
10. If the lumen becomes obstructed during use, insert and gently advance the Stylet through the device to
clear the lumen.
11. After the procedure, power off the light source and vacuum source. Disconnect the Invuity Single Fiber
Optic Cable and suction tubing.
Discard the PhotonSaber F in accordance to hospital procedures and in accordance with local, state and
12.
federal laws and regulations related to clinical waste.
IFU 14462 Rev A 3