Document Number - Invuity PhotonBlade Instructions For Use Manual

INSTRUCTIONS FOR USE
CO # Description
Rev
A 16-0732 Added "During use, do not allow the illumination
output surface of the PhotonBlade 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." to the warnings and
precautions section.
Added bullets 2-9 under the safety section of
warnings and precautions, regarding fire and
combustion risk with electrosurgical devices.
Modified instructions for light operation to add 2
second hold for illumination off. Updated pictures
for new button layout.
Re-formatted (tabular) layout and made minor
grammatical and error corrections. Add printing
instructions page.
Added to Product Use Section: •
B 17-0339
inspect the device and DO NOT USE the device
if there are breaks, chips, cracks, scratches, tears
or missing insulation on the blade or telescoping
shaft of the device.
• DO NOT activate energy unless the active edge
of the blade is in direct contact with tissue.
Failure to ensure the active edge of the blade is in
direct contact with target tissue while activating
energy could result in patient injury, including
burns.
•
anatomy that is in contact with the blade,
waveguide and telescoping shaft. The waveguide
and telescoping shaft should not be touching or
retracting tissue while activating energy.
•
observed from any other areas besides the active
edge of the blade. Added to during use: or rest on
tissue.
Removed symbols and text and add e-IFU/
C 17-0605
Symbols Glossary website. Replaced ™ with ®
on PhotonBlade and updated the trademark
disclaimer. Updated with new images. Updated
printing instructions. Added safety information
about implantable leads and patient return
electrode.

Document Number

IFU 12296 Rev C
PhotonBlade
REVISION HISTORY
While activating energy, be aware of critical
Stop using the device if energy discharge is
Approved Date
12/09/16
Before use,
05/30/17
09/26/17
Page 11 of 12
Effective Originator
Date
12/12/16 J. Hegener
06/07/17 A. Leos
09/26/17 J. Wentz